[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Rules and Regulations]
[Pages 33741-33999]
[FR Doc No: 2016-11867]

Vol. 81

Friday,

No. 103

May 27, 2016

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;
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; Final Rules

Federal Register / Vol. 81 , No. 103 / Friday, May 27, 2016 / Rules
and Regulations

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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending 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, health-related conditions, physiological endpoints,
and/or maintaining a healthy dietary pattern that reflects current
public health conditions in the United States, and corresponds to new
information on consumer understanding and consumption patterns. The
final rule updates the list of nutrients that are required or permitted
to be declared; provides updated Daily Reference Values and Reference
Daily Intake values that are based on current dietary recommendations
from consensus reports; amends requirements for foods represented or
purported to be specifically for children under the age of 4 years and
pregnant and lactating women and establishes nutrient reference values
specifically for these population subgroups; and revises the format and
appearance of the Nutrition Facts label.

DATES:  Effective date: The final rule becomes effective on July 26,
2016. Compliance date: The compliance date of this final rule is July
26, 2018 for manufacturers with $10 million or more in annual food
sales and July 26, 2019 for manufacturers with less than $10 million in
annual food sales. See section III, Effective and Compliance Dates, for
more detail. The incorporation by reference of certain publications
listed in the rule is approved by the Director of the Federal Register
as of July 26, 2016.

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>
SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary
Purpose of the Regulatory Action
Summary of the Major Provisions of the Regulatory Action in Question
Costs and Benefits
I. Background
    A. Legal Authority
    B. Need To Update the Nutrition Facts and Supplement Facts
Labels
II. Comments to the Proposed Rule and the Supplemental Proposed
Rule, Our Responses, and a Description of the Final Rule
    A. Introduction
    B. General Comments
    1. Comments Seeking an Education Campaign or Program
    2. Comments Linking the Nutrition Facts Label to Specific
Diseases
    3. Use of Household Measures
    4. Impact on Other Regulations
    5. Consumer Research
    C. Comments on Legal Issues
    1. First Amendment
    2. Administrative Procedure Act
    3. Federal Food, Drug, and Cosmetic Act
    4. Recordkeeping Authority
    5. Miscellaneous Comments
    D. Factors for Mandatory or Voluntary Declaration of Non-
Statutory Nutrients
    E. 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
    F. Fat
    1. Total Fat
    a. Definition
    b. Mandatory Declaration
    c. DRV
    d. Declaration of Total Fat
    2. Saturated Fat
    a. Definition
    b. Mandatory Declaration
    c. DRV
    3. Trans Fat
    a. Definition
    b. Mandatory Declaration
    c. DRV
    d. Declaring the Amount of Trans Fat
    4. Monounsaturated Fat and Polyunsaturated Fat
    a. Voluntary Declaration
    b. DRV
    c. Declaration of Individual Polyunsaturated Fatty Acids
    G. Cholesterol
    1. Mandatory Declaration
    2. DRV
    H. Carbohydrate
    1. Total Carbohydrate
    a. Calculation of Total Carbohydrate
    b. Classification of Carbohydrates Based on a Chemical
Definition or Physiological Effect
    c. Separate Declaration of Additional Individual Types of
Carbohydrates
    d. Mandatory Declaration
    e. DRV
    f. How Total Carbohydrates Appears on the Label
    g. Calculation of Calories From Carbohydrate
    2. Sugars
    a. Definition
    b. Mandatory Declaration
    c. Changing ``Sugars'' to ``Total Sugars''
    d. DRV
    e. Seasonal Variation in Sugars Content
    3. Added Sugars
    a. Declaration
    (i) Comments on the Rationale for Requiring Mandatory
Declaration of Added Sugars
    (ii) Evidence on Added Sugars and Risk of Chronic Disease
    (iii) New Evidence Presented in the 2015 DGAC Report
    b. The 2015 DGAC Analysis of Dietary Patterns and Health
Outcomes
    c. Authority for Labeling
    (i) Statutory Authority
    (ii) Material Fact
    (iii) Regulations Must Bear a Reasonable Relationship to the
Requirements and Purposes of the Statue
    d. Nutrient Density
    e. Reformulation
    f. Calories from Solid Fats and Added Sugars
    g. Consumer Research and Consumer Use of Added Sugars
Declaration
    h. Voluntary Labeling
    i. How Added Sugars are Declared
    (i) Changing ``Sugars'' to ``Total Sugars''
    (ii) Declaration of Added Sugars in Teaspoons
    (iii) Distinguishing Between Naturally Occurring and Added
Sugars on the Label
    (iv) Replacing ``Sugars'' With ``Added Sugars''
    (v) Distinguishing Between Different Types of Sugars or
Sweeteners
    (vi) Warning Statements
    j. Variability in Sugar Content
    k. Non-Enzymatic Browning and Fermentation
    l. Impact on Nutrient Databases
    m. International Labeling Guidelines
    n. Definition of Added Sugars
    (i) Fruit and Vegetable Juice Concentrates
    (ii) Intended Purpose of Sweetening
    (iii) The ``No Added Sugars'' Nutrient Content Claim
    (iv) Fruit Jellies, Jams, and Preserves
    (v) Dried Fruits
    (vi) Other Sugars/Sweeteners
    (vii) Other Comments
    o. Establishing a DRV and Mandatory Declaration of the Percent
DV for Added Sugars
    (i) Mandatory Declaration of a Percent DV and Whether a DRV
Should be Established
    (ii) DRV of 10 Percent of Total Calories From Added Sugars
    (iii) Food Pattern Modeling
    (iv) The Te Morenga et al. Meta-Analysis
    (v) The IOM Suggested Maximum Intake Level of 25 Percent or Less
of Energy From Added Sugars
    (vi) DRV of 10 Percent of Total Calories
    (vii) Education
    p. Records

    4. Sugar Alcohols
    a. Voluntary Declaration
    b. Use of the Term ``Sugar Alcohols''
    c. DRV
    d. Caloric Value
    5. Dietary Fiber
    a. Dietary fiber
    (i) Definition
    (ii) Mandatory Declaration
    (iii) Analytical Methods
    (iv) DRV
    b. Soluble and Insoluble Fiber
    (i) Definition
    (ii) Voluntary Declaration
    (iii) Analytical Methods
    (iv) DRV
    (v) Caloric Value
    6. Other Carbohydrate
    I. Protein
    1. Mandatory and Voluntary Declaration
    2. Analytical Methods
    3. DRV
    4. Miscellaneous Comments
    J. Sodium
    1. Mandatory Declaration
    2. DRV
    K. Fluoride
    1. Voluntary Declaration
    2. DRV
    3. Miscellaneous Comments
    L. Essential Vitamins and Minerals of Public Health Significance
    1. General Comments
    2. Essential Vitamins and Minerals That Are Mandatory
    a. Calcium
    b. Iron
    c. Vitamin A and Vitamin C
    3. Essential Vitamins and Minerals That Are Voluntary
    a. Vitamin D
    b. Potassium
    4. Other Essential Vitamins and Minerals
    a. Phosphorus
    b. Magnesium
    c. Vitamin K
    d. Choline
    e. Vitamin B12
    M. 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 Absolute Amounts of Vitamins and Minerals
    7. Issues Concerning Specific Vitamins or Minerals
    a. Vitamin K
    b. Chloride
    c. Potassium
    d. Choline
    e. Vitamin B12
    N. Units of Measure, Analytical Methods, and Terms for Vitamins
and Minerals
    1. General Comments
    2. Sodium, Potassium, Copper, and Chloride
    3. Folate and Folic Acid
    a. Units of Measure
    b. Analytical Methods
    c. Terms Used to Declare Folate
    4. Vitamins A, D, and E
    a. General Comments
    b. Specific Comments on the Units of Measure for Individual
Vitamins
    5. Niacin
    O. 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
    a. Declaration of Saturated Fat and Cholesterol
    b. Percent DV Declaration
    3. Declaration of Non-Statutory Nutrients Other Than Essential
Vitamins and Minerals
    a. Voluntary Declaration of Calories From Saturated Fat, and the
Amount of Polyunsaturated and Monounsaturated Fat
    b. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and
Sugar Alcohols
    c. Mandatory Declaration of Trans Fat
    d. Mandatory Declaration of Added Sugars
    e. Voluntary Declaration of Fluoride
    4. Declaration of Essential Vitamins and Minerals
    a. Mandatory Declaration of Calcium and Iron
    b. Mandatory Declaration of Vitamin D and Potassium
    c. Voluntary Declaration of Vitamin A and Vitamin C
    d. Voluntary Declaration of Other Vitamins and Minerals
    5. DRVs and RDIs for Infants Through 12 Months of Age
    a. General Comments
    b. Calories
    c. Total Fat
    d. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber, and
Sugars
    e. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber,
Soluble Fiber, Added Sugars, and Sugar Alcohols
    f. Total Carbohydrates
    g. Protein
    h. Sodium
    i. Fluoride
    j. Other Vitamins and Minerals
    6. DRVs and RDIs for Children 1 Through 3 Years of Age
    a. General Comments
    b. Calories
    c. Total Fat
    d. Saturated Fat, Trans Fat, and Cholesterol
    e. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Insoluble
Fiber, Soluble Fiber, Added Sugars, and Sugar Alcohols
    f. Total Carbohydrates
    g. Dietary Fiber
    h. Protein
    i. Sodium
    j. Fluoride
    k. Other Vitamins and Minerals
    7. DRVs and RDIs for Pregnant Women and Lactating Women
    a. Calories
    b. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate,
Sodium, and Dietary Fiber
    c. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble
Fiber, Insoluble Fiber, Sugars, Added Sugars, and Sugar Alcohols
    d. Protein
    e. Fluoride
    f. Vitamins and Minerals
    P. 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
    7. Miscellaneous Comments
    8. Compliance Requirements for Dietary Supplements
    Q. Format
    1. General Comments
    2. Increasing the Prominence of Calories and Serving Size
    3. Changing the Order of the ``Serving Size'' and ``Servings Per
Container'' Declarations and Increasing the Prominence of ``Servings
Per Container''
    4. Right-Justifying the Quantitative Amounts Declared in the
``Serving size'' Statement
    5. Changing the ``Amount per Serving'' Statement
    6. Declaration of ``Calories From Fat''
    7. Presentation of Percent DVs
    8. Placement of ``Added Sugars''
    9. Declaration of Absolute Amounts of Vitamins and Minerals
    10. Single and Dual Column Labeling
    11. The Footnote
    12. Use of Highlighting With a Type Intermediate Between Bold or
Extra Bold and Regular Type
    13. Addition of a Horizontal Line Beneath the Nutrition Facts
Heading
    14. Replacing ``Total Carbohydrate'' With ``Total Carbs''
    15. Alternative Visual Formats/Fonts
    16. Miscellaneous Comments
    a. Size and Space Issues
    b. Calorie Conversion Factors
    R. 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
    6. Miscellaneous Comments
    S. Technical Amendments
    1. Changing the Name of the Program Office
    2. Changing the Publication Date of Report Incorporated by
Reference
    3. Plain Language Edits
    4. Correcting Sec.  101.9(c)(8)(iii) To Provide Instructions for
Rounding Percent DVs
    5. Miscellaneous Changes
    T. Miscellaneous Comments
III. Effective and Compliance Dates
IV. Economic Analysis of Impacts
V. Paperwork Reduction Act of 1995
    A. Recordkeeping Requirements
    B. Reporting Requirements
    C. Third-Party Disclosure Requirements
    D. Third-Party Disclosure Burden for Manufacturers
VI. Analysis of Environmental Impact

VII. Federalism
VIII. References

Executive Summary

Purpose of the Regulatory Action

    We are amending our regulations for the nutrition labeling of
conventional foods and dietary supplements to help consumers maintain
healthy dietary practices. Section 403(q) of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)) 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.
    The final rule revises our regulations to provide updated nutrition
information on the label and to improve how the nutrition information
is presented to consumers.

Summary of the Major Provisions of the Regulatory Action in Question

    The final rule revises the Nutrition Facts label by:
     Removing 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;
     Requiring the declaration of the gram amount of ``added
sugars'' in a serving of a product, establishing a Daily Reference
Value (DRV), and requiring the percent Daily Value (DV) declaration for
added sugars;
     Changing ``Sugars'' to ``Total Sugars'' and requiring that
``Includes `X' g Added Sugars'' be indented and declared directly below
``Total Sugars'' on the label;
     Updating the list of vitamins and minerals of public
health significance. For example, the final rule requires the
declaration of vitamin D and potassium and permits, rather than
requires, the declaration of vitamins A and C;
     Updating certain reference values used in the declaration
of percent DVs of nutrients on the Nutrition Facts and Supplement Facts
labels;
     Revising the format of the Nutrition Facts and Supplement
Facts labels to increase the prominence of the term ``Calories;''
     Removing the requirement for the footnote table listing
the reference values for certain nutrients for 2,000 and 2,500 calorie
diets;
     Requiring the maintenance of records to support the
declarations of certain nutrients under specified circumstances. For
example, because there are no analytical methods that can distinguish
between dietary fiber (soluble and insoluble fiber) and nondigestible
carbohydrates that do not meet the definition of dietary fiber; added
and naturally occurring sugars or the various forms of vitamin E; or
folate and folic acid, the final rule requires manufacturers to make
and keep certain written records to verify the declarations of dietary
fiber, added sugars, vitamin E, and folate and folic acid in the
labeling of the food associated with such records. The final rule
requires these records to be kept for at least 2 years after
introduction or delivery for introduction of the food into interstate
commerce. A similar requirement exists with respect to added sugars in
foods subject to non-enzymatic browning and fermentation because 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 non-
enzymatic browning and fermentation. However, for manufacturers of such
foods who are unable to reasonably approximate the amount of added
sugars in a serving of food to which the records requirements apply,
the final rule allows manufacturers to submit a petition to request an
alternative means of compliance; and
     Establishing a compliance date of 2 years after the final
rule's effective date, except that manufacturers with less than $10
million in annual food sales have a compliance date of 3 years after
the final rule's effective date. (For more details, see part III.)
    The final rule is the result of significant stakeholder engagement.
We received nearly 300,000 comments, conducted several consumer studies
and made those studies publicly available, and, in light of new
scientific recommendations (particularly for added sugars), issued a
supplemental notice of proposed rulemaking.
    Elsewhere in this issue of the Federal Register, we have published
a final rule that amends the definition of a single-serving container,
requires dual column labeling for certain containers, updates the
reference amounts customarily consumed and serving sizes for several
food product categories, and amends the serving size for breath mints.

Costs and Benefits

    We have developed one final regulatory impact analysis (FRIA) for
this final rule as well as the final rule 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.'' The FRIA discusses key inputs in the
estimation of costs and benefits of the changes finalized by the rules
and assesses the sensitivity of cost and benefit totals to those
inputs. The two nutrition labeling rules--which have a compliance date
of 2 years after the final rule's effective date for manufacturers with
$10 million or more in annual food sales, and 3 years after the final
rule's effective date for manufacturers with less than $10 million in
annual food sales--have impacts, including the sign on net benefits,
that are characterized by substantial uncertainty. The primary
sensitivity analysis shows benefits having the potential to range
between $0.2 and $2 or $5 billion, and costs ranging between $0.2, $0.5
and $0.8 billion (annualized over the next twenty years, in 2014
dollars, at seven percent interest).\1\
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    \1\ There is substantial uncertainty regarding the impacts of
the two nutrition labeling rules. For a full discussion of the
uncertainty, please see the Welfare Estimates--Primary Sensitivity
Analysis section of the regulatory impact analysis.

                            Table 1--Summary of the Primary Sensitivity Analysis of the Costs and Benefits of the Final Rules
                                                                 [in billions of 2014$]
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                                                                             Benefits        Benefits
                                                          Benefits (Low)      (Mean)          (High)        Costs (Low)    Costs (Mean)    Costs (High)
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Present Value
    3%..................................................            $2.8           $33.1           $77.7            $2.3            $4.8            $8.6

    7%..................................................             1.9            22.3            52.5             2.2             4.5             8.3
Annualized Amount
    3%..................................................             0.2             2.2             5.2             0.2             0.3             0.6
    7%..................................................             0.2             2.1             5.0             0.2             0.4             0.8
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Notes: Costs estimates reflect an assumption that the rules have the same compliance date. Compliance period is 36 months for small businesses and 24
  months for large businesses. For purposes of this analysis, we consider a small business to be a business with annual food sales of less than $10
  million, and a large business to be a business with annual food sales of $10 million or more. Costs include relabeling, recordkeeping, fiber study,
  additional labeling, future UPC growth labeling, and reformulation costs. Annualized Amount = Amount/Annualizing Factor. Three percent annualizing
  factor = 14.88. Seven percent annualizing factor = 10.59. The annualizing factors are calculated by summing the inverse of 1 plus the discount rate to
  the power of the year (t = 1 through t = 20).

I. Background

    In general, under section 403(q) of the FD&C Act, a food is deemed
misbranded unless its label or labeling bears nutrition information for
certain nutrients. To implement section 403(q) of the FD&C Act, we have
issued regulations related to:
     Declaration of nutrients on food labeling, including
nutrients that are required or permitted to be declared and the format
for such declaration;
     Label reference values for use in declaring the nutrient
content of a food on its label or labeling;
     Two types of reference values, Reference Daily Intakes
(RDIs) for vitamins and minerals and DRVs for certain nutrients, which
are used to declare nutrient contents as percent DVs on the Nutrition
Facts label;
     Exemptions for certain specified products; and
     A simplified form of nutrition labeling and the
circumstances in which such simplified nutrition labeling can be used.

These regulations are at Sec.  101.9 (21 CFR 101.9).
    Elsewhere in this issue of the Federal Register, we are publishing
a final rule that amends the definition of a single-serving container,
requires dual column labeling for certain containers, updates the
reference amounts customarily consumed and serving sizes for several
food product categories and amends the serving size for breath mints.
    In addition, section 403(q)(5)(F) of the FD&C Act imposes specific
requirements that relate to the labeling of dietary supplement
products. Accordingly, our food labeling regulations, at Sec. Sec.
101.9(j)(6) and 101.36, establish requirements for nutrition labeling
of dietary supplements.

A. Legal Authority

    We are updating the Nutrition Facts label and Supplement Facts
label, as set forth in this final 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 gives the Secretary, and by delegation,
FDA, the 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
revising certain nutrient declarations in the Nutrition Facts label and
Supplement Facts label. In addition, FDA's authority includes section
2(b)(1) of the Nutrition Labeling and Education Act of 1990 (NLEA) (21
U.S.C. 343 note). Specifically, section 2(b)(1)(A) of the NLEA 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. Section 2(b)(1)(A) of the NLEA also states that such information
should be consistent with current scientific knowledge about nutrients
and health. We are changing DVs (RDIs and DRVs, as applicable) for some
nutrients, and these 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 can help
consumers understand the nutrition information and its relative
significance in a total daily diet. Furthermore, section 2(b)(1)(C) of
the NLEA requires that the regulations permit the label or labeling of
food to include nutrition information which is in addition to the
information required by 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 changing the voluntary declaration of certain nutrients in
the Nutrition Facts label consistent with this 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, we
may issue regulations for the efficient enforcement of the FD&C Act 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 establish 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, there is no official method of analysis of the
Association of Official Analytical Chemists (AOAC) International or
other reliable or appropriate analytical procedure, otherwise required
by Sec.  101.9(g), available for us 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 requiring 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
fiber. When vitamin E is present in a food as a mixture of all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol, we are requiring
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 requiring 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 requiring manufacturers
to make and keep records to verify the declared amount of added sugars
in the food. Finally, we are requiring 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 non-enzymatic browning and/or
fermentation.
    The final rule's record requirements for these nutrients 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 we have found such records to be necessary (National
Confectioners Assoc. v. Califano, 569 F.2d 690, 693-94 (D.C. Cir.
1978)). The records we are requiring are only for foods for which an
adequate analytical method is not available. The records will allow us
to verify the declared amount of each nutrient and that such amount is
truthful and not misleading. Thus, the records requirements will 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 the authority to
establish records requirements, but also includes access to such
records. Without such authority, the nutrient declarations for these
specific nutrients that we have 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, we would not know whether
the amount declared on the label or in the labeling of 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 us, as described in
Sec.  101.9(g)(10) and (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

    We first issued regulations related to the Nutrition Facts label in
1993 and amended them in 1995 (to establish new DVs and to update the
DVs (60 FR 67164, December 28, 1995)) and in 2003 (to address the
declaration of trans fats (68 FR 41434, July 11, 2003)). From July 2003
to November 2007, we also issued three advance notices of proposed
rulemaking (ANPRMs) seeking public comment on issues relevant to
updating the Nutrition Facts label. These ANPRMs sought comment on:
     Data that 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 (68
FR 41507, July 11, 2003). We later extended the comment period (69 FR
20838, April 19, 2004) to receive comments that considered the
information in the 2004 meeting of the Nutrition Subcommittee of the
Food Advisory Committee 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;
     The prominence of calories on the food label (70 FR 17008,
April 4, 2005) (the 2005 ANPRM). We took this action in response to
recommendations from the Obesity Working Group established 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 and 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. We also requested comments on questions concerning the
declaration of ``Calories from fat;'' and
     The revision of reference values and mandatory nutrients
(72 FR 62149, November 2, 2007) (the 2007 ANPRM). The 2007 ANPRM
requested comment on various aspects of nutrition labeling, including
new reference values we should use to calculate the percent DV in the
Nutrition Facts and Supplement Facts labels and factors we should
consider in establishing such new reference values. We also requested
comments on whether we should require that certain nutrients be added
or removed from the Nutrition Facts and Supplement Facts labels.
    Additionally, between 1993 and 2013, we received 12 citizen
petitions asking us to make various changes to the Nutrition Facts and
Supplement Facts labels. For example, some petitions asked us to permit
the use of a different term on the Nutrition Facts label, while others
sought changes in definitions, values (such as caloric values or the DV
for a specific nutrient), or the inclusion of more information on the
Nutrition Facts label.
    Yet, as we considered the issues raised in the ANPRMs and the
citizen petitions, the public health profile of the U.S. population
changed, and new

information became available about nutrient definitions, reference
intake values, and analytical methods. New dietary recommendations also
were published. We reconsidered 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. Consequently, in the Federal Register
of March 3, 2014 (79 FR 11879), we issued a proposed rule to amend our
labeling regulations for conventional foods and dietary supplements to
provide updated nutrition information on the label and to help
consumers maintain healthy dietary practices. The preamble to the
proposed rule discussed, in some detail, the reasons why we felt it
necessary to update the Nutrition Facts and Supplement Facts labels
(see 79 FR 11879 at 11884 through 11889). In brief, the preamble to the
proposed rule discussed:
     Rates of chronic disease, such as cardiovascular disease,
diabetes, and cancer, and changes in obesity rates (79 FR 11879 at
11885);
     Dietary recommendations, consensus reports, and national
survey data, such as the Institute of Medicine (IOM) Dietary Reference
Intakes Reports (which resulted in the development of a set of
reference values known collectively as Dietary Reference Intakes (DRIs)
(id. at 11885 through 11887). The DRIs themselves consist of four
categories of reference values: (1) The Estimated Average Requirement
(EAR); (2) Recommended Dietary Allowance (RDA); (3) Adequate Intake
(AI); and (4) Tolerable Upper Intake Level (UL) (id.). The preamble to
the proposed rule explained that 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 and
that 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 and 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. The 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 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, but 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 (id. at 11885 through
11886). The preamble to the proposed rule also discussed the Dietary
Guidelines for Americans (DGA); the DGA is developed jointly by the
U.S. Department of Agriculture and the U.S. Department of Health and
Human Services and provides key recommendations on dietary patterns and
quantitative intake recommendations with respect to micronutrients and
macronutrients (id. at 11886). Although the preamble to the proposed
rule discussed the DGA that was issued in 2010, in February 2015, the
Scientific Report of the 2015 Dietary Guidelines Advisory Committee
(DGAC Report) became publicly available. While the DGAC Report is not a
DGA itself (because the Federal government must determine how to use
the information in the DGAC Report to develop the 2015-2020 version of
the DGA), the DGAC Report contains scientific information on specific
nutrients and vitamins as well as a review of the underlying scientific
evidence. For example, the DGAC Report contains scientific evidence
related to a daily intake recommendation for added sugars. In the
Federal Register of July 27, 2015 (80 FR 44303), we issued a
supplemental proposed rule with respect to the scientific evidence in
the DGAC Report pertaining to added sugars and the possible inclusion
of added sugars to the Nutrition Facts and Supplement Facts labels.
     Consumer use and understanding of the Nutrition Facts
label (79 FR 11879 at 11887). The preamble to the proposed rule
discussed, among other things, the frequency at which consumers use
food labels and the purposes for which they consulted food labels
(id.). The preamble to the proposed rule also noted that consumer
research data suggested that, despite widespread use of food labels,
certain elements of the Nutrition Facts label ``may need improvement''
(such as consumer understanding of the concept of percent DVs) (id.).
We also stated that we intended to continue performing research during
the rulemaking process to evaluate how variations in label format may
affect consumer understanding and use of the Nutrition Facts label as
well as to help inform consumer education (id.).
     Other considerations, including the focus of the Nutrition
Facts label itself and practical limitations (id. at 11887 through
11888). For example, we noted that the Nutrition Facts label
information is to help consumers make more informed choices to consume
a healthy diet and not intended for the clinical management of an
existing disease. However, we also said that we were considering the
large proportion of the U.S. population that is at risk for chronic
disease as we proposed changes to the Nutrition Facts label's content
and format (id. at 11887). Simultaneously, we recognized that there is
not room on the label for all information that may be related to
maintaining healthy dietary practices and that space constraints on the
label of most foods make it impractical to declare all essential
nutrients (id. at 11888). We added that 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
and that, given the amount and format of information that we require on
the label, limits to the voluntary information on the label 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 (id.).
    The preamble to the proposed rule also discussed the citizen
petitions and ANPRMs (id. at 11888 through 11889) as influencing our
development of the proposed rule. Additionally, as stated earlier in
part I.B, in the Federal Register of July 27, 2015 (80 FR 44303), we
issued a supplemental proposed rule to establish a DRV of 10 percent of
total energy intake from added sugars, require the declaration of the
percent DV for added sugars on the label, and to provide text for the
footnotes to be used on the Nutrition Facts label. The

supplemental proposed rule also provided additional data and
information to support the declaration of added sugars on the label and
made our consumer research regarding the footnote text and added sugars
declarations publicly available.

II. Comments to the Proposed Rule and the Supplemental Proposed Rule,
Our Responses, and a Description of the Final Rule

A. Introduction

    The proposed rule would amend our labeling regulations for
conventional foods and dietary supplements to provide updated nutrition
information on the label. In brief, the proposed rule would (among
other things):
     Require the declaration of ``Added Sugars'' on the label.
``Sugars'' include both ``added sugars'' and sugars that are naturally
occurring in food. The proposed rule would require the declaration of
``Added Sugars'' indented under ``Sugars'' so that both would be
listed;
     Remove the requirement for declaring ``Calories from
fat.'' Current research shows that the total fat in the diet is less
important than the type of fat. In addition, our consumer research
shows that removal of the declaration of ``calories from fat'' has no
effect on consumers' ability to judge the healthfulness of a product;
     Revise the nutrients of public health significance that
must be declared on the label. The proposed rule would require the
declaration of vitamin D and potassium. Vitamin D is important for its
role in bone development and general health, and intakes among some
population groups are inadequate. Adequate potassium intake is
beneficial in lowering blood pressure, and intakes of this nutrient are
also low among some population groups. The proposed rule also would no
longer require mandatory labeling for vitamin C or vitamin A because
data indicate that deficiencies are not common. Voluntary labeling for
vitamins C and A would be allowed; and
     Revise DVs for certain nutrients that are either mandatory
or voluntary on the label. Examples include calcium, sodium, dietary
fiber and vitamin D. Some DVs are intended to guide consumers about
maximum intake--saturated fat, for example--while others are intended
to help consumers meet a nutrient requirement--iron, for example. DVs
are used to calculate the percent Daily Value (% DV) on the label,
which helps consumers understand the nutrient information on the
product label in the context of the total diet. We considered revisions
to the DVs based on scientific evidence related to recommendations
published by the IOM and other reports such as the DGA. In addition to
changing some DVs, the proposed rule would change the units used to
declare vitamins A, E, and D from ``international units,'' or ``I.U.''
to a metric measure, milligrams or micrograms, and also would include
the absolute amounts in milligrams or micrograms of vitamins and
minerals, in addition to the % DV, on the label.
    The proposed rule also would change the appearance of the label
itself by highlighting key parts of the label that are important in
addressing current public health problems. For example, the proposed
rule would:
     Highlight the caloric content of foods by increasing the
type size and placing in bold type the number of calories and servings
per container;
     Shift to the left of the label % DV. The % DV is intended
to help consumers place nutrient information in the context of a total
daily diet;
     Declare the actual amount, in addition to % DV, for all
vitamins and minerals when they are declared;
     Change ``Amount Per Serving'' to ``Amount per ___'', with
the blank filled in with the serving size in common household measures,
such as ``Amount per 1 cup'';
     Replace the listing of ``Total Carbohydrate'' with ``Total
Carbs'' and add an indented listing of ``Added Sugars'' directly
beneath the listing for ``Sugars;''
     Right justify the actual amounts of the serving size
information;
     Reverse the order of ``Serving Size'' and ``Servings Per
Container'' declarations; and
     Remove the existing footnote that describes the DVs for
2,000 and 2,500 calories to provide more space to better explain the
percent dietary value.
    The proposed label changes were intended to help consumers maintain
health dietary practices, and we based the updated information on
current data on associations between specific nutrients and chronic
diseases or health-related conditions in the United States and on new
information regarding consumer understanding of the label and
consumption patterns.
    We provided a 90-day comment period for the proposed rule. In the
Federal Register of May 27, 2014 (79 FR 30055), we extended the comment
period by 60 more days after receiving multiple requests to extend the
comment period. In the Federal Register of May 29, 2014 (79 FR 30763),
we announced a public meeting to discuss the proposed rule, as well as
the proposed rule on serving size requirements, and to solicit oral
stakeholder and public comments and to respond to questions about the
proposed rules. Additionally, as we stated in part I.B, in the Federal
Register of July 27, 2015 (80 FR 44303), we issued a supplemental
proposed rule to establish a DRV of 10 percent of total energy intake
from added sugars, to require the declaration of the percent DV for
added sugars, and to provide text for the footnotes to be used on the
Nutrition Facts label. The supplemental proposed rule also provided
additional information to support the declaration of added sugars on
the label and made our consumer research regarding added sugars
declarations and the footnote text publicly available. We also reopened
the comment period for the purpose of inviting public comment on two
consumer studies we added to the administrative record (80 FR 44302).
The two consumer studies pertained to proposed changes to the format of
the Nutrition Facts label and to consumers' interpretations of
information on the Nutrition Facts label. Collectively, with respect to
the proposed rule, the supplemental proposal, and the related Federal
Register documents, we received nearly 300,000 comments from consumers,
foreign governments, industry, trade associations, professional
societies, academia, health professionals, and other government
agencies.
    We discuss the issues raised in the comments on the proposed rule
and supplemental proposed rule and also describe the final rule, in
part II. We preface each comment discussion with a numbered
``Comment,'' and each response by the word ``Response'' to make it
easier to identify comments and our responses. We have numbered each
comment to help distinguish among different topics. The number assigned
is for organizational purposes only and does not signify the comment's
value, importance, or the order in which it was received.
Incorporation by Reference
    Additionally, the final rule incorporates by reference the
``Official Methods of Analysis of the AOAC International,'' 19th
Edition. The ``Official Methods of Analysis of AOAC International''
(AOAC Methods) is a comprehensive collection of chemical and
microbiological methods of analysis. The AOAC Methods have undergone
rigorous scientific review and validation to determine the performance
characteristics for the intended analytical application and

fitness for purpose. Each method includes specific instructions for
performing the chemical analysis of a substance in a particular matrix.
    Although the 19th Edition of the AOAC Methods was available for
purchase from AOAC when we drafted the proposed rule, the reference has
since been sold out at AOAC INTERNATIONAL. Copies, however, can be
obtained or downloaded from secondary sources, and the final rule
identifies one such source. However, we do not endorse any particular
secondary source or reseller and note that other resellers also may
have the 19th Edition of the AOAC Methods for sale.

B. General Comments

    Some comments raised issues that were general in nature or affected
multiple parts of the rule.
    Additionally, one foreign government agency, Health Canada,
provided factual information and comments on various aspects of its
review and update of nutritional information on the Canadian food
label. Health Canada did not advocate a particular outcome or did not
provide comments on possible changes or suggestions to our proposed
rule.
1. Comments Seeking an Education Campaign or Program
    (Comment 1) Several comments suggested that we develop a well-
funded, coordinated, multi-component consumer education campaign to
promote and explain the new Nutrition Facts label, the changes to the
label, and the use of the label to help consumers to make healthier
food and beverage choices. Many comments suggested that we coordinate
our consumer education campaign with other Federal government Agencies
including the Centers for Disease Control and Prevention (CDC), other
parts of the Department of Health and Human Services, the U.S.
Department of Agriculture (USDA), State health departments, and non-
government entities, including food manufacturers, retailers, and non-
profit organizations with an interest in nutrition and health.
    Several comments suggested that our education campaign emphasize
calories because knowledge of calories is important for rolling back
the obesity epidemic. Other comments would focus on sodium because of
its contribution to cardiovascular disease or on nutrients (such as
added sugars) that would be on the Nutrition Facts label for the first
time and nutrients (such as total fat) for which the science has
changed significantly.
    Several comments noted that, although some revisions (such as the
declaration of trans fatty acids and the declaration of food allergens)
have been made to nutrition labeling since implementation of the NLEA,
there have not been changes to the label of the magnitude in the
proposed rule. The comments said, therefore, that public outreach,
through avenues such as Webinars, town hall meetings, and social media,
will be a key component of the nutrition labeling modernization effort.
A few comments suggested that the consumer education program should be
informed by any relevant consumer research. Several comments noted that
there is consumer confusion over the meaning of percent DV and consumer
research had found that consumers do not understand or know how to use
the DVs; thus, the percent DV should be a key area in which to focus
consumer education efforts. One comment specifically stated that
percent DV/added sugars disclosure will create substantial consumer
confusion that does not exist today and that we would need to provide
consumer education in attempt to overcome the confusion. Several
comments stated that education is needed to help consumers understand
the meaning of percent DVs, with inclusion of a brief footnote on
packages, but additional consumer education should be done online.
    Several comments suggested that, although the education campaign is
important for all consumers to know about, understand, and use the
revised Nutrition Facts label, an education campaign should primarily
be designed to reach consumers who are least likely to understand and
use the label, including lower income consumers, communities with
diverse languages and literacy levels who are also more likely to
suffer from many obesity- and nutrition-related chronic diseases than
those with higher incomes and education. The comments stated that we
should use multiple and culturally relevant communication channels and
messengers, and we should field test our messages to ensure they are
relevant and compelling for audience segments. One comment noted that a
Canadian study (Ref. 1) found that participants were significantly less
likely to correctly assess the Nutrition Facts label for calorie and
nutrient information if they reported lower educational attainment,
lower income, or non-white ethnicity. The comment also stated that the
2012 IOM report on front-of-pack labeling (Ref. 2) found that ``a lack
of nutrition knowledge is a major barrier to effective use of the
[Nutrition Facts label] and may actually lower the motivation of some
consumers to use the nutrition information on the label,'' and that
``some racial groups . . . are less likely . . . to use and understand
nutrition labels, primarily because of lack of time to read labels and
lack of understanding of the nutrition information.'' The comment
stated that working with other health departments and organizations
could help extend our educational resources to all rural and urban
communities. Another comment suggested that, to be most effective, we
should incorporate lessons learned on how individuals from various
subpopulations interpret the new label design. The comment noted that
such education needs to accommodate individuals at various levels of
educational achievement and with cultural and ethnic diversity.
    A few comments suggested that we conduct the education campaign
after the final rule's publication and before the rule's compliance
date. One comment suggested that our recommendations be publicized to
groups who interact with the public at least 3 months before
implementation of the new Nutrition Facts label style and elements to
allow for preparation of curricula and development of local educational
and media efforts.
    One comment suggested that, similar to our earlier public service
campaigns such as ``The Real Cost'' campaign targeting youth tobacco
use, we have a unique ability to get the attention of the public and
shape understanding about the risks of lifestyles habits and choices.
Other comments suggested that we integrate the education campaign with
preexisting consumer education programs and initiatives, including the
USDA's Supplemental Nutrition Assistance Program Education (SNAP-Ed)
(the nutrition promotion and obesity prevention component of SNAP),
school-based nutrition education programs, and grocery store labeling
and education initiatives, such as the Boston Public Health
Commission's ``Re-Think Your Drink'' campaign. One comment suggested
that we develop a similar outreach campaign as ``Read the Label'' to
enable Americans to understand the revised label and its uses.
    One comment noted that, while nutrition education has been shown to
have a positive impact on consumers' dietary choices and patterns,
multiple studies suggest that education alone is not adequate to change
consumer behavior around healthy eating for a sustained amount of time.
The comment suggested that, for education efforts to be effective and
sustainable, they should be combined with policy, systems, and
environmental changes that support healthful choices. For example, food

environmental changes, such as increased availability of and access to
healthful foods, combined with education efforts, have been found to be
significantly more effective in changing consumer behavior in the long
run.
    (Response) We agree that a consumer education and outreach campaign
will assist in making the new food label a successful tool in
continuing to help consumers to make healthy food and beverage choices.
Currently, we have available a collection of various educational
materials (e.g., videos, an array of public education materials and
brochures (in English and Spanish)) on numerous nutrition topics,
including materials on the Nutrition Facts label (e.g., ``Read the
Label,'' Make Your Calories Count, Sodium: Look at the Label) (Ref. 3).
These materials are intended for educators, teachers, health
professionals (e.g., dietitians, physicians, and nurses) as well as for
general consumers. Our intent is to update our existing educational
materials and create new educational opportunities to explain how to
use the label to help consumers make healthy dietary choices, with an
emphasis on each of the new changes of the label. We intend to continue
to work on and to create new partnership opportunities with other
Federal government Agencies including other parts of the Department of
Health and Human Services, USDA, State health departments, health
professional organizations, food manufacturers, retailers, and non-
profit organizations that have an interest and responsibilities in
nutrition education and health promotion. These partnerships will help
us develop and disseminate our educational materials that will ease the
transition to the revised nutrition label and help consumers to
understand and use the label to make well-informed dietary choices.
Through our work with both government and non-government entities, our
continued goal is to increase consumers' knowledge and effective use of
the new Nutrition Facts label and to ensure that consumers have
accurate and adequate resources, materials, and information for making
healthy food and beverage choices. Furthermore, we intend to continue a
variety of activities such as conduct and report on existing and
planned food labeling research; to develop education initiatives at the
national and local levels; to build labeling education exchanges; and
to integrate food labeling education into existing programs (e.g.,
USDA-school-based nutrition education programs). We plan to continue to
build partnerships capable of developing and evaluating labeling
education targeted to the dietary needs of diverse populations, such as
low literacy consumers, lower incomes, minorities, and various
subpopulations (e.g., children, older subpopulation, women of
childbearing age) as well as to the general public.
    As for the comments stating that the percent DV should be a key
area to focus consumer education efforts, and that the disclosure of
``% DV/Added sugars'' will create substantial consumer confusion, we
will continue to provide education and outreach to consumers about
using the Nutrition Facts label to make healthful dietary choices. (We
also note that the comments' use of the term ``confusion'' is, itself,
misplaced; a more appropriate characterization would be whether some
consumers we tested ``understand'' or ``misunderstand'' the declaration
of added sugars. However, because the comments used the term
``confusion,'' for convenience, we will use the same term in this
response as well as in other responses on the subject of added sugars,
consumer research, and education, in reference to the findings that
some consumers we tested seemed to misunderstand that the term ``added
sugars'' referred to a subcomponent of total sugars on the label.) The
changes in the ``new'' label will be highlighted and clarified through
these education and outreach endeavors. We are not planning to focus
educational activities on the ``% DV/Added Sugars'' disclosure of the
Nutrition Facts label in isolation. Instead, education and outreach
will focus on a number of aspects of the label to enhance its use and
understanding by consumers.
    As for the comment stating that education efforts should be
combined with policy, systems, and food environmental changes that
support healthy dietary choices, we understand that combining the
Nutrition Facts label education efforts with other policies may be more
effective in supporting healthy dietary choices; however, many
policies, such as consumer access to or increased availability of
healthful foods, are not under our purview and are outside the scope of
this rulemaking. As part of supporting access to healthy foods, we
continue to encourage food product reformulation, such as reducing
sodium content in the food supply.
2. Comments Linking the Nutrition Facts Label to Specific Diseases
    (Comment 2) Many comments recommended mandatory declaration of
specific nutrients (e.g., phosphorous, added sugars, potassium) on the
Nutrition Facts label because, according to the comments, these
nutrients are or may be helpful to persons with an existing acute or
chronic disease (e.g., heart disease, chronic kidney disease,
diabetes). According to the comments, mandatory declaration of the
specific nutrient would be helpful for the management of specific
diseases or conditions.
    (Response) While the Nutrition Facts label information has never
been, nor is it now, targeted to individuals with acute or chronic
disease (e.g., diabetes, chronic kidney disease or cardiovascular
disease (CVD)), consumers with these types of diseases may be able to
use quantitative information on the label to follow advice they have
received from a health care professional concerning their conditions.
However, the nutrient declaration 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.
3. Use of Household Measures
    (Comment 3) Many comments recommended that the amount of total fat,
carbohydrate, sugars, added sugars, protein, and sodium be declared in
common household measurements (e.g. teaspoons) instead of or in
addition to grams (g). The comments said that the metric system has not
been widely adopted in the United States, and the average consumer is
more familiar with household measurements than with grams. The comments
also said that, if the purpose of the information on the label is to
help consumers understand the actual amount of nutrients in a food
product, the declaration of these nutrients in grams defeats the
intended purpose of the label because consumers cannot conceptualize
gram amounts. One comment suggested that we include an icon that would
allow the consumer to visualize a gram and that we could use a teaspoon
for such an icon. Another comment suggested using ounces instead of or
in addition to grams because consumers can understand this information
more easily than gram amounts. The comment also recommended stating on
the label that there are 28 grams in an ounce and 448 grams in a pound.
    (Response) We decline to require the declaration of total fat,
carbohydrate, sugars, added sugars, protein, and sodium in household
measurements or in ounces. Using a volume measure rather than a weight
measurement for total fat, carbohydrate, sugars, added sugars, and
protein would provide inaccurate information. The gram is a measure of
mass or weight while a teaspoon is a measure of volume. The

gram weight of different carbohydrates, fats, and proteins is
different. For example, a teaspoon of sucrose or table sugar weighs 4.2
grams, but a teaspoon of corn syrup weighs 7.3 grams (Ref. 4) and has
1.5 grams of water and 5.1 grams of sugar.
    Additionally, many ingredients provide multiple nutrients, so it
may not be possible for manufacturers to determine the volume
contribution that each ingredient provides towards the various
macronutrients. For example, salt is composed of sodium and chloride.
Other ingredients, such as baking soda, contain sodium. It would be
very difficult for a manufacturer to determine the volume of sodium
contributed by both salt and baking soda in a food such as a cookie.
    We also reiterate that the gram weight is a more precise
measurement. When it comes to some nutrients, particularly added sugars
and sodium, most products contain a fraction of a teaspoon.
    Additionally, dietary recommendations for total fat, total
carbohydrate, sugars, added sugars, protein, and sodium are provided in
grams and milligrams (mg) (Ref. 5). The declaration of these nutrients
in household measurements would make it more difficult for consumers to
compare the amount of the nutrient in a serving of a product to current
dietary recommendations.
    As for the comments suggesting the declaration of teaspoon amounts
in addition to grams, there is limited space available on the label,
especially for small packages and dual column labeling (see part II.Q).
Adding a teaspoon amount before or after the gram declaration of the
nutrients could make it more difficult to read the information on the
label. Therefore, we decline to allow for voluntary declaration of
household measurements of total fat, carbohydrate, sugars, added
sugars, protein, and sodium.
    Finally, with respect to declaring nutrients in ounces or pounds,
we decline to revise the rule as suggested by the comment. Many
products contain an ounce or less of food per serving. If ounces or
pounds were declared on the label for these nutrients, fractions would
have to be declared. The gram weight of a nutrient is a more precise
measurement than ounces or pounds.
4. Impact on Other Regulations
    (Comment 4) Several comments expressed concern that revision of the
RDIs would necessitate revisions to other regulations for nutrient
content claims and health claims. Several comments noted that many
products (such as juices and dairy products) that are now eligible to
make nutrient content claims for nutrients that are increasing (such as
potassium, calcium, vitamin D, and vitamin C) would no longer be able
to do so. Other comments expressed concern that standards of identity
for yogurt, milk, and cheeses might need to be updated. Other comments
noted that food additive regulations for the addition of calcium and
vitamin D to juice would need to be reevaluated; some comments
suggested that we delay finalizing the rule until we update our rules
on nutrient content claims.
    (Response) We will address, as appropriate and as time and
resources permit, the impact on our other regulations that are outside
the scope of this rulemaking in separate rulemaking actions. While we
do intend to revisit our regulations for nutrient content claims at a
later date to determine if changes are necessary, we recognize that
changes to the list of nutrients declared on the Nutrition Facts label
or the RDIs or DRVs of nutrients could affect the ability of some
products to bear certain nutrient content or health claims. We also
recognize that changes to the RDIs for calcium, for example, may impact
certain other regulations, including our food additive regulations in
Sec.  172.380 (21 CFR 172.380), where the use of vitamin D is based on
a product containing a certain percentage of the RDI for calcium.
    We also do not agree to delay finalizing this rule until we provide
any updates to our rules on nutrient content claims. The RDIs are based
on how much of a nutrient should be consumed to meet nutrient needs and
not based on eligibility to make a nutrient content claim.
    (Comment 5) One comment said we should try to finalize all the
anticipated changes to the food package labels simultaneously,
including Nutrition Facts label, a front-of package panel, and health
claims so that a consumer education program about the revised Nutrition
Facts label also could explain all changes at one time, thereby
minimizing consumer confusion and maximizing resources available for
education.
    (Response) We do not agree that the rule should be delayed until we
provide any updates to rules on health claims or any possible rule on
front of pack labeling. The pace at which each individual rulemaking
activity proceeds may be affected by our resources and other
priorities; consequently, it would be impractical to defer action on
this final rule until we complete other possible regulatory actions.
5. Consumer Research
    In the preamble to the supplemental proposed rule (80 FR 44303 at
44305 through 44306), we discussed, among other things, information on
two consumer studies (80 FR 44303), and in the Federal Register of July
27, 2015 (80 FR 44302), we reopened the comment period for the proposed
rule for inviting public comments on two additional consumer studies.
These four consumer studies, conducted in 2014 and 2015, were
randomized controlled experimental studies with English-speaking adult
consumers: (1) The Experimental Study on Consumer Responses to
Nutrition Facts Labels with Declaration of Amount of Added Sugars
(``the added sugars study''); (2) the Experimental Study on Consumer
Responses to Nutrition Facts Labels with Various Footnote Formats
(``the footnote study''); (3) the Experimental Study of Proposed
Changes to the Nutrition Facts Label Formats (``the format study'');
and (4) the Eye-tracking Experimental Study on Consumer Responses to
Modifications to the Nutrition Facts Label Outlined in the Food and
Drug Administration's Proposed Rulemaking (``the eye-tracking study'').
All study participants were adults 18 years of age or older. The
overarching purpose of these studies was to explore how and to what
extent different presentations of the label and its components (e.g.,
different formats of the entire Nutrition Facts label or different
formats of how added sugars may be declared on the label) may affect
consumer responses to the presentations. In addition, the added sugars
study was conducted to enhance our understanding of how inclusion of
added sugars declarations on the Nutrition Facts label may affect how
consumers perceive a product or a label and how to better educate
people in using the Nutrition Facts label in general. In the following
paragraphs, we briefly describe the methodology and key findings of
each study and discuss the characteristics and proper use of the study
data and findings.
    The added sugars study was a randomized, controlled, Web-based
experiment conducted in July and August of 2014 to enhance our
understanding of how inclusion of added sugars declarations on the
Nutrition Facts label may affect how consumers perceive a product or a
label and how to better educate people in using the Nutrition Facts
label in general. At the time the research was designed, we were not
aware of any previous studies of consumer responses to added sugars
information. We

engaged in this research to help inform our potential consumer
education efforts if added sugars were declared on the Nutrition Facts
label. The research design did not include a percent Daily Value for
added sugars on the food label or the ingredient listing that will
appear on packages and therefore did not provide data on how those
pieces of information would affect consumer responses to an added
sugars declaration. Nevertheless, the study achieved its intended
objectives of providing an initial understanding of potential consumer
reactions to added sugars declarations on Nutrition Facts labels.
    Participants (n = 6,480) self-administered the study on their own
computers and were randomly assigned to view mock-ups of one of three
formats of the current Nutrition Facts label: (1) The ``Added Sugars''
format, in which an added sugars declaration was indented below a
``Sugars'' declaration; (2) the ``Total Sugars + Added Sugars'' format,
in which an added sugars declaration was indented below a ``Total
Sugars'' declaration; and (3) the ``Current'' format, in which
``Sugars,'' but not added sugars, was declared on the label. While
viewing their assigned label images, participants answered questions on
their ability to recognize and compare nutrient amounts on the
Nutrition Facts label and their judgments about the foods' overall
healthfulness and relative nutrient levels. The Nutrition Facts label
images were accompanied by a product identity caption (e.g., ``Frozen
Meal'' or ``Cereal''), but no front panel or brand name, either
fictitious or real. The study was designed as a controlled experimental
study that employed random assignment in order to establish causal
relationships between test conditions and consumer responses. Because
the study was not intended to generate population estimates,
participants were selected from members of an online consumer panel in
the United States. To recruit a diverse study sample, quotas were
constructed with the aim of making the sample's distributions of age,
gender, education, race/ethnicity, and census region resemble that of
the U.S. population as closely as possible.
    The added sugars study found that, while added sugars declarations
increased the ability of some participants to identify those products
with less added sugars and to determine the quantity of added sugar in
a food, the declarations decreased the ability of some participants to
correctly identify the quantity of total sugars in a food. The ``Total
Sugars + Added Sugars'' format appeared to help participants better
comprehend the total amount of sugars in a food than the ``Added
Sugars'' format. More details about the study methodology, tested label
formats, and results can be found in an Administrative File entitled
``Experimental Study on Consumer Responses to Nutrition Facts Labels
with Declaration of Amount of Added Sugars (OMB No. 0910-0764)''
(Docket FDA-2012-N-1210).
    The footnote study was a randomized, controlled, Web-based
experiment conducted concurrently with the added sugars study. The
footnote study included 3,866 participants who were different
participants from those in the added sugars study but selected from the
same online consumer panel using the same sampling methodology as that
used in the added sugars study. The purpose of the footnote study was
to explore consumer responses to various formats for the footnote area
of the Nutrition Facts label, including those that provide information
such as various definitions for percent Daily Value, a succinct
statement about daily caloric intake, and general guidelines for high
and low nutrient levels. Participants self-administered the study on
their own computers and were randomly assigned to view a mock-up of one
of seven Nutrition Facts label formats. Five of these Nutrition Facts
formats included modified footnotes; one included the current footnote,
and one included no footnote at all. The footnotes displayed variations
of information such as a description of percent Daily Value, a succinct
statement about daily caloric intake, or a general guideline for
interpreting percent Daily Values, or noted nutrients whose daily
intake should be limited. While viewing a label, participants answered
questions about their judgments of the foods' overall healthfulness and
levels of vitamin A, vitamin C, dietary fiber, fat, and sodium. After
rating the product's nutritional attributes, participants who viewed
labels that included one of the five modified footnotes or the current
footnote were asked to rate the footnote statement's understandability,
usefulness, believability, and helpfulness for the following dietary
tasks: Comparing products, planning a healthy diet, determining the
healthfulness of a food, and deciding how much of a food to eat.
    The footnote study found that all five footnote options produced
similar perceptions and judgments relative to the current footnote and
the no-footnote control. Nevertheless, all five modified footnotes were
rated as easier to understand than the current footnote. Footnote 1 was
perceived to be more believable than the current footnote. Footnote 1
stated the following: ``2,000 calories a day is used for general
nutrition advice. * The % Daily Value tells you how much a nutrient in
a serving of food contributes to a daily diet.'' More details about the
study methodology, tested label formats, and results can be found in an
Administrative File entitled ``Experimental Study on Consumer Responses
to Nutrition Facts Labels with Various Footnote Formats (OMB No. 0910-
0764)'' (Docket FDA-2012-N-1210).
    The format study was a Web-based study conducted in February-March,
2015, to explore consumer responses to: (1) Three different formats of
the Nutrition Facts label (the Current format, the Proposed format, and
the Alternative format discussed in the proposed rule) (80 FR 11879),
with each format embodying all current label elements or most of the
potential changes to them as outlined in the proposed rule (e.g., the
prominence of the calorie declaration, the position of the percent
Daily Value column); (2) the location of the percent Daily Value column
(right or left side of the label); (3) column type (single-column,
dual-column, and dual-calorie); (4) location of sodium declaration on
the Proposed single column label; and (5) the declaration of voluntary
vitamins and fats (voluntary vitamins, voluntary fats, and both
vitamins and fats). A total of 5,430 consumers participated in the
format study; they were recruited from the same online consumer panel
with the same sampling methodology as in the added sugars and the
footnote studies. As in the added sugars study and the footnote study,
participants were randomly assigned to view different Nutrition Facts
label mock-ups and answer questions about their: (1) Perceptions of the
healthfulness and levels of nutrients of a product; (2) identification
of which product in a pair of products was considered healthier; (3)
accuracy of identifying the amount of nutrients per serving and per
container and number of servings per container; and (4) perceptions of
the understandability, usefulness, believability, and helpfulness of
the label for various dietary tasks such as comparing products and
deciding how much of a food to eat.
    We did not find many significant or consistent effects of these
label variations on the answers to the questions we asked. However,
there were some notable and statistically significant differences when
comparing

the current, single-column Nutrition Facts label with the % DV on the
right (the ``Current label''), the single-column Nutrition Facts label
with the % DV on the left (which we had proposed (the ``Proposed
label'')), and an alternative, single-column label with the % DV on the
left (the ``Alternative label''). Respondents were more accurate in
identifying the grams of saturated fat and the % DV for sodium using
the single-column Proposed label (% DV left) compared to the single-
column Current label (% DV right). Respondents were more accurate in
identifying the grams of sugars per serving using the single-column
Current label (% DV right) compared to the single-column Proposed (% DV
left) or single-column Alternative label (% DV left), and they were
more accurate in identifying the grams of sugars per container using
the single-column Current label (% DV right) compared to the single-
column Proposed label (% DV left). Finally, respondents were more
accurate in identifying the grams of added sugars with the single-
column Proposed label (% DV left) as compared to the single-column
Alternative label (% DV left) (respondents assigned to view the Current
label were not asked this question). Among the Proposed labels with %
DV on the left (single-column, dual-column, and dual-calorie), we found
that dual-column labeling significantly improved respondents' ability
to identify the amount of nutrients in the entire container. More
details about the study methodology and results can be found in an
Administrative File entitled ``Experimental study of proposed changes
to the Nutrition Facts label formats (OMB No. 0910-0774)'' (Docket FDA-
2012-N-1210).
    The eye-tracking study, conducted in January-March, 2015, was to
explore whether and to what extent most of the potential label changes
as outlined in the proposed rule (80 FR 11879), in their totality, may
increase consumer attention to various label elements (e.g., calories,
number of servings) and lessen consumer effort in searching for
specific label information. In addition, the eye-tracking study
explored how the difference in the location of the percent Daily Value
column may cause any changes in consumer attention to various label
elements. A total of 160 English-speaking adult consumers in four
cities (Washington, DC, Chicago, IL, Boston, MA, and San Francisco, CA)
participated in the eye-tracking study. They were recruited by
telephone and the sample was composed of some degree of diversity in
socio-demographic characteristics and experience with the Nutrition
Facts label. Due to an unexpected issue during recruiting, the eye-
tracking study did not include any participants who were 35 years of
age or younger. We asked study participants to come to a central
location in each city to view mock-ups of three label formats (the
Current format, the Proposed format and the Alternative format) (80 FR
11879) on a computer screen, recorded participants' eye-movement data
to examine and compare the degree of attention paid to some of the
possible label changes and the level of effort participants used to
perform three categories of task (browsing a label, searching for
specific information on a label such as the amount of sodium per
serving in a product, and identifying which of a pair of products they
would choose for a given purpose such as if they were to buy a
healthier product for themselves). Labels used in this study were
borrowed or adapted from the format study.
    The eye-tracking study showed few statistically significant
differences between the Current and the Proposed formats or between
their variants. Among these differences, no one single format or
variant consistently stood out as the ``best'' format in terms of
degree of participant attention to label information, level of effort
in using label information, or accuracy of information search or
dietary choices. Many of the format differences pertained to two
specific label components: (1) Sodium, carbohydrate, and protein; and
(2) vitamins and minerals. There was little evidence that the Proposed
format led participants to re-allocate their attention to or effort
spent on different label components while browsing a label or making
the dietary choices. More details about the study methodology and
results can be found in an Administrative File entitled ``Eye-tracking
experimental study on consumer responses to modifications to the
Nutrition Facts label outlined in the Food and Drug Administration's
proposed rulemaking (OMB No. 0910-0774)'' (Docket FDA-2012-N-1210).
    For all four studies, we employed a randomized controlled
experimental approach. According to the Office of Management and Budget
(OMB), when Federal Agency research questions involve trying to
determine whether there is a causal relationship between two variables
or whether a program caused a change for participants, the Agency will
need to employ an experimental or quasi-experimental design (rather
than other approaches such as population surveys) to demonstrate how
the study design will allow the Agency to determine causality (Ref. 6).
    We chose to conduct the added sugars, the footnote, and the format
studies using a Web-based approach with mock-ups of the Nutrition Facts
label and footnote. The Web-based approach is quicker in administration
and data collection and more efficient in including participants from
many different parts of the country than other modes of data collection
such as in-person interviews. The approach also reduces administrative
errors in terms of assignment of labels for different participants. We
used mock-ups of the label and footnote rather than real food packages
because the approach helps the studies accomplish their goal of
exploring consumer responses to differences in the presentation of the
label rather than of a food package, which includes other components
such as the front panel, the ingredient list, and imageries. The
presence of these other label elements can weaken a study's ability to
obtain key information on the label and the footnote to answer its
research questions.
    All studies used non-probability samples recruited from either
members of the public at selected geographic locations with a certain
degree of diversity in sociodemographic characteristics (i.e., age,
gender, education, race/ethnicity), as in the eye-tracking study, or
members of a commercial online consumer panel with the sample's
sociodemographic characteristics matched to that of the general
population, as in the added sugars, the footnote, and the format
studies; in all these cases, an individual's probability of being
selected into a sample was unknown. In particular, the online panel
recruitment methodology was based on the opt-in approach, a non-
probability sampling technique. In contrast to probability sampling in
which every individual has some chance of being selected to participate
in a study, not all individuals have some chances of being selected in
a study. To ensure representativeness of selected participants of the
population, it is necessary that everyone has a known probability and
that no one is left out (Ref. 7). In addition, according to OMB's
Guidance on Agency Survey and Statistical Information Collections, for
the purpose of making estimates with measurable sampling error that
represent a population, the sample must be selected using probability
methods, where a subset of the population is chosen randomly such that
each unit has a known nonzero probability of

selection (Ref. 6). Therefore, none of the studies could provide
nationally representative population estimates of consumer
understanding, behaviors, or perceptions, nor could their data be
considered nationally representative.
    The samples of our studies were not selected using a probability
sampling method and the samples came from consumers in selected
locations or an opt-in online consumer panel. Therefore, based on the
AAPOR and OMB guidelines, we do not consider the findings of any of the
four studies projectable to the general population.
    The overarching purpose of our research was to explore how and to
what extent different presentations of the label and its components may
affect consumer responses to the presentations. The added sugars study
also was conducted to enhance our understanding of how inclusion of
added sugars declarations on the Nutrition Facts label may affect how
consumers perceive a product or a label and how to better educate
people in using the Nutrition Facts label in general. We did not aim to
use these studies to help us develop a label that will be understood by
all consumers. We recognize that, regardless of how well a label is
designed, there is always a certain proportion of consumers who
encounter challenges in understanding and using the label.
    In the Federal Register of July 27, 2015 (80 FR 44302), we added a
description and our findings of these four studies to the
administrative record, and we reopened the comment period for the sole
purpose of inviting public comments on the eye-tracking and the format
studies. We also published a supplemental proposed rule that discussed,
among other things, information on the added sugars and the footnote
studies (80 FR 44303). In response, many comments discussed our
studies' findings, methodologies, and implications. Some comments
provided new consumer research information related to issues examined
in our studies, particularly the added sugars declaration. To the
extent that the comments pertained to general issues involving our
study results and methodologies, we address them here. We respond to
comments related to research implications that are specific to the
added sugars declaration or to format issues, such as the footnote,
elsewhere in this document (see, e.g., part II.H.3, ``Added Sugars,''
and part II.Q, ``Format'').
    (Comment 6) While many comments referred to our research findings
as part of the evidence used to support their positions, some comments
suggested that we conduct additional consumer research on selected
changes outlined in the proposed rule. The comments felt further
research is needed because it is difficult to examine the effects of
individual proposed changes based on our studies.
    (Response) One of our missions is to assist in providing the public
with the accurate, science-based information it needs to use medicines
and foods to maintain and improve health (Ref. 8). The objective of the
Nutrition Facts label is to provide nutrition information about
products to help consumers in maintaining healthy dietary practices.
Therefore, as part of our continuing effort to enable consumers to make
informed dietary choices and construct healthful diets, we intend to,
subject to program priorities and resource availability, conduct more
consumer research to help enhance the usefulness and understandability
of the label.
    In the format and the eye-tracking experimental studies, we chose
to examine the combined effects of most of the changes outlined in the
proposed rule, in totality. Nevertheless, in both studies, we also
examined selected individual changes where we thought original consumer
research would be helpful. For example, we were interested in the
effect of the location of the percent Daily Value (left or right)
independent of other format elements and therefore studied that change
on all three label formats (Current, Proposed, and Alternative) (in
both the format and the eye-tracking studies). We also were interested
in the effect of column type (single-column, dual-column, and dual-
calorie) independent of other label format changes and therefore
studied that on all three label formats (in the format study). We also
were interested in some other possible label format changes and
therefore chose to study the effects of moving the location of sodium
declaration on the Proposed single column label (in the format study),
as well as the declaration of voluntary vitamins and fats (voluntary
vitamins, voluntary fats, and both vitamins and fats) (in both the
format and the eye-tracking studies). We believed the original consumer
research on these topics was more useful than on other topics.
Therefore, we took a hybrid approach of studying the differences
between the Current, Proposed, and Alternative formats in totality and
as well as in isolation for selected individual changes.
    (Comment 7) Some comments questioned whether participants in our
studies generally or as assigned in individual conditions were
representative of the consumers in the nation. The comments stated that
such representativeness was important for assessing the effects of the
proposed label format changes on consumer understanding and use of the
label. In particular, the comments were concerned that the lack of such
representativeness, for example, the absence of participants 35 years
of age and younger in the eye-tracking study, would render results
imprecise or misleading. Some comments also encouraged us to obtain
nationally representative samples of the population for future consumer
research studies.
    (Response) While we recognize that our study samples are not
nationally representative, we disagree that the use of such samples
would render our findings imprecise or misleading. The purpose of our
studies was to investigate and compare how different presentations of
label information may cause different responses by consumers. In other
words, we sought to understand the causal relationships between the
label presentations and consumer response rather than develop
nationally representative estimates of the prevalence or extent of
various responses. Therefore, our primary consideration in the study
design was internal validity (i.e., the validity of the causal
relationships) rather than external validity (i.e., the extent that the
results can be generalized to the population or to presentations other
than those studied). Even though we focused on internal validity, we
recognized that, to make the study findings more robust, it was
important that the studies included participants from different
segments of the population in terms of education, gender, race/
ethnicity, and geographic regions. Moreover, the causal relationships
we examined were not necessarily particular to certain segments of the
population, and our samples included consumers with a wide range of
label reading and use practices.
    We doubt the absence of study participants aged 35 years and under
in the eye-tracking study, which was due to an unexpected issue in
recruiting participants from this segment, would have led us to reach
noticeably different conclusions about the label formats. While all of
the eye-tracking participants were over age 35, they were diverse in
many other important factors that the literature suggests may be
related to label viewing and use, such as gender, education, race/
ethnicity, label reading practices, attitudes toward the label, and
nutritional interest (Refs. 9-11).

    (Comment 8) One comment said that the use of terms such as
``healthy'' and ``healthier'' in our studies represented a misuse of a
defined nutrient content claim. The comment also noted that consumers
have different interpretations of the term ``healthy'' and that these
interpretations may be based on considerations that are different from
those defined for the claim ``healthy'' in FDA regulations. In
addition, the comment said that the use of the term ``healthy'' in the
eye-tracking study was a cue to participants that there is a correct
answer and the criterion was ``healthy.''
    (Response) In the consumer studies we conducted for informing this
rulemaking, research participants were presented with and asked to
respond to a Nutrition Facts label. Neither the front panel of a
package nor the ingredient list was provided to participants. In our
studies, the questions that asked participants to assess products'
healthfulness served as one type of measure of potential consumer
reactions to the tested Nutrition Facts label formats and content
modifications. These questions were not connected to the regulatory
meaning of a ``healthy'' claim, which usually appears on the front
panel of a package, and we disagree that the healthfulness questions in
our studies reflect ``a misuse,'' as asserted in the comments, which
mischaracterize the purpose of the healthfulness questions in the
studies we conducted.
    We agree, in part, and disagree, in part, that the use of the term
``healthy'' in the eye-tracking study was a cue to participants that
there was a correct answer and the criterion was ``healthy.'' We agree
that this term was used in the study to prompt participants to use
``healthy'' as the criterion in deciding their response to the task of
choosing which of two products they thought was healthier for
themselves. The primary purpose of this design was to examine whether
and how different label presentations would lead to differences in
participant attention to various parts of a label if participants were
considering a healthy dietary choice. The accuracy of choice was of
less interest in this design. In addition, one of the products
presented to the participants always had lower content of calories,
total fat, saturated fat, sodium and sugars than the other, so the
``correct'' choice was unambiguous. Therefore, we do not believe that
the study design would have biased the answers participants gave in
this task.
    (Comment 9) One comment suggested that we conduct studies that are
not electronically based so that we may have more reliable data that
can contribute to a more successful solution.
    (Response) The comment did not explain why data collected non-
electronically are more reliable than data collected electronically. We
believe the Web-based approach is appropriate for the purposes of our
studies. Furthermore, the comment did not assert that our study results
were necessarily flawed because we collected data electronically.
    (Comment 10) One comment asked us to clarify a conclusion reported
in the preamble to the supplemental proposed rule that when
participants viewing Nutrition Facts labels without added sugars
declarations could not accurately determine the amount of added sugars
in the products and that many participants who viewed Nutrition Facts
labels without added sugars declarations assumed that the more
nutritious products in the study had less added sugars (80 FR 44303 at
44306). The comment asked us to clarify the preceding statement because
it further noted that another document, namely, ``Experimental Study of
Proposed Changes to the Nutrition Facts Label Formats,'' stated that
``respondents assigned to view the Current label were not asked to
identify the grams of added sugars.'' The comment questioned how we
were able to arrive at the conclusion referenced in the supplemental
proposed rule, reasoning that the two statements appear contradictory,
as participants in the format study who viewed the Current label were
not asked questions regarding the amount of added sugars.
    (Response) The two statements are not contradictory because the two
statements refer to different studies. Due to the different purposes of
the studies, the format study did not ask participants who were
assigned to the Current label about the amount of added sugars, whereas
the added sugars study did. We used results from the added sugars
study, rather than findings from the format study, to arrive at the
conclusion stated in the supplemental proposed rule.
    (Comment 11) One comment asked if we balanced the sample for
demographic characteristics in the added sugars and format studies.
    (Response) In the added sugars and format studies, we did balance
our samples on key demographic characteristics. We selected our samples
by matching their key demographic characteristics (i.e., age, gender,
education, race/ethnicity, and census region) to that of the U.S.
population.
    (Comment 12) Some comments said that the order in which we assigned
label formats to participants in the eye-tracking study could have
affected the participants' responses. The comments attributed the
concern to the design that showed all participants the Current label in
the first set of tasks and showed the Proposed or Alternative labels
randomly in the second set of tasks, rather than showing the three
labels to three randomly assigned groups of participants in one set of
tasks. The comments further stated that the design choice was not
explained.
    (Response) We acknowledge that the design could potentially have
yielded different results than a design that randomly assigned
participants to the three formats. We chose our design because the
Current Nutrition Facts label has been on products for approximately 20
years and most, if not all, consumers have had exposure to or used the
label. Consumers have likely developed their own patterns of reading
and use of the Current label. Furthermore, the objective of the study
was to explore whether and how much the two label formats outlined in
the proposed rule would help raise consumer attention to certain label
elements and reduce reading efforts. The design we chose recognized
that participants would carry their own patterns of reading and using
the Current label into tasks based on the Proposed and the Alternative
labels. To the extent that the patterns could have varied between
participants, each participant's responses to the Current label in the
first set of tasks was used as her/his own baseline when we examined
the responses to the Proposed or the Alternative labels in the second
set of tasks. This approach, in turn, could minimize the within-subject
differences between study participants and help reveal the true
differential effects of label format on attention and efforts.
Correspondingly, we applied the difference-in-difference analysis for
this purpose. Therefore, although our design could have produced
different results than a design that randomly assigned participants to
the three label formats, we believe our design is appropriate under the
particular circumstances.
    (Comment 13) One comment said that the sample size of the eye-
tracking study was too small to produce reliable empirical evidence.
The comment also said that, despite the study's claim that the sample
represented a wide variety of demographics, the claim is misleading
because the South and Midwest regions were not included and 69 percent
of the sample had a college or advanced degree.
    (Response) We disagree with the comment. Our sample size
calculations

suggested that the numbers of participants included in various
statistical tests were sufficient to achieve the conventional degree of
statistical power of at least a medium effect size for the non-
parametric analyses we conducted. This is particularly true in terms of
key outcome measures during label browsing (proportion of participants
who noticed a label component at least once, length of time it took
participants to notice a label component for the first time, proportion
of total label viewing time spent on a label component, proportion of
total number of notices spent on a label component), during information
search (proportion of participants who identified target information,
length of time it took participants to find target information, number
of notices of target information before it was found), and during
product identification (length of time it took participants to enter a
choice, proportion of participants who selected a given label,
proportion of participants who noticed a label component at least once
on either of a pair of labels, proportion of total number of notices
spent on a label component, and proportion of total label viewing time
spent on a label component). Additionally, as shown in the study
report, the participants varied in education attained, gender, race/
ethnicity, and geographic locations. Thus, contrary to what the comment
said, the sample did include a wide variety of demographics.
    (Comment 14) Some comments questioned certain design aspects of how
the format experimental study tested the different Nutrition Facts
label formats. In particular, some comments said that the overall study
design was complex and that 29 labels were too many to test at once and
recommended a simpler design. One comment said that questions related
to calories per serving and number of servings were comparatively less
important because they appeared later in the questionnaire. In
addition, the comment asked why the subjective numeracy questions,
which asked participants to self-rate their aptitude for working with
fractions and percentages, appeared at the beginning of the
questionnaire.
    Other comments questioned why certain topics were not included as
part of the questionnaire. For example, one comment noted that,
although the term ``% DV'' was used in place of ``% Daily Value'' in
the Proposed and Alternative label formats, there were no questions
specific to this change in the study. The comment also asked why there
were not more direct questions about serving size. In addition, one
comment said that the study report did not include respondents'
perceptions of each label's ``helpfulness.''
    (Response) The main purpose of the format study was to compare
consumer use and understanding of Current, Proposed, and Alternative
label formats (in their totality). Additionally, the study was designed
to test the effects of the location of Percent Daily Value, column type
(single- vs. dual-column vs. dual-calorie), location of sodium
declaration on the Proposed single-column label, and declaration of
voluntary vitamins and fats on the Proposed label. Given the priorities
chosen, we carefully designed the study, including the necessary number
of test labels, to ensure that the study could provide adequate
statistical power to test hypotheses related to the priority topics.
Thus, the overall study design and number of labels were appropriate.
    Moreover, we disagree with the comment stating the questions about
calories per serving and number of servings appeared later in the
questionnaire and were less important. These questions appeared in the
first half of the questionnaire. In addition, with respect to the
comment on the order of questions related to subjective numeracy, we
conducted the cognitive interviews with the subjective numeracy
questions at the beginning of the study and found that the overall flow
of the questionnaire was working well. We did not use these questions
to screen participants in or out of the study.
    With respect to comments related to questions not included in the
format study, we narrowed our questions to the purpose of the study.
For example, although we did not include specific questions to assess
consumer understanding of the terms ``% DV'' and ``% Daily Value, '' we
assessed the effects of the location of Percent Daily Value through a
question that used the definition of % Daily Value as part of the
question. Specifically, we included a question asking respondents the
percentage of sodium for the day in a serving of a product to see how
the labels compared in helping respondents find the % Daily Value. In
addition, the focus of this study was not on consumer use and
understanding of the meaning of serving size and therefore did not
include a specific question about it. Instead, we focused on how the
label formats affected consumers': (1) Perceptions of the healthfulness
and levels of nutrients of a product; (2) identification of which
product in a pair of products was considered healthier; (3) accuracy of
identifying the amount of nutrients per serving and per container and
number of servings per container; and (4) perceptions of the
understandability, usefulness, believability, and helpfulness of the
label for various dietary tasks such as comparing products and deciding
how much of a food to eat.
    Lastly, we disagree with the comment that we did not report on
respondents' perceptions of label ``helpfulness.'' We reported on
respondents' perceptions of ``helpfulness'' for each set of label
comparisons in the ``Label preference'' rating.
    (Comment 15) Some comments asked us to conduct additional analyses
with the format experimental study on the Nutrition Facts label formats
data. Some comments requested that we provide an analysis specifically
comparing the single-column Current label format to the dual-column
Proposed label format. Another comment asked us to provide the results
related the effect of adding absolute values to the vitamins and
minerals as was found on the Proposed and Alternative labels. One
comment asked why we did not include an analysis of the number of
servings per container.
    (Response) In the notice on Food Labeling: Revision of the
Nutrition and Supplement Facts Labels; Reopening of the Comment Period
as to Specific Documents (80 FR 44302), we reported on the results of
our consumer study ``Experimental Study of Proposed Changes to the
Nutrition Facts Label Formats'' related to key aspects of the changes
we proposed to the format of the nutrition label. The comparisons
suggested by the comments could be made through additional analyses of
the data we collected. While we reported the effects of the format
types within the same column type and the column-type within the same
format type, we did not report the comparison between the Current
single-column format and Proposed dual-column format. Such an analysis
would not have provided us with information on the differences in
formats in which we were most interested. However, for our own
interest, we have since conducted that analysis and the results do not
provide any new information related to our consideration of the format
of the nutrition label. The results of this analysis seem to
corroborate our main finding related to the effects of dual-column
labeling compared to single-column labeling as described in table 7 of
our June 30, 2015 memo to the file (Ref. 12). As reported in that memo,
the Proposed dual-column label (% DV left) scored higher than the
Proposed single-column label (% DV left) on the Total correct per
container measure.

Similarly, in the new comparison, the Proposed dual-column label (% DV
left) scored higher than the Current single-column label (% DV right)
on that same measure. The new comparison demonstrates that the Proposed
dual-column (% DV left) also scored higher on the Total Correct per
serving measure than the Current single-column (% DV right) label.
    In addition, the purpose of our evaluation of consumer views about
how high or low the product is in a vitamin or mineral when absolute
values were provided, compared to a label without this information, was
to understand how some consumers perceive different numbers associated
with various units of measure. In response to the comment on our
findings on absolute amounts, we did complete a review of that aspect
of the data, and the results do not provide any new information related
to our consideration of the declaration of absolute amounts for some or
all nutrients (Ref. 13)). The study did not address how consumers use
or understand absolute amounts for following dietary advice.
Participants who viewed the different label conditions were asked to
rate on a 5-point scale (1 = none or very little; 5 = a lot) how much
of various nutrients they thought were in one serving of the product.
Because the questions asked participants to offer their subjective
perception, rather than report the absolute amount for a nutrient, no
rating offered could be judged as correct or incorrect. Instead, the
ratings simply provided information about how pairing the correct
absolute nutrient amount with the correct % DV affected participants'
perceptions.
    Further analysis found that there was no difference in correctly
identifying the number of servings per container between the single-
column labels, the dual-column labels, or between the Current single-
column (% DV right), and the Proposed dual-column (% DV left) (Ref.
13). Thus, none of these formats had any influence on how participants
identified the number of servings per container, and therefore, did not
provide any new information related to our consideration of the
servings per container.
    (Comment 16) One comment mentioned an eye-tracking study that the
comment did to examine and compare participants' attention to the
Nutrition Facts label either in its current format or in the proposed
format. The comment stated that the study did not find significant
differences between the two formats either in attention to the label in
its totality or in terms of the vitamins and mineral section nor in
healthful food choices made. The comment also stated that moving the
percent Daily Value column to the left side of the label reduced
participants' attention to the percent Daily Value information. In
addition, the comment suggested that more noticeable changes to the
label format, such as using traffic light colors, or descriptors, such
as ``high'' or ``low,'' may have a greater impact on attention and
choice than the changes we proposed.
    (Response) We decline to comment on the findings because the
comment did not provide sufficient details about how the study was
designed and analyzed.
    As for other possible changes of the label that the comment
speculated might affect consumer attention and food choices, e.g.,
traffic light colors or text descriptors, such issues are outside of
the scope of this rulemaking.
    (Comment 17) One comment said that FDA's added sugars study seemed
to be unduly focused on whether consumers could correctly identify
added sugars and how identification of added sugars affected overall
judgment of the product. The comment also stated that the study design
steered participants to think specifically about added sugars
throughout the survey, potentially leading them to judge the labels on
the amount of added sugars.
    (Response) We disagree that the design of the added sugars study
unduly emphasized, or otherwise steered participants to focus on, added
sugars beyond a level necessary to meet the key objectives of the
study. A primary focus of FDA's added sugars study was to explore
participants' understanding of Nutrition Facts labels that include
added sugars declarations relative to participants' understanding of
Nutrition Facts labels that do not include added sugars declarations.
Although the primary objectives of the study pertained to added sugars
declarations, we used a variety of measures to assess a range of
participant reactions to the different labels. For example, we asked
participants to evaluate foods' overall healthfulness as well as the
levels of various nutrients such as saturated fat, sodium, dietary
fiber, and others, in addition to added sugars.
    (Comment 18) One comment noted that the added sugars study varied
the experimental conditions in an unbalanced way, making it difficult
to make inferences about the experimental conditions. The comment also
said that we did not keep the caloric value consistent across products
and, therefore, did not isolate the effect of the added sugars
declarations separately from the effect of calories. The comment also
noted that, in Appendix A of the FDA study report about the results of
the added sugars study (Ref. 14), the ``most nutritious'' frozen meal
had more calories, sodium, fat, and saturated fat, and lower iron and
vitamin C than the ``least nutritious'' frozen meal.
    (Response) Because the comment does not specify what was
``unbalanced'' in the experimental conditions and what specific
inferences were therefore precluded, we do not have sufficient
information to respond to this comment. We disagree that the study did
not isolate the effect of added sugars declarations separately from the
effect of calories because that is in fact what the experimental design
achieved. In other words, by randomly assigning participants to
different experimental conditions, we were able to compare participant
responses in experimental conditions that were treated identically in
all respects other than the display of added sugars information, thus
isolating the effect of added sugars declarations from the effect of
other experimental factors, such as calorie information.
    Regarding Appendix A of the FDA study report (Ref. 14), there was a
typographic error on the nutrition profiles for the frozen meals. Meal
1 should have been labeled the ``least nutritious,'' whereas Meal 3
should have been labeled the ``most nutritious.'' This typographic
error, however, did not in any way affect the rest of the study
description or reported findings.
    (Comment 19) One comment noted that in table 8 of the added sugars
study report (Ref. 14), the mean ``usefulness'' score for those viewing
the control format was 3.93, whereas the mean ``usefulness'' score for
those viewing the added sugars declaration format was 3.97. The comment
stated that the report noted a significant difference between these
scores and requested clarification.
    (Response) The comment is incorrect. The report indicated that
there was no statistically significant difference between the two means
in question.
    (Comment 20) One comment stated that the voluntary responses from
study participants during the debriefing phase of the eye-tracking
study showed that consumers had difficulties using the Current label
and did not understand terms such as saturated fat and trans fat.
    (Response) We disagree that the indicated responses showed that
consumers have difficulties using the Current label and do not
understand terms such as saturated fat and trans fat. The comment did
not interpret this finding in context. The full statement in our study
report is ``When asked, most participants did not report having
difficulties using the Current format as

long as they knew what to look for on the label (table 25) (Ref. 15).
Some, however, mentioned that they did not understand some of the
information on the label, such as fats and trans fat, or had problems
with the small font size of the information'' (eye-tracking study memo
in the re-opener, July 27, 2015, p. 25). Contrary to the comment, the
report states that most of the study participants did not have
difficulties using the Current label, and only some said they did not
understand fats and trans fat.

C. Comments on Legal Issues

    Several comments addressed legal issues. Some comments asserted
that FDA cannot compel an added sugars declaration in nutrition
labeling under the First Amendment. We also received comments that
questioned whether our proposed requirement for an added sugars
declaration and certain other proposed requirements are consistent with
the requirements in the Administrative Procedure Act (APA) and our
authority under the FD&C Act. In addition, we received comments
questioning our authority to require and access records related to the
declarations for added sugars, dietary fiber, soluble fiber, insoluble
fiber, vitamin E, and folate/folic acid. Other comments raised
miscellaneous legal issues.
1. First Amendment
    Many comments on the proposed requirement to include an added
sugars declaration on food labels related to our ability to compel such
speech under the First Amendment. Some comments supported our proposed
requirement for the declaration of added sugars as factual,
uncontroversial information, based on the application of the First
Amendment test set forth in Zauderer v. Office of Disciplinary Counsel
of Supreme Court, 471 U.S. 626 (1985). Most comments raising First
Amendment arguments did not support the proposed declaration, but
differed in their assertion of the applicable First Amendment test.
Many comments asserted that the proposed declaration did not satisfy
the Zauderer test, while other asserted that it failed under the test
set forth in Central Hudson Gas & Electric Corp. v. Public Service
Comm'n, 447 U.S. 557 (1980). Still others asserted that the proposed
declaration was subject to, and failed to satisfy, strict scrutiny
review.
    (Comment 21) Some comments said the added sugars declaration is not
subject to the test in Zauderer, or, even if subject, does not meet
such test. Specifically, one comment stated that Zauderer does not
apply to misleading statements or statements that are subject to
misinterpretation. Other comments said that because there is already a
declaration for total sugars and there is no material difference, or
scientific rationale, for distinguishing between added and intrinsic
sugars, including no ``sufficient nexus to consumer health,'' the
declaration of added sugars is not purely factual and uncontroversial
information for which the First Amendment test in Zauderer would apply.
One comment stated that because added sugars are not chemically
distinct from natural sugars and do not have different health effects,
the declaration of added sugars would be false and misleading and the
Agency could not compel it under the First Amendment. Several comments
stated there are no physiological distinctions between added and
naturally occurring sugars, and therefore, no connection to consumer
health on which to compel such speech.
    (Response) The disclosure of added sugars is factually accurate
nutrition information and industry's interest in not disclosing such
factual information is minimal. In Zauderer, the Supreme Court
explained that ``[b]ecause the extension of First Amendment protection
to commercial speech is justified principally by the value to consumers
of the information such speech provides, [a speaker's] constitutionally
protected interest in not providing any particular factual information
in his advertising is minimal'' (see 471 U.S. at 651 (internal
citations omitted)). Providing consumers the amount of added sugars in
a serving of food ``does not offend the core First Amendment values of
promoting efficient exchange of information'' and ``furthers, rather
than hinders, the First Amendment goal of the discovery of the truth
and contributes to the efficiency of the `marketplace of ideas' ''
(Nat'l Elec. Mfrs. Ass'n v. Sorrell, 272 F.3d 104, 113 through 114 (2d
Cir. 2001). As a result, government requirements to disclose factual
commercial speech are subject to a more lenient constitutional standard
than that set forth under the Central Hudson framework (Zauderer, 471
U.S. at 651). Under Zauderer, the government can require disclosure of
factual information in the realm of commercial speech as long as the
disclosure provides accurate, factual information; is not unjustified
or unduly burdensome; and ``reasonably relate[s]'' to a government
interest (id.).
    The required added sugars declaration readily satisfies the
Zauderer test. First, the declaration of added sugars, which is being
finalized in this rule, provides accurate disclosures of factual
commercial information about the amount of added sugars contained in a
food. The required disclosure requires only facts about the product
(Am. Meat Inst. v. United States, 760 F.3d 18 (D.C. Cir. 2014)
(``country-of-origin labeling qualifies as factual, and the facts
conveyed are directly informative of intrinsic characteristics of the
product AMI is selling'')). This required labeling will help facilitate
the free flow of commercial information by providing a declaration of
added sugars on food labels, and does not ``prescribe what shall be
orthodox in politics, nationalism, religion, or other matters of
opinion'' (Zauderer, 471 U.S. at 651 (quoting W. Va. State Bd. of Educ.
v. Barnette, 319 U.S. 624, 642 (1943))).
    As for the comments stating that there is no material difference or
scientific rationale for distinguishing between total sugars and added
sugars, or between added sugars and naturally occurring sugars, these
comments relate to our rationale for why an added sugars declaration
will assist consumers to maintain healthy dietary practices and not to
whether the declaration is factual and accurate information. We address
these comments in part II.H.3.i. The added sugars declaration conveys
factual and accurate information about the amount of added sugars in a
serving of food.
    Second, the required added sugars declaration is not unduly
burdensome. Factual nutrition information for a number of other
nutrients is currently required to be provided on packaged foods. The
space that is occupied by the indented line for the ``Includes `XX' g
Added Sugars'' declaration, below the ``Total Sugars'' declaration does
not increase the size of the existing Nutrition or Supplement Facts
label, given changes made elsewhere to the label, such as reducing the
size of the footnote in the label. We also note that, as discussed in
our economic analysis (Ref. 16), the cost to manufacturers is reduced
from that in the proposed rule under the compliance timelines in the
final rule which will allow most manufacturers to make revisions to the
label during regularly scheduled label changes for their products.
    Third, the required added sugars declaration is reasonably related
to our government interests in promoting the public health, preventing
misleading labeling, and providing information to consumers to assist
them in maintaining healthy dietary practices, and thus amply satisfies
the remaining element of the Zauderer test. Providing consumers with
information about the added sugars content of food would promote the

public health by ensuring they have information to assist them in
meeting nutrient needs within calorie limits and to assist them in
constructing a healthy dietary pattern that is limited in added sugars
to reduce the risk of CVD. As explained in the preamble to the proposed
rule (79 FR 11879 at 11903), Americans consume too many calories from