[Federal Register Volume 79, Number 41 (Monday, March 3, 2014)]
[Proposed Rules]
[Pages 11879-11987]
[FR Doc No: 2014-04387]

Vol. 79

Monday,

No. 41

March 3, 2014

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 101

Food Labeling: Revision of the Nutrition and Supplement Facts Labels;
Proposed Rule

Federal Register / Vol. 79 , No. 41 / Monday, March 3, 2014 /
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]
RIN 0910-AF22

Food Labeling: Revision of the Nutrition and Supplement Facts
Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to amend its labeling regulations for conventional foods and
dietary supplements to provide updated nutrition information on the
label to assist consumers in maintaining healthy dietary practices. The
updated information is consistent with current data on the associations
between nutrients and chronic diseases or health-related conditions,
reflects current public health conditions in the United States, and
corresponds to new information on consumer behavior and consumption
patterns. We are proposing to update the list of nutrients that are
required or permitted to be declared; provide updated Daily Reference
Values and Reference Daily Intake values that are based on current
dietary recommendations from consensus reports; amend requirements for
foods represented or purported to be specifically for children under
the age of 4 years and pregnant and lactating women and establish
nutrient reference values specifically for these population subgroups;
and revise the format and appearance of the Nutrition Facts label.

DATES: Submit either electronic or written comments on the proposed
rule by June 2, 2014. Submit comments on information collection issues
under the Paperwork Reduction Act of 1995 by April 2, 2014 (see the
``Paperwork Reduction Act of 1995'' section of this document). See
section III of this document for the proposed effective date of a final
rule based on this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-
N-1210, and/or Regulatory Information Number (RIN) 0910-AF22, by any of
the following methods, except that comments on information collection
issues under the Paperwork Reduction Act of 1995 must be submitted to
the Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section
of this document).

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5360 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2012-N-1210 and RIN 0910-AF22 for this rulemaking.
All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For
additional information on submitting comments, see the ``Comments''
heading of the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    With regard to the information collection: Domini Bean, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400T, Rockville, MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

I. Background
    A. Legal Authority
    B. Need To Update the Nutrition Facts and Supplement Facts
Labels
    1. Rates of Chronic Disease
    2. Dietary Recommendations, Consensus Reports, and National
Survey Data
    3. Consumer Use and Understanding of the Nutrition Facts Label
    4. Other Relevant Considerations
    5. Citizen Petitions
    6. Advance Notices of Proposed Rulemaking (ANPRMs)
    7. Impact on Other Regulations
    C. Factors for Mandatory or Voluntary Declaration of Non-
Statutory Nutrients
    1. Factors Considered
    2. Approach for Mandatory Declaration
    3. Approach for Voluntary Declaration
II. The Proposed Rule
    A. Calories
    1. Calories From Fat
    2. Calories From Saturated Fat
    3. Two Thousand Calories as the Reference Caloric Intake Level
    4. Percent DV Declaration for Calories
    B. Fat
    1. Total Fat
    2. Saturated Fat
    3. Trans Fat
    4. Polyunsaturated Fat
    5. Monounsaturated Fat
    C. Cholesterol
    1. Mandatory Declaration
    2. DRV
    D. Carbohydrate
    1. Total Carbohydrate
    2. Sugars
    3. Added Sugars
    4. Sugar Alcohols
    5. Dietary Fiber
    6. Other Carbohydrate
    E. Protein
    1. Mandatory and Voluntary Declaration
    2. Analytical Methods
    3. DRV
    F. Sodium
    1. Mandatory Declaration
    2. DRV
    G. Fluoride
    1. Voluntary Declaration
    2. DRV
    H. Essential Vitamins and Minerals of Public Health Significance
    1. Essential Vitamins and Minerals That Are Mandatory
    2. Essential Vitamins and Minerals That Are Voluntary
    3. Other Essential Vitamins and Minerals
    4. Summary
    I. Reference Daily Intakes for Vitamins and Minerals
    1. Need To Update RDIs
    2. Approach To Setting RDIs: EAR Versus RDA
    3. Approach To Setting RDIs: Adequate Intake
    4. Approach To Setting RDIs: Tolerable Upper Intake Level
    5. Approach To Setting RDIs: Population-Weighted Versus
Population-Coverage
    6. Declaration of the Absolute Amounts of Vitamins and Minerals
    7. Issues Concerning Specific Vitamins and Minerals
    J. Units of Measure, Analytical Methods, and Terms for Vitamins
and Minerals
    1. Sodium, Potassium, Copper, and Chloride
    2. Folate and Folic Acid
    3. Vitamins A, D, and E
    K. 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 Statutorily Required
Nutrients

    3. Declaration of Non-Statutory Nutrients Other Than Essential
Vitamins and Minerals
    4. Declaration of Essential Vitamins and Minerals
    5. DRVs and RDIs for Infants 7 Through 12 Months of Age
    6. DRVs and RDIs for Children 1 Through 3 Years of Age
    7. DRVs and RDIs for Pregnant and Lactating Women
    L. Dietary Supplements
    1. Mandatory Dietary Ingredients
    2. Folate and Folic Acid
    3. Units of Measure
    4. Order of Nutrients Declared on the Label
    5. Subpopulations
    6. Footnote
    M. 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. Changing the ``Amount Per Serving'' Statement
    5. Declaration of ``Calories From Fat''
    6. Presentation of Percent DVs
    7. Placement of ``Added Sugars''
    8. Declaration of Absolute Amounts of Vitamins and Minerals
    9. Single and Dual Column Labeling
    10. The Footnote
    11. Use of Highlighting With a Type Intermediate Between Bold or
Extra Bold and Regular Type
    12. Addition of Horizontal Line Beneath the Nutrition Facts
Heading
    13. Replacing ``Total Carbohydrate'' With ``Total Carbs''
    14. Alternative Visual Formats/Fonts
    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
    1. Changing the Name of the Program Office
    2. Changing the Publication Date of Report Incorporated by
Reference
    3. Plain Language Edits
III. Proposed Effective and Compliance Dates
IV. Analysis of Impacts
V. Paperwork Reduction Act of 1995
VI. Analysis of Environmental Impact
VII. Federalism
VIII. Comments
IX. References

Executive Summary

Purpose of the Regulatory Action

    FDA is proposing to amend the regulations for the nutrition
labeling of conventional foods and dietary supplements to assist
consumers in maintaining healthy dietary practices.
    Following the passage of the Nutrition Labeling and Education Act
(NLEA) of 1990 (the 1990 amendments) (Pub. L. 101-535), which added
section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 343(q)), we issued various regulations related to
nutrition information on food labels, including the declaration of
nutrients, the format for nutrition labeling, reference values for use
in declaring the nutrient content, and allowances for certain specified
products to be exempt from nutrition labeling (Sec.  101.9 (21 CFR
101.9)). In addition, following the passage of the Dietary Supplement
Health and Education Act (DSHEA) of 1994 (Pub. L. 103-417 and 21 U.S.C.
321(ff)), we amended our food labeling regulations to establish
requirements for nutrition labeling of dietary supplements (Sec. Sec.
101.9(j)(6) and 101.36). Section 403(q) of the FD&C Act specifies
certain nutrients to be declared in nutrition labeling, and authorizes
the Secretary of Health and Human Services to require other nutrients
to be declared if the Secretary determines that a nutrient will provide
information regarding the nutritional value of such food that will
assist consumers in maintaining healthy dietary practices. The
Secretary also has discretion under section 403(q) of the FD&C Act to
remove, by regulation and under certain circumstances, nutrient
information that is otherwise explicitly required in food labeling
under this section.
    We are proposing to revise our regulations to provide updated
nutrition information on the label and improve how the nutrition
information is presented to consumers, in light of current scientific
evidence, dietary recommendations of most recent consensus reports, and
public comments received in response to advance notices of proposed
rulemaking. FDA invites comment on its use of the most recent consensus
reports and whether the information and data on which FDA relies from
such reports for proposed changes is consistent with current scientific
information.
Summary of the Major Provisions of the Regulatory Action in Question
    We discuss the need to update the Nutrition Facts and Supplement
Facts labels in section I.B., and our scientific considerations for
mandatory and voluntary declaration of nutrients are presented in
section I.C. In sections II.A. through II.K., we discuss provisions
related to the declaration, reference values, analytical methods, and
definitions of nutrients that are required or permitted to be declared
on the Nutrition Facts label of conventional foods, whereas
corresponding changes to the Supplement Facts label of dietary
supplements are presented in section II.L. We present our
considerations related to the format of the Nutrition Facts and
Supplement Facts labels in section II.M., and discuss issues related to
compliance with the proposed requirements in section II.N. Some of the
key proposed actions and considerations of the proposed rule are
highlighted in this document.
    Among other amendments related to declaration of nutrients, we are
proposing to remove the declaration of ``Calories from fat'' because
current science supports a view that the type of fat is more relevant
than overall total fat intake in increased risk of chronic diseases. In
addition, removal of the ``calories from fat'' disclosure had no effect
on consumers' judgments of product healthfulness, accuracy in
identifying nutrient contents of products, or perceptions in FDA's
consumer research.
    Considering current science and recommendations related to added
sugars, we are also proposing to require the declaration of ``added
sugars,'' that will provide consumers with information they need to
implement the dietary recommendations of the Dietary Guidelines for
Americans, 2010 (2010 DGA).
    We are also proposing to update the list of vitamins and minerals
of public health significance. We currently require the mandatory
declaration of percent Daily Values (DVs) of vitamins A and C, calcium
and iron. We analyzed the nutrient inadequacy for vitamins and minerals
based on biomarker data and total dietary intake (conventional foods
and dietary supplements) using National Health and Nutrition
Examination Survey (NHANES) data and other factors for mandatory and
voluntary declaration discussed in section I.C. to determine which
essential vitamins and minerals should be included as nutrients of
public health significance. Based on this analysis, we are not
proposing any changes to the current requirement for mandatory
declaration of calcium and iron. In addition, we are proposing to
require the declaration of vitamin D and potassium, and to permit,
rather than require, the declaration of vitamins A and C.
    With respect to reference values used to declare percent DVs of
nutrients, since 1993, new reports from the Institute of Medicine (IOM)
and other consensus and policy reports (for example, the 2010 DGA and
the Report of the Dietary Guidelines Advisory Committee on the Dietary
Guidelines for

Americans) have been published that update the quantitative intake
recommendations of nutrients as well as their association with chronic
disease and health-related conditions. We are using these new data to
update, as appropriate, the reference values used in the declaration of
percent DVs of nutrients on the Nutrition Facts and Supplement Facts
labels.
    Among other amendments to reference values, we are proposing an
updated reference value for the declaration of percent DV for sodium
from the current value of 2,400 mg (milligrams) to 2,300 mg based on a
consideration of current science and IOM's report that set Dietary
Reference Intakes (DRIs) for sodium, including a Tolerable Upper Intake
Level of 2,300 mg/day (d) as a reference intake level not to exceed.
    A primary change that we are proposing to the format of the
Nutrition Facts and Supplement Facts labels is to increase the
prominence of the ``Calories,'' numeric value of calories, ``Servings
per container,'' and numeric value of servings per container
declarations. Research suggests that these proposed changes may
increase consumers' attention to the information, and in certain
situations, help consumers to accurately identify the number of
calories in a product. We are also proposing to move the ``% DV'' to
the left side of the label in order to highlight the information for
consumers. We are also proposing to remove the requirement for the
footnote table listing the reference values for certain nutrients for
2,000 and 2,500 calorie diets. We intend to continue to perform
consumer research during this rulemaking process to evaluate how
variations in label format may affect consumer understanding and use of
the Nutrition Facts label. We intend to publish the results of our
research for public review and comment.
[GRAPHIC] [TIFF OMITTED] TP03MR14.001

    We are also proposing to require the maintenance of records to
support the declarations of certain nutrients under specified
circumstances. Currently, there are no analytical methods that can
distinguish between dietary fiber (soluble and insoluble fiber) and
non-digestible carbohydrates that do not meet the definition of dietary
fiber; added and naturally occurring sugars; the various forms of
vitamin E; or folate and folic acid and there are no analytical methods
that can determine the amount of added sugar in specific foods
containing added sugars alone or in combination with naturally
occurring sugars, where the added sugars are subject to fermentation.
Therefore, for products that contain non-digestible carbohydrates that
do not meet the definition of dietary fiber, more than one source of
sugar, added sugars that undergo fermentation, various forms of vitamin
E, or folate and folic acid, we are proposing that manufacturers must
make and keep certain written records to verify their declarations of
each of these nutrients in the labeling of the food associated with
such records. We are also proposing that records must be kept for a
period of at least 2 years after introduction or delivery for
introduction of the food into interstate commerce and

may be kept as original records, as true copies, or electronically, and
manufacturers must provide those records to us for inspection and
copying upon request during an inspection.
    We anticipate that consumer education efforts would be needed to
help with consumer understanding and use of information presented under
the changes to the Nutrition Facts and Supplement Facts labels proposed
in this rule. We plan to use the results of our consumer research to
help inform our future actions on this issue.
    Finally, we are proposing an effective date of 60 days after the
date of the final rule's publication in the Federal Register with a
compliance date 2 years after the effective date. We invite comment on
the proposed compliance date. In addition to the proposed compliance
date, we invite comment on various other issues, as summarized in
section XI.
Costs and Benefits
    We have developed one comprehensive preliminary regulatory impact
analysis that presents the benefits and costs of this proposed rule as
well as the proposed rules entitled 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 taken together. The cumulative impact of these
two nutrition labeling proposals, taken as a whole, is shown in the
following table.

                                          Summary of Costs and Benefits
                                             [In billions of 2011 $]
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                                                                Benefits            Costs         Net benefits
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Present Value (PV):
    3%....................................................             $31.4              $2.3             $29.1
    7%....................................................              21.1               2.3              18.8
Annualized (3% PV Amount)
    3%....................................................               2.0               0.2               1.8
Annualized (7% PV Amount)
    7%....................................................               1.9               0.2               1.7
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Notes: Compliance period is 24 months. Costs include relabeling and reformulation costs, which are one-time
  costs, as well as recordkeeping costs, which recur. Present values of relabeling and reformulation costs are
  equivalent at 3 or 7 percent because we conservatively assume that these one-time costs are incurred upon
  publication of the rule instead of at the end of the compliance period. Recordkeeping costs, because of their
  recurring nature, differ by discount rate; however, such costs comprise a very small percentage of total
  costs.

I. Background

    The 1990 amendments added section 403(q) to the FD&C Act, which
specifies, in part and with certain exceptions, that food is deemed
misbranded unless its label or labeling bears nutrition information for
certain nutrients. To implement the 1990 amendments, on January 6,
1993, FDA issued several rules, including ``Food Labeling: Mandatory
Status of Nutrition Labeling and Nutrient Content Revision, Format for
Nutrition Label (the 1993 nutrient content final rule)''; ``Food
Labeling; Reference Daily Intakes and Daily Reference Values (1993 RDI/
DRV final rule)''; and ``Food Labeling: Serving Sizes'', to modify how
nutrition information is presented on food labels (58 FR 2079; 58 FR
2206; 58 FR 2229, respectively). FDA published regulations related to:
(1) Declaration of nutrients on food labeling, including nutrients that
are required or permitted to be declared and the format for such
declaration; (2) label reference values for use in declaring the
nutrient content of a food on its label or labeling; (3) two types of
reference values, Reference Daily Intakes (RDIs) for vitamins and
minerals and Daily Reference Values (DRVs) for certain nutrients, which
are used to declare nutrient contents as percent DVs on the Nutrition
Facts label; (4) exemptions for certain specified products; and (5) a
simplified form of nutrition labeling and the circumstances in which
such simplified nutrition labeling can be used. (See Sec.  101.9.)
Elsewhere in this issue of the Federal Register, we are publishing a
proposed rule that will amend the definition of a single-serving
container, require dual column labeling for certain containers, update
the reference amounts customarily consumed and serving sizes for
several food product categories and amend the serving size for breath
mints.
    In 1994, DSHEA became law. Among other things, DSHEA amended
section 403(q)(5)(F) of the FD&C Act by adding specific requirements
that relate to the labeling of dietary supplement products.
Accordingly, we amended our food labeling regulations to establish
requirements for nutrition labeling of dietary supplements (Sec. Sec.
101.9(j)(6) and 101.36).
    The regulatory history, our rationale for existing requirements,
and FDA activities related to nutrition labeling of foods and dietary
supplements are described in Reference 1.

A. Legal Authority

    We are proposing to update the Nutrition Facts label and Supplement
Facts label, as set forth in this proposed rule, consistent with our
authority in section 403(q) of the FD&C Act. Section 403(q)(1) of the
FD&C Act states that a food shall be deemed to be misbranded if, with
certain exceptions, it fails to bear nutrition labeling and identifies
specific nutrient and calorie information required in labeling. Section
403(q)(2)(A) of the FD&C Act provides the Secretary, and by delegation,
FDA, with discretion to require by regulation nutrition information
about nutrients other than those specified in section 403(q)(1) of the
FD&C Act to assist consumers in maintaining healthy dietary practices.
Section 403(q)(2)(B) of the FD&C Act permits the Secretary, and by
delegation, FDA, to remove information relating to a nutrient required
by section 403(q)(1) or 403(q)(2)(A) of the FD&C Act if the Secretary
determines that it is not necessary to assist consumers in maintaining
healthy dietary practices. Consistent with these authorities, we are
proposing to revise certain nutrient declarations in the Nutrition
Facts label and Supplement Facts label. In addition, FDA's authority
includes section 2(b)(1) of the 1990 amendments (21 U.S.C. 343 note).
Specifically, section 2(b)(1)(A) of the 1990 amendments requires
nutrition label information be conveyed in a manner that enables the
public to readily observe and comprehend the information and to
understand its relative significance in the context of a total daily
diet. Such section states that such information should be consistent

with current scientific knowledge about nutrients and health. We are
proposing changes to DVs (RDIs and DRVs, as applicable) for some
nutrients, which values are used to calculate the percent DV for use on
food labels. The use of reference values based on current science and
the use of such values to calculate the percent DV assists consumers in
comprehending the nutrition information and its relative significance
in a total daily diet. We are also proposing changes to the format
pertaining to information on the percent DV value. Further, section
2(b)(1)(C) of the 1990 amendments stipulates that regulations ``shall
permit the label or labeling of food to include nutrition information
which is in addition to the information required by such section 403(q)
[of the FD&C Act] and which is of the type described in subparagraph
(1)(or (2) of such section . . . .'' We are proposing changes to the
voluntary declaration of certain nutrients in the Nutrition Facts label
consistent with such authority.
    Other relevant authorities include sections 701(a), 403(a)(1) and
201(n) of the FD&C Act (21 U.S.C. 371(a), 21 U.S.C. 343(a)(1), and 21
U.S.C. 321(n), respectively). Under section 701(a) of the FD&C Act, the
Agency may issue regulations for the efficient enforcement of the FD&C
Act in order to ``effectuate a congressional objective expressed
elsewhere in the Act'' (Association of American Physicians and
Surgeons, Inc. v FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm.
Mfrs. Ass'n. v FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980).)
    We are relying on our authority under sections 403(q), 403(a),
201(n) and 701(a) of the FD&C Act, to propose record requirements to
support nutrient declarations in labeling for added sugars, dietary
fiber, soluble fiber, insoluble fiber, vitamin E, and folate/folic
acid, under certain circumstances, so that we can determine compliance
with labeling requirements and take enforcement action, as needed. For
these nutrients, as explained in section II.N., there is no AOAC
official method of analysis of AOAC International or other reliable or
appropriate analytical procedure, otherwise required by Sec.  101.9(g),
available for FDA to quantify the declared amount of the nutrient,
under certain circumstances. Section 101.9(g) sets forth the standards
for accuracy of the amount statements of nutrients on food labels.
Failing to accurately state the amounts of nutrients on the label under
Sec.  101.9(g) would result in a product being misbranded. Under
section 403(q) of the FD&C Act, a food must bear, in its label or
labeling, the amount of the nutrient the food contains. Moreover, the
nutrient declaration must be truthful and not misleading under sections
403(a)(1) and 201(n) of the FD&C Act. Thus, when a food product
contains dietary fiber (whether soluble, insoluble, or a combination of
both) and added non-digestible carbohydrate(s) that does not meet the
definition of dietary fiber, we are proposing to require manufacturers
to make and keep certain written records to verify the amount of added
non-digestible carbohydrate that does not meet the definition of
dietary. When vitamin E is present in a food as a mixture of all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol, we are proposing
to require manufacturers to make and keep written records to verify the
amount of all rac-[alpha]-tocopherol acetate added to the food and RRR-
[alpha]-tocopherol in the finished food. When a mixture of folate and
folic acid is present in a food, we are proposing to require
manufacturers to make and keep records to verify the amount of folic
acid added to the food and folate in the finished food. When added
sugars as well as naturally occurring sugars are present in a food, we
are proposing to require manufacturers to make and keep records to
verify the declared amount of added sugars in the food. Finally, we are
proposing to require manufacturers to make and keep records to verify
the declared amount of added sugars in specific foods, alone or in
combination with naturally occurring sugars, where the added sugars are
subject to fermentation.
    The proposed record requirements for these nutrients, under the
circumstances described, are designed to ensure that the nutrient
declarations are accurate, truthful and not misleading, based on
information known only to the manufacturer, and to facilitate efficient
and effective action to enforce the requirements when necessary. Our
authority to establish records requirements has been upheld under other
provisions of the FD&C Act where FDA has found such records to be
necessary (National Confectioners Assoc. v Califano, 569 F.2d 690, 693-
94 (D.C. Cir. 1978). The records we propose to require are only for
foods for which an adequate analytical method is not available. The
records would allow us to verify the declared amount of each of these
nutrients and that such amount is truthful and not misleading. Thus,
the proposed records requirements would help in the efficient
enforcement of the FD&C Act.
    The authority granted to FDA under sections 701(a), 403(q),
403(a)(1) and 201(n) of the FD&C Act not only includes authority to
establish records requirements, but also includes access to such
records. Without such authority, the nutrient declarations for these
specific nutrients that FDA has determined are necessary to assist
consumers in maintaining healthy dietary practices under section
403(q)(2)(A) of the FD&C Act are, practically speaking, not
enforceable. Without access to such records, FDA would not know whether
the amount declared on the label or in the labeling of each these
nutrients, under the circumstances described, is truthful and not
misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The
introduction or delivery for introduction into interstate commerce of a
misbranded food is a prohibited act under section 301(a) of the FD&C
Act (21 U.S.C. 331(a)). Thus, to determine whether the food is
misbranded and the manufacturer has committed a prohibited act, we must
have access to the manufacturer's records that we are requiring be made
and kept under sections 403(q), 403(a)(1), 201(n) and 701(a) of the
FD&C Act. Failure to make and keep records and provide the records to
FDA, as described in proposed Sec.  101.9(g)(10) and (g)(11), would
result in the food being misbranded under sections 403(q) and 403(a)(1)
of the FD&C Act.

B. Need To Update the Nutrition Facts and Supplement Facts Labels

    FDA first issued regulations related to the Nutrition Facts label
in 1993. We have not updated the Nutrition Facts label since the 2003
trans fat rulemaking (68 FR 41434; July 11, 2003) or established new or
updated DVs for nutrients since 1995 (60 FR 67164; December 28, 1995).
Since that time, the public health profile of the U.S. population has
changed (e.g., increase in obesity), new information has become
available about nutrient definitions (e.g., vitamin E), reference
intake values, and analytical methods, and new dietary recommendations
(see section I.B.2.) have been published. As a result, we are
reconsidering what nutrients we should require or permit to be listed
on the Nutrition Facts label and what nutrient reference intake values
we should use as a basis for calculating the percent DVs in food
labeling. We also considered corresponding changes to the Supplement
Facts labels. We discuss specific nutrient declarations in greater
detail in section II. Section I.B. includes an overview of information
we considered when forming our tentative conclusions, including
scientific and technical data and recommendations, citizen petitions
submitted to us, and public comments to previous requests

for comment in advance notices of proposed rulemaking on topics related
to this proposed rule. We also considered the role of nutrition
labeling to assist consumers in maintaining healthy dietary practices
and consumers' use and understanding of the Nutrition Facts label.
1. Rates of Chronic Disease
    Chronic diseases, such as heart disease, cancer and stroke are the
leading causes of death and disability in the United States, and
account for 70 percent of all deaths in the United States (Ref. 2). In
2005, 133 million Americans, almost one out of every two adults, had at
least one chronic illness (Ref. 2). An estimated 37 percent of
Americans suffer from cardiovascular disease (CVD) (Ref. 3), 11.3
percent of the population 20 years and older has diabetes, 35 percent
of adults has pre-diabetes (Ref. 4), and 41 percent of the population
is predicted to be diagnosed with cancer during their lifetime (Ref.
5). While the causes of these chronic diseases are multifactorial, poor
diet is a contributing factor associated with morbidity and mortality
(Ref. 6). Many nutrients are associated with chronic disease risk. For
example, diets low in saturated fat and cholesterol, and/or sodium are
associated with a decreased risk of CVD (58 FR 2739; January 6, 1993,
and 58 FR 2820; January 6, 1993). Adequate or increased intake of
calcium and vitamin D may decrease the risk of osteoporosis (73 FR
56477; September 29, 2008).
    Obesity rates have increased dramatically over the last three
decades. Between 1976 and 1980 and 2007 and 2008, obesity rates
increased more than twofold (from 15 to 34 percent) in adults and more
than threefold (from 5 to 17 percent) among children and adolescents
(Refs. 6 to 8). Data published by the U.S. Centers for Disease Control
and Prevention (CDC) indicate that 68 percent of adults and about 32
percent of children aged 2 to 19 years in the U.S. population are
overweight or obese (Refs. 7 and 8). Excessive body weight is a risk
factor for chronic diseases such as heart disease, some forms of
cancer, and type II diabetes (Ref. 9). The 2010 DGA affirmed the role
of over consumption of calories and physical inactivity as the primary
risk factors contributing to an epidemic of overweight and obesity in
this country, and urged for a focus on improved nutrition and physical
activity choices among Americans (Ref. 6).
    Elevated blood pressure, an important risk factor for CVD (Ref.
10), affects about one-third of the U.S. adult population (Ref. 2).
High intakes of sodium are directly associated with elevated blood
pressure (Ref. 10). Average sodium intake for the U.S. population 4
years of age and older is approximately 3,650 mg/d (Ref. 11). Almost
all Americans consume more sodium than the levels recommended by the
2010 DGA (Ref. 12)
    Furthermore, while concerns in recent years have largely shifted
away from nutritional deficiencies, some population subgroups may
consume excess calories but still consume inadequate amounts of certain
micronutrients such as iron, vitamin D, calcium and potassium (see
section II.H.).
    The mandatory declaration of nutrients that have public health
significance, the use of updated DVs based on current scientific
evidence, and the use of a format for the Nutrition Facts label to
assist with consumer use and understanding can help consumers make
informed food choices to consume a nutritionally adequate diet while
monitoring calorie intake and lowering their risk of some chronic
diseases.
2. Dietary Recommendations, Consensus Reports, and National Survey Data
    a. IOM Dietary Reference Intakes Reports (IOM DRI Reports)--In
1994, the Food and Nutrition Board (FNB) of the Institute of Medicine
(IOM) identified principles for the development of a new set of
reference values that could expand and replace the IOM's Recommended
Dietary Allowances (RDAs) of 1989 (Refs. 13 and 14). A comprehensive
review and application of a growing body of nutritional science
research resulted in the development of a set of reference values,
collectively known as DRIs, published from 1997 to 2010 (Ref. 15). The
DRIs represent a shift in the way that reference values are established
or intended for use. In contrast to previous editions of RDAs (e.g.,
the 1968 and 1989 RDAs), which involved establishing single values for
each nutrient with appropriate adjustments for age, sex and
physiological status, the new DRI framework consisted of four
categories of reference values. These categories include the Estimated
Average Requirement (EAR), RDA, Adequate Intake (AI) and Tolerable
Upper Intake Level (UL). For macronutrients--carbohydrates, fats, and
protein--the IOM developed a new set of reference values called the
Acceptable Macronutrient Distribution Ranges (AMDRs).
    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. 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. The
RDA is set using the EAR. In general, the RDA is the EAR plus two times
the standard deviation of the EAR. The RDA is used to plan nutrient
intakes for individuals to ensure a low probability of inadequacy.
Nutrients with EARs and RDAs include carbohydrate, protein, vitamin A,
vitamin C, vitamin E, thiamin, riboflavin, niacin, vitamin
B6, folate, vitamin B12, copper, iodine, iron,
magnesium, phosphorus, selenium, zinc, calcium and vitamin D.
    An AI is the level determined for an essential nutrient or a
nutrient that is beneficial for human health when there is insufficient
evidence to calculate an EAR for that nutrient, and therefore
insufficient evidence on which to establish an RDA. AIs can be based on
a variety of data, including scientific evidence about the essentiality
of a nutrient (i.e., choline, biotin, fluoride), experimental data on
risk reduction of chronic disease (i.e., dietary fiber, potassium), and
median intakes of a nutrient using national survey data (i.e., vitamin
K, pantothenic acid, chromium, manganese, linoleic acid, and [alpha]-
linolenic acid). Although there is less certainty about an AI value
than about an RDA value, the AI is similarly designed to cover the
needs of nearly all individuals. The IOM Dietary Planning Report and
Dietary Assessment Report noted that ``the AI should be used with less
confidence if it has not been established as the mean intake of a
healthy group.''
    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. Nutrients with ULs
include vitamin A, vitamin C, vitamin D, vitamin E, niacin, vitamin
B6, folate, choline, calcium, copper, fluoride, iodine,
iron, magnesium, manganese, molybdenum, phosphorus, selenium, zinc,
sodium, and chloride.
    Moreover, while the previous RDAs primarily focused on reducing the
incidence of diseases of nutrient deficiency in the population, the
DRIs

now take into consideration data on chronic disease risk, such as heart
disease, and developmental abnormalities, such as teratogenicity,
rather than only the signs of deficiency. Finally, where sufficient
data exist, the DRIs take into account the potential benefit or risk to
health of substances that are not essential (such as dietary fiber and
fluoride) that are in addition to the macronutrients of total
carbohydrate, protein, and fat, and the micronutrient vitamins and
minerals permitted or required on the Nutrition Facts label (Ref. 15).
Beginning in 1997, the IOM began publishing its DRIs for those
vitamins, minerals, and macronutrients that are essential in humans or
provide a beneficial role in human health (Refs. 16 to 22). In
addition, the IOM also set AMDRs for carbohydrates, fat, and protein
(Ref. 23). 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. The AMDR is
expressed as a range of percent energy intake (e.g., 20 to 35 percent
of calories from total fat for adults over 18 years of age). The DRIs
and AMDRs were set for the following life stage groups: Infants (0 to 6
and 7 to 12 months); toddlers (1 to 3 years); boys and girls (4 to 8
years); adolescent boys and girls (9 to 13 and 14 to 18 years); adult
men and women (19 to 30, 31 to 50, 51 to 70, and greater than 70
years); and pregnant and lactating women.
    b. IOM Dietary Fiber Report--In 2001, the IOM Panel on the
Definition of Dietary Fiber (the IOM Dietary Fiber Panel) responded to
our request to provide definitions for dietary fiber based on its role
in human physiology and health. The IOM Dietary Fiber Panel developed
two categories of definitions of fiber: ``Dietary Fiber'' and ``Added
Fiber'' in its report Dietary Reference Intakes: Proposed Definition of
Dietary Fiber (the IOM Dietary Fiber Report) (Ref. 24).
    c. IOM Dietary Assessment Report--In 2000, the IOM Subcommittee on
Interpretation and Uses of Dietary Reference Intakes (IOM uses
Committee) published the report, DRIs Application in Dietary Assessment
(IOM Dietary Assessment report) on how to use the DRIs for dietary
assessment of individuals and groups.
    d. IOM Labeling Report--In 2003, the IOM Committee on nutrition
labeling (IOM Labeling Committee) considered how the DRIs can be used
to develop appropriate reference values for nutrition labeling and
published its report, co-funded by FDA, DRI Guiding Principles for
Nutrition Labeling and Fortification (the IOM Labeling Report) (Ref.
25), with the goal of having an updated nutrition label that consumers
can use to make informed dietary choices.
    e. IOM Dietary Planning Report--In 2003, the IOM Subcommittee on
interpretation and uses of DRIs (IOM Uses Committee) published a
report, DRIs Application in Dietary Planning (IOM Dietary Planning
Report) (Ref. 26) on how to use the DRIs for planning intakes of
individuals and groups. This report discusses the use of the DRIs for
food and supplement labels.
    f. IOM Sodium Strategies Report--In 2008, the IOM convened a
Committee on Strategies to Reduce Sodium Intake in the United States to
address a Congressional request for recommendations about various means
that could be employed to reduce dietary sodium intake to levels
recommended by the 2005 DGA (less than 2,300 mg/d and no more than
1,500 mg/d for African-Americans, people with hypertension, and middle-
aged and older adults). The Committee's report, Strategies to Reduce
Sodium Intake in the United States (IOM Sodium Strategies Report),
published in 2010, among other strategies, discusses how the labeling
of sodium on foods can serve as a supporting strategy for reducing
sodium intake (Ref. 27).
    g. IOM Front-Of-Package Nutrition Rating Systems and Symbols Phase
I and Phase II Reports--In 2010, the IOM Committee on Front-of-Package
(FOP) Nutrition Rating Systems and Symbols reviewed the existing FOP
systems and their underlying nutrition criteria. In the Phase I report,
the IOM identified the nutrients for which there was sufficient
evidence of their role in chronic disease risk and which should be
included in a FOP label (Ref. 28). In 2012, the IOM published its phase
II report that recommended developing a single standardized FOP rating
system and updated their recommendations for nutrients to be included
on the FOP label (Ref. 29).
    h. IOM Sodium Intake in Populations Report--In 2012 the IOM
convened a Committee to review and assess the benefits and adverse
outcomes (if any) of reducing the sodium intake in the population,
particularly in the range of 1,500 to 2,300 mg/d. The Committee was
also asked to specifically emphasize relevant subgroups in the analysis
including those 50 years of age and older, African Americans, and those
with diabetes, chronic kidney disease, and congestive heart failure.
The Report was published in May of 2013 and focused its findings and
conclusions on evidence for associations between sodium intake and the
risk of CVD-related events and mortality.
    i. Dietary Guidelines for Americans (DGA), 2010--The 2010 DGA,
developed jointly by the U.S. Department of Agriculture (USDA) and the
U.S. Department of Health and Human Services (HHS), provide several key
recommendations including recommendations about dietary patterns, as
well as quantitative intake recommendations with respect to
micronutrients and macronutrients, most of which are based on the IOM
DRI reports (Ref. 6). In a few cases, the 2010 DGA provided
quantitative intake recommendations for certain nutrients (i.e.,
cholesterol and saturated fat) that were not provided by the IOM DRI
reports (Ref. 6). The 2010 DGA emphasized the importance of meeting
food and nutrient recommendations while balancing calorie needs (Ref.
6). More information regarding the scientific basis that informed the
development of the 2010 DGA can be found in the Report of the Dietary
Guidelines Advisory Committee on the Dietary Guidelines for Americans,
2010 (2010 DGAC) (Ref. 30). An important note related to the 2010 DGA
is the specified intended audience for its recommendations (Ref. 6).
From the 1980s until 1995, the DGAs were targeted toward healthy
Americans and designed to provide advice to healthy individuals about
food choices that promote health and prevent disease (Refs. 31 to 34).
In 2000, the recommendations specified an audience of ``healthy
children ages 2 years and older and adults of any age,'' and the 2005
DGA provided recommendations for the ``general public age 2 years and
older.'' (Refs. 35 and 36). While the DGAs have always taken into
account the needs of subpopulations, the most recent 2010 DGA goes
beyond the traditional target of a ``healthy'' audience to provide
chronic disease,'' noting ``the reality that a large percentage of
Americans are overweight or obese and/or at risk of various chronic
diseases'' (Ref. 6).
    j. National Health and Nutrition Examination Survey (NHANES)--The
NHANES provides the primary source of information on the health and
nutritional status of adults and children in the United States. The
survey examines a nationally representative sample of about 5,000
persons each year. These persons are located in counties across the
country. The survey combines interviews, which include demographic,
socioeconomic, dietary, and health-related questions, and physical
examinations, which consist of

medical, dental, and physiological measurements, as well as laboratory
tests administered by highly trained medical personnel (Ref. 37).
3. Consumer Use and Understanding of the Nutrition Facts Label
    The Nutrition Facts label is intended to help consumers make
informed food choices and maintain healthy dietary practices. Consumers
became increasingly aware of the new label in the years following
implementation of the 1990 amendments, and reported using food labels
more often in their purchasing decisions compared to their use before
the introduction of the Nutrition Facts label (Ref. 38).
    Data from a nationally representative sample of U.S. adults
collected through FDA's Health and Diet Surveys suggest that the
frequency of food label use among consumers progressively increased
between 2002 and 2008 (Refs. 39 to 41). For example, the percentage of
consumers reporting that they ``often'' read a food label the first
time they purchase a food product rose from 44 percent in 2002 to 54
percent in 2008. Among those indicating they read food labels when
purchasing a product for the first time, two-thirds of them in 2008
reported using the label to see how high or low the food was in
calories, salt, vitamins or fat, while more than half said they used
labels to get a general idea of the nutritional content of the product.
A similar increase in reported use of food labels has also been shown
using data from the National Health and Nutrition Examination Surveys
2007-2008 and 2009-1010. The percent of working age adults that
reported using the Nutrition Facts Panel (NFP) always or most of the
time when shopping for food increased to 42% in 2009-2010 from 34% in
2007-2008. Among older adults the percentage increased to 57% in 2009-
2010 from 51% in 2007-2008. (Ref. 42).
    Consumer research data suggest that, despite the widespread use of
food labels, certain elements of the Nutrition Facts label may need
improvement. For example, some consumers have difficulty understanding
the concept of percent DV (Refs. 43 and 44) or are confused by the
label footnote that lists DVs for certain nutrients based on a 2,000
and 2,500 calorie diet (Ref. 45).
    Section 2(b)(1)(A) of the 1990 amendments mandated that FDA
regulations implementing section 403(q) of the FD&C Act require that
nutrition labeling must be conveyed to the public in a manner which
enables the public to readily observe and comprehend such information
and to understand its relative significance in the context of a total
daily diet. In particular, the percent DV of a nutrient present in food
is declared on food labels to help consumers understand the relative
significance of nutrition information in the context of a total daily
diet, compare the nutritional values of food products, and to plan
general diets (58 FR 2206 at 2213; January 6, 1993). We also noted that
the percent DV information advises the consumer how much of a
recommended intake of that nutrient is provided by the food (58 FR 2079
at 2123; January 6, 1993). We developed the term ``Daily Value'' to
refer to all reference values on the nutrition label (DRVs and RDIs).
We noted that some of the reference values were intended to guide
consumers relative to maximum intakes (DRVs) (e.g., saturated fat),
while others were intended to serve as the basis for planning general
diets to meet nutrient requirements (RDIs) (e.g., vitamin C) (58 FR
2079 at 2124). Our research at the time showed that the term ``Daily
Value'' was generally understood by consumers as a point of reference
(58 FR 2079 at 2125).
    In order to determine a nutrition labeling format that could be
used most effectively by consumers, we conducted consumer research and
evaluated research conducted by others in considering requirements for
the nutrition label format (58 FR 2079 at 2115-2121). When available,
we used empirical data on how consumers use and understand the label in
proposing what information should be declared on the label and how. We
used focus group data to inform what we would test in experimental
studies, but did not rely on such data to make policy decisions.
Several comments to the ANPRMs submitted focus group data. However, we
are not relying on focus group data for the proposed changes to the
Nutrition Facts label because focus groups do not yield meaningful
quantitative findings and are not able to support conclusions about the
relationships between the presentation of label information and
consumer responses. As such, they cannot be used to drive the
development of policies, programs, and services. Policy makers and
educators can use focus groups findings to test and refine their ideas,
but should then conduct further research before making important
decisions such as adopting new policies and allocating or redirecting
significant resources to support these policies.
    We have completed one study that examined dual-column labels and
ways to increase prominence of certain label information, and intend to
continue to perform research during this rulemaking process to evaluate
how variations in label format may affect consumer understanding and
use of the Nutrition Facts label. Issues to be addressed include how a
declaration of ``Added Sugars'' and alternative footnote statement may
influence consumer use of the label.
    The overall goal of these studies is to assess a consumer's ability
to use the Nutrition Facts label and assess a consumer's preferences
related to proposed modifications of the Nutrition Facts label format.
In addition, the studies will help us focus our efforts on consumer
education as well as enhance our understanding of whether modifications
to the Nutrition Facts label format could help consumers make more
informed choices based on their perceptions of the nutritional
attributes and overall healthfulness of a food product. (See also
discussion in section II.M.)
4. Other Relevant Considerations
    In developing this proposed rule, we considered changes that would
assist consumers in maintaining healthy dietary practices and recognize
that it is important for the updated Nutrition Facts label to be useful
and relevant to the American population. While the Nutrition Facts
label information has never been nor is it now targeted to individuals
with acute or chronic disease, we are considering the large portion of
the U.S. population that is at risk for chronic disease in proposing
changes to the label's content and format. The population at risk for
chronic disease includes those who are overweight, and therefore at
increased risk of certain chronic diseases, or those who are obese,
leading to a variety of complications including diabetes and CVD. This
approach is consistent with the new IOM DRIs, which are for healthy
individuals, including those at-risk of disease, but not for
individuals with acute or chronic disease or nutrient deficiencies
(Ref. 15). Similarly, the DGAs are for Americans ages 2 years and
older, including those at risk of chronic disease. While consumers with
acute or chronic disease, such as obesity, CVD, or diabetes, may be
able to use quantitative information on the label to follow advice they
have received from a health care professional concerning their
conditions, the nutrient declarations and percent DVs on the label are
to help consumers make more informed choices to consume a healthy diet
and not intended for the clinical management of an existing disease. In
addition, we recognize the importance of federal regulations reflecting
the most current science. In developing this proposed rule, we

considered new scientific evidence and dietary recommendations about
the relationship between nutrients and health.
    Finally, we recognize that the goal of assisting consumers in
maintaining healthy dietary practices requires that we consider certain
practicalities. For example, as we noted in the 1993 nutrient content
final rule (58 FR 2079 at 2107), while the 1990 amendments permit the
Secretary of Health and Human Services to include in the Nutrition
Facts label any information about a nutrient that will assist consumers
in maintaining healthy dietary practices, there is not room on the
label for all information that may be related to maintaining healthy
dietary practices. Space constraints on the label of most foods make
declaring all essential nutrients impractical. In addition, having a
large amount of information on the label could interfere with
consumers' abilities to use the information that has the greatest
public health significance. Therefore, not only are we aware of the
amount and format of mandatory information on the label, but we
recognize that limits to the voluntary information are necessary, so
that voluntary information does not clutter the label, does not
mislead, confuse, or overwhelm the consumer, and does not take away
prominence of and emphasis on the required information.
5. Citizen Petitions
    Since 1993, we received a number of citizen petitions requesting
that FDA make various changes to the Nutrition and Supplement Facts
labels. We are addressing a number of issues raised in the following
petitions within this proposed rule: (1) The Calorie Control Council
submitted a citizen petition on April 13, 1995 (Docket No. FDA-1995-P-
0142) requesting that FDA permit the use of the term ``polyols'' in
lieu of sugar alcohols on the Nutrition Facts label (http://www.regulations.gov/#!docketDetail;D=FDA-1995-P-0142); (2) the American
Cocoa Research Institute submitted a citizen petition on April 4, 1996
(Docket No. FDA-1996-P-0035) recommending the accurate communication of
the scientific fact that stearic acid does not affect blood cholesterol
(http://www.regulations.gov/#!docketDetail;D=FDA-1996-P-0035); (3)
Nabisco, Inc. submitted a citizen petition on May 8, 1997 (Docket No.
FDA-1997-P-0476) requesting that FDA amend the definition of ``total
fat'' and ``saturated fat'' in its food labeling regulations to clarify
that acetic, propionic, and butyric acids may be excluded when
calculating the amount of fat in a food product (http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0476); (4) the Calorie
Control Council submitted a citizen petition on February 13, 1998
(Docket No. FDA-1997-P-0232) requesting that the caloric value of
soluble fiber be no more than 2 kcal/g (http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0232); (5) the Center for Science in the
Public Interest (CSPI) submitted a citizen petition on August 4, 1999
(Docket No. FDA-1999-P-0158) requesting that FDA establish a DV for
added sugars and require the amount of added sugar, and the percent DV
that represents, to be declared on food labels (http://www.regulations.gov/#!docketDetail;D=FDA-1999-P-0158); (6) Protein
Technologies International, Inc. submitted a citizen petition on
December 21, 2000 (FDA-2000-P-0569) requesting that FDA modify the
reference to the method used to calculate protein content (http://www.regulations.gov/#!docketDetail;D=FDA-2000-P-0569); (7) the National
Starch and Chemical Company (``National Starch'') submitted a citizen
petition on July 8, 2004 (Docket No. FDA-2004-P-0094) requesting that
dietary fiber content be excluded from the ``total carbohydrate''
declaration on the Nutrition Facts label (http://www.regulations.gov/#!docketDetail;D=FDA-2004-P-0094); (8) the Sugar Association submitted
a citizen petition on August 15, 2005 (Docket No. FDA-2005-P-0373)
requesting, in part, that FDA amend regulations related to the labeling
of sugar and alternative sweeteners (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0373); (9) CSPI submitted a citizen
petition on November 8, 2005 (Docket No. FDA-2005-P-0196) requesting,
in part, that FDA lower the DV for sodium from 2,400 to 1,500 mg/day
(http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196); (10) an
individual submitted a citizen petition on May 25, 2005 (Docket No.
FDA-2005-P-0126) requesting that FDA preclude the declaration of
[beta]-carotene in supplements as vitamin A (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0126); (11) an
individual submitted a citizen petition on January 17, 2007 (Docket No.
FDA-2007-P-0404) requesting that FDA amend the definition of trans fat
in its food labeling regulations to express the value of ``zero'' for
trans fat when there are ``absolutely no trans fats at all'' and
require the use of a symbol (e.g., ``~'') to indicate when there is
``more than zero but less than 0.5 grams (g) of trans fat per
tablespoon'' (http://www.regulations.gov/#!docketDetail;D=FDA-2007-P-
0404); and (12) CSPI submitted a citizen petition on February 13, 2013
(Docket No. FDA-2013-P-0217) requesting, in part, that FDA revise the
``Sugars'' line on the Nutrition Facts label to address ``added
sugars'' (http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-0217).
    We address the specific requests identified previously for each
citizen petition related to the labeling of conventional foods and
dietary supplements in the appropriate sections in this document.
Requests in these citizen petitions that are unrelated to the content
of the Nutrition Facts label are outside of the scope of this
rulemaking and we will address those requests separately from this
rulemaking.
6. Advance Notices of Proposed Rulemaking (ANPRMs)
    We also published three ANPRMs seeking public comment on issues
relevant to updating the Nutrition Facts label.
    a. ANPRM on Trans Fat--In the Federal Register of July 11, 2003 (68
FR 41507), we published an ANPRM (the 2003 ANPRM) to solicit
information and data that potentially could be used to establish new
nutrient content claims about trans fatty acids; to establish
qualifying criteria for trans fat in nutrient content claims for
saturated fatty acids and cholesterol, lean and extra lean claims, and
health claims that contain a message about cholesterol-raising lipids;
and, in addition, to establish disclosure and disqualifying criteria to
help consumers make heart-healthy food choices. We also requested
comments on whether we should consider statements about trans fat,
either alone or in combination with saturated fat and cholesterol, as a
footnote in the Nutrition Facts label or as a disclosure statement in
conjunction with claims to enhance consumer understanding about
cholesterol-raising lipids and how to use the information to make
healthy food choices. On March 1, 2004 (69 FR 9559), we reopened the
comment period for the 2003 ANPRM to receive comments that considered
the information in the IOM Labeling Report (Ref. 25) published in the
interim that addressed the labeling of trans fat. On April 19, 2004 (69
FR 20838), we extended the comment period for the 2003 ANPRM to receive
comments that considered the information in the 2004 meeting of the
Nutrition Subcommittee of the Food Advisory Committee (Ref.

46), which addressed whether the available scientific evidence
supported listing the percent DV for saturated fat and trans fat
together or separately on the Nutrition Facts label and what the
maximal daily intake of trans fat may be.
    In response to the 2003 ANPRM, we received about 120 comments. We
consider the comments related to determining a DV for trans fat in
section II.B.3. (see also accompanying Ref. 47). Other issues raised by
comments that are unrelated to the DV for trans fat will be addressed
in a separate rulemaking at a future time.
    b. ANPRM on Prominence of Calories--In the Federal Register of
April 4, 2005 (70 FR 17008), we published an ANPRM on the prominence of
calories on the food label (the 2005 ANPRM). The 2005 ANPRM was issued
in response to recommendations from the Obesity Working Group created
by the Commissioner of Food and Drugs to develop an action plan to
address the growing incidence of obesity in the United States. The 2005
ANPRM, in part, requested comments on whether giving more prominence to
the declaration of calories per serving would increase consumer
awareness of the caloric content of the packaged food. We also sought
comment on whether providing a percent DV for total calories would help
consumers understand the caloric content of the packaged food in the
context of a 2,000 calorie diet. In addition, we also requested
comments on questions concerning the declaration of ``Calories from
fat'' (70 FR 17008 at 17010).
    We received about 400 comments to the 2005 ANPRM, each containing
one or more issues, from industry, trade associations, consumer groups,
individual consumers, government, and academia. We consider the
comments in sections II.A. and II.M. (see also accompanying Ref. 47).
    c. ANPRM on Food Labeling: Revision of Reference Values and
Mandatory Nutrients--In the Federal Register of November 2, 2007 (72 FR
62149), we published an ANPRM regarding the revision of reference
values and mandatory nutrients (the 2007 ANPRM). The 2007 ANPRM
requested comment on various aspects of nutrition labeling, including
what new reference values we should use to calculate the percent DV in
the Nutrition Facts and Supplement Facts labels and what factors we
should consider in establishing such new reference values. In addition,
we requested comments on whether we should require that certain
nutrients be added or removed from the Nutrition Facts and Supplement
Facts labels.
    In response to the 2007 ANPRM, we received about 820 comments, from
industry, trade associations, consumer groups, individual consumers,
government, and academia. We consider these comments in each of the
relevant individual nutrient sections in this document (see also
accompanying Ref. 47).
7. Impact on Other Regulations
    We recognize that changes to the list of nutrients declared on the
Nutrition Facts label or the RDIs or DRVs of nutrients will likely
affect other FDA regulations, including certain labeling requirements
for foods in 21 CFR part 101. For example, the DVs are used to
determine, in part, whether a food or dietary supplement is eligible to
bear nutrient content claims or health claims (see for example
Sec. Sec.  101.14, 101.54, 101.76, 101.78, and 101.79). In addition,
our fortification policy refers to RDIs and certain DRVs that are
specified in Sec.  101.9 in describing principles for the rational
addition of nutrients to foods (Sec.  104.20 (21 CFR 104.20)). We plan
to evaluate the impact of the proposed changes to the Nutrition Facts
and Supplement Facts labels, if finalized, on other FDA regulations. We
intend to address, as appropriate, the impact on other FDA regulations
in future separate rulemakings. Thus, issues related to nutrient
content claims and health claims are outside the scope of this
rulemaking.

C. Factors for Mandatory or Voluntary Declaration of Non-Statutory
Nutrients

    Under section 403(q)(1)(C) and (D) of the FD&C Act, nutrition
information in food labeling must include the total number of calories,
derived from any source and derived from the total fat, and the amounts
of total fat, saturated fat, cholesterol, sodium, total carbohydrates,
complex carbohydrates, sugars, dietary fiber, and total protein. For
purposes of this proposed rule, we consider the nutrients that are
explicitly required by the FD&C Act to be declared on the Nutrition
Facts label as ``statutorily required nutrients.'' Section 403(q)(2)(B)
of the FD&C Act permits the Secretary, and by delegation, FDA, to
remove a statutorily required nutrients from the label or labeling of
food, by regulation, if the Secretary determines the information
related to that nutrient is not necessary to assist consumers in
maintaining healthy dietary practices. FDA regulations require the
declaration of the following statutorily required nutrients: Total
calories, calories from fat, total fat, saturated fat, cholesterol,
sodium, total carbohydrates, sugars, dietary fiber, and total protein
(See Ref. 1 for information on regulatory history). As part of the
effort to update the Nutrition Facts label, we reconsidered the
declaration of these statutorily required nutrients. Our considerations
and tentative conclusions on these nutrients are presented within the
discussion of individual nutrients in section II.
    Section 403(q)(2)(A) of the FD&C Act provides that the Secretary
(and by delegation FDA) may, by regulation, require other nutrients to
be declared if the Secretary determines that a nutrient will provide
information regarding the nutritional value of such food that will
assist consumers in maintaining healthy dietary practices. For purposes
of this proposed rule, we consider such nutrients that are not
statutorily required but subject to our discretion under section
403(q)(2)(A) of the FD&C Act, as ``non-statutory nutrients'' to
distinguish such nutrients from those expressly required by the
statute. In the 1993 nutrient content final rule (58 FR 2079), we
considered the existence of a quantitative intake recommendation
highlighted in U.S. consensus reports and the public health
significance of the nutrient in exercising our discretion to determine
which non-statutory nutrients to require or permit on the Nutrition
Facts label. Based on these considerations, with respect to non-
statutory nutrients, we (1) required the declaration of certain
essential vitamins and minerals for which an RDI was established and
that were determined to have public health significance (i.e., vitamins
A and C, iron, and calcium); and (2) permitted the declaration of the
remaining essential vitamins and minerals for which there was an
established RDI or DRV (i.e., vitamin E) or that had public health
significance, as well as permitted the declaration of certain
subcategories of macronutrients for which a DRV was not established
(including monounsaturated fat, polyunsaturated fat, soluble fiber,
insoluble fiber, sugar alcohol, and other carbohydrate) (58 FR 2079).
    In this section, we describe our current thinking related to
considerations used to determine whether a non-statutory nutrient
should be required or permitted to be declared on the Nutrition Facts
label. Applying this current thinking, in section II, we are proposing
the mandatory declaration of certain non-statutory nutrients, voluntary
declaration of others, and proposing to remove the mandatory
declaration of another nutrient. For purposes of this proposed rule, we
use the term ``nutrient'' to refer to

substances that are currently included or that we are considering for
inclusion on the Nutrition Facts label, including carbohydrate, fat,
and protein and their subcomponents (e.g., added sugars, sugar
alcohols, saturated fat), micronutrients (vitamins and minerals), and
to calories, including calories from fat.
1. Factors Considered
    We updated the information that we consider for determining whether
the declaration of a non-statutory nutrient should be mandatory or
voluntary. This update responds to several developments. Since the 1993
nutrient content final rule was published, (1) new scientific data have
provided additional evidence of the role of certain nutrients in
chronic disease risk, health-related conditions, or health-related
physiological endpoints and, in some cases, based on the review of this
evidence, DRIs are now available from the IOM that can be used as
quantitative intake recommendations (i.e., RDA and AI), as well as for
assessing the inadequacy and adequacy of essential vitamins and
minerals in the U.S. population (i.e., EAR and AI); (2) the rates of
certain diseases or health-related conditions have either changed or
remained high; and (3) the process for evaluating the relationship
between a nutrient and chronic disease risk, a health-related
condition, or a health-related physiological endpoint has been refined
based on the use of systematic evidence-based reviews for a number of
nutrients (e.g., 2010 DGA, FDA health claims).
    We continue to be mindful of past factors we considered as part of
our deliberations related to the Nutrition Facts label, such as the
number of nutrients that could be listed in nutrition labeling, that
some individuals could interpret a long list of nutrients as implying
that a food has greater nutritional significance than is the case, and
that there is limited space for nutrition information on the label (55
FR 29487 at 29493; July 19 1990).
    To help us determine whether a non-statutory nutrient should be a
required or permitted declaration, we are considering the same general
types of information used in 1993 when the nutrient content final rule
was published: (1) Existence of quantitative intake recommendations;
and (2) public health significance. We discuss each of these factors in
greater detail in this document.
    a. Quantitative Intake Recommendations--Quantitative intake
recommendations are reference intake levels provided in consensus
reports that can be used to set a DRV or RDI. We expect these consensus
reports to be published for the purpose of setting quantitative intake
recommendations (e.g., the IOM DRI reports). If DRIs are not available
for nutrients, other than essential vitamins and minerals, then we
consider science-based recommendations from other U.S. consensus
reports or the DGA policy reports. Such recommendations may be
identified as a conclusion, key recommendation, or reported in the
executive summary of the consensus report.
    b. Public Health Significance--For the purposes of nutrition
labeling of foods and dietary supplements, we consider public health
significance to refer to two elements. First we consider whether there
is evidence of a relationship between the nutrient and a chronic
disease, health-related condition, or health-related physiological
endpoint. This can be demonstrated either by well-established evidence
or, for essential vitamins and minerals, recommendations regarding the
health consequences of inadequacy of the nutrient. Second we consider
whether there is evidence of a problem related to health in the general
U.S. population. This needs to be demonstrated by both evidence of a
problem with the intake of the nutrient in the general U.S. population
and evidence of the prevalence of the chronic disease, health-related
condition, or health-related physiological endpoint that is linked to
that nutrient in the general U.S. population. We consider public health
significance to refer to the following: (1) Existence of ``well-
established'' scientific evidence from U.S. consensus reports that
there is a relationship between a nutrient and chronic disease risk, a
health-related condition, or a health-related physiological endpoint
and where the intake of such nutrient is of general importance in the
general U.S. population, e.g., where intakes are generally too low or
too high among the U.S. population. U.S. consensus reports are those
reports that provide consensus conclusions or recommendations by a
group of experts as requested by U.S. Government Agencies (e.g., IOM
reports, the DGAs, National Institutes of Health (NIH) consensus
reports). We generally consider scientific evidence to be ``well-
established'' when such consensus reports have determined the evidence
to be ``conclusive,'' ``documented,'' or ``strong.'' Evidence that
meets the significant scientific agreement standard in section
403(r)(3)(B)(i) of the FD&C Act in support of those nutrients and
disease or health-related conditions for which we have authorized a
health claim would be considered ``well-established'' evidence for the
purposes of what public health significance refers to in this proposed
rule; or (2) nutrients for which there are DRIs set by the IOM (i.e.,
RDA or AI) that are based on chronic disease risk (e.g., osteoporosis),
a health-related condition (e.g., blood pressure) or a nutrient
deficiency with clinical significance (e.g., low iron storage leading
to iron deficiency anemia) for which inadequate intakes of these
nutrients are likely to have important clinical consequences. The
nutrients for which this may occur are essential vitamins and minerals;
and (3) for all nutrients, there is evidence of inadequate or excess
intake of the nutrient based on national nutritional survey data or
U.S. consensus reports, and that a substantial prevalence exists in the
general U.S. population of the chronic disease, health-related
condition, or health-related physiological endpoint that was linked to
the particular nutrient (e.g., soluble fiber and coronary heart disease
(CHD) risk, calcium and risk of osteoporosis). Because we remain
concerned about the large number of nutrients that could be listed as
mandatory or voluntary, for essential vitamins and minerals, we are
proposing for mandatory declaration, those for which inadequacy has the
greatest impact on public health because of their association with a
risk of chronic disease, a health-related condition, or a nutrient
deficiency with clinical significance (e.g., iron deficiency anemia).
    The methods used in the evaluation of public health significance of
essential vitamins and minerals are discussed in greater detail in
section II.H. and the accompanying reference document (Ref. 48).
2. Approach for Mandatory Declaration
    In general, we continue to consider mandatory declaration
appropriate when there is public health significance and a quantitative
intake recommendation that can be used for setting a DV (DRV or RDI).
However, we have also considered mandatory declaration based, in part,
on evidence highlighting the role of a nutrient in chronic disease
risk. For example, in 2003, we published a final rule requiring trans
fat declaration on the Nutrition Facts label (68 FR 41434). We
considered data and information related to the risk of coronary heart
disease from consumption of trans fat. In addition, we considered the
public health significance of trans fat intake

based on consensus reports and federal policy statements.
    Information related to nutrient intake and its effect on health is
not static. Recommendations from various scientific bodies of the U.S.
Government that are responsible for public health protection or
research directly relating to human nutrition may change or evolve over
time. We include, as part of our review of nutrient information in this
proposed rule, the current recommendations from such scientific bodies.
In section D.3, we specifically consider recommendations from the 2010
DGA related to the intake of added sugars in the diet and the role of
such information in assisting consumers to maintain healthy dietary
practices. Our review is not based on the factors we have traditionally
considered for mandatory declaration that are related to chronic
disease, health-related condition, or health-related physiological
endpoint linked to the particular nutrient. Instead, our review is
based on the need for nutrient information for consumers to implement
key dietary recommendations to assist consumers to maintain healthy
dietary practices and the need for consumers to be able to readily
observe and comprehend the information and to understand its relative
significance in the context of a total daily diet.
3. Approach for Voluntary Declaration
    For nutrients that are not essential vitamins and minerals (e.g.,
fluoride, soluble and insoluble fiber, monounsaturated fatty acids and
polyunsaturated fatty acids), we consider voluntary declaration to be
appropriate when the nutrient either has a quantitative intake
recommendation but does not have public health significance, or does
not have a quantitative intake recommendation available for setting a
DRV but has public health significance. In addition, we consider that
voluntary declaration should be permitted for essential vitamins or
minerals that we determine do not fit within our considerations for
mandatory declaration, but that have an RDI.
    We invite comment on the factors for considering mandatory and
voluntary declaration of non-statutory nutrients.

II. The Proposed Rule

    In this proposed rule, we address issues related to the information
declared on the Nutrition Facts label, i.e., declaration of nutrients,
definitions, analytical methods, RDIs and DRVs, format, and compliance
with declared values. Sections II.A. through II.E. discuss issues
related to calories and macronutrients (including fat, fatty acids,
cholesterol, carbohydrates, sugars, fiber, and protein), whereas
sections II.F. through II.J. discuss issues related to vitamins and
minerals, and sections II.K. and II.L. discuss nutrition labeling
requirements applicable to certain population subgroups and dietary
supplements, respectively. Section II.M. covers issues related to the
format of the Nutrition Facts label, followed by section II.N., which
focuses on provisions related to compliance and verification. Finally,
section II.O. describes technical amendments to existing provisions in
Sec.  101.9.
    As discussed in this document, our evaluation of these issues was
informed by current scientific evidence, dietary recommendations, and
conclusions of current consensus reports. We took into account any
related requests from petitioners and public comments.

A. Calories

    Section 403(q)(1)(C) of the FD&C Act requires the declaration of
the total number of calories derived from any source. Correspondingly,
FDA regulations require the total caloric content of a food to be
declared on the Nutrition Facts label (Sec.  101.9(c)(1)). We are not
proposing to modify the requirement to declare total calories. However,
we are reconsidering a number of other requirements related to the
declaration of information about calories. The requirements related to
``Calories from fat,'' ``Calories from saturated fat,'' the 2,000
reference calorie intake level, and a percent DV for calories are
discussed in section II.A., whereas requirements related to prominence
of the calorie declaration and the footnote statement and table of DVs
for 2,000 and 2,500 calorie diets are discussed in section II.M.
1. Calories From Fat
    The declaration of ``Calories from fat'' is mandatory (Sec.
101.9(c)(1)(ii)). Section 403(q)(1)(C)(ii) of the FD&C Act requires
total calories from fat to be declared on the label or labeling of
food. Section 403(q)(2)(B) of the FD&C Act provides the Secretary of
Health and Human Services (and by delegation, FDA) with discretion to
remove the requirement by regulation if the Secretary determines that
it is not necessary to assist consumers in maintaining healthy dietary
practices. We reviewed current scientific evidence and recommendations
in current consensus reports in determining whether information on
calories from fat is necessary to assist consumers in maintaining
healthy dietary practices. We also considered comments (Ref. 47) to the
2005 and 2007 ANPRMs, in which we requested comment on various
questions related to ``Calories from fat'' declared on the Nutrition
Facts label. Unlike dietary recommendations that we relied on during
the 1993 rulemaking, current dietary recommendations no longer
emphasize total fat. Certain fatty acids are understood to be
beneficial, while others are understood to have negative health
effects, particularly related to cardiovascular disease (Refs. 6, 36,
and 49). Accordingly, the 2005 DGA shifted its focus from total fat
reduction to reduction in certain types of fatty acids and their
influence on the risk of cardiovascular disease (Ref. 36). The 2002 IOM
Macronutrient Report (Ref. 49) set an AMDR for total fat at 20 to 35
percent of calories, recognizing that there were some benefits to
consuming moderate amounts of fat (Ref. 49). The 2002 IOM Macronutrient
Report and the 2010 DGA (Refs. 6 and 49) concluded that the type of fat
consumed was more relevant in reducing the risk of CHD than overall
total fat intake.
    Based on the these dietary recommendations and consensus reports
that emphasize intake of total calories and the type of fat consumed,
as well as comments to the 2005 and 2007 ANPRMs that supported
eliminating the declaration of ``Calories from fat'' in order to place
greater emphasis on total calories (Ref. 47), we tentatively conclude
that declaration of ``Calories from fat'' is not necessary to assist
consumers in maintaining healthy dietary practices. Therefore, we are
proposing to no longer require, and to not allow voluntarily, the
declaration of ``Calories from fat'' on the Nutrition Facts label.
While eliminating the declaration of ``Calories from fat'' may appear
to be a loss of information on the amount of fat being consumed, as
some comments suggested, 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. Therefore, we are proposing to remove current
Sec.  101.9(c)(1)(ii) to remove the requirement for declaration of
calories from fat (and redesignate Sec.  101.9(c)(1)(iii) as proposed
Sec.  101.9(c)(1)(ii)). We invite comment on the tentative conclusion
to no longer require, and to not allow voluntarily the declaration of
``Calories from fat'' on the Nutrition Facts label.

2. Calories From Saturated Fat
    The declaration of ``Calories from saturated fat'' is voluntary
(Sec.  101.9(c)(1)(iii)). The 2010 DGA continues to recommend that
Americans should consume less than 10 percent of calories from
saturated fat (Ref. 6). Saturated fat is known to increase the risk of
cardiovascular disease and, unlike ``Calories from fat,'' which could
include calories attributable to fatty acids that decrease or increase
the risk of certain diseases, ``Calories from saturated fat'' would
provide information about calories from a source known to increase
disease risk (Ref. 49). We considered the recommendations in current
consensus reports as well as the comments (Ref. 47) received in
response to the 2007 ANPRM requesting comment on whether the
declaration of ``Calories from saturated fat'' should continue to be
voluntary or whether it should be mandatory.
    Based on the recommendations in current consensus reports and
supported by many comments, we tentatively conclude that mandatory
declaration of ``Calories from saturated fat'' is not necessary because
the amount of saturated fat being consumed can still be obtained from
the total saturated fat declaration elsewhere on the Nutrition Facts
label. Additionally, as with total fat, consumers can still 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.
However, because there is strong evidence associating higher intakes of
saturated fat with higher low-density lipoprotein (LDL) cholesterol
levels, information on ``Calories from saturated fat'' can assist
consumers in maintaining healthy dietary practices. Therefore, we are
not proposing to change the current voluntary labeling of ``Calories
from saturated fat'' in the Nutrition Facts label as specified in Sec.
101.9(c)(1)(iii). However, considering our proposal to eliminate the
declaration of ``Calories from fat'' on the Nutrition Facts label (see
section II.A.1.), we are proposing to revise Sec.  101.9(c)(1)(iii) and
(d)(5) to specify that the statement ``Calories from saturated fat,''
when declared, must be indented under the statement of calories. In
addition, we are proposing to redesignate Sec.  101.9(c)(1)(iii) as
proposed Sec.  101.9(c)(1)(ii).
3. Two Thousand Calories as the Reference Caloric Intake Level
    Per FDA regulations, a reference calorie intake level of 2,000
calories is used to set DRVs for total fat, saturated fat, total
carbohydrate, protein, and dietary fiber (Sec.  101.9(c)(9)). In
addition, we require a footnote on the Nutrition Facts label that
states, ``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 with certain DVs based on 2,000 and 2,500 calorie
diets (Sec.  101.9(c)(9)). In reconsidering the 2,000 calories
reference intake level, we considered relevant recommendations from the
IOM macronutrient report that provided estimated energy requirements
(EERs) and the IOM Labeling Report (Refs. 25 and 50). We also
considered comments (Ref. 47) received in response to the 2007 ANPRM,
in which we asked whether 2,000 calories should continue to be used as
the reference calorie intake level and asked questions related to the
use of the EERs.
    An EER is a DRI set by the IOM for energy intake and is defined as
the dietary energy intake that is predicted to maintain energy balance
in a healthy adult of defined age, gender, weight, height, and level of
physical activity consistent with good health. The IOM set EERs for all
life-stage and gender groups and based these EERs on normal weight
individuals (i.e., BMI < 25) (Ref. 50). The IOM Labeling Committee
considered whether there was a basis to use the EERs for developing a
new reference calorie intake level for macronutrients in nutrition
labeling. The IOM Labeling Committee noted that using the EER to derive
a reference calorie intake level would require making assumptions about
height, weight, and physical activity level. Furthermore, the equations
used to calculate the EERs were based on normal weight individuals;
however, the American population has a high prevalence of overweight
and obesity. Thus, the IOM Labeling Committee found that the data
necessary to use the EER concept as the basis for a reference calorie
intake level for nutrition labeling were incomplete and it could not
recommend the approach (Ref. 25). 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 (Ref.
25).
    We agree with the IOM Labeling Report and comments in response to
the 2007 ANPRM (Ref. 47) that the EERs do not provide an appropriate
basis for the derivation of a reference calorie intake level for the
purpose of nutrition labeling. The EERs are influenced by various
parameters such as age, gender, height, weight, and physical activity
level (PAL), which makes it challenging to combine the EERs into a
single reference calorie intake level applicable to the general
population. Further, all of the comments supported the use of the 2,000
calorie reference intake level.
    Therefore, we are not proposing any changes to the current use of
2,000 reference calorie intake level as the basis for setting DRVs for
total fat, saturated fat, total carbohydrate, dietary fiber, and
protein, as specified in Sec.  101.9(c)(9).
4. Percent DV Declaration for Calories
    Current regulations do not provide for a DRV for calories. Setting
a DRV for calories would necessitate the determination of a
quantitative intake recommendation for calories. To determine an
appropriate DRV for calories, we reviewed recommendations in current
consensus reports. We also considered comments (Ref. 47) received in
response to the 2005 and 2007 ANPRMs, in which we asked whether
providing a percent DV disclosure for total calories would assist
consumers in understanding the caloric content of the packaged food in
the context of a 2,000 calorie diet. The IOM macronutrient report is
the most recent consensus report that provides quantitative intake
recommendations for calories (Ref. 50), and those quantitative intake
recommendations are the EERs. For the same reasons that EERs are not
appropriate for setting the reference calorie intake level as described
previously, these EERs are not appropriate for setting a DV for
calories. First, the EERs do not apply to overweight individuals, and
are therefore not applicable to a substantial portion of the general
population. Second, combining the EERs into a single, meaningful
reference value is challenging because they vary by age, gender,
height, weight, and PAL. In addition, DRVs were established for those
nutrients that are important in diet and health interrelationships and/
or based on caloric intake (55 FR 29476 at 29479; July 19, 1990).
Accordingly, most of the DRVs have been based on quantitative intake
recommendations associated with chronic disease risk or a health-
related condition (e.g., total fat, saturated fat, cholesterol, and
dietary fiber). In contrast, the EERs are neither associated with
chronic disease risk or a health-related condition, nor are they
intended to be treated as a single recommended value that can be
applied to the general U.S. population. Thus, we tentatively conclude
that there is no appropriate quantitative intake recommendation and we
are not aware of any other data or information on which a DRV for
calories can be determined. Although a majority of

comments to the ANPRMs supported the addition of a percent DV for total
calories, we are not persuaded to propose to require or permit such
declaration due to the lack of an appropriate quantitative intake
recommendation or other data or information on which FDA could rely to
establish a DRV for calories. We invite comment on the tentative
conclusion not to establish a DRV for calories and include a percent DV
for the declaration of calories.
    Therefore, we are not proposing to set a DRV for calories and, as a
result, a percent DV declaration for calories would be neither required
nor permitted.

B. Fat

    In section II.B., we discuss considerations related to definitions,
declaration, and DRVs for total fat, saturated fat, trans fat,
monounsaturated fat, and polyunsaturated fat.
1. Total Fat
    a. Definition--FDA defines ``fat, total'' or ``total fat'' in Sec.
101.9(c)(2) as a statement of the number of g of total fat in a serving
defined as total lipid fatty acids and expressed as triglycerides.
    In 1997, we received a citizen petition from Nabisco, Inc. (Docket
No. FDA-1997-P-0476) requesting that FDA amend the definitions of
``total fat'' and ``saturated fat'' in its food labeling regulations to
clarify that acetic, propionic, and butyric acids may be excluded when
calculating the amount of fat in a food product (http://www.regulations.gov/# !docketDetail;D=FDA-1997-P-0476). The
petitioner's requests related to the definition and labeling of total
fat are presented here and the petitioner's requests related to the
definition of saturated fat are discussed in section II.B.2.
    With respect to total fat, the petitioner requested that we amend
Sec.  101.9(c)(2) to read as follows: ``Fat, total'' or ``Total fat'':
A statement of the number of g of total fat in a serving defined as
total lipid fatty acids, excluding acetic (C:2), propionic (C:3), and
butyric (C:4) acids and expressed as triglycerides . . .'' The
petitioner stated that acetic, propionic, and butyric acids (``the
acids''), which have very short two, three, and four carbon chains,
respectively, are organic acids that should not be considered fatty
acids for food labeling purposes for the following reasons: (1) The
acids are chemically different from fatty acids because they are water
soluble; (2) the digestion and absorption of the acids are distinctly
different from those of fatty acids; (3) the acids are metabolized
differently than fatty acids and are biochemically and physiologically
more closely related to carbohydrates than to fat; and (4) the acids do
not cause the adverse health effects associated with fat and may even
have benefits that make them distinct from fat. The petitioner noted
that excluding the acids from the definition of fat would not affect
current labeling practices because they are found in such small amounts
in the food supply. In addition, the petitioner asserted that
analytical methods would not be affected because approved AOAC methods
for total fat measurement do not detect the acids.
    We disagree with the petitioner that the acids are chemically
different from fatty acids because they are water soluble and that
insolubility in water is the essential chemical property of a fat.
Fatty acids are monocarbonic acids with chain lengths between 1 and
nearly 30 carbon atoms (Ref. 51). The chain length of a fatty acid
determines its physical properties (Ref. 51). Short-chain fatty acids
are compounds that are soluble in water. As the chain length increases,
water-solubility decreases (Ref. 51). Short chain acids such as acetic,
propionic, and butyric acids are still considered fatty acids although
they are water soluble. Furthermore, the characteristic feature of a
fatty acid is a terminal carboxyl group attached to a chain of alkyl
groups containing carbon atoms of which these short chain acids are
composed (Ref. 52).
    We determine the amount of the major macronutrients (carbohydrate,
fat, and protein) in a food product by their chemical composition. We
tentatively conclude that the petitioner did not provide a scientific
basis on which we could rely to propose to exclude acetic, propionic,
and butyric acids from the definition of total fat based on differences
in chemical composition. Moreover, the petitioner did not explain why
we should define total fat based on physiological differences
identified for such fatty acids compared to other fatty acids, even if
true, and not retain our current approach to define total fat based on
chemical composition. Therefore, we are not proposing any changes to
the current definition of ``total fat.'' We request comment on our
tentative conclusion that acetic, propionic, and butyric acids should
not be excluded from the definition of ``total fat.''
    To clarify what we consider to be a fatty acid, we are proposing to
define ``fatty acids'' in Sec.  101.9(c)(2) as ``aliphatic carboxylic
acids consisting of a chain of akyl groups and characterized by a
terminal carboxyl group.'' This definition is consistent with other
similar definitions found in nutrition and chemistry references (Refs.
51 to 54). We request comment on the proposed definition of fatty
acids.
    b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act
requires the declaration of the amount of total fat on food labels.
Consequently, the Nutrition Facts label includes the mandatory
declaration of the gram amount for total fat in Sec.  101.9(c)(2).
    The 2010 DGA recognizes that the types of fatty acids consumed are
more important in influencing the risk of CVD than the total amount of
fat in the diet (Ref. 6). Current dietary recommendations and clinical
guidelines encourage replacing saturated and trans fatty acids with
beneficial fats, such as polyunsaturated and monounsaturated fatty
acids (Refs. 6 and 55). A high intake of most types of saturated fatty
acids, trans fatty acids, and cholesterol can increase LDL cholesterol
levels, which in turn may increase the risk of CHD (Ref. 49). While
there is a significant amount of evidence showing that a diet high in
saturated or trans fatty acids may be detrimental to health, there is
also evidence that consumption of less than 20 percent of calories from
fat can lead to an increased risk of insufficient intake of vitamin E
and essential fatty acids (Ref. 49). In addition, consumption of a low
fat diet that is high in carbohydrate can lead to a reduction in high
density lipoprotein cholesterol concentration and an increase in blood
triglycerides, which can result in an increased risk of CHD (Ref. 49).
    We concur with the 2010 DGA that consuming a diet low in saturated
fatty acids and cholesterol is more important for reducing CVD risk
than consuming a diet low in total fat. This finding is consistent with
the conclusions in the IOM Macronutrient Report (Ref. 49), as well as
with current practice guidelines such as the National Heart, Lung, and
Blood Institute (NHLBI) Third Report of the Expert Panel on Detection,
Evaluation, and Treatment of High Blood Cholesterol in Adults (Ref.
55). Total fat is a calorie-yielding macronutrient and an important
piece of the macronutrient profile of a food. However, consumption of
inadequate amounts of total fat is also associated with an increased
risk of impaired growth and consumption of excessive amounts of total
fat is associated with an increased risk of chronic diseases, such as
CHD and diabetes (Ref. 49). In addition, the IOM noted that high fat
diets are usually accompanied by increased intakes of saturated fatty
acids which can increase the risk of CHD (Ref. 49). Thus, we
tentatively conclude that

mandatory declaration of total fat on the Nutrition Facts label
continues to be necessary to assist consumers in maintaining healthy
dietary practices. Therefore, we are not proposing any changes to the
current requirement for mandatory declaration of total fat on the
Nutrition Facts label.
    c. DRV--The DRV for total fat is 30 percent of calories (65 g/d)
(Sec.  101.9 (c)(9)). In developing the DRIs for various nutrients, the
IOM cited a lack of data sufficient to determine a defined level of fat
intake at which no risk of inadequacy or prevention of chronic disease
occurs, and therefore, decided to establish neither an AI nor an RDA
for total fat (Ref. 49). Instead, the IOM established an AMDR for total
fat intake of 20 to 35 percent of energy for adults and an AMDR of 25
to 35 percent of energy for children age 4 to 18 years. The AMDRs are
associated with reduced risk of chronic diseases, such as CHD, while
providing for adequate intake of essential nutrients. The 2010 DGA
acknowledged the IOM's AMDR and noted that total fat intake should fall
within the AMDRs set by the IOM (Ref. 6). The IOM Labeling Committee
recommended that AMDRs should be the basis for DVs for protein, total
carbohydrate, and total fat (72 FR 62149 at 62164). Accordingly, for
total fat, the IOM Labeling Committee recommended a population-weighted
midpoint of the AMDR since AMDRs vary with age. A population-weighted
mid-point of the AMDR for adults, i.e., 20 to 35 percent, yields a DRV
of 28 percent or 62 g of total fat. The use of the upper level (35
percent of energy) of the AMDR would increase the DRV from 65 g to 78 g
for a 2,000 calorie diet.
    Considering the recommendations of the IOM Labeling Committee, we
requested comment, in the 2007 ANPRM, on: (1) Whether a population-
weighted midpoint of the AMDR (e.g., 28 percent for adults) should be
used, as suggested in the IOM Labeling Report and (2) whether the upper
level of AMDR of 35 percent (78 g) should be used.
    We reviewed the IOM Labeling Committee's recommendations, IOM DRIs,
and comments in response to the 2007 ANPRM (Ref. 47). We tentatively
conclude that changing the DRV for total fat to the lower end of 20
percent of 2,000 calories would not be appropriate because: (1) It
would not be appropriate for children 4 to 18 years of age because it
falls below the lower end of the AMDR (i.e., 25 to 35 percent of
energy) and (2) scientific evidence supports consumption of greater
than 20 percent of total calories from total fat for reduction in risk
of chronic diseases, such as CHD and diabetes (Ref. 49).
    We also conclude that the upper level of the AMDR of 35 percent of
2,000 calories as the basis for a DRV would provide no meaningful
health benefit and that a population-weighted mid-point of 28 percent
of the AMDR (28 percent of calories) as the basis for the DRV is not
significantly different from a public health outcome standpoint than
the current value of 30 percent of calories. Using the population-
weighted AMDR midpoint approach would result in an insignificant
reduction from the DRV of 65 g (rounded from 30 percent of a 2,000
calorie diet) to 60 g (rounded from 28 percent of calories), which may
imply a greater level of precision in a DRV than is actually true.
    Furthermore, the DRV for total fat is linked to the DRVs for total
carbohydrate and protein. For reasons discussed in sections II.D. and
II.E., we are not proposing to change the DRVs for carbohydrate or
protein at this time. Because the DRV for carbohydrate is determined by
difference, an increase in the DRV for fat would result in a decrease
in the DRV for carbohydrate.
    The DRV of 30 percent of calories fits within the AMDR and
represents a moderate value that is not close to the upper or lower
levels of the AMDR. A majority of comments supported maintaining the
current DRV of 30 percent of calories. As noted previously, the DRV for
total fat was calculated based on a 2,000 reference calorie intake and
the dietary recommendation for fat intake at the time of 30 percent or
less of total caloric intake, amounting to 66.7 g of fat, which was
rounded down to 65 g. Current dietary recommendations for fat intake
provide a range of acceptable intakes (i.e., between 20 and 35 percent
of caloric intake) and encompass the 30 percent value that formed the
basis for the existing DRV. Therefore, we are not proposing any changes
to the current DRV for total fat of 30 percent of calories.
2. Saturated Fat
    a. Definition--FDA regulations define ``Saturated fat'' in Sec.
101.9(c)(2)(i) as the sum of all fatty acids containing no double
bonds. We received a citizen petition from the American Cocoa Research
Institute on April 3, 1996 (Docket No. FDA-1996-P-0035) requesting that
the Agency exclude stearic acid from the definition of saturated fat
because the petitioner claimed that stearic acid does not raise LDL-
cholesterol levels or the risk of CHD (http://www.regulations.gov/#
!docketDetail;D=FDA-1996-P-0035). In the 2007 ANPRM, we did not seek
comments on the definition of saturated fat, but received a few
comments that requested excluding stearic acid from the definition of
saturated fat or permitting a separate listing for stearic acid below
the line for saturated fat (Ref. 47).
    We considered the comments to the 2007 ANPRM and the request by the
American Cocoa Research Institute petition, and do not agree that
stearic acid should be excluded from the definition of saturated fat.
While there is evidence that there are potential differences in the
physiological effects of different saturated fatty acids, including on
LDL cholesterol levels, the definitions of nutrients for food labeling
purposes have traditionally been based on chemical definitions, rather
than on individual physiological effects. The definition for saturated
fat in Sec.  101.9(c)(2)(i) includes all fatty acids without double
bonds and the accepted analytical methods capture all of the saturated
fatty acids, including stearic acid. In adopting this definition, we
addressed the issue of inclusion/exclusion of individual saturated
fatty acids and determined that a chemical definition (which includes
all fatty acids containing no double bonds) was the appropriate
approach to define saturated fat (58 FR 2079 at 2088). We further note
that the 2010 DGA recommendation related to saturated fat intake is
based on scientific evidence related to the intake of all saturated
fatty acids combined, which includes stearic acid. The DGA
recommendation to consume less than 10 percent of calories from
saturated fatty acids makes no specific exclusion of stearic acid and,
instead, relates to the intake of total saturated fatty acids (Ref. 6).
There are no quantitative intake recommendations for stearic acid.
    The inclusion of stearic acid in the definition of saturated fat is
consistent with our overall approach to rely on chemical definitions of
nutrients as the basis for regulatory definitions for food labeling
purposes. The American Cocoa Research Institute petition did not
provide a basis for why we should deviate from this overall approach to
rely on the chemical definition of nutrient as a basis for a regulatory
definition. Thus, we are not proposing to exclude stearic acid from the
definition of saturated fat.
    Finally, we also considered voluntary declaration of stearic acid
on the Nutrition Facts label, as recommended by a few comments. The
effects of stearic acid on LDL cholesterol levels appear to vary
depending on the macronutrient component that is replaced by stearic
acid (Ref. 30).

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 (Ref. 30). Considering
such scientific data, the 2010 DGAC concluded that the potential
effects of changes in dietary intake of stearic acid on the risk of CVD
remain unclear. Thus, the evidence for a role of stearic acid in human
health (e.g., changes in plasma LDL cholesterol levels) is not well-
established. Furthermore, there is no quantitative intake
recommendation available for stearic acid. Therefore, we tentatively
conclude that the individual declaration of stearic acid is not
necessary to assist consumers in maintaining health dietary practices,
consistent with the factors we consider, discussed in section I.C., and
therefore the declaration would not be permitted on the Nutrition Facts
label.
    As discussed in section II.B.1., we received a citizen petition
from Nabisco, Inc. on May 7, 1997 (Docket No. FDA-1997-P-0476)
requesting that FDA amend the definitions of ``total fat'' and
``saturated fat'' in its food labeling regulations to exclude acetic,
propionic, and butyric acids (http://www.regulations.gov/#
!docketDetail;D=FDA-19970-P-0476). With respect to saturated fat, the
petition requested that FDA amend Sec.  101.9(c)(2) to read as follows:
(i) ``Saturated fat,'' or ``Saturated'': A statement of the number of g
of saturated fat in a serving defined as the sum of all fatty acids,
excluding acetic (C:2), propionic (C:3), and butyric (C:4) acids,
containing no double bonds.'' For the same reasons discussed in section
II.B.1. regarding total fat, we are not proposing to exclude acetic,
propionic, and butyric acids from the definition of saturated fat.
    b. Mandatory Declaration--Section 403(q)(1)(D) of the FD&C Act
requires the declaration of the amount of saturated fat on food labels.
Accordingly, FDA regulations require mandatory declaration of the gram
amount for saturated fat (Sec.  101.9(c)(2)).
    Dietary recommendations continue to recognize the well-established
relationship between consumption of saturated fat and its effect on
blood cholesterol levels (Refs. 6 and 49). In addition, the 2010 DGA
provided a quantitative intake recommendation for saturated fat. We are
unaware of evidence to support a determination that information
relating to saturated fat on the Nutrition Facts label is no longer
necessary to assist consumers in maintaining healthy dietary practices.
Therefore, we are not proposing to change the requirement for mandatory
declaration of saturated fat on the Nutrition Facts label in Sec.
101.9(c)(2)(i).
    c. DRV--The DRV for saturated fat is 20 g, which is 10 percent of
calories based on a 2,000 reference calorie intake level (Sec.
101.9(c)(9)). The IOM Labeling Committee recommended that the DV for
saturated fatty acids (along with trans fatty acids and cholesterol)
should be set at a level that is as low as possible in keeping with an
achievable health-promoting diet and consistent with IOM DRIs (Ref.
25). The IOM Labeling Committee suggested that FDA use food composition
data, menu modeling, and data from dietary surveys to estimate minimum
intakes that are consistent with nutritionally adequate and health-
promoting diets for diverse populations. In the 2007 ANPRM, we asked
for public comment on (1) whether the current DRV for saturated fat of
20 g should be retained and (2) whether food composition data, menu
modeling, and data from dietary surveys should be used to establish a
DRV for saturated fat that is as low as possible while consuming a
nutritionally adequate diet. We received several comments in response
to these questions (Ref. 47).
    Current consensus reports that reviewed scientific evidence related
to saturated fatty acid intake continue to recommend saturated fat
intakes of no more than 10 percent of calories, based on risk of CVD.
Specifically, the IOM DRIs recommended that intakes of these fats
should be as low as possible while consuming a nutritionally adequate
diet (Ref. 49). In addition, confirming the relationship between high
intakes of saturated fatty acids and increased risk of unhealthy blood
lipid levels and CHD, the 2010 DGA reaffirmed the recommendation to
reduce saturated fatty acid intake to less than 10 percent of calories
and noted that lowering the intake even more, to 7 percent of calories,
can further reduce the risk of CVD (Ref. 6). The 2002 report from the
National Cholesterol Education Program of the NIH National Heart, Lung,
and Blood Institute established saturated fat intakes of no more than
10 percent of calories as an optimal intake level for reduction of CHD
risk while also establishing intakes of no more than 7 percent of
calories as a therapeutic intake level for treating CHD (Ref. 55).
Although some comments suggested reducing the DRV to 15 g and to lower
the DRV to 7 percent of calories, we are not persuaded to do so because
the current saturated fatty acid recommendation of less than 10 percent
of calories is still appropriate for the general U.S. population and
that the existing DRV of 20 g continues to conform to current dietary
recommendations as a maximum intake level that covers the general U.S.
population.
    We do not consider the use of food composition data, menu modeling,
or dietary survey data as a suitable approach to determine DRVs. We
note that the majority of comments opposed the use of such alternative
methods to determine the DRV for saturated fat.
    We established the current DRVs based on quantitative intake
recommendations and underlying science on the association between
increased intakes and either reduced risk of chronic disease (e.g.,
dietary fiber and CHD) or increased risk of chronic disease (e.g.,
saturated fat and CHD). The approach to determine DRVs using food
composition data, menu modeling, or dietary surveys has a number of
deficiencies. Menu modeling is an approach, based on available foods in
the marketplace, to design a set of food items for meals, which will
meet certain nutrient or food intake pattern recommendations (Ref. 56).
Menu modeling, by its very nature, would not permit the selection of
DRVs that are based on scientific evidence related to actual public
health outcomes. Furthermore, menu modeling permits the creation of
model menus that may be able to meet certain nutrient thresholds
through the inclusion of foods that are not representative of the type
or quantity of foods eaten in the U.S. population or any specific
population and, thus, may result in nutrient intake levels that do not
reflect typical diets and, as such, may be unachievable or
unreasonable. The use of menu modeling can be appropriate in other
circumstances, such as the use of modeling to determine scenarios of
highest possible nutrient intake levels or potential nutrient profiles
of diets. Thus, food composition data and related models can help
provide useful information about consumption trends and the general
nutrient content of the food supply and can serve as an additional
consideration in choosing a reference point for daily intake that is
realistically achievable and practical in light of the current food
supply and consumption patterns. However, these data cannot form the
primary scientific bases for selecting DRVs. Another challenge with the
use of the menu modeling approach is that numerous and rapid changes to
food formulations can make it difficult for food composition databases
to provide current and accurate estimates of nutrient intakes. Based on
these inherent limitations of menu modeling

and the data sources used, we tentatively conclude that the menu
modeling approach, as recommended in the IOM Labeling Report, is an
unsuitable method for determining DRVs (or RDIs). Instead, we intend to
continue using science-based recommendations to set DRVs and RDIs. In
the case of saturated fat, as explained previously, the existing
scientific evidence does not support a change to the current 20 g DRV.
Therefore, we are not proposing any changes to the current DRV of 20 g
for saturated fat as specified in Sec.  101.9(c)(9).
3. Trans Fat
    a. Definition--FDA defines ``Trans fat'' or ``Trans'' in Sec.
101.9(c)(2)(ii) as the sum of all unsaturated fatty acids that contain
one or more isolated (i.e., non-conjugated) double bonds in a trans
configuration. In the 2007 ANPRM, we did not seek public comment on the
definition of trans fat. However, we received a comment recommending
the exclusion of a specific trans fat isomer, vaccenic acid (18:1 t11)
from the definition of trans fat because, according to the comment,
unlike other trans fat isomers, vaccenic acid may not have adverse
health effects. As discussed in the preamble to the final rule
regarding trans fat labeling (68 FR 41434 at 41461), we defined trans
fatty acids by their chemical structure, not their physiological
effects or functional attributes. While the comment provided us with
some preliminary observational data suggesting that trans fat from
ruminant sources, such as vaccenic acid, may not have the same effects
on CHD risk as trans fat from industrial sources, such as partially
hydrogenated oils, we do not agree that potential differences in
physiological effects should be the basis for determining the specific
isomers to be included in a regulatory definition of trans fat. The
definition for trans fat is its chemical definition which captures all
trans fat isomers that have isolated bonds and, thus, vaccenic acid
would be measured by the analytical method used to determine trans fat
content of foods. This chemical definition is consistent with how
polyunsaturated fat is defined as cis, cis-methylene-interrupted (Sec.
101.9(c)(2)(ii)). Accordingly, we are not proposing to change the
definition of trans fat in Sec.  101.9(c)(2)(ii).
    b. Mandatory Declaration--FDA regulations require the declaration
of trans fat on the Nutrition Facts label (Sec.  101.9(c)(2)(ii).
Dietary recommendations continue to recognize the well-established
relationship between consumption of trans fat and its effect on blood
cholesterol levels (Ref. 6). Furthermore, under section 403(r)(3)(C) of
the FD&C Act, we did not object to a 2006 Food and Drug Administration
Modernization Act of 1997 (FDAMA) notification for the health claim
``Diets low in saturated fat and cholesterol, and as low as possible in
trans fat, may reduce the risk of heart disease,'' based on statements
made in the 2005 DGA (Ref. 57). As such, because of its role in chronic
disease, trans fat continues to be a nutrient with public health
significance. We are 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. We tentatively conclude 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 CHD. Therefore, we are not
proposing any changes to the requirement for mandatory declaration of
trans fat on the Nutrition Facts label in Sec.  101.9(c)(2)(ii).
However the Agency recently published a tentative determination that
partially hydrogenated oils, the source of industrially produced trans
fat, may not be generally recognized as safe (78 FR 67169; November 8,
2013). We request comment on whether mandatory labeling of trans fat
would still be necessary if this determination is finalized.
    Per Sec.  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. We received a citizen petition from an individual on January
17, 2007 (Docket No. FDA-2007-P-0404) which requested that FDA amend
the definition of trans fat in its food labeling regulations to express
the value of ``zero'' for trans fat only when there are ``absolutely no
trans fats at all'' and require the use of a symbol (e.g., ``~'') to
indicate when there is ``more than zero but less than 0.5g of trans fat
per tablespoon'' (http://www.regulations.gov/# !docketDetail;D=FDA-
2007-P-0404). The petition claimed that the declaration of zero trans
fats on the label is misleading to consumers because it does not denote
the absence of trans fat (as ``zero'' is defined in Webster's
Dictionary) and that people will consume a food incorrectly thinking
that it has zero amount of trans fat. The petition stated that, because
trans fat is associated with negative effects on heart health, this
situation could be detrimental to people's health.
    Validated analytical methodologies that provide sensitive and
reliable estimates of trans fatty acids in all foods at levels below
0.5 g per serving are currently not available. For most nutrients
declared on the nutrition label, the maximum amount permitted for a
declaration of a zero value is governed by the limitations associated
with analytical methods available to determine the content of a
nutrient in a food. The analytical methods used to determine nutrient
content for purposes of compliance are discussed in more depth in
section II.N. The petition did not provide any information on
alternative analytical methodologies that are more sensitive and
reliable nor did the petition provide any evidence to support the claim
that consumers are misled by the provisions for the declaration of zero
trans fat. Thus, we are not proposing any changes to the requirement
for the declaration of zero when trans fat content is less than 0.5 g
per serving.
    c. DRV--FDA regulations do not provide a DRV for trans fat. At the
time of the issuance of the trans fat final rule, we concurrently
issued the 2003 ANPRM in the same issue of the Federal Register (68 FR
41507) to solicit information and data on several trans fat labeling
issues. In the 2007 ANPRM, we again requested comments on various
issues related to the DV for trans fat, including the use of food
composition data, menu modeling and data from dietary surveys, and a
potential joint percent DV for trans fat and saturated fat. We received
several comments in response to the 2007 ANPRM. We considered the
recommendations in the IOM Labeling Report, available scientific
evidence, and comments (Ref. 47) received in response to both the 2003
and 2007 ANPRMs.
    i. Use of food composition data, menu modeling, and dietary
surveys. FDA considered the approach recommended in the IOM Labeling
Report to use food composition data, menu modeling, and dietary survey
data to estimate a minimum trans fat intake within a nutritionally
adequate diet.
    As explained previously (see section II.B.2.c.), we do not consider
food composition data, menu modeling, or dietary survey data suitable
for determining DRVs. Furthermore, such an approach is not linked to a
health outcome, which we have traditionally used as a basis for
determining DRVs. As described in the IOM macronutrient DRI report
(Ref. 49), the IOM reviewed the evidence for trans fat and was not able
to set a UL for trans fat, which indicates that there is insufficient
scientific evidence from which to determine a specific level of trans
fat intake that would likely pose no risk of adverse health effects. We
continue to

adhere to the approach of determining DRVs for a nutrient based on the
nutrient's association with specific health outcomes (e.g., LDL
cholesterol levels).
    As an additional consideration, even if we were to use the menu
modeling approach, it would be difficult to apply such an approach for
trans fat. Current estimates of trans fat content in food composition
databases are not comprehensive and do not include trans fat content
for all foods. The levels of trans fat in foods have changed since the
publication of the 2003 trans fat final rule, in part due to
reformulation of foods (Ref. 58). The numerous and rapid changes to
food formulations can make it difficult for food composition databases
to provide current and accurate estimates of the usual intake of trans
fat.
    Therefore, we tentatively conclude that the menu modeling approach,
as recommended in the IOM Labeling Report, is an unsuitable method for
determining an appropriate DRV for trans fat.
    ii. Determining a DRV. The IOM did not set a UL for trans fat in
the DRI macronutrient report. The IOM noted that any increase in trans
fat intake increases CHD risk but because trans fats are unavoidable in
ordinary diets, consuming zero percent of calories would require
significant changes in dietary intake patterns that may introduce
undesirable effects and unknown and unquantifiable health risks (Ref.
49). The 2005 and 2010 DGA and the FDA Food Advisory Committee (Refs. 6
and 36) likewise could not set a definitive quantitative intake
recommendation for trans fat. Comments generally supported a single
trans fat DRV and a single percent DV, but noted that such levels are
not possible based on existing science. Although some comments
supported a joint percent DV declaration for saturated and trans fat
combined, the majority of comments opposed it due in large part to the
chemical and physiological differences between these fats. We will
consider determining a DRV for trans fat, if and when scientific
evidence and relevant dietary recommendations become available. At that
time, we will also consider whether a single DRV specific to trans fat
or a provision for joint DV declaration for trans fat and saturated fat
are appropriate. Thus, we tentatively conclude that there is no basis
for setting a DRV for trans fat and, accordingly, we are not proposing
a DRV for trans fat, a joint DRV declaration or joint percent DV
declaration.
4. Polyunsaturated Fat
    Polyunsaturated fats represent two general categories: n-6 and n-3
polyunsaturated fatty acids. The most common n-6 and n-3
polyunsaturated fatty acid in food is linoleic acid and [alpha]-
linolenic acid, respectively. Other n-3 fatty acids found in foods,
particularly in fish, are the long chain fatty acids, eicosapentaeneoic
acid (EPA) and docosahexaenoic acid (DHA).
    a. Voluntary Declaration--FDA regulations permit, but do not
require, the declaration of polyunsaturated fat (defined as cis, cis-
methylene-interrupted polyunsaturated fatty acids) on the Nutrition
Facts label (Sec.  101.9(c)(2)(iii)).
    To determine whether any changes are needed to the current
provision for voluntary declaration, we considered recommendations of
current U.S. consensus reports as well as comments received (Ref. 47)
in response to the 2007 ANPRM, in which we requested comment on whether
declaration of polyunsaturated fat should continue to be voluntary or
made mandatory. Current dietary recommendations advise consumers to
increase intakes of polyunsaturated fatty acids to replace saturated