[Title 21 CFR ]
[Code of Federal Regulations (annual edition) - April 1, 2017 Edition]
[From the U.S. Government Publishing Office]



[[Page i]]

          

          Title 21

Food and Drugs


________________________

Parts 100 to 169

                         Revised as of April 1, 2017

          Containing a codification of documents of general 
          applicability and future effect

          As of April 1, 2017
                    Published by the Office of the Federal Register 
                    National Archives and Records Administration as 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........................     737
      Alphabetical List of Agencies Appearing in the CFR......     757
      List of CFR Sections Affected...........................     767

[[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, 2017), 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

    Each volume of the Code contains amendments published in the Federal 
Register since the last revision of that volume of the Code. Source 
citations for the regulations are referred to by volume number and page 
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instances where the effective date is beyond the cut-off date for the 
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.

PAST PROVISIONS OF THE CODE

    Provisions of the Code that are no longer in force and effect as of 
the revision date stated on the cover of each volume are not carried. 
Code users may find the text of provisions in effect on any given date 
in the past by using the appropriate List of CFR Sections Affected 
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Affected'' is published at the end of each CFR volume. For changes to 
the Code prior to the LSA listings at the end of the volume, consult 
previous annual editions of the LSA. For changes to the Code prior to 
2001, consult the List of CFR Sections Affected compilations, published 
for 1949-1963, 1964-1972, 1973-1985, and 1986-2000.

``[RESERVED]'' TERMINOLOGY

    The term ``[Reserved]'' is used as a place holder within the Code of 
Federal Regulations. An agency may add regulatory information at a 
``[Reserved]'' location at any time. Occasionally ``[Reserved]'' is used 
editorially to indicate that a portion of the CFR was left vacant and 
not accidentally dropped due to a printing or computer error.

INCORPORATION BY REFERENCE

    What is incorporation by reference? Incorporation by reference was 
established by statute and allows Federal agencies to meet the 
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to materials already published elsewhere. For an incorporation to be 
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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 
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    (c) The incorporating document is drafted and submitted for 
publication in accordance with 1 CFR part 51.
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this volume.

[[Page vii]]

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INQUIRIES

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    Oliver A. Potts,
    Director,
    Office of the Federal Register.
    April 1, 2017.

                                
                                      
                            

  

[[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 to 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, 2017.

    For this volume, Robert J. Sheehan, III was Chief Editor. The Code 
of Federal Regulations publication program is under the direction of 
John Hyrum Martinez, assisted by Stephen J. Frattini.

[[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 Note: 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...................................         197
104             Nutritional quality guidelines for foods....         204
105             Foods for special dietary use...............         208
106             Infant formula requirements pertaining to 
                    current good manufacturing practice, 
                    quality control procedures, quality 
                    factors, records and reports, and 
                    notifications...........................         210
107             Infant formula..............................         237
108             Emergency permit control....................         247
109             Unavoidable contaminants in food for human 
                    consumption and food-packaging material.         257
110             Current good manufacturing practice in 
                    manufacturing, packing, or holding human 
                    food....................................         263
111             Current good manufacturing practice in 
                    manufacturing, packaging, labeling, or 
                    holding operations for dietary 
                    supplements.............................         273
112             Standards for the growing, harvesting, 
                    packing, and holding of produce for 
                    human consumption.......................         303
113             Thermally processed low-acid foods packaged 
                    in hermetically sealed containers.......         340
114             Acidified foods.............................         375
115             Shell eggs..................................         381

[[Page 4]]

117             Current good manufacturing practice, hazard 
                    analysis, and risk-based preventive 
                    controls for human food.................         384
118             Production, storage, and transportation of 
                    shell eggs..............................         424
119             Dietary supplements that present a 
                    significant or unreasonable risk........         435
120             Hazard Analysis and Critical Control Point 
                    (HACCP) systems.........................         435
121             Mitigation strategies to protect food 
                    against intentional adulteration........         444
123             Fish and fishery products...................         452
129             Processing and bottling of bottled drinking 
                    water...................................         460
130             Food standards: General.....................         465
131             Milk and cream..............................         472
133             Cheeses and related cheese products.........         491
135             Frozen desserts.............................         543
136             Bakery products.............................         550
137             Cereal flours and related products..........         554
139             Macaroni and noodle products................         569
145             Canned fruits...............................         579
146             Canned fruit juices.........................         620
150             Fruit butters, jellies, preserves, and 
                    related products........................         634
152             Fruit pies..................................         639
155             Canned vegetables...........................         641
156             Vegetable juices............................         663
158             Frozen vegetables...........................         666
160             Eggs and egg products.......................         669
161             Fish and shellfish..........................         674
163             Cacao products..............................         691
164             Tree nut and peanut products................         699
165             Beverages...................................         702
166             Margarine...................................         722
168             Sweeteners and table sirups.................         724
169             Food dressings and flavorings...............         729

[[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.

    Editorial Note: Nomenclature changes to part 100 appear at 81 FR 
49895, July 29, 2016.



                 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.

[[Page 6]]

    (4) The State requirement is subject to preemption under section 
403A(a) of the act because it is not identical to 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,
5001 Campus Dr.,
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, 5001 Campus Dr., 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 Secs. 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 Secs. 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. 101.7 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. 101.7 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; 81 FR 59131, Aug. 29, 2016]



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.
101.7  Declaration of net quantity of contents.
101.8  Vending machines.
101.9  Nutrition labeling of food.
101.10  Nutrition labeling of restaurant foods whose labels or labeling 
          bear nutrient content claims or health claims.
101.11  Nutrition labeling of standard menu items in covered 
          establishments.
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.

[[Page 11]]

101.80  Health claims: dietary noncariogenic carbohydrate sweeteners and 
          dental caries.
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

101.91  Gluten-free labeling of food.
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.
101.108  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; 81 FR 49895, July 29, 2016.



                      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

[[Page 12]]

the principal display panel is too small 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 Secs. 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 
Secs. 101.7(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

[[Page 13]]

for sale at retail, are exempt from 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 Secs. 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 Secs. 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 Secs. 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; 81 FR 
59131, Aug. 29, 2016]



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.

[[Page 14]]

    (c) Where a food is marketed in various optional forms (whole, 
slices, diced, etc.), the particular form shall 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

[[Page 15]]

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) 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''.

[[Page 16]]

    (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''.
    (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 
ingredient 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 Secs. 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

[[Page 17]]

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 ``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

[[Page 18]]

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 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: [email protected], or may be examined at 
the Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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

[[Page 19]]

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 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 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 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; 81 FR 
5590, Feb. 3, 2016]



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. 101.7  Declaration of net quantity of contents.

    (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

[[Page 20]]

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 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 F (4 C).
    (iii) In the case of other foods, express the volume at 68 F (20 
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

[[Page 21]]

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 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

[[Page 22]]

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).
    (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

[[Page 23]]

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 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. 
Redesignated at 81 FR 59131, Aug. 29, 2016]



Sec. 101.8  Vending machines.

    (a) Definitions. The definitions of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this section. In addition, for the purposes of this section:
    Authorized official of a vending machine operator means an owner, 
operator, agent in charge, or any other person authorized by a vending 
machine operator who is not otherwise subject to section 
403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 343(q)(5)(H)(viii)), to register the vending machine operator 
with the Food and Drug Administration (``FDA'') for purposes of 
paragraph (d) of this section.
    Vending machine means a self-service machine that, upon insertion of 
a coin, paper currency, token, card, or key, or by optional manual 
operation, dispenses servings of food in bulk or in

[[Page 24]]

packages, or prepared by the machine, without the necessity of 
replenishing the machine between each vending operation.
    Vending machine operator means a person(s) or entity that controls 
or directs the function of the vending machine, including deciding which 
articles of food are sold from the machine or the placement of the 
articles of food within the vending machine, and is compensated for the 
control or direction of the function of the vending machine.
    (b) Articles of food not covered. Articles of food sold from a 
vending machine are not covered vending machine food if:
    (1) The prospective purchaser can view:
    (i) The calories, serving size, and servings per container listed in 
the Nutrition Facts label on the vending machine food without any 
obstruction. The Nutrition Facts label must be in the format required in 
Sec. 101.9(c) and (d). The Nutrition Facts label must be in a size that 
permits the prospective purchaser to be able to easily read the 
nutrition information contained in the Nutrition Facts label on the 
article of food in the vending machine. Smaller formats allowed for 
Nutrition Facts for certain food labeling under FDA regulation at 
Sec. 101.9 are not considered to be a size that a prospective purchaser 
is able to easily read; or
    (ii) The calories, serving size, and servings per container listed 
in a reproduction of the Nutrition Facts label on the vending machine 
food, provided that the reproduction is a reproduction of an actual 
Nutrition Facts label that complies with Sec. 101.9 for a vending 
machine food, is presented in a size that permits the prospective 
purchaser to be able to easily read the nutrition information, and the 
calories, serving size, and servings per container are displayed by the 
vending machine before the prospective purchaser makes his or her 
purchase; or
    (2) The prospective purchaser can otherwise view visible nutrition 
information, including, at a minimum the total number of calories for 
the article of food as sold at the point of purchase. This visible 
nutrition information must appear on the food label itself. The visible 
nutrition information must be clear and conspicuous and able to be 
easily read on the article of food while in the vending machine, in a 
type size at least 50 percent of the size of the largest printed matter 
on the label and with sufficient color and contrasting background to 
other print on the label to permit the perspective purchaser to clearly 
distinguish the information.
    (c) Requirements for calorie labeling for certain food sold from 
vending machines--(1) Applicability; covered vending machine food. For 
the purposes of this section, the term ``covered vending machine food'' 
means an article of food that is:
    (i) Sold from a vending machine that does not permit the prospective 
purchaser to examine the Nutrition Facts label prior to purchase as 
provided in paragraph (b)(1) of this section or otherwise provide 
visible nutrition information at the point of purchase as provided in 
paragraph (b)(2) of this section; and
    (ii) Sold from a vending machine that:
    (A) Is operated by a person engaged in the business of owning or 
operating 20 or more vending machines; or
    (B) Is operated by a vending machine operator that has voluntarily 
elected to be subject to the requirements of this section by registering 
with FDA under paragraph (d) of this section.
    (2) Calorie declaration. (i) The number of calories for a covered 
vending machine food must be declared in the following manner:
    (A) 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.
    (B) The term ``Calories'' or ``Cal'' must appear adjacent to the 
caloric content value for each food in the vending machine.
    (C) The calorie declaration for a packaged food must include the 
total calories present in the packaged food, regardless of whether the 
packaged food contains a single serving or multiple servings. The 
vending machine operator may voluntarily disclose calories per serving 
in addition to the total calories for the food.

[[Page 25]]

    (D) If a covered vending machine food is one where the prospective 
purchaser selects among options to produce a final vended product (e.g., 
vended coffee, hot chocolate or tea with options for added sugar, sugar 
substitute, milk, and cream), calories must be declared per option or 
for the final vended products.
    (ii) Calorie declarations for covered vending machine food must be 
clear and conspicuous and placed prominently in the following manner:
    (A) The calorie declarations may be placed on a sign in close 
proximity to the article of food or selection button, i.e., in, on, or 
adjacent to the vending machine, but not necessarily attached to the 
vending machine, so long as the calorie declaration is visible at the 
same time as the food, its name, price, selection button, or selection 
number is visible. The sign must give calorie declarations for those 
articles of food that are sold from that particular vending machine.
    (B) When the calorie declaration is in or on the vending machine, 
the calorie declaration must be in a type size no smaller than the name 
of the food on the machine (not the label), selection number, or price 
of the food as displayed on the vending machine, whichever is smallest, 
with the same prominence, i.e., the same color, or in a color at least 
as conspicuous, as the color of the name, if applicable, or price of the 
food or selection number, and the same contrasting background, or a 
background at least as contrasting as the background used for the item 
it is in closest proximity to, i.e., name, selection number, or price of 
the food item as displayed on the machine.
    (C) When the calorie declaration is on a sign adjacent to the 
vending machine, the calorie declaration must be in a type size large 
enough to render it likely to be read and understood by the prospective 
purchaser under customary conditions of purchase and use, and in a type 
that is all black or one color on a white or other neutral background 
that contrasts with the type color.
    (D) Where the vending machine only displays a picture or other 
representation or name of the food item, the calorie declaration must be 
in close proximity to the picture or other representation or name, or in 
close proximity to the selection button.
    (E) For electronic vending machines (e.g., machines with digital or 
electronic or liquid crystal display (LCD) displays), the calorie 
declaration must be displayed before the prospective purchaser makes his 
or her purchase.
    (F) For vending machines with few choices, e.g., popcorn, the 
calorie declaration may appear on the face of the machine so long as the 
declaration is prominent, not crowded by other labeling on the machine, 
and the type size is no smaller than the name of the food on the machine 
(not the label), selection number, or price of the food as displayed on 
the vending machine, whichever is smallest.
    (d) Voluntary provision of calorie labeling for foods sold from 
vending machines--(1) Applicability. A vending machine operator that is 
not subject to the requirements of section 403(q)(5)(H)(viii) of the 
Federal Food, Drug, and Cosmetic Act may, through its authorized 
official, voluntarily register with FDA to be subject to the 
requirements established in paragraph (c)(2) of this section. An 
authorized official of a vending machine operator that voluntarily 
registers cannot be subject to any State or local nutrition labeling 
requirements that are not identical to the requirements in 403(q)(5)(H) 
of the Federal Food, Drug, and Cosmetic Act.
    (2) Who may register? A vending machine operator that is not 
otherwise subject to the requirements of section 403(q)(5)(H) of the 
Federal Food, Drug, and Cosmetic Act may register with FDA.
    (3) What information is required? The vending machine operator must 
provide FDA with the following information:
    (i) The contact information (including name, address, phone number, 
email address), for the vending machine operator;
    (ii) The address of the location of each vending machine owned or 
operated by the vending machine operator that is being registered;
    (iii) Preferred mailing address (if different from the vending 
machine operator address), for purposes of receiving correspondence; and

[[Page 26]]

    (iv) Certification that the information submitted is true and 
accurate, that the person or firm submitting it is authorized to do so, 
and that each registered vending machine will be subject to the 
requirements of this section.
    (v) Information should be submitted by email by typing complete 
information into the portable document format (PDF) form, saving it on 
the registrant's computer, and sending it by email to 
[email protected] If email is not available, the 
registrant can either fill in the PDF form and print it out (or print 
out the blank PDF and fill in the information by hand or typewriter), 
and either fax the completed form to 301-436-2804 or mail it to FDA, 
CFSAN Menu and Vending Machine Labeling Registration, White Oak Building 
22, rm. 0209, 10903 New Hampshire Ave., Silver Spring, MD 20993.
    (vi) Authorized officials of a vending machine operator who elect to 
be subject to the Federal requirements can register by visiting http://
www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/
ucm217762.htm. FDA has created a form that contains fields requesting 
the information in paragraph (d) of this section and made the form 
available at this Web site. Registrants must use this form to ensure 
that complete information is submitted.
    (vii) To keep the establishment's registration active, the 
authorized official of the vending machine operator must register every 
other year within 60 days prior to the expiration of the vending machine 
operator's current registration with FDA. Registration will 
automatically expire if not renewed.
    (e) Vending machine operator contact information. (1) A vending 
machine operator that is subject to section 403(q)(5)(H)(viii) of the 
Federal Food, Drug, and Cosmetic Act or a vending machine operator that 
voluntarily registers to be subject to the requirements under paragraph 
(d) of this section must provide its contact information for vending 
machines selling covered vending machine food. The contact information 
must list the vending machine operator's name, telephone number, and 
mailing address or email address.
    (2) The contact information must be readable and may be placed on 
the face of the vending machine, or otherwise must be placed with the 
calorie declarations as described in paragraph (c)(2)(ii) of this 
section (i.e., on the sign in, on, or adjacent to the vending machine).
    (f) Signatures. Signatures obtained under paragraph (d) of this 
section that meet the definition of electronic signatures in 
Sec. 11.3(b)(7) of this chapter are exempt from the requirements of part 
11 of this chapter.

[79 FR 71291, Dec. 1, 2014]



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 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

[[Page 27]]

(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 at least 200 percent and up to and including 
300 percent of the applicable reference amount, the serving size shall 
be the amount that approximates the reference amount. In addition to 
providing a column within the Nutrition Facts label that lists the 
quantitative amounts and percent Daily Values per serving size, the 
manufacturer shall provide a column within the Nutrition Facts label 
that lists the quantitative amounts and percent Daily Values per 
individual unit. The first column would be based on the serving size for 
the product and the second column would be based on the individual unit. 
The exemptions in paragraphs (b)(12)(i)(A), (B), and (C) of this section 
apply to this provision.
    (E) 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.
    (F) 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

[[Page 28]]

(b)(5)(vi) of this section for expressing the serving size in ounces.
    (G) 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).
    (H) 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 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:

[[Page 29]]

    (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 that contains 
less than 200 percent of the applicable reference amount must be 
considered to be a single-serving container, and the entire content of 
the product must be labeled as one serving. In addition to providing a 
column within the Nutrition Facts label that lists the quantitative 
amounts and percent Daily Values per serving, for a product that is 
packaged and sold individually that contains more than 150 percent and 
less than 200 percent of the applicable reference amount, the Nutrition 
Facts label may voluntarily provide, to the left of the column that 
provides nutrition information per container (i.e., per serving), an 
additional column that lists the quantitative amounts and percent Daily 
Values per common household measure that most closely approximates the 
reference amount.
    (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

[[Page 30]]

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, 5001 Campus Dr., 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, manufacturers may declare 
``varied'' for the number of servings per container provided the 
nutrition information is based on the reference amount expressed in the 
appropriate household measure based on the hierarchy described in 
paragraph (b)(5) of this section. Random weight products are foods such 
as cheeses that are sold as random weights that vary in size, such that 
the net contents for different containers would vary. The manufacturer 
may provide the typical number of servings in parentheses 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 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.

[[Page 31]]

    (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 
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.
    (12)(i) Products that are packaged and sold individually and that 
contain at least 200 percent and up to and including 300 percent of the 
applicable reference amount must provide an additional column within the 
Nutrition Facts label that lists the quantitative amounts and percent 
Daily Values for the entire package, as well as a column listing the 
quantitative amounts and percent Daily Values for a serving that is less 
than the entire package (i.e., the serving size derived from the 
reference amount). The first column would be based on the serving size 
for the product and the second column would be based on the entire 
contents of the package.
    (A) This provision does not apply to products that meet the 
requirements to use the tabular format in paragraph (j)(13)(ii)(A)(1) of 
this section or to products that meet the requirements to use the linear 
format in paragraph (j)(13)(ii)(A)(2) of this section.
    (B) This provision does not apply to raw fruits, vegetables, and 
seafood for which voluntary nutrition labeling is provided in the 
product labeling or advertising or when claims are made about the 
product.
    (C) This provision does not apply to products that require further 
preparation and provide an additional column of nutrition information 
under paragraph (e) of this section, to products that are commonly 
consumed in combination with another food and provide an additional 
column of nutrition information under paragraph (e) of this section, to 
products that provide an additional column of nutrition information for 
two or more groups for which RDIs are established (e.g., both infants 
and children less than 4 years of age), to popcorn products that provide 
an additional column of nutrition information per 1 cup popped popcorn, 
or to varied-weight products covered under paragraph (b)(8)(iii) of this 
section.
    (ii) When a nutrient content claim or health claim is made on the 
label of a product that uses a dual column as required in paragraph 
(b)(2)(i)(D) or (b)(12)(i) of this section, the claim must be followed 
by a statement that sets forth the basis on which the claim is made, 
except that the statement is not required for products when the nutrient 
that is the subject of the claim meets the criteria for the claim based 
on the reference amount for the product and the entire container or the 
unit amount. When a nutrient content

[[Page 32]]

claim is made, the statement must express that the claim refers to the 
amount of the nutrient per serving (e.g., ``good source of calcium per 
serving'' or ``per X [insert unit]_serving'') or per reference amount 
(e.g., ``good source of calcium per [insert reference amount (e.g., per 
8 ounces)]), as required based on Sec. 101.12(g). When a health claim is 
made, the statement shall be ``A serving of _ounces of this product 
conforms to such a diet.''
    (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, USDA Handbook No. 74 (slightly revised, 1973),
    (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;
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate (less the amount of non-digestible 
carbohydrates and sugar alcohols), and total fat, respectively, as 
described in USDA Handbook No. 74 (slightly revised, 1973) pp. 9-11. A 
general factor of 2 calories per gram for soluble non-digestible 
carbohydrates shall be used. The general factors for caloric value of 
sugar alcohols provided in paragraph (c)(1)(i)(F) of this section shall 
be used;
    (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;
    (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; or
    (F) Using the following general factors for caloric value of sugar 
alcohols: Isomalt--2.0 calories per gram, lactitol--2.0 calories per 
gram, xylitol--2.4 calories per gram, maltitol--2.1 calories per gram, 
sorbitol--2.6 calories per gram, hydrogenated starch hydrolysates--3.0 
calories per gram, mannitol--1.6 calories per gram, and erythritol--0 
calories per gram.
    (ii) ``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 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 where fatty acids are aliphatic carboxylic 
acids consisting of a chain of alkyl groups and characterized

[[Page 33]]

by a terminal carboxyl group. 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.
    (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) ``Fluoride'' (VOLUNTARY): A statement of the number of 
milligrams of fluoride in a specified serving of food may be declared 
voluntarily, except that when a claim is made about fluoride content, 
label declaration shall be required. Fluoride content shall be expressed 
as zero when the serving contains less than 0.1 milligrams of fluoride, 
to the nearest 0.1-milligram increment when the serving contains less 
than or equal to 0.8 milligrams of fluoride, and the nearest 0.2 
milligram-increment when a serving contains more than 0.8 milligrams of 
fluoride. Bottled water that bears a statement about added fluoride, as 
permitted by Sec. 101.13(q)(8), must bear nutrition labeling that 
complies with requirements for the simplified format in paragraph (f) of 
this section.
    (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. Dietary fiber is defined as non-digestible soluble and 
insoluble carbohydrates (with 3 or more monomeric units), and lignin 
that are intrinsic and intact in plants; isolated or synthetic non-
digestible carbohydrates (with 3 or more monomeric units) determined by 
FDA to have physiological effects that are beneficial to human health. 
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. The 
following isolated or synthetic non-digestible carbohydrate(s) have been 
determined by FDA to have physiological effects that are beneficial to 
human health and, therefore, shall be included in the calculation of the 
amount of dietary fiber: [beta]-glucan soluble fiber (as described in 
Sec. 101.81(c)(2)(ii)(A)),

[[Page 34]]

psyllium husk (as described in Sec. 101.81(c)(2)(ii)(A)(6)), cellulose, 
guar gum, pectin, locust bean gum, and hydroxypropylmethylcellulose. The 
manufacturer must make and keep records in accordance with paragraphs 
(g)(10) and (11) of this section to verify the declared amount of 
dietary fiber in the label and labeling of food when a mixture of 
dietary fiber, and added non-digestible carbohydrate(s) that does not 
meet the definition of dietary fiber, is present in the food.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber in a serving may be declared voluntarily 
except that when a claim is made on the label or in labeling about 
soluble fiber, label declaration shall be required. Soluble fiber must 
meet the definition of dietary fiber in this paragraph (c)(6)(i). The 
manufacturer must make and keep records in accordance with paragraphs 
(g)(10) and (11) of this section to verify the declared amount of 
soluble fiber in the label and labeling of food when a mixture of 
soluble fiber and added non-digestible carbohydrate(s) that does not 
meet the definition of dietary fiber is present in the food. 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 must meet the definition of dietary fiber in this paragraph 
(c)(6)(i). The manufacturer must make and keep records in accordance 
with paragraphs (g)(10) and (11) of this section to verify the declared 
amount of insoluble fiber in the label and labeling of food when a 
mixture of insoluble and added non-digestible carbohydrate(s) that does 
not meet the definition of dietary fiber is present in the food. 
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) ``Total Sugars'': A statement of the number of grams of sugars 
in a serving, except that the 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 total sugars content is not required and, as a result, 
not declared, the statement ``Not a significant source of total sugars'' 
shall be placed at the bottom of the table of nutrient values in the 
same type size. Total sugars shall be defined as the sum of all free 
mono- and disaccharides (such as glucose, fructose, lactose, and 
sucrose). Total 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 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.
    (iii) ``Added Sugars'': A statement of the number of grams of added 
sugars in a serving, except that label declaration of added sugars 
content is not required for products that contain less than 1 gram of 
added sugars in a serving if no claims are made about sweeteners, 
sugars, added sugars, or sugar alcohol content. If a statement of the 
added sugars content is not required and, as a result, not declared, the 
statement ``Not a significant source of added sugars'' shall be placed 
at the bottom of the table of nutrient values in the same type size. 
Added sugars are either added during the processing of foods, or are 
packaged as such, and include sugars (free, mono- and disaccharides), 
sugars from syrups and honey, and sugars from concentrated fruit or 
vegetable juices that are in excess of what would be expected from the 
same volume of 100 percent fruit or vegetable juice of the same type, 
except that fruit or vegetable

[[Page 35]]

juice concentrated from 100 percent juices sold to consumers, fruit or 
vegetable juice concentrates used towards the total juice percentage 
label declaration under Sec. 101.30 or for Brix standardization under 
Sec. 102.33(g)(2) of this chapter, fruit juice concentrates which are 
used to formulate the fruit component of jellies, jams, or preserves in 
accordance with the standard of identities set forth in Secs. 150.140 
and 150.160 of this chapter, or the fruit component of fruit spreads 
shall not be labeled as added sugars. Added sugars content shall be 
indented under Total Sugars and shall be prefaced with the word 
``Includes'' followed by the amount (in grams) ``Added Sugars'' 
(``Includes `X' g Added Sugars''). It shall be 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 a mixture of naturally occurring and 
added sugars is present in the food, and for specific foods containing 
added sugars, alone or in combination with naturally occurring sugars, 
where the added sugars are subject to fermentation and/or non-enzymatic 
browning, the manufacturer must make and keep records in accordance with 
paragraphs (g)(10) and (11) of this section to verify the declared 
amount of added sugars in the label and labeling of food.
    (iv) ``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 total sugars, or added 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 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 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 a 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 specifically for infants through 12 
months, 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 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,'' except when official

[[Page 36]]

AOAC procedures described in this paragraph (c)(7) require a specific 
factor other than 6.25, that specific factor shall be used.
    (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 specifically for 
infants through 12 months or children 1 through 3 years of age. When 
such a declaration is provided, it should be placed on the label 
adjacent to the statement of grams of protein and aligned under the 
column 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 specifically 
for infants through 12 months 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 ``Report of the 
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,'' 
except that when official AOAC procedures described in paragraph (c)(7) 
of this section require a specific factor other than 6.25, that specific 
factor shall be used. For foods represented or purported to be 
specifically for infants through 12 months, 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 DRV or RDI, 
a value of 50 grams of protein shall be the DRV for adults and children 
4 or more years of age, a value of 11 grams of protein shall be the RDI 
for infants through 12 months, a value of 13 grams shall be the DRV for 
children 1 through 3 years of age, and a value of 71 grams of protein 
shall be the RDI for pregnant women and lactating women.
    (8) ``Vitamins and minerals'': The requirements related to including 
a statement of the amount per serving of vitamins and minerals are 
described in this paragraph (c)(8).
    (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 specifically for infants through 12 
months, children 1 through 3 years, pregnant women, and lactating women 
shall use the RDIs that are specified for the intended group. For foods 
represented or purported to be specifically for both infants through 12 
months of age and children 1 through 3 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 
through 12 months of age and children 1 through 3 years of age. 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. The percent Daily Value based on the RDI values for pregnant 
women and lactating women shall be declared on food represented or 
purported to be specifically for pregnant women and lactating women. 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 quantitative 
amount by weight and percent of the RDI shall include vitamin D, 
calcium, iron, and potassium in that order, for infants through 12 
months, children 1 through 3 years of age, pregnant women, lactating 
women, and adults and children 4 or more years of age. The declaration 
of folic acid shall be included as a quantitative amount by weight when

[[Page 37]]

added as a nutrient supplement or a claim is made about the nutrient. 
The declaration of vitamins and minerals in a food, as a quantitative 
amount by weight and percent of the RDI, may include any of the other 
vitamins and minerals listed in paragraph (c)(8)(iv) of this section. 
The declaration of vitamins and minerals shall include any of the other 
vitamins and minerals listed in paragraph (c)(8)(iv) of this section as 
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 a percent of the Daily Value, when they are added as a 
nutrient supplement, or when a claim is made about them, unless 
otherwise stated as quantitative amount by weight and percent of the 
Daily Value. Other vitamins and minerals need not be declared if neither 
the nutrient nor the component is otherwise referred to on the label or 
the labeling or advertising and the vitamins and minerals are:
    (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. Quantitative amounts and percentages 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 D, calcium, iron, or potassium 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. The quantitative amounts of vitamins and 
minerals, excluding sodium, 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 paragraph (c)(8)(iv) 
of this section, 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, but the 
quantitative amount may be declared in tenths of a milligram).
    (iv) The following RDIs, nomenclature, and units of measure are 
established for the following vitamins and minerals which are essential 
in human nutrition:

----------------------------------------------------------------------------------------------------------------
                                                                                RDI
                                                 ---------------------------------------------------------------
                                                    Adults and
           Nutrient              Unit of measure   children =4      through 12       through 3     and lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Vitamin A.....................  Micrograms RAE               900             500             300           1,300
                                 \2\ (mcg).
Vitamin C.....................  Milligrams (mg).              90              50              15             120
Calcium.......................  Milligrams (mg).           1,300             260             700           1,300
Iron..........................  Milligrams (mg).              18              11               7              27
Vitamin D.....................  Micrograms (mcg)              20              10              15              15
                                 \3\.

[[Page 38]]

 
Vitamin E.....................  Milligrams (mg)               15               5               6              19
                                 \4\.
Vitamin K.....................  Micrograms (mcg)             120             2.5              30              90
Thiamin.......................  Milligrams (mg).             1.2             0.3             0.5             1.4
Riboflavin....................  Milligrams (mg).             1.3             0.4             0.5             1.6
Niacin........................  Milligrams NE                 16               4               6              18
                                 \5\ (mg).
Vitamin B6....................  Milligrams (mg).             1.7             0.3             0.5             2.0
Folate \6\....................  Micrograms DFE               400              80             150             600
                                 \7\ (mcg).
Vitamin B12...................  Micrograms (mcg)             2.4             0.5             0.9             2.8
Biotin........................  Micrograms (mcg)              30               6               8              35
Pantothenic acid..............  Milligrams (mg).               5             1.8               2               7
Phosphorus....................  Milligrams (mg).           1,250             275             460           1,250
Iodine........................  Micrograms (mcg)             150             130              90             290
Magnesium.....................  Milligrams (mg).             420              75              80             400
Zinc..........................  Milligrams (mg).              11               3               3              13
Selenium......................  Micrograms (mcg)              55              20              20              70
Copper........................  Milligrams (mg).             0.9             0.2             0.3             1.3
Manganese.....................  Milligrams (mg).             2.3             0.6             1.2             2.6
Chromium......................  Micrograms (mcg)              35             5.5              11              45
Molybdenum....................  Micrograms (mcg)              45               3              17              50
Chloride......................  Milligrams (mg).           2,300             570           1,500           2,300
Potassium.....................  Milligrams (mg).           4,700             700           3,000           5,100
Choline.......................  Milligrams (mg).             550             150             200             550
Protein.......................  Grams (g).......             N/A              11             N/A          \8\ 71
----------------------------------------------------------------------------------------------------------------
\1\ RDIs are based on dietary reference intake recommendations for infants through 12 months of age.
\2\ RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental [beta]-
  carotene, 12 micrograms [beta]-carotene, or 24 micrograms [alpha]-carotene, or 24 micrograms [beta]-
  cryptoxanthin.
\3\ The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition
  to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in
  parentheses after the declaration of the amount of vitamin D in mcg.
\4\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all
  rac-[alpha]-tocopherol .
\5\ NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan.
\6\ ``Folate'' and ``Folic Acid'' must be used for purposes of declaration in the labeling of conventional foods
  and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative
  amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE.
  Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is
  made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.
\7\ DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid.
\8\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant women and lactating women.

    (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

    (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.
    (vii) When the amount of folate is declared in the labeling of a 
conventional food or a dietary supplement, the nutrient name ``folate'' 
shall be listed for products containing folate (natural folate, and/or 
synthetic folate as a component of dietary supplement, such

[[Page 39]]

as calcium salt of L-5-MTHF), folic acid, or a mixture of folate and 
folic acid. The name of the synthetic form of the nutrient ``folic 
acid'', when added or a claim is made about the nutrient, shall be 
included in parentheses after this declaration with the amount of folic 
acid. The declaration must be folate in mcg DFE (when expressed as a 
quantitative amount by weight in a conventional food or a dietary 
supplement) and the percent DV based on folate in mcg DFE, or for 
conventional food, may be expressed as folate and the percent DV based 
on folate in mcg DFE. When declared, folic acid must be in parentheses, 
mcg of folic acid as shown in paragraph (d)(12) of this section in the 
display that illustrates voluntary declaration of nutrition information.
    (9) The following DRVs, nomenclature, and units of measure are 
established for the following food components:

----------------------------------------------------------------------------------------------------------------
                                                    Adults and
                                                   children =4      through 12       through 3     and lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Fat...........................  Grams (g).......          \1\ 78              30          \2\ 39          \1\ 78
Saturated fat.................  Grams (g).......          \1\ 20             N/A          \2\ 10          \1\ 20
Cholesterol...................  Milligrams (mg).             300             N/A             300             300
Total carbohydrate............  Grams (g).......         \1\ 275              95         \2\ 150         \1\ 275
Sodium........................  Milligrams (mg).           2,300             N/A           1,500           2,300
Dietary Fiber.................  Grams (g).......          \1\ 28             N/A          \2\ 14          \1\ 28
Protein.......................  Grams (g).......          \1\ 50             N/A          \2\ 13             N/A
Added Sugars..................  Grams (g).......          \1\ 50             N/A          \2\ 25          \1\ 50
----------------------------------------------------------------------------------------------------------------
\1\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant women and lactating women
\2\ Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

    (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 where the tabular 
display is permitted as provided for in paragraph (d)(11) of this 
section, 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 through 12 months of 
age and children 1 through 3 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 strongly recommends 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)(7) and (8) of this 
section shall be in type size no smaller than 8 point. Information 
required in paragraph (d)(5) of this section for the 
``Calories'' declaration shall be highlighted in bold or extra bold and 
shall be in a type size no smaller than 16 point except the type size 
for this information required in the tabular displays as shown in 
paragraphs (d)(11), (e)(6)(ii), and (j)(13)(ii)(A)(1) of this section 
and the linear display for small packages as shown in paragraph 
(j)(13)(ii)(A)(2) of this section shall be in a type size no smaller 
than 10 point.

[[Page 40]]

The numeric amount for the information required in paragraph (d)(5) of 
this section shall also be highlighted in bold or extra bold type and 
shall be in a type size no smaller than 22 point, except the type size 
for this information required for the tabular display for small packages 
as shown in paragraph (j)(13)(ii)(A)(1) of this section, and for the 
linear display for small packages as shown in paragraph 
(j)(13)(ii)(A)(2) of this section no smaller than 14 point. The 
information required in paragraph (d)(9) of this section shall be in a 
type size no smaller than 6 point. When provided, the information 
described in paragraph (d)(10) of this section shall be in a type size 
no smaller than 6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(3)(ii), (d)(4), 
and (d)(6) of this section (i.e., ``Nutrition Facts,'' ``Serving size,'' 
``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 in 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 ``Nutrition Facts'' from the servings per container statement 
required in paragraph (d)(3)(i) of this section and shall separate each 
nutrient and its corresponding percent Daily Value required in 
paragraphs (d)(7)(i) and (ii) of this section from the nutrient and 
percent Daily Value above and below it, as shown in paragraph (d)(12) of 
this section and in Appendix B to Part 101.
    (2) The information shall be presented under the identifying heading 
of ``Nutrition Facts'' which shall be set in a type size no smaller than 
all other print size in the nutrition label except for the numerical 
information for ``Calories'' required in paragraph (d)(5) of this 
section, and except for labels presented according to the format 
provided for in paragraphs (d)(11), (d)(13)(ii), (e)(6)(ii), 
(j)(13)(ii)(A)(1), and (j)(13)(ii)(A)(2) 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 servings per container and serving size shall 
immediately follow the heading as shown in paragraph (d)(12) of this 
section. Such information shall include:
    (i) ``__ 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. The information required in this paragraph shall 
be located immediately after the ``Nutrition Facts'' heading and shall 
be in a type size no smaller than 10 point, except the type size for 
this information shall be no smaller than 9 point in the tabular display 
for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this 
section and the linear display for small packages as shown in paragraph 
(j)(13)(ii)(A)(2) of this section. For the linear display for small 
packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, the 
actual number of servings may be listed after the servings per container 
declaration.
    (ii) ``Serving size'': A statement of the serving size as specified 
in paragraph (b)(7) of this section which shall immediately follow the 
``__servings per container'' declaration. The information required in 
this paragraph shall be highlighted in bold or extra bold and be in a 
type size no smaller than 10 point, except the type size shall be no 
smaller than 9 point for this information in the tabular displays as 
shown in paragraphs (d)(11) and (e)(6)(ii) of this section, the tabular 
display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of 
this section, and the linear display for small packages as shown in 
paragraph (j)(13)(ii)(A)(2) of this section. The serving size amount 
must be right justified if adequate space is available. If the ``Serving 
size'' declaration does not fit in the allocated space a type size of no 
smaller

[[Page 41]]

than 8 point may be used on packages of any size.
    (4) A subheading ``Amount per serving'' shall be separated from the 
serving size information by a bar as shown in paragraph (d)(12) of this 
section, except this information is not required for the dual column 
formats shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this 
section.
    (5) Information on calories shall immediately follow the subheading 
``Amount per serving'' and shall be declared in one line. If ``Calories 
from saturated fat'' is declared, it shall be indented under 
``Calories'' and shall be in a type size no smaller than 8 point.
    (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)(ii)(A)(2) 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 for folic acid in conventional 
food and voluntarily declared vitamins and minerals expressed as a 
statement of the amount per serving calculated as a percent of the RDI 
and expressed as a percent Daily Value, 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, ``mg'' for milligrams, or ``mcg'' for micrograms 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 (except sodium) 
shall be separated from information on other nutrients by a bar and may 
be arrayed vertically as shown in paragraph (d)(12) of this section 
(e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, Potassium 
235 mg 6%) or may be listed horizontally. When listed horizontally in 
two columns, vitamin D and calcium should be listed on the first line 
and iron and potassium should be listed on the second line, as shown in 
paragraph (d)(12) of this section in the side-by-side display. When more 
than four vitamins and minerals are declared voluntarily as shown in 
paragraph (d)(12) of this section in the label which illustrates the 
mandatory plus voluntary provisions of paragraph (d) of this section, 
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 the list by a 
bar, except that the footnote may be omitted from foods that can use the 
terms ``calorie free,'' ``free of calories,'' ``without calories,'' 
``trivial source of calories,'' ``negligible source of calories,'' or 
``dietary insignificant source of calories'' on the label or in the 
labeling of foods as defined in Sec. 101.60(b). The first sentence of 
the footnote: ``The % Daily Value tells you how much a nutrient in a 
serving of food contributes to a daily diet'' may be used on foods that 
can

[[Page 42]]

use the terms ``calorie free,'' ``free of calories,'' ``without 
calories,'' ``trivial source of calories,'' ``negligible source of 
calories,'' or ``dietary insignificant source of calories'' on the label 
or in the labeling of foods as defined in Sec. 101.60(b). The footnote 
shall state: ``*The % Daily Value tells you how much a nutrient in a 
serving of food contributes to a daily diet. 2,000 calories a day is 
used for general nutrition advice.'' If the food product is represented 
or purported to be for children 1 through 3 years of age, the second 
sentence of the footnote shall substitute ``1,000 calories'' for ``2,000 
calories.''
    (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 potassium 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 
potassium, the nutrition label may be presented in a tabular display as 
shown in the following sample label.
[GRAPHIC] [TIFF OMITTED] TR27MY16.000

    (12) The following sample labels illustrate the mandatory provisions 
and mandatory plus voluntary provisions of paragraph (d) of this section 
and the side-by-side display.

[[Page 43]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.001


[[Page 44]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.002


[[Page 45]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.003

    (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 to the 
right of the ``Nutrition Facts'' heading, and both the quantitative 
amount by weight (i.e., g/mg/mcg 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 46]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.004

    (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 RDIs are established (e.g., both infants through 12 months of 
age and children 1 through 3 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 serving size information there shall be two or 
more column headings accurately describing the amount per serving size 
of the form of the same food (e.g., ``Per \1/4\ cup mix'' and ``Per 
prepared portion''), the combinations of food, the units, or the RDI 
groups that are being declared as shown in paragraph (e)(5) of this 
section.
    (2) The quantitative information by weight as required in paragraph 
(d)(7)(i) and the information required in paragraph (d)(7)(ii) of this 
section shall be presented for the form of the product as packaged and 
for any other form of the product (e.g., ``as prepared'' or combined 
with another ingredient as shown in paragraph (e)(5) of this section).
    (3) When the dual labeling is presented for two or more forms of the

[[Page 47]]

same food, for combinations of food, for different units, or for two or 
more groups for which RDIs are established, the quantitative information 
by weight and the percent Daily Value shall be presented in two columns 
and the columns shall be separated by vertical lines as shown in 
paragraph (e)(5) of this section.
    (4) Nutrient information for vitamins and minerals (except sodium) 
shall be separated from information on other nutrients by a bar and 
shall be arrayed vertically in the following order: Vitamin D, calcium, 
iron, potassium as shown in paragraph (e)(5) of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:
[GRAPHIC] [TIFF OMITTED] TR27MY16.005

    (6) When dual labeling is presented for a food on a per serving 
basis and per container basis as required in paragraph (b)(12)(i) of 
this section or on a per serving basis and per unit basis as required in 
paragraph (b)(2)(i)(D) of this section, the quantitative information by 
weight as required in paragraph (d)(7)(i) and the percent Daily Value as 
required in paragraph (d)(7)(ii) shall be presented in two columns, and 
the columns shall be separated by vertical lines as shown in the 
displays in paragraph (e)(6)(i) of this section.
    (i) Nutrient information for vitamins and minerals shall be 
separated from information on other nutrients by a bar and shall be 
arrayed vertically in the following order: Vitamin D, calcium, iron, and 
potassium as shown in the following sample labels.

[[Page 48]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.006

    (ii) The following sample label illustrates the provisions of 
paragraphs (b)(2)(i)(D) and (b)(12)(i) of this section for labels that 
use the tabular display.

[[Page 49]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.007

    (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, total sugars, added sugars, protein, vitamin D, calcium, 
iron, and potassium; except that for foods intended for infants through 
12 months of age and children 1 through 3 years of age to which 
paragraph (j)(5)(i) of this section 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, total sugars, added 
sugars, protein, vitamin D, calcium, iron, and potassium.
    (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) 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 
paragraph (f) of this section that are present in insignificant amounts) 
shall be included at the bottom of the nutrition label.

[[Page 50]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.008

    (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, and an asterisk shall be placed at the 
bottom of the label followed by the statement ``% DV = % Daily Value'' 
when ``Daily Value'' is not spelled out in the heading, as shown in 
paragraph (f)(4).
    (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,'' or, if 
no AOAC method is available or appropriate, by other reliable and 
appropriate analytical procedures.
    (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. When a 
nutrient is naturally occurring (indigenous) in a food or an ingredient 
that is added to a food, the total amount of such nutrient in the final 
food product is subject to class II requirements, except that when an 
exogenous source of the nutrient is also added to the final food 
product, the total amount of the nutrient in the final food product 
(indigenous and exogenous) is subject to class I requirements.
    (4) A food with a label declaration of a vitamin, mineral, protein, 
total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, 
polyunsaturated or monounsaturated fat 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) When a vitamin, mineral, protein, or dietary fiber meets the 
definition of a Class I nutrient, the nutrient content of the composite 
must be formulated to

[[Page 51]]

be at least equal to the value for that nutrient declared on the label.
    (ii) When a vitamin, mineral, protein, total carbohydrate, 
polyunsaturated or monounsaturated fat, or dietary fiber meets the 
definition of a Class II nutrient, the nutrient content of the composite 
must be 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, total sugars, added 
sugars (when the only source of sugars in the food is added 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 vitamins, minerals, protein, total 
carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugar 
alcohols, polyunsaturated or monounsaturated fat over labeled amounts 
are acceptable within current good manufacturing practice. Reasonable 
deficiencies of calories, total sugars, added 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) Alternatively, compliance with the provisions set forth in 
paragraphs (g)(1) through (6) of this section may be provided by use of 
an FDA approved database 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 database shall not be considered granted until the Center 
for Food Safety and Applied Nutrition has agreed to all aspects of the 
database 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., 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 
databases may be found in the ``FDA Nutrition Labeling Manual--A Guide 
for Developing and Using Data Bases,'' available from the Office of 
Nutrition and Food Labeling (HFS-800), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740 or by going to http://www.fda.gov.
    (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, 
5001 Campus Dr., College Park, MD 20740.
    (10) The manufacturer must make and keep written records (e.g., 
analyses of databases, recipes, formulations, information from recipes 
or formulations, or batch records) to verify the declared amount of that 
nutrient on the Nutrition Facts label as follows:
    (i) When a mixture of dietary fiber, and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber, is 
present in the food, a manufacturer must make and keep written records 
of the amount of non-digestible carbohydrate(s) added to the food that 
does not meet the definition of dietary fiber.
    (ii) When a mixture of soluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the

[[Page 52]]

food, a manufacturer must make and keep written records necessary to 
verify the amount of the non-digestible carbohydrate(s) added to the 
food that does not meet the definition of dietary fiber.
    (iii) When a mixture of insoluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must make and keep written records 
necessary to verify the amount of the non-digestible carbohydrate(s) 
added to the food that does not meet the definition of dietary fiber.
    (iv) When a mixture of naturally occurring and added sugars is 
present in the food, a manufacturer must make and keep written records 
of the amount of added sugars added to the food during the processing of 
the food, and if packaged as a separate ingredient, as packaged (whether 
as part of a package containing one or more ingredients or packaged as a 
single ingredient).
    (v) When the amount of sugars added to food products is reduced 
through non-enzymatic browning and/or fermentation, manufacturers must:
    (A) Make and keep records of all relevant scientific data and 
information relied upon by the manufacturer that demonstrates the amount 
of added sugars in the food after non-enzymatic browning and/or 
fermentation and a narrative explaining why the data and information are 
sufficient to demonstrate the amount of added sugars declared in the 
finished food, provided the data and information used is specific to the 
type of food that is subject to non-enzymatic browning and/or 
fermentation; or
    (B) Make and keep records of the amount of added sugars added to the 
food before and during the processing of the food, and if packaged as a 
separate ingredient, as packaged (whether as part of a package 
containing one or more ingredients or packaged as a single ingredient) 
and in no event shall the amount of added sugars declared exceed the 
amount of total sugars on the label; or
    (C) Submit a petition, under 21 CFR 10.30, to request an alternative 
means of compliance. The petition must provide scientific data or other 
information for why the amount of added sugars in a serving of the 
product is likely to have a significant reduction in added sugars 
compared to the amount added prior to non-enzymatic browning and/or 
fermentation. A significant reduction would be where reduction in added 
sugars after non-enzymatic browning and/or fermentation may be 
significant enough to impact the label declaration for added sugars by 
an amount that exceeds the reasonable deficiency acceptable within good 
manufacturing practice under paragraph (g)(6) of this section. In 
addition, the scientific data or other information must include the 
reason that the manufacturer is unable to determine a reasonable 
approximation of the amount of added sugars in a serving of their 
finished product and a description of the process that they used to come 
to that conclusion.
    (vi) When a mixture of all rac-[alpha]-tocopherol and RRR-[alpha]-
tocopherol is present in a food, manufacturers must make and keep 
written records of the amount of all rac-[alpha]-tocopherol added to the 
food and RRR-[alpha]-tocopherol in the finished food.
    (vii) When a mixture of folate and folic acid is present in a food, 
manufacturers must make and keep written records of the amount of 
synthetic folate and/or folic acid added to the food and the amount of 
naturally-occurring folate in the finished food.
    (11) Records necessary to verify certain nutrient declarations that 
are specified in paragraph (g)(10) of this section must be kept for a 
period of at least 2 years after introduction or delivery for 
introduction of the food into interstate commerce. Such records must be 
provided to FDA upon request, during an inspection, for official review 
and photocopying or other means of reproduction. Records required to 
verify information on the label may be kept either as original records, 
true copies (such as photocopies, pictures, scanned copies, microfilm, 
microfiche, or other accurate reproductions of the original records), or 
electronic records which must be kept in accordance with part 11 of this 
chapter. These records must be accurate, indelible, and legible.
    Failure to make and keep the records or provide the records to 
appropriate

[[Page 53]]

regulatory authorities, as required by this paragraph (g)(11), would 
result in the food being misbranded under section 403(a)(1) of the act.
    (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, the following may be used as the standard 
serving size for purposes of nutrition labeling of foods subject to this 
paragraph: 1 ounce for solid foods; 2 fluid ounces for nonbeverage 
liquids (e.g., syrups); 8 ounces for beverages that consist of milk and 
fruit juices, nectars and fruit drinks; and 12 fluid ounces for other 
beverages. 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 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 (6) of this section. Proposals for such 
categories may be submitted in writing to the Office of Nutrition and 
Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., 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.

[[Page 54]]

    (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 the percent Daily Value 
and the quantitative amounts for the cereal as sold (e.g., per ounce), 
and the percent Daily Value and the quantitative amounts 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 the percent Daily Value and the quantitative amounts for the dry 
mix (per serving) and the percent Daily Value and the quantitative 
amounts for the serving of the final cake when prepared, as shown in 
paragraph (e)(5) of this section: 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, Sec. 101.10, or Sec. 101.11, as 
applicable.
    (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) Except as provided in Sec. 101.11, food products that 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 claims or 
other nutrition information in any context on the label or in labeling 
or advertising, except as provided in Sec. 101.8(c). Claims or other 
nutrition information, except as provided in Sec. 101.8(c), 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

[[Page 55]]

    (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) Except as provided in Sec. 101.11, 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) Except as provided in Sec. 101.11, 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, except as provided in Sec. 101.8(c), 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 through 12 months of age and children 1 
through 3 years of age shall bear nutrition labeling. The nutrients 
declared for infants through 12 months of age and children 1 through 3 
years of age shall include calories, total fat, saturated fat, trans 
fat, cholesterol, sodium, total carbohydrates, dietary fiber, total 
sugars, added sugars, protein, and the following vitamins and minerals: 
Vitamin D, calcium, iron, and potassium.
    (ii) Foods, other than infant formula, represented or purported to 
be specifically for infants through 12 months of age shall bear 
nutrition labeling, except that:
    (A) Such labeling shall not declare a percent Daily Value for 
saturated fat, trans fat, cholesterol, sodium, dietary fiber, total 
sugars, or added sugars and shall not include a footnote.
    (B) The following sample label illustrates the provisions of 
paragraph (j)(5)(ii) of this section.

[[Page 56]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.009

    (C)-(E) [Reserved]
    (iii) Foods, other than infant formula, represented or purported to 
be specifically for children 1 through 3 years of age shall include a 
footnote that states: ``*The % Daily Value tells you how much a nutrient 
in a serving of food contributes to a daily diet. 1,000 calories a day 
is used for general nutrition advice.''
    (A) The following sample label illustrates the provisions of 
paragraph (j)(5)(iii) of this section.

[[Page 57]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.010

    (B) [Reserved]
    (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

[[Page 58]]

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, 
except as provided in Sec. 101.8(c). Claims or other nutrition 
information, except as provided in Sec. 101.8(c), subject the food to 
the provisions of this section.
    (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 for 
small packages.
[GRAPHIC] [TIFF OMITTED] TR27MY16.011

    (2) The following sample label illustrates the linear display.
      
      

[[Page 59]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.012

    (B) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
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. This abbreviation can also be used on 
    dual-column displays as shown in paragraphs (e)(5), (e)(6)(i), and 
    (e)(6)(ii).
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Vitamin--Vit
Potassium--Potas
Includes--Incl. This abbreviation can also be used on dual-column 
    displays as shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of 
    this section.

    (C) 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

[[Page 60]]

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 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 Nutrition and Food 
Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., 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 hours x 52 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-

[[Page 61]]

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 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 hours x 52 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.
    (l) The standards required in this section are incorporated by 
reference into this section with the approval of the Director of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved 
material is available for inspection at the Office of Nutrition and Food 
Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-
402-2404 and is available from the sources indicated below. It is also 
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/

[[Page 62]]

code_of_federal_regulations/ibr_locations.html.
    (1) AOAC Reseller. Techstreet, 6300 Interfirst Dr., Ann Arbor, MI 
48108, Toll free in United States: 1-800-699-9277, Outside United 
States: 1-734-780-8000, Fax: 1-734-780-2046, www.techstreet.com, 
[email protected] FDA does not endorse any 
particular reseller and notes that other resellers also may have the 
reference for sale. Consult FDA at 240-402-2404 for more information on 
additional resellers.
    (i) ``Official Methods of Analysis of the AOAC INTERNATIONAL,'' 19th 
Edition, Volumes 1 and 2, 2012.
    (ii) [Reserved]
    (2) Food and Agriculture Organization of the United Nations/World 
Health Organization (FAO/WHO), Publications Division, Viale delle Terme 
di Caracalla, 00100 Rome, Italy
    (i) FAO Food and Nutrition Paper 51,''Report of the Joint FAO/WHO 
Expert Consultation on Protein Quality Evaluation,'' Rome, 1991. http://
apps.who.int /iris/bitstream/ 10665/38133/1/9251030979_eng.pdf.
    (ii) [Reserved]
    (3) United States Department of Agriculture (USDA), Agricultural 
Research Service, Washington, DC, Nutrient Data Laboratory, Bldg. 005 
Room 105 BARC-West, Beltsville, MD 20705, 301-504-0630. http://
www.ars.usda.gov/News/docs.htm?docid=9447.
    (i) USDA Handbook No. 74, Energy Value of Foods--basis and 
derivation, by A. L. Merrill and B. K. Watt, (slightly revised, 1973) 
http://www.ars.usda.gov /SP2UserFiles/Place/80400525/Data/Classics/
ah74.pdf.
    (ii) [Reserved]

[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 at www.fdsys.gov.



 Sec. 101.10  Nutrition labeling of restaurant foods whose labels or 
 labeling bear nutrient content claims or health claims.

    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. For the purposes of this section, restaurant food includes 
two categories of food. It includes food which 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. It 
also includes food which is processed and prepared primarily in a retail 
establishment, which is ready for human consumption, which is of the 
type described in the previous sentence, and which is offered for sale 
to consumers but not for immediate human consumption in such 
establishment and which is not offered for sale outside such 
establishment. For standard menu items that are offered for sale in 
covered establishments (as defined in Sec. 101.11(a)), the information 
in the written nutrition information required by 
Sec. 101.11(b)(2)(ii)(A) will serve to meet the requirements of this 
section. Nutrient levels may be determined by nutrient databases, 
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.

[79 FR 71253, Dec. 1, 2014]



Sec. 101.11  Nutrition labeling of standard menu items in covered
establishments.

    (a) Definitions. The definitions of terms in section 201 of the 
Federal Food, Drug, and Cosmetic Act apply to such terms when used in 
this section. In addition, for purposes of this section:
    Authorized official of a restaurant or similar retail food 
establishment means the owner, operator, agent in charge, or other 
person authorized by the owner, operator, or agent in charge to register 
the restaurant or similar retail food establishment, which is not

[[Page 63]]

otherwise subject to section 403(q)(5)(H) of the Federal Food, Drug, and 
Cosmetic Act, with FDA for the purposes of paragraph (d) of this 
section.
    Combination meal means a standard menu item that consists of more 
than one food item, for example a meal that includes a sandwich, a side 
dish, and a drink. A combination meal may be represented on the menu or 
menu board in narrative form, numerically, or pictorially. Some 
combination meals may include a variable menu item or be a variable menu 
item as defined in this paragraph where the components may vary. For 
example, the side dish may vary among several options (e.g., fries, 
salad, or onion rings) or the drinks may vary (e.g., soft drinks, milk, 
or juice) and the customer selects which of these items will be included 
in the meal.
    Covered establishment means a restaurant or similar retail food 
establishment that is a part of a chain with 20 or more locations doing 
business under the same name (regardless of the type of ownership, e.g., 
individual franchises) and offering for sale substantially the same menu 
items, as well as a restaurant or similar retail food establishment that 
is registered to be covered under paragraph (d) of this section.
    Custom order means a food order that is prepared in a specific 
manner based on an individual customer's request, which requires the 
covered establishment to deviate from its usual preparation of a 
standard menu item, e.g., a club sandwich without the bacon if the 
establishment usually includes bacon in its club sandwich.
    Daily special means a menu item that is prepared and offered for 
sale on a particular day, that is not routinely listed on a menu or menu 
board or offered by the covered establishment, and that is promoted by 
the covered establishment as a special menu item for that particular 
day.
    Doing business under the same name means sharing the same name. The 
term ``name'' refers to either:
    (i) The name of the establishment presented to the public; or
    (ii) If there is no name of the establishment presented to the 
public (e.g., an establishment with the generic descriptor ``concession 
stand''), the name of the parent entity of the establishment. When the 
term ``name'' refers to the name of the establishment presented to the 
public under paragraph (i) of this definition, the term ``same'' 
includes names that are slight variations of each other, for example, 
due to the region, location, or size (e.g., ``New York Ave. Burgers'' 
and ``Pennsylvania Ave. Burgers'' or ``ABC'' and ``ABC Express'').
    Food on display means restaurant-type food that is visible to the 
customer before the customer makes a selection, so long as there is not 
an ordinary expectation of further preparation by the consumer before 
consumption.
    Food that is part of a customary market test means food that appears 
on a menu or menu board for less than 90 consecutive days in order to 
test consumer acceptance of the product.
    Location means a fixed position or site.
    Menu or menu board means the primary writing of the covered 
establishment from which a customer makes an order selection, including, 
but not limited to, breakfast, lunch, and dinner menus; dessert menus; 
beverage menus; children's menus; other specialty menus; electronic 
menus; and menus on the Internet. Determining whether a writing is or is 
part of the primary writing of the covered establishment from which a 
customer makes an order selection depends on a number of factors, 
including whether the writing lists the name of a standard menu item (or 
an image depicting the standard menu item) and the price of the standard 
menu item, and whether the writing can be used by a customer to make an 
order selection at the time the customer is viewing the writing. The 
menus may be in different forms, e.g., booklets, pamphlets, or single 
sheets of paper. Menu boards include those inside a covered 
establishment as well as drive-through menu boards at covered 
establishments.
    Offering for sale substantially the same menu items means offering 
for sale a significant proportion of menu items that use the same 
general recipe and are prepared in substantially the same way with 
substantially the same food components, even if the name of the

[[Page 64]]

menu item varies, (e.g., ``Bay View Crab Cake'' and ``Ocean View Crab 
Cake''). ``Menu items'' in this definition refers to food items that are 
listed on a menu or menu board or that are offered as self-service food 
or food on display. Restaurants and similar retail food establishments 
that are part of a chain can still be offering for sale substantially 
the same menu items if the availability of some menu items varies within 
the chain. Having the same name may indicate, but does not necessarily 
guarantee, that menu items are substantially the same.
    Restaurant or similar retail food establishment means a retail 
establishment that offers for sale restaurant-type food, except if it is 
a school as defined by 7 CFR 210.2 or 220.2.
    Restaurant-type food means food that is:
    (i) Usually eaten on the premises, while walking away, or soon after 
arriving at another location; and
    (ii) Either:
    (A) 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; or
    (B) Processed and prepared primarily in a retail establishment, 
ready for human consumption, of the type described in paragraph (ii)(A) 
of this definition, and offered for sale to consumers but not for 
immediate human consumption in such establishment and which is not 
offered for sale outside such establishment.
    Self-service food means restaurant-type food that is available at a 
salad bar, buffet line, cafeteria line, or similar self-service facility 
and that is served by the customers themselves. Self-service food also 
includes self-service beverages.
    Standard menu item means a restaurant-type food that is routinely 
included on a menu or menu board or routinely offered as a self-service 
food or food on display.
    Temporary menu item means a food that appears on a menu or menu 
board for less than a total of 60 days per calendar year. The 60 days 
includes the total of consecutive and non-consecutive days the item 
appears on the menu.
    Variable menu item means a standard menu item that comes in 
different flavors, varieties, or combinations, and is listed as a single 
menu item.
    (b) Requirements for nutrition labeling for food sold in covered 
establishments--(1) Applicability. (i) The labeling requirements in this 
paragraph (b) apply to standard menu items offered for sale in covered 
establishments.
    (ii)(A) The labeling requirements in this paragraph (b) do not apply 
to foods that are not standard menu items, including:
    (1) Items such as condiments that are for general use, including 
those placed on the table or on or behind the counter; daily specials; 
temporary menu items; custom orders; food that is part of a customary 
market test; and
    (2) Self-service food and food on display that is offered for sale 
for less than a total of 60 days per calendar year or fewer than 90 
consecutive days in order to test consumer acceptance.
    (B) The labeling requirements of paragraph (b)(2)(iii) of this 
section do not apply to alcoholic beverages that are foods on display 
and are not self-service foods.
    (2) Nutrition information. (i) Except as provided by paragraph 
(b)(2)(i)(A)(8) of this section, the following must be provided on menus 
and menu boards:
    (A) The number of calories contained in each standard menu item 
listed on the menu or menu board, as usually prepared and offered for 
sale. In the case of multiple-serving standard menu items, this means 
the calories declared must be for the whole menu item listed on the menu 
or menu board as usually prepared and offered for sale (e.g., ``pizza 
pie: 1600 cal''); or per discrete serving unit as long as the discrete 
serving unit (e.g., pizza slice) and total number of discrete serving 
units contained in the menu item are declared on the menu or menu board, 
and the menu item is usually prepared and offered for sale divided in 
discrete serving units (e.g., ``pizza pie: 200 cal/slice, 8 slices''). 
The calories must be declared in the following manner:
    (1) The number of calories must be listed adjacent to the name or 
the price of the associated standard menu item, in a type size no 
smaller than the type

[[Page 65]]

size of the name or the price of the associated standard menu item, 
whichever is smaller, in the same color, or a color at least as 
conspicuous as that used for the name of the associated standard menu 
item, and with the same contrasting background or a background at least 
as contrasting as that used for the name of the associated standard menu 
item.
    (2) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories, 
except that amounts less than 5 calories may be expressed as zero.
    (3) The term ``Calories'' or ``Cal'' must appear as a heading above 
a column listing the number of calories for each standard menu item or 
adjacent to the number of calories for each standard menu item. If the 
term ``Calories'' or ``Cal'' appears as a heading above a column of 
calorie declarations, the term must be in a type size no smaller than 
the smallest type size of the name or price of any menu item on that 
menu or menu board in the same color or a color at least as conspicuous 
as that used for that name or price and in the same contrasting 
background or a background at least as contrasting as that used for that 
name or price. If the term ``Calories'' or ``Cal'' appears adjacent to 
the number of calories for the standard menu item, the term ``Calories'' 
or ``Cal'' must appear in the same type size and in the same color and 
contrasting background as the number of calories.
    (4) Additional requirements that apply to each individual variable 
menu item:
    (i) When the menu or menu board lists flavors or varieties of an 
entire individual variable menu item (such as soft drinks, ice cream, 
doughnuts, dips, and chicken that can be grilled or fried), the calories 
must be declared separately for each listed flavor or variety. Where 
flavors or varieties have the same calorie amounts (after rounding in 
accordance with paragraph (b)(2)(i)(A)(2) of this section), the calorie 
declaration for such flavors or varieties can be listed as a single 
calorie declaration adjacent to the flavors or varieties, provided that 
the calorie declaration specifies that the calorie amount listed 
represents the calorie amounts for each individual flavor or variety.
    (ii) When the menu or menu board does not list flavors or varieties 
for an entire individual variable menu item, and only includes a general 
description of the variable menu item (e.g., ``soft drinks''), the 
calories must be declared for each option with a slash between the two 
calorie declarations where only two options are available (e.g., ``150/
250 calories'') or as a range in accordance with the requirements of 
paragraph (b)(2)(i)(A)(7) of this section where more than two options 
are available (e.g., ``100-250 calories'').
    (iii) When the menu or menu board describes flavors or varieties for 
only part of an individual variable menu item (such as different types 
of cheese offered in a grilled cheese sandwich (e.g., ``Grilled Cheese 
(Cheddar or Swiss)''), the calories must be declared for each option 
with a slash between the two calorie declarations where only two options 
are available (e.g., ``450/500 calories'') or as a range in accordance 
with the requirements of paragraph (b)(2)(i)(A)(7) of this section where 
more than two options are available (e.g., ``450-550 calories'').
    (5) Additional requirements that apply to a variable menu item that 
is offered for sale with the option of adding toppings listed on the 
menu or menu board. When the menu or menu board lists toppings that can 
be added to a menu item (such as pizza or ice cream):
    (i) The calories must be declared for the basic preparation of the 
menu item as listed (e.g., ``small pizza pie,'' ``single scoop ice 
cream'').
    (ii) The calories must be separately declared for each topping 
listed on the menu or menu board (e.g., pepperoni, sausage, green 
peppers, onions on pizza; fudge, almonds, sprinkles on ice cream), 
specifying that the calories are added to the calories contained in the 
basic preparation of the menu item. Where toppings have the same calorie 
amounts (after rounding in accordance with paragraph (b)(2)(i)(A)(2) of 
this section), the calorie declaration for such toppings can be listed 
as a single

[[Page 66]]

calorie declaration adjacent to the toppings, provided that the calorie 
declaration specifies that the calorie amount listed represents the 
calorie amount for each individual topping.
    (iii) The calories for the basic preparation of the menu item must 
be declared for each size of the menu item. The calories for each 
topping listed on the menu or menu board must be declared for each size 
of the menu item, or declared using a slash between the two calorie 
declarations for each topping where only two sizes of the menu item are 
available (e.g., ``adds 150/250 cal'') or as a range for each topping in 
accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this 
section where more than two sizes of the menu item are available (e.g., 
``adds 100-250 cal''). If a slash between two calorie declarations or a 
range of calorie declarations is used, the menu or menu board must 
indicate that the variation in calories for each topping arises from the 
size of the menu item to which the toppings are added.
    (iv) If the amount of the topping included on the basic preparation 
of the menu item decreases based on the total number of toppings ordered 
for the menu item (such as is sometimes the case with pizza toppings), 
the calories for each topping must be declared as single values 
representing the calories for each topping when added to a one-topping 
menu item, specifying that the calorie declaration is for the topping 
when added to a one-topping menu item.
    (6) Additional requirements that apply to a combination meal. Except 
as provided in paragraph (b)(2)(i)(A)(6)(iv) of this section:
    (i) When the menu or menu board lists two options for menu items in 
a combination meal (e.g., a sandwich with a side salad or chips), the 
calories must be declared for each option with a slash between the two 
calorie declarations (e.g., ``350/450 calories'').
    (ii) When the menu or menu board lists three or more options for 
menu items in a combination meal (e.g., a sandwich with chips, a side 
salad, or fruit), the calories must be declared as a range in accordance 
with the requirements of paragraph (b)(2)(i)(A)(7) of this section 
(e.g., ``350-500 calories'').
    (iii) When the menu or menu board includes a choice to increase or 
decrease the size of a combination meal, the calorie difference must be 
declared for the increased or decreased size with a slash between two 
calorie declarations (e.g., ``Adds 100/150 calories,'' ``Subtracts 100/
150 calories'') if the menu or menu board lists two options for menu 
items in the combination meal, or as a range in accordance with the 
requirements of paragraph (b)(2)(i)(A)(7) of this section (e.g., ``Adds 
100-250 calories,'' ``Subtracts 100-250 calories'') if the menu or menu 
board lists three or more options for menu items in the combination 
meal.
    (iv) Where the menu or menu board describes an opportunity for a 
consumer to combine standard menu items for a special price 
(e.g.,''Combine Any Sandwich with Any Soup or Any Salad for $8.99''), 
and the calories for each standard menu item, including each size option 
as described in paragraph (b)(2)(i)(A)(6)(iii) of this section if 
applicable, available for the consumer to combine are declared elsewhere 
on the menu or menu board, the requirements of paragraphs 
(b)(2)(i)(A)(6)(i), (ii), and (iii) of this section do not apply.
    (7) Additional format requirements for declaring calories for an 
individual variable menu item, a combination meal, and toppings as a 
range, if applicable. Calories declared as a range must be in the format 
``xx-yy,'' where ``xx'' is the caloric content of the lowest calorie 
variety, flavor, or combination, and ``yy'' is the caloric content of 
the highest calorie variety, flavor, or combination.
    (8) Exception for a variable menu item that has no clearly 
identifiable upper bound to the range of calories: If the variable menu 
item appears on the menu or menu board and is a self-service food or 
food on display, and there is no clearly identifiable upper bound to the 
range, e.g., all-you-can-eat buffet, then the menu or menu board must 
include a statement, adjacent to the name or price of the item, 
referring customers to the self-service facility for calorie 
information, e.g., ``See buffet for calorie declarations.'' This 
statement must appear in a type size no smaller than the type size of 
the name or price of the variable menu

[[Page 67]]

item, whichever is smaller, and in the same color or a color at least as 
conspicuous as that used for that name or price, with the same 
contrasting background or a background at least as contrasting as that 
used for that name or price.
    (9) Additional requirements that apply to beverages that are not 
self-service. For beverages that are not self-service, calories must be 
declared based on the full volume of the cup served without ice, unless 
the covered establishment ordinarily dispenses and offers for sale a 
standard beverage fill (i.e., a fixed amount that is less than the full 
volume of the cup per cup size) or dispenses a standard ice fill (i.e., 
a fixed amount of ice per cup size). If the covered establishment 
ordinarily dispenses and offers for sale a standard beverage fill or 
dispenses a standard ice fill, the covered establishment must declare 
calories based on such standard beverage fill or standard ice fill.
    (B) The following statement designed to enable consumers to 
understand, in the context of a total daily diet, the significance of 
the calorie information provided on menus and menu boards: ``2,000 
calories a day is used for general nutrition advice, but calorie needs 
vary.'' For menus and menu boards targeted to children, the following 
options may be used as a substitute for or in addition to the succinct 
statement: ``1,200 to 1,400 calories a day is used for general nutrition 
advice for children ages 4 to 8 years, but calorie needs vary.'' or 
``1,200 to 1,400 calories a day is used for general nutrition advice for 
children ages 4 to 8 years and 1,400 to 2,000 calories a day for 
children ages 9 to 13 years, but calorie needs vary.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest type size 
of any calorie declaration appearing on the same menu or menu board and 
in the same color or in a color at least as conspicuous as that used for 
the calorie declarations and with the same contrasting background or a 
background at least as contrasting as that used for the calorie 
declarations.
    (2) For menus, this statement must appear on the bottom of each page 
of the menu. On menu pages that also bear the statement required by 
paragraph (b)(2)(i)(C) of this section, this statement must appear 
immediately above, below, or beside the statement required by paragraph 
(b)(2)(i)(C) of this section.
    (3) For menu boards, this statement must appear on the bottom of the 
menu board, immediately above, below, or beside the statement required 
by paragraph (b)(2)(i)(C) of this section.
    (C) The following statement regarding the availability of the 
additional written nutrition information required in paragraph 
(b)(2)(ii) of this section must be on all forms of the menu or menu 
board: ``Additional nutrition information available upon request.''
    (1) This statement must be posted prominently and in a clear and 
conspicuous manner in a type size no smaller than the smallest type size 
of any calorie declaration appearing on the same menu or menu board and 
in the same color or in a color at least as conspicuous as that used for 
the caloric declarations, and with the same contrasting background or a 
background at least as contrasting as that used for the caloric 
declarations.
    (2) For menus, the statement must appear on the bottom of the first 
page with menu items immediately above, below, or beside the succinct 
statement required by paragraph (b)(2)(i)(B) of this section.
    (3) For menu boards, the statement must appear on the bottom of the 
menu board immediately above, below, or beside the succinct statement 
required by paragraph (b)(2)(i)(B) of this section.
    (ii) The following nutrition information for a standard menu item 
must be available in written form on the premises of the covered 
establishment and provided to the customer upon request. This nutrition 
information must be presented in the order listed and using the 
measurements listed, except as provided in paragraph (b)(2)(ii)(B) of 
this section. Rounding of these nutrients must be in compliance with 
Sec. 101.9(c). The information must be presented in a clear and 
conspicuous manner, including using a color, type size, and contrasting 
background that render the

[[Page 68]]

information likely to be read and understood by the ordinary individual 
under customary conditions of purchase and use. Covered establishments 
may use the abbreviations allowed for Nutrition Facts for certain 
packaged foods in Sec. 101.9(j)(13)(ii)(B):
    (A)(1) Total calories (cal);
    (2) Calories from fat (fat cal);
    (3) Total fat (g);
    (4) Saturated fat (g);
    (5) Trans fat (g);
    (6) Cholesterol (mg);
    (7) Sodium (mg);
    (8) Total carbohydrate (g);
    (9) Dietary fiber (g);
    (10) Sugars (g); and
    (11) Protein (g).
    (B) If a standard menu item contains insignificant amounts of all 
the nutrients required to be disclosed in paragraph (b)(2)(ii)(A) of 
this section, the establishment is not required to include nutrition 
information regarding the standard menu item in the written form. 
However, if the covered establishment makes a nutrient content claim or 
health claim, the establishment is required to provide nutrition 
information on the nutrient that is the subject of the claim in 
accordance with Sec. 101.10. For standard menu items that contain 
insignificant amounts of six or more of the required nutrients, the 
declaration of nutrition information required by paragraph (b)(2)(ii)(A) 
of this section may be presented in a simplified format.
    (1) An insignificant amount is defined as that amount that allows a 
declaration of zero in nutrition labeling, except that for total 
carbohydrates, dietary fiber, and protein, it must be an amount that 
allows a declaration of ``less than one gram.''
    (2) The simplified format must include information, in a column, 
list, or table, on the following nutrients:
    (i) Total calories, total fat, total carbohydrates, protein, and 
sodium; and
    (ii) Calories from fat, and any other nutrients identified in 
paragraph (b)(2)(ii)(A) of this section that are present in more than 
insignificant amounts.
    (3) If the simplified format is used, the statement ``Not a 
significant source of __'' (with the blank filled in with the names of 
the nutrients required to be declared in the written nutrient 
information and calories from fat that are present in insignificant 
amounts) must be included at the bottom of the list of nutrients.
    (C) For variable menu items, the nutrition information listed in 
paragraph (b)(2)(ii)(A) of this section must be declared as follows for 
each size offered for sale:
    (1) The nutrition information required in paragraph (b)(2)(ii)(A) of 
this section must be declared for the basic preparation of the item and, 
separately, for each topping, flavor, or variable component.
    (2) Additional format requirements for toppings if the amount of the 
topping included on the basic preparation of the menu item decreases 
based on the total number of toppings ordered for the menu item (such as 
is sometimes the case with pizza toppings). The nutrients for such 
topping must be declared as single values representing the nutrients for 
each topping when added to a one-topping menu item, specifying that the 
nutrient declaration is for the topping when added to a one-topping menu 
item.
    (3) If the calories and other nutrients are the same for different 
flavors, varieties, and variable components of the combination meal, 
each variety, flavor, and variable component of the combination meal is 
not required to be listed separately. All items that have the same 
nutrient values could be listed together with the nutrient values listed 
only once.
    (D) The written nutrition information required in paragraph 
(b)(2)(ii)(A) of this section may be provided on a counter card, sign, 
poster, handout, booklet, loose leaf binder, or electronic device such 
as a computer, or in a menu, or in any other form that similarly permits 
the written declaration of the required nutrient content information for 
all standard menu items. If the written nutrition information is not in 
a form that can be given to the customer upon request, it must be 
readily available in a manner and location on the premises that allows 
the customer/consumer to review the written nutrition information upon 
request.

[[Page 69]]

    (iii) The following must be provided for a standard menu item that 
is self-service or on display.
    (A) Calories per displayed food item (e.g., a bagel, a slice of 
pizza, or a muffin), or if the food is not offered for sale in a 
discrete unit, calories per serving (e.g., scoop, cup), and the serving 
or discrete unit used to determine the calorie content (e.g., ``per 
scoop'' or ``per muffin'') on either: A sign adjacent to and clearly 
associated with the corresponding food; (e.g., ``150 calories per 
scoop); a sign attached to a sneeze guard with the calorie declaration 
and the serving or unit used to determine the calorie content above each 
specific food so that the consumer can clearly associate the calorie 
declaration with the food, except that if it is not clear to which food 
the calorie declaration and serving or unit refers, then the sign must 
also include the name of the food, e.g., ``Broccoli and cheese 
casserole--200 calories per scoop''; or a single sign or placard listing 
the calorie declaration for several food items along with the names of 
the food items, so long as the sign or placard is located where a 
consumer can view the name, calorie declaration, and serving or unit of 
a particular item while selecting that item.
    (1) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per 
displayed food item''; means per each discrete unit offered for sale, 
for example, a bagel, a slice of pizza, or a muffin.
    (2) For purposes of paragraph (b)(2)(iii)(A) of this section, ``per 
serving'' means, for each food:
    (i) Per serving instrument used to dispense the food offered for 
sale, provided that the serving instrument dispenses a uniform amount of 
the food (e.g., a scoop or ladle);
    (ii) If a serving instrument that dispenses a uniform amount of food 
is not used to dispense the food, per each common household measure 
(e.g., cup or tablespoon) offered for sale or per unit of weight offered 
for sale, e.g., per quarter pound or per 4 ounces; or
    (iii) Per total number of fluid ounces in the cup in which a self-
service beverage is served and, if applicable, the description of the 
cup size (e.g., ``140 calories per 12 fluid ounces (small)'').
    (3) The calories must be declared in the following manner:
    (i) To the nearest 5-calorie increment up to and including 50 
calories and to the nearest 10-calorie increment above 50 calories 
except that amounts less than 5 calories may be expressed as zero.
    (ii) If the calorie declaration is provided on a sign with the 
food's name, price, or both, the calorie declaration, accompanied by the 
term ``Calories'' or ``Cal'' and the amount of the serving or displayed 
food item on which the calories declaration is based must be in a type 
size no smaller than the type size of the name or price of the menu item 
whichever is smaller, in the same color, or a color that is at least as 
conspicuous as that used for that name or price, using the same 
contrasting background or a background at least as contrasting as that 
used for that name or price. If the calorie declaration is provided on a 
sign that does not include the food's name, price, or both, the calorie 
declaration, accompanied by the term ``Calories'' or ``Cal'' and the 
amount of the serving or displayed food item on which the calorie 
declaration is based must be clear and conspicuous.
    (iii) For self-service beverages, calorie declarations must be 
accompanied by the term ``fluid ounces'' and, if applicable, the 
description of the cup size (e.g., ``small,'' ``medium'').
    (B) For food that is self-service or on display and is identified by 
an individual sign adjacent to the food itself where such sign meets the 
definition of a menu or menu board under paragraph (a) of this section, 
the statement required by paragraph (b)(2)(i)(B) of this section and the 
statement required by paragraph (b)(2)(i)(C) of this section. These two 
statements may appear on the sign adjacent to the food itself; on a 
separate, larger sign, in close proximity to the food that can be easily 
read as the consumer is making order selections; or on a large menu 
board that can be easily read as the consumer is viewing the food.
    (C) The nutrition information in written form required by paragraph 
(b)(2)(ii) of this section, except for packaged food insofar as it bears 
nutrition labeling information required by and in accordance with 
paragraph

[[Page 70]]

(b)(2)(ii) of this section and the packaged food, including its label, 
can be examined by a consumer before purchasing the food.
    (c) Determination of nutrient content. (1) A covered establishment 
must have a reasonable basis for its nutrient declarations. Nutrient 
values may be determined by using nutrient databases (with or without 
computer software programs), cookbooks, laboratory analyses, or other 
reasonable means, including the use of Nutrition Facts on labels on 
packaged foods that comply with the nutrition labeling requirements of 
section 403(q)(1) of the Federal Food, Drug, and Cosmetic Act and 
Sec. 101.9, FDA nutrient values for raw fruits and vegetables in 
Appendix C of this part, or FDA nutrient values for cooked fish in 
Appendix D of this part.
    (2) Nutrient declarations for standard menu items must be accurate 
and consistent with the specific basis used to determine nutrient 
values. A covered establishment must take reasonable steps to ensure 
that the method of preparation (e.g., types and amounts of ingredients, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined.
    (3) A covered establishment must provide to FDA, within a reasonable 
period of time upon request, information substantiating nutrient values 
including the method and data used to derive these nutrient values. This 
information must include the following:
    (i) For nutrient databases:
    (A) The name and version (including the date of the version) of the 
database, and, as applicable, the name of the applicable software 
company and any Web site address for the database. The name and version 
of a database would include the name and version of the computer 
software, if applicable;
    (B) The recipe or formula used as a basis for the nutrient 
declarations;
    (C)(1) Information on:
    (i) The amount of each nutrient that the specified amount of each 
ingredient identified in the recipe contributes to the menu item; and
    (ii) How the database was used including calculations or operations 
(e.g., worksheets or computer printouts) to determine the nutrient 
values for the standard menu items;
    (2) If the information in paragraph (c)(3)(i)(C)(1) of this section 
is not available, certification attesting that the database will provide 
accurate results when used appropriately and that the database was used 
in accordance with its instructions;
    (D) A detailed listing (e.g., printout) of the nutrient values 
determined for each standard menu item.
    (E) Any other information pertinent to the final nutrient values of 
the standard menu item (e.g., information about what might cause slight 
variations in the nutrient profile such as moisture variations);
    (F) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (G) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined.
    (ii) For published cookbooks that contain nutritional information 
for recipes in the cookbook:
    (A) The name, author, and publisher of the cookbook used;
    (B) If available, information provided by the cookbook or from the 
author or publisher about how the nutrition information for the recipes 
was obtained;
    (C) A copy of the recipe used to prepare the standard menu item and 
a copy of the nutrition information for that standard menu item as 
provided by the cookbook; and
    (D) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and

[[Page 71]]

amount of a standard menu item offered for sale adhere to the factors on 
which its nutrient values were determined. (Recipes may be divided as 
necessary to accommodate differences in the portion size derived from 
the recipe and that are served as the standard menu item but no changes 
may be made to the proportion of ingredients used.)
    (iii) For laboratory analyses:
    (A) A copy of the recipe for the standard menu item used for the 
nutrient analysis;
    (B) The name and address of the laboratory performing the analysis;
    (C) Copies of analytical worksheets, including the analytical 
method, used to determine and verify nutrition information;
    (D) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined.
    (iv) For nutrition information provided by other reasonable means:
    (A) A detailed description of the means used to determine the 
nutrition information;
    (B) A recipe or formula used as a basis for the nutrient 
determination;
    (C) Any data derived in determining the nutrient values for the 
standard menu item, e.g., nutrition information about the ingredients 
used with the source of the nutrient information;
    (D) A statement signed and dated by a responsible individual, 
employed at the covered establishment or its corporate headquarters or 
parent entity, who can certify that the information contained in the 
nutrient analysis is complete and accurate; and
    (E) A statement signed and dated by a responsible individual 
employed at the covered establishment certifying that the covered 
establishment has taken reasonable steps to ensure that the method of 
preparation (e.g., types and amounts of ingredients in the recipe, 
cooking temperatures) and amount of a standard menu item offered for 
sale adhere to the factors on which its nutrient values were determined.
    (d) Voluntary registration to be subject to the menu labeling 
requirements--(1) Applicability. A restaurant or similar retail food 
establishment that is not part of a chain with 20 or more locations 
doing business under the same name and offering for sale substantially 
the same menu items may voluntarily register to be subject to the 
requirements established in this section. Restaurants and similar retail 
food establishments that voluntarily register will no longer be subject 
to non-identical State or local nutrition labeling requirements.
    (2) Who may register? The authorized official of a restaurant or 
similar retail food establishment as defined in paragraph (a) of this 
section, which is not otherwise subject to paragraph (b) of this 
section, may register with FDA.
    (3) What information is required? Authorized officials for 
restaurants and similar retail food establishments must provide FDA with 
the following information on Form FDA 3757:
    (i) The contact information (including name, address, phone number, 
and email address) for the authorized official;
    (ii) The contact information (including name, address, phone number, 
and email address) of each restaurant or similar retail food 
establishment being registered, as well as the name and contact 
information for an official onsite, such as the owner or manager, for 
each specific restaurant or similar retail food establishment;
    (iii) All trade names the restaurant or similar retail food 
establishment uses;
    (iv) Preferred mailing address (if different from location address 
for each establishment) for purposes of receiving correspondence; and
    (v) Certification that the information submitted is true and 
accurate, that the person submitting it is authorized

[[Page 72]]

to do so, and that each registered restaurant or similar retail food 
establishment will be subject to the requirements of section 
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act and this 
section.
    (4) How to register. Authorized officials of restaurants and similar 
retail food establishments who elect to be subject to requirements in 
section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act can 
register by visiting http://www.fda.gov/food/
ingredientspackaginglabeling/ labelingnutrition/ucm217762.htm. FDA has 
created a form (Form 3757) that contains fields requesting the 
information in paragraph (d)(3) of this section and made the form 
available at this Web site. Registrants must use this form to ensure 
that complete information is submitted.
    (i) Information should be submitted by email by typing complete 
information into the form (PDF), saving it on the registrant's computer, 
and sending it by email to [email protected]
    (ii) If email is not available, the registrant can either fill in 
the form (PDF) and print it out (or print out the blank PDF and fill in 
the information by hand or typewriter), and either fax the completed 
form to 301-436-2804 or mail it to FDA, CFSAN Menu and Vending Machine 
Registration, White Oak Building 22, Rm. 0209, 10903 New Hampshire Ave., 
Silver Spring, MD 20993.
    (5) When to renew the registration. To keep the establishment's 
registration active, the authorized official of the restaurant or 
similar retail food establishment must register every other year within 
60 days prior to the expiration of the establishment's current 
registration with FDA. Registration will automatically expire if not 
renewed.
    (e) Signatures. Signatures obtained under paragraph (d) of this 
section that meet the definition of electronic signatures in 
Sec. 11.3(b)(7) of this chapter are exempt from the requirements of part 
11 of this chapter.
    (f) Misbranding. A standard menu item offered for sale in a covered 
establishment shall be deemed misbranded under sections 201(n), 403(a), 
403(f) and/or 403(q) of the Federal Food, Drug, and Cosmetic Act if its 
label or labeling is not in conformity with paragraph (b) or (c) of this 
section.

[79 FR 71253, Dec. 1, 2014]



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.
    (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;

[[Page 73]]

    (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:
  Foods for Infants and Young Children 1 Through 3 Years of Age \1\ \2\
                                   \3\
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference amount           \4\
------------------------------------------------------------------------
Cereals, dry instant............  15 g..............  _ cup (_ g)
Cereals, prepared, ready-to-      110 g.............  _ cup(s) (_ g)
 serve.
Other cereal and grain products,  7 g for infants     _ cup(s) (_ g) for
 dry ready-to-eat, e.g., ready-    and 20 g for        ready-to-eat
 to-eat cereals, cookies,          young children (1   cereals; piece(s)
 teething biscuits, and toasts.    through 3 years     (_ g) for others
                                   of age) for ready-
                                   to-eat cereals; 7
                                   g for all others.
Dinners, deserts, 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,        110 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);
 young children, ready-to-serve.                       cup(s) (_ mL)
Fruits for young children, ready- 125 g.............  _ cup(s) (_ g)
 to-serve.
Vegetables for young children,    70 g..............  _ cup(s) (_ g)
 ready-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. We further considered data from the
  National Health and Nutrition Examination Survey, 2003-2004, 2005-
  2006, and 2007-2008 conducted by the Centers for Disease Control and
  Prevention, in the U.S. Department of Health and Human Services.
\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 (e.g., 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).

[[Page 74]]

 
\4\ The label statements are meant to provide examples of serving size
  statements that may be used on the label, but the specific wording may
  be changed as appropriate for individual products. 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\
------------------------------------------------------------------------
                                                        Label statement
        Product category           Reference amount           \4\
------------------------------------------------------------------------
Bakery Products:
    Bagels, toaster pastries,     110 g.............  _ piece(s) (_ g)
     muffins (excluding English
     muffins).
    Biscuits, croissants,         55 g..............  _ piece(s) (_ g)
     tortillas, soft bread
     sticks, soft pretzels, corn
     bread, hush puppies,
     scones, crumpets, English
     muffins.
    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
     bagels, toaster pastries,
     muffins (excluding English
     muffins).
    Brownies....................  40 g..............  _ piece(s) (_ g)
                                                       for distinct
                                                       pieces;
                                                       fractional slice
                                                       (_ g) for bulk
    Cakes, heavyweight (cheese    125 g.............  _ piece(s) (_ g)
     cake; pineapple upside-down                       for distinct
     cake; fruit, nut, and                             pieces (e.g.,
     vegetable cakes with more                         sliced or
     than or equal to 35 percent                       individually
     of the finished weight as                         packaged
     fruit, nuts, or vegetables                        products); _
     or any of these                                   fractional slice
     combinations) \ 5\.                               (_ g) for large
                                                       discrete units
    Cakes, mediumweight           80 g..............  _ piece(s) (_ g)
     (chemically leavened cake                         for distinct
     with or without icing or                          pieces (e.g.,
     filling except those                              cupcake); _
     classified as light weight                        fractional slice
     cake; fruit, nut, and                             (_ g) for large
     vegetable cake with less                          discrete units
     than 35 percent of the
     finished weight as fruit,
     nuts, or vegetables or any
     of these combinations;
     light weight cake with
     icing; Boston cream pie;
     cupcake; eclair; cream
     puff) \6\.
    Cakes, lightweight (angel     55 g..............  _ piece(s) (_ g)
     food, chiffon, or sponge                          for distinct
     cake without icing or                             pieces (e.g.,
     filling) \7\.                                     sliced or
                                                       individually
                                                       packaged
                                                       products); _
                                                       fractional slice
                                                       (_ g) for large
                                                       discrete units

[[Page 75]]

 
    Coffee cakes, crumb cakes,    55 g..............  _ piece(s) (_ g)
     doughnuts, Danish, sweet                          for sliced bread
     rolls, sweet quick type                           and distinct
     breads.                                           pieces (e.g.,
                                                       doughnut); 2 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 \8\.
    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
    Eggroll, dumpling, wonton,    20 g..............  _ sheet (_ g);
     or potsticker wrappers.                           wrapper (_ g)
    French toast, crepes,         110 g prepaed for   _ piece(s) (_ g);
     pancakes, variety mixes.      French toast,       _ cup(s) (_ g)
                                   crepes, and         for 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)
     crisps, turnovers, other                          for distinct
     pastries.                                         pieces; _
                                                       fractional slice
                                                       (_ g) for large
                                                       discrete units
    Pie crust, pie shells,        the allowable       _ fractional
     pastry sheets, (e.g.,         declaration         slice(s) (_ g)
     phyllo, puff pastry sheets).  closest to an 8     for large
                                   square inch         discrete units; _
                                   surface area.       shells (_ g); _
                                                       fractional _
                                                       sheet(s) (_ g)
                                                       for distinct
                                                       pieces (e.g.,
                                                       Pastry sheet).
    Pizza crust.................  55 g..............  _ fractional slice
                                                       (_ g)
    Taco shells, hard...........  30 g..............  _ shell(s) (_ g)
    Waffles.....................  85 g..............  _ piece(s) (_ g)
Beverages:
    Carbonated and noncarbonated  360 mL............  12 fl oz (360 mL)
     beverages, wine coolers,
     water.
    Coffee or tea, flavored and   360 mL prepared...  12 fl oz (360 mL)
     sweetened.
Cereals and Other Grain
 Products:
    Breakfast cereals (hot        1 cup prepared; 40  _ cup(s) (_ g)
     cereal type), hominy grits.   g plain dry
                                   cereal; 55 g
                                   flavored,
                                   sweetened 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 76]]

 
    Breakfast cereals, ready-to-  40 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-  60 g..............  _ piece(s) (_ g)
     eat, weighing 43 g or more                        for large
     per cup; biscuit types.                           distinct 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; 45  _ cup(s) (_ g)
     plain.                        g dry.
    Pastas, plain...............  140 g prepared; 55  _ cup(s) (_ g); _
                                   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)

[[Page 77]]

 
    Milk, milk-substitute         240 mL............  1 cup (240 mL); 8
     beverages, milk-based                             fl oz (240 mL)
     drinks, e.g., instant
     breakfast, meal
     replacement, cocoa, soy
     beverage.
    Shakes or shake substitutes,  240 mL............  1 cup (240 mL); 8
     e.g., dairy shake mixes,                          fl oz (240 mL)
     fruit frost mixes.
    Sour cream..................  30 g..............  _ tbsp (_ g)
    Yogurt......................  170 g.............  _ cup (_ g)
Desserts:
    Ice cream, frozen yogurt,     \2/3\ cup--         \2/3\ cup (_ g), _
     sherbet, frozen flavored      includes the        piece(s) (_ g)
     and sweetened ice and pops,   volume for          for individually
     frozen fruit juices: all      coatings and        wrapped or
     types bulk and novelties      wafers.             packaged products
     (e.g., bars, sandwiches,
     cones, cups).
    Sundae......................  1 cup.............  1 cup (_ g)
    Custards, gelatin, or         \1/2\ cup           _ piece(s) (_ g)
     pudding.                      prepared; amount    for distinct unit
                                   to make \1/2\ cup   (e.g.,
                                   prepared when dry.  individually
                                                       packaged
                                                       products); \1/2\
                                                       cup (_ g) for
                                                       bulk
Dessert Toppings and Fillings:
    Cake frostings or icings....  2 tbsp............  _ tbsp(s) (_ g)
    Other dessert toppings,       2 tbsp............  2 tbsp (_ g); 2
     e.g., fruits, syrups,                             tbsp (30 mL)
     spreads, marshmallow cream,
     nuts, dairy and non-dairy
     whipped toppings.
    Pie fillings................  85 g..............  _ cup(s) (_ g)
Egg and Egg Substitutes:
    Egg mixtures, e.g., egg foo   110 g.............  _ piece(s) (_ g)
     young, scrambled eggs,                            for discrete
     omelets.                                          pieces; _ cup(s)
                                                       (_ g)
    Eggs (all sizes) \8\........  50 g..............  1 large, medium,
                                                       etc. (_ g)
    Egg whites, sugared eggs,     An amount to make   _ cup(s) (_ g); _
     sugared egg yolks, and egg    1 large (50 g)      cup(s) (_ mL)
     substitutes (fresh, frozen,   egg.
     dried).
Fats and Oils:
    Butter, margarine, oil,       1 tbsp............  1 tbsp (_ g); 1
     shortening.                                       tbsp (15 mL)
    Butter replacement, powder..  2 g...............  _ tsp(s) (_ g)
    Dressings for salads........  30 g..............  _ tbsp (_ g); _
                                                       tbsp (_ mL)
    Mayonnaise, sandwich          15 g..............  _ tbsp (_ g)
     spreads, mayonnaise-type
     dressings.
    Spray types.................  0.25 g............  About _ seconds
                                                       spray (_ g)
Fish, Shellfish, Game Meats,\9\
 and Meat or Poultry
 Substitutes:
    Bacon substitutes, canned     15 g..............  _ piece(s) (_ g)
     anchovies,\10\ anchovy                            for discrete
     pastes, caviar.                                   pieces; _ tbsp(s)
                                                       (_ g) for others
    Dried, e.g., jerky..........  30 g..............  _ piece(s) (_ g)

[[Page 78]]

 
    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, e.g.,  85 g cooked; 110 g  _ piece(s) (_ g)
     plain or fried fish and       uncooked \11\.      for discrete
     shellfish, fish and                               pieces; _ cup(s)
     shellfish cake.                                   (_ g); _ oz (_ g/
                                                       visual unit of
                                                       measure) if not
                                                       measurable by cup
                                                       \12\
    Fish, shellfish, or game      85 g..............  _ piece(s) (_ g)
     meat \9\, canned \10\.                            for discrete
                                                       pieces; _ cup(s)
                                                       (_ g); 3 oz (85 g/
                                                       _ cup) for
                                                       products that are
                                                       difficult to
                                                       measure the g
                                                       weight of cup
                                                       measure (e.g.,
                                                       tuna); 3 oz (85 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
     Canadian bacon, sausages,                         pieces (e.g.,
     frankfurters, and seafood.                        slices, links); _
                                                       cup(s) (_ g); 2
                                                       oz (56 g/visual
                                                       unit of measure)
                                                       for nondiscrete
                                                       bulk product
    Smoked or pickled fish,\10\   55 g..............  _ piece(s) (_ g)
     shellfish, or game meat                           for distinct
     \9\; fish or shellfish                            pieces (e.g.,
     spread.                                           slices, links) or
                                                       _ cup(s) (_ g); 2
                                                       oz (56 g/visual
                                                       unit of measure)
                                                       for nondiscrete
                                                       bulk product
    Substitutes for bacon bits--
     see Miscellaneous.
Fruits and Fruit Juices:
    Candied or pickled \10\.....  30 g..............  _ piece(s) (_ g)
    Dehydrated fruits--see snack
     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                          piece(s) (_ g)
     cherries \10\.
    Fruit relishes, e.g.,         70 g..............  _ cup(s) (_ g)
     cranberry sauce, cranberry
     relish.
    Fruits used primarily as      50 g..............  See footnote \12\
     ingredients, avocado.
    Fruits used primarily as      50 g..............  _ piece(s) (_ g)
     ingredients, others                               for large fruits;
     (cranberries, lemon, lime).                       _ cup(s) (_ g)
                                                       for small fruits
                                                       measurable by
                                                       cup\12\
    Watermelon..................  280 g.............  See footnote \12\
    All other fruits (except      140 g.............  _ piece(s) (_ g)
     those listed as separate                          for large pieces
     categories), fresh, canned                        (e.g.,
     or frozen.                                        strawberries,
                                                       prunes, apricots,
                                                       etc.); _ cup(s)
                                                       (_ g) for small
                                                       pieces (e.g.,
                                                       blueberries,
                                                       raspberries,
                                                       etc.) \12\
    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.

[[Page 79]]

 
Legumes:
    Tofu,\10\ tempeh............  85 g..............  _ piece(s) (_ g)
                                                       for discrete
                                                       pieces; 3 oz (84
                                                       g/visual unit of
                                                       measure) for bulk
                                                       products
    Beans, plain or in sauce....  130 g for beans in  _ cup (_ g)
                                   sauce or canned
                                   in liquid and
                                   refried beans
                                   prepared; 90 g
                                   for others
                                   prepared; 35 g
                                   dry.
Miscellaneous:
    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 by   for discrete
     sprinkles for cookies, cake   teaspoon.           pieces; 1 tsp (_
     decorations.                                      g)
    Batter mixes, bread crumbs..  30 g..............  _ tbsp(s) (_ g); _
                                                       cup(s) (_ g)
    Chewing gum \8\.............  3 g...............  _ piece(s) (_ g)
    Cocoa powder, carob powder,   1 tbsp............  1 tbsp (_ g)
     unsweetened.
    Cooking wine................  30 mL.............  2 tbsp (30 mL)
    Dietary supplements.........  The maximum amount  _ tablet(s), _
                                   recommended, as     capsules(s), _
                                   appropriate, on     packet(s), _
                                   the label for       tsp(s) (_ g),
                                   consumption per     etc.
                                   eating occasion
                                   or, in the
                                   absence of
                                   recommendations,
                                   1 unit, e.g.,
                                   tablet, capsule,
                                   packet,
                                   teaspoonful, etc.
    Meat, poultry, and fish       Amount to make one  _ tsp(s) (_ g); _
     coating mixes, dry;           reference amount    tbsp(s) (_ g)
     seasoning mixes, dry, e.g.,   of final dish.
     chili seasoning mixes,
     pasta salad seasoning mixes.
    Milk, milk substitute, and    Amount to make 240  _ fl oz (_ mL); _
     fruit juice concentrates      mL drink (without   tsp (_  g); tbsp
     (without alcohol) (e.g.,      ice).               (_ g)
     drink mixers, frozen fruit
     juice concentrate,
     sweetened cocoa powder).
    Drink mixes (without          Amount to make 360  _ fl oz (_ mL); _
     alcohol): All other types     mL drink (without   tsp (_ g); _ tbsp
     (e.g., flavored syrups and    ice).               (_ g)
     powdered drink 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)
     garlic salt).                                     for discrete
                                                       pieces (e.g.,
                                                       individually
                                                       packaged
                                                       products)

[[Page 80]]

 
    Seasoning oils and seasoning  1 tbsp............  1 tbsp (_ g)
     sauces (e.g., coconut
     concentrate, sesame oil,
     almond oil, chili oil,
     coconut oil, walnut oil).
    Seasoning pastes (e.g.,       1 tsp.............  1 tsp (_ g)
     garlic paste, ginger paste,
     curry paste, chili paste,
     miso paste), fresh or
     frozen.
    Spices, herbs (other than     \1/4\ tsp or 0.5 g  \1/4\ tsp (_ g); _
     dietary supplements).         if not measurable   piece(s) (_ g) if
                                   by teaspoon.        not measurable by
                                                       teaspoons (e.g.,
                                                       bay leaf)
Mixed Dishes:
    Appetizers, hors d'oeuvres,   85 g, add 35 g for  _ piece(s) (_ g)
     mini mixed dishes, e.g.,      products with
     mini bagel pizzas, breaded    gravy or sauce
     mozzarella sticks, egg        topping.
     rolls, dumplings,
     potstickers, wontons, mini
     quesadillas, mini quiches,
     mini sandwiches, mini pizza
     rolls, potato skins.
    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, enchiladas,   for products with   for discrete
     pizza, pizza rolls, quiche,   gravy or sauce      pieces; _
     all types of sandwiches.      topping, e.g.,      fractional slice
                                   enchilada with      (_ g) for large
                                   cheese sauce,       discrete units
                                   crepe with white
                                   sauce \13\.
Nuts and Seeds:
    Nuts, seeds and mixtures,     30 g..............  _ piece(s) (_ g)
     all types: Sliced, chopped,                       for large pieces
     slivered, and whole.                              (e.g., unshelled
                                                       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 flours  15 g..............  _ tbsp(s) (_ g); _
                                                       cup (_ g)
Potatoes and Sweet Potatoes/
 Yams:
    French fries, hash browns,    70 g prepared; 85   _ piece(s) (_ g)
     skins, or pancakes.           g for frozen        for large
                                   unprepared French   distinct pieces
                                   fries.              (e.g., patties,
                                                       skins); 2.5 oz
                                                       (70 g/_ pieces)
                                                       for prepared
                                                       fries; 3 oz (84 g/
                                                       _ pieces) for
                                                       unprepared fries
    Mashed, candied, stuffed or   140 g.............  _ piece(s) (_ g)
     with sauce.                                       for discrete
                                                       pieces (e.g.,
                                                       stuffed potato);
                                                       _ cup(s) (_ g)
    Plain, fresh, canned, or      110 g for fresh or  _ piece(s) (_ g)
     frozen.                       frozen; 125 g for   for discrete
                                   vacuum packed;      pieces; _ cup(s)
                                   160 g for canned    (_ g) for sliced
                                   in liquid.          or chopped
                                                       products

[[Page 81]]

 
Salads:
    Gelatin salad...............  120 g.............  _ cup (_ g)
    Pasta or potato salad.......  140 g.............  _ cup(s) (_ g)
    All other salads, e.g., egg,  100 g.............  _ cup(s) (_ g)
     fish, shellfish, bean,
     fruit, or vegetable salads.
Sauces, Dips, Gravies, and
 Condiments:
    Barbecue sauce, hollandaise   2 tbsp............  2 tbsp (_ g); 2
     sauce, tartar sauce, tomato                       tbsp (30 mL)
     chili sauce, other 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)
    Minor main entree sauces      \1/4\ cup.........  \1/4\ cup (_ g);
     (e.g., pizza sauce, pesto                         \1/4\ cup (60 mL)
     sauce, Alfredo 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
     catsup, steak sauce, soy                          tbsp (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 (_ g) for
     pretzels, popcorn, extruded                       small pieces
     snacks, fruit and vegetable-                      (e.g., popcorn);
     based snacks (e.g., fruit                         _ piece(s) (_ g)
     chips), grain-based snack                         for large pieces
     mixes.                                            (e.g., large
                                                       pretzels; pressed
                                                       dried fruit
                                                       sheet); 1 oz (28g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products (e.g.,
                                                       potato chips)
Soups:
    All varieties...............  245 g.............  _ cup (_ g); _ cup
                                                       (_ mL)
    Dry soup mixes, bouillon....  Amount to make 245  _ cup (_ g); _ cup
                                   g.                  (_ mL)
Sugars and Sweets:
    Baking candies (e.g., chips)  15 g..............  _ piece(s) (_ g)
                                                       for large pieces;
                                                       _ tbsp(s) (_ g)
                                                       for small pieces;
                                                       \1/2\ oz (14 g/
                                                       visual unit of
                                                       measure) for bulk
                                                       products
    After-dinner confectioneries  10 g..............  _ piece(s) (_ g)
    Hard candies, breath mints    2 g...............  _ piece(s) (_ g)
     \8\.
    Hard candies, roll-type,      5 g...............  _ piece(s) (_ g)
     mini-size in dispenser
     packages.

[[Page 82]]

 
    Hard candies, others;         15 mL for liquid    _ piece(s) (_ g)
     powdered candies, liquid      candies; 15 g for   for large pieces;
     candies.                      all others.         _ tbsp(s) (_ g)
                                                       for ``mini-size''
                                                       candies
                                                       measurable by
                                                       tablespoon; _
                                                       straw(s) (_ g)
                                                       for powdered
                                                       candies; _ wax
                                                       bottle(s) (_ mL)
                                                       for liquid
                                                       candies; \1/2\ oz
                                                       (14 g/visual unit
                                                       of measure) for
                                                       bulk products
    All other candies...........  30 g..............  _ piece(s) (_ g);
                                                       1 oz (30 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
     butter, molasses, fruit                           tbsp (15 mL)
     pastes, fruit chutneys.
    Marshmallows................  30 g..............  _ cup(s) (_ g) for
                                                       small pieces; _
                                                       piece(s) (_ g)
                                                       for large pieces
    Sugar.......................  8 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 one   solids; _ drop(s)
                                   reference amount    (_ g) for liquid;
                                   for sugar in        _ piece(s) (_ g)
                                   sweetness.          (e.g.,
                                                       individually
                                                       packaged
                                                       products)
    Syrups......................  30 mL for all       2 tbsp (30 mL)
                                   syrups.
Vegetables:
    Dried vegetables, dried       5 g, add 5 g for    _ piece(s); \1/3\
     tomatoes, sun-dried           products packaged   cup (_ g)
     tomatoes, dried mushrooms,    in oil.
     dried seaweed.
    Dried seaweed sheets........  3 g...............  _ piece(s) (_ g);
                                                       _ cup(s) (_ g)
    Vegetables primarily used     4 g...............  _ piece(s) (_ g);
     for garnish or flavor                             _ tbsp(s) (_ g)
     (e.g., pimento,\10\                               for chopped
     parsley, fresh or dried).                         products
    Fresh or canned chili         30 g..............  _ piece(s) (_ g)
     peppers, jalapeno peppers,                        \12\; _ tbsp(s)
     other hot peppers, green                          (_ g); _ cup(s)
     onion.                                            (_ g) for sliced
                                                       or chopped
                                                       products
    All other vegetables without  85 g for fresh or   _ piece(s) (_ g)
     sauce: Fresh, canned, or      frozen; 95 g for    for large pieces
     frozen.                       vacuum packed;      (e.g., Brussels
                                   130 g for canned    sprouts); _
                                   in liquid, cream-   cup(s) (_ g) for
                                   style corn,         small pieces
                                   canned or stewed    (e.g., cut corn,
                                   tomatoes,           green peas); 3 oz
                                   pumpkin, or         (84 g/visual unit
                                   winter squash.      of measure) if
                                                       not measurable by
                                                       cup
    All other vegetables with     110 g.............  _ piece(s) (_ g)
     sauce: Fresh, canned, or                          for large pieces
     frozen.                                           (e.g., Brussels
                                                       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)
    Olives \10\.................  15 g..............  _ piece(s) (_ g);
                                                       _ tbsp(s) (_ g)
                                                       for sliced
                                                       products

[[Page 83]]

 
    Pickles and pickled           30 g..............  1 oz (28 g/visual
     vegetables, all types \10\.                       unit of measure)
    Pickle relishes.............  15 g..............  _ tbsp (_ g)
    Sprouts, all types: Fresh or  1/4 cup...........  \1/4\ cup (_ g)
     canned.
    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 Agriculture and updated
  with data from the National Health and Nutrition Examination Survey,
  2003-2004, 2005-2006 and 2007-2008 conducted by the Centers for
  Diseases Control and Prevention, in the Department of Health and Human
  Services.
\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 (e.g., 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\ The label statements are meant to provide examples of serving size
  statements that may be used on the label, but the specific wording may
  be changed as appropriate for individual products. 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).
\5\ Includes cakes that weigh 10 g or more per cubic inch. The serving
  size for fruitcake is 1 \1/2\ ounces.
\6\ Includes cakes that weigh 4 g or more per cubic inch but less than
  10 g per cubic inch.
\7\ Includes cakes that weigh less than 4 g per cubic inch.
\8\ Label serving size for ice cream cones, eggs, and breath mints 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.
\9\ 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.
\10\ 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).
\11\ 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(j)(11).
\12\ For raw fruit, vegetables, and fish, manufacturers should follow
  the label statement for the serving size specified in Appendices C and
  D to part 101 (21 CFR part 101) Code of Federal Regulations.
\13\ 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 
form, but not the unprepared

[[Page 84]]

form, then the reference amount for the unprepared product must 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.
    (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 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) The reference amount for the combined product must be the 
reference amount, as established in paragraph (b) of this section, for 
the ingredient that is represented as the main ingredient (e.g., peanut 
butter, pancakes, cake) plus proportioned amounts of all minor 
ingredients.
    (2) If the reference amounts are in compatible units, the weights or 
volumes must 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, all 
amounts must be converted to weights and summed, e.g., the reference 
amount for pancakes and syrup would be 110 g (the reference amount for 
pancakes) plus the 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

[[Page 85]]

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)'').
    (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 
Sec. 25.32 of this chapter or

[[Page 86]]

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.
    (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; 81 FR 34041, May 27, 
2016]



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

[[Page 87]]

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.''
    (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. 101.7(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

[[Page 88]]

printed or graphic matter, and in a size no less than that required by 
Sec. 101.7(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, 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 Secs. 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. 101.7(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

[[Page 89]]

    (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 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:

[[Page 90]]

    (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.
    (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

[[Page 91]]

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 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 Secs. 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

[[Page 92]]

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 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; 81 FR 59131, Aug. 29, 2016]



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).

[[Page 93]]

    (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 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

[[Page 94]]

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 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;

[[Page 95]]

    (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, 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

[[Page 96]]

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.
    (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 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

[[Page 97]]

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, 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),

[[Page 98]]

``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
    (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

[[Page 99]]

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 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:

[[Page 100]]

    (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
    (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 an Office of Regulatory Affairs Program 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 Office of Regulatory Affairs Program Director or 
another FDA official senior to an FDA District Director 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 presiding FDA official 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 an Office of Regulatory Affairs Program Director 
or another FDA official senior to an FDA District Director, and a 
written summary of the proceedings shall be prepared by the presiding 
FDA official.
    (1) The presiding FDA official may direct that the hearing be 
conducted in any suitable manner permitted by law and this section. The 
presiding FDA official 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

[[Page 101]]

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 presiding FDA official's report of the hearing.
    (5) The presiding FDA official 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 presiding FDA official may 
give the parties the opportunity to review and comment on the report of 
the hearing.
    (6) The presiding FDA official 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 presiding FDA official shall render a 
decision on the appeal affirming or revoking the detention within 5-
working days after the receipt of the appeal.
    (E) Presiding FDA official's decision. If, based on the evidence 
presented at the hearing or by the appellant in a written appeal, the 
presiding FDA official 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 FDA for 
processing under the EPIA, or destroyed by or under the supervision of 
an officer or employee of FDA; otherwise, the presiding FDA official 
shall issue a written notice that the prior order is withdrawn. If the 
presiding FDA official 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 presiding FDA 
official's decision shall be accompanied by a statement of the reasons 
for the decision. The decision of the presiding FDA official 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 presiding FDA official 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]

    Editorial Note: For Federal Register citations affecting 
Sec. 101.17, see the List of CFR Sections Affected, which appears in the 
Finding Aids section of the printed volume and at www.fdsys.gov.



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

[[Page 102]]

though the names of all such ingredients are stated elsewhere in the 
labeling.
    (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 
Secs. 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 Secs. 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.

[[Page 103]]

    (c) A statement of artificial flavoring, artificial coloring, or 
chemical preservative shall be placed on the food 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

[[Page 104]]

directly or implied, that a food flavored with pyroligneous acid or 
other artificial smoke flavor has been 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

[[Page 105]]

trademark or brand as to be clearly related to the characterizing 
flavor; and
    (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 106]]

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 Secs. 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 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.
    (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; 74 FR 216, Jan. 5, 2009]



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), 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.

[[Page 107]]

    (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 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, the title phrase ``Nutrition 
Facts,'' the declaration of ``Serving size,'' ``Calories'' and the 
numerical value for ``Calories 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.

[[Page 108]]

    (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. 101.7(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
                            Juice                               percent
                                                               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.
    (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

[[Page 109]]

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; 81 FR 33994, May 27, 2016; 81 FR 59131, Aug. 
29, 2016]



    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 Secs. 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, total fat, saturated fat, trans 
fat, cholesterol, sodium, total carbohydrate, dietary fiber, total 
sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, 
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, polyunsaturated fat, 
monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol 
may be declared, but they shall be declared 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.'' 
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 nutritional label in the order and 
manner of indentation specified in Sec. 101.9(c), except that calcium 
and iron shall follow choline, 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 and folic acid, 
vitamin B12, biotin, pantothenic acid, choline, calcium, 
iron, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, 
chromium, molybdenum,

[[Page 110]]

chloride, sodium, potassium, and fluoride. 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 saturated 
fat'' are declared, they shall be indented under ``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), and calories (energy). 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 micrograms (mcg) 
may be included in the parentheses following the percent statement 
(e.g., ``Vitamin A (90% (810 mcg) 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) The amounts shall be expressed in the increments specified in 
Sec. 101.9(c)(1) through (7), which includes increments for sodium.
    (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). The amount of vitamin D may, but is not required to, be 
expressed in IUs, in addition to the mandatory declaration in mcg. Any 
declaration of the amount of vitamin D in IUs must appear in parentheses 
after the declaration of the amount of vitamin D in mcg.
    (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 Daily Value for protein, when present, shall be 
calculated using the corrected amount of protein as specified in 
Sec. 101.9(c)(7)(ii); no percent of the Daily Value shall be given for 
subcomponents for which DRVs or RDIs have not been established (e.g., 
total sugars). Additionally, the percentage of the RDI for protein shall 
be omitted when a food is purported to be for infants through 12 months 
of age.
    (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

[[Page 111]]

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, or added 
sugars, 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.'' If the product is represented or 
purported to be for use by children 1 through 3 years of age, and if the 
percent of Daily Value is declared for total fat, total carbohydrate, 
dietary fiber, or protein, or added sugars, 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 1,000 
calorie diet.''
    (E) The percent of Daily Value shall be based on RDI or DRV values 
for adults and children 4 or more years of age, unless the product is 
represented or purported to be specifically for infants through 12 
months of age, children 1 through 3 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)(11)(ii) of this section.
    (F) For declared subcomponents that have no DRVs or RDIs, 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 a statement ``Daily Value not established.''
    (G) When calories or calories from saturated fat are declared, the 
space under the ``% DV'' 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 ``% DV'' column, the column may be omitted 
as shown in paragraph (e)(11)(vii) of this section. When the ``% DV'' 
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.''
    (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

[[Page 112]]

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.
    (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 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

[[Page 113]]

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)(11)(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) Except as provided for small and intermediate sized packages 
under 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. A font size at least two points greater shall be used for 
``Calories'' and the heading ``Calories'' and the actual number of 
calories per serving shall be highlighted in bold or extra bold type. 
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).
    (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 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

[[Page 114]]

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)(11)(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 115]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.013


[[Page 116]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.014


[[Page 117]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.015


[[Page 118]]


[GRAPHIC] [TIFF OMITTED] TR27MY16.016

    (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:
[GRAPHIC] [TIFF OMITTED] TR27MY16.017

    (f)(1) Compliance with this section will be determined in accordance 
with Sec. 101.9(g)(1) through (g)(8), (g)(10), and (g)(11), except that 
the sample for analysis shall consist of a composite of 12 subsamples 
(consumer packages) or 10 percent of the 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

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section. Reasonable excesses 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 
Nutrition and Food Labeling (HFS-800), Food and Drug Administration, 
5001 Campus Dr., 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)(1) Dietary supplements are subject to the special labeling 
provisions specified in Sec. 101.9(j)(5)(i) for foods other than infant 
formula, represented or purported to be specifically for infants through 
12 months of age and children 1 through 3 years of age.
    (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).
    (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.

[[Page 120]]

    (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; 81 FR 33994, May 27, 2016]



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.



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:

[[Page 121]]

    (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 
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.

[[Page 122]]

    (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, 5001 Campus Dr., 
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 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

[[Page 123]]

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
    (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

[[Page 124]]

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
    (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

[[Page 125]]

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 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

[[Page 126]]

    (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 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

[[Page 127]]

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]



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

[[Page 128]]

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 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

[[Page 129]]

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 Secs. 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
    (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

[[Page 130]]

``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]



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''

[[Page 131]]

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 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

[[Page 132]]

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 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

[[Page 133]]

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
    (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

[[Page 134]]

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 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

[[Page 135]]

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 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

[[Page 136]]

    (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 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

[[Page 137]]

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 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

[[Page 138]]

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 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

[[Page 139]]

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 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

[[Page 140]]

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;
    (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

[[Page 141]]

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 
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

[[Page 142]]

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 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

[[Page 143]]

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:
    (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. 101.   fat as        level for
                   62(b)(2)     defined in    cholesterol
                                Sec. 101.6   specified in
                                2(c)(2)       Sec. 101.13
                                              (h) or less
------------------------------------------------------------------------

[[Page 144]]

 
(B) A single-     Low fat as   Low           The            N/A
 ingredient or a   defined in   saturated     disclosure
 mixture of        Sec. 101.   fat as        level for
 frozen or         62(b)(2)     defined in    cholesterol
 canned fruits                  Sec. 101.6   specified in
 and                            2(c)(2)       Sec. 101.13
 vegetables\1\                                (h) or less
------------------------------------------------------------------------
(C) An enriched   Low fat as   Low           The            N/A
 cereal-grain      defined in   saturated     disclosure
 product that      Sec. 101.   fat as        level for
 conforms to a     62(b)(2)     defined in    cholesterol
 standard of                    Sec. 101.6   specified in
 identity in                    2(c)(2)       Sec. 101.13
 part 136, 137                                (h) or less
 or 139 of this
 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. 101.   fat as        per LS\5\      the RDI or
  101.13(l) or a   62(b)(3)     defined in                   DRV per LS
 main dish                      Sec. 101.6                  of two
 product as                     2(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. 101.   fat as        level for      the RDI or
 table             62(b)(2)     defined in    cholesterol    the DRV per
                                Sec. 101.6   specified in   RA of one
                                2(c)(2)       Sec. 101.13   or more of
                                              (h) or less    vitamin A,
                                                             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
    (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

[[Page 145]]

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:
    (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

[[Page 146]]

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 ______
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

[[Page 147]]

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
    (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.

[[Page 148]]

    (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.
    (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:

[[Page 149]]

    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 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

[[Page 150]]

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),
5001 Campus Dr.,
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), 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.

[[Page 151]]

    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 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

[[Page 152]]

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.
    (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

[[Page 153]]

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) 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

[[Page 154]]

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 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

[[Page 155]]

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.
    (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

[[Page 156]]

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.
    (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

[[Page 157]]

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.
    (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

[[Page 158]]

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, except Sec. 101.14(e)(6) with respect to a raw fruit or 
vegetable.
    (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. (A) The food shall meet all of the nutrient 
content requirements of Sec. 101.62 for a ``low saturated fat'' and 
``low cholesterol'' food.
    (B) The food shall meet the nutrient content requirements of 
Sec. 101.62 for a ``low fat'' food, unless it is a raw fruit or 
vegetable; 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''.
    (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

[[Page 159]]

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, as amended at 81 FR 91722, Dec. 19, 2016]



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.
    (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

[[Page 160]]

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]



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

[[Page 161]]

(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.
    (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

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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, 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

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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 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

[[Page 164]]

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:
    (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

[[Page 165]]

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 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:

[[Page 166]]

    (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.
    (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

[[Page 167]]

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 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

[[Page 168]]

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 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

[[Page 169]]

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 Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039, 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 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

[[Page 170]]

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; 81 FR 5590, Feb. 3, 2016]



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 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

[[Page 171]]

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 Food and Drug 
Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third 
Floor, Silver Spring, MD 20993, 301-796-2039, 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 [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

[[Page 172]]

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 Food and Drug Administration's Main Library, 10903 
New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039, 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 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 Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, or at the National Archives and Records 
Administration (NARA). For information on the availability of this 
material at

[[Page 173]]

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 Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039 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 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);

[[Page 174]]

    (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; 81 FR 5590, Feb. 3, 2016]



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.
    (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

[[Page 175]]

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.
    (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.

[[Page 176]]

    (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 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

[[Page 177]]

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 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 Nutrition, Labeling and Dietary Supplements, Nutrition Programs 
Staff, 5001 Campus Dr., College Park, MD 20740, and may be examined at 
the Food and Drug Administration's Main Library, 10903 New Hampshire 
Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at 
the National Archives and Records Administration

[[Page 178]]

(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 Nutrition, Labeling and Dietary 
Supplements, Nutrition Programs Staff, 5001 Campus Dr., College Park, MD 
20740, or may be examined at the Food and Drug Administration's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039, 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.''
    (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

[[Page 179]]

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]



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



Sec. 101.91  Gluten-free labeling of food.

    (a) Definitions. (1) The term ``gluten-containing grain'' means any 
one of the following grains or their crossbred hybrids (e.g., triticale, 
which is a cross between wheat and rye):
    (i) Wheat, including any species belonging to the genus Triticum;
    (ii) Rye, including any species belonging to the genus Secale; or
    (iii) Barley, including any species belonging to the genus Hordeum.
    (2) The term ``gluten'' means the proteins that naturally occur in a 
gluten-containing grain and that may cause adverse health effects in 
persons with celiac disease (e.g., prolamins and glutelins).
    (3) The labeling claim ``gluten-free'' means:

[[Page 180]]

    (i) That the food bearing the claim in its labeling:
    (A) Does not contain any one of the following:
    (1) An ingredient that is a gluten-containing grain (e.g., spelt 
wheat);
    (2) An ingredient that is derived from a gluten-containing grain and 
that has not been processed to remove gluten (e.g., wheat flour); or
    (3) An ingredient that is derived from a gluten-containing grain and 
that has been processed to remove gluten (e.g., wheat starch), if the 
use of that ingredient results in the presence of 20 parts per million 
(ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more 
gluten per kilogram (kg) of food); or
    (B) Inherently does not contain gluten; and
    (ii) Any unavoidable presence of gluten in the food bearing the 
claim in its labeling is below 20 ppm gluten (i.e., below 20 mg gluten 
per kg of food).
    (b) Requirements. (1) A food that bears the claim ``gluten-free'' in 
its labeling and fails to meet the requirements of paragraph (a)(3) of 
this section will be deemed misbranded.
    (2) A food that bears the claim ``no gluten,'' ``free of gluten,'' 
or ``without gluten'' in its labeling and fails to meet the requirements 
of paragraph (a)(3) of this section will be deemed misbranded.
    (3) A food that bears the term ``wheat'' in the ingredient list or 
in a separate ``Contains wheat'' statement in its labeling, as required 
by 21 U.S.C. 343(w)(1)(A), and also bears the claim ``gluten-free'' or a 
claim identified in paragraph (b)(2) of this section will be deemed 
misbranded unless the word ``wheat'' in the ingredient list or in the 
``Contains wheat'' statement is followed immediately by an asterisk (or 
other symbol) that refers to another asterisk (or other symbol) in close 
proximity to the ingredient statement that immediately precedes the 
following: ``The wheat has been processed to allow this food to meet the 
Food and Drug Administration (FDA) requirements for gluten-free foods.''
    (c) Compliance. When compliance with paragraph (b) of this section 
is based on an analysis of the food, FDA will use a scientifically valid 
method that can reliably detect the presence of 20 ppm gluten in a 
variety of food matrices, including both raw and cooked or baked 
products.
    (d) Preemption. A State or political subdivision of a State may not 
establish or continue into effect any law, rule, regulation, or other 
requirement that is different from the requirements in this section for 
the definition and use of the claim ``gluten-free,'' as well as the 
claims ``no gluten,'' ``free of gluten,'' or ``without gluten.''

[78 FR 47178, Aug. 5, 2013]



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, 
5001 Campus Dr., 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

[[Page 181]]

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 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;

[[Page 182]]

    (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 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:''

[[Page 183]]

    (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 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, 
potassium 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

[[Page 184]]

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 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

[[Page 185]]

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.
    (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 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

[[Page 186]]

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 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

[[Page 187]]

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. 101.108  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 Secs. 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 Secs. 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 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

[[Page 188]]

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 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 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

[[Page 189]]

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 = (32.03 x VB x N x 1000) / 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 190]]

[GRAPHIC] [TIFF OMITTED] TR01JA93.362

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

[[Page 191]]

[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]

[[Page 192]]

                                     

      Appendix B to Part 101--Graphic Enhancements Used by the FDA
[GRAPHIC] [TIFF OMITTED] TR01JA93.364


[[Page 193]]


[GRAPHIC] [TIFF OMITTED] TR11JY03.006


[58 FR 17332, Apr. 2, 1993, as amended at 68 FR 41506, July 11, 2003]

[[Page 194]]



                                 Sec. 

  Appendix C to Part 101--Nutrition Facts for Raw Fruits and Vegetables
[GRAPHIC] [TIFF OMITTED] TR17AU06.007


[[Page 195]]


[GRAPHIC] [TIFF OMITTED] TR17AU06.008

                      [71 FR 47439, Aug. 17, 2006]



                                 Sec. 

[[Page 196]]

         Appendix D to Part 101--Nutrition Facts for Cooked Fish
[GRAPHIC] [TIFF OMITTED] TR17AU06.009

                      [71 FR 47439, Aug. 17, 2006]

[[Page 197]]



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.

    Editorial Note: Nomenclature changes to part 102 appear at 81 FR 
49895, July 29, 2016.



                      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

[[Page 198]]

    (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 
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

[[Page 199]]

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 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, 5001 Campus Dr., 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.

[[Page 200]]

    (8) Copper: AOAC, 13th Ed. (1980), using the method described in 
sections 25.038-25.043, which is incorporated by 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

[[Page 201]]

appear on the principal display panel more conspicuously or in larger 
type 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:

[[Page 202]]

    (1) Indicate that the named juice is present as a flavor or 
flavoring (e.g., ``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 203]]



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 204]]



------------------------------------------------------------------------
                                               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 205]]

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. 101.7 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 
Secs. 101.3 and 102.5(a) of this chapter.
    (2) The label of the product shall bear nutrition labeling in 
accordance with Secs. 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; 
81 FR 59131, Aug. 29, 2016]



                     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 206]]

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 207]]

    (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 208]]



------------------------------------------------------------------------
                                                    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 209]]

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 210]]

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 REQUIREMENTS PERTAINING TO CURRENT GOOD
 MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS,
 RECORDS AND REPORTS, AND NOTIFICATIONS--Table of Contents



                      Subpart A_General Provisions

Sec.
106.1  Status and applicability of the regulations in part 106.
106.3  Definitions.

              Subpart B_Current Good Manufacturing Practice

106.5  Current good manufacturing practice.
106.6  Production and in-process control system.
106.10  Controls to prevent adulteration by workers.
106.20  Controls to prevent adulteration caused by facilities.
106.30  Controls to prevent adulteration caused by equipment or 
          utensils.
106.35  Controls to prevent adulteration due to automatic (mechanical or 
          electronic) equipment.
106.40  Controls to prevent adulteration caused by ingredients, 
          containers, and closures.
106.50  Controls to prevent adulteration during manufacturing.
106.55  Controls to prevent adulteration from microorganisms.
106.60  Controls to prevent adulteration during packaging and labeling 
          of infant formula.
106.70  Controls on the release of finished infant formula.
106.80  Traceability.
106.90  Audits of current good manufacturing practice.

                  Subpart C_Quality Control Procedures

106.91  General quality control.
106.92  Audits of quality control procedures.

                       Subpart D_Conduct of Audits

106.94  Audit plans and procedures.

              Subpart E_Quality Factors for Infant Formulas

106.96  Requirements for quality factors for infant formulas.

[[Page 211]]

                      Subpart F_Records and Reports

106.100  Records.

    Subpart G_Registration, Submission, and Notification Requirements

106.110  New infant formula registration.
106.120  New infant formula submission.
106.121  Quality factor assurances for infant formulas.
106.130  Verification submission.
106.140  Submission concerning a change in infant formula that may 
          adulterate the product.
106.150  Notification of an adulterated or misbranded infant formula.
106.160  Incorporation by reference.

    Authority: 21 U.S.C. 321, 342, 350a, 371.

    Source: 79 FR 8059, Feb. 10, 2014, unless otherwise noted.

    Editorial Note: Nomenclature changes to part 106 appear at 81 FR 
49895, July 29, 2016.



                      Subpart A_General Provisions



Sec. 106.1  Status and applicability of the regulations in part 106.

    (a) The criteria set forth in subparts B, C, and D of this part 
prescribe the steps that manufacturers shall take under section 
412(b)(2) and (b)(3) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350a(b)(2) and (b)(3)) in processing infant formula. If the 
processing of the formula does not comply with any regulation in 
subparts B, C, or D of this part, the formula will be deemed to be 
adulterated under section 412(a)(3) of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The criteria set forth in subpart E of this part prescribe the 
requirements for quality factors that infant formula shall meet under 
section 412(b)(1) of the Federal Food, Drug, and Cosmetic Act. If the 
formula fails to comply with any regulation in subpart E of this part, 
it will be deemed to be adulterated under section 412(a)(2) of the 
Federal Food, Drug, and Cosmetic Act.
    (c) The criteria set forth in subpart F of this part prescribe 
records requirements for quality factors under section 412(b)(1) of the 
Federal Food, Drug, and Cosmetic Act and for good manufacturing 
practices and quality control procedures, including distribution and 
audit records, under section 412(b)(2). If an infant formula 
manufacturer fails to comply with the quality factor record requirements 
in subpart F of this part with respect to an infant formula, the formula 
will be deemed to be adulterated under section 412(a)(2) of the Federal 
Food, Drug, and Cosmetic Act. If an infant formula manufacturer fails to 
comply with the good manufacturing practices or quality control 
procedures record requirements in subpart F of this part with respect to 
an infant formula, the infant formula will be deemed to be adulterated 
under section 412(a)(3) of the Federal Food, Drug, and Cosmetic Act. The 
criteria set forth in subpart F of this part also implement record 
retention requirements under section 412(b)(4) of the Federal Food, 
Drug, and Cosmetic Act. Failure to comply with any regulation in subpart 
F of this part is a violation of section 301(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331(e)).
    (d) The criteria set forth in subpart G of this part describe, in 
part, certain good manufacturing practices, quality control procedures, 
and quality factor records requirements under section 412(b)(1) and 
(b)(2) of the Federal Food, Drug and Cosmetic Act. If an infant formula 
manufacturer fails to comply with such records requirements with respect 
to an infant formula, the infant formula will be deemed to be 
adulterated under section 412(a)(2) or (a)(3) of the Federal Food, Drug, 
and Cosmetic Act, as applicable. The criteria set forth in subpart G of 
this part also describe the circumstances in which an infant formula 
manufacturer is required to register with, submit to, or notify the Food 
and Drug Administration, and the content of a registration, submission, 
or notification, under section 412(c), (d), and (e) of the Federal Food, 
Drug, and Cosmetic Act. Failure to comply with any regulation in subpart 
G of this part is a violation of section 301(s) of the Federal Food, 
Drug, and Cosmetic Act.



Sec. 106.3  Definitions.

    The definitions in this section and the definitions contained in 
section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 
shall apply to infant formula requirements in 21 CFR parts 106 and 107 
of this chapter.

[[Page 212]]

    Eligible infant formula means an infant formula that could be 
lawfully distributed in the United States on December 8, 2014.
    Final product stage means the point in the manufacturing process, 
before distribution of an infant formula, at which the infant formula is 
homogeneous and is not subject to further degradation due to processing.
    Indicator nutrient means a nutrient whose concentration is measured 
during the manufacture of an infant formula to confirm complete addition 
and uniform distribution of a premix or other substance of which the 
indicator nutrient is a part.
    Infant means a person not more than 12 months of age.
    Infant formula means a food which purports to be or is represented 
for special dietary use solely as a food for infants by reason of its 
simulation of human milk or its suitability as a complete or partial 
substitute for human milk.
    In-process production aggregate means a combination of ingredients 
at any point in the manufacturing process before packaging.
    Major change in an infant formula means 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 
bioavailability of nutrients, or any change that causes an infant 
formula to differ fundamentally in processing or in composition from any 
previous formulation produced by the manufacturer. Examples of infant 
formulas deemed to differ fundamentally in processing or in composition 
include:
    (1) Any infant formula produced by a manufacturer who is entering 
the U.S. market;
    (2) Any infant formula powder processed and distributed by a 
manufacturer who previously only produced liquids (or vice versa);
    (3) Any infant formula having a significant revision, addition, or 
substitution of a macronutrient (i.e., protein, fat, or carbohydrate), 
with which the manufacturer has not had previous experience;
    (4) Any infant formula manufactured on a new processing line or in a 
new plant;
    (5) Any infant formula manufactured containing a new constituent not 
listed in section 412(i) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 350a(i)), such as taurine or L-carnitine;
    (6) Any infant formula processed by a manufacturer on new equipment 
that utilizes a new technology or principle (e.g., from terminal 
sterilization to aseptic processing); or
    (7) An infant formula for which there has been a fundamental change 
in the type of packaging used (e.g., changing from metal cans to plastic 
pouches).
    Manufacturer means a person who prepares, reconstitutes, or 
otherwise changes the physical or chemical characteristics of an infant 
formula or packages or labels the product in a container for 
distribution. The term ``manufacturer'' does not include a person who 
prepares, reconstitutes, or mixes infant formula exclusively for an 
infant under his/her direct care or the direct care of the institution 
employing such person.
    Microorganisms means yeasts, molds, bacteria, and viruses and 
includes, but is not limited to, species having public health 
significance.
    New infant formula means:
    (1) An infant formula manufactured by a person that has not 
previously manufactured an infant formula, and
    (2) An infant formula manufactured by a person that has previously 
manufactured infant formula and in which there is a major change in 
processing or formulation from a current or any previous formulation 
produced by such manufacturer, or which has not previously been the 
subject of a submission under section 412(c) of the Federal Food, Drug, 
and Cosmetic Act for the U.S. market.
    Nutrient means any vitamin, mineral, or other substance or 
ingredient that is required in accordance with the ``Nutrients'' table 
set out in section 412(i)(1) of the Federal Food, Drug, and Cosmetic Act 
or by regulations issued under section 412(i)(2) or that is identified 
as essential for infants by the Food and Nutrition Board of the 
Institute of Medicine through its development of a Dietary Reference 
Intake, or that has

[[Page 213]]

been identified as essential for infants by the Food and Drug 
Administration through a Federal Register publication.
    Nutrient premix means a combination of ingredients containing two or 
more nutrients received from a supplier or prepared by an infant formula 
manufacturer.
    Production aggregate means a quantity of product, or, in the case of 
an infant formula produced by continuous process, a specific identified 
amount produced in a unit of time, that is intended to have uniform 
composition, character, and quality, within specified limits, and is 
produced according to a master manufacturing order.
    Production unit means a specific quantity of an infant formula 
produced during a single cycle of manufacture that has uniform 
composition, character, and quality, within specified limits.
    Production unit number or production aggregate number means any 
distinctive combination of letters, numbers, symbols, or any combination 
of them, from which the complete history of the manufacture, processing, 
packing, holding, and distribution of a production aggregate or a 
production unit of infant formula can be determined.
    Quality factors means those factors necessary to demonstrate the 
safety of the infant formula and the bioavailability of its nutrients, 
as prepared for market and when fed as the sole source of nutrition, to 
ensure the healthy growth of infants.
    Representative sample means a sample that consists of a number of 
units that are drawn based on rational criteria, such as random 
sampling, and intended to ensure that the sample accurately portrays the 
material being sampled.
    Shall is used to state mandatory requirements.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33070, June 10, 2014]



              Subpart B_Current Good Manufacturing Practice



Sec. 106.5  Current good manufacturing practice.

    (a) The regulations set forth in this subpart define the minimum 
current good manufacturing practices that are to be used in, and the 
facilities or controls that are to be used for, the manufacture, 
processing, packing, or holding of an infant formula. Compliance with 
these provisions is necessary to ensure that such infant formula 
provides the nutrients required under Sec. 107.100 of this chapter and 
is manufactured in a manner designed to prevent its adulteration. A 
liquid infant formula that is a thermally processed low-acid food 
packaged in a hermetically sealed container is also subject to the 
regulations in part 113 of this chapter, and an infant formula that is 
an acidified food, as defined in Sec. 114.3(b) of this chapter, is also 
subject to the regulations in part 114 of this chapter.
    (b) The failure to comply with any regulation in this subpart in the 
manufacture, processing, packing, or holding of an infant formula shall 
render such infant formula adulterated under section 412(a)(3) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)(3)); the failure 
to comply with any regulation in part 113 of this chapter in the 
manufacture, processing, packing, or holding of a liquid infant formula 
shall render such infant formula adulterated under section 412(a)(3); 
and the failure to comply with any regulation in part 114 of this 
chapter in the manufacture, processing, packing, or holding of an infant 
formula that is an acidified food shall render such infant formula 
adulterated under section 412(a)(3).



Sec. 106.6  Production and in-process control system.

    (a) A manufacturer shall conform to the requirements of this subpart 
by implementing a system of production and in-process controls. This 
production and in-process control system shall cover all stages of 
processing, from the receipt and acceptance of the raw materials, 
ingredients, and components through the storage and distribution of the 
finished product and shall be designed to ensure that all the 
requirements of this subpart are met.
    (b) The production and in-process control system shall be set out in 
a written plan or set of procedures that is designed to ensure that an 
infant formula is manufactured in a manner

[[Page 214]]

that will prevent adulteration of the infant formula.
    (c) At any point, step, or stage in the production process where 
control is necessary to prevent adulteration, a manufacturer shall:
    (1) Establish specifications to be met;
    (2) Monitor the production and in-process control point, step, or 
stage;
    (3) Establish a corrective action plan for use when a specification 
established in accordance with paragraph (c)(1) of this section is not 
met;
    (4) Review the results of the monitoring required by paragraph 
(c)(2) of this section, and review and evaluate the public health 
significance of any deviation from specifications that have been 
established in accordance with paragraph (c)(1) of this section. For any 
specification established in accordance with paragraph (c)(1) of this 
section that a manufacturer fails to meet, an individual qualified by 
education, training, or experience shall conduct a documented review and 
shall make a material disposition decision to reject the affected 
article, to reprocess or otherwise recondition the affected article, or 
to approve and release the article for use or distribution; and
    (5) Establish recordkeeping procedures, in accordance with 
Sec. 106.100(e)(3), that ensure that compliance with the requirements of 
this section is documented.
    (d) Any article that fails to meet a specification established in 
accordance with paragraph (c)(1) of this section shall be controlled 
under a quarantine system designed to prevent its use pending the 
completion of a documented review and material disposition decision.



Sec. 106.10  Controls to prevent adulteration by workers.

    (a) A manufacturer shall employ sufficient personnel, qualified by 
education, training, or experience, to perform all operations, including 
all required recordkeeping, in the manufacture, processing, packing, and 
holding of each infant formula and to supervise such operations to 
ensure that the operations are correctly and fully performed.
    (b) Personnel working directly with infant formula, infant formula 
raw materials, infant formula packaging, or infant formula equipment or 
utensil contact surfaces shall practice good personal hygiene to protect 
the infant formula against contamination. Good personal hygiene 
includes:
    (1) Wearing clean outer garments and, as necessary, protective 
apparel such as head, face, hand, and arm coverings; and
    (2) Washing hands thoroughly in a hand washing facility with soap 
and running water at a suitable temperature before starting work, after 
each absence from the work station, and at any other time when the hands 
may become soiled or contaminated.
    (c) Any person who reports that he or she has, or appears by medical 
examination or supervisory observation to have, an illness, open lesion 
(including boils, sores, or infected wounds), or any other source of 
microbial contamination that creates a reasonable possibility that the 
safety of an infant formula may be adversely affected, shall be excluded 
from direct contact with ingredients, containers, closures, in-process 
materials, equipment, utensils, and infant formula product until the 
condition is corrected or determined by competent medical personnel not 
to jeopardize the safety of the infant formula.



Sec. 106.20  Controls to prevent adulteration caused by facilities.

    (a) Buildings used in the manufacture, processing, packing, or 
holding of infant formula shall be maintained in a clean and sanitary 
condition and shall have space for the separation of incompatible 
operations, such as the handling of raw materials, the manufacture of 
the product, and packaging and labeling operations.
    (b) Separate areas or another system of separation, such as a 
computerized inventory control, a written card system, or an automated 
system of segregation, shall be used for holding raw materials, in-
process materials, and final infant formula product at the following 
times:
    (1) Pending release for use in infant formula production or pending 
release of the final product;
    (2) After rejection for use in, or as, infant formula; and

[[Page 215]]

    (3) After release for use in infant formula production or after 
release of the final product.
    (c) Lighting shall allow easy identification of raw materials, 
packaging, labeling, in-process materials, and finished products that 
have been released for use in infant formula production and shall permit 
the easy reading of instruments and controls necessary in processing, 
packaging, and laboratory analysis. Any lighting fixtures directly over 
or adjacent to exposed raw materials, in-process materials, or bulk 
(unpackaged) finished product shall be protected to prevent glass from 
contaminating the product in the event of breakage.
    (d) A manufacturer shall provide adequate ventilation or control 
equipment to minimize odors and vapors (including steam and noxious 
fumes) in areas where they may contaminate the infant formula; and shall 
minimize the potential for contamination of raw materials, in-process 
materials, final product infant formula, packing materials, and infant 
formula-contact surfaces, through the use of appropriate measures, which 
may include the use of air filtration.
    (e) All rodenticides, insecticides, fungicides, fumigating agents, 
and cleaning and sanitizing agents shall be stored and used in a manner 
that protects against contamination of infant formula.
    (f) Potable water used in the manufacture of infant formula shall 
meet the standards prescribed in the Environmental Protection Agency's 
(EPA's) Primary Drinking Water regulations in 40 CFR part 141, except 
that the water used in infant formula manufacturing shall not be 
fluoridated or shall be defluoridated to a level as low as possible 
prior to use.
    (1) The water shall be supplied under continuous positive pressure 
in a plumbing system that is free of defects that could contaminate an 
infant formula.
    (2) A manufacturer shall test representative samples of the potable 
water drawn at a point in the system at which the water is in the same 
condition that it will be when it is used in infant formula 
manufacturing.
    (3) A manufacturer shall conduct the tests required by paragraph 
(f)(2) of this section with sufficient frequency to ensure that the 
water meets the EPA's Primary Drinking Water Regulations but shall not 
conduct these tests less frequently than annually for chemical 
contaminants, every 4 years for radiological contaminants, and weekly 
for bacteriological contaminants.
    (4) A manufacturer shall make and retain records, in accordance with 
Sec. 106.100(f)(1), of the frequency and results of testing of the water 
used in the production of infant formula.
    (g) There shall be no backflow from, or cross-connection between, 
piping systems that discharge waste water or sewage and piping systems 
that carry water for infant formula manufacturing.
    (h) Only culinary steam shall be used at all direct infant formula 
product contact points. Culinary steam shall be in compliance with the 
3-A Sanitary Standards, No. 60903, which is incorporated by reference at 
Sec. 106.160. Boiler water additives in the steam shall be used in 
accordance with Sec. 173.310 of this chapter.
    (i) Each infant formula manufacturing site shall provide its 
employees with readily accessible toilet facilities and hand washing 
facilities that include hot and cold water, soap or detergent, single-
service towels or air dryers in toilet facilities. These facilities 
shall be maintained in good repair and in a sanitary condition at all 
times. These facilities shall provide for proper disposal of the sewage. 
Doors to the toilet facility shall not open into areas where infant 
formula, ingredients, containers, or closures are processed, handled, or 
stored, except where alternate means have been taken to protect against 
contamination.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33070, June 10, 2014]



Sec. 106.30  Controls to prevent adulteration caused by equipment
or utensils.

    (a) A manufacturer shall ensure that equipment and utensils used in 
the manufacture, processing, packing, or

[[Page 216]]

holding of an infant formula are of appropriate design and are installed 
to facilitate their intended function and their cleaning and 
maintenance.
    (b) A manufacturer shall ensure that equipment and utensils used in 
the manufacture, processing, packing, or holding of an infant formula 
are constructed so that surfaces that contact ingredients, in-process 
materials, or infant formula are made of nontoxic materials and are not 
reactive or absorptive. A manufacturer shall ensure that such equipment 
and utensils are designed to be easily cleanable and to withstand the 
environment of their intended use and that all surfaces that contact 
ingredients, in-process materials, or infant formula are cleaned and 
sanitized, as necessary, and are maintained to protect infant formula 
from being contaminated by any source. All sanitizing agents used on 
such equipment and utensils that are regulated as pesticide chemicals 
under 21 U.S.C. 346a(a) shall comply with the Environmental Protection 
Agency's regulations established under such section, and all other such 
sanitizers shall comply with all applicable Food and Drug Administration 
laws and regulations.
    (c) A manufacturer shall ensure that any substance, such as a 
lubricant or a coolant, that is required for operation of infant formula 
manufacturing equipment and which would render the infant formula 
adulterated if such substance were to come in contact with the formula, 
does not come in contact with formula ingredients, containers, closures, 
in-process materials, or with infant formula product during the 
manufacture of an infant formula.
    (d) A manufacturer shall ensure that each instrument used for 
measuring, regulating, or controlling mixing time and speed, 
temperature, pressure, moisture, water activity, or other parameter at 
any point, step, or stage where control is necessary to prevent 
adulteration of an infant formula during processing is accurate, easily 
read, properly maintained, and present in sufficient number for its 
intended use.
    (1) The instruments and controls shall be calibrated against a known 
reference standard at the time of or before first use and thereafter at 
routine intervals, as specified in writing by the manufacturer of the 
instrument or control, or as otherwise deemed necessary to ensure the 
accuracy of the instrument or control. The known reference standard 
shall be certified for accuracy at the intervals specified in writing by 
the manufacturer of the instrument or control, or at routine intervals 
otherwise deemed necessary to ensure the accuracy of the instrument or 
control. A manufacturer shall make and retain records of the calibration 
activities in accordance with Sec. 106.100(f)(2).
    (2) Instruments and controls that cannot be adjusted to agree with 
the reference standard shall be repaired or replaced.
    (3) If calibration of an instrument shows a failure to meet a 
specification for a point where control is deemed necessary to prevent 
adulteration of infant formula product, a written evaluation of all 
affected product, and of any actions that need to be taken with respect 
to that product, shall be made, in accordance with Sec. 106.100(f)(2).
    (e) The following provisions apply to thermal processing and cold 
storage of infant formulas:
    (1) Equipment and procedures for thermal processing of infant 
formula packaged in hermetically sealed containers shall conform to the 
requirements in 21 CFR parts 108 and 113.
    (2)(i) Except as provided in paragraph (e)(2)(ii) of this section, a 
manufacturer shall maintain all areas of cold storage at a temperature 
of 40 F (4.4 C) or below.
    (ii) A manufacturer may maintain a cold storage area for an in-
process infant formula or for a final infant formula at a temperature 
not to exceed 45 F (7.2 C) for a defined period of time provided that 
the manufacturer has scientific data and other information to 
demonstrate that the time and temperature conditions of such storage are 
sufficient to ensure that there is no significant growth of 
microorganisms of public health significance during the period of 
storage of the in-process or final infant formula product.
    (3)(i) Cold storage compartments and thermal processing equipment 
shall be equipped with easily readable, accurate temperature-indicating 
devices.

[[Page 217]]

    (ii) A manufacturer shall ensure that the temperature of each cold 
storage compartment is maintained by:
    (A) Monitoring the temperature of the cold storage compartment on a 
temperature-indicating device and recording this temperature in a record 
with such frequency as is necessary to ensure that temperature control 
is maintained;
    (B) Equipping the cold storage compartment with one or more 
temperature-recording devices that will reflect, on a continuing basis, 
the true temperature, within the compartment;
    (C) Equipping the cold storage compartment with a high temperature 
alarm that has been validated to function properly and recording the 
temperature in a record with such frequency as is necessary to ensure 
that temperature control is maintained; or
    (D) Equipping the cold storage compartment with a maximum-indicating 
thermometer that has been validated to function properly and recording 
this temperature in a record with such frequency as is necessary to 
ensure that temperature control is maintained.
    (iii) A manufacturer shall, in accordance with Sec. 106.100(f)(3), 
make and retain records of the temperatures recorded in compliance with 
Sec. 106.30(e)(3)(ii).
    (4) When a manufacturer uses a temperature-recording device for a 
cold storage compartment, such device shall not read lower than the 
reference temperature-indicating device.
    (5) A manufacturer shall monitor the temperature in thermal 
processing equipment at points where temperature control is necessary to 
prevent adulteration. Such monitoring shall be at such frequency as is 
required by regulation or is necessary to ensure that temperature 
control is maintained.
    (f) A manufacturer shall ensure that equipment and utensils used in 
the manufacture of infant formula are cleaned, sanitized, and maintained 
at regular intervals to prevent adulteration of the infant formula.
    (1) An individual qualified by education, training, or experience to 
conduct such a review shall review all cleaning, sanitizing, and 
maintenance to ensure that it has been satisfactorily completed.
    (2) A manufacturer shall make and retain records on equipment 
cleaning, sanitizing, and maintenance, in accordance with 
Sec. 106.100(f)(4).
    (g) A manufacturer shall ensure that compressed air or other gases 
that are mechanically introduced into infant formula, that are used to 
clean any equipment, or that come into contact with any other surface 
that contacts ingredients, in-process materials, or infant formula 
product are treated in such a way that their use will not contaminate 
the infant formula with unlawful or other chemical, physical, or 
microbiological contaminants. When compressed gases are used at product 
filling machines to replace air removed from the headspace of 
containers, a manufacturer shall install, as close as practical to the 
end of the gas line that feeds gas into the space, a filter capable of 
retaining particles 0.5 micrometer or smaller.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



Sec. 106.35  Controls to prevent adulteration due to automatic 
(mechanical or electronic) equipment.

    (a) For the purposes of this section:
    (1) ``Hardware'' means all automatic equipment, including mechanical 
and electronic equipment (such as computers), that is used in production 
or quality control of infant formula.
    (2) ``Software'' means any programs, procedures, rules, and 
associated documentation used in the operation of a system.
    (3) ``System'' means a collection of components (including software 
and hardware) organized to accomplish a specific function or set of 
functions in a specified environment.
    (4) ``Validation'' means establishing documented evidence that 
provides a high degree of assurance that a system will consistently 
produce a product meeting its predetermined specifications and quality 
characteristics. Validation can be accomplished through any suitable 
means, such as verification studies or modeling.
    (b) All systems shall be designed, installed, tested, and maintained 
in a manner that will ensure that they are capable of performing their 
intended function and of producing or analyzing

[[Page 218]]

infant formula in accordance with this subpart and subpart C of this 
part.
    (1) A manufacturer shall ensure, at any point, step, or stage where 
control is necessary to prevent adulteration of the infant formula, that 
all hardware is routinely inspected and checked according to written 
procedures and that hardware that is capable of being calibrated is 
routinely calibrated according to written procedures.
    (2) A manufacturer shall check and document the accuracy of input 
into, and output generated by, any system used in the production or 
quality control of an infant formula to ensure that the infant formula 
is not adulterated. The degree and frequency of input/output 
verification shall be based on the complexity and reliability of the 
system and the level of risk associated with the safe operation of the 
system.
    (3) A manufacturer shall ensure that each system is validated prior 
to the release for distribution of any infant formula manufactured using 
the system.
    (4) A manufacturer shall ensure that any system that is modified is 
revalidated following the modification and prior to the release for 
distribution of any infant formula manufactured using the modified 
system. All modifications to software shall be made by a designated 
individual and shall be checked by the infant formula manufacturer to 
ensure that infant formula that is produced or analyzed using the 
modified software complies with this subpart and with subpart C of this 
part.
    (c) A manufacturer shall make and retain records, in accordance with 
Sec. 106.100(f)(5), concerning mechanical or electronic equipment.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



Sec. 106.40  Controls to prevent adulteration caused by ingredients,
containers, and closures.

    (a) The only substances that may be used in an infant formula are 
substances that are safe and suitable for use in infant formula under 
the applicable food safety provisions of the Federal Food, Drug, and 
Cosmetic Act; that is, a substance is used in accordance with the 
Agency's food additive regulations, is generally recognized as safe 
(GRAS) for such use, or is authorized by a prior sanction.
    (b) Infant formula containers and closures shall not be reactive or 
absorptive so as to affect the safety of the infant formula. The 
following substances may be used as packaging material that comes in 
contact with an infant formula:
    (1) A food additive that is the subject of a regulation issued under 
section 409(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
348(c)) and is used consistent with the conditions of use of that 
regulation;
    (2) A food contact substance that is the subject of an effective 
notification under section 409(h) of the Federal Food, Drug, and 
Cosmetic Act and is used consistent with the conditions of use in that 
notification;
    (3) A substance that is exempt from regulation as a food additive 
under Sec. 170.39 of this chapter and its use conforms to the use 
identified in the exemption letter;
    (4) A substance that is generally recognized as safe for use in or 
on infant formula or for use in infant formula packaging;
    (5) A substance the use of which is authorized by a prior sanction 
from the Food and Drug Administration or from the U.S. Department of 
Agriculture; and
    (6) A substance that is not a food additive within the meaning of 
section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(s)) because the substance is not reasonably expected to become a 
component of food or otherwise affect the characteristics of food.
    (c) Ingredients, containers, and closures used in the manufacture of 
infant formula shall be identified with a lot number to be used in 
recording their disposition.
    (d) A manufacturer shall develop written specifications for 
ingredients, containers, and closures used in manufacturing infant 
formula and shall develop and follow written procedures to determine 
whether all ingredients, containers, and closures meet these 
specifications. When any specification is not met, an individual 
qualified by education, training, or experience shall

[[Page 219]]

conduct a documented review, shall determine whether a failure to meet 
such a specification could result in an adulterated infant formula, and 
shall make and document a material disposition decision to reject the 
ingredient, container, or closure or the affected infant formula; to 
reprocess or otherwise recondition the ingredient, container, or closure 
or the affected infant formula; or to approve and release the 
ingredient, container, or closure or the affected infant formula for 
use.
    (e) Ingredients, containers, and closures shall be stored in 
separate areas or separated by a system of segregation, such as a 
computerized inventory control, a written card system, or an automated 
system of segregation, clearly designated for materials pending release 
for use; materials released for use; or materials rejected for use in 
infant formula production.
    (1) Any lot of an ingredient, a container, or a closure that does 
not meet the manufacturer's specifications shall be quarantined under a 
system designed to prevent its use in the manufacture of infant formula 
until an individual qualified by education, training, or experience has 
conducted a documented review, has determined whether such failure could 
result in an adulterated infant formula, and has made and documented a 
material disposition decision to reject the ingredient, container, 
closure, or the affected infant formula; to reprocess or otherwise 
recondition the ingredient, container, closure, or the affected infant 
formula; or to approve and release the ingredient, container, closure, 
or the affected infant formula for use.
    (2) Any ingredient, container, or closure that has been reprocessed 
or otherwise reconditioned shall be the subject of a documented review 
and material disposition decision by an individual qualified by 
education, training, or experience to determine whether it may be 
released for use.
    (3) A manufacturer shall not reprocess or otherwise recondition an 
ingredient, container, or closure rejected because it is contaminated 
with microorganisms of public health significance or other contaminants, 
such as heavy metals.
    (f) If an ingredient, container, or closure that complies with a 
manufacturer's specifications, or that has been released for use 
following a material review and disposition decision, is subsequently 
exposed to air, heat, or other conditions that may adversely affect it, 
or if a manufacturer reasonably believes that an ingredient, container, 
or closure that complies with a manufacturer's specifications, or that 
has been released for use following a material review and disposition 
decision, has been exposed to air, heat, or other conditions that may 
adversely affect it, the ingredient, container, or closure shall be 
quarantined under a system designed to prevent its use in the 
manufacture of infant formula until an individual qualified by 
education, training, or experience has conducted a documented review and 
has made and documented a material disposition decision to reject the 
ingredient, container, or closure; to reprocess or otherwise recondition 
the ingredient, container, or closure; or to approve and release the 
ingredient, container, or closure for use.
    (1) Any ingredient, container, or closure that is reprocessed or 
otherwise reconditioned shall be retested or reexamined and be the 
subject of a documented review and material disposition decision by an 
individual qualified by education, training, or experience to determine 
whether the ingredient, container, or closure should be rejected, 
further reprocessed or otherwise further reconditioned, or approved and 
released for use.
    (2) Any rejected ingredient, container, or closure shall be clearly 
identified as having been rejected for use in infant formula 
manufacturing or processing operations and shall be controlled under a 
quarantine system designed to prevent its use in infant formula 
manufacturing or processing operations.
    (3) Any ingredient, container, or closure that has not been 
manufactured, packaged, labeled, or held under conditions to prevent 
adulteration under section 402(a)(1) through (a)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4)) shall not be 
approved and released for use.

[[Page 220]]

    (g) A manufacturer shall make and retain records, in accordance with 
Sec. 106.100(f)(6), on the ingredients, containers, and closures used in 
the manufacture of infant formula.



Sec. 106.50  Controls to prevent adulteration during manufacturing.

    (a) A manufacturer shall prepare and follow a written master 
manufacturing order that establishes controls and procedures for the 
production of an infant formula.
    (1) The manufacturer shall make and retain records, in accordance 
with Sec. 106.100(e), that include complete information relating to the 
production and control of the production aggregate. An individual 
qualified by education, training, or experience shall conduct an 
investigation of any deviations from the master manufacturing order and 
document any corrective action taken.
    (2) Changes made to the master manufacturing order shall be reviewed 
and approved by a responsible official and include an evaluation of the 
effect of the change on the nutrient content and the suitability of the 
formula for infants.
    (b) A manufacturer shall establish controls to ensure that each raw 
or in-process ingredient required by the master manufacturing order is 
examined by one person and checked by a second person or system. This 
checking shall ensure that the correct ingredient is added during the 
manufacturing process, that the ingredient has been released for use in 
infant formula, and that the correct weight or measure of the ingredient 
is added to the production unit.
    (c) A manufacturer shall establish a system of identification for 
the contents of all compounding and storage containers, processing 
lines, and major equipment used during the manufacture of a production 
aggregate of an infant formula. The system shall permit the 
identification of the processing stage and the unique identification 
number for the particular production unit or production aggregate of 
infant formula.
    (d) A manufacturer shall establish controls to ensure that the 
nutrient levels required by Sec. 107.100 of this chapter are maintained 
in the formula, and that the formula is not contaminated with 
microorganisms or other contaminants. Such controls shall include:
    (1) The mixing time; the speed, temperature, and flow rate of 
product; and other critical parameters necessary to ensure the addition 
of required ingredients to, and the homogeneity of, the formula;
    (2) The spray-drying process for powdered infant formula, including 
the filtering of the intake air before heating, to prevent microbial and 
other contamination;
    (3) The removal of air from the finished product to ensure that 
nutrient deterioration does not occur;
    (4) Ensuring that each container of finished product is properly 
sealed. Such controls shall involve use of established procedures, 
specifications, and intervals of examination that are designed by 
qualified individuals and are sufficient to:
    (i) Detect visible closure or seal defects, and
    (ii) Determine closure strength through destructive testing. A 
manufacturer of a liquid infant formula that is a thermally processed 
low-acid food packaged in a hermetically sealed container shall perform 
such closure integrity testing in accordance with Sec. 113.60(a) of this 
chapter.
    (e) A manufacturer shall establish controls that ensure that the 
equipment used at points where control is deemed necessary to prevent 
adulteration is monitored, so that personnel will be alerted to 
malfunctions.
    (f) A manufacturer shall establish controls for in-process material 
as follows:
    (1) For any specification established in accordance with 
Sec. 106.6(c)(1) that a manufacturer fails to meet for in-process 
material, an individual qualified by education, training, or experience 
shall conduct a documented review and shall make a material disposition 
decision to reject the affected in-process material, to reprocess or 
otherwise recondition the affected in-process material, or to approve 
and release the affected in-process material for use or distribution;
    (2) Pending a documented review and material disposition decision, 
any in-process material that fails to meet any

[[Page 221]]

specification established in accordance with Sec. 106.6(c)(1) shall be 
clearly identified as such and shall be controlled under a quarantine 
system designed to prevent its use in manufacturing or processing 
operations until completion of the documented review and material 
disposition decision;
    (3) Any in-process material that has been reprocessed or otherwise 
reconditioned shall be the subject of a documented review and material 
disposition decision by an individual qualified by education, training, 
or experience to determine whether it may be released for use; and
    (4) Any rejected in-process material shall be clearly identified as 
having been rejected for use in infant formula and shall be controlled 
under a quarantine system designed to prevent its use in infant formula 
manufacturing or processing operations.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



Sec. 106.55  Controls to prevent adulteration from microorganisms.

    (a) A manufacturer of infant formula shall establish a system of 
process controls covering all stages of processing that is designed to 
ensure that infant formula does not become adulterated due to the 
presence of microorganisms in the formula or in the processing 
environment.
    (b) A manufacturer of liquid infant formula shall comply, as 
appropriate, with the procedures specified in part 113 of this chapter 
for thermally processed low-acid foods packaged in hermetically sealed 
containers and part 114 of this chapter for acidified foods.
    (c) A manufacturer of powdered infant formula shall test 
representative samples of each production aggregate of powdered infant 
formula at the final product stage, before distribution, to ensure that 
each production aggregate meets the microbiological quality standards in 
the table in paragraph (e) of this section.
    (d) A manufacturer shall make and retain records, in accordance with 
Sec. 106.100(e)(5)(ii) and (f)(7), on the testing of infant formulas for 
microorganisms.
    (e) A powdered infant formula that contains any microorganism that 
exceeds the M value listed for that microorganism in the table in 
paragraph (e) of this section shall be deemed adulterated under sections 
402(a)(1), 402(a)(4), and 412(a)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350a(a)(3)). The Food and Drug Administration 
will determine compliance with the M values listed below using the 
latest edition of the Bacteriological Analytical Manual (BAM) (http://
www.fda.gov/Food/FoodScienceResearch/LaboratoryMethods/
BacteriologicalAnalyticalManualBAM/default.htm) (accessed April 8, 
2013).

----------------------------------------------------------------------------------------------------------------
                 Microorganism                       n \1\                 Sample size                M value
----------------------------------------------------------------------------------------------------------------
Cronobacter spp...............................              30  10 g (grams)....................          \2\ 0.
Salmonella spp................................              60  25 g............................          \2\ 0.
----------------------------------------------------------------------------------------------------------------
\1\ Number of samples.
\2\ None detected.



Sec. 106.60  Controls to prevent adulteration during packaging 
and labeling of infant formula.

    (a) A manufacturer shall examine packaged and labeled infant formula 
during finishing operations to ensure that all containers and packages 
in the production aggregate have the correct label, the correct use-by 
date, and the correct code established under Sec. 106.80.
    (b) Labels shall be designed, printed, and applied so that the 
labels remain legible and attached during the conditions of processing, 
storage, handling, distribution, and use.
    (c) Packaging used to hold multiple containers of an infant formula 
product shall be labeled as follows:
    (1) Where all containers are the same infant formula product and all 
bear the same code established under Sec. 106.80, the packaging label 
shall include the product name, the name of the manufacturer, 
distributor, or shipper, and the code established under Sec. 106.80.
    (2) Where the containers are not the same infant formula product or 
do not

[[Page 222]]

all bear the same code established under Sec. 106.80, the packaging 
label shall:
    (i) Include the product name of each product, the name of the 
manufacturer, distributor, or shipper of each product, the code 
established under Sec. 106.80 for each product, and a ``use by'' date 
that is no later than the ``use by'' date of the container exhibiting 
the closest ``use by'' date applied to satisfy the requirement of 
Sec. 107.20(c) of this chapter; or
    (ii) Include a unique identification number assigned by the 
packager, provided that the distributor of the package maintains a 
record linked to such unique number that identifies the product name of 
each product, the name of the manufacturer, distributor, or shipper of 
each product, the code established under Sec. 106.80 for each product, 
and the ``use by'' date for each product applied to satisfy the 
requirement of Sec. 107.20(c) of this chapter.



Sec. 106.70  Controls on the release of finished infant formula.

    (a) A manufacturer shall control under a quarantine system designed 
to prevent use or distribution of each production aggregate of infant 
formula until it determines that the production aggregate meets all of 
the manufacturer's specifications, including those adopted to meet the 
standards of Sec. 106.55 on microbiological contamination and of 
Sec. 106.91(a) on quality control procedures, or until the documented 
review of the failure to meet any of the manufacturer's specifications 
finds that the failure does not result in, or could not lead to, 
adulteration of the product.
    (b) Any production aggregate of infant formula that fails to meet 
any of the manufacturer's specifications shall be quarantined under a 
system designed to prevent its use in the manufacture of infant formula 
or its distribution until an individual qualified by education, 
training, or experience has conducted a documented review and has made 
and documented a material disposition decision to reject the infant 
formula; to reprocess or otherwise recondition the infant formula; or to 
approve and release the infant formula. Any production aggregate of 
infant formula that is reprocessed or otherwise reconditioned shall be 
the subject of a documented review and material disposition decision by 
an individual qualified by education, training, or experience to 
determine whether it may be released for use or distribution.
    (c) Any rejected infant formula shall be clearly identified as 
having been rejected for use and shall be controlled under a quarantine 
system designed to prevent its release or distribution.
    (d) A production aggregate of infant formula, including a 
reprocessed or reconditioned production aggregate, that does not meet 
the nutrient requirements of section 412(i) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350a(i)) or that has not been manufactured, 
packaged, labeled, and held under conditions to prevent adulteration 
under sections 402(a)(1) through (a)(4) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342(a)(1) through (a)(4)) shall not be approved 
and released for distribution.



Sec. 106.80  Traceability.

    Each production aggregate of infant formula shall be coded with a 
sequential number that identifies the product and the establishment 
where the product was packed and that permits tracing of all stages of 
manufacture of that production aggregate, including the year, the days 
of the year, and the period during those days that the product was 
packed, and the receipt and handling of raw materials used.



Sec. 106.90  Audits of current good manufacturing practice.

    (a) A manufacturer of an infant formula, or an agent of such 
manufacturer, shall conduct regularly scheduled audits to determine 
whether the manufacturer has complied with the current good 
manufacturing practice regulations in this subpart. Such audits shall be 
conducted at a frequency that is required to ensure compliance with such 
regulations.
    (b) The audits required by paragraph (a) of this section shall be 
performed by an individual or a team of individuals who, as a result of 
education, training, or experience, is knowledgeable in all aspects of 
infant formula production

[[Page 223]]

and of the Agency's regulations concerning current good manufacturing 
practice that such individual or team is responsible for auditing. This 
individual or team of individuals shall have no direct responsibility 
for the matters that such individual or team is auditing and shall have 
no direct interest in the outcome of the audit.



                  Subpart C_Quality Control Procedures



Sec. 106.91  General quality control.

    (a) During manufacture, a manufacturer shall test each production 
aggregate for nutrients as follows:
    (1) Each nutrient premix used in the manufacture of an infant 
formula shall be tested for each nutrient (required under Sec. 107.100 
of this chapter or otherwise added by the manufacturer) that the 
manufacturer is relying on the premix to provide, to ensure that the 
premix is in compliance with the manufacturer's specifications;
    (2) During the manufacturing process, after the addition of the 
premix, or at the final product stage but before distribution, each 
production aggregate of infant formula shall be tested for at least one 
indicator nutrient for each of the nutrient premixes used in the infant 
formula to confirm that the nutrients supplied by each of the premixes 
are present, in the proper concentration, in the production aggregate of 
infant formula.
    (3) At the final product stage, before distribution of an infant 
formula, each production aggregate shall be tested for vitamins A, C, E, 
and thiamin.
    (4) During the manufacturing process or at the final product stage, 
before distribution, each production aggregate shall be tested for all 
nutrients required to be included in such formula under Sec. 107.100 of 
this chapter for which testing is not conducted for compliance with 
paragraphs (a)(1) or (a)(3) of this section and for any nutrient added 
by the manufacturer for which testing is not conducted for compliance 
with paragraph (a)(1) of this section.
    (b) A manufacturer shall test each production aggregate of finished 
product for nutrients as follows:
    (1)(i) For an infant formula that is a new infant formula the 
manufacturer shall collect, from each manufacturing site and at the 
final product stage, a representative sample of the first production 
aggregate of packaged, finished formula in each physical form (powder, 
ready-to-feed, or concentrate) and evaluate the levels of all nutrients 
required under Sec. 107.100 of this chapter and all other nutrients 
added by the manufacturer. The manufacturer shall repeat such testing 
every 4 months thereafter throughout the shelf life of the product.
    (ii) The Food and Drug Administration will exempt the manufacturer 
from the requirements of paragraph (b)(1)(i) of this section if the 
manufacturer of a new infant formula requests an exemption and provides 
analytical data, as required under Sec. 106.120(b)(7), that demonstrates 
that the stability of the new infant formula will likely not differ from 
the stability of formulas with similar composition, processing, and 
packaging for which there are extensive stability data. A manufacturer 
exempt from the requirements of paragraph (b)(1)(i) of this section 
would be required to test the first production aggregate according to 
the requirements of Sec. 106.91(b)(2).
    (2) The manufacturer shall collect, from each manufacturing site and 
at the final product stage, a representative sample of each subsequent 
production aggregate of packaged, finished formula in each physical form 
(powder, ready-to-feed, or concentrate) and evaluate the levels of all 
nutrients required under Sec. 107.100 of this chapter and all other 
nutrients added by the manufacturer. The manufacturer shall repeat such 
testing at the end of the shelf life of the product.
    (3) If the results of the testing required by paragraph (b)(1) of 
this section do not substantiate the shelf life of the infant formula, 
the manufacturer shall address, as appropriate, all production 
aggregates of formula released and pending release for distribution that 
are implicated by the testing results, such as by conducting the testing 
required by paragraph (b)(1) of this section on a subsequently produced 
production aggregate to substantiate the shelf life of the infant 
formula or

[[Page 224]]

revising the use by date for such product so that such date is 
substantiated by the stability testing results.
    (4) If results of the testing required by paragraph (b)(2) of this 
section show that any required nutrient is not present in the production 
aggregate of infant formula at the level required by Sec. 107.100 of 
this chapter or that any nutrient added by the manufacturer is not 
present at the level declared on the label of the production aggregate 
of infant formula, the manufacturer shall:
    (i) Investigate the cause of such variance in the level of any 
required or added nutrient;
    (ii) Evaluate the significance, if any, of the results for other 
production aggregates of the same formula that have been released for 
distribution;
    (iii) Address, as appropriate, all production aggregates of formula 
released and pending release for distribution that are implicated by the 
testing results; and
    (iv) Determine whether it is necessary to conduct the testing 
required by paragraph (b)(1) of this section.
    (5) The testing required by paragraphs (b)(1) and (b)(2) of this 
section is not required to evaluate the level of minerals present in the 
infant formula.
    (c) All quality control testing shall be conducted using 
appropriate, scientifically valid test methods.
    (d) A manufacturer shall make and retain quality control records in 
accordance with Sec. 106.100(e)(5)(i).

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



Sec. 106.92  Audits of quality control procedures.

    (a) A manufacturer of an infant formula, or an agent of such a 
manufacturer, shall conduct regularly scheduled audits to determine 
whether the manufacturer has complied with the requirements for quality 
control procedures that are necessary to ensure that an infant formula 
provides nutrients in accordance with section 412(b) and (i) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(b) and (i)) and is 
manufactured in a manner designed to prevent adulteration of the infant 
formula under section 412(a)(1) and (a)(3) of the Federal Food, Drug, 
and Cosmetic Act. Such audits shall be conducted at a frequency that is 
required to ensure compliance with the requirements for quality control 
procedures.
    (b) The audits required by paragraph (a) of this section shall be 
performed by an individual or a team of individuals who, as a result of 
education, training, or experience, is knowledgeable in all aspects of 
infant formula production and of the regulations concerning quality 
control procedures that such individual or team is responsible for 
auditing. This individual or team of individuals shall have no direct 
responsibility for the matters that such individual or team is auditing 
and shall have no direct interest in the outcome of the audit.



                       Subpart D_Conduct of Audits



Sec. 106.94  Audit plans and procedures.

    (a) A manufacturer shall develop and follow a written audit plan 
that is available at the manufacturing facility for Food and Drug 
Administration inspection.
    (b) The audit plan shall include audit procedures that set out the 
methods the manufacturer uses to determine whether the facility is 
operating in accordance with current good manufacturing practice, with 
the quality control procedures that are necessary to ensure that an 
infant formula provides nutrients in accordance with sections 412(b) and 
(i) of the Federal Food, Drug, and Cosmetic Act, and in a manner 
designed to prevent adulteration of the infant formula.
    (c) The audit procedures shall include:
    (1) An evaluation of the production and in-process control system 
established under Sec. 106.6(b) by:
    (i) Observing the production of infant formula and comparing the 
observed process to the written production and in-process control plan 
required under Sec. 106.6(b);
    (ii) Reviewing records of the monitoring of points, steps, or stages 
where control is deemed necessary to prevent adulteration; and
    (iii) Reviewing records of how deviations from any specification at 
points, steps, or stages where control is deemed necessary to prevent 
adulteration were handled; and

[[Page 225]]

    (2) A review of a representative sample of all records maintained in 
accordance with Sec. 106.100(e) and (f).



              Subpart E_Quality Factors for Infant Formulas



Sec. 106.96  Requirements for quality factors for infant formulas.

    The regulations set forth in this subpart define the minimum 
requirements for quality factors for infant formulas:
    (a) An infant formula shall meet the quality factor of normal 
physical growth.
    (b) A manufacturer of an infant formula that is not an eligible 
infant formula shall demonstrate that a formula supports normal physical 
growth in infants when fed as a sole source of nutrition by conducting, 
in accordance with good clinical practice, an adequate and well-
controlled growth monitoring study of the infant formula that:
    (1) Is no less than 15 weeks in duration, enrolling infants no more 
than 2 weeks old at time of entry into the study;
    (2) Includes the collection and maintenance of data on formula 
intake and anthropometric measures of physical growth, including body 
weight, recumbent length, head circumference, average daily weight 
increment, and average daily recumbent length increment;
    (3) Includes anthropometric measurements made at the beginning and 
end of the study, and at least four additional measurements made at 
intermediate time points with three of the six total measurements made 
within the first 4 weeks of the study and three measurements made at 
approximately 4-week intervals over the remaining 11 weeks of the study;
    (4) Compares the anthropometric data for the test group to a 
concurrent control group or groups at each time point and compares the 
anthropometric data for each infant (body weight for age, body length 
for age, head circumference for age, and weight for length) in the test 
group and the control group to the 2009 CDC growth charts, which are 
incorporated by reference at Sec. 106.160; and
    (5) Compares the data on formula intake of the test group with a 
concurrent control group or groups and a scientifically appropriate 
reference.
    (c) The Food and Drug Administration will exempt a manufacturer from 
the requirements of paragraph (b) of this section, if:
    (1) The manufacturer requests an exemption and provides assurances, 
as required under Sec. 106.121(b), that the changes made by the 
manufacturer to an existing infant formula are limited to changing the 
type of packaging of an existing infant formula (e.g., changing from 
metal cans to plastic pouches); or
    (2) The manufacturer requests an exemption and provides assurances, 
as required under Sec. 106.121, which demonstrate that:
    (i) An alternative method or study design that is based on sound 
scientific principles is available to show that the formula supports 
normal physical growth in infants when the formula is fed as the sole 
source of nutrition;
    (ii) The change made by the manufacturer to an existing formula does 
not affect the ability of the formula to support normal physical growth; 
or
    (iii) The manufacturer markets a formulation in more than one form 
(e.g., liquid and powdered forms) and the quality factor requirements 
are met by the form of the formula that is processed using the method 
that has the greatest potential for adversely affecting nutrient content 
and bioavailability.
    (d) A manufacturer of a new infant formula that is not an eligible 
infant formula shall, in accordance with Sec. 106.100(p)(1), make and 
retain records demonstrating that the formula meets the quality factor 
of normal physical growth.
    (e) An infant formula shall meet the quality factor of sufficient 
biological quality of protein.
    (f) A manufacturer of an infant formula that is not an eligible 
infant formula shall demonstrate that a formula meets the quality factor 
of sufficient biological quality of protein by establishing the 
biological quality of the protein in the infant formula when fed as the 
sole source of nutrition using an

[[Page 226]]

appropriate modification of the Protein Efficiency Ratio (PER) rat 
bioassay described in the ``Official Methods of Analysis of AOAC 
International,'' 18th ed., sections 45.3.04 and 45.3.05, ``AOAC Official 
Method 960.48 Protein Efficiency Ratio Rat Bioassay,'' which is 
incorporated by reference at Sec. 106.160. The PER rat bioassay shall be 
conducted on a formula and the results evaluated prior to the initiation 
of a growth monitoring study of the formula that is required under 
paragraph (b) of this section.
    (g) The Food and Drug Administration will exempt a manufacturer from 
the requirements of paragraph (f) of this section, if:
    (1) The manufacturer requests an exemption and provides assurances 
as required under Sec. 106.121(g) that the changes made by the 
manufacturer to an existing infant formula are limited to changing the 
type of packaging of an existing infant formula (e.g., changing from 
metal cans to plastic pouches); or
    (2) The manufacturer requests an exemption and provides assurances, 
as required under Sec. 106.121(h), that demonstrate that the change made 
by the manufacturer to an existing formula does not affect the 
bioavailability of the protein.
    (3) The manufacturer requests an exemption and provides assurances, 
as required under Sec. 106.121(i), that demonstrate that an alternative 
method to the PER that is based on sound scientific principles is 
available to demonstrate that the formula supports the quality factor 
for the biological quality of the protein.
    (h) A manufacturer of a new infant formula that is not an eligible 
infant formula shall, in accordance with Sec. 106.100(q), make and 
retain records demonstrating that the formula meets the quality factor 
of sufficient biological quality of protein.
    (i) The following provisions for requirements for quality factors 
apply only to an ``eligible infant formula'' as defined in Sec. 106.3:
    (1) An eligible infant formula that fulfills one or more of the 
following criteria meets the quality factor of normal physical growth:
    (i) The scientific evidence on such infant formula meets the 
requirements of paragraph (b) of this section that apply to infant 
formula that is not an eligible infant formula;
    (ii) The scientific evidence on such infant formula meets the 
following provisions:
    (A) The evidence is an adequate and well-controlled growth study, 
conducted in accordance with good clinical practice, to determine 
whether an infant formula supports normal physical growth in infants 
when the formula is fed as the sole source of nutrition;
    (B) The growth study is no less than 4 months in duration, enrolling 
infants no more than 1 month old at time of entry into the study;
    (C) The growth study collects from the study subjects data on 
anthropometric measures of physical growth, including body weight, 
recumbent length, head circumference, and average daily weight 
increment, and plots the data on the following charts from ``Physical 
Growth: National Center for Health Statistics Percentiles'' for body 
weight, body length, and head circumference, which are incorporated by 
reference at Sec. 106.160:
    (1) Figure 1. Length by age percentiles for girls aged birth-36 
months (p. 609);
    (2) Figure 2. Length by age percentiles for boys aged birth-36 
months (p. 610);
    (3) Figure 3. Weight by age percentiles for girls aged birth-36 
months (p. 611);
    (4) Figure 4. Weight by age percentiles for boys aged birth-36 
months (p. 612);
    (5) Figure 5. Head circumference by age percentiles for girls aged 
birth-36 months (p. 613);
    (6) Figure 6. Weight by length percentiles for girls aged birth-36 
months (p. 613);
    (7) Figure 7. Head circumference by age percentiles for boys aged 
birth-36 months (p. 614); and
    (8) Figure 8. Weight by length percentiles for boys aged birth-36 
months (p. 614); and
    (D) The growth study collects anthropometric measurements at the 
beginning of the growth study, at 2 weeks, at 4 weeks, at least monthly 
thereafter, and at the conclusion of the study; or

[[Page 227]]

    (iii) The scientific evidence on such infant formula otherwise 
demonstrates that such formula supports normal physical growth.
    (2) An eligible infant formula that fulfills one or more of the 
following criteria meets the quality factor of sufficient biological 
quality of the protein:
    (i) The scientific evidence on such infant formula meets the 
requirements of paragraph (f) of this section that apply to infant 
formula that is not an eligible infant formula;
    (ii) The scientific evidence on such infant formula is a study that 
establishes the biological quality of the protein in an infant formula 
by demonstrating that the protein source supports adequate growth using 
the Protein Efficiency Ratio (PER) rat bioassay described in sections 
45.3.04 and 45.3.05 of the ``Official Methods of Analysis of the 
Association of Official Analytical Chemists,'' 16th ed., which are 
incorporated by reference at Sec. 106.160; or
    (iii) The scientific evidence on such infant formula otherwise 
demonstrates that the protein in such infant formula is of sufficient 
biological quality.
    (3) The manufacturer of an eligible infant formula may, not later 
than November 12, 2015, submit a petition to the Food and Drug 
Administration under Sec. 10.30 of this chapter that:
    (i) Demonstrates that such formula fulfills one or more of the 
criteria in paragraph (i)(1) of this section; or
    (ii) Demonstrates that such formula fulfills one or more of the 
criteria in paragraph (i)(2) of this section.
    (4) A petition filed under paragraph (i)(3) of this section shall 
address only one infant formula formulation and shall contain all data 
and information relied upon by the manufacturer to demonstrate that such 
formulation fulfills one or more of the criteria in paragraph (i)(1) or 
in paragraph (i)(2) of this section. A manufacturer may combine 
petitions submitted under paragraphs (i)(3)(i) and (i)(3)(ii) of this 
section that relate to the same formulation.
    (5) The manufacturer of each eligible infant formula shall make and 
retain, in accordance with Sec. 106.100(p)(2), records to demonstrate 
that such formula supports normal physical growth in infants when fed as 
the sole source of nutrition and shall make and retain, in accordance 
with Sec. 106.100(q)(2), records to demonstrate that that the protein in 
such infant formula is of sufficient biological quality. The records 
required by this paragraph shall include all relevant scientific data 
and information and a narrative explanation of why the data and 
information demonstrate that the formula supports normal physical growth 
and a narrative explanation of why the data and information demonstrate 
that the protein in such infant formula is of sufficient biological 
quality.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33071, June 10, 2014]



                      Subpart F_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 (21 U.S.C. 
350a)).
    (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 Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(2)(C)).
    (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 Federal Food, 
Drug, and Cosmetic Act and Sec. 107.100 of this chapter.

[[Page 228]]

    (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 Federal Food, Drug, and 
Cosmetic 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) For each production aggregate of infant formula, a manufacturer 
shall prepare and maintain records that include complete information 
relating to the production and control of the production aggregate. 
These records shall include:
    (1) The master manufacturing order. The master manufacturing order 
shall include:
    (i) The significant steps in the production of the production 
aggregate and the date on which each significant step occurred;
    (ii) For a manufacturing facility that has more than one set of 
equipment or more than one processing line, the identity of equipment 
and processing lines for which the manufacturer has identified points, 
steps, or stages in the production process where control is necessary to 
prevent adulteration;
    (iii) The identity of each lot of ingredients, containers, and 
closures used in producing the production aggregate of formula;
    (iv) The amount of each ingredient to be added to the production 
aggregate of infant formula and a check (verification) that the correct 
amount was added; and
    (v) A copy of each infant formula label used on a finished 
production aggregate of infant formula and the results of examinations 
conducted during the finishing operations to provide assurance that the 
containers and packages have the correct label.
    (2) Any deviations from the master manufacturing order and any 
corrective actions taken because of the deviations.
    (3) Documentation, in accordance with Sec. 106.6(c), of the 
monitoring at any point, step, or stage in the manufacturer 's 
production process where control is deemed necessary to prevent 
adulteration. These records shall include:
    (i) A list of the specifications established at each point, step, or 
stage in the production process where control is deemed necessary to 
prevent adulteration, in accordance with Sec. 106.6(c)(1), including 
documentation of the scientific basis for each specification;
    (ii) The actual values obtained during the monitoring operation, any 
deviations from established specifications, and any corrective actions 
taken; and
    (iii) Identification of the person monitoring each point, step, or 
stage in the production process where control is deemed necessary to 
prevent adulteration.
    (4) The conclusions and followup, along with the identity of the 
individual qualified by education, training, or experience who 
investigated:
    (i) Any deviation from the master manufacturing order and any 
corrective actions taken;
    (ii) A finding that a production aggregate or any of its ingredients 
failed to meet the infant formula manufacturer's specifications; and
    (iii) A failure to meet any specification at any point, step, or 
stage in the production process where control is deemed necessary to 
prevent adulteration.
    (5) The results of all testing performed on the production aggregate 
of infant formula, including testing on the in-process production 
aggregate, at the final product stage, and on finished product 
throughout the shelf life of the product. The results recorded shall 
include:
    (i) The results of all quality control testing conducted in 
accordance with Sec. 106.91(a) and (b) to verify that each nutrient 
required by Sec. 107.100 of this chapter is present in each production

[[Page 229]]

aggregate of infant formula at the level required by Sec. 107.100 of 
this chapter, and that all other nutrients added by the manufacturer are 
present at the appropriate level. The record of the results of the 
quality control testing shall include:
    (A) A summary document identifying the stages of the manufacturing 
process at which the nutrient analysis for each required nutrient is 
conducted as required under Sec. 106.91(a); and
    (B) A summary document on the stability testing program conducted 
under Sec. 106.91(b), including the nutrients tested and the frequency 
of nutrient testing throughout the shelf life of the product.
    (ii) For powdered infant formula, the results of any testing 
conducted in accordance with Sec. 106.55(c) to verify compliance with 
the microbiological quality standards in Sec. 106.55(e).
    (f) A manufacturer shall make and retain all records described in 
subparts B and C of this part, including:
    (1) Records, in accordance with Sec. 106.20(f)(4), of the frequency 
and results of testing of the water used in the production of infant 
formula;
    (2) Records, in accordance with Sec. 106.30(d), of accuracy checks 
of instruments and controls. A certification of accuracy of any known 
reference standard used and a history of recertification shall be 
maintained. At a minimum, such records shall specify the instrument or 
control being checked, the date of the accuracy check, the standard 
used, the calibration method used, the results found, any actions taken 
if the instrument is found to be out of calibration, and the initials or 
name of the individual performing the test. If calibration of an 
instrument shows that a specification at a point, step, or stage in the 
production process where control is deemed necessary to prevent 
adulteration has not been met, a written evaluation of all affected 
product, and any actions that need to be taken with respect to that 
product, shall be made.
    (3) Records, in accordance with Sec. 106.30(e)(3)(iii).
    (4) Records, in accordance with Sec. 106.30(f), on equipment 
cleaning, sanitizing, and maintenance that show the date and time of 
such cleaning, sanitizing, and maintenance and the production aggregate 
number of each infant formula processed between equipment startup and 
shutdown for cleaning, sanitizing, and maintenance. The person 
performing and checking the cleaning, sanitizing, and maintenance shall 
date and sign or initial the record indicating that the work was 
performed.
    (5) Records, in accordance with Sec. 106.35(c), on all mechanical 
and electronic equipment used in the production or quality control of 
infant formula. These records shall include:
    (i) A list of all systems used with a description of the computer 
files and the defined capabilities and inherent limitations of each 
system;
    (ii) A copy of all software used;
    (iii) Records that document installation, calibration, testing or 
validation, and maintenance of the systems used;
    (iv) A list of all persons authorized to create or modify software;
    (v) Records that document modifications to software, including the 
identity of the person who modified the software;
    (vi) Records that document retesting or revalidation of modified 
systems; and
    (vii) A backup file of data entered into a computer or related 
system. The backup file shall consist of a hard copy or alternative 
system, such as duplicate electronic records, tapes, or microfilm, 
designed to ensure that backup data are exact and complete, and that 
they are secure from alteration, inadvertent erasures, or loss.
    (6) Records, in accordance with Sec. 106.40(g), on ingredients, 
containers, and closures used in the manufacture of infant formula. 
These records shall include:
    (i) The identity and quantity of each lot of ingredients, 
containers, and closures;
    (ii) The name of the supplier;
    (iii) The supplier's lot numbers;
    (iv) The name and location of the manufacturer of the ingredient, 
container, or closure, if different from the supplier;
    (v) The date of receipt;
    (vi) The receiving code as specified; and

[[Page 230]]

    (vii) The results of any test or examination (including retesting 
and reexamination) performed on the ingredients, containers, or closures 
and the conclusions derived there from and the disposition of all 
ingredients, containers, or closures.
    (7) A full description of the methodology used to test powdered 
infant formula to verify compliance with the microbiological quality 
standards of Sec. 106.55(c) and the methodology used to do quality 
control testing, in accordance with Sec. 106.91(a).
    (g) A manufacturer shall maintain all records pertaining to 
distribution of the infant formula, including records that show that 
formula produced for export only is exported. Such records shall include 
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 make and retain records pertaining to 
regularly scheduled audits, including the audit plans and procedures, 
the findings of the audit, and a listing of any changes made in response 
to these findings. The manufacturer shall make readily available for 
authorized inspection the audit plans and procedures and a statement of 
assurance that the regularly scheduled audits are being conducted. The 
findings of the audit and any changes made in response to these findings 
shall be maintained for the time period required under paragraph (n) of 
this section, but need not be made available to the Food and Drug 
Administration.
    (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 a Food and Drug Administration 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. 106.150.
    (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 and
    (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.
    (5) The manufacturer shall include in a complaint file the following 
information concerning the complaint:

[[Page 231]]

    (i) The name of the infant formula;
    (ii) The production aggregate 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 a Food and Drug 
Administration official.
    (vi) All actions taken to followup 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 paragraph (k)(6) of this section, 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) A manufacturer shall maintain all records required under this 
part in a manner that ensures that both the manufacturer and the Food 
and Drug Administration can be provided with access to such records 
within 24 hours. The manufacturer may maintain the records required 
under this part as original records, as true copies such as photocopies, 
microfilm, microfiche, or other accurate reproductions of the original 
records, or as electronic records. Where reduction techniques, such as 
microfilming, are used, suitable reader and photocopying equipment shall 
be readily available. All electronic records maintained under this part 
shall comply with part 11 of this chapter.
    (n) Production control, product testing, testing results, 
complaints, and distribution records necessary to verify compliance with 
parts 106, 107, 109, 110, 113, and 117 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 production aggregate of infant formula.
    (p) A manufacturer shall make and retain records that demonstrate 
that the formula meets the quality factor of normal physical growth.
    (1) For an infant formula that is not an eligible infant formula, in 
accordance with Sec. 106.96(d), these records shall include:
    (i) Records demonstrating compliance with the requirements in 
Sec. 106.96(b), including records made in compliance with Sec. 106.121; 
or
    (ii) Records demonstrating satisfaction of an applicable exemption 
under Sec. 106.96(c), including records made in compliance with 
Sec. 106.121.
    (2) For an eligible infant formula, in accordance with 
Sec. 106.96(i)(5), these records shall include records demonstrating 
that the formula fulfills one or more of the criteria listed in 
Sec. 106.96(i)(1).

[[Page 232]]

    (q) A manufacturer shall make and retain records that demonstrate 
that a formula meets the quality factor of sufficient biological quality 
of protein.
    (1) For an infant formula that is not an eligible infant formula, in 
accordance with Sec. 106.96(h), these records shall include:
    (i) Records demonstrating compliance with the requirements in 
Sec. 106.96(f), including records made in compliance with Sec. 106.121; 
or
    (ii) Records demonstrating satisfaction of an applicable exemption 
under Sec. 106.96(g), including records made in compliance with 
Sec. 106.121.
    (2) For an eligible infant formula, in accordance with 
Sec. 106.96(i)(5), these records shall include records demonstrating 
that the formula fulfills one or more of the criteria listed in 
Sec. 106.96(i)(2).
    (r) The failure to comply with the records requirements in this 
section applicable to the quality factors shall render the formula 
adulterated under section 412(a)(2) of the Federal Food, Drug, and 
Cosmetic Act. The failure to comply with the records requirements in 
this section applicable to the good manufacturing practices and quality 
control procedures, including distribution and audit records 
requirements, with respect to an infant formula shall render the formula 
adulterated under section 412(a)(3) of the Federal Food, Drug, and 
Cosmetic Act. A failure to retain or make available records applicable 
to the quality factor requirements, quality control procedures, or 
current good manufacturing practices requirements in compliance with 
paragraph (l), (m), or (n) of this section with respect to a formula 
shall render the formula adulterated under section 412(a)(2) or (a)(3) 
of the Federal Food, Drug, and Cosmetic Act, as applicable.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014; 80 
FR 56144, Sept. 17, 2015]



    Subpart G_Registration, Submission, and Notification Requirements



Sec. 106.110  New infant formula registration.

    (a) Before a new infant formula may be introduced or delivered for 
introduction into interstate commerce, including a new infant formula 
for export only, the manufacturer of the formula shall register with the 
Food and Drug Administration, Center for Food Safety and Applied 
Nutrition, Office of Nutrition, Labeling, and Dietary Supplements, 
Infant Formula and Medical Foods Staff (HFS-850), 5001 Campus Dr., 
College Park, MD 20740-3835.
    (b) The new infant formula registration shall include:
    (1) The name of the new infant formula;
    (2) The name of the manufacturer;
    (3) The street address of the place of business of the manufacturer; 
and
    (4) The name and street address of each establishment at which the 
manufacturer intends to manufacture such new infant formula.



Sec. 106.120  New infant formula submission.

    (a) At least 90 days before a new infant formula is introduced or 
delivered for introduction into interstate commerce, a manufacturer 
shall submit notice of its intent to do so to the Food and Drug 
Administration at the address given in Sec. 106.110(a). An original and 
two paper copies of such notice of intent shall be submitted, unless the 
notice is submitted in conformance with part 11 of this chapter, in 
which case a single copy shall be sufficient.
    (b) The new infant formula submission shall include:
    (1) The name and description of the physical form (e.g., powder, 
ready-to feed, or concentrate) of the infant formula;
    (2) An explanation of why the formula is a new infant formula;
    (3) The quantitative formulation of each form of the infant formula 
that is the subject of the notice in units per volume or units per 
weight for liquid formulas, specified either as sold or as fed, and 
units per dry weight for powdered formulas, and the weight of powder to 
be reconstituted with a specified volume of water, and, when applicable, 
a description of any reformulation of the infant formula, including a 
listing of each new or changed ingredient and a discussion of the effect 
of such changes on the nutrient levels in the formulation;

[[Page 233]]

    (4) A description, when applicable, of any change in processing of 
the infant formula. Such description shall identify the specific change 
in processing, including side-by-side, detailed schematic diagrams 
comparing the new processing to the previous processing and processing 
times and temperatures;
    (5) Assurance that the infant formula will not be marketed unless 
the formula meets the requirements for quality factors of section 
412(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a(b)(1)) and the nutrient content requirements of section 412(i) of 
the Federal Food, Drug, and Cosmetic Act.
    (i) Assurance that the formula meets the requirements for quality 
factors, which are set forth in Sec. 106.96, shall be provided by a 
submission that complies with Sec. 106.121;
    (ii) Assurance that the formula complies with the nutrient content 
requirements, which are set forth in Sec. 107.100 of this chapter, shall 
be provided by a statement that the formula will not be marketed unless 
it meets the nutrient requirements of Sec. 107.100 of this chapter, as 
demonstrated by testing required under subpart C of this part; and
    (6) Assurance that the processing of the infant formula complies 
with section 412(b)(2) of the Federal Food, Drug, and Cosmetic Act. Such 
assurance shall include:
    (i) A statement that the formula will be produced in accordance with 
subparts B and C of this part; and
    (ii) The basis on which each ingredient meets the requirements of 
Sec. 106.40(a), e.g. that it is an approved food additive, that it is 
authorized by a prior sanction, or that it is generally recognized as 
safe (GRAS) for its intended use. Any claim that an ingredient is GRAS 
shall be supported by a citation to the Agency's regulations or by an 
explanation, including a list of published studies and a copy of those 
publications, for why, based on the published studies, there is general 
recognition of the safety of the use of the ingredient in infant 
formula.
    (7) If the manufacturer is requesting an exemption under 
Sec. 106.91(b)(1)(ii), the manufacturer shall include the scientific 
evidence that the manufacturer is relying on to demonstrate that the 
stability of the new infant formula will likely not differ from the 
stability of formulas with similar composition, processing, and 
packaging for which there are extensive stability data.
    (c) For a new infant formula for export only, a manufacturer may 
submit, in lieu of the information required under paragraphs (b)(5) and 
(b)(6) of this section, a statement certifying that the infant formula 
meets the specifications of the foreign purchaser, the infant formula 
does not conflict with the laws of the country to which it is intended 
for export, the infant formula is labeled on the outside of the shipping 
package to indicate that it is intended for export only, and the infant 
formula will not be sold or offered for sale in domestic commerce. Such 
manufacturer shall also submit a statement certifying that it has 
adequate controls in place to ensure that such formula is actually 
exported.
    (d) The submission will not constitute notice under section 412 of 
the Federal Food, Drug, and Cosmetic Act unless it complies fully with 
paragraph (b) of this section, as applicable, and the information that 
it contains is set forth in a manner that is readily understandable. The 
Agency will notify the manufacturer if the notice is not complete 
because it does not meet the requirements in section 412(c) and (d) of 
the Federal Food, Drug, and Cosmetic Act.
    (e) If a new infant formula submission contains all the information 
required by paragraph (b) of this section, as applicable, the Food and 
Drug Administration will acknowledge its receipt and notify the 
manufacturer of the date of receipt. The date that the Agency receives a 
new infant formula submission that is complete is the filing date for 
such submission. The manufacturer shall not market the new infant 
formula before the date that is 90 days after the filing date. If the 
information in the submission does not provide the assurances required 
under section 412(d)(1) of the Federal Food, Drug, and Cosmetic Act and 
the regulations of this chapter, the Food and Drug Administration will 
so notify the manufacturer before the expiration of the 90th day.

[[Page 234]]

    (f) If the manufacturer provides additional information in support 
of a new infant formula submission, the Agency will determine whether 
the additional information is a substantive amendment to the new infant 
formula submission. If the Agency determines that the new submission is 
a substantive amendment, the Food and Drug Administration will assign 
the new infant formula submission a new filing date. The Food and Drug 
Administration will acknowledge receipt of the additional information 
and, when applicable, notify the manufacturer of the new filing date, 
which is the date of receipt by the Food and Drug Administration of the 
information that constitutes the substantive amendment to the new infant 
formula submission.
    (g) Submissions relating to exempt infant formulas are subject to 
the provisions of Sec. 107.50 of this chapter.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014]



Sec. 106.121  Quality factor assurances for infant formulas.

    To provide assurance that an infant formula meets the requirements 
for quality factors set forth in Sec. 106.96, the manufacturer shall 
submit the following data and information:
    (a) Unless the manufacturer of a new infant formula can claim an 
exemption under Sec. 106.96(c)(1) or (c)(2), the following assurances 
shall be provided to ensure that the requirements of Sec. 106.96(a) and 
(b) have been met:
    (1) An explanation, in narrative form, setting forth how 
requirements for quality factors in Sec. 106.96(b) have been met;
    (2) Records that contain the information required by Sec. 106.96(b) 
to be collected during the study for each infant enrolled in the study. 
The records shall be identified by subject number, age, feeding group, 
gender, and study day of collection.
    (3) Data, which shall include:
    (i) Statistical evaluation for all measurements, including group 
means, group standard deviations, and measures of statistical 
significance for all measurements for each feeding group at the 
beginning of the study and at every point where measurements were made 
throughout the study, and
    (ii) Calculations of the statistical power of the study before study 
initiation and at study completion.
    (4) A report on attrition and on all occurrences of adverse events 
during the study, which shall include:
    (i) Identification of the infant by subject number and feeding group 
and a complete description of the adverse event, including comparisons 
of the frequency and nature of occurrence in each feeding group and 
information on the health of the infant during the course of the study, 
including the occurrence and duration of any illness;
    (ii) A clinical assessment by a health care provider of the infant's 
health during each suspected adverse event; and
    (iii) A list of all subjects who did not complete the study, 
including the subject number and the reason that each subject did not 
complete the study.
    (b) If the manufacturer is requesting an exemption from the growth 
monitoring study requirements under Sec. 106.96(c)(1), the manufacturer 
shall include a detailed description of the change made by the 
manufacturer to an existing infant formula and an explanation of why the 
change made by the manufacturer to an existing infant formula satisfies 
the criteria of Sec. 106.96(c)(1).
    (c) If the manufacturer is requesting an exemption under 
Sec. 106.96(c)(2)(i), the manufacturer shall include a detailed 
description of the alternative method or alternative study design, an 
explanation of why the method or study design is based on sound 
scientific principles, and data that demonstrate that the formula 
supports normal physical growth in infants when the formula is fed as 
the sole source of nutrition.
    (d) If the manufacturer is requesting an exemption under 
Sec. 106.96(c)(2)(ii), the manufacturer shall include a detailed 
description of the change and an explanation of why the change made by 
the manufacturer to an existing infant formula does not the affect the 
ability of the formula to support normal physical growth.
    (e) If the manufacturer is requesting an exemption under 
Sec. 106.96(c)(2)(iii), the manufacturer shall include a detailed 
description of the two formulations and an explanation of why the

[[Page 235]]

quality factor requirement of normal physical growth is met by the form 
of the formula that is processed using the method that has the greatest 
potential for adversely affecting nutrient content and bioavailability.
    (f) Unless the manufacturer of a new infant formula is requesting an 
exemption under Sec. 106.96(g), the results of the Protein Efficiency 
Ratio bioassay shall be provided in accordance with Sec. 106.96(f).
    (g) If the manufacturer is requesting an exemption under 
Sec. 106.96(g)(1), the manufacturer shall include a detailed description 
of the change made by the manufacturer to an existing infant formula and 
an explanation of why the change made by the manufacturer to an existing 
infant formula satisfies the criteria listed in Sec. 106.96(g)(1).
    (h) If the manufacturer is requesting an exemption under 
Sec. 106.96(g)(2), the manufacturer shall include a detailed description 
of the change and an explanation of why the change made by the 
manufacturer to an existing infant formula does not affect the 
bioavailability of the protein.
    (i) If the manufacturer is requesting an exemption under 
Sec. 106.96(g)(3), the manufacturer shall include a detailed explanation 
of the alternative method, an explanation of why the method is based on 
sound scientific principles, and the data that demonstrate that the 
quality factor for the biological quality of the protein has been met.
    (j) A statement certifying that the manufacturer has collected and 
considered all information and data concerning the ability of the infant 
formula to meet the requirements for quality factors and that the 
manufacturer is not aware of any information or data that would show 
that the formula does not meet the requirements for quality factors.

[79 FR 8059, Feb. 10, 2014, as amended at 79 FR 33072, June 10, 2014]



Sec. 106.130  Verification submission.

    (a) A manufacturer shall, after the first production and before the 
introduction into interstate commerce of a new infant formula (except 
for a new infant formula that is for export only for which a submission 
is received in compliance with Sec. 106.120(c)), verify in a written 
submission to the Food and Drug Administration at the address given in 
Sec. 106.110(a) that the infant formula complies with the requirements 
of the Federal Food, Drug, and Cosmetic Act and is not adulterated.
    (b) The verification submission shall include the following 
information:
    (1) The name of the new infant formula; the filing date for the new 
infant formula submission, in accordance with Sec. 106.120, for the 
subject formula; and the identification number assigned by the Agency to 
the new infant formula submission:
    (2) A statement that the infant formula to be introduced into 
interstate commerce is the same as the infant formula that was the 
subject of the new infant formula notification and for which the 
manufacturer provided assurances in accordance with the requirements of 
Sec. 106.120;
    (3) A summary of test results of the level of each nutrient required 
by Sec. 107.100 of this chapter and any nutrient added by the 
manufacturer in the formula, presented in units per 100 kilocalories at 
the final product stage.
    (4) A certification that the manufacturer has established current 
good manufacturing practices, including quality control procedures and 
in-process controls, and testing required by current good manufacturing 
practice, designed to prevent adulteration of this formula in accordance 
with subparts B and C of this part.
    (c) The submission shall not constitute written verification under 
section 412(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
350a(d)(2)) when any data prescribed in paragraph (b) of this section 
are lacking or are not set forth so as to be readily understood. In such 
circumstances, the Agency will notify the manufacturer that the notice 
is not adequate.



Sec. 106.140  Submission concerning a change in infant formula that
may adulterate the product.

    (a) When a manufacturer makes a change in the formulation or 
processing of the formula that may affect whether the formula is 
adulterated under section 412(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 350a(a)), the manufacturer shall,

[[Page 236]]

before the first processing of such formula, make a submission to the 
Food and Drug Administration at the address given in Sec. 106.110(a). An 
original and two copies shall be submitted.
    (b) The submission shall include:
    (1) The name and physical form of the infant formula (i.e., powder, 
ready-to-feed, or concentrate);
    (2)(i) An explanation of why the change in formulation or processing 
may affect whether the formula is adulterated; and
    (ii) What steps will be taken to ensure that, before the formula is 
introduced into interstate commerce, the formula will not be 
adulterated; and
    (3) A statement that the submission complies with 
Sec. 106.120(b)(3), (b)(4), (b)(5), and (b)(6). When appropriate, a 
statement to the effect that the information required by 
Sec. 106.120(b)(3), (b)(4), (b)(5), or (b)(6) has been provided to the 
Agency previously and has not been affected by the changes that are the 
subject of the current submission, together with the identification 
number assigned by the Agency to the relevant infant formula submission, 
may be provided in lieu of such statement.
    (c) The submission shall not constitute notice under section 412 of 
the Federal Food, Drug, and Cosmetic Act unless it complies fully with 
paragraph (b) of this section, and the information that it contains is 
set forth in a manner that is readily understandable. The Agency will 
notify the manufacturer if the notice is not adequate because it does 
not meet the requirements of section 412(d)(3) of the Federal Food, 
Drug, and Cosmetic Act.



Sec. 106.150  Notification of an adulterated or misbranded infant
formula.

    (a) A manufacturer shall promptly notify the Food and Drug 
Administration in accordance with paragraph (b) of this section when the 
manufacturer has knowledge (that is, actual knowledge that the 
manufacturer had, or the knowledge which a reasonable person would have 
had under like circumstances or which would have been obtained upon the 
exercise of due care) 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 
Federal Food, Drug, and Cosmetic Act (21 U.S.C 350d(i)) or by 
regulations issued under section 412(i)(2); or
    (2) May be otherwise adulterated or misbranded.
    (b) The notification made according to paragraph (a) of this section 
shall be made by telephone, to the Director of the appropriate Food and 
Drug Administration district office. After normal business hours (8 a.m. 
to 4:30 p.m.), the Food and Drug Administration's emergency number, 1-
866-300-4374 shall be used. The manufacturer shall promptly send written 
confirmation of the notification to the Food and Drug Administration, 
Center for Food Safety and Applied Nutrition, Office of Compliance, 
Division of Enforcement (HFS-605), Recall Coordinator, 5001 Campus Dr., 
College Park, MD 20740, and to the appropriate Food and Drug 
Administration district office.



Sec. 106.160  Incorporation by reference.

    (a) Certain material is incorporated by reference into this part 
with the approval of the Director of the Federal Register under 5 U.S.C. 
552(a) and 1 CFR part 51. To enforce any edition other than that 
specified in this section, the Food and Drug Administration must publish 
notice of change in the Federal Register and the material must be 
available to the public. All approved material is available for 
inspection at the Food and Drug Administration library at 10903 New 
Hampshire Ave., Building 2, Third Floor, Silver Spring, MD 20993, 301-
796-2039, and is available from the sources listed below. This material 
is also 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) 3-A Sanitary Standards, Inc., 6888 Elm St., Suite 2D, McLean, VA 
22101-3829, 703-790-0295, and may be ordered online at http://www.3-
a.org/:

[[Page 237]]

    (1) 3-A Sanitary Standards, No. 609-03: A Method of Producing 
Culinary Steam, adopted November 21, 2004, into Sec. 106.20(h).
    (2) [Reserved]
    (c) American Society for Nutrition, 9650 Rockville Pike, Bethesda, 
MD 20814-3998, 301-634-7279, http://www.nutrition.org:
    (1) Physical growth: National Center for Health Statistics 
percentiles, Hamill, P.V.V., T.A. Drizd, C.L. Johnson, R.B. Reed, A.F. 
Roche, and W.M. Moore, American Journal of Clinical Nutrition, vol. 32, 
pp. 607-614, dated March 1979, into Sec. 106.96(i)(1)(ii)(c).
    (2) [Reserved]
    (d) AOAC International, 481 North Frederick Ave., suite 500, 
Gaithersburg, MD 20877-2417, 301-924-7078:
    (1) Official Methods of Analysis of AOAC International, 16th ed., 
dated 1995, into Sec. 106.96(i)(2)(ii):
    (i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency 
Ratio Rat Bioassay, and
    (ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency 
Ratio Calculation Method.
    (2) Official Methods of Analysis of AOAC International, 18th ed., 
dated 2005, into Sec. 106.96(f):
    (i) Section 45.3.04, AOAC Official Method 960.48 Protein Efficiency 
Ratio Rat Bioassay, and
    (ii) Section 45.3.05, AOAC Official Method 982.30 Protein Efficiency 
Ratio Calculation Method.
    (e) Centers for Disease Control and Prevention, 1600 Clifton Rd., 
Atlanta, GA 30333, 1-800-232-4636, http://www.cdc.gov/growthcharts/
who_charts.htm.
    (1) Birth to 24 months: Boys Head circumference-for-age and Weight-
for-length percentiles, dated November 1, 2009, into Sec. 106.96(b)(4).
    (2) Birth to 24 months: Boys Length-for-age and Weight-for-age 
percentiles, dated November 1, 2009, into Sec. 106.96(b)(4).
    (3) Birth to 24 months: Girls Head circumference-for-age and Weight-
for-length percentiles, dated November 1, 2009, into Sec. 106.96(b)(4).
    (4) Birth to 24 months: Girls Length-for-age and Weight-for-age 
percentiles, dated November 1, 2009, into Sec. 106.96(b)(4).



PART 107_INFANT FORMULA--Table of Contents



                      Subpart A_General Provisions

Sec.
107.1  Status and applicability of the regulations in part 107.
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.

    Editorial Note: Nomenclature changes to part 107 appear at 81 FR 
49895, July 29, 2016.



                      Subpart A_General Provisions



Sec. 107.1  Status and applicability of the regulations in part 107.

    (a) The criteria in subpart B of this part describe the labeling 
requirements applicable to infant formula under section 403 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C 343). Failure to comply 
with any regulation in subpart B of this part will render an infant 
formula misbranded under section 403 of the Federal Food, Drug, and 
Cosmetic Act.
    (b) The criteria in subpart C of this part describe the terms and 
conditions for the exemption of an infant formula from the requirements 
of section 412(a), (b), and (c) of the Federal Food, Drug,

[[Page 238]]

and Cosmetic Act (21 U.S.C. 350a(a), (b), and (c)). Failure to comply 
with any regulations in subpart C of this part will result in withdrawal 
of the exemption given under section 412(h)(1) of the Federal Food, 
Drug, and Cosmetic Act.
    (c) Subpart D of this part contains the nutrient requirements for 
infant formula under section 412(i) of the Federal Food, Drug, and 
Cosmetic Act. Failure to comply with any regulation in subpart D of this 
part will render an infant formula adulterated under section 412(a)(1) 
of the Federal Food, Drug, and Cosmetic Act.
    (d) An exempt infant formula is subject to the provisions of 
Sec. 107.50 and other applicable Food and Drug Administration food 
regulations.

[79 FR 8074, Feb. 10, 2014]



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 person who prepares, reconstitutes, or otherwise 
changes the physical or chemical characteristics of an infant formula or 
packages or labels the product in a container for distribution. The term 
``manufacturer'' does not include a person who prepares, reconstitutes, 
or mixes infant formula exclusively for an infant under his/her direct 
care or the direct care of the institution employing such person.
    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, as amended at 79 FR 8074, Feb. 10, 2014]



                           Subpart B_Labeling



Sec. 107.10  Nutrient information.

    (a) The labeling of infant formulas, as defined in section 201(z) 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, supplied by 100 kilocalories, of each 
of the following nutrients and of any other nutrient added by the 
manufacturer:

------------------------------------------------------------------------
                 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 B1).....................  Do.
Riboflavin (Vitamin B2)...................  Do.
Vitamin B6................................  Do.
Vitamin B12...............................  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.
Selenium..................................  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

[[Page 239]]

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 Food and Nutrition Board 
of the Institute of Medicine through its development of a Dietary 
Reference Intake, or has been identified as essential by the Food and 
Drug Administration through a Federal Register publication; 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; 79 
FR 8074, Feb. 10, 2014; 80 FR 35840, June 23, 2015]



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 240]]

[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), Secs. 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 
Secs. 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 241]]

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 242]]

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 243]]

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 the Food 
and Drug Administration, Center for Food Safety and Applied Nutrition, 
Office of Nutrition, Labeling, and Dietary Supplements, Infant Formula 
and Medical Foods Staff (HFS-850), Food and Drug Administration, 5001 
Campus Dr., College Park, MD 20740.
    (2) The manufacturer shall promptly notify the Food and Drug 
Administration when the manufacturer has knowledge (as defined in 
section 412(c)(2) of the Federal Food, Drug, and Cosmetic 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 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.), contact the Food and Drug Administration 
Emergency Call Center at 866-300-4374. The manufacturer shall send a 
followup written confirmation to the Center for Food Safety and Applied 
Nutrition (HFS-605), Food and Drug Administration, 5001 Campus Dr., 
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; 75 FR 32659, June 9, 2010; 79 FR 8074, Feb. 10, 2014]



                     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:

[[Page 244]]



----------------------------------------------------------------------------------------------------------------
                 Nutrients                         Unit of measurement          Minimum level     Maximum 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
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 acid)..................  Milligrams.....................                 8
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.....................................  Do.............................                60
Iodine.....................................  Do.............................                 5                75
Selenium...................................  Do.............................                 2                 7
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.

    (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, as amended at 80 FR 35841, June 23, 2015]



                    Subpart E_Infant Formula Recalls

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

[[Page 245]]



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.



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

[[Page 246]]

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 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) 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 Sec. 5.115 of this chapter and shall provide relevant 
information about the infant formula that is to be recalled.
    (b) Initial written report. Within 14 days after the recall has 
begun, the recalling firm shall provide a written report to the 
appropriate FDA district office. The report shall contain relevant 
information, including the following cumulative information concerning 
the infant formula that is being recalled:
    (1) Number of consignees notified of the recall and date and method 
of notification, including recalls required by Sec. 107.200, information 
about the notice provided for retail display, and the request for its 
display.
    (2) Number of consignees responding to the recall communication and 
quantity of recalled infant formula on hand at each consignee at the 
time the communication was received.
    (3) Quantity of recalled infant formula returned or corrected by 
each consignee contacted and the quantity of recalled infant formula 
accounted for.
    (4) Number and results of effectiveness checks that were made.
    (5) Estimated timeframes for completion of the recall.
    (c) Status reports. The recalling firm shall submit to the 
appropriate FDA 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.

[79 FR 8074, Feb. 10, 2014]



Sec. 107.250  Termination of an infant formula recall.

    The recalling firm may submit a recommendation for termination of 
the recall to the appropriate FDA district office for transmittal to the 
Recall Coordinator, Division of Enforcement (HFS-605), Office of 
Compliance, Center for Food Safety and Applied Nutrition, 5001 Campus 
Dr., College Park, MD 20740, or by email to [email protected], 
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 Division of Enforcement of 
the request for termination. The recalling firm shall

[[Page 247]]

continue to implement the recall strategy until it receives final 
written notification from the Agency that the recall has been 
terminated. The Agency will send such notification, unless the Agency 
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; 79 FR 8075, Feb. 10, 
2014]



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.

    Editorial Note: Nomenclature changes to part 108 appear at 81 FR 
49896, July 29, 2016.



                      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.

[[Page 248]]

    (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 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), 5001 Campus Dr., 
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.

[[Page 249]]



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, 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 Commissioner 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

[[Page 250]]

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 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 Secs. 114.10, 114.80(a) (1) and (2), and (b), 
114.83, 114.89, and 114.100 (b), (c), and (d)

[[Page 251]]

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 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-303), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 5001 Campus Dr., 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, 5001 Campus 
Dr., College Park, MD 20740. These forms also are available on the Food 
and Drug Administration's Web site at http://www.fda.gov/Food/
GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/
ucm2007436.htm. For electronic submission go to FDA's Industry Systems 
Web site at www.access.fda.gov. Foreign processors shall register before 
any offering of foods for import into the United States. 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 2541e (Food Process Filing for Acidified Method). Forms are 
available from the LACF Registration Coordinator (HFS-303), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., 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, 5001 Campus Dr., 
College Park, MD 20740. These forms also are available on the Food and 
Drug Administration's Web site at http://www.fda.gov/Food/
GuidanceRegulation/FoodFacilityRegistration/AcidifiedLACFRegistration/
ucm2007436.htm. For electronic submission go to FDA's Industry Systems 
Web site at www.access.fda.gov.
    (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

[[Page 252]]

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 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

[[Page 253]]

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 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; 81 FR 46831, July 
19, 2016]



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

[[Page 254]]

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-303), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., 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, 5001 Campus Dr., College Park, MD 20740. These forms 
also are available on the Food and Drug Administration's Web site at 
http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/
AcidifiedLACFRegistration/default.htm. For electronic submission go to 
FDA's Industry Systems Web site at www.access.fda.gov. 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 2541d (Food Process Filing for Low-Acid Retorted Method), Form 
FDA 2541f (Food Process Filing for Water Activity/Formulation Control 
Method), or Form FDA 2541g (Food Process Filing for Low-Acid Aseptic 
Systems). These forms are available from the LACF Registration 
Coordinator (HFS-303), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., 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-
303), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740. These forms 
also are available on the Food and Drug Administration's Web site at 
http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/
AcidifiedLACFRegistration/default.htm. For electronic submission, go to 
FDA's Industry Systems Web site at www.access.fda.gov.
    (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

[[Page 255]]

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 LACF Registration Coordinator (HFS-303), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5001 
Campus Dr., 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 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

[[Page 256]]

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, 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 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.)).
    (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

[[Page 257]]

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 
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; 81 FR 46831, July 19, 2016]



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.

    Editorial Note: Nomenclature changes to part 109 appear at 81 FR 
49896, July 29, 2016.



                      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.

[[Page 258]]



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 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