[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2010 Edition]
[From the U.S. Government Printing Office]



[[Page i]]

          

          21


          Parts 100 to 169

                         Revised as of April 1, 2010


          Food and Drugs
          



________________________

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2010
          With Ancillaries
                    Published by
                    Office of the Federal Register
                    National Archives and Records
                    Administration
                    A Special Edition of the Federal Register

[[Page ii]]

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                            Table of Contents



                                                                    Page
  Explanation.................................................       v

  Title 21:
          Chapter I--Food and Drug Administration, Department 
          of Health and Human Services (Continued)                   3
  Finding Aids:
      Table of CFR Titles and Chapters........................     599
      Alphabetical List of Agencies Appearing in the CFR......     619
      List of CFR Sections Affected...........................     629

[[Page iv]]





                     ----------------------------

                     Cite this Code: CFR
                     To cite the regulations in 
                       this volume use title, 
                       part and section number. 
                       Thus, 21 CFR 100.1 refers 
                       to title 21, part 100, 
                       section 1.

                     ----------------------------

[[Page v]]



                               EXPLANATION

    The Code of Federal Regulations is a codification of the general and 
permanent rules published in the Federal Register by the Executive 
departments and agencies of the Federal Government. The Code is divided 
into 50 titles which represent broad areas subject to Federal 
regulation. Each title is divided into chapters which usually bear the 
name of the issuing agency. Each chapter is further subdivided into 
parts covering specific regulatory areas.
    Each volume of the Code is revised at least once each calendar year 
and issued on a quarterly basis approximately as follows:

Title 1 through Title 16.................................as of January 1
Title 17 through Title 27..................................as of April 1
Title 28 through Title 41...................................as of July 1
Title 42 through Title 50................................as of October 1

    The appropriate revision date is printed on the cover of each 
volume.

LEGAL STATUS

    The contents of the Federal Register are required to be judicially 
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie 
evidence of the text of the original documents (44 U.S.C. 1510).

HOW TO USE THE CODE OF FEDERAL REGULATIONS

    The Code of Federal Regulations is kept up to date by the individual 
issues of the Federal Register. These two publications must be used 
together to determine the latest version of any given rule.
    To determine whether a Code volume has been amended since its 
revision date (in this case, April 1, 2010), consult the ``List of CFR 
Sections Affected (LSA),'' which is issued monthly, and the ``Cumulative 
List of Parts Affected,'' which appears in the Reader Aids section of 
the daily Federal Register. These two lists will identify the Federal 
Register page number of the latest amendment of any given rule.

EFFECTIVE AND EXPIRATION DATES

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Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
number of the Federal Register and date of publication. Publication 
dates and effective dates are usually not the same and care must be 
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Code a note has been inserted to reflect the future effective date. In 
those instances where a regulation published in the Federal Register 
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inserted following the text.

OMB CONTROL NUMBERS

    The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires 
Federal agencies to display an OMB control number with their information 
collection request.

[[Page vi]]

Many agencies have begun publishing numerous OMB control numbers as 
amendments to existing regulations in the CFR. These OMB numbers are 
placed as close as possible to the applicable recordkeeping or reporting 
requirements.

OBSOLETE PROVISIONS

    Provisions that become obsolete before the revision date stated on 
the cover of each volume are not carried. Code users may find the text 
of provisions in effect on a given date in the past by using the 
appropriate numerical list of sections affected. For the period before 
January 1, 2001, consult either the List of CFR Sections Affected, 1949-
1963, 1964-1972, 1973-1985, or 1986-2000, published in eleven separate 
volumes. For the period beginning January 1, 2001, a ``List of CFR 
Sections Affected'' is published at the end of each CFR volume.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
requirement to publish regulations in the Federal Register by referring 
to materials already published elsewhere. For an incorporation to be 
valid, the Director of the Federal Register must approve it. The legal 
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if it were published in full in the Federal Register (5 U.S.C. 552(a)). 
This material, like any other properly issued regulation, has the force 
of law.
    What is a proper incorporation by reference? The Director of the 
Federal Register will approve an incorporation by reference only when 
the requirements of 1 CFR part 51 are met. Some of the elements on which 
approval is based are:
    (a) The incorporation will substantially reduce the volume of 
material published in the Federal Register.
    (b) The matter incorporated is in fact available to the extent 
necessary to afford fairness and uniformity in the administrative 
process.
    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
    What if the material incorporated by reference cannot be found? If 
you have any problem locating or obtaining a copy of material listed as 
an approved incorporation by reference, please contact the agency that 
issued the regulation containing that incorporation. If, after 
contacting the agency, you find the material is not available, please 
notify the Director of the Federal Register, National Archives and 
Records Administration, Washington DC 20408, or call 202-741-6010.

CFR INDEXES AND TABULAR GUIDES

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separate volume, revised annually as of January 1, entitled CFR Index 
and Finding Aids. This volume contains the Parallel Table of Authorities 
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that volume.
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This index is based on a consolidation of the ``Contents'' entries in 
the daily Federal Register.
    A List of CFR Sections Affected (LSA) is published monthly, keyed to 
the revision dates of the 50 CFR titles.




[[Page vii]]



REPUBLICATION OF MATERIAL

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    Raymond A. Mosley,
    Director,
    Office of the Federal Register.
    April 1, 2010.







[[Page ix]]



                               THIS TITLE

    Title 21--Food and Drugs is composed of nine volumes. The parts in 
these volumes are arranged in the following order: Parts 1-99, 100-169, 
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-end. The 
first eight volumes, containing parts 1-1299, comprise Chapter I--Food 
and Drug Administration, Department of Health and Human Services. The 
ninth volume, containing part 1300 to end, includes Chapter II--Drug 
Enforcement Administration, Department of Justice, and Chapter III--
Office of National Drug Control Policy. The contents of these volumes 
represent all current regulations codified under this title of the CFR 
as of April 1, 2010.

    For this volume, Robert J. Sheehan, III was Chief Editor. The Code 
of Federal Regulations publication program is under the direction of 
Michael L. White, assisted by Ann Worley.


[[Page 1]]



                        TITLE 21--FOOD AND DRUGS




                  (This book contains parts 100 to 169)

  --------------------------------------------------------------------
                                                                    Part

chapter i--Food and Drug Administration, Department of 
  Health and Human Services (Continued).....................         100

[[Page 3]]



CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)




                           (Parts 100 to 169)

  --------------------------------------------------------------------


  Editorial Notes: 1. Nomenclature changes to chapter I appear at 59 FR 
14366, Mar. 28, 1994, 59 FR 24879, May 9, 1994, 68 FR 13717, Mar. 24, 
2004, 69 FR 18803, Apr. 9, 2004, 70 FR 40880, July 15, 2005, and 70 FR 
67650, Nov. 8, 2005.

                SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION
Part                                                                Page
100             General.....................................           5
101             Food labeling...............................          10
102             Common or usual name for nonstandardized 
                    foods...................................         172
104             Nutritional quality guidelines for foods....         179
105             Foods for special dietary use...............         183
106             Infant formula quality control procedures...         185
107             Infant formula..............................         191
108             Emergency permit control....................         200
109             Unavoidable contaminants in food for human 
                    consumption and food-packaging material.         210
110             Current good manufacturing practice in 
                    manufacturing, packing, or holding human 
                    food....................................         216
111             Current good manufacturing practice in 
                    manufacturing, packaging, labeling, or 
                    holding operations for dietary 
                    supplements.............................         226
113             Thermally processed low-acid foods packaged 
                    in hermetically sealed containers.......         255
114             Acidified foods.............................         282
115             Shell eggs..................................         288
118             Production, storage, and transportation of 
                    shell eggs..............................         291
119             Dietary supplements that present a 
                    significant or unreasonable risk........         302
120             Hazard Analysis and Critical Control Point 
                    (HACCP) systems.........................         302
123             Fish and fishery products...................         311

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129             Processing and bottling of bottled drinking 
                    water...................................         319
130             Food standards: General.....................         324
131             Milk and cream..............................         332
133             Cheeses and related cheese products.........         350
135             Frozen desserts.............................         402
136             Bakery products.............................         409
137             Cereal flours and related products..........         413
139             Macaroni and noodle products................         428
145             Canned fruits...............................         439
146             Canned fruit juices.........................         479
150             Fruit butters, jellies, preserves, and 
                    related products........................         493
152             Fruit pies..................................         501
155             Canned vegetables...........................         503
156             Vegetable juices............................         525
158             Frozen vegetables...........................         528
160             Eggs and egg products.......................         531
161             Fish and shellfish..........................         536
163             Cacao products..............................         553
164             Tree nut and peanut products................         561
165             Beverages...................................         565
166             Margarine...................................         584
168             Sweeteners and table sirups.................         587
169             Food dressings and flavorings...............         591

[[Page 5]]



                 SUBCHAPTER B_FOOD FOR HUMAN CONSUMPTION



PART 100_GENERAL--Table of Contents




                 Subpart A_State and Local Requirements

Sec.
100.1 Petitions requesting exemption from preemption for State or local 
          requirements.
100.2 State enforcement of Federal regulations.

Subparts B-E [Reserved]

          Subpart F_Misbranding for Reasons Other Than Labeling

100.100 Misleading containers.

         Subpart G_Specific Administrative Rulings and Decisions

100.155 Salt and iodized salt.

    Authority: 21 U.S.C. 321, 331, 337, 342, 343, 348, 371.

    Source: 42 FR 14306, Mar. 15, 1977, unless otherwise noted.



                 Subpart A_State and Local Requirements



Sec.  100.1  Petitions requesting exemption from preemption for State or local 

requirements.

    (a) Scope and purpose. (1) This subpart applies to the submission 
and consideration of petitions under section 403A(b) of the Federal 
Food, Drug, and Cosmetic Act (the act), by a State or a political 
subdivision of a State, requesting exemption of a State requirement from 
preemption under section 403A(a) of the act.
    (2) Section 403A(b) of the act provides that where a State 
requirement has been preempted under section 403A(a) of the act, the 
State may petition the agency for an exemption. The agency may grant the 
exemption, under such conditions as it may prescribe by regulation, if 
the agency finds that the State requirement will not cause any food to 
be in violation of any applicable requirement under Federal law, will 
not unduly burden interstate commerce, and is designed to address a 
particular need for information that is not met by the preemptive 
Federal requirement.
    (b) Definitions. (1) Act means the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321 et seq.).
    (2) Agency means the Food and Drug Administration.
    (3) Commissioner means the Commissioner of Food and Drugs.
    (4) State means a State as defined in section 201(a)(1) of the act 
(which includes a territory of the United States, the District of 
Columbia, and Puerto Rico) or any political subdivision of a State 
having authority to issue food standards and food labeling regulations 
having force of law.
    (5) State requirement means any statute, standard, regulation, or 
other requirement that is issued by a State.
    (c) Prerequisites for petitions for exemption from preemption. The 
Food and Drug Administration will consider a petition for exemption from 
preemption on its merits only if the petition demonstrates that:
    (1) The State requirement was enacted or was issued as a final rule 
by an authorized official of the State and is in effect or would be in 
effect but for the provisions of section 403A of the act.
    (2) The State requirement is subject to preemption under section 
403A(a) of the act because of a statutory provision listed in that 
section or because of a Federal standard or other Federal regulation 
that is in effect, or that has been published as a final rule with a 
designated effective date, and that was issued under the authority of a 
statutory provision listed in that section. For the purposes of this 
subpart, all petitions seeking exemption from preemption under section 
403A(a)(3) through (a)(5) of the act submitted before May 8, 1992, will 
be considered timely even though the applicable statutory provisions or 
regulations are not yet in effect.
    (3) The petitioner is an official of a State having authority to act 
for, or on behalf of, the Government in applying for an exemption of 
State requirements from preemption.
    (4) The State requirement is subject to preemption under section 
403A(a) of the act because it is not identical to

[[Page 6]]

the requirement of the preemptive Federal statutory provision or 
regulation including a standard of identity, quality, and fill. ``Not 
identical to'' does not refer to the specific words in the requirement 
but instead means that the State requirement directly or indirectly 
imposes obligations or contains provisions concerning the composition or 
labeling of food, or concerning a food container, that:
    (i) Are not imposed by or contained in the applicable provision 
(including any implementing regulation) of section 401 or 403 of the 
act; or
    (ii) Differ from those specifically imposed by or contained in the 
applicable provision (including any implementing regulation) of section 
401 or 403 of the act.
    (d) Form of petition. (1) All information included in the petition 
should meet the general requirements of Sec.  10.20(c) of this chapter.
    (2) An original and one copy of the petition shall be submitted, or 
the petitioner may submit an original and a computer readable disk 
containing the petition. Contents of the disk should be in a standard 
format, such as ASCII format. (Petitioners interested in submitting a 
disk should contact the Center for Food Safety and Applied Nutrition for 
details.)
    (3) Petitions for exemption from preemption for a State requirement 
shall be submitted to the Division of Dockets Management in the 
following form:

(Date) ----------------
Division of Dockets Management,
Food and Drug Administration,
Department of Health and Human Services,
5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

   Petition Requesting Exemption from Preemption for State Requirement

    The undersigned submits this petition under section 403A(b)of the 
Federal Food, Drug, and Cosmetic Act to request that the Food and Drug 
Administration exempt a State requirement from preemption.
    The undersigned has authority to act for, or on behalf of, the 
(identify State or political subdivision of the State) because (document 
petitioner's authority to submit petition on behalf of the State).

                           A. Action Requested

    1. Identify and give the exact wording of the State requirement and 
give date it was enacted or issued in final form.
    2. Identify the specific standard or regulation that is believed to 
preempt the State requirement and the section and paragraph of the act 
that the standard or regulation implements.

                  B. Documentation of State Requirement

    Provide a copy of the State requirement that is the subject of the 
application. Where available, the application should also include copies 
of any legislative history or background materials used in issuing the 
requirement, including hearing reports or studies concerning the 
development or consideration of the requirement.

                         C. Statement of Grounds

    A petition for an exemption from preemption should contain the 
following:
    1. An explanation of the State requirement and its rationale, and a 
comparison of State and Federal requirements to show differences.
    2. An explanation of why compliance with the State requirement would 
not cause a food to be in violation of any applicable requirement under 
Federal law.
    3. Information on the effect that granting the State petition will 
have on interstate commerce. The petition should contain information on 
economic feasibility, i.e., whether the State and Federal requirements 
have significantly different effects on the production and distribution 
of the food product; comparison of the costs of compliance as shown by 
data or information on the actual or anticipated effect of the State and 
Federal requirements on the sale and price of the food product in 
interstate commerce; and the effect of the State requirement on the 
availability of the food product to consumers. To the extent possible, 
the petition should include information showing that it is practical and 
feasible for producers of food products to comply with the State 
requirement. Such information may be submitted in the form of statements 
from affected persons indicating their ability to comply.
    4. Identification of a particular need for information that the 
State requirement is designed to meet, which need is not met by Federal 
law. The petition should describe the conditions that require the State 
to petition for an exemption, the information need that the State 
requirement fulfills, the inadequacy of the Federal requirement in 
addressing this need, and the geographical area or political subdivision 
in which such need exists.

[[Page 7]]

                         D. Environmental Impact

    The petition shall contain a claim for categorical exclusion under 
21 CFR 25.24 or an environmental assessment under 21 CFR 25.31.

                             E. Notification

    Provide name and address of person, branch, department, or other 
instrumentality of the State government that should be notified of the 
Commissioner's action concerning the petition.

                            F. Certification

    The undersigned certifies, that, to the best knowledge and belief of 
the undersigned, this petition includes all information and views on 
which the petition relies.
(Signature) ------------------------
(Name of petitioner) ----------------
(Mailing address) ------------------
(Telephone number) ----------------
    (Information collection requirements in this section were approved 
by the Office of Management and Budget (OMB) and assigned OMB number 
0910-0277)

    (e) Submission of petition for exemption; public disclosure. The 
availability for public disclosure of a petition for exemption will be 
governed by the rules specified in Sec.  10.20(j) of this chapter.
    (f) Agency consideration of petitions. (1) Unless otherwise 
specified in this section, all relevant provisions and requirements of 
subpart B of part 10 of this chapter, are applicable to State petitions 
requesting exemption from Federal preemption under section 403A(b) of 
the act.
    (2) If a petition does not meet the prerequisite requirements of 
paragraph (c) of this section, the agency will issue a letter to the 
petitioner denying the petition and stating in what respect the petition 
does not meet these requirements.
    (3) If a petition appears to meet the prerequisite requirements in 
paragraph (c) of this section, it will be filed by the Division of 
Dockets Management, stamped with the date of filing, and assigned a 
docket number. The docket number identifies the file established by the 
Division of Dockets Management for all submissions relating to the 
petition, as provided in this part. Subsequent submissions relating to 
the matter must refer to the docket number and will be filed in the 
docket file. The Division of Dockets Management will promptly notify the 
petitioner in writing of the filing and docket number of a petition.
    (4) Any interested person may submit written comments to the 
Division of Dockets Management on a filed petition as provided in Sec.  
10.30(d) of this chapter.
    (5) Within 90 days of the date of filing the agency will furnish a 
response to the petitioner. The response will either:
    (i) State that the agency has tentatively determined that the 
petition merits the granting of an exemption, and that it intends to 
publish in the Federal Register a proposal to grant the exemption 
through rulemaking;
    (ii) Deny the petition and state the reasons for such denial; or
    (iii) Provide a tentative response indicating why the agency has 
been unable to reach a decision on the petition, e.g., because of other 
agency priorities or a need for additional information.
    (g) If a State submitted a petition for exemption of a State 
requirement from preemption under section 403A(a)(3) through (a)(5) of 
the act before May 8, 1992, that State requirement will not be subject 
to preemption until:
    (1) November 8, 1992; or
    (2) Action on the petition, whichever occurs later.

[58 FR 2468, Jan. 6, 1993]



Sec.  100.2  State enforcement of Federal regulations.

    (a) Under section 307 of the Federal Food, Drug, and Cosmetic Act 
(the act), a State may bring, in its own name and within its own 
jurisdiction, proceedings for the civil enforcement, or to restrain 
violations, of sections 401, 403(b), 403(c), 403(d), 403(e), 403(f), 
403(g), 403(h), 403(i), 403(k), 403(q), or 403(r) of the act if the food 
that is the subject of the proceedings is located in the State.
    (b) No proceeding may be commenced by a State under paragraph (a) of 
this section:
    (1) Before 30 days after the State has given notice to the Food and 
Drug Administration (FDA) that the State intends to bring such 
proceeding.
    (2) Before 90 days after the State has given notice to FDA of such 
intent if

[[Page 8]]

FDA has, within such 30 days, commenced an informal or formal 
enforcement action pertaining to the food which would be the subject of 
such proceeding.
    (3) If FDA is diligently prosecuting a proceeding in court 
pertaining to such food, has settled such proceeding, or has settled the 
informal or formal enforcement action pertaining to such food.
    (c) A State may intervene as a matter of right, in any court 
proceeding described in paragraph (b)(3) of this section.
    (d) The notification that a State submits in accordance with 
paragraph (b) of this section should include the following information 
and be submitted in the following recommended format:

(Date) ----------------
Name of State agency ------------
Post office address ------------
Street address ------------
City, State, and ZIP code ------------
Name of product(s) covered by the notification ------------
Reporting official, title, and telephone no. ------------
FAX No. ------------
Agency contact (if different from reporting official), title, and 
telephone no. ------------

Director,
Division of Enforcement (HFS-605),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740.

To Whom It May Concern:
    The undersigned, ------, submits this letter of notification 
pursuant to section 307(b)(1) of the Federal Food, Drug, and Cosmetic 
Act
(21 U.S.C. 337(b)(1)) with respect to --------. (name of products 
covered by the notification and the enforcement action that is to be 
initiated)
Attached hereto, and constituting a part of this letter of notification 
are the following:
    A. The name of the product.
    B. The type and size of each product container.
    C. Copy of the label and labeling of the product.
    D. Manufacturing code (if applicable).
    E. Name and address of firm believed to be responsible for 
violations.
    F. Name and address of parent firm (if known).
    G. Reason for the anticipated State enforcement action (list 
specific violations, including sections of the law violated).
    H. Name of firm against which action is anticipated (if applicable).
    I. Type of enforcement action.
    Yours very truly,
Reporting Agency
By ------------
(Indicate authority)

    (e) The letter of notification should be signed by a State official 
authorized by the State to institute the contemplated enforcement 
actions.
    (f) The letter of notification should be sent to the Division of 
Enforcement (HFS-605), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, FAX number 202-205-4642.
    (g) FDA will notify the State of the date in which its letter of 
notification was received by FDA, Center for Food Safety and Applied 
Nutrition, Division of Enforcement (HFS-605) (within 2 working days 
after date of receipt). This date will be the date of notification for 
the purposes of paragraph (b) of this section.
    (h) The Director, Division of Enforcement, Office of Field Programs, 
Center for Food Safety and Applied Nutrition, FDA, will respond to the 
State's notification within 30 days of the date of notification by 
advising:
    (1) Whether FDA has commenced an informal or formal enforcement 
action pertaining to the food that is the subject of the notification; 
or
    (2) Whether FDA is prosecuting a proceeding in court pertaining to 
such food, has settled such proceeding, or has settled informal or 
formal enforcement action pertaining to such food.
    (i) Information contained in State notification letters shall be 
exempt from public disclosure to the same extent to which such 
information would be so exempt pursuant to Sec. Sec.  20.61, 20.64, and 
20.88 of this chapter.
    (j) Definitions. (1) Informal enforcement actions include warning 
letters, recalls, detentions, or other administrative enforcement 
actions that pertain to the food in question.
    (2) Formal enforcement actions include seizures, injunctions, or 
other civil judicial enforcement actions that pertain to the food in 
question. (Information collection requirements in this section

[[Page 9]]

were approved by the Office of Management and Budget (OMB) and assigned 
OMB control number 0910-0275.)

[58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 66 
FR 56035, Nov. 6, 2001]

Subparts B-E [Reserved]



          Subpart F_Misbranding for Reasons Other Than Labeling



Sec.  100.100  Misleading containers.

    In accordance with section 403(d) of the act, a food shall be deemed 
to be misbranded if its container is so made, formed, or filled as to be 
misleading.
    (a) A container that does not allow the consumer to fully view its 
contents shall be considered to be filled as to be misleading if it 
contains nonfunctional slack-fill. Slack-fill is the difference between 
the actual capacity of a container and the volume of product contained 
therein. Nonfunctional slack-fill is the empty space in a package that 
is filled to less than its capacity for reasons other than:
    (1) Protection of the contents of the package;
    (2) The requirements of the machines used for enclosing the contents 
in such package;
    (3) Unavoidable product settling during shipping and handling;
    (4) The need for the package to perform a specific function (e.g., 
where packaging plays a role in the preparation or consumption of a 
food), where such function is inherent to the nature of the food and is 
clearly communicated to consumers;
    (5) The fact that the product consists of a food packaged in a 
reusable container where the container is part of the presentation of 
the food and has value which is both significant in proportion to the 
value of the product and independent of its function to hold the food, 
e.g., a gift product consisting of a food or foods combined with a 
container that is intended for further use after the food is consumed; 
or durable commemorative or promotional packages; or
    (6) Inability to increase level of fill or to further reduce the 
size of the package (e.g., where some minimum package size is necessary 
to accommodate required food labeling (excluding any vignettes or other 
nonmandatory designs or label information), discourage pilfering, 
facilitate handling, or accommodate tamper-resistant devices).
    (b) [Reserved]

[59 FR 537, Jan. 5, 1994]



         Subpart G_Specific Administrative Rulings and Decisions



Sec.  100.155  Salt and iodized salt.

    (a) For the purposes of this section, the term iodized salt or 
iodized table salt is designated as the name of salt for human food use 
to which iodide has been added in the form of cuprous iodide or 
potassium iodide permitted by Sec. Sec.  184.1265 and 184.1634 of this 
chapter. In the labeling of such products, all words in the name shall 
be equal in prominence and type size. The statement ``This salt supplies 
iodide, a necessary nutrient'' shall appear on the label immediately 
following the name and shall be in letters which are not less in height 
than those required for the declaration of the net quantity of contents 
as specified in Sec.  101.105 of this chapter.
    (b) Salt or table salt for human food use to which iodide has not 
been added shall bear the statement, ``This salt does not supply iodide, 
a necessary nutrient.'' This statement shall appear immediately 
following the name of the food and shall be in letters which are not 
less in height than those required for the declaration of the net 
quantity of contents as specified in Sec.  101.105 of this chapter.
    (c) Salt, table salt, iodized salt, or iodized table salt to which 
anticaking agents have been added may bear in addition to the ingredient 
statement designating the anticaking agent(s), a label statement 
describing the characteristics imparted by such agent(s) (for example, 
``free flowing''), providing such statement does not appear with greater 
prominence or in type size larger than the statements which immediately 
follow the name of the food as required by paragraphs (a) and (b) of 
this section.
    (d) Individual serving-sized packages containing less than \1/2\ 
ounce and packages containing more than 2\1/2\ pounds

[[Page 10]]

of a food described in this section shall be exempt from declaration of 
the statements which paragraphs (a) and (b) of this section require 
immediately following the name of the food. Such exemption shall not 
apply to the outer container or wrapper of a multiunit retail package.
    (e) All salt, table salt, iodized salt, or iodized table salt in 
packages intended for retail sale shipped in interstate commerce 18 
months after the date of publication of this statement of policy in the 
Federal Register, shall be labeled as prescribed by this section; and if 
not so labeled, the Food and Drug Administration will regard them as 
misbranded within the meaning of sections 403 (a) and (f) of the Federal 
Food, Drug, and Cosmetic Act.

[42 FR 14306, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983; 
49 FR 24119, June 12, 1984]



PART 101_FOOD LABELING--Table of Contents




                      Subpart A_General Provisions

Sec.
101.1 Principal display panel of package form food.
101.2 Information panel of package form food.
101.3 Identity labeling of food in packaged form.
101.4 Food; designation of ingredients.
101.5 Food; name and place of business of manufacturer, packer, or 
          distributor.
101.9 Nutrition labeling of food.
101.10 Nutrition labeling of restaurant foods.
101.12 Reference amounts customarily consumed per eating occasion.
101.13 Nutrient content claims--general principles.
101.14 Health claims: general requirements.
101.15 Food; prominence of required statements.
101.17 Food labeling warning, notice, and safe handling statements.
101.18 Misbranding of food.

              Subpart B_Specific Food Labeling Requirements

101.22 Foods; labeling of spices, flavorings, colorings and chemical 
          preservatives.
101.30 Percentage juice declaration for foods purporting to be beverages 
          that contain fruit or vegetable juice.

    Subpart C_Specific Nutrition Labeling Requirements and Guidelines

101.36 Nutrition labeling of dietary supplements.
101.42 Nutrition labeling of raw fruit, vegetables, and fish.
101.43 Substantial compliance of food retailers with the guidelines for 
          the voluntary nutrition labeling of raw fruit, vegetables, and 
          fish.
101.44 Identification of the 20 most frequently consumed raw fruit, 
          vegetables, and fish in the United States.
101.45 Guidelines for the voluntary nutrition labeling of raw fruit, 
          vegetables, and fish.

       Subpart D_Specific Requirements for Nutrient Content Claims

101.54 Nutrient content claims for ``good source,'' ``high,'' ``more,'' 
          and ``high potency.''
101.56 Nutrient content claims for ``light'' or ``lite.''
101.60 Nutrient content claims for the calorie content of foods.
101.61 Nutrient content claims for the sodium content of foods.
101.62 Nutrient content claims for fat, fatty acid, and cholesterol 
          content of foods.
101.65 Implied nutrient content claims and related label statements.
101.67 Use of nutrient content claims for butter.
101.69 Petitions for nutrient content claims.

            Subpart E_Specific Requirements for Health Claims

101.70 Petitions for health claims.
101.71 Health claims: claims not authorized.
101.72 Health claims: calcium, vitamin D, and osteoporosis.
101.73 Health claims: dietary lipids and cancer.
101.74 Health claims: sodium and hypertension.
101.75 Health claims: dietary saturated fat and cholesterol and risk of 
          coronary heart disease.
101.76 Health claims: fiber-containing grain products, fruits, and 
          vegetables and cancer.
101.77 Health claims: fruits, vegetables, and grain products that 
          contain fiber, particularly soluble fiber, and risk of 
          coronary heart disease.
101.78 Health claims: fruits and vegetables and cancer.
101.79 Health claims: Folate and neural tube defects.
101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and 
          dental caries.

[[Page 11]]

101.81 Health claims: Soluble fiber from certain foods and risk of 
          coronary heart disease (CHD).
101.82 Health claims: Soy protein and risk of coronary heart disease 
          (CHD).
101.83 Health claims: plant sterol/stanol esters and risk of coronary 
          heart disease (CHD).

Subpart F_Specific Requirements for Descriptive Claims That Are Neither 
                Nutrient Content Claims nor Health Claims

101.93 Certain types of statements for dietary supplements.
101.95 ``Fresh,'' ``freshly frozen,'' ``fresh frozen,'' ``frozen 
          fresh.''

          Subpart G_Exemptions From Food Labeling Requirements

101.100 Food; exemptions from labeling.
101.105 Declaration of net quantity of contents when exempt.
101.108 Temporary exemptions for purposes of conducting authorized food 
          labeling experiments.

Appendix A to Part 101--Monier-Williams Procedure (With Modifications) 
          for Sulfites in Food, Center for Food Safety and Applied 
          Nutrition, Food and Drug Administration (November 1985)
Appendix B to Part 101--Graphic Enhancements Used by the FDA
Appendix C to Part 101--Nutrition Facts for Raw Fruits and Vegetables
Appendix D to Part 101--Nutrition Facts for Cooked Fish

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 
348, 371; 42 U.S.C. 243, 264, 271.

    Source: 42 FR 14308, Mar. 15, 1977, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 101 appear at 63 FR 
14035, Mar. 24, 1998, 66 FR 17358, Mar. 30, 2001, and 66 FR 56035, Nov. 
6, 2001.



                      Subpart A_General Provisions



Sec.  101.1  Principal display panel of package form food.

    The term principal display panel as it applies to food in package 
form and as used in this part, means the part of a label that is most 
likely to be displayed, presented, shown, or examined under customary 
conditions of display for retail sale. The principal display panel shall 
be large enough to accommodate all the mandatory label information 
required to be placed thereon by this part with clarity and 
conspicuousness and without obscuring design, vignettes, or crowding. 
Where packages bear alternate principal display panels, information 
required to be placed on the principal display panel shall be duplicated 
on each principal display panel. For the purpose of obtaining uniform 
type size in declaring the quantity of contents for all packages of 
substantially the same size, the term area of the principal display 
panel means the area of the side or surface that bears the principal 
display panel, which area shall be:
    (a) In the case of a rectangular package where one entire side 
properly can be considered to be the principal display panel side, the 
product of the height times the width of that side;
    (b) In the case of a cylindrical or nearly cylindrical container, 40 
percent of the product of the height of the container times the 
circumference;
    (c) In the case of any otherwise shaped container, 40 percent of the 
total surface of the container: Provided, however, That where such 
container presents an obvious ``principal display panel'' such as the 
top of a triangular or circular package of cheese, the area shall 
consist of the entire top surface. In determining the area of the 
principal display panel, exclude tops, bottoms, flanges at tops and 
bottoms of cans, and shoulders and necks of bottles or jars. In the case 
of cylindrical or nearly cylindrical containers, information required by 
this part to appear on the principal display panel shall appear within 
that 40 percent of the circumference which is most likely to be 
displayed, presented, shown, or examined under customary conditions of 
display for retail sale.



Sec.  101.2  Information panel of package form food.

    (a) The term information panel as it applies to packaged food means 
that part of the label immediately contiguous and to the right of the 
principal display panel as observed by an individual facing the 
principal display panel with the following exceptions:
    (1) If the part of the label immediately contiguous and to the right 
of the principal display panel is too small

[[Page 12]]

to accommodate the necessary information or is otherwise unusable label 
space, e.g., folded flaps or can ends, the panel immediately contiguous 
and to the right of this part of the label may be used.
    (2) If the package has one or more alternate principal display 
panels, the information panel is immediately contiguous and to the right 
of any principal display panel.
    (3) If the top of the container is the principal display panel and 
the package has no alternate principal display panel, the information 
panel is any panel adjacent to the principal display panel.
    (b) All information required to appear on the label of any package 
of food under Sec. Sec.  101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 
101.36, subpart D of part 101, and part 105 of this chapter shall appear 
either on the principal display panel or on the information panel, 
unless otherwise specified by regulations in this chapter.
    (c) All information appearing on the principal display panel or the 
information panel pursuant to this section shall appear prominently and 
conspicuously, but in no case may the letters and/or numbers be less 
than one-sixteenth inch in height unless an exemption pursuant to 
paragraph (f) of this section is established. The requirements for 
conspicuousness and legibility shall include the specifications of 
Sec. Sec.  101.105(h) (1) and (2) and 101.15.
    (1)(i) Soft drinks packaged in bottles manufactured before October 
31, 1975 shall be exempt from the requirements prescribed by this 
section to the extent that information which is blown, lithographed, or 
formed onto the surface of the bottle is exempt from the size and 
placement requirements of this section.
    (ii) Soft drinks packaged in bottles shall be exempt from the size 
and placement requirements prescribed by this section if all of the 
following conditions are met:
    (A) If the soft drink is packaged in a bottle bearing a paper, 
plastic foam jacket, or foil label, or is packaged in a nonreusable 
bottle bearing a label lithographed onto the surface of the bottle or is 
packaged in metal cans, the product shall not be exempt from any 
requirement of this section other than the exemptions created by Sec.  
1.24(a)(5) (ii) and (v) of this chapter and the label shall bear all 
required information in the specified minimum type size, except the 
label will not be required to bear the information required by Sec.  
101.5 if this information appears on the bottle closure or on the lid of 
the can in a type size not less than one-sixteenth inch in height, or if 
embossed on the lid of the can in a type size not less than one-eighth 
inch in height.
    (B) If the soft drink is packaged in a bottle which does not bear a 
paper, plastic foam jacket or foil label, or is packaged in a reusable 
bottle bearing a label lithographed onto the surface of the bottle:
    (1) Neither the bottle nor the closure is required to bear nutrition 
labeling in compliance with Sec.  101.9, except that any multiunit 
retail package in which it is contained shall bear nutrition labeling if 
required by Sec.  101.9; and any vending machine in which it is 
contained shall bear nutrition labeling if nutrition labeling is not 
present on the bottle or closure, if required by Sec.  101.9.
    (2) All other information pursuant to this section shall appear on 
the top of the bottle closure prominently and conspicuously in letters 
and/or numbers no less than one thirty-second inch in height, except 
that if the information required by Sec.  101.5 is placed on the side of 
the closure in accordance with Sec.  1.24(a)(5)(ii) of this chapter, 
such information shall appear in letters and/or numbers no less than 
one-sixteenth inch in height.
    (3) Upon the petition of any interested person demonstrating that 
the bottle closure is too small to accommodate this information, the 
Commissioner may by regulation establish an alternative method of 
disseminating such information. Information appearing on the closure 
shall appear in the following priority:
    (i) The statement of ingredients.
    (ii) The name and address of the manufacturer, packer, or 
distributor.
    (iii) The statement of identity.
    (2) Individual serving-size packages of food served with meals in 
restaurants, institutions, and on board passenger carriers, and not 
intended for sale at retail, are exempt from

[[Page 13]]

type-size requirements of this paragraph, provided:
    (i) The package has a total area of 3 square inches or less 
available to bear labeling;
    (ii) There is insufficient area on the package available to print 
all required information in a type size of \1/16\ inch in height;
    (iii) The information required by paragraph (b) of this section 
appears on the label in accordance with the provisions of this 
paragraph, except that the type size is not less than \1/32\ inch in 
height.
    (d)(1) Except as provided by Sec. Sec.  101.9(j)(13) and (j)(17) and 
101.36(i)(2) and (i)(5), all information required to appear on the 
principal display panel or on the information panel under this section 
shall appear on the same panel unless there is insufficient space. In 
determining the sufficiency of the available space, except as provided 
by Sec. Sec.  101.9(j)(17) and 101.36(i)(5), any vignettes, designs, and 
other nonmandatory label information shall not be considered. If there 
is insufficient space for all of this information to appear on a single 
panel, it may be divided between these two panels, except that the 
information required under any given section or part shall all appear on 
the same panel. A food whose label is required to bear the ingredient 
statement on the principal display panel may bear all other information 
specified in paragraph (b) of this section on the information panel.
    (2) Any food, not otherwise exempted in this section, if packaged in 
a container consisting of a separate lid and body, and bearing nutrition 
labeling pursuant to Sec.  101.9, and if the lid qualifies for and is 
designed to serve as a principal display panel, shall be exempt from the 
placement requirements of this section in the following respects:
    (i) The name and place of business information required by Sec.  
101.5 shall not be required on the body of the container if this 
information appears on the lid in accordance with this section.
    (ii) The nutrition information required by Sec.  101.9 shall not be 
required on the lid if this information appears on the container body in 
accordance with this section.
    (iii) The statement of ingredients required by Sec.  101.4 shall not 
be required on the lid if this information appears on the container body 
in accordance with this section. Further, the statement of ingredients 
is not required on the container body if this information appears on the 
lid in accordance with this section.
    (e) All information appearing on the information panel pursuant to 
this section shall appear in one place without other intervening 
material.
    (f) If the label of any package of food is too small to accommodate 
all of the information required by Sec. Sec.  101.4, 101.5, 101.8, 
101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of 
this chapter, the Commissioner may establish by regulation an acceptable 
alternative method of disseminating such information to the public, 
e.g., a type size smaller than one-sixteenth inch in height, or labeling 
attached to or inserted in the package or available at the point of 
purchase. A petition requesting such a regulation, as an amendment to 
this paragraph, shall be submitted under part 10 of this chapter.

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006, 
Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58 
FR 44030, Aug. 18, 1993; 60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug. 
12, 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817, Mar. 27, 1998]



Sec.  101.3  Identity labeling of food in packaged form.

    (a) The principal display panel of a food in package form shall bear 
as one of its principal features a statement of the identity of the 
commodity.
    (b) Such statement of identity shall be in terms of:
    (1) The name now or hereafter specified in or required by any 
applicable Federal law or regulation; or, in the absence thereof,
    (2) The common or usual name of the food; or, in the absence 
thereof,
    (3) An appropriately descriptive term, or when the nature of the 
food is obvious, a fanciful name commonly used by the public for such 
food.
    (c) Where a food is marketed in various optional forms (whole, 
slices, diced, etc.), the particular form shall

[[Page 14]]

be considered to be a necessary part of the statement of identity and 
shall be declared in letters of a type size bearing a reasonable 
relation to the size of the letters forming the other components of the 
statement of identity; except that if the optional form is visible 
through the container or is depicted by an appropriate vignette, the 
particular form need not be included in the statement. This 
specification does not affect the required declarations of identity 
under definitions and standards for foods promulgated pursuant to 
section 401 of the act.
    (d) This statement of identity shall be presented in bold type on 
the principal display panel, shall be in a size reasonably related to 
the most prominent printed matter on such panel, and shall be in lines 
generally parallel to the base on which the package rests as it is 
designed to be displayed.
    (e) Under the provisions of section 403(c) of the Federal Food, 
Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is 
an imitation of another food unless its label bears, in type of uniform 
size and prominence, the word ``imitation'' and, immediately thereafter, 
the name of the food imitated.
    (1) A food shall be deemed to be an imitation and thus subject to 
the requirements of section 403(c) of the act if it is a substitute for 
and resembles another food but is nutritionally inferior to that food.
    (2) A food that is a substitute for and resembles another food shall 
not be deemed to be an imitation provided it meets each of the following 
requirements:
    (i) It is not nutritionally inferior to the food for which it 
substitutes and which it resembles.
    (ii) Its label bears a common or usual name that complies with the 
provisions of Sec.  102.5 of this chapter and that is not false or 
misleading, or in the absence of an existing common or usual name, an 
appropriately descriptive term that is not false or misleading. The 
label may, in addition, bear a fanciful name which is not false or 
misleading.
    (3) A food for which a common or usual name is established by 
regulation (e.g., in a standard of identity pursuant to section 401 of 
the act, in a common or usual name regulation pursuant to part 102 of 
this chapter, or in a regulation establishing a nutritional quality 
guideline pursuant to part 104 of this chapter), and which complies with 
all of the applicable requirements of such regulation(s), shall not be 
deemed to be an imitation.
    (4) Nutritional inferiority includes:
    (i) Any reduction in the content of an essential nutrient that is 
present in a measurable amount, but does not include a reduction in the 
caloric or fat content provided the food is labeled pursuant to the 
provisions of Sec.  101.9, and provided the labeling with respect to any 
reduction in caloric content complies with the provisions applicable to 
caloric content in part 105 of this chapter.
    (ii) For the purpose of this section, a measurable amount of an 
essential nutrient in a food shall be considered to be 2 percent or more 
of the Daily Reference Value (DRV) of protein listed under Sec.  
101.9(c)(7)(iii) and of potassium listed under Sec.  101.9(c)(9) per 
reference amount customarily consumed and 2 percent or more of the 
Reference Daily Intake (RDI) of any vitamin or mineral listed under 
Sec.  101.9(c)(8)(iv) per reference amount customarily consumed, except 
that selenium, molybdenum, chromium, and chloride need not be 
considered.
    (iii) If the Commissioner concludes that a food is a substitute for 
and resembles another food but is inferior to the food imitated for 
reasons other than those set forth in this paragraph, he may propose 
appropriate revisions to this regulation or he may propose a separate 
regulation governing the particular food.
    (f) A label may be required to bear the percentage(s) of a 
characterizing ingredient(s) or information concerning the presence or 
absence of an ingredient(s) or the need to add an ingredient(s) as part 
of the common or usual name of the food pursuant to subpart B of part 
102 of this chapter.
    (g) Dietary supplements shall be identified by the term ``dietary 
supplement'' as a part of the statement of identity, except that the 
word ``dietary'' may be deleted and replaced by the name of the dietary 
ingredients in the product (e.g., calcium supplement)

[[Page 15]]

or an appropriately descriptive term indicating the type of dietary 
ingredients that are in the product (e.g., herbal supplement with 
vitamins).

[42 FR 14308, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983; 
58 FR 2227, Jan. 6, 1993; 60 FR 67174, Dec. 28, 1995; 62 FR 49847, Sept. 
23, 1997]



Sec.  101.4  Food; designation of ingredients.

    (a)(1) Ingredients required to be declared on the label or labeling 
of a food, including foods that comply with standards of identity, 
except those ingredients exempted by Sec.  101.100, shall be listed by 
common or usual name in descending order of predominance by weight on 
either the principal display panel or the information panel in 
accordance with the provisions of Sec.  101.2, except that ingredients 
in dietary supplements that are listed in the nutrition label in 
accordance with Sec.  101.36 need not be repeated in the ingredient 
list. Paragraph (g) of this section describes the ingredient list on 
dietary supplement products.
    (2) The descending order of predominance requirements of paragraph 
(a)(1) of this section do not apply to ingredients present in amounts of 
2 percent or less by weight when a listing of these ingredients is 
placed at the end of the ingredient statement following an appropriate 
quantifying statement, e.g., ``Contains -- percent or less of ------'' 
or ``Less than -- percent of ------.'' The blank percentage within the 
quantifying statement shall be filled in with a threshold level of 2 
percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as 
appropriate. No ingredient to which the quantifying phrase applies may 
be present in an amount greater than the stated threshold.
    (b) The name of an ingredient shall be a specific name and not a 
collective (generic) name, except that:
    (1) Spices, flavorings, colorings and chemical preservatives shall 
be declared according to the provisions of Sec.  101.22.
    (2) An ingredient which itself contains two or more ingredients and 
which has an established common or usual name, conforms to a standard 
established pursuant to the Meat Inspection or Poultry Products 
Inspection Acts by the U.S. Department of Agriculture, or conforms to a 
definition and standard of identity established pursuant to section 401 
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the 
statement of ingredients on the label of such food by either of the 
following alternatives:
    (i) By declaring the established common or usual name of the 
ingredient followed by a parenthetical listing of all ingredients 
contained therein in descending order of predominance except that, if 
the ingredient is a food subject to a definition and standard of 
identity established in subchapter B of this chapter that has specific 
labeling provisions for optional ingredients, optional ingredients may 
be declared within the parenthetical listing in accordance with those 
provisions.
    (ii) By incorporating into the statement of ingredients in 
descending order of predominance in the finished food, the common or 
usual name of every component of the ingredient without listing the 
ingredient itself.
    (3) Skim milk, concentrated skim milk, reconstituted skim milk, and 
nonfat dry milk may be declared as ``skim milk'' or ``nonfat milk''.
    (4) Milk, concentrated milk, reconstituted milk, and dry whole milk 
may be declared as ``milk''.
    (5) Bacterial cultures may be declared by the word ``cultured'' 
followed by the name of the substrate, e.g., ``made from cultured skim 
milk or cultured buttermilk''.
    (6) Sweetcream buttermilk, concentrated sweetcream buttermilk, 
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may 
be declared as ``buttermilk''.
    (7) Whey, concentrated whey, reconstituted whey, and dried whey may 
be declared as ``whey''.
    (8) Cream, reconstituted cream, dried cream, and plastic cream 
(sometimes known as concentrated milk fat) may be declared as ``cream''.
    (9) Butteroil and anhydrous butterfat may be declared as 
``butterfat''.
    (10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may 
be declared as ``eggs''.
    (11) Dried egg whites, frozen egg whites, and liquid egg whites may 
be declared as ``egg whites''.

[[Page 16]]

    (12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be 
declared as ``egg yolks''.
    (13) [Reserved]
    (14) Each individual fat and/or oil ingredient of a food intended 
for human consumption shall be declared by its specific common or usual 
name (e.g., ``beef fat'', ``cottonseed oil'') in its order of 
predominance in the food except that blends of fats and/or oils may be 
designated in their order of predominance in the foods as ``------ 
shortening'' or ``blend of ------ oils'', the blank to be filled in with 
the word ``vegetable'', ``animal'', ``marine'', with or without the 
terms ``fat'' or ``oils'', or combination of these, whichever is 
applicable if, immediately following the term, the common or usual name 
of each individual vegetable, animal, or marine fat or oil is given in 
parentheses, e.g., ``vegetable oil shortening (soybean and cottonseed 
oil)''. For products that are blends of fats and/or oils and for foods 
in which fats and/or oils constitute the predominant ingredient, i.e., 
in which the combined weight of all fat and/or oil ingredients equals or 
exceeds the weight of the most predominant ingredient that is not a fat 
or oil, the listing of the common or usual names of such fats and/or 
oils in parentheses shall be in descending order of predominance. In all 
other foods in which a blend of fats and/or oils is used as an 
ingredient, the listing of the common or usual names in parentheses need 
not be in descending order of predominance if the manufacturer, because 
of the use of varying mixtures, is unable to adhere to a constant 
pattern of fats and/or oils in the product. If the fat or oil is 
completely hydrogenated, the name shall include the term hydrogenated, 
or if partially hydrogenated, the name shall include the term partially 
hydrogenated. If each fat and/or oil in a blend or the blend is 
completely hydrogenated, the term ``hydrogenated'' may precede the 
term(s) describing the blend, e.g., ``hydrogenated vegetable oil 
(soybean, cottonseed, and palm oils)'', rather than preceding the name 
of each individual fat and/or oil; if the blend of fats and/or oils is 
partially hydrogenated, the term ``partially hydrogenated'' may be used 
in the same manner. Fat and/or oil ingredients not present in the 
product may be listed if they may sometimes be used in the product. Such 
ingredients shall be identified by words indicating that they may not be 
present, such as ``or'', ``and/or'', ``contains one or more of the 
following:'', e.g., ``vegetable oil shortening (contains one or more of 
the following: cottonseed oil, palm oil, soybean oil)''. No fat or oil 
Fingredient shall be listed unless actually present if the fats and/or 
oils constitute the predominant ingredient of the product, as defined in 
this paragraph (b)(14).
    (15) When all the ingredients of a wheat flour are declared in an 
ingredient statement, the principal ingredient of the flour shall be 
declared by the name(s) specified in Sec. Sec.  137.105, 137.200, 
137.220 and 137.225 of this chapter, i.e., the first ingredient 
designated in the ingredient list of flour, or bromated flour, or 
enriched flour, or self-rising flour is ``flour'', ``white flour'', 
``wheat flour'', or ``plain flour''; the first ingredient designated in 
the ingredient list of durum flour is ``durum flour''; the first 
ingredient designated in the ingredient list of whole wheat flour, or 
bromated whole wheat flour is ``whole wheat flour'', ``graham flour'', 
or ``entire wheat flour''; and the first ingredient designated in the 
ingredient list of whole durum wheat flour is ``whole durum wheat 
flour''.
    (16) Ingredients that act as leavening agents in food may be 
declared in the ingredient statement by stating the specific common or 
usual name of each individual leavening agent in parentheses following 
the collective name ``leavening'', e.g., ``leavening (baking soda, 
monocalcium phosphate, and calcium carbonate)''. The listing of the 
common or usual name of each individual leavening agent in parentheses 
shall be in descending order of predominance: Except, That if the 
manufacturer is unable to adhere to a constant pattern of leavening 
agents in the product, the listing of individual leavening agents need 
not be in descending order of predominance. Leavening agents not present 
in the product may be listed if they are sometimes used in the product. 
Such ingredients shall be identified by words indicating that they may 
not be present, such as

[[Page 17]]

``or'', ``and/or'', ``contains one or more of the following:''.
    (17) Ingredients that act as yeast nutrients in foods may be 
declared in the ingredient statement by stating the specific common or 
usual name of each individual yeast nutrient in parentheses following 
the collective name ``yeast nutrients'', e.g., ``yeast nutrients 
(calcium sulfate and ammonium phosphate)''. The listing of the common or 
usual name of each individual yeast nutrient in parentheses shall be in 
descending order of predominance: Except, That if the manufacturer is 
unable to adhere to a constant pattern of yeast nutrients in the 
product, the listing of the common or usual names of individual yeast 
nutrients need not be in descending order of predominance. Yeast 
nutrients not present in the product may be listed if they are sometimes 
used in the product. Such ingredients shall be identified by words 
indicating that they may not be present, such as ``or'', ``and/or'', or 
``contains one or more of the following:''.
    (18) Ingredients that act as dough conditioners may be declared in 
the ingredient statement by stating the specific common or usual name of 
each individual dough conditioner in parentheses following the 
collective name ``dough conditioner'', e.g., ``dough conditioners (L-
cysteine, ammonium sulfate)''. The listing of the common or usual name 
of each dough conditioner in parentheses shall be in descending order of 
predominance: Except, That if the manufacturer is unable to adhere to a 
constant pattern of dough conditioners in the product, the listing of 
the common or usual names of individual dough conditioners need not be 
in descending order of predominance. Dough conditioners not present in 
the product may be listed if they are sometimes used in the product. 
Such ingredients shall be identified by words indicating that they may 
not be present, such as ``or'', ``and/or'', or ``contains one or more of 
the following:''.
    (19) Ingredients that act as firming agents in food (e.g., salts of 
calcium and other safe and suitable salts in canned vegetables) may be 
declared in the ingredient statement, in order of predominance 
appropriate for the total of all firming agents in the food, by stating 
the specific common or usual name of each individual firming agent in 
descending order of predominance in parentheses following the collective 
name ``firming agents''. If the manufacturer is unable to adhere to a 
constant pattern of firming agents in the food, the listing of the 
individual firming agents need not be in descending order of 
predominance. Firming agents not present in the product may be listed if 
they are sometimes used in the product. Such ingredients shall be 
identified by words indicating that they may not be present, such as 
``or'', ``and/or'', ``contains one or more of the following:''.
    (20) For purposes of ingredient labeling, the term sugar shall refer 
to sucrose, which is obtained from sugar cane or sugar beets in 
accordance with the provisions of Sec.  184.1854 of this chapter.
    (21) [Reserved]
    (22) Wax and resin ingredients on fresh produce when such produce is 
held for retail sale, or when held for other than retail sale by packers 
or repackers shall be declared collectively by the phrase ``coated with 
food-grade animal-based wax, to maintain freshness'' or the phrase 
``coated with food-grade vegetable-, petroleum-, beeswax-, and/or 
shellac-based wax or resin, to maintain freshness'' as appropriate. The 
terms ``food-grade'' and ``to maintain freshness'' are optional. The 
term lac-resin may be substituted for the term shellac.
    (23) When processed seafood products contain fish protein 
ingredients consisting primarily of the myofibrillar protein fraction 
from one or more fish species and the manufacturer is unable to adhere 
to a constant pattern of fish species in the fish protein ingredient, 
because of seasonal or other limitations of species availability, the 
common or usual name of each individual fish species need not be listed 
in descending order of predominance. Fish species not present in the 
fish protein ingredient may be listed if they are sometimes used in the 
product. Such ingredients must be identified by words indicating that 
they may not be present, such as ``or'', ``and/or'', or ``contains one 
or more of the following:'' Fish protein ingredients may

[[Page 18]]

be declared in the ingredient statement by stating the specific common 
or usual name of each fish species that may be present in parentheses 
following the collective name ``fish protein'', e.g., ``fish protein 
(contains one or more of the following: Pollock, cod, and/or pacific 
whiting)''.
    (c) When water is added to reconstitute, completely or partially, an 
ingredient permitted by paragraph (b) of this section to be declared by 
a class name, the position of the ingredient class name in the 
ingredient statement shall be determined by the weight of the 
unreconstituted ingredient plus the weight of the quantity of water 
added to reconstitute that ingredient, up to the amount of water needed 
to reconstitute the ingredient to single strength. Any water added in 
excess of the amount of water needed to reconstitute the ingredient to 
single strength shall be declared as ``water'' in the ingredient 
statement.
    (d) When foods characterized on the label as ``nondairy'' contain a 
caseinate ingredient, the caseinate ingredient shall be followed by a 
parenthetical statement identifying its source. For example, if the 
manufacturer uses the term ``nondairy'' on a creamer that contains 
sodium caseinate, it shall include a parenthetical term such as ``a milk 
derivative'' after the listing of sodium caseinate in the ingredient 
list.
    (e) If the percentage of an ingredient is included in the statement 
of ingredients, it shall be shown in parentheses following the name of 
the ingredient and expressed in terms of percent by weight. Percentage 
declarations shall be expressed to the nearest 1 percent, except that 
where ingredients are present at levels of 2 percent or less, they may 
be grouped together and expressed in accordance with the quantifying 
guidance set forth in paragraph (a)(2) of this section.
    (f) Except as provided in Sec.  101.100, ingredients that must be 
declared on labeling because there is no label for the food, including 
foods that comply with standards of identity, shall be listed 
prominently and conspicuously by common or usual name in the manner 
prescribed by paragraph (b) of this section.
    (g) When present, the ingredient list on dietary supplement products 
shall be located immediately below the nutrition label, or, if there is 
insufficient space below the nutrition label, immediately contiguous and 
to the right of the nutrition label and shall be preceded by the word 
``Ingredients,'' unless some ingredients (i.e., sources) are identified 
within the nutrition label in accordance with Sec.  101.36(d), in which 
case the ingredients listed outside the nutrition label shall be in a 
list preceded by the words ``Other ingredients.'' Ingredients in dietary 
supplements that are not dietary ingredients or that do not contain 
dietary ingredients, such as excipients, fillers, artificial colors, 
artificial sweeteners, flavors, or binders, shall be included in the 
ingredient list.
    (h) The common or usual name of ingredients of dietary supplements 
that are botanicals (including fungi and algae) shall be consistent with 
the names standardized in Herbs of Commerce, 1992 edition, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the American Herbal Products 
Association, 8484 Georgia Ave., suite 370, Silver Spring, MD 20910, 301-
588-1171, FAX 301-588-1174, e-mail: ahpa@ahpa.org, or may be examined at 
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to:http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html. The listing of these names on the label shall be 
followed by statements of:
    (1) The part of the plant (e.g., root, leaves) from which the 
dietary ingredient is derived (e.g., ``Garlic bulb'' or ``Garlic 
(bulb)''), except that this designation is not required for algae. The 
name of the part of the plant shall be expressed in English (e.g., 
``flower'' rather than ``flos'');
    (2) The Latin binomial name of the plant, in parentheses, except 
that this name is not required when it is available in the reference 
entitled: Herbs of

[[Page 19]]

Commerce for the common or usual name listed on the label, and, when 
required, the Latin binomial name may be listed before the part of the 
plant. Any name in Latin form shall be in accordance with 
internationally accepted rules on nomenclature, such as those found in 
the International Code of Botanical Nomenclature and shall include the 
designation of the author or authors who published the Latin name, when 
a positive identification cannot be made in its absence. The 
International Code of Botanical Nomenclature (Tokyo Code), 1994 edition, 
a publication of the International Association for Plant Taxonomy, is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of the International Code of Botanical Nomenclature may 
be obtained from Koeltz Scientific Books, D-61453 Konigstein, Germany, 
and University Bookstore, Southern Illinois University, Carbondale, IL 
62901-4422, 618-536-3321, FAX 618-453-5207, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
    (3) On labels of single-ingredient dietary supplements that do not 
include an ingredient list, the identification of the Latin binomial 
name, when needed, and the part of the plant may be prominently placed 
on the principal display panel or information panel, or included in the 
nutrition label.

[42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978; 
43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr. 
25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR 49847, Sept. 23, 1997; 62 FR 
64634, Dec. 8, 1997; 64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. 30, 
2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003]



Sec.  101.5  Food; name and place of business of manufacturer, packer, or 

distributor.

    (a) The label of a food in packaged form shall specify conspicuously 
the name and place of business of the manufacturer, packer, or 
distributor.
    (b) The requirement for declaration of the name of the manufacturer, 
packer, or distributor shall be deemed to be satisfied, in the case of a 
corporation, only by the actual corporate name, which may be preceded or 
followed by the name of the particular division of the corporation. In 
the case of an individual, partnership, or association, the name under 
which the business is conducted shall be used.
    (c) Where the food is not manufactured by the person whose name 
appears on the label, the name shall be qualified by a phrase that 
reveals the connection such person has with such food; such as 
``Manufactured for ------'', ``Distributed by ------'', or any other 
wording that expresses the facts.
    (d) The statement of the place of business shall include the street 
address, city, State, and ZIP code; however, the street address may be 
omitted if it is shown in a current city directory or telephone 
directory. The requirement for inclusion of the ZIP code shall apply 
only to consumer commodity labels developed or revised after the 
effective date of this section. In the case of nonconsumer packages, the 
ZIP code shall appear either on the label or the labeling (including 
invoice).
    (e) If a person manufactures, packs, or distributes a food at a 
place other than his principal place of business, the label may state 
the principal place of business in lieu of the actual place where such 
food was manufactured or packed or is to be distributed, unless such 
statement would be misleading.



Sec.  101.9  Nutrition labeling of food.

    (a) Nutrition information relating to food shall be provided for all 
products intended for human consumption and offered for sale unless an 
exemption is provided for the product in paragraph (j) of this section.
    (1) When food is in package form, the required nutrition labeling 
information shall appear on the label in the format specified in this 
section.
    (2) When food is not in package form, the required nutrition 
labeling information shall be displayed clearly at the point of purchase 
(e.g., on a

[[Page 20]]

counter card, sign, tag affixed to the product, or some other 
appropriate device). Alternatively, the required information may be 
placed in a booklet, looseleaf binder, or other appropriate format that 
is available at the point of purchase.
    (3) Solicitation of requests for nutrition information by a 
statement ``For nutrition information write to ---------------------- '' 
on the label or in the labeling or advertising for a food, or providing 
such information in a direct written reply to a solicited or unsolicited 
request, does not subject the label or the labeling of a food exempted 
under paragraph (j) of this section to the requirements of this section 
if the reply to the request conforms to the requirements of this 
section.
    (4) If any vitamin or mineral is added to a food so that a single 
serving provides 50 percent or more of the Reference Daily Intake (RDI) 
for the age group for which the product is intended, as specified in 
paragraph (c)(8)(iv) of this section, of any one of the added vitamins 
or minerals, unless such addition is permitted or required in other 
regulations, e.g., a standard of identity or nutritional quality 
guideline, or is otherwise exempted by the Commissioner, the food shall 
be considered a food for special dietary use within the meaning of Sec.  
105.3(a)(1)(iii) of this chapter.
    (b) Except as provided in Sec.  101.9(h)(3), all nutrient and food 
component quantities shall be declared in relation to a serving as 
defined in this section.
    (1) The term serving or serving size means an amount of food 
customarily consumed per eating occasion by persons 4 years of age or 
older which is expressed in a common household measure that is 
appropriate to the food. When the food is specially formulated or 
processed for use by infants or by toddlers, a serving or serving size 
means an amount of food customarily consumed per eating occasion by 
infants up to 12 months of age or by children 1 through 3 years of age, 
respectively.
    (2) Except as provided in paragraphs (b)(3), (b)(4), and (b)(6) of 
this section and for products that are intended for weight control and 
are available only through a weight-control or weight-maintenance 
program, serving size declared on a product label shall be determined 
from the ``Reference Amounts Customarily Consumed Per Eating Occasion * 
* * *'' (reference amounts) that appear in Sec.  101.12(b) using the 
procedures described below. For products that are both intended for 
weight control and available only through a weight-control program, a 
manufacturer may determine the serving size that is consistent with the 
meal plan of the program. Such products must bear a statement, ``for 
sale only through the ------ program'' (fill in the blank with the name 
of the appropriate weight-control program, e.g., Smith's Weight 
Control), on the principal display panel. However, the reference amounts 
in Sec.  101.12(b) shall be used for purposes of evaluating whether 
weight-control products that are available only through a weight-control 
program qualify for nutrient content claims or health claims.
    (i) For products in discrete units (e.g., muffins, sliced products, 
such as sliced bread, or individually packaged products within a 
multiserving package) and for products which consist of two or more 
foods packaged and presented to be consumed together where the 
ingredient represented as the main ingredient is in discrete units 
(e.g., pancakes and syrup), the serving size shall be declared as 
follows:
    (A) If a unit weighs 50 percent or less of the reference amount, the 
serving size shall be the number of whole units that most closely 
approximates the reference amount for the product category;
    (B) If a unit weighs more than 50 percent, but less than 67 percent 
of the reference amount, the manufacturer may declare one unit or two 
units as the serving size;
    (C) If a unit weighs 67 percent or more, but less than 200 percent 
of the reference amount, the serving size shall be one unit;
    (D) If a unit weighs 200 percent or more of the reference amount, 
the manufacturer may declare one unit as the serving size if the whole 
unit can reasonably be consumed at a single-eating occasion.
    (E) For products that have reference amounts of 100 grams (g) (or 
milliliter

[[Page 21]]

(mL)) or larger and are individual units within a multiserving package, 
if a unit contains more than 150 percent but less than 200 percent of 
the reference amount, the manufacturer may decide whether to declare the 
individual unit as 1 or 2 servings.
    (F) The serving size for maraschino cherries shall be expressed as 1 
cherry with the parenthetical metric measure equal to the average weight 
of a medium size cherry.
    (G) The serving size for products that naturally vary in size (e.g., 
pickles, shellfish, whole fish, and fillet of fish) may be the amount in 
ounces that most closely approximates the reference amount for the 
product category. Manufacturers shall adhere to the requirements in 
paragraph (b)(5)(vi) of this section for expressing the serving size in 
ounces.
    (H) For products which consist of two or more foods packaged and 
presented to be consumed together where the ingredient represented as 
the main ingredient is in discrete units (e.g., pancakes and syrup), the 
serving size may be the number of discrete units represented as the main 
ingredient plus proportioned minor ingredients used to make the 
reference amount for the combined product determined in Sec.  101.12(f).
    (I) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in Sec.  101.9 (that is, are 
labeled appropriately for individual sale as single-serving containers), 
the serving size shall be 1 unit.
    (ii) For products in large discrete units that are usually divided 
for consumption (e.g., cake, pie, pizza, melon, cabbage), for unprepared 
products where the entire contents of the package is used to prepare 
large discrete units that are usually divided for consumption (e.g., 
cake mix, pizza kit), and for products which consist of two or more 
foods packaged and presented to be consumed together where the 
ingredient represented as the main ingredient is a large discrete unit 
usually divided for consumption (e.g., prepared cake packaged with a can 
of frosting), the serving size shall be the fractional slice of the 
ready-to-eat product (e.g., 1/12 cake, 1/8 pie, 1/4 pizza, 1/4 melon, 1/
6 cabbage) that most closely approximates the reference amount for the 
product category, and may be the fraction of the package used to make 
the reference amount for the unprepared product determined in Sec.  
101.12(c) or the fraction of the large discrete unit represented as the 
main ingredient plus proportioned minor ingredients used to make the 
reference amount for the combined product determined in Sec.  101.12(f). 
In expressing the fractional slice, manufacturers shall use 1/2, 1/3, 1/
4, 1/5, 1/6, or smaller fractions that can be generated by further 
division by 2 or 3.
    (iii) For nondiscrete bulk products (e.g., breakfast cereal, flour, 
sugar, dry mixes, concentrates, pancake mixes, macaroni and cheese 
kits), and for products which consist of two or more foods packaged and 
presented to be consumed together where the ingredient represented as 
the main ingredient is a bulk product (e.g., peanut butter and jelly), 
the serving size shall be the amount in household measure that most 
closely approximates the reference amount for the product category and 
may be the amount of the bulk product represented as the main ingredient 
plus proportioned minor ingredients used to make the reference amount 
for the combined product determined in Sec.  101.12(f).
    (3) The serving size for meal products and main dish products as 
defined in Sec.  101.13 (l) and (m) that comes in single-serving 
containers as defined in paragraph (b)(6) of this section shall be the 
entire content (edible portion only) of the package. Serving size for 
meal products and main dish products in multiserving containers shall be 
based on the reference amount applicable to the product in Sec.  
101.12(b) if the product is listed in Sec.  101.12(b). Serving size for 
meal products and main dish products in multiserving containers that are 
not listed in Sec.  101.12(b) shall be based on the reference amount 
according to Sec.  101.12(f).
    (4) A variety pack, such as a package containing several varieties 
of single-serving units as defined in paragraph (b)(2)(i) of this 
section, and a product having two or more compartments with each 
compartment containing a

[[Page 22]]

different food, shall provide nutrition information for each variety or 
food per serving size that is derived from the reference amount in Sec.  
101.12(b) applicable for each variety or food and the procedures to 
convert the reference amount to serving size in paragraph (b)(2) of this 
section.
    (5) For labeling purposes, the term common household measure or 
common household unit means cup, tablespoon, teaspoon, piece, slice, 
fraction (e.g., 1/4 pizza), ounce (oz), fluid ounce (fl oz), or other 
common household equipment used to package food products (e.g., jar, 
tray). In expressing serving size in household measures, except as 
specified in paragraphs (b)(5)(iv), (b)(5)(v), (b)(5)(vi), and 
(b)(5)(vii) of this section, the following rules shall be used:
    (i) Cups, tablespoons, or teaspoons shall be used wherever possible 
and appropriate except for beverages. For beverages, a manufacturer may 
use fluid ounces. Cups shall be expressed in 1/4- or 1/3-cup increments. 
Tablespoons shall be expressed as 1, 1 1/3, 1 1/2, 1 2/3, 2, or 3 
tablespoons. Teaspoons shall be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 
teaspoons.
    (ii) If cups, tablespoons or teaspoons are not applicable, units 
such as piece, slice, tray, jar, and fraction shall be used.
    (iii) If paragraphs (b)(5)(i) and (b)(5)(ii) of this section are not 
applicable, ounces may be used with an appropriate visual unit of 
measure such as a dimension of a piece, e.g., 1 oz (28 g/about 1/2 
pickle). Ounce measurements shall be expressed in 0.5 oz increments most 
closely approximating the reference amount.
    (iv) A description of the individual container or package shall be 
used for single serving containers and for individually packaged 
products within multiserving containers (e.g., can, box, package). A 
description of the individual unit shall be used for other products in 
discrete units (e.g., piece, slice, cracker, bar).
    (v) For unprepared products where the entire contents of the package 
is used to prepare large discrete units that are usually divided for 
consumption (e.g., cake mix, pizza kit), the fraction or portion of the 
package may be used.
    (vi) Ounces with an appropriate visual unit of measure, as described 
in paragraph (b)(5)(iii) of this section, may be used for products that 
naturally vary in size as provided for in paragraph (b)(2)(i)(G) of this 
section.
    (vii) As provided for in Sec.  101.9(h)(1), for products that 
consist of two or more distinct ingredients or components packaged and 
presented to be consumed together (e.g. dry macaroni and cheese mix, 
cake and muffin mixes with separate ingredient packages, pancakes and 
syrup), nutrition information may be declared for each component or as a 
composite. The serving size may be provided in accordance with the 
provisions of paragraphs (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this 
section, or alternatively in ounces with an appropriate visual unit of 
measure, as described in paragraph (b)(5)(iii) of this section (e.g., 
declared as separate components: ``3 oz dry macaroni (84 g/about 2/3 
cup)'' and ``1 oz dry cheese mix (28 g/about 2 tbsp);'' declared as a 
composite value: ``4 oz (112 g/about 2/3 cup macaroni and 2 tbsp dry 
cheese mix)'').
    (viii) For nutrition labeling purposes, a teaspoon means 5 
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, 1 fl oz 
means 30 mL, and 1 oz in weight means 28 g.
    (ix) When a serving size, determined from the reference amount in 
Sec.  101.12(b) and the procedures described in this section, falls 
exactly half way between two serving sizes, e.g., 2.5 tbsp, 
manufacturers shall round the serving size up to the next incremental 
size.
    (6) A product that is packaged and sold individually and that 
contains less than 200 percent of the applicable reference amount shall 
be considered to be a single-serving container, and the entire content 
of the product shall be labeled as one serving except for products that 
have reference amounts of 100 g (or mL) or larger, manufacturers may 
decide whether a package that contains more than 150 percent but less 
than 200 percent of the reference amount is 1 or 2 servings. Packages 
sold individually that contain 200 percent or more of the applicable 
reference amount may be labeled as a single-serving if the entire 
content of the package can reasonably

[[Page 23]]

be consumed at a single-eating occasion.
    (7) A label statement regarding a serving shall be the serving size 
expressed in common household measures as set forth in paragraphs (b)(2) 
through (b)(6) of this section and shall be followed by the equivalent 
metric quantity in parenthesis (fluids in milliliters and all other 
foods in grams) except for single-serving containers.
    (i) For a single-serving container, the parenthetical metric 
quantity, which will be presented as part of the net weight statement on 
the principal display panel, is not required except where nutrition 
information is required on a drained weight basis according to Sec.  
101.9(b)(9). However, if a manufacturer voluntarily provides the metric 
quantity on products that can be sold as single servings, then the 
numerical value provided as part of the serving size declaration must be 
identical to the metric quantity declaration provided as part of the net 
quantity of contents statement.
    (ii) The gram or milliliter quantity equivalent to the household 
measure should be rounded to the nearest whole number except for 
quantities that are less than 5 g (mL). The gram (mL) quantity between 2 
and 5 g (mL) should be rounded to the nearest 0.5 g (mL) and the g (mL) 
quantity less than 2 g (mL) should be expressed in 0.1-g (mL) 
increments.
    (iii) In addition, serving size may be declared in ounce and fluid 
ounce, in parenthesis, following the metric measure separated by a slash 
where other common household measures are used as the primary unit for 
serving size, e.g., 1 slice (28 g/1 oz) for sliced bread. The ounce 
quantity equivalent to the metric quantity should be expressed in 0.1 oz 
increments.
    (iv) If a manufacturer elects to use abbreviations for units, the 
following abbreviations shall be used: tbsp for tablespoon, tsp for 
teaspoon, g for gram, mL for milliliter, oz for ounce, and fl oz for 
fluid ounce.
    (v) For products that only require the addition of water or another 
ingredient that contains insignificant amounts of nutrients in the 
amount added and that are prepared in such a way that there are no 
significant changes to the nutrient profile, the amount of the finished 
product may be declared in parentheses at the end of the serving size 
declaration (e.g., 1/2 cup (120 mL) concentrated soup (makes 1 cup 
prepared)).
    (vi) To promote uniformity in label serving sizes in household 
measures declared by different manufacturers, FDA has provided a 
guidance document entitled, ``Guidelines for Determining the Gram Weight 
of the Household Measure.'' The guidance document can be obtained from 
the Office of Nutritional Products, Labeling and Dietary Supplements 
(HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
    (8) Determination of the number of servings per container shall be 
based on the serving size of the product determined by following the 
procedures described in this section.
    (i) The number of servings shall be rounded to the nearest whole 
number except for the number of servings between 2 and 5 servings and 
random weight products. The number of servings between 2 and 5 servings 
shall be rounded to the nearest 0.5 serving. Rounding should be 
indicated by the use of the term about (e.g., about 2 servings, about 
3.5 servings).
    (ii) When the serving size is required to be expressed on a drained 
solids basis and the number of servings varies because of a natural 
variation in unit size (e.g., maraschino cherries, pickles), the 
manufacturer may state the typical number of servings per container 
(e.g., usually 5 servings).
    (iii) For random weight products, a manufacturer may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the reference amount expressed in 
ounces. The manufacturer may provide the typical number of servings in 
parenthesis following the ``varied'' statement.
    (iv) For packages containing several individual single-serving 
containers, each of which is labeled with all required information 
including nutrition labeling as specified in Sec.  101.9 (that is, are 
labeled appropriately for individual sale as single-serving containers), 
the number of servings shall be the number

[[Page 24]]

of individual packages within the total package.
    (v) For packages containing several individually packaged 
multiserving units, the number of servings shall be determined by 
multiplying the number of individual multiserving units in the total 
package by the number of servings in each individual unit.
    (9) The declaration of nutrient and food component content shall be 
on the basis of food as packaged or purchased with the exception of raw 
fish covered under Sec.  101.42 (see 101.44), packaged single-ingredient 
products that consist of fish or game meat as provided for in paragraph 
(j)(11) of this section, and of foods that are packed or canned in 
water, brine, or oil but whose liquid packing medium is not customarily 
consumed (e.g., canned fish, maraschino cherries, pickled fruits, and 
pickled vegetables). Declaration of nutrient and food component content 
of raw fish shall follow the provisions in Sec.  101.45. Declaration of 
the nutrient and food component content of foods that are packed in 
liquid which is not customarily consumed shall be based on the drained 
solids.
    (10) Another column of figures may be used to declare the nutrient 
and food component information:
    (i) Per 100 g or 100 mL, or per 1 oz or 1 fl oz of the food as 
packaged or purchased;
    (ii) Per one unit if the serving size of a product in discrete units 
in a multiserving container is more than 1 unit;
    (iii) Per cup popped for popcorn in a multiserving container.
    (11) If a product is promoted on the label, labeling, or advertising 
for a use that differs in quantity by twofold or greater from the use 
upon which the reference amount in Sec.  101.12(b) was based (e.g., 
liquid cream substitutes promoted for use with breakfast cereals), the 
manufacturer shall provide a second column of nutrition information 
based on the amount customarily consumed in the promoted use, in 
addition to the nutrition information per serving derived from the 
reference amount in Sec.  101.12(b), except that nondiscrete bulk 
products that are used primarily as ingredients (e.g., flour, 
sweeteners, shortenings, oils), or traditionally used for multipurposes 
(e.g., eggs, butter, margarine), and multipurpose baking mixes are 
exempt from this requirement.
    (c) The declaration of nutrition information on the label and in 
labeling of a food shall contain information about the level of the 
following nutrients, except for those nutrients whose inclusion, and the 
declaration of amounts, is voluntary as set forth in this paragraph. No 
nutrients or food components other than those listed in this paragraph 
as either mandatory or voluntary may be included within the nutrition 
label. Except as provided for in paragraphs (f) or (j) of this section, 
nutrient information shall be presented using the nutrient names 
specified and in the following order in the formats specified in 
paragraphs (d) or (e) of this section.
    (1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A 
statement of the caloric content per serving, expressed to the nearest 
5-calorie increment up to and including 50 calories, and 10-calorie 
increment above 50 calories, except that amounts less than 5 calories 
may be expressed as zero. Energy content per serving may also be 
expressed in kilojoule units, added in parentheses immediately following 
the statement of the caloric content.
    (i) Caloric content may be calculated by the following methods. 
Where either specific or general food factors are used, the factors 
shall be applied to the actual amount (i.e., before rounding) of food 
components (e.g., fat, carbohydrate, protein, or ingredients with 
specific food factors) present per serving.
    (A) Using specific Atwater factors (i. e., the Atwater method) given 
in Table 13, ``Energy Value of Foods--Basis and Derivation,'' by A. L. 
Merrill and B. K. Watt, United States Department of Agriculture (USDA) 
Handbook No. 74 (slightly revised, 1973), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is 
available from the Office of Nutritional Products, Labeling and Dietary 
Supplements (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD

[[Page 25]]

20740, or may be inspected at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.;
    (B) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate, and total fat, respectively, as described 
in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51 (the availability of this incorporation by reference is given in 
paragraph (c)(1)(i)(A) of this section);
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate less the amount of insoluble dietary fiber, 
and total fat, respectively, as described in USDA Handbook No. 74 
(slightly revised 1973) pp. 9-11, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of 
this incorporation by reference is given in paragraph (c)(1)(i)(A) of 
this section;
    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of this chapter, or by other means, as 
appropriate; or
    (E) Using bomb calorimetry data subtracting 1.25 calories per gram 
protein to correct for incomplete digestibility, as described in USDA 
Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the 
availability of this incorporation by reference is given in paragraph 
(c)(1)(i)(A) of this section).
    (ii) ``Calories from fat'': A statement of the caloric content 
derived from total fat as defined in paragraph (c)(2) of this section in 
a serving, expressed to the nearest 5-calorie increment, up to and 
including 50 calories, and the nearest 10-calorie increment above 50 
calories, except that label declaration of ``calories from fat'' is not 
required on products that contain less than 0.5 gram of fat in a serving 
and amounts less than 5 calories may be expressed as zero. This 
statement shall be declared as provided in paragraph (d)(5) of this 
section. Except as provided for in paragraph (f) of this section, if 
``Calories from fat'' is not required and, as a result, not declared, 
the statement ``Not a significant source of calories from fat'' shall be 
placed at the bottom of the table of nutrient values in the same type 
size.
    (iii) ``Calories from saturated fat'' or ``Calories from saturated'' 
(VOLUNTARY): A statement of the caloric content derived from saturated 
fat as defined in paragraph (c)(2)(i) of this section in a serving may 
be declared voluntarily, expressed to the nearest 5-calorie increment, 
up to and including 50 calories, and the nearest 10-calorie increment 
above 50 calories, except that amounts less than 5 calories may be 
expressed as zero. This statement shall be indented under the statement 
of calories from fat as provided in paragraph (d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat in a serving defined as total lipid fatty acids and 
expressed as triglycerides. Amounts shall be expressed to the nearest 
0.5 (1/2) gram increment below 5 grams and to the nearest gram increment 
above 5 grams. If the serving contains less than 0.5 gram, the content 
shall be expressed as zero.
    (i) ``Saturated fat,'' or ``Saturated'': A statement of the number 
of grams of saturated fat in a serving defined as the sum of all fatty 
acids containing no double bonds, except that label declaration of 
saturated fat content information is not required for products that 
contain less than 0.5 gram of total fat in a serving if no claims are 
made about fat, fatty acid, or cholesterol content, and if ``calories 
from saturated fat'' is not declared. Except as provided for in 
paragraph (f) of this section, if a statement of the saturated fat 
content is not required and, as a result, not declared, the statement 
``Not a significant source of saturated fat'' shall be placed at the 
bottom of the table of nutrient values. Saturated fat content shall be 
indented and expressed as grams per serving to the nearest 0.5 gram (1/
2) gram increment below 5

[[Page 26]]

grams and to the nearest gram increment above 5 grams. If the serving 
contains less than 0.5 gram, the content shall be expressed as zero.
    (ii) ``Trans fat'' or ``Trans'': A statement of the number of grams 
of trans fat in a serving, defined as the sum of all unsaturated fatty 
acids that contain one or more isolated (i.e., nonconjugated) double 
bonds in a trans configuration, except that label declaration of trans 
fat content information is not required for products that contain less 
than 0.5 gram of total fat in a serving if no claims are made about fat, 
fatty acid or cholesterol content. The word ``trans'' may be italicized 
to indicate its Latin origin. Trans fat content shall be indented and 
expressed as grams per serving to the nearest 0.5 (1/2)-gram increment 
below 5 grams and to the nearest gram increment above 5 grams. If the 
serving contains less than 0.5 gram, the content, when declared, shall 
be expressed as zero. Except as provided for in paragraph (f) of this 
section, if a statement of the trans fat content is not required and, as 
a result, not declared, the statement ``Not a significant source of 
trans fat'' shall be placed at the bottom of the table of nutrient 
values.
    (iii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A 
statement of the number of grams of polyunsaturated fat in a serving 
defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may 
be declared voluntarily, except that when monounsaturated fat is 
declared, or when a claim about fatty acids or cholesterol is made on 
the label or in labeling of a food other than one that meets the 
criteria in Sec.  101.62(b)(1) for a claim for ``fat free,'' label 
declaration of polyunsaturated fat is required. Polyunsaturated fat 
content shall be indented and expressed as grams per serving to the 
nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram 
increment above 5 grams. If the serving contains less than 0.5 gram, the 
content shall be expressed as zero.
    (iv) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A 
statement of the number of grams of monounsaturated fat in a serving 
defined as cis-monounsaturated fatty acids may be declared voluntarily 
except that when polyunsaturated fat is declared, or when a claim about 
fatty acids or cholesterol is made on the label or in labeling of a food 
other than one that meets the criteria in Sec.  101.62(b)(1) for a claim 
for ``fat free,'' label declaration of monounsaturated fat is required. 
Monounsaturated fat content shall be indented and expressed as grams per 
serving to the nearest 0.5 (1/2) gram increment below 5 grams and to the 
nearest gram increment above 5 grams. If the serving contains less than 
0.5 gram, the content shall be expressed as zero.
    (3) ``Cholesterol'': A statement of the cholesterol content in a 
serving expressed in milligrams to the nearest 5-milligram increment, 
except that label declaration of cholesterol information is not required 
for products that contain less than 2 milligrams cholesterol in a 
serving and make no claim about fat, fatty acids, or cholesterol 
content, or such products may state the cholesterol content as zero. 
Except as provided for in paragraph (f) of this section, if cholesterol 
content is not required and, as a result, not declared, the statement 
``Not a significant source of cholesterol'' shall be placed at the 
bottom of the table of nutrient values in the same type size. If the 
food contains 2 to 5 milligrams of cholesterol per serving, the content 
may be stated as ``less than 5 milligrams.''
    (4) ``Sodium'': A statement of the number of milligrams of sodium in 
a specified serving of food expressed as zero when the serving contains 
less than 5 milligrams of sodium, to the nearest 5-milligram increment 
when the serving contains 5 to 140 milligrams of sodium, and to the 
nearest 10-milligram increment when the serving contains greater than 
140 milligrams.
    (5) ``Potassium'' (VOLUNTARY): A statement of the number of 
milligrams of potassium in a specified serving of food may be declared 
voluntarily, except that when a claim is made about potassium content, 
label declaration shall be required. Potassium content shall be 
expressed as zero when the serving contains less than 5 milligrams of 
potassium, to the nearest 5-milligram increment when the serving 
contains less than or equal to 140 milligrams of potassium, and to the 
nearest

[[Page 27]]

10-milligram increment when the serving contains more than 140 
milligrams.
    (6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement 
of the number of grams of total carbohydrate in a serving expressed to 
the nearest gram, except that if a serving contains less than 1 gram, 
the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may 
be used as an alternative, or if the serving contains less than 0.5 
gram, the content may be expressed as zero. Total carbohydrate content 
shall be calculated by subtraction of the sum of the crude protein, 
total fat, moisture, and ash from the total weight of the food. This 
calculation method is described in A. L. Merrill and B. K. Watt, 
``Energy Value of Foods--Basis and Derivation,'' USDA Handbook 74 
(slightly revised 1973) pp. 2 and 3, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability 
of this incorporation by reference is given in paragraph (c)(1)(i)(A) of 
this section).
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber in a serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be expressed 
as zero. Except as provided for in paragraph (f) of this section, if 
dietary fiber content is not required and as a result, not declared, the 
statement ``Not a significant source of dietary fiber'' shall be placed 
at the bottom of the table of nutrient values in the same type size.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber in a serving may be declared voluntarily 
except when a claim is made on the label or in labeling about soluble 
fiber, label declaration shall be required. Soluble fiber content shall 
be indented under dietary fiber and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the content 
may be expressed as zero.
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber in a serving may be declared 
voluntarily except that when a claim is made on the label or in labeling 
about insoluble fiber, label declaration shall be required. Insoluble 
fiber content shall be indented under dietary fiber and expressed to the 
nearest gram except that if a serving contains less than 1 gram, the 
statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be 
used as an alternative, and if the serving contains less than 0.5 gram, 
the content may be expressed as zero.
    (ii) ``Sugars'': A statement of the number of grams of sugars in a 
serving, except that label declaration of sugars content is not required 
for products that contain less than 1 gram of sugars in a serving if no 
claims are made about sweeteners, sugars, or sugar alcohol content. 
Except as provided for in paragraph (f) of this section, if a statement 
of the sugars content is not required and, as a result, not declared, 
the statement ``Not a significant source of sugars'' shall be placed at 
the bottom of the table of nutrient values in the same type size. Sugars 
shall be defined as the sum of all free mono- and disaccharides (such as 
glucose, fructose, lactose, and sucrose). Sugars content shall be 
indented and expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less then 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero.
    (iii) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols in a serving may be declared voluntarily on the 
label, except that when a claim is made on the label or in labeling 
about sugar alcohol or sugars when sugar alcohols are present in the 
food, sugar alcohol content shall be declared. For nutrition labeling 
purposes, sugar alcohols are defined as the sum of saccharide 
derivatives in which a hydroxyl group replaces a ketone or aldehyde 
group and whose use in the food is listed by FDA (e.g., mannitol or 
xylitol) or is generally recognized as

[[Page 28]]

safe (e.g., sorbitol). In lieu of the term ``sugar alcohol,'' the name 
of the specific sugar alcohol (e.g., ``xylitol'') present in the food 
may be used in the nutrition label provided that only one sugar alcohol 
is present in the food. Sugar alcohol content shall be indented and 
expressed to the nearest gram, except that if a serving contains less 
than 1 gram, the statement ``Contains less then 1 gram'' or ``less than 
1 gram'' may be used as an alternative, and if the serving contains less 
than 0.5 gram, the content may be expressed as zero.
    (iv) ``Other carbohydrate'' (VOLUNTARY): A statement of the number 
of grams of other carbohydrates may be declared voluntarily. Other 
carbohydrates shall be defined as the difference between total 
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, 
except that if sugar alcohol is not declared (even if present), it shall 
be defined as the difference between total carbohydrate and the sum of 
dietary fiber and sugars. Other carbohydrate content shall be indented 
and expressed to the nearest gram, except that if a serving contains 
less than 1 gram, the statement ``Contains less than 1 gram'' or ``less 
than 1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero.
    (7) ``Protein'': A statement of the number of grams of protein in a 
serving, expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero. When the protein in foods represented or purported to be for 
adults and children 4 or more years of age has a protein quality value 
that is a protein digestibility-corrected amino acid score of less than 
20 expressed as a percent, or when the protein in a food represented or 
purported to be for children greater than 1 but less than 4 years of age 
has a protein quality value that is a protein digestibility-corrected 
amino acid score of less than 40 expressed as a percent, either of the 
following shall be placed adjacent to the declaration of protein content 
by weight: The statement ``not a significant source of protein,'' or a 
listing aligned under the column headed ``Percent Daily Value'' of the 
corrected amount of protein per serving, as determined in paragraph 
(c)(7)(ii) of this section, calculated as a percentage of the Daily 
Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, 
for protein and expressed as Percent of Daily Value. When the protein 
quality in a food as measured by the Protein Efficiency Ratio (PER) is 
less than 40 percent of the reference standard (casein) for a food 
represented or purported to be for infants, the statement ``not a 
significant source of protein'' shall be placed adjacent to the 
declaration of protein content. Protein content may be calculated on the 
basis of the factor of 6.25 times the nitrogen content of the food as 
determined by the appropriate method of analysis as given in the 
``Official Methods of Analysis of the AOAC International'' (formerly the 
Association of Official Analytical Chemists), 15th Ed. (1990), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, except when the official procedure for a specific food requires 
another factor. Copies may be obtained from AOAC INTERNATIONAL, 481 
North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be 
inspected at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, call 202-
741-6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.
    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the RDI or DRV for protein, as appropriate, and expressed 
as Percent of Daily Value, may be placed on the label, except that such 
a statement shall be given if a protein claim is made for the product, 
or if the product is represented or purported to be for use by infants 
or children under 4 years of age. When such a declaration is provided, 
it shall be placed on the label adjacent to the statement of grams of 
protein and aligned under the column

[[Page 29]]

headed ``Percent Daily Value,'' and expressed to the nearest whole 
percent. However, the percentage of the RDI for protein shall not be 
declared if the food is represented or purported to be for use by 
infants and the protein quality value is less than 40 percent of the 
reference standard.
    (ii) The ``corrected amount of protein (gram) per serving'' for 
foods represented or purported for adults and children 1 or more years 
of age is equal to the actual amount of protein (gram) per serving 
multiplied by the amino acid score corrected for protein digestibility. 
If the corrected score is above 1.00, then it shall be set at 1.00. The 
protein digestibility-corrected amino acid score shall be determined by 
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality 
Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation,'' Rome, 1990, except that when official AOAC 
procedures described in section (c)(7) of this paragraph require a 
specific food factor other than 6.25, that specific factor shall be 
used. The ``Report of the Joint FAO/WHO Expert Consultation on Protein 
Quality Evaluation'' as published by the Food and Agriculture 
Organization of the United Nations/World Health Organization is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies are available from the Center for Food Safety and 
Applied Nutrition (HFS-800), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, or may be inspected at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. For foods represented or purported for 
infants, the corrected amount of protein (grams) per serving is equal to 
the actual amount of protein (grams) per serving multiplied by the 
relative protein quality value. The relative protein quality value shall 
be determined by dividing the subject food protein PER value by the PER 
value for casein. If the relative protein value is above 1.00, it shall 
be set at 1.00.
    (iii) For the purpose of labeling with a percent of the Daily 
Reference Value (DRV) or RDI, a value of 50 grams of protein shall be 
the DRV for adults and children 4 or more years of age, and the RDI for 
protein for children less than 4 years of age, infants, pregnant women, 
and lactating women shall be 16 grams, 14 grams, 60 grams, and 65 grams, 
respectively.
    (8) Vitamins and minerals: A statement of the amount per serving of 
the vitamins and minerals as described in this paragraph, calculated as 
a percent of the RDI and expressed as percent of Daily Value.
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d), (e), and (f) of this section, foods 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women shall use the RDI's 
that are specified for the intended group. For foods represented or 
purported to be for use by both infants and children under 4 years of 
age, the percent of Daily Value shall be presented by separate 
declarations according to paragraph (e) of this section based on the RDI 
values for infants from birth to 12 months of age and for children under 
4 years of age. Similarly, the percent of Daily Value based on both the 
RDI values for pregnant women and for lactating women shall be declared 
separately on foods represented or purported to be for use by both 
pregnant and lactating women. When such dual declaration is used on any 
label, it shall be included in all labeling, and equal prominence shall 
be given to both values in all such labeling. All other foods shall use 
the RDI for adults and children 4 or more years of age.
    (ii) The declaration of vitamins and minerals as a percent of the 
RDI shall include vitamin A, vitamin C, calcium, and iron, in that 
order, and shall include any of the other vitamins and minerals listed 
in paragraph (c)(8)(iv) of this section when they are added as a 
nutrient supplement, or when a claim is made about them. Other vitamins 
and minerals need not be declared if neither the nutrient nor the 
component is otherwise referred to on the label or in labeling or 
advertising and the vitamins and minerals are:

[[Page 30]]

    (A) Required or permitted in a standardized food (e.g., thiamin, 
riboflavin, and niacin in enriched flour) and that standardized food is 
included as an ingredient (i.e., component) in another food; or
    (B) Included in a food solely for technological purposes and 
declared only in the ingredient statement. The declaration may also 
include any of the other vitamins and minerals listed in paragraph 
(c)(8)(iv) of this section when they are naturally occurring in the 
food. The additional vitamins and minerals shall be listed in the order 
established in paragraph (c)(8)(iv) of this section.
    (iii) The percentages for vitamins and minerals shall be expressed 
to the nearest 2-percent increment up to and including the 10-percent 
level, the nearest 5-percent increment above 10 percent and up to and 
including the 50-percent level, and the nearest 10-percent increment 
above the 50-percent level. Amounts of vitamins and minerals present at 
less than 2 percent of the RDI are not required to be declared in 
nutrition labeling but may be declared by a zero or by the use of an 
asterisk (or other symbol) that refers to another asterisk (or symbol) 
that is placed at the bottom of the table and that is followed by the 
statement ``Contains less than 2 percent of the Daily Value of this 
(these) nutrient (nutrients)'' or ``Contains < 2 percent of the Daily 
Value of this (these) nutrient (nutrients).'' Alternatively, except as 
provided for in paragraph (f) of this section, if vitamin A, vitamin C, 
calcium, or iron is present in amounts less than 2 percent of the RDI, 
label declaration of the nutrient(s) is not required if the statement 
``Not a significant source of -- (listing the vitamins or minerals 
omitted)'' is placed at the bottom of the table of nutrient values. 
Either statement shall be in the same type size as nutrients that are 
indented.
    (iv) The following RDI's and nomenclature are established for the 
following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units
Vitamin C, 60 milligrams
Calcium, 1,000 milligrams
Iron, 18 milligrams
Vitamin D, 400 International Units
Vitamin E, 30 International Units
Vitamin K, 80 micrograms
Thiamin, 1.5 milligrams
Riboflavin, 1.7 milligrams
Niacin, 20 milligrams
Vitamin B6, 2.0 milligrams
Folate, 400 micrograms
Vitamin B12, 6 micrograms
Biotin, 300 micrograms
Pantothenic acid, 10 milligrams
Phosphorus, 1,000 milligrams
Iodine, 150 micrograms
Magnesium, 400 milligrams
Zinc, 15 milligrams
Selenium, 70 micrograms
Copper, 2.0 milligrams
Manganese, 2.0 milligrams
Chromium, 120 micrograms
Molybdenum, 75 micrograms
Chloride, 3,400 milligrams

    (v) The following synonyms may be added in parentheses immediately 
following the name of the nutrient or dietary component:

Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
Folate--Folic acid or Folacin.
Alternatively, folic acid or folacin may be listed without parentheses 
in place of folate.

    (vi) A statement of the percent of vitamin A that is present as 
beta-carotene may be declared voluntarily. When the vitamins and 
minerals are listed in a single column, the statement shall be indented 
under the information on vitamin A. When vitamins and minerals are 
arrayed horizontally, the statement of percent shall be presented in 
parenthesis following the declaration of vitamin A and the percent DV of 
vitamin A in the food (e.g., ``Percent Daily Value: Vitamin A 50 (90 
percent as beta-carotene)''). When declared, the percentages shall be 
expressed in the same increments as are provided for vitamins and 
minerals in paragraph (c)(8)(iii) of this section.
    (9) For the purpose of labeling with a percent of the DRV, the 
following DRV's are established for the following food components based 
on the reference caloric intake of 2,000 calories:

------------------------------------------------------------------------
                                        Unit of
         Food component               measurement             DRV
------------------------------------------------------------------------
Fat.............................  gram (g)..........  65
Saturated fatty acids...........  do................  20
Cholesterol.....................  milligrams (mg)...  300

[[Page 31]]

 
Total carbohydrate..............  grams (g).........  300
Fiber...........................  do................  25
Sodium..........................  milligrams (mg)...  2,400
Potassium.......................  do................  3,500
Protein.........................  grams (g).........  50
------------------------------------------------------------------------

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on foods in the following format, as shown in 
paragraph (d)(12) of this section, except on foods on which dual columns 
of nutrition information are declared as provided for in paragraph (e) 
of this section, on those food products on which the simplified format 
is required to be used as provided for in paragraph (f) of this section, 
on foods for infants and children less than 4 years of age as provided 
for in paragraph (j)(5) of this section, and on foods in small or 
intermediate-sized packages as provided for in paragraph (j)(13) of this 
section. In the interest of uniformity of presentation, FDA urges that 
the nutrition information be presented using the graphic specifications 
set forth in appendix B to part 101.
    (i) The nutrition information shall be set off in a box by use of 
hairlines and shall be all black or one color type, printed on a white 
or other neutral contrasting background whenever practical.
    (ii) All information within the nutrition label shall utilize:
    (A) Except as provided for in paragraph (c)(2)(ii) of this section, 
a single easy-to-read type style,
    (B) Upper and lower case letters,
    (C) At least one point leading (i.e., space between two lines of 
text) except that at least four points leading shall be utilized for the 
information required by paragraphs (d)(7) and (d)(8) of this section as 
shown in paragraph (d)(12), and
    (D) Letters should never touch.
    (iii) Information required in paragraphs (d)(3), (d)(5), (d)(7), and 
(d)(8) of this section shall be in type size no smaller than 8 point. 
Except for the heading ``Nutrition Facts,'' the information required in 
paragraphs (d)(4), (d)(6), and (d)(9) of this section and all other 
information contained within the nutrition label shall be in type size 
no smaller than 6 point. When provided, the information described in 
paragraph (d)(10) of this section shall also be in type no smaller than 
6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(4), and (d)(6) 
of this section (i.e., ``Nutrition Facts,'' ``Amount per Serving,'' and 
``% Daily Value*''), the names of all nutrients that are not indented 
according to requirements of paragraph (c) of this section (i.e., 
``Calories,'' ``Total Fat,'' ``Cholesterol,'' ``Sodium,'' ``Total 
Carbohydrate,'' and ``Protein''), and the percentage amounts required by 
paragraph (d)(7)(ii) of this section shall be highlighted by bold or 
extra bold type or other highlighting (reverse printing is not permitted 
as a form of highlighting) that prominently distinguishes it from other 
information. No other information shall be highlighted.
    (v) A hairline rule that is centered between the lines of text shall 
separate ``Amount Per Serving'' from the calorie statements required in 
paragraph (d)(5) of this section and shall separate each nutrient and 
its corresponding percent Daily Value required in paragraphs (d)(7)(i) 
and (d)(7)(ii) of this section from the nutrient and percent Daily Value 
above and below it, as shown in paragraph (d)(12) of this section.
    (2) The information shall be presented under the identifying heading 
of ``Nutrition Facts'' which shall be set in a type size larger than all 
other print size in the nutrition label and, except for labels presented 
according to the format provided for in paragraph (d)(11) of this 
section, unless impractical, shall be set the full width of the 
information provided under paragraph (d)(7) of this section, as shown in 
paragraph (d)(12) of this section.
    (3) Information on serving size shall immediately follow the heading 
as shown in paragraph (d)(12) of this section. Such information shall 
include:
    (i) ``Serving Size'': A statement of the serving size as specified 
in paragraph (b)(7) of this section.
    (ii) ``Servings Per Container'': The number of servings per 
container, except that this statement is not required on single serving 
containers as defined in paragraph (b)(6) of this section or on other 
food containers when this information is stated in the net quantity of 
contents declaration.

[[Page 32]]

    (4) A subheading ``Amount Per Serving'' shall be separated from 
serving size information by a bar as shown in paragraph (d)(12) of this 
section.
    (5) Information on calories shall immediately follow the heading 
``Amount Per Serving'' and shall be declared in one line, leaving 
sufficient space between the declaration of ``Calories'' and ``Calories 
from fat'' to allow clear differentiation, or, if ``Calories from 
saturated fat'' is declared, in a column with total ``Calories'' at the 
top, followed by ``Calories from fat'' (indented), and ``Calories from 
saturated fat'' (indented).
    (6) The column heading ``% Daily Value,'' followed by an asterisk 
(e.g., ``% Daily Value*''), shall be separated from information on 
calories by a bar as shown in paragraph (d)(12) of this section. The 
position of this column heading shall allow for a list of nutrient names 
and amounts as described in paragraph (d)(7) of this section to be to 
the left of, and below, this column heading. The column headings 
``Percent Daily Value,'' ``Percent DV,'' or ``% DV'' may be substituted 
for ``% Daily Value.''
    (7) Except as provided for in paragraph (j)(13) of this section, 
nutrient information for both mandatory and any voluntary nutrients 
listed in paragraph (c) of this section that are to be declared in the 
nutrition label, except vitamins and minerals, shall be declared as 
follows:
    (i) The name of each nutrient, as specified in paragraph (c) of this 
section, shall be given in a column and followed immediately by the 
quantitative amount by weight for that nutrient appended with a ``g'' 
for grams or a ``mg'' for milligrams as shown in paragraph (d)(12) of 
this section. The symbol ``<'' may be used in place of ``less than.''
    (ii) A listing of the percent of the DRV as established in 
paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a 
column aligned under the heading ``% Daily Value'' established in 
paragraph (d)(6) of this section with the percent expressed to the 
nearest whole percent for each nutrient declared in the column described 
in paragraph (d)(7)(i) of this section for which a DRV has been 
established, except that the percent for protein may be omitted as 
provided in paragraph (c)(7) of this section. The percent shall be 
calculated by dividing either the amount declared on the label for each 
nutrient or the actual amount of each nutrient (i.e., before rounding) 
by the DRV for the nutrient, except that the percent for protein shall 
be calculated as specified in paragraph (c)(7)(ii) of this section. The 
numerical value shall be followed by the symbol for percent (i.e., %).
    (8) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed horizontally (e.g., Vitamin A 4%, Vitamin C 2%, Calcium 15%, 
Iron 4%) or may be listed in two columns as shown in paragraph (d)(12) 
of this section, except that when more than four vitamins and minerals 
are declared, they may be declared vertically with percentages listed 
under the column headed ``% Daily Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath the 
list of vitamins and minerals and shall be separated from that list by a 
hairline.
    (i) The footnote shall state:
    Percent Daily Values are based on a 2,000 calorie diet.
    Your daily values may be higher or lower depending on your calorie 
needs.

------------------------------------------------------------------------
                                      Calories:       2,000      2,500
------------------------------------------------------------------------
Total fat........................  Less than             65 g       80 g
Saturated fat....................  Less than             20 g       25 g
Cholesterol......................  Less than           300 mg     300 mg
Sodium...........................  Less than         2,400 mg   2,400 mg
Total carbohydrate...............  ...............      300 g      375 g
Dietary fiber....................  ...............       25 g       30 g
------------------------------------------------------------------------

    (ii) If the percent of Daily Value is given for protein in the 
Percent of Daily Value column as provided in paragraph (d)(7)(ii) of 
this section, protein shall be listed under dietary fiber, and a value 
of 50 g shall be inserted on the same line in the column headed 
``2,000'' and a value of 65 g in the column headed ``2,500''.
    (iii) If potassium is declared in the column described in paragraph 
(d)(7)(i) of this section, potassium shall be listed under sodium and 
the DRV established in paragraph (c)(9) of this section shall be 
inserted on the same line in the numeric columns.

[[Page 33]]

    (iv) The abbreviations established in paragraph (j)(13)(ii)(B) of 
this section may be used within the footnote.
    (10) Caloric conversion information on a per gram basis for fat, 
carbohydrate, and protein may be presented beneath the information 
required in paragraph (d)(9) of this section, separated from that 
information by a hairline. This information may be presented 
horizontally as shown in paragraph (d)(12) of this section (i.e., 
``Calories per gram: fat 9, carbohydrate 4, protein 4'') or vertically 
in columns.
    (11)(i) If the space beneath the information on vitamins and 
minerals is not adequate to accommodate the information required in 
paragraph (d)(9) of this section, the information required in paragraph 
(d)(9) may be moved to the right of the column required in paragraph 
(d)(7)(ii) of this section and set off by a line that distinguishes it 
and sets it apart from the percent Daily Value information. The caloric 
conversion information provided for in paragraph (d)(10) of this section 
may be presented beneath either side or along the full length of the 
nutrition label.
    (ii) If the space beneath the mandatory declaration of iron is not 
adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in paragraph (d)(9) of this 
section, the remaining information may be moved to the right and set off 
by a line that distinguishes it and sets it apart from the nutrients and 
the percent DV information given to the left. The caloric conversion 
information provided for in paragraph (d)(10) of this section may be 
presented beneath either side or along the full length of the nutrition 
label.
    (iii) If there is not sufficient continuous vertical space (i.e., 
approximately 3 in) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of iron, 
the nutrition label may be presented in a tabular display as shown 
below.
[GRAPHIC] [TIFF OMITTED] TR11JY03.000


[[Page 34]]


    (12) The following sample label illustrates the provisions of 
paragraph (d) of this section.
[GRAPHIC] [TIFF OMITTED] TR11JY03.001

    (13)(i) Nutrition labels on the outer label of packages of products 
that contain two or more separately packaged foods that are intended to 
be eaten individually (e.g., variety packs of cereals or snack foods) or 
of packages that are used interchangeably for the same type of food 
(e.g., round ice cream containers) may use an aggregate display.
    (ii) Aggregate displays shall comply with the format requirements of 
paragraph (d) of this section to the maximum extent possible, except 
that the identity of each food shall be specified immediately under the 
``Nutrition Facts'' title, and both the quantitative amount by weight 
(i.e., g/mg amounts) and the percent Daily Value for each nutrient shall 
be listed in separate columns under the name of each food. The following 
sample label illustrates an aggregate display.

[[Page 35]]

[GRAPHIC] [TIFF OMITTED] TR11JY03.002

    (14) In accordance with Sec.  101.15(c)(2), when nutrition labeling 
must appear in a second language, the nutrition information may be 
presented in a separate nutrition label for each language or in one 
nutrition label with the information in the second language following 
that in English. Numeric characters that are identical in both languages 
need not be repeated (e.g., ``Protein/Proteinas 2 g''). All required 
information must be included in both languages.
    (e) Nutrition information may be presented for two or more forms of 
the same food (e.g., both ``as purchased'' and ``as prepared'') or for 
common combinations of food as provided for in paragraph (h)(4) of this 
section, for different units (e.g., slices of bread or per 100 grams) as 
provided for in paragraph (b) of this section, or for two or more groups 
for which RDI's are established (e.g., both infants and children less 
than 4 years of age) as shown in paragraph (e)(5) of this section. When 
such dual labeling is provided, equal prominence shall be given to both 
sets of values. Information shall be presented in a format consistent 
with paragraph (d) of this section, except that:
    (1) Following the subheading of ``Amount Per Serving,'' there shall 
be two or more column headings accurately describing the forms of the 
same food (e.g., ``Mix'' and ``Baked''), the combinations of food, the 
units, or the RDI groups that are being declared. The column 
representing the product as packaged and according to the label serving 
size based on the reference

[[Page 36]]

amount in Sec.  101.12(b) shall be to the left of the numeric columns.
    (2) When the dual labeling is presented for two or more forms of the 
same food, for combinations of food, or for different units, total 
calories and calories from fat (and calories from saturated fat, when 
declared) shall be listed in a column and indented as specified in 
paragraph (d)(5) of this section with quantitative amounts declared in 
columns aligned under the column headings set forth in paragraph (e)(1) 
of this section.
    (3) Quantitative information by weight required in paragraph 
(d)(7)(i) of this section shall be specified for the form of the product 
as packaged and according to the label serving size based on the 
reference amount in Sec.  101.12(b).
    (i) Quantitative information by weight may be included for other 
forms of the product represented by the additional column(s) either 
immediately adjacent to the required quantitative information by weight 
for the product as packaged and according to the label serving size 
based on the reference amount in Sec.  101.12(b) or as a footnote.
    (A) If such additional quantitative information is given immediately 
adjacent to the required quantitative information, it shall be declared 
for all nutrients listed and placed immediately following and 
differentiated from the required quantitative information (e.g., 
separated by a comma). Such information shall not be put in a separate 
column.
    (B) If such additional quantitative information is given in a 
footnote, it shall be declared in the same order as the nutrients are 
listed in the nutrition label. The additional quantitative information 
may state the total nutrient content of the product identified in the 
second column or the nutrient amounts added to the product as packaged 
for only those nutrients that are present in different amounts than the 
amounts declared in the required quantitative information. The footnote 
shall clearly identify which amounts are declared. Any subcomponents 
declared shall be listed parenthetically after principal components 
(e.g., 1/2 cup skim milk contributes an additional 40 calories, 65 mg 
sodium, 6 g total carbohydrate (6 g sugars), and 4 g protein).
    (ii) Total fat and its quantitative amount by weight shall be 
followed by an asterisk (or other symbol) (e.g., ``Total fat (2 g)*'') 
referring to another asterisk (or symbol) at the bottom of the nutrition 
label identifying the form(s) of the product for which quantitative 
information is presented.
    (4) Information required in paragraphs (d)(7)(ii) and (d)(8) of this 
section shall be presented under the subheading ``% DAILY VALUE'' and in 
columns directly under the column headings set forth in paragraph (e)(1) 
of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:

[[Page 37]]

[GRAPHIC] [TIFF OMITTED] TR11JY03.003

    (f) The declaration of nutrition information may be presented in the 
simplified format set forth herein when a food product contains 
insignificant amounts of eight or more of the following: Calories, total 
fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, 
dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, and iron; 
except that for foods intended for children less than 2 years of age to 
which Sec.  101.9(j)(5)(i) applies, nutrition information may be 
presented in the simplified format when a food product contains 
insignificant amounts of six or more of the following: Calories, total 
fat, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin 
A, vitamin C, calcium, and iron.
    (1) An ``insignificant amount'' shall be defined as that amount that 
allows a declaration of zero in nutrition labeling, except that for 
total carbohydrate, dietary fiber, and protein, it shall be an amount 
that allows a declaration of ``less than 1 gram.''
    (2) The simplified format shall include information on the following 
nutrients:
    (i) Total calories, total fat, total carbohydrate, protein, and 
sodium;
    (ii) Calories from fat and any other nutrients identified in 
paragraph (f) of this section that are present in the food in more than 
insignificant amounts; and
    (iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of 
this section when they are required to be added as a nutrient supplement 
to foods for which a standard of identity exists.
    (iv) Any vitamins or minerals listed in paragraph (c)(8)(iv) of this 
section voluntarily added to the food as nutrient supplements.
    (3) Other nutrients that are naturally present in the food in more 
than insignificant amounts may be voluntarily declared as part of the 
simplified format.
    (4) If any nutrients are declared as provided in paragraphs 
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the 
simplified format or if any nutrition claims are made on the label or in 
labeling, the statement ``Not a significant source of ------'' (with the 
blank filled in with the name(s) of any nutrient(s) identified in Sec.  
101.9(f) and calories from fat that are present in insignificant 
amounts) shall be included at the bottom of the nutrition label.
    (5) Except as provided for in paragraphs (j)(5) and (j)(13) of this 
section, nutrient information declared in the simplified format shall be 
presented in the same manner as specified in paragraphs (d) or (e) of 
this section, except that the footnote required in paragraph (d)(9) of 
this section is not required. When the footnote is omitted, an asterisk 
shall be placed at the bottom of the label followed by the statement 
``Percent Daily Values are based on a 2,000 calorie diet'' and, if the 
term ``Daily Value'' is not spelled out in the heading, a statement that 
``DV'' represents ``Daily Value.''

[[Page 38]]

    (g) Compliance with this section shall be determined as follows:
    (1) A collection of primary containers or units of the same size, 
type, and style produced under conditions as nearly uniform as possible, 
designated by a common container code or marking, or in the absence of 
any common container code or marking, a day's production, constitutes a 
``lot.''
    (2) The sample for nutrient analysis shall consist of a composite of 
12 subsamples (consumer units), taken 1 from each of 12 different 
randomly chosen shipping cases, to be representative of a lot. Unless a 
particular method of analysis is specified in paragraph (c) of this 
section, composites shall be analyzed by appropriate methods as given in 
the ``Official Methods of Analysis of the AOAC International,'' 15th Ed. 
(1990), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) or 1 CFR part 51 or, if no AOAC method is available or 
appropriate, by other reliable and appropriate analytical procedures. 
The availability of this incorporation by reference is given in 
paragraph (c)(7) of this section.
    (3) Two classes of nutrients are defined for purposes of compliance:
    (i) Class I. Added nutrients in fortified or fabricated foods; and
    (ii) Class II. Naturally occurring (indigenous) nutrients. If any 
ingredient which contains a naturally occurring (indigenous) nutrient is 
added to a food, the total amount of such nutrient in the final food 
product is subject to class II requirements unless the same nutrient is 
also added.
    (4) A food with a label declaration of a vitamin, mineral, protein, 
total carbohydrate, dietary fiber, other carbohydrate, polyunsaturated 
or monounsaturated fat, or potassium shall be deemed to be misbranded 
under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) unless it meets the following requirements:
    (i) Class I vitamin, mineral, protein, dietary fiber, or potassium. 
The nutrient content of the composite is at least equal to the value for 
that nutrient declared on the label.
    (ii) Class II vitamin, mineral, protein, total carbohydrate, dietary 
fiber, other carbohydrate, polyunsaturated or monounsaturated fat, or 
potassium. The nutrient content of the composite is at least equal to 80 
percent of the value for that nutrient declared on the label. Provided, 
That no regulatory action will be based on a determination of a nutrient 
value that falls below this level by a factor less than the variability 
generally recognized for the analytical method used in that food at the 
level involved.
    (5) A food with a label declaration of calories, sugars, total fat, 
saturated fat, trans fat, cholesterol, or sodium shall be deemed to be 
misbranded under section 403(a) of the act if the nutrient content of 
the composite is greater than 20 percent in excess of the value for that 
nutrient declared on the label. Provided, That no regulatory action will 
be based on a determination of a nutrient value that falls above this 
level by a factor less than the variability generally recognized for the 
analytical method used in that food at the level involved.
    (6) Reasonable excesses of a vitamin, mineral, protein, total 
carbohydrate, dietary fiber, other carbohydrate, polyunsaturated or 
monounsaturated fat, or potassium over labeled amounts are acceptable 
within current good manufacturing practice. Reasonable deficiencies of 
calories, sugars, total fat, saturated fat, trans fat, cholesterol, or 
sodium under labeled amounts are acceptable within current good 
manufacturing practice.
    (7) Compliance will be based on the metric measure specified in the 
label statement of serving size.
    (8) Compliance with the provisions set forth in paragraphs (g)(1) 
through (g)(6) of this section may be provided by use of an FDA approved 
data base that has been computed following FDA guideline procedures and 
where food samples have been handled in accordance with current good 
manufacturing practice to prevent nutrition loss. FDA approval of a data 
base shall not be considered granted until the Center for Food Safety 
and Applied Nutrition has agreed to all aspects of the data base in 
writing. The approval will be granted where a clear need is presented 
(e.g., raw produce and seafood). Approvals will be in effect for a 
limited time, e.g.,

[[Page 39]]

10 years, and will be eligible for renewal in the absence of significant 
changes in agricultural or industry practices. Approval requests shall 
be submitted in accordance with the provisions of Sec.  10.30 of this 
chapter. Guidance in the use of data bases may be found in the ``FDA 
Nutrition Labeling Manual--A Guide for Developing and Using Data 
Bases,'' available from the Office of Nutritional Products, Labeling and 
Dietary Supplements (HFS-800), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740.
    (9) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section (e.g., to develop adequate nutrient 
profiles to comply with the requirements of paragraph (c) of this 
section), FDA may permit alternative means of compliance or additional 
exemptions to deal with the situation. Firms in need of such special 
allowances shall make their request in writing to the Center for Food 
Safety and Applied Nutrition (HFS-800), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740.
    (h) Products with separately packaged ingredients or foods, with 
assortments of food, or to which other ingredients are added by the user 
may be labeled as follows:
    (1) If a product consists of two or more separately packaged 
ingredients enclosed in an outer container or of assortments of the same 
type of food (e.g., assorted nuts or candy mixtures) in the same retail 
package, nutrition labeling shall be located on the outer container or 
retail package (as the case may be) to provide information for the 
consumer at the point of purchase. However, when two or more food 
products are simply combined together in such a manner that no outer 
container is used, or no outer label is available, each product shall 
have its own nutrition information, e.g., two boxes taped together or 
two cans combined in a clear plastic overwrap. When separately packaged 
ingredients or assortments of the same type of food are intended to be 
eaten at the same time, the nutrition information may be specified per 
serving for each component or as a composite value.
    (2) If a product consists of two or more separately packaged foods 
that are intended to be eaten individually and that are enclosed in an 
outer container (e.g., variety packs of cereals or snack foods), the 
nutrition information shall:
    (i) Be specified per serving for each food in a location that is 
clearly visible to the consumer at the point of purchase; and
    (ii) Be presented in separate nutrition labels or in one aggregate 
nutrition label with separate columns for the quantitative amount by 
weight and the percent Daily Value for each food.
    (3) If a package contains a variety of foods, or an assortment of 
foods, and is in a form intended to be used as a gift, the nutrition 
labeling shall be in the form required by paragraphs (a) through (f) of 
this section, but it may be modified as follows:
    (i) Nutrition information may be presented on the label of the outer 
package or in labeling within or attached to the outer package.
    (ii) In the absence of a reference amount customarily consumed in 
Sec.  101.12(b) that is appropriate for the variety or assortment of 
foods in a gift package, 1 ounce for solid foods, 2 fluid ounces for 
nonbeverage liquids (e.g., syrups), and 8 fluid ounces for beverages may 
be used as the standard serving size for purposes of nutrition labeling 
of foods subject to this paragraph. However, the reference amounts 
customarily consumed in Sec.  101.12(b) shall be used for purposes of 
evaluating whether individual foods in a gift package qualify for 
nutrient content claims or health claims.
    (iii) The number of servings per container may be stated as 
``varied.''
    (iv) Nutrition information may be provided per serving for 
individual foods in the package, or, alternatively, as a composite per 
serving for reasonable categories of foods in the package having similar 
dietary uses and similar significant nutritional characteristics. 
Reasonable categories of foods may be used only if accepted by FDA. In 
determining whether a proposed category is reasonable, FDA will consider 
whether

[[Page 40]]

the values of the characterizing nutrients in the foods proposed to be 
in the category meet the compliance criteria set forth in paragraphs 
(g)(3) through (g)(6) of this section. Proposals for such categories may 
be submitted in writing to the Office of Nutritional Products, Labeling 
and Dietary Supplements (HFS-800), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740.
    (v) If a food subject to paragraph (j)(13) of this section because 
of its small size is contained in a gift package, the food need not be 
included in the determination of nutrition information under paragraph 
(h) of this section if it is not specifically listed in a promotional 
catalogue as being present in the gift package, and:
    (A) It is used in small quantities primarily to enhance the 
appearance of the gift package; or
    (B) It is included in the gift package as a free gift or promotional 
item.
    (4) If a food is commonly combined with other ingredients or is 
cooked or otherwise prepared before eating, and directions for such 
combination or preparations are provided, another column of figures may 
be used to declare nutrition information on the basis of the food as 
consumed in the format required in paragraph (e) of this section (e.g., 
a dry ready-to-eat cereal may be described with one set of Percent Daily 
Values for the cereal as sold (e.g., per ounce), and another set for the 
cereal and milk as suggested in the label (e.g., per ounce of cereal and 
1/2 cup of vitamin D fortified skim milk); and a cake mix may be labeled 
with one set of Percent Daily Values for the dry mix (per serving) and 
another set for the serving of the final cake when prepared): Provided, 
That, the type and quantity of the other ingredients to be added to the 
product by the user and the specific method of cooking and other 
preparation shall be specified prominently on the label.
    (i) Except as provided in paragraphs (j)(13) and (j)(17) of this 
section, the location of nutrition information on a label shall be in 
compliance with Sec.  101.2.
    (j) The following foods are exempt from this section or are subject 
to special labeling requirements:
    (1)(i) Food offered for sale by a person who makes direct sales to 
consumers (e.g., a retailer) who has annual gross sales made or business 
done in sales to consumers that is not more than $500,000 or has annual 
gross sales made or business done in sales of food to consumers of not 
more than $50,000, Provided, That the food bears no nutrition claims or 
other nutrition information in any context on the label or in labeling 
or advertising. Claims or other nutrition information subject the food 
to the provisions of this section.
    (ii) For purposes of this paragraph, calculation of the amount of 
sales shall be based on the most recent 2-year average of business 
activity. Where firms have been in business less than 2 years, 
reasonable estimates must indicate that annual sales will not exceed the 
amounts specified. For foreign firms that ship foods into the United 
States, the business activities to be included shall be the total amount 
of food sales, as well as other sales to consumers, by the firm in the 
United States.
    (2) Food products which are:
    (i) Served in restaurants, Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section;
    (ii) Served in other establishments in which food is served for 
immediate human consumption (e.g., institutional food service 
establishments, such as schools, hospitals, and cafeterias; 
transportation carriers, such as trains and airplanes; bakeries, 
delicatessens, and retail confectionery stores where there are 
facilities for immediate consumption on the premises; food service 
vendors, such as lunch wagons, ice cream shops, mall cookie counters, 
vending machines, and sidewalk carts where foods are generally consumed 
immediately where purchased or while the consumer is walking away, 
including similar foods sold from convenience stores; and food delivery 
systems or establishments where ready-to-eat foods are delivered to 
homes or offices), Provided, That the food bears no nutrition

[[Page 41]]

claims or other nutrition information in any context on the label or in 
labeling or advertising. Claims or other nutrition information subject 
the food to the provisions of this section;
    (iii) Sold only in such facilities, Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section;
    (iv) Used only in such facilities and not served to the consumer in 
the package in which they are received (e.g., foods that are not 
packaged in individual serving containers); or
    (v) Sold by a distributor who principally sells food to such 
facilities: Provided, That:
    (A) This exemption shall not be available for those foods that are 
manufactured, processed, or repackaged by that distributor for sale to 
any persons other than restaurants or other establishments that serve 
food for immediate human consumption, and
    (B) The manufacturer of such products is responsible for providing 
the nutrition information on the products if there is a reasonable 
possibility that the product will be purchased directly by consumers.
    (3) Food products that are:
    (i) Of the type of food described in paragraphs (j)(2)(i) and 
(j)(2)(ii) of this section,
    (ii) Ready for human consumption,
    (iii) Offered for sale to consumers but not for immediate human 
consumption,
    (iv) Processed and prepared primarily in a retail establishment, and
    (v) Not offered for sale outside of that establishment (e.g., ready-
to-eat foods that are processed and prepared on-site and sold by 
independent delicatessens, bakeries, or retail confectionery stores 
where there are no facilities for immediate human consumption; by in-
store delicatessen, bakery, or candy departments; or at self-service 
food bars such as salad bars), Provided, That the food bears no 
nutrition claims or other nutrition information in any context on the 
label or in labeling or advertising. Claims or other nutrition 
information subject the food to the provisions of this section.
    (4) Foods that contain insignificant amounts of all of the nutrients 
and food components required to be included in the declaration of 
nutrition information under paragraph (c) of this section, Provided, 
That the food bears no nutrition claims or other nutrition information 
in any context on the label or in labeling or advertising. Claims or 
other nutrition information subject the food to the provisions of this 
section. An insignificant amount of a nutrient or food component shall 
be that amount that allows a declaration of zero in nutrition labeling, 
except that for total carbohydrate, dietary fiber, and protein, it shall 
be an amount that allows a declaration of ``less than 1 gram.'' Examples 
of foods that are exempt under this paragraph include coffee beans 
(whole or ground), tea leaves, plain unsweetened instant coffee and tea, 
condiment-type dehydrated vegetables, flavor extracts, and food colors.
    (5)(i) Foods, other than infant formula, represented or purported to 
be specifically for infants and children less than 2 years of age shall 
bear nutrition labeling, except as provided in paragraph (j)(5)(ii) and 
except that such labeling shall not include calories from fat (paragraph 
(c)(1)(ii) of this section), calories from saturated fat ((c)(1)(iii)), 
saturated fat ((c)(2)(i)), polyunsaturated fat ((c)(2)(ii)), 
monounsaturated fat ((c)(2)(iii)), and cholesterol ((c)(3)).
    (ii) Foods, other than infant formula, represented or purported to 
be specifically for infants and children less than 4 years of age shall 
bear nutrition labeling, except that:
    (A) Such labeling shall not include declarations of percent of Daily 
Value for total fat, saturated fat, cholesterol, sodium, potassium, 
total carbohydrate, and dietary fiber;
    (B) Nutrient names and quantitative amounts by weight shall be 
presented in two separate columns.
    (C) The heading ``Percent Daily Value'' required in paragraph (d)(6) 
of this section shall be placed immediately below the quantitative 
information by weight for protein;
    (D) Percent of Daily Value for protein, vitamins, and minerals shall 
be listed immediately below the heading ``Percent Daily Value''; and

[[Page 42]]

    (E) Such labeling shall not include the footnote specified in 
paragraph (d)(9) of this section.
    (6) Dietary supplements, except that such foods shall be labeled in 
compliance with Sec.  101.36.
    (7) Infant formula subject to section 412 of the act, as amended, 
except that such foods shall be labeled in compliance with part 107 of 
this chapter.
    (8) Medical foods as defined in section 5(b) of the Orphan Drug Act 
(21 U.S.C. 360ee(b)(3)). A medical food is a food which is formulated to 
be consumed or administered enterally under the supervision of a 
physician and which is intended for the specific dietary management of a 
disease or condition for which distinctive nutritional requirements, 
based on recognized scientific principles, are established by medical 
evaluation. A food is subject to this exemption only if:
    (i) It is a specially formulated and processed product (as opposed 
to a naturally occurring foodstuff used in its natural state) for the 
partial or exclusive feeding of a patient by means of oral intake or 
enteral feeding by tube;
    (ii) It is intended for the dietary management of a patient who, 
because of therapeutic or chronic medical needs, has limited or impaired 
capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or 
certain nutrients, or who has other special medically determined 
nutrient requirements, the dietary management of which cannot be 
achieved by the modification of the normal diet alone;
    (iii) It provides nutritional support specifically modified for the 
management of the unique nutrient needs that result from the specific 
disease or condition, as determined by medical evaluation;
    (iv) It is intended to be used under medical supervision; and
    (v) It is intended only for a patient receiving active and ongoing 
medical supervision wherein the patient requires medical care on a 
recurring basis for, among other things, instructions on the use of the 
medical food.
    (9) Food products shipped in bulk form that are not for distribution 
to consumers in such form and that are for use solely in the manufacture 
of other foods or that are to be processed, labeled, or repacked at a 
site other than where originally processed or packed.
    (10) Raw fruits, vegetables, and fish subject to section 403(q)(4) 
of the act, except that the labeling of such foods should adhere to 
guidelines in Sec.  101.45. This exemption is contingent on the food 
bearing no nutrition claims or other nutrition information in any 
context on the label or in labeling or advertising. Claims or other 
nutrition information subject the food to nutrition labeling in 
accordance with Sec.  101.45. The term fish includes freshwater or 
marine fin fish, crustaceans, and mollusks, including shellfish, 
amphibians, and other forms of aquatic animal life.
    (11) Packaged single-ingredient products that consist of fish or 
game meat (i.e., animal products not covered under the Federal Meat 
Inspection Act or the Poultry Products Inspection Act, such as flesh 
products from deer, bison, rabbit, quail, wild turkey, or ostrich) 
subject to this section may provide required nutrition information for a 
3-ounce cooked edible portion (i.e., on an ``as prepared'' basis), 
except that:
    (i) Such products that make claims that are based on values as 
packaged must provide nutrition information on an as packaged basis, and
    (ii) Nutrition information is not required for custom processed fish 
or game meats.
    (12) Game meats (i.e., animal products not covered under the Federal 
Meat Inspection Act or the Poultry Products Inspection Act, such as 
flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich) 
may provide required nutrition information on labeling in accordance 
with the provisions of paragraph (a)(2) of this section.
    (13)(i) Foods in small packages that have a total surface area 
available to bear labeling of less than 12 square inches, Provided, That 
the labels for these foods bear no nutrition claims or other nutrition 
information in any context on the label or in labeling or advertising. 
Claims or other nutrition information subject the food to the provisions 
of this section.
    (A) The manufacturer, packer, or distributor shall provide on the 
label of packages that qualify for and use this

[[Page 43]]

exemption an address or telephone number that a consumer can use to 
obtain the required nutrition information (e.g., ``For nutrition 
information, call 1-800-123-4567'').
    (B) When such products bear nutrition labeling, either voluntarily 
or because nutrition claims or other nutrition information is provided, 
all required information shall be in type size no smaller than 6 point 
or all uppercase type of 1/16 inches minimum height, except that 
individual serving-size packages of food served with meals in 
restaurants, institutions, and on board passenger carriers, and not 
intended for sale at retail, may comply with Sec.  101.2(c)(5).
    (ii) Foods in packages that have a total surface area available to 
bear labeling of 40 or less square inches may modify the requirements of 
paragraphs (c) through (f) and (i) of this section by one or more of the 
following means:
    (A) Presenting the required nutrition information in a tabular or, 
as provided below, linear (i.e., string) fashion rather than in vertical 
columns if the product has a total surface area available to bear 
labeling of less than 12 square inches, or if the product has a total 
surface area available to bear labeling of 40 or less square inches and 
the package shape or size cannot accommodate a standard vertical column 
or tabular display on any label panel. Nutrition information may be 
given in a linear fashion only if the label will not accommodate a 
tabular display.
    (1) The following sample label illustrates the tabular display.
    [GRAPHIC] [TIFF OMITTED] TR11JY03.004
    
    (2) The following sample label illustrates the linear display. When 
nutrition information is given in a linear fashion, bolding is required 
only on the title ``Nutrition Facts`` and is allowed voluntarily for the 
nutrient names for ``Calories,'' ``Total fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total carbohydrate,'' and ``Protein.''
[GRAPHIC] [TIFF OMITTED] TR11JY03.005

    (B) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from fat--Fat cal
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb

[[Page 44]]

Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Other carbohydrate--Other carb

    (C) Omitting the footnote required in paragraph (d)(9) of this 
section and placing another asterisk at the bottom of the label followed 
by the statement ``Percent Daily Values are based on a 2,000 calorie 
diet`` and, if the term ``Daily Value'' is not spelled out in the 
heading, a statement that ``DV'' represents ``Daily Value.''
    (D) Presenting the required nutrition information on any label 
panel.
    (14) Shell eggs packaged in a carton that has a top lid designed to 
conform to the shape of the eggs are exempt from outer carton label 
requirements where the required nutrition information is clearly 
presented immediately beneath the carton lid or in an insert that can be 
clearly seen when the carton is opened.
    (15) The unit containers in a multiunit retail food package where:
    (i) The multiunit retail food package labeling contains all 
nutrition information in accordance with the requirements of this 
section;
    (ii) The unit containers are securely enclosed within and not 
intended to be separated from the retail package under conditions of 
retail sale; and
    (iii) Each unit container is labeled with the statement ``This Unit 
Not Labeled For Retail Sale'' in type size not less than 1/16-inch in 
height, except that this statement shall not be required when the inner 
unit containers bear no labeling at all. The word ``individual'' may be 
used in lieu of or immediately preceding the word ``Retail'' in the 
statement.
    (16) Food products sold from bulk containers: Provided, That 
nutrition information required by this section be displayed to consumers 
either on the labeling of the bulk container plainly in view or in 
accordance with the provisions of paragraph (a)(2) of this section.
    (17) Foods in packages that have a total surface area available to 
bear labeling greater than 40 square inches but whose principal display 
panel and information panel do not provide sufficient space to 
accommodate all required information may use any alternate panel that 
can be readily seen by consumers for the nutrition label. The space 
needed for vignettes, designs, and other nonmandatory label information 
on the principal display panel may be considered in determining the 
sufficiency of available space on the principal display panel for the 
placement of the nutrition label. Nonmandatory label information on the 
information panel shall not be considered in determining the sufficiency 
of available space for the placement of the nutrition label.
    (18) Food products that are low-volume (that is, they meet the 
requirements for units sold in paragraphs (j)(18)(i) or (j)(18)(ii) of 
this section); that, except as provided in paragraph (j)(18)(iv) of this 
section, are the subject of a claim for an exemption that provides the 
information required under paragraph (j)(18)(iv) of this section, that 
is filed before the beginning of the time period for which the exemption 
is claimed, and that is filed by a person, whether it is the 
manufacturer, packer, or distributor, that qualifies to claim the 
exemption under the requirements for average full-time equivalent 
employees in paragraphs (j)(18)(i) or (j)(18)(ii) of this section; and 
whose labels, labeling, and advertising do not provide nutrition 
information or make a nutrient content or health claim.
    (i) For food products first introduced into interstate commerce 
before May 8, 1994, the product shall be exempt for the period:
    (A) Between May 8, 1995, and May 7, 1996, if, for the period between 
May 8, 1994, and May 7, 1995, the person claiming the exemption employed 
fewer than an average of 300 full-time equivalent employees and fewer 
than 400,000 units of that product were sold in the United States; and
    (B) Between May 8, 1996, and May 7, 1997, if for the period between 
May 8, 1995, and May 7, 1996, the person claiming the exemption employed 
fewer than an average of 200 full-time equivalent employees and fewer 
than 200,000 units of that product were sold in the United States.
    (ii) For all other food products, the product shall be eligible for 
an exemption for any 12-month period if, for the

[[Page 45]]

preceding 12 months, the person claiming the exemption employed fewer 
than an average of 100 full-time equivalent employees and fewer than 
100,000 units of that product were sold in the United States, or in the 
case of a food product that was not sold in the 12-month period 
preceding the period for which exemption is claimed, fewer than 100,000 
units of such product are reasonably anticipated to be sold in the 
United States during the period for which exemption is claimed.
    (iii) If a person claims an exemption under paragraphs (j)(18)(i) or 
(j)(18)(ii) of this section for a food product and then, during the 
period of such exemption, the number of full-time equivalent employees 
of such person exceeds the appropriate number, or the number of food 
products sold in the United States exceeds the appropriate number, or, 
if at the end of the period of such exemption, the food product no 
longer qualifies for an exemption under the provisions of paragraphs 
(j)(18)(i) or (j)(18)(ii) of this section, such person shall have 18 
months from the date that the product was no longer qualified as a low-
volume product of a small business to comply with this section.
    (iv) A notice shall be filed with the Office of Nutritional 
Products, Labeling and Dietary Supplements (HFS-800), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740 and contain the following 
information, except that if the person is not an importer and has fewer 
than 10 full-time equivalent employees, that person does not have to 
file a notice for any food product with annual sales of fewer than 
10,000 total units:
    (A) Name and address of person requesting exemption. This should 
include a telephone number or FAX number that can be used to contact the 
person along with the name of a specific contact;
    (B) Names of the food products (including the various brand names) 
for which exemption is claimed;
    (C) Name and address of the manufacturer, distributor, or importer 
of the food product for which an exemption is claimed, if different than 
the person that is claiming the exemption;
    (D) The number of full-time equivalent employees. Provide the 
average number of full-time equivalent individuals employed by the 
person and its affiliates for the 12 months preceding the period for 
which a small business exemption is claimed for a product. The average 
number of full-time equivalent employees is to be determined by dividing 
the total number of hours of salary or wages paid to employees of the 
person and its affiliates by the number of hours of work in a year, 
2,080 hours (i.e., 40 hoursx52 weeks);
    (E) Approximate total number of units of the food product sold by 
the person in the United States in the 12-month period preceding that 
for which a small business exemption is claimed. Provide the approximate 
total number of units sold, or expected to be sold, in a 12-month period 
for each product for which an exemption is claimed. For products that 
have been in production for 1 year or more prior to the period for which 
exemption is claimed, the 12-month period is the period immediately 
preceding the period for which an exemption is claimed. For other 
products, the 12-month period is the period for which an exemption is 
claimed; and
    (F) The notice shall be signed by a responsible individual for the 
person who can certify the accuracy of the information presented in the 
notice. The individual shall certify that the information contained in 
the notice is a complete and accurate statement of the average number of 
full-time equivalent employees of this person and its affiliates and of 
the number of units of the product for which an exemption is claimed 
sold by the person. The individual shall also state that should the 
average number of full-time equivalent employees or the number of units 
of food products sold in the United States by the person exceed the 
applicable numbers for the time period for which exemption is claimed, 
the person will notify FDA of that fact and the date on which the number 
of employees or the number of products sold exceeded the standard.
    (v) FDA may by regulation lower the employee or units of food 
products requirements of paragraph (j)(18)(ii) of this section for any 
food product first

[[Page 46]]

introduced into interstate commerce after May 8, 2002, if the agency 
determines that the cost of compliance with such lower requirement will 
not place an undue burden on persons subject to it.
    (vi) For the purposes of this paragraph, the following definitions 
apply:
    (A) Unit means the packaging or, if there is no packaging, the form 
in which a food product is offered for sale to consumers.
    (B) Food product means food in any sized package which is 
manufactured by a single manufacturer or which bears the same brand 
name, which bears the same statement of identity, and which has similar 
preparation methods.
    (C) Person means all domestic and foreign affiliates, as defined in 
13 CFR 121.401, of the corporation, in the case of a corporation, and 
all affiliates, as defined in 13 CFR 121.401, of a firm or other entity, 
when referring to a firm or other entity that is not a corporation.
    (D) Full-time equivalent employee means all individuals employed by 
the person claiming the exemption. This number shall be determined by 
dividing the total number of hours of salary or wages paid directly to 
employees of the person and of all of its affiliates by the number of 
hours of work in a year, 2,080 hours (i.e., 40 hoursx52 weeks).
    (k) A food labeled under the provisions of this section shall be 
deemed to be misbranded under sections 201(n) and 403(a) of the act if 
its label or labeling represents, suggests, or implies:
    (1) That the food, because of the presence or absence of certain 
dietary properties, is adequate or effective in the prevention, cure, 
mitigation, or treatment of any disease or symptom. Information about 
the relationship of a dietary property to a disease or health-related 
condition may only be provided in conformance with the requirements of 
Sec.  101.14 and part 101, subpart E.
    (2) That the lack of optimum nutritive quality of a food, by reason 
of the soil on which that food was grown, is or may be responsible for 
an inadequacy or deficiency in the quality of the daily diet.
    (3) That the storage, transportation, processing, or cooking of a 
food is or may be responsible for an inadequacy or deficiency in the 
quality of the daily diet.
    (4) That a natural vitamin in a food is superior to an added or 
synthetic vitamin.

[58 FR 2175, Jan. 6, 1993]

    Editorial Note: For Federal Register citations affecting Sec.  
101.9, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and on GPO Access.



Sec.  101.10  Nutrition labeling of restaurant foods.

    Nutrition labeling in accordance with Sec.  101.9 shall be provided 
upon request for any restaurant food or meal for which a nutrient 
content claim (as defined in Sec.  101.13 or in subpart D of this part) 
or a health claim (as defined in Sec.  101.14 and permitted by a 
regulation in subpart E of this part) is made, except that information 
on the nutrient amounts that are the basis for the claim (e.g., ``low 
fat, this meal provides less than 10 grams of fat'') may serve as the 
functional equivalent of complete nutrition information as described in 
Sec.  101.9. Nutrient levels may be determined by nutrient data bases, 
cookbooks, or analyses or by other reasonable bases that provide 
assurance that the food or meal meets the nutrient requirements for the 
claim. Presentation of nutrition labeling may be in various forms, 
including those provided in Sec.  101.45 and other reasonable means.

[61 FR 40332, Aug. 2, 1996]



Sec.  101.12  Reference amounts customarily consumed per eating occasion.

    (a) The general principles and factors that the Food and Drug 
Administration (FDA) considered in arriving at the reference amounts 
customarily consumed per eating occasion (reference amounts) which are 
set forth in paragraph (b) of this section, are that:
    (1) FDA calculated the reference amounts for persons 4 years of age 
or older to reflect the amount of food customarily consumed per eating 
occasion by persons in this population group. These reference amounts 
are based on data set forth in appropriate national food consumption 
surveys.

[[Page 47]]

    (2) FDA calculated the reference amounts for an infant or child 
under 4 years of age to reflect the amount of food customarily consumed 
per eating occasion by infants up to 12 months of age or by children 1 
through 3 years of age, respectively. These reference amounts are based 
on data set forth in appropriate national food consumption surveys. Such 
reference amounts are to be used only when the food is specially 
formulated or processed for use by an infant or by a child under 4 years 
of age.
    (3) An appropriate national food consumption survey includes a large 
sample size representative of the demographic and socioeconomic 
characteristics of the relevant population group and must be based on 
consumption data under actual conditions of use.
    (4) To determine the amount of food customarily consumed per eating 
occasion, FDA considered the mean, median, and mode of the consumed 
amount per eating occasion.
    (5) When survey data were insufficient, FDA took various other 
sources of information on serving sizes of food into consideration. 
These other sources of information included:
    (i) Serving sizes used in dietary guidance recommendations or 
recommended by other authoritative systems or organizations;
    (ii) Serving sizes recommended in comments;
    (iii) Serving sizes used by manufacturers and grocers; and
    (iv) Serving sizes used by other countries.
    (6) Because they reflect the amount customarily consumed, the 
reference amount and, in turn, the serving size declared on the product 
label are based on only the edible portion of food, and not bone, seed, 
shell, or other inedible components.
    (7) The reference amount is based on the major intended use of the 
food (e.g., milk as a beverage and not as an addition to cereal).
    (8) The reference amounts for products that are consumed as an 
ingredient of other foods, but that may also be consumed in the form in 
which they are purchased (e.g., butter), are based on use in the form 
purchased.
    (9) FDA sought to ensure that foods that have similar dietary usage, 
product characteristics, and customarily consumed amounts have a uniform 
reference amount.
    (b) The following reference amounts shall be used as the basis for 
determining serving sizes for specific products:

  Table 1--Reference Amounts Customarily Consumed Per Eating Occasion:
                   Infant and Toddler Foods \1,2,3,4\
------------------------------------------------------------------------
        Product category         Reference amount   Label statement \5\
------------------------------------------------------------------------
Cereals, dry instant...........  15 g............  -- cup (-- g)
Cereals, prepared, ready-to-     110 g...........  -- cup(s) (-- g)
 serve.
Other cereal and grain           7 g for infants   -- cup(s) (-- g) for
 products, dry ready-to-eat,      and 20 g for      ready-to-eat
 e.g., ready-to-eat cereals,      toddlers for      cereals; -- piece(s)
 cookies, teething biscuits,      ready-to-eat      (-- g) for others
 and toasts.                      cereals; 7 g
                                  for all others.
Dinners, desserts, fruits,       15 g............  -- tbsp(s) (-- g); --
 vegetables or soups, dry mix.                      cup(s) (-- g)
Dinners, desserts, fruits,       110 g...........  -- cup(s) (-- g); --
 vegetables or soups, ready-to-                     cup(s) (-- mL)
 serve, junior type.
Dinners, desserts, fruits,       60 g............  -- cup(s) (-- g); --
 vegetables or soups, ready-to-                     cup(s) (-- mL)
 serve, strained type.
Dinners, stews or soups for      170 g...........  -- cup(s) (-- g); --
 toddlers, ready-to-serve.                          cup(s) (-- mL)
Fruits for toddlers, ready-to-   125 g...........  -- cup(s) (-- g)
 serve.
Vegetables for toddlers, ready-  70 g............  -- cup(s) (-- g)
 to- serve.
Eggs/egg yolks, ready-to-serve.  55 g............  -- cup(s) (-- g)
Juices, all varieties..........  120 mL..........  4 fl oz (120 mL)
------------------------------------------------------------------------
\1\ These values represent the amount of food customarily consumed per
  eating occasion and were primarily derived from the 1977-1978 and the
  1987-1988 Nationwide Food Consumption Surveys conducted by the U.S.
  Department of Agriculture.
\2\ Unless otherwise noted in the Reference amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  cereal) is the amount required to make the reference amount of the
  prepared form. Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures in 21 CFR 101.9(b).

[[Page 48]]

 
\4\Copies of the list of products for each product category are
  available from the Office of Nutritional Products, Labeling and
  Dietary Supplements (HFS-800), Center for Food Safety and Applied
  Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
  College Park, MD 20740.
\5\ The label statements are meant to provide guidance to manufacturers
  on the presentation of serving size information on the label, but they
  are not required. The term ``piece'' is used as a generic description
  of a discrete unit. Manufacturers should use the description of a unit
  that is most appropriate for the specific product (e.g., sandwich for
  sandwiches, cookie for cookies, and bar for frozen novelties).


  Table 2--Reference Amounts Customarily Consumed Per Eating Occasion:
                      General Food Supply \1,2,3,4\
------------------------------------------------------------------------
        Product category         Reference amount    Label statement\5\
------------------------------------------------------------------------
Bakery products:
    Biscuits, croissants,        55 g............  -- piece(s) (-- g)
     bagels, tortillas, soft
     bread sticks, soft
     pretzels, corn bread, hush
     puppies.
    Breads (excluding sweet      50 g............  -- piece(s) (-- g)
     quick type), rolls.                            for sliced bread and
                                                    distinct pieces
                                                    (e.g., rolls); 2 oz
                                                    (56 g/-- inch slice)
                                                    for unsliced bread
    Bread sticks--see crackers.  ................  .....................
    Toaster pastries--see        ................  .....................
     coffee cakes.
    Brownies...................  40 g............  -- piece(s) (-- g)
                                                    for distinct pieces;
                                                    fractional slice (--
                                                    g) for bulk
    Cakes, heavy weight (cheese  125 g...........  -- piece(s) (-- g)
     cake; pineapple upside-                        for distinct pieces
     down cake; fruit, nut, and                     (e.g., sliced or
     vegetable cakes with more                      individually
     than or equal to 35                            packaged products);
     percent of the finished                        -- fractional slice
     weight as fruit, nuts, or                      (-- g) for large
     vegetables or any of these                     discrete units
     combined) \6\.
    Cakes, medium weight         80 g............  -- piece(s) (-- g)
     (chemically leavened cake                      for distinct pieces
     with or without icing or                       (e.g., cupcake); --
     filling except those                           fractional slice (--
     classified as light weight                     g) for large
     cake; fruit, nut, and                          discrete units
     vegetable cake with less
     than 35 percent of the
     finished weight as fruit,
     nuts, or vegetables or any
     of these combined; light
     weight cake with icing;
     Boston cream pie; cupcake;
     eclair; cream puff) \7\.
    Cakes, light weight (angel   55 g............  -- piece(s) (-- g)
     food, chiffon, or sponge                       for distinct pieces
     cake without icing or                          (e.g., sliced or
     filling) \8\.                                  individually
                                                    packaged products);
                                                    -- fractional slice
                                                    (-- g) for large
                                                    discrete units
    Coffee cakes, crumb cakes,   55 g............  -- piece(s) (-- g)
     doughnuts, Danish, sweet                       for sliced bread and
     rolls, sweet quick type                        distinct pieces
     breads, muffins, toaster                       (e.g., doughnut); 2
     pastries.                                      oz (56 g/visual unit
                                                    of measure) for bulk
                                                    products (e.g.,
                                                    unsliced bread)
    Cookies....................  30 g............  -- piece(s) (-- g)
    Crackers that are usually    15 g............  -- piece(s) (-- g)
     not used as snack, melba
     toast, hard bread sticks,
     ice cream cones \9\.
    Crackers that are usually    30 g............  -- piece(s) (-- g)
     used as snacks.
    Croutons...................  7 g.............  -- tbsp(s) (-- g); --
                                                    cup(s) (-- g); --
                                                    piece(s) (-- g) for
                                                    large pieces
    French toast, pancakes,      110 g prepared    -- piece(s) (-- g); --
     variety mixes.               for french         cup(s) (-- g) for
                                  toast and         dry mix
                                  pancakes; 40 g
                                  dry mix for
                                  variety mixes.
    Grain-based bars with or     40 g............  -- piece(s) (-- g)
     without filling or
     coating, e.g., breakfast
     bars, granola bars, rice
     cereal bars.
    Ice cream cones--see         ................  .....................
     crackers.
    Pies, cobblers, fruit        125 g...........  -- piece(s) (--g) for
     crisps, turnovers, other                       distinct pieces; --
     pastries.                                      fractional slice (--
                                                    g) for large
                                                    discrete units
    Pie crust..................  1/6 of 8 inch     1/6 of 8 inch crust
                                  crust; 1/8 of 9   (-- g); 1/8 of 9
                                  inch crust.       inch crust (-- g)
    Pizza crust................  55 g............  -- fractional slice
                                                    (-- g)
    Taco shells, hard..........  30 g............  -- shell(s) (-- g)
    Waffles....................  85 g............  -- piece(s) (-- g)
Beverages:
    Carbonated and               240 mL..........  8 fl oz (240 mL)
     noncarbonated beverages,
     wine coolers, water.
    Coffee or tea, flavored and  240 mL prepared.  8 fl oz (240 mL)
     sweetened.
Cereal and Other Grain
 Products:
    Breakfast cereals (hot       1 cup prepared;   -- cup(s) (-- g)
     cereal type), hominy grits.  40 g plain dry
                                  cereal; 55 g
                                  flavored,
                                  sweetened dry
                                  cereal.
    Breakfast cereals, ready-to- 15 g............  -- cup(s) (-- g)
     eat, weighing less than 20
     g per cup, e.g., plain
     puffed cereal grains.

[[Page 49]]

 
    Breakfast cereals, ready-to- 30 g............  -- cup(s) (-- g)
     eat weighing 20 g or more
     but less than 43 g per
     cup; high fiber cereals
     containing 28 g or more of
     fiber per 100 g.
    Breakfast cereals, ready-to- 55 g............  -- piece(s) (-- g)
     eat, weighing 43 g or more                     for large distinct
     per cup; biscuit types.                        pieces (e.g.,
                                                    biscuit type);--
                                                    cup(s) (-- g) for
                                                    all others
    Bran or wheat germ.........  15 g............  -- tbsp(s) (-- g); --
                                                    cup(s) (-- g)
    Flours or cornmeal.........  30 g............  -- tbsp(s) (-- g); --
                                                    cup(s) (-- g)
    Grains, e.g., rice, barley,  140 g prepared;   -- cup(s) (-- g)
     plain.                       45 g dry.
    Pastas, plain..............  140 g prepared;   -- cup(s) (-- g); --
                                  55 g dry.         piece(s) (-- g) for
                                                    large pieces (e.g.,
                                                    large shells or
                                                    lasagna noodles) or
                                                    2 oz (56 g/visual
                                                    unit of measure) for
                                                    dry bulk products
                                                    (e.g., spaghetti)
    Pastas, dry, ready-to-eat,   25 g............  -- cup(s) (-- g)
     e.g., fried canned chow
     mein noodles.
    Starches, e.g., cornstarch,  10 g............  -- tbsp (-- g)
     potato starch, tapioca,
     etc..
    Stuffing...................  100 g...........  -- cup(s) (-- g)
Dairy Products and Substitutes:
    Cheese, cottage............  110 g...........  -- cup (-- g)
    Cheese used primarily as     55 g............  -- cup (-- g)
     ingredients, e.g., dry
     cottage cheese, ricotta
     cheese.
    Cheese, grated hard, e.g.,   5 g.............  -- tbsp (-- g)
     Parmesan, Romano.
    Cheese, all others except    30 g............  -- piece(s) (-- g)
     those listed as separate                       for distinct
     categories--includes cream                     pieces;-- tbsp(s) (--
     cheese and cheese spread.                       g) for cream cheese
                                                    and cheese spread; 1
                                                    oz (28 g/visual unit
                                                    of measure) for bulk
    Cheese sauce--see sauce
     category.
    Cream or cream substitutes,  15 mL...........  1 tbsp (15 mL)
     fluid.
    Cream or cream substitutes,  2 g.............  -- tsp (-- g)
     powder.
    Cream, half & half.........  30 mL...........  2 tbsp (30 mL)
    Eggnog.....................  120 mL..........  1/2 cup (120 mL); 4
                                                    fl oz (120 mL)
    Milk, condensed, undiluted.  30 mL...........  2 tbsp (30 mL)
    Milk, evaporated, undiluted  30 mL...........  2 tbsp (30 mL)
    Milk, milk-based drinks,     240 mL..........  1 cup (240 mL); 8 fl
     e.g., instant breakfast,                       oz (240 mL)
     meal replacement, cocoa.
    Shakes or shake              240 mL..........  1 cup (240 mL); 8 fl
     substitutes, e.g., dairy                       oz (240 mL)
     shake mixes, fruit frost
     mixes.
    Sour cream.................  30 g............  -- tbsp (-- g)
    Yogurt.....................  225 g...........  -- cup (-- g)
Desserts:
    Ice cream, ice milk, frozen  1/2 cup-includes  -- piece(s) (-- g)
     yogurt, sherbet: all         the volume for    for individually
     types, bulk and novelties    coatings and      wrapped or packaged
     (e.g., bars, sandwiches,     wafers for the    products; 1/2 cup (--
     cones).                      novelty type       g) for others
                                  varieties.
    Frozen flavored and          85 g............  -- piece(s) (-- g)
     sweetened ice and pops,                        for individually
     frozen fruit juices: all                       wrapped or packaged
     types, bulk and novelties                      products; -- cup(s)
     (e.g., bars, cups).                            (-- g) for others
    Sundae.....................  1 cup...........  1 cup (-- g)
    Custards, gelatin or         1/2 cup.........  -- piece(s) (-- g)
     pudding.                                       for distinct unit
                                                    (e.g., individually
                                                    packaged products);
                                                    1/2 cup (-- g) for
                                                    bulk
Dessert Toppings and Fillings:
    Cake frostings or icings...  35 g............  -- tbsp(s) (-- g)
    Other dessert toppings,      2 tbsp..........  2 tbsp (-- g); 2 tbsp
     e.g., fruits, syrups,                          (30 mL)
     spreads, marshmallow
     cream, nuts, dairy and
     nondairy whipped toppings.
    Pie fillings...............  85 g............  -- cup(s) (-- g)
Egg and Egg Sustitutes:
    Egg mixtures, e.g., egg foo  110 g...........  -- piece(s) (-- g)
     young, scrambled eggs,                         for discrete pieces;
     omelets.                                       -- cup(s) (-- g)
    Eggs (all sizes) \9\.......  50 g............  1 large, medium, etc.
                                                    (-- g)
    Egg substitutes............  An amount to      -- cup(s) (-- g); --
                                  make 1 large      cup(s) (-- mL)
                                  (50 g) egg.
Fats and Oils:
    Butter, margarine, oil,      1 tbsp..........  1 tbsp (-- g); 1 tbsp
     shortening.                                    (15 mL)
    Butter replacement, powder.  2 g.............  -- tsp(s) (-- g)
    Dressings for salads.......  30 g............  -- tbsp (-- g); --
                                                    tbsp (-- mL)

[[Page 50]]

 
    Mayonnaise, sandwich         15 g............  -- tbsp (-- g)
     spreads, mayonnaise-type
     dressings.
    Spray types................  0.25 g..........  About -- seconds
                                                    spray (-- g)
Fish, Shellfish, Game Meats
 \10\, and Meat or Poultry
 Substitutes:
    Bacon substitutes, canned    15 g............  -- piece(s) (-- g)
     anchovies, \11\ anchovy                        for discrete pieces;
     pastes, caviar.                                -- tbsp(s) (-- g)
                                                    for others
    Dried, e.g., jerky.........  30 g............  -- piece(s) (-- g)
    Entrees with sauce, e.g.,    140 g cooked....  -- cup(s) (-- g); 5
     fish with cream sauce,                         oz (140 g/visual
     shrimp with lobster sauce.                     unit of measure) if
                                                    not measurable by
                                                    cup
    Entrees without sauce,       85 g cooked; 110  -- piece(s) (-- g)
     e.g., plain or fried fish    g uncooked \12\.  for discrete pieces;
     and shellfish, fish and                        -- cup(s) (-- g); --
     shellfish cake.                                oz (-- g/visual unit
                                                    of measure) if not
                                                    measurable by cup
                                                    \13\
    Fish, shellfish or game      55 g............  -- piece(s) (-- g)
     meat \10\, canned \11\.                        for discrete pieces;
                                                    -- cup(s) (-- g); 2
                                                    oz (56 g/-- cup) for
                                                    products that are
                                                    difficult to measure
                                                    the g weight of cup
                                                    measure (e.g.,
                                                    tuna); 2 oz (56 g/--
                                                    pieces) for products
                                                    that naturally vary
                                                    in size (e.g.,
                                                    sardines)
    Substitute for luncheon      55 g............  -- piece(s) (-- g)
     meat, meat spreads,                            for distinct pieces
     Canadian bacon, sausages                       (e.g., slices,
     and frankfurters.                              links); -- cup(s) (--
                                                     g); 2 oz (56 g/
                                                    visual unit of
                                                    measure) for
                                                    nondiscrete bulk
                                                    product
    Smoked or pickled \11\       55 g............  -- piece(s) (-- g)
     fish, shellfish, or game                       for distinct pieces
     meat \10\; fish or                             (e.g., slices,
     shellfish spread.                              links) or -- cup(s)
                                                    (-- g); 2 oz (56 g/
                                                    visual unit of
                                                    measure) for
                                                    nondiscrete bulk
                                                    product
    Substitutes for bacon bits--
     see miscellaneous category.
Fruits and Fruit Juices:
    Candied or pickled \11\....  30 g............  -- piece(s) (-- g)
    Dehydrated fruits--see       ................  .....................
     snacks category.
    Dried......................  40 g............  -- piece(s) (-- g)
                                                    for large pieces
                                                    (e.g., dates, figs,
                                                    prunes); -- cup(s)
                                                    (-- g) for small
                                                    pieces (e.g.,
                                                    raisins)
    Fruits for garnish or        4 g.............  1 cherry (-- g)
     flavor, e.g., maraschino
     cherries \11\.
    Fruit relishes, e.g.,        70 g............  -- cup(s) (-- g)
     cranberry sauce, cranberry
     relish.
    Fruits used primarily as     30 g............  See footnote 13
     ingredients, avocado.
    Fruits used primarily as     55 g............  -- piece(s) (-- g)
     ingredients, others                            for large fruits; --
     (cranberries, lemon, lime).                    cup(s) (-- g) for
                                                    small fruits
                                                    measurable by cup
                                                    \13\
    Watermelon.................  280 g...........  See footnote 13
    All other fruits (except     140 g...........  -- piece(s) (-- g)
     those listed as separate                       for large pieces
     categories), fresh,                            (e.g., strawberries,
     canned, or frozen.                             prunes, apricots,
                                                    etc.); -- cup(s) (--
                                                    g) for small pieces
                                                    (e.g., blueberries,
                                                    raspberries, etc.)
                                                    \13\
    Juices, nectars, fruit       240 mL..........  8 fl oz (240 mL)
     drinks.
    Juices used as ingredients,  5 mL............  1 tsp (5 mL)
     e.g., lemon juice, lime
     juice.
Legumes:
    Bean cake (tofu) \11\,       85 g............  -- piece(s) (-- g)
     tempeh.                                        for discrete pieces;
                                                    3 oz (84 g/visual
                                                    unit of measure) for
                                                    bulk products
    Beans, plain or in sauce...  130 g for beans   -- cup (-- g)
                                  in sauce or
                                  canned in
                                  liquid and
                                  refried beans
                                  prepared; 90 g
                                  for others
                                  prepared; 35 g
                                  dry.
Miscellaneous Category:
    Baking powder, baking soda,  0.6 g...........  -- tsp ( -- g)
     pectin.
    Baking decorations, e.g.,    1 tsp or 4 g if   -- piece(s) (-- g)
     colored sugars and           not measurable    for discrete pieces;
     sprinkles for cookies,       by teaspoon.      1 tsp (-- g)
     cake decorations.
    Batter mixes, bread crumbs.  30 g............  -- tbsp(s) (-- g);--
                                                    cup(s) (-- g)
    Cooking wine...............  30 mL...........  2 tbsp (30 mL)

[[Page 51]]

 
    Dietary supplements........  The maximum       -- tablet(s), --
                                  amount            capsule(s), --
                                  recommended, as   packet(s), -- tsp(s)
                                  appropriate, on   (-- g), etc.
                                  the label for
                                  consumption per
                                  eating
                                  occasion, or,
                                  in the absence
                                  of
                                  recommendations
                                  , 1 unit, e.g.,
                                  tablet,
                                  capsule,
                                  packet,
                                  teaspoonsful,
                                  etc..
    Drink mixers (without        Amount to make    -- fl oz (-- mL)
     alcohol).                    240 mL drink
                                  (without ice).
    Chewing gum \9\............  3 g.............  -- piece(s) (-- g)
    Meat, poultry and fish       Amount to make    -- tsp(s) (-- g); --
     coating mixes, dry;          one reference     tbsp(s) (-- g)
     seasoning mixes, dry,        amount of final
     e.g., chili seasoning        dish.
     mixes, pasta salad
     seasoning mixes.
    Salad and potato toppers,    7 g.............  -- tbsp(s) (-- g)
     e.g., salad crunchies,
     salad crispins,
     substitutes for bacon bits.
  Salt, salt substitutes,        1/4 tsp.........  1/4 tsp ( --g); --
   seasoning salts (e.g.,                           piece(s) ( --g) for
   garlic salt).                                    discrete pieces
                                                    (e.g., individually
                                                    packaged products)
    Spices, herbs (other than    1/4 tsp or 0.5 g  1/4 tsp (-- g); --
     dietary supplements).        if not            piece(s) (-- g) if
                                  measurable by     not measurable by
                                  teaspoon.         teaspoons (e.g., bay
                                                    leaf)
Mixed Dishes:
    Measurable with cup, e.g.,   1 cup...........  1 cup (-- g)
     casseroles, hash, macaroni
     and cheese, pot pies,
     spaghetti with sauce,
     stews, etc..
    Not measurable with cup,     140 g, add 55 g   -- piece(s) (-- g)
     e.g., burritos, egg rolls,   for products      for discrete pieces;
     enchiladas, pizza, pizza     with gravy or     -- fractional slice
     rolls, quiche, all types     sauce topping,    (-- g) for large
     of sandwiches.               e.g., enchilada   discrete units
                                  with cheese
                                  sauce, crepe
                                  with white
                                  sauce \14\.
Nuts and Seeds:
    Nuts, seeds, and mixtures,   30 g............  -- piece(s) (-- g)
     all types: sliced,                             for large pieces
     chopped, slivered, and                         (e.g., unshelled
     whole.                                         nuts);-- tbsp(s) (--
                                                    g) ;-- cup(s) (-- g)
                                                    for small pieces
                                                    (e.g., peanuts,
                                                    sunflower seeds)
    Nut and seed butters,        2 tbsp..........  2 tbsp (-- g)
     pastes, or creams.
    Coconut, nut and seed        15 g............  -- tbsp(s) (-- g); --
     flours.                                        cup (-- g)
Potatoes and Sweet Potatoes/
 Yams:
    French fries, hash browns,   70 g prepared;    -- piece(s) (-- g)
     skins, or pancakes.          85 g for frozen   for large distinct
                                  unprepared        pieces (e.g.,
                                  french fries.     patties, skins); 2.5
                                                    oz (70 g/-- pieces)
                                                    for prepared fries;
                                                    3 oz (84 g/--
                                                    pieces) for
                                                    unprepared fries
    Mashed, candied, stuffed,    140 g...........  -- piece(s) (-- g)
     or with sauce.                                 for discrete pieces
                                                    (e.g., stuffed
                                                    potato); -- cup(s)
                                                    (-- g)
    Plain, fresh, canned, or     110 g for fresh   -- piece(s) (-- g)
     frozen.                      or frozen; 125    for discrete
                                  g for vacuum      pieces;-- cup(s) (--
                                  packed; 160 g     g) for sliced or
                                  for canned in     chopped products
                                  liquid.
Salads:
    Gelatin salad..............  120 g...........  -- cup (-- g)
    Pasta or potato salad......  140 g...........  -- cup(s) (-- g)
    All other salads, e.g.,      100 g...........  -- cup(s) (-- g)
     egg, fish, shellfish,
     bean, fruit, or vegetable
     salads.
Sauces, Dips, Gravies and
 Condiments:
    Barbecue sauce, hollandaise  2 tbsp..........  2 tbsp (-- g); 2 tbsp
     sauce, tartar sauce, other                     (30 mL)
     sauces for dipping (e.g.,
     mustard sauce, sweet and
     sour sauce), all dips
     (e.g., bean dips, dairy-
     based dips, salsa).
    Major main entree sauces,    125 g...........  -- cup (-- g); -- cup
     e.g., spaghetti sauce.                         (-- mL)

[[Page 52]]

 
    Minor main entree sauces     1/4 cup.........  1/4 cup (-- g); 1/4
     (e.g., pizza sauce, pesto                      cup (60 mL)
     sauce), other sauces used
     as toppings (e.g., gravy,
     white sauce, cheese
     sauce), cocktail sauce.
    Major condiments, e.g.,      1 tbsp..........  1 tbsp (-- g); 1 tbsp
     catsup, steak sauce, soy                       (15 mL)
     sauce, vinegar, teriyaki
     sauce, marinades.
    Minor condiments, e.g.,      1 tsp...........  1 tsp (-- g); 1 tsp
     horseradish, hot sauces,                       (5 mL)
     mustards, worcestershire
     sauce.
Snacks:
    All varieties, chips,        30 g............  -- cup(s) (-- g) for
     pretzels, popcorns,                            small pieces (e.g.,
     extruded snacks, fruit-                        popcorn) -- piece(s)
     based snacks (e.g., fruit                      (-- g) for large
     chips,) grain-based snack                      pieces (e.g., large
     mixes.                                         pretzels; pressed
                                                    dried fruit sheet);
                                                    1 oz (28 g/visual
                                                    unit of measure) for
                                                    bulk products (e.g.,
                                                    potato chips)
Soups:
    All varieties..............  245 g...........  -- cup (-- g); -- cup
                                                    (-- mL)
Sugars and Sweets:
    Baking candies (e.g.,        15 g............  -- piece(s) (-- g)
     chips).                                        for large pieces; --
                                                    tbsp(s) (-- g) for
                                                    small pieces; 1/2 oz
                                                    (14 g/visual unit of
                                                    measure) for bulk
                                                    products
    Hard candies, breath mints.  2 g.............  -- piece(s) (-- g)
    Hard candies, roll-type,     5 g.............  -- piece(s) (-- g)
     mini-size in dispenser
     packages.
    Hard candies, others.......  15 g............  -- piece(s) (-- g)
                                                    for large pieces;--
                                                    tbsp(s) (-- g) for
                                                    ``mini-size''
                                                    candies measurable
                                                    by tablespoon; 1/2
                                                    oz (14 g/visual unit
                                                    of measure) for bulk
                                                    products
    All other candies..........  40 g............  -- piece(s) (-- g); 1
                                                    1/2 oz (42 g/visual
                                                    unit of measure) for
                                                    bulk products
    Confectioner's sugar.......  30 g............  -- cup (-- g)
    Honey, jams, jellies, fruit  1 tbsp..........  1 tbsp (-- g); 1 tbsp
     butter, molasses.                              (15 mL)
    Marshmallows...............  30 g............  -- cup(s) (-- g) for
                                                    small pieces; --
                                                    piece(s) (-- g) for
                                                    large pieces
    Sugar......................  4 g.............  -- tsp (-- g) ; --
                                                    piece(s) (-- g) for
                                                    discrete pieces
                                                    (e.g., sugar cubes,
                                                    individually
                                                    packaged products)
    Sugar substitutes..........  An amount         -- tsp(s) (-- g) for
                                  equivalent to     solids; -- drop(s)
                                  one reference     (-- g) for liquid; --
                                  amount for         piece(s) (-- g)
                                  sugar in          (e.g., individually
                                  sweetness.        packaged products)
    Syrups.....................  30 mL for syrups  2 tbsp (30 mL) for
                                  used primarily    syrups used
                                  as an             primarily as an
                                  ingredient        ingredient; 1/4 cup
                                  (e.g., light or   (60 mL) for all
                                  dark corn         others
                                  syrup); 60 mL
                                  for all others.
Vegetables:
    Vegetables primarily used    4 g.............  -- piece(s) (-- g); --
     for garnish or flavor,                          tbsp(s) (-- g) for
     e.g., pimento, parsley.                        chopped products
    Chili pepper, green onion..  30 g............  -- piece(s) (-- g)
                                                    \13\; -- tbsp(s) (--
                                                    g); -- cup(s) (-- g)
                                                    for sliced or
                                                    chopped products
    All other vegetables         85 g for fresh    -- piece(s) (-- g)
     without sauce: fresh,        or frozen; 95 g   for large pieces
     canned, or frozen.           for vacuum        (e.g., brussel
                                  packed; 130 g     sprouts); -- cup(s)
                                  for canned in     (-- g) for small
                                  liquid, cream-    pieces (e.g., cut
                                  style corn,       corn, green peas); 3
                                  canned or         oz (84 g/visual unit
                                  stewed            of measure) if not
                                  tomatoes,         measurable by cup
                                  pumpkin, or       \13\
                                  winter squash.
    All other vegetables with    110 g...........  -- piece(s) (-- g)
     sauce: fresh, canned, or                       for large pieces
     frozen.                                        (e.g., brussel
                                                    sprouts); -- cup(s)
                                                    (-- g) for small
                                                    pieces (e.g., cut
                                                    corn, green peas); 4
                                                    oz (112 g/visual
                                                    unit of measure) if
                                                    not measurable by
                                                    cup
    Vegetable juice............  240 mL..........  8 fl oz (240 mL)

[[Page 53]]

 
    Olives \11\................  15 g............  -- piece(s) (-- g); --
                                                     tbsp(s) (-- g) for
                                                    sliced products
    Pickles, all types \11\....  30 g............  1 oz (28 g/visual
                                                    unit of measure)
    Pickle relishes............  15 g............  -- tbsp (-- g)
    Vegetable pastes, e.g.,      30 g............  -- tbsp (-- g)
     tomato paste.
    Vegetable sauces or purees,  60 g............  -- cup (-- g); -- cup
     e.g, tomato sauce, tomato                      (-- mL)
     puree.
------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food
  customarily consumed per eating occasion and were primarily derived
  from the 1977-1978 and the 1987-1988 Nationwide Food Consumption
  Surveys conducted by the U.S. Department of Argiculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference
  amounts are for the ready-to-serve or almost ready-to-serve form of
  the product (i.e., heat and serve, brown and serve). If not listed
  separately, the reference amount for the unprepared form (e.g., dry
  mixes; concentrates; dough; batter; fresh and frozen pasta) is the
  amount required to make the reference amount of the prepared form.
  Prepared means prepared for consumption (e.g., cooked).
\3\ Manufacturers are required to convert the reference amount to the
  label serving size in a household measure most appropriate to their
  specific product using the procedures in 21 CFR 101.9(b).
\4\ Copies of the list of products for each product category are
  available from the Office of Nutritional Products, Labeling and
  Dietary Supplements (HFS-800), Center for Food Safety and Applied
  Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy.,
  College Park, MD 20740.
\5\ The label statements are meant to provide guidance to manufacturers
  on the presentation of serving size information on the label, but they
  are not required. The term ``piece'' is used as a generic description
  of a discrete unit. Manufacturers should use the description of a unit
  that is most appropriate for the specific product (e.g., sandwich for
  sandwiches, cookie for cookies, and bar for ice cream bars). The
  guidance provided is for the label statement of products in ready-to-
  serve or almost ready-to-serve form. The guidance does not apply to
  the products which require further preparation for consumption (e.g.,
  dry mixes, concentrates) unless specifically stated in the product
  category, reference amount, or label statement column that it is for
  these forms of the product. For products that require further
  preparation, manufacturers must determine the label statement
  following the rules in Sec.   101.9(b) using the reference amount
  determined according to Sec.   101.12(c).
\6\ Includes cakes that weigh 10 g or more per cubic inch.
\7\ Includes cakes that weigh 4 g or more per cubic inch but less than
  10 g per cubic inch.
\8\ Includes cakes that weigh less than 4 g per cubic inch.
\9\ Label serving size for ice cream cones and eggs of all sizes will be
  1 unit. Label serving size of all chewing gums that weigh more than
  the reference amount that can reasonably be consumed at a single-
  eating occasion will be 1 unit.
\10\ Animal products not covered under the Federal Meat Inspection Act
  or the Poultry Products Inspection Act, such as flesh products from
  deer, bison, rabbit, quail, wild turkey, geese, ostrich, etc.
\11\ If packed or canned in liquid, the reference amount is for the
  drained solids, except for products in which both the solids and
  liquids are customarily consumed (e.g., canned chopped clam in juice).
\12\ The reference amount for the uncooked form does not apply to raw
  fish in Sec.   101.45 or to single-ingredient products that consist of
  fish or game meat as provided for in Sec.   101.9(b)(j)(11).
\13\ For raw fruit, vegetables, and fish, manufacturers should follow
  the label statement for the serving size specified in Appendices A and
  B to the regulation entitled ``Food Labeling; Guidelines for Voluntary
  Nutrition Labeling; and Identification of the 20 Most Frequently
  Consumed Raw Fruits, Vegetables, and Fish; Definition of Substantial
  Compliance; Correction'' (56 FR 60880 as amended 57 FR 8174, March 6,
  1992).
\14\ Pizza sauce is part of the pizza and is not considered to be sauce
  topping.

    (c) If a product requires further preparation, e.g., cooking or the 
addition of water or other ingredients, and if paragraph (b) of this 
section provides a reference amount for the product in the prepared but 
not the unprepared form, then the reference amount for the unprepared 
product shall be determined using the following rules:
    (1) Except as provided for in paragraph (c)(2) of this section, the 
reference amount for the unprepared product shall be the amount of the 
unprepared product required to make the reference amount for the 
prepared product as established in paragraph (b) of this section.
    (2) For products where the entire contents of the package is used to 
prepare one large discrete unit usually divided for consumption, the 
reference amount for the unprepared product shall be the amount of the 
unprepared product required to make the fraction of the large discrete 
unit closest to the reference amount for the prepared product as 
established in paragraph (b) of this section.
    (d) The reference amount for an imitation or substitute food or 
altered food, such as a ``low calorie'' version, shall be the same as 
for the food for which it is offered as a substitute.
    (e) If a food is modified by incorporating air (aerated), and 
thereby the density of the food is lowered by 25 percent or more in 
weight than that of an appropriate reference regular food as described 
in Sec.  101.13(j)(1)(ii)(A), and the reference amount of the regular 
food is in grams, the manufacturer may determine the reference amount of 
the aerated food by adjusting for the difference in density of the 
aerated food relative to the density of the appropriate reference food 
provided that the

[[Page 54]]

manufacturer will show FDA detailed protocol and records of all data 
that were used to determine the density-adjusted reference amount for 
the aerated food. The reference amount for the aerated food shall be 
rounded to the nearest 5-g increment. Such products shall bear a 
descriptive term indicating that extra air has been incorporated (e.g., 
whipped, aerated). The density-adjusted reference amounts described in 
paragraph (b) of this section may not be used for cakes except for 
cheese cake. The differences in the densities of different types of 
cakes having different degrees of air incorporation have already been 
taken into consideration in determining the reference amounts for cakes 
in Sec.  101.12(b). In determining the difference in density of the 
aerated and the regular food, the manufacturer shall adhere to the 
following:
    (1) The regular and the aerated product must be the same in size, 
shape, and volume. To compare the densities of products having nonsmooth 
surfaces (e.g., waffles), manufacturers shall use a device or method 
that ensures that the volumes of the regular and the aerated products 
are the same.
    (2) Sample selections for the density measurements shall be done in 
accordance with the provisions in Sec.  101.9(g).
    (3) Density measurements of the regular and the aerated products 
shall be conducted by the same trained operator using the same 
methodology (e.g., the same equipment, procedures, and techniques) under 
the same conditions.
    (4) Density measurements shall be replicated a sufficient number of 
times to ensure that the average of the measurements is representative 
of the true differences in the densities of the regular and the 
``aerated'' products.
    (f) For products that have no reference amount listed in paragraph 
(b) of this section for the unprepared or the prepared form of the 
product and that consist of two or more foods packaged and presented to 
be consumed together (e.g., peanut putter and jelly, cracker and cheese 
pack, pancakes and syrup, cake and frosting), the reference amount for 
the combined product shall be determined using the following rules:
    (1) For bulk products (e.g., peanut butter and jelly), the reference 
amount for the combined product shall be the reference amount, as 
established in paragraph (b) of this section, for the ingredient that is 
represented as the main ingredient plus proportioned amounts of all 
minor ingredients.
    (2) For products where the ingredient represented as the main 
ingredient is one or more discrete units (e.g., cracker and cheese pack, 
pancakes and syrup, cake and frosting), the reference amount for the 
combined product shall be either the number of small discrete units or 
the fraction of the large discrete unit that is represented as the main 
ingredient that is closest to the reference amount for that ingredient 
as established in paragraph (b) of this section plus proportioned 
amounts of all minor ingredients.
    (3) If the reference amounts are in compatible units, they shall be 
summed (e.g., the reference amount for equal volumes of peanut butter 
and jelly for which peanut butter is represented as the main ingredient 
would be 4 tablespoons (tbsp) (2 tbsp peanut butter plus 2 tbsp jelly). 
If the reference amounts are in incompatible units, the weights of the 
appropriate volumes should be used (e.g., 110 grams (g) pancakes plus 
the gram weight of the proportioned amount of syrup).
    (g) The reference amounts set forth in paragraphs (b) through (f) of 
this section shall be used in determining whether a product meets the 
criteria for nutrient content claims, such as ``low calorie,'' and for 
health claims. If the serving size declared on the product label differs 
from the reference amount, and the product meets the criteria for the 
claim only on the basis of the reference amount, the claim shall be 
followed by a statement that sets forth the basis on which the claim is 
made. That statement shall include the reference amount as it appears in 
paragraph (b) of this section followed, in parenthesis, by the amount in 
common household measure if the reference amount is expressed in 
measures other than common household measures (e.g., for a beverage, 
``Very low sodium, 35 mg or less per 240 mL (8 fl oz)'').

[[Page 55]]

    (h) The Commissioner of Food and Drugs, either on his or her own 
initiative or in response to a petition submitted pursuant to part 10 of 
this chapter, may issue a proposal to establish or amend a reference 
amount in paragraph (b) of this section. A petition to establish or 
amend a reference amount shall include:
    (1) Objective of the petition;
    (2) A description of the product;
    (3) A complete sample product label including nutrition label, using 
the format established by regulation;
    (4) A description of the form (e.g., dry mix, frozen dough) in which 
the product will be marketed;
    (5) The intended dietary uses of the product with the major use 
identified (e.g., milk as a beverage and chips as a snack);
    (6) If the intended use is primarily as an ingredient in other 
foods, list of foods or food categories in which the product will be 
used as an ingredient with information on the prioritization of the use;
    (7) The population group for which the product will be offered for 
use (e.g., infants, children under 4 years of age);
    (8) The names of the most closely related products (or in the case 
of foods for special dietary use and imitation or substitute foods, the 
names of the products for which they are offered as substitutes);
    (9) The suggested reference amount (the amount of edible portion of 
food as consumed, excluding bone, seed, shell, or other inedible 
components) for the population group for which the product is intended 
with full description of the methodology and procedures that were used 
to determine the suggested reference amount. In determining the 
reference amount, general principles and factors in paragraph (a) of 
this section should be followed.
    (10) The suggested reference amount shall be expressed in metric 
units. Reference amounts for fluids shall be expressed in milliliters. 
Reference amounts for other foods shall be expressed in grams except 
when common household units such as cups, tablespoons, and teaspoons, 
are more appropriate or are more likely to promote uniformity in serving 
sizes declared on product labels. For example, common household measures 
would be more appropriate if products within the same category differ 
substantially in density, such as frozen desserts.
    (i) In expressing the reference amounts in milliliters, the 
following rules shall be followed:
    (A) For volumes greater than 30 milliliters (mL), the volume shall 
be expressed in multiples of 30 mL.
    (B) For volumes less than 30 mL, the volume shall be expressed in 
milliliters equivalent to a whole number of teaspoons or 1 tbsp, i.e., 
5, 10, or 15 mL.
    (ii) In expressing the reference amounts in grams, the following 
general rules shall be followed:
    (A) For quantities greater than 10 g, the quantity shall be 
expressed in the nearest 5-g increment.
    (B) For quantities less than 10 g, exact gram weights shall be used.
    (11) A petition to create a new subcategory of food with its own 
reference amount shall include the following additional information:
    (i) Data that demonstrate that the new subcategory of food will be 
consumed in amounts that differ enough from the reference amount for the 
parent category to warrant a separate reference amount. Data must 
include sample size; and the mean, standard deviation, median, and modal 
consumed amount per eating occasion for the petitioned product and for 
other products in the category, excluding the petitioned product. All 
data must be derived from the same survey data.
    (ii) Documentation supporting the difference in dietary usage and 
product characteristics that affect the consumption size that 
distinguishes the petitioned product from the rest of the products in 
the category.
    (12) A claim for categorical exclusion under Sec.  25.30 or 25.32 of 
this chapter or an environmental assessment under Sec.  25.40 of this 
chapter, and
    (13) In conducting research to collect or process food consumption 
data in support of the petition, the following general guidelines should 
be followed.
    (i) Sampled population selected should be representative of the 
demographic and socioeconomic characteristics of the target population 
group for which the food is intended.

[[Page 56]]

    (ii) Sample size (i.e., number of eaters) should be large enough to 
give reliable estimates for customarily consumed amounts.
    (iii) The study protocol should identify potential biases and 
describe how potential biases are controlled for or, if not possible to 
control, how they affect interpretation of results.
    (iv) The methodology used to collect or process data should be fully 
documented and should include: study design, sampling procedures, 
materials used (e.g., questionnaire, and interviewer's manual), 
procedures used to collect or process data, methods or procedures used 
to control for unbiased estimates, and procedures used to correct for 
nonresponse.
    (14) A statement concerning the feasibility of convening 
associations, corporations, consumers, and other interested parties to 
engage in negotiated rulemaking to develop a proposed rule consistent 
with the Negotiated Rulemaking Act (5 U.S.C. 561).

[58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at 
59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994; 62 FR 40598, July 
29, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 64 FR 
12890, Mar. 16, 1999; 66 FR 56035, Nov. 6, 2001]



Sec.  101.13  Nutrient content claims--general principles.

    (a) This section and the regulations in subpart D of this part apply 
to foods that are intended for human consumption and that are offered 
for sale, including conventional foods and dietary supplements.
    (b) A claim that expressly or implicitly characterizes the level of 
a nutrient of the type required to be in nutrition labeling under Sec.  
101.9 or under Sec.  101.36 (that is, a nutrient content claim) may not 
be made on the label or in labeling of foods unless the claim is made in 
accordance with this regulation and with the applicable regulations in 
subpart D of this part or in part 105 or part 107 of this chapter.
    (1) An expressed nutrient content claim is any direct statement 
about the level (or range) of a nutrient in the food, e.g., ``low 
sodium'' or ``contains 100 calories.''
    (2) An implied nutrient content claim is any claim that:
    (i) Describes the food or an ingredient therein in a manner that 
suggests that a nutrient is absent or present in a certain amount (e.g., 
``high in oat bran''); or
    (ii) Suggests that the food, because of its nutrient content, may be 
useful in maintaining healthy dietary practices and is made in 
association with an explicit claim or statement about a nutrient (e.g., 
``healthy, contains 3 grams (g) of fat'').
    (3) Except for claims regarding vitamins and minerals described in 
paragraph (q)(3) of this section, no nutrient content claims may be made 
on food intended specifically for use by infants and children less than 
2 years of age unless the claim is specifically provided for in parts 
101, 105, or 107 of this chapter.
    (4) Reasonable variations in the spelling of the terms defined in 
part 101 and their synonyms are permitted provided these variations are 
not misleading (e.g., ``hi'' or ``lo'').
    (5) For dietary supplements, claims for calories, fat, saturated 
fat, and cholesterol may not be made on products that meet the criteria 
in Sec.  101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie'' 
claims, except, in the case of calorie claims, when an equivalent amount 
of a similar dietary supplement (e.g., another protein supplement) that 
the labeled food resembles and for which it substitutes, normally 
exceeds the definition for ``low calorie'' in Sec.  101.60(b)(2).
    (c) Information that is required or permitted by Sec.  101.9 or 
Sec.  101.36, as applicable, to be declared in nutrition labeling, and 
that appears as part of the nutrition label, is not a nutrient content 
claim and is not subject to the requirements of this section. If such 
information is declared elsewhere on the label or in labeling, it is a 
nutrient content claim and is subject to the requirements for nutrient 
content claims.
    (d) A ``substitute'' food is one that may be used interchangeably 
with another food that it resembles, i.e., that it is organoleptically, 
physically, and functionally (including shelf life) similar to, and that 
it is not nutritionally inferior to unless it is labeled as an 
``imitation.''

[[Page 57]]

    (1) If there is a difference in performance characteristics that 
materially limits the use of the food, the food may still be considered 
a substitute if the label includes a disclaimer adjacent to the most 
prominent claim as defined in paragraph (j)(2)(iii) of this section, 
informing the consumer of such difference (e.g., ``not recommended for 
frying'').
    (2) This disclaimer shall be in easily legible print or type and in 
a size no less than that required by Sec.  101.105(i) for the net 
quantity of contents statement, except where the size of the claim is 
less than two times the required size of the net quantity of contents 
statement, in which case the disclaimer shall be no less than one-half 
the size of the claim but no smaller than one-sixteenth of an inch, 
unless the package complies with Sec.  101.2(c)(5), in which case the 
disclaimer may be in type of not less than one thirty-second of an inch.
    (e)(1) Because the use of a ``free'' or ``low'' claim before the 
name of a food implies that the food differs from other foods of the 
same type by virtue of its having a lower amount of the nutrient, only 
foods that have been specially processed, altered, formulated, or 
reformulated so as to lower the amount of the nutrient in the food, 
remove the nutrient from the food, or not include the nutrient in the 
food, may bear such a claim (e.g., ``low sodium potato chips'').
    (2) Any claim for the absence of a nutrient in a food, or that a 
food is low in a nutrient when the food has not been specially 
processed, altered, formulated, or reformulated to qualify for that 
claim shall indicate that the food inherently meets the criteria and 
shall clearly refer to all foods of that type and not merely to the 
particular brand to which the labeling attaches (e.g., ``corn oil, a 
sodium-free food'').
    (f) A nutrient content claim shall be in type size no larger than 
two times the statement of identity and shall not be unduly prominent in 
type style compared to the statement of identity.
    (g) [Reserved]
    (h)(1) If a food, except a meal product as defined in Sec.  
101.13(l), a main dish product as defined in Sec.  101.13(m), or food 
intended specifically for use by infants and children less than 2 years 
of age, contains more than 13.0 g of fat, 4.0 g of saturated fat, 60 
milligrams (mg) of cholesterol, or 480 mg of sodium per reference amount 
customarily consumed, per labeled serving, or, for a food with a 
reference amount customarily consumed of 30 g or less or 2 tablespoons 
or less, per 50 g (for dehydrated foods that must be reconstituted 
before typical consumption with water or a diluent containing an 
insignificant amount, as defined in Sec.  101.9(f)(1), of all nutrients 
per reference amount customarily consumed, the per 50 g criterion refers 
to the ``as prepared'' form), then that food must bear a statement 
disclosing that the nutrient exceeding the specified level is present in 
the food as follows: ``See nutrition information for ---- content'' with 
the blank filled in with the identity of the nutrient exceeding the 
specified level, e.g., ``See nutrition information for fat content.''
    (2) If a food is a meal product as defined in Sec.  101.13(l), and 
contains more than 26 g of fat, 8.0 g of saturated fat, 120 mg of 
cholesterol, or 960 mg of sodium per labeled serving, then that food 
must disclose, in accordance with the requirements as provided in 
paragraph (h)(1) of this section, that the nutrient exceeding the 
specified level is present in the food.
    (3) If a food is a main dish product as defined in Sec.  101.13(m), 
and contains more than 19.5 g of fat, 6.0 g of saturated fat, 90 mg of 
cholesterol, or 720 mg of sodium per labeled serving, then that food 
must disclose, in accordance with the requirements as provided in 
paragraph (h)(1) of this section, that the nutrient exceeding the 
specified level is present in the food.
    (4)(i) The disclosure statement ``See nutrition information for ---- 
content'' shall be in easily legible boldface print or type, in distinct 
contrast to other printed or graphic matter, and in a size no less than 
that required by Sec.  101.105(i) for the net quantity of contents 
statement, except where the size of the claim is less than two times the 
required size of the net quantity of contents statement, in which case 
the disclosure statement shall be no less than one-half the size of the 
claim but no smaller than one-sixteenth of an inch,

[[Page 58]]

unless the package complies with Sec.  101.2(c)(2), in which case the 
disclosure statement may be in type of not less than one thirty-second 
of an inch.
    (ii) The disclosure statement shall be immediately adjacent to the 
nutrient content claim and may have no intervening material other than, 
if applicable, other information in the statement of identity or any 
other information that is required to be presented with the claim under 
this section (e.g., see paragraph (j)(2) of this section) or under a 
regulation in subpart D of this part (e.g., see Sec. Sec.  101.54 and 
101.62). If the nutrient content claim appears on more than one panel of 
the label, the disclosure statement shall be adjacent to the claim on 
each panel except for the panel that bears the nutrition information 
where it may be omitted.
    (iii) If a single panel of a food label or labeling contains 
multiple nutrient content claims or a single claim repeated several 
times, a single disclosure statement may be made. The statement shall be 
adjacent to the claim that is printed in the largest type on that panel.
    (i) Except as provided in Sec.  101.9 or Sec.  101.36, as 
applicable, or in paragraph (q)(3) of this section, the label or 
labeling of a product may contain a statement about the amount or 
percentage of a nutrient if:
    (1) The use of the statement on the food implicitly characterizes 
the level of the nutrient in the food and is consistent with a 
definition for a claim, as provided in subpart D of this part, for the 
nutrient that the label addresses. Such a claim might be, ``less than 3 
g of fat per serving;''
    (2) The use of the statement on the food implicitly characterizes 
the level of the nutrient in the food and is not consistent with such a 
definition, but the label carries a disclaimer adjacent to the statement 
that the food is not ``low'' in or a ``good source'' of the nutrient, 
such as ``only 200 mg sodium per serving, not a low sodium food.'' The 
disclaimer must be in easily legible print or type and in a size no less 
than that required by Sec.  101.105(i) for the net quantity of contents 
statement except where the size of the claim is less than two times the 
required size of the net quantity of contents statement, in which case 
the disclaimer shall be no less than one-half the size of the claim but 
no smaller than one-sixteenth of an inch unless the package complies 
with Sec.  101.2(c)(5), in which case the disclaimer may be in type of 
not less less than one thirty-second of an inch, or
    (3) The statement does not in any way implicitly characterize the 
level of the nutrient in the food and it is not false or misleading in 
any respect (e.g., ``100 calories'' or ``5 grams of fat''), in which 
case no disclaimer is required.
    (4) ``Percent fat free'' claims are not authorized by this 
paragraph. Such claims shall comply with Sec.  101.62(b)(6).
    (j) A food may bear a statement that compares the level of a 
nutrient in the food with the level of a nutrient in a reference food. 
These statements shall be known as ``relative claims'' and include 
``light,'' ``reduced,'' ``less'' (or ``fewer''), and ``more'' claims.
    (1) To bear a relative claim about the level of a nutrient, the 
amount of that nutrient in the food must be compared to an amount of 
nutrient in an appropriate reference food as specified below.
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference food may be a dissimilar food within a product category that 
can generally be substituted for one another in the diet (e.g., potato 
chips as reference for pretzels, orange juice as a reference for vitamin 
C tablets) or a similar food (e.g., potato chips as reference for potato 
chips, one brand of multivitamin as reference for another brand of 
multivitamin).
    (B) For ``light,'' ``reduced,'' ``added,'' ``extra,'' ``plus,'' 
``fortified,'' and ``enriched'' claims, the reference food shall be a 
similar food (e.g., potato chips as a reference for potato chips, one 
brand of multivitamin for another brand of multivitamin), and
    (ii)(A) For ``light'' claims, the reference food shall be 
representative of the type of food that includes the product that bears 
the claim. The nutrient value for the reference food shall be 
representative of a broad base of foods of that type; e.g., a value in a 
representative, valid data base; an average value determined from the 
top three national (or regional) brands, a market basket norm; or, where 
its nutrient

[[Page 59]]

value is representative of the food type, a market leader. Firms using 
such a reference nutrient value as a basis for a claim, are required to 
provide specific information upon which the nutrient value was derived, 
on request, to consumers and appropriate regulatory officials.
    (B) For relative claims other than ``light,'' including ``less'' and 
``more'' claims, the reference food may be the same as that provided for 
``light'' in paragraph (j)(1)(ii)(A) of this section, or it may be the 
manufacturer's regular product, or that of another manufacturer, that 
has been offered for sale to the public on a regular basis for a 
substantial period of time in the same geographic area by the same 
business entity or by one entitled to use its trade name. The nutrient 
values used to determine the claim when comparing a single 
manufacturer's product to the labeled product shall be either the values 
declared in nutrition labeling or the actual nutrient values, provided 
that the resulting label is internally consistent to (i.e., that the 
values stated in the nutrition information, the nutrient values in the 
accompanying information and the declaration of the percentage of 
nutrient by which the food has been modified are consistent and will not 
cause consumer confusion when compared), and that the actual 
modification is at least equal to the percentage specified in the 
definition of the claim.
    (2) For foods bearing relative claims:
    (i) The label or labeling must state the identity of the reference 
food and the percentage (or fraction) of the amount of the nutrient in 
the reference food by which the nutrient in the labeled food differs 
(e.g., ``50 percent less fat than (reference food)'' or ``1/3 fewer 
calories than (reference food)''),
    (ii) This information shall be immediately adjacent to the most 
prominent claim. The type size shall be in accordance with paragraph 
(h)(4)(i) of this section.
    (iii) The determination of which use of the claim is in the most 
prominent location on the label or labeling will be made based on the 
following factors, considered in order:
    (A) A claim on the principal display panel adjacent to the statement 
of identity;
    (B) A claim elsewhere on the principal display panel;
    (C) A claim on the information panel; or
    (D) A claim elsewhere on the label or labeling.
    (iv) The label or labeling must also bear:
    (A) Clear and concise quantitative information comparing the amount 
of the subject nutrient in the product per labeled serving with that in 
the reference food; and
    (B) This statement shall appear adjacent to the most prominent claim 
or to the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.
    (3) A relative claim for decreased levels of a nutrient may not be 
made on the label or in labeling of a food if the nutrient content of 
the reference food meets the requirement for a ``low'' claim for that 
nutrient (e.g., 3 g fat or less).
    (k) The term ``modified'' may be used in the statement of identity 
of a food that bears a relative claim that complies with the 
requirements of this part, followed immediately by the name of the 
nutrient whose content has been altered (e.g., ``Modified fat 
cheesecake''). This statement of identity must be immediately followed 
by the comparative statement such as ``Contains 35 percent less fat than 
------.'' The label or labeling must also bear the information required 
by paragraph (j)(2) of this section in the manner prescribed.
    (l) For purposes of making a claim, a ``meal product shall be 
defined as a food that:
    (1) Makes a major contribution to the total diet by:
    (i) Weighing at least 10 ounces (oz) per labeled serving; and
    (ii) Containing not less than three 40-g portions of food, or 
combinations of foods, from two or more of the following four food 
groups, except as noted in paragraph (l)(1)(ii)(E) of this section.

[[Page 60]]

    (A) Bread, cereal, rice, and pasta group;
    (B) Fruits and vegetables group;
    (C) Milk, yogurt, and cheese group;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts group; except 
that;
    (E) These foods shall not be sauces (except for foods in the above 
four food groups that are in the sauces), gravies, condiments, relishes, 
pickles, olives, jams, jellies, syrups, breadings or garnishes; and
    (2) Is represented as, or is in a form commonly understood to be, a 
breakfast, lunch, dinner, or meal. Such representations may be made 
either by statements, photographs, or vignettes.
    (m) For purposes of making a claim, a ``main dish product'' shall be 
defined as a food that:
    (1) Makes a major contribution to a meal by
    (i) Weighing at least 6 oz per labeled serving; and
    (ii) Containing not less than 40 g of food, or combinations of 
foods, from each of at least two of the following four food groups, 
except as noted in paragraph (m)(1)(ii)(E) of this section.
    (A) Bread, cereal, rice, and pasta group;
    (B) Fruits and vegetables group;
    (C) Milk, yogurt, and cheese group;
    (D) Meat, poultry, fish, dry beans, eggs, and nuts groups; except 
that:
    (E) These foods shall not be sauces (except for foods in the above 
four food groups that are in the sauces) gravies, condiments, relishes, 
pickles, olives, jams, jellies, syrups, breadings, or garnishes; and
    (2) Is represented as, or is in a form commonly understood to be, a 
main dish (e.g, not a beverage or a dessert). Such representations may 
be made either by statements, photographs, or vignettes.
    (n) Nutrition labeling in accordance with Sec.  101.9, Sec.  101.10, 
or Sec.  101.36, as applicable, shall be provided for any food for which 
a nutrient content claim is made.
    (o) Except as provided in Sec.  101.10, compliance with requirements 
for nutrient content claims in this section and in the regulations in 
subpart D of this part, will be determined using the analytical 
methodology prescribed for determining compliance with nutrition 
labeling in Sec.  101.9.
    (p)(1) Unless otherwise specified, the reference amount customarily 
consumed set forth in Sec.  101.12(b) through (f) shall be used in 
determining whether a product meets the criteria for a nutrient content 
claim. If the serving size declared on the product label differs from 
the reference amount customarily consumed, and the amount of the 
nutrient contained in the labeled serving does not meet the maximum or 
minimum amount criterion in the definition for the descriptor for that 
nutrient, the claim shall be followed by the criteria for the claim as 
required by Sec.  101.12(g) (e.g., ``very low sodium, 35 mg or less per 
240 milliliters (8 fl oz.)'').
    (2) The criteria for the claim shall be immediately adjacent to the 
most prominent claim in easily legible print or type and in a size in 
accordance with paragraph (h)(4)(i) of this section.
    (q) The following exemptions apply:
    (1) Nutrient content claims that have not been defined by regulation 
and that are contained in the brand name of a specific food product that 
was the brand name in use on such food before October 25, 1989, may 
continue to be used as part of that brand name for such product, 
provided that they are not false or misleading under section 403(a) of 
the Federal Food, Drug, and Cosmetic Act (the act). However, foods 
bearing such claims must comply with section 403(f), (g), and (h) of the 
act;
    (2) A soft drink that used the term diet as part of its brand name 
before October 25, 1989, and whose use of that term was in compliance 
with Sec.  105.66 of this chapter as that regulation appeared in the 
Code of Federal Regulations on that date, may continue to use that term 
as part of its brand name, provided that its use of the term is not 
false or misleading under section 403(a) of the act. Such claims are 
exempt from the requirements of section 403(r)(2) of the act (e.g., the 
disclosure statement also required by Sec.  101.13(h)). Soft drinks 
marketed after October 25, 1989, may use the term ``diet'' provided they 
are in compliance with the current Sec.  105.66 of this chapter and the 
requirements of Sec.  101.13.
    (3)(i) A statement that describes the percentage of a vitamin or 
mineral in

[[Page 61]]

the food, including foods intended specifically for use by infants and 
children less than 2 years of age, in relation to a Reference Daily 
Intake (RDI) as defined in Sec.  101.9 may be made on the label or in 
labeling of a food without a regulation authorizing such a claim for a 
specific vitamin or mineral unless such claim is expressly prohibited by 
regulation under section 403(r)(2)(A)(vi) of the act.
    (ii) Percentage claims for dietary supplements. Under section 
403(r)(2)(F) of the act, a statement that characterizes the percentage 
level of a dietary ingredient for which a reference daily intake (RDI) 
or daily reference value (DRV) has not been established may be made on 
the label or in labeling of dietary supplements without a regulation 
that specifically defines such a statement. All such claims shall be 
accompanied by any disclosure statement required under paragraph (h) of 
this section.
    (A) Simple percentage claims. Whenever a statement is made that 
characterizes the percentage level of a dietary ingredient for which 
there is no RDI or DRV, the statement of the actual amount of the 
dietary ingredient per serving shall be declared next to the percentage 
statement (e.g., ``40 percent omega-3 fatty acids, 10 mg per capsule'').
    (B) Comparative percentage claims. Whenever a statement is made that 
characterizes the percentage level of a dietary ingredient for which 
there is no RDI or DRV and the statement draws a comparison to the 
amount of the dietary ingredient in a reference food, the reference food 
shall be clearly identified, the amount of that food shall be 
identified, and the information on the actual amount of the dietary 
ingredient in both foods shall be declared in accordance with paragraph 
(j)(2)(iv) of this section (e.g., ``twice the omega-3 fatty acids per 
capsule (80 mg) as in 100 mg of menhaden oil (40 mg)'').
    (4) The requirements of this section do not apply to:
    (i) Infant formulas subject to section 412(h) of the act; and
    (ii) Medical foods defined by section 5(b) of the Orphan Drug Act.
    (5) A nutrient content claim used on food that is served in 
restaurants or other establishments in which food is served for 
immediate human consumption or which is sold for sale or use in such 
establishments shall comply with the requirements of this section and 
the appropriate definition in subpart D of this part, except that:
    (i) Such claim is exempt from the requirements for disclosure 
statements in paragraph (h) of this section and Sec. Sec.  101.54(d), 
101.62(c), (d)(1)(ii)(D), (d)(2)(iii)(C), (d)(3), (d)(4)(ii)(C), and 
(d)(5)(ii)(C); and
    (ii) In lieu of analytical testing, compliance may be determined 
using a reasonable basis for concluding that the food that bears the 
claim meets the definition for the claim. This reasonable basis may 
derive from recognized data bases for raw and processed foods, recipes, 
and other means to compute nutrient levels in the foods or meals and may 
be used provided reasonable steps are taken to ensure that the method of 
preparation adheres to the factors on which the reasonable basis was 
determined (e.g., types and amounts of ingredients, cooking 
temperatures, etc.). Firms making claims on foods based on this 
reasonable basis criterion are required to provide to appropriate 
regulatory officials on request the specific information on which their 
determination is based and reasonable assurance of operational adherence 
to the preparation methods or other basis for the claim; and
    (iii) A term or symbol that may in some contexts constitute a claim 
under this section may be used, provided that the use of the term or 
symbol does not characterize the level of a nutrient, and a statement 
that clearly explains the basis for the use of the term or symbol is 
prominently displayed and does not characterize the level of a nutrient. 
For example, a term such as ``lite fare'' followed by an asterisk 
referring to a note that makes clear that in this restaurant ``lite 
fare'' means smaller portion sizes than normal; or an item bearing a 
symbol referring to a note that makes clear that this item meets the 
criteria for the dietary guidance established by a recognized dietary 
authority would not be considered a nutrient content claim under Sec.  
101.13.
    (6) Nutrient content claims that were part of the common or usual 
names of

[[Page 62]]

foods that were subject to a standard of identity on November 8, 1990, 
are not subject to the requirements of paragraphs (b) and (h) of this 
section or to definitions in subpart D of this part.
    (7) Implied nutrient content claims may be used as part of a brand 
name, provided that the use of the claim has been authorized by the Food 
and Drug Administration. Petitions requesting approval of such a claim 
may be submitted under Sec.  101.69(o).
    (8) The term fluoridated, fluoride added or with added fluoride may 
be used on the label or in labeling of bottled water that contains added 
fluoride.

[58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342, Apr. 2, 1993, as amended 
at 58 FR 44030, Aug. 18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051, 
Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR 11731, Mar. 22, 1996; 61 
FR 40332, Aug. 2, 1996; 61 FR 67452, Dec. 23, 1996; 62 FR 31339, June 9, 
1997; 62 FR 49867, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 63 FR 
26980, May 15, 1998]



Sec.  101.14  Health claims: general requirements.

    (a) Definitions. For purposes of this section, the following 
definitions apply:
    (1) Health claim means any claim made on the label or in labeling of 
a food, including a dietary supplement, that expressly or by 
implication, including ``third party'' references, written statements 
(e.g., a brand name including a term such as ``heart''), symbols (e.g., 
a heart symbol), or vignettes, characterizes the relationship of any 
substance to a disease or health-related condition. Implied health 
claims include those statements, symbols, vignettes, or other forms of 
communication that suggest, within the context in which they are 
presented, that a relationship exists between the presence or level of a 
substance in the food and a disease or health-related condition.
    (2) Substance means a specific food or component of food, regardless 
of whether the food is in conventional food form or a dietary supplement 
that includes vitamins, minerals, herbs, or other similar nutritional 
substances.
    (3) Nutritive value means a value in sustaining human existence by 
such processes as promoting growth, replacing loss of essential 
nutrients, or providing energy.
    (4) Disqualifying nutrient levels means the levels of total fat, 
saturated fat, cholesterol, or sodium in a food above which the food 
will be disqualified from making a health claim. These levels are 13.0 
grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of 
cholesterol, or 480 mg of sodium, per reference amount customarily 
consumed, per label serving size, and, only for foods with reference 
amounts customarily consumed of 30 g or less or 2 tablespoons or less, 
per 50 g. For dehydrated foods that must have water added to them prior 
to typical consumption, the per 50-g criterion refers to the as prepared 
form. Any one of the levels, on a per reference amount customarily 
consumed, a per label serving size or, when applicable, a per 50 g 
basis, will disqualify a food from making a health claim unless an 
exception is provided in subpart E of this part, except that:
    (i) The levels for a meal product as defined in Sec.  101.13(l) are 
26.0 g of fat, 8.0 g of saturated fat, 120 mg of cholesterol, or 960 mg 
of sodium per label serving size, and
    (ii) The levels for a main dish product as defined in Sec.  
101.13(m) are 19.5 g of fat, 6.0 g of saturated fat, 90 mg of 
cholesterol, or 720 mg of sodium per label serving size.
    (5) Disease or health-related condition means damage to an organ, 
part, structure, or system of the body such that it does not function 
properly (e.g., cardiovascular disease), or a state of health leading to 
such dysfunctioning (e.g., hypertension); except that diseases resulting 
from essential nutrient deficiencies (e.g., scurvy, pellagra) are not 
included in this definition (claims pertaining to such diseases are 
thereby not subject to Sec.  101.14 or Sec.  101.70).
    (b) Eligibility. For a substance to be eligible for a health claim:
    (1) The substance must be associated with a disease or health-
related condition for which the general U.S. population, or an 
identified U.S. population subgroup (e.g., the elderly) is at risk, or, 
alternatively, the petition submitted by the proponent of the claim 
otherwise explains the prevalence of the disease or health-related 
condition

[[Page 63]]

in the U.S. population and the relevance of the claim in the context of 
the total daily diet and satisfies the other requirements of this 
section.
    (2) If the substance is to be consumed as a component of a 
conventional food at decreased dietary levels, the substance must be a 
nutrient listed in 21 U.S.C. 343(q)(1)(C) or (q)(1)(D), or one that the 
Food and Drug Administration (FDA) has required to be included in the 
label or labeling under 21 U.S.C. 343(q)(2)(A); or
    (3) If the substance is to be consumed at other than decreased 
dietary levels:
    (i) The substance must, regardless of whether the food is a 
conventional food or a dietary supplement, contribute taste, aroma, or 
nutritive value, or any other technical effect listed in Sec.  170.3(o) 
of this chapter, to the food and must retain that attribute when 
consumed at levels that are necessary to justify a claim; and
    (ii) The substance must be a food or a food ingredient or a 
component of a food ingredient whose use at the levels necessary to 
justify a claim has been demonstrated by the proponent of the claim, to 
FDA's satisfaction, to be safe and lawful under the applicable food 
safety provisions of the Federal Food, Drug, and Cosmetic Act.
    (c) Validity requirement. FDA will promulgate regulations 
authorizing a health claim only when it determines, based on the 
totality of publicly available scientific evidence (including evidence 
from well-designed studies conducted in a manner which is consistent 
with generally recognized scientific procedures and principles), that 
there is significant scientific agreement, among experts qualified by 
scientific training and experience to evaluate such claims, that the 
claim is supported by such evidence.
    (d) General health claim labeling requirements. (1) When FDA 
determines that a health claim meets the validity requirements of 
paragraph (c) of this section, FDA will propose a regulation in subpart 
E of this part to authorize the use of that claim. If the claim pertains 
to a substance not provided for in Sec.  101.9 or Sec.  101.36, FDA will 
propose amending that regulation to include declaration of the 
substance.
    (2) When FDA has adopted a regulation in subpart E of this part 
providing for a health claim, firms may make claims based on the 
regulation in subpart E of this part, provided that:
    (i) All label or labeling statements about the substance-disease 
relationship that is the subject of the claim are based on, and 
consistent with, the conclusions set forth in the regulations in subpart 
E of this part;
    (ii) The claim is limited to describing the value that ingestion (or 
reduced ingestion) of the substance, as part of a total dietary pattern, 
may have on a particular disease or health-related condition;
    (iii) The claim is complete, truthful, and not misleading. Where 
factors other than dietary intake of the substance affect the 
relationship between the substance and the disease or health-related 
condition, such factors may be required to be addressed in the claim by 
a specific regulation in subpart E of this part;
    (iv) All information required to be included in the claim appears in 
one place without other intervening material, except that the principal 
display panel of the label or labeling may bear the reference statement, 
``See ------ for information about the relationship between ------ and 
------,'' with the blanks filled in with the location of the labeling 
containing the health claim, the name of the substance, and the disease 
or health-related condition (e.g., ``See attached pamphlet for 
information about calcium and osteoporosis''), with the entire claim 
appearing elsewhere on the other labeling, Provided that, where any 
graphic material (e.g., a heart symbol) constituting an explicit or 
implied health claim appears on the label or labeling, the reference 
statement or the complete claim shall appear in immediate proximity to 
such graphic material;
    (v) The claim enables the public to comprehend the information 
provided and to understand the relative significance of such information 
in the context of a total daily diet; and
    (vi) If the claim is about the effects of consuming the substance at 
decreased dietary levels, the level of the substance in the food is 
sufficiently low to justify the claim. To meet this

[[Page 64]]

requirement, if a definition for use of the term low has been 
established for that substance under this part, the substance must be 
present at a level that meets the requirements for use of that term, 
unless a specific alternative level has been established for the 
substance in subpart E of this part. If no definition for ``low'' has 
been established, the level of the substance must meet the level 
established in the regulation authorizing the claim; or
    (vii) If the claim is about the effects of consuming the substance 
at other than decreased dietary levels, the level of the substance is 
sufficiently high and in an appropriate form to justify the claim. To 
meet this requirement, if a definition for use of the term high for that 
substance has been established under this part, the substance must be 
present at a level that meets the requirements for use of that term, 
unless a specific alternative level has been established for the 
substance in subpart E of this part. If no definition for ``high'' has 
been established (e.g., where the claim pertains to a food either as a 
whole food or as an ingredient in another food), the claim must specify 
the daily dietary intake necessary to achieve the claimed effect, as 
established in the regulation authorizing the claim; Provided That:
    (A) Where the food that bears the claim meets the requirements of 
paragraphs (d)(2)(vi) or (d)(2)(vii) of this section based on its 
reference amount customarily consumed, and the labeled serving size 
differs from that amount, the claim shall be followed by a statement 
explaining that the claim is based on the reference amount rather than 
the labeled serving size (e.g., ``Diets low in sodium may reduce the 
risk of high blood pressure, a disease associated with many factors. A 
serving of -- ounces of this product conforms to such a diet.'').
    (B) Where the food that bears the claim is sold in a restaurant or 
in other establishments in which food that is ready for immediate human 
consumption is sold, the food can meet the requirements of paragraphs 
(d)(2)(vi) or (d)(2)(vii) of this section if the firm that sells the 
food has a reasonable basis on which to believe that the food that bears 
the claim meets the requirements of paragraphs (d)(2)(vi) or (d)(2)(vii) 
of this section and provides that basis upon request.
    (3) Nutrition labeling shall be provided in the label or labeling of 
any food for which a health claim is made in accordance with Sec.  
101.9; for restaurant foods, in accordance with Sec.  101.10; or for 
dietary supplements, in accordance with Sec.  101.36.
    (e) Prohibited health claims. No expressed or implied health claim 
may be made on the label or in labeling for a food, regardless of 
whether the food is in conventional food form or dietary supplement 
form, unless:
    (1) The claim is specifically provided for in subpart E of this 
part; and
    (2) The claim conforms to all general provisions of this section as 
well as to all specific provisions in the appropriate section of subpart 
E of this part;
    (3) None of the disqualifying levels identified in paragraph (a)(4) 
of this section is exceeded in the food, unless specific alternative 
levels have been established for the substance in subpart E of this 
part; or unless FDA has permitted a claim despite the fact that a 
disqualifying level of a nutrient is present in the food based on a 
finding that such a claim will assist consumers in maintaining healthy 
dietary practices, and, in accordance with the regulation in subpart E 
of this part that makes such a finding, the label bears a disclosure 
statement that complies with Sec.  101.13(h), highlighting the nutrient 
that exceeds the disqualifying level;
    (4) Except as provided in paragraph (e)(3) of this section, no 
substance is present at an inappropriate level as determined in the 
specific provision authorizing the claim in subpart E of this part;
    (5) The label does not represent or purport that the food is for 
infants and toddlers less than 2 years of age except if the claim is 
specifically provided for in subpart E of this part; and
    (6) Except for dietary supplements or where provided for in other 
regulations in part 101, subpart E, the food contains 10 percent or more 
of the Reference Daily Intake or the Daily Reference Value for vitamin 
A, vitamin C,

[[Page 65]]

iron, calcium, protein, or fiber per reference amount customarily 
consumed prior to any nutrient addition.
    (f) The requirements of this section do not apply to:
    (1) Infant formulas subject to section 412(h) of the Federal Food, 
Drug, and Cosmetic Act, and
    (2) Medical foods defined by section 5(b) of the Orphan Drug Act.
    (g) Applicability. The requirements of this section apply to foods 
intended for human consumption that are offered for sale, regardless of 
whether the foods are in conventional food form or dietary supplement 
form.

[58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 58 
FR 44038, Aug. 18, 1993; 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31, 
1994; 61 FR 40332, Aug. 2, 1996; 62 FR 49867, Sept. 23, 1997; 63 FR 
26980, May 15, 1998; 66 FR 17358, Mar. 30, 2001]



Sec.  101.15  Food; prominence of required statements.

    (a) A word, statement, or other information required by or under 
authority of the act to appear on the label may lack that prominence and 
conspicuousness required by section 403(f) of the act by reason (among 
other reasons) of:
    (1) The failure of such word, statement, or information to appear on 
the part or panel of the label which is presented or displayed under 
customary conditions of purchase;
    (2) The failure of such word, statement, or information to appear on 
two or more parts or panels of the label, each of which has sufficient 
space therefor, and each of which is so designed as to render it likely 
to be, under customary conditions of purchase, the part or panel 
displayed;
    (3) The failure of the label to extend over the area of the 
container or package available for such extension, so as to provide 
sufficient label space for the prominent placing of such word, 
statement, or information;
    (4) Insufficiency of label space (for the prominent placing of such 
word, statement, or information) resulting from the use of label space 
for any word, statement, design, or device which is not required by or 
under authority of the act to appear on the label;
    (5) Insufficiency of label space (for the prominent placing of such 
word, statement, or information) resulting from the use of label space 
to give materially greater conspicuousness to any other word, statement, 
or information, or to any design or device; or
    (6) Smallness or style of type in which such word, statement, or 
information appears, insufficient background contrast, obscuring designs 
or vignettes, or crowding with other written, printed, or graphic 
matter.
    (b) No exemption depending on insufficiency of label space, as 
prescribed in regulations promulgated under section 403 (e) or (i) of 
the act, shall apply if such insufficiency is caused by:
    (1) The use of label space for any word, statement, design, or 
device which is not required by or under authority of the act to appear 
on the label;
    (2) The use of label space to give greater conspicuousness to any 
word, statement, or other information than is required by section 403(f) 
of the act; or
    (3) The use of label space for any representation in a foreign 
language.
    (c)(1) All words, statements, and other information required by or 
under authority of the act to appear on the label or labeling shall 
appear thereon in the English language: Provided, however, That in the 
case of articles distributed solely in the Commonwealth of Puerto Rico 
or in a Territory where the predominant language is one other than 
English, the predominant language may be substituted for English.
    (2) If the label contains any representation in a foreign language, 
all words, statements, and other information required by or under 
authority of the act to appear on the label shall appear thereon in the 
foreign language: Provided, however, That individual serving-size 
packages of foods containing no more than 1\1/2\ avoirdupois ounces or 
no more than 1\1/2\ fluid ounces served with meals in restaurants, 
institutions, and passenger carriers and not intended for sale at retail 
are exempt from the requirements of this paragraph (c)(2), if the only 
representation in the foreign language(s) is the name of the food.

[[Page 66]]

    (3) If any article of labeling (other than a label) contains any 
representation in a foreign language, all words, statements, and other 
information required by or under authority of the act to appear on the 
label or labeling shall appear on such article of labeling.



Sec.  101.17  Food labeling warning, notice, and safe handling statements.

    (a) Self-pressurized containers. (1) The label of a food packaged in 
a self-pressurized container and intended to be expelled from the 
package under pressure shall bear the following warning:

    WARNING--Avoid spraying in eyes. Contents under pressure. Do not 
puncture or incinerate. Do not store at temperature above 120 [deg]F. 
Keep out of reach of children.

    (2) In the case of products intended for use by children, the phrase 
``except under adult supervision'' may be added at the end of the last 
sentence in the warning required by paragraph (a)(1) of this section.
    (3) In the case of products packaged in glass containers, the word 
``break'' may be substituted for the word ``puncture'' in the warning 
required by paragraph (a)(1) of this section.
    (4) The words ``Avoid spraying in eyes'' may be deleted from the 
warning required by paragraph (a)(1) of this section in the case of a 
product not expelled as a spray.
    (b) Self-pressurized containers with halocarbon or hydrocarbon 
propellants. (1) In addition to the warning required by paragraph (a) of 
this section, the label of a food packaged in a self-pressurized 
container in which the propellant consists in whole or in part of a 
halocarbon or a hydrocarbon shall bear the following warning:

    WARNING--Use only as directed. Intentional misuse by deliberately 
concentrating and inhaling the contents can be harmful or fatal.

    (2) The warning required by paragraph (b)(1) of this section is not 
required for the following products:
    (i) Products expelled in the form of a foam or cream, which contain 
less than 10 percent propellant in the container.
    (ii) Products in a container with a physical barrier that prevents 
escape of the propellant at the time of use.
    (iii) Products of a net quantity of contents of less than 2 ounces 
that are designed to release a measured amount of product with each 
valve actuation.
    (iv) Products of a net quantity of contents of less than one-half 
ounce.
    (c) Food containing or manufactured with a chloro fluoro carbon or 
other ozone-depleting substance. Labeling requirements for foods that 
contain or are manufactured with a chlorofluorocarbon or other ozone-
depleting substance designated by the Environmental Protection Agency 
(EPA) are set forth in 40 CFR part 82.
    (d) Protein products. (1) The label and labeling of any food product 
in liquid, powdered, tablet, capsule, or similar forms that derives more 
than 50 percent of its total caloric value from either whole protein, 
protein hydrolysates, amino acid mixtures, or a combination of these, 
and that is represented for use in reducing weight shall bear the 
following warning:

    WARNING: Very low calorie protein diets (below 400 Calories per day) 
may cause serious illness or death. Do Not Use for Weight Reduction in 
Such Diets Without Medical Supervision. Not for use by infants, 
children, or pregnant or nursing women.

    (2) Products described in paragraph (d)(1) of this section are 
exempt from the labeling requirements of that paragraph if the protein 
products are represented as part of a nutritionally balanced diet plan 
providing 400 or more Calories (kilocalories) per day and the label or 
labeling of the product specifies the diet plan in detail or provides a 
brief description of that diet plan and adequate information describing 
where the detailed diet plan may be obtained and the label and labeling 
bear the following statement:

    Notice: For weight reduction, use only as directed in the 
accompanying diet plan (the name and specific location in labeling of 
the diet plan may be included in this statement in place of 
``accompanying diet plan''). Do not use in diets supplying less than 400 
Calories per day without medical supervision.

    (3) The label and labeling of food products represented or intended 
for dietery (food) supplementation that derive more than 50 percent of 
their total caloric value from either whole protein, protein 
hydrolysates, amino acid mixtures, or a combination of these,

[[Page 67]]

that are represented specifically for purposes other than weight 
reduction; and that are not covered by the requirements of paragraph (d) 
(1) and (2) of this section; shall bear the following statement:

    Notice: Use this product as a food supplement only. Do not use for 
weight reduction.

    (4) The provisions of this paragraph are separate from and in 
addition to any labeling requirements promulgated by the Federal Trade 
Commission for protein supplements.
    (5) Protein products shipped in bulk form for use solely in the 
manufacture of other foods and not for distribution to consumers in such 
container are exempt from the labeling requirements of this paragraph.
    (6) The warning and notice statements required by paragraphs (d) 
(1), (2), and (3) of this section shall appear prominently and 
conspicuously on the principal display panel of the package label and 
any other labeling.
    (e) Dietary supplements containing iron or iron salts. (1) The 
labeling of any dietary supplement in solid oral dosage form (e.g., 
tablets or capsules) that contains iron or iron salts for use as an iron 
source shall bear the following statement:

    WARNING: Accidental overdose of iron-containing products is a 
leading cause of fatal poisoning in children under 6. Keep this product 
out of reach of children. In case of accidental overdose, call a doctor 
or poison control center immediately.

    (2)(i) The warning statement required by paragraph (e)(1) of this 
section shall appear prominently and conspicuously on the information 
panel of the immediate container label.
    (ii) If a product is packaged in unit-dose packaging, and if the 
immediate container bears labeling but not a label, the warning 
statement required by paragraph (e)(1) of this section shall appear 
prominently and conspicuously on the immediate container labeling in a 
way that maximizes the likelihood that the warning is intact until all 
of the dosage units to which it applies are used.
    (3) Where the immediate container is not the retail package, the 
warning statement required by paragraph (e)(1) of this section shall 
also appear prominently and conspicuously on the information panel of 
the retail package label.
    (4) The warning statement shall appear on any labeling that contains 
warnings.
    (5) The warning statement required by paragraph (e)(1) of this 
section shall be set off in a box by use of hairlines.
    (f) Foods containing psyllium husk. (1) Foods containing dry or 
incompletely hydrated psyllium husk, also known as psyllium seed husk, 
and bearing a health claim on the association between soluble fiber from 
psyllium husk and reduced risk of coronary heart disease, shall bear a 
label statement informing consumers that the appropriate use of such 
foods requires consumption with adequate amounts of fluids, alerting 
them of potential consequences of failing to follow usage 
recommendations, and informing persons with swallowing difficulties to 
avoid consumption of the product (e.g., ``NOTICE: This food should be 
eaten with at least a full glass of liquid. Eating this product without 
enough liquid may cause choking. Do not eat this product if you have 
difficulty in swallowing.''). However, a product in conventional food 
form may be exempt from this requirement if a viscous adhesive mass is 
not formed when the food is exposed to fluids.
    (2) The statement shall appear prominently and conspicuously on the 
information panel or principal display panel of the package label and 
any other labeling to render it likely to be read and understood by the 
ordinary individual under customary conditions of purchase and use. The 
statement shall be preceded by the word ``NOTICE'' in capital letters.
    (g) Juices that have not been specifically processed to prevent, 
reduce, or eliminate the presence of pathogens. (1) For purposes of this 
paragraph (g), ``juice'' means the aqueous liquid expressed or extracted 
from one or more fruits or vegetables, purees of the edible portions of 
one or more fruits or vegetables, or any concentrate of such liquid or 
puree.
    (2) The label of:
    (i) Any juice that has not been processed in the manner described in 
paragraph (g)(7) of this section; or

[[Page 68]]

    (ii) Any beverage containing juice where neither the juice 
ingredient nor the beverage has been processed in the manner described 
in paragraph (g)(7) of this section, shall bear the following warning 
statement:

    WARNING: This product has not been pasteurized and, therefore, may 
contain harmful bacteria that can cause serious illness in children, the 
elderly, and persons with weakened immune systems.

    (3) The warning statement required by this paragraph (g) shall not 
apply to juice that is not for distribution to retail consumers in the 
form shipped and that is for use solely in the manufacture of other 
foods or that is to be processed, labeled, or repacked at a site other 
than originally processed, provided that for juice that has not been 
processed in the manner described in paragraph (g)(7) of this section, 
the lack of such processing is disclosed in documents accompanying the 
juice, in accordance with the practice of the trade.
    (4) The warning statement required by paragraph (g)(2) of this 
section shall appear prominently and conspicuously on the information 
panel or on the principal display panel of the label of the container.
    (5) The word ``WARNING'' shall be capitalized and shall appear in 
bold type.
    (6) The warning statement required by paragraph (g)(2) of this 
section, when on a label, shall be set off in a box by use of hairlines.
    (7)(i) The requirements in this paragraph (g) shall not apply to a 
juice that has been processed in a manner that will produce, at a 
minimum, a reduction in the pertinent microorganism for a period at 
least as long as the shelf life of the product when stored under normal 
and moderate abuse conditions, of the following magnitude:
    (A) A 5-log (i.e., 100,000-fold) reduction; or
    (B) A reduction that is equal to, or greater than, the criterion 
established for process controls by any final regulation requiring the 
application of Hazard Analysis and Critical Control Point (HACCP) 
principles to the processing of juice.
    (ii) For the purposes of this paragraph (g), the ``pertinent 
microorganism'' is the most resistant microorganism of public health 
significance that is likely to occur in the juice.
    (h) Shell eggs. (1) The label of all shell eggs, whether in 
intrastate or interstate commerce, shall bear the following statement:

    SAFE HANDLING INSTRUCTIONS: To prevent illness from bacteria: keep 
eggs refrigerated, cook eggs until yolks are firm, and cook foods 
containing eggs thoroughly.

    (2) The label statement required by paragraph (h)(1) of this section 
shall appear prominently and conspicuously, with the words ``SAFE 
HANDLING INSTRUCTIONS'' in bold type, on the principal display panel, 
the information panel, or on the inside of the lid of egg cartons. If 
this statement appears on the inside of the lid, the words ``Keep 
Refrigerated'' must appear on the principal display panel or information 
panel.
    (3) The label statement required by paragraph (h)(1) of this section 
shall be set off in a box by use of hairlines.
    (4) Shell eggs that have been, before distribution to consumers, 
specifically processed to destroy all viable Salmonella shall be exempt 
from the requirements of paragraph (h) of this section.
    (5) The safe handling statement for shell eggs that are not for 
direct sale to consumers, e.g., those that are to be repacked or labeled 
at a site other than where originally processed, or are sold for use in 
food service establishments, may be provided on cartons or in labeling, 
e.g., invoices or bills of lading in accordance with the practice of the 
trade.
    (6) Under sections 311 and 361 of the Public Health Service Act (PHS 
Act), any State or locality that is willing and able to assist the 
agency in the enforcement of paragraphs (h)(1) through (h)(5) of this 
section, and is authorized to inspect or regulate establishments 
handling packed shell eggs, may in its own jurisdiction, enforce 
paragraphs (h)(1) through (h)(5) of this section through inspections 
under paragraph (h)(8) of this section and through administrative 
enforcement remedies identified in paragraph (h)(7) of this section 
until FDA notifies the State or locality in writing that such assistance 
is no longer needed. When providing

[[Page 69]]

such assistance, a State or locality may follow the hearing procedures 
set out in paragraphs (h)(7)(ii)(C) through (h)(7)(ii)(D) of this 
section, substituting, where necessary, appropriate State or local 
officials for designated FDA officials or may utilize State or local 
hearing procedures if such procedures satisfy due process.
    (7) This paragraph (h) is established under authority of both the 
Federal Food, Drug, and Cosmetic Act (the act) and the PHS Act. Under 
the act, the agency can enforce the food misbranding provisions under 21 
U.S.C. 331, 332, 333, and 334. However, 42 U.S.C. 264 provides for the 
issuance of implementing enforcement regulations; therefore, FDA has 
established the following administrative enforcement procedures for the 
relabeling, diversion, or destruction of shell eggs and informal 
hearings under the PHS Act:
    (i) Upon finding that any shell eggs are in violation of this 
section an authorized FDA representative or State or local 
representative in accordance with paragraph (h)(6) of this section may 
order such eggs to be relabeled under the supervision of said 
representative, diverted, under the supervision of said representative 
for processing in accordance with the Egg Products Inspection Act (EPIA) 
(21 U.S.C. 1031 et seq.), or destroyed by or under the supervision of an 
officer or employee of the FDA, or, if applicable, of the State or 
locality, in accordance with the following procedures:
    (A) Order for relabeling, diversion, or destruction under the PHS 
Act. Any district office of the FDA or any State or locality acting 
under paragraph (h)(6) of this section, upon finding shell eggs held in 
violation of this regulation, may serve upon the person in whose 
possession such eggs are found a written order that such eggs be 
relabeled with the required statement in paragraph (h)(1) of this 
section before further distribution. If the person chooses not to 
relabel, the district office of the FDA or, if applicable, the 
appropriate State or local agency may serve upon the person a written 
order that such eggs be diverted (from direct consumer sale, e.g., to 
food service) under the supervision of an officer or employee of the 
issuing entity, for processing in accordance with the EPIA (21 U.S.C. 
1031 et seq.) or destroyed by or under the supervision of the issuing 
entity, within 10-working days from the date of receipt of the order.
    (B) Issuance of order. The order shall include the following 
information:
    (1) A statement that the shell eggs identified in the order are 
subject to relabeling, diversion for processing in accordance with the 
EPIA, or destruction;
    (2) A detailed description of the facts that justify the issuance of 
the order;
    (3) The location of the eggs;
    (4) A statement that these eggs shall not be sold, distributed, or 
otherwise disposed of or moved except as provided in paragraph 
(h)(7)(i)(E) of this section;
    (5) Identification or description of the eggs;
    (6) The order number;
    (7) The date of the order;
    (8) The text of this entire section;
    (9) A statement that the order may be appealed by written appeal or 
by requesting an informal hearing;
    (10) The name and phone number of the person issuing the order; and
    (11) The location and telephone number of the responsible office or 
agency and the name of its director.
    (C) Approval of director. An order, before issuance, shall be 
approved by the director of the office or agency issuing the order. If 
prior written approval is not feasible, prior oral approval shall be 
obtained and confirmed by written memorandum as soon as possible.
    (D) Labeling or marking of shell eggs under order. An FDA, State, or 
local representative issuing an order under paragraph (h)(7)(i)(A) of 
this section shall label or mark the shell eggs with official tags that 
include the following information:
    (1) A statement that the shell eggs are detained in accordance with 
regulations issued under section 361(a) of the PHS Act (42 U.S.C. 
264(a)).
    (2) A statement that the shell eggs shall not be sold, distributed 
or otherwise disposed of or moved except, after notifying the issuing 
entity in writing, to:
    (i) Relabel, divert them for processing in accordance with the EPIA, 
or destroy them, or

[[Page 70]]

    (ii) Move them to another location for holding pending appeal.
    (3) A statement that the violation of the order or the removal or 
alteration of the tag is punishable by fine or imprisonment or both 
(section 368 of the PHS Act, 42 U.S.C. 271).
    (4) The order number and the date of the order, and the name of the 
government representative who issued the order.
    (E) Sale or other disposition of shell eggs under order. After 
service of the order, the person in possession of the shell eggs that 
are the subject of the order shall not sell, distribute, or otherwise 
dispose of or move any eggs subject to the order unless and until the 
notice is withdrawn after an appeal except, after notifying FDA's 
district office or, if applicable, the State or local agency in writing, 
to:
    (1) Relabel, divert, or destroy them as specified in paragraph 
(h)(7)(i) of this section, or
    (2) Move them to another location for holding pending appeal.
    (ii) The person on whom the order for relabeling, diversion, or 
destruction is served may either comply with the order or appeal the 
order to the FDA Regional Food and Drug Director.
    (A) Appeal of a detention order. Any appeal shall be submitted in 
writing to the FDA District Director in whose district the shell eggs 
are located within 5-working days of the issuance of the order. If the 
appeal includes a request for an informal hearing, the hearing shall be 
held within 5-working days after the appeal is filed or, if requested by 
the appellant, at a later date, which shall not be later than 20-
calendar days after the issuance of the order. The order may also be 
appealed within the same period of 5-working days by any other person 
having an ownership or proprietary interest in such shell eggs. The 
appellant of an order shall state the ownership or proprietary interest 
the appellant has in the shell eggs.
    (B) Summary decision. A request for a hearing may be denied, in 
whole or in part and at any time after a request for a hearing has been 
submitted, if the FDA Regional Food and Drug Director or his or her 
designee determines that no genuine and substantial issue of fact has 
been raised by the material submitted in connection with the hearing or 
from matters officially noticed. If the FDA Regional Food and Drug 
Director determines that a hearing is not justified, written notice of 
the determination will be given to the parties explaining the reason for 
denial.
    (C) Informal hearing. Appearance by any appellant at the hearing may 
be by mail or in person, with or without counsel. The informal hearing 
shall be conducted by the FDA Regional Food and Drug Director or his 
designee, and a written summary of the proceedings shall be prepared by 
the FDA Regional Food and Drug Director.
    (1) The FDA Regional Food and Drug Director may direct that the 
hearing be conducted in any suitable manner permitted by law and this 
section. The FDA Regional Food and Drug Director has the power to take 
such actions and make such rulings as are necessary or appropriate to 
maintain order and to conduct an informal fair, expeditious, and 
impartial hearing, and to enforce the requirements concerning the 
conduct of hearings.
    (2) Employees of FDA will first give a full and complete statement 
of the action which is the subject of the hearing, together with the 
information and reasons supporting it, and may present oral or written 
information relevant to the hearing. The party requesting the hearing 
may then present oral or written information relevant to the hearing. 
All parties may conduct reasonable examination of any person (except for 
the presiding officer and counsel for the parties) who makes any 
statement on the matter at the hearing.
    (3) The hearing shall be informal in nature, and the rules of 
evidence do not apply. No motions or objections relating to the 
admissibility of information and views will be made or considered, but 
any party may comment upon or rebut any information and views presented 
by another party.
    (4) The party requesting the hearing may have the hearing 
transcribed, at the party's expense, in which case a copy of the 
transcript is to be furnished to FDA. Any transcript of the hearing will 
be included with the FDA Regional Food and Drug Director's report of the 
hearing.

[[Page 71]]

    (5) The FDA Regional Food and Drug Director shall prepare a written 
report of the hearing. All written material presented at the hearing 
will be attached to the report. Whenever time permits, the FDA Regional 
Food and Drug Director may give the parties the opportunity to review 
and comment on the report of the hearing.
    (6) The FDA Regional Food and Drug Director shall include as part of 
the report of the hearing a finding on the credibility of witnesses 
(other than expert witnesses) whenever credibility is a material issue, 
and shall include a recommended decision, with a statement of reasons.
    (D) Written appeal. If the appellant appeals the detention order but 
does not request a hearing, the FDA Regional Food and Drug Director 
shall render a decision on the appeal affirming or revoking the 
detention within 5-working days after the receipt of the appeal.
    (E) Regional Food and Drug Director decision. If, based on the 
evidence presented at the hearing or by the appellant in a written 
appeal, the FDA Regional Food and Drug Director finds that the shell 
eggs were held in violation of this section, he shall affirm the order 
that they be relabeled, diverted under the supervision of an officer or 
employee of the FDA for processing under the EPIA, or destroyed by or 
under the supervision of an officer or employee of the FDA; otherwise, 
the FDA Regional Food and Drug Director shall issue a written notice 
that the prior order is withdrawn. If the FDA Regional Food and Drug 
Director affirms the order he shall order that the relabeling, 
diversion, or destruction be accomplished within 10-working days from 
the date of the issuance of his decision. The FDA Regional Food and Drug 
Director's decision shall be accompanied by a statement of the reasons 
for the decision. The decision of the FDA Regional Food and Drug 
Director shall constitute final agency action, reviewable in the courts.
    (F) No appeal. If there is no appeal of the order and the person in 
possession of the shell eggs that are subject to the order fails to 
relabel, divert, or destroy them within 10-working days, or if the 
demand is affirmed by the FDA Regional Food and Drug Director after an 
appeal and the person in possession of such eggs fails to relabel, 
divert, or destroy them within 10-working days, the FDA district office, 
or, if applicable, the State or local agency may designate an officer or 
employee to divert or destroy such eggs. It shall be unlawful to prevent 
or to attempt to prevent such diversion or destruction of the shell eggs 
by the designated officer or employee.
    (8) Persons engaged in handling or storing packed shell eggs for 
retail distribution shall permit authorized representatives of FDA to 
make at any reasonable time such inspection of the establishment in 
which shell eggs are being held, including inspection and sampling of 
the labeling of such eggs as may be necessary in the judgment of such 
representatives to determine compliance with the provisions of this 
section. Inspections may be made with or without notice and will 
ordinarily be made during regular business hours.
    (9) No State or local governing entity shall establish or continue 
in effect any law, rule, regulation, or other requirement requiring safe 
handling instructions on unpasteurized shell eggs that are less 
stringent than those required in paragraphs (h)(1) through (h)(5) of 
this section.

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29, 1977; 
49 FR 13690, Apr. 6, 1984; 49 FR 28548, July 13, 1984; 61 FR 20100, May 
3, 1996; 62 FR 2249, Jan. 15, 1997; 63 FR 8118, Feb. 18, 1998; 63 FR 
37055, July 8, 1998; 63 FR 63982, Nov. 18, 1998; 66 FR 17358, Mar. 30, 
2001; 65 FR 76111, Dec. 5, 2000; 72 FR 46378, Aug. 20, 2007]



Sec.  101.18  Misbranding of food.

    (a) Among representations in the labeling of a food which render 
such food misbranded is a false or misleading representation with 
respect to another food or a drug, device, or cosmetic.
    (b) The labeling of a food which contains two or more ingredients 
may be misleading by reason (among other reasons) of the designation of 
such food in such labeling by a name which includes or suggests the name 
of one or more but not all such ingredients, even though the names of 
all such ingredients are stated elsewhere in the labeling.

[[Page 72]]

    (c) Among representations in the labeling of a food which render 
such food misbranded is any representation that expresses or implies a 
geographical origin of the food or any ingredient of the food except 
when such representation is either:
    (1) A truthful representation of geographical origin.
    (2) A trademark or trade name provided that as applied to the 
article in question its use is not deceptively misdescriptive. A 
trademark or trade name composed in whole or in part of geographical 
words shall not be considered deceptively misdescriptive if it:
    (i) Has been so long and exclusively used by a manufacturer or 
distributor that it is generally understood by the consumer to mean the 
product of a particular manufacturer or distributor; or
    (ii) Is so arbitrary or fanciful that it is not generally understood 
by the consumer to suggest geographic origin.
    (3) A part of the name required by applicable Federal law or 
regulation.
    (4) A name whose market significance is generally understood by the 
consumer to connote a particular class, kind, type, or style of food 
rather than to indicate geographical origin.



              Subpart B_Specific Food Labeling Requirements



Sec.  101.22  Foods; labeling of spices, flavorings, colorings and chemical 

preservatives.

    (a)(1) The term artificial flavor or artificial flavoring means any 
substance, the function of which is to impart flavor, which is not 
derived from a spice, fruit or fruit juice, vegetable or vegetable 
juice, edible yeast, herb, bark, bud, root, leaf or similar plant 
material, meat, fish, poultry, eggs, dairy products, or fermentation 
products thereof. Artificial flavor includes the substances listed in 
Sec. Sec.  172.515(b) and 182.60 of this chapter except where these are 
derived from natural sources.
    (2) The term spice means any aromatic vegetable substance in the 
whole, broken, or ground form, except for those substances which have 
been traditionally regarded as foods, such as onions, garlic and celery; 
whose significant function in food is seasoning rather than nutritional; 
that is true to name; and from which no portion of any volatile oil or 
other flavoring principle has been removed. Spices include the spices 
listed in Sec.  182.10 and part 184 of this chapter, such as the 
following:

Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, 
Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel 
seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour, 
Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper, 
red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme, 
Turmeric.


Paprika, turmeric, and saffron or other spices which are also colors, 
shall be declared as ``spice and coloring'' unless declared by their 
common or usual name.
    (3) The term natural flavor or natural flavoring means the essential 
oil, oleoresin, essence or extractive, protein hydrolysate, distillate, 
or any product of roasting, heating or enzymolysis, which contains the 
flavoring constituents derived from a spice, fruit or fruit juice, 
vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf 
or similar plant material, meat, seafood, poultry, eggs, dairy products, 
or fermentation products thereof, whose significant function in food is 
flavoring rather than nutritional. Natural flavors include the natural 
essence or extractives obtained from plants listed in Sec. Sec.  182.10, 
182.20, 182.40, and 182.50 and part 184 of this chapter, and the 
substances listed in Sec.  172.510 of this chapter.
    (4) The term artificial color or artificial coloring means any 
``color additive'' as defined in Sec.  70.3(f) of this chapter.
    (5) The term chemical preservative means any chemical that, when 
added to food, tends to prevent or retard deterioration thereof, but 
does not include common salt, sugars, vinegars, spices, or oils 
extracted from spices, substances added to food by direct exposure 
thereof to wood smoke, or chemicals applied for their insecticidal or 
herbicidal properties.
    (b) A food which is subject to the requirements of section 403(k) of 
the act shall bear labeling, even though such food is not in package 
form.
    (c) A statement of artificial flavoring, artificial coloring, or 
chemical preservative shall be placed on the food

[[Page 73]]

or on its container or wrapper, or on any two or all three of these, as 
may be necessary to render such statement likely to be read by the 
ordinary person under customary conditions of purchase and use of such 
food. The specific artificial color used in a food shall be identified 
on the labeling when so required by regulation in part 74 of this 
chapter to assure safe conditions of use for the color additive.
    (d) A food shall be exempt from compliance with the requirements of 
section 403(k) of the act if it is not in package form and the units 
thereof are so small that a statement of artificial flavoring, 
artificial coloring, or chemical preservative, as the case may be, 
cannot be placed on such units with such conspicuousness as to render it 
likely to be read by the ordinary individual under customary conditions 
of purchase and use.
    (e) A food shall be exempt while held for sale from the requirements 
of section 403(k) of the act (requiring label statement of any 
artificial flavoring, artificial coloring, or chemical preservatives) if 
said food, having been received in bulk containers at a retail 
establishment, is displayed to the purchaser with either (1) the 
labeling of the bulk container plainly in view or (2) a counter card, 
sign, or other appropriate device bearing prominently and conspicuously 
the information required to be stated on the label pursuant to section 
403(k).
    (f) A fruit or vegetable shall be exempt from compliance with the 
requirements of section 403(k) of the act with respect to a chemical 
preservative applied to the fruit or vegetable as a pesticide chemical 
prior to harvest.
    (g) A flavor shall be labeled in the following way when shipped to a 
food manufacturer or processor (but not a consumer) for use in the 
manufacture of a fabricated food, unless it is a flavor for which a 
standard of identity has been promulgated, in which case it shall be 
labeled as provided in the standard:
    (1) If the flavor consists of one ingredient, it shall be declared 
by its common or usual name.
    (2) If the flavor consists of two or more ingredients, the label 
either may declare each ingredient by its common or usual name or may 
state ``All flavor ingredients contained in this product are approved 
for use in a regulation of the Food and Drug Administration.'' Any 
flavor ingredient not contained in one of these regulations, and any 
nonflavor ingredient, shall be separately listed on the label.
    (3) In cases where the flavor contains a solely natural flavor(s), 
the flavor shall be so labeled, e.g., ``strawberry flavor'', ``banana 
flavor'', or ``natural strawberry flavor''. In cases where the flavor 
contains both a natural flavor and an artificial flavor, the flavor 
shall be so labeled, e.g., ``natural and artificial strawberry flavor''. 
In cases where the flavor contains a solely artificial flavor(s), the 
flavor shall be so labeled, e.g., ``artificial strawberry flavor''.
    (h) The label of a food to which flavor is added shall declare the 
flavor in the statement of ingredients in the following way:
    (1) Spice, natural flavor, and artificial flavor may be declared as 
``spice'', ``natural flavor'', or ``artificial flavor'', or any 
combination thereof, as the case may be.
    (2) An incidental additive in a food, originating in a spice or 
flavor used in the manufacture of the food, need not be declared in the 
statement of ingredients if it meets the requirements of Sec.  
101.100(a)(3).
    (3) Substances obtained by cutting, grinding, drying, pulping, or 
similar processing of tissues derived from fruit, vegetable, meat, fish, 
or poultry, e.g., powdered or granulated onions, garlic powder, and 
celery powder, are commonly understood by consumers to be food rather 
than flavor and shall be declared by their common or usual name.
    (4) Any salt (sodium chloride) used as an ingredient in food shall 
be declared by its common or usual name ``salt.''
    (5) Any monosodium glutamate used as an ingredient in food shall be 
declared by its common or usual name ``monosodium glutamate.''
    (6) Any pyroligneous acid or other artificial smoke flavors used as 
an ingredient in a food may be declared as artificial flavor or 
artificial smoke flavor. No representation may be made, either directly 
or implied, that a food flavored with pyroligneous acid or other 
artificial smoke flavor has been

[[Page 74]]

smoked or has a true smoked flavor, or that a seasoning sauce or similar 
product containing pyroligneous acid or other artificial smoke flavor 
and used to season or flavor other foods will result in a smoked product 
or one having a true smoked flavor.
    (7) Because protein hydrolysates function in foods as both 
flavorings and flavor enhancers, no protein hydrolysate used in food for 
its effects on flavor may be declared simply as ``flavor,'' ``natural 
flavor,'' or ``flavoring.'' The ingredient shall be declared by its 
specific common or usual name as provided in Sec.  102.22 of this 
chapter.
    (i) If the label, labeling, or advertising of a food makes any 
direct or indirect representations with respect to the primary 
recognizable flavor(s), by word, vignette, e.g., depiction of a fruit, 
or other means, or if for any other reason the manufacturer or 
distributor of a food wishes to designate the type of flavor in the food 
other than through the statement of ingredients, such flavor shall be 
considered the characterizing flavor and shall be declared in the 
following way:
    (1) If the food contains no artificial flavor which simulates, 
resembles or reinforces the characterizing flavor, the name of the food 
on the principal display panel or panels of the label shall be 
accompanied by the common or usual name of the characterizing flavor, 
e.g., ``vanilla'', in letters not less than one-half the height of the 
letters used in the name of the food, except that:
    (i) If the food is one that is commonly expected to contain a 
characterizing food ingredient, e.g., strawberries in ``strawberry 
shortcake'', and the food contains natural flavor derived from such 
ingredient and an amount of characterizing ingredient insufficient to 
independently characterize the food, or the food contains no such 
ingredient, the name of the characterizing flavor may be immediately 
preceded by the word ``natural'' and shall be immediately followed by 
the word ``flavored'' in letters not less than one-half the height of 
the letters in the name of the characterizing flavor, e.g., ``natural 
strawberry flavored shortcake,'' or ``strawberry flavored shortcake''.
    (ii) If none of the natural flavor used in the food is derived from 
the product whose flavor is simulated, the food in which the flavor is 
used shall be labeled either with the flavor of the product from which 
the flavor is derived or as ``artificially flavored.''
    (iii) If the food contains both a characterizing flavor from the 
product whose flavor is simulated and other natural flavor which 
simulates, resembles or reinforces the characterizing flavor, the food 
shall be labeled in accordance with the introductory text and paragraph 
(i)(1)(i) of this section and the name of the food shall be immediately 
followed by the words ``with other natural flavor'' in letters not less 
than one-half the height of the letters used in the name of the 
characterizing flavor.
    (2) If the food contains any artificial flavor which simulates, 
resembles or reinforces the characterizing flavor, the name of the food 
on the principal display panel or panels of the label shall be 
accompanied by the common or usual name(s) of the characterizing flavor, 
in letters not less than one-half the height of the letters used in the 
name of the food and the name of the characterizing flavor shall be 
accompanied by the word(s) ``artificial'' or ``artificially flavored'', 
in letters not less than one-half the height of the letters in the name 
of the characterizing flavor, e.g., ``artificial vanilla'', 
``artificially flavored strawberry'', or ``grape artificially 
flavored''.
    (3) Wherever the name of the characterizing flavor appears on the 
label (other than in the statement of ingredients) so conspicuously as 
to be easily seen under customary conditions of purchase, the words 
prescribed by this paragraph shall immediately and conspicuously precede 
or follow such name, without any intervening written, printed, or 
graphic matter, except:
    (i) Where the characterizing flavor and a trademark or brand are 
presented together, other written, printed, or graphic matter that is a 
part of or is associated with the trademark or brand may intervene if 
the required words are in such relationship with the trademark or brand 
as to be clearly related to the characterizing flavor; and

[[Page 75]]

    (ii) If the finished product contains more than one flavor subject 
to the requirements of this paragraph, the statements required by this 
paragraph need appear only once in each statement of characterizing 
flavors present in such food, e.g., ``artificially flavored vanilla and 
strawberry''.
    (iii) If the finished product contains three or more distinguishable 
characterizing flavors, or a blend of flavors with no primary 
recognizable flavor, the flavor may be declared by an appropriately 
descriptive generic term in lieu of naming each flavor, e.g., 
``artificially flavored fruit punch''.
    (4) A flavor supplier shall certify, in writing, that any flavor he 
supplies which is designated as containing no artificial flavor does 
not, to the best of his knowledge and belief, contain any artificial 
flavor, and that he has added no artificial flavor to it. The 
requirement for such certification may be satisfied by a guarantee under 
section 303(c)(2) of the act which contains such a specific statement. A 
flavor user shall be required to make such a written certification only 
where he adds to or combines another flavor with a flavor which has been 
certified by a flavor supplier as containing no artificial flavor, but 
otherwise such user may rely upon the supplier's certification and need 
make no separate certification. All such certifications shall be 
retained by the certifying party throughout the period in which the 
flavor is supplied and for a minimum of three years thereafter, and 
shall be subject to the following conditions:
    (i) The certifying party shall make such certifications available 
upon request at all reasonable hours to any duly authorized office or 
employee of the Food and Drug Administration or any other employee 
acting on behalf of the Secretary of Health and Human Services. Such 
certifications are regarded by the Food and Drug Administration as 
reports to the government and as guarantees or other undertakings within 
the meaning of section 301(h) of the act and subject the certifying 
party to the penalties for making any false report to the government 
under 18 U.S.C. 1001 and any false guarantee or undertaking under 
section 303(a) of the act. The defenses provided under section 303(c)(2) 
of the act shall be applicable to the certifications provided for in 
this section.
    (ii) Wherever possible, the Food and Drug Administration shall 
verify the accuracy of a reasonable number of certifications made 
pursuant to this section, constituting a representative sample of such 
certifications, and shall not request all such certifications.
    (iii) Where no person authorized to provide such information is 
reasonably available at the time of inspection, the certifying party 
shall arrange to have such person and the relevant materials and records 
ready for verification as soon as practicable: Provided, That, whenever 
the Food and Drug Administration has reason to believe that the supplier 
or user may utilize this period to alter inventories or records, such 
additional time shall not be permitted. Where such additional time is 
provided, the Food and Drug Administration may require the certifying 
party to certify that relevant inventories have not been materially 
disturbed and relevant records have not been altered or concealed during 
such period.
    (iv) The certifying party shall provide, to an officer or 
representative duly designated by the Secretary, such qualitative 
statement of the composition of the flavor or product covered by the 
certification as may be reasonably expected to enable the Secretary's 
representatives to determine which relevant raw and finished materials 
and flavor ingredient records are reasonably necessary to verify the 
certifications. The examination conducted by the Secretary's 
representative shall be limited to inspection and review of inventories 
and ingredient records for those certifications which are to be 
verified.
    (v) Review of flavor ingredient records shall be limited to the 
qualitative formula and shall not include the quantitative formula. The 
person verifying the certifications may make only such notes as are 
necessary to enable him to verify such certification. Only such notes or 
such flavor ingredient records as are necessary to verify

[[Page 76]]

such certification or to show a potential or actual violation may be 
removed or transmitted from the certifying party's place of business: 
Provided, That, where such removal or transmittal is necessary for such 
purposes the relevant records and notes shall be retained as separate 
documents in Food and Drug Administration files, shall not be copied in 
other reports, and shall not be disclosed publicly other than in a 
judicial proceeding brought pursuant to the act or 18 U.S.C. 1001.
    (j) A food to which a chemical preservative(s) is added shall, 
except when exempt pursuant to Sec.  101.100 bear a label declaration 
stating both the common or usual name of the ingredient(s) and a 
separate description of its function, e.g., ``preservative'', ``to 
retard spoilage'', ``a mold inhibitor'', ``to help protect flavor'' or 
``to promote color retention''.
    (k) The label of a food to which any coloring has been added shall 
declare the coloring in the statement of ingredients in the manner 
specified in paragraphs (k)(1) and (k)(2) of this section, except that 
colorings added to butter, cheese, and ice cream, if declared, may be 
declared in the manner specified in paragraph (k)(3) of this section, 
and colorings added to foods subject to Sec. Sec.  105.62 and 105.65 of 
this chapter shall be declared in accordance with the requirements of 
those sections.
    (1) A color additive or the lake of a color additive subject to 
certification under 721(c) of the act shall be declared by the name of 
the color additive listed in the applicable regulation in part 74 or 
part 82 of this chapter, except that it is not necessary to include the 
``FD&C'' prefix or the term ``No.'' in the declaration, but the term 
``Lake'' shall be included in the declaration of the lake of the 
certified color additive (e.g., Blue 1 Lake). Manufacturers may 
parenthetically declare an appropriate alternative name of the certified 
color additive following its common or usual name as specified in part 
74 or part 82 of this chapter.
    (2) Color additives not subject to certification may be declared as 
``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added'' (or 
by an equally informative term that makes clear that a color additive 
has been used in the food). Alternatively, such color additives may be 
declared as ``Colored with ------'' or ``------ color'', the blank to be 
filled with the name of the color additive listed in the applicable 
regulation in part 73 of this chapter.
    (3) When a coloring has been added to butter, cheese, or ice cream, 
it need not be declared in the ingredient list unless such declaration 
is required by a regulation in part 73 or part 74 of this chapter to 
ensure safe conditions of use for the color additive. Voluntary 
declaration of all colorings added to butter, cheese, and ice cream, 
however, is recommended.

[42 FR 14308, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 44 
FR 37220, June 26, 1979; 54 FR 24891, June 12, 1989; 58 FR 2875, Jan. 6, 
1993; 63 FR 14818, Mar. 27, 1998]

    Effective Date Note: At 74 FR 216, Jan. 5, 2009, Sec.  101.22 was 
amended by revising paragraph (k)(2), effective January 5, 2011. For the 
convenience of the user, the revised text is set forth as follows:



Sec.  101.22  Foods; labeling of spices, flavorings, colorings and 
          chemical preservatives.

                                * * * * *

    (k) * * *
    (2) Color additives not subject to certification and not otherwise 
required by applicable regulations in part 73 of this chapter to be 
declared by their respective common or usual names may be declared as 
``Artificial Color,'' ``Artificial Color Added,'' or ``Color Added'' (or 
by an equally informative term that makes clear that a color additive 
has been used in the food). Alternatively, such color additives may be 
declared as ``Colored with ----------------'' or ``---------------- 
color,'' the blank to be filled in with the name of the color additive 
listed in the applicable regulation in part 73 of this chapter.

                                * * * * *



Sec.  101.30  Percentage juice declaration for foods purporting to be 

beverages that contain fruit or vegetable juice.

    (a) This section applies to any food that purports to be a beverage 
that contains any fruit or vegetable juice (i.e., the product's 
advertising, label, or labeling bears the name of, or variation on the 
name of, or makes any other direct or indirect representation with 
respect to, any fruit or vegetable juice),

[[Page 77]]

or the label or labeling bears any vignette (i.e., depiction of a fruit 
or vegetable) or other pictorial representation of any fruit or 
vegetable, or the product contains color and flavor that gives the 
beverage the appearance and taste of containing a fruit or vegetable 
juice. The beverage may be carbonated or noncarbonated, concentrated, 
full-strength, diluted, or contain no juice. For example, a soft drink 
(soda) that does not represent or suggest by its physical 
characteristics, name, labeling, ingredient statement, or advertising 
that it contains fruit or vegetable juice does not purport to contain 
juice and therefore does not require a percent juice declaration.
    (b)(1) If the beverage contains fruit or vegetable juice, the 
percentage shall be declared by the words ``Contains -- percent (or %) 
------ juice'' or ``-- percent (or %) juice,'' or a similar phrase, with 
the first blank filled in with the percentage expressed as a whole 
number not greater than the actual percentage of the juice and the 
second blank (if used) filled in with the name of the particular fruit 
or vegetable (e.g., ``Contains 50 percent apple juice'' or ``50 percent 
juice'').
    (2) If the beverage contains less than 1 percent juice, the total 
percentage juice shall be declared as ``less than 1 percent juice'' or 
``less than 1 percent ------ juice'' with the blank filled in with the 
name of the particular fruit or vegetable.
    (3) If the beverage contains 100 percent juice and also contains 
non-juice ingredients that do not result in a diminution of the juice 
soluble solids or, in the case of expressed juice, in a change in the 
volume, when the 100 percent juice declaration appears on a panel of the 
label that does not also bear the ingredient statement, it must be 
accompanied by the phrase ``with added ------,'' the blank filled in 
with a term such as ``ingredient(s),'' ``preservative,'' or 
``sweetener,'' as appropriate (e.g., ``100% juice with added 
sweetener''), except that when the presence of the non-juice 
ingredient(s) is declared as a part of the statement of identity of the 
product, this phrase need not accompany the 100 percent juice 
declaration.
    (c) If a beverage contains minor amounts of juice for flavoring and 
is labeled with a flavor description using terms such as ``flavor'', 
``flavored'', or ``flavoring'' with a fruit or vegetable name and does 
not bear:
    (1) The term ``juice'' on the label other than in the ingredient 
statement; or
    (2) An explicit vignette depicting the fruit or vegetable from which 
the flavor derives, such as juice exuding from a fruit or vegetable; or
    (3) Specific physical resemblance to a juice or distinctive juice 
characteristic such as pulp then total percentage juice declaration is 
not required.
    (d) If the beverage does not meet the criteria for exemption from 
total juice percentage declaration as described in paragraph (c) of this 
section and contains no fruit or vegetable juice, but the labeling or 
color and flavor of the beverage represents, suggests, or implies that 
fruit or vegetable juice may be present (e.g., the product advertising 
or labeling bears the name, a variation of the name, or a pictorial 
representation of any fruit or vegetable, or the product contains color 
and flavor that give the beverage the appearance and taste of containing 
a fruit or vegetable juice), then the label shall declare ``contains 
zero (0) percent (or %) juice''. Alternatively, the label may declare 
``Containing (or contains) no ------ juice'', or ``no ------ juice'', or 
``does not contain ------ juice'', the blank to be filled in with the 
name of the fruits or vegetables represented, suggested, or implied, but 
if there is a general suggestion that the product contains fruit or 
vegetable juice, such as the presence of fruit pulp, the blank shall be 
filled in with the word ``fruit'' or ``vegetable'' as applicable (e.g., 
``contains no fruit juice'', or ``does not contain fruit juice'').
    (e) If the beverage is sold in a package with an information panel 
as defined in Sec.  101.2, the declaration of amount of juice shall be 
prominently placed on the information panel in lines generally parallel 
to other required information, appearing:
    (1) Near the top of the information panel, with no other printed 
label information appearing above the statement except the brand name, 
product

[[Page 78]]

name, logo, or universal product code; and
    (2) In easily legible boldface print or type in distinct contrast to 
other printed or graphic matter, in a height not less than the largest 
type found on the information panel except that used for the brand name, 
product name, logo, universal product code, or the title phrase 
``Nutrition Facts'' appearing in the nutrition information as required 
by Sec.  101.9.
    (f) The percentage juice declaration may also be placed on the 
principal display panel, provided that the declaration is consistent 
with that presented on the information panel.
    (g) If the beverage is sold in a package that does not bear an 
information panel as defined in Sec.  101.2, the percentage juice 
declaration shall be placed on the principal display panel, in type size 
not less than that required for the declaration of net quantity of 
contents statement in Sec.  101.105(i), and be placed near the name of 
the food.
    (h)(1) In enforcing these regulations, the Food and Drug 
Administration will calculate the labeled percentage of juice from 
concentrate found in a juice or juice beverage using the minimum Brix 
levels listed below where single-strength (100 percent) juice has at 
least the specified minimum Brix listed below:

------------------------------------------------------------------------
                                                                   100
                                                                 percent
                             Juice                                juice
                                                                   \1\
------------------------------------------------------------------------
Acerola........................................................      6.0
Apple..........................................................     11.5
Apricot........................................................     11.7
Banana.........................................................     22.0
Blackberry.....................................................     10.0
Blueberry......................................................     10.0
Boysenberry....................................................     10.0
Cantaloupe Melon...............................................      9.6
Carambola......................................................      7.8
Carrot.........................................................      8.0
Casaba Melon...................................................      7.5
Cashew (Caju)..................................................     12.0
Celery.........................................................      3.1
Cherry, dark, sweet............................................     20.0
Cherry, red, sour..............................................     14.0
Crabapple......................................................     15.4
Cranberry......................................................      7.5
Currant (Black)................................................     11.0
Currant (Red)..................................................     10.5
Date...........................................................     18.5
Dewberry.......................................................     10.0
Elderberry.....................................................     11.0
Fig............................................................     18.2
Gooseberry.....................................................      8.3
Grape..........................................................     16.0
Grapefruit.....................................................  \3\10.0
Guanabana (soursop)............................................     16.0
Guava..........................................................      7.7
Honeydew melon.................................................      9.6
Kiwi...........................................................     15.4
Lemon..........................................................  \2\ 4.5
Lime...........................................................    2 4.5
Loganberry.....................................................     10.5
Mango..........................................................     13.0
Nectarine......................................................     11.8
Orange.........................................................  \3\11.8
Papaya.........................................................     11.5
Passion Fruit..................................................     14.0
Peach..........................................................     10.5
Pear...........................................................     12.0
Pineapple......................................................     12.8
Plum...........................................................     14.3
Pomegranate....................................................     16.0
Prune..........................................................     18.5
Quince.........................................................     13.3
Raspberry (Black)..............................................     11.1
Raspberry (Red)................................................      9.2
Rhubarb........................................................      5.7
Strawberry.....................................................      8.0
Tangerine......................................................  \3\11.8
Tomato.........................................................      5.0
Watermelon.....................................................      7.8
Youngberry.....................................................     10.0
------------------------------------------------------------------------
\1\ Indicates Brix value unless other value specified.
\2\ Indicates anhydrous citrus acid percent by weight.
\3\ Brix values determined by refractometer for citrus juices may be
  corrected for citric acid.

    (2) If there is no Brix level specified in paragraph (h)(1) of this 
section, the labeled percentage of that juice from concentrate in a 
juice or juice beverage will be calculated on the basis of the soluble 
solids content of the single-strength (unconcentrated) juice used to 
produce such concentrated juice.
    (i) Juices directly expressed from a fruit or vegetable (i.e., not 
concentrated and reconstituted) shall be considered to be 100 percent 
juice and shall be declared as ``100 percent juice.''
    (j) Calculations of the percentage of juice in a juice blend or a 
diluted juice product made directly from expressed juice (i.e., not from 
concentrate) shall be based on the percentage of the expressed juice in 
the product computed on a volume/volume basis.
    (k) If the product is a beverage that contains a juice whose color, 
taste, or other organoleptic properties have been modified to the extent 
that the original juice is no longer recognizable at the time processing 
is complete, or if its nutrient profile has been diminished to a level 
below the normal nutrient range for the juice, then that juice to which 
such a major modification has been made shall not be included in the 
total percentage juice declaration.

[[Page 79]]

    (l) A beverage required to bear a percentage juice declaration on 
its label, that contains less than 100 percent juice, shall not bear any 
other percentage declaration that describes the juice content of the 
beverage in its label or in its labeling (e.g., ``100 percent natural'' 
or ``100 percent pure''). However, the label or labeling may bear 
percentage statements clearly unrelated to juice content (e.g., 
``provides 100 percent of U.S. RDA of vitamin C'').
    (m) Products purporting to be beverages that contain fruit or 
vegetable juices are exempted from the provisions of this section until 
May 8, 1994. All products that are labeled on or after that date shall 
comply with this section.

[58 FR 2925, Jan. 6, 1993, as amended at 58 FR 44063, Aug. 18, 1993; 58 
FR 49192, Sept. 22, 1993]



    Subpart C_Specific Nutrition Labeling Requirements and Guidelines

    Source: 55 FR 60890, Nov. 27, 1991, unless otherwise noted.



Sec.  101.36  Nutrition labeling of dietary supplements.

    (a) The label of a dietary supplement that is offered for sale shall 
bear nutrition labeling in accordance with this regulation unless an 
exemption is provided for the product in paragraph (h) of this section.
    (b) The declaration of nutrition information on the label and in 
labeling shall contain the following information, using the subheadings 
and the format specified in paragraph (e) of this section.
    (1) Serving size. (i) The subheading ``Serving Size'' shall be 
placed under the heading ``Supplement Facts'' and aligned on the left 
side of the nutrition label. The serving size shall be determined in 
accordance with Sec. Sec.  101.9(b) and 101.12(b), Table 2. Serving size 
for dietary supplements shall be expressed using a term that is 
appropriate for the form of the supplement, such as ``tablets,'' 
``capsules,'' ``packets,'' or ``teaspoonfuls.''
    (ii) The subheading ``Servings Per Container'' shall be placed under 
the subheading ``Serving Size'' and aligned on the left side of the 
nutrition label, except that this information need not be provided when 
it is stated in the net quantity of contents declaration.
    (2) Information on dietary ingredients that have a Reference Daily 
Intake (RDI) or a Daily Reference Value (DRV) as established in Sec.  
101.9(c) and their subcomponents (hereinafter referred to as ``(b)(2)-
dietary ingredients''). (i) The (b)(2)-dietary ingredients to be 
declared, that is, total calories, calories from fat, total fat, 
saturated fat, trans fat, cholesterol, sodium, total carbohydrate, 
dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron, 
shall be declared when they are present in a dietary supplement in 
quantitative amounts by weight that exceed the amount that can be 
declared as zero in nutrition labeling of foods in accordance with Sec.  
101.9(c). Calories from saturated fat and polyunsaturated fat, 
monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and 
other carbohydrate may be declared, but they shall be declared when a 
claim is made about them. Any other vitamins or minerals listed in Sec.  
101.9(c)(8)(iv) or (c)(9) may be declared, but they shall be declared 
when they are added to the product for purposes of supplementation, or 
when a claim is made about them. Any (b)(2)-dietary ingredients that are 
not present, or that are present in amounts that can be declared as zero 
in Sec.  101.9(c), shall not be declared (e.g., amounts corresponding to 
less than 2 percent of the RDI for vitamins and minerals). Protein shall 
not be declared on labels of products that, other than ingredients added 
solely for technological reasons, contain only individual amino acids.
    (A) The names and the quantitative amounts by weight of each (b)(2)-
dietary ingredient shall be presented under the heading ``Amount Per 
Serving.'' When the quantitative amounts by weight are presented in a 
separate column, the heading may be centered over a column of 
quantitative amounts, described by paragraph (b)(2)(ii) of this section, 
if space permits. A heading consistent with the declaration of the 
serving size, such as ``Each Tablet Contains,'' or ``Amount Per 2 
Tablets'' may be used in place of the heading ``Amount Per Serving.''

[[Page 80]]

Other appropriate terms, such as capsule, packet, or teaspoonful, also 
may be used in place of the term ``Serving.''
    (B) The names of dietary ingredients that are declared under 
paragraph (b)(2)(i) of this section shall be presented in a column 
aligned on the left side of the nutrition label in the order and manner 
of indentation specified in Sec.  101.9(c), except that calcium and iron 
shall follow pantothenic acid, and sodium and potassium shall follow 
chloride. This results in the following order for vitamins and minerals: 
Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, 
riboflavin, niacin, vitamin B6, folate, vitamin 
B12, biotin, pantothenic acid, calcium, iron, phosphorus, 
iodine, magnesium, zinc, selenium, copper, manganese, chromium, 
molybdenum, chloride, sodium, and potassium. The (b)(2)-dietary 
ingredients shall be listed according to the nomenclature specified in 
Sec.  101.9 or in paragraph (b)(2)(i)(B)(2) of this section.
    (1) When ``Calories'' are declared, they shall be listed first in 
the column of names, beneath a light bar separating the heading ``Amount 
Per Serving'' from the list of names. When ``Calories from fat'' or 
``Calories from saturated fat'' are declared, they shall be indented 
beneath ``Calories.''
    (2) The following synonyms may be added in parentheses immediately 
following the name of these (b)(2)-dietary ingredients: Vitamin C 
(ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin 
B2), folate (folacin or folic acid), and calories (energy). 
Alternatively, the term ``folic acid'' or ``folacin'' may be listed 
without parentheses in place of ``folate.'' Energy content per serving 
may be expressed in kilojoule units, added in parentheses immediately 
following the statement of caloric content.
    (3) Beta-carotene may be declared as the percent of vitamin A that 
is present as beta-carotene, except that the declaration is required 
when a claim is made about beta-carotene. When declared, the percent 
shall be declared to the nearest whole percent, immediately adjacent to 
or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-
carotene)''). The amount of beta-carotene in terms of international 
units (IU) may be included in parentheses following the percent 
statement (e.g., ``Vitamin A (90% (4500 IU) as beta-carotene)'').
    (ii) The number of calories, if declared, and the quantitative 
amount by weight per serving of each dietary ingredient required to be 
listed under paragraph (b)(2)(i) of this section shall be presented 
either in a separate column aligned to the right of the column of names 
or immediately following the listing of names within the same column. 
The quantitative amounts by weight shall represent the weight of the 
dietary ingredient rather than the weight of the source of the dietary 
ingredient (e.g., the weight of calcium rather than that of calcium 
carbonate).
    (A) These amounts shall be expressed in the increments specified in 
Sec.  101.9(c)(1) through (c)(7), which includes increments for sodium 
and potassium.
    (B) The amounts of vitamins and minerals, excluding sodium and 
potassium, shall be the amount of the vitamin or mineral included in one 
serving of the product, using the units of measurement and the levels of 
significance given in Sec.  101.9(c)(8)(iv), except that zeros following 
decimal points may be dropped, and additional levels of significance may 
be used when the number of decimal places indicated is not sufficient to 
express lower amounts (e.g., the RDI for zinc is given in whole 
milligrams (mg), but the quantitative amount may be declared in tenths 
of a mg).
    (iii) The percent of the Daily Value of all dietary ingredients 
declared under paragraph (b)(2)(i) of this section shall be listed, 
except that the percent for protein may be omitted as provided in Sec.  
101.9(c)(7); no percent shall be given for subcomponents for which DRV's 
have not been established (e.g., sugars); and, for labels of dietary 
supplements of vitamins and minerals that are represented or purported 
to be for use by infants, children less than 4 years of age, or pregnant 
or lactating women, no percent shall be given for total fat, saturated 
fat, cholesterol, total carbohydrate, dietary fiber, vitamin K, 
selenium, manganese, chromium, molybdenum, chloride, sodium, or 
potassium.

[[Page 81]]

    (A) When information on the percent of Daily Values is listed, this 
information shall be presented in one column aligned under the heading 
of ``% Daily Value'' and to the right of the column of amounts. The 
headings ``% Daily Value (DV),'' ``% DV,'' ``Percent Daily Value,'' or 
``Percent DV'' may be substituted for ``% Daily Value.'' The heading ``% 
Daily Value'' shall be placed on the same line as the heading ``Amount 
Per Serving.'' When the acronym ``DV'' is unexplained in the heading and 
a footnote is required under (b)(2)(iii)(D), (b)(2)(iii)(F), or 
(b)(3)(iv) of this section, the footnote shall explain the acronym (e.g. 
``Daily Value (DV) not established'').
    (B) The percent of Daily Value shall be calculated by dividing the 
quantitative amount by weight of each (b)(2)-dietary ingredient by the 
RDI as established in Sec.  101.9(c)(8)(iv) or the DRV as established in 
Sec.  101.9(c)(9) for the specified dietary ingredient and multiplying 
by 100, except that the percent of Daily Value for protein, when 
present, shall be calculated as specified in Sec.  101.9(c)(7)(ii). The 
quantitative amount by weight of each dietary ingredient in this 
calculation shall be the unrounded amount, except that for total fat, 
saturated fat, cholesterol, sodium, potassium, total carbohydrate, and 
dietary fiber, the quantitative amount by weight declared on the label 
(i.e, rounded amount) may be used. The numerical value shall be followed 
by the symbol for percent (i.e., %).
    (C) The percentages based on RDI's and on DRV's shall be expressed 
to the nearest whole percent, except that for dietary ingredients for 
which DRV's have been established, ``Less than 1%'' or ``<1%'' shall be 
used to declare the ``% Daily Value'' when the quantitative amount of 
the dietary ingredient by weight is great enough to require that the 
dietary ingredient be listed, but the amount is so small that the ``% 
Daily Value'' when rounded to the nearest percent is zero (e.g., a 
product that contains 1 gram of total carbohydrate would list the 
percent Daily Value as ``Less than 1%'' or ``<1%'').
    (D) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, or protein, a symbol 
shall follow the value listed for those nutrients that refers to the 
same symbol that is placed at the bottom of the nutrition label, below 
the bar required under paragraph (e)(6) of this section and inside the 
box, that is followed by the statement ``Percent Daily Values are based 
on a 2,000 calorie diet.''
    (E) The percent of Daily Value shall be based on RDI and DRV values 
for adults and children 4 or more years of age, unless the product is 
represented or purported to be for use by infants, children less than 4 
years of age, pregnant women, or lactating women, in which case the 
column heading shall clearly state the intended group. If the product is 
for persons within more than one group, the percent of Daily Value for 
each group shall be presented in separate columns as shown in paragraph 
(e)(10)(ii) of this section.
    (F) For declared subcomponents that have no DRV's and, on the labels 
of dietary supplements of vitamins and minerals that are represented or 
purported to be for use by infants, children less that 4 years of age, 
or pregnant or lactating women, for total fat, saturated fat, 
cholesterol, total carbohydrate, dietary fiber, vitamin K, selenium, 
manganese, chromium, molybdenum, chloride, sodium, or potassium, a 
symbol (e.g., an asterisk) shall be placed in the ``Percent Daily 
Value'' column that shall refer to the same symbol that is placed at the 
bottom of the nutrition label, below the last heavy bar and inside the 
box, and followed by the statement ``Daily Value not established.''
    (G) When calories, calories from fat, or calories from saturated fat 
are declared, the space under the ``% Daily Value'' column shall be left 
blank for these items. When there are no other (b)(2)-dietary 
ingredients listed for which a value must be declared in the ``% Daily 
Value'' column, the column may be omitted as shown in paragraph 
(e)(10)(vii) of this section. When the ``% Daily Value'' column is not 
required, but the dietary ingredients listed are subject to paragraph 
(b)(2)(iii)(F) of this section, the symbol required in that paragraph 
shall immediately follow the quantitative amount by weight for each 
dietary ingredient listed under ``Amount Per Serving.''

[[Page 82]]

    (3) Information on dietary ingredients for which RDI's and DRV's 
have not been established. (i) Dietary ingredients for which FDA has not 
established RDI's or DRV's and that are not subject to regulation under 
paragraph (b)(2) of this section (hereinafter referred to as ``other 
dietary ingredients'') shall be declared by their common or usual name 
when they are present in a dietary supplement, in a column that is under 
the column of names described in paragraph (b)(2)(i)(B) of this section 
or, as long as the constituents of an other dietary ingredient are not 
listed, in a linear display, under the heavy bar described in paragraph 
(e)(6) of this section, except that if no (b)(2)-dietary ingredients are 
declared, other dietary ingredients shall be declared directly beneath 
the heading ``Amount Per Serving'' described in paragraph (b)(2)(i)(A) 
of this section.
    (ii) The quantitative amount by weight per serving of other dietary 
ingredients shall be presented in the same manner as the corresponding 
information required in paragraph (b)(2)(ii) of this section or, when a 
linear display is used, shall be presented immediately following the 
name of the other dietary ingredient. The quantitative amount by weight 
shall be the weight of the other dietary ingredient listed and not the 
weight of any component, or the source, of that dietary ingredient.
    (A) These amounts shall be expressed using metric measures in 
appropriate units (i.e., 1,000 or more units shall be declared in the 
next higher set of units, e.g., 1,100 mg shall be declared as 1.1 g).
    (B) For any dietary ingredient that is a liquid extract from which 
the solvent has not been removed, the quantity listed shall be the 
volume or weight of the total extract. Information on the condition of 
the starting material shall be indicated when it is fresh and may be 
indicated when it is dried. Information may be included on the 
concentration of the dietary ingredient and the solvent used, e.g., 
``fresh dandelion root extract, x (y:z) in 70% ethanol,'' where x is the 
number of milliliters (mL) or mg of the entire extract, y is the weight 
of the starting material and z is the volume (mL) of solvent. Where the 
solvent has been partially removed (not to dryness), the final 
concentration, when indicated, shall be stated (e.g., if the original 
extract was 1:5 and 50 percent of the solvent was removed, then the 
final concentration shall be stated as 1:2.5). Where the name of the 
solvent used is not included in the nutrition label, it is required to 
be listed in the ingredient statement in accordance with Sec.  101.4(g).
    (C) For a dietary ingredient that is an extract from which the 
solvent has been removed, the weight of the ingredient shall be the 
weight of the dried extract.
    (iii) The constituents of a dietary ingredient described in 
paragraph (b)(3)(i) of this section may be listed indented under the 
dietary ingredient and followed by their quantitative amounts by weight 
per serving, except that dietary ingredients described in paragraph 
(b)(2) of this section shall be listed in accordance with that section. 
When the constituents of a dietary ingredient described in paragraph 
(b)(3)(i) of this section are listed, all other dietary ingredients 
shall be declared in a column; however, the constituents themselves may 
be declared in a column or in a linear display.
    (iv) Other dietary ingredients shall bear a symbol (e.g., an 
asterisk) in the column under the heading of ``% Daily Value'' that 
refers to the same symbol placed at the bottom of the nutrition label 
and followed by the statement ``Daily Value not established,'' except 
that when the heading ``% Daily Value'' is not used, the symbol shall 
follow the quantitative amount by weight for each dietary ingredient 
listed.
    (c) A proprietary blend of dietary ingredients shall be included in 
the list of dietary ingredients described in paragraph (b)(3)(i) of this 
section and identified by the term ``Proprietary Blend'' or other 
appropriately descriptive term or fanciful name and may be highlighted 
by bold type. Except as specified in this paragraph, all other 
requirements for the listing of dietary ingredients in dietary 
supplements are applicable.
    (1) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(2) of this section

[[Page 83]]

shall be declared in accordance with paragraph (b)(2) of this section.
    (2) Dietary ingredients contained in the proprietary blend that are 
listed under paragraph (b)(3) of this section (i.e., ``other dietary 
ingredients'') shall be declared in descending order of predominance by 
weight, in a column or linear fashion, and indented under the term 
``Proprietary Blend'' or other appropriately descriptive term or 
fanciful name.
    (3) The quantitative amount by weight specified for the proprietary 
blend shall be the total weight of all other dietary ingredients 
contained in the proprietary blend and shall be placed on the same line 
to the right of the term ``Proprietary Blend'' or other appropriately 
descriptive term or fanciful name underneath the column of amounts 
described in paragraph (b)(2)(ii) of this section. A symbol (e.g., 
asterisk), which refers to the same symbol placed at the bottom of the 
nutrition label that is followed by the statement ``Daily Value not 
established,'' shall be placed under the heading ``% Daily Value,'' if 
present, or immediately following the quantitative amount by weight for 
the proprietary blend.
    (4) The sample label shown in paragraph (e)(10)(v) of this section 
illustrates one method of nutrition labeling a proprietary blend of 
dietary ingredients.
    (d) The source ingredient that supplies a dietary ingredient may be 
identified within the nutrition label in parentheses immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the words ``as'' or ``from'', e.g., ``Calcium (as calcium 
carbonate),'' except that manner of presentation is unnecessary when the 
name of the dietary ingredient (e.g., Oriental ginseng) or its synonym 
(e.g., ascorbic acid) is itself the source ingredient. When a source 
ingredient is identified in parentheses within the nutrition label, or 
when the name of the dietary ingredient or its synonym is the source 
ingredient, it shall not be required to be listed again in the 
ingredient statement that appears outside of the nutrition label. When a 
source ingredient is not identified within the nutrition label, it shall 
be listed in an ingredient statement in accordance with Sec.  101.4(g), 
which shall appear outside and immediately below the nutrition label or, 
if there is insufficient space below the nutrition label, immediately 
contiguous and to the right of the nutrition label.
    (1) Source ingredients shall be identified in accordance with Sec.  
101.4 (i.e., shall be listed by common or usual name, and the listing of 
botanicals shall specify the part of the plant from which the ingredient 
is derived) regardless of whether they are listed in an ingredient 
statement or in the nutrition label.
    (2) When source ingredients are listed within the nutrition label, 
and two or more are used to provide a single dietary ingredient, all of 
the sources shall be listed within the parentheses in descending order 
by weight.
    (3) Representations that the source ingredient conforms to an 
official compendium may be included either in the nutrition label or in 
the ingredient list (e.g., ``Calcium (as calcium carbonate USP)'').
    (e) Nutrition information specified in this section shall be 
presented as follows:
    (1) The title, ``Supplement Facts,'' shall be set in a type size 
larger than all other print size in the nutrition label and, unless 
impractical, shall be set full width of the nutrition label. The title 
and all headings shall be bolded to distinguish them from other 
information.
    (2) The nutrition information shall be enclosed in a box by using 
hairlines.
    (3) All information within the nutrition label shall utilize:
    (i) A single easy-to-read type style,
    (ii) All black or one color type, printed on a white or other 
neutral contrasting background whenever practical,
    (iii) Upper- and lowercase letters, except that all uppercase 
lettering may be utilized for packages that have a total surface area 
available to bear labeling of less than 12 square inches,
    (iv) At least one point leading (i.e., space between lines of text), 
and
    (v) Letters that do not touch.
    (4) Except as provided for small and intermediate-sized packages 
under

[[Page 84]]

paragraph (i)(2) of this section, information other than the title, 
headings, and footnotes shall be in uniform type size no smaller than 8 
point. Type size no smaller than 6 point may be used for column headings 
(e.g., ``Amount Per Serving'' and ``% Daily Value'') and for footnotes 
(e.g., ``Percent Daily Values are based on a 2,000 calorie diet'').
    (5) A hairline rule that is centered between the lines of text shall 
separate each dietary ingredient required in paragraph (b)(2) and (b)(3) 
of this section from the dietary ingredient above and beneath it, as 
shown in paragraph (e)(10) of this section.
    (6) A heavy bar shall be placed:
    (i) Beneath the subheading ``Servings Per Container'' except that if 
``Servings Per Container'' is not required and, as a result, not 
declared, the bar shall be placed beneath the subheading ``Serving 
Size,''
    (ii) Beneath the last dietary ingredient to be listed under 
paragraph (b)(2)(i) of this section, if any, and
    (iii) Beneath the last other dietary ingredient to be listed under 
paragraph (b)(3) of this section, if any.
    (7) A light bar shall be placed beneath the headings ``Amount Per 
Serving'' and ``% Daily Value.''
    (8) If the product contains two or more separately packaged dietary 
supplements that differ from each other (e.g., the product has a packet 
of supplements to be taken in the morning and a different packet to be 
taken in the afternoon), the quantitative amounts and percent of Daily 
Value may be presented as specified in this paragraph in individual 
nutrition labels or in one aggregate nutrition label as illustrated in 
paragraph (e)(10)(iii) of this section.
    (9)(i) The quantitative amount by weight (or volume, if permitted) 
and the percent of Daily Value of each dietary ingredient may be 
presented on a ``per unit'' basis in addition to the ``per serving'' 
basis required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section 
for (b)(2)-dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this 
section for other dietary ingredients. If ``per unit'' information is 
provided, it must be presented in additional columns to the right of the 
``per serving'' information and be clearly identified by appropriate 
headings.
    (ii) Alternatively, if a recommendation is made in other parts of 
the label that a dietary supplement be consumed more than once per day, 
the total quantitative amount by weight (or volume, if permitted) and 
the percent of Daily Value of each dietary ingredient may be presented 
on a ``per day'' basis in addition to the ``per serving'' basis required 
by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section for (b)(2)-
dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this section for 
other dietary ingredients. If ``per day'' information is provided, it 
must be presented in additional columns to the right of the ``per 
serving'' information and be clearly identified by appropriate headings 
and/or be presented in a parenthetical statement as part of the 
``Serving Size'' declaration. A sample illustration for ``per day'' 
information in a column format is provided in paragraph (e)(11)(viii) of 
this section. As illustrated, the additional ``Per Day'' column heading 
is followed parenthetically by the number of servings recommended per 
day in other parts of the label (e.g., ``Per Day (3 Caplets)''). When 
the parenthetical statement format following the ``Serving Size'' 
declaration is used as an alternative to the column format, the 
statement must provide no more than simple instructions regarding how to 
calculate the ``per day'' amount for the number of servings per day 
recommended in other parts of the label (e.g., ``Serving Size: 1 Caplet 
(Multiply amounts by 3 for total daily amount)''). When the 
parenthetical statement format following the ``Serving Size'' 
declaration is used in addition to the column format, the statement must 
provide no more than a simple declaration of the number of servings 
recommended in other parts of the label (e.g., ``Serving Size: 1 Caplet 
(Total daily amount: 3 caplets per day)'').
    (10) In the interest of uniformity of presentation, FDA urges that 
the information be presented using the graphic specifications set forth 
in appendix B to part 101, as applicable.
    (11) The following sample labels are presented for the purpose of 
illustration:

[[Page 85]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.010


[[Page 86]]


[GRAPHIC] [TIFF OMITTED] TR23SE97.011


[[Page 87]]


[GRAPHIC] [TIFF OMITTED] TR23SE97.012


[[Page 88]]


[GRAPHIC] [TIFF OMITTED] TR23SE97.013

    (viii) Dietary supplement illustrating ``per serving'' and ``per 
day'' information:

[[Page 89]]

[GRAPHIC] [TIFF OMITTED] TR13DE06.001

    (12) If space is not adequate to list the required information as 
shown in the sample labels in paragraph (e)(11) of this section, the 
list may be split and continued to the right as long as the headings are 
repeated. The list to the right must be set off by a line that 
distinguishes it and sets it apart from the dietary ingredients and 
percent of Daily Value information given to the left. The following 
sample label illustrates this display:

[[Page 90]]

[GRAPHIC] [TIFF OMITTED] TR23SE97.014

    (f)(1) Compliance with this section will be determined in accordance 
with Sec.  101.9(g)(1) through (g)(8), except that the sample for 
analysis shall consist of a composite of 12 subsamples (consumer 
packages) or 10 percent of the

[[Page 91]]

number of packages in the same inspection lot, whichever is smaller, 
randomly selected to be representative of the lot. The criteria on class 
I and class II nutrients given in Sec.  101.9(g)(3) and (g)(4) also are 
applicable to other dietary ingredients described in paragraph (b)(3)(i) 
of this section. Reasonable excesses of these other dietary ingredients 
over labeled amounts are acceptable within current good manufacturing 
practice.
    (2) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section, FDA may permit alternative means of 
compliance or additional exemptions to deal with the situation in 
accordance with Sec.  101.9(g)(9). Firms in need of such special 
allowances shall make their request in writing to the Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-800), Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740.
    (g) Except as provided in paragraphs (i)(2) and (i)(5) of this 
section, the location of nutrition information on a label shall be in 
compliance with Sec.  101.2.
    (h) Dietary supplements are subject to the exemptions specified as 
follows in:
    (1) Section 101.9(j)(1) for foods that are offered for sale by a 
person who makes direct sales to consumers (i.e., a retailer) who has 
annual gross sales or business done in sales to consumers that is not 
more than $500,000 or has annual gross sales made or business done in 
sales of food to consumers of not more than $50,000, and whose labels, 
labeling, and advertising do not provide nutrition information or make a 
nutrient content or health claim;
    (2) Section 101.9(j)(18) for foods that are low-volume products 
(that is, they meet the requirements for units sold in Sec.  
101.9(j)(18)(i) or (j)(18)(ii)); that, except as provided in Sec.  
101.9(j)(18)(iv), are the subject of a claim for an exemption that 
provides the information required under Sec.  101.9(j)(18)(iv), that is 
filed before the beginning of the time period for which the exemption is 
claimed, and that is filed by a person, whether it is the manufacturer, 
packer, or distributor, that qualifies to claim the exemption under the 
requirements for average full-time equivalent employees in Sec.  
101.9(j)(18)(i) or (j)(18)(ii), and whose labels, labeling, and 
advertising do not provide nutrition information or make a nutrient 
content or health claim;
    (3) Section 101.9(j)(9) for foods shipped in bulk form that are not 
for distribution to consumers in such form and that are for use solely 
in the manufacture of other dietary supplements or that are to be 
processed, labeled, or repacked at a site other than where originally 
processed or packed.
    (i) Dietary supplements are subject to the special labeling 
provisions specified in:
    (1) Section 101.9(j)(5)(i) for foods, other than infant formula, 
represented or purported to be specifically for infants and children 
less than 2 years of age, in that nutrition labels on such foods shall 
not include calories from fat, calories from saturated fat, saturated 
fat, polyunsaturated fat, monounsaturated fat, and cholesterol;
    (2) Section 101.9(j)(13) for foods in small or intermediate-sized 
packages, except that:
    (i) All information within the nutrition label on small-sized 
packages, which have a total surface area available to labeling of less 
than 12 square inches, shall be in type size no smaller than 4.5 point;
    (ii) All information within the nutrition label on intermediate-
sized packages, which have from 12 to 40 square inches of surface area 
available to bear labeling, shall be in type size no smaller than 6 
point, except that type size no smaller than 4.5 point may be used on 
packages that have less than 20 square inches available for labeling and 
more than 8 dietary ingredients to be listed and on packages that have 
20 to 40 square inches available for labeling and more than 16 dietary 
ingredients to be listed.
    (iii) When the nutrition information is presented on any panel under 
Sec.  101.9(j)(13)(ii)(D), the ingredient list shall continue to be 
located immediately below the nutrition label, or, if there is 
insufficient space below the nutrition label, immediately contiguous and 
to the right of the nutrition label as specified in Sec.  101.4(g).

[[Page 92]]

    (iv) When it is not possible for a small or intermediate-sized 
package that is enclosed in an outer package to comply with these type 
size requirements, the type size of the nutrition label on the primary 
(inner) container may be as small as needed to accommodate all of the 
required label information provided that the primary container is 
securely enclosed in outer packaging, the nutrition labeling on the 
outer packaging meets the applicable type size requirements, and such 
outer packaging is not intended to be separated from the primary 
container under conditions of retail sale.
    (v) Where there is not sufficient space on a small or intermediate-
sized package for a nutrition label that meets minimum type size 
requirements of 4.5 points if hairlines are used in accordance with 
paragraph (e)(5) of this section, the hairlines may be omitted and 
replaced by a row of dots connecting the columns containing the name of 
each dietary ingredient and the quantitative amounts (by weight and as a 
percent of Daily Value).
    (3) Section 101.9(j)(15) for foods in multiunit food containers;
    (4) Section 101.9(j)(16) for foods sold in bulk containers; and
    (5) Section 101.9(j)(17) for foods in packages that have a total 
surface area available to bear labeling greater than 40 square inches 
but whose principal display panel and information panel do not provide 
sufficient space to accommodate all required label information, except 
that the ingredient list shall continue to be located immediately below 
the nutrition label, or, if there is insufficient space below the 
nutrition label, immediately contiguous and to the right of the 
nutrition label as specified in Sec.  101.4(g).
    (j) Dietary supplements shall be subject to the misbranding 
provisions of Sec.  101.9(k).

[62 FR 49849, Sept. 23, 1997, as amended at 63 FR 30620, June 5, 1998; 
66 FR 56035, Nov. 6, 2001; 71 FR 51726, Aug. 31, 2006; 71 FR 74791, Dec. 
13, 2006]



Sec.  101.42  Nutrition labeling of raw fruit, vegetables, and fish.

    (a) The Food and Drug Administration (FDA) urges food retailers to 
provide nutrition information, as provided in Sec.  101.9(c), for raw 
fruit, vegetables, and fish at the point-of-purchase. If retailers 
choose to provide such information, they should do so in a manner that 
conforms to the guidelines in Sec.  101.45.
    (b) In Sec.  101.44, FDA has listed the 20 varieties of raw fruit, 
vegetables, and fish that are most frequently consumed during a year and 
to which the guidelines apply.
    (c) FDA has also defined in Sec.  101.43, the circumstances that 
constitute substantial compliance by food retailers with the guidelines.
    (d) By May 8, 1993, FDA will issue a report on actions taken by food 
retailers to provide consumers with nutrition information for raw fruit, 
vegetables, and fish under the guidelines established in Sec.  101.45.
    (1) The report will include a determination of whether there is 
substantial compliance, as defined in Sec.  101.43, with the guidelines.
    (2) In evaluating substantial compliance, FDA will consider only the 
20 varieties of raw fruit, vegetables, and fish most frequently consumed 
as identified in Sec.  101.44.
    (e) If FDA finds that there is substantial compliance with the 
guidelines for the nutrition labeling of raw fruit and vegetables or of 
fish, the agency will so state in the report, and the guidelines will 
remain in effect. FDA will reevaluate the market place for substantial 
compliance every 2 years.
    (f) If FDA determines that there is not substantial compliance with 
the guidelines for raw fruit and vegetables or for raw fish, the agency 
will at that time issue proposed regulations requiring that any person 
who offers raw fruit and vegetables or fish to consumers provide, in a 
manner prescribed by regulations, the nutrition information required by 
Sec.  101.9. Final regulations would have to be issued 6 months after 
issuance of proposed regulations, and they would become effective 6 
months after the date of their promulgation.

[[Page 93]]



Sec.  101.43  Substantial compliance of food retailers with the guidelines for 

the voluntary nutrition labeling of raw fruit, vegetables, and fish.

    (a) The Food and Drug Administration (FDA) will judge a food 
retailer who sells raw agricultural commodities or raw fish to be in 
compliance with the guidelines in Sec.  101.45 with respect to raw 
agricultural commodities if the retailer displays or provides nutrition 
labeling for at least 90 percent of the raw agricultural commodities 
listed in Sec.  101.44 that it sells, and with respect to raw fish if 
the retailer displays or provides nutrition labeling for at least 90 
percent of the types of raw fish listed in Sec.  101.44 that it sells. 
To be in compliance, the nutrition labeling shall:
    (1) Be presented in the store or other type of establishment in a 
manner that is consistent with Sec.  101.45(a)(1);
    (2) Be presented in content and format that are consistent with 
Sec.  101.45 (a)(2), (a)(3), and (a)(4); and
    (3) Include data that have been provided by FDA in appendices C and 
D to part 101 of this chapter, except that the information on potassium 
is voluntary.
    (b) To determine whether there is substantial compliance by food 
retailers with the guidelines in Sec.  101.45 for the voluntary 
nutrition labeling of raw fruit and vegetables and of raw fish, FDA will 
select a representative sample of 2,000 stores, allocated by store type 
and size, for raw fruit and vegetables and for raw fish.
    (c) FDA will find that there is substantial compliance with the 
guidelines in Sec.  101.45 if it finds based on paragraph (a) of this 
section that at least 60 percent of all stores that are evaluated are in 
compliance.
    (d) FDA will evaluate substantial compliance separately for raw 
agricultural commodities and for raw fish.

[55 FR 60890, Nov. 27, 1991, as amended at 61 FR 42759, Aug. 16, 1996]



Sec.  101.44  What are the 20 most frequently consumed raw fruits, vegetables, 

and fish in the United States?

    (a) The 20 most frequently consumed raw fruits are: Apple, avocado 
(California), banana, cantaloupe, grapefruit, grapes, honeydew melon, 
kiwifruit, lemon, lime, nectarine, orange, peach, pear, pineapple, 
plums, strawberries, sweet cherries, tangerine, and watermelon.
    (b) The 20 most frequently consumed raw vegetables are: Asparagus, 
bell pepper, broccoli, carrot, cauliflower, celery, cucumber, green 
(snap) beans, green cabbage, green onion, iceberg lettuce, leaf lettuce, 
mushrooms, onion, potato, radishes, summer squash, sweet corn, sweet 
potato, and tomato.
    (c) The 20 most frequently consumed raw fish are: Blue crab, 
catfish, clams, cod, flounder/sole, haddock, halibut, lobster, ocean 
perch, orange roughy, oysters, pollock, rainbow trout, rockfish, salmon 
(Atlantic/coho/Chinook/sockeye, chum/pink), scallops, shrimp, swordfish, 
tilapia, and tuna.

[71 FR 42044, July 25, 2006]



Sec.  101.45  Guidelines for the voluntary nutrition labeling of raw fruits, 

vegetables, and fish.

    (a) Nutrition labeling for raw fruits, vegetables, and fish listed 
in Sec.  101.44 should be presented to the public in the following 
manner:
    (1) Nutrition labeling information should be displayed at the point 
of purchase by an appropriate means such as by a label affixed to the 
food or through labeling including shelf labels, signs, posters, 
brochures, notebooks, or leaflets that are readily available and in 
close proximity to the foods. The nutrition labeling information may 
also be supplemented by a video, live demonstration, or other media.
    (2) Serving sizes should be determined, and nutrients declared, in 
accordance with Sec.  101.9 (b) and (c), respectively, except that the 
nutrition labeling data should be based on the raw edible portion for 
fruits and vegetables and on the cooked edible portion for fish. The 
methods used to cook fish should be those that do not add fat, breading, 
or seasoning (e.g., salt or spices).
    (3) When nutrition labeling information is provided for more than 
one raw fruit, vegetable, or fish on signs, posters, brochures, 
notebooks, or leaflets, it may be presented in charts with horizontal or 
vertical columns or as a compilation of individual nutrition labels. 
Nutrition labeling that is presented in a linear display (see

[[Page 94]]

Sec.  101.9(j)(13)(ii)(A)(2)) will not be considered to be in 
compliance. The heading ``Nutrition Facts'' must be in a type size 
larger than all other print in the nutrition label. The required 
information (i.e., headings, serving sizes, list of nutrients, 
quantitative amounts by weight (except for vitamins and minerals), and 
percent of Daily Values (DV's) (except for sugars and protein) must be 
clearly presented and of sufficient type size and color contrast to be 
plainly legible, with numeric values for percent of DV highlighted in 
contrast to the quantitative amounts by weight and hairlines between all 
nutrients.
    (i) Declaration of the number of servings per container need not be 
included in the nutrition labeling of raw fruits, vegetables, and fish.
    (ii) Except for the statement ``Percent Daily Values are based on a 
2,000 calorie diet,'' the footnote required in Sec.  101.9(d)(9) is not 
required. However, when labeling is provided in brochures, notebooks, 
leaflets, or similar types of materials, retailers are encouraged to 
include the footnote.
    (iii) When retailers provide nutrition labeling information for more 
than one raw fruit or vegetable on signs or posters or in brochures, 
notebooks, or leaflets, the listings for saturated fat, trans fat, and 
cholesterol may be omitted from the charts or individual nutrition 
labels if a footnote states that most fruits and vegetables provide 
negligible amounts of these nutrients, but that avocados contain 0.5 
gram (g) of saturated fat per ounce (e.g., ``Most fruits and vegetables 
provide negligible amounts of saturated fat, trans fat, and cholesterol; 
avocados provide 0.5 g of saturated fat per ounce''). The footnote also 
may contain information about the polyunsaturated and monounsaturated 
fat content of avocados.
    (iv) When retailers provide nutrition labeling information for more 
than one raw fish on signs or posters or in brochures, notebooks, or 
leaflets, the listings for trans fat, dietary fiber, and sugars may be 
omitted from the charts or individual nutrition labels if the following 
footnote is used, ``Fish provide negligible amounts of trans fat, 
dietary fiber, and sugars.''
    (4) When nutrition labeling is provided for individual raw fruits, 
vegetables, or fish on packages or on signs, posters, brochures, 
notebooks, or leaflets, it should be displayed in accordance with Sec.  
101.9, except that the declaration of the number of servings per 
container need not be included. For individual labels provided by 
retailers on signs and posters, the footnote required in Sec.  
101.9(d)(9) may be shortened to ``Percent Daily Values are based on a 
2,000 calorie diet.''
    (b) Nutrition label values provided by the Food and Drug 
Administration (FDA) in Appendices C and D to part 101 for the 20 most 
frequently consumed raw fruits, vegetables, and fish listed in Sec.  
101.44 shall be used to ensure uniformity in declared values. FDA will 
publish proposed updates of the 20 most frequently consumed raw fruits, 
vegetables, and fish and nutrition label data for these foods (or a 
notice that the data sets have not changed from the previous 
publication) at least every 4 years in the Federal Register.
    (1) The agency encourages the submission of data bases with new or 
additional nutrient data for any of the most frequently consumed raw 
fruits, vegetables, and fish to the Office of Nutritional Products, 
Labeling and Dietary Supplements (HFS-800), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, for review and evaluation. FDA may 
incorporate these data in the next revision of the nutrition labeling 
information for the top 20 raw fruits, vegetables, and fish.
    (i) Guidance in the development of data bases may be found in the 
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data 
Bases,'' available from the FDA Office of Food Labeling.
    (ii) The submission to FDA should include, but need not be limited 
to, information on the following: Source of the data (names of 
investigators, name of organization, place of analyses, dates of 
analyses), number of samples, sampling design, analytical methods, and 
statistical treatment of the data. Proposed quantitative label 
declarations may be included. The proposed values for declaration should 
be determined in

[[Page 95]]

accordance with the ``FDA Nutrition Labeling Manual: A Guide for 
Developing and Using Data Bases.''
    (2) [Reserved]
    (c) Data bases of nutrient values for raw fruits, vegetables, and 
fish that are not among the 20 most frequently consumed may be used to 
develop nutrition labeling values for these foods. This includes data 
bases of nutrient values for specific varieties, species, or cultivars 
of raw fruits, vegetables, and fish not specifically identified among 
the 20 most frequently consumed.
    (1) The food names and descriptions for the fruits, vegetables, and 
fish should clearly identify these foods as distinct from foods among 
the most frequently consumed list for which FDA has provided data.
    (2) Guidance in the development of data bases may be found in the 
``FDA Nutrition Labeling Manual: A Guide for Developing and Using Data 
Bases.''
    (3) Nutrition labeling values computed from data bases are subject 
to the compliance provisions of Sec.  101.9(g).
    (i) Compliance with the provisions of Sec.  101.9(g) may be achieved 
by use of a data base that has been developed following FDA guideline 
procedures and approved by FDA.
    (A) The submission to FDA for approval should include but need not 
be limited to information on the following: Source of the data (names of 
investigators, name of organization, place of analyses, dates of 
analyses), number of samples, sampling design, analytical methods, 
statistical treatment of the data, and proposed quantitative label 
declarations. The values for declaration should be determined in 
accordance with the ``FDA Nutrition Labeling Manual: A Guide for 
Developing and Using Databases.''
    (B) FDA approval of a data base and nutrition labeling values shall 
not be considered granted until the Center for Food Safety and Applied 
Nutrition has agreed to all aspects of the data base in writing. 
Approvals will be in effect for a limited time, e.g., 10 years, and will 
be eligible for renewal in the absence of significant changes in 
agricultural or industry practices (e.g., a change occurs in a 
predominant variety produced). FDA will take steps to revoke its 
approval of the data base and nutrition labeling values if FDA 
monitoring suggests that the data base or nutrition labeling values are 
no longer representative of the item sold in this country. Approval 
requests shall be submitted in accordance with the provision of Sec.  
101.30 of this chapter.
    (ii) [Reserved]

[61 FR 42760, Aug. 16, 1996, as amended at 66 FR 56035, Nov. 6, 2001; 71 
FR 42044, July 25, 2006]



       Subpart D_Specific Requirements for Nutrient Content Claims

    Source: 58 FR 2413, Jan. 6, 1993, unless otherwise noted.



Sec.  101.54  Nutrient content claims for ``good source,'' ``high,'' ``more,'' 

and ``high potency.''

    (a) General requirements. Except as provided in paragraph (e) of 
this section, a claim about the level of a nutrient in a food in 
relation to the Reference Daily Intake (RDI) established for that 
nutrient in Sec.  101.9(c)(8)(iv) or Daily Reference Value (DRV) 
established for that nutrient in Sec.  101.9(c)(9), (excluding total 
carbohydrates) may only be made on the label or in labeling of the food 
if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  101.13; and
    (3) The food for which the claim is made is labeled in accordance 
with Sec.  101.9, Sec.  101.10, or Sec.  101.36, as applicable.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label and in the labeling of 
foods, except meal products as defined in Sec.  101.13(l) and main dish 
products as defined in Sec.  101.13(m), provided that the food contains 
20 percent or more of the RDI or the DRV per reference amount 
customarily consumed.
    (2) The terms defined in paragraph (b)(1) of this section may be 
used on the label and in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The product contains a food that meets the definition of 
``high'' in paragraph (b)(1) of this section; and

[[Page 96]]

    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., the serving of broccoli in this product is 
high in vitamin C).
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label and in the 
labeling of foods, except meal products as defined in Sec.  101.13(l) 
and main dish products as defined in Sec.  101.13(m), provided that the 
food contains 10 to 19 percent of the RDI or the DRV per reference 
amount customarily consumed.
    (2) The terms defined in paragraph (c)(1) of this section may be 
used on the label and in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in 101.13(m), provided 
that:
    (i) The product contains a food that meets the definition of ``good 
source'' in paragraph (c)(1) of this section; and
    (ii) The label or labeling clearly identifies the food that is the 
subject of the claim (e.g., the serving of sweet potatoes in this 
product is a ``good source'' of fiber).
    (d) ``Fiber'' claims. (1) If a nutrient content claim is made with 
respect to the level of dietary fiber, that is, that the product is high 
in fiber, a good source of fiber, or that the food contains ``more'' 
fiber, and the food is not ``low'' in total fat as defined in Sec.  
101.62(b)(2) or, in the case of a meal product, as defined in Sec.  
101.13(l), or main dish product, as defined in Sec.  101.13(m), is not 
``low'' in total fat as defined in Sec.  101.62(b)(3), then the label 
shall disclose the level of total fat per labeled serving.
    (2) The disclosure shall appear in immediate proximity to such 
claim, be in a type size no less than one-half the size of the claim and 
precede any disclosure statement required under Sec.  101.13(h) (e.g., 
``contains [x amount] of total fat per serving. See nutrition 
information for fat content'').
    (e) ``More'' claims. (1) A relative claim using the terms ``more,'' 
``fortified,'' ``enriched,'' ``added,'' ``extra,'' and ``plus'' may be 
used on the label or in labeling of foods to describe the level of 
protein, vitamins, minerals, dietary fiber, or potassium, except as 
limited by Sec.  101.13(j)(1)(i) and except meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 10 percent more of the RDI for 
vitamins or minerals or of the DRV for protein, dietary fiber, or 
potassium (expressed as a percent of the Daily Value) per reference 
amount customarily consumed than an appropriate reference food; and
    (ii) Where the claim is based on a nutrient that has been added to 
the food, that fortification is in accordance with the policy on 
fortification of foods in Sec.  104.20 of this chapter; and
    (iii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percentage (or 
fraction) that the nutrient is greater relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber than white 
bread''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Fiber content of white bread is 1 gram (g) per 
serving; (this product) 3.5 g per serving'') is declared adjacent to the 
most prominent claim or to the nutrition label, except that if the 
nutrition label is on the information panel, the quantitative 
information may be located elsewhere on the information panel in 
accordance with Sec.  101.2.
    (2) A relative claim using the terms ``more,'' ``fortified,'' 
``enriched,'' ``added,'' ``extra,'' and ``plus'' may be used on the 
label or in labeling to describe the level of protein, vitamins, 
minerals, dietary fiber or potassium, except as limited in Sec.  
101.13(j)(1)(i), in meal products as defined in Sec.  101.13(l) or main 
dish products as defined in Sec.  101.13(m), provided that:
    (i) The food contains at least 10 percent more of the RDI for 
vitamins or minerals or of the DRV for protein, dietary fiber, or 
potassium (expressed as a percent of the Daily Value) per 100 g of food 
than an appropriate reference food.
    (ii) Where the claim is based on a nutrient that has been added to 
the food, that fortification is in accordance with the policy on 
fortification of foods in Sec.  104.20 of this chapter; and

[[Page 97]]

    (iii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percentage (or 
fraction) that the nutrient was increased relative to the RDI or DRV are 
declared in immediate proximity to the most prominent such claim (e.g., 
``contains 10 percent more of the Daily Value for fiber per 3 oz than 
does `X brand of product' ''), and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``The fiber content of `X brand of product' is 2 g per 3 
oz. This product contains 4.5 g per 3 oz.'') is declared adjacent to the 
most prominent claim or to the nutrition label, except that if the 
nutrition label is on the information panel, the quantitative 
information may be located elsewhere on the information panel in 
accordance with Sec.  101.2.
    (f) ``High potency'' claims. (1)(i) The term ``high potency'' may be 
used on the label or in the labeling of foods to describe individual 
vitamins or minerals that are present at 100 percent or more of the RDI 
per reference amount customarily consumed.
    (ii) When the term ``high potency'' is used to describe individual 
vitamins or minerals in a product that contains other nutrients or 
dietary ingredients, the label or labeling shall clearly identify which 
vitamin or mineral is described by the term ``high potency'' (e.g., 
``Botanical `X' with high potency vitamin E'').
    (2) The term ``high potency'' may be used on the label or in the 
labeling of a multiingredient food product to describe the product if 
the product contains 100 percent or more of the RDI for at least two-
thirds of the vitamins and minerals that are listed in Sec.  
101.9(c)(8)(iv) and that are present in the product at 2 percent or more 
of the RDI (e.g., ``High potency multivitamin, multimineral dietary 
supplement tablets'').
    (3) Where compliance with paragraphs (f)(1)(i), (f)(1)(ii), or 
(f)(2) of this section is based on a nutrient that has been added to a 
food (other than a dietary supplement), that fortification shall be in 
accordance with the policy on fortification of foods in Sec.  104.20 of 
this chapter.
    (g) Nutrient content claims using the term ``antioxidant.'' A 
nutrient content claim that characterizes the level of antioxidant 
nutrients present in a food may be used on the label or in the labeling 
of that food when:
    (1) An RDI has been established for each of the nutrients;
    (2) The nutrients that are the subject of the claim have recognized 
antioxidant activity; that is, when there exists scientific evidence 
that, following absorption from the gastrointestinal tract, the 
substance participates in physiological, biochemical, or cellular 
processes that inactivate free radicals or prevent free radical-
initiated chemical reactions;
    (3) The level of each nutrient that is the subject of the claim is 
sufficient to qualify for the Sec.  101.54 (b), (c), or (e) claim (e.g., 
to bear the claim ''high in antioxidant vitamin C,'' the product must 
contain 20 percent or more of the RDI for vitamin C). Beta-carotene may 
be a subject of the claim when the level of vitamin A present as beta-
carotene in the food that bears the claim is sufficient to qualify for 
the claim. For example, for the claim ``good source of antioxidant beta-
carotene,'' 10 percent or more of the RDI for vitamin A must be present 
as beta-carotene per reference amount customarily consumed; and
    (4) The names of the nutrients that are the subject of the claim are 
included as part of the claim (e.g., ``high in antioxidant vitamins C 
and E''). Alternatively, when used as part of a nutrient content claim, 
the term ``antioxidant'' or ``antioxidants'' (as in ``high in 
antioxidants'') may be linked by a symbol (e.g., an asterisk ) that 
refers to the same symbol that appears elsewhere on the same panel of a 
product label followed by the name or names of the nutrients with 
recognized antioxidant activity. The list of nutrients shall appear in 
letters of a type size height no smaller than the larger

[[Page 98]]

of one-half of the type size of the largest nutrient content claim or 1/
16 inch.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 59 
FR 394, Jan. 4, 1994; 59 FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5, 
1995; 61 FR 11731, Mar. 22, 1996; 62 FR 31339, June 9, 1997; 62 FR 
49867, 49880, Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR 17358, 
Mar. 30, 2001]



Sec.  101.56  Nutrient content claims for ``light'' or ``lite.''

    (a) General requirements. A claim using the term light or lite to 
describe a food may only be made on the label or in labeling of the food 
if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  101.13; and
    (3) The food is labeled in accordance with Sec.  101.9 or Sec.  
101.10, where applicable.
    (b) ``Light'' claims. The terms ``light'' or ``lite'' may be used on 
the label or in the labeling of foods, except meal products as defined 
in Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
without further qualification, provided that:
    (1) If the food derives 50 percent or more of its calories from fat, 
its fat content is reduced by 50 percent or more per reference amount 
customarily consumed compared to an appropriate reference food as 
specified in Sec.  101.13(j)(1); or
    (2) If the food derives less than 50 percent of its calories from 
fat:
    (i) The number of calories is reduced by at least one-third (33 1/3 
percent) per reference amount customarily consumed compared to an 
appropriate reference food; or
    (ii) Its fat content is reduced by 50 percent or more per reference 
amount customarily consumed compared to the reference food that it 
resembles or for which it substitutes as specified in Sec.  
101.13(j)(1); and
    (3) As required in Sec.  101.13(j)(2) for relative claims:
    (i) The identity of the reference food and the percent (or fraction) 
that the calories and the fat were reduced are declared in immediate 
proximity to the most prominent such claim, (e.g., ``1/3 fewer calories 
and 50 percent less fat than our regular cheese cake'');
    (ii) Quantitative information comparing the level of calories and 
fat content in the product per labeled serving size with that of the 
reference food that it replaces (e.g., ``lite cheesecake--200 calories, 
4 grams (g) fat per serving; regular cheesecake--300 calories, 8 g fat 
per serving'') is declared adjacent to the most prominent claim or to 
the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2; and
    (iii) If the labeled food contains less than 40 calories or less 
than 3 g fat per reference amount customarily consumed, the percentage 
reduction for that nutrient need not be declared.
    (4) A ``light'' claim may not be made on a food for which the 
reference food meets the definition of ``low fat'' and ``low calorie.''
    (c)(1)(i) A product for which the reference food contains 40 
calories or less and 3 g fat or less per reference amount customarily 
consumed may use the term ``light'' or ``lite'' without further 
qualification if it is reduced by 50 percent or more in sodium content 
compared to the reference food; and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sodium was reduced shall be declared in immediate proximity to 
the most prominent such claim (e.g., 50 percent less sodium than our 
regular soy sauce); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``lite soy sauce 500 milligrams (mg) sodium per serving; regular 
soy sauce 1,000 mg per serving'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec.  
101.2.
    (2)(i) A product for which the reference food contains more than 40 
calories or more than 3 g fat per reference amount customarily consumed 
may use the term ``light in sodium'' or ``lite

[[Page 99]]

in sodium'' if it is reduced by 50 percent or more in sodium content 
compared to the reference food, provided that ``light'' or ``lite'' is 
presented in immediate proximity with ``in sodium'' and the entire term 
is presented in uniform type size, style, color, and prominence; and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sodium was reduced shall be declared in immediate proximity to 
the most prominent such claim (e.g., 50 percent less sodium than our 
regular canned peas); and
    (B) Quantitative information comparing the level of sodium per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``lite canned peas, 175 mg sodium per serving; regular canned 
peas 350 mg per serving'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label is 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec.  101.2.
    (iii) Except for meal products as defined in Sec.  101.13(l) and 
main dish products as defined in Sec.  101.13(m), a ``light in sodium'' 
claim may not be made on a food for which the reference food meets the 
definition of ``low in sodium''.
    (d)(1) The terms ``light'' or ``lite'' may be used on the label or 
in the labeling of a meal product as defined in Sec.  101.13(l) and a 
main dish product as defined in Sec.  101.13(m), provided that:
    (i) The food meets the definition of:
    (A) ``Low in calories'' as defined in Sec.  101.60(b)(3); or
    (B) ``Low in fat'' as defined in Sec.  101.62(b)(3); and
    (ii)(A) A statement appears on the principal display panel that 
explains whether ``light'' is used to mean ``low fat,'' ``low 
calories,'' or both (e.g., ``Light Delight, a low fat meal''); and
    (B) The accompanying statement is no less than one-half the type 
size of the ``light'' or ``lite'' claim.
    (2)(i) The term ``light in sodium'' or ``lite in sodium'' may be 
used on the label or in the labeling of a meal product as defined in 
Sec.  101.13(l) and a main dish product as defined in Sec.  101.13(m), 
provided that the food meets the definition of ``low in sodium'' as 
defined in Sec.  101.61(b)(5)(i); and
    (ii) ``Light'' or ``lite'' and ``in sodium'' are presented in 
uniform type size, style, color, and prominence.
    (e) Except as provided in paragraphs (b) through (d) of this 
section, the term ``light'' or ``lite'' may not be used to refer to a 
food that is not reduced in fat by 50 percent, or, if applicable, in 
calories by 1/3 or, when properly qualified, in sodium by 50 percent 
unless:
    (1) It describes some physical or organoleptic attribute of the food 
such as texture or color and the information (e.g., ``light in color'' 
or ``light in texture'') so stated, clearly conveys the nature of the 
product; and
    (2) The attribute (e.g., ``color'' or ``texture'') is in the same 
style, color, and at least one-half the type size as the word ``light'' 
and in immediate proximity thereto.
    (f) If a manufacturer can demonstrate that the word ``light'' has 
been associated, through common use, with a particular food to reflect a 
physical or organoleptic attribute (e.g., light brown sugar, light corn 
syrup, or light molasses) to the point where it has become part of the 
statement of identity, such use of the term ``light'' shall not be 
considered a nutrient content claim subject to the requirements in this 
part.
    (g) The term ``lightly salted'' may be used on a product to which 
has been added 50 percent less sodium than is normally added to the 
reference food as described in Sec.  101.13(j)(1)(i)(B) and 
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as 
defined in Sec.  101.61(b)(4), the statement ``not a low sodium food,'' 
shall appear adjacent to the nutrition label of the food bearing the 
claim, or, if the nutrition label is on the information panel, it may 
appear elsewhere on the information panel in accordance with Sec.  101.2 
and the information required to accompany a relative claim shall appear 
on the label or labeling as specified in Sec.  101.13(j)(2).

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 60 
FR 17206, Apr. 5, 1995]

[[Page 100]]



Sec.  101.60  Nutrient content claims for the calorie content of foods.

    (a) General requirements. A claim about the calorie or sugar content 
of a food may only be made on the label or in the labeling of a food if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  101.13;
    (3) The food for which the claim is made is labeled in accordance 
with Sec.  101.9, Sec.  101.10, or Sec.  101.36, as applicable; and
    (4) For dietary supplements, claims regarding calories may not be 
made on products that meet the criteria in Sec.  101.60(b)(1) or (b)(2) 
for ``calorie free'' or ``low calorie'' claims except when an equivalent 
amount of a similar dietary supplement (e.g., another protein 
supplement) that the labeled food resembles and for which it 
substitutes, normally exceeds the definition for ``low calorie'' in 
Sec.  101.60(b)(2).
    (b) Calorie content claims. (1) The terms ``calorie free,'' ``free 
of calories,'' ``no calories,'' ``zero calories,'' ``without calories,'' 
``trivial source of calories,'' ``negligible source of calories,'' or 
``dietarily insignificant source of calories'' may be used on the label 
or in the labeling of foods, provided that:
    (i) The food contains less than 5 calories per reference amount 
customarily consumed and per labeled serving.
    (ii) As required in Sec.  101.13(e)(2), if the food meets this 
condition without the benefit of special processing, alteration, 
formulation, or reformulation to lower the caloric content, it is 
labeled to disclose that calories are not usually present in the food 
(e.g., ``cider vinegar, a calorie free food'').
    (2) The terms ``low calorie,'' ``few calories,'' ``contains a small 
amount of calories,'' ``low source of calories,'' or ``low in calories'' 
may be used on the label or in labeling of foods, except meal products 
as defined in Sec.  101.13(l) and main dish products as defined in Sec.  
101.13(m), provided that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 grams (g) or greater than 2 tablespoons and does not provide 
more than 40 calories per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and does not provide more than 40 calories 
per reference amount customarily consumed and, except for sugar 
substitutes, per 50 g (for dehydrated foods that must be reconstituted 
before typical consumption with water or a diluent containing an 
insignificant amount, as defined in Sec.  101.9(f)(1), of all nutrients 
per reference amount customarily consumed, the per 50 g criterion refers 
to the ``as prepared'' form).
    (ii) If a food meets these conditions without the benefit of special 
processing, alteration, formulation, or reformulation to vary the 
caloric content, it is labeled to clearly refer to all foods of its type 
and not merely to the particular brand to which the label attaches 
(e.g., ``celery, a low calorie food'').
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of meal products as defined in Sec.  
101.13(l) or main dish products as defined in Sec.  101.13(m), provided 
that:
    (i) The product contains 120 calories or less per 100 g; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the calorie content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which it attaches.
    (4) The terms ``reduced calorie,'' ``reduced in calories,'' 
``calorie reduced,'' ``fewer calories,'' ``lower calorie,'' or ``lower 
in calories'' may be used on the label or in the labeling of foods, 
except as limited by Sec.  101.13(j)(1)(i) and except meal products as 
defined in Sec.  101.13(l) and main dish products as defined in Sec.  
101.13(m), provided that:
    (i) The food contains at least 25 percent fewer calories per 
reference amount customarily consumed than an appropriate reference food 
as described in Sec.  101.13(j)(1); and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the calories differ between the two foods

[[Page 101]]

are declared in immediate proximity to the most prominent such claim 
(e.g., reduced calorie cupcakes ``33 1/3 percent fewer calories than 
regular cupcakes''); and
    (B) Quantitative information comparing the level of the nutrient per 
labeled serving size with that of the reference food that it replaces 
(e.g., ``Calorie content has been reduced from 150 to 100 calories per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or labeling of foods if the reference food meets 
the definition for ``low calorie.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 25 percent fewer calories per 100 g 
of food than an appropriate reference food as described in Sec.  
101.13(j)(1); and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the calories differ between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., Larry's Reduced 
Calorie Lasagna, ``25 percent fewer calories per oz (or 3 oz) than our 
regular Lasagna''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Calorie content has been reduced from 108 calories per 
3 oz to 83 calories per 3 oz.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec.  
101.2.
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or labeling of food if the reference food meets the 
definition for ``low calorie.''
    (c) Sugar content claims--(1) Use of terms such as ``sugar free,'' 
``free of sugar,'' ``no sugar,'' ``zero sugar,'' ``without sugar,'' 
``sugarless,'' ``trivial source of sugar,'' ``negligible source of 
sugar,'' or ``dietarily insignificant source of sugar.'' Consumers may 
reasonably be expected to regard terms that represent that the food 
contains no sugars or sweeteners e.g., ``sugar free,'' or ``no sugar,'' 
as indicating a product which is low in calories or significantly 
reduced in calories. Consequently, except as provided in paragraph 
(c)(2) of this section, a food may not be labeled with such terms 
unless:
    (i) The food contains less than 0.5 g of sugars, as defined in Sec.  
101.9(c)(6)(ii), per reference amount customarily consumed and per 
labeled serving or, in the case of a meal product or main dish product, 
less than 0.5 g of sugars per labeled serving; and
    (ii) The food contains no ingredient that is a sugar or that is 
generally understood by consumers to contain sugars unless the listing 
of the ingredient in the ingredient statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which states 
``adds a trivial amount of sugar,'' ``adds a negligible amount of 
sugar,'' or ``adds a dietarily insignificant amount of sugar;'' and
    (iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or 
bears a relative claim of special dietary usefulness labeled in 
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this 
section, or, if a dietary supplement, it meets the definition in 
paragraph (b)(2) of this section for ``low calorie'' but is prohibited 
by Sec. Sec.  101.13(b)(5) and 101.60(a)(4) from bearing the claim; or
    (B) Such term is immediately accompanied, each time it is used, by 
either the statement ``not a reduced calorie food,'' ``not a low calorie 
food,'' or ``not for weight control.''
    (2) The terms ``no added sugar,'' ``without added sugar,'' or ``no 
sugar added'' may be used only if:
    (i) No amount of sugars, as defined in Sec.  101.9(c)(6)(ii), or any 
other ingredient that contains sugars that functionally substitute for 
added sugars is added during processing or packaging; and

[[Page 102]]

    (ii) The product does not contain an ingredient containing added 
sugars such as jam, jelly, or concentrated fruit juice; and
    (iii) The sugars content has not been increased above the amount 
present in the ingredients by some means such as the use of enzymes, 
except where the intended functional effect of the process is not to 
increase the sugars content of a food, and a functionally insignificant 
increase in sugars results; and
    (iv) The food that it resembles and for which it substitutes 
normally contains added sugars; and
    (v) The product bears a statement that the food is not ``low 
calorie'' or ``calorie reduced'' (unless the food meets the requirements 
for a ``low'' or ``reduced calorie'' food) and that directs consumers' 
attention to the nutrition panel for further information on sugar and 
calorie content.
    (3) Paragraph (c)(1) of this section shall not apply to a factual 
statement that a food, including foods intended specifically for infants 
and children less than 2 years of age, is unsweetened or contains no 
added sweeteners in the case of a food that contains apparent 
substantial inherent sugar content, e.g., juices.
    (4) The claims provided for in paragraph (c)(1) and (c)(2) of this 
section may be used on labels or in labeling of dietary supplements of 
vitamins or minerals that are intended specifically for use by infants 
and children less than 2 years of age.
    (5) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar 
reduced,'' ``less sugar,'' ``lower sugar'' or ``lower in sugar'' may be 
used on the label or in labeling of foods, except meal products as 
defined in Sec.  101.13(l), main dish products as defined in Sec.  
101.13(m), and dietary supplements of vitamins or minerals, provided 
that:
    (i) The food contains at least 25 percent less sugar per reference 
amount customarily consumed than an appropriate reference food as 
described in Sec.  101.13(j)(1); and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sugar differs between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., ``these corn flakes 
contain 25 percent less sugar than our sugar coated corn flakes''); and
    (B) Quantitative information comparing the level of the sugar in the 
product per labeled serving with that of the reference food that it 
replaces (e.g., ``Sugar content has been lowered from 8 g to 6 g per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.
    (6) The terms defined in paragraph (c)(5) of this section may be 
used on the label or in the labeling of a meal product as defined in 
Sec.  101.13(l) and a main dish product as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 25 percent less sugars per 100 g of 
food than an appropriate reference food as described in Sec.  
101.13(j)(1), and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sugars differ between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., reduced sweet and sour 
shrimp dinner, ``25 percent less sugar per 3 oz than our regular sweet 
and sour shrimp dinner''); and
    (B) Quantitative information comparing the level of the nutrient in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Sugar content has been reduced from 17 g per 3 oz to 
13 g per 3 oz.'') is declared adjacent to the most prominent claim or to 
the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 
FR 44031, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, 
1995; 62 FR 15342, Mar. 31, 1997; 62 FR 49881, Sept. 23, 1997]

[[Page 103]]



Sec.  101.61  Nutrient content claims for the sodium content of foods.

    (a) General requirements. A claim about the level of sodium or salt 
in a food may only be made on the label or in the labeling of the food 
if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  101.13; and
    (3) The food for which the claim is made is labeled in accordance 
with Sec.  101.9, Sec.  101.10, or Sec.  101.36, as applicable.
    (b) Sodium content claims. (1) The terms ``sodium free,'' ``free of 
sodium,'' ``no sodium,'' ``zero sodium,'' ``without sodium,'' ``trivial 
source of sodium,'' ``negligible source of sodium,'' or ``dietary 
insignificant source of sodium'' may be used on the label or in the 
labeling of foods, provided that:
    (i) The food contains less than 5 milligrams (mg) of sodium per 
reference amount customarily consumed and per labeled serving or, in the 
case of a meal product or a main dish product, less than 5 mg of sodium 
per labeled serving; and
    (ii) The food contains no ingredient that is sodium chloride or is 
generally understood by consumers to contain sodium, unless the listing 
of the ingredient in the ingredient statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which 
states: ``Adds a trivial amount of sodium,'' ``adds a negligible amount 
of sodium'' or ``adds a dietarily insignificant amount of sodium;'' and
    (iii) As required in Sec.  101.13(e)(2) if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower the sodium content, it is labeled 
to disclose that sodium is not usually present in the food (e.g., ``leaf 
lettuce, a sodium free food'').
    (2) The terms ``very low sodium,'' or ``very low in sodium,'' may be 
used on the label or in labeling of foods, except meal products as 
defined in Sec.  101.13(l) and main dish products as defined in Sec.  
101.13(m), provided that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 grams (g) or greater than 2 tablespoons and contains 35 mg or 
less sodium per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and contains 35 mg or less sodium per 
reference amount customarily consumed and per 50 g (for dehydrated foods 
that must be reconstituted before typical consumption with water or a 
diluent containing an insignificant amount, as defined in Sec.  
101.9(f)(1), of all nutrients per reference amount customarily consumed, 
the per 50-g criterion refers to the ``as prepared'' form);
    (ii) If the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to vary 
the sodium content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which the label attaches 
(e.g., ``potatoes, a very low-sodium food'').
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of meal products as defined in Sec.  
101.13(l) and main dish products as defined in Sec.  101.13(m), provided 
that:
    (i) The product contains 35 mg or less of sodium per 100 g of 
product; and
    (ii) If the product meets this condition without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which the label attaches.
    (4) The terms ``low sodium,'' or ``low in sodium,'' ``little 
sodium,'' ``contains a small amount of sodium,'' or ``low source of 
sodium'' may be used on the label or in the labeling of foods, except 
meal products as defined in Sec.  101.13(l) and main dish products as 
defined in Sec.  101.13(m), provided that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and contains 140 mg or less 
sodium per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and contains 140 mg or less sodium per 
reference amount customarily consumed and per

[[Page 104]]

50 g (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec.  101.9(f)(1), of all nutrients per reference amount 
customarily consumed, the per 50-g criterion refers to the ``as 
prepared'' form); and
    (ii) If the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to vary 
the sodium content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which the label attaches 
(e.g., ``fresh spinach, a low sodium food''); and
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in labeling of meal products as defined in Sec.  
101.13(l) and main dish products as defined in Sec.  101.13(m), provided 
that:
    (i) The product contains 140 mg or less sodium per 100 g; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
the sodium content, it is labeled to clearly refer to all foods of its 
type and not merely to the particular brand to which the label attaches.
    (6) The terms ``reduced sodium,'' ``reduced in sodium,'' ``sodium 
reduced,'' ``less sodium,'' ``lower sodium,'' or ``lower in sodium'' may 
be used on the label or in labeling of foods, except meal products as 
defined in Sec.  101.13(l) and main dish products as defined in Sec.  
101.13(m), provided that:
    (i) The food contains at least 25 percent less sodium per reference 
amount customarily consumed than an appropriate reference food as 
described in Sec.  101.13(j)(1).
    (ii) As required for Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sodium differs from the labeled food are declared in immediate 
proximity to the most prominent such claim (e.g., ``reduced sodium ----
--, 50 percent less sodium than regular ------''); and
    (B) Quantitative information comparing the level of the sodium in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Sodium content has been lowered from 300 to 150 mg per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.
    (iii) Claims described in paragraph (b)(6) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low sodium.''
    (7) The terms defined in paragraph (b)(6) of this section may be 
used on the label or in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 25 percent less sodium per 100 g of 
food than an appropriate reference food as described in Sec.  
101.13(j)(1), and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the sodium differs from the reference food are declared in 
immediate proximity to the most prominent such claim (e.g., reduced 
sodium eggplant parmigiana dinner ``30 percent less sodium per oz (or 3 
oz) than our regular eggplant parmigiana dinner'').
    (B) Quantitative information comparing the level of sodium in the 
product per specified weight with that of the reference food that it 
replaces (e.g., ``Sodium content has been reduced from 217 mg per 3 oz 
to 150 mg per 3 oz.'') is declared adjacent to the most prominent claim 
or to the nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.
    (iii) Claims described in paragraph (b)(7) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low sodium.''
    (c) The term ``salt'' is not synonymous with ``sodium.'' Salt refers 
to sodium chloride. However, references to salt content such as 
``unsalted,'' ``no

[[Page 105]]

salt,'' ``no salt added'' are potentially misleading.
    (1) The term ``salt free'' may be used on the label or in labeling 
of foods only if the food is ``sodium free'' as defined in paragraph 
(b)(1) of this section.
    (2) The terms ``unsalted,'' ``without added salt,'' and ``no salt 
added'' may be used on the label or in labeling of foods only if:
    (i) No salt is added during processing;
    (ii) The food that it resembles and for which it substitutes is 
normally processed with salt; and
    (iii) If the food is not sodium free, the statement, ``not a sodium 
free food'' or ``not for control of sodium in the diet'' appears 
adjacent to the nutrition label of the food bearing the claim, or, if 
the nutrition label is on the information panel, it may appear elsewhere 
on the information panel in accordance with Sec.  101.2.
    (3) Paragraph (c)(2) of this section shall not apply to a factual 
statement that a food intended specifically for infants and children 
less than 2 years of age is unsalted, provided such statement refers to 
the taste of the food and is not otherwise false and misleading.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 
FR 44032, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, 
1995]



Sec.  101.62  Nutrient content claims for fat, fatty acid, and cholesterol 

content of foods.

    (a) General requirements. A claim about the level of fat, fatty 
acid, and cholesterol in a food may only be made on the label or in the 
labeling of foods if:
    (1) The claim uses one of the terms defined in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  101.13;
    (3) The food for which the claim is made is labeled in accordance 
with Sec.  101.9, Sec.  101.10, or Sec.  101.36, as applicable; and
    (4) For dietary supplements, claims for fat, saturated fat, and 
cholesterol may not be made on products that meet the criteria in Sec.  
101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie'' claims.
    (b) Fat content claims. (1) The terms ``fat free,'' ``free of fat,'' 
``no fat,'' ``zero fat,'' ``without fat,'' ``negligible source of fat,'' 
or ``dietarily insignificant source of fat'' or, in the case of milk 
products, ``skim'' may be used on the label or in labeling of foods, 
provided that:
    (i) The food contains less than 0.5 gram (g) of fat per reference 
amount customarily consumed and per labeled serving or, in the case of a 
meal product or main dish product, less than 0.5 g of fat per labeled 
serving; and
    (ii) The food contains no added ingredient that is a fat or is 
generally understood by consumers to contain fat unless the listing of 
the ingredient in the ingredient statement is followed by an asterisk 
that refers to the statement below the list of ingredients, which states 
``adds a trivial amount of fat,'' ``adds a negligible amount of fat,'' 
or ``adds a dietarily insignificant amount of fat;'' and
    (iii) As required in Sec.  101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower fat content, it is labeled to 
disclose that fat is not usually present in the food (e.g., ``broccoli, 
a fat free food'').
    (2) The terms ``low fat,'' ``low in fat,'' ``contains a small amount 
of fat,'' ``low source of fat,'' or ``little fat'' may be used on the 
label or in labeling of foods, except meal products as defined in Sec.  
101.13(l) and main dish products as defined in Sec.  101.13(m), provided 
that:
    (i)(A) The food has a reference amount customarily consumed greater 
than 30 g or greater than 2 tablespoons and contains 3 g or less of fat 
per reference amount customarily consumed; or
    (B) The food has a reference amount customarily consumed of 30 g or 
less or 2 tablespoons or less and contains 3 g or less of fat per 
reference amount customarily consumed and per 50 g of food (for 
dehydrated foods that must be reconstituted before typical consumption 
with water or a diluent containing an insignificant amount, as defined 
in Sec.  101.9(f)(1), of all nutrients per reference amount customarily 
consumed, the per 50-g criterion refers to the ``as prepared'' form); 
and

[[Page 106]]

    (ii) If the food meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
fat content, it is labeled to clearly refer to all foods of its type and 
not merely to the particular brand to which the label attaches (e.g., 
``frozen perch, a low fat food'').
    (3) The terms defined in paragraph (b)(2) of this section may be 
used on the label or in labeling of meal products as defined in Sec.  
101.13(l) or main dish products as defined in Sec.  101.13(m), provided 
that:
    (i) The product contains 3 g or less of total fat per 100 g and not 
more than 30 percent of calories from fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
fat content, it is labeled to clearly refer to all foods of its type and 
not merely to the particular brand to which the label attaches.
    (4) The terms ``reduced fat,'' ``reduced in fat,'' ``fat reduced,'' 
``less fat,'' ``lower fat,'' or ``lower in fat'' may be used on the 
label or in the labeling of foods, except meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 25 percent less fat per reference 
amount customarily consumed than an appropriate reference food as 
described in Sec.  101.13(j)(1); and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the fat differs between the two foods and are declared in immediate 
proximity to the most prominent such claim (e.g., ``reduced fat--50 
percent less fat than our regular brownies''); and
    (B) Quantitative information comparing the level of fat in the 
product per labeled serving with that of the reference food that it 
replaces (e.g., ``Fat content has been reduced from 8 g to 4 g per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.
    (iii) Claims described in paragraph (b)(4) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low fat.''
    (5) The terms defined in paragraph (b)(4) of this section may be 
used on the label or in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 25 percent less fat per 100 g of food 
than an appropriate reference food as described in Sec.  101.13(j)(1); 
and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the fat differs between the two foods are declared in immediate 
proximity to the most prominent such claim (e.g., reduced fat spinach 
souffle, ``33 percent less fat per 3 oz than our regular spinach 
souffle''); and
    (B) Quantitative information comparing the level of fat in the 
product per specified weight with that of the reference food that it 
replaces (e.g., ``Fat content has been reduced from 7.5 g per 3 oz to 5 
g per 3 oz.'') is declared adjacent to the most prominent claim, to the 
nutrition label, or, if the nutrition label is located on the 
information panel, it may appear elsewhere on the information panel in 
accordance with Sec.  101.2.
    (iii) Claims described in paragraph (b)(5) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low fat.''
    (6) The term ``-- percent fat free'' may be used on the label or in 
the labeling of foods, provided that:
    (i) The food meets the criteria for ``low fat'' in paragraph (b)(2) 
or (b)(3) of this section;
    (ii) The percent declared and the words ``fat free'' are in uniform 
type size; and
    (iii) A ``100 percent fat free'' claim may be made only on foods 
that meet the criteria for ``fat free'' in paragraph (b)(1) of this 
section, that contain less than 0.5 g of fat per 100 g, and that contain 
no added fat.
    (c) Fatty acid content claims. The label or labeling of foods that 
bear claims

[[Page 107]]

with respect to the level of saturated fat shall disclose the level of 
total fat and cholesterol in the food in immediate proximity to such 
claim each time the claim is made and in type that shall be no less than 
one-half the size of the type used for the claim with respect to the 
level of saturated fat. Declaration of cholesterol content may be 
omitted when the food contains less than 2 milligrams (mg) of 
cholesterol per reference amount customarily consumed or in the case of 
a meal or main dish product less than 2 mg of cholesterol per labeled 
serving. Declaration of total fat may be omitted with the term defined 
in paragraph (c)(1) of this section when the food contains less than 0.5 
g of total fat per reference amount customarily consumed or, in the case 
of a meal product or a main dish product, when the product contains less 
than 0.5 g of total fat per labeled serving. The declaration of total 
fat may be omitted with the terms defined in paragraphs (c)(2) through 
(c)(5) of this section when the food contains 3 g or less of total fat 
per reference amount customarily consumed or in the case of a meal 
product or a main dish product, when the product contains 3 g or less of 
total fat per 100 g and not more than 30 percent calories from fat.
    (1) The terms ``saturated fat free,'' ``free of saturated fat,'' 
``no saturated fat,'' ``zero saturated fat,'' ``without saturated fat,'' 
``trivial source of saturated fat,'' ``negligible source of saturated 
fat,'' or ``dietarily insignificant source of saturated fat'' may be 
used on the label or in the labeling of foods, provided that:
    (i) The food contains less than 0.5 g of saturated fat and less than 
0.5 g trans fatty acid per reference amount customarily consumed and per 
labeled serving, or in the case of a meal product or main dish product, 
less than 0.5 g of saturated fat and less than 0.5 g trans fatty acid 
per labeled serving; and
    (ii) The food contains no ingredient that is generally understood by 
consumers to contain saturated fat unless the listing of the ingredient 
in the ingredient statement is followed by an asterisk that refers to 
the statement below the list of ingredients which states, ``adds a 
trivial amount of saturated fat,'' ``adds a negligible amount of 
saturated fat,'' or ``adds a dietarily insignificant amount of saturated 
fat;'' and
    (iii) As required in Sec.  101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower saturated fat content, it is 
labeled to disclose that saturated fat is not usually present in the 
food.
    (2) The terms ``low in saturated fat,'' ``low saturated fat,'' 
``contains a small amount of saturated fat,'' ``low source of saturated 
fat,'' or ``a little saturated fat'' may be used on the label or in the 
labeling of foods, except meal products as defined in Sec.  101.13(l) 
and main dish products as defined in Sec.  101.13(m), provided that:
    (i) The food contains 1 g or less of saturated fatty acids per 
reference amount customarily consumed and not more than 15 percent of 
calories from saturated fatty acids; and
    (ii) If a food meets these conditions without benefit of special 
processing, alteration, formulation, or reformulation to lower saturated 
fat content, it is labeled to clearly refer to all foods of its type and 
not merely to the particular brand to which the label attaches (e.g., 
``raspberries, a low saturated fat food'').
    (3) The terms defined in paragraph (c)(2) of this section may be 
used on the label or in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The product contains 1 g or less of saturated fatty acids per 
100 g and less than 10 percent calories from saturated fat; and
    (ii) If the product meets these conditions without the benefit of 
special processing, alteration, formulation, or reformulation to lower 
saturated fat content, it is labeled to clearly refer to all foods of 
its type and not merely to the particular brand to which the label 
attaches.
    (4) The terms ``reduced saturated fat,'' ``reduced in saturated 
fat,'' ``saturated fat reduced,'' ``less saturated fat,'' ``lower 
saturated fat,'' or ``lower in saturated fat'' may be used on the label 
or in the labeling of foods, except as limited by Sec.  101.13(j)(1)(i) 
and

[[Page 108]]

except meal products as defined in Sec.  101.13(l) and main dish 
products as defined in Sec.  101.13(m), provided that:
    (i) The food contains at least 25 percent less saturated fat per 
reference amount customarily consumed than an appropriate reference food 
as described in Sec.  101.13(j)(1); and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food and the percent (or fraction) 
that the saturated fat differs between the two foods are declared in 
immediate proximity to the most prominent such claim (e.g., ``reduced 
saturated fat. Contains 50 percent less saturated fat than the national 
average for nondairy creamers''); and
    (B) Quantitative information comparing the level of saturated fat in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Saturated fat reduced from 3 g to 1.5 g per serving'') 
is declared adjacent to the most prominent claim or to the nutrition 
label, except that if the nutrition label is on the information panel, 
the quantitative information may be located elsewhere on the information 
panel in accordance with Sec.  101.2.
    (iii) Claims described in paragraph (c)(4) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low saturated 
fat.''
    (5) The terms defined in paragraph (c)(4) of this section may be 
used on the label or in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) The food contains at least 25 percent less saturated fat per 100 
g of food than an appropriate reference food as described in Sec.  
101.13(j)(1), and
    (ii) As required in Sec.  101.13(j)(2) for relative claims:
    (A) The identity of the reference food, and the percent (or 
fraction) that the fat differs between the two foods are declared in 
immediate proximity to the most prominent such claim (e.g., reduced 
saturated fat Macaroni and Cheese, ``33 percent less saturated fat per 3 
oz than our regular Macaroni and Cheese'').
    (B) Quantitative information comparing the level of saturated fat in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Saturated fat content has been reduced from 2.5 g per 
3 oz to 1.7 g per 3 oz.'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label in 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec.  101.2.
    (iii) Claims described in paragraph (c)(5) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low saturated 
fat.''
    (d) Cholesterol content claims. (1) The terms ``cholesterol free,'' 
``free of cholesterol,'' ``zero cholesterol,'' ``without cholesterol,'' 
``no cholesterol,'' ``trivial source of cholesterol,'' ``negligible 
source of cholesterol,'' or ``dietarily insignificant source of 
cholesterol'' may be used on the label or in the labeling of foods, 
provided that:
    (i) For foods that contain 13 g or less of total fat per reference 
amount customarily consumed, per labeled serving, and per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec.  101.9(f)(1), of all nutrients per reference amount 
customarily consumed, the per 50-g criterion refers to the ``as 
prepared'' form), or, in the case of meal products, 26.0 g or less total 
fat per labeled serving, or, in the case of main dish products, 19.5 g 
or less total fat per labeled serving:
    (A) The food contains less than 2 mg of cholesterol per reference 
amount customarily consumed and per labeling serving or, in the case of 
a meal product or main dish product, less than 2 mg of cholesterol per 
labeled serving; and
    (B) The food contains no ingredient that is generally understood by 
consumers to contain cholesterol, unless the listing of the ingredient 
in the ingredient statement is followed by an asterisk that refers to 
the statement

[[Page 109]]

below the list of ingredients, which states ``adds a trivial amount of 
cholesterol,'' ``adds a negligible amount of cholesterol,'' or ``adds a 
dietarily insignificant amount of cholesterol;'' and
    (C) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed or, in the case of a meal product 
or main dish product, 2 g or less of saturated fatty acids per labeled 
serving; and
    (D) As required in Sec.  101.13(e)(2), if the food contains less 
than 2 mg of cholesterol per reference amount customarily consumed or in 
the case of a meal product or main dish product, less than 2 mg of 
cholesterol per labeled serving without the benefit of special 
processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to disclose that cholesterol is not 
usually present in the food (e.g., ``applesauce, a cholesterol-free 
food'').
    (ii) For food that contain more than 13 g of total fat per reference 
amount customarily consumed, per labeling serving, or per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec.  101.9(f)(1), of all nutrients per reference amount 
customarily consumed, the per 50-g criterion refers to the ``as 
prepared'' form), or in the case of a meal product, more than 26 g of 
total fat per labeled serving, or, in the case of a main dish product 
more than 19.5 g of total fat per labeled serving:
    (A) The food contains less than 2 mg of cholesterol per reference 
amount customarily consumed and per labeling serving or, in the case of 
a meal product or main dish product, less than 2 mg of cholesterol per 
labeled serving; and
    (B) The food contains no ingredient that is generally understood by 
consumers to contain cholesterol, unless the listing of the ingredient 
in the ingredient statement is followed by an asterisk that refers to 
the statement below the list of ingredients, which states ``adds a 
trivial amount of cholesterol,'' ``adds a negligible amount of 
cholesterol,'' or ``adds a dietarily insignificant amount of 
cholesterol;'' and
    (C) The food contains 2 g or less of saturated fatty acids per 
reference amount cutomarily consumed or, in the case of a meal product 
or main dish product less than 2 g of saturated fatty acids per labeled 
serving; and
    (D) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec.  101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel, the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
appears more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (E) As required in Sec.  101.13(e)(2), if the food contains less 
than 2 mg of cholesterol per reference amount customarily consumed or in 
the case of a meal product or main dish product less than 2 mg of 
cholesterol per labeled serving without the benefit of special 
processing, alteration, formulation, or reformulation to lower 
cholesterol content, it is labeled to disclose that cholesterol is not 
usually present in the food (e.g., ``canola oil, a cholesterol-free 
food, contains 14 g of fat per serving''); or
    (F) If the food contains less than 2 mg of cholesterol per reference 
amount customarily consumed or in the case of a meal product or main 
dish product less than 2 mg of cholesterol per labeled serving only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec.  101.13(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec.  101.13(j)(2) for relative claims:
    (1) The identity of the reference food and the percent (or fraction) 
that the cholesterol was reduced are declared in immediate proximity to 
the most

[[Page 110]]

prominent such claim (e.g., ``cholesterol-free margarine, contains 100 
percent less cholesterol than butter''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Contains no cholesterol compared with 30 mg 
cholesterol in one serving of butter. Contains 13 g of fat per 
serving.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.
    (2) The terms ``low in cholesterol,'' ``low cholesterol,'' 
``contains a small amount of cholesterol,'' ``low source of 
cholesterol,'' or ``little cholesterol'' may be used on the label or in 
the labeling of foods, except meal products as defined in Sec.  
101.13(l) and main dish products as defined in Sec.  101.13(m), provided 
that:
    (i) For foods that have a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons and contain 13 g or less 
of total fat per reference amount customarily consumed and per labeled 
serving:
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec.  101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower cholesterol content, it is 
labeled to clearly refer to all foods of that type and not merely to the 
particular brand to which the label attaches (e.g., ``low fat cottage 
cheese, a low cholesterol food.'').
    (ii) For foods that have a reference amount customarily consumed of 
30 g or less or 2 tablespoons or less and contain 13 g or less of total 
fat per reference amount customarily consumed, per labeled serving, and 
per 50 g (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec.  101.9(f)(1), of all nutrients per reference amount 
customarily consumed, the per 50-g criterion refers to the ``as 
prepared'' form);
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated foods that must 
be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec.  101.9(f)(1), of 
all nutrients per reference amount customarily consumed, the per 50-g 
criterion refers to the ``as prepared'' form);
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec.  101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower cholesterol content, it is 
labeled to clearly refer to all foods of that type and not merely to the 
particular brand to which the label attaches (e.g., ``low fat cottage 
cheese, a low cholesterol food'').
    (iii) For foods that have a reference amount customarily consumed 
greater than 30 g or greater than 2 tablespoons and contain more than 13 
g of total fat per reference amount customarily consumed or per labeled 
serving,
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec.  101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel, the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
is made more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (D) As required in Sec.  101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to

[[Page 111]]

lower cholesterol content, it is labeled to clearly refer to all foods 
of that type and not merely to the particular brand to which the label 
attaches; or
    (E) If the food contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec.  101.13(d) that has a 
significant (e.g., 5 percent or more of a national or regional market) 
market share. As required in Sec.  101.13(j)(2) for relative claims:
    (1) The identity of the reference food and the percent (or fraction) 
that the cholesterol has been reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``low-cholesterol 
peanut butter sandwich crackers, contains 83 percent less cholesterol 
than our regular peanut butter sandwich crackers''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 5 mg per serving; 
contains 13 g of fat per serving.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec.  
101.2.
    (iv) For foods that have a reference amount customarily consumed of 
30 g or less or 2 tablespoons or less and contain more than 13 g of 
total fat per reference amount customarily consumed, per labeled 
serving, or per 50 g (for dehydrated foods that must be reconstituted 
before typical consumption with water or a diluent containing an 
insignificant amount, as defined in Sec.  101.9(f)(1), of all nutrients 
per reference amount customarily consumed, the per 50-g criterion refers 
to the ``as prepared'' form),
    (A) The food contains 20 mg or less of cholesterol per reference 
amount customarily consumed and per 50 g (for dehydrated foods that must 
be reconstituted before typical consumption with water or a diluent 
containing an insignificant amount, as defined in Sec.  101.9(f)(1), of 
all nutrients per reference amount customarily consumed, the per 50-g 
criterion refers to the ``as prepared'' form),
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec.  101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel, the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
is made more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (D) As required in Sec.  101.13(e)(2), if the food meets these 
conditions without the benefit of special processing, alteration, 
formulation, or reformulation to lower cholesterol content, it is 
labeled to clearly refer to all foods of that type and not merely to the 
particular brand to which the label attaches; or
    (E) If the food contains 20 mg or less of cholesterol only as a 
result of special processing, alteration, formulation, or reformulation, 
the amount of cholesterol is substantially less (i.e., meets 
requirements of paragraph (d)(4)(ii)(A) of this section) than the food 
for which it substitutes as specified in Sec.  101.13(d) that has a 
significant (i.e., 5 percent or more of a national or regional market) 
market share. As required in Sec.  101.13(j)(2) for relative claims:
    (1) The identity of the reference food and the percent (or fraction) 
that the cholesterol has been reduced are declared in immediate 
proximity to the most prominent such claim (e.g., ``low-cholesterol 
peanut butter sandwich crackers, contains 83 percent less cholesterol 
than our regular peanut butter sandwich crackers''); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg

[[Page 112]]

to 5 mg per serving; contains 13 g of fat per serving.'') is declared 
adjacent to the most prominent claim or to the nutrition label, except 
that if the nutrition label is on the information panel, the 
quantitative information may be located elsewhere on the information 
panel in accordance with Sec.  101.2.
    (3) The terms defined in paragraph (d)(2) of this section may be 
used on the label and in labeling of meal products as defined in Sec.  
101.13(l) or a main dish product as defined in Sec.  101.13(m) provided 
that the product meets the requirements of paragraph (d)(2) of this 
section except that the determination as to whether paragraph (d)(2)(i) 
or (d)(2)(iii) of this section applies to the product will be made only 
on the basis of whether the meal product contains 26 g or less of total 
fat per labeled serving or the main dish product contain 19.5 g or less 
of total fat per labeled serving, the requirement in paragraphs 
(d)(2)(i)(A) and (d)(2)(iii)(A) of this section shall be limited to 20 
mg of cholesterol per 100 g, and the requirement in paragraphs 
(d)(2)(i)(B) and (d)(2)(iii)(B) of this section shall be modified to 
require that the food contain 2 g or less of saturated fat per 100 g 
rather than per reference amount customarily consumed.
    (4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,'' 
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,'' or 
``lower in cholesterol'' except as limited by Sec.  101.13(j)(1)(i) may 
be used on the label or in labeling of foods or foods that substitute 
for those foods as specified in Sec.  101.13(d), excluding meal products 
as defined in Sec.  101.13(l) and main dish products as defined in Sec.  
101.13(m), provided that:
    (i) For foods that contain 13 g or less of total fat per reference 
amount customarily consumed, per labeled serving, and per 50 g if the 
reference amount customarily consumed is 30 g or less or 2 tablespoons 
or less (for dehydrated foods that must be reconstituted before typical 
consumption with water or a diluent containing an insignificant amount, 
as defined in Sec.  101.9(f)(1), of all nutrients per reference amount 
customarily consumed, the per 50-g criterion refers to the ``as 
prepared'' form):
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec.  101.13(j)(1) and for which it 
substitutes as specified in Sec.  101.13(d) that has a significant 
(i.e., 5 percent or more) market share; and
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed; and
    (C) As required in Sec.  101.13(j)(2) for relative claims:
    (1) The identity of the reference food and the percent (or fraction) 
that the cholesterol has been reduced are declared in immediate 
proximity to the most prominent such claim; and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``[labeled product] 50 mg cholesterol per serving; 
[reference product] 30 mg cholesterol per serving'') is declared 
adjacent to the most prominent claim or to the nutrition label, except 
that if the nutrition label is on the information panel, the 
quantitative information may be located elsewhere on the information 
panel in accordance with Sec.  101.2.
    (ii) For foods that contain more than 13 g of total fat per 
reference amount customarily consumed, per labeled serving, or per 50 g 
if the reference amount customarily consumed is 30 g or less or 2 
tablespoons or less (for dehydrated foods that must be reconstituted 
before typical consumption with water or a diluent containing an 
insignificant amount, as defined in Sec.  101.9(f)(1), of all nutrients 
per reference amount customarily consumed, the per 50-g criterion refers 
to the ``as prepared'' form):
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec.  101.13(j)(1) and for which it 
substitutes as specified in Sec.  101.13(d) that has a significant 
(i.e., 5 percent or more of a national or regional market) market share;
    (B) The food contains 2 g or less of saturated fatty acids per 
reference amount customarily consumed;

[[Page 113]]

    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec.  101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel, the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
is made more than once on a panel, the disclosure shall be made in 
immediate proximity to the claim that is printed in the largest type; 
and
    (D) As required in Sec.  101.13(j)(2) for relative claims:
    (1) The identity of the reference food and the percent (or fraction) 
that the cholesterol has been reduced are declared in immediate 
proximity to the most prominent such claim (e.g., 25 percent less 
cholesterol than ------); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per labeled serving with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 55 mg to 30 mg per serving. 
Contains 13 g of fat per serving.'') is declared adjacent to the most 
prominent claim or to the nutrition label, except that if the nutrition 
label is on the information panel, the quantitative information may be 
located elsewhere on the information panel in accordance with Sec.  
101.2.
    (iii) Claims described in paragraph (d)(4) of this section may not 
be made on the label or in labeling of a food if the nutrient content of 
the reference food meets the definition for ``low cholesterol.''
    (5) The terms defined in paragraph (d)(4) of this section may be 
used on the label or in the labeling of meal products as defined in 
Sec.  101.13(l) and main dish products as defined in Sec.  101.13(m), 
provided that:
    (i) For meal products that contain 26.0 g or less of total fat per 
labeled serving or for main dish products that contain 19.5 g or less of 
total fat per labeled serving;
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec.  101.13(j)(1) and for which it 
substitutes as specified in Sec.  101.13(d) that has a significant 
(e.g., 5 percent or more of a national or regional market) market share;
    (B) The food contains 2 g or less of saturated fatty acids per 100 
g; and
    (C) As required in Sec.  101.13(j)(2) for relative claims:
    (1) The identity of the reference food, and the percent (or 
fraction) that the cholesterol has been reduced are declared in 
immediate proximity to the most prominent such claim (e.g., ``25% less 
cholesterol per 3 oz than ------); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Cholesterol content has been reduced from 35 mg per 3 
oz to 25 mg per 3 oz.'') is declared adjacent to the most prominent 
claim or to the nutrition label, except that if the nutrition label is 
on the information panel, the quantitative information may be located 
elsewhere on the information panel in accordance with Sec.  101.2.
    (ii) For meal products that contain more than 26.0 g of total fat 
per labeled serving or for main dish products that contain more than 
19.5 g of total fat per labeled serving:
    (A) The food has been specifically formulated, altered, or processed 
to reduce its cholesterol by 25 percent or more from the reference food 
it resembles as defined in Sec.  101.13(j)(1) and for which it 
substitutes as specified in Sec.  101.13(d) that has a significant 
(e.g., 5 percent or more of a national or regional market) market share.
    (B) The food contains 2 g or less of saturated fatty acids per 100 
g;
    (C) The label or labeling discloses the level of total fat in a 
serving (as declared on the label) of the food. Such disclosure shall 
appear in immediate proximity to such claim preceding any disclosure 
statement required under Sec.  101.13(h) in type that shall be no less 
than one-half the size of the type used for such claim. If the claim 
appears on more than one panel the disclosure shall be made on each 
panel except for the panel that bears nutrition labeling. If the claim 
is made more than once on a panel, the disclosure shall be made in

[[Page 114]]

immediate proximity to the claim that is printed in the largest type; 
and
    (D) As required in Sec.  101.13(j)(2) for relative claims:
    (1) The identity of the reference food and the percent (or fraction) 
that the cholesterol has been reduced are declared in immediate 
proximity to the most prominent such claim (e.g., 25 percent less 
cholesterol than ------); and
    (2) Quantitative information comparing the level of cholesterol in 
the product per specified weight with that of the reference food that it 
replaces (e.g., ``Cholesterol lowered from 30 mg to 22 mg per 3 oz of 
product.'') is declared adjacent to the most prominent claim or to the 
nutrition label, except that if the nutrition label is on the 
information panel, the quantitative information may be located elsewhere 
on the information panel in accordance with Sec.  101.2.
    (iii) Claims described in paragraph (d)(5) of this section may not 
be made on the label or in the labeling of a food if the nutrient 
content of the reference food meets the definition for ``low 
cholesterol.''
    (e) ``Lean'' and ``extra lean'' claims. (1) The term ``lean'' may be 
used on the label or in labeling of foods except meal products as 
defined in Sec.  101.13(l) and main dish products as defined in Sec.  
101.13(m) provided that the food is a seafood or game meat product and 
as packaged contains less than 10 g total fat, 4.5 g or less saturated 
fat, and less than 95 mg cholesterol per reference amount customarily 
consumed and per 100 g;
    (2) The term defined in paragraph (e)(1) of this section may be used 
on the label or in labeling of a mixed dish not measurable with a cup as 
defined in Sec.  101.12(b) in table 2, provided that the food contains 
less than 8 g total fat, 3.5 g or less saturated fat and less than 80 mg 
cholesterol per reference amount customarily consumed;
    (3) The term defined in paragraph (e)(1) of this section may be used 
on the label or in the labeling of meal products as defined in Sec.  
101.13(l) or main dish products as defined in Sec.  101.13(m) provided 
that the food contains less than 10 g total fat, 4.5 g or less saturated 
fat, and less than 95 mg cholesterol per 100 g and per labeled serving;
    (4) The term ``extra lean'' may be used on the label or in the 
labeling of foods except meal products as defined in Sec.  101.13(l) and 
main dish products as defined in Sec.  101.13(m) provided that the food 
is a discrete seafood or game meat product and as packaged contains less 
than 5 g total fat, less than 2 g saturated fat, and less than 95 mg 
cholesterol per reference amount customarily consumed and per 100 g; and
    (5) The term defined in paragraph (e)(4) of this section may be used 
on the label or in labeling of meal products as defined in Sec.  
101.13(l) and main dish products as defined in Sec.  101.13(m) provided 
that the food contains less than 5 g of fat, less than 2 g of saturated 
fat, and less than 95 mg of cholesterol per 100 g and per labeled 
serving.
    (f) Misbranding. Any label or labeling containing any statement 
concerning fat, fatty acids, or cholesterol that is not in conformity 
with this section shall be deemed to be misbranded under sections 
201(n), 403(a), and 403(r) of the Federal Food, Drug, and Cosmetic Act.

[58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343, Apr. 2, 1993, as amended 
at 58 FR 44032, Aug. 18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394, 
Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995; 61 FR 59001, Nov. 20, 1996; 63 
FR 26980, May 15, 1998; 72 FR 1459, Jan. 12, 2007]



Sec.  101.65  Implied nutrient content claims and related label statements.

    (a) General requirements. An implied nutrient content claim can only 
be made on the label and in labeling of the food if:
    (1) The claim uses one of the terms described in this section in 
accordance with the definition for that term;
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec.  101.13; and
    (3) The food for which the claim is made is labeled in accordance 
with Sec.  101.9, Sec.  101.10, or Sec.  101.36, as applicable.
    (b) Label statements that are not implied claims. Certain label 
statements about the nature of a product are not nutrient content claims 
unless such statements are made in a context that would make them an 
implied claim under Sec.  101.13(b)(2). The following types

[[Page 115]]

of label statements are generally not implied nutrient content claims 
and, as such, are not subject to the requirements of Sec.  101.13 and 
this section:
    (1) A claim that a specific ingredient or food component is absent 
from a product, provided that the purpose of such claim is to facilitate 
avoidance of the substances because of food allergies (see Sec.  105.62 
of this chapter), food intolerance, religious beliefs, or dietary 
practices such as vegetarianism or other nonnutrition related reason, 
e.g., ``100 percent milk free;''
    (2) A claim about a substance that is nonnutritive or that does not 
have a nutritive function, e.g., ``contains no preservatives,'' ``no 
artificial colors;''
    (3) A claim about the presence of an ingredient that is perceived to 
add value to the product, e.g., ``made with real butter,'' ``made with 
whole fruit,'' or ``contains honey,'' except that claims about the 
presence of ingredients other than vitamins or minerals or that are 
represented as a source of vitamins and minerals are not allowed on 
labels or in labeling of dietary supplements of vitamins and minerals 
that are not in conventional food form.
    (4) A statement of identity for a food in which an ingredient 
constitutes essentially 100 percent of a food (e.g., ``corn oil,'' ``oat 
bran,'' ``dietary supplement of vitamin C 60 mg tablet'').
    (5) A statement of identity that names as a characterizing 
ingredient, an ingredient associated with a nutrient benefit (e.g., 
``corn oil margarine,'' ``oat bran muffins,'' or ``whole wheat 
bagels''), unless such claim is made in a context in which label or 
labeling statements, symbols, vignettes, or other forms of communication 
suggest that a nutrient is absent or present in a certain amount; and
    (6) A label statement made in compliance with a specific provision 
of part 105 of this chapter, solely to note that a food has special 
dietary usefulness relative to a physical, physiological, pathological, 
or other condition, where the claim identifies the special diet of which 
the food is intended to be a part.
    (c) Particular implied nutrient content claims. (1) Claims about the 
food or an ingredient therein that suggest that a nutrient or an 
ingredient is absent or present in a certain amount (e.g., ``high in oat 
bran'') are implied nutrient content claims and must comply with 
paragraph (a) of this section.
    (2) The phrases ``contains the same amount of [nutrient] as a 
[food]'' and ``as much [nutrient] as a [food]'' may be used on the label 
or in the labeling of foods, provided that the amount of the nutrient in 
the reference food is enough to qualify that food as a ``good source'' 
of that nutrient, and the labeled food, on a per serving basis, is an 
equivalent, good source of that nutrient (e.g., ``as much fiber as an 
apple,'' ``Contains the same amount of Vitamin C as an 8 oz glass of 
orange juice.'').
    (3) Claims may be made that a food contains or is made with an 
ingredient that is known to contain a particular nutrient, or is 
prepared in a way that affects the content of a particular nutrient in 
the food, if the finished food is either ``low'' in or a ``good source'' 
of the nutrient that is associated with the ingredient or type of 
preparation. If a more specific level is claimed (e.g., ``high in ------
), that level of the nutrient must be present in the food. For example, 
a claim that a food contains oat bran is a claim that it is a good 
source of dietary fiber; that a food is made only with vegetable oil is 
a claim that it is low in saturated fat; and that a food contains no oil 
is a claim that it is fat free.
    (d) General nutritional claims. (1) This paragraph covers labeling 
claims that are implied nutrient content claims because they:
    (i) Suggest that a food because of its nutrient content may help 
consumers maintain healthy dietary practices; and
    (ii) Are made in connection with an explicit or implicit claim or 
statement about a nutrient (e.g., ``healthy, contains 3 grams of fat'').
    (2) You may use the term ``healthy'' or related terms (e.g., 
``health,'' ``healthful,'' ``healthfully,'' ``healthfulness,'' 
``healthier,'' ``healthiest,'' ``healthily,'' and ``healthiness'') as an 
implied nutrient content claim on the label or in labeling of a food 
that is useful in creating a diet that is consistent with dietary 
recommendations if:

[[Page 116]]

    (i) The food meets the following conditions for fat, saturated fat, 
cholesterol, and other nutrients:

------------------------------------------------------------------------
                                    The           The
   If the food      The fat      saturated    cholesterol     The food
      is...        level must    fat level     level must       must
                     be...      must be...       be...       contain...
------------------------------------------------------------------------
(A) A raw fruit   Low fat as   Low           The            N/A
 or vegetable      defined in   saturated     disclosure
                   Sec.         fat as        level for
                   101.62(b)(   defined in    cholesterol
                   2)           Sec.          specified in
                                101.62(c)(2   Sec.
                                )             101.13(h) or
                                              less
------------------------------------------------------------------------
(B) A single-     Low fat as   Low           The            N/A
 ingredient or a   defined in   saturated     disclosure
 mixture of        Sec.         fat as        level for
 frozen or         101.62(b)(   defined in    cholesterol
 canned fruits     2)           Sec.          specified in
 and                            101.62(c)(2   Sec.
 vegetables\1\                  )             101.13(h) or
                                              less
------------------------------------------------------------------------
(C) An enriched   Low fat as   Low           The            N/A
 cereal-grain      defined in   saturated     disclosure
 product that      Sec.         fat as        level for
 conforms to a     101.62(b)(   defined in    cholesterol
 standard of       2)           Sec.          specified in
 identity in                    101.62(c)(2   Sec.
 part 136, 137                  )             101.13(h) or
 or 139 of this                               less
 chapter
------------------------------------------------------------------------
(D) A raw,        Less than 5  Less than 2   Less than 95   At least 10
 single-           grams (g)    g saturated   mg             percent of
 ingredient        total fat    fat per RA    cholesterol    the RDI\3\
 seafood or game   per RA\2\    and per 100   per RA and     or the
 meat              and per      g             per 100 g      DRV\4\ per
                   100 g                                     RA of one
                                                             or more of
                                                             vitamin A,
                                                             vitamin C,
                                                             calcium,
                                                             iron,
                                                             protein, or
                                                             fiber
------------------------------------------------------------------------
(E) A meal        Low fat as   Low           90 mg or less  At least 10
 product as        defined in   saturated     cholesterol    percent of
 defined in Sec.   Sec.         fat as        per LS\5\      the RDI or
   101.13(l) or    101.62(b)(   defined in                   DRV per LS
 a main dish       3)           Sec.                         of two
 product as                     101.62(c)(3                  nutrients
 defined in Sec.                )                            (for a main
   101.13(m)                                                 dish
                                                             product) or
                                                             of three
                                                             nutrients
                                                             (for a meal
                                                             product)
                                                             of: vitamin
                                                             A, vitamin
                                                             C, calcium,
                                                             iron,
                                                             protein, or
                                                             fiber
------------------------------------------------------------------------
(F) A food not    Low fat as   Low           The            At least 10
 specifically      defined in   saturated     disclosure     percent of
 listed in this    Sec.         fat as        level for      the RDI or
 table             101.62(b)(   defined in    cholesterol    the DRV per
                   2)           Sec.          specified in   RA of one
                                101.62(c)(2   Sec.           or more of
                                )             101.13(h) or   vitamin A,
                                              less           vitamin C,
                                                             calcium,
                                                             iron,
                                                             protein or
                                                             fiber
------------------------------------------------------------------------
\1\ May include ingredients whose addition does not change the nutrient
  profile of the fruit or vegetable.
\2\ RA means Reference Amount Customarily Consumed per Eating Occasion
  (Sec.   101.12(b)).
\3\ RDI means Reference Daily Intake (Sec.   101.9(c)(8)(iv)).
\4\ DRV means Daily Reference Value (Sec.   101.9(c)(9)).
\5\ LS means Labeled Serving, i.e., the serving size that is specified
  in the nutrition information on the product label (Sec.   101.9(b)).

    (ii) The food meets the following conditions for sodium:

------------------------------------------------------------------------
         If the food is...               The sodium level must be...
------------------------------------------------------------------------
(A) A food with a RA that is         480 mg or less sodium per RA and
 greater than 30 g or 2 tablespoons   per LS
 (tbsp.)
------------------------------------------------------------------------
(B) A food with a RA that is equal   480 mg or less sodium per 50 g\1\
 to or less than 30 g or 2 tbsp.
------------------------------------------------------------------------
(C) A meal product as defined in     600 mg or less sodium per LS
 Sec.   101.13(l) or a main dish
 product as defined in Sec.
 101.13(m)
------------------------------------------------------------------------
\1\ For dehydrated food that is typically reconstituted with water or a
  liquid that contains insignificant amounts per RA of all nutrients (as
  defined in Sec.   101.9(f)(1)), the 50 g refers to the ``prepared''
  form of the product.

    (iii) The food complies with the definition and declaration 
requirements in this part 101 for any specific nutrient content claim on 
the label or in labeling, and

[[Page 117]]

    (iv) If you add a nutrient to the food specified in paragraphs 
(d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 
10 percent requirement, that addition must be in accordance with the 
fortification policy for foods in Sec.  104.20 of this chapter.

[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 59 
FR 394, Jan. 4, 1994; 59 FR 24249, May 10, 1994; 59 FR 50828, Oct. 6, 
1994; 62 FR 49858, Sept. 23, 1997; 63 FR 14355, Mar. 25, 1998; 70 FR 
56848, Sept. 29, 2005]



Sec.  101.67  Use of nutrient content claims for butter.

    (a) Claims may be made to characterize the level of nutrients, 
including fat, in butter if:
    (1) The claim complies with the requirements of Sec.  101.13 and 
with the requirements of the regulations in this subpart that define the 
particular nutrient content claim that is used and how it is to be 
presented. In determining whether a claim is appropriate, the 
calculation of the percent fat reduction in milkfat shall be based on 
the 80 percent milkfat requirement provided by the statutory standard 
for butter (21 U.S.C. 321a);
    (2) The product contains cream or milk, including milk constituents 
(including, but not limited to, whey, casein, modified whey, and salts 
of casein), or both, with or without added salt, with or without safe 
and suitable colorings, with or without nutrients added to comply with 
paragraph (a)(3) of this section, and with or without safe and suitable 
bacterial cultures. The product may contain safe and suitable 
ingredients to improve texture, prevent syneresis, add flavor, extend 
shelf life, improve appearance, and add sweetness. The product may 
contain water to replace milkfat although the amount of water in the 
product shall be less than the amount of cream, milk, or milk 
constituents;
    (3) The product is not nutritionally inferior, as defined in Sec.  
101.3(e)(4), to butter as produced under 21 U.S.C. 321a; and
    (4) If the product would violate 21 U.S.C. 321a but for the nutrient 
content claim that characterizes the level of nutrients, that claim 
shall be an explicit claim that is included as part of the common or 
usual name of the product.
    (b) Deviations from the ingredient provisions of 21 U.S.C. 321a must 
be the minimum necessary to achieve similar performance characteristics 
as butter as produced under 21 U.S.C. 321a, or the food will be deemed 
to be adulterated under section 402(b) of the act. The performance 
characteristics (e.g., physical properties, organoleptic 
characteristics, functional properties, shelf life) of the product shall 
be similar to butter as produced under 21 U.S.C. 321a. If there is a 
significant difference in performance characteristics (that materially 
limits the uses of the product compared to butter,) the label shall 
include a statement informing the consumer of such difference (e.g., if 
appropriate, ``not recommended for baking purposes''). Such statement 
shall comply with the requirements of Sec.  101.13(d). The modified 
product shall perform at least one of the principal functions of butter 
substantially as well as butter as produced under 21 U.S.C. 321a.
    (c)(1) Each of the ingredients used in the food shall be declared on 
the label as required by the applicable sections of this part.
    (2) Safe and suitable ingredients added to improve texture, prevent 
syneresis, add flavor, extend shelf life, improve appearance, or add 
sweetness and water added to replace milkfat shall be identified with an 
asterisk in the ingredient statement. The statement ``*Ingredients not 
in regular butter'' shall immediately follow the ingredient statement in 
the same type size.

[58 FR 2455, Jan. 6, 1993]



Sec.  101.69  Petitions for nutrient content claims.

    (a) This section pertains to petitions for claims, expressed or 
implied, that:
    (1) Characterize the level of any nutrient which is of the type 
required to be in the label or labeling of food by section 403(q)(1) or 
(q)(2) of the Federal Food, Drug, and Cosmetic Act (the act); and
    (2) That are not exempted under section 403(r)(5)(A) through 
(r)(5)(C) of the act from the requirements for such claims in section 
403(r)(2).
    (b) Petitions included in this section are:

[[Page 118]]

    (1) Petitions for a new (heretofore unauthorized) nutrient content 
claim;
    (2) Petitions for a synonymous term (i.e., one that is consistent 
with a term defined by regulation) for characterizing the level of a 
nutrient; and
    (3) Petitions for the use of an implied claim in a brand name.
    (c) An original and one copy of the petition to be filed under the 
provisions of section 403(r)(4) of the act shall be submitted, or the 
petitioner may submit an original and a computer readable disk 
containing the petition. Contents of the disk should be in a standard 
format, such as ASCII format. Petitioners interested in submitting a 
disk should contact the Food and Drug Administration's (FDA) Center for 
Food Safety and Applied Nutrition for details. If any part of the 
material submitted is in a foreign language, it shall be accompanied by 
an accurate and complete English translation. The petition shall state 
the petitioner's post office address to which published notices as 
required by section 403 of the act may be sent.
    (d) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of FDA. However, 
any reference to unpublished information furnished by a person other 
than the applicant will not be considered unless use of such information 
is authorized (with the understanding that such information may in whole 
or part be subject to release to the public) in a written statement 
signed by the person who submitted it. Any reference to published 
information should be accompanied by reprints or photostatic copies of 
such references.
    (e) If nonclinical laboratory studies are included in a petition 
submitted under section 403(r)(4) of the act, the petition shall 
include, with respect to each nonclinical study contained in the 
petition, either a statement that the study has been, or will be, 
conducted in compliance with the good laboratory practice regulations as 
set forth in part 58 of this chapter or, if any such study was not 
conducted in compliance with such regulations, a brief statement of the 
reason for the noncompliance.
    (f) If clinical investigations are included in a petition submitted 
under section 403(r)(4) of the act, the petition shall include a 
statement regarding each such clinical investigation relied upon in the 
petition that the study either was conducted in compliance with the 
requirements for institutional review set forth in part 56 of this 
chapter or was not subject to such requirements in accordance with Sec.  
56.104 or Sec.  56.105 of this chapter, and that it was conducted in 
compliance with the requirements for informed consent set forth in part 
50 of this chapter.
    (g) The availability for public disclosure of petitions submitted to 
the agency under this section will be governed by the rules specified in 
Sec.  10.20(j) of this chapter.
    (h) All petitions submitted under this section shall include either 
a claim for a categorical exclusion under Sec.  25.30 or 25.32 of this 
chapter or an environmental assessment under Sec.  25.40 of this 
chapter.
    (i) The data specified under the several lettered headings should be 
submitted on separate sheets or sets of sheets, suitably identified. If 
such data have already been submitted with an earlier application from 
the petitioner, the present petition may incorporate it by specific 
reference to the earlier petition.
    (j) The petition must be signed by the petitioner or by his attorney 
or agent, or (if a corporation) by an authorized official.
    (k) The petition shall include a statement signed by the person 
responsible for the petition, that to the best of his knowledge, it is a 
representative and balanced submission that includes unfavorable 
information, as well as favorable information, known to him pertinent to 
the evaluation of the petition.
    (l) All applicable provisions of part 10--Administrative Practices 
and Procedures, may be used by FDA, the petitioner or any outside party 
with respect to any agency action on the petition.
    (m)(1) Petitions for a new nutrient content claim shall include the 
following data and be submitted in the following form.

(Date) ------------
Name of petitioner ------------

[[Page 119]]

Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ------------------------ submits this petition 
under section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the 
act) with respect to (statement of the claim and its proposed use).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the descriptive term and the nutrient 
that the term is intended to characterize with respect to the level of 
such nutrient. The statement should address why the use of the term as 
proposed will not be misleading. The statement should provide examples 
of the nutrient content claim as it will be used on labels or labeling, 
as well as the types of foods on which the claim will be used. The 
statement shall specify the level at which the nutrient must be present 
or what other conditions concerning the food must be met for the use of 
the term in labels or labeling to be appropriate, as well as any factors 
that would make the use of the term inappropriate.
    B. A detailed explanation, supported by any necessary data, of why 
use of the food component characterized by the claim is of importance in 
human nutrition by virtue of its presence or absence at the levels that 
such claim would describe. This explanation shall also state what 
nutritional benefit to the public will derive from use of the claim as 
proposed, and why such benefit is not available through the use of 
existing terms defined by regulation under section 403(r)(2)(A)(i) of 
the act. If the claim is intended for a specific group within the 
population, the analysis should specifically address nutritional needs 
of such group, and should include scientific data sufficient for such 
purpose.
    C. Analytical data that shows the amount of the nutrient that is the 
subject of the claim and that is present in the types of foods for which 
the claim is intended. The assays should be performed on representative 
samples using the AOAC INTERNATIONAL (AOAC International) methods where 
available. If no AOAC International method is available, the petitioner 
shall submit the assay method used, and data establishing the validity 
of the method for assaying the nutrient in the particular food. The 
validation data should include a statistical analysis of the analytical 
and product variability.
    D. A detailed analysis of the potential effect of the use of the 
proposed claim on food consumption and of any corresponding changes in 
nutrient intake. The latter item shall specifically address the intake 
of nutrients that have beneficial and negative consequences in the total 
diet. If the claim is intended for a specific group within the 
population, the above analysis shall specifically address the dietary 
practices of such group and shall include data sufficient to demonstrate 
that the dietary analysis is representative of such group.
    E. The petitioner is required to submit either a claim for 
categorical exclusion under Sec.  25.30 or Sec.  25.32 of this chapter 
or an environmental assessment under Sec.  25.40 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------
    (Indicate authority)

    (2) Within 15 days of receipt of the petition, the petitioner will 
be notified by letter of the date on which the petition was received by 
the agency. Such notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition), and the petitioner will 
subsequently be notified of the agency's decision to file or deny the 
petition; or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) Within 100 days of the date of receipt of the petition, FDA will 
notify the petitioner by letter that the petition has either been filed 
or denied. If denied, the notification shall state the reasons therefor. 
If filed, the date of the notification letter becomes the date of filing 
for the purposes of section 403(r)(4)(A)(i) of the act. If FDA does not 
act within such 100 days, the petition shall be deemed to be denied 
unless an extension is mutually agreed upon by the FDA and the 
petitioner. A petition that has been denied, or has been deemed to be 
denied, without filing shall not be made available to the public. A 
filed petition shall be available to the public as provided under 
paragraph (g) of this section.
    (4) Within 90 days of the date of filing FDA will by letter of 
notification to the petitioner:
    (i) Deny the petition; or

[[Page 120]]

    (ii) Inform the petitioner that a proposed regulation to provide for 
the requested use of the new term will be published in the Federal 
Register. FDA will publish the proposal to amend the regulations to 
provide for the requested use of the nutrient content claim in the 
Federal Register within 90 days of the date of filing. The proposal will 
also announce the availability of the petition for public disclosure.
    (iii) If FDA does not act within 90 days of the date of filing, the 
petition shall be deemed to be denied unless an extension is mutually 
agreed upon by FDA and the petitioner.
    (5) If FDA issues a proposal, the rulemaking shall be completed 
within 540 days of the date of receipt of the petition.
    (n)(1) Petitions for a synonymous term shall include the following 
data and be submitted in the following form.

(Date)------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800)
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ------------ submits this petition under section 
403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) with 
respect to (statement of the synonymous term and its proposed use in a 
nutrient content claim that is consistent with an existing term that has 
been defined under section 403(r)(2) of the act).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the synonymous descriptive term, the 
existing term defined by a regulation under section 403(r)(2)(A)(i) of 
the act with which the synonymous term is claimed to be consistent. The 
statement should address why the proposed synonymous term is consistent 
with the term already defined by the agency, and why the use of the 
synonymous term as proposed will not be misleading. The statement should 
provide examples of the nutrient content claim as it will be used on 
labels or labeling, as well as the types of foods on which the claim 
will be used. The statement shall specify whether any limitations not 
applicable to the use of the defined term are intended to apply to the 
use of the synonymous term.
    B. A detailed explanation, supported by any necessary data, of why 
use of the proposed term is requested, including an explanation of 
whether the existing defined term is inadequate for the purpose of 
effectively characterizing the level of a nutrient. This item shall also 
state what nutritional benefit to the public will derive from use of the 
claim as proposed, and why such benefit is not available through the use 
of existing term defined by regulation. If the claim is intended for a 
specific group within the population, the analysis should specifically 
address nutritional needs of such group, and should include scientific 
data sufficient for such purpose.
    C. The petitioner is required to submit either a claim for 
categorical exclusion under Sec.  25.30 or Sec.  25.32 of this chapter 
or an environmental assessment under Sec.  25.40 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------
    (Indicate authority)

    (2) Within 15 days of receipt of the petition the petitioner will be 
notified by letter of the date on which the petition was received. Such 
notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition) and the petitioner will 
subsequently be notified of the agency's decision to grant the 
petitioner permission to use the proposed term or to deny the petition; 
or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) Within 90 days of the date of receipt of the petition that is 
accepted for review (i.e., that has not been found to be incomplete and 
consequently denied, FDA will notify the petitioner by letter of the 
agency's decision to grant the petitioner permission to use the proposed 
term, with any conditions or limitations on such use specified, or to 
deny the petition, in which case the letter shall state the reasons 
therefor. Failure of the petition to fully address the requirements of 
this section shall be grounds for denial of the petition.

[[Page 121]]

    (4) As soon as practicable following the agency's decision to either 
grant or deny the petition, FDA will publish a notice in the Federal 
Register informing the public of his decision. If the petition is 
granted the Food and Drug Administration will list, the approved 
synonymous term in the regulations listing terms permitted for use in 
nutrient content claims.
    (o)(1) Petitions for the use of an implied nutrient content claim in 
a brand name shall include the following data and be submitted in the 
following form:

(Date)------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800),
Food and Drug Administration,
Department of Health and Human Services,
Washington, DC 20204.
To Whom It May Concern:
    The undersigned, ---------------------- submits this petition under 
section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) 
with respect to (statement of the implied nutrient content claim and its 
proposed use in a brand name).
    Attached hereto and constituting a part of this petition, are the 
following:
    A. A statement identifying the implied nutrient content claim, the 
nutrient the claim is intended to characterize, the corresponding term 
for characterizing the level of such nutrient as defined by a regulation 
under section 403(r)(2)(A)(i) of the act, and the brand name of which 
the implied claim is intended to be a part. The statement should address 
why the use of the brandname as proposed will not be misleading. It 
should address in particular what information is required to accompany 
the claim or other ways in which the claim meets the requirements of 
sections 201(n) and 403(a) of the act. The statement should provide 
examples of the types of foods on which the brand name will appear. It 
shall also include data showing that the actual level of the nutrient in 
the food qualifies the food to bear the corresponding term defined by 
regulation. Assay methods used to determine the level of a nutrient 
should meet the requirements stated under petition format item C in 
paragraph (k)(1) of this section.
    B. A detailed explanation, supported by any necessary data, of why 
use of the proposed brand name is requested. This item shall also state 
what nutritional benefit to the public will derive from use of the brand 
name as proposed. If the branded product is intended for a specific 
group within the population, the analysis should specifically address 
nutritional needs of such group and should include scientific data 
sufficient for such purpose.
    C. The petitioner is required to submit either a claim for 
categorical exclusion under Sec.  25.30 or Sec.  25.32 of this chapter 
or an environmental assessment under Sec.  25.40 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------

    (2) Within 15 days of receipt of the petition the petitioner will be 
notified by letter of the date on which the petition was received. Such 
notice will inform the petitioner:
    (i) That the petition is undergoing agency review (in which case a 
docket number will be assigned to the petition); or
    (ii) That the petition is incomplete, e.g., it lacks any of the data 
required by this part, it presents such data in a manner that is not 
readily understood, or it has not been submitted in quadruplicate, in 
which case the petition will be denied, and the petitioner will be 
notified as to what respect the petition is incomplete.
    (3) FDA will publish a notice of the petition in the Federal 
Register announcing its availability to the public and seeking comment 
on the petition. The petition shall be available to the public to the 
extent provided under paragraph (g) of this section. The notice shall 
allow 30 days for comments.
    (4) Within 100 days of the date of receipt of the petition that is 
accepted for review (i.e., that has not been found to be incomplete and 
subsequently returned to the petitioner), FDA will:
    (i) Notify the petitioner by letter of the agency's decision to 
grant the petitioner permission to use the proposed brand name if such 
use is not misleading, with any conditions or limitations on such use 
specified; or
    (ii) Deny the petition, in which case the letter shall state the 
reasons therefor. Failure of the petition to fully address the 
requirements of this section shall be grounds for denial of the 
petition. Should FDA not notify the petitioner of his decision on the 
petition within 100 days, the petition shall be considered to be 
granted.
    (5) As soon as practicable following the granting of a petition, the 
Commissioner of Food and Drugs will publish a

[[Page 122]]

notice in the Federal Register informing the public of such fact.

[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 58 
FR 44033, Aug. 18, 1993; 62 FR 40598, July 29, 1997; 63 FR 26718, May 
14, 1998; 63 FR 40024, July 27, 1998; 67 FR 9585, Mar. 4, 2002; 69 FR 
16481, Mar. 30, 2004]



            Subpart E_Specific Requirements for Health Claims



Sec.  101.70  Petitions for health claims.

    (a) Any interested person may petition the Food and Drug 
Administration (FDA) to issue a regulation regarding a health claim. An 
original and one copy of the petition shall be submitted, or the 
petitioner may submit an original and a computer readable disk 
containing the petition. Contents of the disk should be in a standard 
format, such as ASCII format. (Petitioners interested in submitting a 
disk should contact the Center for Food Safety and Applied Nutrition for 
details.) If any part of the material submitted is in a foreign 
language, it shall be accompanied by an accurate and complete English 
translation. The petition shall state the petitioner's post office 
address to which any correspondence required by section 403 of the 
Federal Food, Drug, and Cosmetic Act may be sent.
    (b) Pertinent information may be incorporated in, and will be 
considered as part of, a petition on the basis of specific reference to 
such information submitted to and retained in the files of FDA. Such 
information may include any findings, along with the basis of the 
findings, of an outside panel with expertise in the subject area. Any 
reference to published information shall be accompanied by reprints, or 
easily readable copies of such information.
    (c) If nonclinical laboratory studies are included in a petition, 
the petition shall include, with respect to each nonclinical study 
contained in the petition, either a statement that the study has been 
conducted in compliance with the good laboratory practice regulations as 
set forth in part 58 of this chapter, or, if any such study was not 
conducted in compliance with such regulations, a brief statement of the 
reason for the noncompliance.
    (d) If clinical or other human investigations are included in a 
petition, the petition shall include a statement that they were either 
conducted in compliance with the requirements for institutional review 
set forth in part 56 of this chapter, or were not subject to such 
requirements in accordance with Sec.  56.104 or Sec.  56.105, and a 
statement that they were conducted in compliance with the requirements 
for informed consent set forth in part 50 of this chapter.
    (e) All data and information in a health claim petition are 
available for public disclosure after the notice of filing of petition 
is issued to the petitioner, except that clinical investigation reports, 
adverse reaction reports, product experience reports, consumer 
complaints, and other similar data and information shall only be 
available after deletion of:
    (1) Names and any information that would identify the person using 
the product.
    (2) Names and any information that would identify any third party 
involved with the report, such as a physician or hospital or other 
institution.
    (f) Petitions for a health claim shall include the following data 
and be submitted in the following form:

(Date)------------
Name of petitioner ------------
Post office address ------------
Subject of the petition ------------
Food and Drug Administration,
Office of Nutritional Products, Labeling and Dietary Supplements (HFS-
800),
5100 Paint Branch Pkwy.,
College Park, MD 20740,
    The undersigned, ------------------ submits this petition pursuant 
to section 403(r)(4) or 403(r)(5)(D) of the Federal Food, Drug, and 
Cosmetic Act with respect to (statement of the substance and its health 
claim).
    Attached hereto, and constituting a part of this petition, are the 
following:
    A. Preliminary requirements. A complete explanation of how the 
substance conforms to the requirements of Sec.  101.14(b) (21 CFR 
101.14(b)). For petitions where the subject substance is a food 
ingredient or a component of a food ingredient, the petitioner should 
compile a comprehensive list of the specific ingredients that will be 
added to the food to supply the substance in the food bearing the health 
claim. For each such ingredient listed, the petitioner should state how 
the ingredient complies with the requirements of Sec.  101.14(b)(3)(ii), 
e.g., that its use is generally recognized as safe (GRAS),

[[Page 123]]

listed as a food additive, or authorized by a prior sanction issued by 
the agency, and what the basis is for the GRAS claim, the food additive 
status, or prior sanctioned status.
    B. Summary of scientific data. The summary of scientific data 
provides the basis upon which authorizing a health claim can be 
justified as providing the health benefit. The summary must establish 
that, based on the totality of publicly available scientific evidence 
(including evidence from well-designed studies conducted in a manner 
which is consistent with generally recognized scientific procedures and 
principles), there is significant scientific agreement among experts 
qualified by scientific training and experience to evaluate such claims, 
that the claim is supported by such evidence.
    The summary shall state what public health benefit will derive from 
use of the claim as proposed. If the claim is intended for a specific 
group within the population, the summary shall specifically address 
nutritional needs of such group and shall include scientific data 
showing how the claim is likely to assist in meeting such needs.
    The summary shall concentrate on the findings of appropriate review 
articles, National Institutes of Health consensus development 
conferences, and other appropriate resource materials. Issues addressed 
in the summary shall include answers to such questions as:
    1. Is there an optimum level of the particular substance to be 
consumed beyond which no benefit would be expected?
    2. Is there any level at which an adverse effect from the substance 
or from foods containing the substance occurs for any segment of the 
population?
    3. Are there certain populations that must receive special 
consideration?
    4. What other nutritional or health factors (both positive and 
negative) are important to consider when consuming the substance?
    In addition, the summary of scientific data shall include a detailed 
analysis of the potential effect of the use of the proposed claim on 
food consumption, specifically any change due to significant alterations 
in eating habits and corresponding changes in nutrient intake resulting 
from such changes in food consumption. The latter item shall 
specifically address the effect on the intake of nutrients that have 
beneficial and negative consequences in the total diet.
    If the claim is intended for a significant subpopulation within the 
general U.S. population, the analysis shall specifically address the 
dietary practices of such group, and shall include data sufficient to 
demonstrate that the dietary analysis is representative of such group 
(e.g., adolescents or the elderly).
    If appropriate, the petition shall explain the prevalence of the 
disease or health-related condition in the U.S. population and the 
relevance of the claim in the context of the total daily diet.
    Also, the summary shall demonstrate that the substance that is the 
subject of the proposed claim conforms to the definition of the term 
``substance'' in Sec.  101.14(a)(2).
    C. Analytical data that show the amount of the substance that is 
present in representative foods that would be candidates to bear the 
claim should be obtained from representative samples using methods from 
the AOAC INTERNATIONAL (AOAC), where available. If no AOAC method is 
available, the petitioner shall submit the assay method used and data 
establishing the validity of the method for assaying the substance in 
food. The validation data should include a statistical analysis of the 
analytical and product variability.
    D. Model health claim. One or more model health claims that 
represent label statements that may be used on a food label or in 
labeling for a food to characterize the relationship between the 
substance in a food to a disease or health-related condition that is 
justified by the summary of scientific data provided in section C of the 
petition. The model health claim shall include:
    1. A brief capsulized statement of the relevant conclusions of the 
summary, and
    2. A statement of how this substance helps the consumer to attain a 
total dietary pattern or goal associated with the health benefit that is 
provided.
    E. The petition shall include the following attachments:
    1. Copies of any computer literature searches done by the petitioner 
(e.g., Medline).
    2. Copies of articles cited in the literature searches and other 
information as follows:
    a. All information relied upon for the support of the health claim, 
including copies of publications or other information cited in review 
articles and used to perform meta-analyses.
    b. All information concerning adverse consequences to any segment of 
the population (e.g., sensitivity to the substance).
    c. All information pertaining to the U.S. population.
    F. The petitioner is required to submit either a claim for 
categorical exclusion under Sec.  25.30 or Sec.  25.32 of this chapter 
or an environmental assessment under Sec.  25.40 of this chapter.
    Yours very truly,
    Petitioner ------------
    By ------------
    (Indicate authority)

    (g) The data specified under the several lettered headings should be 
submitted on separate pages or sets of pages, suitably identified. If 
such data have already been submitted with an earlier application from 
the petitioner

[[Page 124]]

or any other final petition, the present petition may incorporate it by 
specific reference to the earlier petition.
    (h) The petition shall include a statement signed by the person 
responsible for the petition that, to the best of his/her knowledge, it 
is a representative and balanced submission that includes unfavorable 
information as well as favorable information, known to him/her to be 
pertinent to the evaluation of the proposed health claim.
    (i) The petition shall be signed by the petitioner or by his/her 
attorney or agent, or (if a corporation) by an authorized official.
    (j) Agency action on the petition. (1) Within 15 days of receipt of 
the petition, the petitioner will be notified by letter of the date on 
which the petition was received. Such notice will inform the petitioner 
that the petition is undergoing agency review and that the petitioner 
will subsequently be notified of the agency's decision to file for 
comprehensive review or deny the petition.
    (2) Within 100 days of the date of receipt of the petition, FDA will 
notify the petitioner by letter that the petition has either been filed 
for comprehensive review or denied. The agency will deny a petition 
without reviewing the information contained in ``B. Summary of 
Scientific Data'' if the information in ``A. Preliminary Requirements'' 
is inadequate in explaining how the substance conforms to the 
requirements of Sec.  101.14(b). If the petition is denied, the 
notification will state the reasons therefor, including justification of 
the rejection of any report from an authoritative scientific body of the 
U.S. Government. If filed, the date of the notification letter becomes 
the date of filing for the purposes of this regulation. If FDA does not 
act within such 100 days, the petition shall be deemed to be denied 
unless an extension is mutually agreed upon by FDA and the petitioner. A 
petition that has been denied, or has been deemed to be denied, without 
filing will not be made available to the public. A filed petition will 
be available to the public to the extent provided under paragraph (e) of 
this section.
    (3) Within 90 days of the date of filing, FDA will by letter of 
notification to the petitioner:
    (i) Deny the petition, or
    (ii) Inform the petitioner that a proposed regulation to provide for 
the requested use of the health claim will be published in the Federal 
Register. If the petition is denied, the notification will state the 
reasons therefor, including justification for the rejection of any 
report from an authoritative scientific body of the U.S. Government. FDA 
will publish the proposal to amend the regulations to provide for the 
requested use of the health claim in the Federal Register within 90 days 
of the date of filing. The proposal will also announce the availability 
of the petition for public review.
    (iii) If FDA does not act within 90 days of the date of filing, the 
petition shall be deemed to be denied unless an extension is mutually 
agreed upon by FDA and the petitioner.
    (4)(i) Within 270 of the date of publication of the proposal, FDA 
will publish a final rule that either authorizes use of the health claim 
or explains why the agency has decided not to authorize one.
    (ii) For cause, FDA may extend, no more than twice, the period in 
which it will publish a final rule; each such extension will be for no 
more than 90 days. FDA will publish a notice of each extension in the 
Federal Register. The document will state the basis for the extension, 
the length of the extension, and the date by which the final rule will 
be published, which date shall be within 540 days of the date of receipt 
of the petition.

[58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 59 
FR 425, Jan. 4, 1994; 62 FR 28232, May 22, 1997; 62 FR 40599, July 29, 
1997; 63 FR 26719, May 14, 1998; 63 FR 40024, July 27, 1998; 66 FR 
56035, Nov. 6, 2001]



Sec.  101.71  Health claims: claims not authorized.

    Health claims not authorized for foods in conventional food form or 
for dietary supplements of vitamins, minerals, herbs, or other similar 
substances:
    (a) Dietary fiber and cardiovascular disease.

[[Page 125]]

    (b) Zinc and immune function in the elderly.

[58 FR 2534, Jan. 6, 1993, as amended at 58 FR 2548, 2578, 2620, 2639, 
2664, 2714, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993; 59 FR 437, Jan. 4, 
1994; 65 FR 58918, Oct. 3, 2000]



Sec.  101.72  Health claims: calcium, vitamin D, and osteoporosis.

    (a) Relationship between calcium, vitamin D, and osteoporosis. An 
inadequate intake of calcium or calcium and vitamin D contributes to low 
peak bone mass, which has been identified as one of many risk factors in 
the development of osteoporosis. Peak bone mass is the total quantity of 
bone present at maturity, and experts believe that it has the greatest 
bearing on whether a person will be at risk of developing osteoporosis 
and related bone fractures later in life. Another factor that influences 
total bone mass and susceptibility to osteoporosis is the rate of bone 
loss after skeletal maturity. Vitamin D is required for normal 
absorption of calcium and to prevent the occurrence of high serum 
parathyroid hormone (PTH) concentration, which stimulates mobilization 
of calcium from the skeleton and can lower bone mass. Calcium, along 
with vitamin D and several other nutrients, is required for normal bone 
mineralization. While vitamin D is required for optimal bone 
mineralization, it is more effective when calcium intake is adequate. An 
adequate intake of calcium and vitamin D is thought to exert a positive 
effect during adolescence and early adulthood in optimizing the amount 
of bone that is laid down. However, the upper limit of peak bone mass is 
genetically determined. The mechanism through which adequate intakes of 
calcium and vitamin D and optimal peak bone mass reduce the risk of 
osteoporosis is thought to be as follows. All persons lose bone with 
age. Hence, those with higher bone mass at maturity take longer to reach 
the critically reduced mass at which bones can fracture easily. The rate 
of bone loss after skeletal maturity also influences the amount of bone 
present at old age and can influence an individual's risk of developing 
osteoporosis. Maintenance of adequate intakes of calcium and vitamin D 
later in life is thought to be important in reducing the rate of bone 
loss particularly in the elderly and in women during the first decade 
following menopause, but a significant protective effect is also seen 
among men and younger women.
    (b) Significance of calcium or calcium and vitamin D. Adequate 
calcium intake, or adequate calcium and vitamin D intake, is not the 
only recognized risk factor in the development of osteoporosis, which is 
a multifactorial bone disease. Maintenance of adequate calcium and 
vitamin D intakes throughout life is necessary to achieve optimal peak 
bone mass and to reduce the risk of osteoporosis in later life. However, 
vitamin D is most effective in this regard when calcium intake is 
adequate. Increasing intake of calcium has been shown to have beneficial 
effects on bone health independent of dietary vitamin D.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating calcium or, when appropriate, calcium and vitamin D with a 
reduced risk of osteoporosis may be made on the label or labeling of a 
food described in paragraphs (c)(2)(ii) and (d)(1) of this section, 
provided that:
    (A) The claim makes clear the importance of adequate calcium intake, 
or when appropriate, adequate calcium and vitamin D intake, throughout 
life, in a healthful diet, are essential to reduce osteoporosis risk. 
The claim does not imply that adequate calcium intake, or when 
appropriate, adequate calcium and vitamin D intake, is the only 
recognized risk factor for the development of osteoporosis;
    (B) The claim does not attribute any degree of reduction in risk of 
osteoporosis to maintaining an adequate dietary calcium intake, or when 
appropriate, an adequate dietary calcium and vitamin D intake, 
throughout life.
    (ii) Nature of the food. (A) The food shall meet or exceed the 
requirements for a ``high'' level of calcium as defined in Sec.  
101.54(b);
    (B) The calcium content of the product shall be assimilable;
    (C) Dietary supplements shall meet the United States Pharmacopeia 
(USP)

[[Page 126]]

standards for disintegration and dissolution applicable to their 
component calcium salts, except that dietary supplements for which no 
USP standards exist shall exhibit appropriate assimilability under the 
conditions of use stated on the product label;
    (D) A food or total daily recommended supplement intake shall not 
contain more phosphorus than calcium on a weight per weight basis.
    (d) Optional information. (1) The claim may include the term 
``vitamin D'' if the food meets or exceeds the requirements for a 
``high'' level of vitamin D as defined in Sec.  101.54(b);
    (2) The claim may include information from paragraphs (a) and (b) of 
this section.
    (3) The claim may make reference to physical activity.
    (4) The claim may include information on the number of people in the 
United States, including the number of people in certain subpopulations 
in the United States, who have osteoporosis or low bone density. The 
sources of this information must be identified, and it must be current 
information from the National Center for Health Statistics, the National 
Institutes of Health, or the National Osteoporosis Foundation.
    (5) The claim may state that the role of adequate calcium intake, or 
when appropriate, the role of adequate calcium and vitamin D intake, 
throughout life is linked to reduced risk of osteoporosis through the 
mechanism of optimizing peak bone mass during adolescence and early 
adulthood. The phrase ``build and maintain good bone health'' may be 
used to convey the concept of optimizing peak bone mass. The claim may 
also state that adequate intake of calcium, or when appropriate, 
adequate intake of calcium and vitamin D, is linked to reduced risk of 
osteoporosis through the mechanism of slowing the rate of bone loss for 
persons with a family history of the disease, post-menopausal women, and 
elderly men and women.
    (e) Model health claims. The following model health claims may be 
used in food labeling to describe the relationship between calcium and 
osteoporosis:

Adequate calcium throughout life, as part of a well-balanced diet, may 
reduce the risk of osteoporosis.

Adequate calcium as part of a healthful diet, along with physical 
activity, may reduce the risk of osteoporosis in later life.
    (f) Model additional health claims for calcium and vitamin D. The 
following model health claims may be used in food labeling to describe 
the relationship between calcium, vitamin D, and osteoporosis:

Adequate calcium and vitamin D throughout life, as part of a well-
balanced diet, may reduce the risk of osteoporosis.

Adequate calcium and vitamin D as part of a healthful diet, along with 
physical activity, may reduce the risk of osteoporosis in later life.

[73 FR 56486, Sept. 29, 2008]



Sec.  101.73  Health claims: dietary lipids and cancer.

    (a) Relationship between fat and cancer. (1) Cancer is a 
constellation of more than 100 different diseases, each characterized by 
the uncontrolled growth and spread of abnormal cells. Cancer has many 
causes and stages in its development. Both genetic and environmental 
risk factors may affect the risk of cancer. Risk factors include a 
family history of a specific type of cancer, cigarette smoking, alcohol 
consumption, overweight and obesity, ultraviolet or ionizing radiation, 
exposure to cancer-causing chemicals, and dietary factors.
    (2) Among dietary factors, the strongest positive association has 
been found between total fat intake and risk of some types of cancer. 
Based on the totality of the publicly available scientific evidence, 
there is significant scientific agreement among experts, qualified by 
training and experience to evaluate such evidence, that diets high in 
total fat are associated with an increased cancer risk. Research to 
date, although not conclusive, demonstrates that the total amount of 
fats, rather than any specific type of fat, is positively associated 
with cancer risk. The mechanism by which total fat affects cancer has 
not yet been established.
    (3) A question that has been the subject of considerable research is 
whether

[[Page 127]]

the effect of fat on cancer is site-specific. Neither human nor animal 
studies are consistent in the association of fat intake with specific 
cancer sites.
    (4) Another question that has been raised is whether the association 
of total fat intake to cancer risk is independently associated with 
energy intakes, or whether the association of fat with cancer risk is 
the result of the higher energy (caloric) intake normally associated 
with high fat intake. FDA has concluded that evidence from both animal 
and human studies indicates that total fat intake alone, independent of 
energy intake, is associated with cancer risk.
    (b) Significance of the relationship between fat intake and risk of 
cancer. (1) Cancer is ranked as a leading cause of death in the United 
States. The overall economic costs of cancer, including direct health 
care costs and losses due to morbidity and mortality, are very high.
    (2) U.S. diets tend to be high in fat and high in calories. The 
average U.S. diet is estimated to contain 36 to 37 percent of calories 
from total fat. Current dietary guidelines from the Federal Government 
and other national health professional organizations recommend that 
dietary fat intake be reduced to a level of 30 percent or less of energy 
(calories) from total fat. In order to reduce intake of total fat, 
individuals should choose diets which are high in vegetables, fruits, 
and grain products (particularly whole grain products), choose lean cuts 
of meats, fish, and poultry, substitute low-fat dairy products for 
higher fat products, and use fats and oils sparingly.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in fat with reduced risk of cancer may be made on 
the label or labeling of a food described in paragraph (c)(2)(ii) of 
this section, provided that:
    (A) The claim states that diets low in fat ``may'' or ``might'' 
reduce the risk of some cancers;
    (B) In specifying the disease, the claim uses the following terms: 
``some types of cancer'' or ``some cancers'';
    (C) In specifying the nutrient, the claim uses the term ``total 
fat'' or ``fat'';
    (D) The claim does not specify types of fat or fatty acid that may 
be related to the risk of cancer;
    (E) The claim does not attribute any degree of cancer risk reduction 
to diets low in fat; and
    (F) The claim indicates that the development of cancer depends on 
many factors.
    (ii) Nature of the food. The food shall meet all of the nutrient 
content requirements of Sec.  101.62 for a ``low fat'' food; except that 
fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey, 
geese, ostrich) may meet the requirements for ``extra lean'' in Sec.  
101.62.
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors for development of cancer: Family history of 
a specific type of cancer, cigarette smoking, alcohol consumption, 
overweight and obesity, ultraviolet or ionizing radiation, exposure to 
cancer-causing chemicals, and dietary factors.
    (2) The claim may include information from paragraphs (a) and (b) of 
this section which summarize the relationship between dietary fat and 
cancer and the significance of the relationship.
    (3) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and Department of Health and Human Services (DHHS), 
Government Printing Office.
    (4) The claim may include information on the number of people in the 
United States who have cancer. The sources of this information must be 
identified, and it must be current information from the National Center 
for Health Statistics, the National Institutes of Health, or ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS, 
Government Printing Office.
    (e) Model health claims. The following model health claims may be 
used in food labeling to describe the relationship between dietary fat 
and cancer:
    (1) Development of cancer depends on many factors. A diet low in 
total fat may reduce the risk of some cancers.

[[Page 128]]

    (2) Eating a healthful diet low in fat may help reduce the risk of 
some types of cancers. Development of cancer is associated with many 
factors, including a family history of the disease, cigarette smoking, 
and what you eat.

[58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993]



Sec.  101.74  Health claims: sodium and hypertension.

    (a) Relationship between sodium and hypertension (high blood 
pressure). (1) Hypertension, or high blood pressure, generally means a 
systolic blood pressure of greater than 140 millimeters of mercury (mm 
Hg) or a diastolic blood pressure of greater than 90 mm Hg. 
Normotension, or normal blood pressure, is a systolic blood pressure 
below 140 mm Hg and diastolic blood pressure below 90 mm Hg. Sodium is 
specified here as the chemical entity or electrolyte ``sodium'' and is 
distinguished from sodium chloride, or salt, which is 39 percent sodium 
by weight.
    (2) The scientific evidence establishes that diets high in sodium 
are associated with a high prevalence of hypertension or high blood 
pressure and with increases in blood pressure with age, and that diets 
low in sodium are associated with a low prevalence of hypertension or 
high blood pressure and with a low or no increase of blood pressure with 
age.
    (b) Significance of sodium in relation to high blood pressure. (1) 
High blood pressure is a public health concern primarily because it is a 
major risk factor for mortality from coronary heart disease and stroke. 
Early management of high blood pressure is a major public health goal 
that can assist in reducing mortality associated with coronary heart 
disease and stroke. There is a continuum of mortality risk that 
increases as blood pressures rise. Individuals with high blood pressure 
are at greatest risk, and individuals with moderately high, high normal, 
and normal blood pressure are at steadily decreasing risk. The 
scientific evidence indicates that reducing sodium intake lowers blood 
pressure and associated risks in many but not all hypertensive 
individuals. There is also evidence that reducing sodium intake lowers 
blood pressure and associated risks in many but not all normotensive 
individuals as well.
    (2) The populations at greatest risk for high blood pressure, and 
those most likely to benefit from sodium reduction, include those with 
family histories of high blood pressure, the elderly, males because they 
develop hypertension earlier in life than females, and black males and 
females. Although some population groups are at greater risk than 
others, high blood-pressure is a disease of public health concern for 
all population groups. Sodium intake, alcohol consumption, and obesity 
are identified risk factors for high blood pressure.
    (3) Sodium intakes exceed recommended levels in almost every group 
in the United States. One of the major public health recommendations 
relative to high blood pressure is to decrease consumption of salt. On a 
population-wide basis, reducing the average sodium intake would have a 
small but significant effect on reducing the average blood pressure, 
and, consequently, reducing mortality from coronary heart disease and 
stroke.
    (4) Sodium is an essential nutrient, and experts have recommended a 
safe minimum level of 500 milligrams (mg) sodium per day and an upper 
level of 2,400 mg sodium per day, the FDA Daily Value for sodium.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in sodium with reduced risk of high blood pressure 
may be made on the label or labeling of a food described in paragraph 
(c)(2)(ii) of this section, provided that:
    (A) The claim states that diets low in sodium ``may'' or ``might'' 
reduce the risk of high blood pressure;
    (B) In specifying the disease, the claim uses the term ``high blood 
pressure'';
    (C) In specifying the nutrient, the claim uses the term ``sodium'';
    (D) The claim does not attribute any degree of reduction in risk of 
high blood pressure to diets low in sodium; and
    (E) The claim indicates that development of high blood pressure 
depends on many factors.

[[Page 129]]

    (ii) Nature of the food. The food shall meet all of the nutrient 
content requirements of Sec.  101.61 for a ``low sodium'' food.
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors for development of high blood pressure in 
addition to dietary sodium consumption: Family history of high blood 
pressure, growing older, alcohol consumption, and excess weight.
    (2) The claim may include information from paragraphs (a) and (b) of 
this section, which summarizes the relationship between dietary sodium 
and high blood pressure and the significance of the relationship.
    (3) The claim may include information on the number of people in the 
United States who have high blood pressure. The sources of this 
information must be identified, and it must be current information from 
the National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Health and Human Services (DHHS) and 
U.S. Department of Argiculture (USDA), Government Printing Office.
    (4) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: U.S. Dietary Guidelines for Americans, DHHS and USDA, 
Government Printing Office.
    (5) In specifying the nutrient, the claim may include the term 
``salt'' in addition to the term ``sodium.''
    (6) In specifying the disease, the claim may include the term 
``hypertension'' in addition to the term ``high blood pressure.''
    (7) The claim may state that individuals with high blood pressure 
should consult their physicians for medical advice and treatment. If the 
claim defines high or normal blood pressure, then the health claim must 
state that individuals with high blood pressure should consult their 
physicians for medical advice and treatment.
    (e) Model health claims. The following are model health claims that 
may be used in food labeling to describe the relationship between 
dietary sodium and high blood pressure:
    (1) Diets low in sodium may reduce the risk of high blood pressure, 
a disease associated with many factors.
    (2) Development of hypertension or high blood pressure depends on 
many factors. [This product] can be part of a low sodium, low salt diet 
that might reduce the risk of hypertension or high blood pressure.

[58 FR 2836, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993]



Sec.  101.75  Health claims: dietary saturated fat and cholesterol and risk of 

coronary heart disease.

    (a) Relationship between dietary saturated fat and cholesterol and 
risk of coronary heart disease. (1) Cardiovascular disease means 
diseases of the heart and circulatory system. Coronary heart disease is 
the most common and serious form of cardiovascular disease and refers to 
diseases of the heart muscle and supporting blood vessels. High blood 
total- and low density lipoprotein (LDL)- cholesterol levels are major 
modifiable risk factors in the development of coronary heart disease. 
High coronary heart disease rates occur among people with high blood 
cholesterol levels of 240 milligrams/decaliter (mg/dL) (6.21 millimoles 
per liter (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL 
(4.13 mmol/L) or above. Borderline high risk blood cholesterol levels 
range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL 
(3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) include 
fatty acids and cholesterol. Total fat, commonly referred to as fat, is 
composed of saturated fat (fatty acids containing no double bonds), and 
monounsaturated and polyunsaturated fat (fatty acids containing one or 
more double bonds).
    (2) The scientific evidence establishes that diets high in saturated 
fat and cholesterol are associated with increased levels of blood total- 
and LDL-cholesterol and, thus, with increased risk of coronary heart 
disease. Diets low in saturated fat and cholesterol are associated with 
decreased levels of blood total- and LDL-cholesterol, and thus, with 
decreased risk of developing coronary heart disease.

[[Page 130]]

    (b) Significance of the relationship between dietary saturated fat 
and cholesterol and risk of coronary heart disease. (1) Coronary heart 
disease is a major public health concern in the United States, primarily 
because it accounts for more deaths than any other disease or group of 
diseases. Early management of risk factors for coronary heart disease is 
a major public health goal that can assist in reducing risk of coronary 
heart disease. There is a continuum of mortality risk from coronary 
heart disease that increases with increasing levels of blood LDL-
cholesterol. Individuals with high blood LDL-cholesterol are at greatest 
risk. A larger number of individuals with more moderately elevated 
cholesterol also have increased risk of coronary events; such 
individuals comprise a substantial proportion of the adult U.S. 
population. The scientific evidence indicates that reducing saturated 
fat and cholesterol intakes lowers blood LDL-cholesterol and risk of 
heart disease in most individuals. There is also evidence that reducing 
saturated fat and cholesterol intakes in persons with blood cholesterol 
levels in the normal range also reduces risk of heart disease.
    (2) Other risk factors for coronary heart disease include a family 
history of heart disease, high blood pressure, diabetes, cigarette 
smoking, obesity (body weight 30 percent greater than ideal body 
weight), and lack of regular physical exercise.
    (3) Intakes of saturated fat exceed recommended levels in many 
people in the United States. Intakes of cholesterol are, on average, at 
or above recommended levels. One of the major public health 
recommendations relative to coronary heart disease risk is to consume 
less than 10 percent of calories from saturated fat, and an average of 
30 percent or less of total calories from all fat. Recommended daily 
cholesterol intakes are 300 mg or less per day.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in saturated fat and cholesterol with reduced risk 
of coronary heart disease may be made on the label or labeling of a food 
described in paragraph (c)(2)(ii) of this section provided that:
    (A) The claim states that diets low in saturated fat and cholesterol 
``may'' or ``might'' reduce the risk of heart disease;
    (B) In specifying the disease, the claim uses the terms ``heart 
disease'' or ``coronary heart disease;''
    (C) In specifying the nutrient, the claim uses the terms ``saturated 
fat'' and ``cholesterol'' and lists both;
    (D) The claim does not attribute any degree of risk reduction for 
coronary heart disease to diets low in dietary saturated fat and 
cholesterol; and
    (E) The claim states that coronary heart disease risk depends on 
many factors.
    (ii) Nature of the food. The food shall meet all of the nutrient 
content requirements of Sec.  101.62 for a ``low saturated fat,'' ``low 
cholesterol,'' and ``low fat'' food; except that fish and game meats 
(i.e., deer, bison, rabbit, quail, wild turkey, geese, and ostrich) may 
meet the requirements for ``extra lean'' in Sec.  101.62.
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors in addition to saturated fat and cholesterol 
about which there is general scientific agreement that they are major 
risk factors for this disease: A family history of coronary heart 
disease, elevated blood total and LDL-cholesterol, excess body weight, 
high blood pressure, cigarette smoking, diabetes, and physical 
inactivity.
    (2) The claim may indicate that the relationship of saturated fat 
and cholesterol to heart disease is through the intermediate link of 
``blood cholesterol'' or ``blood total- and LDL cholesterol.''
    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between dietary saturated 
fat and cholesterol and risk of coronary heart disease, and the 
significance of the relationship.
    (4) In specifying the nutrients, the claim may include the term 
``total fat'' in addition to the terms ``saturated fat'' and 
``cholesterol''.

[[Page 131]]

    (5) The claim may include information on the number of people in the 
United States who have coronary heart disease. The sources of this 
information shall be identified, and it shall be current information 
from the National Center for Health Statistics, the National Institutes 
of Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Health and Human Services (DHHS) and 
U.S. Department of Agriculture (USDA), Government Printing Office.
    (6) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' DHHS and USDA, 
Government Printing Office.
    (7) The claim may state that individuals with elevated blood total- 
or LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total- or LDL-
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment.
    (e) Model health claims.The following are model health claims that 
may be used in food labeling to describe the relationship between 
dietary saturated fat and cholesterol and risk of heart disease:
    (1) While many factors affect heart disease, diets low in saturated 
fat and cholesterol may reduce the risk of this disease;
    (2) Development of heart disease depends upon many factors, but its 
risk may be reduced by diets low in saturated fat and cholesterol and 
healthy lifestyles;
    (3) Development of heart disease depends upon many factors, 
including a family history of the disease, high blood LDL-cholesterol, 
diabetes, high blood pressure, being overweight, cigarette smoking, lack 
of exercise, and the type of dietary pattern. A healthful diet low in 
saturated fat, total fat, and cholesterol, as part of a healthy 
lifestyle, may lower blood cholesterol levels and may reduce the risk of 
heart disease;
    (4) Many factors, such as a family history of the disease, increased 
blood- and LDL-cholesterol levels, high blood pressure, cigarette 
smoking, diabetes, and being overweight, contribute to developing heart 
disease. A diet low in saturated fat, cholesterol, and total fat may 
help reduce the risk of heart disease; and
    (5) Diets low in saturated fat, cholesterol, and total fat may 
reduce the risk of heart disease. Heart disease is dependent upon many 
factors, including diet, a family history of the disease, elevated blood 
LDL-cholesterol levels, and physical inactivity.

[58 FR 2757, Jan. 6, 1993]



Sec.  101.76  Health claims: fiber-containing grain products, fruits, and 

vegetables and cancer.

    (a) Relationship between diets low in fat and high in fiber-
containing grain products, fruits, and vegetables and cancer risk. (1) 
Cancer is a constellation of more than 100 different diseases, each 
characterized by the uncontrolled growth and spread of abnormal cells. 
Cancer has many causes and stages in its development. Both genetic and 
environmental risk factors may affect the risk of cancer. Risk factors 
include: A family history of a specific type of cancer, cigarette 
smoking, overweight and obesity, alcohol consumption, ultraviolet or 
ionizing radiation, exposure to cancer-causing chemicals, and dietary 
factors.
    (2) The scientific evidence establishes that diets low in fat and 
high in fiber-containing grain products, fruits, and vegetables are 
associated with a reduced risk of some types of cancer. Although the 
specific role of total dietary fiber, fiber components, and the multiple 
nutrients and other substances contained in these foods are not yet 
fully understood, many studies have shown that diets low in fat and high 
in fiber-containing foods are associated with reduced risk of some types 
of cancer.
    (b) Significance of the relationship between consumption of diets 
low in fat and high in fiber-containing grain products, fruits, and 
vegetables and risk of cancer. (1) Cancer is ranked as a leading cause 
of death in the United States. The overall economic costs of cancer, 
including direct health care costs and losses due to morbidity and 
mortality, are very high.

[[Page 132]]

    (2) U.S. diets tend to be high in fat and low in grain products, 
fruits, and vegetables. Studies in various parts of the world indicate 
that populations who habitually consume a diet high in plant foods have 
lower risks of some cancers. These diets generally are low in fat and 
rich in many nutrients, including, but not limited to, dietary fiber. 
Current dietary guidelines from Federal government agencies and 
nationally recognized health professional organizations recommend 
decreased consumption of fats (less than 30 percent of calories), 
maintenance of desirable body weight, and increased consumption of 
fruits and vegetables (five or more servings daily), and grain products 
(six or more servings daily).
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in fat and high in fiber-containing grain 
products, fruits, and vegetables with reduced risk of cancer may be made 
on the label or labeling of a food described in paragraph (c)(2)(ii) of 
this section, provided that:
    (A) The claim states that diets low in fat and high in fiber-
containing grain products, fruits, and vegetables ``may'' or ``might'' 
reduce the risk of some cancers;
    (B) In specifying the disease, the claim uses the following terms: 
``some types of cancer,'' or ``some cancers'';
    (C) The claim is limited to grain products, fruits, and vegetables 
that contain dietary fiber;
    (D) The claim indicates that development of cancer depends on many 
factors;
    (E) The claim does not attribute any degree of cancer risk reduction 
to diets low in fat and high in fiber-containing grain products, fruits, 
and vegetables;
    (F) In specifying the dietary fiber component of the labeled food, 
the claim uses the term ``fiber'', ``dietary fiber'' or ``total dietary 
fiber''; and
    (G) The claim does not specify types of dietary fiber that may be 
related to risk of cancer.
    (ii) Nature of the food. (A) The food shall be or shall contain a 
grain product, fruit, or vegetable.
    (B) The food shall meet the nutrient content requirements of Sec.  
101.62 for a ``low fat'' food.
    (C) The food shall meet, without fortification, the nutrient content 
requirements of Sec.  101.54 for a ``good source'' of dietary fiber.
    (d) Optional information. (1) The claim may include information from 
paragraphs (a) and (b) of this section, which summarize the relationship 
between diets low in fat and high in fiber-containing grain products, 
fruits, and vegetables, and some types of cancer and the significance of 
the relationship.
    (2) The claim may identify one or more of the following risk factors 
for development of cancer: Family history of a specific type of cancer, 
cigarette smoking, overweight and obesity, alcohol consumption, 
ultraviolet or ionizing radiation, exposure to cancer causing chemicals, 
and dietary factors.
    (3) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and Department of Health and Human Services (DHHS), 
Government Printing Office.
    (4) The claim may include information on the number of people in the 
United States who have cancer. The sources of this information must be 
identified, and it must be current information from the National Center 
for Health Statistics, the National Institutes of Health, or ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS, 
Government Printing Office.
    (e) Model health claims. The following model health claims may be 
used in food labeling to characterize the relationship between diets low 
in fat and high in fiber-containing grain products, fruits, and 
vegetables and cancer risk:
    (1) Low fat diets rich in fiber-containing grain products, fruits, 
and vegetables may reduce the risk of some types of cancer, a disease 
associated with many factors.
    (2) Development of cancer depends on many factors. Eating a diet low 
in fat and high in grain products, fruits, and vegetables that contain 
dietary fiber may reduce your risk of some cancers.

[58 FR 2548, Jan. 6, 1993]

[[Page 133]]



Sec.  101.77  Health claims: fruits, vegetables, and grain products that 

contain fiber, particularly soluble fiber, and risk of coronary heart disease.

    (a) Relationship between diets low in saturated fat and cholesterol 
and high in fruits, vegetables, and grain products that contain fiber, 
particularly soluble fiber, and risk of coronary heart disease. (1) 
Cardiovascular disease means diseases of the heart and circulatory 
system. Coronary heart disease is the most common and serious form of 
cardiovascular disease and refers to diseases of the heart muscle and 
supporting blood vessels. High blood total- and low density lipoprotein 
(LDL)- cholesterol levels are major modifiable risk factors in the 
development of coronary heart disease. High coronary heart disease rates 
occur among people with high blood cholesterol levels of 240 milligrams 
per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-cholesterol 
levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk blood 
cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 
130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary 
lipids (fats) include fatty acids and cholesterol. Total fat, commonly 
referred to as fat, is composed of saturated fat (fatty acids containing 
no double bonds), and monounsaturated and polyunsaturated fat (fatty 
acids containing one or more double bonds).
    (2) The scientific evidence establishes that diets high in saturated 
fat and cholesterol are associated with increased levels of blood total- 
and LDL-cholesterol and, thus, with increased risk of coronary heart 
disease. Diets low in saturated fat and cholesterol are associated with 
decreased levels of blood total- and LDL-cholesterol, and thus, with 
decreased risk of developing coronary heart disease.
    (3) Populations with relatively low blood cholesterol levels tend to 
have dietary patterns that are not only low in total fat, especially 
saturated fat and cholesterol, but are also relatively high in fruits, 
vegetables, and grain products. Although the specific roles of these 
plant foods are not yet fully understood, many studies have shown that 
diets high in plant foods are associated with reduced risk of coronary 
heart disease. These studies correlate diets rich in fruits, vegetables, 
and grain products and nutrients from these diets, such as some types of 
fiber, with reduced coronary heart disease risk. Persons consuming these 
diets frequently have high intakes of dietary fiber, particularly 
soluble fibers. Currently, there is not scientific agreement as to 
whether a particular type of soluble fiber is beneficial, or whether the 
observed protective effects of fruits, vegetables, and grain products 
against heart disease are due to other components, or a combination of 
components, in these diets, including, but not necessarily limited to, 
some types of soluble fiber, other fiber components, other 
characteristics of the complex carbohydrate content of these foods, 
other nutrients in these foods, or displacement of saturated fat and 
cholesterol from the diet.
    (b) Significance of the relationship between diets low in saturated 
fat and cholesterol, and high in fruits, vegetables, and grain products 
that contain fiber, particularly soluble fiber, and risk of coronary 
heart disease. (1) Coronary heart disease is a major public health 
concern in the United States, primarily because it accounts for more 
deaths than any other disease or group of diseases. Early management of 
risk factors for coronary heart disease is a major public health goal 
that can assist in reducing risk of coronary heart disease. There is a 
continuum of mortality risk from coronary heart disease that increases 
with increasing levels of blood LDL-cholesterol. Individuals with high 
blood LDL-cholesterol are at greatest risk. A larger number of 
individuals with more moderately elevated cholesterol also have 
increased risk of coronary events; such individuals comprise a 
substantial proportion of the adult U.S. population. The scientific 
evidence indicates that reducing saturated fat and cholesterol intakes 
lowers blood LDL-cholesterol and risk of heart disease in most 
individuals, including persons with blood cholesterol levels in the 
normal range. Additionally, consuming diets high in fruits, vegetables, 
and grain products, foods that contain soluble fiber, may be a useful 
adjunct to a low saturated fat and low cholesterol diet.

[[Page 134]]

    (2) Other risk factors for coronary heart disease include a family 
history of heart disease, high blood pressure, diabetes, cigarette 
smoking, obesity (body weight 30 percent greater than ideal body 
weight), and lack of regular physical exercise.
    (3) Intakes of saturated fat exceed recommended levels in many 
people in the United States. Intakes of cholesterol are, on average, at 
or above recommended levels. Intakes of fiber-containing fruits, 
vegetables, and grain products are about half of recommended intake 
levels. One of the major public health recommendations relative to 
coronary heart disease risk is to consume less than 10 percent of 
calories from saturated fat, and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 mg or less per day. Recommended total dietary fiber intakes are 
about 25 grams (g) daily, of which about 25 percent (about 6 g) should 
be soluble fiber.
    (4) Current dietary guidance recommendations encourage decreased 
consumption of dietary fat, especially saturated fat and cholesterol, 
and increased consumption of fiber-rich foods to help lower blood LDL-
cholesterol levels. Results of numerous studies have shown that fiber-
containing fruits, vegetables, and grain products can help lower blood 
LDL-cholesterol.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets low in saturated fat and cholesterol and high in 
fruits, vegetables, and grain products that contain fiber, particularly 
soluble fiber, with reduced risk of heart disease may be made on the 
label or labeling of a food described in paragraph (c)(2)(ii) of this 
section, provided that:
    (A) The claim states that diets low in saturated fat and cholesterol 
and high in fruits, vegetables, and grain products that contain fiber 
``may'' or ``might'' reduce the risk of heart disease;
    (B) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease;''
    (C) The claim is limited to those fruits, vegetables, and grains 
that contain fiber;
    (D) In specifying the dietary fiber, the claim uses the term 
``fiber,'' ``dietary fiber,'' ``some types of dietary fiber,'' ``some 
dietary fibers,'' or ``some fibers;'' the term ``soluble fiber'' may be 
used in addition to these terms;
    (E) In specifying the fat component, the claim uses the terms 
``saturated fat'' and ``cholesterol;'' and
    (F) The claim indicates that development of heart disease depends on 
many factors; and
    (G) The claim does not attribute any degree of risk reduction for 
coronary heart disease to diets low in saturated fat and cholesterol and 
high in fruits, vegetables, and grain products that contain fiber.
    (ii) Nature of the food. (A) The food shall be or shall contain a 
fruit, vegetable, or grain product.
    (B) The food shall meet the nutrient content requirements of Sec.  
101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low fat'' 
food.
    (C) The food contains, without fortification, at least 0.6 g of 
soluble fiber per reference amount customarily consumed;
    (D) The content of soluble fiber shall be declared in the nutrition 
information panel, consistent with Sec.  101.9(c)(6)(i)(A).
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors for heart disease about which there is 
general scientific agreement: A family history of coronary heart 
disease, elevated blood-, total- and LDL-cholesterol, excess body 
weight, high blood pressure, cigarette smoking, diabetes, and physical 
inactivity.
    (2) The claim may indicate that the relationship of diets low in 
saturated fat and cholesterol, and high in fruits, vegetables, and grain 
products that contain fiber to heart disease is through the intermediate 
link of ``blood cholesterol'' or ``blood total- and LDL-cholesterol.''
    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between diets low in 
saturated fat and cholesterol and high in fruits,

[[Page 135]]

vegetables, and grain products that contain fiber and coronary heart 
disease, and the significance of the relationship.
    (4) In specifying the nutrients, the claim may include the term 
``total fat'' in addition to the terms ``saturated fat'' and 
``cholesterol.''
    (5) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and Department of Health and Human Services (DHHS), 
Government Printing Office (GPO).
    (6) The claim may state that individuals with elevated blood total- 
and LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total- and LDL-
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment.
    (7) The claim may include information on the number of people in the 
United States who have heart disease. The sources of this information 
shall be identified, and it shall be current information from the 
National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' USDA and DHHS, GPO.
    (e) Model health claims. The following model health claims may be 
used in food labeling to characterize the relationship between diets low 
in saturated fat and cholesterol and high in fruits, vegetables, and 
grain products that contain soluble fiber:
    (1) Diets low in saturated fat and cholesterol and rich in fruits, 
vegetables, and grain products that contain some types of dietary fiber, 
particularly soluble fiber, may reduce the risk of heart disease, a 
disease associated with many factors.
    (2) Development of heart disease depends on many factors. Eating a 
diet low in saturated fat and cholesterol and high in fruits, 
vegetables, and grain products that contain fiber may lower blood 
cholesterol levels and reduce your risk of heart disease.

[58 FR 2578, Jan. 6, 1993]



Sec.  101.78  Health claims: fruits and vegetables and cancer.

    (a) Relationship between substances in diets low in fat and high in 
fruits and vegetables and cancer risk. (1) Cancer is a constellation of 
more than 100 different diseases, each characterized by the uncontrolled 
growth and spread of abnormal cells. Cancer has many causes and stages 
in its development. Both genetic and environmental risk factors may 
affect the risk of cancer. Risk factors include a family history of a 
specific type of cancer, cigarette smoking, alcohol consumption, 
overweight and obesity, ultraviolet or ionizing radiation, exposure to 
cancer-causing chemicals, and dietary factors.
    (2) Although the specific roles of the numerous potentially 
protective substances in plant foods are not yet understood, many 
studies have shown that diets high in plant foods are associated with 
reduced risk of some types of cancers. These studies correlate diets 
rich in fruits and vegetables and nutrients from these diets, such as 
vitamin C, vitamin A, and dietary fiber, with reduced cancer risk. 
Persons consuming these diets frequently have high intakes of these 
nutrients. Currently, there is not scientific agreement as to whether 
the observed protective effects of fruits and vegetables against cancer 
are due to a combination of the nutrient components of diets rich in 
fruits and vegetables, including but not necessarily limited to dietary 
fiber, vitamin A (as beta-carotene) and vitamin C, to displacement of 
fat from such diets, or to intakes of other substances in these foods 
which are not nutrients but may be protective against cancer risk.
    (b) Significance of the relationship between consumption of diets 
low in fat and high in fruits and vegetables and risk of cancer. (1) 
Cancer is ranked as a leading cause of death in the United States. The 
overall economic costs of cancer, including direct health care costs and 
losses due to morbidity and mortality, are very high.
    (2) U.S. diets tend to be high in fat and low in fruits and 
vegetables. Studies in various parts of the world indicate that 
populations who habitually consume a diet high in plant foods have lower 
risks of some cancers. These

[[Page 136]]

diets generally are low in fat and rich in many nutrients, including, 
but not limited to, dietary fiber, vitamin A (as beta-carotene), and 
vitamin C. Current dietary guidelines from Federal Government agencies 
and nationally recognized health professional organizations recommend 
decreased consumption of fats (less than 30 percent of calories), 
maintenance of desirable body weight, and increased consumption of 
fruits and vegetables (5 or more servings daily), particularly those 
fruits and vegetables which contain dietary fiber, vitamin A, and 
vitamin C.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating substances in diets low in fat and high in fruits and 
vegetables with reduced risk of cancer may be made on the label or 
labeling of a food described in paragraph (c)(2)(ii) of this section, 
provided that:
    (A) The claim states that diets low in fat and high in fruits and 
vegetables ``may'' or ``might'' reduce the risk of some cancers;
    (B) In specifying the disease, the claim uses the following terms: 
``some types of cancer'', or ``some cancers'';
    (C) The claim characterizes fruits and vegetables as foods that are 
low in fat and may contain vitamin A, vitamin C, and dietary fiber;
    (D) The claim characterizes the food bearing the claim as containing 
one or more of the following, for which the food is a good source under 
Sec.  101.54: dietary fiber, vitamin A, or vitamin C;
    (E) The claim does not attribute any degree of cancer risk reduction 
to diets low in fat and high in fruits and vegetables;
    (F) In specifying the fat component of the labeled food, the claim 
uses the term ``total fat'' or ``fat'';
    (G) The claim does not specify types of fats or fatty acids that may 
be related to risk of cancer;
    (H) In specifying the dietary fiber component of the labeled food, 
the claim uses the term ``fiber'', ``dietary fiber'', or ``total dietary 
fiber'';
    (I) The claim does not specify types of dietary fiber that may be 
related to risk of cancer; and
    (J) The claim indicates that development of cancer depends on many 
factors.
    (ii) Nature of the food. (A) The food shall be or shall contain a 
fruit or vegetable.
    (B) The food shall meet the nutrient content requirements of Sec.  
101.62 for a ``low fat'' food.
    (C) The food shall meet, without fortification, the nutrient content 
requirements of Sec.  101.54 for a ``good source'' of at least one of 
the following: vitamin A, vitamin C, or dietary fiber.
    (d) Optional information. (1) The claim may include information from 
paragraphs (a) and (b) of this section, which summarize the relationship 
between diets low in fat and high in fruits and vegetables and some 
types of cancer and the significance of the relationship.
    (2) The claim may identify one or more of the following risk factors 
for development of cancer: Family history of a specific type of cancer, 
cigarette smoking, alcohol consumption, overweight and obesity, 
ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, 
and dietary factors.
    (3) The claim may use the word ``beta-carotene'' in parentheses 
after the term vitamin A, provided that the vitamin A in the food 
bearing the claim is beta-carotene.
    (4) The claim may indicate that it is consistent with ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and the Department of Health and Human Services 
(DHHS), Government Printing Office.
    (5) The claim may include information on the number of people in the 
United States who have cancer. The sources of this information must be 
identified, and it must be current information from the National Center 
for Health Statistics, the National Institutes of Health, or ``Nutrition 
and Your Health: Dietary Guidelines for Americans,'' USDA and DHHS, 
Government Printing Office.
    (e) Model health claims. The following model health claims may be 
used in food labeling to characterize the relationship between 
substances in diets low in fat and high in fruits and vegetables and 
cancer:

[[Page 137]]

    (1) Low fat diets rich in fruits and vegetables (foods that are low 
in fat and may contain dietary fiber, vitamin A, and vitamin C) may 
reduce the risk of some types of cancer, a disease associated with many 
factors. Broccoli is high in vitamins A and C, and it is a good source 
of dietary fiber.
    (2) Development of cancer depends on many factors. Eating a diet low 
in fat and high in fruits and vegetables, foods that are low in fat and 
may contain vitamin A, vitamin C, and dietary fiber, may reduce your 
risk of some cancers. Oranges, a food low in fat, are a good source of 
fiber and vitamin C.

[58 FR 2639, Jan. 6, 1993]



Sec.  101.79  Health claims: Folate and neural tube defects.

    (a) Relationship between folate and neural tube defects--(1) 
Definition. Neural tube defects are serious birth defects of the brain 
or spinal cord that can result in infant mortality or serious 
disability. The birth defects anencephaly and spina bifida are the most 
common forms of neural tube defects and account for about 90 percent of 
these defects. These defects result from failure of closure of the 
covering of the brain or spinal cord during early embryonic development. 
Because the neural tube forms and closes during early pregnancy, the 
defect may occur before a woman realizes that she is pregnant.
    (2) Relationship. The available data show that diets adequate in 
folate may reduce the risk of neural tube defects. The strongest 
evidence for this relationship comes from an intervention study by the 
Medical Research Council of the United Kingdom that showed that women at 
risk of recurrence of a neural tube defect pregnancy who consumed a 
supplement containing 4 milligrams (mg)(4,000 micrograms (mcg)) folic 
acid daily before conception and continuing into early pregnancy had a 
reduced risk of having a child with a neural tube defect. (Products 
containing this level of folic acid are drugs). In addition, based on 
its review of a Hungarian intervention trial that reported 
periconceptional use of a multivitamin and multimineral preparation 
containing 800 mcg (0.8 mg) of folic acid, and its review of the 
observational studies that reported periconceptional use of 
multivitamins containing 0 to 1,000 mcg of folic acid, the Food and Drug 
Administration concluded that most of these studies had results 
consistent with the conclusion that folate, at levels attainable in 
usual diets, may reduce the risk of neural tube defects.
    (b) Significance of folate--(1) Public health concern. Neural tube 
defects occur in approximately 0.6 of 1,000 live births in the United 
States (i.e., approximately 6 of 10,000 live births; about 2,500 cases 
among 4 million live births annually). Neural tube defects are believed 
to be caused by many factors. The single greatest risk factor for a 
neural tube defect-affected pregnancy is a personal or family history of 
a pregnancy affected with a such a defect. However, about 90 percent of 
infants with a neural tube defect are born to women who do not have a 
family history of these defects. The available evidence shows that diets 
adequate in folate may reduce the risk of neural tube defects but not of 
other birth defects.
    (2) Populations at risk. Prevalence rates for neural tube defects 
have been reported to vary with a wide range of factors including 
genetics, geography, socioeconomic status, maternal birth cohort, month 
of conception, race, nutrition, and maternal health, including maternal 
age and reproductive history. Women with a close relative (i.e., 
sibling, niece, nephew) with a neural tube defect, those with insulin-
dependent diabetes mellitus, and women with seizure disorders who are 
being treated with valproic acid or carbamazepine are at significantly 
increased risk compared with women without these characteristics. Rates 
for neural tube defects vary within the United States, with lower rates 
observed on the west coast than on the east coast.
    (3) Those who may benefit. Based on a synthesis of information from 
several studies, including those which used multivitamins containing 
folic acid at a daily dose level of =400 mcg (=0.4 
mg), the Public Health Service has inferred that folate alone at levels 
of 400 mcg (0.4 mg) per day may reduce the risk of neural tube defects. 
The protective effect found in studies of lower dose

[[Page 138]]

folate measured by the reduction in neural tube defect incidence, ranges 
from none to substantial; a reasonable estimate of the expected 
reduction in the United States is 50 percent. It is expected that 
consumption of adequate folate will avert some, but not all, neural tube 
defects. The underlying causes of neural tube defects are not known. 
Thus, it is not known what proportion of neural tube defects will be 
averted by adequate folate consumption. From the available evidence, the 
Public Health Service estimates that there is the potential for averting 
50 percent of cases that now occur (i.e., about 1,250 cases annually). 
However, until further research is done, no firm estimate of this 
proportion will be available.
    (c) Requirements. The label or labeling of food may contain a 
folate/neural tube defect health claim provided that:
    (1) General requirements. The health claim for a food meets all of 
the general requirements of Sec.  101.14 for health claims, except that 
a food may qualify to bear the health claim if it meets the definition 
of the term ``good source.''
    (2) Specific requirements--(i) Nature of the claim--(A) 
Relationship. A health claim that women who are capable of becoming 
pregnant and who consume adequate amounts of folate daily during their 
childbearing years may reduce their risk of having a pregnancy affected 
by spina bifida or other neural tube defects may be made on the label or 
labeling of food provided that:
    (B) Specifying the nutrient. In specifying the nutrient, the claim 
shall use the terms ``folate,'' ``folic acid,'' ``folacin,'' ``folate, a 
B vitamin,'' ``folic acid, a B vitamin,'' or ``folacin, a B vitamin.''
    (C) Specifying the condition. In specifying the health- related 
condition, the claim shall identify the birth defects as ``neural tube 
defects,'' ``birth defects spina bifida or anencephaly,'' ``birth 
defects of the brain or spinal cord anencephaly or spina bifida,'' 
``spina bifida and anencephaly, birth defects of the brain or spinal 
cord,'' ``birth defects of the brain or spinal cord;'' or ``brain or 
spinal cord birth defects.''
    (D) Multifactorial nature. The claim shall not imply that folate 
intake is the only recognized risk factor for neural tube defects.
    (E) Reduction in risk. The claim shall not attribute any specific 
degree of reduction in risk of neural tube defects from maintaining an 
adequate folate intake throughout the childbearing years. The claim 
shall state that some women may reduce their risk of a neural tube 
defect pregnancy by maintaining adequate intakes of folate during their 
childbearing years. Optional statements about population-based estimates 
of risk reduction may be made in accordance with paragraph (c)(3)(vi) of 
this section.
    (F) Safe upper limit of daily intake. Claims on foods that contain 
more than 100 percent of the Daily Value (DV) (400 mcg) when labeled for 
use by adults and children 4 or more years of age, or 800 mcg when 
labeled for use by pregnant or lactating women) shall identify the safe 
upper limit of daily intake with respect to the DV. The safe upper limit 
of daily intake value of 1,000 mcg (1 mg) may be included in 
parentheses.
    (G) The claim shall state that folate needs to be consumed as part 
of a healthful diet.
    (ii) Nature of the food--(A) Requirements. The food shall meet or 
exceed the requirements for a ``good source'' of folate as defined in 
Sec.  101.54;
    (B) Dietary supplements. Dietary supplements shall meet the United 
States Pharmacopeia (USP) standards for disintegration and dissolution, 
except that if there are no applicable USP standards, the folate in the 
dietary supplement shall be shown to be bioavailable under the 
conditions of use stated on the product label.
    (iii) Limitation. The claim shall not be made on foods that contain 
more than 100 percent of the RDI for vitamin A as retinol or preformed 
vitamin A or vitamin D per serving or per unit.
    (iv) Nutrition labeling. The nutrition label shall include 
information about the amount of folate in the food. This information 
shall be declared after the declaration for iron if only the levels of 
vitamin A, vitamin C, calcium, and iron are provided, or in accordance 
with Sec.  101.9 (c)(8) and (c)(9) if other optional vitamins or 
minerals are declared.

[[Page 139]]

    (3) Optional information--(i) Risk factors. The claim may 
specifically identify risk factors for neural tube defects. Where such 
information is provided, it may consist of statements from Sec.  
101.79(b)(1) or (b)(2) (e.g., Women at increased risk include those with 
a personal history of a neural tube defect-affected pregnancy, those 
with a close relative (i.e., sibling, niece, nephew) with a neural tube 
defect; those with insulin-dependent diabetes mellitus; those with 
seizure disorders who are being treated with valproic acid or 
carbamazepine) or from other parts of this paragraph (c)(3)(i).
    (ii) Relationship between folate and neural tube defects. The claim 
may include statements from paragraphs (a) and (b) of this section that 
summarize the relationship between folate and neural tube defects and 
the significance of the relationship except for information specifically 
prohibited from the claim.
    (iii) Personal history of a neural tube defect-affected pregnancy. 
The claim may state that women with a history of a neural tube defect 
pregnancy should consult their physicians or health care providers 
before becoming pregnant. If such a statement is provided, the claim 
shall also state that all women should consult a health care provider 
when planning a pregnancy.
    (iv) Daily value. The claim may identify 100 percent of the DV (100% 
DV; 400 mcg) for folate as the target intake goal.
    (v) Prevalence. The claim may provide estimates, expressed on an 
annual basis, of the number of neural tube defect-affected births among 
live births in the United States. Current estimates are provided in 
Sec.  101.79(b)(1), and are approximately 6 of 10,000 live births 
annually (i.e., about 2,500 cases among 4 million live births annually). 
Data provided in Sec.  101.79(b)(1) shall be used, unless more current 
estimates from the U.S. Public Health Service are available, in which 
case the latter may be cited.
    (vi) Reduction in risk. An estimate of the reduction in the number 
of neural tube defect-affected births that might occur in the United 
States if all women consumed adequate folate throughout their 
childbearing years may be included in the claim. Information contained 
in paragraph (b)(3) of this section may be used. If such an estimate 
(i.e., 50 percent) is provided, the estimate shall be accompanied by 
additional information that states that the estimate is population-based 
and that it does not reflect risk reduction that may be experienced by 
individual women.
    (vii) Diets adequate in folate. The claim may identify diets 
adequate in folate by using phrases such as ``Sources of folate include 
fruits, vegetables, whole grain products, fortified cereals, and dietary 
supplements.'' or ``Adequate amounts of folate can be obtained from 
diets rich in fruits, dark green leafy vegetables, legumes, whole grain 
products, fortified cereals, or dietary supplements.'' or ``Adequate 
amounts of folate can be obtained from diets rich in fruits, including 
citrus fruits and juices, vegetables, including dark green leafy 
vegetables, legumes, whole grain products, including breads, rice, and 
pasta, fortified cereals, or a dietary supplement.''
    (d) Model health claims. The following are examples of model health 
claims that may be used in food labeling to describe the relationship 
between folate and neural tube defects:
    (1) Examples 1 and 2. Model health claims appropriate for foods 
containing 100 percent or less of the DV for folate per serving or per 
unit (general population). The examples contain only the required 
elements:
    (i) Healthful diets with adequate folate may reduce a woman's risk 
of having a child with a brain or spinal cord birth defect.
    (ii) Adequate folate in healthful diets may reduce a woman's risk of 
having a child with a brain or spinal cord birth defect.
    (2) Example 3. Model health claim appropriate for foods containing 
100 percent or less of the DV for folate per serving or per unit. The 
example contains all required elements plus optional information: Women 
who consume healthful diets with adequate folate throughout their 
childbearing years may reduce their risk of having a child with a birth 
defect of the brain or spinal cord. Sources of folate include

[[Page 140]]

fruits, vegetables, whole grain products, fortified cereals, and dietary 
supplements.
    (3) Example 4. Model health claim appropriate for foods intended for 
use by the general population and containing more than 100 percent of 
the DV of folate per serving or per unit: Women who consume healthful 
diets with adequate folate may reduce their risk of having a child with 
birth defects of the brain or spinal cord. Folate intake should not 
exceed 250% of the DV (1,000 mcg).

[61 FR 8779, Mar. 5, 1996; 61 FR 48529, Sept. 13, 1996, as amended at 65 
FR 58918, Oct. 3, 2000]



Sec.  101.80  Health claims: dietary noncariogenic carbohydrate sweeteners and 

dental caries.

    (a) Relationship between dietary carbohydrates and dental caries. 
(1) Dental caries, or tooth decay, is a disease caused by many factors. 
Both environmental and genetic factors can affect the development of 
dental caries. Risk factors include tooth enamel crystal structure and 
mineral content, plaque quantity and quality, saliva quantity and 
quality, individual immune response, types and physical characteristics 
of foods consumed, eating behaviors, presence of acid producing oral 
bacteria, and cultural influences.
    (2) The relationship between consumption of fermentable 
carbohydrates, i.e., dietary sugars and starches, and tooth decay is 
well established. Sucrose, also known as sugar, is one of the most, but 
not the only, cariogenic sugars in the diet. Bacteria found in the mouth 
are able to metabolize most dietary carbohydrates, producing acid and 
forming dental plaque. The more frequent and longer the exposure of 
teeth to dietary sugars and starches, the greater the risk for tooth 
decay.
    (3) Dental caries continues to affect a large proportion of 
Americans. Although there has been a decline in the prevalence of dental 
caries among children in the United States, the disease remains 
widespread throughout the population, imposing a substantial burden on 
Americans. Recent Federal government dietary guidelines recommend that 
Americans choose diets that are moderate in sugars and avoid excessive 
snacking. Frequent between-meal snacks that are high in sugars and 
starches may be more harmful to teeth than eating such foods at meals 
and then brushing.
    (4) Noncariogenic carbohydrate sweeteners, such as sugar alcohols, 
can be used to replace dietary sugars, such as sucrose and corn 
sweeteners, in foods such as chewing gums and certain confectioneries. 
Noncariogenic carbohydrate sweeteners are significantly less cariogenic 
than dietary sugars and other fermentable carbohydrates.
    (b) Significance of the relationship between noncariogenic 
carbohydrate sweeteners and dental caries. Noncariogenic carbohydrate 
sweeteners do not promote dental caries. The noncariogenic carbohydrate 
sweeteners listed in paragraph (c)(2)(ii) of this section are slowly 
metabolized by bacteria to form some acid. The rate and amount of acid 
production is significantly less than that from sucrose and other 
fermentable carbohydrates and does not cause the loss of important 
minerals from tooth enamel.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met, except that noncariogenic carbohydrate sweetener-
containing foods listed in paragraph (c)(2)(ii) of this section are 
exempt from Sec.  101.14(e)(6).
    (2) Specific requirements--(i) Nature of the claim. A health claim 
relating noncariogenic carbohydrate sweeteners, compared to other 
carbohydrates, and the nonpromotion of dental caries may be made on the 
label or labeling of a food described in paragraph (c)(2)(iii) of this 
section, provided that:
    (A) The claim shall state that frequent between-meal consumption of 
foods high in sugars and starches can promote tooth decay.
    (B) The claim shall state that the noncariogenic carbohydrate 
sweetener present in the food ``does not promote,'' ``may reduce the 
risk of,'' ``useful [or is useful] in not promoting,'' or ``expressly 
[or is expressly] for not promoting'' dental caries.
    (C) In specifying the nutrient, the claim shall state ``sugar 
alcohol,'' ``sugar alcohols,'' or the name or

[[Page 141]]

names of the substances listed in paragraph (c)(2)(ii) of this section, 
e.g., ``sorbitol.'' D-tagatose may be identified as ``tagatose.''
    (D) In specifying the disease, the claim uses the following terms: 
``dental caries'' or ``tooth decay.''
    (E) The claim shall not attribute any degree of the reduction in 
risk of dental caries to the use of the noncariogenic carbohydrate 
sweetener-containing food.
    (F) The claim shall not imply that consuming noncariogenic 
carbohydrate sweetener-containing foods is the only recognized means of 
achieving a reduced risk of dental caries.
    (G) Packages with less than 15 square inches of surface area 
available for labeling are exempt from paragraphs (A) and (C) of this 
section.
    (H) When the substance that is the subject of the claim is a 
noncariogenic sugar, the claim shall identify the substance as a sugar 
that, unlike other sugars, does not promote the development of dental 
caries.
    (ii) Nature of the substance. Eligible noncariogenic carbohydrate 
sweeteners are:
    (A) The sugar alcohols xylitol, sorbitol, mannitol, maltitol, 
isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated 
glucose syrups, and erythritol, or a combination of these.
    (B) The sugars D-tagatose and isomaltulose.
    (C) Sucralose.
    (iii) Nature of the food. (A) The food shall meet the requirement in 
Sec.  101.60(c)(1)(i) with respect to sugars content, except that the 
food may contain D-tagatose or isomaltulose.
    (B) A food whose labeling includes a health claim under this section 
shall contain one or more of the noncariogenic carbohydrate sweeteners 
listed in paragraph (c)(2)(ii) of this section.
    (C) When carbohydrates other than those listed in paragraph 
(c)(2)(ii) of this section are present in the food, the food shall not 
lower plaque pH below 5.7 by bacterial fermentation either during 
consumption or up to 30 minutes after consumption, as measured by the 
indwelling plaque pH test found in ``Identification of Low Caries Risk 
Dietary Components,'' dated 1983, by T. N. Imfeld, in Volume 11, 
Monographs in Oral Science, 1983. The Director of the Office of the 
Federal Register has approved the incorporation by reference of this 
material in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may 
obtain copies from Karger AG Publishing Co., P.O. Box, Ch-4009 Basel, 
Switzerland, or you may examine a copy at the Center for Food Safety and 
Applied Nutrition's Library, Harvey W. Wiley Federal Building, 5100 
Paint Branch Pkwy., College Park, MD, or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
    (d) Optional information. (1) The claim may include information from 
paragraphs (a) and (b) of this section, which describe the relationship 
between diets containing noncariogenic carbohydrate sweeteners and 
dental caries.
    (2) The claim may indicate that development of dental caries depends 
on many factors and may identify one or more of the following risk 
factors for dental caries: Frequent consumption of fermentable 
carbohydrates, such as dietary sugars and starches; presence of oral 
bacteria capable of fermenting carbohydrates; length of time fermentable 
carbohydrates are in contact with the teeth; lack of exposure to 
fluoride; individual susceptibility; socioeconomic and cultural factors; 
and characteristics of tooth enamel, saliva, and plaque.
    (3) The claim may indicate that oral hygiene and proper dental care 
may help to reduce the risk of dental disease.
    (4) The claim may indicate that a substance listed in paragraph 
(c)(2)(ii) of this section serves as a sweetener.
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between noncariogenic 
carbohydrate sweetener-containing foods and dental caries.
    (1) Examples of the full claim:
    (i) Frequent eating of foods high in sugars and starches as between-
meal

[[Page 142]]

snacks can promote tooth decay. The sugar alcohol [name, optional] used 
to sweeten this food may reduce the risk of dental caries.
    (ii) Frequent between-meal consumption of foods high in sugars and 
starches promotes tooth decay. The sugar alcohols in [name of food] do 
not promote tooth decay.
    (iii) Frequent eating of foods high in sugars and starches as 
between-meal snacks can promote tooth decay. [Name of sugar from 
paragraph (c)(2)(ii)(B) of this section], the sugar used to sweeten this 
food, unlike other sugars, may reduce the risk of dental caries.
    (iv) Frequent between-meal consumption of foods high in sugars and 
starches promotes tooth decay. [Name of sugar from paragraph 
(c)(2)(ii)(B) of this section], the sugar in [name of food], unlike 
other sugars, does not promote tooth decay.
    (v) Frequent eating of foods high in sugars and starches as between-
meal snacks can promote tooth decay. Sucralose, the sweetening 
ingredient used to sweeten this food, unlike sugars, does not promote 
tooth decay.
    (2) Example of the shortened claim for small packages:
    (i) Does not promote tooth decay.
    (ii) May reduce the risk of tooth decay.
    (iii) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] 
sugar does not promote tooth decay.
    (iv) [Name of sugar from paragraph (c)(2)(ii)(B) of this section] 
sugar may reduce the risk of tooth decay.

[61 FR 43446, Aug. 23, 1996, as amended at 62 FR 63655, Dec. 2, 1997; 66 
FR 66742, Dec. 27, 2001; 67 FR 71470, Dec. 2, 2002; 71 FR 15563, Mar. 
29, 2006; 72 FR 52789, Sept. 17, 2007]



Sec.  101.81  Health claims: Soluble fiber from certain foods and risk of 

coronary heart disease (CHD).

    (a) Relationship between diets that are low in saturated fat and 
cholesterol and that include soluble fiber from certain foods and the 
risk of CHD. (1) Cardiovascular disease means diseases of the heart and 
circulatory system. Coronary heart disease (CHD) is one of the most 
common and serious forms of cardiovascular disease and refers to 
diseases of the heart muscle and supporting blood vessels. High blood 
total cholesterol and low density lipoprotein (LDL)-cholesterol levels 
are associated with increased risk of developing coronary heart disease. 
High CHD rates occur among people with high total cholesterol levels of 
240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-
cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high 
risk total cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 
mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. 
The scientific evidence establishes that diets high in saturated fat and 
cholesterol are associated with increased levels of blood total- and 
LDL-cholesterol and, thus, with increased risk of CHD.
    (2) Populations with a low incidence of CHD tend to have relatively 
low blood total cholesterol and LDL-cholesterol levels. These 
populations also tend to have dietary patterns that are not only low in 
total fat, especially saturated fat and cholesterol, but are also 
relatively high in fiber-containing fruits, vegetables, and grain 
products, such as whole oat products.
    (3) Scientific evidence demonstrates that diets low in saturated fat 
and cholesterol may reduce the risk of CHD. Other evidence demonstrates 
that the addition of soluble fiber from certain foods to a diet that is 
low in saturated fat and cholesterol may also help to reduce the risk of 
CHD.
    (b) Significance of the relationship between diets that are low in 
saturated fat and cholesterol and that include soluble fiber from 
certain foods and the risk of CHD. (1) CHD is a major public health 
concern in the United States. It accounts for more deaths than any other 
disease or group of diseases. Early management of risk factors for CHD 
is a major public health goal that can assist in reducing risk of CHD. 
High blood total and LDL-cholesterol are major modifiable risk factors 
in the development of CHD.
    (2) Intakes of saturated fat exceed recommended levels in the diets 
of many people in the United States. One of the major public health 
recommendations relative to CHD risk is to consume less than 10 percent 
of calories from saturated fat and an average of 30 percent or less of 
total calories

[[Page 143]]

from all fat. Recommended daily cholesterol intakes are 300 milligrams 
(mg) or less per day. Scientific evidence demonstrates that diets low in 
saturated fat and cholesterol are associated with lower blood total- and 
LDL-cholesterol levels. Soluble fiber from certain foods, when included 
in a low saturated fat and cholesterol diet, also helps to lower blood 
total- and LDL-cholesterol levels.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met. The label and labeling of foods containing psyllium husk 
shall be consistent with the provisions of Sec.  101.17(f).
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets that are low in saturated fat and cholesterol and that 
include soluble fiber from certain foods with reduced risk of heart 
disease may be made on the label or labeling of a food described in 
paragraph (c)(2)(iii) of this section, provided that:
    (A) The claim states that diets that are low in saturated fat and 
cholesterol and that include soluble fiber from certain foods ``may'' or 
``might'' reduce the risk of heart disease.
    (B) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease'';
    (C) In specifying the substance, the claim uses the term ``soluble 
fiber'' qualified by the name of the eligible source of soluble fiber 
(provided in paragraph (c)(2)(ii)) of this section. Additionally, the 
claim may use the name of the food product that contains the eligible 
source of soluble fiber;
    (D) In specifying the fat component, the claim uses the terms 
``saturated fat'' and ``cholesterol'';
    (E) The claim does not attribute any degree of risk reduction for 
CHD to diets that are low in saturated fat and cholesterol and that 
include soluble fiber from the eligible food sources from paragraph 
(c)(2)(ii) of this section; and
    (F) The claim does not imply that consumption of diets that are low 
in saturated fat and cholesterol and that include soluble fiber from the 
eligible food sources from paragraph (c)(2)(ii) of this section is the 
only recognized means of achieving a reduced risk of CHD.
    (G) The claim specifies the daily dietary intake of the soluble 
fiber source that is necessary to reduce the risk of coronary heart 
disease and the contribution one serving of the product makes to the 
specified daily dietary intake level. Daily dietary intake levels of 
soluble fiber sources listed in paragraph (c)(2)(ii) of this section 
that have been associated with reduced risk coronary heart disease are:
    (1) 3 g or more per day of [beta]-glucan soluble fiber from either 
whole oats or barley, or a combination of whole oats and barley.
    (2) 7 g or more per day of soluble fiber from psyllium seed husk.
    (ii) Nature of the substance--Eligible sources of soluble fiber. (A) 
Beta ([beta]) glucan soluble fiber from the whole oat and barley sources 
listed below. [beta]-glucan soluble fiber will be determined by method 
No. 992.28 from the ``Official Methods of Analysis of the AOAC 
INTERNATIONAL,'' 16th ed. (1995), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be 
obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College 
Park, MD 20740, or at the National Archives and Records Administration 
(NARA). For information on the availability of this material at NARA, 
call 202-741-6030, or go to: http://www.archives.gov/federal--register/
code--of--federal--regulations/ibr--locations.html;
    (1) Oat bran. Oat bran is produced by grinding clean oat groats or 
rolled oats and separating the resulting oat flour by suitable means 
into fractions such that the oat bran fraction is not more than 50 
percent of the original starting material and provides at least 5.5 
percent (dry weight basis (dwb)) [beta]-glucan soluble fiber and a total 
dietary fiber content of 16 percent (dwb), and such that at least one-
third of the total dietary fiber is soluble fiber;
    (2) Rolled oats. Rolled oats, also known as oatmeal, produced from 
100 percent dehulled, clean oat groats by steaming, cutting, rolling, 
and flaking, and provides at least 4 percent (dwb) of

[[Page 144]]

[beta]-glucan soluble fiber and a total dietary fiber content of at 
least 10 percent.
    (3) Whole oat flour. Whole oat flour is produced from 100 percent 
dehulled, clean oat groats by steaming and grinding, such that there is 
no significant loss of oat bran in the final product, and provides at 
least 4 percent (dwb) of [beta]-glucan soluble fiber and a total dietary 
fiber content of at least 10 percent (dwb).
    (4) Oatrim. The soluble fraction of alpha-amylase hydrolyzed oat 
bran or whole oat flour, also known as oatrim. Oatrim is produced from 
either oat bran as defined in paragraph (c)(2)(ii)(A)(1) of this section 
or whole oat flour as defined in paragraph (c)(2)(ii)(A)(3) of this 
section by solubilization of the starch in the starting material with an 
alpha-amylase hydrolysis process, and then removal by centrifugation of 
the insoluble components consisting of a high portion of protein, lipid, 
insoluble dietary fiber, and the majority of the flavor and color 
components of the starting material. Oatrim shall have a beta-glucan 
soluble fiber content up to 10 percent (dwb) and not less than that of 
the starting material (dwb).
    (5) Whole grain barley and dry milled barley. Dehulled and hull-less 
whole grain barley with a [beta]-glucan soluble fiber content of at 
least 4 percent (dwb) and a total dietary fiber content of at least 10 
percent (dwb). Dry milled barley grain products include barley bran, 
barley flakes, barley grits, pearl barley, barley flour, barley meal, 
and sieved barley meal that are produced from clean, sound dehulled or 
hull-less barley grain using standard dry milling techniques, which may 
include steaming or tempering, and that contain at least 4 percent (dwb) 
of [beta]-glucan soluble fiber and at least 8 percent (dwb) of total 
dietary fiber, except barley bran and sieved barley meal for which the 
minimum [beta]-glucan soluble fiber content is 5.5 percent (dwb) and 
minimum total dietary fiber content is 15 percent (dwb). Dehulled 
barley, hull-less barley, barley bran, barley flakes, barley grits, 
pearl barley, and barley flour are as defined in the Barley Glossary 
(AACC Method 55-99), published in Approved Methods of the American 
Association of Cereal Chemists, 10th ed. (2000), pp. 1 and 2, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the American Association of Cereal 
Chemists, Inc., 3340 Pilot Knob Rd., St. Paul, Minnesota, 55121, or may 
be examined at the Center for Food Safety and Applied Nutrition Library, 
5100 Paint Branch Pkwy., College Park, MD 20740, or at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html. Barley meal is unsifted, ground barley 
grain not subjected to any processing to separate the bran, germ, and 
endosperm. Sieved barley meal is an endosperm cell wall-enriched 
fraction of ground barley separated from meal by sieving or by air 
classification.
    (6) Barley betafiber. Barley betafiber is the ethanol precipitated 
soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain 
barley. Barley betafiber is produced by hydrolysis of whole grain barley 
flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section, with a 
cellulase and alpha-amylase enzyme preparation, to produce a clear 
aqueous extract that contains mainly partially hydrolyzed beta-glucan 
and substantially hydrolyzed starch. The soluble, partially hydrolyzed 
beta-glucan is separated from the insoluble material by centrifugation, 
and after removal of the insoluble material, the partially hydrolyzed 
beta-glucan soluble fiber is separated from the other soluble compounds 
by precipitation with ethanol. The product is then dried, milled and 
sifted. Barley betafiber shall have a beta-glucan soluble fiber content 
of at least 70 percent on a dry weight basis.
    (B)(1) Psyllium husk from the dried seed coat (epidermis) of the 
seed of Plantago (P.) ovata, known as blond psyllium or Indian psyllium, 
P. indica, or P. psyllium. To qualify for this claim, psyllium seed 
husk, also known as psyllium husk, shall have a purity of no less than 
95 percent, such that it contains 3 percent or less protein, 4.5

[[Page 145]]

percent or less of light extraneous matter, and 0.5 percent or less of 
heavy extraneous matter, but in no case may the combined extraneous 
matter exceed 4.9 percent, as determined by U.S. Pharmacopeia (USP) 
methods described in USP's ``The National Formulary,'' USP 23, NF 18, p. 
1341, (1995), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the U.S. 
Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 
20852, or may be examined at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html;
    (2) FDA will determine the amount of soluble fiber that is provided 
by psyllium husk by using a modification of the Association of Official 
Analytical Chemists' International (AOAC's) method for soluble dietary 
fiber (991.43) described by Lee et al., ``Determination of Soluble and 
Insoluble Dietary Fiber in Psyllium-containing Cereal Products,'' 
Journal of the AOAC International, 78 (No. 3):724-729, 1995, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at 
the Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740 or at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html;
    (iii) Nature of the food eligible to bear the claim. (A) The food 
product shall include:
    (1) One or more of the whole oat or barley foods from paragraphs 
(c)(2)(ii)(A)(1), (2), (3), and (5) of this section, and the whole oat 
or barley foods shall contain at least 0.75 gram (g) of soluble fiber 
per reference amount customarily consumed of the food product; or
    (2) The food containing the oatrim from paragraph (c)(2)(ii)(A)(4) 
of this section or the barley betafiber from paragraph (c)(2)(ii)(A)(6) 
of this section shall contain at least 0.75 g of beta-glucan soluble 
fiber per reference amount customarily consumed of the food product; or
    (3) Psyllium husk that complies with paragraph (c)(2)(ii)(B) of this 
section, and the psyllium food shall contain at least 1.7 g of soluble 
fiber per reference amount customarily consumed of the food product;
    (B) The amount of soluble fiber shall be declared in the nutrition 
label, consistent with Sec.  101.9(c)(6)(i)(A).
    (C) The food shall meet the nutrient content requirement in Sec.  
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
    (D) The food shall meet the nutrient content requirement in Sec.  
101.62(b)(2) for a ``low fat'' food, unless the food exceeds this 
requirement due to fat content derived from whole oat sources listed in 
paragraph (c)(2)(ii)(A) of this section.
    (d) Optional information. (1) The claim may state that the 
development of heart disease depends on many factors and may identify 
one or more of the following risk factors for heart disease about which 
there is general scientific agreement: A family history of CHD; elevated 
blood total and LDL-cholesterol; excess body weight; high blood 
pressure; cigarette smoking; diabetes; and physical inactivity. The 
claim may also provide additional information about the benefits of 
exercise and management of body weight to help lower the risk of heart 
disease;
    (2) The claim may state that the relationship between intake of 
diets that are low in saturated fat and cholesterol and that include 
soluble fiber from the eligible food sources from paragraph (c)(2)(ii) 
of this section and reduced risk of heart disease is through the 
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol;''
    (3) The claim may include information from paragraphs (a) and (b) of 
this

[[Page 146]]

section, which summarize the relationship between diets that are low in 
saturated fat and cholesterol and that include soluble fiber from 
certain foods and coronary heart disease and the significance of the 
relationship;
    (4) The claim may specify the name of the eligible soluble fiber;
    (5) The claim may state that a diet low in saturated fat and 
cholesterol that includes soluble fiber from whole oats or barley is 
consistent with ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Agriculture (USDA) and Department of 
Health and Human Services (DHHS), Government Printing Office (GPO);
    (6) The claim may state that individuals with elevated blood total- 
and LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total- and LDL-
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment;
    (7) The claim may include information on the number of people in the 
United States who have heart disease. The sources of this information 
shall be identified, and it shall be current information from the 
National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' USDA and DHHS, GPO.
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between diets that 
are low in saturated fat and cholesterol and that include soluble fiber 
from certain foods and reduced risk of heart disease:
    (1) Soluble fiber from foods such as [name of soluble fiber source 
from paragraph (c)(2)(ii) of this section and, if desired, the name of 
food product], as part of a diet low in saturated fat and cholesterol, 
may reduce the risk of heart disease. A serving of [ name of food] 
supplies -------- grams of the [grams of soluble fiber specified in 
paragraph (c)(2)(i)(G) of this section] soluble fiber from [name of the 
soluble fiber source from paragraph (c)(2)(ii) of this section] 
necessary per day to have this effect.
    (2) Diets low in saturated fat and cholesterol that include [------
-- grams of soluble fiber specified in paragraph (c)(2)(i)(G) of this 
section] of soluble fiber per day from [name of soluble fiber source 
from paragraph (c)(2)(ii) of this section and, if desired, the name of 
the food product] may reduce the risk of heart disease. One serving of 
[name of food] provides -------- grams of this soluble fiber.

[62 FR 3600, Jan. 23, 1997, as amended at 62 FR 15344, Mar. 31, 1997; 63 
FR 8119, Feb. 18, 1998; 66 FR 66742, Dec. 27, 2001; 67 FR 61782, Oct. 2, 
2002; 68 FR 15355, Mar. 31, 2003; 70 FR 40880, July 15, 2005; 70 FR 
76162, Dec. 23, 2005; 73 FR 9947, Feb. 25, 2008; 73 FR 23953, May 1, 
2008]



Sec.  101.82  Health claims: Soy protein and risk of coronary heart disease 

(CHD).

    (a) Relationship between diets that are low in saturated fat and 
cholesterol and that include soy protein and the risk of CHD. (1) 
Cardiovascular disease means diseases of the heart and circulatory 
system. CHD is one of the most common and serious forms of 
cardiovascular disease and refers to diseases of the heart muscle and 
supporting blood vessels. High blood total cholesterol and low density 
lipoprotein (LDL)-cholesterol levels are associated with increased risk 
of developing CHD. High CHD rates occur among people with high total 
cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 
millimole per liter (mmol/L)) or above and LDL-cholesterol levels of 160 
mg/dL (4.13 mmol/L) or above. Borderline high risk total cholesterol 
levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 
mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence 
establishes that diets high in saturated fat and cholesterol are 
associated with increased levels of blood total and LDL-cholesterol and, 
thus, with increased risk of CHD.
    (2) Populations with a low incidence of CHD tend to have relatively 
low blood total cholesterol and LDL-cholesterol levels. These 
populations also tend to have dietary patterns that are not only low in 
total fat, especially saturated fat and cholesterol, but are also 
relatively high in plant foods that contain dietary fiber and other 
components.

[[Page 147]]

    (3) Scientific evidence demonstrates that diets low in saturated fat 
and cholesterol may reduce the risk of CHD. Other evidence demonstrates 
that the addition of soy protein to a diet that is low in saturated fat 
and cholesterol may also help to reduce the risk of CHD.
    (b) Significance of the relationship between diets that are low in 
saturated fat and cholesterol and that include soy protein and the risk 
of CHD. (1) CHD is a major public health concern in the United States. 
It accounts for more deaths than any other disease or group of diseases. 
Early management of risk factors for CHD is a major public health goal 
that can assist in reducing risk of CHD. High blood total and LDL-
cholesterol are major modifiable risk factors in the development of CHD.
    (2) Intakes of saturated fat exceed recommended levels in the diets 
of many people in the United States. One of the major public health 
recommendations relative to CHD risk is to consume less than 10 percent 
of calories from saturated fat and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 mg or less per day. Scientific evidence demonstrates that diets low 
in saturated fat and cholesterol are associated with lower blood total 
and LDL-cholesterol levels. Soy protein, when included in a low 
saturated fat and cholesterol diet, also helps to lower blood total and 
LDL-cholesterol levels.
    (c) Requirements. (1) All requirements set forth in Sec.  101.14 
shall be met.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets that are low in saturated fat and cholesterol and that 
include soy protein with reduced risk of heart disease may be made on 
the label or labeling of a food described in paragraph (c)(2)(iii) of 
this section, provided that:
    (A) The claim states that diets that are low in saturated fat and 
cholesterol and that include soy protein ``may'' or ``might'' reduce the 
risk of heart disease;
    (B) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease'';
    (C) In specifying the substance, the claim uses the term ``soy 
protein'';
    (D) In specifying the fat component, the claim uses the terms 
``saturated fat'' and ``cholesterol'';
    (E) The claim does not attribute any degree of risk reduction for 
CHD to diets that are low in saturated fat and cholesterol and that 
include soy protein;
    (F) The claim does not imply that consumption of diets that are low 
in saturated fat and cholesterol and that include soy protein is the 
only recognized means of achieving a reduced risk of CHD; and
    (G) The claim specifies the daily dietary intake of soy protein that 
is necessary to reduce the risk of coronary heart disease and the 
contribution one serving of the product makes to the specified daily 
dietary intake level. The daily dietary intake level of soy protein that 
has been associated with reduced risk of coronary heart disease is 25 
grams (g) or more per day of soy protein.
    (ii) Nature of the substance. (A) Soy protein from the legume seed 
Glycine max.
    (B) FDA will assess qualifying levels of soy protein in the 
following fashion: FDA will measure total protein content by the 
appropriate method of analysis given in the ``Official Methods of 
Analysis of the AOAC International,'' as described at Sec.  101.9(c)(7). 
For products that contain no sources of protein other than soy, FDA will 
consider the amount of soy protein as equivalent to the total protein 
content. For products that contain a source or sources of protein in 
addition to soy, FDA will, using the measurement of total protein 
content, calculate the soy protein content based on the ratio of soy 
protein ingredients to total protein ingredients in the product. FDA 
will base its calculation on information identified and supplied by 
manufacturers, such as nutrient data bases or analyses, recipes or 
formulations, purchase orders for ingredients, or any other information 
that reasonably substantiates the ratio of soy protein to total protein. 
Manufacturers must maintain records sufficient to substantiate the claim 
for as long as the products are marketed and provide these records, on 
written request, to appropriate regulatory officials.

[[Page 148]]

    (iii) Nature of the food eligible to bear the claim. (A) The food 
product shall contain at least 6.25 g of soy protein per reference 
amount customarily consumed of the food product;
    (B) The food shall meet the nutrient content requirements in Sec.  
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
    (C) The food shall meet the nutrient content requirement in Sec.  
101.62 for a ``low fat'' food, unless it consists of or is derived from 
whole soybeans and contains no fat in addition to the fat inherently 
present in the whole soybeans it contains or from which it is derived.
    (d) Optional information. (1) The claim may state that the 
development of heart disease depends on many factors and may identify 
one or more of the following risk factors for heart disease about which 
there is general scientific agreement: A family history of CHD; elevated 
blood total and LDL-cholesterol; excess body weight; high blood 
pressure; cigarette smoking; diabetes; and physical inactivity. The 
claim may also provide additional information about the benefits of 
exercise and management of body weight to help lower the risk of heart 
disease;
    (2) The claim may state that the relationship between intake of 
diets that are low in saturated fat and cholesterol and that include soy 
protein and reduced risk of heart disease is through the intermediate 
link of ``blood cholesterol'' or ``blood total and LDL-cholesterol'';
    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between diets that are 
low in saturated fat and cholesterol and that include soy protein and 
CHD and the significance of the relationship;
    (4) The claim may state that a diet low in saturated fat and 
cholesterol that includes soy protein is consistent with ``Nutrition and 
Your Health: Dietary Guidelines for Americans,'' U.S. Department of 
Agriculture (USDA) and Department of Health and Human Services (DHHS), 
Government Printing Office (GPO);
    (5) The claim may state that individuals with elevated blood total 
and LDL-cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total and LDL-
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment;
    (6) The claim may include information on the number of people in the 
United States who have heart disease. The sources of this information 
shall be identified, and it shall be current information from the 
National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' USDA and DHHS, GPO;
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between diets that 
are low in saturated fat and cholesterol and that include soy protein 
and reduced risk of heart disease:
    (1) 25 grams of soy protein a day, as part of a diet low in 
saturated fat and cholesterol, may reduce the risk of heart disease. A 
serving of [name of food] supplies ---- grams of soy protein.
    (2) Diets low in saturated fat and cholesterol that include 25 grams 
of soy protein a day may reduce the risk of heart disease. One serving 
of [name of food] provides ---- grams of soy protein.

[64 FR 57732, Oct. 26, 1999]

    Effective Date Note: At 64 FR 57732, Oct. 26, 1999, Sec.  101.82 was 
added. Paragraph (c)(2)(ii)(B) contains information collection and 
recordkeeping requirements and will not become effective until approval 
has been given by the Office of Management and Budget.



Sec.  101.83  Health claims: plant sterol/stanol esters and risk of coronary 

heart disease (CHD).

    (a) Relationship between diets that include plant sterol/stanol 
esters and the risk of CHD. (1) Cardiovascular disease means diseases of 
the heart and circulatory system. Coronary heart disease (CHD) is one of 
the most common and serious forms of cardiovascular disease and refers 
to diseases of the heart muscle and supporting blood vessels. High blood 
total cholesterol and low density lipoprotein (LDL) cholesterol

[[Page 149]]

levels are associated with increased risk of developing coronary heart 
disease. High CHD rates occur among people with high total cholesterol 
levels of 240 milligrams per deciliter (mg/dL) (6.21 millimole per liter 
(mmol/l)) or above and LDL cholesterol levels of 160 mg/dL ( 4.13 mmol/
l) or above. Borderline high risk blood cholesterol levels range from 
200 to 239 mg/dL (5.17 to 6.18 mmol/l) for total cholesterol, and 130 to 
159 mg/dL (3.36 to 4.11 mmol/l) of LDL cholesterol.
    (2) Populations with a low incidence of CHD tend to have relatively 
low blood total cholesterol and LDL cholesterol levels. These 
populations also tend to have dietary patterns that are not only low in 
total fat, especially saturated fat and cholesterol, but are also 
relatively high in plant foods that contain dietary fiber and other 
components.
    (3) Scientific evidence demonstrates that diets that include plant 
sterol/stanol esters may reduce the risk of CHD.
    (b) Significance of the relationship between diets that include 
plant sterol/stanol esters and the risk of CHD. (1) CHD is a major 
public health concern in the United States. It accounts for more deaths 
than any other disease or group of diseases. Early management of risk 
factors for CHD is a major public health goal that can assist in 
reducing risk of CHD. High blood total and LDL cholesterol are major 
modifiable risk factors in the development of CHD.
    (2) The scientific evidence establishes that including plant sterol/
stanol esters in the diet helps to lower blood total and LDL cholesterol 
levels.
    (c) Requirements--(1) General. All requirements set forth in Sec.  
101.14 shall be met, except Sec.  101.14(a)(4) with respect to the 
disqualifying level for total fat per 50 grams (g) in dressings for 
salad and spreads and Sec.  101.14(e)(6) with respect to dressings for 
salad.
    (2) Specific requirements--(i) Nature of the claim. A health claim 
associating diets that include plant sterol/stanol esters with reduced 
risk of heart disease may be made on the label or labeling of a food 
described in paragraph (c)(2)(iii) of this section, provided that:
    (A) The claim states that plant sterol/stanol esters should be 
consumed as part of a diet low in saturated fat and cholesterol;
    (B) The claim states that diets that include plant sterol/stanol 
esters ``may'' or ``might'' reduce the risk of heart disease;
    (C) In specifying the disease, the claim uses the following terms: 
``heart disease'' or ``coronary heart disease'';
    (D) In specifying the substance, the claim uses the term ``plant 
sterol esters'' or ``plant stanol esters,'' except that if the sole 
source of the plant sterols or stanols is vegetable oil, the claim may 
use the term ``vegetable oil sterol esters'' or ``vegetable oil stanol 
esters'';
    (E) The claim does not attribute any degree of risk reduction for 
CHD to diets that include plant sterol/stanol esters;
    (F) The claim does not imply that consumption of diets that include 
plant sterol/stanol esters is the only recognized means of achieving a 
reduced risk of CHD; and
    (G) The claim specifies the daily dietary intake of plant sterol or 
stanol esters that is necessary to reduce the risk of CHD and the 
contribution one serving of the product makes to the specified daily 
dietary intake level. Daily dietary intake levels of plant sterol and 
stanol esters that have been associated with reduced risk of are:
    (1) 1.3 g or more per day of plant sterol esters.
    (2) 3.4 g or more per day of plant stanol esters.
    (H) The claim specifies that the daily dietary intake of plant 
sterol or stanol esters should be consumed in two servings eaten at 
different times of the day with other foods.
    (ii) Nature of the substance--(A) Plant sterol esters. (1) Plant 
sterol esters prepared by esterifying a mixture of plant sterols from 
edible oils with food-grade fatty acids. The plant sterol mixture shall 
contain at least 80 percent beta-sitosterol, campesterol, and 
stigmasterol (combined weight).
    (2) FDA will measure plant sterol esters by the method entitled 
``Determination of the Sterol Content in Margarines, Halvarines, 
Dressings, Fat Blends and Sterol Fatty Acid Ester

[[Page 150]]

Concentrates by Capillary Gas Chromatography,'' developed by Unilever 
United States, Inc., dated February 1, 2000. The method, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, may be obtained from the Center for Food Safety and Applied 
Nutrition, Office of Nutritional Products, Labeling, and Dietary 
Supplements, Division of Nutrition Science and Policy, 5100 Paint Branch 
Pkwy., College Park, MD 20740, and may be examined at the Center for 
Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (B) Plant stanol esters. (1) Plant stanol esters prepared by 
esterifying a mixture of plant stanols derived from edible oils or 
byproducts of the kraft paper pulping process with food-grade fatty 
acids. The plant stanol mixture shall contain at least 80 percent 
sitostanol and campestanol (combined weight).
    (2) FDA will measure plant stanol esters by the following methods 
developed by McNeil Consumer Heathcare dated February 15, 2000: 
``Determination of Stanols and Sterols in Benecol Tub Spread''; 
``Determination of Stanols and Sterols in Benecol Dressing''; 
``Determination of Stanols and Sterols in Benecol Snack Bars''; or 
``Determination of Stanols and Sterols in Benecol Softgels.'' These 
methods are incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51. Copies may be obtained from the Center for Food 
Safety and Applied Nutrition, Office of Nutritional Products, Labeling, 
and Dietary Supplements, Division of Nutrition Science and Policy, 5100 
Paint Branch Pkwy., College Park, MD 20740, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, 5100 Paint 
Branch Pkwy., College Park, MD 20740, and at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://
www.archives.gov/federal--register/code--of--federal--regulations/ibr--
locations.html.
    (iii) Nature of the food eligible to bear the claim. (A) The food 
product shall contain:
    (1) At least 0.65 g of plant sterol esters that comply with 
paragraph (c)(2)(ii)(A)(1) of this section per reference amount 
customarily consumed of the food products eligible to bear the health 
claim, specifically spreads and dressings for salad, or
    (2) At least 1.7 g of plant stanol esters that comply with paragraph 
(c)(2)(ii)(B)(1) of this section per reference amount customarily 
consumed of the food products eligible to bear the health claim, 
specifically spreads, dressings for salad, snack bars, and dietary 
supplements in softgel form.
    (B) The food shall meet the nutrient content requirements in Sec.  
101.62 for a ``low saturated fat'' and ``low cholesterol'' food; and
    (C) The food must meet the limit for total fat in Sec.  
101.14(a)(4), except that spreads and dressings for salad are not 
required to meet the limit for total fat per 50 g if the label of the 
food bears a disclosure statement that complies with Sec.  101.13(h); 
and
    (D) The food must meet the minimum nutrient contribution requirement 
in Sec.  101.14(e)(6) unless it is a dressing for salad.
    (d) Optional information. (1) The claim may state that the 
development of heart disease depends on many factors and may identify 
one or more of the following risk factors for heart disease about which 
there is general scientific agreement: A family history of CHD; elevated 
blood total and LDL cholesterol; excess body weight; high blood 
pressure; cigarette smoking; diabetes; and physical inactivity. The 
claim may also provide additional information about the benefits of 
exercise and management of body weight to help lower the risk of heart 
disease.
    (2) The claim may state that the relationship between intake of 
diets that include plant sterol/stanol esters and reduced risk of heart 
disease is through the intermediate link of ``blood cholesterol'' or 
``blood total and LDL cholesterol.''

[[Page 151]]

    (3) The claim may include information from paragraphs (a) and (b) of 
this section, which summarize the relationship between diets that 
include plant sterol/stanol esters and the risk of CHD and the 
significance of the relationship.
    (4) The claim may include information from the following paragraph 
on the relationship between saturated fat and cholesterol in the diet 
and the risk of CHD: The scientific evidence establishes that diets high 
in saturated fat and cholesterol are associated with increased levels of 
blood total and LDL cholesterol and, thus, with increased risk of CHD. 
Intakes of saturated fat exceed recommended levels in the diets of many 
people in the United States. One of the major public health 
recommendations relative to CHD risk is to consume less than 10 percent 
of calories from saturated fat and an average of 30 percent or less of 
total calories from all fat. Recommended daily cholesterol intakes are 
300 mg or less per day. Scientific evidence demonstrates that diets low 
in saturated fat and cholesterol are associated with lower blood total 
and LDL cholesterol levels.
    (5) The claim may state that diets that include plant sterol or 
stanol esters and are low in saturated fat and cholesterol are 
consistent with ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Agriculture (USDA) and Department of 
Health and Human Services (DHHS), Government Printing Office (GPO).
    (6) The claim may state that individuals with elevated blood total 
and LDL cholesterol should consult their physicians for medical advice 
and treatment. If the claim defines high or normal blood total and LDL 
cholesterol levels, then the claim shall state that individuals with 
high blood cholesterol should consult their physicians for medical 
advice and treatment.
    (7) The claim may include information on the number of people in the 
United States who have heart disease. The sources of this information 
shall be identified, and it shall be current information from the 
National Center for Health Statistics, the National Institutes of 
Health, or ``Nutrition and Your Health: Dietary Guidelines for 
Americans,'' U.S. Department of Agriculture (USDA) and Department of 
Health and Human Services (DHHS), Government Printing Office (GPO).
    (e) Model health claim. The following model health claims may be 
used in food labeling to describe the relationship between diets that 
include plant sterol or stanol esters and reduced risk of heart disease:
    (1) For plant sterol esters: (i) Foods containing at least 0.65 g 
per serving of plant sterol esters, eaten twice a day with meals for a 
daily total intake of at least 1.3 g, as part of a diet low in saturated 
fat and cholesterol, may reduce the risk of heart disease. A serving of 
[name of the food] supplies ------grams of vegetable oil sterol esters.
    (ii) Diets low in saturated fat and cholesterol that include two 
servings of foods that provide a daily total of at least 1.3 g of 
vegetable oil sterol esters in two meals may reduce the risk of heart 
disease. A serving of [name of the food] supplies ------grams of 
vegetable oil sterol esters.
    (2) For plant stanol esters: (i) Foods containing at least 1.7 g per 
serving of plant stanol esters, eaten twice a day with meals for a total 
daily intake of at least 3.4 g, as part of a diet low in saturated fat 
and cholesterol, may reduce the risk of heart disease. A serving of 
[name of the food] supplies ------grams of plant stanol esters.
    (ii) Diets low in saturated fat and cholesterol that include two 
servings of foods that provide a daily total of at least 3.4 g of 
vegetable oil stanol esters in two meals may reduce the risk of heart 
disease. A serving of [name of the food] supplies ------grams of 
vegetable oil stanol esters.

[65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov. 24, 2000, as amended at 
66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958, 
July 21, 2005]

[[Page 152]]



Subpart F_Specific Requirements for Descriptive Claims That Are Neither 
                Nutrient Content Claims nor Health Claims



Sec.  101.93  Certain types of statements for dietary supplements.

    (a)(1) No later than 30 days after the first marketing of a dietary 
supplement that bears one of the statements listed in section 403(r)(6) 
or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, 
or distributor of the dietary supplement shall notify the Office of 
Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center 
for Food Safety and Applied Nutrition, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, that it has included 
such a statement on the label or in the labeling of its product. An 
original and two copies of this notification shall be submitted.
    (2) The notification shall include the following:
    (i) The name and address of the manufacturer, packer, or distributor 
of the dietary supplement that bears the statement;
    (ii) The text of the statement that is being made;
    (iii) The name of the dietary ingredient or supplement that is the 
subject of the statement, if not provided in the text of the statement; 
and
    (iv) The name of the dietary supplement (including brand name), if 
not provided in response to paragraph (a)(2)(iii) on whose label, or in 
whose labeling, the statement appears.
    (3) The notice shall be signed by a responsible individual or the 
person who can certify the accuracy of the information presented and 
contained in the notice. The individual shall certify that the 
information contained in the notice is complete and accurate, and that 
the notifying firm has substantiation that the statement is truthful and 
not misleading.
    (b) Disclaimer. The requirements in this section apply to the label 
or labeling of dietary supplements where the dietary supplement bears a 
statement that is provided for by section 403(r)(6) of the Federal Food, 
Drug, and Cosmetic Act (the act), and the manufacturer, packer, or 
distributor wishes to take advantage of the exemption to section 
201(g)(1)(C) of the act that is provided by compliance with section 
403(r)(6) of the act.
    (c) Text for disclaimer. (1) Where there is one statement, the 
disclaimer shall be placed in accordance with paragraph (d) of this 
section and shall state:

    This statement has not been evaluated by the Food and Drug 
Administration. This product is not intended to diagnose, treat, cure, 
or prevent any disease.

    (2) Where there is more than one such statement on the label or in 
the labeling, each statement shall bear the disclaimer in accordance 
with paragraph (c)(1) of this section, or a plural disclaimer may be 
placed in accordance with paragraph (d) of this section and shall state:
    These statements have not been evaluated by the Food and Drug 
Administration. This product is not intended to diagnose, treat, cure, 
or prevent any disease.
    (d) Placement. The disclaimer shall be placed adjacent to the 
statement with no intervening material or linked to the statement with a 
symbol (e.g., an asterisk) at the end of each such statement that refers 
to the same symbol placed adjacent to the disclaimer specified in 
paragraphs (c)(1) or (c)(2) of this section. On product labels and in 
labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on 
each panel or page where there such is a statement. The disclaimer shall 
be set off in a box where it is not adjacent to the statement in 
question.
    (e) Typesize. The disclaimer in paragraph (c) of this section shall 
appear in boldface type in letters of a typesize no smaller than one-
sixteenth inch.
    (f) Permitted structure/function statements. Dietary supplement 
labels or labeling may, subject to the requirements in paragraphs (a) 
through (e) of this section, bear statements that describe the role of a 
nutrient or dietary ingredient intended to affect the structure or 
function in humans or that characterize the documented mechanism by 
which a nutrient or dietary ingredient acts to maintain such structure 
or function, provided that such statements are not disease claims under 
paragraph (g) of this section. If

[[Page 153]]

the label or labeling of a product marketed as a dietary supplement 
bears a disease claim as defined in paragraph (g) of this section, the 
product will be subject to regulation as a drug unless the claim is an 
authorized health claim for which the product qualifies.
    (g) Disease claims. (1) For purposes of 21 U.S.C. 343(r)(6), a 
``disease'' is damage to an organ, part, structure, or system of the 
body such that it does not function properly (e.g., cardiovascular 
disease), or a state of health leading to such dysfunctioning (e.g., 
hypertension); except that diseases resulting from essential nutrient 
deficiencies (e.g., scurvy, pellagra) are not included in this 
definition.
    (2) FDA will find that a statement about a product claims to 
diagnose, mitigate, treat, cure, or prevent disease (other than a 
classical nutrient deficiency disease) under 21 U.S.C. 343(r)(6) if it 
meets one or more of the criteria listed below. These criteria are not 
intended to classify as disease claims statements that refer to the 
ability of a product to maintain healthy structure or function, unless 
the statement implies disease prevention or treatment. In determining 
whether a statement is a disease claim under these criteria, FDA will 
consider the context in which the claim is presented. A statement claims 
to diagnose, mitigate, treat, cure, or prevent disease if it claims, 
explicitly or implicitly, that the product:
    (i) Has an effect on a specific disease or class of diseases;
    (ii) Has an effect on the characteristic signs or symptoms of a 
specific disease or class of diseases, using scientific or lay 
terminology;
    (iii) Has an effect on an abnormal condition associated with a 
natural state or process, if the abnormal condition is uncommon or can 
cause significant or permanent harm;
    (iv) Has an effect on a disease or diseases through one or more of 
the following factors:
    (A) The name of the product;
    (B) A statement about the formulation of the product, including a 
claim that the product contains an ingredient (other than an ingredient 
that is an article included in the definition of ``dietary supplement'' 
under 21 U.S.C. 321(ff)(3)) that has been regulated by FDA as a drug and 
is well known to consumers for its use or claimed use in preventing or 
treating a disease;
    (C) Citation of a publication or reference, if the citation refers 
to a disease use, and if, in the context of the labeling as a whole, the 
citation implies treatment or prevention of a disease, e.g., through 
placement on the immediate product label or packaging, inappropriate 
prominence, or lack of relationship to the product's express claims;
    (D) Use of the term ``disease'' or ``diseased,'' except in general 
statements about disease prevention that do not refer explicitly or 
implicitly to a specific disease or class of diseases or to a specific 
product or ingredient; or
    (E) Use of pictures, vignettes, symbols, or other means;
    (v) Belongs to a class of products that is intended to diagnose, 
mitigate, treat, cure, or prevent a disease;
    (vi) Is a substitute for a product that is a therapy for a disease;
    (vii) Augments a particular therapy or drug action that is intended 
to diagnose, mitigate, treat, cure, or prevent a disease or class of 
diseases;
    (viii) Has a role in the body's response to a disease or to a vector 
of disease;
    (ix) Treats, prevents, or mitigates adverse events associated with a 
therapy for a disease, if the adverse events constitute diseases; or
    (x) Otherwise suggests an effect on a disease or diseases.

[62 FR 49886, Sept. 23, 1997, as amended at 62 FR 49867, Sept. 23, 1997; 
65 FR 1050, Jan. 6, 2000; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 
6, 2001]



Sec.  101.95  ``Fresh,'' ``freshly frozen,'' ``fresh frozen,'' ``frozen 

fresh.''

    The terms defined in this section may be used on the label or in 
labeling of a food in conformity with the provisions of this section. 
The requirements of the section pertain to any use of the subject terms 
as described in paragraphs (a) and (b) of this section that expressly or 
implicitly refers to the food on labels or labeling, including use in a 
brand name and use as a sensory modifier. However, the use of the term 
``fresh'' on labels or labeling is

[[Page 154]]

not subject to the requirements of paragraph (a) of this section if the 
term does not suggest or imply that a food is unprocessed or 
unpreserved. For example, the term ``fresh'' used to describe 
pasteurized whole milk is not subject to paragraph (a) of this section 
because the term does not imply that the food is unprocessed (consumers 
commonly understand that milk is nearly always pasteurized). However, 
the term ``fresh'' to describe pasta sauce that has been pasteurized or 
that contains pasteurized ingredients would be subject to paragraph (a) 
of this section because the term implies that the food is not processed 
or preserved. Uses of fresh not subject to this regulation will be 
governed by the provisions of 403(a) of the Federal Food, Drug, and 
Cosmetic Act (the act).
    (a) The term ``fresh,'' when used on the label or in labeling of a 
food in a manner that suggests or implies that the food is unprocessed, 
means that the food is in its raw state and has not been frozen or 
subjected to any form of thermal processing or any other form of 
preservation, except as provided in paragraph (c) of this section.
    (b) The terms ``fresh frozen'' and ``frozen fresh,'' when used on 
the label or in labeling of a food, mean that the food was quickly 
frozen while still fresh (i.e., the food had been recently harvested 
when frozen). Blanching of the food before freezing will not preclude 
use of the term ``fresh frozen'' to describe the food. ``Quickly 
frozen'' means frozen by a freezing system such as blast-freezing (sub-
zero Fahrenheit temperature with fast moving air directed at the food) 
that ensures the food is frozen, even to the center of the food, quickly 
and that virtually no deterioration has taken place.
    (c) Provisions and restrictions. (1) The following do not preclude 
the food from use of the term ``fresh:''
    (i) The addition of approved waxes or coatings;
    (ii) The post-harvest use of approved pesticides;
    (iii) The application of a mild chlorine wash or mild acid wash on 
produce; or
    (iv) The treatment of raw foods with ionizing radiation not to 
exceed the maximum dose of 1 kiloGray in accordance with Sec.  179.26 of 
this chapter.
    (2) A food meeting the definition in paragraph (a) of this section 
that is refrigerated is not precluded from use of ``fresh'' as provided 
by this section.

[58 FR 2426, Jan. 6, 1993]



          Subpart G_Exemptions From Food Labeling Requirements



Sec.  101.100  Food; exemptions from labeling.

    (a) The following foods are exempt from compliance with the 
requirements of section 403(i)(2) of the act (requiring a declaration on 
the label of the common or usual name of each ingredient when the food 
is fabricated from two or more ingredients).
    (1) An assortment of different items of food, when variations in the 
items that make up different packages packed from such assortment 
normally occur in good packing practice and when such variations result 
in variations in the ingredients in different packages, with respect to 
any ingredient that is not common to all packages. Such exemption, 
however, shall be on the condition that the label shall bear, in 
conjunction with the names of such ingredients as are common to all 
packages, a statement (in terms that are as informative as practicable 
and that are not misleading) indicating by name other ingredients which 
may be present.
    (2) A food having been received in bulk containers at a retail 
establishment, if displayed to the purchaser with either:
    (i) The labeling of the bulk container plainly in view, provided 
ingredient information appears prominently and conspicuously in 
lettering of not less than one-fourth of an inch in height; or
    (ii) A counter card, sign, or other appropriate device bearing 
prominently and conspicuously, but in no case with lettering of less 
than one-fourth of an inch in height, the information required to be 
stated on the label pursuant to section 403(i)(2) of the Federal Food, 
Drug, and Cosmetic Act (the act).
    (3) Incidental additives that are present in a food at insignificant 
levels

[[Page 155]]

and do not have any technical or functional effect in that food. For the 
purposes of this paragraph (a)(3), incidental additives are:
    (i) Substances that have no technical or functional effect but are 
present in a food by reason of having been incorporated into the food as 
an ingredient of another food, in which the substance did have a 
functional or technical effect.
    (ii) Processing aids, which are as follows:
    (a) Substances that are added to a food during the processing of 
such food but are removed in some manner from the food before it is 
packaged in its finished form.
    (b) Substances that are added to a food during processing, are 
converted into constituents normally present in the food, and do not 
significantly increase the amount of the constitutents naturally found 
in the food.
    (c) Substances that are added to a food for their technical or 
functional effect in the processing but are present in the finished food 
at insignificant levels and do not have any technical or functional 
effect in that food.
    (iii) Substances migrating to food from equipment or packaging or 
otherwise affecting food that are not food additives as defined in 
section 201(s) of the act; or if they are food additives as so defined, 
they are used in conformity with regulations established pursuant to 
section 409 of the act.
    (4) For the purposes of paragraph (a)(3) of this section, any 
sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite, 
potasssium bisulfite, sodium metabisulfite, and potassium metabisulfite) 
that has been added to any food or to any ingredient in any food and 
that has no technical effect in that food will be considered to be 
present in an insignificant amount only if no detectable amount of the 
agent is present in the finished food. A detectable amount of sulfiting 
agent is 10 parts per million or more of the sulfite in the finished 
food. Compliance with this paragraph will be determined using sections 
20.123-20.125, ``Total Sulfurous Acid,'' in ``Official Methods of 
Analysis of the Association of Official Analytical Chemists,'' 14th Ed. 
(1984), which is incorporated by reference and the refinements of the 
``Total Sulfurous Acid'' procedure in the ``Monier-Williams Procedure 
(with Modifications) for Sulfites in Foods,'' which is appendix A to 
part 101. A copy of sections 20.123-20-125 of the Official Methods of 
Analysis of the Association of Official Analytical Chemists'' is 
available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 
500, Gaithersburg, MD 20877, or available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
    (b) A food repackaged in a retail establishment is exempt from the 
following provisions of the act if the conditions specified are met.
    (1) Section 403(e)(1) of the act (requiring a statement on the label 
of the name and place of business of the manufacturer, packer, or 
distributor).
    (2) Section 403(g)(2) of the act (requiring the label of a food 
which purports to be or is represented as one for which a definition and 
standard of identity has been prescribed to bear the name of the food 
specified in the definition and standard and, insofar as may be required 
by the regulation establishing the standard the common names of the 
optional ingredients present in the food), if the food is displayed to 
the purchaser with its interstate labeling clearly in view, or with a 
counter card, sign, or other appropriate device bearing prominently and 
conspicuously the information required by these provisions.
    (3) Section 403(i)(1) of the act (requiring the label to bear the 
common or usual name of the food), if the food is displayed to the 
purchaser with its interstate labeling clearly in view, or with a 
counter card, sign, or other appropriate device bearing prominently and 
conspicuously the common or usual name of the food, or if the common or 
usual name of the food is clearly revealed by its appearance.
    (c) An open container (a container of rigid or semirigid 
construction, which

[[Page 156]]

is not closed by lid, wrapper, or otherwise other than by an uncolored 
transparent wrapper which does not obscure the contents) of a fresh 
fruit or fresh vegetable, the quantity of contents of which is not more 
than 1 dry quart, shall be exempt from the labeling requirements of 
sections 403(e), (g)(2) (with respect to the name of the food specified 
in the definition and standard), and (i)(1) of the act; but such 
exemption shall be on the condition that if two or more such containers 
are enclosed in a crate or other shipping package, such crate or package 
shall bear labeling showing the number of such containers enclosed 
therein and the quantity of the contents of each.
    (d) Except as provided by paragraphs (e) and (f) of this section, a 
shipment or other delivery of a food which is, in accordance with the 
practice of the trade, to be processed, labeled, or repacked in 
substantial quantity at an establishment other than that where 
originally processed or packed, shall be exempt, during the time of 
introduction into and movement in interstate commerce and the time of 
holding in such establishment, from compliance with the labeling 
requirements of section 403 (c), (e), (g), (h), (i), (k), and (q) of the 
act if:
    (1) The person who introduced such shipment or delivery into 
interstate commerce is the operator of the establishment where such food 
is to be processed, labeled, or repacked; or
    (2) In case such person is not such operator, such shipment or 
delivery is made to such establishment under a written agreement, signed 
by and containing the post office addresses of such person and such 
operator, and containing such specifications for the processing, 
labeling, or repacking, as the case may be, of such food in such 
establishment as will ensure, if such specifications are followed, that 
such food will not be adulterated or misbranded within the meaning of 
the act upon completion of such processing, labeling, or repacking. Such 
person and such operator shall each keep a copy of such agreement until 
2 years after the final shipment or delivery of such food from such 
establishment, and shall make such copies available for inspection at 
any reasonable hour to any officer or employee of the Department who 
requests them.
    (3) The article is an egg product subject to a standard of identity 
promulgated in part 160 of this chapter, is to be shipped under the 
conditions specified in paragraph (d) (1) or (2) of this section and for 
the purpose of pasteurization or other treatment as required in such 
standard, and each container of such egg product bears a conspicuous tag 
or label reading ``Caution--This egg product has not been pasteurized or 
otherwise treated to destroy viable Salmonella microorganisms''. In 
addition to safe and suitable bactericidal processes designed 
specifically for Salmonella destruction in egg products, the term 
``other treatment'' in the first sentence of this paragraph shall 
include use in acidic dressings in the processing of which the pH is not 
above 4.1 and the acidity of the aqueous phase, expressed as acetic 
acid, is not less than 1.4 percent, subject also to the conditions that:
    (i) The agreement required in paragraph (d)(2) of this section shall 
also state that the operator agrees to utilize such unpasteurized egg 
products in the processing of acidic dressings according to the 
specifications for pH and acidity set forth in this paragraph, agrees 
not to deliver the acidic dressing to a user until at least 72 hours 
after such egg product is incorporated in such acidic dressing, and 
agrees to maintain for inspection adequate records covering such 
processing for 2 years after such processing.
    (ii) In addition to the caution statement referred to above, the 
container of such egg product shall also bear the statement 
``Unpasteurized ------ for use in acidic dressings only'', the blank 
being filled in with the applicable name of the eggs or egg product.
    (e) Conditions affecting expiration of exemptions: (1) An exemption 
of a shipment or other delivery of a food under paragraph (d) (1) or (3) 
of this section shall, at the beginning of the act of removing such 
shipment or delivery, or any part thereof, from such establishment 
become void ab initio if the food comprising such shipment, delivery, or 
part is adulterated or misbranded within the meaning of the act when so 
removed.

[[Page 157]]

    (2) An exemption of a shipment or other delivery of a food under 
paragraph (d) (2) or (3) of this section shall become void ab initio 
with respect to the person who introduced such shipment or delivery into 
interstate commerce upon refusal by such person to make available for 
inspection a copy of the agreement, as required by paragraph (d) (2) or 
(3) of this section.
    (3) An exemption of a shipment or other delivery of a food under 
paragraph (d) (2) or (3) of this section shall expire:
    (i) At the beginning of the act of removing such shipment or 
delivery, or any part thereof, from such establishment if the food 
constituting such shipment, delivery, or part is adulterated or 
misbranded within the meaning of the act when so removed; or
    (ii) Upon refusal by the operator of the establishment where such 
food is to be processed, labeled, or repacked, to make available for 
inspection a copy of the agreement, as required by such paragraph.
    (f) The word ``processed'' as used in this paragraph shall include 
the holding of cheese in a suitable warehouse at a temperature of not 
less than 35 [deg]F for the purpose of aging or curing to bring the 
cheese into compliance with requirements of an applicable definition and 
standard of identity. The exemptions provided for in paragraph (d) of 
this section shall apply to cheese which is, in accordance with the 
practice of the trade, shipped to a warehouse for aging or curing, on 
condition that the cheese is identified in the manner set forth in one 
of the applicable following paragraphs, and in such case the provisions 
of paragraph (e) of this section shall also apply:
    (1) In the case of varieties of cheese for which definitions and 
standards of identity require a period of aging whether or not they are 
made from pasteurized milk, each such cheese shall bear on the cheese a 
legible mark showing the date at which the preliminary manufacturing 
process has been completed and at which date curing commences, and to 
each cheese, on its wrapper or immediate container, shall be affixed a 
removable tag bearing the statement ``Uncured ------ cheese for 
completion of curing and proper labeling'', the blank being filled in 
with the applicable name of the variety of cheese. In the case of swiss 
cheese, the date at which the preliminary manufacturing process had been 
completed and at which date curing commences is the date on which the 
shaped curd is removed from immersion in saturated salt solution as 
provided in the definition and standard of identity for swiss cheese, 
and such cheese shall bear a removable tag reading, ``To be cured and 
labeled as `swiss cheese,' but if eyes do not form, to be labeled as 
`swiss cheese for manufacturing' ''.
    (2) In the case of varieties of cheeses which when made from 
unpasteurized milk are required to be aged for not less than 60 days, 
each such cheese shall bear a legible mark on the cheese showing the 
date at which the preliminary manufacturing process has been completed 
and at which date curing commences, and to each such cheese or its 
wrapper or immediate container shall be affixed a removable tag reading, 
``------ cheese made from unpasteurized milk. For completion of curing 
and proper labeling'', the blank being filled in with the applicable 
name of the variety of cheese.
    (3) In the case of cheddar cheese, washed curd cheese, colby cheese, 
granular cheese, and brick cheese made from unpasteurized milk, each 
such cheese shall bear a legible mark on the cheese showing the date at 
which the preliminary manufacturing process has been completed and at 
which date curing commences, and to each such cheese or its wrapper or 
immediate container shall be affixed a removable tag reading ``------ 
cheese made from unpasteurized milk. For completion of curing and proper 
labeling, or for labeling as ------ cheese for manufacturing'', the 
blank being filled in with the applicable name of the variety of cheese.
    (g) The label declaration of a harmless marker used to identify a 
particular manufacturer's product may result in unfair competition 
through revealing a trade secret. Exemption from the label declaration 
of such a marker is granted, therefore, provided that the following 
conditions are met:
    (1) The person desiring to use the marker without label declaration 
of its

[[Page 158]]

presence has submitted to the Commissioner of Food and Drugs full 
information concerning the proposed usage and the reasons why he 
believes label declaration of the marker should be subject to this 
exemption; and
    (2) The person requesting the exemption has received from the 
Commissioner of Food and Drugs a finding that the marker is harmless and 
that the exemption has been granted.
    (h) Wrapped fish fillets of nonuniform weight intended to be 
unpacked and marked with the correct weight at or before the point of 
retail sale in an establishment other than that where originally packed 
shall be exempt from the requirement of section 403(e)(2) of the act 
during introduction and movement in interstate commerce and while held 
for sale prior to weighing and marking:
    (1) Provided, That (i) The outside container bears a label 
declaration of the total net weight; and
    (ii) The individual packages bear a conspicuous statement ``To be 
weighed at or before time of sale'' and a correct statement setting 
forth the weight of the wrapper;
    (2) Provided further, That it is the practice of the retail 
establishment to weigh and mark the individual packages with a correct 
net-weight statement prior to or at the point of retail sale. A 
statement of the weight of the wrapper shall be set forth so as to be 
readily read and understood, using such term as ``wrapper tare--ounce'', 
the blank being filled in with the correct average weight of the wrapper 
used.
    (3) The act of delivering the wrapped fish fillets during the retail 
sale without the correct net-weight statement shall be deemed an act 
which results in the product's being misbranded while held for sale. 
Nothing in this paragraph shall be construed as requiring net-weight 
statements for wrapped fish fillets delivered into institutional trade 
provided the outside container bears the required information.
    (i) Wrapped clusters (consumer units) of bananas of nonuniform 
weight intended to be unpacked from a master carton or container and 
weighed at or before the point of retail sale in an establishment other 
than that where originally packed shall be exempt from the requirements 
of section 403(e)(2) of the act during introduction and movement in 
interstate commerce and while held for sale prior to weighing:
    (1) Provided, That (i) The master carton or container bears a label 
declaration of the total net weight; and
    (ii) The individual packages bear a conspicuous statement ``To be 
weighed at or before the time of sale'' and a correct statement setting 
forth the weight of the wrapper; using such term as ``wrapper tare -- 
ounce'', the blank being filled in with the correct average weight of 
the wrapper used;
    (2) Provided further, That it is the practice of the retail 
establishment to weigh the individual packages either prior to or at the 
time of retail sale.
    (3) The act of delivering the wrapped clusters (consumer units) 
during the retail sale without an accurate net weight statement or 
alternatively without weighing at the time of sale shall be deemed an 
act which results in the product's being misbranded while held for sale. 
Nothing in this paragraph shall be construed as requiring net-weight 
statements for clusters (consumer units) delivered into institutional 
trade, provided that the master container or carton bears the required 
information.

[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986; 58 
FR 2188, 2876, Jan. 6, 1993; 66 FR 17358, Mar. 30, 2001]



Sec.  101.105  Declaration of net quantity of contents when exempt.

    (a) The principal display panel of a food in package form shall bear 
a declaration of the net quantity of contents. This shall be expressed 
in the terms of weight, measure, numerical count, or a combination of 
numerical count and weight or measure. The statement shall be in terms 
of fluid measure if the food is liquid, or in terms of weight if the 
food is solid, semisolid, or viscous, or a mixture of solid and liquid; 
except that such statement may be in terms of dry measure if the food is 
a fresh fruit, fresh vegetable, or other dry commodity that is 
customarily sold by dry measure. If there is a firmly established 
general consumer usage and trade custom of declaring the contents of a 
liquid by

[[Page 159]]

weight, or a solid, semisolid, or viscous product by fluid measure, it 
may be used. Whenever the Commissioner determines that an existing 
practice of declaring net quantity of contents by weight, measure, 
numerical count, or a combination in the case of a specific packaged 
food does not facilitate value comparisons by consumers and offers 
opportunity for consumer confusion, he will by regulation designate the 
appropriate term or terms to be used for such commodity.
    (b)(1) Statements of weight shall be in terms of avoirdupois pound 
and ounce.
    (2) Statements of fluid measure shall be in terms of the U.S. gallon 
of 231 cubic inches and quart, pint, and fluid ounce subdivisions 
thereof, and shall:
    (i) In the case of frozen food that is sold and consumed in a frozen 
state, express the volume at the frozen temperature.
    (ii) In the case of refrigerated food that is sold in the 
refrigerated state, express the volume at 40 [deg]F (4 [deg]C).
    (iii) In the case of other foods, express the volume at 68 [deg]F 
(20 [deg]C).
    (3) Statements of dry measure shall be in terms of the U.S. bushel 
of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions 
thereof.
    (c) When the declaration of quantity of contents by numerical count 
does not give adequate information as to the quantity of food in the 
package, it shall be combined with such statement of weight, measure, or 
size of the individual units of the foods as will provide such 
information.
    (d) The declaration may contain common or decimal fractions. A 
common fraction shall be in terms of halves, quarters, eighths, 
sixteenths, or thirty-seconds; except that if there exists a firmly 
established general consumer usage and trade custom of employing 
different common fractions in the net quantity declaration of a 
particular commodity, they may be employed. A common fraction shall be 
reduced to its lowest terms; a decimal fraction shall not be carried out 
to more than two places. A statement that includes small fractions of an 
ounce shall be deemed to permit smaller variations than one which does 
not include such fractions.
    (e) The declaration shall be located on the principal display panel 
of the label, and with respect to packages bearing alternate principal 
panels it shall be duplicated on each principal display panel.
    (f) The declaration shall appear as a distinct item on the principal 
display panel, shall be separated (by at least a space equal to the 
height of the lettering used in the declaration) from other printed 
label information appearing above or below the declaration and (by at 
least a space equal to twice the width of the letter ``N'' of the style 
of type used in the quantity of contents statement) from other printed 
label information appearing to the left or right of the declaration. It 
shall not include any term qualifying a unit of weight, measure, or 
count (such as ``jumbo quart'' and ``full gallon'') that tends to 
exaggerate the amount of the food in the container. It shall be placed 
on the principal display panel within the bottom 30 percent of the area 
of the label panel in lines generally parallel to the base on which the 
package rests as it is designed to be displayed: Provided, That on 
packages having a principal display panel of 5 square inches or less, 
the requirement for placement within the bottom 30 percent of the area 
of the label panel shall not apply when the declaration of net quantity 
of contents meets the other requirements of this part.
    (g) The declaration shall accurately reveal the quantity of food in 
the package exclusive of wrappers and other material packed therewith: 
Provided, That in the case of foods packed in containers designed to 
deliver the food under pressure, the declaration shall state the net 
quantity of the contents that will be expelled when the instructions for 
use as shown on the container are followed. The propellant is included 
in the net quantity declaration.
    (h) The declaration shall appear in conspicuous and easily legible 
boldface print or type in distinct contrast (by typography, layout, 
color, embossing, or molding) to other matter on the package; except 
that a declaration of

[[Page 160]]

net quantity blown, embossed, or molded on a glass or plastic surface is 
permissible when all label information is so formed on the surface. 
Requirements of conspicuousness and legibility shall include the 
specifications that:
    (1) The ratio of height to width (of the letter) shall not exceed a 
differential of 3 units to 1 unit (no more than 3 times as high as it is 
wide).
    (2) Letter heights pertain to upper case or capital letters. When 
upper and lower case or all lower case letters are used, it is the lower 
case letter ``o'' or its equivalent that shall meet the minimum 
standards.
    (3) When fractions are used, each component numeral shall meet one-
half the minimum height standards.
    (i) The declaration shall be in letters and numerals in a type size 
established in relationship to the area of the principal display panel 
of the package and shall be uniform for all packages of substantially 
the same size by complying with the following type specifications:
    (1) Not less than one-sixteenth inch in height on packages the 
principal display panel of which has an area of 5 square inches or less.
    (2) Not less than one-eighth inch in height on packages the 
principal display panel of which has an area of more than 5 but not more 
than 25 square inches.
    (3) Not less than three-sixteenths inch in height on packages the 
principal display panel of which has an area of more than 25 but not 
more than 100 square inches.
    (4) Not less than one-fourth inch in height on packages the 
principal display panel of which has an area of more than 100 square 
inches, except not less than \1/2\ inch in height if the area is more 
than 400 square inches.


Where the declaration is blown, embossed, or molded on a glass or 
plastic surface rather than by printing, typing, or coloring, the 
lettering sizes specified in paragraphs (h)(1) through (4) of this 
section shall be increased by one-sixteenth of an inch.
    (j) On packages containing less than 4 pounds or 1 gallon and 
labeled in terms of weight or fluid measure:
    (1) The declaration shall be expressed both in ounces, with 
identification by weight or by liquid measure and, if applicable (1 
pound or 1 pint or more) followed in parentheses by a declaration in 
pounds for weight units, with any remainder in terms of ounces or common 
or decimal fractions of the pound (see examples set forth in paragraphs 
(m) (1) and (2) of this section), or in the case of liquid measure, in 
the largest whole units (quarts, quarts and pints, or pints, as 
appropriate) with any remainder in terms of fluid ounces or common or 
decimal fractions of the pint or quart (see examples in paragraphs (m) 
(3) and (4) of this section).
    (2) If the net quantity of contents declaration appears on a random 
package, that is a package which is one of a lot, shipment, or delivery 
of packages of the same consumer commodity with varying weights and with 
no fixed weight pattern, it may, when the net weight exceeds 1 pound, be 
expressed in terms of pounds and decimal fractions of the pound carried 
out to not more than two decimal places. When the net weight does not 
exceed 1 pound, the declaration on the random package may be in decimal 
fractions of the pound in lieu of ounces (see example in paragraph 
(m)(5) of this section).
    (3) The declaration may appear in more than one line. The term ``net 
weight'' shall be used when stating the net quantity of contents in 
terms of weight. Use of the terms ``net'' or ``net contents'' in terms 
of fluid measure or numerical count is optional. It is sufficient to 
distinguish avoirdupois ounce from fluid ounce through association of 
terms; for example, ``Net wt. 6 oz'' or ``6 oz Net wt.'' and ``6 fl oz'' 
or ``Net contents 6 fl oz''.
    (k) On packages containing 4 pounds or 1 gallon or more and labeled 
in terms of weight or fluid measure, the declaration shall be expressed 
in pounds for weight units with any remainder in terms of ounces or 
common or decimal fraction of the pound, or in the case of fluid 
measure, it shall be expressed in the largest whole unit (gallons 
followed by common or decimal fraction of a gallon or by the next 
smaller whole unit or units (quarts, or quarts and pints)) with any 
remainder in terms of fluid ounces or common or decimal fractions of the 
pint or quart (see paragraph (m)(6) of this section).

[[Page 161]]

    (l) [Reserved]
    (m) Examples:
    (1) A declaration of 1\1/2\ pounds weight shall be expressed as 
``Net Wt. 24 oz (1 lb 8 oz),'' ``Net Wt. 24 oz (1\1/2\ lb),'' or ``Net 
Wt. 24 oz (1.5 lb)''.
    (2) A declaration of three-fourths pound avoirdupois weight shall be 
expressed as ``Net Wt. 12 oz''.
    (3) A declaration of 1 quart liquid measure shall be expressed as 
``Net 32 fl oz (1 qt)''.
    (4) A declaration of 1\3/4\ quarts liquid measure shall be expressed 
as ``Net contents 56 fluid ounces (1 quart 1\1/2\ pints)'' or as ``Net 
56 fluid oz (1 qt 1 pt 8 oz)'', but not in terms of quart and ounce such 
as ``Net 56 fluid oz (1 quart 24 ounces)''.
    (5) On a random package, declaration of three-fourths pound 
avoirdupois may be expressed as ``Net Wt. .75 lb''.
    (6) A declaration of 2\1/2\ gallons liquid measure shall be 
expressed as ``Net contents 2\1/2\ gallons,'' ``Net contents 2.5 
gallons,'' or ``Net contents 2 gallons 2 quarts'' and not as ``2 gallons 
4 pints''.
    (n) For quantities, the following abbreviations and none other may 
be employed (periods and plural forms are optional):

weight wt
ounce oz
pound lb
gallon gal
pint pt
quart qt
fluid fl

    (o) Nothing in this section shall prohibit supplemental statements 
at locations other than the principal display panel(s) describing in 
nondeceptive terms the net quantity of contents; Provided, that such 
supplemental statements of net quantity of contents shall not include 
any term qualifying a unit of weight, measure, or count that tends to 
exaggerate the amount of the food contained in the package; for example, 
``jumbo quart'' and ``full gallon''. Dual or combination declarations of 
net quantity of contents as provided for in paragraphs (a), (c), and (j) 
of this section (for example, a combination of net weight plus numerical 
count, net contents plus dilution directions of a concentrate, etc.) are 
not regarded as supplemental net quantity statements and may be located 
on the principal display panel.
    (p) A separate statement of the net quantity of contents in terms of 
the metric system is not regarded as a supplemental statement and an 
accurate statement of the net quantity of contents in terms of the 
metric system of weight or measure may also appear on the principal 
display panel or on other panels.
    (q) The declaration of net quantity of contents shall express an 
accurate statement of the quantity of contents of the package. 
Reasonable variations caused by loss or gain of moisture during the 
course of good distribution practice or by unavoidable deviations in 
good manufacturing practice will be recognized. Variations from stated 
quantity of contents shall not be unreasonably large.
    (r) The declaration of net quantity of contents on pickles and 
pickle products, including relishes but excluding one or two whole 
pickles in clear plastic bags which may be declared by count, shall be 
expressed in terms of the U.S. gallon of 231 cubic inches and quart, 
pint, and fluid ounce subdivisions thereof.
    (s) On a multiunit retail package, a statement of the quantity of 
contents shall appear on the outside of the package and shall include 
the number of individual units, the quantity of each individual unit, 
and, in parentheses, the total quantity of contents of the multiunit 
package in terms of avoirdupois or fluid ounces, except that such 
declaration of total quantity need not be followed by an additional 
parenthetical declaration in terms of the largest whole units and 
subdivisions thereof, as required by paragraph (j)(1) of this section. A 
multiunit retail package may thus be properly labeled: ``6-16 oz 
bottles--(96 fl oz)'' or ``3-16 oz cans--(net wt. 48 oz)''. For the 
purposes of this section, ``multiunit retail package'' means a package 
containing two or more individually packaged units of the identical 
commodity and in the same quantity, intended to be sold as part of the 
multiunit retail package but capable of being individually sold in full 
compliance with all requirements of the regulations in this part. Open 
multiunit retail packages that do not obscure the number of units or 
prevent examination of the labeling on each of the individual units are 
not

[[Page 162]]

subject to this paragraph if the labeling of each individual unit 
complies with the requirements of paragraphs (f) and (i) of this 
section. The provisions of this section do not apply to that butter or 
margarine covered by the exemptions in Sec.  1.24(a) (10) and (11) of 
this chapter.
    (t) Where the declaration of net quantity of contents is in terms of 
net weight and/or drained weight or volume and does not accurately 
reflect the actual quantity of the contents or the product falls below 
the applicable standard of fill of container because of equipment 
malfunction or otherwise unintentional product variation, and the label 
conforms in all other respects to the requirements of this chapter 
(except the requirement that food falling below the applicable standard 
of fill of container shall bear the general statement of substandard 
fill specified in Sec.  130.14(b) of this chapter), the mislabeled food 
product, including any food product that fails to bear the general 
statement of substandard fill specified in Sec.  130.14(b) of this 
chapter, may be sold by the manufacturer or processor directly to 
institutions operated by Federal, State or local governments (schools, 
prisons, hospitals, etc.): Provided, That:
    (1) The purchaser shall sign a statement at the time of sale stating 
that he is aware that the product is mislabeled to include 
acknowledgment of the nature and extent of the mislabeling, (e.g., 
``Actual net weight may be as low as --% below labeled quantity'') and 
that any subsequent distribution by him of said product except for his 
own institutional use is unlawful. This statement shall be kept on file 
at the principal place of business of the manufacturer or processor for 
2 years subsequent to the date of shipment of the product and shall be 
available to the Food and Drug Administration upon request.
    (2) The product shall be labeled on the outside of its shipping 
container with the statement(s):
    (i) When the variation concerns net weight and/or drained weight or 
volume, ``Product Mislabeled. Actual net weight (drained weight or 
volume where appropriate) may be as low as --% below labeled quantity. 
This Product Not for Retail Distribution'', the blank to be filled in 
with the maximum percentage variance between the labeled and actual 
weight or volume of contents of the individual packages in the shipping 
container, and
    (ii) When the variation is in regard to a fill of container 
standard, ``Product Mislabeled. Actual fill may be as low as --% below 
standard of fill. This Product Not for Retail Distribution''.
    (3) The statements required by paragraphs (t)(2) (i) and (ii) of 
this section, which may be consolidated where appropriate, shall appear 
prominently and conspicuously as compared to other printed matter on the 
shipping container and in boldface print or type on a clear, contrasting 
background in order to render them likely to be read and understood by 
the purchaser under ordinary conditions of purchase.

[42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



Sec.  101.108  Temporary exemptions for purposes of conducting authorized food 

labeling experiments.

    (a) The food industry is encouraged to experiment voluntarily, under 
controlled conditions and in collaboration with the Food and Drug 
Administration, with and other formats for presenting nutrition and 
other related food labeling information that is consistent with the 
current quantitative system in Sec. Sec.  101.9 and 105.66 of this 
chapter.
    (b) Any firm that intends to undertake a labeling experiment that 
requires exemptions from certain requirements of Sec. Sec.  101.9 and 
105.66 of this chapter should submit a written proposal containing a 
thorough discussion of each of the following information items that 
apply to the particular experiment:
    (1) A description of the labeling format to be tested;
    (2) A statement of the criteria to be used in the experiment for 
assigning foods to categories, e.g., nutrient or other values defining 
``low'' and ``reduced'';
    (3) A draft of the material to be used in the store, e.g., shelf 
tags, booklets, posters, etc.;
    (4) The dates on which the experiment will begin and end and on 
which

[[Page 163]]

a written report of analysis of the experimental data will be submitted 
to FDA, together with a commitment not to continue the experiment beyond 
the proposed ending date without FDA approval;
    (5) The geographic area or areas in which the experiment is to be 
conducted;
    (6) The mechanism to measure the effectiveness of the experiment;
    (7) The method for conveying to consumers the required nutrition and 
other labeling information that is exempted from the label during the 
experiment;
    (8) The method that will be or has been used to determine the actual 
nutritional characteristics of foods for which a claim is made; and
    (9) A statement of the sections of the regulations for which an 
exemption is sought.
    (c) The written proposal should be sent to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. The proposal should be clearly identified 
as a request for a temporary exemption for purposes of conducting 
authorized food labeling experiments and submitted as a citizen petition 
under Sec.  10.30 of this chapter.
    (d) Approval for food labeling experiments will be given by FDA in 
writing. Foods labeled in violation of existing regulations will be 
subject to regulatory action unless an FDA-approved exemption to the 
specific regulation has been granted for that specific product.
    (e) Reporting requirements contained in Sec.  101.108(b) have been 
approved by this Office of Management and Budget and assigned number 
0910-0151.

[48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994; 62 
FR 15343, Mar. 31, 1997]



      Sec. Appendix A to Part 101--Monier-Williams Procedure (With 

Modifications) for Sulfites in Food, Center for Food Safety and Applied 

         Nutrition, Food and Drug Administration (November 1985)

    The AOAC official method for sulfites (Official Methods of Analysis, 
14th Edition, 20.123-20.125, AOAC INTERNATIONAL) has been modified, in 
FDA laboratories, to facilitate the determination of sulfites at or near 
10 ppm in food. Method instructions, including modifications, are 
described below.
    Apparatus--The apparatus shown diagrammatically (Figure 1) is 
designed to accomplish the selective transfer of sulfur dioxide from the 
sample in boiling aqueous hydrochloric acid to a solution of 3% hydrogen 
peroxide. This apparatus is easier to assemble than the official 
apparatus and the back pressure inside the apparatus is limited to the 
unavoidable pressure due to the height of the 3% 
H2O2 solution above the tip of the bubbler (F). 
Keeping the backpressure as low as possible reduces the likelihood that 
sulfur dioxide will be lost through leaks.
    The apparatus should be assembled as shown in Fig. 1 with a thin 
film of stopcock grease on the sealing surfaces of all the joints except 
the joint between the separatory funnel and the flask. Each joint should 
be clamped together to ensure a complete seal throughout the analysis. 
The separatory funnel, B, should have a capacity of 100 ml or greater. 
An inlet adapter, A, with a hose connector (Kontes K-183000 or 
equivalent) is required to provide a means of applying a head of 
pressure above the solution. (A pressure equalizing dropping funnel is 
not recommended because condensate, perhaps with sulfur dioxide, is 
deposited in the funnel and the side arm.) The round bottom flask, C, is 
a 1000 ml flask with three 24/40 tapered joints. The gas inlet tube, D, 
(Kontes K-179000 or equivalent) should be of sufficient length to permit 
introduction of the nitrogen within 2.5 cm of the bottom of the flask. 
The Allihn condenser, E, (Kontes K-431000-2430 or equivalent) has a 
jacket length of 300 mm. The bubbler, F, was fabricated from glass 
according to the dimensions given in Fig. 2. The 3% hydrogen peroxide 
solution can be contained in a vessel, G, with an i.d. of ca. 2.5 cm and 
a depth of 18 cm.
    Buret--A 10 ml buret (Fisher Cat. No. 03-848-2A or equivalent) with 
overflow tube and hose connections for an Ascarite tube or equivalent 
air scrubbing apparatus. This will permit the maintenance of a carbon 
dioxide-free atmosphere over the standardized 0.01N sodium hydroxide.
    Chilled Water Circulator--The condensor must be chilled with a 
coolant, such as 20% methanol-water, maintained at 5 [deg]C. A 
circulating pump equivalent to the Neslab Coolflow 33 is suitable.

                                Reagents

    (a) Aqueous hydrochloric acid, 4N.--For each analysis prepare 90 ml 
of hydrochloric acid by adding 30 ml of concentrated hydrochloric acid 
(12N) to 60 ml of distilled water.
    (b) Methyl red indicator--Dissolve 250 mg of methyl red in 100 ml 
ethanol.
    (c) Hydrogen peroxide solution, 3%--Dilute ACS reagent grade 30% 
hydrogen peroxide to

[[Page 164]]

3% with distilled water. Just prior to use, add three drops of methyl 
red indicator and titrate to a yellow end-point using 0.01N sodium 
hydroxide. If the end-point is exceeded discard the solution and prepare 
another 3% H2O2 solution.
    (d) Standardized titrant, 0.01N NaOH--Certified reagent may be used 
(Fisher SO-5-284). It should be standardized with reference standard 
potassium hydrogen phthalate.
    (e) Nitrogen--A source of high purity nitrogen is required with a 
flow regulator that will maintain a flow of 200 cc per minute. To guard 
against the presence of oxygen in the nitrogen, an oxygen scrubbing 
solution such as an alkaline pyrogallol trap may be used. Prepare 
pyrogallol trap as follows:
    1. Add 4.5 g pyrogallol to the trap.
    2. Purge trap with nitrogen for 2 to 3 minutes.
    3. Prepare a KOH solution prepared by adding 65g KOH to 85 ml 
distilled water (caution: heat).
    4. Add the KOH solution to the trap while maintaining an atmosphere 
of nitrogen in the trap.

                              Determination

    Assemble the apparatus as shown in Fig. 1. The flask C must be 
positioned in a heating mantle that is controlled by a power regulating 
device such as Variac or equivalent. Add 400 ml of distilled water to 
flask C. Close the stopcock of separatory funnel, B, and add 90 ml of 4N 
hydrochloric acid to the separatory funnel. Begin the flow of nitrogen 
at a rate of 20010 cc/min. The condenser coolant 
flow must be initiated at this time. Add 30 ml of 3% hydrogen peroxide, 
which has been titrated to a yellow end-point with 0.01N NaOH, to 
container G. After fifteen minutes the apparatus and the distilled water 
will be thoroughly de-oxygenated and the apparatus is ready for sample 
introduction.
    Sample preparation (solids)--Transfer 50 g of food, or a quantity of 
food with a convenient quantity of SO2 (500 to 1500 mcg 
SO2), to a food processor or blender. Add 100 ml of 5% 
ethanol in water and briefly grind the mixture. Grinding or blending 
should be continued only until the food is chopped into pieces small 
enough to pass through the 24/40 point of flask C.
    Sample preparation (liquids)--Mix 50 g of the sample, or a quantity 
with a convenient quantity of SO2 (500 to 1500 mcg 
SO2), with 100 ml of 5% ethanol in water.
    Sample introduction and distillation--Remove the separatory funnel 
B, and quantitatively transfer the food sample in aqueous ethanol to 
flask C. Wipe the tapered joint clean with a laboratory tissue, apply 
stopcock grease to the outer joint of the separatory funnel, and return 
the separatory funnel, B, to tapered joint flask C. The nitrogen flow 
through the 3% hydrogen peroxide solution should resume as soon as the 
funnel, B, is re-inserted into the appropriate joint in flask C. Examine 
each joint to ensure that it is sealed.
    Apply a head pressure above the hydrochloric acid solution in B with 
a rubber bulb equipped with a valve. Open the stopcock in B and permit 
the hydrochloric acid solution to flow into flask C. Continue to 
maintain sufficient pressure above the acid solution to force the 
solution into the flask C. The stopcock may be closed, if necessary, to 
pump up the pressure above the acid and then opened again. Close the 
stopcock before the last few milliliters drain out of the separatory 
funnel, B, to guard against the escape of sulfur dioxide into the 
separatory funnel.
    Apply the power to the heating mantle. Use a power setting which 
will cause 80 to 90 drops per minute of condensate to return to the 
flask from condenser, E. After 1.75 hours of boiling the contents of the 
1000 ml flask and remove trap G.
    Titration.--Titrate the contents with 0.01N sodium hydroxide. 
Titrate with 0.01N NaOH to a yellow end-point that persists for at least 
twenty seconds. Compute the sulfite content, expressed as micrograms 
sulfur dioxide per gram of food (ppm) as follows:

ppm=(32.03xVB xNx1000)/Wt

where 32.03=milliequivalent weight of sulfur dioxide; 
VB=volume of sodium hydroxide titrant of normality, N, 
required to reach endpoint; the factor, 1000, converts milliequivalents 
to microequivalents and Wt=weight (g) of food sample introduced into the 
1000 ml flask.

[[Page 165]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.362

      Figure 1. The optimized Monier-Williams apparatus. Component 
                    identification is given in text.

[[Page 166]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.363

 Figure 2. Diagram of bubbler (F in Figure 1). Lengths are given in mm.

[42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986]

      Appendix B to Part 101--Graphic Enhancements Used by the FDA

[[Page 167]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.364


[[Page 168]]


[GRAPHIC] [TIFF OMITTED] TR11JY03.006


[58 FR 17332, Apr. 2, 1993, as amended at 70 FR 41506, July 11, 2005]

[[Page 169]]



    Sec. Appendix C to Part 101--Nutrition Facts for Raw Fruits and 
                               Vegetables

[GRAPHIC] [TIFF OMITTED] TR17AU06.007


[[Page 170]]


[GRAPHIC] [TIFF OMITTED] TR17AU06.008


[71 FR 47439, Aug. 17, 2006]

[[Page 171]]



      Sec. Appendix D to Part 101--Nutrition Facts for Cooked Fish

[GRAPHIC] [TIFF OMITTED] TR17AU06.009


[71 FR 47439, Aug. 17, 2006]

[[Page 172]]



PART 102_COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS--Table of Contents




                      Subpart A_General Provisions

Sec.
102.5 General principles.
102.19 Petitions.

        Subpart B_Requirements for Specific Nonstandardized Foods

102.22 Protein hydrolysates.
102.23 Peanut spreads.
102.26 Frozen ``heat and serve'' dinners.
102.28 Foods packaged for use in the preparation of ``main dishes'' or 
          ``dinners.''
102.33 Beverages that contain fruit or vegetable juice.
102.37 Mixtures of edible fat or oil and olive oil.
102.39 Onion rings made from diced onion.
102.41 Potato chips made from dried potatoes.
102.45 Fish sticks or portions made from minced fish.
102.46 Pacific whiting.
102.47 Bonito.
102.49 Fried clams made from minced clams.
102.50 Crabmeat.
102.54 Seafood cocktails.
102.55 Nonstandardized breaded composite shrimp units.
102.57 Greenland turbot (Reinhardtius hippoglossoides).

    Authority: 21 U.S.C. 321, 343, 371.

    Source: 42 FR 14322, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  102.5  General principles.

    (a) The common or usual name of a food, which may be a coined term, 
shall accurately identify or describe, in as simple and direct terms as 
possible, the basic nature of the food or its characterizing properties 
or ingredients. The name shall be uniform among all identical or similar 
products and may not be confusingly similar to the name of any other 
food that is not reasonably encompassed within the same name. Each class 
or subclass of food shall be given its own common or usual name that 
states, in clear terms, what it is in a way that distinguishes it from 
different foods.
    (b) The common or usual name of a food shall include the 
percentage(s) of any characterizing ingredient(s) or component(s) when 
the proportion of such ingredient(s) or component(s) in the food has a 
material bearing on price or consumer acceptance or when the labeling or 
the appearance of the food may otherwise create an erroneous impression 
that such ingredient(s) or component(s) is present in an amount greater 
than is actually the case. The following requirements shall apply unless 
modified by a specific regulation in subpart B of this part.
    (1) The percentage of a characterizing ingredient or component shall 
be declared on the basis of its quantity in the finished product (i.e., 
weight/weight in the case of solids, or volume/volume in the case of 
liquids).
    (2) The percentage of a characterizing ingredient or component shall 
be declared by the words ``containing (or contains) -- percent (or %) --
----'' or ``-- percent (or %) ------'' with the first blank filled in 
with the percentage expressed as a whole number not greater than the 
actual percentage of the ingredient or component named and the second 
blank filled in with the common or usual name of the ingredient or 
component. The word ``containing'' (or ``contains''), when used, shall 
appear on a line immediately below the part of the common or usual name 
of the food required by paragraph (a) of this section. For each 
characterizing ingredient or component, the words ``-- percent or %) --
----'' shall appear following or directly below the word ``containing'' 
(or contains), or directly below the part of the common or usual name of 
the food required by paragraph (a) of this section when the word 
``containing'' (or contains) is not used, in easily legible boldface 
print or type in distinct contrast to other printed or graphic matter, 
and in a height not less than the larger of the following alternatives:
    (i) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (ii) Not less than one-half the height of the largest type appearing 
in the part of the common or usual name of

[[Page 173]]

the food required by paragraph (a) of this section.
    (c) The common or usual name of a food shall include a statement of 
the presence or absence of any characterizing ingredient(s) or 
component(s) and/or the need for the user to add any characterizing 
ingredient(s) or component(s) when the presence or absence of such 
ingredient(s) or component(s) in the food has a material bearing on 
price or consumer acceptance or when the labeling or the appearance of 
the food may otherwise create an erroneous impression that such 
ingredient(s) or component(s) is present when it is not, and consumers 
may otherwise be misled about the presence or absence of the 
ingredient(s) or component(s) in the food. The following requirements 
shall apply unless modified by a specific regulation in subpart B of 
this part.
    (1) The presence or absence of a characterizing ingredient or 
component shall be declared by the words ``containing (or contains) ----
--'' or ``containing (or contains) no ------'' or ``no ------'' or 
``does not contain ------'', with the blank being filled in with the 
common or usual name of the ingredient or component.
    (2) The need for the user of a food to add any characterizing 
ingredient(s) or component(s) shall be declared by an appropriate 
informative statement.
    (3) The statement(s) required under paragraph (c)(1) and/or (2) of 
this section shall appear following or directly below the part of the 
common or usual name of the food required by paragraphs (a) and (b) of 
this section, in easily legible boldface print or type in distinct 
contrast to other printed or graphic matter, and in a height not less 
than the larger of the alternatives established under paragraphs (b)(2) 
(i) and (ii) of this section.
    (d) A common or usual name of a food may be established by common 
usage or by establishment of a regulation in subpart B of this part, in 
part 104 of this chapter, in a standard of identity, or in other 
regulations in this chapter.



Sec.  102.19  Petitions.

    (a) The Commissioner of Food and Drugs, either on his own initiative 
or on behalf of any interested person who has submitted a petition, may 
publish a proposal to issue, amend, or revoke, under this part, a 
regulation prescribing a common or usual name for a food, pursuant to 
part 10 of this chapter.
    (b) If the principal display panel of a food for which a common or 
usual name regulation is established is too small to accommodate all 
mandatory requirements, the Commissioner may establish by regulation an 
acceptable alternative, e.g., a smaller type size. A petition requesting 
such a regulation, which would amend the applicable regulation, shall be 
submitted pursuant to part 10 of this chapter.

[42 FR 14322, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



        Subpart B_Requirements for Specific Nonstandardized Foods



Sec.  102.22  Protein hydrolysates.

    The common or usual name of a protein hydrolysate shall be specific 
to the ingredient and shall include the identity of the food source from 
which the protein was derived.
    (a) ``Hydrolyzed wheat gluten,'' ``hydrolyzed soy protein,'' and 
``autolyzed yeast extract'' are examples of acceptable names. 
``Hydrolyzed casein'' is also an example of an acceptable name, whereas 
``hydrolyzed milk protein'' is not an acceptable name for this 
ingredient because it is not specific to the ingredient (hydrolysates 
can be prepared from other milk proteins). The names ``hydrolyzed 
vegetable protein'' and ``hydrolyzed protein'' are not acceptable 
because they do not identify the food source of the protein.
    (b) [Reserved]

[58 FR 2876, Jan. 6, 1993]



Sec.  102.23  Peanut spreads.

    (a) The common or usual name of a spreadable peanut product that 
does not conform to Sec.  164.150 of this chapter, and more than 10 
percent of which consists of nonpeanut ingredients, shall consist of the 
term ``peanut spread'' and a statement of the percentage by weight of 
peanuts in the product in the manner set forth in Sec.  102.5(b), except

[[Page 174]]

that peanut percentages shall be based on the amount of peanuts used to 
make the finished food and shall be declared in 5-percent increments 
expressed as a multiple of 5, not to exceed the actual percentage of 
peanuts in the products.
    (b) A spreadable peanut product that is nutritionally inferior to 
peanut butter shall be labeled as an imitation of peanut butter under 
Sec.  101.3(e)(2) of this chapter; a spreadable peanut product shall be 
considered nutritionally equivalent to peanut butter if it meets all of 
the following conditions:
    (1) Protein. (i) The protein content of the product is at least 24 
percent by weight of the finished product, and the overall biological 
quality of the protein contained in the product is at least 68 percent 
that of casein; or
    (ii) The protein content of the product is at least 16.6 percent by 
weight of the finished product, and the overall biological quality of 
the protein contained in the product is equal to or greater than that of 
casein.
    (2) Other nutrients. The product contains the following levels of 
nutrients per 100 grams of product:

------------------------------------------------------------------------
                                                               Amount
                         Nutrient                           (milligrams)
------------------------------------------------------------------------
Niacin....................................................         15.3
Vitamin B6................................................         0.33
Folic acid................................................         0.08
Iron......................................................          2.0
Zinc......................................................          2.9
Magnesium.................................................        173.0
Copper....................................................          0.6
------------------------------------------------------------------------

    (c) Compliance with the requirements of paragraph (b) of this 
section shall be determined by methods described in the following 
references except that in determining protein quantity in products with 
mixed protein sources a nitrogen conversion factor of 6.25 may be used.
    (1) Protein quantity: ``Official Methods of Analysis of the 
Association of Official Analytical Chemists'' (AOAC), 13th Ed. (1980), 
using the method described in section 27.007, which is incorporated by 
reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North 
Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.
    (2) Biological quality of protein: AOAC, 13th Ed. (1980), using the 
method described in sections 43.212-43.216, which is incorporated by 
reference. The availability of this incorporation by reference is given 
in paragraph (c)(1) of this section.
    (3) Niacin: AOAC, 13th Ed. (1980), using the method described in 
sections 43.044-43.046, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.
    (4) Vitamin B6: AOAC, 13th Ed. (1980), using the method 
described in sections 43.188-43.193, which is incorporated by reference. 
The availability of this incorporation by reference is given in 
paragraph (c)(1) of this section.
    (5) Folic acid: Using the method described in U.S. Department of 
Agriculture Handbook No. 29, modified by use of ascorbate buffer as 
described by Ford and Scott, Journal of Dairy Research, 35:85-90 (1968), 
which is incorporated by reference. Copies are available from the Center 
for Food Safety and Applied Nutrition (HFS-800), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
    (6) Iron: AOAC, 13th Ed. (1980), using the method described in 
sections 43.217-43.219, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.
    (7) Zinc: AOAC, 13th Ed. (1980), using the method described in 
sections 25.150-25.153, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.
    (8) Copper: AOAC, 13th Ed. (1980), using the method described in 
sections 25.038-25.043, which is incorporated by

[[Page 175]]

reference. The availability of this incorporation by reference is given 
in paragraph (c)(1) of this section.
    (9) Magnesium: AOAC, 13th Ed. (1980), using the method described in 
sections 2.109-2.113, which is incorporated by reference. The 
availability of this incorporation by reference is given in paragraph 
(c)(1) of this section.

[42 FR 36455, July 15, 1977, as amended at 47 FR 11821, Mar. 19, 1982; 
49 FR 5609, Feb. 14, 1984; 54 FR 24891, June 12, 1989; 61 FR 14479, Apr. 
2, 1996; 63 FR 14035, Mar. 24, 1998; 66 FR 17358, Mar. 30, 2001; 66 FR 
56035, Nov. 6, 2001]



Sec.  102.26  Frozen ``heat and serve'' dinners.

    (a) A frozen ``heat and serve'' dinner:
    (1) Shall contain at least three components, one of which shall be a 
significant source of protein and each of which shall consist of one or 
more of the following: meat, poultry, fish, cheese, eggs, vegetables, 
fruit, potatoes, rice, or other cereal based products (other than bread 
or rolls).
    (2) May also contain other servings of food (e.g., soup, bread or 
rolls, beverage, dessert).
    (b) The common or usual name of the food consists of all of the 
following:
    (1) The phrase ``frozen `heat and serve' dinner,'' except that the 
name of the predominant characterizing ingredient or other appropriately 
descriptive term may immediately precede the word ``dinner'' (e.g., 
``frozen chicken dinner'' or ``frozen heat and serve beef dinner''). The 
words ``heat and serve'' are optional. The word ``frozen'' is also 
optional, provided that the words ``Keep Frozen'' or the equivalent are 
prominently and conspicuously placed on the principal display panel in 
type size not less than that specified in Sec.  102.5(b)(2)(i).
    (2) The phrase ``containing (or contains) ------'' the blank to be 
filled in with an accurate description of each of the three or more dish 
components listed in paragraph (a)(1) of this section in their order of 
descending predominance by weight (e.g., ham, mashed potatoes, and 
peas), followed by any of the other servings specified in paragraph 
(a)(2) of this section contained in the package (e.g., onion soup, 
enriched white bread, and artificially flavored vanilla pudding) in 
their order of descending predominance by weight. This part of the name 
shall be placed immediately following or directly below the part 
specified in paragraph (b)(1) of this section in the manner set forth in 
Sec.  102.5(c)(3). The words ``contains'' or ``containing'' are 
optional.
    (3) If the labeling implies that the package contains other foods 
and these foods are not present in the package, e.g., if a vignette on 
the package depicts a ``serving suggestion'' which includes any foods 
not present in the package, the principal display panel shall bear a 
statement that such foods are not present, in type size not less than 
that specified in Sec.  102.5(b)(2)(i).



Sec.  102.28  Foods packaged for use in the preparation of ``main dishes'' or 

``dinners.''

    (a) The common or usual name of a packaged food which is represented 
on the principal display panel by word or vignette to be used in the 
preparation of a ``main dish'', ``dinner'', or other such food serving, 
and to which some other important characterizing ingredient(s) or 
component(s) not present in the package must be added, consists of all 
the following:
    (1) The common or usual name of each important ingredient or 
component in the package, in descending order of predominance by weight 
(e.g., ``noodles and tomato sauce'').
    (2) An appropriate informative statement identifying the food to be 
prepared by use of the package contents (e.g., ``for preparation of 
chicken casserole'').
    (3) An appropriate informative statement that additional 
characterizing ingredient(s) or component(s) must be added and which 
names the additional characterizing ingredient(s) or component(s) (e.g., 
``you must add ------ to complete the recipe,'' the blank to be filled 
in with the name(s) of the important characterizing ingredient(s) or 
component(s) that must be added).
    (b) The labeling required by paragraph (a) of this section shall 
appear on the principal display panel.
    (1) No word in the statement required by paragraph (a)(2) of this 
section may appear on the principal display panel more conspicuously or 
in larger type

[[Page 176]]

than the smallest and least conspicuous type employed on the panel for 
any word, phrase or statement within the scope of paragraph (a)(1) of 
this section.
    (2) Every word in the statement required by paragraph (a)(3) of this 
section shall appear on the principal display panel in easily legible 
bold face print or type in distinct contrast to other printed or graphic 
matter, and in a height not less than the larger of the following 
alternatives:
    (i) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (ii) Not less than one-half the height of the largest type appearing 
in the part of the common or usual name of the food required by 
paragraphs (a) (1) and (2) of this section.
    (c) Any vignette which shows any food or characterizing 
ingredient(s) or component(s) not included in the package shall be 
accompanied either by the statement required by paragraph (a)(3) of this 
section or by a separate statement specifying the food or characterizing 
ingredient(s) or component(s) shown in the vignette but not included in 
the package.
    (d) If the statement specified in paragraph (a)(2) of this section 
is used on any panel in addition to the principal display panel as a 
product identification statement, the complete common or usual name 
shall appear on such panel in the manner specified in paragraph (b) of 
this section.
    (e) When a brand name or other prominent product designation 
contains a word or words that includes or suggests an important 
characterizing ingredient(s) or component(s) that must be added, or 
otherwise states or implies that the package contains a complete main 
dish, dinner, or other food serving, the part of the common or usual 
name of the food required by paragraph (a)(3) of this section shall 
appear in direct conjunction with such brand name or other designation 
and in type size not less than one-half the height of the largest type 
appearing in such brand name or other designation.



Sec.  102.33  Beverages that contain fruit or vegetable juice.

    (a) For a carbonated or noncarbonated beverage that contains less 
than 100 percent and more than 0 percent fruit or vegetable juice, the 
common or usual name shall be a descriptive name that meets the 
requirements of Sec.  102.5(a) and, if the common or usual name uses the 
word ``juice,'' shall include a qualifying term such as ``beverage,'' 
``cocktail,'' or ``drink'' appropriate to advise the consumer that the 
product is less than 100 percent juice (e.g., ``diluted grape juice 
beverage'' or ``grape juice drink'').
    (b) If the product is a diluted multiple-juice beverage or blend of 
single-strength juices and names, other than in the ingredient 
statement, more than one juice, then the names of those juices, except 
in the ingredient statement, must be in descending order of predominance 
by volume unless the name specifically shows that the juice with the 
represented flavor is used as a flavor (e.g., raspberry-flavored apple 
and pear juice drink). In accordance with Sec.  101.22(i)(1)(iii) of 
this chapter, the presence of added natural flavors is not required to 
be declared in the name of the beverage unless the declared juices alone 
do not characterize the product before the addition of the added 
flavors.
    (c) If a diluted multiple-juice beverage or blend of single-strength 
juices contains a juice that is named or implied on the label or 
labeling other than in the ingredient statement (represented juice), and 
also contains a juice other than the named or implied juice 
(nonrepresented juice), then the common or usual name for the product 
shall indicate that the represented juice is not the only juice present 
(e.g., ``Apple blend; apple juice in a blend of two other fruit 
juices.'')
    (d) In a diluted multiple-juice beverage or blend of single-strength 
juices where one or more, but not all, of the juices are named on the 
label other than in the ingredient statement, and where the named juice 
is not the predominant juice, the common or usual name for the product 
shall:
    (1) Indicate that the named juice is present as a flavor or 
flavoring (e.g.,

[[Page 177]]

``Raspcranberry''; raspberry and cranberry flavored juice drink); or
    (2) Include the amount of the named juice, declared in a 5- percent 
range (e.g., Raspcranberry; raspberry and cranberry juice beverage, 10- 
to 15-percent cranberry juice and 3- to 8-percent raspberry juice). The 
5-percent range, when used, shall be declared in the manner set forth in 
Sec.  102.5(b)(2).
    (e) The common or usual name of a juice that has been modified shall 
include a description of the exact nature of the modification (e.g., 
``acid-reduced cranberry juice,'' ``deflavored, de colored grape 
juice'').
    (f) If the product is a beverage that contains a juice whose color, 
taste, or other organoleptic properties have been modified to the extent 
that the original juice is no longer recognizable at the time processing 
is complete, or if its nutrient profile has been diminished to a level 
below the normal nutrient range for the juice, then the source fruits or 
vegetables from which the modified juice was derived may not be depicted 
on the label by vignette or other pictorial representation.
    (g)(1) If one or more juices in a juice beverage is made from 
concentrate, the name of the juice must include a term indicating that 
fact, such as ``from concentrate,'' or ``reconstituted.'' Such terms 
must be included in the name of each individual juice or it may be 
stated once adjacent to the product name so that it applies to all the 
juices, (e.g., ``cherry juice (from concentrate) in a blend of two other 
juices'' or ``cherry juice in a blend of 2 other juices (from 
concentrate)''). The term shall be in a type size no less than one-half 
the height of the letters in the name of the juice.
    (2) If the juice is 100 percent single species juice consisting of 
juice directly expressed from a fruit or vegetable whose Brix level has 
been raised by the addition of juice concentrate from the same fruit or 
vegetable, the name of the juice need not include a statement that the 
juice is from concentrate. However, if water is added to this 100 
percent juice mixture to adjust the Brix level, the product shall be 
labeled with the term ``from concentrate'' or ``reconstituted.''

[58 FR 2926, Jan. 6, 1993; 58 FR 17103, Apr. 1, 1993, as amended at 58 
FR 44063, Aug. 18, 1993; 62 FR 15343, Mar. 31, 1997]



Sec.  102.37  Mixtures of edible fat or oil and olive oil.

    The common or usual name of a mixture of edible fats and oils 
containing less than 100 percent and more than 0 percent olive oil shall 
be as follows:
    (a) A descriptive name for the product meeting the requirements of 
Sec.  102.5(a), e.g., ``cottonseed oil and olive oil'' or another 
descriptive phrase, and
    (b) When the label bears any representation, other than in the 
ingredient listing, of the presence of olive oil in the mixture, the 
descriptive name shall be followed by a statement of the percentage of 
olive oil contained in the product in the manner set forth in Sec.  
102.5(b)(2).



Sec.  102.39  Onion rings made from diced onion.

    (a) The common or usual name of the food product that resembles and 
is of the same composition as onion rings, except that it is composed of 
comminuted onions, shall be as follows:
    (1) When the product is composed of dehydrated onions, the name 
shall be ``onion rings made from dried diced onions.''
    (2) When the product is composed of any form of onion other than 
dehydrated, the name shall be ``onion rings made from diced onions.''
    (b) The words ``made from dried diced onions'' or ``made from diced 
onions'' shall immediately follow or appear on a line(s) immediately 
below the words ``onion rings'' in easily legible boldface print or type 
in distinct contrast to other printed or graphic matter, and in a height 
not less than the larger of the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``onion rings.''

[[Page 178]]



Sec.  102.41  Potato chips made from dried potatoes.

    (a) The common or usual name of the food product that resembles and 
is of the same composition as potato chips, except that it is composed 
of dehydrated potatoes (buds, flakes, granules, or other form), shall be 
``potato chips made from dried potatoes.''
    (b) The words ``made from dried potatoes'' shall immediately follow 
or appear on a line(s) immediately below the words ``potato chips'' in 
easily legible boldface print or type in distinct contrast to other 
printed or graphic matter, and in a height not less than the larger of 
the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``potato chips.''



Sec.  102.45  Fish sticks or portions made from minced fish.

    (a) The common or usual name of the food product that resembles and 
is of the same composition as fish sticks or fish portions, except that 
it is composed of comminuted fish flesh, shall be ``fish ------ made 
from minced fish,'' the blank to be filled in with the word ``sticks'' 
or ``portions'' as the case may be.
    (b) The words ``made from minced fish'' shall immediately follow or 
appear on a line(s) immediately below the words ``fish ------'' in 
easily legible boldface print or type in distinct contrast to other 
printed or graphic matter, and in a height not less than the larger of 
the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``fish ------.''



Sec.  102.46  Pacific whiting.

    ``Pacific whiting'' or ``North Pacific whiting'' is the common or 
usual name of the food fish Merluccius productus.

[44 FR 45617, Aug. 3, 1979]



Sec.  102.47  Bonito.

    ``Bonito'' or ``bonito fish'' is the common or usual name of the 
following food fishes:

Cybiosarda elegans (Whitely, 1935)--Leaping bonito
Gymnosarda unicolor (Ruppell, 1838)--Dogtooth tuna
Orcynopsis unicolor (Geoffroy St. Hilaire, 1817)--Plain bonito
Sarda australis (Macleay, 1880)--Australian bonito
Sarda chiliensis (Cuvier, 1831)--Eastern Pacific bonito
Sarda orientalis (Temminck and Schlegel, 1844)--Striped bonito
Sarda sarda (Bloch, 1793)--Atlantic bonito

[55 FR 45797, Oct. 31, 1990]



Sec.  102.49  Fried clams made from minced clams.

    (a) The common or usual name of the food product that resembles and 
is of the same composition as fried clams, except that it is composed of 
comminuted clams, shall be ``fried clams made from minced clams.''
    (b) The words ``made from minced clams'' shall immediately follow or 
appear on a line(s) immediately below the words ``fried clams'' and in 
easily legible boldface print or type in distinct contrast to other 
printed or graphic matter, and in a height not less than the larger of 
the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and not 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``fried clams.''



Sec.  102.50  Crabmeat.

    The common or usual name of crabmeat derived from each of the 
following designated species of crabs shall be as follows:

[[Page 179]]



------------------------------------------------------------------------
                                               Common or usual name of
          Scientific name of crab                     crabmeat
------------------------------------------------------------------------
Chionoecetes opilio,                        Snow crabmeat.
  Chionoecetes tanneri,
  Chionoecetes bairdii, and
  Chionoecetes angulatus
Erimacrus isenbeckii                        Korean variety crabmeat or
                                             Kegani crabmeat.
Lithodes aequispina                         Brown King crabmeat.
Paralithodes brevipes                       King crabmeat or Hanasaki
                                             crabmeat.
Paralithodes camtschaticus                  King crabmeat and
                                             Paralithodes Platypus.
------------------------------------------------------------------------


[42 FR 14322, Mar. 15, 1977, as amended at 60 FR 34460, July 3, 1995]



Sec.  102.54  Seafood cocktails.

    The common or usual name of a seafood cocktail in package form 
fabricated with one or more seafood ingredients shall be:
    (a) When the cocktail contains only one seafood ingredient, the name 
of the seafood ingredient followed by the word ``cocktail'' (e.g., 
shrimp cocktail, crabmeat cocktail) and a statement of the percentage by 
weight of that seafood ingredient in the product in the manner set forth 
in Sec.  102.5(b).
    (b) When the cocktail contains more than one seafood ingredient, the 
term ``seafood cocktail'' and a statement of the percentage by weight of 
each seafood ingredient in the product in the manner set forth in Sec.  
102.5(b).



Sec.  102.55  Nonstandardized breaded composite shrimp units.

    (a) The common on usual name of the food product that conforms to 
the definition and standard of identity described by Sec.  161.175(c)(6) 
of this chapter, except that the food is made from comminuted shrimp and 
is not in raw frozen form, shall be ``------ made from minced shrimp,'' 
the blank to be filled in with the words ``breaded shrimp sticks'' or 
``breaded shrimp cutlets'' depending upon the shape of the product, or 
if prepared in a shape other than that of sticks or cutlets ``breaded 
shrimp ------ made from minced shrimp,'' the blank to be filled by a 
word or phrase that accurately describes the shape and that is not 
misleading.
    (b) The words ``made from minced shrimp'' shall immediately follow 
or appear on a line(s) immediately below the other words required by 
this section in easily legible boldface print or type in distinct 
contrast to other printed or graphic matter, and in a height not less 
than the larger of the following alternatives:
    (1) Not less than one-sixteenth inch in height on packages having a 
principal display panel with an area of 5 square inches or less and no 
less than one-eighth inch in height if the area of the principal display 
panel is greater than 5 square inches; or
    (2) Not less than one-half the height of the largest type used in 
the words ``breaded shrimp sticks'' or the other comparable words 
required by this section.



Sec.  102.57  Greenland turbot (Reinhardtius hippoglossoides).

    ``Greenland turbot'' is the common or usual name of the food fish 
Reinhardtius hippoglossoides, a species of Pleuronectidae right-eye 
flounders. The term ``halibut'' may be associated only with Atlantic 
halibut (Hippoglossus hippoglossus) or Pacific halibut (Hippoglossus 
stenolepis).



PART 104_NUTRITIONAL QUALITY GUIDELINES FOR FOODS--Table of Contents




                      Subpart A_General Provisions

Sec.
104.5 General principles.

                     Subpart B_Fortification Policy

104.20 Statement of purpose.

            Subpart C_Specific Nutritional Quality Guidelines

104.47 Frozen ``heat and serve'' dinner.

    Authority: 21 U.S.C. 321, 343, 371(a).

    Source: 42 FR 14327, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  104.5  General principles.

    (a) A nutritional quality guideline prescribes the minimum level or 
range of nutrient composition (nutritional quality) appropriate for a 
given class of food.
    (b) Labeling for a product which complies with all of the 
requirements of

[[Page 180]]

the nutritional quality guideline established for its class of food may 
state ``This product provides nutrients in amounts appropriate for this 
class of food as determined by the U.S. Government,'' except that the 
words ``this product'' are optional. This statement, if used, shall be 
printed on the principal display panel, and may also be printed on the 
information panel, in letters not larger than twice the size of the 
minimum type required for the declaration of net quantity of contents by 
Sec.  101.105 of this chapter. Labeling of noncomplying products may not 
include any such statement or otherwise represent, suggest, or imply the 
product as being, in whole or in part, in compliance with a guideline.
    (c) A product bearing the statement provided for in paragraph (b) of 
this section, in addition to meeting the requirements of the applicable 
nutritional quality guideline, shall comply with the following 
requirements:
    (1) The label of the product shall bear the common or usual name of 
the food in accordance with the provisions of the guideline and 
Sec. Sec.  101.3 and 102.5(a) of this chapter.
    (2) The label of the product shall bear nutrition labeling in 
accordance with Sec. Sec.  101.2 and 101.9 of this chapter and all other 
labeling required by applicable sections of part 101 of this chapter.
    (d) No claim or statement may be made on the label or in labeling 
representing, suggesting, or implying any nutritional or other 
differences between a product to which nutrient addition has or has not 
been made in order to meet the guideline, except that a nutrient 
addition shall be declared in the ingredient statement.
    (e) Compliance with a nutrient level specified in a nutritional 
quality guideline shall be determined by the procedures and requirements 
established in Sec.  101.9(g) of this chapter.
    (f) A product within a class of food for which a nutritional quality 
guideline has been established and to which has been added a discrete 
nutrient either for which no minimum nutrient level or nutrient range or 
other allowance has been established as appropriate in the nutritional 
quality guideline, or at a level that exceeds any maximum established as 
appropriate in the guideline, shall be ineligible to bear the guideline 
statement provided for in paragraph (b) of this section, and such a 
product shall also be deemed to be misbranded under the act unless the 
label and all labeling bear the following prominent and conspicuous 
statement: ``The addition of ------ to (or ``The addition of ------ at 
the level contained in) this product has been determined by the U.S. 
Government to be unnecessary and inappropriate and does not increase the 
dietary value of the food,'' the blank to be filled in with the common 
or usual name of the nutrient(s) involved.

[42 FR 14327, Mar. 15, 1977, as amended at 63 FR 14818, Mar. 27, 1998]



                     Subpart B_Fortification Policy



Sec.  104.20  Statement of purpose.

    (a) The fundamental objective of this subpart is to establish a 
uniform set of principles that will serve as a model for the rational 
addition of nutrients to foods. The achievement and maintenance of a 
desirable level of nutritional quality in the nation's food supply is an 
important public health objective. The addition of nutrients to specific 
foods can be an effective way of maintaining and improving the overall 
nutritional quality of the food supply. However, random fortification of 
foods could result in over- or underfortification in consumer diets and 
create nutrient imbalances in the food supply. It could also result in 
deceptive or misleading claims for certain foods. The Food and Drug 
Administration does not encourage indiscriminate addition of nutrients 
to foods, nor does it consider it appropriate to fortify fresh produce; 
meat, poultry, or fish products; sugars; or snack foods such as candies 
and carbonated beverages. To preserve a balance of nutrients in the 
diet, manufacturers who elect to fortify foods are urged to utilize 
these principles when adding nutrients to food. It is reasonable to 
anticipate that the Reference Daily Intakes (RDI's) as delineated in 
Sec.  101.9 of this chapter and in paragraph (d) of this section will be 
amended from time to time to list additional nutrients and/or to change 
the levels of specific RDI's as improved

[[Page 181]]

knowledge about human nutrient requirements and allowances develops. The 
policy set forth in this section is based on U.S. dietary practices and 
nutritional needs and may not be applicable in other countries.
    (b) A nutrient(s) listed in paragraph (d)(3) of this section may 
appropriately be added to a food to correct a dietary insufficiency 
recognized by the scientific community to exist and known to result in 
nutritional deficiency disease if:
    (1) Sufficient information is available to identify the nutritional 
problem and the affected population groups, and the food is suitable to 
act as a vehicle for the added nutrients. Manufacturers contemplating 
using this principle are urged to contact the Food and Drug 
Administration before implementing a fortification plan based on this 
principle.
    (2) The food is not the subject of any other Federal regulation for 
a food or class of food that requires, permits, or prohibits nutrient 
additions. (Other Federal regulations include, but are not limited to, 
standards of identity promulgated under section 401 of the Federal Food, 
Drug, and Cosmetic Act, nutritional quality guidelines established in 
subpart C of this part, and common or usual name regulations established 
in part 102 of this chapter.)
    (c) A nutrient(s) listed in paragraph (d)(3) of this section may 
appropriately be added to a food to restore such nutrient(s) to a 
level(s) representative of the food prior to storage, handling, and 
processing, when:
    (1) The nutrient is shown by adequate scientific documentation to 
have been lost in storage, handling, or processing in a measurable 
amount equal to at least 2 percent of the Daily Reference Value (DRV) of 
protein and of potassium and 2 percent of the Reference Daily Intake 
(RDI) in a normal serving of the food.
    (2) Good manufacturing practices and normal storage and handling 
procedures cannot prevent the loss of such nutrient(s),
    (3) All nutrients, including protein, iodine and vitamin D, that are 
lost in a measurable amount are restored and all ingredients of the food 
product that contribute nutrients are considered in determining 
restoration levels; and
    (4) The food is not the subject of any other Federal regulation that 
requires or prohibits nutrient addition(s), or the food has not been 
fortified in accordance with any other Federal regulation that permits 
voluntary nutrient additions.
    (d) A nutrient(s) listed in paragraph (d)(3) of this section may be 
added to a food in proportion to the total caloric content of the food, 
to balance the vitamin, mineral, and protein content if:
    (1) A normal serving of the food contains at least 40 kilocalories 
(that is, 2 percent of a daily intake of 2,000 kilocalories);
    (2) The food is not the subject of any other Federal regulation for 
a food or class of food that requires, permits, or prohibits nutrient 
additions; and
    (3) The food contains all of the following nutrients per 100 
calories based on 2,000 calorie total intake as a daily standard:

------------------------------------------------------------------------
                                                                 Amount
         Nutrient              Unit of measurement      DRV or   per 100
                                                       RDI \1\  calories
------------------------------------------------------------------------
Protein...................  grams (g)................     50       2.5
Vitamin A.................  International Unit (IU)..  5,000     250
Vitamin C.................  milligrams (mg)..........     60       3
Calcium...................  g........................      1       0.05
Iron......................  mg.......................     18       0.9
Vitamin D.................  IU.......................    400      20
Vitamin E.................  do.......................     30       1.5
Thiamin...................  mg.......................      1.5     0.08
Riboflavin................  do.......................      1.7     0.09
Niacin....................  do.......................     20       1
Vitamin B6................  do.......................      2.0     0.1
Folate....................  micrograms ([micro]g)....    400      20
Vitamin B12...............  do.......................      6.0     0.3
Biotin....................  mg.......................      0.3     0.015
Pantothenic acid..........  do.......................     10       0.5
Phosphorus................  g........................      1.0     0.05
Magnesium.................  mg.......................    400      20
Zinc......................  do.......................     15       0.8
Iodine....................  [micro]g.................    150       7.5
Copper....................  mg.......................      2.0     0.1
Potassium.................  do.......................  3,500     175
------------------------------------------------------------------------
\1\ RDI's for adults and children 4 or more years of age.

    (e) A nutrient(s) may appropriately be added to a food that replaces 
traditional food in the diet to avoid nutritional inferiority in 
accordance with Sec.  101.3(e)(2) of this chapter.
    (f) Nutrient(s) may be added to foods as permitted or required by 
applicable regulations established elsewhere in this chapter.
    (g) A nutrient added to a food is appropriate only when the 
nutrient:

[[Page 182]]

    (1) Is stable in the food under customary conditions of storage, 
distribution, and use;
    (2) Is physiologically available from the food;
    (3) Is present at a level at which there is a reasonable assurance 
that consumption of the food containing the added nutrient will not 
result in an excessive intake of the nutrient, considering cumulative 
amounts from other sources in the diet; and
    (4) Is suitable for its intended purpose and is in compliance with 
applicable provisions of the act and regulations governing the safety of 
substances in food.
    (h) Any claims or statements in the labeling of food about the 
addition of a vitamin, mineral, or protein to a food shall be made only 
if the claim or statement is not false or misleading and otherwise 
complies with the act and any applicable regulations. The following 
label claims are acceptable:
    (1) The labeling claim ``fully restored with vitamins and minerals'' 
or ``fully restored with vitamins and minerals to the level of 
unprocessed ------'' (the blank to be filled in with the common or usual 
name of the food) may be used to describe foods fortified in accordance 
with the principles established in paragraph (c) of the section.
    (2) The labeling claim, ``vitamins and minerals (and ``protein'' 
when appropriate) added are in proportion to caloric content'' may be 
used to describe food fortified in accordance with the principles 
established in paragraph (d) of this section.
    (3) When labeling claims are permitted, the term ``enriched,'' 
``fortified,'' ``added,'' or similar terms may be used interchangeably 
to indicate the addition of one or more vitamins or minerals or protein 
to a food, unless an applicable Federal regulation requires the use of 
specific words or statements.
    (i) It is inappropriate to make any claim or statement on a label or 
in labeling, other than in a listing of the nutrient ingredients as part 
of the ingredient statement, that any vitamin, mineral, or protein has 
been added to a food to which nutrients have been added pursuant to 
paragraph (e) of this section.

[45 FR 6323, Jan. 25, 1980, as amended at 58 FR 2228, Jan. 6, 1993]



            Subpart C_Specific Nutritional Quality Guidelines



Sec.  104.47  Frozen ``heat and serve'' dinner.

    (a) A product, for which a common or usual name is established in 
Sec.  102.26 of this chapter, in order to be eligible to bear the 
guideline statement set forth at Sec.  104.5(b), shall contain at least 
the following three components:
    (1) One or more sources of protein derived from meat, poultry, fish, 
cheese, or eggs.
    (2) One or more vegetables or vegetable mixtures other than 
potatoes, rice, or cereal-based product.
    (3) Potatoes, rice, or cereal-based product (other than bread or 
rolls) or another vegetable or vegetable mixture.
    (b) The three or more components named in paragraph (a) of this 
section, including their sauces, gravies, breading, etc.:
    (1) Shall contribute not less than the minimum levels of nutrients 
prescribed in paragraph (d) of this section.
    (2) Shall be selected so that one or more of the listed protein 
sources of paragraph (a)(1) of this section, excluding their sauces, 
gravies, breading, etc., shall provide not less than 70 percent of the 
total protein supplied by the components named in paragraph (a) of this 
section.
    (c) If it is necessary to add any nutrient(s) in order to meet the 
minimum nutrient levels prescribed in paragraph (d) of this section, the 
addition of each such nutrient may not result in a total nutrient level 
exceeding 150 percent of the minimum level prescribed. Nutrients used 
for such addition shall be biologically available in the final product.
    (d) Minimum levels of nutrients for a frozen ``heat and serve'' 
dinner are as follows:

[[Page 183]]



------------------------------------------------------------------------
                                                    Minimum levels for
                                                     frozen ``heat and
                                                     serve'' dinner--
                                                 -----------------------
                                                   For each
                                                      100
                    Nutrient                       Calories     For the
                                                   (keal) of     total
                                                   the total  components
                                                  components   specified
                                                   specified    in par.
                                                    in par.       (a)
                                                      (a)
------------------------------------------------------------------------
Protein, grams..................................        4.60        16.0
Vitamin A, IU...................................      150.00       520.0
Thiamine, mg....................................         .05          .2
Riboflavin, mg..................................         .06          .2
Niacin, mg......................................         .99         3.4
Pantothenic acid, mg............................         .32         1.1
Vitamin, B6, mg.................................         .15          .5
Vitamin, B1.....................................         .33         1.1
Iron, mg........................................         .62         2.2
------------------------------------------------------------------------

    (1) A frozen ``heat and serve'' dinner prepared from conventional 
food ingredients listed in paragraph (a) of this section will also 
contain folic acid, magnesium, iodine, calcium, and zinc. Minimum levels 
for these nutrients cannot be established at the present time but may be 
specified as additional data are obtained.
    (2) The minimum levels for pantothenic acid, vitamin B-6, and 
vitamin B-12 are tentative. Final levels will be established when 
sufficient data are available. Until final levels are established, a 
product containing less than the tentative levels will not be deemed to 
be misbranded when labeled in accordance with Sec.  104.5(b).
    (3) When technologically practicable, iodized salt shall be used or 
iodine shall be present at a level equivalent to that which would be 
present if iodized salt were used in the manufacture of the product.
    (4) When technologically practicable, product components and 
ingredients shall be selected to obtain the desirable calcium to 
phosphorous ratio of 1:1. Technological addition of phosphates shall be 
minimized and shall not exceed the amount necessary for the intended 
effect.
    (e) If the product includes servings of food which are not 
prescribed by paragraph (a) of this section (e.g., soup, bread or rolls, 
beverage, or dessert), their contribution shall not be considered in 
determining compliance with the nutrient levels established in paragraph 
(d) of this section but shall be included in any nutrition labeling.
    (f) For the purposes of labeling, an ``average serving'' shall be 
one entire frozen ``heat and serve'' dinner.

[42 FR 14327, Mar. 5, 1977]



PART 105_FOODS FOR SPECIAL DIETARY USE--Table of Contents




                      Subpart A_General Provisions

Sec.
105.3 Definitions and interpretations.

                       Subpart B_Label Statements

105.62 Hypoallergenic foods.
105.65 Infant foods.
105.66 Label statements relating to usefulness in reducing or 
          maintaining body weight.

Subpart C [Reserved]

Subpart D--Standards of Identity [Reserved]

    Authority: 21 U.S.C. 321, 341, 343, 348, 350, 371, 379e.

    Source: 42 FR 14328, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  105.3  Definitions and interpretations.

    The definitions and interpretations of terms contained in section 
201 of the Federal Food, Drug, and Cosmetic Act (hereafter ``the act'') 
shall be applicable with the following additions:
    (a)(1) The term special dietary uses, as applied to food for man, 
means particular (as distinguished from general) uses of food, as 
follows:
    (i) Uses for supplying particular dietary needs which exist by 
reason of a physical, physiological, pathological or other condition, 
including but not limited to the conditions of diseases, convalescence, 
pregnancy, lactation, allergic hypersensitivity to food, underweight, 
and overweight;
    (ii) Uses for supplying particular dietary needs which exist by 
reason of age, including but not limited to the ages of infancy and 
childhood;
    (iii) Uses for supplementing or fortifying the ordinary or usual 
diet with any vitamin, mineral, or other dietary property. Any such 
particular use of a food is a special dietary use, regardless

[[Page 184]]

of whether such food also purports to be or is represented for general 
use.
    (2) The use of an artificial sweetener in a food, except when 
specifically and solely used for achieving a physical characteristic in 
the food which cannot be achieved with sugar or other nutritive 
sweetener, shall be considered a use for regulation of the intake of 
calories and available carbohydrate, or for use in the diets of 
diabetics and is therefore a special dietary use.
    (b)-(d) [Reserved]
    (e) For the purposes of the regulations in this part, the terms 
infant, child, and adult mean persons not more than 12 months old, more 
than 12 months but less than 12 years old, and 12 years or more old, 
respectively.

[42 FR 14328, Mar. 15, 1977, as amended at 44 FR 16006, Mar. 16, 1979; 
44 FR 49665, Aug. 24, 1979]



                       Subpart B_Label Statements



Sec.  105.62  Hypoallergenic foods.

    If a food purports to be or is represented for special dietary use 
by reason of the decrease or absence of any allergenic property or by 
reason of being offered as food suitable as a substitute for another 
food having an allergenic property, the label shall bear:
    (a) The common or usual name and the quantity or proportion of each 
ingredient (including spices, flavoring, and coloring) in case the food 
is fabricated from two or more ingredients.
    (b) A qualification of the name of the food, or the name of each 
ingredient thereof in case the food is fabricated from two or more 
ingredients, to reveal clearly the specific plant or animal that is the 
source of such food or of such ingredient, if such food or such 
ingredient consists in whole or in part of plant or animal matter and 
such name does not reveal clearly the specific plant or animal that is 
such a source.
    (c) An informative statement of the nature and effect of any 
treatment or processing of the food or any ingredient thereof, if the 
changed allergenic property results from such treatment or processing.



Sec.  105.65  Infant foods.

    (a) If a food (other than a dietary supplement of vitamins and/or 
minerals alone) purports to be or is represented for special dietary use 
for infants, the label shall bear, if such food is fabricated from two 
or more ingredients, the common or usual name of each ingredient, 
including spices, flavoring, and coloring.
    (b) If such food, or any ingredient thereof, consists in whole or in 
part of plant or animal matter and the name of such food or ingredient 
does not clearly reveal the specific plant or animal which is its 
source, such name shall be so qualified as to reveal clearly the 
specific plant or animal that is such source.

[42 FR 14328, Mar. 15, 1977, as amended at 47 FR 947, Jan. 8, 1982; 49 
FR 10090, Mar. 19, 1984; 50 FR 1840, Jan. 14, 1985]



Sec.  105.66  Label statements relating to usefulness in reducing or 

maintaining body weight.

    (a) General requirements. Any food that purports to be or is 
represented for special dietary use because of usefulness in reducing or 
maintaining body weight shall bear:
    (1) Nutrition labeling in conformity with Sec.  101.9, or, where 
applicable, Sec.  101.36 of this chapter, unless exempt under that 
section; and
    (2) A conspicuous statement of the basis upon which the food claims 
to be of special dietary usefulness.
    (b) Nonnutritive ingredients. (1) Any food subject to paragraph (a) 
of this section that achieves its special dietary usefulness by use of a 
nonnutritive ingredient (i.e., one not utilized in normal metabolism) 
shall bear on its label a statement that it contains a nonnutritive 
ingredient and the percentage by weight of the nonnutritive ingredient.
    (2) A special dietary food may contain a nonnutritive sweetener or 
other ingredient only if the ingredient is safe for use in the food 
under the applicable law and regulations of this chapter. Any food that 
achieves its special dietary usefulness in reducing or maintaining body 
weight through the use of a nonnutritive sweetener shall bear on its 
label the statement required by paragraph (b)(1) of this section, but 
need not state the percentage by weight of the nonnutritive sweetener. 
If a nutritive sweetener(s) as well as

[[Page 185]]

nonnutritive sweetener(s) is added, the statement shall indicate the 
presence of both types of sweetener, e.g., ``Sweetened with nutritive 
sweetener(s) and nonnutritive sweetener(s).''
    (c) ``Low calorie'' foods. A food purporting to be ``low calorie'' 
must comply with the criteria set forth for such foods in Sec.  
101.60(b)(2) and (b)(3) of this chapter.
    (d) ``Reduced calorie'' foods and other comparative calorie claims. 
A food purporting to be ``reduced calorie'' or otherwise containing 
fewer calories than a reference food must comply with the criteria set 
forth for such food in Sec.  101.60(b)(4) and (b)(5) of this chapter.
    (e) Label terms suggesting usefulness as low calorie or reduced 
calorie foods. (1) Except as provided in paragraphs (e)(2) and (e)(3) of 
this section, and in Sec.  101.13(q)(2) of this chapter for soft drinks, 
a food may be labeled with terms such as ``diet,'' ``dietetic,'' 
``artificially sweetened,'' or ``sweetened with nonnutritive sweetener'' 
only if the claim is not false and misleading, and the food is labeled 
``low calorie'' or ``reduced calorie'' or bears another comparative 
calorie claim in compliance with part 101 of this chapter and this 
section.
    (2) Paragraph (e)(1) of this section shall not apply to any use of 
such terms that is specifically authorized by regulation governing a 
particular food, or, unless otherwise restricted by regulation, to any 
use of the term ``diet'' that clearly shows that the food is offered 
solely for a dietary use other than regulating body weight, e.g., ``for 
low-sodium diets.''
    (3) Paragraph (e)(1) of this section shall not apply to any use of 
such terms on a formulated meal replacement or other food that is 
represented to be of special dietary use as a whole meal, pending the 
issuance of a regulation governing the use of such terms on foods.
    (f) ``Sugar free,'' and ``no added sugar.'' Criteria for the use of 
the terms ``sugar free'' and ``no added sugar'' are provided for in 
Sec.  101.60(c) of this chapter.

[58 FR 2430, Jan. 6, 1993]

Subpart C [Reserved]

Subpart D--Standards of Identity [Reserved]



PART 106_INFANT FORMULA QUALITY CONTROL PROCEDURES--Table of Contents




                      Subpart A_General Provisions

Sec.
106.1 Status and applicability of the quality control procedures 
          regulation.
106.3 Definitions.

 Subpart B_Quality Control Procedures for Assuring Nutrient Content of 
                             Infant Formulas

106.20 Ingredient control.
106.25 In-process control.
106.30 Finished product evaluation.
106.90 Coding.

                      Subpart C_Records and Reports

106.100 Records.

                   Subpart D_Notification Requirements

106.120 New formulations and reformulations.

    Authority: 21 U.S.C. 321, 350a, 371.

    Source: 47 FR 17025, Apr. 20, 1982, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  106.1  Status and applicability of the quality control procedures 

regulation.

    (a) The criteria set forth in Sec. Sec.  106.20, 106.25, 106.30, 
106.90, and 106.100 shall apply in determining whether an infant formula 
meets the safety, quality, and nutrient requirements of section 412 of 
the act and the requirements of regulations promulgated under section 
412(a)(2) of the act.
    (b) The failure to comply with any regulation set forth in 
Sec. Sec.  106.20, 106.25, 106.30, 106.90, and 106.100 applicable to the 
manufacturing, processing, and packaging of an infant formula shall 
render such formula adulterated under section 412(a)(1)(C) of the act.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.

[[Page 186]]



Sec.  106.3  Definitions.

    The definitions and interpretations contained in section 201 of the 
act are applicable to such terms when used in this part. The following 
definitions shall also apply:
    (a) Indicator nutrient. An indicator nutrient is a nutrient whose 
concentration is measured during the manufacture of an infant formula to 
confirm complete addition and/or uniform distribution of a premix or 
other substance of which the indicator nutrient is a part.
    (b) In-process batch. An in-process batch is a combination of 
ingredients at any point in the manufacturing process before packaging.
    (c) Manufacturer. A manufacturer is a person who prepares, 
reconstitutes, or otherwise changes the physical or chemical 
characteristics of an infant formula and/or packages the product in a 
container for distribution.
    (d) Nutrient. A nutrient is any vitamin, mineral, or other substance 
required in accordance with the table set out in section 412(g) of the 
act or by regulations promulgated under section 412(a)(2)(A) of the act.
    (e) Nutrient premix. A nutrient premix is a combination of 
ingredients containing two or more nutrients. A nutrient premix either 
may be received from a supplier or be prepared by an infant formula 
manufacturer.



 Subpart B_Quality Control Procedures for Assuring Nutrient Content of 
                             Infant Formulas



Sec.  106.20  Ingredient control.

    (a) Except as provided in Sec.  106.20(b), no analysis before use in 
manufacturing is needed for ingredients that are generally stable in 
shipping and storage, and that either are received under a supplier's 
guarantee or certification that the mixture has been analyzed as to 
nutrient composition or are labeled as having nutrient compositions 
complying with specifications in the U.S. Pharmacopeia, the National 
Formulary, the Food Chemicals Codex, or other similar recognized 
standards.
    (b) Unless each batch of finished product is analyzed as specified 
in Sec.  106.30(b)(1) before release of product for commercial or 
charitable distribution, the following shall apply:
    (1) When an ingredient is relied upon as a source of a nutrient(s) 
and when evidence indicates that such nutrient(s) in that ingredient is 
likely to be affected adversely by shipping or storage conditions, the 
manufacturer shall analyze that ingredient for each relied-upon nutrient 
that may be affected, using validated analytical methods.
    (2) Ingredients, including nutrient premixes, that are either 
without a supplier's guarantee or certification, or not labeled as 
complying with prescribed standards, shall be sampled and analyzed for 
each relied-upon nutrient by the manufacturer, except that ingredients 
used as a major source of protein or fat need not be analyzed for each 
relied-upon nutrient if the manufacturer has records to show that each 
relied-upon nutrient is present at a reasonably constant level. Nutrient 
premixes prepared by the infant formula manufacturer shall be sampled 
and analyzed for each relied-upon nutrient. Nutrient premixes which are 
received from suppliers shall be sampled and analyzed for each relied-
upon nutrient unless the supplier has sampled and analyzed each batch of 
premix for each relied-upon nutrient and has so certified in writing.



Sec.  106.25  In-process control.

    (a) For each infant formula, a master manufacturing order shall be 
prepared and approved by a responsible official of the manufacturer. The 
manufacturer shall establish a quality control system that assures and 
verifies the addition of each ingredient specified in the manufacturing 
order.
    (b) Unless each batch of finished product is analyzed as specified 
in Sec.  106.30(b)(1), the manufacturer shall analyze each in-process 
batch for:
    (1) Solids;
    (2) Protein, fat, and carbohydrates (carbohydrates either by 
analysis or by mathematical difference);
    (3) The indicator nutrient(s) in each nutrient premix;
    (4) Each nutrient added independently of nutrient premixes during 
formulation of the product, except for linoleic acid, vitamin D, vitamin 
K, choline, inositol, and biotin; and

[[Page 187]]

    (5) Solids or an appropriate nutrient to confirm proper dilution 
when final dilution is made after performance of the analyses in 
paragraph (b) (1) through (4) of this section.



Sec.  106.30  Finished product evaluation.

    (a) The manufacturer shall establish criteria for sampling and 
testing to ensure that each batch of infant formula meets the nutrient 
requirements of section 412(g) of the act or of regulations promulgated 
under section 412(a)(2) of the act before release of product for 
commercial or charitable distribution.
    (b)(1) Immediate analysis. Before release of product for commercial 
or charitable distribution, the manufacturer shall analyze 
representative samples of each batch of finished product for:
    (i) Specific nutrient(s) to assess process degradation; and
    (ii) All nutrients not previously analyzed for by the manufacturers, 
unless each in-process batch is analyzed for nutrients as specified in 
Sec.  106.25(b) and the ingredients are analyzed as specified in Sec.  
106.20(b). No analyses are needed for linoleic acid, vitamin D, vitamin 
K, choline, inositol, and biotin; and for nutrients that are added as a 
part of a nutrient premix analyzed by the manufacturer or having a 
supplier's guarantee or certification and for which an indicator 
nutrient(s) was analyzed by the manufacturer.
    (2) Periodic analysis. The manufacturer shall sample at least one 
newly processed finished product batch every 3 months and shall analyze 
representative samples for all nutrients except those that the 
manufacturers measured in the immediate analysis of that product batch.
    (3) Stability analysis. Using representative samples collected from 
finished product batches, the manufacturer shall conduct stability 
analysis for selected nutrients with sufficient frequency to 
substantiate the maintenance of nutrient content throughout the shelf 
life of the product.
    (c) The manufacturer shall evaluate new formulations and the effect 
of changes in ingredients or processing conditions that could affect the 
level of nutrients by means of a testing program designed to confirm 
uniformity of batches and to determine the effects of such changes. The 
following shall apply:
    (1) A minor change is a minor reduction in nutrient levels, a minor 
increase in levels of nutrients that are subject to maximum limits 
established under section 412(g) of the act or in regulations 
established under section 412(a)(2) of the act, or any other change 
where experience or theory would not predict a possible significant 
adverse impact on nutrient levels or nutrient availability. After a 
minor change the manufacturer shall analyze representative samples for 
all nutrients so changed and those possibly affected by the change.
    (2) A major change is any new formulation, or any change of 
ingredients or processes where experience or theory would predict a 
possible significant adverse impact on levels of nutrients or 
availability of nutrients. After a major change the manufacturer shall 
analyze representative samples for osmolality, all nutrients, and the 
biological quality of the protein. A protein biological quality analysis 
is not necessary for a formulation change that is not expected to have 
an adverse effect on the biological quality of the protein. Vitamin D 
shall be determined by the rat bioassay method as prescribed in 
``Official Methods of Analysis of the Association of Official Analytical 
Chemists'' (AOAC), 13th Ed. (1980), sections 43.195-43.208, ``Vitamin D 
(30)--Official Final Action,'' which is incorporated by reference. 
Copies are available from the AOAC INTERNATIONAL, 481 North Frederick 
Ave., suite 500, Gaithersburg, MD 20877, or available for inspection at 
the National Archives and Records Administration (NARA). For information 
on the availability of this material at NARA, call 202-741-6030, or go 
to: http://www.archives.gov/federal--register/code--of--federal--
regulations/ibr--locations.html.Before release of the product for 
commercial or charitable distribution, the manufacturer shall have 
completed all appropriate analyses except that shipment of the product 
need not be delayed until results of

[[Page 188]]

the vitamin D bioassay and, if required, a protein biological quality 
bioassay are complete, provided such bioassays have been initiated, and 
if another analysis for the vitamin D has been run and the protein 
content has been determined by a suitable method. The biological quality 
of the protein shall be determined by an appropriate modification of the 
AOAC bioassay method of analysis. The manufacturer shall analyze 
additional samples from the same batch for vitamin D, by any suitable 
method, and for the biological quality of the protein. The manufacturer 
shall perform such analyses at least annually for a period not to exceed 
the expected shelf life of the product.
    (d) A simple adjustment in the level of an ingredient to accommodate 
inconsistencies in processing is considered to be neither a minor nor a 
major change.

[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 
63 FR 14035, Mar. 24, 1998]



Sec.  106.90  Coding.

    The manufacturer shall code all infant formulas in conformity with 
the coding requirements that are applicable to thermally processed low-
acid foods packaged in hermetically sealed containers as prescribed in 
Sec.  113.60(c).



                      Subpart C_Records and Reports



Sec.  106.100  Records.

    (a) Every manufacturer of infant formula shall maintain the records 
specified in this regulation in order to permit the Food and Drug 
Administration to determine whether each manufacturer is in compliance 
with section 412 of the Federal Food, Drug, and Cosmetic Act (the act).
    (b) The manufacturer shall maintain all records that pertain to 
food-packaging materials subject to Sec.  174.5 of this chapter and that 
bear on whether such materials would cause an infant formula to be 
adulterated within the meaning of section 402(a)(2)(C) of the act.
    (c) The manufacturer shall maintain all records that pertain to 
nutrient premix testing that it generates or receives. Such records 
shall include, but are not limited to:
    (1) Any results of testing conducted to ensure that each nutrient 
premix is in compliance with the premix certificate and guarantee and 
specifications that have been provided to the manufacturer by the premix 
supplier, including tests conducted when nutrients exceed their 
expiration date or shelf life (retest date).
    (2) All certificates and guarantees given by premix suppliers 
concerning the nutrients required by section 412(i) of the act and Sec.  
107.100 of this chapter.
    (d) The premix supplier shall maintain the results of all testing 
conducted to provide all certificates and guarantees concerning nutrient 
premixes for infant formulas. Such records shall include but are not 
limited to:
    (1) The results of tests conducted to determine the purity of each 
nutrient required by section 412(i) of the act or Sec.  107.100 of this 
chapter and any other nutrient listed in the certificate and guarantee;
    (2) The weight of each nutrient added;
    (3) The results of any quantitative tests conducted to determine the 
amount of each nutrient certified or guaranteed; and
    (4) The results of any quantitative tests conducted to identify the 
nutrient levels present when nutrient premixes exceed their expiration 
date or shelf life (retest date).
    (e) The manufacturer shall maintain all records necessary to ensure 
proper nutrient quality control in the manufacture of infant formula 
products. Such records shall include the results of any testing 
conducted to verify that each nutrient required by section 412(i) of the 
act or Sec.  107.100 of this chapter is present in each batch of infant 
formula at the appropriate concentration. This requirement pertains to 
ingredients, in process batch and finished product from the time of 
manufacture through its expiration date.
    (f) The manufacturer shall maintain all records necessary to ensure 
required nutrient content at the final product stage. Such records shall 
include, but are not limited to, testing results for vitamins A, 
B1 (thiamine),

[[Page 189]]

C, and E for each batch of infant formula. ``Final product stage'' means 
the point in the manufacturing process prior to distribution at which 
the infant formula is homogenous and not subject to further degradation 
from the manufacturing process.
    (g) The manufacturer shall maintain all records pertaining to 
distribution of the infant formula. Such records shall include, but not 
be limited to, all information and data necessary to effect and monitor 
recalls of the manufacturer's infant formula products in accordance with 
subpart E of part 107 of this chapter.
    (h) The manufacturer shall maintain all records pertaining to the 
microbiological quality and purity of raw materials and finished 
powdered infant formula.
    (i) [Reserved]
    (j) The manufacturer shall maintain all records pertaining to 
regularly scheduled audits, including audit plans and procedures. Audit 
plans identify the specific manufacturing and quality control procedures 
to be reviewed. Audit procedures are the methods used to review the 
manufacturing and quality control procedures. Records of audits shall 
include the information and data necessary for a determination as to 
whether the manufacturer complies with the current good manufacturing 
practices and quality procedures identified in parts 106, 107, 109, 110, 
and 113 of this chapter. The records shall include written assurances 
from the manufacturer that regularly scheduled audits are being 
conducted by appropriately trained individuals who do not have any 
direct responsibility for the manufacture or production of infant 
formula, and that the complete audit plans and procedures for the firm 
have been followed. The actual written reports of the audits need not be 
made available.
    (k) The manufacturer shall maintain procedures describing how all 
written and oral complaints regarding infant formula will be handled. 
The manufacturer shall follow these procedures and shall include in them 
provisions for the review of any complaint involving an infant formula 
and for determining the need for an investigation of the possible 
existence of a hazard to health.
    (1) For purposes of this section, every manufacturer shall interpret 
a ``complaint'' as any communication that contains any allegation, 
written or oral, expressing dissatisfaction with a product for any 
reason, including concerns about the possible existence of a hazard to 
health and about appearance, taste, odor, and quality. Correspondence 
about prices, package size or shape, or other matters that could not 
possibly reveal the existence of a hazard to health shall not, for 
compliance purposes, be considered a complaint and therefore need not be 
made available to an FDA investigator.
    (2) When a complaint shows that a hazard to health possibly exists, 
the manufacturer shall conduct an investigation into the validity of the 
complaint. Where such an investigation is conducted, the manufacturer 
shall include in its file on the complaint the determination as to 
whether a hazard to health exists and the basis for that determination. 
No investigation is necessary when the manufacturer determines that 
there is no possibility of a hazard to health. When no investigation is 
necessary, the manufacturer shall include in the record the reason that 
an investigation was found to be unnecessary and the name of the 
responsible person making that determination.
    (3) When there is a reasonable possibility of a causal relationship 
between the consumption of an infant formula and an infant's death, the 
manufacturer shall, within 15 days of receiving such information, 
conduct an investigation and notify the agency as required in Sec.  
106.120(b).
    (4) The manufacturer shall maintain in designated files all records 
pertaining to the complaints it receives. The manufacturer shall 
separate the files into two classes:
    (i) Those complaints that allege that the infant became ill from 
consuming the product or required treatment by a physician or health-
care provider.
    (ii) Those complaints that may involve a possible existence of a 
hazard to health but do not refer to an infant becoming ill or the need 
for treatment by physician or a health care provider.

[[Page 190]]

    (5) The manufacturer shall include in a complaint file the following 
information concerning the complaint:
    (i) The name of the infant formula;
    (ii) The batch number;
    (iii) The name of complainant;
    (iv) A copy of the complaint or a memo of the telephone conversation 
or meeting and all correspondence with the complainant;
    (v) By reference or copy, all the associated manufacturing records 
and complaint investigation records needed to evaluate the complaint. 
When copies of such records are not maintained in the complaint file, 
they must be available within 24 hours when requested by an FDA 
official.
    (vi) All actions taken to follow up on the complaint; and
    (vii) All findings and evaluations of the complaint.
    (6) The manufacturer should maintain the files regarding infant 
formula complaints at the establishment where the infant formula was 
manufactured, processed, or packed. When the manufacturer wishes to 
maintain all consumer complaints for the entire firm at one location 
other than at the facility where an infant formula was manufactured, 
processed, or packed, the manufacturer may do so as long as all records 
required by this section are available within 24 hours of request for 
inspection at that facility. However, all records of consumer 
complaints, including summaries, any reports, and any files, maintained 
at the manufacturing facility or at any other facility shall be made 
available to investigators for review and copying upon request.
    (l) The manufacturer shall make readily available for authorized 
inspection all records required under this part or copies of such 
records. Records shall be available at any reasonable time at the 
establishment where the activities described in such records occurred. 
(Infant formula complaint files may be maintained at one facility, as 
provided in Sec.  106.100(k)(6), if all required records are readily 
available at that facility.) These records or copies thereof shall be 
subject to photocopying or other means of reproduction as part of such 
inspection. Records that can be immediately retrieved from another 
location by electronic means shall be considered as meeting the 
requirements of this paragraph.
    (m) Records required under this part may be retained either as 
original records or as true copies such as photocopies, microfilm, 
microfiche, or other accurate reproductions of the original records. 
Where reduction techniques, such as microfilming are used, suitable 
reader and photocopying equipment shall be readily available.
    (n) Production control, product testing, testing results, 
complaints, and distribution records necessary to verify compliance with 
parts 106, 107, 109, 110, and 113 of this chapter, or with other 
appropriate regulations, shall be retained for 1 year after the 
expiration of the shelf life of the infant formula or 3 years from the 
date of manufacture, whichever is greater.
    (o) The manufacturer shall maintain quality control records that 
contain sufficient information to permit a public health evaluation of 
any batch of infant formula.

[56 FR 66571, Dec. 24, 1991; 57 FR 7435, Mar. 2, 1992]



                   Subpart D_Notification Requirements



Sec.  106.120  New formulations and reformulations.

    (a) Information required by section 412(b)(2) and (3) of the act 
shall be submitted to Center for Food Safety and Applied Nutrition (HFS-
830), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740.
    (b) The manufacturer shall promptly notify the Food and Drug 
Administration when the manufacturer has knowledge (as defined in 
section 412(c)(2) of the act) that reasonably supports the conclusion 
that an infant formula that has been processed by the manufacturer and 
that has left an establishment subject to the control of the 
manufacturer may not provide the nutrients required by section 412(g) of 
the act and by regulations promulgated under section 412(a)(2) of the 
act, or when there is an infant formula that is otherwise adulterated or 
misbranded and that may present risk to human health. This notification 
shall be made,

[[Page 191]]

by telephone, to the Director of the appropriate Food and Drug 
Administration district office specified in part 5, subpart M of this 
chapter. After normal business hours (8 a.m. to 4:30 p.m.) the FDA 
emergency number, 301-443-1240, shall be used. The manufacturer shall 
send a followup written confirmation to the Center for Food Safety and 
Applied Nutrition (HFS-605), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, and to the appropriate Food and 
Drug Administration district office specified in part 5, subpart M of 
this chapter.

[47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12, 1989; 
61 FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 
6, 2001; 69 FR 17291, Apr. 2, 2004]



PART 107_INFANT FORMULA--Table of Contents




                      Subpart A_General Provisions

Sec.
107.3 Definitions.

                           Subpart B_Labeling

107.10 Nutrient information.
107.20 Directions for use.
107.30 Exemptions.

                    Subpart C_Exempt Infant Formulas

107.50 Terms and conditions.

                     Subpart D_Nutrient Requirements

107.100 Nutrient specifications.

                    Subpart E_Infant Formula Recalls

107.200 Food and Drug Administration-required recall.
107.210 Firm-initiated product removals.
107.220 Scope and effect of infant formula recalls.
107.230 Elements of an infant formula recall.
107.240 Notification requirements.
107.250 Termination of an infant formula recall.
107.260 Revision of an infant formula recall.
107.270 Compliance with this subpart.
107.280 Records retention.

    Authority: 21 U.S.C. 321, 343, 350a, 371.

    Source: 50 FR 1840, Jan. 14, 1985, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  107.3  Definitions.

    The following definitions shall apply, in addition to the 
definitions contained in section 201 of the Federal Food, Drug, and 
Cosmetic Act (the act):
    Exempt formula. An exempt infant formula is an infant formula 
intended for commercial or charitable distribution that is represented 
and labeled for use by infants who have inborn errors of metabolism or 
low birth weight, or who otherwise have unusual medical or dietary 
problems.
    Manufacturer. A manufacturer is a person who prepares, 
reconstitutes, or otherwise changes the physical or chemical 
characteristics of an infant formula or packages the infant formula in 
containers for distribution.
    References. References in this part to regulatory sections of the 
Code of Federal Regulations are to chapter I of title 21, unless 
otherwise noted.

[50 FR 48186, Nov. 22, 1985]



                           Subpart B_Labeling



Sec.  107.10  Nutrient information.

    (a) The labeling of infant formulas, as defined in section 201(aa) 
of the Federal Food, Drug, and Cosmetic Act, shall bear in the order 
given, in the units specified, and in tabular format, the following 
information regarding the product as prepared in accordance with label 
directions for infant consumption:
    (1) A statement of the number of fluid ounces supplying 100 
kilocalories (in case of food label statements, a kilocalorie is 
represented by the word ``Calorie''); and
    (2) A statement of the amount of each of the following nutrients 
supplied by 100 kilocalories:

------------------------------------------------------------------------
                 Nutrients                       Unit of measurement
------------------------------------------------------------------------
Protein...................................  Grams.
Fat.......................................  Do.
Carbohydrate..............................  Do.
Water.....................................  Do.
Linoleic acid.............................  Milligrams.
Vitamins:
  Vitamin A...............................  International units.
  Vitamin D...............................  Do.
  Vitamin E...............................  Do.
  Vitamin K...............................  Micrograms.
  Thiamine (Vitamin B 1)..................  Do.
  Riboflavin (Vitamin B 2.................  Do.

[[Page 192]]

 
  Vitamin B 6.............................  Do.
  Vitamin B 12............................  Do.
  Niacin..................................  Do.
  Folic acid (Folacin)....................  Do.
  Pantothenic acid........................  Do.
  Biotin..................................  Do.
  Vitamin C (Ascorbic acid)...............  Milligrams.
  Choline.................................  Do.
  Inositol................................  Do.
Minerals:
  Calcium.................................  Milligrams.
  Phosphorus..............................  Do.
  Magnesium...............................  Do.
  Iron....................................  Do.
  Zinc....................................  Do.
  Manganese...............................  Micrograms.
  Copper..................................  Do.
  Iodine..................................  Do.
  Sodium..................................  Milligrams.
  Potassium...............................  Do.
  Chloride................................  Do.
------------------------------------------------------------------------

    (b) In addition the following apply:
    (1) Vitamin A content may also be declared on the label in units of 
microgram retinol equivalents, vitamin D content in units of micrograms 
cholecalciferol, vitamin E content in units of milligram alpha-
tocopherol equivalents, and sodium, potassium, and chloride content in 
units of millimoles, micromoles, or milliequivalents. When these 
declarations are made they shall appear in parentheses immediately 
following the declarations in International Units for vitamins A, D, and 
E, and immediately following the declarations in milligrams for sodium, 
potassium, and chloride.
    (2) Biotin, choline, and inositol content shall be declared except 
when they are not added to milk-based infant formulas.
    (3) Each of the listed nutrients, and the caloric density, may also 
be declared on the label on other bases, such as per 100 milliliters or 
per liter, as prepared for infant consumption.
    (4) One of the following statements shall appear on the principal 
display panel, as appropriate:
    (i) The statement ``Infant Formula With Iron'', or a similar 
statement, if the product contains 1 milligram or more of iron in a 
quantity of product that supplies 100 kilocalories when prepared in 
accordance with label directions for infant consumption.
    (ii) The statement ``Additional Iron May Be Necessary'', or a 
similar statement, if the product contains less than 1 milligram of iron 
in a quantity of product that supplies 100 kilocalories when prepared in 
accordance with label directions for infant consumption.
    (5) Any additional vitamin may be declared at the bottom of the 
vitamin list and any additional minerals may be declared between iodine 
and sodium, provided that any additionally declared nutrient (i) has 
been identified as essential by the National Academy of Sciences through 
its development of a recommended dietary allowance or an estimated safe 
and adequate daily dietary intake range, or has been identified as 
essential by the Food and Drug Administration through a Federal Register 
publication or establishment of a U.S. Recommended Daily Allowance, and 
(ii) is provided at a level considered in these publications as having 
biological significance, when these levels are known.

[50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002]



Sec.  107.20  Directions for use.

    In addition to the applicable labeling requirements in parts 101 and 
105 of this chapter, the product label shall bear:
    (a) Under the heading ``Directions For Preparation and Use'', 
directions for:
    (1) Storage of infant formula before and after the container has 
been opened, including a statement indicating that prolonged storage at 
excessive temperatures should be avoided;
    (2) Agitating liquid infant formula before opening the container, 
such as ``Shake Well Before Opening'';
    (3) ``Sterilization'' of water, bottle, and nipples when necessary 
for preparing infant formula for use;
    (4) Dilution of infant formula, when appropriate. Directions for 
powdered infant formula shall contain the weight and volume of powdered 
formula to be reconstituted.
    (b) In close proximity to the ``Directions for Preparation and Use'' 
a pictogram depicting the major steps for preparation of that infant 
formula, such as (for a concentrated formula):

[[Page 193]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.366

    (c) A ``Use by ------'' date, the blank to be filled in with the 
month and year selected by the manufacturer, packer, or distributor of 
the infant formula on the basis of tests or other information showing 
that the infant formula, until that date, under the conditions of 
handling, storage, preparation, and use prescribed by label directions, 
will: (1) when consumed, contain not less than the quantity of each 
nutrient, as set forth on its label; and (2) otherwise be of an 
acceptable quality (e.g., pass through an ordinary bottle nipple).
    (d) The statement ``Add Water'' or ``Do Not Add Water'', as 
appropriate, to appear on the principal display panel of concentrated or 
ready-to-feed infant formulas. In close proximity to the statement ``Add 
Water'', a symbol such as
[GRAPHIC] [TIFF OMITTED] TC01MR93.000


if the addition of water is necessary. The symbol shall be placed on a 
white background encircled by a dark border.
    (e) A warning statement beneath or in close proximity to the 
``Directions For Preparation and Use'' that cautions against improper 
preparation or use of an infant formula, such as ``THE HEALTH OF YOUR 
INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND 
USE''.
    (f) A statement indicating that parents should consult their 
physicians about the use of infant formulas, such as ``USE AS DIRECTED 
BY A PHYSICIAN''.

[50 FR 1840, Jan. 14, 1985, as amended at 67 FR 9585, Mar. 4, 2002]



Sec.  107.30  Exemptions.

    When containers of ready-to-feed infant formula, to be sold at the 
retail level, are contained within a multiunit package, the labels of 
the individual containers shall contain all of the label information 
required by section 403 of the Federal Food, Drug, and Cosmetic Act (the 
act), Sec. Sec.  107.10 and 107.20, and all appropriate sections of part 
101 of this chapter, except that the labels of the individual containers 
contained within the outer package shall be exempt from compliance with 
the requirements of section 403 (e)(1) and (i)(2) of the act; and 
Sec. Sec.  107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided 
that (a) the multiunit package meets all the requirements of this part; 
(b) individual containers are securely enclosed within and are not 
intended to be separated

[[Page 194]]

from the retail package under conditions of retail sale; and (c) the 
label on each individual container includes the statement ``This Unit 
Not Intended For Individual Sale'' in type size not less than one-
sixteenth inch in height. The word ``Retail'' may be used in lieu of or 
immediately following the word ``Individual'' in the statement.



                    Subpart C_Exempt Infant Formulas



Sec.  107.50  Terms and conditions.

    (a) Terms and conditions. Section 412(f)(1) of the act exempts from 
the requirements of section 412(a), (b), and (c)(1)(A) of the act infant 
formulas that are represented and labeled for use by an infant who has 
an inborn error of metabolism or low brith weight or who otherwise has 
an unusual medical or dietary problem, if such formulas comply with 
regulations prescribed by the Secretary. The regulations in this subpart 
establish the terms and conditions that a manufacturer must meet with 
respect to such infant formulas.
    (b) Infant formulas generally available at the retail level. (1) 
These exempt infant formulas can generally be purchased from retail 
store shelves that are readily available to the public. Such formulas 
are also typically represented and labeled for use to provide dietary 
management for diseases or conditions that are not clinically serious or 
life-threatening, even though such formulas may also be represented and 
labeled for use in clinically serious or life-threatening disorders.
    (2) Except as provided in paragraphs (b)(4) and (5) of this section, 
an infant formula manufacturer shall, with respect to each formula 
covered by this paragraph, comply with the nutrient requirements of 
section 412(g) of the act or of regulations promulgated under section 
412(a)(2) of the act, the quality control procedure requirements of part 
106, and the labeling requirements of subpart B of this part.
    (3) To retain the exempt status of an infant formula covered by this 
paragraph, the manufacturer shall submit to the Food and Drug 
Administration (FDA), at the address specified in paragraph (e)(1) of 
this section, on or before May 21, 1986, or on or before the 90th day 
before the first processing of the infant formula for commercial or 
charitable distribution, whichever occurs later, the label and other 
labeling of the infant formula, a complete quantitative formulation for 
the infant formula, and a detailed description of the medical conditions 
for which the infant formula is represented. FDA will review the 
information under paragraph (d) of this section.
    (4) To retain the exempt status of an infant formula covered by this 
paragraph, when any change in ingredients or processes that may result 
in an adverse impact on levels of nutrients or availability of nutrients 
is instituted, the manufacturer shall submit to FDA at the address 
specified in paragraph (e)(1) of this section, before the first 
processing of the infant formula, the label and other labeling of the 
infant formula, a complete quantitative formulation for the infant 
formula, a detailed description of the reformulation and the rationale 
for the reformulation, a complete description of the change in 
processing, and a detailed description of the medical conditions for 
which the infant formula is represented. FDA will review that 
information under paragraph (d) of this section.
    (5) A manufacturer may deviate from the requirements of paragraph 
(b)(2) of this section only with respect to those specific requirements 
for which it submits to FDA, at the address specified in paragraph 
(e)(1) of this section, the medical, nutritional, scientific, or 
technological rationale (including any appropriate animal or human 
clinical studies). FDA will review that information under paragraph (d) 
of this section.
    (c) Infant formulas not generally available at the retail level. (1) 
These exempt infant formulas are not generally found on retail shelves 
for general consumer purchase. Such formulas typically are prescribed by 
a physician, and must be requested from a pharmacist or are distributed 
directly to institutions such as hospitals, clinics, and State or 
Federal agencies. Such formulas are also generally represented and 
labeled solely to provide dietary management for specific diseases or 
conditions that are clinically serious or life-threatening

[[Page 195]]

and generally are required for prolonged periods of time. Exempt infant 
formulas distributed directly to institutions such as hospitals, 
clinics, and State or Federal agencies that are of the same formulation 
as those generally available at the retail level are subject to the 
requirements of paragraph (b) of this section rather than to the 
requirements of this paragraph.
    (2) Except as provided for in paragraph (c)(5) of this section, an 
infant formula manufacturer shall, with respect to each formula covered 
by this paragraph, comply with the nutrient requirements of section 
412(g) of the act or of regulations promulgated under section 412(a)(2) 
of the act, and the labeling requirements of subpart B of this part.
    (3) Each manufacturer of an infant formula covered by this paragraph 
shall establish quality control procedures designed to ensure that the 
infant formula meets applicable nutrient requirements of this section, 
including any special nutritional characteristics for the specific 
disorders or conditions for which the formula is represented for use. 
Each manufacturer shall maintain records of such quality control 
procedures sufficient to permit a public health evaluation of each 
manufactured batch of infant formula and shall permit any authorized FDA 
employee at all reasonable times to have access to and to copy and 
verify the records referred to in this paragraph.
    (4) To retain the exempt status of an infant formula covered by this 
paragraph, the manufacturer shall submit the information required by 
paragraphs (b)(3) and (4) of this section.
    (5) A manufacturer may deviate from the requirements of paragraph 
(c)(2) of this section only with respect to those specific requirements 
for which it submits to FDA, at the address specified in paragraph 
(e)(1) of this section, the medical, nutritional, scientific, or 
technological rationale (including any appropriate animal or human 
clinical studies). FDA will review that information under paragaraph (d) 
of this section.
    (6) The requirements of this section do not apply to an infant 
formula specially and individually prepared for one or more specific 
infants on a physician's request.
    (d) FDA review of exempt status. (1) FDA's Center for Food Safety 
and Applied Nutrition will review information submitted by infant 
formula manufacturers under paragraph (b) (3), (b) (4), or (c)(4) of 
this section. On the basis of such review and other information 
available to the agency, the Center for Food Safety and Applied 
Nutrition may impose additional conditions on, or modify requirements 
for, the quality control procedures, nutrient specifications, or 
labeling of an infant formula, or withdraw a product's exempt status. 
Such determinations will be made by the Director of the Center for Food 
Safety and Applied Nutrition.
    (2)(i) If after completing its review of all information submitted, 
the Center for Food Safety and Applied Nutrition concludes that 
additional or modified quality control, nutrient, or labeling 
requirements are needed, or that a product's exempt status is withdrawn, 
the Center for Food Safety and Applied Nutrition will so notify the 
manufacturer and this notification will specify the reasons therefor. 
Upon receipt of this notification, the manufacturer has 10 working days 
to have the decision reviewed under Sec.  10.75 by the office of the 
Commissioner of Food and Drugs. A determination by the Director of the 
Center for Food Safety and Applied Nutrition that is not appealed 
becomes a final agency decision.
    (ii) After a final decision by the Director or by the office of the 
Commissioner that a product's exempt status is withdrawn, the 
manufacturer shall comply with the nutrient requirements of section 
412(g) of the act or of regulations promulgated under section 412(a)(2) 
of the act, the quality control requirements of part 106, and the 
labeling requirements of subpart B of this part.
    (iii) The compliance date for the withdrawal of a product's exempt 
status or the imposition of additional or modified quality control, 
nutrient, or labeling requirements is 60 calendar days after issuance of 
the final decision except as otherwise provided for reasons stated in 
the decision. If the agency determines that a health hazard

[[Page 196]]

may exist and so notifies the manufacturer, withdrawal of a product's 
exempt status shall be effective on the date of receipt of notification 
from the Director of the Center for Food Safety and Applied Nutrition. 
Additional or modified requirements, or the withdrawal of an exemption, 
apply only to those formulas that are manufactured after the compliance 
date. A postponement of the compliance date may be granted for good 
cause.
    (3) FDA may decide that withdrawal of an exemption is necessary 
when, on the basis of its review under paragraph (d)(1) of this section, 
it concludes that quality control procedures are not adequate to ensure 
that the formula contains all required nutrients, that deviations in 
nutrient levels are not supported by generally accepted scientific, 
nutritional, or medical rationale, or that deviations from subpart B of 
this part are not necessary to provide appropriate directions for 
preparation and use of the infant formula, or that additional labeling 
information is necessary.
    (4) FDA will use the following criteria in determining whether 
deviations from the requirements of this subpart are necessary and will 
adequately protect the public health:
    (i) A deviation from the nutrient requirements of section 412(g) of 
the act or of regulations promulgated under section 412(a)(2) of the act 
is necessary to provide an infant formula that is appropriate for the 
dietary management of a specific disease, disorder, or medical 
condition;
    (ii) For exempt infant formulas subject to paragraph (b) of this 
section, a deviation from the quality control procedures requirements of 
part 106 is necessary because of unusal or difficult technological 
problems in manufacturing the infant formula; and
    (iii) A deviation from the labeling requirements of subpart B of 
this part is necessary because label information, including pictograms 
and symbols required by those regulations, could lead to inappropriate 
use of the product.
    (e) Notification requirements. (1) Information required by 
paragraphs (b) and (c) of this section shall be submitted to Center for 
Food Safety and Applied Nutrition (HFS-830), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
    (2) The manufacturer shall promptly notify FDA when the manufacturer 
has knowledge (as defined in section 412(c)(2) of the act) that 
reasonably supports the conclusion that an exempt infant formula that 
has been processed by the manufacturer and that has left an 
establishment subject to the control of the manufacturer may not provide 
the nutrients required by paragraph (b) or (c) of this section, or when 
there is an exempt infant formula that may be otherwise adulterated or 
misbranded and if so adulterated or misbranded presents a risk of human 
health. This notification shall be made, by telephone, to the Director 
of the appropriate FDA district office specified in part 5, subpart M of 
this chapter. After normal business hours (8 a.m. to 4:30 p.m.), the FDA 
emergency number, 301-443-1240, shall be used. The manufacturer shall 
send a followup written confirmation to the Center for Food Safety and 
Applied Nutrition (HFS-605), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, and to the appropriate FDA 
district office specified in part 5, subpart M of this chapter.

[50 FR 48187, Nov. 22, 1985, as amended at 61 FR 14479, Apr. 2, 1996; 66 
FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 67 FR 9585, Mar. 4, 
2002; 69 FR 17291, Apr. 2, 2004]



                     Subpart D_Nutrient Requirements



Sec.  107.100  Nutrient specifications.

    (a) An infant formula shall contain the following nutrients at a 
level not less than the minimum level specified and not more than the 
maximum level specified for each 100 kilocalories of the infant formula 
in the form prepared for consumption as directed on the container:

------------------------------------------------------------------------
                                                        Minimum  Maximum
       Nutrients              Unit of measurement        level    level
------------------------------------------------------------------------
Protein                  Grams                             1.8       4.5
Fat                       do                               3.3       6.0
                         Percent calories                 30        54
Linoleic acid            Milligrams                      300     .......
                         Percent calories                  2.7   .......
------------------------------------------------------------------------
                                Vitamins
------------------------------------------------------------------------
Vitamin A                International Units             250       750

[[Page 197]]

 
Vitamin D                 do                              40       100
Vitamin E                 do                               0.7   .......
Vitamin K                Micrograms                        4     .......
Thiamine (vitamin B1)     do                              40     .......
Riboflavin (vitamin B2)   do                              60     .......
Vitamin B6                do                              35     .......
Vitamin B12               do                               0.15  .......
Niacin \1\                do                             250     .......
Folic acid (folacin)      do                               4     .......
Pantothenic acid          do                             300     .......
Biotin \2\                do                               1.5   .......
Vitamin C (ascorbic      Milligrams                        8     .......
 acid)
Choline \2\               do                               7     .......
Inositol \2\              do                               4     .......
------------------------------------------------------------------------
                                Minerals
------------------------------------------------------------------------
Calcium                   do                              60     .......
Phosphorus                do                              30     .......
Magnesium                 do                               6     .......
Iron                      do                               0.15      3.0
Zinc                      do                               0.5   .......
Manganese                Micrograms                        5     .......
Copper                   Micrograms                       60     .......
Iodine                    do                               5        75
Sodium                   Milligrams                       20        60
Potassium                 do                              80       200
Chloride                  do                              55       150
------------------------------------------------------------------------
\1\ The generic term ``niacin'' includes niacin (nicotinic acid) and
  niacinamide (nicotinamide).
\2\ Required only for non-milk-based infant formulas.


In addition to the specifications established in the table in this 
paragraph for vitamins and minerals, the following also apply:
    (b) Vitamin E shall be present at a level of at least 0.7 
International Unit of vitamin E per gram of linoleic acid.
    (c) Any vitamin K added shall be in the form of phylloquinone.
    (d) Vitamin B6 shall be present at a level of at least 15 
micrograms of vitamin B6 for each gram of protein in excess 
of 1.8 grams of protein per 100 kilocalories of infant formula in the 
form prepared for consumption as directed on the container.
    (e) The ratio of calcium to phosphorus in infant formula in the form 
prepared for consumption as directed on the container shall be no less 
than 1.1 and not more than 2.0.
    (f) Protein shall be present in an amount not to exceed 4.5 grams 
per 100 kilocalories regardless of quality, and not less than 1.8 grams 
per 100 kilocalories of infant formula in the form prepared for 
consumption as directed on the container when its biological quality is 
equivalent to or better than that of casein. If the biological quality 
of the protein is less than that of casein, the minimum amount of 
protein shall be increased proportionately to compensate for its lower 
biological quality. For example, an infant formula containing protein 
with a biological quality of 75 percent of casein shall contain at least 
2.4 grams of protein (1.8/0.75). No protein with a biological quality 
less than 70 percent of casein shall be used.

[50 FR 45108, Oct. 30, 1985]



                    Subpart E_Infant Formula Recalls

    Source: 54 FR 4008, Jan. 27, 1989, unless otherwise noted.



Sec.  107.200  Food and Drug Administration-required recall.

    When the Food and Drug Administration determines that an adulterated 
or misbranded infant formula presents a risk to human health, a 
manufacturer shall immediately take all actions necessary to recall that 
formula, extending to and including the retail level, consistent with 
the requirements of this subpart.



Sec.  107.210  Firm-initiated product removals.

    (a) If a manufacturer has determined to recall voluntarily from the 
market an infant formula that is not subject to Sec.  107.200 but that 
otherwise violates the laws and regulations administered by the Food and 
Drug Administration (FDA) and that would be subject to legal action, the 
manufacturer, upon prompt notification to FDA, shall administer such 
voluntary recall consistent with the requirements of this subpart.
    (b) If a manufacturer has determined to withdraw voluntarily from 
the market an infant formula that is adulterated or misbranded in only a 
minor way and that would not be subject to legal action, such removal 
from the market is deemed to be a market withdrawal, as defined in Sec.  
7.3(j) of this chapter. As required by Sec.  107.240(a), the 
manufacturer shall promptly notify FDA of such violative formula and 
may, but is not required to, conduct such market withdrawal consistent 
with the requirements of this subpart pertaining to product recalls.

[[Page 198]]



Sec.  107.220  Scope and effect of infant formula recalls.

    (a) The requirements of this subpart apply:
    (1) When the Food and Drug Administration has determined that it is 
necessary to remove from the market a distributed infant formula that is 
in violation of the laws and regulations administered by the Food and 
Drug Administration and that poses a risk to human health; or
    (2) When a manufacturer has determined that it is necessary to 
remove from the market a distributed infant formula that:
    (i) Is no longer subject to the manufacturer's control;
    (ii) Is in violation of the laws and regulations administered by the 
Food and Drug Administration and against which the agency could initiate 
legal or regulatory action; and
    (iii) Does not present a human risk.
    (b) The Food and Drug Administration will monitor continually the 
recall action and will take appropriate actions to ensure that the 
violative infant formula is removed from the market.



Sec.  107.230  Elements of an infant formula recall.

    A recalling firm shall conduct an infant formula recall with the 
following elements:
    (a) The recalling firm shall evaluate in writing the hazard to human 
health associated with the use of the infant formula. This health hazard 
evaluation shall include consideration of any disease, injury, or other 
adverse physiological effect that has been or that could be caused by 
the infant formula and of the seriousness, likelihood, and consequences 
of the diseases, injury, or other adverse physiological effect. The Food 
and Drug Administration will conduct its own health hazard evaluation 
and promptly notify the recalling firm of the results of that evaluation 
if the criteria for recall under Sec.  107.200 have been met.
    (b) The recalling firm shall devise a written recall strategy suited 
to the individual circumstances of the particular recall. The recall 
strategy shall take into account the health hazard evaluation and 
specify the following: The extent of the recall; if necessary, the 
public warning to be given about any hazard presented by the infant 
formula; the disposition of the recalled infant formula; and the 
effectiveness checks that will be made to determine that the recall is 
carried out.
    (c) The recalling firm shall promptly notify each of its affected 
direct accounts about the recall. The format of a recall communication 
shall be distinctive, and the content and extent of a recall 
communication shall be commensurate with the hazard of the infant 
formula being recalled and the strategy developed for the recall. The 
recall communication shall instruct consignees to report back quickly to 
the recalling firm about whether they are in possession of the recalled 
infant formula and shall include a means of doing so. The recalled 
communication shall also advise consignees how to return the recall 
infant formula to the manufacturer or otherwise dispose of it. The 
recalling firm shall send a followup recall communication to any 
consignee that does not respond to the initial recall communication.
    (d) If the infant formula presents a risk to human health, the 
recalling firm shall request that each establishment, at which such 
infant formula is sold or available for sale, post at the point of 
purchase of such formula a notice of such recall at such establishment. 
The notice shall be provided by the recalling firm after approval of the 
notice by the Food and Drug Administration. The recalling firm shall 
also request that each retail establishment maintain such notice on 
display until such time as the Food and Drug Administration notifies the 
recalling firm that the agency considers the recall completed.
    (e) The recalling firm shall furnish promptly to the appropriate 
Food and Drug Administration district office listed in part 5, subpart M 
of this chapter, as they are available, copies of the health hazard 
evaluation, the recall strategy, and all recall communications 
(including, for a recall under Sec.  107.200, the notice to be displayed 
at

[[Page 199]]

retail establishments) directed to consignees, distributors, retailers, 
and members of the public.

[54 FR 4008, Jan. 27, 1989, as amended at 66 FR 17358, Mar. 30, 2001; 69 
FR 17291, Apr. 2, 2004]



Sec.  107.240  Notification requirements.

    (a) Notification of a violative infant formula. A manufacturer shall 
promptly notify the Food and Drug Administration when the manufacturer 
has knowledge (as defined in section 412(e)(2) of the Federal Food, 
Drug, and Cosmetic Act (the act)) that reasonably supports the 
conclusion that an infant formula that has been processed by the 
manufacturer and that has left an establishment subject to the control 
of the manufacturer:
    (1) May not provide the nutrients required by section 412(i) of the 
act and by regulations promulgated under section 412(i)(2) of the act; 
or
    (2) May be otherwise adulterated or misbranded.
    (b) Method of notification. The notification made pursuant to Sec.  
107.240(a) shall be made, by telephone, to the Director of the 
appropriate Food and Drug Administration district office listed in part 
5, subpart M of this chapter. After normal business hours (8 a.m. to 
4:30 p.m.), FDA's emergency number, 301-443-1240, shall be used. The 
manufacturer shall send written confirmation of the notification to the 
Center for Food Safety and Applied Nutrition (HFS-605), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and to 
the appropriate Food and Drug Administration district office listed in 
part 5, subpart M of this chapter.
    (c) Reports about an infant formula recall--(1) Telephone report. 
When a determination is made that an infant formula is to be recalled, 
the recalling firm shall telephone within 24 hours the appropriate Food 
and Drug Administration district office listed in part 5, subpart M of 
this chapter and shall provide relevant information about the infant 
formula that is to be recalled.
    (2) Initial written report. Within 14 days after the recall has 
begun, the recalling firm shall provide a written report to the 
appropriate Food and Drug Administration district office. The report 
shall contain relevant information, including the following cumulative 
information concerning the infant formula that is being recalled:
    (i) Number of consignees notified of the recall, and date and method 
of notification, including, for a recall pursuant to Sec.  107.200 
information about the notice provided for retail display and the request 
for its display.
    (ii) Number of consignees responding to the recall communication and 
quantity of recalled infant formula on hand at the time it was received.
    (iii) Quantity of recalled infant formula returned or corrected by 
each consignee contacted and the quantity of recalled infant formula 
accounted for.
    (iv) Number and results of effectiveness checks that were made.
    (v) Estimated timeframes for completion of the recall.
    (3) Status reports. The recalling firm shall submit to the 
appropriate Food and Drug Administration district office a written 
status report on the recall at least every 14 days until the recall is 
terminated. The status report shall describe the steps taken by the 
recalling firm to carry out the recall since the last report and the 
results of these steps.

[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66 
FR 17359, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 69 FR 17291, Apr. 2, 
2004]



Sec.  107.250  Termination of an infant formula recall.

    The recalling firm may submit a recommendation for termination of 
the recall to the appropriate Food and Drug Administration district 
office listed in part 5, subpart M of this chapter for transmittal to 
the Center for Food Safety and Applied Nutrition (HFS-605), for action. 
Any such recommendation shall contain information supporting a 
conclusion that the recall strategy has been effective. The agency will 
respond within 15 days of receipt by the Center for Food Safety and 
Applied Nutrition (HFS-605), of the request for termination. The 
recalling firm shall continue to implement the recall strategy until it 
receives final written notification from the agency that the recall has 
been terminated.

[[Page 200]]

The agency will send such a notification unless it has information, from 
FDA's own audits or from other sources, demonstrating that the recall 
has not been effective. The agency may conclude that a recall has not 
been effective if:
    (a) The recalling firm's distributors have failed to retrieve the 
recalled infant formula; or
    (b) Stocks of the recalled infant formula remain in distribution 
channels that are not in direct control of the recalling firm.

[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 14479, Apr. 2, 1996; 66 
FR 17359, Mar. 30, 2001; 69 FR 17291, Apr. 2, 2004]



Sec.  107.260  Revision of an infant formula recall.

    If after a review of the recalling firm's recall strategy or 
periodic reports or other monitoring of the recall, the Food and Drug 
Administration concludes that the actions of the recalling firm are 
deficient, the agency shall notify the recalling firm of any serious 
deficiency. The agency may require the firm to:
    (a) Change the extent of the recall, if the agency concludes on the 
basis of available data that the depth of the recall is not adequate in 
light of the risk to human health presented by the infant formula.
    (b) Carry out additional effectiveness checks, if the agency's 
audits, or other information, demonstrate that the recall has not been 
effective.
    (c) Issue additional notifications to the firm's direct accounts, if 
the agency's audits, or other information demonstrate that the original 
notifications were not received, or were disregarded in a significant 
number of cases.



Sec.  107.270  Compliance with this subpart.

    A recalling firm may satisfy the requirements of this subpart by any 
means reasonable calculated to meet the obligations set forth in this 
Subpart E. The recall guidance in subpart C of part 7 of this chapter 
specify procedures that may be useful to a recalling firm in determining 
how to comply with these regulations.

[54 FR 4008, Jan. 27, 1989, as amended at 65 FR 56479, Sept. 19, 2000]



Sec.  107.280  Records retention.

    Each manufacturer of an infant formula shall make and retain such 
records respecting the distribution of the infant formula through any 
establishment owned or operated by such manufacturer as may be necessary 
to effect and monitor recalls of the formula. Such records shall be 
retained for at least 1 year after the expiration of the shelf life of 
the infant formula.

[54 FR 4008, Jan. 27, 1989, as amended at 67 FR 9585, Mar. 4, 2002]



PART 108_EMERGENCY PERMIT CONTROL--Table of Contents




                      Subpart A_General Provisions

Sec.
108.3 Definitions.
108.5 Determination of the need for a permit.
108.6 Revocation of determination of need for permit.
108.7 Issuance or denial of permit.
108.10 Suspension and reinstatement of permit.
108.12 Manufacturing, processing, or packing without a permit, or in 
          violation of a permit.
108.19 Establishment of requirements for exemption from section 404 of 
          the act.

  Subpart B_Specific Requirements and Conditions for Exemption From or 
                   Compliance With an Emergency Permit

108.25 Acidified foods.
108.35 Thermal processing of low-acid foods packaged in hermetically 
          sealed containers.

    Authority: 21 U.S.C. 342, 344, 371.

    Source: 42 FR 14334, Mar. 15, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  108.3  Definitions.

    (a) The definitions contained in section 201 of the Federal Food, 
Drug, and Cosmetic Act are applicable to such terms when used in this 
part.
    (b) Commissioner means the Commissioner of Food and Drugs.
    (c) Act means the Federal Food, Drug, and Cosmetic Act, as amended.
    (d) Permit means an emergency permit issued by the Commissioner 
pursuant to section 404 of the act for such

[[Page 201]]

temporary period of time as may be necessary to protect the public 
health.
    (e) Manufacture, processing, or packing of food in any locality 
means activities conducted in a single plant or establishment, a series 
of plants under a single management, or all plants in an industry or 
region, by a manufacturer, processor, or packer.



Sec.  108.5  Determination of the need for a permit.

    (a) Whenever the Commissioner determines after investigation that a 
manufacturer, processor, or packer of a food for which a regulation has 
been promulgated in subpart B of this part does not meet the mandatory 
conditions and requirements established in such regulation, he shall 
issue to such manufacturer, processor, or packer an order determining 
that a permit shall be required before the food may be introduced or 
delivered for introduction into interstate commerce by that person. The 
order shall specify the mandatory conditions and requirements with which 
there is a lack of compliance.
    (1) The manufacturer, processor, or packer shall have 3 working days 
after receipt of such order within which to file objections. Such 
objections may be filed by telegram, telex, or any other mode of written 
communication addressed to the Center for Food Safety and Applied 
Nutrition, Food and Drug Administration (HFS-605), 5100 Paint Branch 
Pkwy., College Park, MD 20740. If such objections are filed, the 
determination is stayed pending a hearing to be held within 5 working 
days after the filing of objections on the issues involved unless the 
Commissioner determines that the objections raise no genuine and 
substantial issue of fact to justify a hearing.
    (2) If the Commissioner finds that there is an imminent hazard to 
health, the order shall contain this finding and the reasons therefor, 
and shall state that the determination of the need for a permit is 
effective immediately pending an expedited hearing.
    (b) A hearing under this section shall be conducted by the 
Commissioner or his designee at a location agreed upon by the objector 
and the Commissioner or, if such agreement cannot be reached, at a 
location designated by the Commissioner. The manufacturer, processor, or 
packer shall have the right to cross-examine the Food and Drug 
Administration's witnesses and to present witnesses on his own behalf.
    (c) Within 5 working days after the hearing, and based on the 
evidence presented at the hearing, the Commissioner shall determine 
whether a permit is required and shall so inform the manufacturer, 
processor, or packer in writing, with the reasons for his decision.
    (d) The Commissioner's determination of the need for a permit 
constitutes final agency action from which appeal lies to the courts. 
The Commissioner will not stay a determination of the need for a permit 
pending court appeal except in unusual circumstances, but will 
participate in expediting any such appeal.

[42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12, 1989; 
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]



Sec.  108.6  Revocation of determination of need for permit.

    (a) A permit shall be required only during such temporary period as 
is necessary to protect the public health.
    (b) Whenever the Commissioner has reason to believe that a permit 
holder is in compliance with the mandatory requirements and conditions 
established in subpart B of this part and is likely to remain in 
compliance, he shall, on his own initiative or on the application of the 
permit holder, revoke both the determination of need for a permit and 
the permit that had been issued. If denied, the applicant shall, upon 
request, be afforded a hearing conducted in accordance with Sec.  108.5 
(b) and (c) as soon as practicable. Such revocation is without prejudice 
to the initiation of further permit proceedings with respect to the same 
manufacturer, processor, or packer should later information again show 
the need for a permit.



Sec.  108.7  Issuance or denial of permit.

    (a) After a determination and notification by the Commissioner in 
accordance with the provisions of Sec.  108.5 that a manufacturer, 
processor, or packer requires a permit, such manufacturer,

[[Page 202]]

processor, or packer may not thereafter introduce or deliver for 
introduction into interstate commerce any such food manufactured, 
processed, or packed by him unless he holds a permit issued by the 
Commissioner or obtains advance written approval of the Food and Drug 
Administration pursuant to Sec.  108.12(a).
    (b) Any manufacturer, processor, or packer for whom the Commissioner 
has made a determination that a permit is necessary may apply to the 
Commissioner for the issuance of such a permit. The application shall 
contain such data and information as is necessary to show that all 
mandatory requirements and conditions for the manufacturer, processing 
or packing of a food for which regulations are established in subpart B 
of this part are met and, in particular, shall show that the deviations 
specified in the Commissioner's determination of the need for a permit 
have been corrected or suitable interim measures established. Within 10 
working days after receipt of such application, (except that the 
Commissioner may extend such time an additional 10 working days where 
necessary), the Commissioner shall issue a permit, deny the permit, or 
offer the applicant a hearing conducted in accordance with Sec.  108.5 
(b) and (c) as to whether the permit should be issued. The Commissioner 
shall issue such a permit to which shall be attached, in addition to the 
mandatory requirements and conditions of subpart B of this part, any 
additional requirements or conditions which may be necessary to protect 
the public health if he finds that all mandatory requirements and 
conditions of subpart B of this part are met or suitable interim 
measures are established.
    (c) Denial of a permit constitutes final agency action from which 
appeal lies to the courts. The Commissioner will not stay such denial 
pending court appeal except in unusual circumstances, but will 
participate in expediting any such appeal.



Sec.  108.10  Suspension and reinstatement of permit.

    (a) Whenever the Commissioner finds that a permit holder is not in 
compliance with the mandatory requirements and conditions established by 
the permit, he shall immediately suspend the permit and so inform the 
permit holder, with the reasons for the suspension.
    (b) Upon application for reinstatement of a permit, the Commissioner 
shall, within 10 working days, reinstate the permit if he finds that the 
person is in compliance with the mandatory requirements and conditions 
established by the permit or deny the application.
    (c) Any person whose permit has been suspended or whose application 
for reinstatement has been denied may request a hearing. The hearing 
shall be conducted by the Commissioner or his designee within 5 working 
days of receipt of the request at a location agreed upon by the objector 
and the Commissioner or, if an agreement cannot be reached, at a 
location designated by the Commissioner. The permit holder shall have 
the right to present witnesses on his own behalf and to cross-examine 
the Food and Drug Administration's witnesses.
    (d) Within 5 working days after the hearing, and based on the 
evidence presented at the hearing, the Commissioner shall determine 
whether the permit shall be reinstated and shall so inform the permit 
holder, with the reasons for his decision.
    (e) Denial of an application for reinstatement of a permit 
constitutes final agency action from which appeal lies to the courts. 
The Commisioner will not stay such denial pending court appeal except in 
unusual circumstances, but will participate in expediting any such 
appeal.



Sec.  108.12  Manufacturing, processing, or packing without a permit, or in 

violation of a permit.

    (a) A manufacturer, processor, or packer may continue at his own 
risk to manufacture, process, or pack without a permit a food for which 
the Commissioner has determined that a permit is required. All food so 
manufactured, processed, or packed during such period without a permit 
shall be retained by the manufacturer, processor, or packer and may not 
be introduced or delivered for introduction into interstate commerce 
without the advance written approval of the Food and Drug 
Administration. Such approval may be granted only upon an adequate 
showing that

[[Page 203]]

such food is free from microorganisms of public health significance. The 
manufacturer, processor, or packer may provide to the Commissioner, for 
his consideration in making any such determination, an evaluation of the 
potential public health significance of such food by a competent 
authority in accordance with procedures recognized as being adequate to 
detect any potential hazard to public health. Within 20 working days 
after receipt of a written request for such written approval the Food 
and Drug Administration shall either issue such written approval or deny 
the request. If the request is denied, the applicant shall, upon 
request, be afforded a prompt hearing conducted in accordance with Sec.  
108.5 (b) and (c).
    (b) Except as provided in paragraph (a) of this section, no 
manufacturer, processor, or packer may introduce or deliver for 
introduction into interstate commerce without a permit or in violation 
of a permit a food for which the Commissioner has determined that a 
permit is required. Where a manufacturer, processor, or packer utilizes 
a consolidation warehouse or other storage facility under his control, 
interstate shipment of any such food from the point of production to 
that warehouse or storage facility shall not violate this paragraph, 
provided that no further introduction or delivery for introduction into 
interstate commerce is made from that consolidated warehouse or storage 
facility except as provided in paragraph (a) of this section.



Sec.  108.19  Establishment of requirements for exemption from section 404 of 

the act.

    (a) Whenever the Commissioner finds after investigation that the 
distribution in interstate commerce of any class of food may, by reason 
of contamination with microorganisms during the manufacture, processing, 
or packing thereof in any locality, be injurious to health, and that 
such injurious nature cannot be adequately determined after such 
articles have entered interstate commerce, he shall promulgate 
regulations in Subpart B of this part establishing requirements and 
conditions governing the manufacture, processing, or packing of the food 
necessary to protect the public health. Such regulations may be proposed 
by the Commissioner on his own initiative or in response to a petition 
from any interested person pursuant to part 10 of this chapter.
    (b) A manufacturer, processor, or packer of a food for which a 
regulation has been promulgated in subpart B of this part shall be 
exempt from the requirement for a permit only if he meets all of the 
mandatory requirements and conditions established in that regulation.

[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]



  Subpart B_Specific Requirements and Conditions for Exemption From or 
                   Compliance With an Emergency Permit



Sec.  108.25  Acidified foods.

    (a) Inadequate or improper manufacture, processing, or packing of 
acidified foods may result in the distribution in interstate commerce of 
processed foods that may be injurious to health. The harmful nature of 
such foods cannot be adequately determined after these foods have 
entered into interstate commerce. The Commissioner of Food and Drugs 
therefore finds that, to protect the public health, it may be necessary 
to require any commericial processor, in any establishment engaged in 
the manufacture, processing, or packing of acidified foods, to obtain 
and hold a temporary emergency permit provided for under section 404 of 
the Federal Food, Drug, and Cosmetic Act. Such a permit may be required 
whenever the Commissioner finds, after investigation, that the 
commercial processor has failed to fulfill all the requirements of this 
section, including registration and filing of process information, and 
the mandatory portions of Sec. Sec.  114.10, 114.80(a) (1) and (2), and 
(b), 114.83, 114.89, and 114.100 (b), (c), and (d) of this chapter as 
they relate to acidified foods. These requirements are intended to 
ensure safe manufacturing, processing, and packing processes and to 
permit the Food and Drug Administration to verify that these processes 
are being followed. Failure to meet these requirements shall constitute 
a

[[Page 204]]

prima facie basis for the immediate application of the emergency permit 
control provisions of section 404 of the act to that establishment, 
under the procedures established in subpart A of this part.
    (b) The definitions in Sec.  114.3 of this chapter are applicable 
when those terms are used in this section.
    (c)(1) Registration. A commercial processor, when first engaging in 
the manufacture, processing, or packing of acidified foods in any State, 
as defined in section 201(a)(1) of the act, shall, not later than 10 
days after first so engaging, register and file with the Food and Drug 
Administration on Form FDA 2541 (food canning establishment 
registration) information including, but not limited to, the name of the 
establishment, principal place of business, the location of each 
establishment in which that processing is carried on, the processing 
method in terms of acidity and pH control, and a list of foods so 
processed in each establishment. These forms are available from the LACF 
Registration Coordinator (HFS-618), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or at any Food and Drug Administration district 
office. The completed form shall be submitted to the Center for Food 
Safety and Applied Nutrition (HFS-565), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740. Commercial processors 
presently so engaged shall register within 120 days after the effective 
date of this regulation. Foreign processors shall register within 120 
days after the effective date of this regulation or before any offering 
of foods for import into the United States, whichever is later. 
Commercial processors duly registered under this section shall notify 
the Food and Drug Administration not later than 90 days after the 
commercial processor ceases or discontinues the manufacture, processing, 
or packing of the foods in any establishment, except that this 
notification shall not be required for temporary cessations due to the 
seasonal character of an establishment's production or by temporary 
conditions including, but not limited to, labor disputes, fire, or acts 
of God.
    (2) Process filing. A commercial processor engaged in the processing 
of acidified foods shall, not later than 60 days after registration, and 
before packing any new product, provide the Food and Drug Administration 
information on the scheduled processes including, as necessary, 
conditions for heat processing and control of pH, salt, sugar, and 
preservative levels and source and date of the establishment of the 
process, for each acidified food in each container size. Filing of this 
information does not constitute approval of the information by the Food 
and Drug Administration, and information concerning processes and other 
data so filed shall be regarded as trade secrets within the meaning of 
21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted 
on form FDA 2541a (food canning establishment process filing form for 
all methods except aseptic). Forms are available from the LACF 
Registration Coordinator (HFS-618), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740, or at Food and Drug Administration district 
office. The completed form shall be submitted to the LACF Registration 
Coordinator (HFS-618), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740.
    (3) Process adherence and information--(i) Scheduling. A commercial 
processor engaged in processing acidified foods in any registered 
establishment shall process each food in conformity with at least the 
scheduled processes filed under paragraph (c)(2) of this section.
    (ii) Process and pH information availability. When requested by the 
Food and Drug Administration in writing, a commercial processor engaged 
in the processing of acidified foods shall provide the Food and Drug 
Administration with any process and procedure information that the Food 
and Drug Administration deems necessary to determine the adequacy of the 
process. Furnishing of this information does not constitute approval by 
the Food and Drug Administration of the content of the information 
filed, and the information concerning processes and other data so 
furnished shall be considered

[[Page 205]]

trade secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905 
(to the extent that they qualify under those provisions).
    (d) A commercial processor engaged in the processing of acidified 
foods shall promptly report to the Food and Drug Administration any 
instance of spoilage, process deviation, or contamination with 
microorganisms, the nature of which has potential health-endangering 
significance, where any lot of such food has in whole or in part entered 
distribution in commerce.
    (e) A commercial processor engaged in the processing of acidified 
foods shall prepare and maintain files on a current procedure for use 
for products under the processor's control, which that processor will 
ask the distributor to follow, including plans for recalling products 
that may be injurious to health; for identifying, collecting, ware 
housing, and controlling products; for determining the effectiveness of 
recalls; for notifying the Food and Drug Administration of any recalls; 
and for implementing recall programs.
    (f) All plant personnel involved in acidification, pH control, heat 
treatment, or other critical factors of the operation shall be under the 
operating supervision of a person who has attended a school approved by 
the Commissioner for giving instruction in food-handling techniques, 
food protection principles, personal hygiene, plant sanitation 
practices, pH controls, and critical factors in acidification, and who 
has satisfactorily completed the prescribed course of instruction. The 
Commissioner will consider students who have satisfactorily completed 
the required portions of the courses presented under Sec.  108.35 and 
part 113 of this chapter before March 16, 1979, as having satisfactorily 
completed the prescribed course of instruction under this section and 
part 114 of this chapter. The Commissioner will not withhold approval of 
any school qualified to give such instruction.
    (g) A commercial processor engaged in the processing of acidified 
foods shall prepare, review, and retain at the processing plant or other 
reasonably accessible location for a period of 3 years from the date of 
manufacture, all records of processing, deviations in processing, pH, 
and other records specified in part 114 of this chapter. Upon written 
demand during the course of a factory inspection under section 704 of 
the act by a duly authorized employee of the Food and Drug 
Administration, a commercial processor shall permit the inspection and 
copying by that employee of these records to verify the pH and the 
adequacy of processing.
    (h) This section shall not apply to the commercial processing of any 
food processed under the continuous inspection of the meat and poultry 
inspection program of the Food Safety and Inspection Service of the 
Department of Agriculture under the Federal Meat Inspection Act (34 
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the 
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat. 
791 (21 U.S.C. 451 et seq.)).
    (i) Wherever the Commissioner finds that any State regulates the 
commercial processing of acidified foods under effective regulations 
specifying at least the requirements of part 114 of this chapter, the 
Commissioner shall issue a notice stating that compliance with such 
State regulations shall constitute compliance with this section, if the 
State through its regulatory agency or each processor of acidified foods 
in the State files with the Food and Drug Administration the 
registration information and the processing information prescribed in 
paragraph (c) of this section.
    (j) Imports: (1) This section applies to any foreign commercial 
processor engaged in the processing of acidified foods and offering 
those foods for import into the United States except that, in lieu of 
providing for the issuance of an emergency permit under paragraph (a) of 
this section, the Commissioner will request the Secretary of the 
Treasury to refuse admission into the United States, under section 801 
of the act, to any acidified foods which the Commissioner determines, 
after investigation, may result in the distribution in interstate 
commerce of processed foods that may be injurious to health as set forth 
in paragraph (a) of this section.
    (2) Any acidified food so refused admission shall not be admitted 
until the Commissioner determines that the

[[Page 206]]

commercial processor offering the food for import has complied with the 
requirements of this section and that the food is not injurious to 
health. To assist the Commissioner in making this determination, a duly 
authorized employee of the Food and Drug Administration shall be 
permitted to inspect the commercial processor's manufacturing, 
processing, and packing facilities.
    (k) The following information submitted to the Food and Drug 
Administration under this section is not available for public disclosure 
unless it has been previously disclosed to the public as defined in 
Sec.  20.81 of this chapter or it relates to a product or ingredient 
that has been abandoned and no longer represents a trade secret or 
confidential commercial or financial information as defined in Sec.  
20.61 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
information.
    (2) Production, sales, distribution, and similar information, except 
that any compilation of the information aggregated and prepared in a way 
that does not reveal information which is not available for public 
disclosure under this provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.

[44 FR 16207, Mar. 16, 1979, as amended at 54 FR 24891, June 12, 1989; 
61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]



Sec.  108.35  Thermal processing of low-acid foods packaged in hermetically 

sealed containers.

    (a) Inadequate or improper manufacture, processing, or packing of 
thermally processed low-acid foods in hermetically sealed containers may 
result in the distribution in interstate commerce of processed foods 
that may be injurious to health. The harmful nature of such foods cannot 
be adequately determined after these foods have entered into interstate 
commerce. The Commissioner of Food and Drugs therefore finds that, in 
order to protect the public health, it may be necessary to require any 
commercial processor, in any establishment engaged in the manufacture, 
processing, or packing of thermally processed low-acid foods in 
hermetically sealed containers, to obtain and hold a temporary emergency 
permit provided for under section 404 of the Federal Food, Drug, and 
Cosmetic Act. Such a permit may be required whenever the Commissioner 
finds, after investigation, that the commercial processor has failed to 
fulfill all the requirements of this section, including registration and 
the filing of process information, and the mandatory portions of part 
113 of this chapter. These requirements are intended to ensure safe 
manufacture, processing, and packing procedures and to permit the Food 
and Drug Administration to verify that these procedures are being 
followed. Such failure shall constitute a prima facie basis for the 
immediate application of the emergency permit control provisions of 
section 404 of the act to that establishment, pursuant to the procedures 
established in subpart A of this part.
    (b) The definitions in Sec.  113.3 of this chapter are applicable 
when such terms are used in this section.
    (c) Registration and process filing--(1) Registration. A commercial 
processor when first engaging in the manufacture, processing, or packing 
of thermally processed low-acid foods in hermetically sealed containers 
in any state, as defined in section 201(a)(1) of the act, shall, not 
later than 10 days after first so engaging, register with the Food and 
Drug Administration on Form FDA 2541 (food canning establishment 
registration) information including (but not limited to) his name, 
principal place of business, the location of each establishment in which 
such processing is carried on, the processing method in terms of the 
type of processing equipment employed, and a list of the low-acid foods 
so processed in each such establishment. These forms are available from 
the LACF Registration Coordinator (HFS-618), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at any Food and Drug Administration 
district office. The completed form shall be submitted to the LACF 
Registration Coordinator (HFS-618), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park,

[[Page 207]]

MD 20740. Commercial processors presently so engaged shall register not 
later than July 13, 1973. Commercial processors duly registered in 
accordance with this section shall notify the Food and Drug 
Administration not later than 90 days after such commercial processor 
ceases or discontinues the manufacture, processing, or packing of 
thermally processed foods in any establishment: Provided, That such 
notification shall not be required as to the temporary cessation 
necessitated by the seasonal character of the particular establishment's 
production or caused by temporary conditions including but not limited 
to strikes, lockouts, fire, or acts of God.
    (2) Process filing. A commercial processor engaged in the thermal 
processing of low-acid foods packaged in hermetically sealed containers 
shall, not later than 60 days after registration and prior to the 
packing of a new product, provide the Food and Drug Administration 
information as to the scheduled processes including but not limited to 
the processing method, type of retort or other thermal processing 
equipment employed, minimum initial temperatures, times and temperatures 
of processing, sterilizing value (Fo), or other equivalent scientific 
evidence of process adequacy, critical control factors affecting heat 
penetration, and source and date of the establishment of the process, 
for each such low-acid food in each container size: Provided, That the 
filing of such information does not constitute approval of the 
information by the Food and Drug Administration, and that information 
concerning processes and other data so filed shall be regarded as trade 
secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This 
information shall be submitted on the following forms as appropriate: 
Form FDA 2541a (food canning establishment process filing for all 
methods except aseptic), or Form FDA 2541c (food canning establishment 
process filing for aseptic systems). These forms are available from the 
LACF Registration Coordinator (HFS-618), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, or at any Food and Drug Administration 
district office. The completed form(s) shall be submitted to the LACF 
Registration Coordinator (HFS-618), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740.
    (i) If all the necessary information is not available for existing 
products, the processor shall, at the time the existing information is 
provided to the Food and Drug Administration request in writing an 
extension of time for submission of such information, specifying what 
additional information is to be supplied and the date by which it is to 
be submitted. Within 30 working days after receipt of such request the 
Food and Drug Administration shall either grant or deny such request in 
writing.
    (ii) If a packer intentionally makes a change in a previously filed 
scheduled process by reducing the initial temperature or retort 
temperature, reducing the time of processing, or changing the product 
formulation, the container, or any other condition basic to the adequacy 
of scheduled process, he shall prior to using such changed process 
obtain substantiation by qualified scientific authority as to its 
adequacy. Such substantiation may be obtained by telephone, telegram, or 
other media, but must be promptly recorded, verified in writing by the 
authority, and contained in the packer's files for review by the Food 
and Drug Administration. Within 30 days after first use, the packer 
shall submit to the Center for Food Safety and Applied Nutrition (HFS-
617), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740 a complete description of the modifications made and 
utilized, together with a copy of his file record showing prior 
substantiation by a qualified scientific authority as to the safety of 
the changed process. Any intentional change of a previously filed 
scheduled process or modification thereof in which the change consists 
solely of a higher initial temperature, a higher retort temperature, or 
a longer processing time, shall not be considered a change subject to 
this paragraph, but if that modification is thereafter to be regularly 
scheduled, the modified process shall be promptly

[[Page 208]]

filed as a scheduled process, accompanied by full information on the 
specified forms as provided in this paragraph.
    (iii) Many packers employ an ``operating'' process in which retort 
operators are instructed to use retort temperatures and/or processing 
times slightly in excess of those specified in the scheduled process as 
a safety factor to compensate for minor fluctuations in temperature or 
time to assure that the minimum times and temperatures in the scheduled 
process are always met. This would not constitute a modification of the 
scheduled process.
    (3) Process adherence and information. (i) A commercial processor 
engaged in the thermal processing of low-acid foods packaged in 
hermetically sealed containers in any registered establishment shall 
process each low-acid food in each container size in conformity with at 
least the scheduled processes and modifications filed pursuant to 
paragraph (c)(2) of this section.
    (ii) Process information availability: When requested by the Food 
and Drug Administration in writing, a commercial processor engaged in 
thermal processing of low-acid foods packaged in hermetically sealed 
containers shall provide the Food and Drug Administration with any 
information concerning processes and procedures which is deemed 
necessary by the Food and Drug Administration to determine the adequacy 
of the process: Provided, That the furnishing of such information does 
not constitute approval of the information by the Food and Drug 
Administration, and that the information concerning processes and other 
data so furnished shall be regarded as trade secrets within the meaning 
of 21 U.S.C. 331(j) and 18 U.S.C. 1905.
    (d) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall promptly 
report to the Food and Drug Administration any instance of spoilage or 
process deviation the nature of which indicates potential health 
significance where any lot of such food has in whole or in part entered 
distribution.
    (e) A commercial processor engaged in thermal processing of low-acid 
foods packaged in hermetically sealed containers shall promptly report 
to the Food and Drug Administration any instance wherein any lot of such 
food, which may be injurious to health by reason of contamination with 
microorganisms, has in whole or in part entered distribution.
    (f) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall have 
prepared and in his files a current procedure which he will use for 
products under his control and which he will ask his distributor to 
follow, including plans for effecting recalls of any product that may be 
injurious to health; for identifying, collecting, warehousing, and 
controlling the product; for determining the effectiveness of such 
recall; for notifying the Food and Drug Administration of any such 
recall; and for implementing such recall program.
    (g) All operators of retorts, thermal processing systems, aseptic 
processing and packaging systems, or other thermal processing systems, 
and container closure inspectors shall be under the operating 
supervision of a person who has attended a school approved by the 
Commissioner for giving instruction in retort operations, aseptic 
processing and packaging systems operations or other thermal processing 
systems operations, and container closure inspections, and has 
satisfactorily completed the prescribed course of instruction: Provided, 
That this requirement shall not apply in the State of California as 
listed in paragraph (j) of this section. The Commissioner will not 
withhold approval of any school qualified to give such instruction.
    (h) A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers shall prepare, 
review, and retain at the processing plant for a period of not less than 
one year, and at the processing plant or other reasonably accessible 
location for an additional two years, all records of processing, 
deviations in processing, container closure inspections, and other 
records specified in part 113 of this chapter. If during the first year 
of the three-year record retention period the processing plant is closed 
for a prolonged period between seasonal packs,

[[Page 209]]

the records may be transferred to some other reasonably accessible 
location at the end of the seasonal pack. Upon written demand during the 
course of a factory inspection pursuant to section 704 of the act by a 
duly authorized employee of the Food and Drug Administration, a 
commercial processor shall permit the inspection and copying by such 
employee of these records to verify the adequacy of processing, the 
integrity of container closures, and the coding of the products.
    (i) This section shall not apply to the commercial processing of any 
food processed under the continuous inspection of the meat and poultry 
inspection program of the Animal and Plant Health Inspection Service of 
the Department of Agriculture under the Federal Meat Inspection Act (34 
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the 
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat. 
791 (21 U.S.C. 451 et seq.)).
    (j) Compliance with State regulations: (1) Wherever the Commissioner 
finds that any State regulates the commercial thermal processing of low-
acid foods in accordance with effective regulations specifying at least 
the requirements of part 113 of this chapter, he shall issue a notice 
stating that compliance with such State regulations shall constitute 
compliance with part 113 of this chapter. However, the provisions of 
this section shall remain applicable to the commercial processing of 
low-acid foods in any such State, except that, either the State through 
its regulatory agency or each processor of low-acid foods in such State 
shall file with the Center for Food Safety and Applied Nutrition the 
registration information and the processing information prescribed in 
paragraph (c) of this section.
    (2) The Commissioner finds that the regulations adopted by the State 
of California under the laws relating to cannery inspections governing 
thermal processing of low-acid foods packaged in hermetically sealed 
containers satisfy the requirements of part 113 of this chapter.

Accordingly, processors, who under the laws relating to cannery 
inspections are licensed by the State of California and who comply with 
such state regulations, shall be deemed to comply with the requirements 
of part 113 of this chapter.
    (k) Imports: (1) This section shall apply to any foreign commercial 
processor engaged in the thermal processing of low-acid foods packaged 
in hermetically sealed containers and offering such foods for import 
into the United States except that, in lieu of providing for the 
issuance of an emergency permit under paragraph (a) of this section, the 
Commissioner will request the Secretary of the Treasury to refuse 
admission into the United States, pursuant to section 801 of the act, of 
any such low-acid foods which the Commissioner determines, after 
investigation, may result in the distribution in interstate commerce of 
processed foods that may be injurious to health as set forth in 
paragraph (a) of this section.
    (2) Any such food refused admission shall not be admitted until such 
time as the Commissioner may determine that the commercial processor 
offering the food for import is in compliance with the requirements and 
conditions of this section and that such food is not injurious to 
health. For the purpose of making such determination, the Commissioner 
reserves the right for a duly authorized employee of the Food and Drug 
Administration to inspect the commercial processor's manufacturing, 
processing, and packing facilities.
    (l) The following data and information submitted to the Food and 
Drug Administration pursuant to this section are not available for 
public disclosure unless they have been previously disclosed to the 
public as defined in Sec.  20.81 of this chapter or they relate to a 
product or ingredient that has been abandoned and they no longer 
represent a trade secret or confidential commercial or financial 
information as defined in Sec.  20.81 of this chapter:
    (1) Manufacturing methods or processes, including quality control 
information.
    (2) Production, sales, distribution, and similar data and 
information, except that any compilation of such data and information 
aggregated and prepared in a way that does not reveal data or 
information which is not available for public disclosure under this

[[Page 210]]

provision is available for public disclosure.
    (3) Quantitative or semiquantitative formulas.

[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 
54 FR 24891, June 12, 1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 
6, 2001]



PART 109_UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-

PACKAGING MATERIAL--Table of Contents




                      Subpart A_General Provisions

Sec.
109.3 Definitions and interpretations.
109.4 Establishment of tolerances, regulatory limits, and action levels.
109.6 Added poisonous or deleterious substances.
109.7 Unavoidability.
109.15 Use of polychlorinated biphenyls (PCB's) in establishments 
          manufacturing food-packaging materials.
109.16 Ornamental and decorative ceramicware.

Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances

109.30 Tolerances for polychlorinated biphenyls (PCB's).

Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]

Subpart D--Naturally Occurring Poisonous or Deleterious Substances 
[Reserved]

    Authority: 21 U.S.C. 321, 336, 342, 346, 346a, 348, 371.

    Source: 42 FR 52819, Sept. 30, 1977, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  109.3  Definitions and interpretations.

    (a) Act means the Federal Food, Drug, and Cosmetic Act.
    (b) The definitions of terms contained in section 201 of the act are 
applicable to such terms when used in this part unless modified in this 
section.
    (c) A naturally occurring poisonous or deleterious substance is a 
poisonous or deleterious substance that is an inherent natural 
constituent of a food and is not the result of environmental, 
agricultural, industrial, or other contamination.
    (d) An added poisonous or deleterious substance is a poisonous or 
deleterious substance that is not a naturally occurring poisonous or 
deleterious substance. When a naturally occurring poisonous or 
deleterious substance is increased to abnormal levels through 
mishandling or other intervening acts, it is an added poisonous or 
deleterious substance to the extent of such increase.
    (e) Food includes human food and substances migrating to food from 
food-contact articles.



Sec.  109.4  Establishment of tolerances, regulatory limits, and action 

levels.

    (a) When appropriate under the criteria of Sec.  109.6, a tolerance 
for an added poisonous or deleterious substance, which may be a food 
additive, may be established by regulation in subpart B of this part 
under the provisions of section 406 of the act. A tolerance may prohibit 
any detectable amount of the substance in food.
    (b) When appropriate under the criteria of Sec.  109.6, and under 
section 402(a)(1) of the act, a regulatory limit for an added poisonous 
or deleterious substance, which may be a food additive, may be 
established by regulation in subpart C of this part under the provisions 
of sections 402(a)(1) and 701(a) of the act. A regulatory limit may 
prohibit any detectable amount of the substance in food. The regulatory 
limit established represents the level at which food is adulterated 
within the meaning of section 402(a)(1) of the act.
    (c)(1) When appropriate under the criteria of Sec.  109.6, an action 
level for an added poisonous or deleterious substance, which may be a 
food additive, may be established to define a level of contamination at 
which a food may be regarded as adulterated.
    (2) Whenever an action level is established or changed, a notice 
shall be published in the Federal Register as soon as practicable 
thereafter. The notice shall call attention to the material supporting 
the action level which shall be on file with the Division of Dockets 
Management before the notice

[[Page 211]]

is published. The notice shall invite public comment on the action 
level.
    (d) A regulation may be established in subpart D of this part to 
identify a food containing a naturally occurring poisonous or 
deleterious substance which will be deemed to be adulterated under 
section 402(a)(1) of the act. These regulations do not constitute a 
complete list of such foods.

[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]



Sec.  109.6  Added poisonous or deleterious substances.

    (a) Use of an added poisonous or deleterious substance, other than a 
pesticide chemical, that is also a food additive, will be controlled by 
a regulation issued under section 409 of the act when possible. When 
such a use cannot be approved under the criteria of section 409 of the 
act, or when the added poisonous or deleterious substance is not a food 
additive, a tolerance, regulatory limit, or action level may be 
established pursuant to the criteria in paragraphs (b), (c), or (d) of 
this section. Residues resulting from the use of an added poisonous or 
deleterious substance that is also a pesticide chemical will ordinarily 
be controlled by a tolerance established in a regulation issued under 
sections 406, 408, or 409 of the act by the U.S. Environmental 
Protection Agency (EPA). When such a regulation has not been issued, an 
action level for an added poisonous or deleterious substance that is 
also a pesticide chemical may be established by the Food and Drug 
Administration. The Food and Drug Administration will request EPA to 
recommend such an action level pursuant to the criteria established in 
paragraph (d) of this section.
    (b) A tolerance for an added poisonous or deleterious substance in 
any food may be established when the following criteria are met:
    (1) The substance cannot be avoided by good manufacturing practice.
    (2) The tolerance established is sufficient for the protection of 
the public health, taking into account the extent to which the presence 
of the substance cannot be avoided and the other ways in which the 
consumer may be affected by the same or related poisonous or deleterious 
substances.
    (3) No technological or other changes are foreseeable in the near 
future that might affect the appropriateness of the tolerance 
established. Examples of changes that might affect the appropriateness 
of the tolerance include anticipated improvements in good manufacturing 
practice that would change the extent to which use of the substance is 
unavoidable and anticipated studies expected to provide significant new 
toxicological or use data.
    (c) A regulatory limit for an added poisonous or deleterious 
substance in any food may be established when each of the following 
criteria is met:
    (1) The substance cannot be avoided by current good manufacturing 
practices.
    (2) There is no tolerance established for the substance in the 
particular food under sections 406, 408, or 409 of the act.
    (3) There is insufficient information by which a tolerance may be 
established for the substance under section 406 of the act or 
technological changes appear reasonably possible that may affect the 
appropriateness of a tolerance. The regulatory limit established 
represents the level at which food is adulterated within the meaning of 
section 402(a)(1) of the act.
    (d) An action level for an added poisonous or deleterious substance 
in any food may be established when the criteria in paragraph (b) of 
this section are met, except that technological or other changes that 
might affect the appropriateness of the tolerance are foreseeable in the 
near future. An action level for an added poisonous or deleterious 
substance in any food may be established at a level at which the Food 
and Drug Administration may regard the food as adulterated within the 
meaning of section 402(a)(1) of the act, without regard to the criteria 
in paragraph (b) of this section or in section 406 of the act. An action 
level will be withdrawn when a tolerance or regulatory limit for the 
same substance and use has been established.
    (e) Tolerances will be established under authority appropriate for 
action levels (sections 306, 402(a), and 701(a) of the act, together 
with section 408 or 409 of the act, if appropriate) as well as under 
authority appropriate for tolerances (sections 406 and 701 of the act).

[[Page 212]]

In the event the effectiveness of a tolerance is stayed pursuant to 
section 701(e)(2) of the act by the filing of an objection, the order 
establishing the tolerance shall be deemed to be an order establishing 
an action level until final action is taken upon such objection.

[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]



Sec.  109.7  Unavoidability.

    (a) Tolerances and action levels in this part are established at 
levels based on the unavoidability of the poisonous or deleterious 
substance concerned and do not establish a permissible level of 
contamination where it is avoidable.
    (b) Compliance with tolerances, regulatory limits, and action levels 
does not excuse failure to observe either the requirement in section 
402(a)(4) of the act that food may not be prepared, packed, or held 
under insanitary conditions or the other requirements in this chapter 
that food manufacturers must observe current good manufacturing 
practices. Evidence obtained through factory inspection or otherwise 
indicating such a violation renders the food unlawful, even though the 
amounts of poisonous or deleterious substances are lower than the 
currently established tolerances, regulatory limits, or action levels. 
The manufacturer of food must at all times utilize quality control 
procedures which will reduce contamination to the lowest level currently 
feasible.

[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]



Sec.  109.15  Use of polychlorinated biphenyls (PCB's) in establishments 

manufacturing food-packaging materials.

    (a) Polychlorinated biphenyls (PCB's) represent a class of toxic 
industrial chemicals manufactured and sold under a variety of trade 
names, including: Aroclor (United States); Phenoclor (France); Colphen 
(Germany); and Kanaclor (Japan). PCB's are highly stable, heat 
resistant, and nonflammable chemicals. Industrial uses of PCB's include, 
or did include in the past, their use as electrical transformer and 
capacitor fluids, heat transfer fluids, hydraulic fluids, and 
plasticizers, and in formulations of lubricants, coatings, and inks. 
Their unique physical and chemical properties and widespread, 
uncontrolled industrial applications have caused PCB's to be a 
persistent and ubiquitous contaminant in the environment, causing the 
contamination of certain foods. In addition, incidents have occurred in 
which PCB's have directly contaminated animal feeds as a result of 
industrial accidents (leakage or spillage of PCB fluids from plant 
equipment). These accidents in turn caused the contamination of food 
products intended for human consumption (meat, milk and eggs). 
Investigations by the Food and Drug Administration have revealed that a 
significant percentage of paper food-packaging material contains PCB's 
which can migrate to the packaged food. The origin of PCB's in such 
material is not fully understood. Reclaimed fibers containing carbonless 
copy paper (contains 3 to 5 percent PCB's) have been identified as a 
primary source of PCB's in paper products. Some virgin paper products 
have also been found to contain PCB's, the source of which is generally 
attributed to direct contamination from industrial accidents from the 
use of PCB-containing equipment and machinery in food packaging 
manufacturing establishments. Since PCB's are toxic chemicals, the PCB 
contamination of food-packaging materials as a result of industrial 
accidents, which can cause the PCB contamination of food, represents a 
hazard to public health. It is therefore necessary to place certain 
restrictions on the industrial uses of PCB's in establishments 
manufacturing food-packaging materials.
    (b) The following special provisions are necessary to preclude the 
accidental PCB contamination of food-packaging materials:
    (1) New equipment or machinery for manufacturing food-packaging 
materials shall not contain or use PCB's.
    (2) On or before September 4, 1973, the management of establishments 
manufacturing food-packaging materials shall:
    (i) Have the heat exchange fluid used in existing equipment for 
manufacturing food-packaging materials sampled and tested to determine 
whether it contains PCB's or verify the absence of

[[Page 213]]

PCB's in such formulations by other appropriate means. On or before 
Sept. 4, 1973, any such fluid formulated with PCB's must to the fullest 
extent possible commensurate with current good manufacturing practices 
be replaced with a heat exchange fluid that does not contain PCB's.
    (ii) Eliminate to the fullest extent possible commensurate with 
current good manufacturing practices from the establishment any other 
PCB-containing equipment, machinery and materials wherever there is a 
reasonable expectation that such articles could cause food-packaging 
materials to become contaminated with PCB's either as a result of normal 
use or as a result of accident, breakage, or other mishap.
    (iii) The toxicity and other characteristics of fluids selected as 
PCB replacements must be adequately determined so that the least 
potentially hazardous replacement is used. In making this determination 
with respect to a given fluid, consideration should be given to (a) its 
toxicity; (b) the maximum quantity that could be spilled onto a given 
quantity of food before it would be noticed, taking into account its 
color and odor; (c) possible signaling devices in the equipment to 
indicate a loss of fluid, etc.; and (d) its environmental stability and 
tendency to survive and be concentrated through the food chain. The 
judgment as to whether a replacement fluid is sufficiently non-hazardous 
is to be made on an individual installation and operation basis.
    (c) The provisions of this section do not apply to electrical 
transformers and condensers containing PCB's in sealed containers.



Sec.  109.16  Ornamental and decorative ceramicware.

    (a) Lead is a toxic metal that is used as a component of glazes and 
decorative decals on ceramics, including some ornamental and decorative 
ceramicware. The use of ornamental or decorative ceramicware to prepare, 
serve, or hold food may result in the leaching of lead from the glaze or 
decoration into the food. The provisions of paragraph (b) of this 
section are necessary to ensure that ornamental or decorative 
ceramicware bear adequate indications that they are not to be used for 
food-handling purposes.
    (b) Ornamental or decorative ceramicware initially introduced or 
initially delivered for introduction into interstate commerce on or 
after July 13, 1994 appears to be suitable for food use will be 
considered to be for food use unless:
    (1) It bears:
    (i) A conspicuous stick-on label on a surface clearly visible to 
consumers that states in legible script in letters at least 3.2 
millimeters (0.125 inch) in height one of the following messages: ``Not 
for Food Use. May Poison Food,'' ``Not for Food Use. Glaze contains 
lead. Food Use May Result in Lead Poisoning,'' and ``Not for Food Use--
Food Consumed from this Vessel May be Harmful,'' and
    (ii) A conspicuous and legible permanent statement of the message 
selected from paragraph (b)(1)(i) of this section molded or fired onto 
the exterior surface of the base or, when the ceramicware is not fired 
after decoration, permanently painted onto the exterior surface of the 
base. This permanent statement shall be in letters at least 3.2 
millimeters (0.125 inch) in height, except that if insufficient space 
exists for the permanent statement in letters of such height, the 
statement shall be in the largest letters that will allow it to fit on 
the base of the piece, provided that the letters are at least 1.6 
millimeters (0.062 inch) in height; or
    (2) A hole is bored through the potential food-contact surface.
    (c) In addition to steps required under paragraphs (b)(1) and (b)(2) 
of this section, the following optional information may be provided on 
the ware:
    (1) A further explanatory statement concerning the decorative nature 
of the piece, such as ``Decorative'' or ``For Decorative Purposes 
Only,'' may be used; however, such additional statement shall be placed 
after the required statement.
    (2) A symbol may be used to advise that a piece of ornamental or 
decorative ceramicware is not to be used with food, as illustrated 
below.

[[Page 214]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.368


The circle of the above symbol should be at least 2.54 centimeters (1 
inch) in diameter. The symbol may be used on the temporary label or 
applied to the base of the piece in the same manner as the permanent 
statement.

[59 FR 1641, Jan. 12, 1994]



Subpart B_Tolerances for Unavoidable Poisonous or Deleterious Substances



Sec.  109.30  Tolerances for polychlorinated biphenyls (PCB's).

    (a) Polychlorinated biphenyls (PCB's) are toxic, industrial 
chemicals. Because of their widespread, uncontrolled industrial 
applications, PCB's have become a persistent and ubiquitous contaminant 
in the environment. As a result, certain foods and animal feeds, 
principally those of animal and marine origin, contain PCB's as 
unavoidable, environmental contaminants. PCB's are transmitted to the 
food portion (meat, milk, and eggs) of food-producing animals ingesting 
PCB-contaminated animal feed. In addition, a significant percentage of 
paper food-packaging materials contain PCB's which may migrate to the 
packaged food. The source of PCB's in paper food-packaging materials is 
primarily of certain types of carbonless copy paper (containing 3 to 5 
percent PCB's) in waste paper stocks used for manufacturing recycled 
paper. Therefore, temporary tolerances for residues of PCB's as 
unavoidable environmental or industrial contaminants are established for 
a sufficient period of time following the effective date of this 
paragraph to permit the elimination of such contaminants at the earliest 
practicable time. For the purposes of this paragraph, the term 
``polychlorinated biphenyls (PCB's)'' is applicable to mixtures of 
chlorinated biphenyl compounds, irrespective of which mixture of PCB's 
is present as the residue. The temporary tolerances for residues of 
PCB's are as follows:
    (1) 1.5 parts per million in milk (fat basis).
    (2) 1.5 parts per million in manufactured dairy products (fat 
basis).
    (3) 3 parts per million in poultry (fat basis).
    (4) 0.3 parts per million in eggs.
    (5) 0.2 parts per million in finished animal feed for food-producing 
animals (except the following finished animal feeds: feed concentrates, 
feed supplements, and feed premixes).
    (6) 2 parts per million in animal feed components of animal origin, 
including fishmeal and other by-products of marine origin and in 
finished animal feed concentrates, supplements, and premixes intended 
for food producing animals.
    (7) 2 parts per million in fish and shellfish (edible portion). The 
edible portion of fish excludes head, scales, viscera, and inedible 
bones.
    (8) 0.2 parts per million in infant and junior foods.
    (9) 10 parts per million in paper food-packaging material intended 
for or used with human food, finished animal feed and any components 
intended for animal feeds. The tolerance shall not apply to paper food-
packaging material separated from the food therein by a functional 
barrier which is impermeable to migration of PCB's.
    (b) A compilation entitled ``Analytical Methodology for 
Polychlorinated Biphenyls, June 1979'' for determining compliance with 
the tolerances established in this section is available from the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    (c) A barrier is functional for purposes of paragraph (a)(9) of this 
section if the barrier limits migration of PCB's from the packaging 
material to food to a level not exceeding the migration which occurs 
under the same test conditions from packaging material containing 10 
parts per million PCB without the use of a barrier. A class of barrier 
material is functional for purposes of paragraph (a)(9) of this section 
if a

[[Page 215]]

representative barrier of the class limits migration of PCB's from the 
packaging material to food to a level not exceeding the migration which 
occurs under the same test conditions from packaging material containing 
10 parts per million PCB without the use of a barrier. Migration levels 
shall be determined for purpose of this paragraph solely by use of 
testing conditions described in ``Test Procedures for Determination of 
PCB Permeability of Food Packaging, Inner-Wraps, September 1976, revised 
May 1983'', which is incorporated by reference. Copies are available 
from the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or 
available for inspection at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html. A 
class of barrier material shall be deemed functional only if the 
definition of the class and the designation of one or more 
representative barriers has been approved by the Director, Center for 
Food Safety and Applied Nutrition, Food and Drug Administration. In the 
event that the Director, Center for Food Safety and Applied Nutrition, 
does not approve a proposal made to the Center regarding the definition 
of a class of barrier material or the designation of representative 
barriers, the Director shall advise the person making the proposal of 
the reasons for the Center's disapproval within 90 days of receipt of 
the proposal. All proposals for definition of classes and determinations 
of the Food and Drug Administration regarding such proposals shall be on 
file with the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    (d) Any person who asserts that a barrier or class of barriers is 
functional shall submit the results of tests conducted to determine the 
functionality of the barrier or class of barriers to Center for Food 
Safety and Applied Nutrition (HFS-308), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740. All barriers or classes 
of barriers shall be tested with the four solid food receptors specified 
in ``Test Procedures for Determination of PCB Permeability of Food 
Packaging, Inner-Wraps, September 1976, revised May 1983'', which is 
incorporated by reference. The availability of this reference is given 
in paragraph (c) of this section. The test results as to each barrier 
shall be accompanied by (1) a description of the barrier's composition 
adequate to enable identification; and (2) a specific definition of the 
barrier by relevant technical characteristics. The Center for Food 
Safety and Applied Nutrition shall review submitted test results 
promptly. Within 60 days of the receipt of test results, the Director, 
Center for Food Safety and Applied Nutrition, shall notify the person 
submitting the test results whether the tests were conducted in 
accordance with the ``Analytical Methodology for Polychlorinated 
Biphenyls; June 1979'', which is incorporated by reference, or the 
``Test Procedures for Determination of PCB Permeability of Food 
Packaging, Inner-Wraps, September 1976, revised May 1983'' and whether, 
therefore, the barrier or class of barriers is deemed functional within 
the meaning of paragraph (c) of this section. The test results and any 
response of the Food and Drug Administration shall be placed on file 
with the Division of Dockets Management, Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

[42 FR 52819, Sept. 30, 1977, as amended at 44 FR 38340, June 29, 1979; 
46 FR 8459, Jan. 27, 1981; 48 FR 10811, Mar. 15, 1983; 48 FR 37021, Aug. 
16, 1983; 54 FR 24892, June 12, 1989; 59 FR 14364, Mar. 28, 1994; 61 FR 
14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]

    Effective Date Note: At 38 FR 22794, Aug. 24, 1973, the following 
appeared concerning Sec.  109.30(a)(9) (formerly 122.10(a)(9)):
* * * Sec.  109.30(a)(9) is hereby stayed pending full review of the 
objections and requests for hearing. * * *
    In the interim, as stated in the final order (38 FR 18098) the Food 
and Drug Administration will enforce the temporary tolerance level 
established by Sec.  109.30(a)(9) by seizing any paper food-packaging 
material shipped in interstate commerce after September 4, 1973 
containing higher than the specified

[[Page 216]]

level of PCB's as adulterated in violation of sec. 402 of the act.

Subpart C--Regulatory Limits for Added Poisonous or Deleterious Substances 
[Reserved]

Subpart D--Naturally Occurring Posionous or Deleterious Substances 
[Reserved]



PART 110_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR 

HOLDING HUMAN FOOD--Table of Contents




                      Subpart A_General Provisions

Sec.
110.3 Definitions.
110.5 Current good manufacturing practice.
110.10 Personnel.
110.19 Exclusions.

                   Subpart B_Buildings and Facilities

110.20 Plant and grounds.
110.35 Sanitary operations.
110.37 Sanitary facilities and controls.

                           Subpart C_Equipment

110.40 Equipment and utensils.

Subpart D [Reserved]

                Subpart E_Production and Process Controls

110.80 Processes and controls.
110.93 Warehousing and distribution.

Subpart F [Reserved]

                     Subpart G_Defect Action Levels

110.110 Natural or unavoidable defects in food for human use that 
          present no health hazard.

    Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.

    Source: 51 FR 24475, June 19, 1986, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  110.3  Definitions.

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) are applicable to such 
terms when used in this part. The following definitions shall also 
apply:
    (a) Acid foods or acidified foods means foods that have an 
equilibrium pH of 4.6 or below.
    (b) Adequate means that which is needed to accomplish the intended 
purpose in keeping with good public health practice.
    (c) Batter means a semifluid substance, usually composed of flour 
and other ingredients, into which principal components of food are 
dipped or with which they are coated, or which may be used directly to 
form bakery foods.
    (d) Blanching, except for tree nuts and peanuts, means a 
prepackaging heat treatment of foodstuffs for a sufficient time and at a 
sufficient temperature to partially or completely inactivate the 
naturally occurring enzymes and to effect other physical or biochemical 
changes in the food.
    (e) Critical control point means a point in a food process where 
there is a high probability that improper control may cause, allow, or 
contribute to a hazard or to filth in the final food or decomposition of 
the final food.
    (f) Food means food as defined in section 201(f) of the act and 
includes raw materials and ingredients.
    (g) Food-contact surfaces are those surfaces that contact human food 
and those surfaces from which drainage onto the food or onto surfaces 
that contact the food ordinarily occurs during the normal course of 
operations. ``Food-contact surfaces'' includes utensils and food-contact 
surfaces of equipment.
    (h) Lot means the food produced during a period of time indicated by 
a specific code.
    (i) Microorganisms means yeasts, molds, bacteria, and viruses and 
includes, but is not limited to, species having public health 
significance. The term ``undesirable microorganisms'' includes those 
microorganisms that are of public health significance, that subject food 
to decomposition, that indicate that food is contaminated with filth, or 
that otherwise may cause food to be adulterated within the meaning of 
the act. Occasionally in these regulations, FDA used the adjective 
``microbial'' instead of using an adjectival

[[Page 217]]

phrase containing the word microorganism.
    (j) Pest refers to any objectionable animals or insects including, 
but not limited to, birds, rodents, flies, and larvae.
    (k) Plant means the building or facility or parts thereof, used for 
or in connection with the manufacturing, packaging, labeling, or holding 
of human food.
    (l) Quality control operation means a planned and systematic 
procedure for taking all actions necessary to prevent food from being 
adulterated within the meaning of the act.
    (m) Rework means clean, unadulterated food that has been removed 
from processing for reasons other than insanitary conditions or that has 
been successfully reconditioned by reprocessing and that is suitable for 
use as food.
    (n) Safe-moisture level is a level of moisture low enough to prevent 
the growth of undesirable microorganisms in the finished product under 
the intended conditions of manufacturing, storage, and distribution. The 
maximum safe moisture level for a food is based on its water activity 
(aw). An aw will be considered safe for a food if 
adequate data are available that demonstrate that the food at or below 
the given aw will not support the growth of undesirable 
microorganisms.
    (o) Sanitize means to adequately treat food-contact surfaces by a 
process that is effective in destroying vegetative cells of 
microorganisms of public health significance, and in substantially 
reducing numbers of other undesirable microorganisms, but without 
adversely affecting the product or its safety for the consumer.
    (p) Shall is used to state mandatory requirements.
    (q) Should is used to state recommended or advisory procedures or 
identify recommended equipment.
    (r) Water activity (aw) is a measure of the free moisture 
in a food and is the quotient of the water vapor pressure of the 
substance divided by the vapor pressure of pure water at the same 
temperature.



Sec.  110.5  Current good manufacturing practice.

    (a) The criteria and definitions in this part shall apply in 
determining whether a food is adulterated (1) within the meaning of 
section 402(a)(3) of the act in that the food has been manufactured 
under such conditions that it is unfit for food; or (2) within the 
meaning of section 402(a)(4) of the act in that the food has been 
prepared, packed, or held under insanitary conditions whereby it may 
have become contaminated with filth, or whereby it may have been 
rendered injurious to health. The criteria and definitions in this part 
also apply in determining whether a food is in violation of section 361 
of the Public Health Service Act (42 U.S.C. 264).
    (b) Food covered by specific current good manufacturing practice 
regulations also is subject to the requirements of those regulations.



Sec.  110.10  Personnel.

    The plant management shall take all reasonable measures and 
precautions to ensure the following:
    (a) Disease control. Any person who, by medical examination or 
supervisory observation, is shown to have, or appears to have, an 
illness, open lesion, including boils, sores, or infected wounds, or any 
other abnormal source of microbial contamination by which there is a 
reasonable possibility of food, food-contact surfaces, or food-packaging 
materials becoming contaminated, shall be excluded from any operations 
which may be expected to result in such contamination until the 
condition is corrected. Personnel shall be instructed to report such 
health conditions to their supervisors.
    (b) Cleanliness. All persons working in direct contact with food, 
food-contact surfaces, and food-packaging materials shall conform to 
hygienic practices while on duty to the extent necessary to protect 
against contamination of food. The methods for maintaining cleanliness 
include, but are not limited to:
    (1) Wearing outer garments suitable to the operation in a manner 
that protects against the contamination of food, food-contact surfaces, 
or food-packaging materials.

[[Page 218]]

    (2) Maintaining adequate personal cleanliness.
    (3) Washing hands thoroughly (and sanitizing if necessary to protect 
against contamination with undesirable microorganisms) in an adequate 
hand-washing facility before starting work, after each absence from the 
work station, and at any other time when the hands may have become 
soiled or contaminated.
    (4) Removing all unsecured jewelry and other objects that might fall 
into food, equipment, or containers, and removing hand jewelry that 
cannot be adequately sanitized during periods in which food is 
manipulated by hand. If such hand jewelry cannot be removed, it may be 
covered by material which can be maintained in an intact, clean, and 
sanitary condition and which effectively protects against the 
contamination by these objects of the food, food-contact surfaces, or 
food-packaging materials.
    (5) Maintaining gloves, if they are used in food handling, in an 
intact, clean, and sanitary condition. The gloves should be of an 
impermeable material.
    (6) Wearing, where appropriate, in an effective manner, hair nets, 
headbands, caps, beard covers, or other effective hair restraints.
    (7) Storing clothing or other personal belongings in areas other 
than where food is exposed or where equipment or utensils are washed.
    (8) Confining the following to areas other than where food may be 
exposed or where equipment or utensils are washed: eating food, chewing 
gum, drinking beverages, or using tobacco.
    (9) Taking any other necessary precautions to protect against 
contamination of food, food-contact surfaces, or food-packaging 
materials with microorganisms or foreign substances including, but not 
limited to, perspiration, hair, cosmetics, tobacco, chemicals, and 
medicines applied to the skin.
    (c) Education and training. Personnel responsible for identifying 
sanitation failures or food contamination should have a background of 
education or experience, or a combination thereof, to provide a level of 
competency necessary for production of clean and safe food. Food 
handlers and supervisors should receive appropriate training in proper 
food handling techniques and food-protection principles and should be 
informed of the danger of poor personal hygiene and insanitary 
practices.
    (d) Supervision. Responsibility for assuring compliance by all 
personnel with all requirements of this part shall be clearly assigned 
to competent supervisory personnel.

[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]



Sec.  110.19  Exclusions.

    (a) The following operations are not subject to this part: 
Establishments engaged solely in the harvesting, storage, or 
distribution of one or more ``raw agricultural commodities,'' as defined 
in section 201(r) of the act, which are ordinarily cleaned, prepared, 
treated, or otherwise processed before being marketed to the consuming 
public.
    (b) FDA, however, will issue special regulations if it is necessary 
to cover these excluded operations.



                   Subpart B_Buildings and Facilities



Sec.  110.20  Plant and grounds.

    (a) Grounds. The grounds about a food plant under the control of the 
operator shall be kept in a condition that will protect against the 
contamination of food. The methods for adequate maintenance of grounds 
include, but are not limited to:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the plant 
buildings or structures that may constitute an attractant, breeding 
place, or harborage for pests.
    (2) Maintaining roads, yards, and parking lots so that they do not 
constitute a source of contamination in areas where food is exposed.
    (3) Adequately draining areas that may contribute contamination to 
food by seepage, foot-borne filth, or providing a breeding place for 
pests.
    (4) Operating systems for waste treatment and disposal in an 
adequate manner so that they do not constitute a source of contamination 
in areas where food is exposed.

[[Page 219]]


If the plant grounds are bordered by grounds not under the operator's 
control and not maintained in the manner described in paragraph (a) (1) 
through (3) of this section, care shall be exercised in the plant by 
inspection, extermination, or other means to exclude pests, dirt, and 
filth that may be a source of food contamination.
    (b) Plant construction and design. Plant buildings and structures 
shall be suitable in size, construction, and design to facilitate 
maintenance and sanitary operations for food-manufacturing purposes. The 
plant and facilities shall:
    (1) Provide sufficient space for such placement of equipment and 
storage of materials as is necessary for the maintenance of sanitary 
operations and the production of safe food.
    (2) Permit the taking of proper precautions to reduce the potential 
for contamination of food, food-contact surfaces, or food-packaging 
materials with microorganisms, chemicals, filth, or other extraneous 
material. The potential for contamination may be reduced by adequate 
food safety controls and operating practices or effective design, 
including the separation of operations in which contamination is likely 
to occur, by one or more of the following means: location, time, 
partition, air flow, enclosed systems, or other effective means.
    (3) Permit the taking of proper precautions to protect food in 
outdoor bulk fermentation vessels by any effective means, including:
    (i) Using protective coverings.
    (ii) Controlling areas over and around the vessels to eliminate 
harborages for pests.
    (iii) Checking on a regular basis for pests and pest infestation.
    (iv) Skimming the fermentation vessels, as necessary.
    (4) Be constructed in such a manner that floors, walls, and ceilings 
may be adequately cleaned and kept clean and kept in good repair; that 
drip or condensate from fixtures, ducts and pipes does not contaminate 
food, food-contact surfaces, or food-packaging materials; and that 
aisles or working spaces are provided between equipment and walls and 
are adequately unobstructed and of adequate width to permit employees to 
perform their duties and to protect against contaminating food or food-
contact surfaces with clothing or personal contact.
    (5) Provide adequate lighting in hand-washing areas, dressing and 
locker rooms, and toilet rooms and in all areas where food is examined, 
processed, or stored and where equipment or utensils are cleaned; and 
provide safety-type light bulbs, fixtures, skylights, or other glass 
suspended over exposed food in any step of preparation or otherwise 
protect against food contamination in case of glass breakage.
    (6) Provide adequate ventilation or control equipment to minimize 
odors and vapors (including steam and noxious fumes) in areas where they 
may contaminate food; and locate and operate fans and other air-blowing 
equipment in a manner that minimizes the potential for contaminating 
food, food-packaging materials, and food-contact surfaces.
    (7) Provide, where necessary, adequate screening or other protection 
against pests.



Sec.  110.35  Sanitary operations.

    (a) General maintenance. Buildings, fixtures, and other physical 
facilities of the plant shall be maintained in a sanitary condition and 
shall be kept in repair sufficient to prevent food from becoming 
adulterated within the meaning of the act. Cleaning and sanitizing of 
utensils and equipment shall be conducted in a manner that protects 
against contamination of food, food-contact surfaces, or food-packaging 
materials.
    (b) Substances used in cleaning and sanitizing; storage of toxic 
materials. (1) Cleaning compounds and sanitizing agents used in cleaning 
and sanitizing procedures shall be free from undesirable microorganisms 
and shall be safe and adequate under the conditions of use. Compliance 
with this requirement may be verified by any effective means including 
purchase of these substances under a supplier's guarantee or 
certification, or examination of these substances for contamination. 
Only the following toxic materials may be used or stored in a plant 
where food is processed or exposed:

[[Page 220]]

    (i) Those required to maintain clean and sanitary conditions;
    (ii) Those necessary for use in laboratory testing procedures;
    (iii) Those necessary for plant and equipment maintenance and 
operation; and
    (iv) Those necessary for use in the plant's operations.
    (2) Toxic cleaning compounds, sanitizing agents, and pesticide 
chemicals shall be identified, held, and stored in a manner that 
protects against contamination of food, food-contact surfaces, or food-
packaging materials. All relevant regulations promulgated by other 
Federal, State, and local government agencies for the application, use, 
or holding of these products should be followed.
    (c) Pest control. No pests shall be allowed in any area of a food 
plant. Guard or guide dogs may be allowed in some areas of a plant if 
the presence of the dogs is unlikely to result in contamination of food, 
food-contact surfaces, or food-packaging materials. Effective measures 
shall be taken to exclude pests from the processing areas and to protect 
against the contamination of food on the premises by pests. The use of 
insecticides or rodenticides is permitted only under precautions and 
restrictions that will protect against the contamination of food, food-
contact surfaces, and food-packaging materials.
    (d) Sanitation of food-contact surfaces. All food-contact surfaces, 
including utensils and food-contact surfaces of equipment, shall be 
cleaned as frequently as necessary to protect against contamination of 
food.
    (1) Food-contact surfaces used for manufacturing or holding low-
moisture food shall be in a dry, sanitary condition at the time of use. 
When the surfaces are wet-cleaned, they shall, when necessary, be 
sanitized and thoroughly dried before subsequent use.
    (2) In wet processing, when cleaning is necessary to protect against 
the introduction of microorganisms into food, all food-contact surfaces 
shall be cleaned and sanitized before use and after any interruption 
during which the food-contact surfaces may have become contaminated. 
Where equipment and utensils are used in a continuous production 
operation, the utensils and food-contact surfaces of the equipment shall 
be cleaned and sanitized as necessary.
    (3) Non-food-contact surfaces of equipment used in the operation of 
food plants should be cleaned as frequently as necessary to protect 
against contamination of food.
    (4) Single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) should be stored in appropriate 
containers and shall be handled, dispensed, used, and disposed of in a 
manner that protects against contamination of food or food-contact 
surfaces.
    (5) Sanitizing agents shall be adequate and safe under conditions of 
use. Any facility, procedure, or machine is acceptable for cleaning and 
sanitizing equipment and utensils if it is established that the 
facility, procedure, or machine will routinely render equipment and 
utensils clean and provide adequate cleaning and sanitizing treatment.
    (e) Storage and handling of cleaned portable equipment and utensils. 
Cleaned and sanitized portable equipment with food-contact surfaces and 
utensils should be stored in a location and manner that protects food-
contact surfaces from contamination.

[51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]



Sec.  110.37  Sanitary facilities and controls.

    Each plant shall be equipped with adequate sanitary facilities and 
accommodations including, but not limited to:
    (a) Water supply. The water supply shall be sufficient for the 
operations intended and shall be derived from an adequate source. Any 
water that contacts food or food-contact surfaces shall be safe and of 
adequate sanitary quality. Running water at a suitable temperature, and 
under pressure as needed, shall be provided in all areas where required 
for the processing of food, for the cleaning of equipment, utensils, and 
food-packaging materials, or for employee sanitary facilities.
    (b) Plumbing. Plumbing shall be of adequate size and design and 
adequately installed and maintained to:

[[Page 221]]

    (1) Carry sufficient quantities of water to required locations 
throughout the plant.
    (2) Properly convey sewage and liquid disposable waste from the 
plant.
    (3) Avoid constituting a source of contamination to food, water 
supplies, equipment, or utensils or creating an unsanitary condition.
    (4) Provide adequate floor drainage in all areas where floors are 
subject to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor.
    (5) Provide that there is not backflow from, or cross-connection 
between, piping systems that discharge waste water or sewage and piping 
systems that carry water for food or food manufacturing.
    (c) Sewage disposal. Sewage disposal shall be made into an adequate 
sewerage system or disposed of through other adequate means.
    (d) Toilet facilities. Each plant shall provide its employees with 
adequate, readily accessible toilet facilities. Compliance with this 
requirement may be accomplished by:
    (1) Maintaining the facilities in a sanitary condition.
    (2) Keeping the facilities in good repair at all times.
    (3) Providing self-closing doors.
    (4) Providing doors that do not open into areas where food is 
exposed to airborne contamination, except where alternate means have 
been taken to protect against such contamination (such as double doors 
or positive air-flow systems).
    (e) Hand-washing facilities. Hand-washing facilities shall be 
adequate and convenient and be furnished with running water at a 
suitable temperature. Compliance with this requirement may be 
accomplished by providing:
    (1) Hand-washing and, where appropriate, hand-sanitizing facilities 
at each location in the plant where good sanitary practices require 
employees to wash and/or sanitize their hands.
    (2) Effective hand-cleaning and sanitizing preparations.
    (3) Sanitary towel service or suitable drying devices.
    (4) Devices or fixtures, such as water control valves, so designed 
and constructed to protect against recontamination of clean, sanitized 
hands.
    (5) Readily understandable signs directing employees handling 
unproteced food, unprotected food-packaging materials, of food-contact 
surfaces to wash and, where appropriate, sanitize their hands before 
they start work, after each absence from post of duty, and when their 
hands may have become soiled or contaminated. These signs may be posted 
in the processing room(s) and in all other areas where employees may 
handle such food, materials, or surfaces.
    (6) Refuse receptacles that are constructed and maintained in a 
manner that protects against contamination of food.
    (f) Rubbish and offal disposal. Rubbish and any offal shall be so 
conveyed, stored, and disposed of as to minimize the development of 
odor, minimize the potential for the waste becoming an attractant and 
harborage or breeding place for pests, and protect against contamination 
of food, food-contact surfaces, water supplies, and ground surfaces.



                           Subpart C_Equipment



Sec.  110.40  Equipment and utensils.

    (a) All plant equipment and utensils shall be so designed and of 
such material and workmanship as to be adequately cleanable, and shall 
be properly maintained. The design, construction, and use of equipment 
and utensils shall preclude the adulteration of food with lubricants, 
fuel, metal fragments, contaminated water, or any other contaminants. 
All equipment should be so installed and maintained as to facilitate the 
cleaning of the equipment and of all adjacent spaces. Food-contact 
surfaces shall be corrosion-resistant when in contact with food. They 
shall be made of nontoxic materials and designed to withstand the 
environment of their intended use and the action of food, and, if 
applicable, cleaning compounds and sanitizing agents. Food-contact 
surfaces shall be maintained to protect food from being contaminated by 
any source, including unlawful indirect food additives.

[[Page 222]]

    (b) Seams on food-contact surfaces shall be smoothly bonded or 
maintained so as to minimize accumulation of food particles, dirt, and 
organic matter and thus minimize the opportunity for growth of 
microorganisms.
    (c) Equipment that is in the manufacturing or food-handling area and 
that does not come into contact with food shall be so constructed that 
it can be kept in a clean condition.
    (d) Holding, conveying, and manufacturing systems, including 
gravimetric, pneumatic, closed, and automated systems, shall be of a 
design and construction that enables them to be maintained in an 
appropriate sanitary condition.
    (e) Each freezer and cold storage compartment used to store and hold 
food capable of supporting growth of microorganisms shall be fitted with 
an indicating thermometer, temperature-measuring device, or temperature-
recording device so installed as to show the temperature accurately 
within the compartment, and should be fitted with an automatic control 
for regulating temperature or with an automatic alarm system to indicate 
a significant temperature change in a manual operation.
    (f) Instruments and controls used for measuring, regulating, or 
recording temperatures, pH, acidity, water activity, or other conditions 
that control or prevent the growth of undesirable microorganisms in food 
shall be accurate and adequately maintained, and adequate in number for 
their designated uses.
    (g) Compressed air or other gases mechanically introduced into food 
or used to clean food-contact surfaces or equipment shall be treated in 
such a way that food is not contaminated with unlawful indirect food 
additives.

Subpart D [Reserved]



                Subpart E_Production and Process Controls



Sec.  110.80  Processes and controls.

    All operations in the receiving, inspecting, transporting, 
segregating, preparing, manufacturing, packaging, and storing of food 
shall be conducted in accordance with adequate sanitation principles. 
Appropriate quality control operations shall be employed to ensure that 
food is suitable for human consumption and that food-packaging materials 
are safe and suitable. Overall sanitation of the plant shall be under 
the supervision of one or more competent individuals assigned 
responsibility for this function. All reasonable precautions shall be 
taken to ensure that production procedures do not contribute 
contamination from any source. Chemical, microbial, or extraneous-
material testing procedures shall be used where necessary to identify 
sanitation failures or possible food contamination. All food that has 
become contaminated to the extent that it is adulterated within the 
meaning of the act shall be rejected, or if permissible, treated or 
processed to eliminate the contamination.
    (a) Raw materials and other ingredients. (1) Raw materials and other 
ingredients shall be inspected and segregated or otherwise handled as 
necessary to ascertain that they are clean and suitable for processing 
into food and shall be stored under conditions that will protect against 
contamination and minimize deterioration. Raw materials shall be washed 
or cleaned as necessary to remove soil or other contamination. Water 
used for washing, rinsing, or conveying food shall be safe and of 
adequate sanitary quality. Water may be reused for washing, rinsing, or 
conveying food if it does not increase the level of contamination of the 
food. Containers and carriers of raw materials should be inspected on 
receipt to ensure that their condition has not contributed to the 
contamination or deterioration of food.
    (2) Raw materials and other ingredients shall either not contain 
levels of microorganisms that may produce food poisoning or other 
disease in humans, or they shall be pasteurized or otherwise treated 
during manufacturing operations so that they no longer contain levels 
that would cause the product to be adulterated within the meaning of the 
act. Compliance with this requirement may be verified by any effective 
means, including purchasing raw materials and other ingredients under a 
supplier's guarantee or certification.

[[Page 223]]

    (3) Raw materials and other ingredients susceptible to contamination 
with aflatoxin or other natural toxins shall comply with current Food 
and Drug Administration regulations and action levels for poisonous or 
deleterious substances before these materials or ingredients are 
incorporated into finished food. Compliance with this requirement may be 
accomplished by purchasing raw materials and other ingredients under a 
supplier's guarantee or certification, or may be verified by analyzing 
these materials and ingredients for aflatoxins and other natural toxins.
    (4) Raw materials, other ingredients, and rework susceptible to 
contamination with pests, undesirable microorganisms, or extraneous 
material shall comply with applicable Food and Drug Administration 
regulations and defect action levels for natural or unavoidable defects 
if a manufacturer wishes to use the materials in manufacturing food. 
Compliance with this requirement may be verified by any effective means, 
including purchasing the materials under a supplier's guarantee or 
certification, or examination of these materials for contamination.
    (5) Raw materials, other ingredients, and rework shall be held in 
bulk, or in containers designed and constructed so as to protect against 
contamination and shall be held at such temperature and relative 
humidity and in such a manner as to prevent the food from becoming 
adulterated within the meaning of the act. Material scheduled for rework 
shall be identified as such.
    (6) Frozen raw materials and other ingredients shall be kept frozen. 
If thawing is required prior to use, it shall be done in a manner that 
prevents the raw materials and other ingredients from becoming 
adulterated within the meaning of the act.
    (7) Liquid or dry raw materials and other ingredients received and 
stored in bulk form shall be held in a manner that protects against 
contamination.
    (b) Manufacturing operations. (1) Equipment and utensils and 
finished food containers shall be maintained in an acceptable condition 
through appropriate cleaning and sanitizing, as necessary. Insofar as 
necessary, equipment shall be taken apart for thorough cleaning.
    (2) All food manufacturing, including packaging and storage, shall 
be conducted under such conditions and controls as are necessary to 
minimize the potential for the growth of microorganisms, or for the 
contamination of food. One way to comply with this requirement is 
careful monitoring of physical factors such as time, temperature, 
humidity, aw, pH, pressure, flow rate, and manufacturing 
operations such as freezing, dehydration, heat processing, 
acidification, and refrigeration to ensure that mechanical breakdowns, 
time delays, temperature fluctuations, and other factors do not 
contribute to the decomposition or contamination of food.
    (3) Food that can support the rapid growth of undesirable 
microorganisms, particularly those of public health significance, shall 
be held in a manner that prevents the food from becoming adulterated 
within the meaning of the act. Compliance with this requirement may be 
accomplished by any effective means, including:
    (i) Maintaining refrigerated foods at 45 [deg]F (7.2 [deg]C) or 
below as appropriate for the particular food involved.
    (ii) Maintaining frozen foods in a frozen state.
    (iii) Maintaining hot foods at 140 [deg]F (60 [deg]C) or above.
    (iv) Heat treating acid or acidified foods to destroy mesophilic 
microorganisms when those foods are to be held in hermetically sealed 
containers at ambient temperatures.
    (4) Measures such as sterilizing, irradiating, pasteurizing, 
freezing, refrigerating, controlling pH or controlling aw 
that are taken to destroy or prevent the growth of undesirable 
microorganisms, particularly those of public health significance, shall 
be adequate under the conditions of manufacture, handling, and 
distribution to prevent food from being adulterated within the meaning 
of the act.
    (5) Work-in-process shall be handled in a manner that protects 
against contamination.
    (6) Effective measures shall be taken to protect finished food from 
contamination by raw materials, other ingredients, or refuse. When raw 
materials,

[[Page 224]]

other ingredients, or refuse are unprotected, they shall not be handled 
simultaneously in a receiving, loading, or shipping area if that 
handling could result in contaminated food. Food transported by conveyor 
shall be protected against contamination as necessary.
    (7) Equipment, containers, and utensils used to convey, hold, or 
store raw materials, work-in-process, rework, or food shall be 
constructed, handled, and maintained during manufacturing or storage in 
a manner that protects against contamination.
    (8) Effective measures shall be taken to protect against the 
inclusion of metal or other extraneous material in food. Compliance with 
this requirement may be accomplished by using sieves, traps, magnets, 
electronic metal detectors, or other suitable effective means.
    (9) Food, raw materials, and other ingredients that are adulterated 
within the meaning of the act shall be disposed of in a manner that 
protects against the contamination of other food. If the adulterated 
food is capable of being reconditioned, it shall be reconditioned using 
a method that has been proven to be effective or it shall be reexamined 
and found not to be adulterated within the meaning of the act before 
being incorporated into other food.
    (10) Mechanical manufacturing steps such as washing, peeling, 
trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, 
shredding, extruding, drying, whipping, defatting, and forming shall be 
performed so as to protect food against contamination. Compliance with 
this requirement may be accomplished by providing adequate physical 
protection of food from contaminants that may drip, drain, or be drawn 
into the food. Protection may be provided by adequate cleaning and 
sanitizing of all food-contact surfaces, and by using time and 
temperature controls at and between each manufacturing step.
    (11) Heat blanching, when required in the preparation of food, 
should be effected by heating the food to the required temperature, 
holding it at this temperature for the required time, and then either 
rapidly cooling the food or passing it to subsequent manufacturing 
without delay. Thermophilic growth and contamination in blanchers should 
be minimized by the use of adequate operating temperatures and by 
periodic cleaning. Where the blanched food is washed prior to filling, 
water used shall be safe and of adequate sanitary quality.
    (12) Batters, breading, sauces, gravies, dressings, and other 
similar preparations shall be treated or maintained in such a manner 
that they are protected against contamination. Compliance with this 
requirement may be accomplished by any effective means, including one or 
more of the following:
    (i) Using ingredients free of contamination.
    (ii) Employing adequate heat processes where applicable.
    (iii) Using adequate time and temperature controls.
    (iv) Providing adequate physical protection of components from 
contaminants that may drip, drain, or be drawn into them.
    (v) Cooling to an adequate temperature during manufacturing.
    (vi) Disposing of batters at appropriate intervals to protect 
against the growth of microorganisms.
    (13) Filling, assembling, packaging, and other operations shall be 
performed in such a way that the food is protected against 
contamination. Compliance with this requirement may be accomplished by 
any effective means, including:
    (i) Use of a quality control operation in which the critical control 
points are identified and controlled during manufacturing.
    (ii) Adequate cleaning and sanitizing of all food-contact surfaces 
and food containers.
    (iii) Using materials for food containers and food- packaging 
materials that are safe and suitable, as defined in Sec.  130.3(d) of 
this chapter.
    (iv) Providing physical protection from contamination, particularly 
airborne contamination.
    (v) Using sanitary handling procedures.
    (14) Food such as, but not limited to, dry mixes, nuts, intermediate 
moisture food, and dehydrated food, that relies on the control of 
aw for preventing the

[[Page 225]]

growth of undesirable microorganisms shall be processed to and 
maintained at a safe moisture level. Compliance with this requirement 
may be accomplished by any effective means, including employment of one 
or more of the following practices:
    (i) Monitoring the aw of food.
    (ii) Controlling the soluble solids-water ratio in finished food.
    (iii) Protecting finished food from moisture pickup, by use of a 
moisture barrier or by other means, so that the aw of the 
food does not increase to an unsafe level.
    (15) Food such as, but not limited to, acid and acidified food, that 
relies principally on the control of pH for preventing the growth of 
undesirable microorganisms shall be monitored and maintained at a pH of 
4.6 or below. Compliance with this requirement may be accomplished by 
any effective means, including employment of one or more of the 
following practices:
    (i) Monitoring the pH of raw materials, food in process, and 
finished food.
    (ii) Controlling the amount of acid or acidified food added to low-
acid food.
    (16) When ice is used in contact with food, it shall be made from 
water that is safe and of adequate sanitary quality, and shall be used 
only if it has been manufactured in accordance with current good 
manufacturing practice as outlined in this part.
    (17) Food-manufacturing areas and equipment used for manufacturing 
human food should not be used to manufacture nonhuman food-grade animal 
feed or inedible products, unless there is no reasonable possibility for 
the contamination of the human food.

[51 FR 24475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000]



Sec.  110.93  Warehousing and distribution.

    Storage and transportation of finished food shall be under 
conditions that will protect food against physical, chemical, and 
microbial contamination as well as against deterioration of the food and 
the container.

Subpart F [Reserved]



                     Subpart G_Defect Action Levels



Sec.  110.110  Natural or unavoidable defects in food for human use that 

present no health hazard.

    (a) Some foods, even when produced under current good manufacturing 
practice, contain natural or unavoidable defects that at low levels are 
not hazardous to health. The Food and Drug Administration establishes 
maximum levels for these defects in foods produced under current good 
manufacturing practice and uses these levels in deciding whether to 
recommend regulatory action.
    (b) Defect action levels are established for foods whenever it is 
necessary and feasible to do so. These levels are subject to change upon 
the development of new technology or the availability of new 
information.
    (c) Compliance with defect action levels does not excuse violation 
of the requirement in section 402(a)(4) of the act that food not be 
prepared, packed, or held under unsanitary conditions or the 
requirements in this part that food manufacturers, distributors, and 
holders shall observe current good manufacturing practice. Evidence 
indicating that such a violation exists causes the food to be 
adulterated within the meaning of the act, even though the amounts of 
natural or unavoidable defects are lower than the currently established 
defect action levels. The manufacturer, distributor, and holder of food 
shall at all times utilize quality control operations that reduce 
natural or unavoidable defects to the lowest level currently feasible.
    (d) The mixing of a food containing defects above the current defect 
action level with another lot of food is not permitted and renders the 
final food adulterated within the meaning of the act, regardless of the 
defect level of the final food.
    (e) A compilation of the current defect action levels for natural or 
unavoidable defects in food for human use that present no health hazard 
may be obtained upon request from the Center for Food Safety and Applied 
Nutrition

[[Page 226]]

(HFS-565), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740.

[51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66 
FR 56035, Nov. 6, 2001]



PART 111_CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, 

LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS--Table of Contents




                      Subpart A_General Provisions

Sec.
111.1 Who is subject to this part?
111.3 What definitions apply to this part?
111.5 Do other statutory provisions and regulations apply?

                           Subpart B_Personnel

111.8 What are the requirements under this subpart B for written 
          procedures?
111.10 What requirements apply for preventing microbial contamination 
          from sick or infected personnel and for hygienic practices?
111.12 What personnel qualification requirements apply?
111.13 What supervisor requirements apply?
111.14 Under this subpart B, what records must you make and keep?

                  Subpart C_Physical Plant and Grounds

111.15 What sanitation requirements apply to your physical plant and 
          grounds?
111.16 What are the requirements under this subpart C for written 
          procedures?
111.20 What design and construction requirements apply to your physical 
          plant?
111.23 Under this subpart C, what records must you make and keep?

                    Subpart D_Equipment and Utensils

111.25 What are the requirements under this subpart D for written 
          procedures?
111.27 What requirements apply to the equipment and utensils that you 
          use?
111.30 What requirements apply to automated, mechanical, or electronic 
          equipment?
111.35 Under this subpart D, what records must you make and keep?

  Subpart E_Requirement to Establish a Production and Process Control 
                                 System

111.55 What are the requirements to implement a production and process 
          control system?
111.60 What are the design requirements for the production and process 
          control system?
111.65 What are the requirements for quality control operations?
111.70 What specifications must you establish?
111.73 What is your responsibility for determining whether established 
          specifications are met?
111.75 What must you do to determine whether specifications are met?
111.77 What must you do if established specifications are not met?
111.80 What representative samples must you collect?
111.83 What are the requirements for reserve samples?
111.87 Who conducts a material review and makes a disposition decision?
111.90 What requirements apply to treatments, in-process adjustments, 
          and reprocessing when there is a deviation or unanticipated 
          occurrence or when a specification established in accordance 
          with Sec.  111.70 is not met?
111.95 Under this subpart E, what records must you make and keep?

   Subpart F_Production and Process Control System: Requirements for 
                             Quality Control

111.103 What are the requirements under this subpart F for written 
          procedures?
111.105 What must quality control personnel do?
111.110 What quality control operations are required for laboratory 
          operations associated with the production and process control 
          system?
111.113 What quality control operations are required for a material 
          review and disposition decision?
111.117 What quality control operations are required for equipment, 
          instruments, and controls?
111.120 What quality control operations are required for components, 
          packaging, and labels before use in the manufacture of a 
          dietary supplement?
111.123 What quality control operations are required for the master 
          manufacturing record, the batch production record, and 
          manufacturing operations?
111.127 What quality control operations are required for packaging and 
          labeling operations?
111.130 What quality control operations are required for returned 
          dietary supplements?
111.135 What quality control operations are required for product 
          complaints?

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111.140 Under this subpart F, what records must you make and keep?

   Subpart G_Production and Process Control System: Requirements for 
 Components, Packaging, and Labels and for Product That You Receive for 
              Packaging or Labeling as a Dietary Supplement

111.153 What are the requirements under this subpart G for written 
          procedures?
111.155 What requirements apply to components of dietary supplements?
111.160 What requirements apply to packaging and labels received?
111.165 What requirements apply to a product received for packaging or 
          labeling as a dietary supplement (and for distribution rather 
          than for return to the supplier)?
111.170 What requirements apply to rejected components, packaging, and 
          labels, and to rejected products that are received for 
          packaging or labeling as a dietary supplement?
111.180 Under this subpart G, what records must you make and keep?

 Subpart H_Production and Process Control System: Requirements for the 
                       Master Manufacturing Record

111.205 What is the requirement to establish a master manufacturing 
          record?
111.210 What must the master manufacturing record include?

 Subpart I_Production and Process Control System: Requirements for the 
                         Batch Production Record

111.255 What is the requirement to establish a batch production record?
111.260 What must the batch record include?

   Subpart J_Production and Process Control System: Requirements for 
                          Laboratory Operations

111.303 What are the requirements under this subpart J for written 
          procedures?
111.310 What are the requirements for the laboratory facilities that you 
          use?
111.315 What are the requirements for laboratory control processes?
111.320 What requirements apply to laboratory methods for testing and 
          examination?
111.325 Under this subpart J, what records must you make and keep?

   Subpart K_Production and Process Control System: Requirements for 
                        Manufacturing Operations

111.353 What are the requirements under this subpart K for written 
          procedures?
111.355 What are the design requirements for manufacturing operations?
111.360 What are the requirements for sanitation?
111.365 What precautions must you take to prevent contamination?
111.370 What requirements apply to rejected dietary supplements?
111.375 Under this subpart K, what records must you make and keep?

   Subpart L_Production and Process Control System: Requirements for 
                    Packaging and Labeling Operations

111.403 What are the requirements under this subpart L for written 
          procedures?
111.410 What requirements apply to packaging and labels?
111.415 What requirements apply to filling, assembling, packaging, 
          labeling, and related operations?
111.420 What requirements apply to repackaging and relabeling?
111.425 What requirements apply to a packaged and labeled dietary 
          supplement that is rejected for distribution?
111.430 Under this subpart L, what records must you make and keep?

                   Subpart M_Holding and Distributing

111.453 What are the requirements under this subpart M for written 
          procedures?
111.455 What requirements apply to holding components, dietary 
          supplements, packaging, and labels?
111.460 What requirements apply to holding in-process material?
111.465 What requirements apply to holding reserve samples of dietary 
          supplements?
111.470 What requirements apply to distributing dietary supplements?
111.475 Under this subpart M, what records must you make and keep?

                 Subpart N_Returned Dietary Supplements

111.503 What are the requirements under this subpart N for written 
          procedures?
111.510 What requirements apply when a returned dietary supplement is 
          received?
111.515 When must a returned dietary supplement be destroyed, or 
          otherwise suitably disposed of?
111.520 When may a returned dietary supplement be salvaged?

[[Page 228]]

111.525 What requirements apply to a returned dietary supplement that 
          quality control personnel approve for reprocessing?
111.530 When must an investigation be conducted of your manufacturing 
          processes and other batches?
111.535 Under this subpart N, what records must you make and keep?

                      Subpart O_Product Complaints

111.553 What are the requirements under this subpart O for written 
          procedures?
111.560 What requirements apply to the review and investigation of a 
          product complaint?
111.570 Under this subpart O, what records must you make and keep?

                   Subpart P_Records and Recordkeeping

111.605 What requirements apply to the records that you make and keep?
111.610 What records must be made available to FDA?

    Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 
264.

    Source: 72 FR 34942, June 25, 2007, unless otherwise noted.



                      Subpart A_General Provisions



Sec.  111.1  Who is subject to this part?

    (a) Except as provided by paragraph (b) of this section, you are 
subject to this part if you manufacture, package, label, or hold a 
dietary supplement, including:
    (1) A dietary supplement you manufacture but that is packaged or 
labeled by another person; and
    (2) A dietary supplement imported or offered for import in any State 
or territory of the United States, the District of Columbia, or the 
Commonwealth of Puerto Rico.
    (b) The requirements pertaining to holding dietary supplements do 
not apply to you if you are holding those dietary supplements at a 
retail establishment for the sole purpose of direct retail sale to 
individual consumers. A retail establishment does not include a 
warehouse or other storage facility for a retailer or a warehouse or 
other storage facility that sells directly to individual consumers.



Sec.  111.3  What definitions apply to this part?

    The definitions and interpretations of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when 
used in this part. For the purpose of this part, the following 
definitions also apply:
    Actual yield means the quantity that is actually produced at any 
appropriate step of manufacture or packaging of a particular dietary 
supplement.
    Batch means a specific quantity of a dietary supplement that is 
uniform, that is intended to meet specifications for identity, purity, 
strength, and composition, and that is produced during a specified time 
period according to a single manufacturing record during the same cycle 
of manufacture.
    Batch number, lot number, or control number means any distinctive 
group of letters, numbers, or symbols, or any combination of them, from 
which the complete history of the manufacturing, packaging, labeling, 
and/or holding of a batch or lot of dietary supplements can be 
determined.
    Component means any substance intended for use in the manufacture of 
a dietary supplement, including those that may not appear in the 
finished batch of the dietary supplement. Component includes dietary 
ingredients (as described in section 201(ff) of the act) and other 
ingredients.
    Contact surface means any surface that contacts a component or 
dietary supplement, and those surfaces from which drainage onto the 
component or dietary supplement, or onto surfaces that contact the 
component or dietary supplement, occurs during the normal course of 
operations. Examples of contact surfaces include containers, utensils, 
tables, contact surfaces of equipment, and packaging.
    Ingredient means any substance that is used in the manufacture of a 
dietary supplement and that is intended to be present in the finished 
batch of the dietary supplement. An ingredient includes, but is not 
necessarily limited to, a dietary ingredient as defined in section 
201(ff) of the act.
    In-process material means any material that is fabricated, 
compounded, blended, ground, extracted, sifted,

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sterilized, derived by chemical reaction, or processed in any other way 
for use in the manufacture of a dietary supplement.
    Lot means a batch, or a specific identified portion of a batch, that 
is uniform and that is intended to meet specifications for identity, 
purity, strength, and composition; or, in the case of a dietary 
supplement produced by continuous process, a specific identified amount 
produced in a specified unit of time or quantity in a manner that is 
uniform and that is intended to meet specifications for identity, 
purity, strength, and composition.
    Microorganisms means yeasts, molds, bacteria, viruses, and other 
similar microscopic organisms having public health or sanitary concern. 
This definition includes species that:
    (1) May have public health significance;
    (2) May cause a component or dietary supplement to decompose;
    (3) Indicate that the component or dietary supplement is 
contaminated with filth; or
    (4) Otherwise may cause the component or dietary supplement to be 
adulterated.
    Must is used to state a requirement.
    Pest means any objectionable insect or other animal including birds, 
rodents, flies, mites, and larvae.
    Physical plant means all or any part of a building or facility used 
for or in connection with manufacturing, packaging, labeling, or holding 
a dietary supplement.
    Product complaint means any communication that contains any 
allegation, written, electronic, or oral, expressing concern, for any 
reason, with the quality of a dietary supplement, that could be related 
to current good manufacturing practice. Examples of product complaints 
are: Foul odor, off taste, illness or injury, disintegration time, color 
variation, tablet size or size variation, under-filled container, 
foreign material in a dietary supplement container, improper packaging, 
mislabeling, or dietary supplements that are superpotent, subpotent, or 
contain the wrong ingredient, or contain a drug or other contaminant 
(e.g., bacteria, pesticide, mycotoxin, glass, lead).
    Quality means that the dietary supplement consistently meets the 
established specifications for identity, purity, strength, and 
composition, and limits on contaminants, and has been manufactured, 
packaged, labeled, and held under conditions to prevent adulteration 
under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.
    Quality control means a planned and systematic operation or 
procedure for ensuring the quality of a dietary supplement.
    Quality control personnel means any person, persons, or group, 
within or outside of your organization, who you designate to be 
responsible for your quality control operations.
    Representative sample means a sample that consists of an adequate 
number of units that are drawn based on rational criteria, such as 
random sampling, and that are intended to ensure that the sample 
accurately portrays the material being sampled.
    Reprocessing means using, in the manufacture of a dietary 
supplement, clean, uncontaminated components or dietary supplements that 
have been previously removed from manufacturing and that have been made 
suitable for use in the manufacture of a dietary supplement.
    Reserve sample means a representative sample of product that is held 
for a designated period of time.
    Sanitize means to adequately treat cleaned equipment, containers, 
utensils, or any other cleaned contact surface by a process that is 
effective in destroying vegetative cells of microorganisms of public 
health significance, and in substantially reducing numbers of other 
microorganisms, but without adversely affecting the product or its 
safety for the consumer.
    Theoretical yield means the quantity that would be produced at any 
appropriate step of manufacture or packaging of a particular dietary 
supplement, based upon the quantity of components or packaging to be 
used, in the absence of any loss or error in actual production.
    Water activity (aw) is a measure of the free moisture in 
a component or dietary supplement and is the quotient of

[[Page 230]]

the water vapor pressure of the substance divided by the vapor pressure 
of pure water at the same temperature.
    We means the U.S. Food and Drug Administration (FDA).
    You means a person who manufactures, packages, labels, or holds 
dietary supplements.



Sec.  111.5  Do other statutory provisions and regulations apply?

    In addition to this part, you must comply with other applicable 
statutory provisions and regulations under the act related to dietary 
supplements.



                           Subpart B_Personnel



Sec.  111.8  What are the requirements under this subpart B for written 

procedures?

    You must establish and follow written procedures for fulfilling the 
requirements of this subpart.



Sec.  111.10  What requirements apply for preventing microbial contamination 

from sick or infected personnel and for hygienic practices?

    (a) Preventing microbial contamination. You must take measures to 
exclude from any operations any person who might be a source of 
microbial contamination, due to a health condition, where such 
contamination may occur, of any material, including components, dietary 
supplements, and contact surfaces used in the manufacture, packaging, 
labeling, or holding of a dietary supplement. Such measures include the 
following:
    (1) Excluding from working in any operations that may result in 
contamination any person who, by medical examination, the person's 
acknowledgement, or supervisory observation, is shown to have, or 
appears to have, an illness, infection, open lesion, or any other 
abnormal source of microbial contamination, that could result in 
microbial contamination of components, dietary supplements, or contact 
surfaces, until the health condition no longer exists; and
    (2) Instructing your employees to notify their supervisor(s) if they 
have or if there is a reasonable possibility that they have a health 
condition described in paragraph (a)(1) of this section that could 
result in microbial contamination of any components, dietary 
supplements, or any contact surface.
    (b) Hygienic practices. If you work in an operation during which 
adulteration of the component, dietary supplement, or contact surface 
could occur, you must use hygienic practices to the extent necessary to 
protect against such contamination of components, dietary supplements, 
or contact surfaces. These hygienic practices include the following:
    (1) Wearing outer garments in a manner that protects against the 
contamination of components, dietary supplements, or any contact 
surface;
    (2) Maintaining adequate personal cleanliness;
    (3) Washing hands thoroughly (and sanitizing if necessary to protect 
against contamination with microorganisms) in an adequate hand-washing 
facility:
    (i) Before starting work; and
    (ii) At any time when the hands may have become soiled or 
contaminated;
    (4) Removing all unsecured jewelry and other objects that might fall 
into components, dietary supplements, equipment, or packaging, and 
removing hand jewelry that cannot be adequately sanitized during periods 
in which components or dietary supplements are manipulated by hand. If 
hand jewelry cannot be removed, it must be covered by material that is 
maintained in an intact, clean, and sanitary condition and that 
effectively protects against contamination of components, dietary 
supplements, or contact surfaces;
    (5) Maintaining gloves used in handling components or dietary 
supplements in an intact, clean, and sanitary condition. The gloves must 
be of an impermeable material;
    (6) Wearing, where appropriate, in an effective manner, hair nets, 
caps, beard covers, or other effective hair restraints;
    (7) Not storing clothing or other personal belongings in areas where 
components, dietary supplements, or any contact surfaces are exposed or 
where contact surfaces are washed;
    (8) Not eating food, chewing gum, drinking beverages, or using 
tobacco products in areas where components,

[[Page 231]]

dietary supplements, or any contact surfaces are exposed, or where 
contact surfaces are washed; and
    (9) Taking any other precautions necessary to protect against the 
contamination of components, dietary supplements, or contact surfaces 
with microorganisms, filth, or any other extraneous materials, including 
perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied 
to the skin.



Sec.  111.12  What personnel qualification requirements apply?

    (a) You must have qualified employees who manufacture, package, 
label, or hold dietary supplements.
    (b) You must identify who is responsible for your quality control 
operations. Each person who is identified to perform quality control 
operations must be qualified to do so and have distinct and separate 
responsibilities related to performing such operations from those 
responsibilities that the person otherwise has when not performing such 
operations.
    (c) Each person engaged in manufacturing, packaging, labeling, or 
holding, or in performing any quality control operations, must have the 
education, training, or experience to perform the person's assigned 
functions.



Sec.  111.13  What supervisor requirements apply?

    (a) You must assign qualified personnel to supervise the 
manufacturing, packaging, labeling, or holding of dietary supplements.
    (b) Each supervisor whom you use must be qualified by education, 
training, or experience to supervise.



Sec.  111.14  Under this subpart B, what records must you make and keep?

    (a) You must make and keep records required under this subpart B in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart B; and
    (2) Documentation of training, including the date of the training, 
the type of training, and the person(s) trained.



                  Subpart C_Physical Plant and Grounds



Sec.  111.15  What sanitation requirements apply to your physical plant and 

grounds?

    (a) Grounds. You must keep the grounds of your physical plant in a 
condition that protects against the contamination of components, dietary 
supplements, or contact surfaces. The methods for adequate ground 
maintenance include:
    (1) Properly storing equipment, removing litter and waste, and 
cutting weeds or grass within the immediate vicinity of the physical 
plant so that it does not attract pests, harbor pests, or provide pests 
a place for breeding;
    (2) Maintaining roads, yards, and parking lots so that they do not 
constitute a source of contamination in areas where components, dietary 
supplements, or contact surfaces are exposed;
    (3) Adequately draining areas that may contribute to the 
contamination of components, dietary supplements, or contact surfaces by 
seepage, filth or any other extraneous materials, or by providing a 
breeding place for pests;
    (4) Adequately operating systems for waste treatment and disposal so 
that they do not constitute a source of contamination in areas where 
components, dietary supplements, or contact surfaces are exposed; and
    (5) If your plant grounds are bordered by grounds not under your 
control, and if those other grounds are not maintained in the manner 
described in this section, you must exercise care in the plant by 
inspection, extermination, or other means to exclude pests, dirt, and 
filth or any other extraneous materials that may be a source of 
contamination.
    (b) Physical plant facilities. (1) You must maintain your physical 
plant in a clean and sanitary condition; and
    (2) You must maintain your physical plant in repair sufficient to 
prevent components, dietary supplements, or contact surfaces from 
becoming contaminated.
    (c) Cleaning compounds, sanitizing agents, pesticides, and other 
toxic materials. (1) You must use cleaning compounds and sanitizing 
agents that are free from microorganisms of public

[[Page 232]]

health significance and that are safe and adequate under the conditions 
of use.
    (2) You must not use or hold toxic materials in a physical plant in 
which components, dietary supplements, or contact surfaces are 
manufactured or exposed, unless those materials are necessary as 
follows:
    (i) To maintain clean and sanitary conditions;
    (ii) For use in laboratory testing procedures;
    (iii) For maintaining or operating the physical plant or equipment; 
or
    (iv) For use in the plant's operations.
    (3) You must identify and hold cleaning compounds, sanitizing 
agents, pesticides, pesticide chemicals, and other toxic materials in a 
manner that protects against contamination of components, dietary 
supplements, or contact surfaces.
    (d) Pest control. (1) You must not allow animals or pests in any 
area of your physical plant. Guard or guide dogs are allowed in some 
areas of your physical plant if the presence of the dogs will not result 
in contamination of components, dietary supplements, or contact 
surfaces;
    (2) You must take effective measures to exclude pests from the 
physical plant and to protect against contamination of components, 
dietary supplements, and contact surfaces on the premises by pests; and
    (3) You must not use insecticides, fumigants, fungicides, or 
rodenticides, unless you take precautions to protect against the 
contamination of components, dietary supplements, or contact surfaces.
    (e) Water supply. (1) You must provide water that is safe and 
sanitary, at suitable temperatures, and under pressure as needed, for 
all uses where water does not become a component of the dietary 
supplement.
    (2) Water that is used in a manner such that the water may become a 
component of the dietary supplement, e.g., when such water contacts 
components, dietary supplements, or any contact surface, must, at a 
minimum, comply with applicable Federal, State, and local requirements 
and not contaminate the dietary supplement.
    (f) Plumbing. The plumbing in your physical plant must be of an 
adequate size and design and be adequately installed and maintained to:
    (1) Carry sufficient amounts of water to required locations 
throughout the physical plant;
    (2) Properly convey sewage and liquid disposable waste from your 
physical plant;
    (3) Avoid being a source of contamination to components, dietary 
supplements, water supplies, or any contact surface, or creating an 
unsanitary condition;
    (4) Provide adequate floor drainage in all areas where floors are 
subject to flooding-type cleaning or where normal operations release or 
discharge water or other liquid waste on the floor; and
    (5) Not allow backflow from, or cross connection between, piping 
systems that discharge waste water or sewage and piping systems that 
carry water used for manufacturing dietary supplements, for cleaning 
contact surfaces, or for use in bathrooms or hand-washing facilities.
    (g) Sewage disposal. You must dispose of sewage into an adequate 
sewage system or through other adequate means.
    (h) Bathrooms. You must provide your employees with adequate, 
readily accessible bathrooms. The bathrooms must be kept clean and must 
not be a potential source of contamination to components, dietary 
supplements, or contact surfaces.
    (i) Hand-washing facilities. You must provide hand-washing 
facilities that are designed to ensure that an employee's hands are not 
a source of contamination of components, dietary supplements, or any 
contact surface, by providing facilities that are adequate, convenient, 
and furnish running water at a suitable temperature.
    (j) Trash disposal. You must convey, store, and dispose of trash to:
    (1) Minimize the development of odors;
    (2) Minimize the potential for the trash to attract, harbor, or 
become a breeding place for pests;
    (3) Protect against contamination of components, dietary 
supplements, any contact surface, water supplies, and grounds 
surrounding your physical plant; and

[[Page 233]]

    (4) Control hazardous waste to prevent contamination of components, 
dietary supplements, and contact surfaces.
    (k) Sanitation supervisors. You must assign one or more employees to 
supervise overall sanitation. Each of these supervisors must be 
qualified by education, training, or experience to develop and supervise 
sanitation procedures.



Sec.  111.16  What are the requirements under this subpart C for written 

procedures?

    You must establish and follow written procedures for cleaning the 
physical plant and for pest control.



Sec.  111.20  What design and construction requirements apply to your physical 

plant?

    Any physical plant you use in the manufacture, packaging, labeling, 
or holding of dietary supplements must:
    (a) Be suitable in size, construction, and design to facilitate 
maintenance, cleaning, and sanitizing operations;
    (b) Have adequate space for the orderly placement of equipment and 
holding of materials as is necessary for maintenance, cleaning, and 
sanitizing operations and to prevent contamination and mixups of 
components and dietary supplements during manufacturing, packaging, 
labeling, or holding;
    (c) Permit the use of proper precautions to reduce the potential for 
mixups or contamination of components, dietary supplements, or contact 
surfaces, with microorganisms, chemicals, filth, or other extraneous 
material. Your physical plant must have, and you must use, separate or 
defined areas of adequate size or other control systems, such as 
computerized inventory controls or automated systems of separation, to 
prevent contamination and mixups of components and dietary supplements 
during the following operations:
    (1) Receiving, identifying, holding, and withholding from use, 
components, dietary supplements, packaging, and labels that will be used 
in or during the manufacturing, packaging, labeling, or holding of 
dietary supplements;
    (2) Separating, as necessary, components, dietary supplements, 
packaging, and labels that are to be used in manufacturing from 
components, dietary supplements, packaging, or labels that are awaiting 
material review and disposition decision, reprocessing, or are awaiting 
disposal after rejection;
    (3) Separating the manufacturing, packaging, labeling, and holding 
of different product types including different types of dietary 
supplements and other foods, cosmetics, and pharmaceutical products;
    (4) Performing laboratory analyses and holding laboratory supplies 
and samples;
    (5) Cleaning and sanitizing contact surfaces;
    (6) Packaging and label operations; and
    (7) Holding components or dietary supplements.
    (d) Be designed and constructed in a manner that prevents 
contamination of components, dietary supplements, or contact surfaces.
    (1) The design and construction must include:
    (i) Floors, walls, and ceilings that can be adequately cleaned and 
kept clean and in good repair;
    (ii) Fixtures, ducts, and pipes that do not contaminate components, 
dietary supplements, or contact surfaces by dripping or other leakage, 
or condensate;
    (iii) Adequate ventilation or environmental control equipment such 
as airflow systems, including filters, fans, and other air-blowing 
equipment, that minimize odors and vapors (including steam and noxious 
fumes) in areas where they may contaminate components, dietary 
supplements, or contact surfaces;
    (iv) Equipment that controls temperature and humidity, when such 
equipment is necessary to ensure the quality of the dietary supplement; 
and
    (v) Aisles or working spaces between equipment and walls that are 
adequately unobstructed and of adequate width to permit all persons to 
perform their duties and to protect against contamination of components, 
dietary supplements, or contact surfaces with clothing or personal 
contact.
    (2) When fans and other air-blowing equipment are used, such fans 
and

[[Page 234]]

equipment must be located and operated in a manner that minimizes the 
potential for microorganisms and particulate matter to contaminate 
components, dietary supplements, or contact surfaces;
    (e) Provide adequate light in:
    (1) All areas where components or dietary supplements are examined, 
processed, or held;
    (2) All areas where contact surfaces are cleaned; and
    (3) Hand-washing areas, dressing and locker rooms, and bathrooms.
    (f) Use safety-type light bulbs, fixtures, skylights, or other glass 
or glass-like materials when the light bulbs, fixtures, skylights or 
other glass or glass-like materials are suspended over exposed 
components or dietary supplements in any step of preparation, unless 
your physical plant is otherwise constructed in a manner that will 
protect against contamination of components or dietary supplements in 
case of breakage of glass or glass-like materials.
    (g) Provide effective protection against contamination of components 
and dietary supplements in bulk fermentation vessels, by, for example:
    (1) Use of protective coverings;
    (2) Placement in areas where you can eliminate harborages for pests 
over and around the vessels;
    (3) Placement in areas where you can check regularly for pests, pest 
infestation, filth or any other extraneous materials; and
    (4) Use of skimming equipment.
    (h) Use adequate screening or other protection against pests, where 
necessary.



Sec.  111.23  Under this subpart C, what records must you make and keep?

    (a) You must make and keep records required under this subpart C in 
accordance with subpart P of this part.
    (b) You must make and keep records of the written procedures for 
cleaning the physical plant and for pest control.
    (c) You must make and keep records that show that water, when used 
in a manner such that the water may become a component of the dietary 
supplement, meets the requirements of Sec.  111.15(e)(2).



                    Subpart D_Equipment and Utensils



Sec.  111.25  What are the requirements under this subpart D for written 

procedures?

    You must establish and follow written procedures for fulfilling the 
requirements of this subpart D, including written procedures for:
    (a) Calibrating instruments and controls that you use in 
manufacturing or testing a component or dietary supplement;
    (b) Calibrating, inspecting, and checking automated, mechanical, and 
electronic equipment; and
    (c) Maintaining, cleaning, and sanitizing, as necessary, all 
equipment, utensils, and any other contact surfaces that are used to 
manufacture, package, label, or hold components or dietary supplements.



Sec.  111.27  What requirements apply to the equipment and utensils that you 

use?

    (a) You must use equipment and utensils that are of appropriate 
design, construction, and workmanship to enable them to be suitable for 
their intended use and to be adequately cleaned and properly maintained.
    (1) Equipment and utensils include the following:
    (i) Equipment used to hold or convey;
    (ii) Equipment used to measure;
    (iii) Equipment using compressed air or gas;
    (iv) Equipment used to carry out processes in closed pipes and 
vessels; and
    (v) Equipment used in automated, mechanical, or electronic systems.
    (2) You must use equipment and utensils of appropriate design and 
construction so that use will not result in the contamination of 
components or dietary supplements with:
    (i) Lubricants;
    (ii) Fuel;
    (iii) Coolants;
    (iv) Metal or glass fragments;
    (v) Filth or any other extraneous material;
    (vi) Contaminated water; or
    (vii) Any other contaminants.
    (3) All equipment and utensils you use must be:

[[Page 235]]

    (i) Installed and maintained to facilitate cleaning the equipment, 
utensils, and all adjacent spaces;
    (ii) Corrosion-resistant if the equipment or utensils contact 
components or dietary supplements;
    (iii) Made of nontoxic materials;
    (iv) Designed and constructed to withstand the environment in which 
they are used, the action of components or dietary supplements, and, if 
applicable, cleaning compounds and sanitizing agents; and
    (v) Maintained to protect components and dietary supplements from 
being contaminated by any source.
    (4) Equipment and utensils you use must have seams that are smoothly 
bonded or maintained to minimize accumulation of dirt, filth, organic 
material, particles of components or dietary supplements, or any other 
extraneous materials or contaminants.
    (5) Each freezer, refrigerator, and other cold storage compartment 
you use to hold components or dietary supplements:
    (i) Must be fitted with an indicating thermometer, temperature-
measuring device, or temperature-recording device that indicates and 
records, or allows for recording by hand, the temperature accurately 
within the compartment; and
    (ii) Must have an automated device for regulating temperature or an 
automated alarm system to indicate a significant temperature change in a 
manual operation.
    (6) Instruments or controls used in the manufacturing, packaging, 
labeling, or holding of a dietary supplement, and instruments or 
controls that you use to measure, regulate, or record temperatures, 
hydrogen-ion concentration (pH), water activity, or other conditions, to 
control or prevent the growth of microorganisms or other contamination 
must be:
    (i) Accurate and precise;
    (ii) Adequately maintained; and
    (iii) Adequate in number for their designated uses.
    (7) Compressed air or other gases you introduce mechanically into or 
onto a component, dietary supplement, or contact surface or that you use 
to clean any contact surface must be treated in such a way that the 
component, dietary supplement, or contact surface is not contaminated.
    (b) You must calibrate instruments and controls you use in 
manufacturing or testing a component or dietary supplement. You must 
calibrate:
    (1) Before first use; and
    (2) At the frequency specified in writing by the manufacturer of the 
instrument and control; or
    (3) At routine intervals or as otherwise necessary to ensure the 
accuracy and precision of the instrument and control.
    (c) You must repair or replace instruments or controls that cannot 
be adjusted to agree with the reference standard.
    (d) You must maintain, clean, and sanitize, as necessary, all 
equipment, utensils, and any other contact surfaces used to manufacture, 
package, label, or hold components or dietary supplements.
    (1) Equipment and utensils must be taken apart as necessary for 
thorough maintenance, cleaning, and sanitizing.
    (2) You must ensure that all contact surfaces, used for 
manufacturing or holding low-moisture components or dietary supplements, 
are in a dry and sanitary condition when in use. When the surfaces are 
wet-cleaned, they must be sanitized, when necessary, and thoroughly 
dried before subsequent use.
    (3) If you use wet processing during manufacturing, you must clean 
and sanitize all contact surfaces, as necessary, to protect against the 
introduction of microorganisms into components or dietary supplements. 
When cleaning and sanitizing is necessary, you must clean and sanitize 
all contact surfaces before use and after any interruption during which 
the contact surface may have become contaminated. If you use contact 
surfaces in a continuous production operation or in consecutive 
operations involving different batches of the same dietary supplement, 
you must adequately clean and sanitize the contact surfaces, as 
necessary.
    (4) You must clean surfaces that do not come into direct contact 
with components or dietary supplements as frequently as necessary to 
protect against

[[Page 236]]

contaminating components or dietary supplements.
    (5) Single-service articles (such as utensils intended for one-time 
use, paper cups, and paper towels) must be:
    (i) Stored in appropriate containers; and
    (ii) Handled, dispensed, used, and disposed of in a manner that 
protects against contamination of components, dietary supplements, or 
any contact surface.
    (6) Cleaning compounds and sanitizing agents must be adequate for 
their intended use and safe under their conditions of use;
    (7) You must store cleaned and sanitized portable equipment and 
utensils that have contact surfaces in a location and manner that 
protects them from contamination.

[72 FR 34942, June 25, 2007, as amended at 73 FR 13124, Mar. 12, 2008]



Sec.  111.30  What requirements apply to automated, mechanical, or electronic 

equipment?

    For any automated, mechanical, or electronic equipment that you use 
to manufacture, package, label, or hold a dietary supplement, you must:
    (a) Design or select equipment to ensure that dietary supplement 
specifications are consistently met;
    (b) Determine the suitability of the equipment by ensuring that your 
equipment is capable of operating satisfactorily within the operating 
limits required by the process;
    (c) Routinely calibrate, inspect, or check the equipment to ensure 
proper performance. Your quality control personnel must periodically 
review these calibrations, inspections, or checks;
    (d) Establish and use appropriate controls for automated, 
mechanical, and electronic equipment (including software for a computer 
controlled process) to ensure that any changes to the manufacturing, 
packaging, labeling, holding, or other operations are approved by 
quality control personnel and instituted only by authorized personnel; 
and
    (e) Establish and use appropriate controls to ensure that the 
equipment functions in accordance with its intended use. These controls 
must be approved by quality control personnel.



Sec.  111.35  Under this subpart D, what records must you make and keep?

    (a) You must make and keep records required under this subpart D in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart, including written procedures for:
    (i) Calibrating instruments and controls that you use in 
manufacturing or testing a component or dietary supplement;
    (ii) Calibrating, inspecting, and checking automated, mechanical, 
and electronic equipment; and
    (iii) Maintaining, cleaning, and sanitizing, as necessary, all 
equipment, utensils, and any other contact surfaces that are used to 
manufacture, package, label, or hold components or dietary supplements;
    (2) Documentation, in individual equipment logs, of the date of the 
use, maintenance, cleaning, and sanitizing of equipment, unless such 
documentation is kept with the batch record;
    (3) Documentation of any calibration, each time the calibration is 
performed, for instruments and controls that you use in manufacturing or 
testing a component or dietary supplement. In your documentation, you 
must:
    (i) Identify the instrument or control calibrated;
    (ii) Provide the date of calibration;
    (iii) Identify the reference standard used including the 
certification of accuracy of the known reference standard and a history 
of recertification of accuracy;
    (iv) Identify the calibration method used, including appropriate 
limits for accuracy and precision of instruments and controls when 
calibrating;
    (v) Provide the calibration reading or readings found;
    (vi) Identify the recalibration method used, and reading or readings 
found, if accuracy or precision or both accuracy and precision limits 
for instruments and controls were not met; and
    (vii) Include the initials of the person who performed the 
calibration and any recalibration.
    (4) Written records of calibrations, inspections, and checks of 
automated, mechanical, and electronic equipment;

[[Page 237]]

    (5) Backup file(s) of current software programs (and of outdated 
software that is necessary to retrieve records that you are required to 
keep in accordance with subpart P of this part, when current software is 
not able to retrieve such records) and of data entered into computer 
systems that you use to manufacture, package, label, or hold dietary 
supplements.
    (i) Your backup file (e.g., a hard copy of data you have entered, 
diskettes, tapes, microfilm, or compact disks) must be an exact and 
complete record of the data you entered.
    (ii) You must keep your backup software programs and data secure 
from alterations, inadvertent erasures, or loss; and
    (6) Documentation of the controls that you use to ensure that 
equipment functions in accordance with its intended use.



  Subpart E_Requirement to Establish a Production and Process Control 
                                 System



Sec.  111.55  What are the requirements to implement a production and process 

control system?

    You must implement a system of production and process controls that 
covers all stages of manufacturing, packaging, labeling, and holding of 
the dietary supplement to ensure the quality of the dietary supplement 
and that the dietary supplement is packaged and labeled as specified in 
the master manufacturing record.



Sec.  111.60  What are the design requirements for the production and process 

control system?

    (a) Your production and in-process control system must be designed 
to ensure that the dietary supplement is manufactured, packaged, 
labeled, and held in a manner that will ensure the quality of the 
dietary supplement and that the dietary supplement is packaged and 
labeled as specified in the master manufacturing record; and
    (b) The production and in-process control system must include all 
requirements of subparts E through L of this part and must be reviewed 
and approved by quality control personnel.



Sec.  111.65  What are the requirements for quality control operations?

    You must implement quality control operations in your manufacturing, 
packaging, labeling, and holding operations for producing the dietary 
supplement to ensure the quality of the dietary supplement and that the 
dietary supplement is packaged and labeled as specified in the master 
manufacturing record.



Sec.  111.70  What specifications must you establish?

    (a) You must establish a specification for any point, step, or stage 
in the manufacturing process where control is necessary to ensure the 
quality of the dietary supplement and that the dietary supplement is 
packaged and labeled as specified in the master manufacturing record.
    (b) For each component that you use in the manufacture of a dietary 
supplement, you must establish component specifications as follows:
    (1) You must establish an identity specification;
    (2) You must establish component specifications that are necessary 
to ensure that specifications for the purity, strength and composition 
of dietary supplements manufactured using the components are met; and
    (3) You must establish limits on those types of contamination that 
may adulterate or may lead to adulteration of the finished batch of the 
dietary supplement to ensure the quality of the dietary supplement.
    (c) For the in-process production:
    (1) You must establish in-process specifications for any point, 
step, or stage in the master manufacturing record where control is 
necessary to help ensure that specifications are met for the identity, 
purity, strength, and composition of the dietary supplements and, as 
necessary, for limits on those types of contamination that may 
adulterate or may lead to adulteration of the finished batch of the 
dietary supplement;
    (2) You must provide adequate documentation of your basis for why 
meeting the in-process specifications, in combination with meeting 
component specifications, will help ensure that the specifications are 
met for the identity,

[[Page 238]]

purity, strength, and composition of the dietary supplements and for 
limits on those types of contamination that may adulterate or may lead 
to adulteration of the finished batch of the dietary supplement; and
    (3) Quality control personnel must review and approve the 
documentation that you provide under paragraph (c)(2) of this section.
    (d) You must establish specifications for dietary supplement labels 
(label specifications) and for packaging that may come in contact with 
dietary supplements (packaging specifications). Packaging that may come 
into contact with dietary supplements must be safe and suitable for its 
intended use and must not be reactive or absorptive or otherwise affect 
the safety or quality of the dietary supplement.
    (e) For each dietary supplement that you manufacture you must 
establish product specifications for the identity, purity, strength, and 
composition of the finished batch of the dietary supplement, and for 
limits on those types of contamination that may adulterate, or that may 
lead to adulteration of, the finished batch of the dietary supplement to 
ensure the quality of the dietary supplement.
    (f) If you receive a product from a supplier for packaging or 
labeling as a dietary supplement (and for distribution rather than for 
return to the supplier), you must establish specifications to provide 
sufficient assurance that the product you receive is adequately 
identified and is consistent with your purchase order.
    (g) You must establish specifications for the packaging and labeling 
of the finished packaged and labeled dietary supplements, including 
specifications that ensure that you used the specified packaging and 
that you applied the specified label.



Sec.  111.73  What is your responsibility for determining whether established 

specifications are met?

    You must determine whether the specifications you establish under 
Sec.  111.70 are met.



Sec.  111.75  What must you do to determine whether specifications are met?

    (a) Before you use a component, you must:
    (1)(i) Conduct at least one appropriate test or examination to 
verify the identity of any component that is a dietary ingredient, 
unless you petition the agency under paragraph (a)(1)(ii) of this 
section and the agency exempts you from such testing;
    (ii) You may submit a petition, under 21 CFR 10.30, to request an 
exemption from the testing requirements in paragraph (a)(1)(i) of this 
section. The petition must set forth the scientific rationale, and must 
be accompanied by the supporting data and information, for proposed 
alternative testing that will demonstrate that there is no material 
diminution of assurance, compared to the assurance provided by 100 
percent identity testing, of the identity of the dietary ingredient 
before use when the dietary ingredient is obtained from one or more 
suppliers identified in the petition. If FDA grants the petition, you 
must conduct the tests and examinations for the dietary ingredient, 
otherwise required under Sec.  111.75(a)(1)(i), under the terms 
specified by FDA when the petition is granted; and
    (2) Confirm the identity of other components and determine whether 
other applicable component specifications established in accordance with 
Sec.  111.70(b) are met. To do so, you must either:
    (i) Conduct appropriate tests or examinations; or
    (ii) Rely on a certificate of analysis from the supplier of the 
component that you receive, provided that:
    (A) You first qualify the supplier by establishing the reliability 
of the supplier's certificate of analysis through confirmation of the 
results of the supplier's tests or examinations;
    (B) The certificate of analysis includes a description of the test 
or examination method(s) used, limits of the test or examinations, and 
actual results of the tests or examinations;
    (C) You maintain documentation of how you qualified the supplier;
    (D) You periodically re-confirm the supplier's certificate of 
analysis; and

[[Page 239]]

    (E) Your quality control personnel review and approve the 
documentation setting forth the basis for qualification (and re-
qualification) of any supplier.
    (b) You must monitor the in-process points, steps, or stages where 
control is necessary to ensure the quality of the finished batch of 
dietary supplement to:
    (1) Determine whether the in-process specifications are met; and
    (2) Detect any deviation or unanticipated occurrence that may result 
in a failure to meet specifications.
    (c) For a subset of finished dietary supplement batches that you 
identify through a sound statistical sampling plan (or for every 
finished batch), you must verify that your finished batch of the dietary 
supplement meets product specifications for identity, purity, strength, 
composition, and for limits on those types of contamination that may 
adulterate or that may lead to adulteration of the finished batch of the 
dietary supplement. To do so:
    (1) You must select one or more established specifications for 
identity, purity, strength, composition, and the limits on those types 
of contamination that may adulterate or that may lead to adulteration of 
the dietary supplement that, if tested or examined on the finished 
batches of the dietary supplement, would verify that the production and 
process control system is producing a dietary supplement that meets all 
product specifications (or only those product specifications not 
otherwise exempted from this provision by quality control personnel 
under paragraph (d) of this section);
    (2) You must conduct appropriate tests or examinations to determine 
compliance with the specifications selected in paragraph (c)(1) of this 
section;
    (3) You must provide adequate documentation of your basis for 
determining that compliance with the specification(s) selected under 
paragraph (c)(1) of this section, through the use of appropriate tests 
or examinations conducted under paragraph (c)(2) of this section, will 
ensure that your finished batch of the dietary supplement meets all 
product specifications for identity, purity, strength, and composition, 
and the limits on those types of contamination that may adulterate, or 
that may lead to the adulteration of, the dietary supplement; and
    (4) Your quality control personnel must review and approve the 
documentation that you provide under paragraph (c)(3) of this section.
    (d)(1) You may exempt one or more product specifications from 
verification requirements in paragraph (c)(1) of this section if you 
determine and document that the specifications you select under 
paragraph (c)(1) of this section for determination of compliance with 
specifications are not able to verify that the production and process 
control system is producing a dietary supplement that meets the exempted 
product specification and there is no scientifically valid method for 
testing or examining such exempted product specification at the finished 
batch stage. In such a case, you must document why, for example, any 
component and in-process testing, examination, or monitoring, and any 
other information, will ensure that such exempted product specification 
is met without verification through periodic testing of the finished 
batch; and
    (2) Your quality control personnel must review and approve the 
documentation that you provide under paragraph (d)(1) of this section.
    (e) Before you package or label a product that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier), you must visually examine the 
product and have documentation to determine whether the specifications 
that you established under Sec.  111.70 (f) are met.
    (f)(1) Before you use packaging, you must, at a minimum, conduct a 
visual identification of the containers and closures and review the 
supplier's invoice, guarantee, or certification to determine whether the 
packaging specifications are met; and
    (2) Before you use labels, you must, at a minimum, conduct a visual 
examination of the label and review the supplier's invoice, guarantee, 
or certification to determine whether label specifications are met.
    (g) You must, at a minimum, conduct a visual examination of the 
packaging and labeling of the finished packaged

[[Page 240]]

and labeled dietary supplements to determine whether you used the 
specified packaging and applied the specified label.
    (h)(1) You must ensure that the tests and examinations that you use 
to determine whether the specifications are met are appropriate, 
scientifically valid methods.
    (2) The tests and examinations that you use must include at least 
one of the following:
    (i) Gross organoleptic analysis;
    (ii) Macroscopic analysis;
    (iii) Microscopic analysis;
    (iv) Chemical analysis; or
    (v) Other scientifically valid methods.
    (i) You must establish corrective action plans for use when an 
established specification is not met.

[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007; 
73 FR 27727, May 14, 2008]



Sec.  111.77  What must you do if established specifications are not met?

    (a) For specifications established under Sec.  111.70(a), (b)(2), 
(b)(3), (c), (d), (e), and (g) that you do not meet, quality control 
personnel, in accordance with the requirements in subpart F of this 
part, must reject the component, dietary supplement, package or label 
unless such personnel approve a treatment, an in-process adjustment, or 
reprocessing that will ensure the quality of the finished dietary 
supplement and that the dietary supplement is packaged and labeled as 
specified in the master manufacturing record. No finished batch of 
dietary supplements may be released for distribution unless it complies 
with Sec.  111.123(b).
    (b) For specifications established under Sec.  111.70(b)(1) that you 
do not meet, quality control personnel must reject the component and the 
component must not be used in manufacturing the dietary supplement.
    (c) For specifications established under Sec.  111.70(f) that you do 
not meet, quality control personnel must reject the product and the 
product may not be packaged or labeled for distribution as a dietary 
supplement.



Sec.  111.80  What representative samples must you collect?

    The representative samples that you must collect include:
    (a) Representative samples of each unique lot of components, 
packaging, and labels that you use to determine whether the components, 
packaging, and labels meet specifications established in accordance with 
Sec.  111.70(b) and (d), and as applicable, Sec.  111.70(a) (and, when 
you receive components, packaging, or labels from a supplier, 
representative samples of each unique shipment, and of each unique lot 
within each unique shipment);
    (b) Representative samples of in-process materials for each 
manufactured batch at points, steps, or stages, in the manufacturing 
process as specified in the master manufacturing record where control is 
necessary to ensure the identity, purity, strength, and composition of 
dietary supplements to determine whether the in-process materials meet 
specifications established in accordance with Sec.  111.70(c), and as 
applicable, Sec.  111.70(a);
    (c) Representative samples of a subset of finished batches of each 
dietary supplement that you manufacture, which you identify through a 
sound statistical sampling plan (or otherwise every finished batch), 
before releasing for distribution to verify that the finished batch of 
dietary supplement meets product specifications established in 
accordance with Sec.  111.70(e), and as applicable, Sec.  111.70(a);
    (d) Representative samples of each unique shipment, and of each 
unique lot within each unique shipment, of product that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier) to determine whether the 
received product meets specifications established in accordance with 
Sec.  111.70(f), and as applicable, Sec.  111.70(a); and
    (e) Representative samples of each lot of packaged and labeled 
dietary supplements to determine whether the packaging and labeling of 
the finished packaged and labeled dietary supplements meet 
specifications established in accordance with Sec.  111.70(g), and as 
applicable, Sec.  111.70(a).

[[Page 241]]



Sec.  111.83  What are the requirements for reserve samples?

    (a) You must collect and hold reserve samples of each lot of 
packaged and labeled dietary supplements that you distribute.
    (b) The reserve samples must:
    (1) Be held using the same container-closure system in which the 
packaged and labeled dietary supplement is distributed, or if 
distributing dietary supplements to be packaged and labeled, using a 
container-closure system that provides essentially the same 
characteristics to protect against contamination or deterioration as the 
one in which it is distributed for packaging and labeling elsewhere;
    (2) Be identified with the batch, lot, or control number;
    (3) Be retained for 1 year past the shelf life date (if shelf life 
dating is used), or for 2 years from the date of distribution of the 
last batch of dietary supplements associated with the reserve sample, 
for use in appropriate investigations; and
    (4) Consist of at least twice the quantity necessary for all tests 
or examinations to determine whether or not the dietary supplement meets 
product specifications.



Sec.  111.87  Who conducts a material review and makes a disposition decision?

    Quality control personnel must conduct all required material reviews 
and make all required disposition decisions.



Sec.  111.90  What requirements apply to treatments, in-process adjustments, 

and reprocessing when there is a deviation or unanticipated occurrence or when 

a specification established in accordance with Sec.  111.70 is not met?

    (a) You must not reprocess a rejected dietary supplement or treat or 
provide an in-process adjustment to a component, packaging, or label to 
make it suitable for use in the manufacture of a dietary supplement 
unless:
    (1) Quality control personnel conduct a material review and make a 
disposition decision to approve the reprocessing, treatment, or in-
process adjustment; and
    (2) The reprocessing, treatment, or in-process adjustment is 
permitted by Sec.  111.77;
    (b) You must not reprocess any dietary supplement or treat or 
provide an in-process adjustment to a component to make it suitable for 
use in the manufacture of a dietary supplement, unless:
    (1) Quality control personnel conduct a material review and make a 
disposition decision that is based on a scientifically valid reason and 
approves the reprocessing, treatment, or in-process adjustment; and
    (2) The reprocessing, treatment or in-process adjustment is 
permitted by Sec.  111.77;
    (c) Any batch of dietary supplement that is reprocessed, that 
contains components that you have treated, or to which you have made in-
process adjustments to make them suitable for use in the manufacture of 
the dietary supplement must be approved by quality control personnel and 
comply with Sec.  111.123(b) before releasing for distribution.



Sec.  111.95  Under this subpart E, what records must you make and keep?

    (a) You must make and keep records required under this subpart E in 
accordance with subpart P of this part.
    (b) Under this subpart E, you must make and keep the following 
records:
    (1) The specifications established;
    (2) Documentation of your qualification of a supplier for the 
purpose of relying on the supplier's certificate of analysis;
    (3) Documentation for why meeting in-process specifications, in 
combination with meeting component specifications, helps ensure that the 
dietary supplement meets the specifications for identity, purity, 
strength, and composition; and for limits on those types of 
contamination that may adulterate or may lead to adulteration of the 
finished batch of the dietary supplement; and
    (4) Documentation for why the results of appropriate tests or 
examinations for the product specifications selected under Sec.  
111.75(c)(1) ensure that the dietary supplement meets all product 
specifications;

[[Page 242]]

    (5) Documentation for why any component and in-process testing, 
examination, or monitoring, and any other information, will ensure that 
a product specification that is exempted under Sec.  111.75(d) is met 
without verification through periodic testing of the finished batch, 
including documentation that the selected specifications tested or 
examined under Sec.  111.75 (c)(1) are not able to verify that the 
production and process control system is producing a dietary supplement 
that meets the exempted product specification and there is no 
scientifically valid method for testing or examining such exempted 
product specification at the finished batch stage.
    (6) Documentation of FDA's response to a petition submitted under 
Sec.  111.75(a)(1)(ii) providing for an exemption from the provisions of 
Sec.  111.75(a)(1)(i).

[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007]



   Subpart F_Production and Process Control System: Requirements for 
                             Quality Control



Sec.  111.103  What are the requirements under this subpart F for written 

procedures?

    You must establish and follow written procedures for the 
responsibilities of the quality control operations, including written 
procedures for conducting a material review and making a disposition 
decision, and for approving or rejecting any reprocessing.



Sec.  111.105  What must quality control personnel do?

    Quality control personnel must ensure that your manufacturing, 
packaging, labeling, and holding operations ensure the quality of the 
dietary supplement and that the dietary supplement is packaged and 
labeled as specified in the master manufacturing record. To do so, 
quality control personnel must perform operations that include:
    (a) Approving or rejecting all processes, specifications, written 
procedures, controls, tests, and examinations, and deviations from or 
modifications to them, that may affect the identity, purity, strength, 
or composition of a dietary supplement;
    (b) Reviewing and approving the documentation setting forth the 
basis for qualification of any supplier;
    (c) Reviewing and approving the documentation setting forth the 
basis for why meeting in-process specifications, in combination with 
meeting component specifications, will help ensure that the identity, 
purity, strength, and composition of the dietary supplement are met;
    (d) Reviewing and approving the documentation setting forth the 
basis for why the results of appropriate tests or examinations for each 
product specification selected under Sec.  111.75(c)(1) will ensure that 
the finished batch of the dietary supplement meets product 
specifications;
    (e) Reviewing and approving the basis and the documentation for why 
any product specification is exempted from the verification requirements 
in Sec.  111.75(c)(1), and for why any component and in-process testing, 
examination, or monitoring, or other methods will ensure that such 
exempted product specification is met without verification through 
periodic testing of the finished batch;
    (f) Ensuring that required representative samples are collected;
    (g) Ensuring that required reserve samples are collected and held;
    (h) Determining whether all specifications established under Sec.  
111.70(a) are met; and
    (i) Performing other operations required under this subpart.



Sec.  111.110  What quality control operations are required for laboratory 

operations associated with the production and process control system?

    Quality control operations for laboratory operations associated with 
the production and process control system must include:
    (a) Reviewing and approving all laboratory control processes 
associated with the production and process control system;
    (b) Ensuring that all tests and examinations required under Sec.  
111.75 are conducted; and

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    (c) Reviewing and approving the results of all tests and 
examinations required under Sec.  111.75.



Sec.  111.113  What quality control operations are required for a material 

review and disposition decision?

    (a) Quality control personnel must conduct a material review and 
make a disposition decision if:
    (1) A specification established in accordance with Sec.  111.70 is 
not met;
    (2) A batch deviates from the master manufacturing record, including 
when any step established in the master manufacturing record is not 
completed and including any deviation from specifications;
    (3) There is any unanticipated occurrence during the manufacturing 
operations that adulterates or may lead to adulteration of the 
component, dietary supplement, or packaging, or could lead to the use of 
a label not specified in the master manufacturing record;
    (4) Calibration of an instrument or control suggests a problem that 
may have resulted in a failure to ensure the quality of a batch or 
batches of a dietary supplement; or
    (5) A dietary supplement is returned.
    (b)(1) When there is a deviation or unanticipated occurrence during 
the production and in-process control system that results in or could 
lead to adulteration of a component, dietary supplement, or packaging, 
or could lead to the use of a label not specified in the master 
manufacturing record, quality control personnel must reject the 
component, dietary supplement, packaging, or label unless it approves a 
treatment, an in-process adjustment, or reprocessing to correct the 
applicable deviation or occurrence.
    (2) When a specification established in accordance with Sec.  111.70 
is not met, quality control personnel must reject the component, dietary 
supplement, package or label, unless quality control personnel approve a 
treatment, an in-process adjustment, or reprocessing, as permitted in 
Sec.  111.77.
    (c) The person who conducts a material review and makes the 
disposition decision must, at the time of performance, document that 
material review and disposition decision.



Sec.  111.117  What quality control operations are required for equipment, 

instruments, and controls?

    Quality control operations for equipment, instruments, and controls 
must include:
    (a) Reviewing and approving all processes for calibrating 
instruments and controls;
    (b) Periodically reviewing all records for calibration of 
instruments and controls;
    (c) Periodically reviewing all records for calibrations, 
inspections, and checks of automated, mechanical, or electronic 
equipment; and
    (d) Reviewing and approving controls to ensure that automated, 
mechanical, or electronic equipment functions in accordance with its 
intended use.



Sec.  111.120  What quality control operations are required for components, 

packaging, and labels before use in the manufacture of a dietary supplement?

    Quality control operations for components, packaging, and labels 
before use in the manufacture of a dietary supplement must include:
    (a) Reviewing all receiving records for components, packaging, and 
labels;
    (b) Determining whether all components, packaging, and labels 
conform to specifications established under Sec.  111.70 (b) and (d);
    (c) Conducting any required material review and making any required 
disposition decision;
    (d) Approving or rejecting any treatment and in-process adjustments 
of components, packaging, or labels to make them suitable for use in the 
manufacture of a dietary supplement; and
    (e) Approving, and releasing from quarantine, all components, 
packaging, and labels before they are used.



Sec.  111.123  What quality control operations are required for the master 

manufacturing record, the batch production record, and manufacturing 

operations?

    (a) Quality control operations for the master manufacturing record, 
the batch production record, and manufacturing operations must include:
    (1) Reviewing and approving all master manufacturing records and all

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modifications to the master manufacturing records;
    (2) Reviewing and approving all batch production-related records;
    (3) Reviewing all monitoring required under subpart E;
    (4) Conducting any required material review and making any required 
disposition decision;
    (5) Approving or rejecting any reprocessing;
    (6) Determining whether all in-process specifications established in 
accordance with Sec.  111.70(c) are met;
    (7) Determining whether each finished batch conforms to product 
specifications established in accordance with Sec.  111.70(e); and
    (8) Approving and releasing, or rejecting, each finished batch for 
distribution, including any reprocessed finished batch.
    (b) Quality control personnel must not approve and release for 
distribution:
    (1) Any batch of dietary supplement for which any component in the 
batch does not meet its identity specification;
    (2) Any batch of dietary supplement, including any reprocessed 
batch, that does not meet all product specifications established in 
accordance with Sec.  111.70(e);
    (3) Any batch of dietary supplement, including any reprocessed 
batch, that has not been manufactured, packaged, labeled, and held under 
conditions to prevent adulteration under section 402(a)(1), (a)(2), 
(a)(3), and (a)(4) of the act; and
    (4) Any product received from a supplier for packaging or labeling 
as a dietary supplement (and for distribution rather than for return to 
the supplier) for which sufficient assurance is not provided to 
adequately identify the product and to determine that the product is 
consistent with your purchase order.



Sec.  111.127  What quality control operations are required for packaging and 

labeling operations?

    Quality control operations for packaging and labeling operations 
must include:
    (a) Reviewing the results of any visual examination and 
documentation to ensure that specifications established under Sec.  
111.70(f) are met for all products that you receive for packaging and 
labeling as a dietary supplement (and for distribution rather than for 
return to the supplier);
    (b) Approving, and releasing from quarantine, all products that you 
receive for packaging or labeling as a dietary supplement (and for 
distribution rather than for return to the supplier) before they are 
used for packaging or labeling;
    (c) Reviewing and approving all records for packaging and label 
operations;
    (d) Determining whether the finished packaged and labeled dietary 
supplement conforms to specifications established in accordance with 
Sec.  111.70(g);
    (e) Conducting any required material review and making any required 
disposition decision;
    (f) Approving or rejecting any repackaging of a packaged dietary 
supplement;
    (g) Approving or rejecting any relabeling of a packaged and labeled 
dietary supplement; and
    (h) Approving for release, or rejecting, any packaged and labeled 
dietary supplement (including a repackaged or relabeled dietary 
supplement) for distribution.



Sec.  111.130  What quality control operations are required for returned 

dietary supplements?

    Quality control operations for returned dietary supplements must 
include:
    (a) Conducting any required material review and making any required 
disposition decision; including:
    (1) Determining whether tests or examination are necessary to 
determine compliance with product specifications established in 
accordance with Sec.  111.70(e); and
    (2) Reviewing the results of any tests or examinations that are 
conducted to determine compliance with product specifications 
established in accordance with Sec.  111.70(e);
    (b) Approving or rejecting any salvage and redistribution of any 
returned dietary supplement;

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    (c) Approving or rejecting any reprocessing of any returned dietary 
supplement; and
    (d) Determining whether the reprocessed dietary supplement meets 
product specifications and either approving for release, or rejecting, 
any returned dietary supplement that is reprocessed.



Sec.  111.135  What quality control operations are required for product 

complaints?

    Quality control operations for product complaints must include 
reviewing and approving decisions about whether to investigate a product 
complaint and reviewing and approving the findings and followup action 
of any investigation performed.



Sec.  111.140  Under this subpart F, what records must you make and keep?

    (a) You must make and keep the records required under this subpart F 
in accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for the responsibilities of the quality 
control operations, including written procedures for conducting a 
material review and making a disposition decision and written procedures 
for approving or rejecting any reprocessing;
    (2) Written documentation, at the time of performance, that quality 
control personnel performed the review, approval, or rejection 
requirements by recording the following:
    (i) Date that the review, approval, or rejection was performed; and
    (ii) Signature of the person performing the review, approval, or 
rejection; and
    (3) Documentation of any material review and disposition decision 
and followup. Such documentation must be included in the appropriate 
batch production record and must include:
    (i) Identification of the specific deviation or the unanticipated 
occurrence;
    (ii) Description of your investigation into the cause of the 
deviation from the specification or the unanticipated occurrence;
    (iii) Evaluation of whether or not the deviation or unanticipated 
occurrence has resulted in or could lead to a failure to ensure the 
quality of the dietary supplement or a failure to package and label the 
dietary supplement as specified in the master manufacturing record;
    (iv) Identification of the action(s) taken to correct, and prevent a 
recurrence of, the deviation or the unanticipated occurrence;
    (v) Explanation of what you did with the component, dietary 
supplement, packaging, or label;
    (vi) A scientifically valid reason for any reprocessing of a dietary 
supplement that is rejected or any treatment or in-process adjustment of 
a component that is rejected; and
    (vii) The signature of the individual(s) designated to perform the 
quality control operation, who conducted the material review and made 
the disposition decision, and of each qualified individual who provides 
information relevant to that material review and disposition decision.



   Subpart G_Production and Process Control System: Requirements for 

 Components, Packaging, and Labels and for Product That You Receive for 

              Packaging or Labeling as a Dietary Supplement



Sec.  111.153  What are the requirements under this subpart G for written 

procedures?

    You must establish and follow written procedures for fulfilling the 
requirements of this subpart G.



Sec.  111.155  What requirements apply to components of dietary supplements?

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment that you receive for appropriate 
content label, container damage, or broken seals to determine whether 
the container condition may have resulted in contamination or 
deterioration of the components;
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment you receive to ensure the components are 
consistent with your purchase order;

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    (c) You must quarantine components before you use them in the 
manufacture of a dietary supplement until:
    (1) You collect representative samples of each unique lot of 
components (and, for components that you receive, of each unique 
shipment, and of each unique lot within each unique shipment);
    (2) Quality control personnel review and approve the results of any 
tests or examinations conducted on components; and
    (3) Quality control personnel approve the components for use in the 
manufacture of a dietary supplement, including approval of any treatment 
(including in-process adjustments) of components to make them suitable 
for use in the manufacture of a dietary supplement, and releases them 
from quarantine.
    (d)(1) You must identify each unique lot within each unique shipment 
of components that you receive and any lot of components that you 
produce in a manner that allows you to trace the lot to the supplier, 
the date received, the name of the component, the status of the 
component (e.g., quarantined, approved, or rejected); and to the dietary 
supplement that you manufactured and distributed.
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of components 
that you receive and any lot of components that you produce.
    (e) You must hold components under conditions that will protect 
against contamination and deterioration, and avoid mixups.



Sec.  111.160  What requirements apply to packaging and labels received?

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment for appropriate content label, 
container damage, or broken seals to determine whether the container 
condition may have resulted in contamination or deterioration of the 
packaging and labels.
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment to ensure that the packaging or labels are 
consistent with your purchase order.
    (c) You must quarantine packaging and labels before you use them in 
the manufacture of a dietary supplement until:
    (1) You collect representative samples of each unique shipment, and 
of each unique lot within each unique shipment, of packaging and labels 
and, at a minimum, conduct a visual identification of the immediate 
containers and closures;
    (2) Quality control personnel review and approve the results of any 
tests or examinations conducted on the packaging and labels; and
    (3) Quality control personnel approve the packaging and labels for 
use in the manufacture of a dietary supplement and release them from 
quarantine.
    (d)(1) You must identify each unique lot within each unique shipment 
of packaging and labels in a manner that allows you to trace the lot to 
the supplier, the date received, the name of the packaging and label, 
the status of the packaging and label (e.g., quarantined, approved, or 
rejected); and to the dietary supplement that you distributed; and
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of packaging 
and labels.
    (e) You must hold packaging and labels under conditions that will 
protect against contamination and deterioration, and avoid mixups.



Sec.  111.165  What requirements apply to a product received for packaging or 

labeling as a dietary supplement (and for distribution rather than for return 

to the supplier)?

    (a) You must visually examine each immediate container or grouping 
of immediate containers in a shipment of product that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier) for appropriate content label, 
container damage, or broken seals to determine whether the container 
condition may have resulted in contamination or deterioration of the 
received product.
    (b) You must visually examine the supplier's invoice, guarantee, or 
certification in a shipment of the received product to ensure that the 
received

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product is consistent with your purchase order.
    (c) You must quarantine the received product until:
    (1) You collect representative samples of each unique shipment, and 
of each unique lot within each unique shipment, of received product;
    (2) Quality control personnel review and approve the documentation 
to determine whether the received product meets the specifications that 
you established under Sec.  111.70(f); and
    (3) Quality control personnel approve the received product for 
packaging or labeling as a dietary supplement and release the received 
product from quarantine.
    (d)(1) You must identify each unique lot within each unique shipment 
of received product in a manner that allows you to trace the lot to the 
supplier, the date received, the name of the received product, the 
status of the received product (e.g., quarantined, approved, or 
rejected), and to the product that you packaged or labeled and 
distributed as a dietary supplement.
    (2) You must use this unique identifier whenever you record the 
disposition of each unique lot within each unique shipment of the 
received product.
    (e) You must hold the received product under conditions that will 
protect against contamination and deterioration, and avoid mixups.



Sec.  111.170  What requirements apply to rejected components, packaging, and 

labels, and to rejected products that are received for packaging or labeling 

as a dietary supplement?

    You must clearly identify, hold, and control under a quarantine 
system for appropriate disposition any component, packaging, and label, 
and any product that you receive for packaging or labeling as a dietary 
supplement (and for distribution rather than for return to the 
supplier), that is rejected and unsuitable for use in manufacturing, 
packaging, or labeling operations.



Sec.  111.180  Under this subpart G, what records must you make and keep?

    (a) You must make and keep records required under this subpart G in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart.
    (2) Receiving records (including records such as certificates of 
analysis, suppliers' invoices, and suppliers' guarantees) for 
components, packaging, and labels and for products that you receive for 
packaging or labeling as a dietary supplement (and for distribution 
rather than for return to the supplier); and
    (3) Documentation that the requirements of this subpart were met.
    (i) The person who performs the required operation must document, at 
the time of performance, that the required operation was performed.
    (ii) The documentation must include:
    (A) The date that the components, packaging, labels, or products 
that you receive for packaging or labeling as a dietary supplement were 
received;
    (B) The initials of the person performing the required operation;
    (C) The results of any tests or examinations conducted on 
components, packaging, or labels, and of any visual examination of 
product that you receive for packaging or labeling as a dietary 
supplement; and
    (D) Any material review and disposition decision conducted on 
components, packaging, labels, or products that you receive for 
packaging or labeling as a dietary supplement.



 Subpart H_Production and Process Control System: Requirements for the 
                       Master Manufacturing Record



Sec.  111.205  What is the requirement to establish a master manufacturing 

record?

    (a) You must prepare and follow a written master manufacturing 
record for each unique formulation of dietary supplement that you 
manufacture, and for each batch size, to ensure uniformity in the 
finished batch from batch to batch.
    (b) The master manufacturing record must:

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    (1) Identify specifications for the points, steps, or stages in the 
manufacturing process where control is necessary to ensure the quality 
of the dietary supplement and that the dietary supplement is packaged 
and labeled as specified in the master manufacturing record; and
    (2) Establish controls and procedures to ensure that each batch of 
dietary supplement that you manufacture meets the specifications 
identified in accordance with paragraph (b)(1) of this section.
    (c) You must make and keep master manufacturing records in 
accordance with subpart P of this part.



Sec.  111.210  What must the master manufacturing record include?

    The master manufacturing record must include:
    (a) The name of the dietary supplement to be manufactured and the 
strength, concentration, weight, or measure of each dietary ingredient 
for each batch size;
    (b) A complete list of components to be used;
    (c) An accurate statement of the weight or measure of each component 
to be used;
    (d) The identity and weight or measure of each dietary ingredient 
that will be declared on the Supplement Facts label and the identity of 
each ingredient that will be declared on the ingredients list of the 
dietary supplement;
    (e) A statement of any intentional overage amount of a dietary 
ingredient;
    (f) A statement of theoretical yield of a manufactured dietary 
supplement expected at each point, step, or stage of the manufacturing 
process where control is needed to ensure the quality of the dietary 
supplement, and the expected yield when you finish manufacturing the 
dietary supplement, including the maximum and minimum percentages of 
theoretical yield beyond which a deviation investigation of a batch is 
necessary and material review is conducted and disposition decision is 
made;
    (g) A description of packaging and a representative label, or a 
cross-reference to the physical location of the actual or representative 
label;
    (h) Written instructions, including the following:
    (1) Specifications for each point, step, or stage in the 
manufacturing process where control is necessary to ensure the quality 
of the dietary supplement and that the dietary supplement is packaged 
and labeled as specified in the master manufacturing record;
    (2) Procedures for sampling and a cross-reference to procedures for 
tests or examinations;
    (3) Specific actions necessary to perform and verify points, steps, 
or stages in the manufacturing process where control is necessary to 
ensure the quality of the dietary supplement and that the dietary 
supplement is packaged and labeled as specified in the master 
manufacturing record.
    (i) Such specific actions must include verifying the weight or 
measure of any component and verifying the addition of any component; 
and
    (ii) For manual operations, such specific actions must include:
    (A) One person weighing or measuring a component and another person 
verifying the weight or measure; and
    (B) One person adding the component and another person verifying the 
addition.
    (4) Special notations and precautions to be followed; and
    (5) Corrective action plans for use when a specification is not met.



 Subpart I_Production and Process Control System: Requirements for the 
                         Batch Production Record



Sec.  111.255  What is the requirement to establish a batch production record?

    (a) You must prepare a batch production record every time you 
manufacture a batch of a dietary supplement;
    (b) Your batch production record must include complete information 
relating to the production and control of each batch;
    (c) Your batch production record must accurately follow the 
appropriate master manufacturing record and you

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must perform each step in the production of the batch; and
    (d) You must make and keep batch production records in accordance 
with subpart P of this part.



Sec.  111.260  What must the batch record include?

    The batch production record must include the following:
    (a) The batch, lot, or control number:
    (1) Of the finished batch of dietary supplement; and
    (2) That you assign in accordance with Sec.  111.415(f) for the 
following:
    (i) Each lot of packaged and labeled dietary supplement from the 
finished batch of dietary supplement;
    (ii) Each lot of dietary supplement, from the finished batch of 
dietary supplement, that you distribute to another person for packaging 
or labeling;
    (b) The identity of equipment and processing lines used in producing 
the batch;
    (c) The date and time of the maintenance, cleaning, and sanitizing 
of the equipment and processing lines used in producing the batch, or a 
cross-reference to records, such as individual equipment logs, where 
this information is retained;
    (d) The unique identifier that you assigned to each component (or, 
when applicable, to a product that you receive from a supplier for 
packaging or labeling as a dietary supplement), packaging, and label 
used;
    (e) The identity and weight or measure of each component used;
    (f) A statement of the actual yield and a statement of the 
percentage of theoretical yield at appropriate phases of processing;
    (g) The actual results obtained during any monitoring operation;
    (h) The results of any testing or examination performed during the 
batch production, or a cross-reference to such results;
    (i) Documentation that the finished dietary supplement meets 
specifications established in accordance with Sec.  111.70(e) and (g);
    (j) Documentation, at the time of performance, of the manufacture of 
the batch, including:
    (1) The date on which each step of the master manufacturing record 
was performed; and
    (2) The initials of the persons performing each step, including:
    (i) The initials of the person responsible for weighing or measuring 
each component used in the batch;
    (ii) The initials of the person responsible for verifying the weight 
or measure of each component used in the batch;
    (iii) The initials of the person responsible for adding the 
component to the batch; and
    (iv) The initials of the person responsible for verifying the 
addition of components to the batch;
    (k) Documentation, at the time of performance, of packaging and 
labeling operations, including:
    (1) The unique identifier that you assigned to packaging and labels 
used, the quantity of the packaging and labels used, and, when label 
reconciliation is required, reconciliation of any discrepancies between 
issuance and use of labels;
    (2) An actual or representative label, or a cross-reference to the 
physical location of the actual or representative label specified in the 
master manufacturing record; and
    (3) The results of any tests or examinations conducted on packaged 
and labeled dietary supplements (including repackaged or relabeled 
dietary supplements), or a cross-reference to the physical location of 
such results;
    (l) Documentation at the time of performance that quality control 
personnel:
    (1) Reviewed the batch production record, including:
    (i) Review of any monitoring operation required under subpart E of 
this part; and
    (ii) Review of the results of any tests and examinations, including 
tests and examinations conducted on components, in-process materials, 
finished batches of dietary supplements, and packaged and labeled 
dietary supplements;
    (2) Approved or rejected any reprocessing or repackaging; and
    (3) Approved and released, or rejected, the batch for distribution, 
including any reprocessed batch; and

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    (4) Approved and released, or rejected, the packaged and labeled 
dietary supplement, including any repackaged or relabeled dietary 
supplement.
    (m) Documentation at the time of performance of any required 
material review and disposition decision.
    (n) Documentation at the time of performance of any reprocessing.



   Subpart J_Production and Process Control System: Requirements for 
                          Laboratory Operations



Sec.  111.303  What are the requirements under this subpart J for written 

procedures?

    You must establish and follow written procedures for laboratory 
operations, including written procedures for the tests and examinations 
that you conduct to determine whether specifications are met.



Sec.  111.310  What are the requirements for the laboratory facilities that 

you use?

    You must use adequate laboratory facilities to perform whatever 
testing and examinations are necessary to determine whether:
    (a) Components that you use meet specifications;
    (b) In-process specifications are met as specified in the master 
manufacturing record; and
    (c) Dietary supplements that you manufacture meet specifications.



Sec.  111.315  What are the requirements for laboratory control processes?

    You must establish and follow laboratory control processes that are 
reviewed and approved by quality control personnel, including the 
following:
    (a) Use of criteria for establishing appropriate specifications;
    (b) Use of sampling plans for obtaining representative samples, in 
accordance with subpart E of this part, of:
    (1) Components, packaging, and labels;
    (2) In-process materials;
    (3) Finished batches of dietary supplements;
    (4) Product that you receive for packaging or labeling as a dietary 
supplement (and for distribution rather than for return to the 
supplier); and
    (5) Packaged and labeled dietary supplements.
    (c) Use of criteria for selecting appropriate examination and 
testing methods;
    (d) Use of criteria for selecting standard reference materials used 
in performing tests and examinations; and
    (e) Use of test methods and examinations in accordance with 
established criteria.



Sec.  111.320  What requirements apply to laboratory methods for testing and 

examination?

    (a) You must verify that the laboratory examination and testing 
methodologies are appropriate for their intended use.
    (b) You must identify and use an appropriate scientifically valid 
method for each established specification for which testing or 
examination is required to determine whether the specification is met.



Sec.  111.325  Under this subpart J, what records must you make and keep?

    (a) You must make and keep records required under this subpart J in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for laboratory operations, including written 
procedures for the tests and examinations that you conduct to determine 
whether specifications are met;
    (2) Documentation that laboratory methodology established in 
accordance with this subpart J is followed.
    (i) The person who conducts the testing and examination must 
document, at the time of performance, that laboratory methodology 
established in accordance with this subpart J is followed.
    (ii) The documentation for laboratory tests and examinations must 
include the results of the testing and examination.

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   Subpart K_Production and Process Control System: Requirements for 
                        Manufacturing Operations



Sec.  111.353  What are the requirements under this subpart K for written 

procedures?

    You must establish and follow written procedures for manufacturing 
operations.



Sec.  111.355  What are the design requirements for manufacturing operations?

    You must design or select manufacturing processes to ensure that 
product specifications are consistently met.



Sec.  111.360  What are the requirements for sanitation?

    You must conduct all manufacturing operations in accordance with 
adequate sanitation principles.



Sec.  111.365  What precautions must you take to prevent contamination?

    You must take all the necessary precautions during the manufacture 
of a dietary supplement to prevent contamination of components or 
dietary supplements. These precautions include:
    (a) Performing manufacturing operations under conditions and 
controls that protect against the potential for growth of microorganisms 
and the potential for contamination;
    (b) Washing or cleaning components that contain soil or other 
contaminants;
    (c) Using water that, at a minimum, complies with the applicable 
Federal, State, and local requirements and does not contaminate the 
dietary supplement when the water may become a component of the finished 
batch of dietary supplement;
    (d) Performing chemical, microbiological, or other testing, as 
necessary to prevent the use of contaminated components;
    (e) Sterilizing, pasteurizing, freezing, refrigerating, controlling 
hydrogen-ion concentration (pH), controlling humidity, controlling water 
activity (aw), or using any other effective means to remove, 
destroy, or prevent the growth of microorganisms and prevent 
decomposition;
    (f) Holding components and dietary supplements that can support the 
rapid growth of microorganisms of public health significance in a manner 
that prevents the components and dietary supplements from becoming 
adulterated;
    (g) Identifying and holding any components or dietary supplements, 
for which a material review and disposition decision is required, in a 
manner that protects components or dietary supplements that are not 
under a material review against contamination and mixups with those that 
are under a material review;
    (h) Performing mechanical manufacturing steps (such as cutting, 
sorting, inspecting, shredding, drying, grinding, blending, and sifting) 
by any effective means to protect the dietary supplements against 
contamination, by, for example:
    (1) Cleaning and sanitizing contact surfaces;
    (2) Using temperature controls; and
    (3) Using time controls.
    (i) Using effective measures to protect against the inclusion of 
metal or other foreign material in components or dietary supplements, 
by, for example:
    (1) Filters or strainers,
    (2) Traps,
    (3) Magnets, or
    (4) Electronic metal detectors.
    (j) Segregating and identifying all containers for a specific batch 
of dietary supplements to identify their contents and, when necessary, 
the phase of manufacturing; and
    (k) Identifying all processing lines and major equipment used during 
manufacturing to indicate their contents, including the name of the 
dietary supplement and the specific batch or lot number and, when 
necessary, the phase of manufacturing.



Sec.  111.370  What requirements apply to rejected dietary supplements?

    You must clearly identify, hold, and control under a quarantine 
system for appropriate disposition any dietary supplement that is 
rejected and unsuitable for use in manufacturing, packaging, or labeling 
operations.

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Sec.  111.375  Under this subpart K, what records must you make and keep?

    (a) You must make and keep records required under this subpart K in 
accordance with subpart P of this part.
    (b) You must make and keep records of the written procedures for 
manufacturing operations.



   Subpart L_Production and Process Control System: Requirements for 
                    Packaging and Labeling Operations



Sec.  111.403  What are the requirements under this subpart L for written 

procedures?

    You must establish and follow written procedures for packaging and 
labeling operations.



Sec.  111.410  What requirements apply to packaging and labels?

    (a) You must take necessary actions to determine whether packaging 
for dietary supplements meets specifications so that the condition of 
the packaging will ensure the quality of your dietary supplements;
    (b) You must control the issuance and use of packaging and labels 
and reconciliation of any issuance and use discrepancies. Label 
reconciliation is not required for cut or rolled labels if a 100-percent 
examination for correct labels is performed by appropriate electronic or 
electromechanical equipment during or after completion of finishing 
operations; and
    (c) You must examine, before packaging and labeling operations, 
packaging and labels for each batch of dietary supplement to determine 
whether the packaging and labels conform to the master manufacturing 
record; and
    (d) You must be able to determine the complete manufacturing history 
and control of the packaged and labeled dietary supplement through 
distribution.



Sec.  111.415  What requirements apply to filling, assembling, packaging, 

labeling, and related operations?

    You must fill, assemble, package, label, and perform other related 
operations in a way that ensures the quality of the dietary supplement 
and that the dietary supplement is packaged and labeled as specified in 
the master manufacturing record. You must do this using any effective 
means, including the following:
    (a) Cleaning and sanitizing all filling and packaging equipment, 
utensils, and dietary supplement packaging, as appropriate;
    (b) Protecting manufactured dietary supplements from contamination, 
particularly airborne contamination;
    (c) Using sanitary handling procedures;
    (d) Establishing physical or spatial separation of packaging and 
label operations from operations on other components and dietary 
supplements to prevent mixups;
    (e) Identifying, by any effective means, filled dietary supplement 
containers that are set aside and held in unlabeled condition for future 
label operations, to prevent mixups;
    (f) Assigning a batch, lot, or control number to:
    (1) Each lot of packaged and labeled dietary supplement from a 
finished batch of dietary supplement; and,
    (2) Each lot of dietary supplement, from a finished batch of dietary 
supplement, that you distribute to another person for packaging or 
labeling.
    (g) Examining a representative sample of each batch of the packaged 
and labeled dietary supplement to determine whether the dietary 
supplement meets specifications established in accordance with Sec.  
111.70(g); and
    (h) Suitably disposing of labels and packaging for dietary 
supplements that are obsolete or incorrect to ensure that they are not 
used in any future packaging and label operations.



Sec.  111.420  What requirements apply to repackaging and relabeling?

    (a) You may repackage or relabel dietary supplements only after 
quality control personnel have approved such repackaging or relabeling.
    (b) You must examine a representative sample of each batch of 
repackaged or relabeled dietary supplements to determine whether the 
repackaged or relabeled dietary supplements meet all specifications 
established in accordance with Sec.  111.70(g).

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    (c) Quality control personnel must approve or reject each batch of 
repackaged or relabeled dietary supplement prior to its release for 
distribution.



Sec.  111.425  What requirements apply to a packaged and labeled dietary 

supplement that is rejected for distribution?

    You must clearly identify, hold, and control under a quarantine 
system for appropriate disposition any packaged and labeled dietary 
supplement that is rejected for distribution.



Sec.  111.430  Under this subpart L, what records must you make and keep?

    (a) You must make and keep records required under this subpart L in 
accordance with subpart P of this part.
    (b) You must make and keep records of the written procedures for 
packaging and labeling operations.



                   Subpart M_Holding and Distributing



Sec.  111.453  What are the requirements under this subpart for M written 

procedures?

    You must establish and follow written procedures for holding and 
distributing operations.



Sec.  111.455  What requirements apply to holding components, dietary 

supplements, packaging, and labels?

    (a) You must hold components and dietary supplements under 
appropriate conditions of temperature, humidity, and light so that the 
identity, purity, strength, and composition of the components and 
dietary supplements are not affected.
    (b) You must hold packaging and labels under appropriate conditions 
so that the packaging and labels are not adversely affected.
    (c) You must hold components, dietary supplements, packaging, and 
labels under conditions that do not lead to the mixup, contamination, or 
deterioration of components, dietary supplements, packaging, and labels.



Sec.  111.460  What requirements apply to holding in-process material?

    (a) You must identify and hold in-process material under conditions 
that protect against mixup, contamination, and deterioration.
    (b) You must hold in-process material under appropriate conditions 
of temperature, humidity, and light.



Sec.  111.465  What requirements apply to holding reserve samples of dietary 

supplements?

    (a) You must hold reserve samples of dietary supplements in a manner 
that protects against contamination and deterioration. This includes:
    (1) Holding the reserve samples under conditions consistent with 
product labels or, if no storage conditions are recommended on the 
label, under ordinary storage conditions; and
    (2) Using the same container-closure system in which the packaged 
and labeled dietary supplement is distributed, or if distributing 
dietary supplements to be packaged and labeled, using a container-
closure system that provides essentially the same characteristics to 
protect against contamination or deterioration as the one in which you 
distribute the dietary supplement for packaging and labeling elsewhere.
    (b) You must retain reserve samples for 1 year past the shelf life 
date (if shelf life dating is used), or for 2 years from the date of 
distribution of the last batch of dietary supplements associated with 
the reserve samples, for use in appropriate investigations.



Sec.  111.470  What requirements apply to distributing dietary supplements?

    You must distribute dietary supplements under conditions that will 
protect the dietary supplements against contamination and deterioration.



Sec.  111.475  Under this subpart M, what records must you make and keep?

    (a) You must make and keep records required under this subpart M in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for holding and distributing operations; and
    (2) Records of product distribution.

[[Page 254]]



                 Subpart N_Returned Dietary Supplements



Sec.  111.503  What are the requirements under this subpart N for written 

procedures?

    You must establish and follow written procedures to fulfill the 
requirements of this subpart.



Sec.  111.510  What requirements apply when a returned dietary supplement is 

received?

    You must identify and quarantine returned dietary supplements until 
quality control personnel conduct a material review and make a 
disposition decision.



Sec.  111.515  When must a returned dietary supplement be destroyed, or 

otherwise suitably disposed of?

    You must destroy, or otherwise suitably dispose of, any returned 
dietary supplement unless the outcome of a material review and 
disposition decision is that quality control personnel do the following:
    (a) Approve the salvage of the returned dietary supplement for 
redistribution or
    (b) Approve the returned dietary supplement for reprocessing.



Sec.  111.520  When may a returned dietary supplement be salvaged?

    You may salvage a returned dietary supplement only if quality 
control personnel conduct a material review and make a disposition 
decision to allow the salvage.



Sec.  111.525  What requirements apply to a returned dietary supplement that 

quality control personnel approve for reprocessing?

    (a) You must ensure that any returned dietary supplements that are 
reprocessed meet all product specifications established in accordance 
with Sec.  111.70(e); and
    (b) Quality control personnel must approve or reject the release for 
distribution of any returned dietary supplement that is reprocessed.



Sec.  111.530  When must an investigation be conducted of your manufacturing 

processes and other batches?

    If the reason for a dietary supplement being returned implicates 
other batches, you must conduct an investigation of your manufacturing 
processes and each of those other batches to determine compliance with 
specifications.



Sec.  111.535  Under this subpart N, what records must you make and keep?

    (a) You must make and keep records required under this subpart N in 
accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart N.
    (2) Any material review and disposition decision on a returned 
dietary supplement;
    (3) The results of any testing or examination conducted to determine 
compliance with product specifications established under Sec.  
111.70(e); and,
    (4) Documentation of the reevaluation by quality control personnel 
of any dietary supplement that is reprocessed and the determination by 
quality control personnel of whether the reprocessed dietary supplement 
meets product specifications established in accordance with Sec.  
111.70(e).



                      Subpart O_Product Complaints



Sec.  111.553  What are the requirements under this subpart O for written 

procedures?

    You must establish and follow written procedures to fulfill the 
requirements of this subpart O.



Sec.  111.560  What requirements apply to the review and investigation of a 

product complaint?

    (a) A qualified person must:
    (1) Review all product complaints to determine whether the product 
complaint involves a possible failure of a dietary supplement to meet 
any of its specifications, or any other requirements of this part 111, 
including those specifications and other requirements that, if not met, 
may result in a risk of illness or injury; and

[[Page 255]]

    (2) Investigate any product complaint that involves a possible 
failure of a dietary supplement to meet any of its specifications, or 
any other requirements of this part, including those specifications and 
other requirements that, if not met, may result in a risk of illness or 
injury.
    (b) Quality control personnel must review and approve decisions 
about whether to investigate a product complaint and review and approve 
the findings and followup action of any investigation performed.
    (c) The review and investigation of the product complaint by a 
qualified person, and the review by quality control personnel about 
whether to investigate a product complaint, and the findings and 
followup action of any investigation performed, must extend to all 
relevant batches and records.



Sec.  111.570  Under this subpart O, what records must you make and keep?

    (a) You must make and keep the records required under this subpart O 
in accordance with subpart P of this part.
    (b) You must make and keep the following records:
    (1) Written procedures for fulfilling the requirements of this 
subpart,
    (2) A written record of every product complaint that is related to 
good manufacturing practice,
    (i) The person who performs the requirements of this subpart must 
document, at the time of performance, that the requirement was 
perform