[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Proposed Rules]
[Pages 6732-6823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29272]
[[Page 6731]]
Vol. 82
Thursday,
No. 12
January 19, 2017
Part II
Book 2 of 3 Books
Pages 6731-7274
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 301, 304, 316, et al.
Revision of the Nutrition Facts Labels for Meat and Poultry Products
and Updating Certain Reference Amounts Customarily Consumed; Proposed
Rule
Federal Register / Vol. 82 , No. 12 / Thursday, January 19, 2017 /
Proposed Rules
[[Page 6732]]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 304, 316, 317, 318, 319, 320, 327, 362, 381, 412
and 413
[Docket No. FSIS-2014-0024]
RIN 0583-AD56
Revision of the Nutrition Facts Labels for Meat and Poultry
Products and Updating Certain Reference Amounts Customarily Consumed
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: Consistent with the recent changes that the Food and Drug
Administration (FDA) finalized, the Food Safety and Inspection Service
(FSIS) is proposing to amend the nutrition labeling requirements for
meat (including fish of the order Siluriformes) and poultry products to
better reflect the most recent scientific research and dietary
recommendations and to improve the presentation of nutrition
information to assist consumers in maintaining healthy dietary
practices. FSIS is proposing to update the list of nutrients that are
required or permitted to be declared; provide updated Daily Reference
Values (DRVs) and Reference Daily Intake (RDI) values that are based on
current dietary recommendations from consensus reports; and amend the
labeling requirements for foods represented or purported to be
specifically for children under the age of 4 years and pregnant women
and lactating women and establish nutrient reference values
specifically for these population subgroups. FSIS is also proposing to
revise the format and appearance of the Nutrition Facts label; amend
the definition of a single-serving container; require dual-column
labeling for certain containers; and update and modify several
reference amounts customarily consumed (RACCs or reference amounts).
Finally, FSIS is proposing to consolidate the nutrition labeling
regulations for meat and poultry products into a new Code of Federal
Regulations (CFR) part.
DATES: Comments must be received by March 20, 2017.
ADDRESSES: FSIS invites interested persons to submit comments on this
proposed rule. Comments may be submitted by one of the following
methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for
submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, Patriots
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163B,
Washington, DC 20250-3700.
Hand- or Courier-Delivered Submittals: Deliver to Patriots
Plaza 3, 355 E Street SW., Room 8-163B, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2014-0024. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Jeff Canavan, Deputy Director,
Labeling and Program Delivery Staff, Office of Policy and Program
Development, Food Safety and Inspection Service, U.S. Department of
Agriculture, Stop Code 3784, Patriots Plaza 3, 8-161A, 1400
Independence Avenue SW., Washington, DC 20250-3700; Telephone (301)
504-0879; Fax (202) 245-4792.
SUPPLEMENTARY INFORMATION:
Executive Summary
The Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) and
the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.)
direct the Secretary of Agriculture to maintain meat and poultry
product inspection programs designed to assure consumers that meat and
poultry products distributed to them (including imports) are safe,
wholesome, not adulterated, and properly marked, labeled, and packaged.
The FMIA and PPIA (``the Acts'') also provide that the labels of meat
and poultry products must be approved by the Secretary of Agriculture,
who has delegated this authority to FSIS, before these products can
enter commerce. The Acts prohibit the sale or offer for sale by any
person, firm, or corporation of any article in commerce under any name
or other marking or labeling that is false or misleading or in any
container of a misleading form or size (21 U.S.C 607(d); 21 U.S.C
457(c)). The Acts also prohibit the distribution in-commerce of meat or
poultry products that are adulterated or misbranded. The FMIA and PPIA
give FSIS broad authority to promulgate such rules and regulations as
are necessary to carry out the provisions of the Acts (21 U.S.C. 621
and 463(b)).
To prevent meat and poultry products from being misbranded, the
meat and poultry product inspection regulations require that the labels
of meat and poultry products include specific information, and that
such information be displayed as prescribed in the regulations (9 CFR
part 317 and part 381). The nutrition labeling requirements for meat
and meat food products are in 9 CFR 317.300-317.400, and the nutrition
labeling requirements for poultry products are in 9 CFR 381.400-
381.500. The nutrition labeling regulations for meat and poultry
products include requirements regarding: Location of nutrition
information; labeling with number of servings; nutrition label content;
reference amounts customarily consumed per eating occasion; and
nutrient content claims.
On March 3, 2014, the Food and Drug Administration (FDA) published
two proposed rules, ``Food Labeling: Revision of the Nutrition and
Supplement Facts Labels'' (the ``FDA Nutrition Labeling Proposed
Rule'')(79 FR 11880) and ``Food Labeling: Serving Sizes of Foods That
Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column
Labeling; Updating, Modifying, and Establishing Certain Reference
Amounts Customarily Consumed; Serving Size for Breath Mints; and
Technical Amendments'' (the ``FDA Serving Size Proposed Rule'')(79 FR
11989). FDA proposed these rules to update the Nutrition Facts label to
reflect newer nutrition and public health research and recent dietary
recommendations from expert groups and to improve the presentation of
nutrition information to help consumers make more informed choices and
maintain healthy dietary practices. On July 27, 2015, FDA published a
supplemental notice of proposed rulemaking ``Food Labeling: Revision of
the Nutrition and Supplement Facts Labels; Supplemental Notice of
Proposed Rulemaking'' (the ``FDA Nutrition Labeling Supplemental
Proposed Rule'') (80 FR 44303) to revise certain provisions of the FDA
Nutrition Labeling Proposed Rule. On May 27, 2016, FDA published two
final rules, ``Food Labeling: Revision of the Nutrition and Supplement
Facts Labels''
[[Page 6733]]
(the ``FDA Nutrition Labeling Final Rule'')(81 FR 33742) and ``Food
Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at
One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily Consumed; Serving
Size for Breath Mints; and Technical Amendments'' (the ``FDA Serving
Size Final Rule'') (81 FR 34000).
FSIS has reviewed FDA's analysis, and to ensure that there is
consistency in how nutrition information is presented across the food
supply, FSIS is proposing to amend the nutrition labeling regulations
for meat and poultry products to parallel, to the extent possible,
FDA's final regulations. This approach will clarify information for
consumers and improve efficiency in the marketplace.
FSIS is proposing to consolidate the nutrition labeling regulations
that currently are presented separately for meat and for poultry
products (in 9 CFR 317.300-317.400 and 381.400-381.500, respectively)
into a single part, 9 CFR part 413. Consistent with FDA's final
regulations, FSIS is also proposing to update the list of nutrients
that are required or permitted to be declared and to provide updated
DRVs and RDIs that are based on current dietary recommendations from
consensus reports. For example, FSIS is proposing to remove the
requirement to declare ``Calories from Fat;'' require the declaration
of ``Added Sugars,'' vitamin D, and potassium; permit the voluntary
declaration of vitamins A and C; and update the reference value for the
declaration of percent Daily Value (DV) for sodium from the current
value of 2,400 mg (milligrams) to 2,300 mg. FSIS is also proposing to
amend the requirements for foods represented or purported to be
specifically for children under the age of 4 years and pregnant women
and lactating women and establish nutrient reference values
specifically for these population subgroups.
FSIS is also proposing to revise the format and appearance of the
Nutrition Facts label. Some of the proposed changes include increasing
the type size for ``Calories,'' ``servings per container,'' and the
``Serving size'' declarations, and bolding the number of calories and
the ``Serving size'' declaration to highlight this information.
FSIS is also proposing to amend the definition of a single-serving
container; require dual-column labeling for certain containers; and
update and modify several RACCs. These proposed changes will provide
consumers information to assist them in maintaining healthy dietary
practices.
[GRAPHIC] [TIFF OMITTED] TP19JA17.000
Summary of Costs and Benefits
Quantitative costs for the proposed rule include relabeling,
recordkeeping, and reformulation. Quantitative benefits are a measure
of expected health improvements experienced from increased label-use by
overweight and hypertensive adults. The summary of cost and benefits in
Table 1 are annualized at a 3 percent discount rate over 20 years with
a compliance period of 24 months for large manufacturers and 36 months
for small.
[[Page 6734]]
Table 1--Summary of Costs and Benefits
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Costs Benefits Net benefits
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Annualized (3% Discount Rate, 20 Years)......................... $10,802,809 $36,894,007 $26,091,198
Annualized (7% Discount Rate, 20 Years)......................... 14,603,562 22,541,264 7,937,702
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Table of Contents
I. Background
II. The Proposed Rule
A. Consolidating the Nutrition Labeling Requirements Into 9 CFR
Part 413
B. Calories
1. Calories From Fat
2. Calories From Saturated Fat
3. Two Thousand Calories as the Reference Caloric Intake Level
4. Percent Daily Value (DV) Declaration for Calories
C. Fat
1. Total Fat
a. Definition
b. DRV
2. Saturated Fat
a. Definition
b. Mandatory Declaration
c. Dietary Reference Value (DRV)
3. Trans Fat
4. Polyunsaturated Fat
a. Voluntary Declaration
b. DRV
c. Declaration of Individual Polyunsaturated Fatty Acids
5. Monounsaturated Fat
a. Voluntary Declaration
b. DRV
D. Cholesterol
1. Mandatory Declaration
2. DRV
E. Carbohydrate
1. Total Carbohydrate
a. Calculation of Total Carbohydrate
b. Classification of Carbohydrates Based on a Chemical
Definition or Physiological Effect
c. Separate Declaration of Additional Individual Types of
Carbohydrates
d. Mandatory Declaration
e. DRV
f. Calculation of Calories From Carbohydrate
2. Sugars
a. Mandatory Declaration
b. DRV
3. Added Sugars
a. Declaration
b. Proposed Definition
c. Daily Value
d. Compliance
4. Sugar Alcohols
a. DRV
b. Caloric Value
5. Fiber
a. Dietary Fiber
i. Definition
ii. Mandatory Declaration
iii. Analytical Methods
iv. DRV
b. Soluble and Insoluble Fiber
i. Analytical methods
ii. DRV
iii. Caloric Value
6. Other Carbohydrate
F. Protein
1. Analytical Methods
G. Sodium
H. Fluoride
I. Essential Vitamins and Minerals
1. Updates to Declaration of Vitamins and Minerals and Reference
Daily Intakes
2. Terms for Vitamins and Minerals
J. Labeling of Foods for Infants, Young Children, and Pregnant
or Lactating Women
1. Age Range for Infants and Young Children
2. Mandatory Declaration of Calories and Other Nutrients
a. Declaration of Saturated Fat and Cholesterol
b. Percent DV Declaration
c. Mandatory Declaration of Added Sugars
d. Mandatory Declaration of Trans Fat
3. Voluntary Declaration of Nutrients Other Than Essential
Vitamins and Minerals
a. Voluntary Declaration of Calories From Saturated Fat, and the
Amount of Polyunsaturated and Monounsaturated Fat
b. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and
Sugar Alcohols
c. Voluntary Declaration of Fluoride
4. Declaration of Essential Vitamins and Minerals
a. Mandatory Declaration of Calcium and Iron
b. Mandatory Declaration of Vitamin D and Potassium
c. Voluntary Declaration of Vitamin A and Vitamin C
d. Voluntary Declaration of Other Vitamins and Minerals
5. DRVs and Reference Daily Intakes (RDIs) for Infants Through
12 Months of Age
a. Calories
b. Total Fat
c. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber, and
Sugars
d. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber,
Soluble Fiber, Insoluble Fiber, Added Sugars, and Sugar Alcohols
e. Total Carbohydrate
f. Protein
g. Sodium
h. Fluoride
i. Vitamins and Minerals
6. DRVs and RDIs for Children 1 Through 3 Years of Age
a. Calories
b. Total Fat
c. Saturated Fat, Trans Fat, and Cholesterol
d. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Added
Sugars, Insoluble Fiber, Soluble Fiber, and Sugar Alcohols
e. Total Carbohydrate
f. Dietary Fiber
g. Protein
h. Sodium
i. Fluoride
j. Vitamins and Minerals
7. DRVs and RDIs for Pregnant Women and Lactating Women
a. Calories
b. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate,
Sodium, Added Sugars, and Dietary Fiber
c. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble
Fiber, Insoluble Fiber, Sugars, and Sugar Alcohols
d. Protein
e. Fluoride
f. Vitamins and Minerals
K. Format
1. Increasing the Prominence of Calories and Serving Size
2. Changing the Order of the ``Serving Size'' and ``Servings Per
Container'' Declarations and Increasing the Prominence of ``Servings
Per Container''
3. Right-Justifying the Quantitative Amounts Declared in the
``Serving size'' Statement
4. Presentation of Percent DVs
5. Placement of ``Added Sugars''
6. Declaration of Absolute Amounts of Vitamins and Minerals
7. The Footnote
8. Addition of a Horizontal Line Beneath the Nutrition Facts
Heading
L. Single-Serving Containers/Units and Dual-Column Labeling
1. Single-Serving Containers/Units
2. Dual-Column Labeling
3. Use of Nutrient Content Claims and Health Claims on Products
With Dual-Column Labeling per Serving and per Container
4. Additional Changes to Serving Size Regulations
M. Reference Amounts Customarily Consumed
1. Factors Considered To Determine the Existing RACCs To Update
2. Changes to Table 1: Reference Amounts Customarily Consumed
per Eating Occasion: Food Labeling for Infants and Children 1
Through 3 Years of Age
3. Changes to Table 2: Reference Amounts Customarily Consumed
per Eating Occasion: General Food Supply
N. Compliance
1. Level of Variance Allowed for the Label Declaration of
Specific Nutrients
2. Methods Used To Determine Compliance
3. Records Requirements
4. Inclusion of Potassium as a Mineral
5. Requirements for Other Carbohydrate, Soluble and Insoluble
Fiber, Added Sugars, and Sugar Alcohols
O. Technical Amendments
III. Executive Order 12866 and Executive Order 13563
IV. Regulatory Flexibility Act
V. Paperwork Requirements
VI. E-Government Act
[[Page 6735]]
VII. Executive Order 12988, Civil Justice Reform
VIII. Executive Order 13175
IX. USDA Nondiscrimination Statement
X. Additional Public Notification
XI. Proposed Regulatory Amendments
I. Background
The Nutrition Labeling and Education Act (NLEA) of 1990 required
the nutrition labeling of most foods regulated by the FDA. Because FSIS
is committed to providing consumers with the most informative labeling
system possible, FSIS published regulations establishing comparable
nutrition labeling requirements for meat and poultry products on
January 6, 1993 (58 FR 632). These regulations required nutrition
labels on the packages of all multi-ingredient and heat-processed meat
and poultry products, unless an exemption applied. The required
nutrition labeling provisions were referred to as ``the mandatory
nutrition labeling program.'' The Agency's 1993 regulations also
established guidelines for voluntary nutrition labeling of single-
ingredient, raw meat and poultry products, including single-ingredient,
raw ground or chopped products.
FSIS published technical amendments to the 1993 final rule (August
18, 1993, 58 FR 43787; September 10, 1993, 58 FR 47624; and March 16,
1994, 59 FR 12157), a final rule on the placement of nutrition labeling
on meat and poultry products (August 8, 1994), a final rule with
additional technical amendments to the nutrition labeling regulations
(September 1, 1994; 59 FR 45189), and a final rule to provide codified
language for provisions that previously cross-referenced FDA's
nutrition labeling regulations on January 3, 1995 (60 FR 174). FSIS
also published a final rule to require nutrition labeling of the major
cuts of single-ingredient raw meat and poultry products and ground or
chopped meat and poultry products on December 29, 2010 (75 FR 82164).
Currently, FSIS requires nutrition labels on the packages of all
multi-ingredient and heat-processed meat and poultry products, and all
ground or chopped products, unless an exemption applies (9 CFR 317.300;
317.301; 381.400; 381.401). FSIS also requires that nutrition
information be provided on the label or at the point-of-purchase for
the major cuts of single-ingredient, raw meat and poultry products
identified in 9 CFR 317.344 and 381.444 that are not ground or chopped,
except for certain exemptions. The following exemptions in 9 CFR
317.400 and 381.500 from the nutrition labeling requirements apply to
the major cuts of single-ingredient, raw meat and poultry products and
ground or chopped meat and poultry products:
Products intended for further processing, provided that
the labels for these products bear no nutrition claims or nutrition
information;
Products that are not for sale to consumers, provided that
the labels for these products bear no nutrition claims or nutrition
information;
Products in small packages that are individually wrapped
packages of less than \1/2\ ounce net weight, provided that the labels
for these products bear no nutrition claims or nutrition information;
Products that are custom slaughtered or prepared; and
Products intended for export.
FSIS also provides the following additional exemptions in 9 CFR
317.400 and 381.500 for ground or chopped products:
Ground or chopped products that qualify for the small
business exemption in 9 CFR 317.400(a)(1) or 381.500(a)(1);
Products that are ground or chopped at an individual
customer's request and that are prepared and served at retail, provided
that the labels or labeling of these products bears no nutrition claims
or nutrition information;
Ground or chopped products in packages that have a total
surface area for labeling of less than 12 square inches, provided that
the product's labeling includes no nutrition claims or nutrition
information and provided that an address or telephone number that a
consumer can use to obtain the required information is included on the
label; and
Ground products produced by small businesses that use
statements of percent fat and percent lean on the label or in labeling
of ground products, provided they include no other nutrition claims or
nutrition information on the product labels or labeling.
Generally, ready-to-eat products that are packaged and portioned at
a retail store or similar retail-type establishment and multi-
ingredient products (e.g., sausage) processed at a retail store or
similar retail-type establishment are exempt from nutrition labeling,
provided that this exemption does not apply to ready-to-eat or multi-
ingredient ground or chopped products described in 9 CFR 317.301 or
381.401. Restaurant menus also do not generally fall within the scope
of FSIS's current nutrition labeling regulations (9 CFR 317.400 and
381.500). However, FDA requires that restaurants and similar retail
food establishments that are part of a chain with 20 or more locations
doing business under the same name and offering for sale substantially
the same menu items disclose certain nutrition information for standard
menu items (see ``Food Labeling; Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail Food Establishments''; December
1, 2014; 79 FR 71155). FDA also requires that operators who own or
operate 20 or more vending machines disclose calorie information for
food sold from vending machines, subject to certain exemptions (see
``Food Labeling; Calorie Labeling of Articles of Food in Vending
Machines''; December 1, 2014; 79 FR 71259).
FSIS does not require nutrition information for single-ingredient,
raw meat and poultry products that are not major cuts and that are not
ground or chopped. But, if nutrition information is provided for these
products, it must be provided in accordance with the nutrition labeling
requirements for the major cuts (9 CFR 317.300 and 381.400).
II. The Proposed Rule
Nutrition labeling continues to be an integral part of USDA's
efforts to educate consumers about nutrition and diet. Since 1980, USDA
and the Department of Health and Human Services (HHS) have jointly
published the Dietary Guidelines for Americans (DGA) every five years.
The 2015-2020 DGA provides advice on food choices that promote overall
health, reduce the risk of chronic disease, and help individuals attain
and maintain a healthy weight.\1\ The nutrition labeling information
that FSIS is proposing to require in this rule would assist consumers
in maintaining healthy dietary practices. The information should also
help consumers follow the advice in the 2015-2020 DGA.
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\1\ U.S. Department of Agriculture and U.S. Department of Health
and Human Services, 2015--2020 Dietary Guidelines for Americans, 8th
edition, Washington, DC: U.S. Government Printing Office, December
2015. Available at http://www.health.gov/dietaryguidelines/2015.asp.
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For example, the 2015-2020 DGA concluded that some Americans do not
consume enough vitamin D or potassium, and inadequate intake of these
nutrients presents public health concerns (pages 60). Vitamin D is
important for bone health, and potassium helps to reduce the effects of
excess sodium on blood pressure. This proposed rule would require
vitamin D and potassium to be declared on nutrition labels, to assist
consumers in maintaining healthy dietary practices. Moreover,
consistent with the 2015-2020 DGA, the information should help
consumers follow the 2015-2020 DGA's
[[Page 6736]]
advice to select foods that provide more of these nutrients (page 60).
Additionally, the 2015-2020 DGA does not consider low intake of
vitamins A and C to be a major public health concern (page 60).
Currently, vitamins A and C must be declared on the Nutrition Facts
label, but this proposed rule would make their declaration voluntary.
This proposed rule also proposes changes to the Daily Values for
certain nutrients, consistent with the more recent scientific evidence
from the 2015-2020 DGA. For example, FSIS is proposing to amend the
current DV for sodium of 2,400 to 2,300 mg, which is consistent with
the scientific evidence reflected in the 2015-2020 DGA's recommendation
to limit intake of sodium to less than 2,300 mg per day and is the
upper limit for individuals ages 14 years and older set by the
Institute of Medicine. (page 15). Revising DVs to reflect the most
current science on nutrient requirements will help consumers choose a
better overall diet.
The 2015-2020 DGA also supports listing added sugars on nutrition
labels. It affirms that poor diet and physical inactivity are primary
factors contributing to overweight, obesity, and chronic illness (pages
2-3). Calories from added sugars, solid fats (including saturated and
trans fats), and refined grains replace nutrient-dense foods and make
it difficult to consume sufficient nutrients while controlling caloric
intake (page 14). FSIS is proposing to require that added sugars be
listed on nutrition labels to assist consumers in selecting a more
nutrient-dense diet while controlling the total number of calories
consumed (see section II.E.3 for discussion of the rationale for the
proposed changes).
Section 403(q)(1)(A) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 343(q)(1)(A)) defines serving size as an amount
customarily consumed and which is expressed in a common household
measure that is appropriate to the food. FSIS, consistent with FDA, is
proposing to update, modify, and establish certain RACCs and require
that packages which contain more than 150 percent and less than 200
percent of a given RACC be labeled as containing one serving,
regardless of the RACC of the product. Certain packages that contain at
least 200 percent and up to and including 300 percent of a given RACC
would be required to include dual column labels that provide nutrition
information per serving or per package, as applicable. These changes
will ensure that serving sizes are based on current consumption data
and will provide consumers with information on the Nutrition Facts
label related to the serving size that will assist them in maintaining
healthy dietary practices.
Finally, FSIS is proposing several updates to the design of the
current Nutrition Facts labels, including making the caloric content
and serving size declarations more prominent. These and other changes
aim to address current public health problems such as obesity, chronic
disease, and nutrient deficiency by emphasizing important nutritional
information and providing additional information to consumers.
A. Consolidating the Nutrition Labeling Requirements Into 9 CFR Part
413
Currently, the nutrition labeling regulations for meat and poultry
products are presented separately (in 9 CFR 317.300-317.400 and
381.400-381.500, respectively). FSIS believes that the public would be
better served by consolidating these regulations in one part of title
9. Rather than searching through two separate parts of title 9-CFR
parts 317 and 381-- to find the nutrition labeling regulations,
interested parties would only have to read part 413. Therefore, FSIS is
proposing to consolidate the nutrition labeling regulations for meat
and poultry products into a single part, 9 CFR part 413.
B. Calories
FSIS requires the total number of calories per serving of a meat or
poultry product to be declared on the Nutrition Facts label (9 CFR
317.309(c)(1); 9 CFR 381.409(c)(1); and proposed 9 CFR 413.309(c)(1)).
FSIS is not proposing to change this requirement but is proposing
changes to the requirements related to ``Calories from fat'' and
``Calories for saturated fat.''
1. Calories from Fat
FSIS currently requires that ``Calories from Fat'' be declared on
Nutrition Facts labels (9 CFR 317.309(c)(1)(ii); 9 CFR
381.409(c)(1)(ii)). FSIS is proposing to no longer require, and to not
allow voluntarily, the declaration of ``Calories from fat'' on the
Nutrition Facts label.
Section 403(q)(2)(B) of the FD&C Act (21 U.S.C. 343(q)(2)(B))
grants the Secretary of HHS (and by delegation, FDA) discretion to
remove information relating to a nutrient required to be declared on
food labels by regulation if the Secretary determines that it is not
necessary to assist consumers in maintaining healthy dietary practices.
FDA considered a number of factors related to the declaration of
``Calories from Fat,'' including dietary recommendations and consensus
reports that emphasize intake of total calories and the type of fat
consumed, as well as comments from their 2005 and 2007 Advanced Notices
of Proposed Rulemaking (ANPRMS) (April 4, 2005, 70 FR 17008; November
2, 2007; 72 FR 62149) that supported eliminating the declaration of
``Calories from fat'' in order to place greater emphasis on total
calories. FDA determined that the declaration of ``Calories from fat''
is not necessary to assist consumers in maintaining healthy dietary
practices (81 FR 33780). Under FDA's Nutrition Labeling Final Rule, FDA
no longer requires, and does not allow voluntarily, the declaration of
``Calories from fat'' on the Nutrition Facts label (81 FR 33780). FSIS
has reviewed FDA's analysis and has tentatively concluded that the
declaration of ``Calories from fat'' is not necessary to assist
consumers in maintaining healthy dietary practices. FSIS agrees with
FDA that ``the amount of fat being consumed can still be obtained from
the total fat declaration elsewhere on the Nutrition Facts label, and
consumers can still use the percent DV for total fat to put fat content
in the context of a total daily diet, compare products, and plan
diets'' (79 FR 11891; 81 FR 33780).
2. Calories From Saturated Fat
Under current FSIS regulations, the declaration of ``Calories from
saturated fat'' on the Nutrition Facts label is voluntary (9 CFR
317.309(c)(1)(iii); 9 CFR 381.409(c)(1)(iii); will be consolidated in
proposed 9 CFR 413.309(c)(1)(ii)). FSIS continues to believe that
``Calories from saturated fat'' can be declared voluntarily. The amount
of saturated fat can be obtained from the total saturated fat
declaration on the Nutrition Facts label, and consumers can use the
percent DV for saturated fat to put saturated fat content in the
context of a total daily diet, compare products, and plan diets (79 FR
11892; 81 FR 33781). Therefore, FSIS does not believe it is necessary
to require the mandatory declaration of ``Calories from saturated fat''
on the Nutrition Facts label. But with the revisions to the Nutrition
Facts label, FSIS is proposing to require that ``Calories from
saturated fat'' be indented when declared under the statement of
calories (proposed 9 CFR 413.309(c)(1)(ii)).
3. Two Thousand Calories as the Reference Caloric Intake Level
FSIS regulations (9 CFR 317.309(c)(9) and 381.409(c)(9)) set a
percent DRV for fat, saturated fatty acids, cholesterol, total
carbohydrate, fiber, sodium, potassium, and protein, based on a
reference caloric intake of 2,000
[[Page 6737]]
calories. Just as FDA did not make any changes to the reference calorie
intake, FSIS is not proposing any changes to the reference caloric
intake currently used to set the DRVs under 9 CFR 317.309(c)(9) and
381.409(c)(9) (which will both be consolidated in proposed 9 CFR
413.309(c)(9)).
FDA considered a number of factors related to the reference calorie
intake of 2,000 calories, including the relevant recommendations from
the IOM macronutrient report \2\ that provided estimated energy
requirements, the IOM Labeling Report,\3\ and the comments regarding
the 2,000 calorie reference intake level received in response to FDA's
2007 ANPRM (79 FR 11892). FDA decided not to propose changes to the
reference calorie intake level (81 FR 33782). ``The IOM Labeling
Committee concluded that retaining the current 2,000 reference calorie
intake level would be the best approach as it would provide continuity
and would not encourage higher calorie intake and overconsumption of
energy'' (79 FR 11892). FSIS agrees with FDA and the recommendation of
the IOM Labeling Committee.
---------------------------------------------------------------------------
\2\ Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat,
Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients),
Chapter 5: Energy'', Washington, DC: National Academies Press; 2002.
\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. Percent Daily Value (DV) Declaration for Calories
FSIS's current regulations do not establish a DRV for calories and
do not require a percent DV declaration for calories. FDA reviewed
recommendations in current consensus reports, including the IOM
macronutrient report,\4\ and comments received in response to their
2005 and 2007 ANPRMs (79 FR 11892, 11893). FDA decided not to require a
percent DV for total calories because of a lack of an appropriate
quantitative intake recommendation or other data or information on
which FDA could rely to establish a DRV for calories (81 FR 33782).
FSIS agrees with FDA's conclusion.
---------------------------------------------------------------------------
\4\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-
tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all rac-[alpha]-
tocopherol.
---------------------------------------------------------------------------
C. Fat
1. Total Fat
a. Definition and Mandatory Declaration
FSIS is not proposing any changes to its definition of ``total
fat'' under 9 CFR 317.309(c)(2) and 381.409(c)(2) (which will both be
consolidated in proposed 9 CFR 413.309(c)(2)). FSIS is proposing to
define ``fatty acids'' in 9 CFR 413.309(c)(2) as aliphatic carboxylic
acids consisting of a chain of alkyl groups and characterized by a
terminal carboxyl group to harmonize with FDA's Nutrition Labeling
Final Rule and clarify what FSIS considers to be a fatty acid. FSIS is
not proposing to change the requirement for mandatory declaration for
total fat on the Nutrition Facts label.
b. DRV
FSIS's regulations 9 CFR 317.309(c)(9) and 381.409(c)(9), which
would be consolidated in proposed 9 CFR 413.309(c)(9), set 65 grams as
the DRV for total fat based on a reference calorie intake of 2,000
calories (i.e., 30 percent of a 2,000 calorie diet). In FDA's Nutrition
Labeling Final Rule, FDA increased the DRV for total fat to 78 grams,
or 35 percent of a 2,000 calorie diet. The upper level of the IOM
Acceptable Macronutrient Distribution Range (AMDR) \5\ for total fat
for adults is 35 percent and serves as an appropriate basis on which to
set the DRV for total fat (81 FR 33784). FDA reviewed new information
and evidence that corroborated the position that the types of fats
consumed are more important in influencing the risk of heart disease
than is the total amount of fat (81 FR 33784). FDA stated that keeping
the DRV for total fat at 30 percent of calories could be misinterpreted
as advising consumers to limit their intake of total fat to 30 percent
or less, and that it is conceivable that consumers could view foods
that are good sources of mono and polyunsaturated fats negatively
because their percent DV declaration for total fat is high (81 FR
33784). FSIS agrees with FDA's analysis, and is proposing to increase
the DRV for total fat from 30 percent of calories to 35 percent of
calories for a DRV of 78 grams.
---------------------------------------------------------------------------
\5\ ``The AMDR for a macronutrient is based on the amount of the
macronutrient that is associated with a reduced risk of chronic
disease while providing adequate intakes of essential nutrients''
(79 FR 11886).
---------------------------------------------------------------------------
2. Saturated Fat
a. Definition
FSIS regulations currently define ``Saturated fat'' as the sum of
all fatty acids, including stearic acid, containing no double bonds
(see 9 CFR 317.309(c)(2)(i); 381.409(c)(2)(i); and 21 CFR
101.9(c)(2)(i)). However, in FSIS's 1993 Nutrition Labeling of Meat and
Poultry Products final rule, based on requests from the red meat
industry and the scientific knowledge in 1993 that stearic acid did not
have the same serum cholesterol-raising effects of the other three
saturated fatty acids, myristic, palmitic, and lauric acids, FSIS
provided for the voluntary declaration of stearic acid as a
subcomponent of saturated fat (58 FR 641). FDA had no similar request
for the voluntary listing of stearic acid and did not provide for such
listing.
In FDA's Nutrition Labeling Proposed Rule, FDA considered voluntary
declaration of stearic acid on the Nutrition Facts label, as
recommended by a few comments to their 2007 ANPRM (79 FR 11894). The
effects of stearic acid on Low-density lipoprotein (LDL) cholesterol
levels appear to vary depending on the macronutrient component that is
replaced by stearic acid (79 FR 11894). FDA found that moderate
evidence indicates that when stearic acid substitutes for other
saturated fatty acids or trans fat, plasma LDL cholesterol levels
decrease, whereas when it replaces monounsaturated or polyunsaturated
fatty acids, LDL cholesterol levels increase (79 FR 11894). Considering
such scientific data, the Report of the Dietary Guidelines Advisory
Committee on the Dietary Guidelines for Americans, 2010 (2010 DGAC),\6\
concluded that the potential effects of changes in dietary intake of
stearic acid on the risk of CVD remain unclear (79 FR 11894). In FDA's
Nutrition Labeling Proposed Rule, FDA tentatively concluded that the
individual declaration of stearic acid is not necessary to assist
consumers in maintaining healthy dietary practices, and proposed to not
permit the declaration on the Nutrition Facts label (79 FR 11894). FDA
addressed the evidence for a role of stearic acid in human health
(e.g., changes in plasma LDL cholesterol levels), which is not well-
established, and the fact that there is no quantitative intake
recommendation available for stearic acid (Id.) In FDA's final rule,
FDA did not exclude stearic acid from the calculation of the percent DV
for
[[Page 6738]]
saturated fat because the scientific evidence supporting the current
dietary recommendations for saturated fat does not differentiate among
the individual saturated fatty acids (81 FR 33786).
---------------------------------------------------------------------------
\6\ U.S. Department of Agriculture and U.S. Department of Health
and Human Services. (2010) ``Report of the Dietary Guidelines
Advisory Committee on the Dietary Guidelines for Americans, 2010'',
Washington, DC: U.S. Government Printing Office. Retrieved from
http://www.cnpp.usda.gov/dietary-guidelines-2010.
---------------------------------------------------------------------------
Based on this updated scientific information and the fact that few
if any companies have included stearic acid as a voluntary nutrient in
the current Nutrition Facts label, FSIS is proposing to remove the
voluntary declaration of stearic acid below saturated fat.
Also, consistent with FDA's final rule, FSIS is not proposing to
exclude acetic, propionic, and butyric acids from the definition of
saturated fat.
b. Mandatory Declaration
FSIS requires the mandatory declaration of the number of grams of
saturated fat per serving (9 CFR 317.309(c)(2)(i) and 381.409(c)(2)(i)
will be consolidated in proposed 9 CFR 413.309(c)(2)(i)). FSIS is not
proposing to change this requirement because FSIS is unaware of any
evidence that supports that this information is no longer needed to
assist consumers in maintaining healthy dietary practices.
c. Dietary Reference Value (DRV)
FSIS's regulations 9 CFR 317.309(c)(9) and 381.409(c)(9), which
will be consolidated in proposed 9 CFR 413.309(c)(9), set 20 grams as
the DRV for saturated fat based on a reference calorie intake of 2,000
calories. FSIS is not proposing to change the DRV for saturated fat.
FDA reviewed the IOM Labeling Committee recommendation,\7\ the
comments in response to their 2007 ANPRM, and current consensus reports
relating to the DRV for saturated fat, and stated that ``the existing
scientific evidence does not support a change to the current 20 g DRV''
for saturated fat (79 FR 11895-11896). FDA determined ``the existing
DRV of 20 grams is consistent with the scientific evidence supporting a
maximum intake level that covers the general U.S. population.'' (81 FR
33786). FSIS has reviewed FDA's analysis and has tentatively concluded
not to change the DRV for saturated fat.
---------------------------------------------------------------------------
\7\ Institute of Medicine (IOM) of the National Academies,
``Dietary Reference Intakes: Guiding Principles for Nutrition
Labeling and Fortification'', Washington, DC: National Academies
Press; 2003.
---------------------------------------------------------------------------
3. Trans Fat
On July 11, 2003, FDA published a final rule requiring
manufacturers to declare trans fatty acids, or trans fat, on the
Nutrition Facts label of conventional foods and some dietary
supplements (68 FR 41461). At that time, FSIS published information on
its Web site stating that FSIS was planning rulemaking on trans fat
label declarations to consider provisions in the meat and poultry
regulations that are consistent with FDA's rules.\8\ In the interim,
FSIS has not objected to the voluntary declaration of trans fat in
Nutrition Facts labels on food products under its jurisdiction if the
declaration is made in accordance with FDA regulations published in the
Federal Register on July 11, 2003, that amended 21 CFR part 101. There
are no FDA or FSIS provisions for claims regarding trans fatty acids.
Thus, any labeling that includes a statement regarding trans fatty
acids that is outside of and in addition to the Nutrition Facts label
declaration would need to be submitted to FSIS (the Labeling and
Program Delivery Staff (LPDS)) for evaluation. To date, FSIS has not
permitted any claims regarding trans fatty acids.
---------------------------------------------------------------------------
\8\ http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/trans-fat-declarations.
---------------------------------------------------------------------------
Based on FSIS's label review, FSIS believes that the majority of
meat and poultry product Nutrition Facts labels voluntarily declare
trans fat. However, because FSIS is now proposing major modifications
to the Nutrition Facts label, FSIS believes it is time to address the
need for trans fat labeling on meat and poultry products. According to
FDA's Nutrition Labeling Proposed Rule, trans fat continues to be a
nutrient with public health significance because of its role in chronic
disease (79 FR 11896). FDA is unaware of evidence to support a
determination that information relating to trans fat on the Nutrition
Facts label is not necessary to assist consumers in maintaining healthy
dietary practices (79 FR 11896). FDA tentatively concluded that
information on the amount of trans fat in food products allows
consumers to reduce their intake of trans fat and thus reduce the risk
of coronary heart disease (CHD) (79 FR 11896). However, in 2013, FDA
published a tentative determination that partially hydrogenated oils
(PHOs), the source of industrially produced trans fat, may not be
generally recognized as safe (GRAS)(78 FR 67169; November 8, 2013). FDA
requested comment on whether mandatory labeling of trans fat would
still be necessary if this determination is finalized (79 FR 11896).
Per 21 CFR 101.9(c)(2)(ii), if a food contains less than 0.5 g of trans
fat per serving, the content, when declared, is to be expressed as
zero. On June 17, 2015, FDA published a final determination that there
is no longer a consensus among qualified experts that PHOs, which are
the primary dietary source of industrially-produced trans fatty acid
are GRAS for any use in human food and therefore are food additives
subject to section 409 of the FD&C Act (80 FR 34650). FDA has set a
compliance period of three years for companies to either reformulate
products without PHOs or petition FDA to permit specific uses of PHOs.
Following the compliance period, no PHOs can be added to human food
unless they are otherwise approved by FDA. In FDA's Nutrition Labeling
Final Rule, FDA did not make any changes to the requirement for
mandatory declaration of trans fat on the Nutrition Facts label in 21
CFR 101.9(c)(2)(ii), stating ``it is premature to consider removing
trans fat from the Nutrition Facts label at this time.'' (81 FR 33786-
88).
Although FDA's final determination that PHOs are not GRAS for use
in any human food may eliminate the source of industrially produced
trans fat, FSIS recognizes that there are trans fats caused by the way
that some animals, such as cattle, sheep and goats, digest their food
(the ruminating process). Consistent with FDA's Nutrition Labeling
Final Rule (81 FR 33786-33787), FSIS is proposing to require the
declaration of trans fat in the Nutrition Facts label (proposed 9 CFR
413.309(c)(2)(ii)). The mandatory declaration of trans fat will assist
consumers in making informed choices and maintaining healthy dietary
practices.
4. Polyunsaturated Fat
a. Voluntary Declaration
FSIS permits the voluntary declaration of the number of grams of
polyunsaturated fat per serving (defined as cis, cis-methylene
interrupted polyunsaturated fatty acids) on the Nutrition Facts label
(9 CFR 317.309(c)(2)(ii) and 381.409(c)(2)(ii), which will be
consolidated in proposed 9 CFR 413.309(c)(2)(iii)). FDA considered
current consensus reports and comments received in response to their
2007 ANPRM when deciding to propose to continue to permit the voluntary
declaration of polyunsaturated fat on the Nutrition Facts label (79 FR
11897; 81 FR 33788). FDA recognized that, although polyunsaturated fat
is related to public health as a replacement for saturated fat, there
is no dose-response relationship between polyunsaturated fat and risk
of CHD, independent of saturated fat, and therefore continued to permit
the voluntary declaration of polyunsaturated fat (81 FR 33788-89). FSIS
has reviewed FDA's analysis and agrees with its conclusion and
therefore,
[[Page 6739]]
is not proposing to make any changes to the voluntary declaration of
polyunsaturated fat. Polyunsaturated fat has public health significance
because replacing saturated fatty acids with polyunsaturated and
monounsaturated fatty acids reduces blood LDL cholesterol levels and in
turn the risk of cardiovascular disease (CVD).\9\ Polyunsaturated fat
is a macronutrient, not an essential vitamin or mineral, does not have
a quantitative intake recommendation, but does have public health
significance. Therefore, FSIS believes it is appropriate to continue to
permit the voluntary declaration of polyunsaturated fat consistent with
FDA's final rule.
---------------------------------------------------------------------------
\9\ U.S. Department of Agriculture and U.S. Department of Health
and Human Services. (2010) ``Report of the Dietary Guidelines
Advisory Committee on the Dietary Guidelines for Americans, 2010'',
4 . Washington, DC: U.S. Government Printing Office. Retrieved from
http://www.cnpp.usda.gov/dietary-guidelines-2010.
---------------------------------------------------------------------------
b. DRV
FSIS's regulations do not provide a DRV for polyunsaturated fat.
FDA did not propose a DRV for polyunsaturated fat, tentatively
concluding ``that there is no appropriate quantitative intake
recommendation to form a basis for setting a DRV for polyunsaturated
fat'' (79 FR 11898). FDA did not change its position in the final rule
(81 FR 33789). Consistent with FDA's final rule, FSIS is not proposing
to provide a DRV for polyunsaturated fat.
c. Declaration of Individual Polyunsaturated Fatty Acids
FSIS's regulations do not permit the declaration of individual
polyunsaturated fatty acids on the Nutrition Facts label. Consistent
with FDA's final rule, FSIS is not proposing to provide for the
individual declaration of either n-3 or n-6 polyunsaturated fatty acids
or the declaration of eicosapentaeneoic acid (EPA) or docosahexaenoic
acid (DHA) on the Nutrition Facts label (81 FR 33789).
5. Monounsaturated Fat
a. Voluntary Declaration
FSIS's regulations currently allow the voluntary declaration of
monounsaturated fat (defined as cis-monounsaturated fatty acids (e.g.,
oleic acid)) on the Nutrition Facts label (9 CFR 317.309(c)(2)(iii) and
381.409(c)(2)(iii), which would be consolidated in proposed 9 CFR
413.309(c)(2)(iv)). Consistent with FDA's final rule, FSIS is not
proposing to change the voluntary declaration of monounsaturated fat
(81 FR 33788).
b. DRV
FSIS's regulations do not provide a DRV for monounsaturated fat.
FDA did not provide a DRV for monounsaturated fat for the same reasons
it did not set a DRV for polyunsaturated fat (81 FR 33789). Consistent
with FDA's final rule, FSIS is not proposing to set a DRV for
monounsaturated fat.
D. Cholesterol
1. Mandatory Declaration
FSIS's regulations require the amount of cholesterol be declared on
the Nutrition Facts label (9 CFR 317.309(c)(3) and 381.409(c)(3), which
would be consolidated in proposed 9 CFR 413.309(c)(3)). Consistent with
FDA's final rule, FSIS is not proposing changes to the requirement for
mandatory declaration of cholesterol.
2. DRV
FSIS sets 300 mg as the DRV for cholesterol based on the reference
calorie intake of 2,000 calories (9 CFR 317.309(c)(9) and
381.409(c)(9), which would be consolidated in proposed 9 CFR
413.309(c)(9)). FSIS is not proposing to change the DRV for
cholesterol.
E. Carbohydrate
1. Total Carbohydrate
a. Calculation of Total Carbohydrate
FSIS requires the number of grams of total carbohydrate per serving
be listed on the Nutrition Facts label (9 CFR 317.309(c)(6) and
381.409(c)(6), which would be consolidated in proposed 9 CFR
413.309(c)(6)). Total carbohydrate content must be calculated by
subtracting the sum of the crude protein, total fat, moisture, and ash
from the total weight of the product (9 CFR 317.309(c)(6) and
381.409(c)(6), which would be consolidated in proposed 9 CFR
413.309(c)(6)).
FDA considered a citizen petition requesting that dietary fiber be
excluded from the calculation of total carbohydrate, comments received
on its 2007 ANPRM, and scientific evidence and declined to change the
current method for calculating total carbohydrate (79 FR 11899-11900;
81 FR 33794-33795). Just as FDA is not making any change, FSIS has
reviewed FDA's analysis and has decided not to propose to change the
current method for calculating total carbohydrate.
b. Classification of Carbohydrates Based on a Chemical Definition or
Physiological Effect
FSIS is not proposing to change its requirements for the
classification or declaration of carbohydrates (9 CFR 317.309(c)(6) and
381.409(c)(6), which would be consolidated in proposed 9 CFR
413.309(c)(6)). FSIS agrees with FDA that a chemical definition for
total carbohydrate is still consistent with the classification and
declaration of fat on the Nutrition Facts label (79 FR 11901; 81
33795). It would be difficult to apply a definition for total
carbohydrates based on physiological effects because the different
components of carbohydrates have different physiological effects.
c. Separate Declaration of Additional Individual Types of Carbohydrates
FSIS is not proposing to require the separate declaration of
additional types of individual carbohydrates (e.g., starch) because, as
FDA also concluded, the comments to the 2007 ANPRM did not support the
declaration of additional types of carbohydrates, such as starch (81 FR
33795).
d. Mandatory Declaration
FSIS requires the number of grams of total carbohydrate per serving
be listed on the Nutrition Facts label (9 CFR 317.309(c)(6) and
381.409(c)(6), which would be consolidated in proposed 9 CFR
413.309(c)(6)), and has tentatively concluded, that the mandatory
declaration of total carbohydrates continues to be necessary to assist
consumers in making informed choices. Therefore, consistent with FDA's
Nutrition Labeling Final Rule, FSIS is not proposing to change the
requirement for mandatory declaration of total carbohydrate.
e. DRV
FSIS sets 300 grams as the DRV for total carbohydrate based on 60
percent of a 2,000 calorie diet ((0.60 x 2,000 calories)/4 calories per
gram of carbohydrate = 300 grams) (9 CFR 317.309(c)(9) and
381.409(c)(9), which would be consolidated in proposed 9 CFR
413.309(c)(9)). The percentage of calories from total carbohydrate,
total fat, and protein must add up to 100 percent on the Nutrition
Facts label. Because, as discussed in part (II)(C)(1), FSIS is
proposing to increase the DRV for total fat from 30 to 35 percent of
calories consistent with FDA's final rule, either the DRV for total
carbohydrate or protein must be decreased. As discussed in FDA's
Nutrition Labeling Final Rule, decreasing the DRV for protein from 10
percent of calories to 5 percent of calories to account for the
increase in the DRV for total fat would result in a DRV of 5 grams of
protein, which falls below the RDA for protein for children
[[Page 6740]]
and adults 9 years and older (81 FR 33784). Therefore, consistent with
FDA's final rule, FSIS is proposing to decrease the DRV for total
carbohydrate from 60 percent of calories to 55 percent of calories for
a DRV of 275 grams to account for the increase in the DRV for total
fat.
f. Calculation of Calories From Carbohydrate
FSIS requires that calories from total carbohydrate be calculated
using the general factor of 4 calories per gram total carbohydrate less
the amount of insoluble dietary fiber (9 CFR 317.309(c)(1)(i)(C) and
381.409(c)(1)(i)(C)). Consistent with FDA's final rule, FSIS is
proposing a new definition for dietary fiber (see section II.E.5) that
only allows for the declaration of dietary fibers that FDA has
determined to have a physiological effect that is beneficial to human
health. The new definition of dietary fiber includes: (1) Non-
digestible soluble and insoluble carbohydrates (with 3 or more
monomeric units) and lignin that are intrinsic and intact in plants;
and (2) 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. For the purpose of calculating
calories from carbohydrate, all soluble and insoluble non-digestible
carbohydrates should be excluded from the calculation, not just those
known to meet the definition of dietary fiber. Therefore, FSIS is
proposing that all soluble and insoluble non-digestible carbohydrates
be excluded from the calculation for calories from total carbohydrate
(proposed 9 CFR 413.309(c)(1)(i)(C)).
2. Sugars
a. Mandatory Declaration
FSIS requires a statement of the number of grams of sugars per
serving on the Nutrition Facts label, except for products that contain
less than 1 gram of sugars per serving if no claims are made about
sweeteners, sugars, or sugar alcohol content (9 CFR 317.309(c)(6)(ii)
and 381.409(c)(6)(ii); would be consolidated in proposed 9 CFR
413.309(c)(6)(ii)). FSIS defines sugars as the sum of all free mono-
and disaccharides (such as glucose, fructose, lactose, and sucrose) (9
CFR 317.309(c)(6)(ii) and 381.409(c)(6)(ii)). Consistent with FDA's
final rule, FSIS has tentatively concluded that the mandatory
declaration of sugars continues to be necessary to assist consumers in
making informed choices and maintaining healthy dietary practices. But,
FSIS is proposing to replace the declaration of ``Sugars'' with the
term ``Total Sugars,'' which is also consistent with FDA's final rule.
The rationale for this proposed change is discussed in part K(5).
b. DRV
FSIS's regulations do not provide a DRV for sugars. FDA did not
propose a DRV for sugars because there are no upper limits or set
dietary reference values on which a DRV for sugars could be based (79
FR 11902). Consistent with FDA's final rule, FSIS is not proposing to
set a DRV for sugars.
3. Added Sugars
a. Declaration
FSIS's regulations do not define ``added sugars'' nor permit its
declaration on the Nutrition Facts label. FDA is requiring the
declaration of added sugars on the Nutrition Facts label and
considered, in its review, new data and information from U.S. consensus
reports and scientific evidence supporting recommendations related to
the consumption of added sugars, a citizen petition, and public
comments (79 FR 11902-11906; 81 FR 33799-33851) and FDA's consumer
study on added sugars \10\ (80 FR 44306). FSIS has reviewed FDA's
analysis and is also proposing to require the declaration of added
sugars on the Nutrition Facts label to provide consumers with the
information they need to make more informed choices and meet the
dietary recommendation to reduce caloric intake from added sugars. FSIS
is proposing changes consistent with FDA's final rule. FSIS is
proposing to require the mandatory declaration of added sugars as an
indented line item underneath the declaration of ``Total Sugars'' on
the Nutrition Facts label. FSIS is also proposing that the phrase ``Not
a significant source of added sugars'' be placed at the bottom of the
table of nutrient values if a statement of the added sugars content is
not required and, as a result, is not provided. FSIS is also proposing
that a statement of added sugars content would not be required for
products that contain less than 1 gram of added sugars in a serving if
no claims are made about sweeteners, sugars, or sugar alcohol content
(proposed 9 CFR 413.309(c)(6)(iii)). FSIS is also proposing to permit
alternative statements for added sugars similar to the current
alternative statements for total carbohydrate, dietary fiber, soluble
fiber, insoluble fiber, sugars, and sugar alcohol, when a serving
contains less than 1 gram of the nutrient. Proposed 9 CFR
413.309(c)(6)(iii) would provide for the alternative statements
``Contains less than 1 gram'' or ``less than 1 gram,'' or, if the
serving contains less than 0.5 g of added sugars, the content can be
expressed as zero.
---------------------------------------------------------------------------
\10\ U.S. Food and Drug Administration. Memorandum to the File--
``Experimental study on consumer responses to Nutrition Facts labels
with declaration of amount of added sugars (OMB No. 0910-0764),''
2015.
---------------------------------------------------------------------------
b. Proposed Definition
FSIS regulations do not currently define the term ``added sugars.''
Because FSIS is proposing to require the mandatory declaration of added
sugars on the Nutrition Facts label, FSIS is also proposing to define
the term ``added sugars.'' Proposed 9 CFR 413.309(c)(6)(iii) defines
``added sugars'' as sugars that are either added during the processing
of foods or are packaged as such and include sugars (free, mono- and
disaccharides), sugars from syrups, honey, and fruit juice concentrates
(see proposed 9 CFR 413.309(c)(6)(iii) for specific requirements for
fruit juice concentrates) (see proposed 9 CFR 413.309(c)(6)(iii) for
the complete ``added sugars'' definition). Examples of ``added sugars''
added to meat and poultry products include: Table sugar, brown sugar,
corn sweetener, corn syrup, dextrose, fructose, apple juice concentrate
glucose, Glucono-Delta-Lactone (GDL), high-fructose corn syrup, invert
sugar, lactose, maltose, malt sugar, maple syrup, molasses, raw sugar,
turbinado, sugar, trehalose, and sucrose. Sugar alcohols would not be
considered added sugars.
c. Daily Value
FDA established a DRV for added sugars of 10 percent of total
energy intake based on new information in the ``Scientific Report of
the 2015 Dietary Guidelines Advisory Committee'' (the ``2015 DGAC
report'' \11\) regarding added sugars (80 FR 44308; 81 FR 33842).
Consistent with FDA's final rule, FSIS is proposing a DRV for added
sugars of 50 g for children and adults 4 years of age and older,
including pregnant women and lactating women, and that the percent DV
for added sugars be declared on the Nutrition Facts label. As discussed
in FDA's supplemental proposed rule, the 2015 DGAC report recommended
reducing the intake of added sugars, including an added sugars
declaration and a percent DV for added sugars declaration in the
Nutrition Facts label, and recommended that Americans keep added sugars
intake below 10 percent of total energy intake (80 FR
[[Page 6741]]
44308). FSIS's proposed DRV of 50 g for added sugars was determined by
taking 10 percent of the 2,000 reference calorie intake for adults and
children 4 years of age and older (.10 x 2,000 = 200 calories) and then
dividing by 4 calories/gram, which provides a 50 g reference amount for
added sugars as the DRV.
---------------------------------------------------------------------------
\11\ http://www.health.gov/dietaryguidelines/2015-scientific-report/.
---------------------------------------------------------------------------
d. Compliance
FSIS is not aware of an analytical method that is capable of
distinguishing between added and intrinsically occurring sugars in a
food product, nor did FDA identify such a method (79 FR 11906).
Therefore, to verify compliance with the proposed mandatory declaration
of added sugars, FSIS is proposing in 9 CFR 413.309(h)(8)(iv) that
establishments make and keep certain records to verify the amount of
added sugars in the product (see compliance section II.N. below for
more details about this requirement). For example, FSIS is proposing
that a manufacturer must make and keep written records of the amount of
sugars added to the product during the processing of the product 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).
FSIS is aware that sugars in some foods may undergo chemical
changes as a result of non-enzymatic browning (i.e., Maillard reactions
and caramelization) or fermentation during food processing. Some sugars
are metabolized or otherwise transformed and converted into compounds
that are no longer recognizable or detectable as sugars through
conventional analytical methods.\12\ As FDA concluded, FSIS expects
that the amount of added sugars transformed during non-enzymatic
browning reactions in most products is insignificant relative to the
initial levels of sugars (81 FR 33830-33831). Unlike browning
reactions, fermentation is a process that typically involves the action
of desirable microorganisms (e.g., yeasts and lactic acid bacteria) and
enzymes that convert organic compounds, especially sugars and other
carbohydrates, into simpler compounds such as carbon dioxide, lactic
acid, and ethyl alcohol.13 14 Fermented sausages are one
example of a fermented meat product and include certain types of
pepperoni, salami, Lebanon bologna, mettwurst, and certain types of
chorizo. Fermentation can affect the flavor, color, and microbiological
safety of meat products. Both natural and controlled meat fermentation
involve lactic acid bacteria. This type of bacteria converts naturally
occurring glycogen and added sugars into lactic acid. This conversion
reduces the amount of sugar in a meat product.\15\ However, FSIS
expects that the majority of manufacturers would be able to use the
amount of sugars added as an ingredient as a reasonable approximation
of the amount of added sugars in a serving of their product. When the
amount of added sugars is reduced through non-enzymatic browning or
fermentation, FSIS is proposing in 9 CFR 413.309(h)(8)(v) to require:
(1) Records of scientific data and information that demonstrate the
amount of added sugars in the food after non-enzymatic browning 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 manufactured; or (2) records of the amount of
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.
---------------------------------------------------------------------------
\12\ Skibsted, L.H., Risbo, J., Andersen, M.L. ``Chemical
Deterioration and Physical Instability of Food and Beverages''.
Woodhead Publishing; 2010; pp. 70-94.
\13\ Lewis, R.J., Sr., editor. Hawley's Condensed Chemical
Dictionary. 15th Ed. John Wiley & Sons, 2007; pp. 549-550.
\14\ Murano, P.S. ``Understanding Food Science and Technology''.
Belmont, California: Wadsworth/Thomas Learning; 2003; pp. 123-125.
\15\ Toldr[aacute], et al., ``Handbook of Fermented Meat and
Poultry,'' Wiley Blackwell; 2015; Chapters 1-2.
---------------------------------------------------------------------------
In some food products, non-enzymatic browning or fermentation could
result in a significant reduction in the amount of added sugars,
leaving manufacturers with no way to reasonably approximate the amount
of added sugars in a serving of the finished food. Similar to FDA, FSIS
is proposing that manufacturers may submit a request to FSIS's LPDS to
use an alternative means of compliance. The request 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 or fermentation.
4. Sugar Alcohols
For nutrition labeling purposes, consistent with FDA, FSIS defines
sugar alcohols ``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)'' (9 CFR 317.309(c)(6)(iii) and
381.409(c)(6)(iii), which would be consolidated in proposed 9 CFR
413.309(c)(6)(iv)). Consistent with FDA, FSIS permits the voluntary
declaration of sugar alcohols on the Nutrition Facts label (9 CFR
317.309(c)(6)(iii) and 381.409(c)(6)(iii)). FSIS is not proposing to
change the voluntary declaration of sugar alcohols on the Nutrition
Facts label, just as FDA did not.
a. DRV
Consistent with FDA, FSIS does not provide a DRV for sugar alcohols
and is not proposing a DRV for sugar alcohols because there is no
quantitative reference intake recommendation for sugar alcohols from
current consensus reports on which to base a DRV.
b. Caloric Value
Caloric content for total carbohydrate less the amount of insoluble
dietary fiber is calculated using a factor of 4 calories per gram (9
CFR 317.309(c)(1)(i)(C) and 381.409(c)(1)(i)(C)). FSIS has reviewed the
Life Sciences Research Office reports 16 17 that recommended
the following caloric values for sugar alcohols: isomalt (2.0 kcal/g);
lactitol (2.0 kcal/g), xylitol (2.4 kcal/g); maltitol (2.1 kcal/g);
sorbitol (2.6 kcal/g); hydrogenated starch hydrolysates (3.0 kcal/g);
and mannitol (1.6 kcal/g). FSIS has tentatively concluded that the
values recommended by the Life Sciences Research Office are closer to
the energy contribution of sugar alcohols than the current factors.
FSIS also reviewed FDA's analysis for determining a caloric value for
erythritol and agrees with the analysis (81 FR 33852). Therefore,
consistent with FDA's final rule (81 FR 33852), FSIS is proposing to
amend its regulations to establish the following general factors for
caloric values for sugar alcohols: isomalt (2.0 kcal/g); lactitol (2.0
kcal/g), xylitol (2.4 kcal/g); maltitol (2.1 kcal/g); sorbitol (2.6
kcal/g); hydrogenated starch hydrolysates (3.0 kcal/g); mannitol (1.6
kcal/g); and erythritol (0 kcal/g). Proposed 9 CFR 413.309(c)(1)(i)(F)
will establish these values, and proposed 9 CFR 413.309(c)(1)(i)(C)
will clarify that the
[[Page 6742]]
factor of 4 kcal/g does not apply to sugar alcohols.
---------------------------------------------------------------------------
\16\ Life Sciences Research Office. ``The Evaluation of the
Energy of Certain Sugar Alcohols Used as Food Ingredients'',
Bethesda, MD: Life Sciences Research Office; 1994.
\17\ Life Sciences Research Office. ``Evaluation of the Net
Energy Value of Maltitol'', Bethesda, MD: Life Sciences Research
Office; 1999.
---------------------------------------------------------------------------
5. Fiber
a. Dietary Fiber
i. Definition
FSIS's regulations do not define ``dietary fiber.'' After
considering IOM recommendations, comments received on FDA's 2007 ANPRM,
and international guidelines (e.g., The Codex Alimentarius Commission's
definition of dietary fiber), FDA adopted a definition of dietary fiber
that is equivalent to the IOM's definition of ``total fiber'' and
emphasizes the beneficial physiological effects in humans (81 FR
33853). FSIS has reviewed FDA's analysis and is proposing to include a
definition for dietary fiber in 9 CFR 413.309(c)(6)(i) that is
consistent with FDA's definition. FSIS is proposing the following
definition for dietary fiber: (1) Non-digestible soluble and insoluble
carbohydrates (with 3 or more monomeric units) and lignin that are
intrinsic and intact in plants; and (2) 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.
FSIS is proposing to include isolated or synthetic non-digestible
carbohydrates that have been determined by FDA to have a physiological
effect that is beneficial to human health in the proposed definition of
dietary fiber in 9 CFR 413.309(c)(6)(i). For example, [beta]-glucan
soluble fiber and psyllium husk that are added to foods meet the
proposed definition of dietary fiber and would be listed in 9 CFR
413.309(c)(6)(i). FSIS would consider amending 9 CFR 413.309(c)(6)(i)
to list any additional isolated or synthetic non-digestible
carbohydrates that FDA determines have a physiological effect that is
beneficial to human health.
ii. Mandatory Declaration
FSIS requires that a statement of the number of grams of total
dietary fiber per serving be declared on the Nutrition Facts label,
except when a serving contains less than 1 gram of total dietary fiber
(9 CFR 317.309(c)(6)(i) and 381.409(c)(6)(i), which would be
consolidated in proposed 9 CFR 413.309(c)(6)(i)). FSIS is not proposing
to change the requirement for mandatory declaration of dietary fiber,
just as FDA did not.
iii. Analytical Methods
The amount of dietary fiber may be calculated by subtracting the
amount of non-digestible carbohydrates added during processing that do
not meet the proposed definition of dietary fiber from the value
obtained using AOAC 2009.01, AOAC 2011.25, or an equivalent AOAC method
of analysis as given in the ``Official Methods of Analysis of the AOAC
International'' 19th Edition. Because an AOAC method would not
accurately quantify the dietary fiber that meets the proposed
definition if the product contains both non-digestible carbohydrates
that meet the definition and those that do not, consistent with FDA's
final rule, FSIS is proposing to require that manufacturers maintain
written records to verify the amount of added non-digestible
carbohydrates that do not meet the proposed definition of dietary
fiber. (See Compliance section II.N. below.)
iv. DRV
Currently, 25 g is the DRV for total dietary fiber based on the
reference calorie intake of 2,000 calories (9 CFR 317.309(c)(9) and
381.409(c)(9)). FSIS is proposing to amend its regulations to establish
28 g as the DRV for total dietary fiber (proposed 9 CFR 413.309(c)(9)).
FSIS is proposing to use 28 g as the DRV for total dietary fiber
because: (1) the IOM set an adequate intake level (AI) of 14 g/1,000
kcal for total fiber primarily based on the intake level that was
associated with the greatest reduction in the risk of CHD; \18\ and (2)
FDA now uses 14 g/1,000 kcal as the basis for a DRV for dietary fiber
and setting a DRV of 28 g for dietary fiber using a reference calorie
intake of 2,000 calories (81 FR 33865-33866).
---------------------------------------------------------------------------
\18\ Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat,
Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients),
Chapter 7: Dietary, Functional, and Total Fiber'', Washington, DC:
National Academies Press; 2002.
---------------------------------------------------------------------------
b. Soluble and Insoluble Fiber
Soluble fibers (e.g., pectin) dissolve in water and are digested by
the bacteria in the large intestine. Insoluble fibers (e.g., cellulose)
do not dissolve in water and are not digested by the bacteria in the
large intestine. FSIS regulations do not define the terms soluble and
insoluble fiber, but provide for the voluntary declaration of soluble
and insoluble fiber (9 CFR 317.309(c)(6)(i) and 381.409(c)(6)(i)),
which would be consolidated in proposed 9 CFR 413.309(c)(6)(i)).
Consistent with FDA, FSIS is proposing that when soluble fiber or
insoluble fiber is declared, the soluble fiber and insoluble fiber must
meet the definition of ``dietary fiber'' in proposed 9 CFR
413.309(c)(6)(i) because they are components of dietary fiber.
i. Analytical Methods
AOAC 2011.25 or an equivalent AOAC method may be used to calculate
soluble and insoluble fiber that meet the proposed definition of
dietary fiber and can be declared on the Nutrition Facts label. AOAC
2011.25 can measure low molecular weight non-digestible carbohydrates,
as well as separately measure soluble and insoluble non-digestible
carbohydrates.\19\ Consistent with FDA, if a product contains a mixture
of non-digestible carbohydrates that do not meet the proposed dietary
fiber definition, and the label of the product declares soluble or
insoluble fiber content, FSIS is proposing to require establishments to
make and keep records to verify the amount of non-digestible
carbohydrate(s) that does not meet the proposed definition of dietary
fiber present in the food. (See discussion in compliance section II.N.
below.)
---------------------------------------------------------------------------
\19\ McCleary, B.V., DeVries, J.W., Rader, J.I., et al.
``Determination of Total Dietary Fiber (CODEX definition) by
Enzymatic-Gravimetric Method and Liquid Chromatography:
Collaborative Study''. Journal of AOAC International. 2010;93:221-
233.
---------------------------------------------------------------------------
ii. DRV
FDA did not find a basis on which to derive DRVs for soluble or
insoluble fiber. Consistent with FDA's final rule, FSIS is not
proposing DRVs for soluble fiber or insoluble fiber.
iii. Caloric value
FSIS regulations provide that the caloric content of a product may
be calculated by, among other methods, using general factors of 4, 4,
and 9 calories per gram for protein, total carbohydrate less the amount
of insoluble dietary fiber, and total fat, respectively (9 CFR
317.309(c)(1)(i)(C) and 381.409(c)(1)(i)(C)). Soluble fiber, which is
included in total carbohydrate, is assigned a general factor of 4 kcal/
g. FDA established a general factor of 2 kcal/g as the caloric value of
soluble non-digestible carbohydrates (81 FR 33867). Insoluble non-
digestible carbohydrates are not included in the caloric calculation
(81 FR 33867). FDA required that calories from carbohydrate be
calculated using a general factor of 4 kcal/g of total carbohydrate
less the amount of non-digestible carbohydrates, which includes soluble
(2 kcal/g) and insoluble non-digestible carbohydrates (0 kcal/g) that
do and do not meet the definition of dietary fiber (81 FR 33867). The
calorie contribution of soluble non-digestible carbohydrate would be
added
[[Page 6743]]
to that sum to determine the total carbohydrate calorie contribution
(Id.). Therefore, in order to harmonize with FDA's regulations, FSIS is
proposing the same changes to the caloric value for soluble non-
digestible carbohydrates and the calculation of calories from
carbohydrate.
6. Other Carbohydrate
FSIS's regulations define ``Other carbohydrate'' as the difference
between total carbohydrate and the sum of dietary fiber, sugars, and
sugar alcohol, except that if sugar alcohol is not declared (even if
present), ``Other carbohydrate'' is defined as the difference between
total carbohydrate and the sum of dietary fiber and sugars (9 CFR
317.309(c)(6)(iv) and 381.409(c)(6)(iv)). A statement of the number of
grams of ``Other carbohydrate'' per serving may be voluntarily declared
on the Nutrition Facts label (9 CFR 317.309(c)(6)(iv) and
381.409(c)(6)(iv)).
FDA concluded that ``Other carbohydrate'' should no longer be
permitted on the Nutrition Facts label because of its lack of public
health significance and a quantitative intake recommendation for
``Other carbohydrate'' is not available from relevant consensus reports
(81 FR 33867-33868). FDA removed the provision that allows for its
voluntary declaration in the regulations (81 FR 33867-33868). FSIS has
reviewed FDA's analysis and is proposing to no longer permit the
voluntary declaration of ``Other carbohydrate'' on the Nutrition Facts
label for the reasons above.
F. Protein
FSIS's regulations require that a statement of the number of grams
of protein per serving be declared on the Nutrition Facts label (9 CFR
317.309(c)(7) and 381.409(c)(7), which would be consolidated in
proposed 9 CFR 413.309(c)(7)). The DRV for protein is 50 g and
represents 10 percent of the 2,000 reference calories intake level.
Consistent with FDA, FSIS is not proposing to change the mandatory
declaration of protein or the DRV for protein.
1. Analytical Methods
Under FSIS's regulations (9 CFR 317.309(c)(7) and 381.409(c)(7)),
protein may be calculated on the basis of the factor of 6.25 times the
nitrogen content of the food as determined by appropriate methods of
analysis in accordance with 9 CFR 317.309(h) or 9 CFR 381.409(h),
except when the procedure for a specific food requires another factor.
According to 9 CFR 317.309(h)(2) and 381.409(h)(2), FSIS determines
compliance by appropriate methods and procedures used by the Department
for each nutrient in accordance with the Chemistry Laboratory
Guidebook, or, if no USDA method is available and appropriate for the
nutrient, by appropriate methods for the nutrient in accordance with
the 1990 edition of the Official Methods of Analysis of the AOAC
International, formerly Association of Official Analytical Chemists,
15th ed., to determine compliance with the nutrition labeling
regulations. FSIS is proposing to update the version of the Official
Methods of Analysis of the AOAC International referenced in the
regulations because more analytical methods for nutrients have been
published in later versions. The 20th edition is the most recent
edition of the published AOAC methods, so FSIS is proposing in 9 CFR
413.309(h) that the 20th edition be used if no USDA method is
available. If a newer version of the Official Methods of Analysis of
the AOAC International is published before a final rule is published
for this rulemaking, FSIS will consider using the most recent version
of the official AOAC methods in the final rule.
G. Sodium
FSIS's regulations require the declaration of the number of
milligrams of sodium per serving on the Nutrition Facts label (9 CFR
317.309(c)(4) and 381.409(c)(4), which would be consolidated in
proposed 9 CFR 413.309(c)(4)). Consistent with FDA, FSIS is not
proposing to change the requirement that sodium be declared.
FSIS's regulations set a DRV of 2,400 mg of sodium based on a
reference caloric intake of 2,000 calories (9 CFR 317.309(c)(9) and
381.409(c)(9)). FDA considered the following options for updating the
DRV for sodium: ``(1) A DRV of 2,300 mg which reflects the Upper Intake
Level (UL) \20\ for individuals aged 14 years and older; (2) An RDI of
1,500 mg which reflects the AI for individuals 9 to 50 years of age;
and (3) Alternative approaches such as retaining a DRV of 2,400 mg,
using a tiered approach or setting a DRV of 1,900 mg based on the UL
for children 4 to 9 years of age'' (79 FR 11915). In FDA's Nutrition
Labeling Proposed Rule, FDA tentatively concluded that 2,300 mg is the
most appropriate DV for sodium to ``assist consumers in maintaining
healthy dietary practices and in understanding the relative
significance of the sodium content within the context of a total daily
diet'' (79 FR 11917). FDA did not change its view in the final rule
that 2,300 mg/day is an appropriate DRV for sodium (81 FR 33874-33880).
FSIS has reviewed FDA's analysis, and consistent with FDA's Nutrition
Labeling Final Rule, FSIS is proposing to set a DRV of 2,300 mg for
sodium (proposed 9 CFR 413.309(c)(9)).
---------------------------------------------------------------------------
\20\ ``The UL is the highest average daily intake level likely
to pose no risk of adverse health effects for nearly all people in a
particular group. The UL is not intended to be a recommended level
of intake. The UL is used to assess the risk of adverse health
effects from excessive nutrient intake. As intake above the UL
increases, so does the potential for risk of adverse health
effects'' (79 FR 11885).
---------------------------------------------------------------------------
H. Fluoride
FSIS's regulations do not permit the declaration of fluoride on the
Nutrition Facts label. FDA amended its regulations to provide for the
voluntary declaration of fluoride because fluoride's positive health
effects are well established (e.g., reduces the risk of dental caries),
but an appropriate quantitative intake recommendation is not available
for setting a DRV (81 FR 33880-33884) (proposed 9 CFR 413.309(c)(5)).
FSIS has reviewed FDA's analysis and consistent with FDA, FSIS is
proposing to (i) permit the voluntary declaration of fluoride on the
Nutrition Facts label; (ii) require the mandatory declaration of
fluoride when a claim about fluoride is made on the label or in
labeling of the product; and (iii) require that when fluoride content
is declared, it must be expressed as zero when a serving contains less
than 0.1 mg of fluoride, to the nearest 0.1 mg increment when a serving
contains less than or equal to 0.8 mg of fluoride, and the nearest 0.2
mg when a serving contains more than 0.8 mg of fluoride, consistent
with how FSIS and FDA have approached incremental values for other
nutrients that are present in products in small amounts. FSIS is not
proposing a DRV for fluoride because an appropriate quantitative intake
recommendation is not available for setting a DRV.
I. Essential Vitamins and Minerals
1. Updates to Declaration of Vitamins and Minerals and Reference Daily
Intakes
FSIS currently requires the declaration of vitamin A, vitamin C,
calcium, and iron on the Nutrition Facts label (9 CFR 317.309(c)(8)(ii)
and 381.409(c)(8)(ii)). Vitamin D, vitamin E, vitamin B6,
vitamin B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, copper, and
potassium may all be declared voluntarily on the Nutrition Facts label
(9 CFR 317.309(c)(8)(iv),
[[Page 6744]]
381.409(c)(8)(iv), 317.309(c)(9), and 381.409(c)(9)). FSIS has also
permitted the voluntary declaration of nutrients for which FSIS has not
codified RDIs, but that are codified in Title 21 of FDA's
regulations.\21\ These nutrients are vitamin K, selenium, manganese,
chromium, molybdenum, and chloride.
---------------------------------------------------------------------------
\21\ http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/trans-fat-declarations/trans-fat-declaration.
---------------------------------------------------------------------------
FDA amended its regulations to: (i) Require the declaration of
vitamin D, calcium, iron, and potassium on the Nutrition Facts label;
(ii) allow the voluntary declaration of vitamin A and C; (iii) retain
the voluntary declaration of vitamin E, vitamin K, vitamin
B6, vitamin B12, thiamin, riboflavin, niacin,
folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc,
selenium, copper, manganese, chromium, molybdenum, and chloride; and
(iv) allow the voluntary declaration of choline (81 FR 33884-33897).
FDA made these changes based on its analysis of data and consideration
of such factors as public health significance, quantitative intake
recommendations, and the role of a nutrient in chronic disease risk (81
FR 33884-33897). Consistent with FDA and proposed 9 CFR
413.309(c)(8)(ii), the vitamins and minerals would be updated in
proposed 9 CFR 413.363(b)(4) to replace ``vitamin A, vitamin C,
calcium, and iron'' with ``vitamin D, calcium, iron, and potassium.''
FDA also revised the existing RDIs for vitamins and minerals after
considering the Dietary Reference Intakes (DRIs) \22\ set by the IOM
that reflect current nutrient requirements (81 FR 33897-33901). Percent
DVs for vitamins and minerals that are required or permitted on the
Nutrition Facts label are based on RDIs (9 CFR 317.309(c)(8)(iv) and
381.409(c)(8)(iv)).
---------------------------------------------------------------------------
\22\ A set of reference values that include the Estimated
Average Requirement, RDA, Adequate Intake, and Tolerable Upper
Intake Level. See 79 FR 11885-6 for more background on DRIs.
---------------------------------------------------------------------------
FSIS is proposing to adopt FDA's list of nutrients as mandatory or
voluntary components of nutrition labeling, the definition of those
nutrients, and the increments for declaring nutrients, in the interest
of harmonizing with FDA (proposed 9 CFR 413.309(c)(8)(iv)). Consistent
with FDA's final rule, FSIS is also proposing to update the RDIs for
calcium, copper, folate, iodine, iron, magnesium, niacin, phosphorus,
riboflavin, thiamin, zinc, and vitamins A, B6,
B12, C, D, and E and to establish RDIs for vitamin K,
selenium, manganese, chromium, molybdenum, chloride, and choline
(proposed 9 CFR 413.309(c)(8)(iv)) (see Table 2). A more extensive
discussion of FDA's list of nutrients and RDIs can be found in the
preamble of FDA's Nutrition Labeling Proposed and Final Rules (79 FR
11918-11931; 81 FR 33897-33901).
Table 2--Current and Proposed RDIs for Nutrition Labeling
[Based on a 2,000 calorie intake for adults and children 4 or more years of age]
----------------------------------------------------------------------------------------------------------------
Nutrient Current RDIs Proposed RDIs
----------------------------------------------------------------------------------------------------------------
Vitamins:
Biotin.............................. .3 milligram............... 30 micrograms.
Choline............................. N/A........................ 550 milligrams.
Folate \6\.......................... .4 milligram............... 400 micrograms DFE.\1\
Niacin.............................. 20 milligrams.............. 16 milligrams NE.\2\
Pantothenic acid.................... 10 milligrams.............. 5 milligrams.
Riboflavin.......................... 1.7 milligrams............. 1.3 milligrams.
Thiamin............................. 1.5 milligrams............. 1.2 milligrams.
Vitamin A........................... 5,000 International Units.. 900 micrograms RAE.\3\
Vitamin B6.......................... 2.0 milligrams............. 1.7 milligrams.
Vitamin B12......................... 6 micrograms............... 2.4 micrograms.
Vitamin C........................... 60 milligrams.............. 90 milligrams.
Vitamin D........................... 400 International Units.... 20 micrograms.\4\
Vitamin E........................... 30 International Units..... 15 milligrams.\5\
Vitamin K........................... N/A........................ 120 micrograms.
Minerals:
Calcium............................. 1.0 gram................... 1,300 milligrams.
Chloride............................ N/A........................ 2,300 milligrams.
Chromium............................ N/A........................ 35 micrograms.
Copper.............................. 2.0 milligrams............. 0.9 milligrams.
Iodine.............................. 150 micrograms............. 150 micrograms.
Iron................................ 18 milligrams.............. 18 milligrams.
Magnesium........................... 400 milligrams............. 420 milligrams.
Manganese........................... N/A........................ 2.3 milligrams.
Molybdenum.......................... N/A........................ 45 micrograms.
Phosphorus.......................... 1.0 gram................... 1,250 milligrams.
Potassium \7\....................... 3,500 milligrams........... 4,700 milligrams.
Selenium............................ N/A........................ 55 micrograms.
Zinc................................ 15 milligrams.............. 11 milligrams.
----------------------------------------------------------------------------------------------------------------
\1\ DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg of folic acid.
\2\ NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 mg of tryptophan.
\3\ RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 micrograms supplemental [beta]-
carotene, 12 micrograms [beta]-carotene, or 24 micrograms [alpha]- carotene, or 24 micrograms [beta]-
cryptoxanthin.
\4\ 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.
\5\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all
rac-[alpha]-tocopherol.
\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\ These minerals currently have a DRV and we are proposing to establish an RDI.
[[Page 6745]]
2. Terms for Vitamins and Minerals
FSIS currently allows the term ``Folacin'' to be added in
parenthesis immediately following the term ``Folate'' on the Nutrition
Facts label (9 CFR 317.309(c)(8)(v) and 381.409(c)(8)(v)). FSIS is
proposing to remove the synonym ``folacin'' from 9 CFR 317.309(c)(8)(v)
and 381.409(c)(8)(v) and require that the term ``folate'' be used on
meat and poultry products that contain folate, folic acid, or a mixture
of folate and folic acid (proposed 9 CFR 413.309(c)(8)(vii)). The
declaration must be folate in mcg DFE (when expressed as a quantitative
amount by weight) and the percent Daily Value based on folate in mcg
DFE, or may be expressed as folate and the percent DV based on folate
in mcg DFE. Because of the proposed changes to the units of measure for
folate that take into account the differences between folate and folic
acid, FSIS is proposing that 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 after the folate declaration. FSIS's proposed
changes are consistent with FDA's Nutrition Labeling Final Rule (81 FR
33909-33912).
J. Labeling of Foods for Infants, Young Children, and Pregnant or
Lactating Women
The general labeling requirements for foods in 9 CFR 317.309(c) and
381.409(c) apply to foods for infants, young children, and pregnant
women and lactating women with certain exceptions. For example, meat
and poultry products represented or purported to be specifically for
infants and children less than 4 years of age are not permitted to
include declarations of percent DV for the following nutrients: Total
fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate,
and dietary fiber (9 CFR 317.400(c)(2)(i) and 381.500(c)(2)(i)). There
are additional exceptions to labeling for meat and poultry products
represented or purported to be specifically for infants and children
less than 2 years of age. For example, these foods are also not
permitted to declare calories from fat, calories from saturated fat,
saturated fat, stearic acid, polyunsaturated fat, monounsaturated fat
and cholesterol on the Nutrition Facts label (9 CFR 317.400(c)(1) and
381.500(c)(1)).
FSIS regulations do not include DRVs or RDIs for nutrients,
generally, for infants, children under 4 years of age, or pregnant
women and lactating women. However, there are requirements for a DRV
for protein for children 4 or more years of age, and an RDI for protein
for each of the following subpopulations: (1) Children less than 4
years of age; (2) infants; (3) pregnant women; and (4) lactating women
(9 CFR 317.309(c)(7)(iii) and 381.409(c)(7)(iii)).
FDA changed its requirements for the labeling of foods, other than
infant formula, represented or purported to be specifically for
infants, children under 4 years of age, and pregnant women and
lactating women after considering current consensus reports, changes to
the Nutrition Facts label, and comments to its 2007 ANPRM (81 FR 33916-
33932). FSIS has reviewed FDA's analysis and is proposing to make
consistent changes to its requirements for the labeling of meat and
poultry products represented or purported to be specifically for
infants, children under 4 years of age, and pregnant women and
lactating women (proposed 9 CFR 413.309(c)).
1. Age Range for Infants and Young Children
FSIS regulations currently use the age ranges ``less than 2 years
of age'' and ``less than 4 years of age'' to establish labeling
requirements for meat and poultry products represented or purported to
be specifically for infants and young children (9 CFR 317.400(c) and
381.500(c)). FDA amended its regulations so that the age categories
were changed to infants through 12 months and young children 1 through
3 years (13 through 48 months) which would be consistent with the age
ranges used in the IOM's DRIs for infants and children (81 FR 33916-
33917). FDA's new DVs are also based on these age-specific DRIs (81 FR
33916-33917)
Consistent with FDA's final rule, FSIS is proposing to replace the
current category of infants and children less than 4 years in 9 CFR
317.400(c)(1); 381.500(c)(1); 317.309(c)(7)-(8); 381.409(c)(7)-(8);
317.309(d)(1); 381.409(d)(1); 317.313(b)(3); 381.413(b)(3);
317.313(q)(3); and 381.413(q)(3) with infants through 12 months and
children 1 through 3 years of age (proposed 9 CFR 413.400(c)(1);
413.309(c)(7)-(9); 413.309(d)(1); 413.313(b)(3); and 413.313(q)(3)).
2. Mandatory Declaration of Calories and Other Nutrients
Currently, meat and poultry products represented or purported to be
specifically for infants and children less than 4 years must declare
certain nutrients, including calories, calories from fat, total fat,
saturated fat, cholesterol, sodium, total carbohydrate, sugars, dietary
fiber, and protein (9 CFR 317.400(c)(2) and 381.500(c)(2)). For meat
and poultry products represented or purported to be for infants and
children less than 2 years, the declaration of certain nutrients, which
include calories from fat, saturated fat, and cholesterol, is not
required or permitted (9 CFR 317.400(c)(1) and 381.500(c)(1)).
a. Declaration of Saturated Fat and Cholesterol
Because FSIS is proposing new categories of infants through 12
months and children 1 through 3 years of age, FSIS is considering
whether there is a need to require or permit the declaration of
calories from fat, saturated fat, and cholesterol in the labeling for
foods represented or purported to be specifically for these
subpopulations. As discussed in section II.B.1. above, FSIS is
proposing to no longer require and not permit the declaration of
calories from fat on the Nutrition Facts label (proposed 9 CFR
413.309(c)(1)(ii)). Therefore, if these proposed changes are finalized,
the exception in 9 CFR 317.400(c)(1) and 381.500(c)(1) for calories
from fat will no longer be needed, and the reference to calories from
fat will be removed. FSIS's regulations currently do not require or
permit the labeling of any fat, with the exception of total fat, or
fatty acids on meat and poultry products represented or purported to be
specifically for children less than 2 years of age.
FDA considered a recent consensus report suggesting that: Fat
intake in infants less than 12 months of age should not be restricted.
Fat is still an important source of calories for infants and young
children. Evidence suggests a diet with saturated fat of less than 10
percent of calories and cholesterol intake less than 300 mg/d can
safely and effectively reduce the levels of total and LDL cholesterol
in healthy children, and that the 2010 DGA recommended that Americans 2
years of age and older consume less saturated fatty acids and less than
300 mg/d of cholesterol (79 FR 11934). FDA requires, except for the
declaration of calories from fat, the mandatory declaration of
statutorily required nutrients under section 403(q) of the FD&C Act
that include saturated fat and cholesterol on the label of foods
represented or purported to be specifically for infants through 12
months and children 1 through 3 years of age (81 FR 33917-33918).
Therefore, consistent with FDA's final rule, FSIS is proposing to
require the declaration of saturated fat and cholesterol on the label
of meat and poultry products purported to be for infants through 12
months and children 1 through 3 years of age (proposed 9 CFR
413.400(c)(1)).
[[Page 6746]]
Currently, meat and poultry products consumed by pregnant women and
lactating women must declare certain nutrients, including calories,
calories from fat, total fat, saturated fat, cholesterol, sodium, total
carbohydrate, sugars, dietary fiber, and protein. As discussed in FDA's
Nutrition Labeling Proposed Rule, women of reproductive age consume the
same foods as the general population and, in general, continue
consuming similar foods during pregnancy and lactation (79 FR 11934).
FDA requires, except for the declaration of calories from fat, the
mandatory declaration of statutorily required nutrients under section
403(q) of the FD&C Act (81 FR 33917-33918).
Accordingly, FSIS is proposing to require the mandatory declaration
of calories and the amount of total fat, saturated fat, cholesterol,
sodium, total carbohydrate, dietary fiber, sugars, and protein on foods
represented or purported to be specifically for infants through 12
months of age, children 1 through 3 years of age, and pregnant women
and lactating women and to permit the declaration of calories from
saturated fat such that these nutrients would be subject to the same
requirements applicable to meat and poultry products for the general
population (proposed 9 CFR 413.309(c)).
b. Percent DV Declaration
Currently, the percent DV declaration is not permitted on the
Nutrition Facts label for meat and poultry products represented or
purported to be specifically for infants and children less than 4 years
of age (which includes infants and children less than 2 years of age)
for total fat, saturated fat, cholesterol, sodium, potassium, total
carbohydrate, and dietary fiber (9 CFR 317.400(c)(2)(i) and
381.500(c)(2)(i)). Percent DV is required for protein and vitamins and
other minerals and, as discussed in sections II.F and II.I, provides
information in a manner that enables consumers to understand the
relative significance of nutrition information in the context of a
total daily diet. FDA concluded that it is appropriate to require
declarations of percent DV for those nutrients for which FDA is
establishing a DRV or RDI for infants through 12 months, for children 1
through 3 years of age, and for pregnant women and lactating women (81
FR 33918-33919). Accordingly, FSIS is proposing in 9 CFR
413.400(c)(2)(i) to require declarations of percent DV for those
nutrients for which FSIS is establishing a DRV or RDI for infants
through 12 months, for children 1 through 3 years of age, and for
pregnant women and lactating women consistent with FDA's Nutrition
Labeling Final Rule.
c. Mandatory Declaration of Added Sugars
As discussed in section II.E.3, FSIS is proposing to require the
mandatory declaration of added sugars on the Nutrition Facts label. The
2010 DGA provides recommendations for consumption of added sugars for
the U.S. population 2 years of age and older but not for infants and
children under age 2. It is expected, however, that the role of added
sugars are not markedly different between children 1 and 2 years of age
(79 FR 11936). Similarly, the IOM has established DRI ranges for 1-
through-3-year-olds because growth velocity is most similar during this
age range (79 FR 11936; 81 FR 33916). FDA has concluded that mandatory
declaration of added sugars is needed for foods for infants through 12
months, just as it is for the general population, to provide consumers
with information to construct a healthy dietary pattern that meets the
dietary recommendations for added sugars (81 FR 33921).
Consistent with FDA's Nutrition Labeling Final Rule, FSIS is
proposing the mandatory declaration of added sugars on the Nutrition
Facts label of meat and poultry products represented or purported to be
specifically for infants through 12 months, children 1 through 3 years
of age, and pregnant women and lactating women.
d. Mandatory Declaration of Trans Fat
As discussed in section II.C.3, FSIS is proposing to require the
mandatory declaration of trans fat on the Nutrition Facts label. The
mandatory declaration of trans fat is needed for foods for infants
through 12 months, children 1 through 3 years of age, and pregnant
women and lactating women, just as it is needed for the general
population to assist in maintaining healthy dietary practices. For
example, the relationship between the consumption of trans fat and risk
of CHD is well established 23 24 and cardiovascular disease
is also known to begin in childhood.25 26
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\23\ U.S. Department of Agriculture and U.S. Department of
Health and Human Services. (2010) ``Dietary Guidelines for
Americans, 2010'', 7th Ed., Washington DC: U.S. Government Printing
Office. Retrieved from http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm.
\24\ Institute of Medicine (IOM) of the National Academies.
``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat,
Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients),
Chapter 8: Dietary Fats: Total Fat and Fatty Acids'', Washington,
DC: National Academies Press; 2002.
\25\ U.S. Department of Health and Human Services, National
Institutes of Health, and National, Heart Lung and Blood Institute.
(October, 2012) ``Integrated Guidelines for Cardiovascular Health
and Risk Reduction In Children and Adolescents: The Report of the
Expert Panel''; NIH Publication No. 12-7486A. Retrieved from http://www.nhlbi.nih.gov/guidelines/cvd_ped/index.htm.
\26\ American Academy of Pediatrics. ``Chapter 32:
Hyperlipidemia and Prevention of Cardiovascular Disease''. In:
Pediatric Nutrition Handbook 6th Ed. Kleinman, R.E., ed. American
Academy of Pediatrics; 2009; p.723.
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Consistent with FDA's Nutrition Labeling Final Rule, FSIS is
proposing to require the declaration of trans fat on the Nutrition
Facts label of meat and poultry products represented or purported to be
specifically for infants through 12 months, children 1 through 3 years
of age, and pregnant women and lactating women.
3. Voluntary Declaration of Nutrients Other Than Essential Vitamins and
Minerals
Currently, meat and poultry products represented or purported to be
specifically for infants and children less than 2 years of age are not
permitted to declare calories from fat, calories from saturated fat,
and the amount of polyunsaturated fat and monounsaturated fat (9 CFR
317.400(c)(1) and 381.500(c)(1)), whereas soluble fiber, insoluble
fiber, and sugar alcohols can be voluntarily declared. Polyunsaturated
fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar
alcohols can be voluntarily declared on the label of meat and poultry
products represented or purported to be specifically for children 2
through 4 years of age and pregnant women and lactating women (9 CFR
317.400(c)(2) and 381.500(c)(2)). FSIS is proposing the following
changes to voluntary declaration of certain nutrients.
a. Voluntary Declaration of Calories From Saturated Fat, and the Amount
of Polyunsaturated and Monounsaturated Fat
For infants through 12 months, there are no specific
recommendations provided about calories from saturated,
polyunsaturated, or monounsaturated fat. However, as discussed in FDA's
Nutrition Labeling Proposed Rule, there is some evidence to suggest
that reduction of total and LDL cholesterol levels can occur with
reducing saturated fat intake to less than 10 percent of calories,
beginning in infancy and sustained throughout childhood into
adolescence (79 FR 11935). Because consensus reports provide no
discussion or recommendation about providing nutrient guidelines for
fatty acids to children under the age of 2 years, and there is no
evidence to suggest that infants through 12 months of age would
[[Page 6747]]
be different than children 1 through 3 years of age, FDA explained that
there is no basis to continue to prohibit the declaration of calories
from saturated fat or polyunsaturated and monounsaturated fats on foods
represented or purported to be specifically for infants and children
less than 2 years of age (81 FR 33919-33920).
Also, as discussed in FDA's Nutrition Labeling Proposed Rule,
quantitative intake recommendations are not available from relevant
U.S. consensus reports for monounsaturated and polyunsaturated fats for
children 1 through 3 years of age or pregnant women and lactating
women. There is well-established evidence to indicate that replacing
saturated fatty acids with polyunsaturated and monounsaturated fatty
acids reduces blood LDL cholesterol levels and, therefore, the risk of
CVD; and that monounsaturated and polyunsaturated fats have public
health significance when they replace saturated fat (79 FR 11936). FDA
finalized its proposed requirements and permits the declaration of
calories from saturated fat, polyunsaturated and monounsaturated fat on
foods represented or purported to be specifically for infants through
12 months and children 1 through 3 years of age (81 FR 33919-33920).
Consistent with FDA's Nutrition Labeling Final Rule, FSIS is
proposing to revise 9 CFR 317.400(c)(1) and 381.500(c)(1) (which would
be consolidated in proposed 9 CFR 413.400(c)(1)) to remove the
exceptions for the declaration of calories from saturated fat and the
amount of polyunsaturated fat and monounsaturated fat on meat and
poultry products represented or purported to be specifically for
infants through 12 months, children 1 through 3 years of age, or
pregnant or lactating women. If finalized, these declarations for the
new age categories, infants through 12 months and children 1 through 3
years of age, would be the same as the proposed voluntary declarations
for foods for the general population.
b. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and Sugar
Alcohols
As discussed in section II.E, FSIS is proposing to allow the
declaration of soluble fiber and insoluble fiber that meet the
definition of ``dietary fiber'' on the Nutrition Facts label for the
general population. FDA has concluded that there is no evidence to
suggest that the role of these nutrients would be different among
infants through 12 months, children 1 through 3 years of age, or
pregnant women and lactating women compared to the general population
(81 FR 33920).
FSIS has reviewed FDA's analysis and is not proposing any changes
to the provisions for the voluntary declaration of soluble fiber,
insoluble fiber, and sugar alcohols on the label of meat and poultry
products represented or purported to be specifically for infants
through 12 months, children 1 through 3 years of age, or pregnant women
and lactating women, consistent with FDA's Nutrition Labeling Final
Rule (81 FR 33920).
c. Voluntary Declaration of Fluoride
FSIS regulations currently do not provide for the declaration of
fluoride on the Nutrition Facts label of any meat or poultry product.
For the reasons discussed in section II.H, FSIS is proposing to permit
voluntary declaration of fluoride on the labeling of meat and poultry
products for the general population. As discussed in FDA's Nutrition
Labeling Proposed Rule and Final Rule (in which FDA did not change its
tentative conclusions from the proposed rule), because fluoride
provides protection against dental caries by strengthening the tooth
enamel before and after teeth appear, and because excessive fluoride
intake can cause dental fluorosis in young children, the declaration of
fluoride on foods represented or purported to be specifically for
children 1 through 3 years of age and for pregnant women and lactating
women can assist in maintaining healthy dietary practices (79 FR 11936;
81 FR 33921). Further, while evidence on dental caries is lacking for
infants through 12 months of age, there is no reason to expect the role
of fluoride in the protection against dental caries to be different
from other age groups (Id.). Therefore, consistent with FDA's Nutrition
Labeling Final Rule on the voluntary declaration of fluoride for these
subpopulations, FSIS is proposing to permit the voluntary declaration
of fluoride on meat and poultry products represented or purported to be
specifically for infants through 12 months of age, children 1 through 3
years of age, and pregnant women and lactating women (proposed 9 CFR
413.309(c)(5)).
4. Declaration of Essential Vitamins and Minerals
FSIS requires the declarations of vitamin A, vitamin C, calcium,
and iron on the Nutrition Facts label, and there are no specific
exceptions to this requirement for meat and poultry products
represented or purported to be specifically for infants and children
less than 2 years and children less than 4 years of age, and pregnant
women and lactating women (9 CFR 317.309(c)(8) and 381.409(c)(8)). FSIS
is proposing to replace the current categories ``infants and children
less than 2 years of age and children less than 4 years of age'' with
``infants through 12 months and children 1 through 3 years of age.''
Since the needs of essential vitamin and minerals are increased for
both pregnant women and lactating women, FDA applied its conclusions
about nutrient inadequacy during pregnancy to lactating women and made
the requirements related to essential vitamins and minerals in labeling
of foods for pregnant women and lactating women the same (81 FR 33921-
33922). Consistent with FDA's Nutrition Labeling Final Rule, FSIS is
proposing to remove the current provision in 9 CFR 317.309(c)(8)(i) and
381.409(c)(8)(i) that requires separate declaration of percent DVs
based on both RDI values for pregnant women and for lactating women in
the labeling of foods represented or purported to be for use by both
pregnant women and lactating women (proposed 9 CFR 413.309(c)(8)(i)).
a. Mandatory Declaration of Calcium and Iron
FSIS is not proposing any changes to the mandatory declaration of
calcium on foods for the general population (see section II.I.1.). As
discussed in FDA's Nutrition Labeling Proposed Rule, the AI for calcium
for infants through 12 months of age is based on average calcium
consumption of this nutrient rather than on chronic disease risk,
health related-condition, or physiological endpoints (79 FR 11937). For
children 1 through 3 years of age and pregnant women and lactating
women, the Recommended Dietary Allowances (RDAs) \27\ for calcium are
based, in part, on bone health (79 FR 11937).
---------------------------------------------------------------------------
\27\ ``The RDA is an estimate of the average intake level that
meets the nutrient requirements of nearly all (97 to 98 percent)
healthy individuals in a particular life stage and gender group''
(79 FR 11885).
---------------------------------------------------------------------------
FDA's analysis of the Centers for Disease Control and Prevention
(CDC) National Health and Nutrition Examination Survey (NHANES) 2003-
2006 data estimated that infants ages 7 to 12 months have usual calcium
intakes above the AI and estimated that about 12 percent of children 1
through 3 years of age had usual intakes of calcium below the Estimated
Average
[[Page 6748]]
Requirement (EAR), \28\ based on intakes from conventional foods only
(79 FR 11937). FDA has found that promoting the development of eating
patterns that are associated with adequate calcium intake later in life
is important given that calcium intakes are inadequate for the majority
of the population. Intakes of calcium, which is necessary for growth
and bone development, are inadequate among children. Also, similar to
the general population, approximately 20 percent of pregnant women
consumed less than the EAR for calcium from conventional foods as well
as from conventional foods and supplements (79 FR 11937).
---------------------------------------------------------------------------
\28\ ``The EAR is the average daily nutrient intake level that
is estimated to meet the requirements of half of the healthy
individuals in a particular life stage and gender group. EARs are
used for assessing the statistical probability of adequacy of
nutrient intakes of groups of people'' (79 FR 11885).
---------------------------------------------------------------------------
FDA concluded that calcium is a nutrient of public health
significance for children 1 through 3 years of age and pregnant women
and lactating women and infants through 12 months and requires the
mandatory declaration of calcium on foods purported to be specifically
for infants through 12 months, children 1 through 3 years of age, or
pregnant and lactating women (81 FR 33922). Consistent with FDA's
Nutrition Labeling Final Rule, FSIS is not proposing to change the
mandatory declaration of calcium for meat and poultry products
purported to be specifically for infants through 12 months, children 1
through 3 years of age, or pregnant or lactating women.
FSIS is not proposing any changes to the mandatory declaration of
iron on foods for the general population (see section II.I.1.). As
discussed in FDA's Nutrition Labeling Proposed Rule, although the EAR
and RDA are based on daily iron requirements and not directly on
chronic disease risk, iron deficiency is associated with delayed normal
infant motor function (i.e., normal activity and movement) and mental
function (i.e., normal thinking and processing skills) (79 FR 11937).
FDA's analysis of NHANES 2003-2006 data estimated that about 18 percent
of infants ages 7 to 12 months have usual iron intakes below the EAR,
based on intakes from conventional foods only and 4 percent of infants
ages 7 to 12 months have usual iron intakes below the EAR based on
intakes from conventional foods and supplements (79 FR 11937; 81 FR
33922).
As discussed in FDA's Nutrition Labeling Proposed Rule, about 1
percent of children 1 through 3 years of age have usual iron intakes
below the EAR, based on intakes from conventional foods only, and 0.4
percent of children have usual iron intakes below the EAR based on
intakes from conventional foods and supplements (79 FR 11937). The IOM
set the EAR by modeling components of iron requirements. The prevalence
of iron deficiency in children ages 1 to 2 years has been reported to
be 14.4 percent, and the prevalence of iron deficiency anemia in
children younger than 5 years has been reported to be 14.9 percent. FDA
requires the mandatory declaration of iron in the labeling of foods for
infants through 12 months and children 1 through 3 years of age (81 FR
33922).
As discussed in FDA's Nutrition Labeling Proposed Rule, inadequate
iron intakes during pregnancy are of public health significance because
of the adverse effects for both the mother and the fetus (such as
maternal anemia, premature delivery, low birth weight, and increased
perinatal infant mortality) (79 FR 11938). FDA analyzed NHANES 2003-
2006 data and estimated that 5 percent of pregnant women 14 to 50 years
of age had usual iron intakes below the EAR based on intakes from
conventional foods, and 4 percent of pregnant women 14 to 50 years of
age had usual iron intakes below the EAR based on intakes from
conventional foods and supplements. The EAR for iron for pregnant women
was based on estimates of iron stores needed during the first trimester
(79 FR 11938). FDA's analysis of NHANES 2003-2006 data also indicated
that, among pregnant women aged 12 to 49 years, 25 percent were iron
deficient, and 13 percent had iron deficiency anemia (79 FR 11938). FDA
considered iron deficiency based on two out of three cutoffs of iron
deficiency variables (transferrin saturation, serum ferritin, and
erythrocyte protoporphyrin) (79 FR 11938).
FDA found that calcium and iron have quantitative intake
recommendations and have public health significance for infants through
12 months, children 1 through 3 years of age, and pregnant women and
lactating women. FDA did not receive comments to its proposed rule to
change its tentative conclusion that the declaration of calcium and
iron is necessary to assist consumers in maintaining healthy dietary
practices (81 FR 33922). FSIS has reviewed FDA's analysis and is
proposing to require the mandatory declaration of calcium and iron on
foods represented or purported to be specifically for infants through
12 months, children 1 through 3 years of age, or pregnant women and
lactating women without providing any exceptions for these
subpopulations from the requirement for declaration of calcium and iron
applicable to foods for the general population (proposed 9 CFR
413.309(c)(8)(ii)).
b. Mandatory Declaration of Vitamin D and Potassium
FSIS is proposing to require the declaration of vitamin D on meat
and poultry products for the general population (see section II.I.1.).
FDA identified vitamin D as a nutrient of public health significance in
children 1 through 3 years of age and pregnant women based on the high
prevalence of inadequate intakes of vitamin D and its important role in
bone development and health (81 FR 33922-33923). FDA also identified
vitamin D as a nutrient of public health significance for infants
through 12 months of age based on its importance for growth and
development during infancy (81 FR 33922-33923).
FSIS is proposing to require the declaration of potassium on foods
for the general population (see proposed 9 CFR 413.309(c)(8)(ii) and
section II.I.1.). As discussed in FDA's Nutrition Labeling Proposed
Rule, the AI for infants is based on average potassium intake from
breast milk and complementary foods (79 FR 11938). The AI for the other
life-stage and gender groups is set at a level to maintain blood
pressure, reduce the adverse effects of sodium chloride intake on blood
pressure, and reduce the risk of recurrent kidney stones (79 FR 11938).
FSIS has reviewed FDA's analysis of potassium intake from NHANES
2003-2006 for infants 7 to 12 months of age; potassium intake for
children 1 through 3 years of age; and the importance of potassium in
the risk reduction of chronic diseases for children 2 years of age and
older (79 FR 11938). Because of the benefits of adequate potassium
intake in lowering blood pressure and data indicating low likelihood of
potassium adequacy, FSIS agrees with FDA that it is important to
establish healthy dietary practices for later life (79 FR 11938). FDA
tentatively concluded in the Nutrition Labeling Proposed Rule that
there is no basis to conclude that the public health significance of
potassium among infants through 12 months of age would be different
than the science-based evidence for children 1 through 3 years of age,
and that potassium is of public health significance to infants through
12 months, children 1 through 3 years of age and pregnant women and
lactating women (79 FR 11938). FDA did not change its tentative
conclusion in the final rule (81 FR 33922-33923).
[[Page 6749]]
Consistent with FDA's Nutrition Labeling Final Rule, FSIS is
proposing to require the labeling of vitamin D and potassium on foods
represented or purported to be specifically for infants through 12
months of age, children 1 through 3 years of age, and pregnant women
and lactating women based on the quantitative intake recommendations
for vitamin D and potassium and the public health significance of these
nutrients. Consequently, FSIS is not providing for any exceptions for
these subpopulations from the general requirement in proposed 9 CFR
413.309(c)(8)(ii) to declare vitamin D and potassium.
c. Voluntary Declaration of Vitamin A and Vitamin C
FSIS is proposing to no longer require the declaration of vitamin A
and vitamin C on foods for the general population (see section
II.I.1.). As discussed in FDA's Nutrition Labeling Proposed Rule, none
of the DRIs (AIs or RDAs) for vitamin A were based on chronic disease
risk, a health related-condition, or health-related physiological
endpoints (79 FR 11939).
FDA looked at vitamin A intake from NHANES 2003-2006 for children
and pregnant women and found a very low prevalence of inadequate
intakes of vitamins A and C or inadequate status among children 1
through 3 years of age or pregnant women and also the lack of evidence
to indicate that this would be different for infants or lactating women
(79 FR 11939). FDA concluded that vitamin A and vitamin C are not of
public health significance among infants through 12 months of age,
children 1 through 3 years of age, and pregnant women and lactating
women and that this supports the voluntary declaration of vitamins A
and C in the labeling of foods for young children (81 FR 33923-33924).
Consistent with FDA's Nutrition Labeling Final Rule, FSIS is proposing
to permit, but not to require, that the declaration of vitamin A and
vitamin C on foods represented and purported to be specifically for
infants through 12 months, children 1 through 3 years of age, or
pregnant women and lactating women. Similar to other voluntary
nutrients, the declaration of vitamins A and C would be required when
claims are made about them on the label or labeling (proposed 9 CFR
413.309(c)(8)(ii)).
d. Voluntary Declaration of Other Vitamins and Minerals
As discussed in section II.I.3., for the general population, FSIS
is proposing to permit the voluntary declaration of vitamin E, vitamin
K, vitamin B6, vitamin B12, thiamin, riboflavin,
niacin, folate, biotin, pantothenic acid, phosphorus, iodine,
magnesium, zinc, selenium, copper, manganese, chromium, molybdenum,
chloride, and choline (proposed 9 CFR 413.309(c)(8)(ii)). As discussed
in FDA's Nutrition Labeling Proposed Rule, vitamins and minerals other
than iron, calcium, vitamin D, and potassium for infants either have
DRIs that are not based on chronic disease risk, heath-related
conditions, or health-related physiological endpoints or are not shown
to have public health significance because of the prevalence of a
clinically relevant nutrient deficiency (79 FR 11939). FDA determined,
in the final rule that, for infants through 12 months, children 1
through 3 years of age, and pregnant women and lactating women, the
essential vitamins and minerals, other than iron, calcium, vitamin D
and potassium, do not have public health significance, and there is no
basis for the declaration of these nutrients to be different from that
proposed for the general population (81 FR 33924). Consistent with
FDA's Nutrition Labeling Final Rule, FSIS is proposing to allow the
voluntary declaration of vitamin E, vitamin K, vitamin B6,
vitamin B12, thiamin, riboflavin, niacin, folate, biotin,
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, chloride, and choline on foods
represented or purported to be specifically for infants through 12
months, children 1 through 3 years of age, or pregnant women and
lactating women, unless the labeling makes a claim about them, in which
case the nutrients would have to be declared (proposed 9 CFR
413.309(c)(8)(ii)).
5. DRVs and Reference Daily Intakes (RDIs) for Infants Through 12
Months of Age
FSIS regulations do not include DRVs or RDIs for nutrients for
infants through 12 months of age, except an RDI for protein of 14 g for
infants. Consistent with FDA, FSIS is considering establishing DRVs and
RDIs for nutrients for infants through 12 months of age and revisions
to the current RDI for protein.
a. Calories
FSIS's regulations do not provide, and FDA has not established, a
reference calorie intake level for infants and children less than 2
years of age. As discussed in FDA's Nutrition Labeling Proposed Rule,
there is no quantitative intake recommendation for calories for
infants, and FDA is not aware of other scientific data and information
on which it could rely to establish that level (79 FR 11939). FDA did
not establish a reference calorie intake for infants through 12 months
of age in the final rule (81 FR 33925). Therefore, consistent with
FDA's Nutrition Labeling Final Rule, FSIS is not proposing to establish
a reference calorie intake level for infants through 12 months (81 FR
33925).
b. Total Fat
As discussed in FDA's Nutrition Labeling Proposed Rule, the IOM set
an AI of 30 g/d for fat for infants through 12 months of age based on
the average intake of human milk and complementary foods. There was no
AI available in 1993, and the current AI provides a basis to determine
an appropriate DRV for total fat for this subpopulation that can assist
consumers in maintaining healthy dietary practices among this
subpopulation (79 FR 11939). FDA established a DRV of 30 g for fat for
infants through 12 months in its final rule (81 FR 33925). Therefore,
consistent with FDA's Nutrition Labeling Final Rule, FSIS is proposing
to include a DRV of 30 g for fat for infants through 12 months of age
(proposed 9 CFR 413.309(c)(9)).
c. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber, and Sugars
As discussed in FDA's Nutrition Labeling Proposed Rule, there are
no quantitative intake recommendations from U.S. consensus reports
available for saturated fat, trans fat, cholesterol, dietary fiber, and
sugars for infants (79 FR 11939). FDA was not aware of other reliable
scientific data and information on which to establish DRVs for these
nutrients for infants through 12 months of age (79 FR 11939). FDA did
not establish DRVs for infants through 12 months of age for these
nutrients in its final rule (81 FR 33925). Accordingly, FSIS is not
proposing to establish DRVs for these nutrients for infants through 12
months of age, consistent with FDA's Nutrition Labeling Final Rule
because appropriate scientific data is not available.
d. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber, Soluble
Fiber, Insoluble Fiber, Added Sugars, and Sugar Alcohols
As discussed in FDA's Nutrition Labeling Proposed Rule,
quantitative intake recommendations from U.S. consensus reports are not
available for polyunsaturated fat, monounsaturated fat, insoluble
fiber, soluble fiber, added sugars, or sugar alcohols for infants (79
[[Page 6750]]
FR 11940). FDA was not aware of other reliable scientific data and
information on which to establish DRVs for these nutrients for this
subpopulation (79 FR 11940). FDA did not establish DRVs for infants
through 12 months of age for these nutrients in its final rule (81 FR
33925). Accordingly, consistent with FDA's Nutrition Labeling Final
Rule, FSIS is not proposing to establish DRVs for these nutrients for
infants through 12 months of age because appropriate scientific data
are not available.
e. Total Carbohydrate
As discussed in FDA's Nutrition Labeling Proposed Rule, the IOM set
an AI of 95 g/d for carbohydrate for infants through 12 months of age
based on the average intake of human milk and complementary foods.
There was no AI available in 1993, and the current AI provides a basis
on which FDA could determine an appropriate DRV for total carbohydrate
for this subpopulation that can assist consumers in maintaining healthy
dietary practices among this subpopulation (79 FR 11940). FDA
established a DRV of 95 g for total carbohydrate for infants through 12
months of age in its final rule (81 FR 33925). Therefore, consistent
with FDA's Nutrition Labeling Final Rule, FSIS is proposing to
establish a DRV of 95 g for total carbohydrate for infants through 12
months of age (proposed 9 CFR 413.309(c)(9)).
f. Protein
As discussed in FDA's Nutrition Labeling Proposed Rule, the DV for
protein for infants is an RDI, rather than a DRV. Before 1993, FDA
established the RDIs for protein for all age groups based on the 1989
RDA. In 1993, FDA changed the RDI for protein for the general
population to a DRV (58 FR 2206 at 2216). FDA retained the RDI for
infants based on the highest 1968 RDA value (14 g/d for infants) to be
consistent with a population-coverage approach, but it found no reason
to change the approach of using the RDI for infants through 12 months.
FDA determined that it would be appropriate to revise the RDI to rely
on current quantitative intake recommendations. In 2002, the IOM
established an RDA for infants through 12 months of 1.2 g/kg/d based on
nitrogen balance studies and using a reference body weight of 9 kg
consistent with current growth charts for infants. Protein intakes are
well above the current and proposed RDI, and mean protein intake for
infants 6 to 11 months of age was well above the RDA of 11 g/d (79 FR
11940). FDA established an RDI of 11 grams for protein for infants
through 12 months of age in its final rule (81 FR 33925). Accordingly,
consistent with FDA's Nutrition Labeling Final Rule, FSIS is proposing
to establish an RDI of 11 g for protein for infants through 12 months
of age (proposed 9 CFR 413.309(c)(8)(iv)).
g. Sodium
FSIS is proposing to establish a DRV for sodium based on the IOM's
UL for the general population (section II.G.). However, as discussed in
FDA's Nutrition Labeling Proposed Rule, the IOM did not set a UL for
sodium for infants through 12 months of age because there was
insufficient data on adverse effects of chronic overconsumption in this
age group (79 FR 11940). In addition, FDA was not aware of other
reliable scientific data and information on which to establish a DRV
for sodium for this subpopulation (79 FR 11940). FDA did not establish
a DRV for sodium for infants through 12 months of age in its final rule
(81 FR 33926). Therefore, consistent with FDA's Nutrition Labeling
Final Rule, FSIS is not proposing a DRV for sodium for infants through
12 months of age because of the lack of appropriate scientific data.
h. Fluoride
As discussed in section II.H, although the IOM set an AI for
fluoride, the AIs for infants through 12 months and children 1 through
3 years are close to the Environmental Protection Agency benchmarks for
total fluoride intake. FDA did not propose a DRV for fluoride for use
in the labeling of foods for the general population because of a
concern about excess intakes associated with dental fluorosis (79 FR
11918). FDA did not establish a DRV for fluoride for infants through 12
months in its final rule (81 FR 33926). The use of such a DRV to
calculate percent DV may have the unintended effect of consumers
selecting foods with higher fluoride amounts, which are not necessary
or advised (79 FR 11940). Accordingly, consistent with FDA's Nutrition
Labeling Final Rule, FSIS is not proposing to establish a DRV for
fluoride for infants through 12 months of age.
i. Vitamins and Minerals
FSIS regulations do not include DRVs or RDIs for nutrients,
generally, for infants, children under 4 years of age, or pregnant
women and lactating women. However, there are requirements for a DRV
for protein for children 4 or more years of age and an RDI for protein
for (1) children less than 4 years of age; (2) infants; (3) pregnant
women; and (4) lactating women (9 CFR 317.309(c)(7)(iii) and
381.409(c)(7)(iii)).
FDA reviewed current quantitative intake recommendations for
vitamins and minerals for infants and considered comments received in
response to its 2007 ANPRM to determine appropriate RDIs for vitamins
and minerals for infants through 12 months of age (79 FR 11940). FSIS
agrees with FDA that it is important to establish RDIs for infants
through 12 months of age because infants in this age range transition
from a diet of mostly breast milk and infant formula to infant cereal
and baby foods; that labeling foods for this subpopulation with percent
DV declarations can assist parents in making nutritious food choices;
that the DRIs (AIs and RDAs) provide a basis on which to determine RDIs
for vitamins and minerals for this subpopulation; that it is
appropriate to use RDAs and, in the absence of RDAs, AIs to determine
appropriate micronutrient RDIs for infants; that both RDAs and AIs are
sufficient for setting RDIs because they both represent intake levels
that are expected to meet or exceed the nutrient needs of the majority
of infants; that the IOM established DRIs based on scientific knowledge
that update and supersede previous RDA recommendations; and that DRIs
are available for infants through 12 months of age (79 FR 11940).
FDA established RDIs for vitamin A, vitamin C, vitamin D, vitamin
E, vitamin K, vitamin B12, folate, choline, riboflavin,
niacin, vitamin B6, calcium, iron, thiamin, biotin,
pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium,
copper, manganese, chromium, molybdenum, chloride, and potassium for
infants through 12 months of age in its final rule (81 FR 33926-33927).
Accordingly, consistent with FDA's Nutrition Labeling Final Rule (81 FR
33926-33927), FSIS is proposing to include a listing of RDIs for these
same nutrients for infants through 12 months of age (proposed 9 CFR
413.309(c)(8)(iv)).
6. DRVs and RDIs for Children 1 Through 3 Years of Age
FSIS regulations do not include DRVs or RDIs for nutrients for
children 1 through 3 years of age, except an RDI for protein of 16 g
for children less than 4 years of age. As discussed in FDA's Nutrition
Labeling Proposed Rule, FDA reviewed scientific evidence and current
recommendations, as well as comments in response to FDA's 2007 ANPRM,
to consider establishing DRVs and RDIs for nutrients for this
subpopulation and to consider revisions
[[Page 6751]]
to the current RDI for protein (79 FR 11940).
a. Calories
FSIS regulations currently do not provide a reference calorie
intake level for nutrition labeling for children ages 1 through 3
years. FDA established a reference calorie intake level for children 1
through 3 years of age and set DRVs using quantitative intake
recommendations that are based on calories (e.g., total fat, saturated
fat, and dietary fiber). Current recommendations from the IOM, American
Heart Association (AHA), American Academy of Pediatrics (AAP), and the
2015-2020 DGA for caloric intake range from 800 to 900 calories/d for
children 1 year old, approximately 1,000 calories/d for children 2
years of age, and from 1,000 to 1,200 calories/d for children 3 years
of age. FDA considered that an average of the range of these caloric
intake recommendations (800 to 1,200 calories/d), i.e., 1,000 calories/
d, provides a reasonable reference calorie intake level (79 FR 11941).
FDA established a reference calorie intake of 1,000 calories/day for
children aged 1 through 3 years in its final rule (81 FR 33927). FSIS
has reviewed FDA's analysis and is proposing to provide a reference
calorie intake level of 1,000 calories/day for children 1 through 3
years of age (proposed 9 CFR 413.309(c)(9)) consistent with FDA's
Nutrition Labeling Final Rule.
b. Total Fat
Currently, FSIS regulations do not provide a DRV for total fat for
children ages 1 through 3 years. As discussed in FDA's Nutrition
Labeling Proposed Rule, FDA agreed with a comment to its 2007 ANPRM
that 35 percent of calories from fat for children 1 through 3 years of
age, the midpoint of the IOM AMDR of 30 to 40 percent, serves as an
appropriate basis on which to set the DRV for total fat. The approach
to calculating the DRV for total fat is consistent with FDA's approach
to setting the DRV for total fat for the general population. Thirty-
five percent is consistent with AHA and AAP recommendations that 30 to
40 percent of calories consumed by children 12 through 24 months of
age, and 30 to 35 percent of calories consumed by children 24 through
48 months of age, should come from fat (79 FR 11941). In FDA's
Nutrition Labeling Proposed Rule, FDA tentatively concluded that 35
percent of total calories from fat (i.e., 39 g using the finalized
reference calorie intake level of 1,000 calories/d) is an appropriate
DRV for total fat for children 1 through 3 years of age (Id.). FDA
established a DRV of 39 grams for total fat in its final rule (81 FR
33927-33928). FSIS has reviewed FDA's analysis and is proposing to
establish a DRV of 39 g for fat for children 1 through 3 years of age
(proposed 9 CFR 413.309(c)(9)) consistent with FDA's Nutrition Labeling
Final Rule.
c. Saturated Fat, Trans Fat, and Cholesterol
FSIS has not established DRVs for saturated fat, trans fat, or
cholesterol for children 1 through 3 years of age. As discussed in
FDA's Nutrition Labeling Proposed Rule, FDA considered a comment to its
2007 ANPRM that suggested using the midpoint of 10 to 15 percent of
calories for saturated fat, 2 percent of calories for trans fat based
on estimates of mean trans fat intake for the U.S. population 3 years
of age and older, and less than or equal to 300 mg/d for cholesterol
based on the 2005 DGA recommendation. CVD is known to begin in
childhood, and the 2010 DGA recommended that Americans 2 years of age
and older consume less than 10 percent of calories from saturated fat
and less than 300 mg/d of cholesterol (79 FR 11941). FDA tentatively
concluded that it is appropriate to set a DRV of 10 g for saturated
fat, based on 10 percent of total calories from saturated fat and using
the proposed reference calorie intake level of 1,000 calories/d which
equals 11 g, rounded down to 10 g, and a DRV of 300 mg for cholesterol
for children 1 through 3 years of age (79 FR 11941). FDA established a
DRV of 10 g for saturated fat and a DRV of 300 mg for cholesterol for
children 1 through 3 years of age in its final rule (81 FR 33928).
Consistent with FDA's Nutrition Labeling Final Rule, FSIS is proposing
to establish a DRV of 10 g for saturated fat and a DRV of 300 mg for
cholesterol for children 1 through 3 years of age (proposed 9 CFR
413.309(c)(9)).
FSIS is not proposing to establish a DRV for trans fat because the
IOM and 2015-2020 DGA do not provide any specific appropriate levels of
intake and FDA did not establish a DRV for trans fat (81 FR 33928).
d. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Added Sugars,
Insoluble Fiber, Soluble Fiber, and Sugar Alcohols
FSIS has not established DRVs for polyunsaturated fat,
monounsaturated fat, sugars, added sugars, insoluble fiber, soluble
fiber, or sugar alcohol for children 1 through 3 years of age. As
discussed in FDA's Nutrition Labeling Proposed Rule, FDA stated that
there was no reliable data or information available to establish DRVs
for polyunsaturated fat, monounsaturated fat, sugars, insoluble fiber,
soluble fiber, and sugar alcohols, and tentatively concluded that there
was no basis for setting DRVs for these nutrients (79 FR 11941). FDA
established a DRV reference point for the added sugars declaration at
10 percent of calories in its final rule, after considering the
scientific evidence in the 2015 DGAC report (81 FR 33842). FDA set a
DRV for children 1 through 3 years of age of 25 g of added sugars
(1,000 calorie reference amount x .10 = 100 calories and 100 calories /
4 calories/gram = 25 grams) (81 FR 33928-33929). FSIS has reviewed
FDA's analysis and is proposing a DRV for added sugars of 25 g for
children 1 through 3 years of age and that the percent DV for added
sugars be declared on the Nutrition Facts label consistent with FDA's
final rule. FSIS is not proposing DRVs for polyunsaturated fat,
including n-3 or n-6 polyunsaturated fatty acids, monounsaturated fat,
sugars, soluble fiber, insoluble fiber, or sugar alcohols for children
1 through 3 years of age consistent with the FDA Nutrition Labeling
Final Rule.
e. Total Carbohydrate
FSIS has not established a DRV for total carbohydrate for children
1 through 3 years of age. As discussed in section II.E.1, consistent
with FDA, FSIS is proposing a DRV for total carbohydrate for the
general population based on the percentage of calories in a 2,000
calorie diet remaining after the sum of the DRV for fat (30 percent)
plus the DRV for protein (10 percent) have been subtracted consistent
with FDA's Nutrition Labeling Final Rule. As discussed in FDA's
proposed rule, FDA considered this method to be appropriate for setting
a DRV for total carbohydrate for children 1 through 3 years of age
because it falls within the IOM AMDR recommendation of 45 to 65 percent
of calories from carbohydrates for children 1 through 3 years of age
(79 FR 11941). FDA tentatively concluded that an appropriate DRV for
total carbohydrate is 60 percent of calories (i.e., 150 g using the
proposed reference calorie intake level of 1,000 calories/d) (Id.) FDA
did not receive comments on its tentative conclusion and finalized this
requirement as proposed (81 FR 33929). Consistent with FDA's Nutrition
Labeling Final Rule, FSIS is proposing to set a DRV of 150 g for total
carbohydrate for children 1 through 3 years of age (proposed 9 CFR
413.309(c)(9)).
[[Page 6752]]
f. Dietary Fiber
FSIS has not established a DRV for dietary fiber for children 1
through 3 years of age. As discussed in FDA's Nutrition Labeling
Proposed Rule, FDA tentatively concluded that the AI of 14 g/1,000
calories for dietary fiber for children 1 through 3 years of age should
be used to set a DRV for dietary fiber to be consistent with how other
proposed DRVs are being set; for example, proposing a reference calorie
intake level of 1,000 calories/d for this subpopulation (79 FR 11941-
11942). FDA established a DRV of 14 g for dietary fiber in its final
rule (81 FR 33929). Consistent with FDA's Nutrition Labeling Final
Rule, FSIS is proposing to establish a DRV of 14 g for dietary fiber
for children 1 through 3 years of age (9 CFR 413.309(c)(9)).
g. Protein
The current RDI for protein for children less than 4 years of age
was based on the 1989 RDA for protein of 16 g/d (9 CFR
317.309(c)(7)(iii) and 381.409(c)(7)(iii)).
As discussed in FDA's Nutrition Labeling Proposed Rule, FDA
considered current recommendations and acknowledged that protein
intakes are well above the current RDI; the mean protein intake for
children 12 to 23 months of age was 44 g/d; the protein AMDR for
children 1 through 3 years of age is 5 to 20 percent of calories; and
the proposed reference calorie intake level and the approaches used for
the proposed DRVs for fat and carbohydrate are based on percent of
calories (79 FR 11942). FDA tentatively concluded that the DV for
protein for children 1 through 3 years of age should be a DRV, rather
than an RDI (using the RDA), and that a DRV for protein should be based
on 5 percent of 1,000 calories or 50 calories, which equals 12.5 g or,
when rounded up, is 13 g (Id.) FDA established a DRV for protein of 13
g for children 1 through 3 years of age in its final rule (81 FR
33929). FSIS agrees with FDA's conclusion and is proposing to establish
a DRV for protein of 13 g for children 1 through 3 years of age
(proposed 9 CFR 413.309(c)(9)) consistent with FDA's Nutrition Labeling
Final Rule.
h. Sodium
For the general population, FSIS is proposing to establish a DRV
based on the UL for sodium (section II.G.). There is no current DRV for
sodium for children 1 through 3 years of age.
As discussed in FDA's Nutrition Labeling Proposed Rule, FDA agreed
with comments to its 2007 ANPRM that 1,500 mg is an appropriate DRV for
sodium for children 1 through 3 years of age (79 FR 11942). FDA did not
receive comments on this proposed requirement and finalized this
requirement (81 FR 33929). Consistent with FSIS's proposed approach for
the general population and FDA's Nutrition Labeling Final Rule, FSIS is
proposing to establish a DRV of 1,500 mg for sodium for children 1
through 3 years of age (proposed 9 CFR 413.309(c)(9)).
i. Fluoride
FSIS has not established a DV for fluoride for children 1 through 3
years of age. As discussed in section II.H, FSIS is not establishing a
DRV for fluoride for the general population. FSIS agrees with FDA that
a DRV for fluoride is not warranted for children 1 through 3 years of
age and is not proposing to establish a DRV for fluoride for children 1
through 3 years of age (79 FR 11942; 81 FR 33929).
j. Vitamins and Minerals
FSIS regulations do not currently include a table listing the RDIs
for children less than 4 years of age. The preamble to FDA's 1993 DRV/
RDI final rule provides a table listing RDIs for children less than 4
years of age (58 FR 2206 at 2213), which is also provided in FDA's Food
Labeling Guide. FDA reviewed current quantitative intake
recommendations for vitamins and minerals for infants and considered
comments received in response to their 2007 ANPRM to determine
appropriate RDIs for vitamins and minerals for children 1 through 3
years of age.
As discussed in FDA's Nutrition Labeling Proposed Rule, the IOM's
quantitative intake recommendations (AIs and RDAs) provide a basis on
which to determine RDIs for vitamins and minerals for this
subpopulation. The IOM determined that available evidence was
sufficient to establish appropriate RDAs and AIs for vitamins and
minerals for this subpopulation; that it is appropriate to use RDAs
and, in the absence of RDAs, AIs to determine appropriate micronutrient
RDIs for children 1 through 3 years of age; that the RDA, when
available, is the best estimate of an intake level that will meet the
nutrient goals of practically all consumers who would use the Nutrition
Facts label; that AIs have less certainty than RDAs, but they represent
goals for nutrient intake for individuals and provide the best estimate
based on current science for use in setting RDIs for such nutrients;
that promoting the development of eating patterns associated with
adequate potassium intake later in life is important because chronic
conditions such as elevated blood pressure, bone demineralization, and
kidney stones likely result from inadequate potassium intakes over an
extended period of time, including childhood; and that the AI for
potassium is 3,000 mg/d and is considered an appropriate basis for
establishing a RDI for potassium for children 1 through 3 years of age
(79 FR 11942). FDA established RDIs for vitamin A, vitamin C, vitamin
D, vitamin E, vitamin K, vitamin B12, folate, choline,
riboflavin, niacin, vitamin B6, calcium, iron, thiamin,
biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc,
selenium, copper, manganese, chromium, molybdenum, chloride, and
potassium for children 1 through 3 years of age in its final rule (81
FR 33929-33930).
Therefore, consistent with FDA's Nutrition Labeling Final Rule (81
FR 33927), using the RDAs and AIs, FSIS is proposing to establish RDIs
as set forth in proposed 9 CFR 413.309(c)(8)(iv) for these same
nutrients for children 1 through 3 years of age.
7. DRVs and RDIs for Pregnant Women and Lactating Women
a. Calories
The reference calorie intake of 2,000 used for the general
population applies to pregnant women and lactating women (9 CFR
317.309(c)(9) and 381.409(c)(9)). As discussed in FDA's Nutrition
Labeling Proposed Rule, the calorie needs for pregnant women and
lactating women are similar to the general population, and few products
are purported for pregnant women and lactating women (79 FR 11943). FDA
explained that the calorie needs for pregnant and lactating women are
similar to the general population (Id.) FDA established a 2,000
reference calorie intake level for the DRV for pregnant women and
lactating women in its final rule (81 FR 33931). Consistent with FDA's
final rule, FSIS is proposing to use the 2,000 reference calorie intake
level for setting DRVs for pregnant women and lactating women (proposed
9 CFR 413.309(c)(9)).
b. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate, Sodium,
Added Sugars, and Dietary Fiber
FSIS regulations do not provide DRVs for total fat, saturated fat,
cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant
women and lactating women. As discussed in FDA's Nutrition Labeling
Proposed Rule, quantitative intake recommendations for total fat,
saturated fat, cholesterol, total carbohydrate, sodium, and dietary
fiber
[[Page 6753]]
for pregnant women and lactating women are generally similar to the
general population (79 FR 11943). FDA tentatively concluded that the
DRVs for total fat, saturated fat, cholesterol, total carbohydrate,
sodium, and dietary fiber for pregnant women and lactating women should
remain the same as for the general population (Id.). FDA established
DRVs for pregnant women and lactating women using the same DRVs for
these nutrients as used for the general population (81 FR 33931). FDA
also requires a DRV of 50 g of added sugars for adults and children 4
years of age and older, including pregnant women and lactating women
(81 FR 33931). Consistent with FDA's final rule, FSIS is proposing to
establish DRVs for pregnant women and lactating women using the
proposed DRVs for the general population for total fat, saturated fat,
cholesterol, total carbohydrate, sodium, added sugars and dietary fiber
(proposed 9 CFR 413.309(c)(9)).
c. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble Fiber,
Insoluble Fiber, Sugars, and Sugar Alcohols
There are no DRVs for trans fat, polyunsaturated fat,
monounsaturated fat, soluble fiber, insoluble fiber, sugars, or sugar
alcohol for pregnant women and lactating women. As discussed in
sections II.C. and II.E., FSIS is not proposing DRVs for these
nutrients for the general population because of a lack of quantitative
intake recommendations. Similarly, quantitative intake recommendations
are lacking for these nutrients for pregnant women and lactating women.
Therefore, FSIS is not proposing to establish DRVs for trans fat,
polyunsaturated and monounsaturated fat, soluble fiber, insoluble
fiber, sugars, or sugar alcohols for pregnant women and lactating women
consistent with FDA's Nutrition Labeling Final Rule (81 FR 33931).
d. Protein
FSIS has established RDIs of 60 g protein for pregnant women and 65
g protein for lactating women (9 CFR 317.309(c)(7)(iii) and
381.409(c)(7)(iii)). As discussed in FDA's Nutrition Labeling Proposed
Rule, the IOM established 71 g/d protein as the RDA for pregnant women
and lactating women based on the needs for maternal and fetal
development and human milk production (79 FR 11943). FDA tentatively
concluded that the DV for protein for pregnant women and lactating
women should remain an RDI (using the RDA) instead of a DRV because the
DRV approach used to calculate protein for the general population based
on 10 percent of 2,000 calories, which equals 50 g of protein/d, falls
short of the recommended protein needs of pregnant women and lactating
women of 71 g/d (Id.). FDA did not receive comments on its tentative
conclusion and established an RDI of 71 g for protein for pregnant
women and lactating women in its final rule (81 FR 33931). Consistent
with FDA's final rule, FSIS is proposing to establish an RDI of 71 g
for protein for pregnant women and lactating women (proposed
413.309(c)(7)(iii)).
e. Fluoride
There is no DRV for fluoride for the general population or for
pregnant women and lactating women. While an AI has been established
for fluoride, FSIS is not proposing to establish a DRV for fluoride for
the general population for the reasons discussed in section II.H.
Similarly, because the AI for fluoride for pregnant women and lactating
women is not different from the general population, as discussed in
FDA's Nutrition Labeling Proposed Rule (79 FR 11943), FSIS is not
proposing a DRV for fluoride for pregnant women and lactating women.
f. Vitamins and Minerals
While not included in FSIS regulations, the preamble to the FDA
1993 DRV/RDI final rule provides a table listing RDIs for pregnant
women and lactating women (58 FR 2206 at 2213), which is also provided
in FDA's Food Labeling Guide (79 FR 11943). As discussed in FDA's
Nutrition Labeling Proposed Rule, FDA reviewed current quantitative
intake recommendations for vitamins and minerals for pregnant women and
lactating women and concluded that it is appropriate to establish RDIs
for pregnant women and lactating women for vitamins and minerals that
have DRIs, using population-coverage RDAs and AIs, instead of
population-weighted EARs (79 FR 11943). In addition, FDA established a
single set of RDIs intended for both pregnant women and lactating women
because nutrient needs during pregnancy and lactation are similar and
because using one set of RDIs would address practical concerns related
to limited space on food labels (81 FR 33932).
Therefore, FSIS is proposing to establish RDIs as set forth in
proposed 9 CFR 413.309(c)(8)(iv) for vitamin A, vitamin C, vitamin D,
vitamin E, vitamin K, vitamin B12, folate, choline,
riboflavin, niacin, vitamin B6, calcium, iron, thiamin,
biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc,
selenium, copper, manganese, chromium, molybdenum, chloride, and
potassium for pregnant women and lactating women consistent with FDA's
Nutrition Labeling Final Rule.
K. Format
FSIS requires that nutrition information for meat and poultry
products be presented in a specific format on the labels of those
products (see 9 CFR 317.309(d)(1)-(f) and 381.409(d)(1)-(f)). Since
1995 when FSIS last published a final rule effecting the nutrition
labeling format regulations (60 FR 174; January 3, 1995), more research
has been done on trends in health conditions and how best to present
information to consumers. FDA, in its changes to the Nutrition Facts
label format, took into consideration ``graphic design principles such
as alignment, consistency, repetition, and contrast,'' emphasizing
``key nutrients and key information'' through highlighting and
``removing or modifying parts of the label to assist consumers in
maintaining healthy dietary practices'' (79 FR 11948; 81 FR 33936).
FSIS has reviewed FDA's rationale for the changes to the Nutrition
Facts label format (see 79 FR 11948-11955; 81 FR 33936-33959) and
agrees with its approach. FSIS believes it is necessary to propose
changes to the Nutrition Facts label format for meat and poultry
products that will parallel, to the extent possible, FDA's new
regulations. This approach will help prevent consumer confusion and
non-uniformity in the marketplace. Therefore, FSIS is proposing the
following changes to the Nutrition Facts label format.
1. Increasing the Prominence of Calories and Serving Size
Consistent with FDA's final rule (81 FR 33937-33940), FSIS is
proposing (i) to increase the type size for ``Calories'' and the
numeric value for ``Calories,'' and (ii) to require that the numeric
value for calories be highlighted in bold or extra bold type (proposed
9 CFR 413.309(d)). These changes will emphasize the importance of
calories on the label and draw more consumer attention to the calories
declaration.
2. Changing the Order of the ``Serving Size'' and ``Servings per
Container'' Declarations and Increasing the Prominence of ``Servings
per Container''
FSIS currently requires that information on serving size, which
includes a statement of the serving size and the number of servings per
container, follow the heading ``Nutrition Facts'' (9 CFR 317.309(d)(3)
and
[[Page 6754]]
381.409(d)(3)). Consistent with FDA's Nutrition Labeling Final Rule
(see 81 FR 33940-33943), FSIS is proposing to (i) reverse the order of
the declarations of ``Servings Per Container'' and ``Serving Size;''
(ii) require that no capital letters are used for serving size
information, except for the first letter in ``Serving size;'' (iii)
require that ``__servings per container'' (with the blank filled in
with the actual number of servings) be in type size no smaller than 10
point (except for the tabular and linear displays for small packages)
(proposed 9 CFR 413.309(d)(3)(i)); and (iv) require that the serving
size information be highlighted in bold or extra bold type and be in a
type size no smaller that 10 point (except for the linear display for
small packages)(proposed 9 CFR 413.309(d)(3)(i)). FSIS has tentatively
concluded that these proposed changes will help consumers better
locate, identify, and understand the information in the Nutrition Facts
label and assist consumers in making informed purchase decisions and
maintaining health dietary practices.
3. Right-Justifying the Quantitative Amounts Declared in the ``Serving
size'' Statement
Currently, the label statement for ``Serving size'' expressed in
common household measures (e.g., cup, tablespoon, piece or slice) and
gram amounts is stated immediately adjacent to the ``Serving Size''
declaration as seen in 9 CFR 317.309(d)(12) and 381.409(d)(12). FSIS is
proposing to require that the ``Serving size'' declaration be left-
justified and the corresponding numerical value as determined in
proposed 9 CFR 413.309(b)(9) be right-justified (proposed 9 CFR
413.309(d)(3)(i)). FSIS agrees with FDA that the proposed change will
create more white space on the Nutrition Facts label that ``would
result in a less cluttered appearance, heightened focus and emphasis,
and improved readability'' and will improve ease of use for consumers
(79 FR 11950).
4. Presentation of Percent DVs
FSIS currently requires that the column heading ``% Daily Value''
and a list of nutrient names and amounts as described in 9 CFR
317.309(d)(7) and 381.409(d)(7) be to the left of and below this column
heading in the Nutrition Facts label (9 CFR 317.309(d)(6) and (7) and
381.409(d)(6) and (7)). On all dual column labels, including those (1)
for two or more forms of the same food (proposed 9 CFR 413.309(e)(5));
(2) displaying nutrition information per container and per unit, in
addition to nutrition information per serving (proposed 9 CFR
413.309(e)(6)(i); (3) using the tabular display (proposed 9 CFR
413.309(e)(6)(ii)); and (4) that provide the aggregate display
(proposed 9 CFR 413.309(d)(13)(ii)), FSIS is proposing to use thin
vertical lines to separate the information in the ``% Daily Value''
column from the information in the column containing the quantitative
weights. Further, FSIS is proposing to use the same style of thin
vertical lines to separate each of the dual columns and aggregate
display columns from each other. FSIS has tentatively concluded that
the use of these vertical lines will help differentiate the columns and
make the information easier to read for consumers. In addition, FSIS is
proposing that protein would no longer be listed with the vitamins and
minerals at the bottom of these labels as currently required.
5. Placement of ``Added Sugars''
As discussed in section II.E.3 of this proposed rule, FSIS is
proposing to require the declaration of added sugars as an indented
line item underneath the declaration of ``Total Sugars'' on the
Nutrition Facts label. ``Added Sugars'' would be the only mandatory
nutrient required to be listed in a double indentation format on the
Nutrition Facts label.
FDA conducted a consumer study that, among other things, looked at
how consumers would use the new information regarding added sugars, but
did not evaluate the impact of listing a percent DV for added sugars on
the Nutrition Facts label (80 FR 44306). The study was a controlled,
randomized, web-based experiment where participants viewed three
different Nutrition Facts label formats and responded to questions
regarding their ability to accurately recognize and compare nutrients
on the Nutrition Facts label and their judgments about the foods'
overall healthfulness and relative nutrient levels (80 FR 44306). The
study found that when both total and added sugars declarations appeared
on the label, the majority of study participants correctly reported the
added sugars amount and accurately identified which products had less
added sugars (80 FR 44306). The study also found that where an added
sugars declaration was indented below a ``Total Sugars'' declaration
the study participants' understanding that added sugars are part of the
total amount of sugars in the product improved (80 FR 44306).
Therefore, consistent with FDA's final rule, FSIS is proposing to use
the term ``Total Sugars'' instead of ``Sugars'' on the label. A summary
of FDA's Added Sugars Experiment is available at 80 FR 44306 and a full
description is available in the FDA Nutrition Labeling Supplemental
Proposed Rule docket.\29\
---------------------------------------------------------------------------
\29\ U.S. Food and Drug Administration. Memorandum to the File--
``Experimental study on consumer responses to Nutrition Facts labels
with declaration of amount of added sugars (OMB No. 0910-0764),''
2015.
---------------------------------------------------------------------------
FDA's Nutrition Labeling Final Rule also addressed commenters'
concerns regarding potential consumer confusion when including an
``Added Sugars'' declaration under ``Total Sugars'' on the Nutrition
Facts label. Based on the recommendations of two independent FDA
experts, as well as literature suggesting linking terms are useful for
increasing comprehension, FDA added the word ``Includes'' in front of
``Added Sugars'' (81 FR 33827.) FDA also minimized the line between
``Total Sugars'' and ``Added Sugars'' to help denote that ``Added
Sugars'' are a subcomponent of ``Total Sugars.'' Consistent with FDA,
FSIS is proposing to add the word ``Includes'' in front of ``Added
Sugars'' such that the added sugars declaration reads ``Includes X g
Added Sugars.'' FSIS is also proposing to minimize the hairline between
``Total Sugars'' and ``Added Sugars.''
6. Declaration of Absolute Amounts of Vitamins and Minerals
FSIS currently requires that the quantitative amount by weight of
mandatory and voluntary nutrients be declared on the Nutrition Facts
label, except for vitamins and minerals (other than sodium and
potassium) which must be declared only as percent DVs(9 CFR
317.309(c)(8) and 381.309(c)(8)). Consistent with FDA's Nutrition
Labeling Final Rule (81 FR 33946-33949), FSIS is not proposing to
require the declaration of the absolute amounts of all mandatory and
voluntary vitamins and minerals as well as the percent DV declaration
on the Nutrition Facts label. FSIS is, however, proposing to clarify in
proposed 9 CFR 413.309(c)(8) that the declaration of voluntarily
declared vitamins and minerals listed in proposed 9 CFR
413.309(c)(8)(iv) may include the quantitative amount by weight and
percent of the RDI. FSIS is also proposing that if vitamins or minerals
are added or there is a claim made about them, the manufacturer must
include a declaration of the nutrient as a percent DV, or
alternatively, as a quantitative amount by weight and percent DV
(proposed 9 CFR 413.309(c)(8)(ii)).
[[Page 6755]]
7. The Footnote
FSIS currently requires that a footnote, preceded by an asterisk,
be placed beneath the list of vitamins and minerals and be separated
from that list by a hairline on the Nutrition Facts label (9 CFR
317.309(d)(9) and 381.409(d)(9)). The footnote must state ``Percent
Daily Values are based on a 2,000 calorie diet. Your daily values may
be higher or lower depending on your calorie needs'' followed by a
table that lists the DRVs for total fat, saturated fat, cholesterol,
sodium, total carbohydrate, and dietary fiber based on 2,000 and 2,500
calorie diets. (9 CFR 317.309(d)(9)(i) and 381.409(d)(9)(i)). Caloric
conversion information on a per-gram basis for fat, carbohydrate, and
protein may be presented beneath the information required in paragraph
9 CFR 317.309(d)(9) and 381.409(d)(9) separated by a hairline (9 CFR
317.309(d)(10) and 381.409(d)(10)).
Comments to FDA's 2007 ANPRM cited to research that the comments
said showed that consumers do not understand what information is being
conveyed in the footnote (79 FR 11953). In 2014, FDA conducted a
controlled, randomized, web-based experiment that compared consumer
reactions to seven footnote formats, which included five modified
footnotes, in addition to the current footnote and no footnote at all,
for explaining percent DVs and how to use them (the ``Footnote
Experiment'').\30\ In FDA's Nutrition Labeling Final Rule, FDA
finalized a revised footnote requirement (81 FR 33952). FDA removed the
requirement for the footnote table listing the DRVs for total fat,
saturated fat, cholesterol, sodium, total carbohydrate, and dietary
fiber for 2,000 and 2,500 calorie diets that is specified in 21 CFR
101.9(d)(9)(i) and added the following footnote text: ``*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.'' Id. The footnote text is similar to one of the options tested
in the Footnote Experiment, except that the sentences in the footnote
are reversed (80 FR 44309). The study participants perceived the
language in this footnote to be more useful than the current footnote;
and FDA switched the order of the sentences in the footnote so the
explanation of the %DV clearly follows the asterisk that leads to the
footnote in the %DV column (80 FR 44309).
---------------------------------------------------------------------------
\30\ U.S. Food and Drug Administration. Memorandum to the File--
``Experimental study on consumer responses to Nutrition Facts labels
with various footnote formats (OMB No. 0910-0764),'' 2015.
---------------------------------------------------------------------------
FDA stated that the new footnote ``which explains the term ``%
Daily Value'' and provides a reference calorie level will assist
consumers in better understanding the information of the Nutrition
Facts label and in maintaining healthy dietary practices'' (81 FR
33952). FDA did not change the caloric conversion information in the
footnote specified in 21 CFR 101.9(d)(10. FDA stated, in its Nutrition
Labeling Proposed Rule, that ``increasing the type size, bolding key
elements of the footnote (space permitting), and adding a bar clearly
separating it from the micronutrient information directly above will
assist consumers in using the information'' (79 FR 11953). FDA did not
finalize this proposed requirement.
Under the Nutrition Labeling Final Rule, FDA now allows the
footnote to be omitted from products that qualify for a simplified
format (21 CFR 101.9(f)), provided that the following abbreviated
statement is used ``%DV = %Daily Value'' in a type size no smaller than
6 point on these package labels when Daily Value is not spelled out in
the column heading (81 FR 33952). FDA is also not requiring the
footnote on small or intermediate-sized packages (21 CFR
101.9(j)(13)(ii)(A)(1) and (2)), but manufacturers may voluntarily
include the abbreviated footnote on these packages. The abbreviated
statement would allow for more space on the label and informs consumers
what %DV means. In addition, FDA is providing an exemption from the
footnote requirement for 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 21 CFR 101.60(b) (81 FR 33952). FDA is also
allowing the voluntary use of the first part of the footnote statement,
``*The %Daily Value tells you how much a nutrient in a serving of food
contributes to a daily diet'' on these products (81 FR 33952). FDA
stated that such products would have little to no impact on the average
daily 2,000 calorie intake, which the footnote addresses (80 FR 44309).
Consistent with FDA's Nutrition Labeling Final Rule (81 FR 33949-
33954), FSIS is proposing to remove the requirement for the footnote
table listing the DRVs for total fat, saturated fat, cholesterol,
sodium, total carbohydrate, and dietary fiber for 2,000 and 2,500
calorie diets (proposed 9 CFR 413.309(d)(9)(i)). FSIS is also proposing
the following footnote text: ``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.'' Consistent with
FDA, FSIS is not proposing changes to the caloric conversion
information in the footnote currently specified in 9 CFR 317.309(d)(10)
and 381.409(d)(10) (which would be consolidated in proposed 9 CFR
413.309(d)(10)). FSIS is proposing that the footnote may be omitted
from products that qualify for a simplified format (proposed 9 CFR
413.309(f)), provided that the following abbreviated statement is used
``%DV = %Daily Value,'' when the package labels do not spell out Daily
Value in the column heading. FSIS is also proposing that the footnote
may be omitted from small or intermediate-sized packages (proposed 9
CFR 413.309(g)). FSIS is also proposing an exemption from the footnote
requirement for foods that can use 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'' on the
label or in the labeling of foods as defined in proposed 9 CFR
413.360(b). FSIS is also proposing to allow the voluntary use of the
first part of the footnote statements, ``*The %Daily Value tells you
how much a nutrient in a serving of food contributes to a daily diet,''
on these products.
8. Addition of a Horizontal Line Beneath the Nutrition Facts Heading
FSIS requires that the ``Nutrition Facts'' heading on the Nutrition
Facts label be set in a type size larger than all other print size in
the nutrition label (9 CFR 317.309(d)(2) and 381.409(d)(2)). FDA
amended its regulations to require a hairline rule be inserted directly
beneath the ``Nutrition Facts'' heading on all label formats, except
for the linear display for small packages, to direct the reader's eye
to the serving size information, place emphasis on the information
about servings, and break the information into smaller chunks to make
it easier to process (79 FR 11954; 81 FR 33954). Consistent with FDA's
final rule, FSIS is proposing to require that a hairline rule be
inserted immediately below the ``Nutrition Facts'' heading on all
nutrition label formats except for the linear display for small
packages (proposed 9 CFR 413.309(d)(1)(iii)).
[[Page 6756]]
L. Single-Serving Containers/Units and Dual-Column Labeling
1. Single-Serving Containers/Units
FSIS's current regulations require that a product that is packaged
and sold individually and that contains less than 200 percent of the
applicable RACC be considered a single-serving container, and that the
entire content of the product be labeled as one serving, except that
for products that have RACCs of 100g or 100mL or larger, manufacturers
may decide whether a package containing more than 150 percent but less
than 200 percent of the RACC be labeled as 1 or 2 servings (9 CFR
317.309(b)(8) and 381.409(b)(8)). FSIS's current regulations also
require that for products that have RACCs of 100g or 100mL or larger
and are individual units within a multi-serving package, manufacturers
may decide whether an individual unit that contains more than 150
percent but less than 200 percent of the RACC be labeled as 1 or 2
servings (9 CFR 317.309(b)(4)(v) and 381.409(b)(4)(v)).
Based on a review of recent research, FDA has determined that many
consumers do not correctly calculate nutrient amounts in food products
by multiplying the nutrient amount by the number of servings per
container (79 FR 11998-11999). FDA also found that the exemption from
the requirement to label a product with a large RACC as a single-
serving container is no longer warranted because ``there is a low
correlation between the RACCs (whether the reference amount is more
than or less than 100 g or mL) and the consumption variation for all
products containing less than 200 percent of the RACC, regardless of
whether the RACC is `large' (i.e., greater than 100 g or 100 mL) or
not'' (79 FR 12001). Under pre-existing FDA regulations, if a package
or discrete unit of food with a ``large'' RACC contained more than 150
percent but less than 200 percent of the RACC, the manufacturer was
permitted to decide whether to declare the package or individual unit
as 1 or 2 servings (81 FR 34004-34008). The FDA Serving Size Final
Rule, however, removed this exemption and, for products subject to FDA
requirements, requires that all packages of food containing less than
200 percent of the RACC be labeled as a single serving (see 21 CFR
101.9(b)(6)), and that discrete units containing at least 67 percent of
the RACC but less than 200 percent of the RACC be labeled as a single
serving (see 21 CFR 101.9(b)(2)(i)(C)). FDA also removed the provision
that products packaged and sold individually and containing 200 percent
or more of the applicable RACC may be labeled as a single serving if
the entire contents of the container can reasonably be consumed at a
single eating occasion (81 FR 34004-34008).
FSIS has reviewed FDA's research and analysis and tentatively
agrees with FDA's conclusions. Therefore, FSIS is proposing to revise
the requirements for single-serving labeling so that a product packaged
and sold individually that contains less than 200 percent of the
applicable RACC must be considered a single serving, and that a
discrete unit containing at least 150 percent but less than 200 percent
of the RACC must be labeled as one serving regardless of whether the
RACC exceeds 100 g or mL (proposed 9 CFR 413.309(b)(8)).
2. Dual-Column Labeling
FSIS currently permits manufacturers to voluntarily provide an
additional column of nutrition information (i.e., dual column labeling)
in the following situations:
Per 100 g, 100 mL, or 1 oz of the product as packaged or
purchased (9 CFR 317.309(b)(13)(i) and 381.409(b)(13)(i));
Per one unit if the serving size of a product in discrete
units in a multi-serving container is more than one unit (9 CFR
317.309(b)(13)(ii) and 381.409(b)(13)(ii));
For the product alone if the product is commonly combined
with other ingredients or is cooked or otherwise prepared before
eating, and directions for such combination or preparations are
provided (e.g., a cream soup mix may be labeled with one set of DVs for
the dry mix (per serving), and another set for the serving of the final
soup when prepared (e.g., per serving of cream soup mix and 1 cup of
vitamin D fortified whole milk)(9 CFR 317.309 (b)(15) and
381.409(b)(15));
For two or more forms of the same product (e.g., both
``raw'' and ``cooked'') as provided in 9 CFR 317.309(b)(3) and (e) and
381.409(b)(3) and (e); and
For two or more groups for which RDIs are established
(e.g., both infants and children less than 4 years of age) as provided
in 9 CFR 317.309(c)(8)(i) and (e) and 381.409(c)(8)(i) and (e).
Research has shown that package and portion sizes have a
considerable impact on the amount of food consumed, and that the size
of the package or unit of food can set a consumption norm for
consumers; that consumers do not correctly calculate nutrient amounts
in food products by multiplying the nutrient amount by the number of
servings per container; and that dual-column labeling with the
nutrition information given per serving and per package may help
certain consumers recognize nutrient amounts per package in certain
types of packaged food (79 FR 11998-11999). Therefore, consistent with
FDA's Serving Size Final Rule, FSIS is proposing mandatory dual-column
labeling on certain packages of meat and poultry products.
FSIS is proposing that meat and poultry products in packages or
units that contain at least 200 percent and up to and including 300
percent of the applicable RACC be required to have two columns in the
Nutrition Facts label. One column would list the quantitative amounts
and percent DVs for the entire package or unit, and the other column
would list the quantitative amounts and percent DVs for a serving,
based on the amount most closely approximating the RACC, that is less
than the entire package or unit (proposed 9 CFR 413.309(b)(4)(iv) and 9
CFR 413.309(b)(16)). FSIS is proposing an upper limit of 300 percent
for dual-column labeling based on FDA's analysis that showed that ''
providing an upper limit at 300 percent of the RACC would ensure that
dual-column labeling captures 90 percent of the consumption habits for
about 91 percent of food products and limit the possibility that dual-
column labeling will be required for package sizes that are not likely
to be consumed in a single eating occasion'' (81 FR 34015-34016).
Providing nutrition information for these products in dual columns will
make it easier for consumers, regardless of whether they consume the
entire container or unit in a single eating occasion, consume part of
the entire container or unit in a single eating occasion, or share the
container or unit, to identify the amount of nutrients consumed without
having to perform mathematical calculations.
FSIS is proposing that meat and poultry products in packages that
meet the requirements to use a tabular display for small packages or to
use a linear format be exempt from the dual-column labeling
requirements (proposed 9 CFR 413.309(b)(16)(i)(A)). FSIS is also
proposing that products that require further preparation and provide
two columns of nutrition information (e.g., one column ``as purchased''
and one column ``as prepared'') would be exempt from the dual-column
labeling requirements in proposed 9 CFR 413.309(b)(16). If products
that already provide two columns of nutrition information for ``as
purchased'' and ``as prepared'' forms of the product were required to
have dual-column labeling with nutrition information per serving size
and per the entire container, the products would have at least three
columns of nutrition information, or
[[Page 6757]]
manufacturers would decide to no longer provide the voluntary
information for the prepared form of the product. FSIS is also
proposing that products that are commonly consumed in combination with
another food and provide an additional column of nutrition information
under proposed 9 CFR 413.309(e) be exempt from the dual-column labeling
requirements in proposed 9 CFR 413.309(b)(16). Similar to the products
that require further preparation, nutrition information based on the
entire container of an uncombined food (e.g., the dry mix alone for a
cream soup mix) (for a food that is commonly combined with another
food) may be less meaningful to consumers than information on a serving
of the combined food (e.g., per serving of cream soup mix and 1 cup of
vitamin D fortified whole milk) because these types of products are
commonly consumed in combination with another food. FSIS is also
proposing that products that provide an additional column of nutrition
information for two or more groups for which RDIs are established
(e.g., both infants through 12 months and children 1 through 3 years of
age) and random weight products be exempt from the dual-column labeling
requirements (proposed 9 CFR 413.309(b)(16)(i)(C)). Information
provided for subpopulations will be more useful to distinct populations
for certain products than information per-container or unit.
FSIS is proposing that the Nutrition Facts label for a meat or
poultry product that is packaged and sold individually that contains
more than 150 percent and less than 200 percent of the applicable
reference amount, 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 (proposed 9 CFR 317.309(b)(8)).
3. Use of Nutrient Content Claims and Health Claims on Products With
Dual-Column Labeling per Serving and per Container
RACCs set forth in 9 CFR 317.312(b)-(e) and 381.412(b)-(e) are
currently used to determine whether a product meets the criteria for a
nutrient content claim (9 CFR 317.313(p) and 381.413(p)). Consistent
with the FDA Serving Size Final Rule, if nutrition information is
presented on a per serving basis and on a per container or unit basis
(i.e., the proposed dual-column labeling requirements or if a dual-
column is provided voluntarily) on the Nutrition Facts Label, FSIS is
proposing to require that the nutrient content claim be followed by a
statement that sets forth the basis on which the claim is made
(proposed 9 CFR 413.309(b)(16)(ii)). The statement must express the
amount of the nutrient in a serving (e.g., ``good source of calcium''
``a serving of __oz of this product contains __mg of calcium'' or for a
health claim ``A serving of _ounces of this product conforms to such a
diet''). However, if the serving size declared on the product label
differs from the RACC, 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, FSIS is
proposing that the claim must be followed by the criteria for the claim
as required by proposed 9 CFR 413.313(p). This criteria statement would
help clarify that the nutrient content claim or health claim is based
on the RACC and not the amount in the entire container. FSIS is also
proposing that this criteria statement would not be required for
products when the nutrient that is the subject of the claim meets the
criteria based on the entire container amount or the unit amount, as
applicable (proposed 9 CFR 413.309(b)(16)(ii)).
4. Additional Changes to Serving Size Regulations
FSIS currently allows by policy the use of an ounce unit in the
serving size, e.g., 4oz (112g), instead of a household unit, e.g., 1
piece (112g), when the size of the product naturally varies in weight
and is not uniform in size (e.g., poultry parts, such as chicken
breasts and chicken wings, and non-formed meat cuts, such as pork
chops). Consistent with 21 CFR 101.9(b)(2)(i)(G), proposed 9 CFR
413.309(b)(4)(vii) would permit the use of an ounce unit in the serving
size for products that naturally vary in size (e.g., poultry parts or
non-formed cuts of meat).
Current FSIS regulations require the serving size to declare the
as-packaged amount in accordance with 9 CFR 317.309(b)(3) and
381.409(b)(3). Consistent with 21 CFR 101.9(b)(7)(v), proposed 9 CFR
413.309(b)(9)(5) would permit the serving size to include the finished
product amount as part of the serving size when water or other
ingredients with insignificant amounts of nutrients are instructed to
be added during preparation. For example, when the consumer is directed
to add a specific amount of water to prepare a condensed soup, the
serving size may state ``\1/2\ cup (120g) concentrated soup (makes 1
cup prepared)'' instead of ``\1/2\ cup (120g).''
Currently, FSIS requires the serving size for a product marketed
for two different purposes, e.g., gravy or a soup, to be based on the
larger serving size, e.g., soup (1 cup RACC) instead of gravy (\1/4\
cup RACC) (9 CFR 317.312 and 381.412). Consistent with 21 CFR
101.9(b)(11), proposed 9 CFR 413.309(b)(13)(iii) would require the
Nutrition Facts label to include the nutrient information for both
marketed serving sizes when the amount served for each differs in
quantity by twofold or greater based on the RACC in accordance with
proposed 9 CFR 413.313(b) (e.g., the Nutrition Facts label would
provide nutrient data for both soup (1 cup) and gravy (\1/4\ cup)
because the soup serving size is greater than twofold over the serving
size for gravy).
M. Reference Amounts Customarily Consumed
1. Factors Considered To Determine the Existing RACCs To Update
The current RACCs for meat and poultry products are listed in 9 CFR
317.312 and 381.412, respectively. The RACCs represent the amount of
food customarily consumed per eating occasion and are listed by product
categories. The RACCs and product categories are used as the basis for
determining serving sizes for specific products. The current RACCs were
primarily derived from the 1977-1978 (http://www.ars.usda.gov/Services/docs.htm?docid=16184) and the 1987-1988 (http://www.ars.usda.gov/Services/docs.htm?docid=16185) Nationwide Food Consumption Surveys
conducted by USDA. Since the current RACCs were established, there is
new consumption data that shows that the amount of foods Americans
customarily consume has changed, and there are new food products in the
marketplace. Therefore, FSIS analyzed more up-to-date consumption data
to determine whether the RACCs and product categories for meat and
poultry products needed to be updated or revised.
FSIS analyzed the recent consumption data from the NHANES 2003-2008
surveys using Statistical Analysis Systems (SAS) \31\ and Survey Data
Analysis (SUDAAN) \32\ procedures to determine the amount of food being
consumed by individuals. FSIS
[[Page 6758]]
considered the following factors in determining whether to revise the
1993 RACCs and product categories: (1) Whether there was an adequate
sample size from the NHANES 2003-2008 consumption data for the product
category; (2) whether the median intake estimate from the NHANES 2003-
2008 consumption data for the product significantly differs (i.e., at
least a 25 percent difference) from the 1993 RACC; (3) whether the
intake distribution was skewed (based on comparing the median intake
estimate with the mean intake estimate from the NHANES 2003-2008
consumption data); (4) the ``reasonable consumption amount'' from the
Food and Nutrient Database for Dietary Studies (FNDDS) \33\; (5) the
difference between the median intake estimates, converted to common
household measures as applicable, and the 1993 RACC for the product;
(6) the median intake estimates for comparable products; and (7) the
RACCs for comparable FDA-regulated products. More detailed information
about how the factors were applied to change or not change the RACCs
for a specific food product are contained in a rationale chart
available on the FSIS Web site.\34\ FDA used similar methodology for
updating the RACCs for foods regulated by FDA. The following sections
describe the proposed changes to the RACC tables in FSIS's regulations.
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\31\ SAS version 9.2 Cary, NC, 2011 http://www.sas.com/technologies/analytics/statistics/stat/index.html.
\32\ SUDAAN version 10.1 Research Triangle Park, NC, 2011 http://www.rti.org/page.cfm/Survey_Statistics.
\33\ The reasonable consumption amount is a default consumption
amount of food that researchers have defined and is used in NHANES
when survey participants cannot recall the amount of food that was
consumed at one eating occasion. Agricultural Research Service, Food
Surveys Research Group, ``U.S. Department of Agriculture, Food and
Nutrient Database for Dietary Studies, 4.1'' Beltsville, MD, 2010.
\34\ http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/proposed-rules>.
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2. Changes to Table 1: Reference Amounts Customarily Consumed per
Eating Occasion: Food Labeling for Infants and Children 1 Through 3
Years of Age
FSIS is proposing to combine the tables containing the RACCs for
infant and toddler foods that exist in 9 CFR 317.312 for meat products
and 9 CFR 381.412 for poultry products into a new table for meat and
poultry products in proposed 9 CFR 413.312 for infants and children 1
through 3 years of age. FSIS is also proposing to add a third column
titled ``label statement'' to the RACC table to provide examples of how
the ``label statement'' may appear in the Nutrition Facts label as a
formatted serving size and to parallel the FDA proposed RACC table 1
(21 CFR 101.12(b)). The titles of the combined product categories would
stay the same, except the combined product category for meat sticks and
poultry sticks would be titled ``Plain meats, plain poultry, meat
sticks, poultry sticks, ready to serve.''
FSIS is also proposing to change the RACC from 60 g to 110 g for
the product category ``Dinners, ready-to-serve, strained type.'' The
2003-2008 median intake estimates for dinner, ready-to-serve, strained
type poultry was 101.8 g, and dinner, ready-to-serve, strained type,
meat was 88.9 g. FDA, which regulates products containing less than 2%
cooked meat or poultry, and less than 3% raw meat, increased the RACC
for the comparable product category, ``Dinner, desserts, fruits,
vegetables, or soups, ready-to-serve, strained type'' from 60 g to 110
g. The 2003-2008 median intake estimates for these two product
categories was 104 g and 103 g, respectively. The products in these FDA
regulated product categories are comparable to the FSIS regulated
product category, ``Dinner, ready-to-serve, strained type, poultry''
and ``Dinner, ready-to-serve, strained type meat'', because all of the
products have similar type usage and product characteristics as
strained baby foods. In addition, the current RACC for ``Dinner, soups,
ready-to-serve junior type'' is 110 g, and the same RACC for both
strained type and junior baby foods would help consumers compare
nutrition information.
FSIS is also proposing to update the footnotes to proposed RACC
Table 1 as follows: Footnote 1 would be updated to include new data
sources, footnote 2 would be updated to include ``brown and serve'' as
a type of ``almost ready-to-serve'' product and to include ``(e.g.,
ready to serve)'' after ``prepared for consumption,'' and footnote 4
would be added to explain the purpose and use of the third column
titled ``label statement'' in RACC Table 1.
3. Changes to Table 2: Reference Amounts Customarily Consumed per
Eating Occasion: General Food Supply
FSIS is proposing to combine the tables containing the RACCs for
the general food supply that currently exist in 9 CFR 317.312 for meat
products and 9 CFR 381.412 for poultry products into a new table for
meat and poultry products in proposed 9 CFR 413.312. FSIS is proposing
to include a third column titled ``label statement'' in the new RACC
table for meat and poultry products. The ``label statement'' column,
which provides similar examples to what FDA provides in FDA RACC table
2 (21 CFR 101.12(b), provides examples of how serving size statements
may appear in the Nutrition Facts label as a formatted serving size.
For example, the RACC for a raw poultry cut is 114 grams but the
formatted serving size in the Nutrition Facts label would be based on
instructions in proposed 9 CFR 413.309(b), for example, 4oz (112g).
FSIS is also proposing to change some of the RACCs and product
categories, establish new product categories for the general food
supply, and update the footnotes to RACC table 2 as follows.
In the product category ``Egg mixtures (western style omelet,
souffl[eacute], egg foo young),'' FSIS is proposing to combine the meat
and poultry categories for egg mixtures into one product category. The
new name for the product category would be ``Egg mixtures with meat or
poultry; e.g., western style omelet, souffle[eacute], egg foo young.''
Egg mixtures with meat and egg mixtures with poultry are comparable
products with similar dietary usage and product characteristics. The
same RACC will help consumers compare nutrition information between
these products.
FSIS is proposing to combine the meat and poultry categories for
luncheon meat into one product category as follows, ``Luncheon
products, luncheon meat, bologna, poultry bologna, Canadian style
bacon, poultry Canadian style bacon, meat or poultry pattie crumbles,
blood pudding, meat or poultry luncheon loaf, old fashioned loaf,
berlinger, bangers, minced luncheon roll, thuringer, liver sausage,
mortadella, uncured sausage (franks), ham and cheese loaf, P&P loaf,
scrapple souse, head cheese, pizza loaf, olive loaf, pate, deviled ham,
sandwich spread, teawurst, cervelat, Lebanon bologna, potted meat or
poultry food product, taco fillings, pie fillings.'' Luncheon meat and
luncheon products made with poultry are comparable products with
similar dietary usage and product characteristics. The same RACC will
help consumers compare nutrition information between these products.
FSIS is proposing to combine the meat and poultry categories for
entrees without sauce into one product category as follows, ``Entrees
without sauce; e.g., cuts of meat or poultry including marinated,
tenderized, injected cuts of meat or poultry, patties, corn dogs,
croquettes, fritters, cured ham, dry cured ham, dry cured cappicola,
cured poultry ham products, corned beef, pastrami, country ham, pork
shoulder picnic, meatballs, pureed adult foods.'' Entrees without sauce
made with meat or poultry are comparable products with similar dietary
usage and product characteristics. The same RACC will
[[Page 6759]]
help consumers compare nutrition information between these products.
FSIS is proposing to combine the meat and poultry categories for
mixed dishes not measurable with a cup into one product category as
follows, ``Mixed dishes NOT measurable with a cup; e.g., burrito, egg
roll, enchilada, pizza, pizza roll, quiche, all types of sandwiches
with meat or poultry, cracker and meat/poultry lunch type packages,
gyro, Stromboli, burger on a bun, poultry burger on a bun, frank on a
bun, poultry frank on a bun, calzone, taco, stuffed pockets, foldovers,
stuffed vegetables with meat or poultry, shish kabobs, empanada,
chicken cordon bleu.'' Mixed dishes not measurable with a cup made with
meat or poultry are comparable products with similar dietary usage and
product characteristics. The same RACC will help consumers compare
nutrition information between these products.
FSIS is proposing to combine the meat and poultry categories for
mixed dishes measurable with a cup into one product category as
follows, ``Mixed dishes measurable with a cup; e.g., casserole,
macaroni and cheese with meat or poultry, pot pie, spaghetti with
sauce, poultry spaghetti with sauce, meat or poultry chili, meat or
poultry chili with beans, hash, creamed chipped beef, creamed dried
poultry, ravioli in sauce, stroganoff, Brunswick stew, goulash, poultry
a la king, meat or poultry stew, ragout, meat or poultry lasagna, meat
or poultry filled pasta.'' Mixed dishes measurable with a cup made with
meat or poultry are comparable products with similar dietary usage and
product characteristics. The same RACC (1 cup) will help consumers
compare nutrition information between these products.
FSIS is proposing to combine the meat and poultry categories for
``Salads-all other'' into one product category as follows, ``Salads--
all other meat salads, all other poultry salads; e.g., chicken salad,
ham salad, turkey salad.'' Salads made with meat and salads made with
poultry are comparable products with similar dietary usage and product
characteristics. The same RACC (100g) will help consumers compare
nutrition information between these products.
FSIS is proposing to combine the meat and poultry categories for
``Soups-all varieties'' into one category as follows, ``Soups with meat
or poultry-all varieties.'' Soups made with meat and soups made with
poultry are comparable products with similar dietary usage and product
characteristics. The same RACC (245g) will help consumers compare
nutrition information between these products.
FSIS is proposing to create a new product category ``Appetizers,
hors d'oeuvres, Mini mixed dishes with meat or poultry; e.g., mini
bagel pizzas, mini egg rolls, dumplings, mini pizza rolls, mini
quesadilla, mini quiche'' with a RACC of 85 g ready-to-serve (plus 35 g
for products with sauce toppings). Recently, several mini or snack-size
versions of several products in the ``Mixed dishes, not measurable with
a cup'' product category have become available, such as mini pizza
rolls, mini egg rolls, mini quiche, and mini sandwiches. Also, since
1993, other miniature products (smaller individual piece products) that
are often used as appetizers and hors d'oeuvres have become available
in the market place. To accommodate appetizer type products, the USDA's
Guide to Federal Food Labeling Requirements for Meat and Poultry
Products (2007) \35\ includes a RACC of 85 g for ``Appetizers (e.g.,
meat (or poultry), hors d'oeuvers, mini eggrolls, mini pizza rolls,
bagel pizza).'' Miniature products with or without meat have similar
dietary usage and product characteristics and are often used
interchangeably by consumers. If the product is marketed for use with a
sauce, FSIS is proposing to use 35 g for the amount of the sauce. This
amount is calculated proportionally based on adding 55 g of sauce or
gravy for a RACC of 140 g for the product category, ``Mixed dishes not
measurable with cup,'' under the general category ``Mixed Dishes.''
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\35\ http://www.fsis.usda.gov/shared/PDF/Labeling_Requirements_Guide.pdf. 85 g for Appetizers is a suggested
RACC provided in Guidance by USDA (see question 68 at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/labeling-policies/faq-generic-labeling).
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FSIS is proposing to create a new category ``Appetizers, hors
d'oeuvres--Dips with meat or poultry; e.g., chicken dip, chicken and
cheese dip, meat dip'' with a RACC of 2 tbsp. ready-to-serve. Recently,
dip products with amenable amounts of meat or poultry, for example,
cheesy chicken dip and chicken dip, meant to be served with chips such
as corn chips, have been introduced into the market place. The ``All
dips (e.g., bean dips, dairy-based dips, salsa)'' product category in
FDA's regulations is comparable to the proposed FSIS ``Dip with Meat or
Poultry'' product category, because dips with meat or poultry have
similar dietary usage and product characteristics as dips regulated by
FDA. Therefore, FSIS is proposing to establish a RACC of 2 tablespoons
for the proposed ``Dip with Meat or Poultry'' product category.
Establishing the same RACC for products with similar dietary usage,
similar amounts customarily consumed, and product characteristics
whether they are regulated by FDA or FSIS will help consumers compare
nutrition information between these products.
FSIS is proposing to create a new product category ``Candies with
meat or poultry; e.g., chocolate with bacon, chocolate dipped bacon,
chocolate with salami'' with a RACC of 30 g ready-to-serve. Recently,
candies with amenable amounts of meat or poultry, for example,
chocolate bars with bacon, chocolate dipped bacon, and chocolate bars
with salami, have been introduced into the market place. Such products
have been marketed as ``Candies'' based on information available from
the Mintel Global New Products Database \36\ for products that are
currently available in the market, and they are comparable to products
in the ``All Other Candies'' product category, which is regulated by
FDA. FDA's Serving Size Final Rule updated the RACC from 40 g to 30 g
for the ``All Other Candies'' product category. Because the products in
both FDA's and FSIS's candy product categories have similar usage and
product characteristics, the same RACC (30g) for FDA's ``All Other
Candies'' product category and FSIS's ``Candies with meat or poultry;
e.g., chocolate with bacon, chocolate dipped bacon, chocolate with
salami'' product category will help consumers compare nutrition
information between these products.
---------------------------------------------------------------------------
\36\ Mintel Global New Products Database (GNPD). Mintel Group
Ltd. 333 West Wacker Drive, Suite 1100, Chicago, IL 60606. Internet:
http://www.gnpd.com/sinatra/gnpd/frontpage/ (accessed September 23,
2014).
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FSIS is proposing to combine the separate canned meat and poultry
categories into one product category as follows, ``Canned Meats (e.g.,
canned beef, canned pork) and Canned Poultry (e.g., canned chicken,
canned turkey).'' FSIS is also proposing to increase the RACC from 55 g
to 85 g. There was an inadequate sample size for a reliable 2003-2008
intake estimate (82.1 g) for ``Canned Meats,'' and the 2003-2008 median
intake estimate (89.5 g) for ``Canned Poultry'' did not show a
significant change from the 1993 RACC. But, FDA updated the 1993 RACC
for the ``Fish, shellfish, and game meat, canned'' product category
from 55 g to 85 g. FDA's ``Fish, shellfish, and game meat, canned''
product category is comparable to FSIS's ``Canned Meats (e.g., canned
beef, canned pork) and Canned Poultry'' category. The same RACC for
products with similar dietary usage and product characteristics whether
regulated by FDA or FSIS will
[[Page 6760]]
help consumers compare nutrition information between these products.
Therefore, FSIS is proposing that the RACC for ``Canned Meats (e.g.,
canned beef, canned pork) and Canned Poultry (e.g., canned chicken,
canned turkey)'' be 85 g.
FSIS is proposing to include pork back fat into the category for
``Bacon'' with the category name of ``Bacon; e.g., bacon, beef
breakfast strips, pork breakfast strips, pork rinds, pork back fat''
because its use is most similar to that of bacon and pork rinds. FSIS
is proposing the RACC for pork back fat to be 15 g ready-to-eat and 54
g ready-to-cook to reflect the previously established RACCs for bacon
and pork rinds. The categories for bacon and poultry bacon products
were not combined into one category because of their differing ready-
to-cook RACCs. In addition, FSIS is proposing to modify the category
name for poultry bacon to ``poultry bacon, poultry breakfast strips''
to clarify that these are different products as indicated by the
differing ready-to-cook amounts from the 1993 regulation.
FSIS is proposing the following category names for the combined
meat and poultry product categories that have the same RACC values and
did not meet any of the factors for updating the RACCs: ``Salad and
potato toppers; e.g., bacon bits, poultry bacon bits,'' ``Dried meat or
poultry products; e.g., jerky, dried beef or poultry, Parma ham, meat
or poultry sausage products with a moisture/protein ratio of less than
2:1; e.g., pepperoni,'' ``Snacks, e.g., meat or poultry snack food
sticks,'' ``Linked meat or poultry products, Vienna sausage,
frankfurters, poultry franks, pork sausage, imitation frankfurters,
bratwurst, kielbasa, Polish sausage, poultry Polish sausage, summer
sausage, mettwurst, smoked country sausage, smoked sausage, poultry
smoked sausage, smoked pickled meat or poultry meat, pickled pigs
feet,'' ``Salads--pasta or potato, potato salad with bacon, potato
salad with poultry, macaroni and meat or poultry salad,'' ``Major main
entr[eacute]e type sauce; e.g., spaghetti sauce with meat or poultry,
spaghetti sauce with meatballs, spaghetti sauce with poultry
meatballs,'' ``Minor main entr[eacute]e type sauce; e.g., pizza sauce
with meat or poultry, gravy,'' and ``Seasoning mixes dry, bases,
extracts, dried broths and stock/juice, freeze dry trail mix products
with meat or poultry: As reconstituted: Amount to make one Reference
Amount of the final dish; e.g., Gravy, Major main entr[eacute]e type
sauce, Soup, Entr[eacute]e measurable with a cup.''
FSIS is proposing to update the footnotes to proposed 9 CFR 413.312
Table 2 as follows: Footnote 1 will be updated to include new data
sources and to clarify that the RACC values presented in the table are
for the ``edible portion'' of the food, and Footnote 6 will be added to
explain the purpose and use of the ``label statement'' column.
N. Compliance
Currently, 9 CFR 317.309(h) and 381.409(h) provide information
about how FSIS determines compliance with its nutrition labeling
requirements, including the methods of analysis used, reasonable
excesses and deficiencies of nutrients, acceptable levels of variance
from declared values, and records requirements. FSIS is proposing to
consolidate 9 CFR 317.309(h) and 381.409(h) into a single section
(proposed 9 CFR 413.309(h)). The following discusses the additional
revisions that FSIS will be proposing in 9 CFR 413.309(h), as compared
to current 9 CFR 317.309(h) and 381.409(h).
1. Level of Variance Allowed for the Label Declaration of Specific
Nutrients
Proposed 9 CFR 413.309(h)(5) establishes that a meat or poultry
product with a label declaration of calories, sugars, added sugars
(when the only source of sugars in the food is added sugars), total
fat, saturated fat, cholesterol, or sodium shall be deemed to be
misbranded under sections 1(n) of the FMIA (21 U.S.C. 601(n)(1)) or
4(h) of the PPIA (21 U.S.C. 453(h)) if the nutrient content of the
composite is greater than 20 percent in excess of the value for that
nutrient declared on the label. However, no regulatory action will be
based on such a determination if the excess is less than the inherent
nutrient variation in a product or the variability generally recognized
for the analytical method used in that product at the level involved.
FSIS is not proposing to change the level of variance allowed for the
label declaration of nutrients.
2. Methods Used To Determine Compliance
Under proposed 9 CFR 413.309(h)(2), a sample for nutrient analysis
must consist of at least six consumer units, each from a production
lot, or alternatively, chosen randomly to be representative of a
production lot. In each case, the units may be individually analyzed,
and the results averaged, or the units may be combined, and the
composite analyzed. FSIS will consider the results--whether the average
or the single result from the composite--to be the nutrient content of
the composite. All analyses must be performed, if possible, by the
appropriate methods and procedures used by the U.S. Department of
Agriculture (USDA) for each nutrient in accordance with the ``Chemistry
Laboratory Guidebook.'' If no USDA method is available, the appropriate
methods for the nutrient in accordance with the 2016 edition of the
``Official Methods of Analysis'' of the AOAC International, 20th ed.,
must be used, unless a particular method of analysis is specified in 9
CFR 413.309(c). If no USDA, AOAC, or specified method is available or
appropriate, any other reliable and appropriate analytical procedures
may be used, as determined by FSIS. The current edition (20th ed.) of
the ``Official Methods of Analysis'' includes many updates to the 15th
edition.
When FSIS issued 9 CFR 317.309(h) and 381.409(h) on compliance with
nutrition labeling requirements, the most current version of the AOAC
methods was its 15th edition, and, therefore, FSIS identified the 15th
edition in its regulation. Newer and better methods of analysis have
since been validated and recognized as ``official'' methods in the
current 20th edition. Accordingly, FSIS is proposing, in 9 CFR
413.309(h)(2), to use the 20th edition and incorporate it by reference
in 9 CFR (h)(9)(i). The ``Official Methods of Analysis of AOAC
International'' is a comprehensive collection of chemical and
microbiological methods of analysis. The Official Methods of Analysis
have undergone rigorous scientific review and validation to determine
the performance characteristics for the intended analytical application
and fitness for purpose. Each method includes specific instructions for
performing the chemical analysis of a substance in a particular matrix.
If a newer edition of the Official Methods of Analysis is published
before issuance of a final rule, FSIS intends to finalize this rule
with the newer edition, as appropriate, provided there are no
substantive changes in the newer edition requiring additional comment.
FSIS does not currently sample or conduct routine nutrient analyses
of products for regulatory purposes because FSIS has not, in the past,
found gross non-compliance with the nutrition labeling requirements
(i.e., large variations in the nutrient content of the samples compared
to the declared nutrition information provided on product labels).
FSIS, for a limited period of time, is conducting surveillance sampling
for nutrient content of raw ground beef samples
[[Page 6761]]
collected for pathogen analysis, such as Shiga toxin-producing
Escherichia coli (STEC) and Salmonella, to ascertain compliance with
the recent nutrition labeling requirements for raw ground product
packages. FSIS randomly analyzes samples of raw ground beef products in
consumer-ready packaging bearing a Nutrition Facts label that have
already been collected for pathogen analysis at Federally-inspected
establishments. In addition, when Office of Investigation, Enforcement
and Audit (OIEA) Investigators collect samples of raw ground beef in
consumer-ready packaging bearing a Nutrition Facts label at retail for
pathogen analysis, the FSIS laboratory also randomly selects some of
these samples for nutrient content analysis. The nutrient content
results are non-regulatory and are for surveillance purposes only at
this time. If there is a discrepancy between the laboratory results and
the Nutrition Facts label, LPDS directly contacts the establishment or
the OIEA-Compliance and Investigation Division Regional Director with
the results of the nutrient content testing.
FSIS will explore its regulatory options, including seeking
criminal penalties or rescinding label approvals, if it discovers a
violation of the nutrition labeling requirements. In addition, FSIS
will consider when additional surveillance sampling for nutrient
content should be conducted for various products, as well as when
regulatory verification testing should occur.
3. Records Requirements
Currently, FSIS regulations require that establishment management
maintain records to support the validity of nutrient declarations
contained on meat and poultry product labels (9 CFR 317.309(h)(8) and
381.409(h)(8)). Such records are required to be made available to the
inspector or any duly authorized representative of FSIS upon request (9
CFR 317.309(h)(8) and 381.409(h)(8)). These records are generally
required to be retained for 2 years (9 CFR 320.3 and 381.177). FSIS is
proposing to consolidate the requirements in 9 CFR 317.309(h)(8) and
381.409(h)(8) into proposed 9 CFR 413.309(h)(8).
As discussed in sections II.E.5.a. (dietary fiber), II.E.5.b.
(soluble and insoluble fiber), II.E.3. (added sugars), II.J.2. (vitamin
E), and II.J.3. (folate), there are no suitable analytical procedures
for measuring the following nutrients under the circumstances
described: (1) Dietary fiber (when non-digestible carbohydrates that do
and do not meet the proposed definition of dietary fiber are both
contained in a food product); (2) soluble fiber (when a mixture of
soluble fiber and non-digestible carbohydrates that do not meet the
definition of dietary fiber is present in a food); (3) insoluble fiber
(when a mixture of insoluble fiber and non-digestible carbohydrates
that do not meet the definition of dietary fiber is present in a food);
(4) added sugars (when a food product contains both naturally occurring
sugars and added sugars); (5) vitamin E (when a food product contains
both RRR-[alpha]-tocopherol and all rac-[alpha]-tocopherol); and (6)
folate (when a food product contains both folate and folic acid).
Because there are no reliable or appropriate analytical procedures
available for FSIS to ensure that the declared nutrient amount for
certain nutrients is truthful, accurate, and in compliance with all
applicable labeling requirements, FSIS is proposing to require specific
recordkeeping for certain nutrients. FSIS is proposing to require that
manufacturers make and keep written records to verify the declaration
of: (1) The amount of added non-digestible carbohydrates that do not
meet the proposed definition of dietary fiber when the dietary fiber
present in a food is a mixture of dietary fiber and non-digestible
carbohydrates that do not meet the definition of dietary fiber
(proposed 9 CFR 413.309(h)(8)(i)); (2) the amount of added non-
digestible carbohydrates that do not meet the proposed definition of
dietary fiber when the food contains a mixture of soluble fiber and
non-digestible carbohydrates that do not meet the definition of dietary
fiber (proposed 9 CFR 413.309(h)(8)(ii)); (3) the amount of added
insoluble non-digestible carbohydrates that do not meet the proposed
definition of dietary fiber when the food contains a mixture of
insoluble fiber and non-digestible carbohydrates that do not meet the
definition of dietary fiber (proposed 9 CFR 413.309(h)(8)(iii)); (4)
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), when both naturally occurring and
added sugars are present in a food (proposed 9 CFR 413.309(h)(8)(iv));
(5)(a) scientific data and information that demonstrate the amount of
added sugars in the food after non-enzymatic browning 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 manufactured; or (b) records of the amount of 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 (proposed 9 CFR 413.309(h)(8)(v);
(6) the amount of all rac-[alpha]-tocopherol added to the food and RRR-
[alpha]-tocopherol in the finished food when a mixture of both forms of
vitamin E is present in a food (proposed 9 CFR 413.309(h)(8)(vi)); and
(7) the amount of synthetic folate or folic acid added to the food and
the amount of naturally-occurring folate in the finished food, when a
mixture of folate and folic acid is present in a food (proposed 9 CFR
413.309(h)(8)(vii)).
Most manufacturers should already have the types of records needed
to validate the declared amount of each nutrient. They are in the best
position to know which records will contain the information necessary
for FSIS to determine compliance. These records may include analyses of
databases, recipes or formulations, or batch records. FSIS recognizes
that the nutrient profile of processed foods that have dietary fiber,
soluble fiber, insoluble fiber, added sugars, vitamin E, or folate/
folic acid can vary depending on the recipe or formulation, the
suppliers of ingredients, and other factors. Although the nutrient
levels in foods may change if a manufacturer changes ingredient
suppliers or recipes, manufacturers still need to ensure that the
records they maintain substantiate the nutrient composition of the
specific food. Therefore, manufacturers must be able to distinguish
among the same or similar products they have in the marketplace that
may contain differing amounts of a declared nutrient. The records
required under proposed 9 CFR 413.309(h)(8) must be available for
review and copying while the product is available for purchase in the
marketplace. There is a wide range of shelf lives among food products.
The current retention period for nutrition labeling records under 9 CFR
320.3 and 381.177--a period not to exceed two years after December 31
of the year in which the transaction to which the record relates has
occurred--will be sufficient to enforce the nutrient declarations on
the nutrition labels.
4. Inclusion of Potassium as a Mineral
Potassium is currently the only vitamin or mineral specified as a
Class I and Class II nutrient in 9 CFR
[[Page 6762]]
317.309(h)(4)(i-ii) and 381.409(h)(4)(i-ii). Potassium is a mineral for
which an RDI is being proposed (proposed 9 CFR 413.309(c)(8)(iv)), and
the absolute amount would be required to be declared along with a
percent DV on the Nutrition Facts label. FSIS has tentatively concluded
that there is no need to separately list potassium under the
description of Class I and Class II nutrients because it is encompassed
within the minerals category. Therefore, FSIS is proposing to omit a
specific reference to potassium in proposed 9 CFR 413.309(h)(4) and
(h)(6). Any listing of potassium on the Nutrition Facts label will have
to meet the specific compliance requirements for minerals under 9 CFR
413.309(h)(4) and (h)(6).
5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber,
Added Sugars, and Sugar Alcohols
The labeling requirements for Class I and Class II nutrients are
provided in proposed 9 CFR 413.309(h)(4). For the reasons discussed in
section II.E.6., FSIS is proposing to omit the provision for voluntary
declaration of ``Other carbohydrate'' in proposed 9 CFR 413.309(c)(6)
that is in 9 CFR 317.309(c)(6)(iv) and 381.409(c)(6)(iv). Therefore,
FSIS is proposing to omit the compliance requirements related to
``Other carbohydrate'' in proposed 9 CFR 413.309(h)(4) and (h)(6) that
are in 9 CFR 317.309(h)(4) and (h)(6) and 381.409(h)(4) and (h)(6)).
Dietary fiber is included as both a Class I and Class II nutrient
because food products may contain only non-digestible carbohydrates
that meet the definition of dietary fiber and that may be naturally
occurring or that may be added to fortified or fabricated foods. The
same is true for soluble and insoluble fiber, yet these nutrients are
not currently listed as Class I or Class II nutrients (see 9 CFR
317.309(h)(4) and 381.409(h)(4)). Therefore, FSIS is proposing to
include dietary fiber in 9 CFR 413.309(h)(4) as both a Class I and
Class II nutrient.
Currently, 9 CFR 317.309(h)(5) and 381.409(h)(5) (consolidated in
proposed 9 CFR 413.309(h)(5)) specify that a food with a label
declaration of calories, sugars, total fat, saturated fat, cholesterol,
or sodium is deemed to be misbranded under section 1(n) of the FMIA (21
U.S.C. 601(n)(1)) or 4(h) of the PPIA (21 U.S.C. 453(h)) if the
nutrient content of the composite is greater than 20 percent in excess
of the value for that nutrient declared on the label. The nutrients
listed in this section can have a negative impact on health in the
general U.S. population if consumed in excess, and there are current
dietary recommendations to reduce the consumption of these nutrients.
Therefore, FSIS is ensuring in proposed 9 CFR 413.309(h)(5) that foods
do not contain excessive amounts of these nutrients of which the
consumer is unaware.
Current dietary recommendations acknowledge that Americans consume
excess amounts of added sugars and encourage reducing intake of
calories from added sugars. A FSIS has an interest in ensuring that
foods do not contain excessive amounts of added sugars that are not
declared on the label (see section II.E.3) and is proposing to include
added sugars in 9 CFR 413.309(h)(5). In some food products, all of the
sugars are added. In such cases, an analytical method could be used to
determine the amount of added sugars, and the permitted analytical
variability would be applicable. Accordingly, FSIS is proposing to
include ``added sugars (when the only source of sugars in the food is
added sugars)'' among the list of nutrients in proposed 9 CFR
413.309(h)(5).
Reasonable excesses or deficiencies in relation to certain declared
nutrients are acceptable within current good manufacturing practice.
FSIS is proposing to allow reasonable excesses over the labeled amount
of soluble and insoluble fiber and sugar alcohols when they are
acceptable within current good manufacturing practice, and reasonable
deficiencies under labeled amounts of added sugars when they are
acceptable within current good manufacturing practice (proposed 9 CFR
413.309(h)(6)). FSIS expects that when a food product only contains
added sugars, when all of the dietary fiber (both soluble and
insoluble) is added non-digestible carbohydrates that meet the
definition of dietary fiber, when all of the vitamin E is all rac-
[alpha]-tocopherol, and when only folic acid is present in a food, the
declared amount must be at least equal to the amount of the nutrient
added to the food.
In summary, FSIS is proposing the following changes related to
compliance in 9 CFR 413.309(h) as compared to current 9 CFR 317.309(h)
and 381.409(h): (1) Cite the 20th edition of the Official Methods of
Analysis of the AOAC International and incorporate it as the reference
for the appropriate methods used to determine compliance with amounts
of nutrients declared on the Nutrition Facts label (proposed 9 CFR
413.309(h)(2) and (h)(9)(i)); (2) establish general recordkeeping
requirements when records are necessary to verify information related
to dietary fiber, soluble and insoluble fiber, added sugars, folate,
and vitamin E provided on the label (proposed 9 CFR 413.309(h)(8)); (3)
omit a specific reference to potassium in proposed 9 CFR
413.309(h)(4)(i-ii) and (h)(6) such that any listing of potassium on
the Nutrition Facts label would meet the specific compliance
requirements for minerals under proposed 9 CFR 413.309(h)(4) and
(h)(6); (4) include dietary fiber, under proposed 9 CFR 413.309(h)(4);
(5) include added sugars within proposed 9 CFR 413.309(h)(5) such that
the label declaration of added sugars will be deemed misbranded under
sections 1(n) of the FMIA (21 U.S.C. 601(n)(1)) or 4(h) of the PPIA (21
U.S.C. 453(h)) if the nutrient content of the composite is greater than
20 percent in excess of the added sugars declared on the label, and
within proposed 9 CFR 413.309(h)(6) such that reasonable deficiencies
of added sugars would be permitted; (6) include soluble and insoluble
fiber and sugar alcohols within proposed 9 CFR 413.309(h)(6) such that
reasonable excesses of these nutrients would be permitted; and (7)
consistent with the tentative conclusion in section II.E.6., omit
references to ``Other carbohydrate'' in proposed 9 CFR 413.309(h).
O. Technical Amendments
FSIS is proposing to update the name of Food Labeling Division in
proposed 9 CFR 413.312 and 413.369 to the Labeling and Program Delivery
Staff, Office of Policy and Program Development. FSIS is also proposing
to update the docket room address in proposed 9 CFR 413.309.
Proposed 9 CFR 413.400(a)(1)(ii) is updated to remove compliance
criteria that expired in July 1997.
FSIS is proposing to update the cross-references to parts 317 and
381 in sections 301.2, 304.2, 316.8, 316.11, 316.13, 317.16, 318.10,
319.1, 319.10, 320.1, 327.15, 362.2, 381.172, 381.2, and 412.2.
III. Executive Order 12866 and Executive Order 13563
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This proposed rule has been designated an ``economically
significant regulatory
[[Page 6763]]
action'' under section 3(f) of Executive Order 12866. Accordingly, the
rule has been reviewed by the Office of Management and Budget.
Need for the Rule
The USDA began requiring nutrition and serving size information on
food labels in the early 1990's (58 FR 632). The requirements were
intended to provide producers with a credible way of communicating
nutrient related information to consumers and ensure consumers had
access to the necessary information for maintaining a healthy diet.
Today, nearly 80 percent of U.S. adults report using nutrition labels
at least some of the time,\37\ Table 1--Use of Nutritional Facts Label
by Average Daily Caloric, Sodium and Sugar Intake from Food at Home.
However, over the past 20 years American caloric and nutritional
consumption and recommendations \38\ for daily nutrition requirements
have changed and no longer match the current nutrition labeling
requirements. This gradual reversion to underlying information
asymmetries raises concerns over the usefulness of the information
provided on nutritional facts and serving size labels. In addition,
consumer groups have raised concerns over the required formats.
According to national consumer surveys,\39\ a sizeable number of
consumers effectively lack access to the provided information because
of their inability to simply read or quickly comprehend nutritional
labels, leading to inadequate information distribution. The proposed
rule seeks to correct the market failures caused by asymmetric and
inadequate information by ensuring that nutritional and serving size
requirements for FSIS products is consistent with FDA's requirements
and are based on current diets and nutritional needs as well as
addressing those issues that inhibit consumers from using this
information.
---------------------------------------------------------------------------
\37\ NHANES. 2013. ``Questionnaires, Datasets, and Related
Documentation'' Centers for Disease Control and Prevention. Accessed
on 5/6/2014. Data derived from the Consumer Behavior Phone Follow-up
Module--Adult http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.
\38\ U.S. Department of Health and Human Services and U.S.
Department of Agriculture. 2015-2020 Dietary Guidelines for
Americans. 8th Edition. December 2015. Available at http://health.gov/dietaryguidelines/2015/guidelines/.
\39\ Health and Diet Survey. 2008. U.S. Food and Drug
Administration. http://www.fda.gov/Food/FoodScienceResearch/ConsumerBehaviorResearch/ucm193895.htm National Health and Nutrition
Examination Survey Questionnaire, NHANES. 2009-2010. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.
Table 1--Use of Nutritional Facts Label by Average Daily Caloric, Sodium and Sugar Intake From Food at Home
----------------------------------------------------------------------------------------------------------------
Portion of the Caloric intake Sodium intake Sugar intake \2\
Nutritional facts label use population \1\ \2\ (kcal) \2\ (mg) (mg)
----------------------------------------------------------------------------------------------------------------
Always or Most of the Time............ 102,281,465 (43%) 1,439 2,327 85
Sometimes............................. 83,877,978 (36%) 1,462 2,325 89
Rarely................................ 33,653,297 (14%) 1,554 2,429 103
Never................................. 15,807,324 (7%) 1,741 2,517 122
----------------------------------------------------------------------------------------------------------------
\1\ Population includes all individuals 16 years of age and older.
\2\ Intake values are limited to food consumed at home.
Source: NHANES. 2013. ``Questionnaires, Datasets, and Related Documentation'' Centers for Disease Control and
Prevention. Accessed on 5/6/2014. Table derived from data in the Consumer Behavior Phone Follow-up Module--
Adult, Dietary Interview--Individual Foods, First Day, and Demographic Variables & Sample Weights. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.
Government labeling requirements provide producers with a credible
way to communicate product attributes that are not obvious to
consumers, e.g., calorie count or amount of fiber per serving. In this
manner, labeling requirements allow producers to compete based on
nutritional quality. In turn, consumers use nutritional fact and
serving size labels to select products with desired qualities and tie
individual decisions to overall health impacts.\40\ More than 185
million adults reported referencing the Nutrition Facts label at least
some of the time.\41\ Further still, recent research conducted by the
Economic Research Service indicated that use of nutritional and health
information is on the rise.\42\ The 2008 Health and Diet Survey
conducted by the FDA provides further insight into food label use.\43\
When consumers were asked ``when you buy a product for the first time,
how often do you read (ingredient and nutrition) information,'' 54
percent reported often, and 23 percent reported sometimes. Ninety
percent of label users reported using food labels to see how high or
low the food is in calories and macro- and micro-nutrients like sodium,
fat, or vitamins either often or sometimes (66 percent often, 24
percent sometimes). Lastly, 49 percent of survey respondents affirmed
that during the previous two weeks, they had based a decision to buy or
use a food product based on the nutrition label. Clearly, many
consumers demand and use nutritional information on food labels.
However, the changes in consumers' diets and basing the nutrition facts
and serving size labels on outdated recommendations does not clearly
and conspicuously reveal the essential information to consumers.
---------------------------------------------------------------------------
\40\ Caswell, J. and E.M. Mojduszka. 1996. Using information
labeling to influence the market for quality in food products.
American Journal of Agricultural Economics. 29: 47-54.
\41\ NHANES. 2013. ``Questionnaires, Datasets, and Related
Documentation'' Centers for Disease Control and Prevention. Accessed
on 5/6/2014. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm NHANES.
\42\ Todd, J. 2014. Changes in eating patterns and diet quality
among working-age adults, 2005-2010. U.S. Department of Agriculture,
Economic Research Service. ERR-161. Todd 2014.
\43\ Choiniere, C.J. and A. Lando. 2008. ``, FDA 2008 Health and
Diet Survey-Consumer Behavior Research'' Accessed on 5/6/2014. <
http://www.fda.gov/Food/FoodScienceResearch/ConsumerBehaviorResearch/ucm193895.htm.>
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[[Page 6764]]
As is shown on Graph 1, from 1971--2010, mean energy intake
increased by 240 kcal/day \44\ although recent reports suggest
overweight and obesity has leveled-off nationally and even declined in
certain groups.\45\ During this period, an emphasis on health aspects
such as ``low in sodium'' or ``low in fat'' led consumers to disregard
other pertinent health information, e.g., calorie count, sugars and
serving size, leading to overconsumption.\46\ Between 1970 and 2005,
sugars and sweeteners available for consumption increased by 19
percent. This increase in supply enabled an increase in consumption
such that by 2004, the daily sugar intake for men and women averaged
25.4 tsp (406 kcal) and 18.3 tsp (292 kcal) respectively.\47\ From
2007-2010, children and adults consumed more than double the amount of
recommended added sugars, with lower income individuals consuming more
added sugars than higher income individuals.\48\ For perspective, the
2015-2020 Dietary Guidelines for Americans recommends less than 10
percent of calories per day from added sugars combined, yet added
sugars alone contributed an average of 16 percent of the total calories
in American diets. The increase in caloric density worsened the
negative health impacts associated with overconsumption. Updating
nutrition facts and serving size labels so as to take into
consideration current consumption patterns, dietary recommendations,
and scientific evidence will help producers credibly communicate hard
to distinguish product attributes as well as aid current and future
label-users overcome the issues presented above.
---------------------------------------------------------------------------
\44\ Ford, E.S. and W. H. Dietz. 2013. Trends in energy intake
among adults in the United States: finding from NHANES. American
Journal of Clinical Nutrition. 97: 848-853. Ford and Dietz, 2013.
\45\ Fryar, C, Carroll, M., Ogden, C. 2014. Prevalence of
Overweight, Obesity, and Extreme Obesity Among Adults: United
States, 1960-162 Through 2011-2012. CDC National Center for Health
Statistics. http://www.cdc.gov/nchs/data/hestat/obesity_adult_11_12/obesity_adult_11_12.htm.
\46\ Chandon, P. 2013. How package design and packaged-based
marketing claims lead to overeating. Applied Economic Perspectives
and Policy. 35: 7-31.
\47\ Johnson, R.K., L.J. Appel, M. Brands, B.V. Howard, M.
Lefevre, R.H. Lustig, F. Sacks, L.M. Steffen, and J. Wylie-Rosett.
2009. Dietary sugars intake and cardiovascular health a scientific
statement from the American Heart Association. Circulation. 1012-
1020.
\48\ Biing-Hwan Lin and Rosanna Mentzer Morrison. 2014. ERS's
Food Consumption and Nutrient Intake Data-Tool for Assessing
Americans' Diets. USDA Economic Research Service. https://www.ers.usda.gov/amber-waves/2014/october/erss-food-consumption-and-nutrient-intake-data-tools-for-assessing-americans-diets/.
[GRAPHIC] [TIFF OMITTED] TP19JA17.001
Of those U.S. adults who rarely or never use Nutrition Facts
labels, over 31 million of them are overweight or obese; conditions
linked to increased incidence of coronary heart disease, stroke, type 2
diabetes, cancer, and high blood pressure. For perspective, overweight
and obese individuals spend 10 and 43 percent more money on health care
as compared to normal weight individuals, respectively.\49\ Overall
annual medical expenditure caused by overweight or obesity has been
estimated to account for between 5 and 7 percent of national medical
expenditures \50\ and is projected to increase to 17 percent by
2030.\51\ With regard to health care providers, obesity accounts for
8.5 percent of Medicare spending, 12 percent of Medicaid spending, and
13 percent of private payer spending.\52\
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\49\ Tsai, A.G., D.F. Williamson, and H.A. Glick. 2010. Direct
medical cost of overweight and obesity in the USA: A quantitative
systematic review. Obesity Reviews. 12: 50-61. Tsai et al. 2010.
\50\ Tsai, A.G., D.F. Williamson, and H.A. Glick. 2010. Direct
medical cost of overweight and obesity in the USA: A quantitative
systematic review. Obesity Reviews. 12: 50-61. Tsai et al. 2010.
\51\ Wang, Y.C., K.M, T.Marsh, S.L. Gortmaker, and M. Brown.
2011. Health and economic burden of the projected obesity trends in
the USA and the UK. The Lancet. 378: 815-825 Wang 2011.
\52\ Finkelstein, E.A., J.G. Trogdon, J.W. Cohen, and W.Dietz.
2009. Annual medical spending attributable to obesity: Payer and
service-specific estimates. Health Affairs Web Exclusive. 33:11.
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A daily energy surplus of 50-100 kcals will lead to overweight and
[[Page 6765]]
obesity.\53\ Thus, the 92-279 kcal difference in kcals consumed at home
between those who rarely or never read labels as compared to those who
at least sometimes read labels is understood to be significant, Table
1--Use of Nutritional Facts Label by Average Daily Caloric, Sodium and
Sugar Intake from Food at Home. When asked why they did not use
nutritional labels, approximately 10 percent of overweight respondents
exclusively had issues related to readability and comprehensibility:
The print is too small, they would not know what to look for, or they
do not have enough time. Addressing these design limitations would
provide consumers with information that will convey relevant nutrition
information.
---------------------------------------------------------------------------
\53\ Finkelstein, E.A., C.J. Ruhm, and K.M. Kosal. 2005.
Economic causes and consequences of obesity. Annual Review of Public
Health. 26. 239-257. and Johnson, R. K., L.J. Appel, M. Brands, B.V.
Howard, M. Lefevre, R.H. Lustig, F. Sacks, L.M. Steffen, and J.
Wylie-Rosett. 2009. Dietary sugars intake and cardiovascular health
a scientific statement from the American Heart Association.
Circulation: 1012-1020.
---------------------------------------------------------------------------
These modest reductions are known to lead to significant benefits
in the form of weight loss, health improvements, and reduced medical
expenditures.\54\ These issues can be addressed by altering the design
and content of nutritional and serving size labels, e.g., reducing the
variance between food labels by more closely aligning FSIS's
requirements with FDA's, providing a calorie count for the entire
package and or utilizing a dual column layout when appropriate, along
with increasing and bolding the font size for the most salient
information.
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\54\ Dall, T.M., V.L. Fulgoni III, Y. Zhang, K.J. Reimers, P.T.
Packard, and J.D. Astwood. 2009. Potential health benefits and
medical cost savings from calorie, sodium, and saturated fat
reductions in the American diet. American Journal of Health
Promotion. 23. 412-422 and Sturm, R. 2002 The effects of obesity,
smoking, and drinking on medical problems and costs. Health Risks
and Costs. 21: 245-253.
---------------------------------------------------------------------------
In total, the USDA and FDA regulate roughly 50,000 \55\ and 740,000
\56\ labels. The proposed rule reduces the amount of inconsistent
information across FSIS and FDA products by more closely aligning
nutrition labeling requirements with FDA's final changes, which ensures
that food nutrition information is consistent across food products.
This proposed rule allows nutrition labeling to more accurately reflect
current dietary guidelines and is more easily understood by consumers.
As will be detailed in the following sections, the magnitude of the sum
of public health benefits brought about by even a small change in
consumer behavior because of the information provided by the label
warrants the proposed rule.
---------------------------------------------------------------------------
\55\ IRI (2012). InfoScan data. Information Resources, Inc.
(IRI).
\56\ Nutrition Facts/Serving Sizes Combined PRIA for Docket No.
FDA-2012-N-1210 and Docket No. FDA-2004-N-0258. Available at: http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/UCM385669.pdf.
---------------------------------------------------------------------------
Baseline
FSIS estimates that there are roughly 50,000 different retail
nutrition labels for meat or poultry products, roughly 25 percent of
which are private labels (store brand). The Agency estimates that FSIS
products are produced by 3,307 establishments, of which, 3,125 are
considered either small or very small establishments. The number of
labels and establishments is based on Information Resources,
Incorporated (IRI) scanner data \57\ and the Small Business
Administration's (SBA's) business size classifications.
---------------------------------------------------------------------------
\57\ Any opinions, findings, recommendations, or conclusions are
those of the authors and do not necessarily reflect the views of the
Economic Research Service, U.S. Department of Agriculture. The
analysis, findings, and conclusions expressed in this paper also
should not be attributed to either Nielsen or Information Resources,
Inc. (IRI). This research was conducted in collaboration with USDA
under a Third Party Agreement with IRI.
---------------------------------------------------------------------------
There are almost 50 million adults who rarely or never use the
Nutrition Facts label. Of this population, nearly 32 million are
overweight, are obese, or have hypertension, Table 11 and 12. FSIS
estimated this proposed rule would impact a portion of these consumers
by increasing the usability of nutrition labeling which will, in turn,
improve their health and welfare.
Expected Costs of the Proposed Rule
Quantitative costs for the proposed rule include relabeling,
recordkeeping, and reformulation costs. FSIS anticipates allowing a 24-
month compliance period with a 36-month compliance for small
businesses,\58\ consistent with FDA's final rules (81 FR 33742 and 81
FR 34000). On December 1, 2014, FSIS issued a final rule that
established January 1, 2018, as the uniform compliance date for new
meat and poultry product labeling regulations that are issued between
January 1, 2015 and December 31, 2016 (79 FR 71007). However, according
to the uniform compliance date final rule, if any food labeling
regulation involves special circumstances that justify a compliance
date other than the uniform compliance date, FSIS will determine an
appropriate compliance date and will publish that compliance date in
the rulemaking (79 FR 71008). FSIS is proposing not to use the uniform
compliance date for a final rule resulting from this proposed rule
because, depending on when the final rule is published, the use of the
uniform compliance date may result in a compliance period of less than
24 months.
---------------------------------------------------------------------------
\58\ Small Businesses are based on the Small Business
Administration (SBA) size standards. The SBA defines a small
business in NAICS code 311611--Animal (except Poultry) Slaughter and
NAICS code 311612--Meat Processed from Carcasses as having less than
1,000 employees. A business in NAICS code 311615--Poultry Processing
has a small business standard of less than 1,250 employees and NAICS
code Seafood Product Preparation and Packaging has a less than 750-
employee standard.
United States Small Business Administration (SBA), Table of
Small Business Standards Matched to North American Industry
Classification System Codes. Effective February 26, 2016. Available
at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
---------------------------------------------------------------------------
The combined expected annualized costs equal $10.8 million
annualized at a 3 percent rate over 20 years. The one-time costs,
staggered over the first three years, are $165,540,072. In addition,
consumers will incur costs associated with learning how to use new
labels, which is a form of qualitative costs. What follows are details
for each of the quantitative costs.
Relabeling Costs
To estimate the costs associated with relabeling products under
USDA jurisdiction, this analysis utilized the 2014 FDA Labeling Cost
Model \59\ and Information Resources, Inc. (IRI) scanner data. The cost
of relabeling depends on the number of labels required to change,
whether or not the change can be coordinated with another label update,
and the type of label change (extensive, major or minor). To determine
the number of FSIS regulated labels in the retail market, we relied on
IRI scanner data. Overall, there are 56,905 labels in the retail market
under FSIS jurisdiction (14,056 private and 42,849 branded), though
some are exempt from nutrition labeling per 9 CFR 317.400 and 381.500.
To find the number of labels that are exempt, we utilized data from IRI
and the National Meat Case Study. Data from IRI estimates 30.64 percent
(3,619 private and 13,806 branded labels) of meat and poultry products
are fresh in the retail market, thus possibly eligible for a labeling
exemption. Of these products, approximately 39 percent do not have
[[Page 6766]]
nutrition labeling.\60\ Therefore, we estimate there are 50,110 FSIS
labels with nutrition labeling; 12,645 private (14,056 - (3,619 x 39%))
and 37,465 branded (42,849 - (13,806 x 39%)). See Table 2 below for
details.
---------------------------------------------------------------------------
\59\ RTI International. ``2014 FDA Labeling Cost Model.''
Prepared by Mary K. Muth, Samantha Bradley, Jenna Brophy, Kristen
Capogrossi, Michaela C. Coglaiti, and Shawn A. Karns. Contract No.
HHSF-223-2011-10005B, Task Order 20, August 2015.
\60\ National Cattlemen's Beef Association, 2010. A Snapshot of
Today's Retail Meat Case, 2010 National Meat Case Study Executive
Summary. Available here: http://www.beefretail.org/CMDocs/BeefRetail/research/2010NationalMeatCaseStudy.pdf.
Table 2--Total Number of FSIS UPCs With Nutrition Facts Labels
----------------------------------------------------------------------------------------------------------------
Number of UPCs
Type of label Total FSIS exempt from Total FSIS
labels NFL UPCs with NFL
----------------------------------------------------------------------------------------------------------------
Branded......................................................... 42,849 5,384 37,465
Private......................................................... 14,056 1,411 12,645
-----------------------------------------------
Total....................................................... 56,905 6,795 50,110
----------------------------------------------------------------------------------------------------------------
Using SBA's small business definition of small business and IRI
scanner data, FSIS estimates 53.6 percent of UPCs are from small
businesses and 46.4 percent of UPCs are from large. The 26,859 UPCs
(53.6 percent of 50,110) from small manufacturers have 36 months to
comply with the proposed regulations and the 23,251 (46.4 percent of
50,110) from large manufacturers will have 24 months to comply. In
total, there are 6,778 private labels (12,645 x 53.6%) and 20,081
branded labels (37,465 x 53.6%) for small businesses, and 5,867 private
labels (12,645 x 46.4%) and 17,384 branded labels (37,465 x 46.4%) for
large businesses. The Small Business Administration (SBA) defines a
small business in NAICS code 311611--Animal (except Poultry) Slaughter
and NAICS code 311612--Meat Processed from Carcasses as having less
than 1,000 employees.\61\ A business in NAICS code 311615--Poultry
Processing has a small business standard of less than 1,250 employees
and NAICS code Seafood Product Preparation and Packaging has a less
than 750-employee standard. \62\
---------------------------------------------------------------------------
\61\ United States Small Business Administration (SBA), Table of
Small Business Standards Matched to North American Industry
Classification System Codes. Effective February 26, 2016. Available
at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
\62\ United States Small Business Administration (SBA), Table of
Small Business Standards Matched to North American Industry
Classification System Codes. Effective February 26, 2016. Available
at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
---------------------------------------------------------------------------
To adjust for inflation in the 2014 FDA Labeling Cost Model, we
updated the wage rates using the most current (2015) wages and applied
a benefits and overhead factor of two to estimate the total cost per
type of label change. The cost estimates in 2015 U.S. Dollars (USD) are
$572 per label (with a range of $141 to $1,620) for minor coordinated
changes and $3,887 per label (with a range of $1,842 to $7,741) for
minor uncoordinated changes (FDA Labeling Cost Model, 2014). The cost
estimates in 2015 USD are $1,152 per label (with a range of $296 and
$3,204) for major coordinated changes and $9,401 per label (with a
range of $5,125 to $17,400) for major uncoordinated changes. The cost
estimate in 2015 USD is $13,858 per label (with a range of $7,038 and
$25,399) for both coordinated and uncoordinated extensive changes.
Based on FDA's Labeling Cost Model, the majority of the label
changes required by the proposed rule are considered minor. Minor
changes are categorized as alterations that do not require the entire
label to be redesigned, e.g., changing a single color or updating the
ingredient list. In contrast, a major change requires completely
redesigning a label, e.g., changing multiple colors or modifying the
front of the package. An extensive change is a major format change
requiring a modification to the product packaging to accommodate
labeling information. An example of an extensive change is increasing
the package surface area.
Over 24 percent of the labels will undergo a major change; 22.8
percent (11,432/50,110) for the dual column and 1.6 percent (805/
50,110) for removing a front of package (FOP) health or nutrient claim
in response to changes in the DVs, RACCs, or the definition of dietary
fiber, Table 3. The estimate of products requiring a dual column label
was determined using IRI scanner data and identifying packaged products
containing between 200 to 300 percent of the RACC. From this group,
packaged products that required further processing before consuming or
that are traditionally eaten in combination with other products, such
as raw meat, poultry, and condiments, were excluded as they are
exempted from the dual column labeling requirements. Alterations of
health and nutrient claims were dependent on updates in Daily Values,
RACCs, or the definition of dietary fiber.
Extensive changes are changes for products that may increase their
package size to continue to make a health or nutrient content claim in
response to the change in definition of a single-serving container. The
proposed rule requires products that have RACCs of 100 g or larger and
are packaged such that they contain more than 150 percent but less than
200 percent of the RACC to be defined as a single-serving container.
Using IRI scanner data, we identified the UPCs with RACCs over 100 g
that contain more than 150 percent but less than 200 percent of the
RACC and that make a health or nutrient content claim. Based on these
criteria, we estimate 13 UPCs may have an extensive change due to
increasing the package size to continue to make a health or nutrient
content claim. See Table 3 below for details.
Table 3--Number of Label Changes by Type of Label Changes
------------------------------------------------------------------------
Type of change Description of change Number of UPCs
------------------------------------------------------------------------
Major.......................... Dual Column Label...... 11,432
FOP claim and RACC, 805
Daily Value, or fiber
change.
Extensive...................... Over 100 g RACC and FOP 13
claim.
Minor.......................... Total Minor Change..... 37,860
---------------
[[Page 6767]]
Total Number of NFL under ....................... 50,110
USDA Jurisdiction.
------------------------------------------------------------------------
As shown in Table 4--Label Changes That Can Be Coordinated with a
Planned Change, private (store brand) labels change less frequently
than branded labels. Allowing a producer to coordinate a required label
change with a planned change saves costs associated with recordkeeping,
labor, and materials. As such, under a 24 month compliance period for
large businesses, changes to all branded labels will be coordinated
with another planned label change. However, for private (store brand)
labels only 26 percent will be coordinated with another change, and 74
percent will be uncoordinated. Allowing small businesses 36 months to
comply, all branded products can coordinate a change and 57 percent of
private labels can coordinate the label changes, Table 4--Label Changes
That Can Be Coordinated with a Planned Change. As a result, the mid-
point annualized cost at a 3 percent discount rate over 20 years for
updating all of the labels under USDA jurisdiction is estimated to
equal $4,484,734, with an average per label one-time cost of $1,371,
Table 5. The total one-time cost, staggered over the total 36-month
compliance period, is $68,723,156 with a range of $26,933,776 to
$159,581,369.
Table 4--Label Changes That Can Be Coordinated With a Planned Change
----------------------------------------------------------------------------------------------------------------
Weighted
Compliance period (months) Branded Private label average \1\
(percent) (percent) (percent)
----------------------------------------------------------------------------------------------------------------
12.............................................................. 11 5 10
18.............................................................. 37 15 32
24.............................................................. 100 26 82
30.............................................................. 100 40 85
36.............................................................. 100 57 89
42.............................................................. 100 100 100
----------------------------------------------------------------------------------------------------------------
\1\ Based on IRI data analysis, 25% of FSIS labels are private and 75% are branded.
Source: August 2015, ``2014 FDA Labeling Cost Model''.
Table 5--Alternative 2--Labeling Costs
[24 Month for large, 36 months for small]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Small Large Costs
---------------------------------------------------------------------------------------------------------------
Private Branded Private Branded Lower Mean Upper
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Number of Labels.................. 6,778 20,081 5,867 17,384 .............. .............. ..............
Coordinated Change:
Major............................... 943 4,904 373 4,245 $3,097,640 $12,055,680 $33,529,860
Minor............................... 2,919 15,172 1,153 13,134 4,565,298 18,520,216 52,452,360
Uncoordinated Change:
Extensive........................... 2 5 1 5 91,494 180,154 330,187
Major............................... 712 0 1,060 0 9,081,500 16,658,572 30,832,800
Minor............................... 2,202 0 3,280 0 10,097,844 21,308,534 42,436,162
---------------------------------------------------------------------------------------------------------------
Total Cost...................... .............. .............. .............. .............. 26,933,776 68,723,156 159,581,369
Annualized Cost (3% DR, 20 Year)........ .............. .............. .............. .............. 1,757,644 4,484,734 10,413,956
Annualized Cost (7% DR, 20 Year)........ .............. .............. .............. .............. 2,376,035 6,062,598 14,077,899
Average Per label one time cost......... .............. .............. .............. .............. 537 1,371 3,184.62
Per label Annualized Cost (3% DR, 20 .............. .............. .............. .............. 35 89 208
Year)..................................
Per label Annualized Cost (7% DR, 20 .............. .............. .............. .............. 47 121 281
Year)..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping Cost
This proposed rule requires that under certain circumstances
manufacturers must maintain additional records to verify the amount of
added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E,
and folate/folic acid in products. Thus, if adopted, manufacturers will
be required to maintain records sufficient to verify the label
declaration for these nutrients. Examples of appropriate retained
records include nutrient database analyses, nutrient database
calculation based on recipes or formulations, batch records, or any
other information a
[[Page 6768]]
manufacturer retains which verify the nutrient content in the final
product.
We assume that manufacturers currently have records for added
sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E, and
folate/folic acid. However, the proposed changes will require
manufacturers to maintain these records and verify as needed. Thus, the
recordkeeping cost is the initial time burden for meat and poultry
product manufacturers to maintain these records to verify the amount of
such nutrients in a food and to make such records available to
appropriate regulatory officials upon request. From IRI scanner data,
we estimate there are roughly 3,307 manufacturers making products
regulated by FSIS. The declaration of Vitamin E and folate/folic acid
is not mandatory unless accompanied with a nutrient claim. However,
consistent with FDA's Final RIA, FSIS estimates each manufacturer would
incur six hours of recordkeeping burden, one hour for each nutrient,
resulting in 19,842 recordkeeping hours for the industry as a whole.
This estimate is likely an overestimate as not all manufacturers will
need to keep records for added sugars, dietary fiber, soluble fiber,
vitamin E, and folate/folic acid. According to the Bureau of Labor
Statistics, Occupational Employment and Wages, the median hourly wage
of an operations manager is $46.99 \63\ with a range of $31.13 to 73.21
at the 25th and 75th percentile. In addition to the base wage, FSIS
increased this cost by 100 percent to account for benefits and
overhead. Consequently, FSIS assumed a mid-point total hourly
compensation rate of $93.98 ($46.99 x 2) with a range of $62.26 (31.13
x 2) to $146.42 (73.21 x 2). The total recordkeeping costs, discounted
over 20 years using a 3 percent discount rate are an estimated $121,690
with a range of $80,617 to $189,592.
---------------------------------------------------------------------------
\63\ Bureau of Labor Statistics, Occupational Employment and
Wages, May 2015. Mean hourly wage for 11-1021 General and Operations
Managers. Accessed May 26, 2016. available at: http://www.bls.gov/oes/current/oes111021.htm#(1).
Table 6--Estimated Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Total annual Cost (in 2015 USD)
Type of declaration recordkeeping -----------------------------------------------
burden hours Lower Mid Upper
----------------------------------------------------------------------------------------------------------------
Added Sugars.................................... 3,307 $205,894 $310,792 $484,211
Dietary Fiber................................... 3,307 205,894 310,792 484,211
Soluble Fiber................................... 3,307 205,894 310,792 484,211
Insoluble Fiber................................. 3,307 205,894 310,792 484,211
Vitamin E....................................... 3,307 205,894 310,792 484,211
Folate/Folic Acid............................... 3,307 205,894 310,792 484,211
---------------------------------------------------------------
Total....................................... 19,842 1,235,363 1,864,751 2,905,266
Annualized 3%, 20 years......................... .............. 80,617 121,690 189,592
Annualized 7%, 20 years......................... .............. 108,981 164,504 256,296
Median hourly wage for operations manager....... .............. .............. .............. 93.98
25 percentile wage estimate..................... .............. .............. .............. 62.26
75 percentile wage estimate..................... .............. .............. .............. 146.42
----------------------------------------------------------------------------------------------------------------
Reformulation Costs
The proposed rule could motivate food manufacturers to reformulate
their products. Food manufacturers may reformulate their products due
to the increased visibility of added sugars or to maintain a health or
nutrient content claim driven by a change in the Daily Values or RACC
and changes in the definition of dietary fiber. We estimate
reformulation costs associated with each group in the sections below.
Note that we do not anticipate reformulation costs for mandating trans
fat labeling because trans fat in meat and poultry products are usually
naturally occurring.
Consistent with FDA, the Agency estimated costs using the 2014 FDA
Reformulation Cost Model.\64\ The model accounts for variations in food
product complexity, company size, compliance period, reformulation
types and activities. Consistent with FDA, the Agency estimated the
cost of reformulation for a minor nonfunctional ingredient at all
complexity levels, (low, medium and high) at all company size levels,
(small, medium and large). As defined by the reformulation model, small
businesses have less than $1 million in annual sales, medium businesses
have between $1-500 million in annual sales, and large businesses have
over $500 million in sales. The reformulation model estimates all
private label brands are medium businesses and branded products are
small, medium or large, depending on the type of product or brand.
---------------------------------------------------------------------------
\64\ RTI International. ``Reformulation Cost Model.'' Prepared
by Mary K. Muth, Samantha Bradley, Jenna Brophy, Kristen Capogrossi,
Michaela Coglaiti, Shawn Karns, and Catherine Viator. Contract No.
HHSF-223-2011-10005B, Task Order 20, August 2015.
---------------------------------------------------------------------------
The compliance period used in our estimate is 24 months for all
businesses, as an estimate for a 36-month compliance period for a small
business is not available in the model. The model only estimates the
cost for small businesses at the 12 or 24-month compliance period and
at the 12, 24 or 36 month for large businesses. Therefore, the
reformulation cost estimates is an overestimate.
To adjust for inflation in the 2014 Reformulation model, we
adjusted the wage rates using the most current (2015) Consumer Price
Index for All Urban Consumers and applied a benefits and overhead
factor of two to estimate the total cost per formula. The cost per
formula ranges from $4,723 to $361,371 for a high complexity product,
$2,898 to $361,371 for a medium complexity product, and $2,264 to
$338,918 for a low complexity product. The cost varies by the size of
company, with large and medium businesses having higher costs per
formula than small businesses.
Number of Product Reformulations for Added Sugars Declaration
The proposed rule emphasizes the amount of sugar in a product by
requiring a label to declare both the amount of ``Total Sugar'' and
``Added Sugars'' with a Daily Reference Value (DRV) for added sugars of
10 percent of calories.\65\ Manufacturers may decide to reformulate
products in light of these
[[Page 6769]]
new requirements. This model uses IRI data to identify those USDA
regulated products that exceed the proposed DRV for added sugars. Based
on this proposed provision, FSIS regulates roughly 12,080 products
where sugar contributes to more than 10 percent of the calories.
Reformulation costs are based on the formula counts, not individual
product labels. Many of these products have the same formula. For
example, while there is one original Slim Jim formula, there is a
plethora of products, e.g., in different sizes. Therefore, the FDA's
Reformulation Cost Model was used to determine the number of formulas
from the number of products. We found 10,518 formulas associated with
these 12,080 products with high sugar content.
---------------------------------------------------------------------------
\65\ 50 grams for children and adults 4 years of age and older
and 25 grams for children 1 through 3 years of age.
---------------------------------------------------------------------------
FSIS does not estimate that manufacturers would reformulate all
10,518 products because reformulation is voluntary and can be quite
expensive. We assume 7.5 to 9 percent (8.25%) of all formulas with high
sugar content will reformulate, which is consistent with FDA's
assumptions.\66\ Table 7 below summarizes the total formulas that may
reformulate for added sugars.
---------------------------------------------------------------------------
\66\ Regulatory Impact Analysis for Final Rules on ``Food
labeling: Revision of the Nutrition and Supplement Facts Labels''.
Docket No. FDA-2012-N-1210 and ``Food Labeling: Serving Sizes of
Foods that can Reasonably be consumed at One Eating Occasion: Dual-
Column Labeling: Updating, Modifying, and Establishing Certain
Reference Amounts Customarily Consumed; Serving Size for Breath
Mints: and Technical Amendments'' Docket No. FDA-2004-N-0258., page
70, available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM506797.pdf.
Table 7--Total Formulas That May Reformulate for Added Sugars Declaration
----------------------------------------------------------------------------------------------------------------
Branded Branded Branded Private
Complexity formulas (small) (medium) (large) (medium) Total formulas
----------------------------------------------------------------------------------------------------------------
High............................ 93 205 87 213 598
Medium.......................... 83 86 21 51 241
Low............................. 7 8 2 12 29
----------------------------------------------------------------------------------------------------------------
Number of Product Reformulations to Maintain Health and Nutrient
Content Claims
The proposed rule would disqualify some products from bearing a
health or nutrient claim as a result of changes in the RACC categories,
changes in Daily Values for certain vitamins and minerals, and
modifications to the definition of fiber to exclude certain isolated
and synthetic fibers from the definition. As a result, manufacturers of
these products would either have to remove the claim from the product's
label or reformulate in order to continue to make the claim.\67\
---------------------------------------------------------------------------
\67\ To illustrate, consider these examples:
1. Reformulate due to DV change--A Beef Tomato Sauce with 12 mgs
of vitamin C makes a ``High in Vitamin C'' claim since it meets the
claim requirement of 20 percent or more of the Vitamin C RDI per
RACC. By increasing the Vitamin C RDI from 60 mg to 90 mg, the
product can no longer make the claim.
2. Reformulate due to New Fiber definition--A product with
mostly synthetic fiber is making an ``excellent source of fiber''
fiber since certain synthetic and isolated fibers are included in
the fiber definition. By removing some synthetic fibers from the
fiber definition, the product can no longer make the claim.
---------------------------------------------------------------------------
To determine the reformulation cost related to RACC changes, the
Agency used IRI scanner data and identified 62 products with new or
changing RACC categories with a health or nutrient claim (e.g., ``good
source of . . .,'' ``low cholesterol,'' etc.). To determine the
reformulation cost of Daily Value (DV) changes, we used IRI scanner
data and identified 12 products with claims for the proposed vitamins
and mineral DV changes (e.g., ``good source of Vitamin C''). For the
fiber claims, we refined the IRI scanner data and identified 731
products containing a synthetic or isolated fiber with a fiber claim.
As noted above, reformulation costs are by formula counts, not by
individual labels. We used FDA's Reformulation Cost Model to determine
the number of formulas from the number of products. This work
identified 53 formulas for RACC changes, 11 formulas for DV changes,
and 654 formulas for new fiber definition. FSIS assumed that
manufacturers will elect to reformulate 50 percent of their products
and to remove the claim from the other 50 percent. Therefore, 365
formulas will incur reformulation costs: 30 formulas for RACC, 6
formulas for Daily Value and 329 formulas for fiber. The estimates may
vary due to rounding in the business size and complexity categories.
See Table 8 below for summary of the formulas that may reformulate due
to the new fiber definition, or for changes in the Daily Vales or RACC.
Table 8--Total Formulas That May Reformulate for New Fiber Definition, DV, or RACC
----------------------------------------------------------------------------------------------------------------
Branded Branded Branded Private
Complexity formulas (small) (medium) (large) (medium) Total formulas
----------------------------------------------------------------------------------------------------------------
High............................ 56 127 59 103 345
Medium.......................... 4 6 4 6 20
----------------------------------------------------------------------------------------------------------------
Total Reformulation Cost for Sugars Declaration and To Maintain Health
and Nutrient Content Claims
The mean one-time cost for reformulation is $77,294,020, with an
average per formula one-time cost of $77,009. The annualized cost at a
3 percent discount rate over 20 years for reformulation is $6,196,385,
with a range of $2,908,387 to $10,019,460. One-time reformulation costs
are $94,952,165 with a range of $44,567,540 to $153,536,199. See Table
9 below for a summary of the estimated reformulation cost in 2015
dollars.
Table 9--Alternative 2--Reformulation Cost
----------------------------------------------------------------------------------------------------------------
Lower Mid Upper
----------------------------------------------------------------------------------------------------------------
High Complexity Formulas........................................ $36,295,355 $77,294,020 $124,785,011
[[Page 6770]]
Med Complexity Formulas......................................... 7,488,995 15,983,483 25,998,357
Low Complexity Formulas......................................... 783,190 1,674,662 2,752,831
-----------------------------------------------
Total Cost.................................................. 44,567,540 94,952,165 153,536,199
Annualized Cost (3% DR, 20 Year)................................ 2,908,387 6,196,385 10,019,460
Annualized Cost (7% DR, 20 Year)................................ 3,931,645 8,376,460 13,544,608
Average Per formula one time cost............................... 36,146 77,009 124,522
Per formula Annualized Cost (3% DR, 20 Year).................... 2,359 5,025 8,126
Per formula Annualized Cost (7% DR, 20 Year).................... 3,189 6,794 10,985
----------------------------------------------------------------------------------------------------------------
Quantitative Benefits of the Proposed Rule
By ensuring that recommendations are based on current dietary
guidelines and making the most salient information prominent, the
proposed rule will benefit the nearly 186 million Americans who
frequently or sometimes use nutritional facts and serving size labels.
However, this Preliminary Regulatory Impact Analysis (PRIA) limits the
quantitative benefits to the medical costs savings for overweight or
hypertensive adults who report not using or rarely using Nutrition
Facts labels that are expected to experience health benefits with
increased label use and modified diet. The annual present value of
benefits at a 3 percent discount rate over 20 years is estimated at
$36,894,007. A detailed description of this analysis follows.
As noted in the Need for Rule section above, a significant portion
of U.S. citizens are overweight, obese, or hypertensive. Such
conditions afflict individuals and society with poorer health and
higher medical expenditures. It is well established that improved
nutrition reduces overweight, obesity, and hypertension rates, which in
turn reduces medical expenses.\68\ Based on the NHANES analysis, using
and understanding the Nutrition Facts label is linked to healthier
diets. If finalized, this proposed rule will improve nutritional labels
by updating and simplifying the information found on them. The
frequency of label usage will increase as improved, and simpler to
understand information will be available to the consumer, which will,
in turn, promote consumption of healthier diets, e.g., lower caloric or
sodium consumption.
---------------------------------------------------------------------------
\68\ Campos, A., J. Doxey, and D. Hammond. 2011. Nutrition
labels on pre-packaged foods: a systematic review. Public Health
Nutrition. 14: 1496-1506;, Dall, T.M., V.L. Fulgoni III, Y. Zhang,
K.J. Reimers, P.T. Packard, and J.D. Astwood. 2009. Potential health
benefits and medical cost savings from calorie, sodium, and
saturated fat reductions in the American diet. American Journal of
Health Promotion. 23: 412-422;, Mokdad, A.H., J.S. Marks, D.F.
Stroup, and J.L. Gerberdin. 2004. Actual causes of death in the
U.S., 2000. American Medical Association. 291: 1238-1245; and Young,
L.R. and M. Nestle. 2002. The contribution of expanding portion
sizes to the US obesity epidemic. American Journal of Public Health.
83: 717-724.
---------------------------------------------------------------------------
In this analysis, quantified benefits are a measure of expected
health improvements resulting from increased label-use, causing diet
modification for some overweight and hypertensive adults. The benefits
analysis can be broken down into a series of steps. The first step is
determining the baseline caloric and sodium intake for consumers by
label-use. The second step is estimating the number of consumers who
could potentially change their behavior from increased label-use
because of this rule. The third step is estimating the change in diet
from increased label-use. The final step is measuring the medical cost
savings benefit using the Dall et al. (2009), Nutrition Impact Model,
which links the health benefits and medical cost savings from
reductions in caloric and sodium intake. A description of each step in
the benefits analysis is given in this section.
Benefits Analysis: Baseline Caloric and Sodium Intake for Consumers by
Label-Use
The first step in this analysis is to determine the baseline
relationship between caloric and sodium intake with label-use. To
determine this relationship, FSIS used NHANES data to correlate use of
nutritional and serving size labels with caloric and sodium intake.
NHANES is a continuous CDC survey with data released in two-year
segments. This analysis included data from the 2009-2010 survey. NHANES
collects detailed information through questionnaires, dietary recall,
and a physical exam. In the Flexible Consumer Behavior Survey (FCBS)
section of NHANES, respondents provided information on how frequently
they used nutritional and serving size information found on food
labels. Also, respondents who reported rarely or never using labels
provided reasons for not doing so.
In the dietary recall component, respondents report everything they
ate or drank, and where the food was obtained, for two days (two 24
hour periods). Food obtained from a store or catalog was identified as
food at home (FAH). This analysis excluded calories consumed away from
home, as these foods typically do not include a Nutrition Facts label.
Weights were applied to the dataset to account for the survey design
(including oversampling of certain groups), survey non-response, and
post stratification so that the population totals represent the U.S.
Census civilian non-institutionalized adult population.
The baseline links degree of label use, ranging from always to
never, with average caloric, sugar and sodium intake, Table 1--Use of
Nutritional Facts Label by Average Daily Caloric, Sodium and Sugar
Intake from Food at Home. While data limitations prevent establishing
causation between label use and behavior, the two are inversely
correlated. Revealed in Table 1--Use of Nutritional Facts Label by
Average Daily Caloric, Sodium and Sugar Intake from Food at Home,
Nutrition Facts label use has an inverse relationship with total
caloric, sugar and sodium intake. Based on this information, this
analysis assumes if an average consumer who ``never'' used the
Nutrition Facts label began to rarely read labels, they would reduce
their daily caloric intake by 187 kcals. For most overweight or obese
individuals, a stable daily reduction of 187 kcals would lead to weight
loss and corresponding reductions in medical expenditures.\69\ Like
caloric and sodium intake, sugar consumption is greater for
[[Page 6771]]
individuals that use nutrition information less.
---------------------------------------------------------------------------
\69\ Dall et al. 2009--``With the 100-kcal reduction, for
example, the number of obese adults would decline by more than 34
million. Many obese adults would move into the overweight category,
with a net decrease of overweight adults of close to 37 million . .
. The prevalence of chronic conditions associated with excess weight
would decline such that national medical expenditures would be
approximately $58 billion lower than current spending levels.''
---------------------------------------------------------------------------
Further, we find as nutritional label usage increases, not only is
the average caloric intake reduced, but also the portion of calories
from sugar is reduced. For consumers that ``never'' use the Nutrition
Facts label, calories from sugar account for 27 percent of their total
at home consumption.\70\ In contrast, for consumers that most
frequently use the Nutrition Facts label, calories from sugar account
for 23 percent of their total at home consumption.\71\ Overall, the
less an individual uses nutritional information, the more sugar
accounts for total caloric intake.
---------------------------------------------------------------------------
\70\ Per Table 1--Use of Nutritional Facts Label by Average
Daily Caloric, Sodium and Sugar Intake from Food at Home, consumers
that ``never'' use the Nutrition Facts panel consume 1,741 kcal and
122 grams of sugar from foods at home each day. A gram of sugar =
3.87 calories. ((122mg*3.87)/1,741)
\71\ Per Table 1--Use of Nutritional Facts Label by Average
Daily Caloric, Sodium and Sugar Intake from Food at Home, consumers
that ``Always or Most of the Time'' use the Nutrition Facts panel
consume 1,439 kcal and 85 grams of sugar from foods at home each
day. A gram of sugar = 3.87 calories. ((85mg*3.87)/1,439)
---------------------------------------------------------------------------
Benefits Analysis: Estimating the Number of Consumers Who Will
Potentially Change Their Behavior
This study monetizes the health benefits derived from adults:
--Who report rarely or never reading Nutrition Facts labels;
--Who are overweight or hypertensive;
--Whose reasons for not reading labels will be addressed by the
proposed rule;
--Who are expected to change their behavior.
For caloric reduction benefits, we only include overweight
individuals who are maintaining or losing weight. This is because the
Nutrition Impact Model assumed that all overweight adults are at weight
equilibrium and not gaining weight. The overweight and gaining weight
adults may not experience weight loss from a small reduction in caloric
intake and therefore will not obtain the medical cost savings from
weight loss as calculated in the Nutrition Impact Model. The caloric
reduction benefits from the model is calculated by a constant reduction
in caloric intake below the Estimated Energy Requirement \72\ (EER)
(i.e. a level of caloric intake below that required to maintain current
body weight) for a given weight, age, height and gender and physical
activity level (PAL) for overweight adults. It takes about four years
until a new weight equilibrium is reached where the EER equals the new
daily caloric intake. Utilizing NHANES dietary recall data, most adults
(72.8 percent \73\) are consuming at or below their EER. Although
NHANES dietary recall data is self-reported and individuals, especially
overweight or obese individuals, sometimes underreport caloric intake
in these types of surveys 74 75, the dietary recall
component of NHANES is used in reporting for the Dietary Guidelines for
Americans and many other official government documents. Also, this
finding is consistent with recent reports in which prevalence of
obesity and overweight have stabilized and in some population groups
have reduced in recent years.76 77 Therefore, this analysis
measures the benefit of caloric reduction among overweight adult
consumers maintaining or losing weight.
---------------------------------------------------------------------------
\72\ For adult males: EER = 662 - (9.53 x age) + PAL x (15.91 x
weight + 539.6 x height);
For adult females: EER = 354 - (6.91 x age) + PAL x (9.36 x
weight + 726 x height).
\73\ The IOM PAL (1.11 for men and 1.12 for women) associated
with low physical activity was utilized in estimating individuals
EER. All other components of the IOM EER calculation (gender, age,
weight, height) were derived from NHANES 2009-2010.
\74\ Archer E, Hand GA, Blair SN (2013) Correction: Validity of
U.S. Nutritional Surveillance: National Health and Nutrition
Examination Survey Caloric Energy Intake Data, 1971-2010. PLoS ONE
8(10): http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0076632.
\75\ Champagne C, et al, (2002) Energy Intake and Energy
Expenditure: A controlled Study Comparing Dietitians and Non-
dietitians, Journal of the American Dietetic Association, Available
at: http://www.sciencedirect.com/science/article/pii/S0002822302903160.
\76\ Ogden C.L., Carroll M.D., Kit B.K., Flegal K.M. Prevalence
of obesity in the United States, 2009-2010. NCHS data brief, no 82.
Hyattsville, MD: National Center for Health Statistics. 2012.
\77\ Flegal K.M., Carroll M.D., Kit B.K., Ogden C.L. Prevalence
of Obesity and Trends in the Distribution of Body Mass Index Among
U.S. Adults, 1999-2010. JAMA. 2012;307(5):491-497. doi:10.1001/
jama.2012.39.
---------------------------------------------------------------------------
NHANES data identified the number of overweight adults who are
maintaining or losing weight that never or rarely use labels, Table 8.
An overweight adult maintaining or losing weight has a Body Mass Index
(BMI) of 25 or over, aged 16 years or older and consumes calories equal
to or less than their Estimated Energy Requirement, EER.\78\ Based on
NHANES data, 60 percent (9,501,972) of users who never read labels are
either overweight or obese. Conversely, 64 percent (21,611,037) of
label-users who rarely read labels are overweight or obese, Table 11.
To find the number of overweight individuals maintaining or losing
weight, we relied on NHANES data and the Institute of Medicine (IOM)
EER calculation. Below are the IOM calculations:
---------------------------------------------------------------------------
\78\ For adult males: EER = 662 - (9.53 x age) + PAL x (15.91 x
weight + 539.6 x height);
For adult females: EER = 354 - (6.91 x age) + PAL x (9.36 x
weight + 726 x height).
---------------------------------------------------------------------------
For adult males:
EER = 662 - (9.53 x age) + PAL x (15.91 x weight + 539.6 x height)
For adult females:
EER = 354 - (6.91 x age) + PAL x (9.36 x weight + 726 x height)
For a conservative estimate, the IOM PAL coefficient associated
with sedentary activity estimated individuals EER (1.0 for men and
women). All other components of the IOM EER calculation (gender, age,
weight, height) were derived from NHANES 2009-2010 and calculated using
SAS.\79\ The overweight individuals with a kcal intake at or less than
their EER are maintaining or losing weight. The analysis found
approximately 57.5 percent of these overweight rarely label-users are
maintaining or losing weight, while 55.7 percent of overweight never
label-users are maintaining or losing weight. In total, there are
12,428,680 rarely label-users and 5,293,397 never label-users that are
overweight and maintaining or losing weight, Table 11.
---------------------------------------------------------------------------
\79\ SAS version 9.2 Cary, NC, 2011 http://www.sas.com/technologies/analytics/statistics/stat/index.html.
---------------------------------------------------------------------------
Although the same person can experience health costs savings from
both caloric and sodium reduction, it may overestimate benefits if
using both the caloric and sodium reduction models. Therefore, to avoid
double counting for the sodium reduction benefits, the analysis
excluded the population benefiting from caloric reduction, overweight
rarely and never label-users maintaining or losing weight. The sodium
reduction analysis only includes hypertensive individuals who are
normal weight or overweight and gaining weight. An estimated 461,384
and 118,705 normal weight hypertensive adults rarely or never use
labels, respectively. In addition, an estimated 563,394 rarely and
551,856 never adult label-users are overweight and gaining weight with
hypertension. In total, there are 1,024,778 rarely and 670,561 never
hypertensive label-users who are normal weight or overweight and
gaining weight, Table 12.
While the proposed changes will help many normal weight, non-
hypertensive consumers use labels to maintain healthy diets, this
analysis does not quantify these benefits.
Identifying the reasons overweight or hypertensive consumers do not
read nutritional and serving size information is another important
factor in estimating
[[Page 6772]]
increased label use. NHANES respondents that rarely or never read
nutrition information were able to select multiple reasons for not
reading labels. Responses provided for not reading labels were mixed,
Table 10. Many of the reasons for not reading labels are not addressed
by this proposed rule and will not lead to increased label use: i.e.
``I can't read English well'' or ``I usually buy food that I'm used to,
so I don't feel the need to check labels.'' The proposed rule is
intended to make the most important information more prominent and the
entire label quicker to read, reducing the time spent gathering
information on the label. As such, only those overweight or
hypertensive consumers who exclusively selected a combination of ``the
print is too small,'' ``I won't know what to look for,'' and ``I don't
have time'' reasons for not reading labels were considered in the mid-
point benefits estimate. That group constitutes approximately 10
percent. Of this group, approximately 1 percent exclusively replied
``the print is too small,'' approximately 2 percent exclusively replied
``I won't know what to look for,'' approximately 3 percent exclusively
replied ``I don't have time,'' and approximately 4 percent gave a
combination of these reasons for not using labels, Table 10. Excluded
from the mid-point benefits estimate were consumers who reported not
using labels because for a variety of reasons, they expressed little to
no interest in the information, or because they could not read English.
As such, this analysis assumes that only 10 percent of overweight/
hypertensive rarely/never users will increase their label use as a mid-
point estimate, Table 11 and 12.
For the lower bound estimate, only those overweight or hypertensive
consumers who exclusively gave ``the print is too small for me to
read'' reason for not reading labels were considered (1 percent) as
print size is directly changed by the regulation. The lower bound
estimate excludes everyone who did not exclusively give ``the print is
too small for me to read'' as a reason for not reading labels, 99
percent of consumers.
For the upper bound estimate, only those overweight or hypertensive
consumers who selected one or more of the following reasons for not
reading labels were considered: ``the print is too small,'' ``I won't
know what to look for,'' and ``I don't have time''. This group
constitutes approximately 44 percent. The upper bound estimate includes
consumers who gave the three above reasons and does not exclude anyone
if they gave other reasons for not using labels.
Table 10--Reasons Overweight Rarely and Never Users Do Not Use Labels
----------------------------------------------------------------------------------------------------------------
Total
Exclusive responses from
Total response Exclusive group, no exclusive
Reasons for not reading labels with overlap response \2\ overlap \3\ group w/
\1\ (%) (%) (%) overlap \4\
(%)
----------------------------------------------------------------------------------------------------------------
Targeted Population
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr---------------------------------------------------------------
The print is too small for me to read........... 16 1 10 44
I won't know what to look for even if I read the 20 2
labels.........................................
I don't have time............................... 24 3
----------------------------------------------------------------------------------------------------------------
Other
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr---------------------------------------------------------------
I usually buy foods that I'm used to, so I don't 53 7
feel that I need to check labels...............
I buy what I or my family like, I don't care 51 5
about the labels...............................
I have a good diet so there is no need to check. 12 1
I'm satisfied with my health so there is no need 25 2
for me to check................................
I don't think food labels are important to me... 15 2
I can't read English well....................... 8 2
Other/Refused/Don't know........................ 14 8
----------------------------------------------------------------------------------------------------------------
\1\ Total Response with Overlap includes the percentage of NHANES respondents who gave this reason for rarely
or never using food labels.
\2\ Exclusive Response includes the percentage of respondents who only gave this reason for rarely or never
using food labels. The lower-bound estimate is 1% for consumers who exclusively gave ``the print is too small
for me to read'' reason.
\3\ Exclusive Group No Overlap includes the percentage of NHANES respondents who only gave some combination of 3
reasons that are addressed by the rule: ``The Print is too small for me to read,'' ``I won't know what to look
for even if I read the labels'' and or ``I don't have time''. This is the mid-point estimate.
\4\ Total Responses from Exclusive Group with Overlap includes the percentage of NHANES respondents who gave
some combination of 3 reasons that are addressed by the rule: ``The Print is too small for me to read,'' ``I
won't know what to look for'' and ``I don't have time''. This is the upper-bound estimate.
Source: NHANES. 2013. ``Questionnaires, Datasets, and Related Documentation'' Centers for Disease Control and
Prevention. Accessed on 1/23/2014. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.
Increasing label use does not necessarily lead to a change in
behavior. Our analysis further refines the benefits analysis by
estimating only a portion of the overweight or hypertensive rarely/
never label-users increasing their label use will potentially change
their diet. This estimate was derived from data in the FDA 2008 Health
and Diet Survey. In 2008, FDA asked consumers ``In the last two weeks,
can you remember an instance where your decision to buy or use a food
product was changed because you read the nutrition label?'' and 49
percent of respondents said yes.\80\ As such, this analysis assumes
only 49 percent of overweight/hypertensive consumers who increase label
use will potentially change their behavior, Table 11 and 12. As a mid-
point estimate, there are 868,382 overweight users maintaining or
losing weight that could potentially increase label use and reduce
their caloric intake (1,772,208 * 49%). This estimate ranges from
86,838 (177,221 * 49%) to 3,820,880 (7,797,714 * 49%) for the lower and
upper bound, Table 11. As a mid-point estimate, there
[[Page 6773]]
are 83,072 hypertensive normal weight or overweight and gaining weight
individuals that could potentially increase their label use and reduce
their sodium intake (169,534 * 49%). This estimate ranges from 8,307
(16,953 * 49%) to 365,515 (745,949 * 49%) for the lower and upper
bound, Table 12.
---------------------------------------------------------------------------
\80\ Choiniere, C.J. and A. Lando. 2008. ``FDA 2008 Health and
Diet Survey--Consumer Behavior Research'' Accessed on 5/6/2014.
<http://www.fda.gov/Food/FoodScienceResearch/ConsumerBehaviorResearch/ucm193895.htm.
Table 11--Calculating the Targeted Population for Caloric Reduction Benefits
----------------------------------------------------------------------------------------------------------------
Rarely Never Totals
----------------------------------------------------------------------------------------------------------------
Start with all users............................................ 33,653,297 15,807,324 49,460,621
Reduce to only:
Overweight Users............................................ 21,611,037 9,501,972 31,113,009
Overweight users maintaining or losing weight............... 12,428,680 5,293,397 17,722,077
Lower bound population (1% of users)............................ 124,287 52,934 177,221
Mid-point population (10% of users)............................. 1,242,868 529,340 1,772,208
Upper bound population (44% of users)........................... 5,468,619 2,329,095 7,797,714
Lower bound population expected to change behavior (49% of lower 60,901 25,938 86,838
bound pop.)....................................................
Mid-point population expected to change behavior (49% of mid- 609,005 259,376 868,382
point pop.)....................................................
Upper bound population expected to change behavior (49% of upper 2,679,623 1,141,257 3,820,880
bound pop.)....................................................
----------------------------------------------------------------------------------------------------------------
Source: NHANES. 2013. ``Questionnaires, Datasets, and Related Documentation'' Centers for Disease Control and
Prevention. Accessed on 1/23/2014. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.
Table 12--Calculating the Targeted Population for Sodium Reduction Benefits
----------------------------------------------------------------------------------------------------------------
Rarely Never Totals
----------------------------------------------------------------------------------------------------------------
Start with all users............................................ 33,653,297 15,807,324 49,460,621
Reduce to only hypertensive users:
Normal weight............................................... 461,384 118,705 580,089
Overweight and gaining weight............................... 563,394 551,856 1,115,250
Total hypertensive normal weight or overweight and gaining 1,024,778 670,561 1,695,339
weight.........................................................
Lower bound population (1% of users)............................ 10,248 6,706 16,953
Target Population (10% of users)................................ 102,478 67,056 169,534
Upper bound population (44% of users)........................... 450,902 295,047 745,949
Lower bound population expected to change behavior (49% of lower 5,022 3,286 8,307
bound pop.)....................................................
Mid-point population expected to change behavior (49% of mid- 50,214 32,857 83,072
point pop.)....................................................
Upper bound population expected to change behavior (49% of upper 220,942 144,573 365,515
bound pop.)....................................................
----------------------------------------------------------------------------------------------------------------
Source: NHANES. 2013. ``Questionnaires, Datasets, and Related Documentation'' Centers for Disease Control and
Prevention. Accessed on 1/23/2014. http://www.cdc.gov/nchs/nhanes/nhanes_questionnaires.htm.
Benefits Analysis: Estimating Changes in Diet
FSIS assumed that the population expected to change its behavior
will do so by moderately increasing its label-use from either never to
rarely or rarely to sometimes. The expected diet change is the
difference in caloric and sodium intake between each user group.
Accordingly, the mid-point estimate of 259,376 overweight consumers who
never use the Nutrition Facts label could potentially begin to rarely
use labels and reduce their daily caloric intake by 187 kcals (1,741-
1,554). The mid-point estimate of 609,005 overweight consumers who
rarely use the Nutrition Facts label could potentially begin to use
labels sometimes and reduce their caloric intake by 92 kcal (1,554-
1,462). The same formula is followed for the normal weight consumers
with hypertension resulting in a 87 mg daily sodium reduction for the
32,857 former never label-users and 104 mg reduction for 50,214 former
rarely label-users.
Benefits Analysis: Estimate the Economic Benefits of Caloric and Sodium
Reduction
To quantify the medical cost savings from reductions in caloric and
sodium intake, FSIS used the Nutrition Impact Model developed by Tim
Dall et al. (2009). The Nutrition Impact Model estimates the potential
health benefits of weight loss by reducing daily caloric intake for
overweight adults.
The Nutrition Impact Model also estimates the benefits of sodium
reduction in adults with hypertension. The model combines these
benefits to estimate national medical costs savings from changes in
dietary habits among the general adult population. The model concludes
modest to aggressive changes in diet can improve health and reduce
annual national medical expenditures by $60 to $120 billion.
The Nutrition Impact Model used scientific reports and peer-
reviewed literature to quantify the relationships between dietary
change, body mass index, and blood pressure (Systolic BP/Diastolic BP)
and between these same factors and disease risk. By modeling the
reduction in health conditions associated with long-term improved
nutritional intake, the model can measure the potential health
conditions averted by reducing daily caloric and sodium intake in the
American diet. For example, weight loss can improve or prevent many
diseases risks such as cancer and diabetes, resulting in a medical
savings. The benefits of caloric reductions in overweight adults is
measured by the medical savings of reductions in the following health
conditions; arthritis, asthma, cancer, cerebrovascular disease,
congestive heart failure, coronary heart disease, diabetes, esophagus/
stomach disease, gallbladder disease, gynecological conditions, kidney/
urinary disease, other cardiovascular disease, and sleep apnea. The
benefits of sodium reductions are measured by the medical savings of
reductions in hypertension cases. Some health conditions are jointly
attributed to multiple risk factors.
Caloric Reduction Benefits
For caloric reductions benefits, the Nutrition Impact Model begins
to calculate the benefits starting in the fourth year of diet as weight
loss is more
[[Page 6774]]
significant in the first few years then stabilizes in year four with
little additional weight loss. As discussed in the Nutrition Impact
Model, if the total overweight and obese population (139 million people
in 2007) reduced their daily caloric intake by 100 kcal, many obese
adults would move into the overweight category while many overweight
adults would move into the normal weight category. In turn, the
prevalence of chronic health conditions associated with excess weight
would be reduced. There would be 1.7 million fewer cases of coronary
heart disease and 1.5 million fewer cases of type 2 diabetes in a given
year. Overall, a 100 kcal reduction in the diets of all U.S. overweight
adults (139 million) will lead to $58.4 billion in national medical
costs savings annually, or $420 ($58.4B/139M) per overweight adult
after a period of four years. Also, the Nutrition Impact Model
concludes that if the overweight and obese population reduced its daily
caloric intake by 500-kcal, almost the entire U.S. adult population
would stabilize at normal weight levels with national medical savings
at $110.5 billion, or $795 per overweight person.
As displayed in Table 13, our analysis expects potentially 259,376
overweight adults to reduce their total caloric intake by 187 kcal and
609,005 adults to reduce their total caloric intake by 92 kcal as the
mid-point estimate. The Nutrition Impact Model estimates a 92 kcal
reduction could potentially result in $55 billion of annual medical
savings after 4 years or $395.68 ($55B/139M) dollars per person. For a
187 kcal reduction, the potential annual medical savings is $84 billion
or $575.54 ($84B/139M) per person after four years. Table 13 provides
details of the distribution of increased label users, associated
reductions in calories, and potential savings.
Recognizing that individuals will benefit from both improved FDA
and FSIS labels, this analysis took additional steps to distill out
benefits specific to FSIS products with Nutrition Facts labeling.
First, our analysis scaled down the estimate by only including the
average caloric and sodium intake of FSIS products for adults. Using
Table 1B--Mean Intake of Energy and Mean Contribution (KCAL) of Various
Foods among U.S. Population by Age from the National Cancer
Institute,\81\ we estimate about 397 of the 2,199 daily calorie
consumption (18.1 percent) from adults are derived from USDA products
affected by this rulemaking.\82\ These products include all chicken and
chicken mixed dishes, beef and beef mixed dishes, burgers, sausages,
franks, bacon and ribs and some pizzas, pasta dishes, and eggs and egg
mixed dishes.
---------------------------------------------------------------------------
\81\ Sources of Energy among the U.S. Population, 2005-06.
Applied Research Program Web site. National Cancer Institute. http://appliedresearch.cancer.gov/diet/foodsources/energy/. Table 1B.
Updated April 11, 2014. Accessed June 21, 2014.
\82\ FDA estimated 353 of 2,157 calories (16.4 percent) an
average American consumes daily come from USDA products in FDAs
Nutrition Facts/Serving Sizes Combined PRIA. This differs from our
estimate by age, group and food product category. FDA used the
average kcal intake for all age groups, including children (2,157)
and our estimate used the average kcal for adults age 19 plus
(2,199). Also, we assumed half of pizzas and pasta dishes were USDA
products and FDA did not. FDA included cold cuts, which was not
included in the 30 most common food groups in adult diets.
---------------------------------------------------------------------------
In addition, although the analysis only incorporates sodium and
caloric intake from food at home, some meat and poultry products are
exempt from nutrition labeling, and therefore removed from the benefits
analysis. As discussed in the cost section above, we estimate
approximately 11.95 percent (30.64% * 39%) of food-at-home meat and
poultry products are exempt from nutrition labeling. Therefore, our
analysis further scales back the benefits estimate first by removing
81.9 percent for the kcal intake of FDA products and second by removing
11.95 percent for the FSIS products exempt from nutrition labeling.
This results in the mid-point annual benefits of $79,173,871 (496M *
(100% - 81.9%) * (100% - 11.95%)) for caloric reduction. The lower
bound estimate is $7,917,474 and upper bound estimate is $348,365,416,
Table 13.
Table 13--Annual Medical Savings from Reducing Caloric Intake [supcaret]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lower bound Mid-point
Lower bound Mid-point Upper bound Potential total total Upper bound total
User type number of number of number of savings per potential potential potential savings
users users users person savings savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sometimes..................................... 60,901 609,005 2,679,623 $395.68 $24,097,308 $240,971,098 $1,060,273,229
Rarely........................................ 25,938 259,376 1,141,257 575.54 14,928,357 149,281,263 656,839,054
---------------------------------------------------------------------------------------------------------
Annual benefits after 4 years ($ 2007)........ ........... ........... ........... ........... 39,025,665 390,252,361 1,717,112,283
Annual benefits after 4 years ($ 2015) *...... ........... ........... ........... ........... 49,679,672 496,791,256 2,185,883,936
Benefits from USDA products ($ 2015).......... ........... ........... ........... ........... 7,917,474 79,173,871 348,365,416
--------------------------------------------------------------------------------------------------------------------------------------------------------
[supcaret] It is expected to take 4 years for the medical benefits from a reduction in calories to be experienced.
\2\ CPI-U for Medical Care of 1.273% was used to adjust for inflation (2007-2015).
Sodium Reduction Benefits
While the benefits of caloric reduction weight-loss are measured at
year four in the Nutrition Impact Model, sodium reduction benefits are
experienced right away. In most individuals, blood pressure is reduced
within days to weeks of reducing sodium intake.\83\ Therefore, the
potential benefits are estimated in the first year for increased label
use for adults with hypertension. The Nutrition Impact Model estimates
1.5 million fewer cases of hypertension with a potential annual savings
of $2.3 billion if adults with hypertension reduced their daily sodium
intake by 400 mg.
---------------------------------------------------------------------------
\83\ He F.J., Li J., and G.A. MacGregor. 2013. Effect of longer-
term modest salt reduction on blood pressure. Cochrane Database of
Systematic Reviews. Issue 4. Art. No,: CD004937. DOI: 10.1002/
14651858.CD004937. pub2.
---------------------------------------------------------------------------
As displayed in Table 14, our mid-point estimate expects 32,857
adults with hypertension to reduce their sodium intake by 87 mg for
food at home, and 50,214 adults with hypertension to reduce their
sodium intake by 104 mg for food at home. The Nutrition Impact Model
estimates a 104 mg daily sodium reduction for all adults with
hypertension results in $1.17B dollars of annual medical savings, or
$27.86 ($1.17B/42M) dollars per person. For an 87 mg daily sodium
reduction for all adults with hypertension, the potential annual
medical savings are $1.11B, or $26.43 ($1.11B/42M) per person.
As calculated with the caloric benefits, our analysis scaled down
the estimate for sodium reduction benefits by only incorporating the
average sodium intake of FSIS products with labeling for adults. Using
Table 1B--Mean Intake of Sodium, Mean Intake of Energy, and Mean Sodium
Contribution
[[Page 6775]]
(mg) of Various Foods Among US Population, by Age, NHANES 2005-06,\84\
we estimate about 965 of the 3,535 daily sodium consumption (27.3%
percent) from adults are derived from USDA products. These products
include all chicken and chicken mixed dishes, beef and beef mixed
dishes, burgers, cold cuts, sausages, franks, bacon and ribs and some
pizzas, pasta dishes, and eggs and egg mixed dishes.
---------------------------------------------------------------------------
\84\ Sources of Energy among the U.S. Population, 2005-06.
Applied Research Program Web site. National Cancer Institute. http://appliedresearch.cancer.gov/diet/foodsources/energy/. Table 1B.
Updated April 11, 2014. Accessed June 21, 2014.
---------------------------------------------------------------------------
In addition, as discussed in the caloric reduction benefits section
above, we scaled back the potential benefits by 11.95 percent for the
food-at-home FSIS products that are exempt from nutrition labeling.
Overall, our benefits estimate scales back the benefits by removing
72.7 percent for the sodium intake of FDA products and removing 11.95
percent for the FSIS products exempt from nutrition labeling, resulting
in the mid-point annual benefits estimate of $693,815 ($2.9M*(100%-
72.7%) * (100%-11.95%)) for sodium reduction. The lower bound estimate
is $69,389 and upper bound estimate is $3,052,804, Table 14.
Table 14--Annual Medical Savings from Reducing Sodium Intake [supcaret]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Lower bound Mid-point Upper bound
Lower bound Mid-point Upper bound Potential total total total
User type number of number of number of savings per potential potential potential
users users users person savings savings savings
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sometimes.............................................. 5,022 50,214 220,942 $27.86 $139,913 $1,398,962 $6,155,444
Rarely................................................. 3,286 32,857 144,573 26.43 86,849 868,411 3,821,064
Annual benefits after 4 years ($ 2007)................. ........... ........... ........... ........... 226,762 2,267,373 9,976,508
Annual benefits after 4 years ($ 2015) *........... ........... ........... ........... ........... 288,668 2,886,366 12,700,095
Benefits from USDA products ($ 2015)............... ........... ........... ........... ........... 69,389 693,815 3,052,804
--------------------------------------------------------------------------------------------------------------------------------------------------------
[supcaret] It is expected to take 4 years for the medical benefits from a reduction in calories to be experienced.
\2\ CPI-U for Medical Care of 1.273% was used to adjust for inflation (2007-2015).
Summary of Potential Benefits Over 20 Years With a 24 Month Compliance
Period for Large and 36 Month Compliance Period for Small Businesses
The welfare gains from caloric and sodium reduction estimated above
reflect the full annual potential impact of the regulation without
adjusting for the potential lag between reaching a particular weight
and experiencing the associated health outcomes and medical cost
savings. However, industry would need time to modify labels under the
new regulations. Table 15 uses the FDA Cost Label model \85\ to
estimate the frequency of label changes in twelve-month increments. As
shown in Table 4--Label Changes That Can Be Coordinated with a Planned
Change, only 10 percent of all labels will be updated by the end of the
first year and 82 percent by the end of the second year. After 24
months, all large manufacturers are in compliance and 82 percent of
small businesses are in compliance. Based on IRI scanner data and SBA
small business standards, 53.6 percent of FSIS labels are from small
businesses and 46.4 percent are from Large. Therefore, after 24 months,
90.35 percent of FSIS's Nutrition Facts labels are updated ((100% of
Large * 46.4% of labels) + (82% of Small * 53.6% of Labels)). After 36
months, 100 percent of FSIS's nutrition facts labels are updated.
---------------------------------------------------------------------------
\85\ RTI International. ``2014 FDA Labeling Cost Model.''
Prepared by Mary K. Muth, Samantha Bradley, Jenna Brophy, Kristen
Capogrossi, Michaela C. Coglaiti, and Shawn A. Karns. Contract No.
HHSF-223-2011-10005B, Task Order 20, August 2015.
---------------------------------------------------------------------------
To arrive at the present value estimate of potential benefits, FSIS
multiplied the percentage of label changes in each 12 month period by
the annual potential benefits estimate. The percentage of label changes
estimates the percentage of updated labels at a given time: 10 percent
after 12 months, 90.35 percent after 24 months, and 100 percent after
36 or more months. Again, the Nutrition Impact Model estimates benefits
immediately for reductions in sodium intake and at year four for
reductions in caloric intake. Therefore, benefits for caloric reduction
start four years after the labels update while benefits for sodium
reduction are realized as the labels are updated. For example, as is
shown in Table 4--Label Changes That Can Be Coordinated with a Planned
Change, 12 months after publication of the final rule, an estimated 10
percent of FSIS labels are changed, resulting in 10 percent of the
annual sodium benefits and no quantified benefits for the caloric
intake reductions. After 24 months, 90.35 percent of Nutrition Facts
labels are updated, resulting in 90.35 percent of the annual sodium
benefits and no quantified benefits for the caloric intake reductions.
The benefits in year 6 are a product of 100 percent of the sodium
reduction benefits and 10 percent of the caloric reduction benefits as
four years have passed since 10 percent of the labels were updated. Not
until year seven are the full annual sodium and caloric reduction mid-
point benefits without latency applied.
FSIS could not determine the weight-level-to-health outcome latency
for each health condition included in the Nutrition Impact Model. But,
to try and account for this latency, FSIS assumed a uniform health
impacts time pattern between present age and age 80 and a uniform age
distribution between age 18 and 79 to determine weighting factors that
could be applied to the benefits estimates from the Nutrition Impact
Model to calculate the present and annualized benefits. FSIS multiplied
average weighting factors of 0.665 (3 percent discount rate) and 0.458
(7 percent discount rate) by the present value annual benefit from
caloric and sodium reduction to estimate the total annual health impact
for each year. FSIS is requesting comment on accounting for latency
between weight change and health outcomes.
The mid-point present value, discounted at 3 percent rate is $549
million and $239 million with a 7 percent discount rate. The mid-point
annual benefit is $37 million at a 3 percent discount rate and $23
million at 7 percent. The lower bound estimate is $3,689,445 and upper
bound estimate is $162,333,818 at a 3 percent discount rate, Table 15.
[[Page 6776]]
Table 15--Present Value of Benefits Over 20 Years Given a 24 Month Compliance Period for Large and 36 Month
Compliance Period for Small Businesses
----------------------------------------------------------------------------------------------------------------
Mid-point
Lower bound benefits from Upper bound
Year benefits from caloric and benefits from
caloric and sodium caloric and
sodium reduction reductions sodium reduction
----------------------------------------------------------------------------------------------------------------
NPV 3%.................................................... $54,889,631 $548,889,659 $2,415,117,294
NPV 7%.................................................... 23,880,540 238,802,476 1,050,732,115
Annual PV 3%.............................................. 3,689,445 36,894,007 162,333,818
Annual PV 7%.............................................. 2,254,154 22,541,264 99,181,679
----------------------------------------------------------------------------------------------------------------
Uncertainty in the Quantitative Benefits Analysis
The ramifications of the proposed rule are not expected to have a
significant impact on the food market. As a mid-point estimate, we
estimate potentially 609,005 adults would potentially reduce their
caloric intake by 92 kcals, and 259,376 adults will potentially reduce
their caloric intake by 187 kcals for FDA and FSIS regulated products.
Additionally, as a mid-point estimate, we estimate potentially 50,214
adults would potentially reduce their sodium intake by 104 mg and
32,857 adults would potentially reduce sodium intake by 87 mg for FDA
and FSIS regulated products. Only a small portion of the caloric and
sodium intake are from meat or poultry products as only 18 percent of
all caloric intake is from FSIS products. Further still, this small
change in diet may lead to increased consumption of lower calorie or
lower sodium products, including food products reformulated in response
to the changes on the label. Therefore, we estimate the market impact
will distribute across all food markets with minimal impact on meat and
poultry markets. The benefits analysis for the proposed rule may
underestimate the full consumer welfare gain for several reasons. This
analysis only includes the potential medical savings for the overweight
and hypertension population that sparsely uses labels. The analysis
does not account for benefits in diet modifications for children under
the age of 16 or most people of normal weight. Though, we can expect
the diet behavior of adults to transfer to their children under the age
of 16. Normal weight consumers and consumers currently using labels
when buying food may modify their diet and benefit from the new content
and design on the Nutrition Facts label. The analysis only includes
benefits from caloric and sodium reductions leading to averted health
conditions associated with hypertension, overweight and obesity. Many
major health conditions are associated with obesity; therefore the
medical savings benefit for calorie reduction weight-loss is
substantial in overweight and obese individuals. However, other
modifications to the label, such as updates to RACCs and Daily Values
for added sugars, nutrients and minerals, may help consumers adjust
their diet and improve their personal welfare. Modifications such as
the dual column labels will simplify the calculation for total
nutrients in an entire package, which may contribute to a healthful
diet. Additionally, health benefits from caloric reduction do occur
before four years, and health benefits may continue to increase over
time; however the Nutrition Impact Model begins to calculate the
benefits from caloric reductions starting at year four. FSIS has no
means to quantify these benefits. Further, there may be indirect
benefits to reducing caloric and sodium intake through improved
lifestyle, wages, or productivity that are not measured in this
benefits estimate. Therefore, the resulting potential benefits estimate
should be interpreted as an underestimate of overall benefits.
However, data supporting the benefits analysis is from national
consumer surveys where results are on self-reported behavior changes,
which could potentially overstate actual results. In addition, the
consumers in our quantitative benefits estimate may lose utility
associated with consuming products high in sugar, calories and
sodium.\86\ Furthermore, as noted earlier in the analysis, the
available estimates of the relationship between label use and calorie
and sodium intake generally establish only correlation, but the way
they are used to develop benefits estimates reflects an assumption of
causation. Therefore, in some instances, the analysis may overestimate
the welfare gains.
---------------------------------------------------------------------------
\86\ Ashley, Elizabeth M., Clark Nardinelli and Rosemarie A.
Lavaty. ``Estimating the Benefits of Public Health Policies that
Reduce Harmful Consumption.'' Health Economics 24(5): 617-624. May
2015. http://onlinelibrary.wiley.com/doi/10.1002/hec.3040/full.
---------------------------------------------------------------------------
Qualitative Benefits
FSIS believes there are several additional benefits associated with
the proposed changes which are hard to quantify. To start, the millions
of normal weight not hypertensive users who currently use nutritional
information will benefit from the clearer label format. Additionally,
the proposed changes would harmonize the labels between FDA and USDA
products, reducing producer administration costs. Further still, the
proposed changes could potentially simplify the communication of hard
to distinguish, but sought after, product attributes benefiting both
producers and consumers.
The mandatory declaration of trans fat, added sugars, vitamin D and
potassium and other changes on the Nutrition Facts label will assist
consumers in making informed choices and maintaining healthy dietary
practices. Consumers can better determine which products are suitable
for their personal preference and dietary needs. The more up-to-date
information included on the Nutrition Facts label better reflects the
current recommendations for American diets, allowing consumers to make
informed decisions leading to an increase in consumer welfare.
Small businesses will benefit from the additional 12-month
compliance period. Allowing small businesses additional time to comply
reduces costs of relabeling, reformulation and recordkeeping and allows
additional time to understand and implement the proposed regulations.
Also, the Agency believes that the public would be better served by
having the regulations governing nutrition labeling consolidated in one
part of title 9. Rather than searching through two separate parts of
title 9--317 and 381--to find the nutrition labeling regulations,
interested parties would only have to survey one, 9 CFR part 413, to be
able to apply nutrition panels to their meat and poultry products.
[[Page 6777]]
Alternative Regulatory Approaches
Four alternatives, Table 16, are considered for the proposed
serving size and Nutrition Facts label proposed rule.
Alternative 1: Take no regulatory action by continuing
with the existing labeling requirements.
Alternative 2: The proposed rule, giving large
manufacturers a 24-month compliance period and small manufacturers 36-
months.
Alternative 3: The proposed rule, giving manufacturers a
42-month compliance period.
Alternative 4: The proposed rule, giving all manufacturers
24-months to comply.
Alternative 5: The proposed rule, giving large
manufacturers a 12-month compliance period and small manufactures 24-
months.
Table 16--Comparison of the Considered Alternatives
----------------------------------------------------------------------------------------------------------------
Considered Alternative Benefits \1\ Costs \1\ Net benefits \1\
----------------------------------------------------------------------------------------------------------------
1--Take No Action................. Zero................. Zero...................... Zero.
2--The Proposed Rule--24-month About 1 million Costs equal $10.8 million. In addition to the $26.1
compliance large, 36-month consumers would Relabeling FSIS products million in net benefits,
compliance small. increase their label will be coordinated and the proposed rule would
use, leading to uncoordinated and is harmonize USDA and FDA
roughly $36.9 estimated to cost labels and give small
million in health industry $4.5 million. businesses additional
benefits. Small Recordkeeping costs are compliance time.
businesses benefit estimated at $121,690.
from the additional Reformulation is expected
compliance time. to cost industry $6.2
million.
3--42-month Compliance Period..... The extended Costs equal $7.8 million. Net benefits are $28.6
compliance period The extended compliance million. In comparison
delays the speed at period reduces labeling to alternative 2,
which an estimated 1 costs to $2.3 million by benefits are reduced 1.4
million consumers allowing all coordinated percent, and costs are
would increase their changes. Recordkeeping reduced 27.9 percent.
label use. This costs remain at $121,690. However, alternative 3's
delay reduces health Reformulation costs are compliance period is
benefits to $36.4 expected to cost $5.3 longer than alternative
million. million. Consumers and 2's, delaying benefits.
producers would incur
costs because FSIS and
FDA labels would be
inconsistent.
4--24-month Compliance Period..... About 1 million Costs equal to $11.4 Net benefits are $25.8
consumers would million. Small businesses million, 1 percent lower
increase their label do not have additional than alternative 2's.
use leading to time to comply, While benefits are
roughly $37.2 increasing labeling costs $288,829 higher than
million in health to $5.1 million for the alternative 2's, costs
benefits. additional uncoordinated are $619,687 higher. The
changes. In addition, increase in benefits may
reformulation is expected be reduced due to
to increase to $6.2 confusion between
million. Recordkeeping inconsistent FSIS and
costs remain at $121,690. FDA labels.
Consumers and producers
would incur costs because
FSIS and FDA labels would
be inconsistent.
5--12-month compliance large, 24- Updates to the labels Costs equal to $17.4 Net benefits are $21.1
month compliance small. for FDA and FSIS million, the highest of million, almost 20
products have the all alternatives. percent lower than
same compliance Labeling costs increase alternative 2's. While
date. About 1 to $8.5 million for the benefits are 4 percent
million consumers coordinated and higher than alternative
would increase their uncoordinated changes. 2's, costs are 61
label use leading to Recordkeeping costs percent higher.
roughly $38.5 remain at $121,690. Qualitative benefits are
million in health Reformulation costs are consistency between FSIS
benefits. expected to cost $8.8 and FDA labels.
million. In addition,
both consumers and
producers would incur
costs because USDA and
FDA labels would be
inconsistent.
----------------------------------------------------------------------------------------------------------------
\1\ All quantified benefits and costs are annualized at 3 percent over 20 years.
Alternative 1--Take No Regulatory Action by Continuing With the
Existing Labeling
Both producers and consumers will be worse off absent the proposed
action. While ``no action'' means the 3,307 manufacturers with roughly
50,000 products under USDA jurisdiction would continue to be regulated
in the same manner as they currently are, the market will be impacted
in several costly ways.
First, no action would create inconsistencies between USDA and FDA
labels. As such, the manufacturers that produce products regulated by
both USDA and FDA will have to operate under two differentiated
procedures, e.g., maintaining multiple label formats, recording
different product attributes, and utilizing differing RACCs for
products with similar uses. This would increase administration costs
for producers and make label use more difficult for consumers,
decreasing their benefit.\87\
---------------------------------------------------------------------------
\87\ Bialkova, S. and H. Trijp. 2010. What determines consumer
attention to nutrition labels? Food Quality and Preference. 21 1042-
1051 and Campos, A., J. Doxey, and D. Hammond. 2011. Nutrition
labels on pre-packaged foods: a systematic review. Public Health
Nutrition. 14: 1496-1506. Bialkova and Trijp, 2010 and Campos et
al., 2011.
---------------------------------------------------------------------------
Second, if the USDA were to take ``no action,'' the Agency would
fail to address the health problems related to diet by making it more
difficult for consumers to heed dietary guidelines. Third, the ``no
action'' would fail to make any improvements to address the problems
that prohibit millions of consumers from using labels: The print being
too small, not knowing what to look for, or not having enough time. The
targeted population of nearly 32 million overweight or hypertensive
adults, whom rarely or never use the Nutrition Facts label, would
continue to not read the labels and continue with high sodium or
calorie diets. In combination, these impacts would hinder producers
vying to compete based on hard to
[[Page 6778]]
distinguish health and nutritional attributes, reducing market
competition, and would do nothing to address the nation's overweight
and obesity epidemic.
Alternative 2--The Proposed Rule, Giving Large Manufacturers a 24-Month
Compliance Period and Small Manufacturers 36-Months
Alternative 2, the proposed rule, addresses many of the current
nutritional and serving size labels' short comings by applying the
changes proposed in the preamble with a 24-month compliance period for
large and 36-month for small, consistent with FDA's compliance period.
While industry will incur costs associated with relabeling,
recordkeeping, and reformulation, consumers will benefit from an
increase in information which may lead to improved health. The
estimated net benefits are $26.1 million. The proposed costs and
benefits associated with this alternative are detailed in Expected
Costs of the Proposed Rule and Quantitative Benefits of the Proposed
Rule sections of this PRIA.
Alternative 3--The Proposed Rule, Giving Manufacturers a 42 Month
Compliance Period
Alternative 3 would apply the changes detailed in the preamble but
extends the compliance period to 42 months. Compared to alternative 2,
this alternative reduces costs while holding benefits nearly constant.
As shown in Table 4--Label Changes That Can Be Coordinated with a
Planned Change, a 42-month compliance period would provide industry
sufficient time to coordinate all required label changes, subsequently
reducing annualized relabeling costs by about $2.1 million, as compared
to alternative 2. Recordkeeping costs would remain the same as
alternative 2 and annualized reformulation costs would be reduced by
about $1 million.
Health benefits would be delayed by extending the compliance
period. Annual benefits at a 3 percent discount rate under alternative
3 are estimated to be $36.4 million, which is roughly $500,000 less
than alternative 2's estimated annual benefits. However, a 42-month
compliance period would result in delayed label updates, and extend
inconsistencies between USDA and FDA labels for an additional 18 months
compared to alternative 2.
Also, extending the compliance period would require a further
exception to current uniform compliance guidelines \88\ set by the
Agency. Consistent with FDA's uniform compliance dates for food labels,
USDA sets uniform compliance dates in 2-year increments to enhance the
industry's ability to make orderly adjustments to new labeling
requirements without unduly exposing consumers to outdated labels.
Further, cost estimates may be understated as producers who market FDA-
regulated and FSIS related products may voluntarily adopt the FDA
timetable and not use the additional compliance period allotted.
---------------------------------------------------------------------------
\88\ Uniform Compliance Date for Food Labeling Regulations, 79
FR 71007 (2014). Depending on the Alternative 2 final publication
date, Alternative 2 may not deviate from the uniform compliance
date, except for small businesses as they have an additional 12
months to comply.
---------------------------------------------------------------------------
Relabeling Costs
Alternative 3 applies FDA's 2014 Labeling Cost Model to estimate
the cost of relabeling roughly 50,000 food labels under a 42-month
compliance period. In this scenario both branded and private (store
brand) label changes can be coordinated, reducing the average one time
per label cost from $1,371 to $717, Table 17. In sum, extending the
compliance period reduces the average annualized relabeling costs to
$2.3 million, assuming a 3 percent discount rate over 20 years.
Table 17--Alternative 3--Labeling Costs
[42 Month]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs
Private Branded --------------------------------------------------------
Lower Mid Upper
---------------------------------------------------------------------------------------------------------------------------------------
Total Number of Labels.................. 12,645 37,465 ................. ................. .................
Coordinated Change:
Major............................... 3,088 9,149 $3,622,152 $14,097,024 $39,207,348
Minor............................... 9,554 28,306 5,338,260 21,655,920 61,333,200
Uncoordinated Change:
Extensive........................... 3 10 91,494 180,154 330,187
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Cost...................... ................. ................. 9,051,906 35,933,098 100,870,735
Annualized Cost (3% DR, 20 Year)........ ................. ................. 590,709 2,344,921 6,582,619
Annualized Cost (7% DR, 20 Year)........ ................. ................. 798,538 3,169,935 8,898,583
Average Per label one time cost......... ................. ................. 181 717 2,013
Per label Annualized Cost (3% DR, 20 ................. ................. 12 47 131
Year)..................................
Per label Annualized Cost (7% DR, 20 ................. ................. 16 63 178
Year)..................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recordkeeping Costs
Alternative 3 does not alter the recordkeeping requirements as
presented in the Expected Cost section above. As such, we assume the
recordkeeping costs associated under alternative 3 are equal to those
under alternative 2.
Reformulation Costs
Extending the compliance period reduces the cost for product
reformulation. However, the longest compliance period covered in the
2014 Reformulation Cost Model is 36 months for large and 24 months for
small businesses. As such, the reformulation costs associated with
alternative 3 are based on a 24 month compliance period for small and
36 month compliance
[[Page 6779]]
period for large. Therefore, the reformulation costs are under
estimated for this alterative.
Table 18--Alternative 3--Reformulation Cost
[42 months]
----------------------------------------------------------------------------------------------------------------
Lower Mid Upper
----------------------------------------------------------------------------------------------------------------
High............................................................ $30,918,175 $65,967,997 $107,198,289
Med............................................................. 6,568,245 14,044,083 22,986,932
Low............................................................. 714,402 1,529,728 2,526,885
-----------------------------------------------
Total Cost.................................................. 38,200,822 81,541,808 132,712,106
Annualized Cost (3% DR, 20 Year)................................ 2,492,908 5,321,253 8,660,522
Annualized Cost (7% DR, 20 Year)................................ 3,369,988 7,193,430 11,707,555
Average Per formula one time cost............................... 30,982 66,133 107,634
Per formula Annualized Cost (3% DR, 10 Year).................... 2,022 4,316 7,024
Per formula Annualized Cost (7% DR, 10 Year).................... 2,733 5,834 9,495
----------------------------------------------------------------------------------------------------------------
Quantitative Benefits
Again, the present value of health benefits was derived by
multiplying the percentage of label changes in each 12 month period by
annual health benefits. The prolonged compliance period reduces the
rate labels are updated, which in turn reduces the rate at which
consumers are exposed to updated labels and overall benefits. As is
shown on Table 19, the expected difference in annual health benefits
between alternative 2 and alternative 3 is about $0.5 million.
Alternative 3 has the benefit of saving roughly $3 million annually
from reductions in labeling and reformulation costs, $2.1 million of
which is derived from reductions in labeling costs.
Table 19--Comparison of Alternatives 2 and 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative 2 Alternative 3
-----------------------------------------------------------------------------------------------
Benefits Costs \1\ Net benefits Benefits Costs \1\ Net benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual PV2 3%........................................... $36,894,007 $10,802,809 $26,091,198 $36,382,559 $7,787,864 $28,594,695
Annual PV 7%............................................ 22,541,264 14,603,562 7,937,702 22,154,586 10,527,869 11,626,717
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Costs include relabeling, recordkeeping, and reformulation costs.
\2\ Present Value (PV) is the current worth of a future sum of money or stream of cash flows given a specified rate of return.
Qualitative Benefits
Alternative 3 is expected to have the same type of qualitative
benefits as alternative 2, but their realization is delayed. Labels
would not be harmonized as soon as alternative 2, resulting in
confusion between USDA and FDA labels. Producers who market FDA-
regulated products also may voluntarily adopt the FDA timetable and
update their labels prior to the 42-month compliance period.
Alternative 4--The Proposed Rule, Giving All Manufacturers 24 Months To
Comply
Under this alternative, all manufacturers are given a 24 month
compliance period. This alternative does not give small businesses
additional time to comply and is inconsistent with FDA's compliance
period.
Relabeling Costs
Under alternative 4, small and large businesses are given 24 months
to comply with the proposed changes. Under a 24-month compliance
period, all branded labels and 26 percent of private labels will incur
a coordinated label change while 74 percent of private labels will
incur an uncoordinated label change, Table 20.
Table 20--Alternative 4--Labeling Costs
[24 Month compliance period]
----------------------------------------------------------------------------------------------------------------
Costs
Private Branded -----------------------------------------------
Lower Mean Upper
----------------------------------------------------------------------------------------------------------------
Total Number of Labels.......... 12,645 37,465 .............. .............. ..............
Coordinated Change:
Major....................... 803 9,149 $2,945,792 $11,464,704 $31,886,208
Minor....................... 2,484 28,306 4,341,390 17,611,880 49,879,800
Uncoordinated Change:
Major....................... 2,285 .............. 11,710,625 21,481,285 39,759,000
Minor....................... 7,070 .............. 13,022,940 27,481,090 54,728,870
Extensive................... 3 10 91,494 180,154 330,187
-------------------------------------------------------------------------------
Total Cost.............. .............. .............. 32,112,241 78,219,113 176,584,065
Annualized Cost (3% DR, 20 Year) .............. .............. 2,095,580 5,104,420 11,523,517
Annualized Cost (7% DR, 20 Year) .............. .............. 2,832,868 6,900,309 15,577,838
[[Page 6780]]
Average Per label one time cost. .............. .............. 641 1,561 3,524.00
Per label Annualized Cost (3% .............. .............. 42 102 230
DR, 20 Year)...................
Per label Annualized Cost (7% .............. .............. 57 138 311
DR, 20 Year)...................
----------------------------------------------------------------------------------------------------------------
Recordkeeping Costs
Compared to alternative 2, alternative 4 does not alter the
recordkeeping requirements. As such, we assume the recordkeeping costs
associated under alternative 4 are equal to those under alternative 2.
Reformulation Costs
Reducing the compliance period for small businesses increases the
cost for product reformulation. However, the longest compliance period
covered in the 2014 Reformulation Cost Model for small businesses is 24
months. Therefore, the reformulation cost for alternative 2 and
alternative 3 are both estimated on a 24 month compliance period for
both large and small businesses. Alternative 2 overestimated
reformulation cost since this alternative is based on a 24 month
compliance period for large and 36 months for small businesses and
alternative 4 reformulation cost is most accurate given the compliance
period is 24 months for large and small businesses.
Table 9--Alternative 2--Reformulation Cost
----------------------------------------------------------------------------------------------------------------
Lower Mid Upper
----------------------------------------------------------------------------------------------------------------
High Complexity Formulas........................................ $36,295,355 $77,294,020 $124,785,011
Med Complexity Formulas......................................... 7,488,995 15,983,483 25,998,357
Low Complexity Formulas......................................... 783,190 1,674,662 2,752,831
Total Cost.................................................. 4,567,540 94,952,165 153,536,199
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Annualized Cost (3% DR, 20 Year)................................ 2,908,387 6,196,385 10,019,460
Annualized Cost (7% DR, 20 Year)................................ 3,931,645 8,376,460 13,544,608
Average Per formula one time cost............................... 36,146 77,009 124,522
Per formula Annualized Cost (3% DR, 20 Year).................... 2,359 5,025 8,126
Per formula Annualized Cost (7% DR, 20 Year).................... 3,189 6,794 10,985
----------------------------------------------------------------------------------------------------------------
Quantitative Benefits
The reduced compliance period increases the rate labels are
updated, which in turn increases the rate at which consumers are
exposed to updated labels, resulting in earlier and higher consumer
welfare benefits. Again, the present value of health benefits was
calculated by multiplying the percentage of label changes in each 12
month period by annual health benefits. As is shown in Table 22, the
expected difference in annual health benefits between alternative 2 and
alternative 4 is about $288,829. Alternative 4 increases the annual
labeling cost by over $0.6 million annually. Overall, the net benefit
decreases by $330,858 under alternative 4.
Table 22--Comparison of Alternatives 2 and 4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative 2 Alternative 4
-----------------------------------------------------------------------------------------------
Benefits Costs \1\ Net Benefits Benefits Costs \1\ Net Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual PV\2\ 3%......................................... $36,894,007 $10,802,809 $26,091,198 $37,182,836 $11,422,496 $25,760,340
Annual PV 7%............................................ 22,541,264 14,603,562 7,937,702 22,763,888 15,441,274 7,322,614
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Costs include relabeling, recordkeeping, and reformulation costs.
\2\ Present Value (PV) is the current worth of a future sum of money or stream of cash flows given a specified rate of return.
Qualitative Benefits
Alternative 4 may benefit consumers from the potential
reformulation of products to reduce added sugars. Also, alternative 4
would still benefit the public by consolidating nutrition labeling
regulations to one location; however, it would result in
inconsistencies between products regulated by either the FDA or USDA.
These inconsistencies would likely increase confusion amongst both
producers and consumers, reducing overall benefits.
Alternative 5--The Proposed Rule, Giving Large Manufacturers 12-Month
Compliance Period and Small 24-Month Compliance
Alternative 5 more closely aligns the compliance date with FDA
labels. Sharing the same compliance date with FDA products allows for
harmonized labels across agencies. However, FSIS labels will have a
shorter time to comply than FDA by sharing the same compliance date.
FDA is giving a 24-month compliance period for large businesses and 36
months for small businesses to comply, the same compliance period as
alternative 2. Also, compared to alternative 2, this alternative
greatly increases costs while holding benefits nearly constant. For
[[Page 6781]]
these reasons, this is not our preferred alternative. The sections
below outline the costs and benefits for this alternative.
Relabeling Costs
Alternative 5 applies FDA's 2014 Labeling Cost Model to estimate
the cost of relabeling roughly 50,000 food labels under a 12-month
compliance period for large manufacturers and 24 months for small.
Reducing the compliance period increases the number of uncoordinated
changes, resulting in higher labeling costs. For a 12-month compliance
period, only 11 percent of branded and 5 percent of private labels will
have a coordinated change. For a 24-month compliance period, only 26
percent of private brands will have a coordinated change. The average
one-time per label cost increases from $1,371 to $2,591, Table 23.
Table 23--Alternative 5--Labeling Costs
[12 month for large, 24 months for small]
----------------------------------------------------------------------------------------------------------------
Costs
Small Large -----------------------------------------------
Lower Mean Upper
----------------------------------------------------------------------------------------------------------------
Total Number of Labels.......... 26,859 23,251 .............. .............. ..............
Coordinated Change:
Major....................... 5,334 1,828 $2,119,952 $8,250,624 $22,947,048
Minor....................... 16,504 5,656 3,124,560 12,675,520 35,899,200
Uncoordinated Change:
Extensive................... 7 6 91,494 180,154 330,187
Major....................... 1,225 3,850 26,008,391 47,708,270 88,301,659
Minor....................... 3,789 11,911 28,919,400 61,025,900 121,533,700
Total Cost.............. .............. .............. 60,263,797 129,840,468 269,011,794
-------------------------------------------------------------------------------
Annualized Cost (3% DR, 20 Year) .............. .............. 3,932,693 8,473,125 17,555,163
Annualized Cost (7% DR, 20 Year) .............. .............. 5,316,333 11,454,226 23,731,598
Average Per label one time cost. .............. .............. 1,203 2,591 5,368.43
Per label Annualized Cost (3% .............. .............. 78 169 350
DR, 20 Year)...................
Per label Annualized Cost (7% .............. .............. 106 229 474
DR, 20 Year)...................
----------------------------------------------------------------------------------------------------------------
Recordkeeping Costs
Alternative 5 does not alter the recordkeeping requirements as
presented in the Expected Cost section above. As such, we assume the
recordkeeping costs associated under alternative 5 are equal to those
under alternative 2.
Reformulation Costs
Reducing the compliance period increases the cost for product
reformulation. However, the longest compliance period covered in the
2014 Reformulation Cost Model for a small business is 24 months.
Therefore, the reformulation cost for small and medium businesses in
alternative 2 is based on a 24 month compliance period, resulting in an
overestimate of cost in alternative 2. Even with the overestimation in
alternative 2 reformulation cost, the one-time cost for reformulation
increases by $40.2 million with alternative 5, with an average per
formula cost increasing from $77,009 to $109,638, Table 24. The
increase is attributed to the 12-month compliance period for large
manufacturers.
Table 24--Alternative 5--Reformulation Cost
[12 month large, 24 months small]
----------------------------------------------------------------------------------------------------------------
Lower Mid Upper
----------------------------------------------------------------------------------------------------------------
High Complexity Formulas........................................ $52,426,895 $111,272,089 $177,545,177
Med Complexity Formulas......................................... 10,251,245 21,801,633 35,032,632
Low Complexity Formulas......................................... 989,550 2,109,464 3,430,665
Total Cost...................................................... 63,667,690 135,183,186 216,008,474
Annualized Cost (3% DR, 20 Year)................................ 4,154,824 8,821,780 14,096,274
Annualized Cost (7% DR, 20 Year)................................ 5,616,616 11,925,548 19,055,768
Average Per formula one time cost............................... 51,636 109,638 175,189
Per formula Annualized Cost (3% DR, 20 Year).................... 3,370 7,155 11,433
Per formula Annualized Cost (7% DR, 20 Year).................... 4,555 9,672 15,455
----------------------------------------------------------------------------------------------------------------
Quantitative Benefits
By reducing the compliance period, labels are updated faster,
resulting in earlier consumer welfare benefits. Again, the present
value of health benefits was derived by multiplying the percentage of
label changes in each 12-month period by annual health benefits.
Alternative 5 proposed a 12-month compliance period for large and 24
month compliance period for small. Based on IRI scanner data and SBA
small business standards, 53.6 percent of labels are from small
businesses and 46.4 percent are from Large. Utilizing these proportions
and Table 4--Label Changes That Can Be Coordinated with a Planned
Change, we estimate that after 12 months, 50.76 percent of FSIS's
Nutrition Facts labels are updated ((100% of Large * 46.4% of labels) +
(10% of Small * 53.6% of Labels)). After 24 months, 100 percent of
FSIS's nutrition facts labels are updated.
As shown in Table 25, the expected increase in annual health
benefits between alternative 2 and alternative 5 is about $1.6 million.
However, alternative 5 increases cost by $6.6
[[Page 6782]]
million annually, of which $4 million is derived from increases in
labeling costs.
Table 25--Comparison of Alternatives 2 and 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alternative 2 Alternative 5
-----------------------------------------------------------------------------------------------
Benefits Costs \1\ Net Benefits Benefits Costs \1\ Net Benefits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual PV 3%............................................ $36,894,007 $10,802,809 $26,091,198 $38,470,229 $17,416,595 $21,053,634
Annual PV 7%............................................ 22,541,264 14,603,562 7,937,702 23,794,722 23,544,278 250,444
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Costs include relabeling, recordkeeping, and reformulation costs.
\2\ Present Value (PV) is the current worth of a future sum of money or stream of cash flows given a specified rate of return.
Qualitative Benefits
Alternative 5 is expected to have similar qualitative benefits as
alternative 2, with the additional benefit of harmonized labels between
FSIS and FDA. Assuming FSIS has a one-year lag from FDA's final rule
(81 FR 33742 and 81 FR 34000), under this alternative, USDA and FDA
labels will have the same compliance date, resulting in less confusion
over similar food products.
IV. Regulatory Flexibility Act
The FSIS Administrator made a preliminary determination that this
proposed rule will not have a significant impact on a substantial
number of small entities, as defined by the Regulatory Flexibility Act
(5 U.S.C. 601). This determination was made because small businesses
only account for 50 percent of the Nutrition Facts Labels and are given
an additional 12 months to comply, reducing the costs of the proposed
regulations.
All manufacturers are required to update labels if this proposed
rule is finalized. FSIS considered other alternatives and the preferred
alternative gives small businesses an additional 12 months to comply
with the regulations to reduce the impact on small businesses. The
additional compliance time reduces the burden and cost for small
business and is consistent with FDA's compliance period.
On the basis of IRI scanner data, FSIS estimates that 3,307
manufacturers produce roughly 50,000 different retail labels with
nutrition labeling for meat or poultry products. Using SBA's small
business definition \89\and IRI scanner data, FSIS estimates 3,125
small manufacturers would be affected by the proposed rule. The small
FSIS manufacturers produce 26,859 labels (53.6 percent of 50,110) as
shown in Table 5--Alternative 2--Labeling Costs (24 Month for Large, 36
Months for Small). Note that the disproportionately large percentage of
labels from the 182 large manufacturers is attributable to the fact
that they typically produce more labeled products per manufacturer than
small manufacturers.
The average one-time cost per label change is $1,208 or $79
annualized over 10 years at a 3-percent discount rate for small
businesses. The annualized costs at a 3-percent discount rate for all
labels changes from small retail manufacturers is $2,116,554 with an
average cost of $677 ($2.1M/3,125) per small business. Relabeling costs
for small businesses are less than half ($2.1M out of $4.5M) of the
total annualized cost at a 3-percent discount rate (Table 5--
Alternative 2--Labeling Costs (24 Month for Large, 36 Months for
Small)). These estimates in Table 5 include small business relabeling
costs from minor, major, extensive coordinated and uncoordinated
changes for a 36-month compliance period.
V. Paperwork Requirements
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection and
recordkeeping requirements included in this proposed rule have been
submitted for approval to OMB.
Title: Revision of the Nutrition Facts Labels for Meat and Poultry
Products and Updating Certain Reference Amounts Customarily Consumed.
Type of Collection: New.
Abstract: The proposed rule contains information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the PRA. The provisions include burden for
recordkeeping, annual reporting, and third-party disclosure for the
declaration of Added Sugars, Dietary Fiber, Soluble Fiber, Insoluble
Fiber, Vitamin E, and Folate/Folic Acid. The likely respondents to this
information collection are manufacturers of FSIS retail food products
containing Added Sugars, Dietary Fiber, Soluble Fiber, Insoluble Fiber,
Vitamin E, and Folate/Folic Acid.
Proposed Recordkeeping and Annual Record Reporting Requirements
Under this proposed rule manufacturers must maintain additional
records for Added Sugars, Dietary Fiber, Soluble Fiber, Insoluble
Fiber, Dietary Fiber, Vitamin E, and Folate/Folic Acid. Manufacturers
are also required to provide these records to the inspector or any duly
authorized representative of the Agency upon request.\90\
---------------------------------------------------------------------------
\90\ Proposed 9 CFR 413.309(h)(8).
---------------------------------------------------------------------------
FSIS believes the new records required from this proposed rule are
records that responsible manufacturers use and retain as a normal part
of business. Thus, the recordkeeping burden consists of the time
required to identify and assemble the records for copying and holding
and the reporting burden consists of the time required to assemble and
provide records to the appropriate FSIS officials. FSIS estimates one
hour of recordkeeping and one hour of recordkeeping burden for each
newly required nutrient per manufacturer. If the rule is finalized as
proposed, the declaration for added sugars, dietary fiber, soluble
fiber, and insoluble fiber would be mandatory and 3,307 manufacturers
for FSIS products would incur this burden. The declaration of Vitamin E
and folate/folic acid is not mandatory unless accompanied with a
nutrient claim. However, we estimate that roughly all 3,307 FSIS
manufacturers will incur a one hour recordkeeping burden for the
mandatory components and one hour record burden for vitamin E and folic
acid. As shown in Table 26, the initial recordkeeping and reporting
burden for covered respondents is 39,684 hours.
[[Page 6783]]
Table 27--Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Hours of Hours of
Number of recordkeeping reporting Total burden
Type of declaration respondents burden per burden per hours
respondent respondent
----------------------------------------------------------------------------------------------------------------
Added Sugars.................................... 3,307 1 1 6,614
Dietary Fiber................................... 3,307 1 1 6,614
Soluble Fiber................................... 3,307 1 1 6,614
Insoluble Fiber................................. 3,307 1 1 6,614
Vitamin E....................................... 3,307 1 1 6,614
Folate/Folic Acid............................... 3,307 1 1 6,614
----------------------------------------------------------------------------------------------------------------
\2\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
added sugars, dietary fiber, and soluble and insoluble fiber. Manufacturers will only need to keep records for
products with both added and naturally occurring sugars and products with non-digestible carbohydrates
(soluble or insoluble) that do and do not meet the definition of dietary fiber.
\3\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
vitamin E and folate/folic acid. The declaration of vitamin E and folate/folic acid is not mandatory unless a
health or nutrient content claim is being made or these nutrients are directly added to the food for
enrichment purposes.
Third Party Disclosures Burden for Manufacturers
FSIS estimated that the burden associated with the proposed changes
would be a one-time burden for the food manufacturers to revise the
nutrition labels. We estimate the one-time third party disclosure
burden would be approximately two hours. Each label would require a
respondent one hour of review to determine how to bring it into
compliance with the proposed requirements. FSIS estimated each label
redesign would require one additional hour per label, for a total of
two hours per unique label for each respondent. Based on estimates from
IRI scanner data, there are 50,110 unique nutrition labels under FSIS
jurisdiction. Therefore, the estimated burden for this collection of
information is 200,440 hours for respondents as shown in Table 27.
Table 28--Estimated Annual Third Party Disclosure
----------------------------------------------------------------------------------------------------------------
Average time
Action Number of burden per Total hours
labels disclosure
----------------------------------------------------------------------------------------------------------------
Reviewing Labels................................................ 50,110 2 100,220
Label Redesign.................................................. 50,110 2 100,220
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total hours................................................. .............. .............. 200,440
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Summary of Burden for Paperwork Reduction Act Section
Estimate of Burden: FSIS estimates that it would take 2.00 hours
per respondent for recordkeeping and record reporting. FSIS also
estimates it will take a respondent 2 hours per label to review and
redesign the label.
Respondents: Manufacturers of FSIS products at the retail level.
Estimated Number of respondents: 3,307.
Estimated Number of FSIS labels: 50,110.
Estimated Number of Responses per Respondent: about 73 hours.
Estimated Total Annual Burden on Respondents: 241,411 hours.
Copies of this information collection assessment can be obtained
from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and
Inspection Service, USDA, 1400 Independence Avenue SW., Room 6065,
South Building, Washington, DC 20250.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Comments may be sent to both Gina Kouba, Paperwork Reduction Act
Coordinator, at the address provided above, and the Desk Officer for
Agriculture, Office of Information and Regulatory Affairs, Office of
Management and Budget, Washington, DC 20253. To be most effective,
comments should be sent to OMB.
VI. E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to government
information and services, and for other purposes.
VII. Executive Order 12988, Civil Justice Reform
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. Under this rule: (1) All State and local laws and
regulations that are inconsistent with this rule will be preempted; (2)
no retroactive effect will be given to this rule; and (3) no
administrative proceedings will be required before parties may file
suit in court challenging this rule.
[[Page 6784]]
VIII. Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult
and coordinate with tribes on a government-to-government basis on
policies that have tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects on one or
more Indian tribes, on the relationship between the Federal Government
and Indian tribes or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.
FSIS has assessed the impact of this rule on Indian tribes and
determined that this rule does not, to our knowledge, have tribal
implications that require tribal consultation under E.O. 13175. If a
Tribe requests consultation, the Food Safety and Inspection Service
will work with the Office of Tribal Relations to ensure meaningful
consultation is provided where changes, additions and modifications
identified herein are not expressly mandated by Congress.
IX. USDA Nondiscrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.
How To File a Complaint of Discrimination
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW., Washington, DC 20250-9410.
Fax: (202) 690-7442.
Email: [email protected].
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.), should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
X. Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS Web page located at:
http://www.fsis.usda.gov/federal-register .
FSIS also will make copies of this publication available through
the FSIS Constituent Update, which is used to provide information
regarding FSIS policies, procedures, regulations, Federal Register
notices, FSIS public meetings, and other types of information that
could affect or would be of interest to our constituents and
stakeholders. The Update is available on the FSIS Web page. Through the
Web page, FSIS is able to provide information to a much broader, more
diverse audience. In addition, FSIS offers an email subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at: http://www.fsis.usda.gov/subscribe . Options range from recalls to export
information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves, and have the option to password
protect their accounts.
XI. Proposed Regulatory Amendments
List of Subjects
9 CFR Parts 301 and 304
Meat inspection.
9 CFR Part 316
Food labeling, Food packaging, Meat inspection.
9 CFR Part 317
Food labeling, Food packaging, Meat inspection, Nutrition,
Reporting and recordkeeping.
9 CFR Part 318
Food additives, Food packaging, Laboratories, Meat inspection,
Reporting and recordkeeping requirements, Signs and symbols.
9 CFR Part 319
Food grades and standards, Food labeling, Frozen foods, Meat
inspection, Oils and fats.
9 CFR Part 320
Meat inspection, Reporting and recordkeeping.
9 CFR Part 327
Food labeling, Food packaging, Imports, Meat inspection.
9 CFR Part 362
Meat inspection, Poultry and poultry products, Reporting and
recordkeeping.
9 CFR Part 381
Administrative practice and procedure, Animal diseases, Crime,
Exports, Food grades and standards, Food labeling, Food packaging,
Government employees, Grant programs--agriculture, Imports,
Intergovernmental relations, Laboratories, Meat inspection, Nutrition,
Polychlorinated biphenyls (PCB's), Poultry and poultry products,
Reporting and recordkeeping requirements, Seizures and forfeitures,
Signs and symbols, Technical assistance, Transportation.
9 CFR Parts 412 and 413
Food labeling, Food packaging, Meat inspection, Poultry and poultry
products, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, FSIS is proposing to
amend 9 CFR Chapter III as follows:
PART 301--TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS
0
1. The authority citation for part 301 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 U.S.C. 138-138i, 450, 1901-
1906; 7 CFR 2.7, 2.18, 2.53.
0
2. Amend Sec. 301.2 by revising paragraph (10) under the definition of
``Misbranded'' to read as follows:
Sec. 301.2 Definitions.
* * * * *
(10) If it purports to be or is represented for special dietary
uses, unless its label bears such information concerning its vitamin,
mineral, and other dietary properties as is required by the regulations
in part 317 of this subchapter and part 413 of subchapter E.
* * * * *
PART 304--APPLICATION FOR INSPECTION; GRANT OF INSPECTION
0
3. The authority citation for part 304 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
4. Amend Sec. 304.2 by revising paragraph (b) to read as follows:
Sec. 304.2 Information to be furnished; grant or refusal of
inspection.
* * * * *
(b) The Administrator is authorized to grant inspection upon his or
her
[[Page 6785]]
determination that the applicant and the establishment are eligible
therefor and to refuse to grant inspection at any establishment if he
or she determines that it does not meet the requirements of this part
or the regulations in parts 305, 307, and part 416, Sec. Sec. 416.1
through 416.6 of this chapter, or that the applicant has not received
approval of labeling and containers to be used at the establishment as
required by the regulations in parts 316 and 317 of this subchapter and
part 412 of subchapter E. Any application for inspection may be refused
in accordance with the rules of practice in part 500 of this chapter.
* * * * *
PART 316--MARKING PRODUCTS AND THEIR CONTAINERS
0
5. The authority citation for part 316 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.17, 2.55.
0
6. Amend paragraph (b) of Sec. 316.8 by replacing the phrase ``this
part and part 317 of this subchapter'' with ``this part, part 317 of
this subchapter, and part 413 of subchapter E.''
0
7. Amend paragraph (e) of Sec. 316.11 by adding the phrase ``and part
413 of subchapter E'' after ``in part 317 of this subchapter''.
0
8. Amend paragraph (b) of Sec. 316.13 by adding the phrase ``and part
413 of subchapter E'' after ``part 317 of this subchapter''.
PART 317--LABELING, MARKING DEVICES, AND CONTAINERS
0
9. The authority citation for part 317 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
10. Amend Sec. 317.16 by replacing the phrase ``this part 317'' with
``this part 317 or part 413 of subchapter E''.
Subpart B--[Removed and Reserved]
0
11. Remove and reserve subpart B, consisting of Sec. Sec. 317.300
through 317.400.
PART 318--ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND
PREPARATION OF PRODUCTS
0
12. The authority citation for part 318 continues to read as follows:
Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 601-695; 7
CFR 2.18, 2.53.
0
13. Amend paragraph (b) of Sec. 318.10 by replacing the phrase ``part
317 of the regulations in this subchapter'' with ``part 412 of
subchapter E''.
PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
0
14. The authority citation for part 319 continues to read as follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
0
15. Amend paragraph (a) of Sec. 319.1 by adding the phrase ``and part
413 of subchapter E'' after ``part 317 of this subchapter''.
0
16. Amend Sec. 319.10 by revising paragraph (a) to read as follows:
Sec. 319.10 Requirements for substitute standardized meat food
products named by use of an expressed nutrition content claim and a
standardized term.
(a) Description. The meat food products prescribed by this general
definition and standard of identity are those products that substitute,
in accordance with Sec. 413.313(d), for a standardized product defined
in this part and use the name of that standardized product in their
statements of identity, but that do not comply with the established
standard because of a compositional deviation that results from
reduction of a constituent that is described by an expressed nutrient
content claim that has been defined by regulation in part 413 of
subchapter E. The expressed nutrient content claim shall comply with
the requirements of Sec. 413.313 and with the requirements of part
413, which define the particular nutrient content claim that is used.
The meat food product shall comply with the relevant standard in this
part in all other respects, except as provided in paragraphs (b) and
(c) of this section.
* * * * *
0
17. Amend paragraph (b) of Sec. 319.10 by replacing the reference to
``Sec. 317.313(d)(1) and (2)'' with ``Sec. 413.313(d)(1) and (2)''.
PART 320--RECORDS, REGISTRATION, AND REPORTS
0
18. The authority citation for part 320 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.7, 2.18, 2.53.
0
19. Amend Sec. 320.1 by revising paragraph (b)(8) to read as follows:
Sec. 320.1 Records required to be kept.
* * * * *
(b) * * *
(8) Records of nutrition labeling as required by part 413 of
subchapter E.
* * * * *
PART 327--IMPORTED PRODUCTS
0
20. The authority citation for part 327 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
21. Amend Sec. 327.15 by revising paragraph (b) to read as follows:
Sec. 327.15 Outside containers of foreign products; marking and
labeling; application of official inspection legend.
* * * * *
(b) All labeling used with an outside container of foreign product
must be approved in accordance with part 317 of this subchapter and
parts 412 and 413 of subchapter E.
* * * * *
PART 362--VOLUNTARY POULTRY INSPECTION REGULATIONS
0
22. The authority citation for part 362 continues to read as follows:
Authority: 7 U.S.C. 1622; 7 CFR 2.18(g) and (i) and 2.53.
0
23. Amend paragraph (a) of Sec. 362.2 by replacing ``Part 381'' with
``parts 381 and 413.''
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
0
24. The authority citation for part 381 continues to read as follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
Sec. 381.172 [Amended]
0
25. Amend Sec. 381.172 by revising paragraphs (a) and (b) to read as
follows:
(a) Description. The poultry products prescribed by this general
definition and standard of identity are those products that substitute,
in accordance with Sec. 413.313(d), for a standardized product defined
in this subpart and use the name of that standardized product in their
statements of identity, but that do not comply with the established
standard because of a compositional deviation that results from
reduction of a constituent that is described by an expressed nutrient
content claim that has been defined by regulation in this subpart. The
expressed nutrient content claim shall comply with the requirements of
Sec. 413.313 and with the requirements in part 413 which define the
particular nutrient content claim that is used. The poultry product
shall comply with the relevant standard in this part in all other
respects, except as provided in paragraphs (b) and (c) of this section.
(b) Performance characteristics. The performance characteristics,
such as physical properties, functional properties, and shelf-life, of
the poultry product shall be similar to those of the standardized
poultry product produced under subpart P of this part. If there is
[[Page 6786]]
a significant difference in a performance characteristic that
materially limits the use of the product compared to the use of the
standardized product defined in subpart P of this part, the label shall
include a statement in accordance with Sec. 413.313(d)(1) and (2) that
informs the consumer of such differences (e.g., if appropriate, ``not
recommended for frozen storage'' or ``not suitable for roller
grilling''). Deviations from the ingredient provisions of the standard
must be the minimum necessary to qualify for the nutrient content
claim, while maintaining similar performance characteristics.
* * * * *
0
26. Amend Sec. 381.175 by revising paragraph (b)(5) to read as
follows:
Sec. 381.175 Required records to be kept.
* * * * *
(b) * * *
(5) Records of nutrition labeling as required by part 413.
* * * * *
Subpart Y--[Removed and Reserved]
0
27. Remove and reserve subpart Y, consisting of Sec. Sec. 381.400
through 381.500.
PART 412--LABEL APPROVAL
0
28. The authority citation for part 412 continues to read as follows:
Authority: 21 U.S.C. 451-470, 601-695; 7 CFR 2.18, 2.53.
0
29. Amend Sec. 412.2 by revising paragraph (a)(1) to read as follows:
Sec. 412.2 Approval of generic labels.
(a)(1) An official establishment, or an establishment certified
under a foreign inspection system in accordance with part 327, or part
381, subpart T of this chapter, is authorized to use generically
approved labels, as defined in paragraph (b) of this section, and thus
is free to use such labels without submitting them to the Food Safety
and Inspection Service for approval, provided the label, in accordance
with this section, displays all mandatory features in a prominent
manner in compliance with parts 317, 381, and 413 and is not otherwise
false or misleading in any particular.
* * * * *
0
30. Add part 413 to subchapter E to read as follows:
PART 413--NUTRITION LABELING
Sec.
413.1-413.299 [Reserved]
413.300 Nutrition labeling of meat, meat food products, and poultry
products.
413.301 Required nutrition labeling of ground or chopped products.
413.302 Location of nutrition information.
413.303-413.307 [Reserved]
413.308 Labeling of products with number of servings.
413.309 Nutrition label content.
413.310-413.311 [Reserved]
413.312 Reference amounts customarily consumed per eating occasion.
413.313 Nutrient content claims; general principles.
413.314-413.343 [Reserved]
413.344 Identification of major cuts of meat products and poultry
products.
413.345 Nutrition labeling of single-ingredient, raw meat or poultry
products that are not ground or chopped products described in Sec.
413.301.
413.346-413.353 [Reserved]
413.354 Nutrient content claims for ``good source,'' ``high,'' and
``more''.
413.355 [Reserved]
413.356 Nutrient content claims for ``light'' or ``lite''.
413.357-413.359 [Reserved]
413.360 Nutrient content claims for calorie content.
413.361 Nutrient content claims for the sodium content.
413.362 Nutrient content claims for fat, fatty acids, and
cholesterol content.
413.363 Nutrient content claims for ``healthy''.
413.364-413.368 [Reserved]
413.369 Labeling applications for nutrient content claims.
413.370-413.379 [Reserved]
413.380 Label statements relating to usefulness in reducing or
maintaining body weight.
413.381-413.399 [Reserved]
413.400 Exemptions from nutrition labeling.
Authority: 21 U.S.C. 451-470, 601-695; 7 CFR 2.7, 2.18, 2.53.
Sec. 413.300 Nutrition labeling of meat, meat food products, and
poultry products.
(a) Nutrition labeling must be provided for all meat, meat food
products, and poultry products intended for human consumption and
offered for sale, except single-ingredient, raw meat or poultry
products that are not ground or chopped meat or poultry products
described in Sec. 413.301 and are not major cuts of single-ingredient,
raw meat or poultry products identified in Sec. 413.344, unless the
product is exempted under Sec. 413.400. Nutrition labeling must be
provided for the major cuts of single-ingredient, raw meat or poultry
products identified in Sec. 413.344, either in accordance with the
provisions of Sec. 413.309 for nutrition labels, or in accordance with
the provisions of Sec. 413.345 for point-of-purchase materials, except
as exempted under Sec. 413.400. For all other products for which
nutrition labeling is required, including ground or chopped meat or
poultry products described in Sec. 413.301, nutrition labeling must be
provided in accordance with the provisions of Sec. 413.309, except as
exempted under Sec. 413.400.
(b) Nutrition labeling may be provided for single-ingredient, raw
meat or poultry products that are not ground or chopped meat or poultry
products described in Sec. 413.301 and that are not major cuts of
single-ingredient, raw meat or poultry products identified in Sec.
413.344, either in accordance with the provisions of Sec. 413.309 for
nutrition labels, or in accordance with the provisions of Sec. 413.345
for point-of-purchase materials.
Sec. 413.301 Required nutrition labeling of ground or chopped
products.
(a) Nutrition labels must be provided for all ground or chopped
products (livestock species or kind) and hamburger with or without
added seasonings (including, but not limited to, ground beef, ground
beef patties, ground sirloin, ground pork, ground lamb, ground chicken,
ground turkey, and (kind) burgers) that are intended for human
consumption and offered for sale, in accordance with the provisions of
Sec. 413.309, except as exempted under Sec. 413.400.
(b) [Reserved]
Sec. 413.302 Location of nutrition information.
(a) Nutrition information on a label of a packaged product shall
appear on the label's principal display panel or on the information
panel, except as provided in paragraphs (b) and (c) of this section.
(b) Nutrition information for gift packs may be shown at a location
other than on the product label, provided that the labels for these
products bear no nutrition claim. In lieu of on the product label,
nutrition information may be provided by alternate means such as
product label inserts.
(c) Products 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 information. In
determining the sufficiency of available space for the nutrition
information, the space needed for vignettes, designs, and other
nonmandatory label information on the principal display panel may be
considered.
[[Page 6787]]
Sec. Sec. 413.303-413.307 [Reserved]
Sec. 413.308 Labeling of products with number of servings.
The label of any package of a product that bears a representation
as to the number of servings contained in such package shall meet the
requirements of Sec. 317.2(h)(10) or Sec. 381.121(c)(7).
Sec. 413.309 Nutrition label content.
(a) All nutrient and food component quantities shall be declared in
relation to a serving as defined in this section.
(b)(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 product. When the product 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)(8), (b)(12), and (b)(14)
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--
General Food Supply'' (Reference Amounts) that appear in Sec.
413.312(b) using the procedures described in this paragraph (b). 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. 413.312(b) shall
be used for purposes of evaluating whether weight-control products that
are available only through a weight-control program qualify for
nutrition claims.
(3) The declaration of nutrient and food component content shall be
on the basis of the product ``as packaged'' for all products, except
that single-ingredient, raw products that are not ground or chopped
products described in Sec. 413.301 may be declared on the basis of the
product ``as consumed''. For single-ingredient, raw products that are
not ground or chopped products described in Sec. 413.301, if data are
based on the product `as consumed,' the data must be presented in
accordance with Sec. 413.345(d). In addition to the required
declaration on the basis of ``as packaged'' for products other than
single-ingredient, raw products that are not ground or chopped products
described in Sec. 413.301, the declaration may also be made on the
basis of ``as consumed,'' provided that preparation and cooking
instructions are clearly stated.
(4) For products in discrete units (e.g., hot dogs, chicken wings,
and individually packaged products within a multi-serving 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., beef fritters and barbecue
sauce, chicken wings and barbecue sauce), the serving size shall be
declared as follows:
(i) 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.
(ii) 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.
(iii) If a unit weighs 67 percent or more but less than 200 percent
of the Reference Amount, the serving size shall be one unit.
(iv) 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)(16)(i)(A), (B), and (C) of this
section apply to this provision.
(v) 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., beef fritters and
barbecue sauce, chicken wings and barbecue sauce), 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 as determined in Sec. 413.312(c).
(vi) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., are
labeled appropriately for individual sale as single-serving
containers), the serving size shall be 1 unit.
(vii) The serving size for products that naturally vary in size
(e.g., chicken breast, poultry parts, pork chop) may be the amount in
ounces that most closely approximates the reference amount for the
product category. Manufacturers shall adhere to the requirements in
paragraph (b)(7)(iii) of this section for expressing the serving size
in ounces.
(5) For products in large discrete units that are usually divided
for consumption (e.g., pizza, pan of poultry lasagna), 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.
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, the serving size shall be the fractional slice
of the ready-to-eat product (e.g., \1/8\ quiche, \1/4\ pizza) that most
closely approximates the Reference Amount for the product category. The
serving size may be the fraction of the package used to make the
Reference Amount for the unprepared product determined in Sec.
413.312(d) or the fraction of the large discrete unit represented as
the main ingredient plus proportioned minor ingredients used to make
the Reference Amount of the combined product determined in Sec.
413.312(c). 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.
(6) For nondiscrete bulk products (e.g., whole roast beef,
marinated beef tenderloin, large can of chili, whole turkey, turkey
breast, ground poultry), 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.,
roast beef and gravy, turkey breast and gravy), 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
[[Page 6788]]
combined product determined in Sec. 413.312(c).
(7) 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), or other common
household equipment used to package food products (e.g., jar or tray).
In expressing serving size in household measures, except as specified
in paragraphs (b)(7)(iv), (v), and (vi) of this section, the following
rules shall be used:
(i) Cups, tablespoons, or teaspoons shall be used wherever possible
and appropriate. Cups shall be expressed in \1/4\- or \1/3\-cup
increments, tablespoons in whole number of tablespoons for quantities
less than \1/4\ cup but greater than or equal to 2 tablespoons (tbsp),
1, 1\1/3\, 1\1/2\, or 1\1/2\ tbsp for quantities less than 2 tbsp but
greater than or equal to 1 tbsp, and teaspoons in whole number of
teaspoons for quantities less than 1 tbsp but greater than or equal to
1 teaspoon (tsp), and in \1/4\-tsp increments for quantities less than
1 tsp.
(ii) If cups, tablespoons or teaspoons are not applicable, units
such as piece, slice, tray, jar, and fraction shall be used.
(iii) If cups, tablespoons and teaspoons, or units such as piece,
slice, tray, jar, or fraction are not applicable, ounces may be used.
Ounce measurements shall be expressed in 0.5-ounce increments most
closely approximating the Reference Amount with rounding indicated by
the use of the term ``about'' (e.g., about 2.5 ounces).
(iv) A description of the individual container or package shall be
used for single-serving containers and for individually packaged
products within multi-serving containers (e.g., can, box, package,
meal, or dinner). A description of the individual unit shall be used
for other products in discrete units (e.g., chop, slice, link, or
patty).
(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., pizza kit), the fraction or portion of
the package may be used.
(vi) For products that consist of two or more distinct ingredients
or components packaged and presented to be consumed together (e.g., ham
with a glaze packet, chicken wings with a glaze packet), the nutrition
information may be declared for each component or as a composite. The
serving size shall be provided in accordance with the provisions of
paragraphs (b)(4), (b)(5), and (b)(6) of this section, whichever is
applicable.
(vii) For nutrition labeling purposes, a teaspoon means 5
milliliters (mL), a tablespoon means 15 mL, a cup means 240 mL, and 1
oz in weight means 28 grams (g).
(viii) When a serving size, determined from the Reference Amount in
Sec. 413.312(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.
(8) 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.
(9) 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)(8) of this section and shall be followed by the
equivalent metric quantity in parenthesis (fluids in milliliters and
all other foods in grams), except for single-serving containers.
(i) For a single-serving container, the parenthetical metric
quantity, which will be presented as part of the net weight statement
on the principal display panel, is not required except where nutrition
information is required on a drained weight basis according to
paragraph (b)(11) of this section. 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, 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 bologna or for
sliced chicken roll. 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, and oz for 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 (120g) concentrated soup (makes 1 cup
prepared)).
(10) 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 must 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
must 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., pickled pigs feet), 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)(7) of this section. Random weight products are foods such
as meat roasts or whole turkeys 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''
[[Page 6789]]
statement (e.g., varied (approximately 8 servings per pound)).
(iv) For packages containing several individual single-serving
containers, each of which is labeled with all required information
including nutrition labeling as specified in this section (i.e., 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 multi-
serving units, the number of servings shall be determined by
multiplying the number of individual multi-serving units in the total
package by the number of servings in each individual unit. The
declaration of the number of servings per container need not be
included in nutrition labeling of single-ingredient, raw products that
are not ground or chopped products described in Sec. 413.301,
including those that have been previously frozen.
(11) The declaration of nutrient and food component content shall
be on the basis of product as packaged or purchased with the exception
of single-ingredient, raw products that are not ground or chopped
products described in Sec. 413.301 and products that are packed or
canned in water, brine, or oil but whose liquid packing medium is not
customarily consumed. Declaration of the nutrient and food component
content of products that are packed in liquid which is not customarily
consumed shall be based on the drained solids.
(12) The serving size for meal-type products and main-dish products
as defined in Sec. 413.313(l) and Sec. 413.313(m) in single-serving
containers will be the entire edible content of the package. Serving
size for meal-type products and main-dish products in multi-serve
containers will be based on the reference amount applicable to the
product in Sec. 413.312(b) if the product is listed in Sec.
413.312(b). Serving size for meal-type products and main-dish products
in multi-serve containers that are not listed in Sec. 413.312(b) will
be based on the reference amount according to Sec. 413.312(c), (d),
and (e).
(13) Another column of figures may be used to declare the nutrient
and food component information in the same format as required by Sec.
413.309(e).
(i) Per 100 grams, 100 milliliters, or 1 ounce of the product as
packaged or purchased.
(ii) Per one unit if the serving size of a product in discrete
units in is more than one unit.
(14) If a product consists of assortments of meat, meat food
products, or poultry products (e.g., variety packs) in the same
package, nutrient content shall be expressed on the entire package
contents or on each individual product.
(15) If a product 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 product as
consumed in the format required in paragraph (e) of this section (e.g.,
a cream soup mix may be labeled with the percent Daily Value and
quantitative amounts for the dry mix alone (per serving), and the
percent Daily Value and quantitative amounts for the serving of the
final soup when prepared (e.g., per serving of cream soup mix and 1 cup
of vitamin D fortified whole milk)): 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.
(16)(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 display for small packages in paragraph
(g)(1)(i)(A) of this section or to products that meet the requirements
to use the linear format in paragraph (g)(1)(i)(B) of this section.
(B) 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
through 12 months and children 1 through 3 years of age), or to random-
weight products covered under paragraph (b)(10)(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 in accordance with paragraph
(b) 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 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. 413.313(p). 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 meat or meat food product or poultry product shall
contain information about the level of the following nutrients, except
for those nutrients whose inclusion, and the declaration of the
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 (g) 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 parenthesis 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
[[Page 6790]]
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 21 CFR, 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 per 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 per 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 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.
(i) ``Saturated fat'' or ``Saturated'': A statement of the number
of grams of saturated fat per serving defined as the sum of all fatty
acids containing no double bonds, except that label declaration of
saturated fat content information is not required for products that
contain less than 0.5 gram of total fat per serving if no claims are
made about fat, fatty acid, or cholesterol content, and if ``calories
from saturated fat'' is not declared. Saturated fat content shall be
indented and expressed as grams per serving to the nearest 0.5 (\1/2\)-
gram increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(A) [Reserved]
(B) [Reserved]
(ii) ``Trans Fat'' or ``Trans'': A statement of the number of grams
of trans fat in a serving, defined as the sum of all unsaturated fatty
acids that contain one or more isolated (i.e., nonconjugated) double
bonds in a trans configuration. The word ``trans'' may be italicized to
indicate its Latin origin. Trans fat content shall be indented and
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram
increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content, when
declared, shall be expressed as zero.
(iii) ``Polyunsaturated fat'' or ``Polyunsaturated'' (VOLUNTARY): A
statement of the number of grams of polyunsaturated fat per serving
defined as cis, cis-methylene-interrupted polyunsaturated fatty acids
may be declared voluntarily, except that when monounsaturated fat is
declared, or when a claim about fatty acids or cholesterol is made on
the label or in labeling of a product other than one that meets the
criteria in Sec. 413.362(b)(1) for a claim for ``fat free,'' label
declaration of polyunsaturated fat is required. Polyunsaturated fat
content shall be indented and expressed as grams per serving to the
nearest 0.5 (\1/2\)-gram increment below 5 grams and to the nearest
gram increment above 5 grams. If the serving contains less than 0.5
gram, the content shall be expressed as zero.
(iv) ``Monounsaturated fat'' or ``Monounsaturated'' (VOLUNTARY): A
statement of the number of grams of monounsaturated fat per serving
defined as cis-monounsaturated fatty acids may be declared voluntarily,
except that when polyunsaturated fat is declared, or when a claim about
fatty acids or cholesterol is made on the label or in labeling of a
product other than one that meets the criteria in Sec. 413.362(b)(1)
for a claim for ``fat free,'' label declaration of monounsaturated fat
is required. Monounsaturated fat content shall be indented and
expressed as grams per serving to the nearest 0.5 (\1/2\)-gram
increment below 5 grams and to the nearest gram increment above 5
grams. If the serving contains less than 0.5 gram, the content shall be
expressed as zero.
(3) ``Cholesterol'': A statement of the cholesterol content per
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 of
cholesterol per serving and make no claim about fat, fatty acids, or
cholesterol content, or such products may state the cholesterol content
as zero. If the product 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
per serving 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.
(6) ``Carbohydrate, total'' or ``Total carbohydrate'': A statement
of the number of grams of total carbohydrate per 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 product. This
calculation method is described in USDA Handbook No. 74 (slightly
revised, 1973), pp. 2-3.
[[Page 6791]]
(i) ``Dietary fiber'': A statement of the number of grams of total
dietary fiber per 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 21 CFR 101.81(c)(2)(ii)(A)), psyllium husk (as
described in 21 CFR 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
(h) 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 per serving may be declared voluntarily
except when a claim is made on the label or in labeling about soluble
fiber, label declaration shall be required. Soluble fiber must meet the
definition of dietary fiber in this paragraph (c)(6)(i). The
manufacturer must maintain records in accordance with paragraph (h)(8)
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 per serving may be declared
voluntarily except 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 paragraph (h)(8) 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
per serving, except that the label declaration of sugars content is not
required for products that contain less than 1 gram of sugars per
serving if no claims are made about sweeteners, sugars, or sugar
alcohol content. 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. 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 maintain records in accordance with paragraph
(h)(8) 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 per serving may be declared voluntarily on the
label, except that when a claim is made on the label or in labeling
about sugar alcohol, total sugars, or added sugars when sugar alcohols
are present in the product, 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 product may
be used in the nutrition label, provided that only one sugar alcohol is
present in the product. 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 per
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 products represented or
[[Page 6792]]
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 product 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 ``%Daily Value'' of the corrected amount of protein per
serving, as determined in paragraph (c)(7)(ii) of this section,
calculated as a percentage of the Daily Reference Value (DRV) or
Reference Daily Intake (RDI), as appropriate, for protein and expressed
as percent of Daily Value. When the protein quality in a product as
measured by the Protein Efficiency Ratio (PER) is less than 40 percent
of the reference standard (casein) for a product 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 of 6.25 times the nitrogen
content of the food as determined by appropriate methods of analysis in
accordance with Sec. 413.309(h), except when the procedure for a
specific food requires a specific factor other than 6.25, that 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 of age or children 1 through 3 years of age.
When such a declaration is provided, it shall be placed on the label
adjacent to the statement of grams of protein and aligned under the
column headed ``%Daily Value,'' and expressed to the nearest whole
percent. However, the percentage of the RDI for protein shall not be
declared if the product 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 (grams) per serving'' for
products represented or purported to be for adults and children 1 or
more years of age is equal to the actual amount of protein (grams) 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 products 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 product's
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) through (g) of this section, products
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
products represented or purported to be specifically for both infants
through 12 months 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 and for 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 products 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
added 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, 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 in labeling 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 product; or
(B) Included in a product solely for technological purposes and
declared only in the ingredients 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
[[Page 6793]]
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) 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
---------------------------------------------------------------
Nutrient Unit of measure Adults and Infants \1\ Children 1 Pregnant women
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\.
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 micrograms 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 additional
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 parenthesis immediately
following the name of the nutrient or dietary component:
Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
(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
[[Page 6794]]
of vitamin A and the percent of Daily Value of vitamin A in the product
(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
product the nutrient name ``folate'' shall be listed for products
containing folate (natural folate, and/or synthetic folate), 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)
and the percent Daily Value based on folate in mcg DFE, or 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:
----------------------------------------------------------------------------------------------------------------
DRV
---------------------------------------------------------------
Food component Unit of Adults and Infants Children 1 Pregnant women
measurement children >=4 through 12 through 3 and lactating
years months years women
----------------------------------------------------------------------------------------------------------------
Fat........................... Grams (g)....... \1\ 78 30 \2\ 39 \1\ 78
Saturated fatty acids......... 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 products in the following format, as
shown in paragraph (d)(12) of this section, except on foods where the
horizontal 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 permitted 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 Sec. 413.400(c), and on foods in small or
intermediate-sized packages as provided for in paragraph (g) of this
section.
(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) 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, and
(D) Letters should never touch.
(iii) Information required in paragraphs (d)(7) and (d)(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)(iii), (e)(6)(ii), and (g)(1)(i)(A) of this section, and the
linear display for small packages as shown in paragraph (g)(1)(i)(B) of
this section shall be in a type size no smaller than 10 point. 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 (g)(1)(i)(A) of this section, and for the linear
display for small packages as shown in paragraph (g)(1)(i)(B) 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 of Daily Value
required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from
the nutrient and percent of Daily Value above and below it, as shown in
paragraph (d)(12) of this section.
(2) The information shall be presented under the identifying
heading of ``Nutrition Facts'' which shall be set in a type size 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)(iii),
[[Page 6795]]
(d)(13)(ii), (e)(6)(ii), (g)(1)(i)(A) and (g)(1)(i)(B) 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)(8) of this section or on single-
ingredient, raw products that are not ground or chopped products
described in Sec. 413.301. 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 (g)(1)(i)(A) of this
section and the linear display for small packages as shown in paragraph
(g)(1)(i)(B) of this section. For the linear display for small packages
as shown in paragraph (g)(1)(i)(B) 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)(9) of this section 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 (g)(1)(i)(A) of this section, and the
linear display for small packages as shown in paragraph (g)(1)(i)(B) 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 than 8 point
may be used on packages of any size.
(4) A subheading ``Amount per serving'' shall be separated from
serving size information by a bar as shown in paragraph (d)(12) of this
section, 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. ``Per__'' (e.g., per \1/2\ a burrito)'' is required for dual
column formats.
(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 (g)(1)(i)(B) of this
section, and except as permitted by Sec. 413.400(d)(2), 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 or ``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
shall 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 percentage
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,'' ``no calories,''
``zero calories,'' ``without calories,'' ``trivial source of
calories,'' ``negligible source of calories,'' or ``dietarily
insignificant source of calories'' on the label or in the labeling of
foods as defined in 9 CFR 413.360(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 than
can use 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'' on the label or in the labeling of
foods as defined in 9 CFR 413.360(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), separated from that information by a
hairline. This information may be presented horizontally (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)
[[Page 6796]]
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 of 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 of 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 inches) 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 horizontal display
as shown in the following sample label.
[GRAPHIC] [TIFF OMITTED] TP19JA17.002
(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 6797]]
[GRAPHIC] [TIFF OMITTED] TP19JA17.003
(13)(i) Nutrition labeling on the outer label of packages of
products that contain two or more products in the same packages (e.g.,
variety packs) or of packages that are used interchangeably for the
same type of food (e.g., meat salad containers, poultry salad
containers) may use an aggregate display.
(ii) Aggregate displays shall comply with format requirements of
paragraph (d) of this section to the maximum extent possible, except
that the identity of each food shall be specified 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 6798]]
[GRAPHIC] [TIFF OMITTED] TP19JA17.004
(14) When nutrition labeling appears 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 product (e.g., both ``as purchased'' and ``as prepared'') or
for common combinations of foods as provided for in paragraph (b) of
this section, for different units (e.g., per nugget 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 (c)(8)(i) 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 product (e.g., ``raw'' and ``roasted''), the
combinations of foods, 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 (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) but
may be on the basis of 'as consumed' for single-ingredient, raw
products that are not ground or chopped products described in Sec.
413.301, and according to the label serving size based on the Reference
Amount in Sec. 413.312(b).
(3) When the dual labeling is presented for two or more forms of
the same food, for combinations of food, for different units, or for
two or more groups for which RDIs are established, 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:
[[Page 6799]]
[GRAPHIC] [TIFF OMITTED] TP19JA17.005
(6) When dual labeling is presented for a food on a per serving
basis and per container basis as required in paragraph (b)(16)(i) of
this section or on a per serving basis and per unit basis as required
in paragraph (b)(4)(iv) of this section, the quantitative information
by weight as required in (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.
[GRAPHIC] [TIFF OMITTED] TP19JA17.006
(ii) The following sample label illustrates the provisions of
paragraphs (b)(4)(iv) and (b)(16)(i) of this section for labels that
use the dual column format in the horizontal display.
[[Page 6800]]
[GRAPHIC] [TIFF OMITTED] TP19JA17.007
(f)(1) The declaration of nutrition information may be presented in
the simplified format as set forth herein when any required nutrients,
other than the core nutrients (i.e., calories, total fat, sodium, total
carbohydrate, and protein), are present in insignificant amounts. An
insignificant amount shall be defined as that amount that may be
rounded to zero in nutrition labeling, except that for total
carbohydrate, dietary fiber, total sugars, added sugars, and protein,
it shall be an amount less than 1 gram.
(2) The simplified format shall include information on the
following nutrients:
(i) Total calories, total fat, sodium, total carbohydrate, and
protein;
(ii) Any of the following that are present in more than
insignificant amounts: saturated fat, trans fat, cholesterol, dietary
fiber, total sugars, added sugars, vitamin D, calcium, iron, and
potassium; and
(iii) Any vitamins and minerals listed in paragraph (c)(8)(iv) of
this section when they are added in fortified or fabricated foods.
(3) Other nutrients that are naturally present in the product in
more than insignificant amounts may be voluntarily declared as part of
the simplified format.
(4) Any required nutrient, other than a core nutrient, that is
present in an insignificant amount may be omitted from the columnar
listing, provided that the following statement is included at the
bottom of the nutrition label, ``Not a significant source of __.'' The
blank shall be filled in with the appropriate nutrient or food
component. Alternatively, amounts of vitamins and minerals present in
insignificant amounts may be declared by the use of an asterisk (or
symbol) that is placed at the bottom of the table of nutrient values
and that is followed by the statement ``Contains less than 2 percent of
the Daily Value of this (these) nutrient (nutrients).''
(5) Except as provided for in paragraph (g) of this section and in
Sec. 413.400(c) and (d), 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 the following example that illustrates
the simplified display
[GRAPHIC] [TIFF OMITTED] TP19JA17.008
(g) 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) of this section and Sec. 413.302(a) by
one or more of the following means:
(1)(i) Presenting the required nutrition information in a tabular
or linear 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 package shape or size will not accommodate a tabular
display.
(A) The following sample label illustrates the tabular display for
small packages.
[[Page 6801]]
[GRAPHIC] [TIFF OMITTED] TP19JA17.009
(B) The following sample label illustrates the linear display.
[GRAPHIC] [TIFF OMITTED] TP19JA17.010
(2) 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
(3) Omitting the footnote statement and placing another asterisk at
the bottom of the label followed by the statement ``%DV=%Daily Value.''
(4) Presenting the required nutrition information on any other
label panel.
(h) Compliance with this section shall be determined as follows:
(1) A production lot is a set of food production consumer units
that are from one production shift. Alternatively, a collection of
consumer units of the same size, type, and style produced under
conditions as nearly uniform as possible, designated by a common
container code or marking, constitutes a production lot.
(2) The sample for nutrient analysis shall consist of a composite
of a minimum of six consumer units, each from a production lot.
Alternatively, the sample for nutrient analysis shall consist of a
composite of a minimum of six consumer units, each randomly chosen to
be representative of a production lot. In each case, the units may be
individually analyzed and the results of the analyses averaged, or the
units would be composited and the composite analyzed. In both cases,
the results, whether an average or a single result from a composite,
will be considered by the Agency to be the nutrient content of a
composite. All analyses shall be performed by appropriate methods and
procedures used by the Department for each nutrient in accordance with
the ``Chemistry Laboratory Guidebook,'' or, if no USDA method is
available and appropriate for the nutrient, by appropriate methods for
the nutrient in accordance with the 2016 edition of the ``Official
Methods of Analysis'' of the AOAC International, unless a particular
method of analysis is specified in Sec. 413.309(c), or, if no USDA,
AOAC, or specified method is available and appropriate, by other
reliable and appropriate analytical procedures as so determined by the
Agency.
(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 product 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 1(n) of the Federal Meat Inspection Act (21
U.S.C. 601(n)(1)) or 4(h) of the Poultry Products Inspection Act (21
U.S.C. 453(h)) 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 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, 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 product at the level involved.
(5) A product 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 1(n) of the Federal Meat
Inspection Act (21 U.S.C. 601(n)(1)) or 4(h) of the Poultry Products
Inspection
[[Page 6802]]
Act (21 U.S.C. 453(h)) 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 product at the level involved, and
inherent nutrient variation in a product.
(6) The amount of vitamins, minerals, protein, total carbohydrate,
dietary fiber, soluble fiber, insoluble fiber, sugar alcohols,
polyunsaturated or monounsaturated fat may vary over labeled amounts
within good manufacturing practice. The amount of calories, sugars,
added sugars, total fat, saturated fat, trans fat, cholesterol, or
sodium may vary under labeled amounts within good manufacturing
practice.
(7) Compliance will be based on the metric measure specified in the
label statement of the serving size.
(8) The management of the official establishment or establishment
certified under a foreign inspection system, in accordance with parts
327 and 381, subpart T, of this chapter must maintain records in
accordance with parts 320 and 381, subpart Q, of this chapter to
support the validity of nutrient declarations contained on product
labels including the records in subparagraphs (h)(8)(i)-(vii) of this
section for documenting the amount of dietary fiber, soluble fiber,
insoluble fiber, added sugars, tocopherol, folate, and folic acid. Such
records shall be made available to the inspector or any duly authorized
representative of the Agency upon request.
(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 maintain 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 food, a manufacturer must maintain 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 maintain 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 maintain 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 the process of yeast-leavening, non-enzymatic browning or
fermentation, manufacturers must:
(A) Maintain records of all relevant scientific data and
information relied upon by the manufacturer that demonstrates the
amount of added sugars in the food after the process of non-enzymatic
browning, yeast-leavening, fermentation, or the manufacture of reaction
flavors 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 or
fermentation; or
(B) Maintain 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 request to FSIS to use an alternative means of
compliance. The request must provide scientific data or other
information for why the amount of added sugars in a serving of 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 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 Sec. 413.309(h)(6). 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 maintain 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 maintain 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.
(9) The compliance provisions set forth in paragraph (h)(1) through
(8) of this section shall not apply to single-ingredient, raw products
that are not ground or chopped products described in Sec. 413.301,
including those that have been previously frozen, when nutrition
labeling is based on the most current representative data base values
contained in USDA's National Nutrient Data Bank or its released form,
the USDA National Nutrient Database for Standard Reference as provided
in Sec. 413.345(e) and (f).
(i) 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 the FSIS Docket
Clerk, Room 8-164A, Patriots Plaza 3, 355 E Street SW., Washington, DC,
and is available from the sources indicated below. It is also available
for inspection at the National Archives and Records Administration
(NARA), call 202-741-6030, or go to http://www.archives.gov/federal_register/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]. FSIS does not endorse any
particular reseller and notes that other resellers also may have the
reference for sale.
(i) ``Official Methods of Analysis of the AOAC INTERNATIONAL,''
20th Edition, Volumes 1 and 2, 2016.
(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:/
/
[[Page 6803]]
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]
Sec. Sec. 413.310-413.311 [Reserved]
Sec. 413.312 Reference amounts customarily consumed per eating
occasion.
(a) The general principles followed in arriving at the reference
amounts customarily consumed per eating occasion (Reference Amounts),
as set forth in paragraph (b) of this section, are:
(1) The Reference Amounts are calculated 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) The Reference Amounts are calculated for an infant or child
under 4 years of age to reflect the amount of food customarily consumed
per eating occasion by infants through 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 product is
specially formulated or processed for use by an infant through 12
months of age 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, the mean, median, and mode of the consumed amount per eating
occasion were considered.
(5) When survey data were insufficient, FSIS took various other
sources of information on serving sizes of food into consideration.
These other sources of information included:
(i) Serving sizes used in dietary guidance recommendations or
recommended by other authoritative systems or organizations;
(ii) Serving sizes recommended in comments;
(iii) Serving sizes used by manufacturers and grocers; and
(iv) Serving sizes used by other countries.
(6) Because they reflect the amount customarily consumed, the
Reference Amount and, in turn, the serving size declared on the product
label are based on only the edible portion of food, and not bone, seed,
shell, or other inedible components.
(7) The Reference Amount is based on the major intended use of the
product (e.g., a mixed dish measurable with a cup as a main dish and
not as a side dish).
(8) The Reference Amounts for products that are consumed as an
ingredient of other products, but that may also be consumed in the form
in which they are purchased (e.g., ground beef), are based on use in
the form purchased.
(9) FSIS sought to ensure that foods that have similar dietary
usage, product characteristics, and customarily consumed amounts have a
uniform Reference Amount.
(b) The following Product Categories and Reference Amounts shall be
used as the basis for determining serving sizes for specific products:
Table 1--Meat and Poultry Product Reference Amounts Customarily Consumed per Eating Occasion: Foods for Infants
and Young Children 1 Through 3 Years of Age 1 2 3
----------------------------------------------------------------------------------------------------------------
Reference
Product category amount (g) Label statement \4\
----------------------------------------------------------------------------------------------------------------
Infant and Toddler Foods:
Dinner Dry Mix....................... 15 _tbsp(s) (_g); cup(s) (_g).
Dinner, ready-to-serve, strained type 110 _cup(s) (_g);_cup(s) (mL).
Dinner, soups, ready-to-serve, junior 110 _cup(s) (_g); cup(s) (_mL).
type.
Dinner, stew or soup, ready-to-serve 170 _cup(s) (_g); cup(s) (_mL).
young children.
Plain meats, plain poultry, meat 55 2 oz (56g); _link(s) (_g).
sticks, poultry sticks, ready to
serve.
----------------------------------------------------------------------------------------------------------------
\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 and updated by the U.S. Department of Agriculture based on 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., dehydrated cereal) is the amount required to make one
Reference Amount of the prepared form. Prepared means prepared for consumption (e.g., ready to serve).
\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 established by the regulation.
\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., patty for patties, link for links, etc.).
[[Page 6804]]
Table 2--Meat and Poultry Product Reference Amounts Customarily Consumed per Eating Occasion: General Food
Supply 1 2 3 4 5
----------------------------------------------------------------------------------------------------------------
Reference amount Reference amount
Product category -------------------------------------------------- Label statement \6\
Ready-to-serve Ready-to-cook
----------------------------------------------------------------------------------------------------------------
Egg mixtures with meat or poultry; 110 g.................. n/a.................... 4 oz (112g); _piece(s)
e.g., western style omelet, (_g).
souffl[eacute], egg foo young.
Lard, margarine, shortening.......... 1 tbsp................. n/a.................... 1 tbsp (_g).
Salad and potato toppers; e.g., bacon 7 g.................... n/a.................... _tbsp (_g).
bits, poultry bacon bits.
Bacon; e.g., bacon, beef breakfast 15 g................... 54 g = bacon, pork _piece(s) (_g) _pieces
strips, pork breakfast strips, pork rinds, pork back fat; pan fried (_g).
rinds, pork back fat. 30 g = meat breakfast
strips.
Poultry bacon, poultry breakfast 15 g................... 26 g = poultry bacon; _piece(s) (_g); _pieces
strips. 18 g = poultry pan fried (_g).
breakfast strips.
Dried meat or poultry products; e.g., 30 g................... n/a.................... _piece(s) (_g);
jerky, dried beef or poultry, Parma _slice(s) (_g); 2 oz
ham, meat or poultry sausage (28g).
products with a moisture/protein
ratio of less than 2:1; e.g.,
pepperoni.
Snacks; e.g., meat or poultry snack 30 g................... n/a.................... _piece(s) (_g); 2 oz
food sticks. (28g).
Luncheon products, luncheon meat, 55 g................... n/a.................... _slice(s) (_g);
bologna, poultry bologna, Canadian _piece(s) (_g); _cup
style bacon, poultry Canadian style (_g); 2 oz (56g).
bacon, meat or poultry pattie
crumbles, blood pudding, meat or
poultry luncheon loaf, old fashioned
loaf, berlinger, bangers, minced
luncheon roll, thuringer, liver
sausage, mortadella, uncured sausage
(franks), ham and cheese loaf, P&P
loaf, scrapple souse, head cheese,
pizza loaf, olive loaf, pate,
deviled ham, sandwich spread,
teawurst, cervelat, Lebanon bologna,
potted meat or poultry food product,
taco fillings, pie fillings.
Linked meat or poultry sausage 55 g................... n/a.................... _slice(s) (_g);
products, Vienna sausage, 75 g = uncooked meat _piece(s) (_g); _oz
frankfurters, poultry franks, pork sausage; 69 g = (_g).
sausage, imitation frankfurters, uncooked poultry
bratwurst, kielbasa, Polish sausage, sausage.
poultry Polish sausage, summer
sausage, mettwurst, smoked country
sausage, smoked sausage, poultry
smoked sausage, smoked pickled meat
or poultry meat, pickled pigs feet.
Entrees without sauce; e.g., cuts of 85 g................... 114 g.................. _piece(s) (_g);
meat or poultry including marinated, _slice(s) (_g); _oz
tenderized, injected cuts of meat or (_g); _cup (_g).
poultry, patties, corn dogs,
croquettes, fritters, cured ham, dry
cured ham, dry cured cappicola,
cured poultry ham products, corned
beef, pastrami, country ham, pork
shoulder picnic, meatballs, pureed
adult foods.
Appetizers, hors d'oeuvres--Mini 85 g (add 35 g for n/a.................... _piece(s) (_g);
mixed dishes with meat or poultry; products with gravy or _piece(s) plus sauce
e.g., mini bagel pizzas, mini egg sauce toppings). (_g).
rolls, dumplings, mini pizza rolls,
mini quesadilla, mini quiche.
Appetizers, hors d'oeuvres--Dips with 2 tbsp................. n/a.................... 2 tbsp (_g).
meat or poultry; e.g., chicken dip,
chicken and cheese dip, meat dip.
Canned meats (e.g., canned beef, 85 g................... n/a.................... _cup (_g); 3 oz (84g).
canned pork) and Canned Poultry
(e.g., canned chicken, canned
turkey).
Entrees with sauce; e.g., barbecued 140 g.................. n/a.................... _cup (_g); 2 oz (56g).
meat or poultry in sauce, meat or
poultry and gravy.
Mixed dishes NOT measurable with a 140 g (add 55 g for n/a.................... _piece(s) (_g);
cup; e.g., burrito, egg roll, products with gravy or _piece(s) plus sauce
enchilada, pizza, pizza roll, sauce toppings). (_g); 5 oz (140g); _oz
quiche, all types of sandwiches with (_g).
meat or poultry, cracker and meat/
poultry lunch type packages, gyro,
Stromboli, burger on a bun, poultry
burger on a bun, frank on a bun,
poultry frank on a bun, calzone,
taco, stuffed pockets, foldovers,
stuffed vegetables with meat or
poultry, shish kabobs, empanada,
chicken cordon bleu.
[[Page 6805]]
Mixed dishes measurable with a cup; 1 cup.................. n/a.................... 1 cup (_g).
e.g., casserole, macaroni and cheese
with meat or poultry, pot pie,
spaghetti with sauce, poultry
spaghetti with sauce, meat or
poultry chili, meat or poultry chili
with beans, hash, creamed chipped
beef, creamed dried poultry, ravioli
in sauce, stroganoff, Brunswick
stew, goulash, poultry a la king,
meat or poultry stew, ragout, meat
or poultry lasagna, meat or poultry
filled pasta.
Salads--pasta or potato, potato salad 140 g.................. n/a.................... _cup (_g).
with bacon, potato salad with
poultry, macaroni and meat or
poultry salad.
Salads--all other meat salads, all 100 g.................. n/a.................... _cup (_g).
other poultry salads; e.g., chicken
salad, ham salad, turkey salad.
Soups with meat or poultry--all 245 g.................. n/a.................... _cup (_g).
varieties.
Major main entr[eacute]e type sauce; 125 g.................. n/a.................... _cup (_g); _meatballs
e.g., spaghetti sauce with meat or plus _cup sauce (_g).
poultry, spaghetti sauce with
meatballs, spaghetti sauce with
poultry meatballs.
Minor main entr[eacute]e sauce; e.g., 1/4 c.................. n/a.................... 1/4 c (_g).
pizza sauce with meat or poultry,
gravy.
Seasoning mixes dry, bases, extracts,
dried broths and stock/juice, freeze
dry trail mix products with meat or
poultry.
As reconstituted:
Amount to make one Reference
Amount of the final dish; e.g.,.
Gravy........................ \1/4\ c................ n/a.................... \1/4\ c (_g);
Major main entr[eacute]e type 125 g.................. n/a.................... _cup (125 g);
sauce.
Soup......................... 245 g.................. n/a.................... _cup (245 g);
Entr[eacute]e measurable with 1 cup.................. n/a.................... 1 cup (_g).
a cup.
Candies with meat or poultry; e.g., 30 g................... n/a.................... _squares (_g); _pieces
chocolate with bacon, chocolate (_g); 1 oz (28g).
dipped bacon, chocolate with salami.
----------------------------------------------------------------------------------------------------------------
\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 by U.S. Department of Agriculture based on 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\ Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure
most appropriate to their specific product using the procedures established by regulation.
\3\ Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist
manufacturers in identifying appropriate product Reference.
\4\ 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 chicken with broth).
\5\ Pizza sauce is part of the pizza and is not considered to be a sauce topping.
\6\ The label statements are meant to provide examples of serving size statements that may be used on the label,
but that 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., patty for patties, meatballs for meatballs, link for links,
etc.). 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. 413.309(b) using the reference amount
determined according to Sec. 413.412(b).
(c) 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., lunch meat with cheese and crackers), 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.,
lunchmeat) 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., ingredients in equal volumes such as
tablespoons). If the Reference Amounts are in incompatible units, all
amounts must be converted to weights and summed (e.g., grams of one
ingredient plus gram weight of tablespoons of a second ingredient).
(d) 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 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
[[Page 6806]]
established in paragraph (b) of this section.
(e) The Reference Amount for an imitation or substitute product or
altered product as defined in Sec. 413.313(d), such as a ``low
calorie'' version, shall be the same as for the product for which it is
offered as a substitute.
(f) The Reference Amounts set forth in paragraphs (b) through (e)
of this section shall be used in determining whether a product meets
the criteria for nutritional claims. If the serving size declared on
the product label differs from the Reference Amount, and the product
meets the criteria for the claim only on the basis of the Reference
Amount, the claim shall be followed by a statement that sets forth the
basis on which the claim is made. That statement shall include the
Reference Amount as it appears in paragraph (b) of this section
followed, in parentheses, by the amount in common household measure if
the Reference Amount is expressed in measures other than common
household measures.
(g) The Administrator, on his or her own initiative or on behalf of
any interested person who has submitted a labeling application, may
issue a proposal to establish or amend a Product Category or Reference
Amount identified in paragraph (b) of this section.
(1) Labeling applications and supporting documentation to be filed
under this section shall be submitted in quadruplicate, except that the
supporting documentation may be submitted on a computer disc copy. If
any part of the material submitted is in a foreign language, it shall
be accompanied by an accurate and complete English translation. The
labeling application shall state the applicant's post office address.
(2) Pertinent information will be considered as part of an
application on the basis of specific reference to such information
submitted to and retained in the files of the Food Safety and
Inspection Service. 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.
(3) The availability for public disclosure of labeling
applications, along with supporting documentation, submitted to the
Agency under this section will be governed by the rules specified in
subchapter D, title 9.
(4) Data accompanying the labeling application, such as food
consumption data, shall be submitted on separate sheets, suitably
identified. If such data has already been submitted with an earlier
labeling application from the applicant, the present labeling
application must provide the data.
(5) The labeling application must be signed by the applicant or by
his or her attorney or agent, or (if a corporation) by an authorized
official.
(6) The labeling application shall include a statement signed by
the person responsible for the labeling application, that to the best
of his or her knowledge, it is a representative and balanced submission
that includes unfavorable information, as well as favorable
information, known to him or her pertinent to the evaluation of the
labeling application.
(7) Labeling applications for a new Reference Amount and/or Product
Category shall be accompanied by the following data which shall be
submitted in the following form to the Director, Labeling and Program
Delivery Staff, Office of Policy and Program Development, Food Safety
and Inspection Service, Washington, DC 20250:
(Date)
The undersigned, _____ submits this labeling application
pursuant to 9 CFR 413.312 with respect to Reference Amount and/or
Product Category.
Attached hereto, in quadruplicate, or on a computer disc copy,
and constituting a part of this labeling application, are the
following:
(i) A statement of the objective of the labeling application;
(ii) A description of the product;
(iii) A complete sample product label including nutrition label,
using the format established by regulation;
(iv) A description of the form in which the product will be
marketed;
(v) The intended dietary uses of the product with the major use
identified (e.g., ham as a luncheon meat, turkey as a luncheon
meat);
(vi) 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;
(vii) The population group for which the product will be offered
for use (e.g., infants through 12 months, children under 4 years of
age);
(viii) 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);
(ix) The suggested Reference Amount (the amount of edible
portion of food as consumed, excluding bone, skin 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.
(x) The suggested Reference Amount shall be expressed in metric
units. Reference Amounts for 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
mixed dishes measurable with a cup.
(A) In expressing the Reference Amount in grams, the following
general rules shall be followed:
(1) For quantities greater than 10 grams, the quantity shall be
expressed in nearest 5 grams increment.
(2) For quantities less than 10 grams, exact gram weights shall
be used.
(B) [Reserved]
(xi) A labeling application for a new subcategory of food with
its own Reference Amount shall include the following additional
information:
(A) 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 product
identified in the labeling application and for other products in the
category. All data must be derived from the same survey data.
(B) Documentation supporting the difference in dietary usage and
product characteristics that affect the consumption size that
distinguishes the product identified in the labeling application
from the rest of the products in the category.
(xii) In conducting research to collect or process food
consumption data in support of the labeling application, the
following general guidelines should be followed.
(A) Sampled population selected should be representative of the
demographic and socioeconomic characteristics of the target
population group for which the food is intended.
(B) Sample size (i.e., number of eaters) should be large enough
to give reliable estimates for customarily consumed amounts.
(C) 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.
(D) The methodology used to collect or process data including
study design, sampling procedures, materials used (e.g.,
questionnaire, interviewer's manual), procedures used to collect or
process data, methods or procedures used to control for unbiased
estimates, and procedures used to
[[Page 6807]]
correct for nonresponse, should be fully documented.
(xiii) A statement concerning the feasibility of convening
associations, corporations, consumers, and other interested parties
to engage in negotiated rulemaking to develop a proposed rule.
Yours very truly,
Applicant--------------------------------------------------------------
By---------------------------------------------------------------------
(Indicate authority)
(8) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall
inform the applicant that the labeling application is undergoing Agency
review and that the applicant shall subsequently be notified of the
Agency's decision to consider for further review or deny the labeling
application.
(9) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(10) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
Reference Amount or Product Category is false or misleading. The
notification letter shall inform the applicant that the applicant may
submit a written statement by way of answer to the notification, and
that the applicant shall have the right to request a hearing with
respect to the merits or validity of the Administrator's decision to
deny the use of the proposed Reference Amount or Product Category.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(11) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish in the Federal Register
a proposed rule to amend the regulations to authorize the use of the
Reference Amount or Product Category. The proposal shall also summarize
the labeling application, including where the supporting documentation
can be reviewed. The Administrator's proposed rule shall seek comment
from consumers, the industry, consumer and industry groups, and other
interested persons on the labeling application and the use of the
proposed Reference Amount or Product Category. After public comment has
been received and reviewed by the Agency, the Administrator shall make
a determination on whether the proposed Reference Amount or Product
Category shall be approved for use on the labeling of meat food
products or poultry food products.
(i) If the Reference Amount or Product Category is denied by the
Administrator, the Agency shall notify the applicant, in writing, of
the basis for the denial, including the reason why the Reference Amount
or Product Category on the labeling was determined by the Agency to be
false or misleading. The notification letter shall also inform the
applicant that the applicant may submit a written statement by way of
answer to the notification, and that the applicant shall have the right
to request a hearing with respect to the merits or validity of the
Administrator's decision to deny the use of the proposed Reference
Amount and/or Product Category.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of an answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the Reference Amount or Product Category is approved, the
Agency shall notify the applicant, in writing, and shall also publish
in the Federal Register a final rule amending the regulations to
authorize the use of the Reference Amount or Product Category.
Sec. 413.313 Nutrient content claims; general principles.
(a) This section applies to meat, meat food products, or poultry
products that are intended for human consumption and that are offered
for sale.
(b) A claim which, expressly or by implication, characterizes the
level of a nutrient (nutrient content claim) of the type required in
nutrition labeling pursuant to Sec. 413.309, may not be made on a
label or in labeling of that product unless the claim is made in
accordance with the applicable provisions in this part.
(1) An expressed nutrient content claim is any direct statement
about the level (or range) of a nutrient in the product, e.g., ``low
sodium'' or ``contains 100 calories.''
(2) An implied nutrient content claim is any claim that:
(i) Describes the product 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 product, 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 products intended specifically for use by infants through 12
months and children less than 2 years of age unless the claim is
specifically provided for in this part.
(4) Reasonable variations in the spelling of the terms defined in
applicable provisions in this part and their synonyms are permitted
provided these variations are not misleading (e.g., ``hi'' or ``lo'').
(c) Information that is required or permitted by Sec. 413.309 to
be declared in nutrition labeling, and that appears as
[[Page 6808]]
part of the nutrition label, is not a nutrient content claim and is not
subject to the requirements of this section. If such information is
declared elsewhere on the label or in labeling, it is a nutrient
content claim and is subject to the requirements for nutrient content
claims.
(d) A ``substitute'' product is one that may be used
interchangeably with another product 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 product, the product 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. 317.2(h) or Sec. 381.121(c)
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 statement shall be
no less than one-half the size of the claim but no smaller than \1/16\-
inch minimum height, except as permitted by Sec. 413.400(d)(2).
(e)(1) Because the use of a ``free'' or ``low'' claim before the
name of a product implies that the product differs from other products
of the same type by virtue of its having a lower amount of the
nutrient, only products that have been specially processed, altered,
formulated, or reformulated so as to lower the amount of the nutrient
in the product, remove the nutrient from the product, or not include
the nutrient in the product, may bear such a claim (e.g., ``low sodium
beef noodle soup'', ``low sodium chicken noodle soup'').
(2) Any claim for the absence of a nutrient in a product, or that a
product is low in a nutrient when the product has not been specially
processed, altered, formulated, or reformulated to qualify for that
claim shall indicate that the product inherently meets the criteria and
shall clearly refer to all products of that type and not merely to the
particular brand to which the labeling attaches (e.g., ``lard, a sodium
free food'', ``chicken breast meat, a low sodium food'').
(f) A nutrient content claim shall be in type size and style no
larger than two times that of the statement of identity and shall not
be unduly prominent in type style compared to the statement of
identity.
(g) Labeling information required in Sec. Sec. 413.313, 413.354,
413.356, 413.360, 413.361, 413.362, and 413.380, whose type size is not
otherwise specified, is required to be in letters and/or numbers no
less than \1/16\ inch in height, except as permitted by Sec.
413.400(d)(2).
(h) [Reserved]
(i) Except as provided in Sec. 413.309 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 product implicitly
characterizes the level of the nutrient in the product and is
consistent with a definition for a claim, as provided in this part, for
the nutrient that the label addresses. Such a claim might be, ``less
than 10 g of fat per serving;''
(2) The use of the statement on the product implicitly
characterizes the level of the nutrient in the product and is not
consistent with such a definition, but the label carries a disclaimer
adjacent to the statement that the product is not ``low'' in or a
``good source'' of the nutrient, such as ``only 200 milligrams (mg)
sodium per serving, not a low sodium product.'' The disclaimer must be
in easily legible print or type and in a size no less than required by
Sec. 317.2(h) or Sec. 381.121(c) for the net quantity of contents,
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 statement shall be no less than one-half the size of the
claim but no smaller than \1/16\-inch minimum height, except as
permitted by Sec. 413.400(d)(2);
(3) The statement does not in any way implicitly characterize the
level of the nutrient in the product 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. 413.362(b)(6).
(j) A product may bear a statement that compares the level of a
nutrient in the product with the level of a nutrient in a reference
product. 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 product must be compared to an amount of
nutrient in an appropriate reference product as specified in this
paragraph (j).
(i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the
reference product may be a dissimilar product within a product category
that can generally be substituted for one another in the diet or a
similar product.
(B) For ``light,'' ``reduced,'' and ``added'' claims, the reference
product shall be a similar product, and
(ii)(A) For ``light'' claims, the reference product shall be
representative of the type of product that includes the product that
bears the claim. The nutrient value for the reference product shall be
representative of a broad base of products 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 product 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 product 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,
provided the name of the competitor is not used on the labeling of the
product. 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 labeling is internally consistent
(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 product 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 products bearing relative claims:
(i) The label or labeling must state the identity of the reference
product and the percent (or fraction) of the amount of the nutrient in
the reference product by
[[Page 6809]]
which the nutrient has been modified, (e.g., ``50 percent less fat than
`reference product' '' or ``\1/3\ fewer calories than `reference
product' ''); and
(ii) This information shall be immediately adjacent to the most
prominent claim in easily legible boldface print or type, in distinct
contrast to other printed or graphic matter, that is no less than that
required by Sec. 317.2(h) or Sec. 381.121(c) for net quantity of
contents, 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 referral statement shall be no less than one-half the size of the
claim, but no smaller than \1/16\-inch minimum height, except as
permitted by Sec. 413.400(d)(2).
(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 size with
that in the reference product; and
(B) This statement shall appear adjacent to the most prominent
claim or to the nutrition information.
(3) A relative claim for decreased levels of a nutrient may not be
made on the label or in labeling of a product if the nutrient content
of the reference product meets the requirement for a ``low'' claim for
that nutrient.
(k) The term ``modified'' may be used in the statement of identity
of a product 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 `product'
''). This statement of identity must be immediately followed by the
comparative statement such as ``contains 35 percent less fat than
`reference product.' '' 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-type'' product will be
defined as a product that:
(1) Makes a major contribution to the diet by:
(i) Weighing at least 10 ounces per labeled serving; and
(ii) Containing not less than three 40 gram 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;
(B) Fruits and vegetables;
(C) Milk, yogurt, and cheese;
(D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
(E) These foods will not be sauces (except for foods in the four
food groups in paragraph (l)(1)(ii)(A) through (D) of this section,
that are in the sauces), gravies, condiments, relishes, pickles,
olives, jams, jellies, syrups, breadings, or garnishes; and
(2) Is represented as, or is in the form commonly understood to be,
a breakfast, lunch, dinner, meal, or entree. Such representations may
be made by statements, photographs, or vignettes.
(m) For purposes of making a claim, a main-dish product will be
defined as a food that:
(1) Makes a major contribution to the meal by:
(i) Weighing at least 6 ounces per labeled serving; and
(ii) Containing not less than 40 grams of food, or combinations of
foods, from two or more of the following four food groups, except as
noted in paragraph (m)(1)(ii)(E) of this section.
(A) Bread, cereal, rice, and pasta;
(B) Fruits and vegetables;
(C) Milk, yogurt, and cheese;
(D) Meat, poultry, fish, dry beans, eggs, and nuts; except that:
(E) These foods will not be sauces (except for foods in the four
food groups in paragraph (m)(l)(ii)(A) through (D) of this section,
that are in the sauces), gravies, condiments, relishes, pickles,
olives, jams, jellies, syrups, breadings, or garnishes; and
(3) Is represented as, or is in a form commonly understood to be, a
main dish (e.g., not a beverage or dessert). Such representations may
be made by statements, photographs, or vignettes.
(n) Nutrition labeling in accordance with Sec. 413.309, shall be
provided for any food for which a nutrient content claim is made.
(o) Compliance with requirements for nutrient content claims shall
be in accordance with Sec. 413.309(h).
(p)(1) Unless otherwise specified, the reference amount customarily
consumed set forth in Sec. 413.312(b) through (e) 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. 413.312(f) (e.g., ``very low sodium, 35 mg or less
per 55 grams'').
(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 that
is no less than that required by Sec. 317.2(h) or Sec. 381.121(c) for
net quantity of contents, 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 criteria statement shall be no less than
one-half the size of the claim but no smaller than \1/16\-inch minimum
height, except as permitted by Sec. 413.400(d)(2).
(q) The following exemptions apply:
(1) Nutrient content claims that have not been defined by
regulation and that appear as part of a brand name that was in use
prior to November 27, 1991, may continue to be used as part of that
brand name, provided they are not false or misleading under section
1(n) of the Federal Meat Inspection Act (21 U.S.C. 601(n)(1)) or 4(h)
of the Poultry Products Inspection Act (21 U.S.C. 453(h)).
(2) [Reserved]
(3) A statement that describes the percentage of a vitamin or
mineral in the food, including foods intended specifically for use by
infants through 12 months and children less than 2 years of age, in
relation to a Reference Daily Intake (RDI) as defined in Sec. 413.309
may be made on the label or in the labeling of a food without a
regulation authorizing such a claim for a specific vitamin or mineral.
(4) The requirements of this section do not apply to infant
formulas and medical foods, as described in 21 CFR 101.13(q)(4).
(5) [Reserved]
(6) Nutrient content claims that were part of the name of a product
that was subject to a standard of identity as of November 27, 1991, are
not subject to the requirements of paragraph (b) of this section
whether or not they meet the definition of the descriptive term.
(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 FSIS.
Labeling applications requesting approval of such a claim may be
submitted pursuant to Sec. 413.369.
[[Page 6810]]
Sec. Sec. 413.314-413.343 [Reserved]
Sec. 413.344 Identification of major cuts of meat products and
poultry products.
(a) The major cuts of single-ingredient, raw meat products are:
Beef chuck blade roast, beef loin top loin steak, beef rib roast large
end, beef round eye round steak, beef round top round steak, beef round
tip roast, beef chuck arm pot roast, beef loin sirloin steak, beef
round bottom round steak, beef brisket (whole, flat half, or point
half), beef rib steak small end, beef loin tenderloin steak, pork loin
chop, pork loin country style ribs, pork loin top loin chop boneless,
pork loin rib chop, pork spareribs, pork loin tenderloin, pork loin
sirloin roast, pork shoulder blade steak, pork loin top roast boneless,
ground pork, lamb shank, lamb shoulder arm chop, lamb shoulder blade
chop, lamb rib roast, lamb loin chop, lamb leg (whole, sirloin half, or
shank half), veal shoulder arm steak, veal shoulder blade steak, veal
rib roast, veal loin chop, and veal cutlets.
(b) The major cuts of single-ingredient, raw poultry products are:
Whole chicken (without neck and giblets), chicken breast, chicken wing,
chicken drumstick, chicken thigh, whole turkey (without necks and
giblets; separate nutrient panels for white and dark meat permitted as
an option), turkey breast, turkey wing, turkey drumstick, and turkey
thigh.
Sec. 413.345 Nutrition labeling of single-ingredient, raw meat or
poultry products that are not ground or chopped products described in
Sec. 413.301.
(a)(1) Nutrition information on the major cuts of single-
ingredient, raw meat or poultry products identified in Sec. 413.344,
including those that have been previously frozen, is required, either
on their label or at their point-of-purchase, unless exempted under
Sec. 413.400. If nutrition information is presented on the label, it
must be provided in accordance with Sec. 413.309. If nutrition
information is presented at the point-of-purchase, it must be provided
in accordance with the provisions of this section.
(2) Nutrition information on single-ingredient, raw products that
are not ground or chopped products described in Sec. 413.301 and are
not major cuts of single-ingredient, raw products identified in Sec.
413.344, including those that have been previously frozen, may be
provided at their point-of-purchase in accordance with the provisions
of this section or on their label, in accordance with the provisions of
Sec. 413.309.
(3) A retailer may provide nutrition information at the point-of-
purchase by various methods, such as by posting a sign or by making the
information readily available in brochures, notebooks, or leaflet form
in close proximity to the food. The nutrition labeling information may
also be supplemented by a video, live demonstration, or other media. If
a nutrition claim is made on point-of-purchase materials, all of the
format and content requirements of Sec. 413.309 apply. However, if
only nutrition information--and not a nutrition claim--is supplied on
point-of-purchase materials, the requirements of Sec. 413.309 apply,
provided, however:
(i) The listing of percent of Daily Value for the nutrients (except
vitamins and minerals specified in Sec. 413.309(c)(8)) and footnote
required by Sec. 413.309(d)(9) may be omitted; and
(ii) The point-of-purchase materials are not subject to any of the
format requirements.
(b) [Reserved]
(c) For the point-of-purchase materials, the declaration of
nutrition information may be presented in a simplified format as
specified in Sec. 413.309(f).
(d) The nutrition label data for products covered in paragraphs
(a)(1) and (a)(2) must be based on either the raw or cooked edible
portions of meat cuts with external cover fat at trim levels reflecting
current marketing practices or the raw or cooked edible portions of
poultry cuts with skin. If data are based on cooked portions, the
methods used to cook the products must be specified and should be those
which do not add nutrients from other ingredients such as flour,
breading, and salt. Additional nutritional data may be presented on an
optional basis for the raw or cooked edible portions of the separable
lean of meat cuts or the raw or cooked edible portions of the skinless
poultry meat.
(e) Nutrient data that are the most current representative data
base values contained in USDA's National Nutrient Data Bank or its
released form, the USDA National Nutrient Database for Standard
Reference, may be used for nutrition labeling of single-ingredient, raw
products, including those that have been previously frozen. These data
may be composite data that reflect different quality grades of beef or
different classes of turkey or other variables affecting nutrient
content. Alternatively, data that reflect specific grades or specific
classes or other variables may be used, except that if data are used on
labels attached to a product which is labeled as to grade of meat or
class of poultry or other variables, the data must represent the
product in the package when such data are contained in the
representative data base. When data are used on labels attached to a
product, the data must represent the edible meat tissues or the edible
poultry tissues present in the package.
(f) If the nutrition information is provided in accordance with
paragraph (e) of this section, a nutrition label or labeling will not
be subject to the Agency compliance review under Sec. 413.309(h),
unless a nutrition claim is made on the basis of the representative
data base values.
(g) Retailers may use data bases that they believe reflect the
nutrient content of single-ingredient, raw products, including those
that have been previously frozen; however, such labeling shall be
subject to the compliance procedures of paragraph (e) of this section
and the requirements specified in this part for the mandatory nutrition
labeling program.
Sec. Sec. 413.346-413.353 [Reserved]
Sec. 413.354 Nutrient content claims for ``good source,'' ``high,''
and ``more.''
(a) General requirements. Except as provided in paragraph (e) of
this section, a claim about the level of a nutrient in a product in
relation to the Reference Daily Intake (RDI) or Daily Reference Value
(DRV) established for that nutrient (excluding total carbohydrate) in
Sec. 413.309(c), may only be made on the label or in labeling of the
product 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. 413.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 413.309.
(b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or
``excellent source of'' may be used on the label or in labeling of
products, except meal-type products as defined in Sec. 413.313(l), and
main-dish products as defined in Sec. 413.313(m) provided that the
product 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 or in labeling of a meal-type product as defined in
Sec. 413.313(l), and main-dish product as defined in Sec. 413.313(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
[[Page 6811]]
the claim (e.g., ``the serving of broccoli in this meal is high in
vitamin C'').
(c) ``Good Source'' claims. (1) The terms ``good source,''
``contains,'' or ``provides'' may be used on the label or in labeling
of products, except meal-type products as described in Sec.
413.313(l), and main-dish products as defined in Sec. 413.313(m)
provided that the product 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 or in labeling of a meal-type product as defined in
Sec. 413.313(l), and main-dish product as defined in Sec. 413.313(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
meal 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, i.e., that the product is high
in fiber, a good source of fiber, or that the product contains ``more''
fiber, and the product is not ``low'' in total fat as defined in Sec.
413.362(b)(2) or, in the case of a meal-type product or a main-dish
product, is not ``low'' in total fat as defined in Sec. 413.362(b)(3),
then the labeling shall disclose the level of total fat per labeled
serving size (e.g., ``contains 12 grams (g) of fat per serving''); and
(2) The disclosure shall appear in immediate proximity to such
claim and be in a type size no less than one-half the size of the
claim.
(e) ``More'' claims. (1) A relative claim using the terms ``more''
and ``added'' may be used on the label or in labeling to describe the
level of protein, vitamins, minerals, dietary fiber, or potassium in a
product, except meal-type products as defined in Sec. 413.313(l), and
main-dish products as defined in Sec. 413.313(m) provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per reference amount
customarily consumed than an appropriate reference product as described
in Sec. 413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (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 `reference
product'''); and
(B) Quantitative information comparing the level of the nutrient in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``fiber content of `reference product'
is 1 g per serving; `this product' contains 4 g per serving'').
(2) A relative claim using the terms ``more'' and ``added'' may be
used on the label or in labeling to describe the level of protein,
vitamins, minerals, dietary fiber, or potassium in meal-type products
as defined in Sec. 413.313(l), and main-dish products as defined in
Sec. 413.313(m) provided that:
(i) The product contains at least 10 percent more of the RDI or the
DRV for protein, vitamins, minerals, dietary fiber, or potassium
(expressed as a percent of the Daily Value) per 100 g of product than
an appropriate reference product as described in Sec. 413.313(j)(1);
and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (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 per 3 ounces
(oz) than does `reference product'''), and
(B) Quantitative information comparing the level of the nutrient in
the meal-type product or a main-dish product per specified weight with
that of the reference product that it replaces is declared adjacent to
the most prominent claim or to the nutrition information (e.g., ``fiber
content of `reference product' is 2 g per 3 oz; `this product' contains
5 g per 3 oz'').
Sec. 413.355 [Reserved]
Sec. 413.356 Nutrient content claims for ``light'' or ``lite.''
(a) General requirements. A claim using the terms ``light'' or
``lite'' to describe a product may only be made on the label or in
labeling of the product 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. 413.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 413.309.
(b) ``Light'' claims. The terms ``light'' or ``lite'' may be used
on the label or in labeling of products, except meal-type products as
defined in Sec. 413.313(l) and main-dish products as defined in Sec.
413.313(m), without further qualification, provided that:
(1) If the product 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
product as described in Sec. 413.313(j)(1); or
(2) If the product 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 product as described in Sec. 413.313(j)(1); or
(ii) Its fat content is reduced by 50 percent or more per reference
amount customarily consumed compared to the appropriate reference
product as described in Sec. 413.313(j)(1); and
(3) As required in Sec. 413.313(j)(2) for relative claims:
(i) The identity of the reference product 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 the market leader''); and
(ii) Quantitative information comparing the level of calories and
fat content in the product per labeled serving size with that of the
reference product that it replaces is declared adjacent to the most
prominent claim or to the nutrition information (e.g., ``lite `this
product'--200 calories, 4 grams (g) fat; regular `reference product'--
300 calories, 8 g fat per serving''); and
(iii) If the labeled product 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 product for which the
reference product meets the definition of ``low fat'' and ``low
calorie.''
(c)(1)(i) A product for which the reference product contains 40
calories or less and 3 g fat or less per reference amount customarily
consumed may use the terms ``light'' or ``lite'' without further
qualification if it is reduced by 50 percent or more in sodium content
compared to the reference product; and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``50
[[Page 6812]]
percent less sodium than the market leader''); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., ``lite `this product'--500 milligrams (mg) sodium
per serving; regular `reference product'--1,000 mg sodium per
serving'').
(2)(i) A product for which the reference product contains more than
40 calories or more than 3 g fat per reference amount customarily
consumed may use the terms ``light in sodium'' or ``lite in sodium'' if
it is reduced by 50 percent or more in sodium content compared to the
reference product, 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. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim (e.g., ``50 percent less
sodium than the market leader''); and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information (e.g., or ``lite `this product'--170 mg sodium per serving;
regular `reference product'--350 mg per serving'').
(3) Except for meal-type products as defined in Sec. 413.313(l)
and main-dish products as defined in Sec. 413.313(m), a ``light in
sodium'' claim may not be made on a product for which the reference
product meets the definition of ``low in sodium.''
(d)(1) The terms ``light'' or ``lite'' may be used on the label or
in labeling of a meal-type product as defined in Sec. 413.313(l) and
main-dish product as defined in Sec. 413.313(m), provided that:
(i) The product meets the definition of:
(A) ``Low in calories'' as defined in Sec. 413.360(b)(3); or
(B) ``Low in fat'' as defined in Sec. 413.362(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 terms ``light in sodium'' or ``lite in sodium'' may be
used on the label or in labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that the product meets the definition of ``low in sodium'' as
defined in Sec. 413.361(b)(5)(i); and
(ii) ``Light'' or ``lite'' and ``in sodium'' are presented in
uniform type size, style, color, and prominence.
(3) The term ``light'' or ``lite'' may be used in the brand name of
a product to describe the sodium content, provided that:
(i) The product is reduced by 50 percent or more in sodium content
compared to the reference product;
(ii) A statement specifically stating that the product is ``light
in sodium'' or ``lite in sodium'' appears:
(A) Contiguous to the brand name; and
(B) In uniform type size, style, color, and prominence as the
product name; and
(iii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium was reduced are declared in immediate
proximity to the most prominent such claim; and
(B) Quantitative information comparing the level of sodium per
labeled serving size with that of the reference product it replaces is
declared adjacent to the most prominent claim or to the nutrition
information.
(e) Except as provided in paragraphs (b) through (d) of this
section, the terms ``light'' or ``lite'' may not be used to refer to a
product 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
product 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 product to
reflect a physical or organoleptic attribute 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 product as described in Sec. 413.313(j)(1)(i)(B) and
(j)(1)(ii)(B), provided that if the product is not ``low in sodium'' as
defined in Sec. 413.361(b)(4), the statement ``not a low sodium
food,'' shall appear adjacent to the nutrition information and the
information required to accompany a relative claim shall appear on the
label or labeling as specified in Sec. 413.313(j)(2).
Sec. Sec. 413.357-413.359 [Reserved]
Sec. 413.360 Nutrient content claims for calorie content.
(a) General requirements. A claim about the calorie or sugar
content of a product may only be made on the label or in labeling of
the product 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. 413.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 413.309.
(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 labeling of products, provided that:
(i) The product contains less than 5 calories per reference amount
customarily consumed and per labeled serving size; and
(ii) If the product meets this condition without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(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 products, except
meal-type products as defined in Sec. 413.313(l) and main-dish
products as defined in Sec. 413.313(m), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and does
not provide more than 40 calories per reference amount customarily
consumed; or
(B) The product has a reference amount customarily consumed of 30 g
[[Page 6813]]
or less or 2 tbsp or less and does not provide more than 40 calories
per reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 413.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the caloric content, it is labeled to clearly refer to all products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains 120 calories or less 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 calorie content, it is labeled to clearly refer to all products 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 labeling of products,
except meal-type products as defined in Sec. 413.313(l) and main-dish
products as defined in Sec. 413.313(m), provided that:
(i) The product contains at least 25 percent fewer calories per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
lower calorie `product'-- ``33\1/3\ percent fewer calories than our
regular `product' ''); and
(B) Quantitative information comparing the level of calories in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``calorie content has been reduced
from 150 to 100 calories per serving'').
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of products if the reference
product 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 labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains at least 25 percent fewer calories per 100
g of product than an appropriate reference product as described in
Sec. 413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the calories differ between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``calorie reduced `product', 25% less calories per ounce (oz) (or 3 oz)
than our regular `product' ''); and
(B) Quantitative information comparing the level of calories in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., ``calorie content has been reduced from
110 calories per 3 oz to 80 calories per 3 oz'').
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of products if the reference
product meets the definition for ``low calorie.''
(c) Sugar content claims. (1) 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'' may reasonably
be expected to be regarded by consumers as terms that represent that
the product 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 product may not be labeled with
such terms unless:
(i) The product contains less than 0.5 g of sugars, as defined in
Sec. 413.309(c)(6)(ii), per reference amount customarily consumed and
per labeled serving size or, in the case of a meal-type product or a
main-dish product, less than 0.5 g of sugars per labeled serving size;
(ii) The product 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 ingredients 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
(B) Such term is immediately accompanied, each time it is used, by
either the statement ``not a reduced calorie product,'' ``not a low
calorie product,'' 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. 413.309(c)(6)(ii), or
any other ingredient that contains sugars that functionally substitute
for added sugars is added during processing or packaging;
(ii) The product does not contain an ingredient containing added
sugars such as jam, jelly, or concentrated fruit juice;
(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 product, and a functionally
insignificant increase in sugars results;
(iv) The product that it resembles and for which it substitutes
normally contains added sugars; and
(v) The product bears a statement that the product is not ``low
calorie'' or ``calorie reduced'' (unless the product meets the
requirements for a ``low'' or ``reduced calorie'' product) 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 product, including products intended specifically for
infants and children less than 2 years of age, is unsweetened or
contains no added sweeteners in the case of a product that contains
apparent substantial inherent sugar content, e.g., juices.
(4) 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 products, except meal-type
products as defined in Sec. 413.313(l) and main-dish products as
defined in Sec. 413.313(m), provided that:
(i) The product contains at least 25 percent less sugars per
reference amount customarily consumed than an
[[Page 6814]]
appropriate reference product as described in Sec. 413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g., ``this
product contains 25 percent less sugar than our regular product''); and
(B) Quantitative information comparing the level of the sugar in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sugar content has been lowered from
8 g to 6 g per serving'').
(5) The terms defined in paragraph (c)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains at least 25 percent less sugars per 100 g
of product than an appropriate reference product as described in Sec.
413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sugars differ between the two products are declared
in immediate proximity to the most prominent such claim (e.g.,
``reduced sugar `product'--25% less sugar than our regular `product'
''); and
(B) Quantitative information comparing the level of the nutrient in
the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sugar content has been reduced from
17 g per 3 oz to 13 g per 3 oz'').
Sec. 413.361 Nutrient content claims for the sodium content.
(a) General requirements. A claim about the level of sodium in a
product may only be made on the label or in labeling of the product 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. 413.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 413.309.
(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 ``dietarily
insignificant source of sodium'' may be used on the label or in
labeling of products, provided that:
(i) The product contains less than 5 milligrams (mg) of sodium per
reference amount customarily consumed and per labeled serving size or,
in the case of a meal-type product or a main-dish product, less than 5
mg of sodium per labeled serving size;
(ii) The product contains no ingredient that is sodium chloride or
is generally understood by consumers to contain sodium unless the
listing of the ingredient in the ingredients 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) 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 products of
its type and not merely to the particular brand to which the label
attaches.
(2) The terms ``very low sodium'' or ``very low in sodium'' may be
used on the label or in labeling of products, except meal-type products
as defined in Sec. 413.313(l) and main-dish products as defined in
Sec. 413.313(m), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 grams (g) or greater than 2 tablespoons (tbsp) and
contains 35 mg or less sodium per reference amount customarily
consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 35 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 413.309(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 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 products of
its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(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 products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms ``low sodium,'' ``low in sodium,'' ``little sodium,''
``contains a small amount of sodium,'' or ``low source of sodium'' may
be used on the label and in labeling of products, except meal-type
products as defined in Sec. 413.313(l) and main-dish products as
defined in Sec. 413.313(m), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp and contains 140 mg or less
sodium per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 140 mg or less sodium per
reference amount customarily consumed and per 50 g (for dehydrated
products that must be reconstituted before typical consumption with
water or a diluent containing an insignificant amount, as defined in
Sec. 413.309(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 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 products of
its type and not merely to the particular brand to which the label
attaches.
(5) The terms defined in paragraph (b)(4) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains 140 mg or less sodium per 100 g of
product; 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 products 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
[[Page 6815]]
sodium,'' or ``lower in sodium'' may be used on the label or in
labeling of products, except meal-type products as defined in Sec.
413.313(l) and main-dish products as defined in Sec. 413.313(m),
provided that:
(i) The product contains at least 25 percent less sodium per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g.,
``reduced sodium `product', 50 percent less sodium than regular
`product' ''); and
(B) Quantitative information comparing the level of sodium in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``sodium content has been lowered from
300 to 150 mg per serving'').
(iii) Claims described in paragraph (b)(6) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product 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 labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains at least 25 percent less sodium per 100 g
of product than an appropriate reference product as described in Sec.
413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the sodium differs between the two products are declared
in immediate proximity to the most prominent such claim (e.g.,
``reduced sodium `product'--30% less sodium per 3 oz than our `regular
product' ''); and
(B) Quantitative information comparing the level of sodium in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent claim or to the
nutrition information (e.g., ``sodium content has been reduced from 220
mg per 3 oz to 150 mg per 3 oz'').
(iii) Claims described in paragraph (b)(7) of this section may not
be made on the label or in labeling of products if the nutrient content
of the reference product 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 products only if the product 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 products only if:
(i) No salt is added during processing;
(ii) The product that it resembles and for which it substitutes is
normally processed with salt; and
(iii) If the product is not sodium free, the statement, ``not a
sodium free product'' or ``not for control of sodium in the diet''
appears adjacent to the nutrition information of the product bearing
the claim.
(3) Paragraph (c)(2) of this section shall not apply to a factual
statement that a product intended specifically for infants and children
less than 2 years of age is unsalted, provided such statement refers to
the taste of the product and is not false or otherwise misleading.
Sec. 413.362 Nutrient content claims for fat, fatty acids, and
cholesterol content.
(a) General requirements. A claim about the level of fat, fatty
acid, and cholesterol in a product may only be made on the label or in
labeling of products 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. 413.313; and
(3) The product for which the claim is made is labeled in
accordance with Sec. 413.309.
(b) Fat content claims. (1) The terms ``fat free,'' ``free of
fat,'' ``no fat,'' ``zero fat,'' ``without fat,'' ``nonfat,'' ``trivial
source of fat,'' ``negligible source of fat,'' or ``dietarily
insignificant source of fat'' may be used on the label or in labeling
of products, provided that:
(i) The product contains less than 0.5 gram (g) of fat per
reference amount customarily consumed and per labeled serving size or,
in the case of a meal-type product or a main-dish product, less than
0.5 g of fat per labeled serving size;
(ii) The product 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 ingredients 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) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label
attaches.
(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 and in labeling of products, except meal-type products as
defined in Sec. 413.313(l) and main-dish products as defined in Sec.
413.313(m), provided that:
(i)(A) The product has a reference amount customarily consumed
greater than 30 g or greater than 2 tablespoons (tbsp) and contains 3 g
or less of fat per reference amount customarily consumed; or
(B) The product has a reference amount customarily consumed of 30 g
or less or 2 tbsp or less and contains 3 g or less of fat per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in Sec.
413.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form).
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (b)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains 3 g or less of total fat per 100 g of
product and not more than 30 percent of calories from fat; and
(ii) If the product meets these conditions without the benefit of
special processing, alteration, formulation, or reformulation to lower
the fat content, it is labeled to clearly refer to all products of its
type and not merely to the
[[Page 6816]]
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 labeling of products, except meal-type products as defined
in Sec. 413.313(l) and main-dish products as defined in Sec.
413.313(m), provided that:
(i) The product contains at least 25 percent less fat per reference
amount customarily consumed than an appropriate reference product as
described in Sec. 413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., ``reduced
fat--50 percent less fat than our regular `product' ''); and
(B) Quantitative information comparing the level of fat in the
product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``fat content has been reduced from 8
g to 4 g per serving'').
(iii) Claims described in paragraph (b)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product 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 labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains at least 25 percent less fat per 100 g of
product than an appropriate reference product as described in Sec.
413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the fat differs between the two products are declared in
immediate proximity to the most prominent such claim (e.g., ``reduced
fat `product', 33 percent less fat per 3 oz than our regular `product'
''); and
(B) Quantitative information comparing the level of fat in the
product per specified weight with that of the reference product that it
replaces is declared adjacent to the most prominent such claim or to
the nutrition information (e.g., ``fat content has been reduced from 8
g per 3 oz to 5 g per 3 oz'').
(iii) Claims described in paragraph (b)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low fat.''
(6) The term ``__ percent fat free'' may be used on the label or in
labeling of products, provided that:
(i) The product 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 products
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.
(iv) A synonym for ``__ percent fat free'' is ``__ percent lean.''
(c) Fatty acid content claims. (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
labeling of products, provided that:
(i) The product contains less than 0.5 g of saturated fat and less
than 0.5 g trans fatty acids per reference amount customarily consumed
and per labeled serving size or, in the case of a meal-type product or
a main-dish product, less than 0.5 g of saturated fat and less than 0.5
g trans fatty acids per labeled serving size;
(ii) The product contains no ingredient that is generally
understood by consumers to contain saturated fat unless the listing of
the ingredient in the ingredients 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) 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 products
of its type and not merely to the particular brand to which the label
attaches.
(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
labeling of products, except meal-type products as defined in Sec.
413.313(l) and main-dish products as defined in Sec. 413.313(m),
provided that:
(i) The product contains 1 g or less of saturated fat per reference
amount customarily consumed and not more than 15 percent of calories
from saturated fat; and
(ii) If the product 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 products
of its type and not merely to the particular brand to which the label
attaches.
(3) The terms defined in paragraph (c)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains 1 g or less of saturated fat 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 products
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 labeling of products, except meal-type products as defined in
Sec. 413.313(l) and main-dish products as defined in Sec. 413.313(m),
provided that:
(i) The product contains at least 25 percent less saturated fat per
reference amount customarily consumed than an appropriate reference
product as described in Sec. 413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``reduced saturated fat `product', contains 50 percent less saturated
fat than the national average for `product' ''); and
(B) Quantitative information comparing the level of saturated fat
in the product per labeled serving size with that of the reference
product that it replaces is declared adjacent to the most prominent
claim or to the nutrition information (e.g., ``saturated fat reduced
from 3 g to 1.5 g per serving'').
(iii) Claims described in paragraph (c)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product meets the definition for ``low
saturated fat.''
(5) The terms defined in paragraph (c)(4) of this section may be
used on the
[[Page 6817]]
label or in labeling of a meal-type product as defined in Sec.
413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains at least 25 percent less saturated fat per
100 g of product than an appropriate reference product as described in
Sec. 413.313(j)(1); and
(ii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product and the percent (or
fraction) that the saturated fat differs between the two products are
declared in immediate proximity to the most prominent such claim (e.g.,
``reduced saturated fat `product','' ``50 percent less saturated fat
than our regular `product' ''); and
(B) Quantitative information comparing the level of saturated fat
in the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``saturated fat content has been
reduced from 2.5 g per 3 oz to 1.5 g per 3 oz'').
(iii) Claims described in paragraph (c)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product 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 labeling of products,
provided that:
(i) The product contains less than 2 milligrams (mg) of cholesterol
per reference amount customarily consumed and per labeled serving size
or, in the case of a meal-type product as defined in Sec. 413.313(l)
and main-dish product as defined in Sec. 413.313(m), less than 2 mg of
cholesterol per labeled serving size;
(ii) The product contains no ingredient that is generally
understood by consumers to contain cholesterol, unless the listing of
the ingredient in the ingredients 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'';
(iii) The product contains 2 g or less of saturated fat per
reference amount customarily consumed or, in the case of a meal-type
product as defined in Sec. 413.313(l) and main-dish product as defined
in Sec. 413.313(m), 2 g or less of saturated fat per labeled serving
size; and
(iv) If the product 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 products of
its type and not merely to the particular brand to which it attaches;
or
(v) If the product meets these conditions only as a result of
special processing, alteration, formulation, or reformulation, the
amount of cholesterol is reduced by 25 percent or more from the
reference product it replaces as described in Sec. 413.313(j)(1) and
for which it substitutes as described in Sec. 413.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share. As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product 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
`product', contains 100 percent less cholesterol than `reference
product' ''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``contains no cholesterol compared
with 30 mg in one serving of `reference product' '').
(2) The terms ``low in cholesterol,'' ``low cholesterol,''
``contains a small amount of cholesterol,'' ``low source of
cholesterol,'' or ``little cholesterol'' may be used on the label or in
labeling of products, except meal-type products as defined in Sec.
413.313(l) and main-dish products as defined in Sec. 413.313(m),
provided that:
(i)(A) If the product has a reference amount customarily consumed
greater than 30 g or greater than 2 tbsp:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed; and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed; or
(B) If the product has a reference amount customarily consumed of
30 g or less or 2 tbsp or less:
(1) The product contains 20 mg or less of cholesterol per reference
amount customarily consumed and per 50 g (for dehydrated products that
must be reconstituted before typical consumption with water or a
diluent containing an insignificant amount, as defined in Sec.
413.309(f)(1), of all nutrients per reference amount customarily
consumed, the per-50-g criterion refers to the ``as prepared'' form);
and
(2) The product contains 2 g or less of saturated fat per reference
amount customarily consumed.
(ii) If the product 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 products of
its type and not merely to the particular brand to which the label
attaches; or
(iii) If the product contains 20 mg or less of cholesterol only as
a result of special processing, alteration, formulation, or
reformulation, the amount of cholesterol is reduced by 25 percent or
more from the reference product it replaces as described in Sec.
413.313(j)(1) and for which it substitutes as described in Sec.
413.313(d) that has a significant (e.g., 5 percent or more of a
national or regional market) market share. As required in Sec.
413.313(j)(2) for relative claims:
(A) The identity of the reference product 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 `product', contains 85 percent less cholesterol than our
regular `product' ''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol lowered from 30 mg to 5
mg per serving'').
(3) The terms defined in paragraph (d)(2) of this section may be
used on the label or in labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product contains 20 mg or less of cholesterol per 100 g of
product;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) If the product 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 products of
its type and not merely to the particular brand to which the label
attaches.
(4) The terms ``reduced cholesterol,'' ``reduced in cholesterol,''
``cholesterol reduced,'' ``less cholesterol,'' ``lower cholesterol,''
or ``lower in cholesterol'' may be used on the label or in labeling of
products or products that substitute for those products as specified in
[[Page 6818]]
Sec. 413.313(d), excluding meal-type products as defined in Sec.
413.313(l) and main-dish products as defined in Sec. 413.313(m),
provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 413.313(j)(1) and
for which it substitutes as described in Sec. 413.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per
reference amount customarily consumed; and
(iii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product 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 `reference product' ''); and
(B) Quantitative information comparing the level of cholesterol in
the product per labeled serving size with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol lowered from 55 mg to 30
mg per serving'').
(iv) Claims described in paragraph (d)(4) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product 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 labeling of a meal-type product as defined in
Sec. 413.313(l) and main-dish product as defined in Sec. 413.313(m),
provided that:
(i) The product has been specifically formulated, altered, or
processed to reduce its cholesterol by 25 percent or more from the
reference product it replaces as described in Sec. 413.313(j)(1) and
for which it substitutes as described in Sec. 413.313(d) that has a
significant (e.g., 5 percent or more of a national or regional market)
market share;
(ii) The product contains 2 g or less of saturated fat per 100 g of
product; and
(iii) As required in Sec. 413.313(j)(2) for relative claims:
(A) The identity of the reference product 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 than `reference product' ''); and
(B) Quantitative information comparing the level of cholesterol in
the product per specified weight with that of the reference product
that it replaces is declared adjacent to the most prominent claim or to
the nutrition information (e.g., ``cholesterol content has been reduced
from 35 mg per 3 oz to 25 mg per 3 oz'').
(iv) Claims described in paragraph (d)(5) of this section may not
be made on the label or in labeling of a product if the nutrient
content of the reference product 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 a
product, provided that the product contains less than 10 g of fat, 4.5
g or less of saturated fat, and less than 95 mg of cholesterol per 100
g of product and per reference amount customarily consumed for
individual foods, and per 100 g of product and per labeled serving size
for meal-type products as defined in Sec. 413.313(l) and main-dish
products as defined in Sec. 413.313(m).
(2) The term ``extra lean'' may be used on the label or in labeling
of a product, provided that the product contains less than 5 g of fat,
less than 2 g of saturated fat, and less than 95 mg of cholesterol per
100 g of product and per reference amount customarily consumed for
individual foods, and per 100 g of product and per labeled serving size
for meal-type products as defined in Sec. 413.313(l) and main-dish
products as defined in Sec. 413.313(m).
(f) A statement of the lean percentage may be used on the label or
in labeling of ground or chopped products described in Sec. 413.301
when the product does not meet the criteria for ``low fat,'' defined in
Sec. 413.362(b)(2), provided that a statement of the fat percentage is
contiguous to and in lettering of the same color, size, type, and on
the same color background, as the statement of the lean percentage.
Sec. 413.363 Nutrient content claims for ``healthy.''
(a) The term ``healthy,'' or any other derivative of the term
``health,'' may be used on the labeling of any meat, meat food product,
or poultry product, provided that the product is labeled in accordance
with Sec. 413.309 and Sec. 413.313.
(b)(1) The product shall meet the requirements for ``low fat'' and
``low saturated fat,'' as defined in Sec. 413.362, except that single-
ingredient, raw products may meet the total fat and saturated fat
criteria for ``extra lean'' in Sec. 413.362.
(2) The product shall not contain more than 60 milligrams (mg) of
cholesterol per reference amount customarily consumed, per labeled
serving size, and, only for foods with reference amounts customarily
consumed of 30 grams (g) or less or 2 tablespoons (tbsp) or less, per
50 g, and, for dehydrated products that must be reconstituted with
water or a diluent containing an insignificant amount, as defined in
Sec. 413.309(f)(1), of all nutrients, the per-50-g criterion refers to
the prepared form, except that:
(i) A main-dish product, as defined in Sec. 413.313(m), and a
meal-type product, as defined in Sec. 413.313(l), and including meal-
type products that weigh more than 12 ounces (oz) per serving
(container), shall not contain more than 90 mg of cholesterol per
labeled serving size; and
(ii) Single-ingredient, raw products may meet the cholesterol
criterion for ``extra lean'' in Sec. 413.362.
(3) The product shall not contain more than 480 mg of sodium per
reference amount customarily consumed, per labeled serving size, and,
only for foods with reference amounts customarily consumed of 30 g or
less or 2 tbsp or less, per 50 g, and, for dehydrated products that
must be reconstituted with water or a diluent containing an
insignificant amount, as defined in Sec. 413.309(f)(1), of all
nutrients, the per-50-g criterion refers to the prepared form, except
that:
(i) A main-dish product, as defined in Sec. 413.313(m), and a
meal-type product, as defined in Sec. 413.313(l), and including meal-
type products that weigh more than 12 oz per serving (container), shall
not contain more than 600 mg of sodium per labeled serving size; \1\
and
---------------------------------------------------------------------------
\1\ This regulation previously provided that, after January 1,
2006, individual meat and poultry products bearing the claim
``healthy'' (or any derivative of the term ``health'') must contain
no more than 360 mg of sodium and that meal-type products bearing
the claim ``healthy'' (or any other derivative of the term
``health'') must contain no more than 600 mg of sodium.
Implementation of these sodium level requirements for products
bearing the claim ``healthy'' (or any derivative of the term
``health'') has been deferred indefinitely due to technological
barriers and consumer preferences.
---------------------------------------------------------------------------
(ii) The requirements of this paragraph (b)(3) do not apply to
single-ingredient, raw products.
(4) The product shall contain 10 percent or more of the Reference
Daily Intake or Daily Reference Value as defined in Sec. 413.309 for
vitamin A, vitamin C, calcium, iron, protein, or fiber per reference
amount customarily consumed prior to any nutrient addition, except
that:
(i) A main-dish product, as defined in Sec. 413.313(m), and
including main-dish products that weigh less than 10 oz per serving
(container), shall meet the level for two of the nutrients per labeled
serving size; and
[[Page 6819]]
(ii) A meal-type product, as defined in Sec. 413.313(l), shall
meet the level for three of the nutrients per labeled serving size.
Sec. Sec. 413.364-413.368 [Reserved]
Sec. 413.369 Labeling applications for nutrient content claims.
(a) This section pertains to labeling applications for claims,
express or implied, that characterize the level of any nutrient
required to be on the label or in labeling of product by this part.
(b) Labeling applications included in this section are:
(1) Labeling applications for a new (heretofore unauthorized)
nutrient content claim,
(2) Labeling applications 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) Labeling applications for the use of an implied claim in a
brand name.
(c) Labeling applications and supporting documentation to be filed
under this section shall be submitted in quadruplicate, except that the
supporting documentation may be submitted on a computer disc copy. If
any part of the material submitted is in a foreign language, it shall
be accompanied by an accurate and complete English translation. The
labeling application shall state the applicant's post office address.
(d) Pertinent information will be considered as part of an
application on the basis of specific reference to such information
submitted to and retained in the files of the Food Safety and
Inspection Service. 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 accompany a labeling
application, the applicant shall include, with respect to each
nonclinical study included with the application, 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 chapter
1, title 21, 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 accompany a labeling application,
the applicant shall include, with respect to each clinical
investigation included with the application, either a statement that
the investigation was conducted in compliance with the requirements for
institutional review set forth in part 56 of chapter 1, title 21, or
was not subject to such requirements in accordance with Sec. 56.194 or
Sec. 56.105, and that it was conducted in compliance with the
requirements for informed consents set forth in part 50 of chapter 1,
title 21.
(g) The availability for public disclosure of labeling
applications, along with supporting documentation, submitted to the
Agency under this section will be governed by the rules specified in
subchapter D, title 9.
(h) The data specified under this section to accompany a labeling
application shall be submitted on separate sheets, suitably identified.
If such data has already been submitted with an earlier labeling
application from the applicant, the present labeling application must
provide the data.
(i) The labeling application must be signed by the applicant or by
his or her attorney or agent, or (if a corporation) by an authorized
official.
(j) The labeling application shall include a statement signed by
the person responsible for the labeling application, that to the best
of his or her knowledge, it is a representative and balanced submission
that includes unfavorable information, as well as favorable
information, known to him or her pertinent to the evaluation of the
labeling application.
(k)(1) Labeling applications for a new nutrient content claim shall
be accompanied by the following data which shall be submitted in the
following form to the Director, Labeling and Program Delivery Staff,
Office of Policy and Program Development, Food Safety and Inspection
Service, Washington, DC 20250.
-----------------------------------------------------------------------
(Date)
The undersigned, ___, submits this labeling application pursuant
to 9 CFR 413.369 with respect to (statement of the claim and its
proposed use). Attached hereto, in quadruplicate, or on a computer
disc copy, and constituting a part of this labeling application, are
the following:
(i) A statement identifying the nutrient content claim and the
nutrient that the term is intended to characterize with respect to
the level of such nutrient. The statement shall address why the use
of the term as proposed will not be misleading. The statement shall
provide examples of the nutrient content claim as it will be used on
labels or labeling, as well as the types of products on which the
claim will be used. The statement shall also specify the level at
which the nutrient must be present or what other conditions
concerning the product must be met for the appropriate use of the
term in labels or labeling, as well as any factors that would make
the use of the term inappropriate.
(ii) 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. If the
claim is intended for a specific group within the population, the
analysis shall specifically address nutritional needs of such group,
and scientific data sufficient for such purpose, and data and
information to the extent necessary to demonstrate that consumers
can be expected to understand the meaning of the term under the
proposed conditions of use.
(iii) Analytical data that demonstrates the amount of the
nutrient that is present in the products for which the claim is
intended. The assays should be performed on representative samples
in accordance with Sec. 413.309(h). If no USDA or AOAC methods are
available, the applicant 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 shall include a
statistical analysis of the analytical and product variability.
(iv) A detailed analysis of the potential effect of the use of
the proposed claim on food consumption, and any corresponding
changes in nutrient intake. The analysis 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 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.
Yours very truly,
Applicant--------------------------------------------------------------
By---------------------------------------------------------------------
(Indicate authority)
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall
inform the applicant that the labeling application is undergoing Agency
review and that the applicant shall subsequently be notified of the
Agency's decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it
[[Page 6820]]
has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
nutrient content claim is false or misleading. The notification letter
shall inform the applicant that the applicant may submit a written
statement by way of answer to the notification, and that the applicant
shall have the right to request a hearing with respect to the merits or
validity of the Administrator's decision to deny the use of the
proposed nutrient content claim.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish in the Federal Register
a proposed rule to amend the regulations to authorize the use of the
nutrient content claim. The proposal shall also summarize the labeling
application, including where the supporting documentation can be
reviewed. The Administrator's proposed rule shall seek comment from
consumers, the industry, consumer and industry groups, and other
interested persons on the labeling application and the use of the
proposed nutrient content claim. After public comment has been received
and reviewed by the Agency, the Administrator shall make a
determination on whether the proposed nutrient content claim shall be
approved for use on the labeling of meat and meat food products and
poultry products.
(i) If the claim is denied by the Administrator, the Agency shall
notify the applicant, in writing, of the basis for the denial,
including the reason why the claim on the labeling was determined by
the Agency to be false or misleading. The notification letter shall
also inform the applicant that the applicant may submit a written
statement by way of answer to the notification, and that the applicant
shall have the right to request a hearing with respect to the merits or
validity of the Administrator's decision to deny the use of the
proposed nutrient content claim.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make final determination for the Secretary. Any such
determination by the Secretary shall be conclusive unless, within 30
days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the
applicant, in writing, and shall also publish in the Federal Register a
final rule amending the regulations to authorize the use of the claim.
(l)(1) Labeling applications for a synonymous term shall be
accompanied by the following data which shall be submitted in the
following form to the Director, Labeling and Program Delivery Staff,
Office of Policy and Program Development, Food Safety and Inspection
Service, Washington, DC 20250:
-----------------------------------------------------------------------
(Date)
The undersigned, ___ submits this labeling application pursuant to 9
CFR 413.369 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 part 413).
Attached hereto, in quadruplicate, or on a computer disc copy,
and constituting a part of this labeling application, are the
following:
(i) A statement identifying the synonymous term, the existing
term defined by a regulation with which the synonymous term is
claimed to be consistent, and the nutrient that the term is intended
to characterize the level of. The statement shall address why the
use of the synonymous term as proposed will not be misleading. The
statement shall provide examples of the nutrient content claim as it
will be used on labels or labeling, as well as the types of products
on which the claim will be used. The statement shall also specify
whether any limitations not applicable to the use of the defined
term are intended to apply to the use of the synonymous term.
(ii) A detailed explanation supported by any necessary data of
why use of the proposed term is requested, including whether the
existing defined term is inadequate for the purpose of effectively
characterizing the level of a nutrient. 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. If the claim is
intended for a specific group within the population, the analysis
shall specifically address nutritional needs of such group,
scientific data sufficient for such purpose, and data and
information to the extent necessary to demonstrate that consumers
can be expected to understand the meaning of the term under the
proposed conditions of use.
Yours very truly,
Applicant--------------------------------------------------------------
By---------------------------------------------------------------------
(Indicate authority)
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall
inform the applicant that the labeling application is undergoing Agency
review and that the applicant shall subsequently be notified of the
Agency's decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
synonymous term is false or misleading. The notification letter shall
inform the applicant that the applicant may submit a written statement
by way
[[Page 6821]]
of answer to the notification, and that the applicant shall have the
right to request a hearing with respect to the merits or validity of
the Administrator's decision to deny the use of the proposed synonymous
term.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(5) If the claim is approved, the Agency shall notify the
applicant, in writing, and shall publish in the Federal Register a
notice informing the public that the synonymous term has been approved
for use.
(m)(1) Labeling applications for the use of an implied nutrient
content claim in a brand name shall be accompanied by the following
data which shall be submitted in the following form to the Director,
Labeling and Program Delivery Staff, Office of Policy and Program
Development, Food Safety and Inspection Service, Washington, DC 20250:
-----------------------------------------------------------------------
(Date)
The undersigned, ___ submits this labeling application pursuant
to 9 CFR 413.369 with respect to (statement of the implied nutrient
content claim and its proposed use in a brand name).
Attached hereto, in quadruplicate, or on a computer disc copy,
and constituting a part of this labeling application, are the
following:
(i) 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, and the brand name of which the implied
claim is intended to be a part. The statement shall address why the
use of the brand-name as proposed will not be misleading. The
statement shall provide examples of the types of products on which
the brand name will appear. It shall also include data showing that
the actual level of the nutrient in the food would qualify the label
of the product to bear the corresponding term defined by regulation.
Assay methods used to determine the level of a nutrient shall meet
the requirements stated under labeling application format in
paragraph (k)(1)(iii) of this section.
(ii) A detailed explanation supported by any necessary data of
why use of the proposed brand name is requested. This explanation
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
shall specifically address nutritional needs of such group and
scientific data sufficient for such purpose.
Yours very truly,
Applicant--------------------------------------------------------------
By---------------------------------------------------------------------
(2) Upon receipt of the labeling application and supporting
documentation, the applicant shall be notified, in writing, of the date
on which the labeling application was received. Such notice shall
inform the applicant that the labeling application is undergoing Agency
review and that the applicant shall subsequently be notified of the
Agency's decision to consider for further review or deny the labeling
application.
(3) Upon review of the labeling application and supporting
documentation, the Agency shall notify the applicant, in writing, that
the labeling application is either being considered for further review
or that it has been summarily denied by the Administrator.
(4) If the labeling application is summarily denied by the
Administrator, the written notification shall state the reasons
therefor, including why the Agency has determined that the proposed
implied nutrient content claim is false or misleading. The notification
letter shall inform the applicant that the applicant may submit a
written statement by way of answer to the notification, and that the
applicant shall have the right to request a hearing with respect to the
merits or validity of the Administrator's decision to deny the use of
the proposed implied nutrient content claim.
(i) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall constitute the complaint and answer
in the proceeding, which shall thereafter be conducted in accordance
with the Department's Uniform Rules of Practice.
(ii) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(5) If the labeling application is not summarily denied by the
Administrator, the Administrator shall publish a notice of the labeling
application in the Federal Register seeking comment on the use of the
implied nutrient content claim. The notice shall also summarize the
labeling application, including where the supporting documentation can
be reviewed. The Administrator's notice shall seek comment from
consumers, the industry, consumer and industry groups, and other
interested persons on the labeling application and the use of the
implied nutrient content claim. After public comment has been received
and reviewed by the Agency, the Administrator shall make a
determination on whether the implied nutrient content claim shall be
approved for use on the labeling of meat food products or for poultry
products.
(i) If the claim is denied by the Administrator, the Agency shall
notify the applicant, in writing, of the basis for the denial,
including the reason why the claim on the labeling was determined by
the Agency to be false or misleading. The notification letter shall
also inform the applicant that the applicant may submit a written
statement by way of answer to the notification, and that the applicant
shall have the right to request a hearing with respect to the merits or
validity of the Administrator's decision to deny the use of the
proposed implied nutrient content claim.
(A) If the applicant fails to accept the determination of the
Administrator and files an answer and requests a hearing, and the
Administrator, after review of the answer, determines the initial
determination to be correct, the Administrator shall file with the
Hearing Clerk of the Department the notification, answer, and the
request for a hearing, which shall thereafter be conducted in
accordance with the Department's Uniform Rules of Practice.
[[Page 6822]]
(B) The hearing shall be conducted before an administrative law
judge with the opportunity for appeal to the Department's Judicial
Officer, who shall make the final determination for the Secretary. Any
such determination by the Secretary shall be conclusive unless, within
30 days after receipt of the notice of such final determination, the
applicant appeals to the United States Court of Appeals for the circuit
in which the applicant has its principal place of business or to the
United States Court of Appeals for the District of Columbia Circuit.
(ii) If the claim is approved, the Agency shall notify the
applicant, in writing, and shall also publish in the Federal Register a
notice informing the public that the implied nutrient content claim has
been approved for use.
Sec. Sec. 413.370-413.379 [Reserved]
Sec. 413.380 Label statements relating to usefulness in reducing or
maintaining body weight.
(a) General requirements. Any product that purports to be or is
represented for special dietary use because of usefulness in reducing
body weight shall bear:
(1) Nutrition labeling in conformity with Sec. 413.309 of this
part, unless exempt under that section, and
(2) A conspicuous statement of the basis upon which the product
claims to be of special dietary usefulness.
(b) Nonnutritive ingredients. (1) Any product 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 product may contain a nonnutritive sweetener
or other ingredient only if the ingredient is safe for use in the
product under the applicable law and regulations of this chapter. Any
product 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 nutritive sweeteners as well as nonnutritive
sweeteners are added, the statement shall indicate the presence of both
types of sweetener; e.g., ``Sweetened with nutritive sweeteners and
nonnutritive sweeteners.''
(c) ``Low calorie'' foods. A product purporting to be ``low
calorie'' must comply with the criteria set forth for such foods in
Sec. 413.360.
(d) ``Reduced calorie'' foods and other comparative claims. A
product purporting to be ``reduced calorie'' or otherwise containing
fewer calories than a reference food must comply with the criteria set
forth for such foods in Sec. 413.360(b) (4) and (5).
(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, a product may be labeled with terms such as ``diet,''
``dietetic,'' ``artificially sweetened,'' or ``sweetened with
nonnutritive sweetener'' only if the claim is not false or misleading,
and the product is labeled ``low calorie'' or ``reduced calorie'' or
bears another comparative calorie claim in compliance with the
applicable provisions in this part.
(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 product 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 product 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. 413.360(c).
Sec. Sec. 413.381-413.399 [Reserved]
Sec. 413.400 Exemptions from nutrition labeling.
(a) The following products are exempt from nutrition labeling:
(1) Food products produced by small businesses, other than the
major cuts of single-ingredient, raw products identified in Sec.
413.344 produced by small businesses, provided that the labels for
these products bear no nutrition claims or nutrition information, and
ground or chopped products described in Sec. 413.301 produced by small
businesses that bear a statement of the lean percentage and fat
percentage on the label or in labeling in accordance with Sec.
413.362(f), provided that labels or labeling for these products bear no
other nutrition claims or nutrition information,
(i) A food product, for the purposes of the small business
exemption, is defined as a formulation, not including distinct flavors
which do not significantly alter the nutritional profile, sold in any
size package in commerce.
(ii) For purposes of this paragraph, a small business is any
single-plant facility, including a single retail store, or multi-plant
company/firm, including a multi-retail store operation, that employs
500 or fewer people and produces no more than 100,000 pounds of the
product qualifying the firm for exemption from this part.
(iii) For purposes of this paragraph, calculation of the amount of
pounds shall be based on the most recent 2-year average of business
activity. Where firms have been in business less than 2 years or where
products have been produced for less than 2 years, reasonable estimates
must indicate that the annual pounds produced will not exceed the
amounts specified.
(2) Products intended for further processing, provided that the
labels for these products bear no nutrition claim or nutrition
information,
(3) Products that are not for sale to consumers, provided that the
labels for these products bear no nutrition claims or nutrition
information,
(4) Products in small packages that are individually wrapped
packages of less than \1/2\ ounce net weight, provided that the labels
for these products bear no nutrition claims or nutrition information,
(5) Products custom slaughtered or prepared,
(6) Products intended for export, and
(7) The following products prepared and served or sold at retail
provided that the labels or the labeling of these products bear no
nutrition claims or nutrition information:
(i) Ready-to-eat products that are packaged or portioned at a
retail store or similar retail-type establishment, provided, however,
that this exemption does not apply to ready-to-eat ground or chopped
products described in Sec. 413.301 that are packaged or portioned at a
retail establishment, unless the establishment qualifies for an
exemption under (a)(1) of this section;
(ii) Multi-ingredient products (e.g., sausage) processed at a
retail store or similar retail-type establishment, provided, however,
that this exemption does not apply to multi-ingredient ground or
chopped products described in Sec. 413.301 that are processed at a
retail establishment, unless the establishment qualifies for an
exemption under (a)(1) of this section; and
(iii) Products that are ground or chopped at an individual
customer's request.
[[Page 6823]]
(b) Restaurant menus generally do not constitute labeling or fall
within the scope of these regulations.
(c)(1) Foods 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 carbohydrate, dietary fiber, total sugars, added sugars,
protein, and the following vitamins and minerals: Vitamin D, calcium,
iron, and potassium.
(2) Foods represented or purported to be specifically for infants
through 12 months of age shall bear nutrition labeling, except that:
(i) Such labeling shall not declare a percent of Daily Value for
saturated fat, trans fat, cholesterol, sodium, dietary fiber, total
sugars, or added sugars and shall not include a footnote.
(ii) The following sample label illustrates the provisions of
paragraph (c)(2) of this section.
[GRAPHIC] [TIFF OMITTED] TP19JA17.011
(3) Foods 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.''
(i) The following sample label illustrates the provisions of
paragraph (c)(3) of this section.
[GRAPHIC] [TIFF OMITTED] TP19JA17.012
(ii) [Reserved]
(d)(1) Products in packages that have a total surface area
available to bear labeling of less than 12 square inches are exempt
from nutrition labeling, provided that the labeling for these products
bear no nutrition claims or other nutrition information, except that
this exemption does not apply to the major cuts of single-ingredient,
raw products identified in Sec. 413.344. The manufacturer, packer, or
distributor shall provide, on the label of packages that qualify for
and use this exemption, an address or telephone number that a consumer
can use to obtain the required nutrition information (e.g., ``For
nutrition information call 1-800-123-4567'').
(2) When products bear nutrition labeling, either voluntarily or
because nutrition claims or other nutrition information is provided,
all required information shall be provided in accordance with 9 CFR
413.309(d) for the linear nutrition display as shown in 9 CFR
413.309(g)(1)(i)(B).
Done at Washington, DC, on: November 28, 2016.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2016-29272 Filed 1-18-17; 8:45 am]
BILLING CODE 3410-DM-P