Document ID: FDA-2012-N-1210-0875
Agency: fda
Document Type: Rule
Title: Food Labeling: Revision of the Nutrition and Supplement Facts Labels
Posted Date: 2016-05-27T04:00Z

[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Rules and Regulations]
[Pages 33741-33999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11867]

[[Page 33741]]

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  

[[Page 33742]]

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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, 240-402-5429, email: 
NutritionProgramStaff@fda.hhs.gov.

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

[[Page 33743]]

    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

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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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value
    3%..................................................            $2.8           $33.1           $77.7            $2.3            $4.8            $8.6

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

[[Page 33746]]

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

[[Page 33747]]

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

[[Page 33748]]

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

[[Page 33749]]

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

[[Page 33750]]

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

[[Page 33751]]

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

[[Page 33752]]

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

[[Page 33753]]

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

[[Page 33754]]

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).

[[Page 33755]]

    (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

[[Page 33756]]

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.

[[Page 33757]]

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

[[Page 33758]]

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

[[Page 33759]]

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 
solid fats and added sugars, which makes it difficult for consumers to 
meet nutrient needs within their calorie limits. The 2010 DGA noted 
that solid fats and added sugars contribute a substantial portion of 
calories (35 percent) in the American diet, with 16 percent on average 
from added sugars. Recommended calorie limits for most consumers, as 
set forth in the 2010 DGA, can only reasonably accommodate 5 to15 
percent of calories from solid fats and added sugars combined (id.). 
While it is true that excess calorie consumption from any source can 
lead to weight gain, the statistics on calorie consumption from solid 
fats and added sugars suggest that, for many consumers, added sugars 
contribute to excess calorie intake. In fact, the 2010 DGA also noted 
that excess calories from solid fats and added sugars have implications 
for weight management (id.). Moreover, there is strong evidence showing 
that children who consume more sugar-sweetened beverages have greater 
adiposity (body fat) compared to those with a lower intake (id.).
    The 2015 DGAC report further contributed to the scientific support 
for the added sugars declaration. For the first time, the 2015 DGAC 
conducted a systematic review of the relationship between dietary 
patterns and health outcomes. The DGAC found a strong association of a 
dietary pattern characterized, in part, by lower consumption of sugar-
sweetened foods and beverages relative to a less healthy dietary 
pattern and reduced risk of CVD. We reviewed and considered the 
evidence that the 2015 DGAC relied upon, including an existing review 
from the Nutrition Evidence Library (NEL) Dietary Patterns Systematic 
Review Project as well as the NHLBI Lifestyle Interventions to Reduce 
Cardiovascular Risk: Systematic Evidence Review from the Lifestyle Work 
Group (``NHLBI Lifestyle Evidence Review'') (Ref. 17) and the 
associated American Heart Association (AHA)/American College of 
Cardiology (ACC) Guideline on Lifestyle Management to Reduce 
Cardiovascular Risk (``Lifestyle Management Report'') (Ref. 18). The 
diet quality of the general U.S. population ``does not meet 
recommendations for vegetables, fruit, dairy, or whole grains, and 
exceeds recommendations, leading to overconsumption, for the nutrients 
sodium and saturated fat and the food components refined grains, solid 
fats, and added sugars.'' While intake levels of added sugars still 
remain high at an average of 13.4 percent of calories among the U.S. 
population, the amount of added sugars available for the calorie ranges 
covered by the USDA Food Patterns (1,000 to 3,200 calories) ranges from 
only 4 to 9 percent (Ref. 19).
    The scientific evidence, and other data and information, supports 
the need for an added sugars declaration to promote the public health.
    In addition, the declaration of added sugars provides information 
that is material because, without the declaration of added sugars, 
consumers would not have access to information about the amount of 
added sugars in a serving of food. The current ``Sugars'' declaration 
on the label does not provide information on how much added sugars are 
present in a food, nor does the ingredient listing. The contribution of 
naturally occurring sugars and added sugars cannot be determined based 
on the ``Sugars'' declaration that includes both types of sugars. In 
addition, although ingredients are listed in order of predominance by 
weight (21 CFR 101.4), the ingredient information is not a substitute 
for the gram amount of added sugars. An ingredient listing would not 
enable the consumer to understand the amount of added sugars in grams 
and therefore, the contribution of the food to the daily dietary 
recommended limit of less than 10 percent of calories from added 
sugars.
    Added sugars are found in many foods in the marketplace. Consumers 
are likely to be aware that added sugars are present in some sweet 
foods, such as sugar-sweetened beverages and candy, but in other foods, 
such as sweetened grains, mixed dishes, condiment, gravies, spreads, 
and salad dressings, the presence of added sugars is not as obvious. 
The majority of food sources of added sugars are beverages (excluding 
milk and 100 percent fruit juice), snacks, and sweets; however, 22 
percent of food sources of added sugars are from other categories of 
foods such as grains, mixed dishes, dairy, condiments, gravies, 
spreads, salad dressings, fruits and fruit juice, and vegetables (Ref. 
20). Small amounts of added sugars that are contributed to diet by a 
wide variety of foods can add up over the course of the day and can 
make it difficult for an individual to eat sufficient amounts of foods 
from the basic food groups to meet nutrient needs without exceeding the 
amount of calories they need in a day for weight maintenance. Because 
added sugars are in such a wide variety of foods in the food supply, 
consumers need to have information on the label so that they can 
consider the amount of added sugars in both foods that supply large 
amounts of added sugars as well as those that supply smaller amounts 
when constructing a healthy dietary pattern that contains less than 10 
percent of calories.
    Without the declared amount of added sugars, consumers would be 
denied access to the information they need to reduce the intake of 
added sugars to the recommended daily limit. As discussed in our 
response to comment 159, added sugars is a material fact, within the 
meaning of section 201(n) of the FD&C Act. Mandatory labeling that 
provides information about the contribution to daily caloric intake of 
added sugars is necessary to ensure that full, factual information is 
imparted to consumers so they have access to the information needed to 
follow a healthy dietary pattern and will not be misled in purchasing 
decisions because they have no information about added sugars content 
and further could not calculate it based on the other information on 
the label--total sugars content or ingredient labeling.
    Furthermore, the declaration of added sugars is also reasonably 
related to the government's interest in providing information needed to 
assist consumers in maintaining healthy dietary practices by providing 
them with information about added sugars content in a serving of food 
to construct diets containing more nutrient-dense foods and reduce 
calorie intake from added sugars by reducing consumption of added 
sugars to less than 10 percent calories. Survey data show that 
consumers use the Nutrition Facts label and the percent Daily Value at 
point-of-purchase and review the nutrient contribution of food (Refs. 
21-23) products. Thus, by requiring the added sugars declaration on the 
Nutrition Facts label, we will give consumers a tool they need to 
include added sugars as part of a healthy dietary pattern that avoids 
excess calories from added sugars and is associated with a reduced risk 
of CVD.
    Some comments asserted that Zauderer is limited to cases where the 
government interest is in preventing consumer deception. Case law 
interpreting Zauderer clarifies that the government need not establish 
that compelled disclosure will prevent consumer deception for the 
Zauderer standard to apply. In American Meat Institute, the court held 
that ``[t]he language with which Zauderer justified its approach . . . 
sweeps far more

[[Page 33760]]

broadly than the interest in remedying deception'' 760 F.3d 18, 22 
(D.C. Cir. 2014) (en banc). In reaching the conclusion that the 
applicability of Zauderer extends beyond regulations in which the 
government is attempting to mandate a disclosure to remedy deception, 
the court focused on the ``material differences between disclosure 
requirements and outright prohibitions on speech,'' (id. at 21 (quoting 
Zauderer, 471 U.S. at 650)), the fact that ``the First Amendment 
interests implicated by disclosure requirements are substantially 
weaker than those at stake when speech is actually suppressed,'' (id. 
(quoting Zauderer, 471 U.S. at 652 n.14)), and the fact 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] constitutionally protected 
interest in not providing any particular factual information in his 
advertising is minimal,'' (id. (citing Zauderer, 471 U.S. at 651)). The 
court found that, ``[a]ll told, Zauderer's characterization of the 
speaker's interest in opposing forced disclosure of such information as 
`minimal' seems inherently applicable beyond the problem of deception'' 
(id.). Several other circuits concur (see Pharm. Care Mgmt. Ass'n v. 
Rowe, 429 F.3d 294, 297 through 298, 310, 316 (1st Cir. 2005); N.Y. 
State Rest. Ass'n v. N.Y. City Bd. of Health, 556 F.3d 114, 133 (2d 
Cir. 2009); Nat'l Elec. Mfrs. Ass'n v. Sorrell, 272 F.3d 104, 115 (2d 
Cir. 2001) (affirming use of the ``reasonable-relationship Zauderer 
standard when the compelled disclosure at issue . . . was not intended 
to prevent `consumer confusion or deception' ''); Disc. Tobacco City & 
Lottery, Inc. v. United States, 674 F.3d 509, 556 (6th Cir. 2012) 
(holding that ``Zauderer's framework can apply even if the required 
disclosure's purpose is something other than or in addition to 
preventing consumer deception'')).
    (Comment 22) One comment stated the proposed declaration of added 
sugars violates the First Amendment because the requirement is not 
reasonably related to a legitimate regulatory interest. Another comment 
asserted that an added sugars declaration would not assist consumers in 
maintaining healthy dietary practices. Another comment stated that even 
if the declaration of added sugars was purely factual and not 
controversial, the declaration is ``unjustified and unduly burdensome'' 
(citing Zauderer, 471 U.S. at 651), where there is no scientific 
evidence that added sugars contributes to obesity or heart disease and 
there is no recommended daily allowance.
    (Response) As explained in our response to comment 21, the required 
added sugars declaration assists consumers in maintaining healthy 
dietary practices and 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. Furthermore, we disagree with the comment 
suggesting that the added sugars declaration is unjustified and unduly 
burdensome because ``no scientific evidence exists to support FDA's 
assumption that added sugars contribute to obesity or heart disease'' 
and due to the lack of a DV for added sugars. To the extent the comment 
suggests we were relying on a specific nutrient-disease relationship 
between added sugars and obesity or heart disease in the general 
population, the comment misunderstands our rationale for the 
declaration. We stated that our scientific basis for the added sugars 
declaration, in fact, differed from our rationale to support other 
mandatory nutrients related to the intake of a nutrient and risk of 
chronic disease, a health-related condition or a physiological endpoint 
(see 79 FR 11879 at 11904). Although we recognized that U.S. consensus 
reports do not support a cause and effect relationship between added 
sugars consumption and risk of obesity or heart disease (id.), we 
considered, in the preamble to the proposed rule (79 FR 11879 at 11902 
through 11908) and the supplemental proposed rule (80 FR 44303 at 44307 
through 44309), the contribution of added sugars to healthy dietary 
patterns, and the impact to public health from such patterns. In the 
latter, we included a proposed DV for the added sugars declaration.
    (Comment 23) One comment stated that the disclosure of added sugars 
is disclosure of factually accurate nutritional data and analogized the 
disclosure to the disclosure of allergens under the Federal Food 
Allergen Labeling and Consumer Protection Act (FALCPA). The comment 
said that Congress imposed requirements for nutrient and allergen 
disclosures so consumers can make ``safer, healthier, and more informed 
choices about the foods they eat'' and not because food labels were 
deceptive without the information. The comment cited Zauderer and Nat'l 
Elec. Mfrs. Ass'n v. Sorrell, 272 F.3d 104, 113 through 114 (2d Cir. 
2001) for support that industry's interest in not disclosing such 
factual information is minimal. The comment also stated that we 
articulated a rational basis for requiring consumers to maintain 
healthy dietary practices (citing N.Y. State Rest. Ass'n v. N. Y. City 
Bd. of Health, 556 F.3d 114, n.21 and at 136 (2d Cir. 2009), and Pharm. 
Care Mgmt. Ass'n v. Rowe, 429 F.3d 294 (1st Cir. 2005)).
    (Response) We agree that the disclosure of added sugars is 
factually accurate nutrition information and that industry's interest 
in not disclosing such factual information is minimal. We also agree 
that Congress imposed nutrition labeling requirements to help consumers 
have access to information that would assist them in choosing healthy 
diets. Congress prescribed that foods subject to the nutrition-label 
requirements are ``deemed to be misbranded'' if they do not provide 
nutrition labels as required (see section 403 and 403(q) of the FD&C 
Act). Congress also has indicated that labeling's failure to provide 
certain material information is to be taken into account in determining 
whether such labeling is misleading (see section 201(n) of the FD&C 
Act). We do not respond to the portion of the comment on Congress' 
intent with respect to allergen labeling under FALCPA because it is 
outside the scope of this rule.
    (Comment 24) One comment stated the added sugars labeling is not to 
provide purely factual information to prevent consumer deception, but 
to shape consumer behavior.
    (Response) As explained in the preamble to the proposed rule (see 
79 FR 11879 at 11905), the added sugars declaration will provide 
information to consumers on the amount of added sugars in a serving of 
food. We recognize that added sugars can be a part of a healthy dietary 
pattern when not consumed in excess amounts. The purpose of the added 
sugars declaration is not to discourage the consumption of the class of 
foods that contain added sugars, but rather to increase consumer 
understanding of the quantity of added sugars in foods to enable the 
consumer to understand the relative significance of the contribution of 
added sugars from a serving of a particular food in the context of the 
total daily diet. A consumer may or may not elect to reduce the 
consumption of certain foods with added sugars, based on his or her 
individual need and dietary choice. The declaration provides purely 
factual information so that consumers will have access to the 
information they need about the amount of added sugars in a food, and 
that they are not able to obtain from the current nutrient declaration 
of ``Sugars'' or ``Total Sugars'' alone.

[[Page 33761]]

Through our consumer education, we plan to help consumers understand 
the changes we are making in the final rule and how the information can 
assist them to include a variety of foods in their daily diet so that 
they understand how to achieve a healthy dietary pattern.
    (Comment 25) One comment stated the added sugars declaration would 
compel misleading labeling because it would mislead consumers into 
believing that a sweetened dried cranberry is less healthy than a 
naturally sweetened dried fruit, due to the cranberry's added sugar 
content.
    (Response) The comment seems to refer to the consumer research data 
related to consumer perceptions of ``healthful'' that we discuss in our 
response to comment 184. We do not agree that the results in our added 
sugars study or the results submitted by comments on consumer 
perceptions support the assertion that an added sugars declaration 
would compel misleading labeling. As we have stated, a consumer's 
belief, opinion, or previous exposure to information about added sugars 
and their impact to health, whether based on science or not, may affect 
how a consumer may view a food with an added sugars declaration. These 
factors can influence how a consumer perceives the factual statement 
about the amount of added sugars on a label and may result in some 
consumer confusion and misunderstanding about the food containing the 
added sugars that is not based on the declaration itself, but instead, 
on the consumer's own misperceptions. For example, a consumer may 
erroneously think a food, which can be part of a healthy dietary 
pattern, is not ``healthful'' because it contains some amount of added 
sugars. This is likely not unique to added sugars. Consumers obtain 
information from a number of sources, previous experiences, or in 
response to specific health concerns. For example, there is a large 
body of data and information on other nutrients to limit, e.g., 
saturated fat, cholesterol, and sodium, which may influence consumer 
perception of how ``healthful'' a food may be. A consumer may choose to 
avoid all or most sources of food with sodium or saturated fat present, 
or present in a certain amount, based on their beliefs or specific 
dietary needs.
    A consumer's lack of understanding about what added sugars are or 
how to use the added sugars declaration to limit added sugars intake 
does not mean the factual declaration of the amount of added sugars in 
a serving of food is misleading. Consumers need more, not less, 
information about the added sugars content of a food to learn how to 
understand and use the information in planning a healthy dietary 
pattern. Furthermore, the term ``unhealthful'' when describing a food 
with added sugars is a relative term and must be viewed in the context 
of the day's total dietary intake. For example, a food with a high 
amount of added sugars may be understandably viewed as ``unhealthful'' 
because, if consumed, it may result in overconsumption of added sugars 
for the day. We need to correct the misperceptions consumers may have 
about added sugars and provide them with information they need to 
include a variety of foods in their diet, as part of a healthy dietary 
pattern, so they can understand how to include added sugars in their 
diets at levels less than 10 percent of calories to avoid 
overconsumption. We intend to educate consumers on the changes to the 
food label, and in particular, to the declaration of added sugars so 
that consumers can expand their food choices to include nutrient dense 
foods, such as cranberries with added sugars, and still achieve a 
healthy dietary pattern.
    (Comment 26) Another comment stated that an added sugars 
declaration and percent DV will compel false information on the label 
because the amount of added sugars will need to be overstated on yeast-
leavened products, in violation of the First Amendment.
    (Response) We disagree that an added sugars declaration on yeast-
leavened products will need to be overstated and therefore compel false 
information on the label. We allow for reasonable deficiencies in foods 
generally for label amounts of calories, sugars, added sugars, 
saturated fat, trans fat, cholesterol and sodium, within current good 
manufacturing practices (see final Sec.  101.9(g)(6)). Furthermore, as 
we have stated in our response to comment 200, we recognize that 
labeling of added sugars in products that undergo fermentation and non-
enzymatic browning may not be exact, but that manufacturers of most 
products that participate in these reactions should be able to provide 
a reasonable approximation of the amount of added sugars in a serving 
of their product based on information in the literature and their own 
analyses. To the extent a manufacturer has reason to believe the amount 
of added sugars in a serving of food may be significant enough to 
impact the label declaration by an amount that exceeds the reasonable 
deficiency acceptable within current manufacturing practice, and is 
unable to reasonably approximate the amount of added sugars in a 
serving of food, the manufacturer may submit a petition to request an 
alternative means of compliance.
    (Comment 27) One comment stated that, even if the added sugars 
declaration is not false or misleading, Zauderer still would not apply 
to the requirement to include a % DV for the declaration of added 
sugars because the % DV is not designed to prevent consumer fraud or 
deception. The comment stated it is not clear whether consumers know 
what the % DV represents. The comment suggested that the mere 
declaration may lead a consumer to consider added sugars as 
``inherently dangerous.''
    (Response) We disagree with the suggestion that, if the % DV is not 
designed to prevent consumer fraud or deception, Zauderer would not 
apply. As we explained in our response to comment 21, the Zauderer test 
is not limited in this way. Moreover, we are unclear as to the 
comment's basis for its assertion that consumers would consider added 
sugars as ``inherently dangerous.'' The comment provided no data or 
information for its assertion. We consider that view, should it exist, 
to be a consumer misperception. We plan to address consumer 
misperceptions about added sugars as part of our consumer education 
effort.
    (Comment 28) Some comments asserted that the test in Zauderer is 
not applicable to the added sugars declaration and that Central Hudson 
provides the appropriate test with which to evaluate the declaration 
under the First Amendment.
    (Response) While we disagree that the required added sugars 
declaration should be subject to the Central Hudson standard, it would 
nonetheless be Constitutional under the standard set forth in Central 
Hudson. If the Central Hudson standard were applicable to the required 
added sugars declaration, we would need to identify a ``government 
interest [that] is substantial,'' establish that ``the regulation 
directly advances the government interest asserted,'' and show that the 
regulation ``is not more extensive than is necessary to serve that 
interest'' (Central Hudson, 447 U.S. at 566). Under the Central Hudson 
test, we have the discretion to ``judge what manner of regulation may 
best be employed'' to serve the substantial government interest (see 
City of Cincinnati v. Discovery Network, Inc., 507 U.S. 410, 416 n.12 
(1993) (citing Bd. of Trustees v. Fox, 492 U.S. 469, 480 (1989))).
    (Comment 29) Some comments stated there is no substantial 
government interest for which we can require an added sugars 
declaration under Central

[[Page 33762]]

Hudson because there is no material difference between added and 
intrinsic sugars in food. One comment stated that ``scientific studies 
have not sufficiently shown that FDA has a substantial interest in 
preventing consumer intake of added sugars.'' Another comment stated 
that FDA's interest in compelling an added sugars declaration is not 
substantial where there is no causal relationship between added sugars 
and risk of chronic disease, but only evidence of a strong association 
between a dietary pattern characterized, in part, by a reduced intake 
of sugar-sweetened foods and beverages and a reduced risk of CVD. The 
comment further stated that, just as there is no substantial government 
interest for added sugars, there is no such interest for total sugar 
content or for the percent DV for added sugars; the comment stated 
there is no material health or safety difference between a food with 
added sugars as compared to naturally occurring sugars.
    (Response) We disagree that we have no substantial government 
interest to support the declaration of added sugars. We have an 
interest in promoting the public health, preventing misleading 
labeling, and providing information to consumers to assist them in 
maintaining healthy dietary practices. Promoting the public health is 
part of our mission to ensure, in part, that foods are properly labeled 
(section 1003 of the FD&C Act (21 U.S.C. 393)). In addition, for over 
20 years, we have had a substantial government interest in ensuring 
that consumers have access to information about food on the nutrition 
label that is truthful and not misleading, and an interest in ensuring 
that nutrition information will assist consumers in maintaining healthy 
dietary practices. Based on the more recent scientific evidence on 
reducing added sugars consumption as part of a healthy dietary pattern, 
we have a substantial interest in ensuring the accuracy and 
completeness of added sugars information in labeling. Our government 
interests are substantial and supported as such (Rubin v. Coors Brewing 
Co., 514 U.S. 476, 485 (1995) (recognizing that the government has a 
substantial interest in promoting the health of its citizens); see 
also, Am. Meat Inst. v. U.S. Dep't Agric., 760 F.3d 18 (D.C. Cir. 2014) 
(en banc) (finding the context and history of disclosures in labeling 
by USDA one of several interests to support a substantial government 
interest under Central Hudson); N.Y. State Rest. Ass'n v. N.Y. City Bd. 
of Health (556 F.3d 114, 134 (2d Cir. 2009) (finding the promotion of 
``informed consumer decision-making so as to reduce obesity and the 
diseases associated with it'' through posting of calorie content 
information on menus to be a substantial government interest)).
    We also disagree that there is no material difference between added 
and intrinsic sugars for purposes of achieving a healthy dietary 
pattern to avoid excess discretionary calories from added sugars and 
reduced risk of chronic disease. As we discuss in our response to 
comment 143, there is a strong association with respect to the 
consumption of a healthy dietary pattern characterized, in part, by a 
lower intake of sugar-sweetened foods and beverages, and a reduced risk 
of CVD, compared to less healthy dietary patterns with higher intakes 
of added sugars. Foods that are composed of naturally occurring or 
intrinsic sources of sugars, e.g., fruits and vegetables, are distinct 
from the category of sugar-sweetened foods and beverages and are not 
food categories recommended to be reduced as part of the healthy 
dietary pattern. Furthermore, evidence and conclusions from the 2010 
DGA support the conclusion that consumption of excess calories from 
added sugars can lead to a less nutrient-dense diet. With respect to 
the comments related to the scientific support for the added sugars 
declaration, we disagree that a causal relationship must be shown 
between added sugars and a risk of chronic disease (e.g., a dose-
response relationship between a nutrient and risk of disease) before we 
can make the requisite finding under section 403(q)(2)(A) of the FD&C 
Act that added sugars would assist consumers in maintaining healthy 
dietary practices (see part II.H.3.a). No such dose-response 
requirement exists in section 403(q) of the FD&C Act or in implementing 
regulations. Furthermore, the comment's characterization that 
``scientific studies have not sufficiently shown that FDA has a 
substantial interest in preventing consumer intake of added sugars'' 
mischaracterizes the purpose of the nutrient declaration. We are not 
``preventing'' consumer intake of added sugars. Instead, we are 
providing factual, accurate information to the consumer about the 
amount of added sugars in serving of food to enable consumers to 
understand and use the information to make informed dietary choices and 
construct their daily diets.
    (Comment 30) One comment said that consumer interest alone does not 
make information material and consumer interest is not a substantial 
government interest, and therefore, the added sugar declaration cannot 
be compelled under the First Amendment.
    (Response) We are not requiring the declaration of added sugars 
based on consumer interest. We are requiring an added sugars 
declaration to provide information to assist consumers with food 
purchases that can reduce their intake of added sugars and enable them 
to achieve a healthy dietary pattern. A healthy dietary pattern, 
characterized in part by lower amounts of added sugars than that found 
in the U.S. general population's dietary pattern, is strongly 
associated with a reduced risk of chronic disease (Disc. Tobacco & 
Lottery, Inc. v. United States, 674 F.3d 509, 564 (6th Cir. 2012) 
(finding a reasonable relationship between tobacco warning statements 
and a government interest in ``promoting greater public understanding 
of the risks''); Sorrell, 272 F. 3d at 115 (finding a rational 
relationship between the state's goal of reducing mercury contamination 
and required label disclosures on mercury-containing light bulbs). The 
required declaration of added sugars is consistent with the First 
Amendment and our authority in sections 403(a), 201(n), 403(q)(2)(A) 
and 701(a) of the FD&C Act.
    (Comment 31) Some comments questioned how an added sugars 
declaration would directly advance the government interest related to 
consumer health. One comment stated that, even if FDA had a substantial 
government interest, FDA has not shown that the declaration directly 
advances that interest (citing Central Hudson, 447 U.S. at 566) and to 
a ``material degree'' (citing Florida Bar v. Went For It, Inc., 515 
U.S. 618, 626 (1995)) because FDA has not shown there would be any 
``discernable effect on consumer behavior'' and that FDA must 
demonstrate that an added sugars declaration is related to ``its 
desired change in consumer behavior or an improvement in consumer 
health.'' Another comment cited Edenfeld v. Fain, 507 U.S. 761 at 770 
through 771 (1993), stating that FDA will not be able to carry the 
burden to ``demonstrate that the harms it recites are real and that its 
restriction will in fact alleviate them to a material degree.'' The 
comment stated that we have not and cannot demonstrate a concrete harm 
in the absence of a mandatory added sugars declaration.
    (Response) The added sugars declaration directly advances our 
government interests in promoting consumer health, preventing 
misleading labeling, and assisting consumers in maintaining healthy 
dietary practices. As we explain in our response to comment 137, 
Americans consume too many calories from solid fats and added sugars, 
which replace nutrient-dense foods and make it difficult for consumers 
to achieve the recommended

[[Page 33763]]

nutrient intake while controlling their calorie intake. Consumers can 
only reasonably accommodate 5 to 15 percent of calories from solid fats 
and added sugars combined, yet the 2015 DGAC found intakes from added 
sugars alone at approximately 13.4 percent. Excess calories from solid 
fats and added sugars have implications for weight management. 
Moreover, there is strong evidence showing that children who consume 
more sugar-sweetened beverages have greater adiposity (body fat) 
compared to those with a lower intake.
    The scientific evidence shows that, although there is moderate 
evidence of an association with healthy dietary patterns (with lower 
added sugars) compared to less healthy patterns and measures of 
increased body weight or obesity, type 2 diabetes, cancer, and 
congenital anomalies, there is a strong association of a dietary 
pattern characterized, in part, by lower consumption of sugar-sweetened 
foods and beverages, relative to a less healthy dietary pattern found 
in the general U.S. population, and reduced risk of CVD. Thus, the 
scientific review supports that a healthy dietary pattern that is 
characterized by a lower consumption of added sugars, not a lower 
consumption of naturally occurring sugars, is strongly associated with 
a reduced risk of CVD.
    The declaration of added sugars would provide consumers with 
information about the amount of added sugars in a food product that is 
currently absent from the label. The failure to disclose the amount of 
added sugars in a product is an omission of a material fact. The 
reasonable consumer would expect that the information on the label 
would give them the most important nutrition information, relative to 
the need to construct a healthy dietary pattern that limits the excess 
consumption of added sugars. The omission of added sugars runs counter 
to that expectation, impeding rational consumer choice. A healthy 
dietary pattern, when compared to the current dietary pattern in 
general U.S. population, is associated with a reduced risk of CVD and 
avoids excess discretionary calories from added sugars and solid fats. 
Consumers need information about added sugars in all foods, not just 
those that contain a certain threshold level or that are found in 
select food categories (e.g., beverages) to reduce overall intake of 
added sugars in the diet. Consumers can use the declared amount of 
added sugars to compare products and make food selections to achieve a 
healthy dietary pattern that is associated with a reduced risk of CVD. 
Therefore, the added sugars declaration is required to ensure that the 
labeling is not misleading.
    Consumers need to understand the amount of added sugars in food to 
understand the relative contribution of the food to total dietary 
intake. The percent DV provides information on how much added sugars in 
a serving of food contributes to the recommended limit of less than 10 
percent calories from added sugars. As we explain in our response to 
comment 21, consumers use the Nutrition Facts label at point-of-
purchase and review the nutrient contribution of food products to help 
them choose products and compare products. By providing this 
information, consumers can have the information they need to achieve a 
healthy dietary pattern that is characterized by lower levels of added 
sugars through a lower total consumption of sugar-sweetened foods and 
beverages. A healthy dietary pattern is also characterized by a higher 
consumption of vegetables, fruits, whole grains, low-fat dairy, and 
seafood, and lower consumption of red and processed meat and refined 
grains. In addition, the declaration of added sugars on the nutrition 
label would assist consumers in maintaining healthy dietary practices 
by providing them with information necessary to meet the key 
recommendations to construct daily diets containing nutrient-dense 
foods and reduce calorie intake from added sugars by reducing 
consumption of added sugars to less than 10 percent calories. Thus, by 
providing this information on the food label, we can directly and 
materially advance an interest in promoting public health, preventing 
misleading labeling, and assisting consumers in maintaining healthy 
dietary practices. We have sufficient support to demonstrate that the 
declaration directly advances our government interests, including 
scientific support for the added sugars declaration, evidence to 
support consumer use of the label, and expert opinion to support 
consumer understanding of the added sugars declaration based on changes 
made to the proposed declaration (see Florida Bar v. Went For It, Inc., 
515 U.S. 618, 628 (1995) (justifying speech restrictions ``by reference 
to studies, and anecdotes pertaining to different locales altogether . 
. . or even, in a case applying strict scrutiny, to justify 
restrictions based solely on history, consensus, and `simple common 
sense' '') (citations omitted)).
    We disagree with the comment's assertion that we must show a 
``discernable effect on consumer behavior'' and that we must 
demonstrate that an added sugars declaration is related to a ``desired 
change in consumer behavior or an improvement in consumer health.'' 
Achieving specific changes in consumer behavior and/or health are not 
the government interests we assert, and the law does not require that 
these specific showings be made. We note that, to the extent the 
comment suggests we need a connection to consumer health for purposes 
of the added sugars declaration, we have described that relationship in 
the proposed rule, the supplemental proposed rule, and the final rule.
    (Comment 32) One comment acknowledged the strong association 
between a dietary pattern characterized, in part, by a reduced intake 
of sugar-sweetened foods and beverages and reduced CVD risk. However, 
most comments questioned how an added sugars declaration would directly 
advance our government interest to assist consumers to maintain healthy 
dietary practices and focused on health outcomes for which they say 
there is only moderate or no direct evidence of an association between 
added sugars consumption and a disease or health-related condition. For 
example, some comments stated there is no evidence that added sugars 
has an impact on obesity, and therefore, a declaration would not assist 
consumers to maintain healthy dietary practices. Another comment said 
that a link to added sugars intake and health based on the 2010 DGA is 
flawed, citing to a statement in the preamble to the proposed rule that 
added sugars do not contribute to weight gain more than any other 
source of calories (79 FR 11879 at 11904) even though the 2010 DGA 
recommendation is to reduce the intake of calories from added sugars. 
Other comments focused on the evidence in Chapter 6 of the DGAC Report, 
which the comments describe as ``moderate'' evidence, to support a 
specific relationship between added sugars and disease risk. The 
comments appeared to suggest that we are relying only on evidence in 
Chapter 2 Part D of the 2015 DGAC Report to support our basis for the 
added sugars declaration, and not the moderate evidence in Chapter 6. 
One comment suggested the moderate evidence provides a lower level of 
scientific certainty to support a reasonable fit between the disclosure 
and FDA's government interest.
    (Response) The comments focusing on evidence related to a specific 
relationship between added sugars intake in the general U.S. population 
and a direct link to obesity to support a mandatory declaration of 
added sugars

[[Page 33764]]

may have overlooked the discussion in the preamble to the proposed rule 
(79 FR 11879 at 11904). We are not establishing or relying on a direct 
link to obesity from added sugars intake for the general population. 
There is adequate evidence that the U.S. population consumes excess 
calories from added sugars, above the discretionary calories permitted 
within a recommended caloric intake (id. at 11903). The 2010 DGA 
supports the need for an added sugars declaration to provide the 
information necessary for consumers to identify the contribution of 
discretionary calories from added sugars, which are consumed in excess 
by the general U.S. population based on recommended calorie limits, to 
their daily diet in order to reduce their intake of added sugars to 
within recommended calorie limits. While it is true that excess 
calories from any source leads to weight gain, we know that the U.S. 
general population consumes added sugars in excess of the recommended 
limit of less than 10 percent of calories. Moreover, we have additional 
support for the declaration of added sugars, as lower intakes of sugar-
sweetened foods and beverages were part of a healthy dietary pattern 
that was found to be strongly associated with a decreased risk of CVD 
(see part II.H.3.a and II.H.3.b). Furthermore, we disagree we are 
mischaracterizing the evidence on which we rely because we do not cite 
to moderate evidence in the 2015 DGAC. Although the evidence concerning 
a cause and effect relationship between added sugars intake and reduced 
risk of a disease is still emerging, there is a strong association 
found for a healthier dietary pattern, characterized in part by a 
reduced intake of overall added sugars compared to less healthy dietary 
patterns like those consumed by the general U.S. population, and 
reduced risk of CVD.
    (Comment 33) One comment said that we have not identified any 
direct relationship between the added sugars declaration and an 
interest in helping consumers to maintain healthy dietary practices by 
reducing added sugars consumption. The comment questioned the strong 
association found between dietary patterns and risk of CVD in the 2015 
DGAC Report, based on criticisms by FDA of menu modeling to establish 
DRVs in the preamble to the proposed rule (79 FR 11895 at 11896).
    (Response) To the extent the comment asserts we must have a direct 
relationship between a nutrient and a reduced risk of disease before 
the nutrient is eligible for mandatory labeling under section 
403(q)(2)(A) of the FD&C Act, we disagree for the reasons we set forth 
in our response to comment 58. Furthermore, the analysis that was 
conducted related to dietary patterns and health outcomes that is 
discussed in Chapter 2 of the 2015 DGAC Report is not based on modeling 
of dietary patterns, but rather on a review of diet quality studies 
where dietary quality indices were used to assess how adherence to a 
healthy dietary pattern is associated with health outcomes (Ref. 19). 
Therefore, statements that we have made in the past related to food 
pattern modeling do not apply to the evidence that we considered 
related to healthy dietary patterns that are characterized, in part, by 
lower intakes of sugar-sweetened foods and beverages relative to less 
healthy dietary patterns and CVD risk.
    (Comment 34) One comment stated that consumer research demonstrates 
that, while an added sugars declaration may allow consumers to 
determine the amount of added sugars in a product accurately and 
compare products based on the amount of added sugars and percent DV 
contribution, the evidence does not demonstrate that consumers would 
maintain healthy dietary practices or that consumer understanding of a 
product's healthfulness is improved. Another comment suggested that we 
must demonstrate that a % DV disclosure for added sugars would have a 
``direct and material effect on consumer behavior.'' The comment said 
there is no evidence that consumers understand the % DV and how to use 
the information for the added sugars declaration.
    (Response) We interpret the comments as questioning how an added 
sugars declaration (and percent DV) would directly advance our 
government interest to assist consumers to maintain healthy dietary 
practices. The comments may misunderstand our authority under section 
403(q)(2)(A) of the FD&C Act. Section 403(q) of the FD&C Act gives us 
the discretion to require a nutrient declaration when we determine that 
the information is necessary to assist consumers to maintain healthy 
dietary practices. The determination is based on a review of the 
scientific evidence and other available data and information related to 
the need for the nutrition information to be available to the consumer 
as part of the Nutrition Facts label. The declaration places the 
information in the hands of the consumer so that the consumer can make 
a judgment about whether to purchase a given food based on the nutrient 
content and can understand the relative significance of the information 
in the context of a total daily diet (see our response to comment 33). 
Our government interest does not rest on the notion that there must be 
some percent of consumers who we know will modify their diet to consume 
more or less of a nutrient before we can compel a label declaration for 
that nutrient or the percent DV. Consumers do not know the amount of 
added sugars in foods without a required declaration. Furthermore, the 
comment may misunderstand that the nutrition information on Nutrition 
Facts label is to assist consumers in understanding the relative 
significance of the information in the context of a total daily diet 
and does not require a threshold level of a change in consumer behavior 
before the nutrient can then be required on the nutrition label. The 
final rule does not define when a food is ``healthy'' based on the 
amount of added sugars in a serving of the food; instead, through the 
Nutrition Facts label, we are providing information about the amount of 
added sugars so that consumers can understand the relative significance 
of a food's contribution to the total added sugars intake in the 
context of the total daily diet and use that information to decide what 
foods to choose as part of that dietary intake for the day.
    (Comment 35) One comment stated the added sugars declaration must 
be understandable to directly advance the government interest to assist 
consumers to maintain healthy dietary practices. The comment said the 
added sugars study provides only weak evidence that consumers 
understand the declaration. The comment cited our statements in the 
supplemental proposed rule and study memorandum that acknowledge that a 
number of participants were confused about the distinction between 
sugars and added sugars on the labels studied and that some 
participants identified a more nutritious product with more added 
sugars as less healthy.
    (Response) We considered the results from our consumer research on 
the added sugars declaration, in addition to consumer research on the 
declaration submitted in comments (see part II.B.5). As a result of the 
findings showing that some consumers may be confused by the 
juxtaposition of total sugars followed by added sugars indented below 
total sugars, we revised the declaration to address those concerns. We 
now include the word ``Total'' before ``Sugars'' and use the phrase 
``Includes ``XX'' g Added Sugars'' indented below ``Total Sugars'' to 
mitigate the observed misunderstanding by some consumers to add the 
total and added sugars values together. With the change to the 
declaration, we expect that consumers will understand that

[[Page 33765]]

added sugars are a component of total sugars (see our response to 
comment 188). We also considered results showing that some consumers 
may perceive products with more added sugars as less healthy (see our 
responses to comments 55 and 184) and plan to address consumer 
perceptions as part of our consumer education. The factual declaration 
of the amount of added sugars in a serving of food is not misleading 
based on consumer perceptions about whether a food with added sugars is 
``unhealthful.''
    (Comment 36) One comment said that we must identify the public harm 
caused by not declaring added sugars, demonstrate how the declaration 
will alleviate this harm, and show this is the least intrusive approach 
to comport with a company's constitutional protection of its right to 
free speech. The comment also said that we must show there is a 
different or greater harm from added sugars that is not present for the 
same level of naturally occurring sugars.
    (Response) We discuss how the added sugars declaration comports to 
the Central Hudson analysis, including why added sugars are 
distinguished from naturally occurring sugars, in our response to 
comment 29. Central Hudson requires the regulation to be no more 
extensive than necessary to serve the asserted government interest 
(Central Hudson, 447 U.S. at 566). This standard does not require the 
government to employ ``the least restrictive means'' of regulation or 
to achieve a perfect fit between means and ends (see Bd. of Trustees v. 
Fox, 492 U.S. 469, 480 (1989)). Instead, it is sufficient that the 
government achieve a ``reasonable'' fit by adopting regulations `` `in 
proportion to the interest served.' '' (id. (quoting In re R.M.J., 455 
U.S. at 203)). The requirement of narrow tailoring is satisfied ``so 
long as the . . . regulation promotes a substantial government interest 
that would be achieved less effectively absent the regulation'' (United 
States v. Albertini, 472 U.S. 675, 689 (1985)). The added sugars 
declaration will give consumers a tool they need to include added 
sugars as part of a healthy dietary pattern--information that would not 
be readily available absent the regulation.
    (Comment 37) One comment took exception to the fact that the 
requirement for added sugars labeling is for all foods and not limited 
to a smaller subset of foods that account for the majority of added 
sugars consumption (e.g., sweetened beverages), and thus, is ``more 
extensive than necessary to serve [the government] interest'' (citing 
Central Hudson, 447 U.S. at 566).
    (Response) We disagree. The required added sugars declaration is no 
more extensive than necessary to serve its purpose (see Central Hudson, 
447 U.S. at 566). Again, this standard does not require the government 
to employ ``the least restrictive means'' of regulation or to achieve a 
perfect fit between means and ends, but rather a ``reasonable'' fit by 
adopting regulations ```in proportion to the interest served''' (Bd. of 
Trustees v. Fox, 492 U.S. 469, 480 (1989)). Moreover, the required 
disclosure does more to advance our interests to promote public health, 
prevent misleading labeling, and assist consumers in maintaining 
healthy dietary practices than a disclosure that was limited to a 
subset of foods. Added sugars are used in a variety of foods from all 
food categories. For example, although some foods, such as sugar-
sweetened beverages, may contain more added sugars relative to other 
beverages, that does not mean that a consumer is going to consume only 
those sugar-sweetened beverages that contain the most added sugars, and 
therefore, would only need added sugars information on the foods that 
contain some higher threshold of added sugars. Furthermore, the percent 
DV of less than 10 percent of calories from added sugars pertains to 
all calorie sources of added sugars, not just those categories that 
contain a certain higher amount of added sugars per serving of food 
relative to other foods in the same or similar food category. 
Therefore, a consumer needs to understand the contribution of all 
sources of added sugars in his or her diet to reduce calories from 
added sugars to less than 10 percent of the total. Those foods with 
fewer added sugars consumed over the course of a day can add up to 
levels that may meet or exceed 10 percent of total calories. Moreover, 
for some food categories, consumers may not even recognize the food as 
one that contributes added sugars to the diet (e.g., condiments, 
sauces, canned fruits and vegetables, and some snacks), much less, the 
relative contribution. Limiting the required disclosure to only certain 
foods that exceed a certain level of added sugars before a declaration 
is required would undermine our efforts in getting information needed 
for making informed food purchases into the hand of consumers to enable 
them to achieve a healthy dietary pattern. In addition, the required 
disclosure is not unduly burdensome in that it is a factual disclosure 
confined to one line on the Nutrition Facts label and will enable 
consumers to understand the information in the Nutrition Facts label 
and how the contribution of added sugars from a food fits into the 
daily diet.
    (Comment 38) One comment questioned whether the use of the 
Nutrition Facts format was too restrictive under the First Amendment 
for conveying nutrition information about a product, noting that 
Congress did not prescribe a particular format or means by which to 
convey nutrition information. The comment stated that section 403(q) of 
the FD&C Act provides that a food will be misbranded ``unless its label 
or labeling bears nutrition information.'' The comment suggested that 
nutrition information conveyed through labeling that does not 
physically accompany the product, such as at the point of purchase, on 
the Internet, or through a smart phone application, would be a less 
prescriptive means of conveying the required information.
    (Response) To the extent the comment suggests a completely 
different approach to conveying nutrition information that is separated 
from, and not on, the food label itself, by use of a smart phone, 
Internet, or posted somewhere in the store, the comment provided no 
data or information to support why those approaches would assist 
consumers as well as, if not better, than having the information on the 
label itself at point-of-purchase. Not all consumers own smart phones 
or computers, or even if they did, would necessarily take these 
electronic devices to the store to research the nutrient profile of 
each food they are considering to purchase. It also is unclear how 
added sugars and other nutrient information in the Nutrition Facts 
label would be accessed by posting in the aisles or somewhere else in 
the store for the number of foods stocked within each area or how a 
consumer would find the information that matched the product picked up 
off the shelf. The Nutrition Facts label provides product-specific 
information that is readily accessible to the consumer at point-of-
purchase in the store, when consumers would use the information to 
understand the nutrient content and compare products for purposes of 
deciding whether to purchase the product. Because the comment's 
suggested alternative would be less effective than the required 
disclosure in advancing the relevant government interests, we disagree 
with the comment.
    (Comment 39) One comment stated the compelled disclosure of added 
sugars is more extensive than necessary to serve ``a speculative 
interest by FDA.'' The comment suggested that an

[[Page 33766]]

interest to help consumers select diets that are nutrient rich, where 
foods high in solid fats and added sugars do not displace food with 
greater nutrient density, could be served by consumer education and not 
a listing of added sugars.
    (Response) We disagree our interest is speculative. We have 
substantial government interests in promoting the public health, 
preventing misleading labeling, and assisting consumers to maintain 
healthy dietary practices. These interests are supported by the science 
and our 20-plus year history of the use of the Nutrition Facts label to 
convey accurate, truthful, non-misleading information about the 
nutrient content of a food to the consumer at point-of-purchase. We do 
not consider consumer education alone to be a reasonable alternative to 
the declaration on the label because consumers need to know the amount 
of added sugars in specific foods, not simply general concepts, and to 
understand how to incorporate added sugars into a healthy dietary 
pattern. Providing the gram amount of added sugars in a serving of food 
on the label, which is the same information provided for other 
nutrients on the label, is sufficiently narrowly tailored to advance 
our interests in providing nutrition information to promote the public 
health, prevent misleading labeling, and assist consumers in 
maintaining healthy dietary practices. The nutrition information will 
be readily available to consumers at point-of-purchase which is the 
time and place that is critical to a consumer's purchasing decision and 
considering the relative significance of the information in the context 
of their total daily diet. Because the proposed alternative would be 
less effective than the required disclosure in advancing the relevant 
government interests, we disagree with the comment.
    (Comment 40) One comment stated an added sugars declaration does 
not seem to fit the requirements under Central Hudson to directly 
advance the government interest asserted or not be more extensive than 
necessary to serve that interest because: (1) The current label already 
provides information on nutrient density and total sugar content; (2) 
there is no consumer research showing that consumers understand the 
meaning and role of added sugars; (3) there is no nutritional or 
physiological difference between added and naturally occurring sugars; 
and (4) other sources of excess calories would contribute to weight 
gain.
    (Response) We have explained, in our response to comment 39, why 
the added sugars declaration directly advances our substantial 
government interests. We also explained, in our response to comment 39, 
why the added sugars declaration is not more extensive than necessary 
to serve our government interests. We disagree that the current label 
provides information on nutrient density because, although the current 
label provides information on total sugar content, it does not provide 
information on added sugars content which is information consumers need 
to understand to avoid the excess contribution of empty calories. To 
the extent the comment suggests that we would need consumer research 
showing that consumers understand the meaning and role of added sugars 
before we require a declaration of added sugars, we disagree. The FD&C 
Act does not require us to establish that consumers have a level of 
understanding about a nutrient before we can compel disclosure of that 
nutrient on the label. In fact, the label is the means by which the 
consumer can access new nutrition information that we have determined 
is necessary to maintain healthy dietary practices.
    (Comment 41) One comment stated that added sugars declaration is 
subject to strict scrutiny (citing Reed v. Town of Gilbert, 135 S. Ct. 
2218 (2015)) because of discrimination between added and naturally 
occurring sugars. The comment stated that the two categories of label 
declarations for added sugars and naturally occurring sugars is a 
content-based regulation of speech. In particular, the comment stated 
that cranberries and other fruit to which sugar is added are 
nutritionally comparable to fruit that contains only natural sugars, so 
a declaration of added sugars would mislead consumers into believing 
the products without added sugars are healthier. The comment said there 
is no compelling government interest, and the declaration is not 
narrowly tailored, where the added sugars are listed in the ingredient 
statement. The comment said a footnote could be provided to clarify the 
sugars are added for palatability.
    (Response) We disagree that the added sugars declaration is subject 
to strict scrutiny under Reed v. Town of Gilbert. Reed involved a town 
sign code, which involves ``quintessential public fora'' (McLaughlin v. 
City of Lowell, 2015 U.S. Dist. LEXIS 144336 (D. Mass. Oct. 23, 2015)). 
Reed does not apply to commercial speech, which is the only type of 
speech at issue here (see, e.g., CTIA--The Wireless Ass'n v. City of 
Berkeley, Cal., Civ. No. 15-2529 (EMC), 2015 U.S. Dist. LEXIS 126071 
*31 through 33 (N.D. Cal. Sept. 21, 2015) (``[A]s the Supreme Court has 
emphasized, the starting premise in all commercial speech cases is the 
same: The First Amendment values commercial speech for different 
reasons than non-commercial speech, and nothing in its recent opinions, 
including Reed, even comes close to suggesting that that well-
established distinction is no longer valid.''); Chiropractors United 
for Research & Educ., LLC v. Conway, 2015 U.S. Dist. LEXIS 133559 (W.D. 
Ky. Oct. 1, 2015) (``Because the New Solicitation Statute constrains 
only commercial speech, the strict scrutiny analysis of Reed is 
inapposite.''); San Francisco Apt. Ass'n v. City & Cnty. of San 
Francisco, 2015 U.S. Dist. LEXIS 150630 (N.D. Cal. Nov. 5, 2015) 
(``Reed is inapplicable to the present case, for several reasons, 
including that it does not concern commercial speech.''); Cal. Outdoor 
Equity Partners v. City of Corona, 2015 U.S. Dist. LEXIS 89454 (C.D. 
Cal. July 9, 2015) (``Reed does not concern commercial speech''); 
Timilsina v. West Valley City, 2015 U.S. Dist. LEXIS 101949 (D. Utah 
June 30, 2015) (``Because the parties agree this case concerns 
commercial speech and the Central Hudson applies, the Court need not 
address how the regulation would fare under [Reed]'')). Moreover, Reed 
involved review of ``content-based restrictions on speech'' (Reed, 135 
S. Ct. at 2231). Here, we are requiring the disclosure of factual 
information, which is properly reviewed under the standards articulate 
in Zauderer and its progeny (Sorrell, 272 F.3d at 113 to 114 
(``Commercial disclosure requirements are treated differently from 
restrictions on commercial speech because mandated disclosure of 
accurate, factual, commercial information does not offend the core 
First Amendment values of promoting efficient exchange of information 
or protecting individual liberty interests. Such disclosure furthers, 
rather than hinders, the First Amendment goal of the discovery of truth 
and contributes to the efficiency of the 'marketplace of ideas.' '')). 
The added sugars declarations, together with the other nutrient 
declaration on the nutrition label, contribute to the marketplace of 
ideas by providing information that may help consumers to use and 
understand the amount of added sugars, along with the other nutrients 
listed, in constructing a healthy dietary pattern to reduce the risk of 
chronic disease and achieve a calorie intake that limits excess intake 
of empty calories from unhealthy types of fats and from added sugars.
    With respect to the comment's assertion that products with 
different

[[Page 33767]]

added sugars content would mislead consumers into believing the 
products without added sugars are healthier, we explain in our 
discussion of consumer research in part II.H.3.g why the findings of 
some consumer perceptions about what is ``healthy'' does not mean that 
the added sugars declaration is misleading. Furthermore, we also 
explain, in our response to comment 21, why the ingredient listing is 
not sufficient to convey the amount of added sugars in serving of a 
product. With respect to the use of a footnote or other language on the 
palatability of a food without added sugars, we are not setting forth 
requirements in this final rule on labeling information about this 
practice, and any labeling information must be truthful and not 
misleading. Lastly, as we explain in our response to comment 28, we 
disagree that we do not have a substantial government interest or that 
the added sugars declaration is not narrowly tailored.
    (Comment 42) One comment stated that an added sugars declaration is 
inconsistent with the First Amendment because it would send a message 
with which the manufacturer disagrees. The comment said it is the total 
number of calories consumed, not the type of calories consumed, which 
determines the potential for weight gain. Another comment stated that a 
strict scrutiny test should be applied to the added sugars declaration 
because the declaration is ``an inherently subjective, judgmental 
statement in the guise of a purely factual declaration.'' The comment 
stated that the declaration is ``designed to convey the unsupported 
opinion that added sugars are somehow more adverse to health than 
sugars that occur naturally.'' Another comment stated that an added 
sugars declaration would compel food producers to tell their consumers 
that avoiding added sugars is a meaningful factor in maintaining 
healthy dietary practices, which producers do not believe to be true, 
and requires a higher level of scrutiny to support (citing United 
States v. United Foods, 533 U.S. 405, 411 (2001)). Some comments said 
that we have conceded that the declaration is not meaningful based on 
statements we made in the preamble to the proposed rule (79 FR 11879 at 
11903 through 11904) about added sugars, e.g., that added sugars are 
not chemically different than natural sugars, and there is lack of 
scientific agreement on the effects from added sugars to health 
outcomes and contribution to weight gain compared to other calorie 
sources.
    (Response) The declaration of added sugars is an assertion of fact 
in the context of a commercial communication; it is not subjective, 
judgmental, or a matter of opinion. Courts have rejected similar 
arguments from industry attempting to assert that heightened scrutiny 
should be applied to regulation of commercial speech (see, e.g., N.Y. 
State Rest. Ass'n v. N.Y. City Bd. of Health, 556 F.3d 114, 134 (2d 
Cir. 2009) (rejecting argument that menu calorie content disclosures be 
subject to strict scrutiny review); Discount Tobacco, 674 F.3d at 525-
27 (rejecting argument that strict scrutiny applied to tobacco 
warnings, as a compelled `` `subjective and highly controversial' 
marketing campaign expressing its disapproval of their lawful 
products'')). In contrast, United Foods (533 U.S. 405 at 411), which 
concerned the payment of subsidies for speech that was disfavored, has 
no bearing on the nutrient declaration for added sugars.
    The scientific evidence on which we rely relates to dietary 
patterns and impact to health from consumption of a healthy dietary 
pattern characterized, in part, by a reduced added sugars intake. Added 
sugars are distinguishable from naturally occurring sugars when 
consumed as part of a healthy dietary pattern compared to the current 
U.S. general population's dietary pattern. Indeed, the declaration of 
added sugars is not based on a specific relationship between added 
sugars and disease risk, contrary to what the comments suggest. We made 
that distinction clear in the preamble to the proposed rule (79 FR 
11879 at 11904) when we stated that our rationale to support an added 
sugars mandatory declaration in labeling is different from our 
rationale to support other mandatory nutrients to date which generally 
relates to the intake of a nutrient and a risk of chronic disease.
2. Administrative Procedure Act
    (Comment 43) One comment said that we do not have the required 
reasonable basis to mandate the added sugars declaration because, 
unlike the differences between saturated fats and trans fat, there is 
no physiological distinction between added and naturally occurring 
sugars, no analytical methods to distinguish these sugars, inadequate 
evidence to support a direct contribution of added sugars to obesity or 
heart disease, and that our rationale does not relate to the intake of 
a nutrient and risk of chronic disease, health-related condition or 
physiological endpoint. Another comment cited specific statements we 
made related to added sugars and their link to obesity and other 
statements in which we have stated there is inadequate evidence to 
support the direct contribution of added sugars to obesity, suggesting 
that this is a reversal of the Agency position.
    (Response) We disagree that we do not have a sufficient scientific 
basis to support an added sugars declaration. As we stated in our 
response to comment 21, a physiological distinction between added and 
naturally occurring sugars is not a prerequisite to mandatory 
declaration under section 403(q)(2)(A) of the FD&C Act. Nor is an 
analytical method specific to added sugars a prerequisite to mandatory 
declaration under this section (see the discussion in our response to 
comment 45). Furthermore, we explained in the preamble to the proposed 
rule that our scientific basis for the added sugars declaration for the 
general population, in fact, differed from our rationale to support 
other mandatory nutrients related to the intake of a nutrient and risk 
of chronic disease, a health-related condition or a physiological 
endpoint (see 79 FR 11879 at 11904). Rather than relying on a causal 
relationship between added sugars to obesity or heart disease, we 
considered, in the preamble to the proposed rule (79 FR 11879 at 11902 
through 11908) and the preamble to the supplemental proposed rule (80 
FR 44303 at 44307 through 44309), the contribution of added sugars as 
part of healthy dietary patterns and the impact to public health from 
such patterns. Thus, the comments erroneously focused on the nutrient, 
added sugars, and its independent relationship to health in the general 
population rather than our rationale for mandatory declaration of added 
sugars as part of a healthy dietary pattern.
    (Comment 44) One comment stated the added sugars declaration 
appears to be arbitrary and capricious because the rationale to support 
the added sugars declaration is dramatically different from the 
rationale to support other mandatory nutrients and the added sugars 
content of a food does not always reflect a food's nutritional value 
(such as yogurt) or convey information that is not otherwise available 
from the total sugars declaration. Another comment suggested that the 
supplemental proposed rule does not provide adequate notice and 
explanation for the departures from established precedent and must 
acknowledge the change and provide a reasoned explanation for the 
change (citing Prevor v. FDA, 895 F. Supp. 2d 90 (D.D.C. 2012) and 
Paralyzed Veterans of Am. v. DC Arena L.P., 117 F.3d 579, 586 (D.C. 
Cir. 1997)).
    (Response) We disagree with the comments that suggest the required 
added sugars declaration is arbitrary and capricious under the APA. For 
each nutrient we require be declared on the nutrition label, we 
consider whether the nutrient will assist consumers in

[[Page 33768]]

maintaining healthy dietary practices, consistent with our statutory 
authority in section 403(q) of the FD&C Act. We consider the scientific 
evidence related to that standard for each nutrient we consider for 
mandatory declaration. The scientific evidence on which we rely to make 
that determination for a particular nutrient may differ. With respect 
to added sugars, we considered the evidence related to a healthy 
dietary pattern that is associated with a reduced risk of CVD, 
consumption data showing that Americans are consuming too many calories 
from added sugars, evidence showing that it is difficult to meet 
nutrient needs within calorie limits if one consumes too many added 
sugars, and evidence showing that increased intake of sugar-sweetened 
beverages is associated with greater adiposity in children. 
Specifically, we explained that we were reconsidering whether to 
require the declaration of added sugars based on new data and 
information, including U.S. consensus reports and recommendations 
related to the consumption of added sugars, a citizen petition, and 
public comments (79 FR 11879 at 11902). We explained our rationale for 
requiring an added sugars declaration in the preambles to the proposed 
rule (79 FR 11879 at 11904 and the supplemental proposed rule (80 FR 
44303 at 44308)). The evidence in the 2015 DGAC report, through the use 
of studies on diet quality, supports evidence of a strong association 
between a dietary pattern characterized, in part, by a reduced intake 
of sugar-sweetened foods and beverages and a reduced risk of CVD. We 
also set forth in the supplemental proposed rule our rationale for use 
of the reference amount for added sugars of less than 10 percent total 
daily caloric intake (id.). Thus, we provided the requisite showing, 
consistent with our obligations under the APA, for why an added sugars 
declaration is necessary to assist consumers in maintaining healthy 
dietary practices (see Home Care Ass'n of Am. v. Weil, 799 F.3d 1084 
(D.C. Cir. 2015) (stating the APA imposes ``no special burden when an 
Agency elects to change course'' and the ``reasoned explanation'' under 
the APA for an alternative approach includes an Agency awareness of the 
change in position and good reasons for the change (citing FCC v. Fox 
Television Stations, Inc., 556 U.S. 502, 515 (2009)). We are not 
limited to one body of scientific evidence when exercising our 
discretion under section 403(q)(2)(A) of the FD&C Act; instead, we have 
broad discretion to consider the new scientific evidence and how 
nutrition information may impact human health.
    Moreover, with respect to the comment that the added sugars 
declaration conveys no more information than one could obtain from the 
total sugars declaration, we disagree. As we explain in our response to 
comment 161, the added sugars declaration does convey information that 
is not otherwise available from the total sugars declaration. 
Furthermore, it is not clear why the comment suggests the added sugars 
content does not reflect a food's nutritional value (such as yogurt). 
The added sugars declaration reflects the contribution of that nutrient 
in a serving of the food. We agree that a food, such as yogurt, can 
provide nutritional value to the overall diet even though it contains 
added sugars. The added sugars declaration is one piece of information 
on the nutritional label to help inform the consumer about how the food 
fits into the overall dietary pattern so that the consumer can use that 
information to help achieve a healthy dietary pattern. The cases cited 
by the comment (Prevor v. FDA, 895 F. Supp. 2d 90 (D.D.C. 2012) and 
Paralyzed Veterans of Am. v. D.C. Arena L.P., 117 F.3d 579, 586 (D.C. 
Cir. 1997) (overruled in part by Perez v. Mortg. Bankers Ass'n, 135 S. 
Ct. 1199 (2015))) involve questions related to interpretative rules. 
Therefore, we do not consider them to be applicable to this final rule, 
which is a legislative rule, for which we provided notice and an 
opportunity to comment.
    (Comment 45) Some comments stated that the declaration of added 
sugars is inconsistent with FDA's approach on whether to declare other 
nutrients, specifically stearic acid, acetic, propionic and butyric 
acids, dietary fiber, and carbohydrates, and cited statements in the 
preamble to the proposed rule related to chemically distinct nutrients. 
The comments stated that our rationale for not labeling these other 
substances separately is based on the fact that these are not 
chemically distinct or are based on whether analytical techniques are 
available to verify the declared amount on the label. The comments said 
that we did not explain why we departed from our traditional approach 
for the added sugars declaration, and, therefore, our decision 
regarding the declaration of added sugars appears arbitrary and 
capricious under the APA (citing Atchison, T. & S. F. R. v. Witchita 
Board of Trade, 412 U.S. 800 (1973) and Allentown Mack Sales and Serv. 
v. NLRB, 522 U.S. 359 (1998)).
    (Response) We disagree with the suggestion that we only consider 
requiring the mandatory declaration of a nutrient where the nutrient is 
chemically distinct from other nutrients or when there is an available 
analytical method to test the presence of the nutrient in a food. The 
comment cited particular statements in the preamble to the proposed 
rule in which we made reference to a nutrient's chemical definition, 
composition, or structure. However, the statements cited in the comment 
do not support the propositions asserted by the comment. We consider 
the need for a mandatory declaration based on whether the nutrient is 
necessary to assist consumers to maintain healthy dietary practices, 
consistent with our authority under section 403(q)(2)(A) of the FD&C 
Act, whereas the statements cited by the comment concern 
characteristics of nutrients that are not necessarily related to 
whether the nutrient can assist consumers to maintain healthy dietary 
practices. For example, as part of our discussion of stearic acid in 
the preamble to the proposed rule (79 FR 11879 at 11894), we did not 
agree to declare stearic acid as a nutrient rather than as part of the 
saturated fat declaration because saturated fat intake is based on 
scientific evidence related to the intake of all saturated fatty acids, 
including stearic acid, and the potential effects to human health from 
changes in the dietary intake of stearic acid on the risk of CVD remain 
unclear (79 FR 11879 at 11894 through 11895). Furthermore, we 
discussed, in response to a request in a petition requesting FDA to 
define total fat to exclude acetic, propionic, and butyric acids, based 
on the chemical differences of these acids from other fatty acids 
comprising total fat, that these acids were not chemically distinct 
based on the reasons set forth by the petitioner (79 FR 11879 at 
11893). We further explained that the petitioner did not explain why we 
should define total fat based on physiological differences, even if 
such differences existed (id.). Thus, we examine, on a case-by-case 
basis, whether a nutrient is necessary to assist consumers to maintain 
healthy dietary practices.
    Similarly, the statements the comment included for dietary fibers 
and carbohydrate classification are taken out of context and do not 
support the comment's proposition. We discussed the reasons for 
separating dietary fiber from the definition of total carbohydrate and 
determined, for several reasons, it was not necessary to change the 
calculation of carbohydrate by difference (79 FR 11879 at 11900). We 
also referenced the 2007 ANPRM in

[[Page 33769]]

which we were considering whether to classify carbohydrates by chemical 
definition or physiological effect (79 FR 11878 at 11901). While we 
recognized that analytical methods would distinguish carbohydrates 
based on chemical structure and not physiological effects, we 
determined that given the various components of total carbohydrate and 
different types of physiological effects of these components that, for 
the class of total carbohydrates, a definition based on physiological 
effects would not be a better approach than a chemical definition 
(id.). We did not consider an analytical method to be a necessary 
prerequisite to the declaration for carbohydrate. Thus, we have not 
limited ourselves to the need for a chemical distinction for a nutrient 
before we would consider the mandatory declaration of the nutrient 
under section 403(q)(2)(A) of the FD&C Act. For these reasons, we 
disagree with the comment's apparent assertion that we departed from a 
traditional approach related to requiring a nutrient be chemically 
distinct for mandatory labeling, and that therefore the added sugars 
declaration is somehow arbitrary and capricious under the APA.
    (Comment 46) One comment stated that we would violate section 
706(2) of the APA if we finalized a declaration for added sugars 
because the proposed declaration of added sugars was not reasoned 
decision making, where we did not complete the consumer study before 
proposing the required declaration. The comment cited references that 
would analogize this situation to one where an Agency relied on a 
defective or discredited study to support a rule (e.g., St. James 
Hospital v. Heckler, 760 F. 2d 1460, 1468 (7th Cir. 1985); Almay, Inc. 
v. Califano, 569 F.2d 674 (D.C. Cir. 1977), or where the study authors 
did not agree with the use of the research for a particular application 
relied on by an Agency (Humana of Aurora, Inc. v. Heckler, 753 F.2d 
1579 (10th Cir. 1985)). With respect to the consumer research we 
conducted on added sugars, the comment asserted that, ``FDA in this 
situation recognized that such a study was essential'' and that without 
a consumer study, the factual basis for the requirement would be 
lacking (citing Motor Vehicle Mfrs. Ass'n of United States v. State 
Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983)). The comment also 
said we failed to provide an adequate notice and opportunity for 
comment on the results of the consumer research study because the 
comment period would be closed before the study is completed (citing 
Doe v. Rumsfeld, 341 F. Supp. 2d 1 (D.D.C. 2004); Service v. Dulles, 
354 U.S. 363 (1957); Conn. Light & Power Co., v. Nuclear Regulatory 
Com, 673 F.2d 525, 530 through 531 (D.C. Cir. 1982); and American Iron 
& Steel Inst. v. OSHA, 939 F.2d 975, 1009 through 1010 (D.C. Cir. 
1991); Small Refiner Lead Phase-Down Task Force v. Environmental 
Protection Agency, 705 F.2d 506, 540 through 541 (D.C. Cir. 1983); 
Sierra Club v. Costle, 657 F.2d 298, 398 (D.C. Cir. 1981)).
    (Response) We disagree that a consumer study related to the added 
sugars declaration is required before we can finalize a requirement to 
compel the declaration under section 403(q)(2)(A) of the FD&C Act. Our 
discretionary authority to require an added sugars declaration can be 
exercised if we determine the declaration is necessary to assist 
consumers to maintain healthy dietary practices. Our rationale for the 
declaration is supported by sufficient evidence set forth in the 2010 
DGA and the 2015 DGAC Report, in part, related to the role of sugar-
sweetened foods and beverages as part of a healthy dietary pattern 
compared to less healthy dietary patterns, and the relationship between 
healthy dietary patterns and risk of chronic disease. In addition, the 
evidence and conclusions from the 2010 DGA support that consumption of 
excess calories from added sugars can lead to a less nutrient-dense 
diet and that current consumption data show that Americans are 
consuming too many calories from added sugars. Moreover, there is 
strong evidence that greater intake of sugar-sweetened beverages is 
associated with increased adiposity in children. Furthermore, section 
403(q) of the FD&C Act does not require us to complete a consumer study 
before we can make the finding in section 403(q)(2)(A) of the FD&C Act 
to require a nutrient declaration.
    We explained why we were conducting consumer research in the 
preamble to the proposed rule. We discussed, in the context of the 
placement of added sugars on the label, our plan to conduct a consumer 
study to help enhance our understanding of how consumers would 
comprehend and use the new information and to publish the results of 
the consumer research when available (79 FR 11879 at 11952). We 
published the results of our consumer research in a supplemental 
proposed rule to present those study findings (80 FR 44303; July 27, 
2015), and provided the raw data for the consumer study in response to 
requests for such data (80 FR 54446; September 10, 2015). Contrary to 
what the comment suggested, the consumer research studied consumer 
reactions to the declaration to help inform our future educational 
efforts related to food labeling and was not conducted for the purpose 
of determining whether we had the requisite scientific basis to declare 
added sugars under section 403(q)(2)(A) of the FD&C Act (80 FR 44303 at 
44306). We consider consumer research helpful to understand how to best 
utilize our consumer education efforts when changes to the label are 
made. Moreover, in response to our findings from the ``Experimental 
Study on Consumer Responses to the Nutrition Facts Labels with 
Declaration of Amount of Added Sugars'' that showed some participants 
were confused by the total sugars declaration when added sugars was 
indented below total sugars, we considered these findings and comments 
received on the consumer research in making changes to the declaration 
of added sugars to reduce the potential for consumer confusion. With 
respect to the comment that we failed to provide an adequate notice and 
opportunity for comment on the results of the consumer research study, 
we note that this comment was submitted in response to the proposed 
rule published in March 2014, before the publication of the consumer 
research results in July 2015 and raw data in September 2015. 
Therefore, the cases to which the comment cites, concerning the need 
for notice and opportunity for comment, are moot. Furthermore, we are 
not relying on a defective or discredited study to support a rule or 
one where the study authors do not agree with the use of the research 
for a particular application relied on by the Agency and therefore do 
not need to address the cases cited in comments on these issues.
    (Comment 47) One comment asserted that we did not provide an 
adequate legal justification for why we were not relying on the IOM DRI 
Report with respect to developing a DRI for added sugars and instead 
relying on evidence in the DGAC Report.
    (Response) We disagree that we did not provide an adequate 
explanation for the DRV for added sugars, nor did the comment further 
explain the basis for its assertion. We explained why we were not 
relying on the IOM DRI Report in the preamble to the proposed rule (79 
FR 11879 at 11906). Specifically, we explained that the IOM did not 
establish a DRI, such as a UL, for added sugars, nor did the IOM define 
an intake level at which an inadequate micronutrient intakes occur. 
Thus, there was no level for added sugars, based on the IOM review, on 
which we could rely for a reference amount. In the preamble to the

[[Page 33770]]

supplemental proposed rule (80 FR 44303 at 44308), we discussed the 
availability of the data and information from the 2015 DGAC Report to 
support a DRV for added sugars to below 10 percent of total energy 
intake based on the modeling of dietary patterns, current added sugars 
consumption data, and a published meta-analysis on sugars intake and 
body weight (id.). We tentatively concluded that the scientific 
information in the 2015 DGAC Report provided the basis on which we 
could rely to support a DRV reference point for the added sugars 
declaration (id.). We respond to comments in this final rule to further 
explain the basis for the added sugars declaration under our authority 
in section 403(q)(2)(A) of the FD&C Act.
    (Comment 48) One comment questioned whether we provided 
stakeholders with an opportunity to provide meaningful comments. 
Specifically, the comment seemed to object to the period provided for 
comment on the raw data for the consumer studies, and the limited scope 
of the comment on the supplement proposed rule to the issues presented 
in that document. The comment stated that we have no authority to 
propose rules in a ``piecemeal fashion'' and must consider comments 
that address the impact of the final rule as a whole.
    (Response) We consider the comment periods provided for the 
supplemental proposed rule (80 FR 44303; July 27, 2015) and the raw 
data on the consumer studies (80 FR 5446; September 10, 2015), to 
October 13, 2015 to be sufficient. The comment did not provide any 
basis for why the comment period did not provide a sufficient time 
during which meaningful comments could be submitted, nor did the 
comment provide a basis to support its assertion that we lack authority 
to issue a supplement to the proposed rule. The supplemental proposed 
rule (80 FR 44303) provided notice and an opportunity for comment on 
relevant new data and information for consideration in the final rule, 
including the findings of the consumer study on the added sugars 
declaration and footnote. Thus, there was adequate notice and an 
opportunity for comment on the issues. We considered the comments we 
received in response to the proposed rule and supplemental proposed 
rule when developing the final rule.
    (Comment 49) One comment suggested that we are ignoring the section 
of the DGAC Report that focuses on scientific studies about the 
specific relationship between added sugars and CVD, for which there is 
moderate evidence, and referred to this as a ``blatant abuse of 
discretion.'' The comment stated that we are mischaracterizing the 
evidence related to a specific relationship between added sugars and 
CVD as ``strong'' rather than ``moderate'' and described this outcome 
as arbitrary and capricious and an abuse of discretion in violation of 
the APA. Other comments stated that the ``moderate'' evidence does not 
meet our standard of ``significant scientific consensus'' or the 
``factual basis'' standard required (citing Motor Vehicle Mfrs Ass'n v. 
State Farm Mut. Auto. Ins Co., 463 U.S. 29 (1983) and A.L. Pharma, Inc. 
v. Shalala, 62 F.3d 1484, 1491 (D.C. Cir. 1995)). One comment further 
stated the specific relationship between added sugars and CVD is 
moderate, and as such, the evidence is mixed and inconclusive and 
therefore such a change in policy will be overturned (citing AFL-CIO v. 
Dole, 745 F. Supp. 18, 21 (D.D.C. 1990) rev'd on other grounds, 923 
F.2d 182 (DC Dir. 1991)).
    (Response) The comments may not have considered or appreciated the 
evidence on which we rely for the added sugars declaration. There is 
scientific evidence demonstrating a strong association between a 
healthy dietary pattern characterized, in part, by a lower amount of 
sugar-sweetened foods and beverages and the reduced risk of CVD. The 
scientific evidence in Chapter 6 of the 2015 DGAC report, concerns an 
entirely different body of evidence based on an independent 
relationship of added sugars with chronic disease risk. The comments do 
not address the evidence of the strong association between a healthy 
dietary pattern (including, with regard to added sugars, lower intakes 
of sugar-sweetened foods and beverages), relative to less healthy 
dietary patterns, and reduced risk of chronic disease, set forth in 
Chapter 2 Part D of the 2015 DGAC report. Our reliance on this 
scientific evidence does not mean we abused our discretion, nor does it 
mean we are mischaracterizing the evidence. We are not relying on the 
scientific evidence with regard to the independent relationship of 
added sugars and specific chronic diseases as the basis to require an 
added sugars declaration, and we have described the basis for our 
required added sugars declaration and the evidence we rely on in the 
preamble to the proposed rule (79 FR 11879 at 11902 through 11905), the 
supplemental proposed rule (80 FR 44303 at 44307 through 44308) and 
this final rule.
    (Comment 50) One comment asserted the DGAC report violates the 
National Nutrition Monitoring and Related Research Act of 1990 (NNMRRA) 
because there were no scientific studies reviewed by the DGAC on 
consumer comprehension of an added sugars declaration, and therefore, 
the recommendation for added sugars labeling was not based on a 
preponderance of the scientific and medical knowledge required under 
section 301(a) of the NNMRRA for information and guidelines in the 
report. The comment stated that FDA's reliance on the DGAC report for 
added sugars labeling therefore violates section 706(2) of the APA in 
that it lacks a factual basis and is thus arbitrary and capricious in 
violation of the APA. The comment also stated that the HHS and USDA 
violated section 5 of the Federal Advisory Committee Act (FACA) in 
creating the 2015 DGAC because the committee was not ``fairly 
balanced.'' The comment said that our reliance on the DGAC Report is 
arbitrary and capricious in violation of section 706(2) of the APA. 
Another comment said the proposed added sugars declaration and DRV 
violate FACA because the DGAC Report and the science supporting the 
requirements are not sufficiently reliable or objective.
    (Response) We disagree that the required declaration of added 
sugars violates section 706(2) of the APA based on independent 
authorities in NNMRRA and FACA with respect to the 2015 DGAC Report. 
The mandatory added sugars declaration in nutrition labeling is based 
on our authority in section 403(q)(2)(A) of the FD&C Act and not on the 
separate and independent authority in NNMRRA. Contrary to what the 
comments stated, we considered and relied on the scientific evidence in 
the DGAC Report for the purpose of determining whether an added sugars 
declaration will assist consumers in maintaining healthy dietary 
practices, and did not rely on a DGAC Report recommendation. The 
comment concerning whether the 2015 DGAC Report violated section 301(a) 
of NNMRRA is separate and distinct from our authority under section 
403(q)(2)(A) of the FD&C Act and outside the scope of this rule.
    Moreover, with respect to the comments expressing concerns about 
section 5 of FACA in relation to the 2015 DGAC Report, we reviewed the 
available scientific evidence to determine whether to require an added 
sugars declaration, based on our authority in section 403(q)(2)(A) of 
the FD&C Act. We included, in our review, evidence from the 2015 DGAC 
Report, the 2010 DGA, NHANES data on U.S. consumption patterns, and 
other data and information. The DGAC selection and review process is an 
interagency

[[Page 33771]]

process that includes HHS and USDA and is outside the scope of this 
rule.
    (Comment 51) One comment stated that we should further consider the 
effects of the definitions (such as dietary fiber) and Daily Values on 
existing nutrient content and health claims authorized under section 
403(r) of the FD&C Act. The comment stated that claims for certain 
foods that currently qualify for a claim may no longer qualify, and the 
comment stated it anticipated that restrictions may include claims that 
are part of brand names and trademarks, and therefore, implicate First 
Amendment and Fifth Amendment ``takings'' issues. The comment further 
stated that, without a thorough evaluation of these ``collateral 
implications'' the final rule ``would fall short of administrative law 
requirements'' (citing Prometheus Radio Project v. FCC, 373 F.3d 372, 
420-21) (3d Cir. 2004) and Sprint Corp. v. FCC, 315 F.3d 369, 377 (D.C. 
Cir. 2003)).
    (Response) In the preamble to the proposed rule (79 FR 11879 at 
11889), we recognized that changes to the list of nutrients declared on 
the label and changes to the RDIs and DRVs of nutrients could affect 
whether some foods that contained a nutrient content or a health claim 
prior to the publication of the final rule would no longer meet a 
defined term or eligibility requirement to make the claim. We stated 
that we plan to evaluate the impact of any changes in a final rule on 
other FDA regulations and address them, as appropriate, in a future 
rulemaking (id.). To the extent the comment suggests we must consider 
impacts to food products that currently declare certain non-digestible 
carbohydrates as dietary fiber, but that may no longer be able to 
declare these carbohydrates as dietary fiber based on the definition of 
``dietary fiber'' in the final rule, we provided notice and an 
opportunity to comment on the proposed definition and have responded to 
comments in this final rule.
    To the extent the comment suggests we must enlarge the scope of 
this rulemaking to consider what specific food products may no longer 
qualify for a nutrient content or health claim, or may include claims 
that are part of brand names, we disagree. The final rule concerns 
changes to the nutrient declarations in the Nutrition Facts label and 
Supplement Facts label under our authority in section 403(q) of the 
FD&C Act. The final rule does not include within its scope nutrient 
content claim or health claim regulations we promulgated under our 
independent authority in section 403(r) of the FD&C Act. Our decision 
on what RDI or DRV we select for a nutrient for purposes of nutrition 
labeling to ensure the information will assist consumers in maintaining 
healthy dietary practices is distinct from, and would precede a 
decision on, how to define a term for a nutrient content claim or 
establish an eligibility criterion for a health claim. Therefore, we 
are not obligated to consider changes to the requirements for nutrient 
content claims or health claims in this final rule (see Home Box 
Office, Inc. v. FCC, 567 F.2d 9, 36 n. 58 (D.C. Cir. 1977), cert. 
denied, 434 U.S. 829 (1977) (``In determining what points are 
significant, the `arbitrary and capricious' standard of review must be 
kept in mind . . . only comments which, if true, raise points relevant 
to the agency's decision and which, if adopted, would require a change 
in an agency's proposed rule cast doubt on the reasonableness of a 
position taken by the agency.'')).
    For example, we have established a number of defined terms for 
nutrient content claims based on the percent of the DV provided in a 
reference amount customarily consumed for food that bears the claim 
(e.g., ``high'' and ``good source'' in 21 CFR 101.54). Any changes we 
may consider to the definition of those terms based on changes made to 
the DV in this final rule would be in a separate rulemaking, consistent 
with our authority in section 403(r) of the FD&C Act. We plan to 
evaluate the impact of any changes on other FDA regulations and 
address, as appropriate, those impacts in a future rulemaking. 
Furthermore, the comment suggesting there may be restrictions in using 
claims that include brand names and trademarks did not provide any 
further explanation. To the extent there are such circumstances, those 
would be considered in a separate rulemaking where we consider such 
claims. Lastly, the cases cited by the comment concern the distinction 
between an interpretive rule and a legislative rule and are 
inappropriate to this final rule, which is a legislative rule for which 
we provided notice and an opportunity to comment.
3. Federal Food, Drug, and Cosmetic Act
    We are updating the Nutrition Facts label and Supplement Facts 
label, as set forth in this final rule, consistent with our authorities 
in sections 403(q), 403(a)(1) and 201(n), and 701(a) of the FD&C Act.
    (Comment 52) Some comments questioned whether the declaration of 
added sugars to limit consumption of added sugars was a material fact 
under sections 403(a) and 201(n) of the FD&C Act. One comment stated 
that we must demonstrate that the absence of a declaration of added 
sugars on the nutrition label would be misleading to consumers.
    (Response) The declaration of added sugars is a material fact under 
sections 403(a) and 201(n) of the FD&C Act, as we explain in our 
response to comment 159. Under section 201(n) of the FD&C Act, labeling 
is misleading if it fails to reveal facts that are material with 
respect to consequences which may result from the use of the article to 
which the labeling relates under the conditions of use prescribed or 
under conditions of use as are customary or usual.
    Here, we have determined that the evidence shows that healthy 
dietary patterns associated with a decreased risk of chronic disease 
are lower in added sugars, consumption of too much added sugars can 
impact the nutrient density of the diet, and consumption of sugar-
sweetened foods and beverages are associated with increased adiposity 
in children. Furthermore, the scientific evidence supports limiting 
added sugars intake to less than 10 percent of total calories. We note 
that this limit was adopted as a recommendation in the 2015-2020 DGA. 
The current intake of discretionary calories from added sugars in the 
U.S. population is excessive. The excess intake of calories from added 
sugars displaces the calories from other foods that are needed as part 
of a healthy dietary pattern in order to reduce the risk of CVD. 
Without information on the amount of added sugars in a serving of a 
food, consumers would not be able to determine the amount of added 
sugars in particular foods, and therefore would not have the 
information they need to place a particular food in the context of 
their total daily diet to construct a healthy dietary pattern that 
contains less than 10 percent of calories from added sugars. Thus, the 
amount of added sugars in a food is a material fact with respect to the 
consequences which may result from the use of the article under the 
conditions of use prescribed or under conditions of use as are 
customary or usual.
    Moreover, section 403(q) of the FD&C Act gives us the authority to 
require nutrient declarations that we have determined provide 
information that will assist consumers to maintain healthy dietary 
practices.
    (Comment 53) Some comments said the declaration of added sugars is 
itself misleading. The comments highlighted statements in the preamble 
of the proposed rule that there is no physiological difference between 
added sugars and those sugars that are intrinsic to food and there is 
no scientifically supported quantitative intake

[[Page 33772]]

recommendation for added sugars on which a DRV for added sugars can be 
derived and that U.S. consensus reports have determined that inadequate 
evidence exists to support the direct contribution of added sugars to 
obesity or heart disease (79 FR 11879 at 11905 through 11906). Another 
comment stated that because added sugars are not chemically distinct 
from natural sugars or have different health effects, the declaration 
of added sugars would be false and misleading.
    (Response) We disagree that the declaration of added sugars is 
misleading. The statutory basis for requiring an added sugars 
declaration is whether the Secretary, and by delegation, FDA, 
determines that the nutrient should be included in the labeling of food 
for the purpose of providing information regarding the nutritional 
value of such food that will assist consumers in maintaining healthy 
dietary practices. The statutory framework does not require that the 
nutrient be linked in isolation to any particular chronic diseases nor 
does it specify that the nutrient must be physiologically unique. 
Furthermore, we have determined that there is a scientifically 
supported basis for requiring a DRV of 10 percent for added sugars. We 
address questions as to the specific scientific basis for that DRV in 
part II.H.3. The inclusion of this DRV and the other issues described 
by the comment do not make the declaration of added sugars misleading. 
The declaration of added sugars is a factual statement of the amount of 
this nutrient in the product.
    (Comment 54) One comment said that the declaration of added sugars, 
as applied to cranberry juice products that are nutrient dense and 
sweetened for palatability, presents the same issue related to 
misleading labeling under section 403(a)(1) of the FD&C Act, where 
foods naturally free or low in a nutrient that bear a claim of ``free'' 
or ``low'' must be labeled as a food that is low in that nutrient 
(``broccoli, a fat free food'') to avoid implying the food has been 
altered as compared to foods of the same type. The comment said that 
requiring an added sugars declaration on a cranberry juice product that 
has fewer total sugars than juice containing all natural sugars is 
misleading because it implies the cranberry product with added sugars 
is less nutritious and generally unhealthy (citing United States v. 
Ninety-Five Barrels, 265 U.S. 438, 442-443 (1924) and United States v. 
An Article of Food . . . ``Manischevitz . . . Diet Thins,'' 377 F.Supp. 
746 (E.D.N.Y. 1974)). The comment expressed concern that a shopper 
would focus on the added sugars declaration and not the total sugars 
declaration.
    (Response) The listing of added sugars, which is a subset of the 
amount of total sugars, is not misleading. It is the factual statement 
of the amount of added sugars in a product and the declaration of added 
sugars is one of a number of nutrient declarations on the label which 
consumers can use to assist them in maintaining healthy dietary 
practices. We disagree that the declaration of added sugars is 
equivalent to the need to clarify that all broccoli is fat-free when 
making a fat-free claim about broccoli. First, the declaration of the 
amount of added sugars is not a claim, it is a required declaration. A 
package of broccoli would be required to declare 0 grams of fat on the 
Nutrition Facts label without any additional explanation (Sec.  
101.9(c)(2)). Furthermore, the two cited cases cited by the comment are 
not relevant to the requirement to state the factual declaration of the 
amount of added sugars in a product. The Supreme Court in Ninety-Five 
Barrels was discussing a label of an imitation product that claimed to 
contain the actual ingredient. The Manischevitz Diet Thins case was 
addressing a product using the name ``diet'' that had the same calories 
and overall nutritional profile as the regular non-diet product. Both 
cases found these specific terms used were misleading and noted that 
the FD&C Act condemned statements that mislead about the make-up of the 
product. The declaration of added sugars provides more information to 
consumers about the nutritional make-up of the product to use to help 
them maintain healthy dietary practices. Consumers may have perceptions 
or preferences about a number of nutrients, and which nutrients they 
focus on in choosing food may vary. As we discuss in our response to 
comment 184, whether consumers regard a product as healthy can be a 
combination of many factors, and we intend to engage in education and 
outreach efforts to help consumers understand the role of the added 
sugars declaration and other aspects of the revised Nutrition Facts and 
Supplement Facts labels.
    (Comment 55) One comment stated that the declaration of added 
sugars on cranberry juice, even if true, is ``grossly misleading'' 
under sections 403(a)(1) and 201(n) of the FD&C Act because of a 
failure to reveal the material fact that the human body processes added 
sugars and naturally occurring sugars in the same way. The comment said 
that consumers will falsely regard the cranberry juice as less healthy 
when compared to other fruit juices that have all naturally occurring 
sugars. The comment suggested an alternative method for labeling to 
ensure the added sugars declaration is no longer misleading. The 
alternative method would apply to ``nutritious products made from 
unpalatable fruits'' and would remove the indented Added Sugars 
declaration such that ``The grams and percent of daily value for added 
sugars in a dried unpalatable fruit (a fruit in its raw state has total 
sugars of less than 5 percent and an average Brix-to-acid ration of six 
or less), and a juice product made with at least 27 percent juice of an 
unpalatable fruit, that is sweetened for fruit palatability and 
contains total sugars comparable to naturally sweetened dried fruits 
and 100 percent fruit juices, may be declared by an asterisk next to 
the declaration of total sugars with a footnote at the bottom of the 
nutrition facts panel that shall state: `**Total sugars include sugars 
added for fruit palatability.' ''
    (Response) We disagree with the comment stating that the lack of 
difference in the way the body processes added versus naturally 
occurring sugars is a material fact with regard to the rationale for 
the added sugars declaration. The added sugars declaration is intended 
to assist consumers in maintaining healthy dietary practices based on 
the recommendation to decrease consumption of added sugars and the 
impact of a diet that includes high amounts of added sugars on chronic 
disease measures. We have addressed the consumer research on cranberry 
juice in our response to comment 184 and disagree that the added sugars 
declaration on cranberry juice misbrands the product. While we have 
modified the declaration of added sugars in the final rule, we have 
determined that no additional labeling is needed, as discussed in our 
response to comment 184.
    (Comment 56) One comment stated that the term ``nutrient'' is not 
defined in the FD&C Act or FDA regulations and that it is reasonable 
for Congress to have intended the term to refer to substances that are 
chemically and structurally distinct from each other, with different 
physiological effects, and not based on whether the substance is added 
or inherent to a food. For these reasons, the comment suggested added 
sugars are not an additional nutrient within the context of section 
403(q)(2)(A) of the FD&C Act. The comment referred to the listing of 
nutrients in section 403 of the FD&C Act (e.g., total fat, saturated 
fat, cholesterol, sodium) as scientifically or chemically distinct 
substances and that the nutrients listed in section

[[Page 33773]]

403(q)(1)(D) and (E) of the FD&C Act are not distinguished based on 
whether they are added or inherent to a product. Furthermore, the 
comment said that the fact that verification of the added sugars 
declaration cannot be achieved through objective testing and requires 
records is another reason why Congress did not intend added sugars to 
be a nutrient (citing Util. Air Regulatory Group v. EPA, 134 S. Ct. 
2427 (2014)). Another comment stated that we do not have the statutory 
authority to require the declaration of added sugars because they are 
not ``additional nutrients'' and are part of total sugars.
    (Response) We disagree with the comments that added sugars is not 
compatible with the term ``nutrient'' in sections 403(q)(2) and 
403(q)(1)(D) of the FD&C Act. With regard to the argument that it 
cannot be an additional nutrient if it is a component of total sugars 
or if it is not chemically distinct from total sugars, section 
403(q)(1)(D) of the FD&C Act includes several nutrients that are 
subcomponents of other nutrients on the list, so the comments' 
arguments that each nutrient currently required is chemically distinct 
or that each nutrient is not a subcomponent of another listed nutrient 
is simply not correct. Total fat includes saturated fat, and total 
carbohydrates include sugars and dietary fiber. As these nutrients were 
all required by Congress to be declared on the label, we further 
disagree that Congress intended the nutrients to all be chemically and 
structurally distinct from each other and to have distinct 
physiological effects. Furthermore, the House committee report for the 
NLEA (H.R. 3562) (Report 101-538, June 13, 1990 at page 14) states that 
the Secretary may provide definitions of the nutrients required under 
403(q)(1)(D) or 403(q)(2) of the FD&C Act, and we have done so 
consistent with the public health and based on sound scientific 
principles.
    Additionally, the specific concerns and recommendations about added 
sugars' contribution to the daily diet that are distinct from total 
sugars has led to the requirement for the declaration of added sugars, 
consistent with the stated statutory purpose of assisting consumers to 
maintain healthy dietary practices. Nutrient content claims are defined 
in Sec.  101.13(b) as claims that expressly or implicitly characterize 
the level of a nutrient of the type required to be in nutrition 
labeling under Sec.  101.9 or under Sec.  101.36. We have a ``no added 
sugar,'' ``without added sugar,'' or ``no sugar added'' nutrient 
content claim regulation (Sec.  101.60(c)(2)), supporting the fact that 
added sugars are considered to be a nutrient under the FD&C Act.
    Also, we disagree that, because records would be needed to enforce 
the added sugars declaration, Congress did not intend that added sugars 
be considered a nutrient. Congress did not include any reference to 
``objective testing'' or how enforcement would occur in the statutory 
language with regard to what nutrients should be declared on the label. 
The only criterion discussed in the statutory provision for adding a 
nutrient to the label is whether it will assist consumers in 
maintaining healthy dietary practices. Thus, the comment's reference to 
Util. Air Regulatory Group v. EPA, where the Supreme Court determined 
that an Agency had applied a more general definition to a statutory 
provision with a more narrow meaning given the context of the program, 
is also misplaced in this context. There is no context in the specific 
statutory provision about which nutrients should be declared on the 
label that indicates that it should be limited to nutrients that can be 
``objectively measured.''
    (Comment 57) Some comments stated the added sugars declaration does 
not assist consumers in maintaining healthy dietary practices under 
section 403(q)(2)(A) of the FD&C Act because it misleads consumers into 
believing that products without added sugars, but with the same or 
greater calories and total sugars, are healthier if the product 
contains naturally occurring sugars. Some comments considered our past 
statements, including that added sugars are not chemically distinct 
from naturally occurring sugars and added sugars are not independently 
and directly linked to any disease, health-related condition such as 
obesity, or physiological endpoint, to support the proposition that the 
added sugars declaration would not assist consumers in maintaining 
healthy dietary practices by providing consumers information to 
construct diets that are nutrient dense and reduce calorie intake from 
added sugars.
    (Response) We do not agree that the declaration of added sugars 
misleads consumers based on our consumer research results and those 
results submitted in the comments in response to questions about how 
``healthy'' a product is that contains added sugars. The declaration of 
added sugars provides information about the amount of a single nutrient 
that consumers can use as part of their decisions in building a healthy 
dietary pattern. We are requiring the declaration of added sugars 
because a dietary pattern characterized, in part, by larger amounts of 
added sugars is associated with greater risk of CVD than a healthy 
dietary pattern that includes less added sugars. Therefore, inclusion 
of added sugars above and beyond what is naturally present in foods 
that are part of a healthy dietary pattern is a public health concern. 
The declaration is needed for consumers to be able to identify the 
amount of added sugars in a serving of a product in order to fit that 
product into their total daily diet.
    Added sugars are not chemically different than sugars that are 
naturally present in foods, and one should not avoid all foods that are 
relatively higher in added sugars than others. Consumers can eat a 
healthy diet that includes added sugars, but, in order to carefully 
choose foods so that the overall diet is not high in added sugars 
relative to calorie needs, it is important to consider the amount of 
added sugars in a serving of a product and how the added sugars content 
of that product should be balanced with other food choices.
    (Comment 58) One comment stated that an added sugars declaration is 
not related to the purpose of the NLEA because it does not help 
consumers reduce the risk of a diet-related disease (citing House 
Committee Report 101-538, 101st Congress, 2nd Sess., 13 through 14 and 
the Congressional Record (136 Cong. Rec. H5836 101st Cong. 2nd Sess. 
(July 30, 1990 at 19 and 21)), S. 16610 Cong. Rec. (Oct. 24, 1990)). 
The comment referenced statements from the preamble to the proposed 
rule related to our rationale for other mandatory nutrient declarations 
that relate to the intake of a nutrient that is specifically related to 
the risk of chronic disease, health-related condition, or a 
physiological endpoint. Another comment stated that the purpose of our 
added sugars declaration is to help consumers with dietary planning and 
is not reasonably related to the requirements and purpose of the 
statute.
    (Response) First, we note again that the statutory language in 
section 403(q)(2) of the FD&C Act is that a nutrient can be required 
for the purposes of providing information regarding the nutritional 
value of such food that will assist consumers in maintaining healthy 
dietary practices. This statutory basis is how we determined to propose 
the mandatory declaration of added sugars. Furthermore, the statements 
cited by the comment relating to the Congressional history of the NLEA 
are taken out of context and inappropriately limit the scope of the 
NLEA and its nutrient declaration requirements. The purpose statement 
at the beginning of the House

[[Page 33774]]

Committee Report that the comment referenced actually states, ``The 
purpose of this legislation is to clarify and to strengthen the Food 
and Drug Administration's legal authority to require nutrition labeling 
on foods, and to establish the circumstances under which claims may be 
made about nutrients in foods'' (House Committee Report 101-538, 101st 
Congress, 2nd Sess., 7). The comment's reference to the statements on 
the House floor by Congressman Madigan excluded the most relevant point 
about his more narrow bill with respect to specific chronic disease 
outcomes, that ``Chairman Waxman has graciously included much of the 
language in my bill in this comprehensive nutrition labeling bill'' 
(136 Cong. Rec. H5836 101st Cong. 2nd Sess. (July 30, 1990, at H5843). 
The statement from Senator Hatch seemingly focused on chronic disease 
also follows the more general statement by his co-sponsor Senator 
Metzenbaum that described the broader focus on healthy dietary 
practices, stating, ``By providing the public with better nutrition 
information, this bill makes a major step forward in enabling consumers 
to select foods to protect and improve their health'' (136 Cong. Rec. 
No. 147, S. 16607 101st Cong. 2nd Sess. (Oct 24, 1990, at S. 16608)).
    While the preamble to the proposed rule discussed a different 
framework than an independent relationship between the nutrient and a 
risk of chronic disease, a health-related condition, or a physiological 
endpoint in the general population, added sugars are part of a dietary 
pattern linked to health effects and has been discussed in the recent 
DGA. In 2010, the scientific evidence supported a key DGA 
recommendation to reduce consumption of added sugars because of their 
effect on health due to the inability to eat excess added sugar and 
consume necessary nutrients within recommended calorie limits. In 2015, 
the DGAC Report included evidence that diets that included high amounts 
of added sugars were linked to increased risk of CVD compared to 
dietary patterns that included lower consumption of added sugars. The 
declaration of added sugars squarely fits within the statutory 
framework to assist consumers to maintain healthy dietary practices.
    (Comment 59) One comment said we cannot rely on section 
403(q)(2)(A) of the FD&C Act to support an added sugars declaration 
where we do not rely on an added sugars content of a food to determine 
if the food is ``healthy'' consistent with the nutrient content claim 
requirements for ``healthy'' in 21 CFR 101.65(d)(2). The comment seemed 
to assert that finalizing a requirement for an added sugars 
declaration, where the term ``healthy'' requires no limitation on added 
sugars content, is arbitrary and capricious under section 706(2) of the 
APA (5 U.S.C. 706(2)) and a violation of section 403(q)(1)(D) the FD&C 
Act (also citing Frisby v. HUD, 755 F.2d 1052, 1055 through 1056 (3d 
Cir. 1985) for the proposition that the Agency must follow its own 
regulations). Another comment stated that added sugars content is not 
included in the nutrient content claim for ``healthy,'' and, therefore, 
an added sugars declaration would not assist consumers in maintaining 
healthy dietary practices.
    (Response) We are relying on our authority in section 403(q)(2)(A) 
of the FD&C Act to require the declaration of added sugars, and the 
only consideration for that statutory provision is whether the 
declaration will assist consumers to maintain healthy dietary 
practices. The Frisby case cited by the comment is not relevant because 
the definition of the voluntary ``healthy'' claim under section 403(r) 
of the FD&C Act does not bear on the determination of whether to 
require a declaration on the nutrition facts label, and we plan to 
revisit claims, including the healthy claim, after we finish this 
rulemaking. Furthermore, our finalizing a requirement for an added 
sugars declaration and any separate consideration of the healthy claim 
under section 403(r) of the FD&C Act do not violate the APA, as 
discussed in our response to comment 51.
    (Comment 60) One comment stated the proposed added sugars 
declaration and DRV violate the NLEA because the 2015 DGAC Report and 
the science on which we rely are not sufficiently reliable or 
objective. Another comment suggested that the declaration of added 
sugars violates the FD&C Act and the APA because the DRV for added 
sugars is not based on a NAS report, which the comment stated ``the 
House Committee Report urged'' FDA to rely on for nutrients listed on 
the label, and therefore, presents impermissible and inconsistent 
Agency reasoning that is arbitrary and capricious (citing Allentown 
Mack. Sales & Serv., Inc. v. NLRB, 522 U.S. 359, 374 through 375 
(1998)). The comment considered the use of the 2015 DGAC Report as the 
basis for the DRV to be a departure from past practice that is not 
sufficiently explained and without ``sufficient scientific consensus.''
    (Response) The comment conflates several arguments and statements 
and is incorrect in its reliance on the NLEA's legislative history to 
support its position. The reference to the National Academy of Science 
report in this context also is misplaced. As stated in the comment 
itself, the House Committee's reference in 1990 was to a specific 
National Academy of Science report that had been commissioned at the 
time. The report stated that the ``Committee expects the Secretary to 
consider the hearing record before the Subcommittee and the NAS study 
on nutrition labeling, if that study is available in sufficient time to 
meet the statutory deadline'' (H.R. Rep. No. 101-538, at 17). If the 
report was not completed, it did not need to be taken into 
consideration. Furthermore, this statement in the report did not 
constitute a limiting statement as to future decisions regarding other 
nutrients and what they should be based on. In addition, the comment 
only stated that the decision with regard to the DRV for added sugars 
is based on an impermissible source and did not dispute the entire 
decision to require the declaration of added sugars.
    The reference to the NLRB case is similarly misplaced. The case 
refers to an Agency changing the standard it is applying to a 
determination of the evidence without describing any reasoned basis for 
the change. Here, we have provided a reasoned explanation for requiring 
the declaration and DRV for added sugars, and have done so throughout 
the rulemaking process. The science on the contributions of dietary 
patterns has evolved, and the 2015 DGAC Report contains evidence with 
regard to the effect of a diet that includes lower amounts of added 
sugars compared to a diet that includes higher amounts of added sugars. 
This evidence supplements the growing scientific evidence from the 2010 
DGA and concern about added sugars and their impact on public health 
and the ability to maintain healthy dietary practices by consuming a 
diet sufficient in nutrients within calorie limits, which we included 
in our rationale for the proposed declaration for added sugars. The 
ability of a nutrient declaration to assist consumers in maintaining 
healthy dietary practices remains the determination upon which a new 
nutrient declaration is based.
    (Comment 61) One comment said that we have not adequately explained 
our departure from what the comment characterized as the 2010 DGA's 
focus on added sugars labeling, stating further that we relied on the 
2015 DGAC Report for a strong association between a dietary pattern 
characterized, in part, by a reduced intake of sugar-sweetened foods 
and beverages and reduced risk of

[[Page 33775]]

CVD, which the comment stated is contrary to the law (citing Motor 
Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42 
(1983) and Nat'l Ass'n of Home Builders v. EPA, 682 F.3d 1032, 1037 
(D.C. Cir. 2012)). The comment suggested that NLEA does not authorize 
us to rely on this basis for labeling, and, instead, we must rely on 
the presence or absence of a specific nutrient and disease relationship 
between added sugars and CVD before requiring such labeling, for which 
the comment states only moderate evidence is available. The comment 
cited studies to suggest there is no reliable correlation between added 
sugar content in food and healthy dietary choices or patterns.
    (Response) First, this comment misrepresents the 2010 DGA, citing 
and quoting a line from Appendix 4 that lists the current nutrients 
that are displayed on the Nutrition Facts label and saying that this 
statement is the focus of the 2010 DGA recommendation with regard to 
added sugars, rather than the key recommendation and substantive 
chapter of the 2010 DGA. The comment also mistakenly states that the 
proposed rule and the supplemental proposed rule rely on the findings 
in the 2015 DGAC Report. As we stated in the preamble to the 
supplemental proposed rule (80 FR 44303 at 44307 through 44308), the 
science underlying the 2015 DGAC Report provides further support for 
the declaration of added sugars, which was supported in the proposed 
rule in part by the scientific evidence in the 2010 DGA related to 
reducing calories from added sugar. Thus, contrary to what the comment 
seemed to suggest, we are not departing from the science set forth in 
the 2010 DGA that is included in the evidence on which we rely for 
added sugars, but are also including additional evidence from the 2015 
DGAC Report to further support the added sugars declaration, so the 
cases cited regarding the level of explanation that is necessary to 
explain a change in policy are not relevant.
    The comment suggested that reliance on a rationale other than a 
specific disease relationship between added sugars and CVD is not 
permitted by the NLEA. The NLEA and FD&C Act state that nutrient 
declarations can be added if determined to assist consumers in 
maintaining healthy dietary practices. There is no further restriction 
on the evidence that can be used to support a declaration in the 
statute. Both the preamble to proposed rule and the preamble to the 
supplemental proposed rule thoroughly explain the rationale for the 
required declaration for added sugars.
    Furthermore, a healthy dietary pattern, characterized in part by a 
reduced amount of sugar sweetened foods and beverages, is strongly 
associated with a reduced risk of CVD compared to less healthy dietary 
patterns. Thus, we disagree with the comment's statement that there is 
no reliable correlation between added sugar content in food and healthy 
dietary choices or patterns. The studies cited by the comment that 
looked at nutrient content claims and the data underlying a 2002 IOM 
suggested maximum intake level of 25 percent or less of added sugars 
are not relevant to the basis for our declaration of added sugars. One 
study cited by the comment described how small amounts of added sugars 
may increase the palatability of nutrient-dense foods. We acknowledged 
this finding in the preamble to the proposed rule (79 FR 11879 at 
11905), and it is consistent with the requirement to declare added 
sugars and the percent DV so that consumers can understand how to 
incorporate such amounts of added sugars into their daily diets.
4. Recordkeeping Authority
    The preamble to the proposed rule (79 FR 11879 at 11884 and 11956 
through 11957) discussed our legal authority for the proposed 
recordkeeping requirements. We stated that we were relying on our 
authority under sections 403(q), 403(a), 201(n) and 701(a) of the FD&C 
Act, to propose record requirements to support nutrient declarations in 
labeling for added sugars, dietary fiber, soluble fiber, insoluble 
fiber, vitamin E, and folate/folic acid, under certain circumstances, 
so that we can determine compliance with labeling requirements and take 
enforcement action, as needed. We described how the records 
requirements would apply only to the narrow circumstances where there 
are not any appropriate reliable analytical methods that can be used to 
verify the compliance of a nutrient declaration.
    We noted that 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 
and, moreover, the nutrient declaration must be truthful and not 
misleading under sections 403(a)(1) and 201(n) of the FD&C Act. Thus, 
we stated that the proposed recordkeeping requirements 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. Furthermore, the records would allow us to verify the 
declared amount of each of these nutrients and that such amount is 
truthful and not misleading. Thus, the proposed records requirements 
would help in the efficient enforcement of the FD&C Act. We also noted 
that 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, and cited National Confectioners Assoc. v. Califano, 
569 F.2d 690, 693 through 694 (D.C. Cir. 1978)) (79 FR 11879 at 11884 
and 11957). In addition to having the authority to require the 
maintenance of such records, we further stated that our authority also 
provided for FDA to have access to such records because in order 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. Without such authority to 
access the records supporting the declarations, these nutrient 
declarations that have been determined to be necessary to assist 
consumers to maintain healthy dietary practices would be unenforceable.
    (Comment 62) While several comments supported our proposed 
requirement, many comments broadly asserted that we do not have the 
authority to require recordkeeping.
    (Response) The FD&C Act requires foods to bear truthful and not 
misleading information about the amount of nutrients in the food to 
assist consumers in maintaining health dietary practices (sections 
403(q), 403(a)(1), and 201(n) of the FD&C Act). As we stated in the 
preamble to the proposed rule (79 FR 11879 at 11956), under section 
701(a) of the FD&C Act, we may issue regulations for the efficient 
enforcement of the FD&C Act in order to ``effectuate a congressional 
objective expressed elsewhere in the Act'' (Association of American 
Physicians and Surgeons, Inc. v. FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) 
(citing Pharm. Mfrs. Ass'n. v. FDA, 484 F. Supp. 1179, 1183 (D. Del. 
1980))). The recordkeeping requirements are intended to ensure that the 
nutrient declarations, which would be based on information known only 
to the manufacturer, are truthful and not misleading, and to facilitate 
efficient enforcement of the requirements for nutrient declaration when 
necessary. The recordkeeping requirements are only for foods for which 
official AOAC or other reliable and appropriate

[[Page 33776]]

analytical methods are not available. FDA access to information, in the 
form of a record, required to support an added sugars, dietary fiber, 
soluble fiber, insoluble fiber, vitamin E, and/or folate/folic acid 
declaration, where the information is known only to the manufacturer, 
is a practical alternative means by which we can verify that the 
nutrient declarations comply with section 403(q) of the FD&C Act and 
thus, assist in the efficient enforcement of the FD&C Act. Moreover, 
such information would also be necessary for the manufacturer to 
maintain in order to ensure the accuracy of the label.
    (Comment 63) Several comments stated that the FD&C Act does not 
give us express authority to require recordkeeping for nutrition 
labeling. Other comments specifically argued that sections 403(q), 
403(a) and 201(n) of the FD&C Act do not provide for recordkeeping 
authority and that Congress had exercised care in defining the scope of 
our recordkeeping authority in the statute. Additionally, some comments 
said that Congress has not given FDA general records authority and 
Congress must grant specific authority to FDA to access manufacturing 
records but declined to do so for nutrition labeling. Several comments 
pointed out instances in the FD&C Act that provide express 
recordkeeping authority, arguing that the fact that Congress provided 
it in certain contexts means that it was not intended here.
    (Response) Courts have not found that a specific grant of authority 
from Congress is necessary in order to promulgate every portion of 
every regulation (see, e.g., American Trucking Ass'ns, Inc. v. United 
States, 344 U.S. 298, 308-313 (1953) (``the promulgation of these rules 
. . . falls within the Commission's power, despite the absence of 
specific reference to leasing practices in the Act [citation omitted]. 
The grant of general rulemaking power necessary for enforcement compels 
this result.'') and Permian Basin Area Rate Cases, 390 U.S. 747, 780 
(1968) (``We are, in the absence of compelling evidence that such was 
Congress' intention, unwilling to prohibit administrative action 
imperative for the achievement of an Agency's ultimate purposes.'')). 
This was also held to be true in Califano, where the court found that 
Congress had not intended to immunize the manufacturers from 
requirements, including recordkeeping, by not having an express 
recordkeeping provision in the statute (Califano, 569 F.2d at 693; see 
also Morrow v. Clayton, 326 F.2d 36, 44 (10th Cir. 1963) (Powers of an 
Agency are not limited to those expressly granted by statutes--where 
the end is required, appropriate means are given and every grant of 
power carries with it the use of necessary and lawful means for its 
effective execution) and Weinberger v. Bentex Pharmaceuticals, Inc., 
412 U.S. 645, 653 (1973) (Some Agency authority is ``implicit in the 
regulatory scheme, not spelled out in haec verba'' in the statute)).
    Furthermore, we disagree that the express grant of records 
authority in other contexts means that it was expressly contemplated 
and rejected under the circumstances proposed here. The provision for 
efficient enforcement of the FD&C Act in section 701(a) of the FD&C 
Act, along with the authority to require or voluntary permit these 
nutrient declarations under section 403(q) of the FD&C Act to prevent 
misleading labeling, provides the ability to require such records to 
effectuate the goal of enforcing nutrition labeling for those limited 
products covered by the recordkeeping requirements.
    (Comment 64) Several comments stated that courts have repeatedly 
explained that FDA cannot create records access using section 701(a) of 
the FD&C Act, citing Association of American Physicians & Surgeons v. 
FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) and National Confectioners 
Association v. Califano, 569 F.2d 690, 695 (D.C. Cir. 1978).
    (Response) The comments' reading of these cases is not correct. 
First, while the cited cases state that section 701(a) of the FD&C Act 
is not an unlimited or stand-alone provision, neither case found that 
maintenance of records was not a proper exercise of authority related 
to section 701(a) of the FD&C Act, when combined with authority 
provided in other substantive sections of the FD&C Act. In fact, 
maintenance of records was one requirement that the court in Califano 
upheld, stating, ``In our opinion however the coding and record-keeping 
requirements here at issue clearly do not distend the scope of 
regulation authorized by the Act'' (Califano, 569 F.2d at 695). One 
section in Assn. Amer. Physicians & Surgeons that the comment quoted is 
``Section 371 [701(a)] does not constitute an independent grant of 
authority that permits FDA to issue any regulation the Agency 
determines would advance the public health. Rather, 371 permits FDA to 
use rules as a means of administering authorities otherwise delegated 
to it by the Congress.'' Unlike the separate requirement to do testing 
and include labeling that were discussed in Assn. Amer. Physicians & 
Surgeons, the limited records requirement discussed here is for the 
express purpose of administering the delegated authority in section 
403(q) of the FD&C Act to require truthful and not misleading labeling 
and accurate nutrition labeling for the purpose of assisting consumers 
to maintain healthy dietary practices. In essence, it is a requirement 
simply to document how the manufacturer complied with the substantive 
requirements in certain circumstances.
    The cited cases support the requirement of records to simply 
document how the manufacturer complies with the rule in this context. 
The court in Califano even cites case law that specifically addresses 
the relevance of remedying enforcement problems, which is the basis for 
the recordkeeping requirement here, stating that ``. . . whether 
statutory scheme as a whole justified promulgation of the regulation . 
. . will depend not merely on an inquiry into statutory purpose, but 
concurrently on an understanding of what types of enforcement problems 
are encountered by FDA, the need for various sorts of supervision in 
order to effectuate the goals of the Act, and the safeguards devised to 
protect legitimate trade secrets'' (Califano, 569 F.2d at 693 (citing 
Toilet Goods Association, Inc. v. Gardner, 387 U.S. 158, 163 (1967))). 
As we have discussed, in the case of the Nutrition Facts rule, the 
purpose of the statute is to ensure truthful and not misleading 
labeling as well as to assist consumers to maintain healthy dietary 
practices by providing nutrition information on the labels of food. The 
requirement to maintain these records would effectuate that purpose by 
allowing enforcement of the declarations of certain required nutrients.
    (Comment 65) One comment argued that section 701(a) of the FD&C Act 
cannot be reasonably construed to authorize records access because it 
does not constitute a separate grant of authority and cannot be read to 
authorize recordkeeping authority if that authority is not already 
included in the other sections being used for authority, such as 
sections 403(q), 403(a), and 201(n) of the FD&C Act, in this case.
    (Response) We agree that section 701(a) of the FD&C Act does not 
constitute a completely separate grant of authority to promulgate any 
regulation to protect the public health, but we disagree that it cannot 
be used to authorize records access for the nutrient declarations 
identified when there is no express authority in section 403(q) of the 
FD&C Act to require and access these specific records, as the comment 
argues. If there had to be an express provision in every relevant 
substantive provisions of the statute, such as section

[[Page 33777]]

403(q) of the FD&C Act, reference to section 701(a) of the FD&C Act and 
its use to effectuate the efficient enforcement of the FD&C Act would 
never be necessary, and it would be rendered superfluous.
    Furthermore, as discussed in greater detail in our response to 
comment 64, this notion was explicitly rejected in Califano, where the 
court stated that it was rejecting the idea that the regulation must 
stand or fall on the substantive section alone and found that Congress 
had not intended to immunize the manufacturers from requirements, 
including recordkeeping, by not having an express provision in the 
statute (Califano, 569 F.2d at 693; see also Morrow v. Clayton, 326 
F.2d 36, 44 (10th Cir. 1963) and Weinberger v. Bentex Pharmaceuticals, 
Inc., 412 U.S. 645, 653 (1973)). In the current context, records access 
is necessary to efficiently enforce the statutory requirements in 
certain limited circumstances.
    (Comment 66) One comment argued that the case law we cited did not 
support our records access authority because the cases were not 
specific to nutrition labeling and were related to drug labeling. The 
comment said that the cases have no bearing on the issues here. Another 
comment argued that we should not have relied on National Confectioners 
Association v. Califano because it was decided before the NLEA was 
enacted.
    (Response) We first note that many cases cited by these and other 
comments are not specific to nutrition labeling and were decided well 
before the NLEA was enacted. We disagree with these comments and find 
the cases, which many comments also cited, to be both applicable and 
the best indication of the proper reading of the FD&C Act. While it is 
rare to find case law that directly mirrors the situation at issue, 
Califano is striking in that it specifically affirms our authority to 
promulgate a recordkeeping requirement for certain food products when 
needed to be able to effectuate the statutory purpose. Congress has not 
acted to overturn that decision, which was the applicable existing 
legal framework when Congress was enacting the NLEA.
    (Comment 67) Several comments referenced section 301(e) of the FD&C 
Act, regarding what recordkeeping violations constitute a prohibited 
act, as an exclusive list of what recordkeeping provisions are 
authorized and as evidence that sections 403(q), 403(a), 201(n), and 
701(a) of the FD&C Act do not authorize recordkeeping provisions.
    (Response) We disagree that the absence of the specified provisions 
in the list of prohibited acts regarding records bears on whether we 
have the authority to require records under the statute. Section 301(e) 
of the FD&C Act, regarding prohibited acts, refers to the express 
recordkeeping requirements in the FD&C Act. Moreover, a prohibited act 
violation in section 301(e) of the FD&C Act is separate and distinct 
from a misbranding violation in section 403(q) of the FD&C Act. It is a 
prohibited act under section 301(a) of the FD&C Act to introduce, or 
deliver for introduction, a misbranded food into interstate commerce. 
Thus, the fact that there is not a prohibited act violation for access 
to, and copying of, records related to the nutrient declarations for 
these select nutrients under section 403(q) of the FD&C Act does not 
mean that we do not have authority under sections 403(q) and 701(a) of 
the FD&C Act to require these records under these circumstances. As we 
explained earlier, express authority in section 403(q) of the FD&C Act 
is not needed for these records (see Califano, 569 F.2d at 693). 
Maintenance of and access to records for certain nutrition labeling 
declarations only under certain circumstances is necessary for the 
efficient enforcement of the Nutrition Facts labeling requirements, 
whether or not compliance with the those requirements are included as 
prohibited act under the statute.
    (Comment 68) Several comments referenced a statement in the 
preamble to the 1993 nutrition labeling final rule stating that, to 
support a misbranding charge for inaccurate nutrient content 
information, we must have accurate, reliable, and objective data to 
present in a court of law and that, to obtain that information, we rely 
upon the work performed by our trained employees because we do not have 
legal authority in most instances to inspect a food manufacturing 
firm's records (58 FR 2079 at 2110, January 6, 1993). The comments 
asserted that this statement was evidence that we recognized that we do 
not have the authority to access manufacturing records as part of our 
enforcement of the nutrition labeling requirements.
    (Response) We do not agree with this characterization of the 
statement in the 1993 final rule. The cited statement was part of a 
discussion of why we perform our own laboratory analyses and use those 
results for enforcement, rather than looking at or verifying laboratory 
analysis results kept in the records of a manufacturer. When there are 
available reliable laboratory analyses in order to test for a specific 
nutrient, we still rely on those analyses for compliance purposes. As 
we have described, the records requirements in this final rule apply 
only to the narrow circumstances where there are not any appropriate 
reliable analytical methods that can be used to verify the compliance 
of a nutrient declaration.
    Where there are appropriate reliable analytical methods, we would 
not need to access manufacturing records in order to enforce the FD&C 
Act. However, the narrow circumstances where we do have the authority 
and are exercising the authority here are those circumstances where we 
do not have access to appropriate reliable analytical methods.
    (Comment 69) While one comment pointed out that Sec.  101.9(g)(9) 
already contemplates and provides a mechanism for the use of an 
alternative means of compliance for nutrition labeling, supporting our 
use of an alternative means to enforce compliance here, a few comments 
took exception to the preamble to the proposed rule's reference to 
situations where our regulations already provided for maintenance of 
records in the nutrition context. The comments stated that those 
instances regarding aeration to reduce fat and caloric content of foods 
(58 FR 2229 at 2271, January 6, 1993) and caloric content of new 
products with reduced digestibility (58 FR 2079 at 2111) were optional 
recordkeeping in instances where a manufacturer chooses to depart from 
the established regulations or to support a voluntary claim, rather 
than the broad regulations we proposed here for all manufacturers.
    (Response) These examples were provided as illustrations of the use 
of records in a compliance context, not to demonstrate our authority. 
Any discussion of these other regulatory examples does not affect our 
authority with regard to this particular records requirement. We do not 
agree that these are broad regulations; rather, they are for a quite 
limited purpose and scope--only required when the manufacturer is 
including a mixture of products that cannot be distinguished by the 
analytical methods detailed in the regulations. The requirements also 
are quite flexible, not requiring any particular records and allowing 
the manufacturer to determine the best records to establish and 
maintain in order to comply. Furthermore, we disagree with the comment 
that the cited existing regulations with reliance on records for 
compliance purposes are all optional or voluntary. In the context of 
calculating appropriate caloric content of new products with reduced 
digestibility, the caloric declaration is a required declaration, and 
products wishing to adjust the declared amount because they are using 
certain novel

[[Page 33778]]

ingredients would need to submit documentation of their calculations to 
FDA.
    (Comment 70) Several comments stated that, because they believed we 
did not have a scientific basis for requiring the declaration of added 
sugars, our authority to require records to verify the added sugars 
declaration was questionable.
    (Response) Please see part II.H.3 for a more detailed discussion of 
our scientific basis for requiring the declaration of added sugars. 
Because the added sugar declaration is necessary to assist consumers in 
maintaining healthy dietary practices, which is the statutory mandate, 
the recordkeeping requirements are necessary and authorized for the 
efficient enforcement of the FD&C Act.
    (Comment 71) Multiple comments argued that our authority excludes 
access to ``recipes for food,'' among other proprietary information. 
Some comments stated that we may not access or that we lack authority 
to access recipes for food, or that recipes were protected by Congress. 
Another comment stated that it is ``beyond the scope of the Agency to 
inspect records related to product formulation.'' Other comments noted 
that the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002 (Pub. L. 107-188) (BT Act), as well as section 414 
of the FD&C Act, expressly carve out recipes as a record that we cannot 
access even in food safety emergency situations.
    (Response) The exclusion of recipes that several comments referred 
to is found in the BT Act, and there is no more general protection of 
recipes by Congress. We further disagree that the parameters of the 
recordkeeping authority in the BT Act affect our ability to require 
records here. The purpose of the review of records under the BT Act is 
distinct from the purpose of the record review for nutrition labeling, 
and section 306 of the BT Act says that it shall not be construed to 
limit the ability of the Secretary to require records under other 
provisions of the FD&C Act.
    Furthermore, the final rule's recordkeeping requirement is flexible 
and does not require any specific document to support the declarations. 
While the preamble to the proposed rule provided some examples of 
records that manufacturers may choose to maintain (see, e.g., 79 FR 
11879 at 11956), they are not required to maintain any particular 
record and would also be permitted to maintain redacted documents if 
they established the necessary information. See part II.R.3 for a 
description of the variety of records that manufacturers can establish 
or maintain to meet the requirements.
    We discuss other comments regarding the proper handling and 
confidentiality of any proprietary information that is submitted in 
part II.R.3.
    (Comment 72) Some comments said that the recordkeeping authority 
previously given to FDA, as in the case of the Public Health Security 
and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-
188), were unrelated to nutrition labeling.
    (Response) We agree that the BT Act authority is unrelated, and we 
disagree that the scope of recordkeeping authority in the BT Act limits 
our ability to require records. Section 306 of the BT Act states that 
it shall not be construed to limit the ability of the Secretary to 
require records under other provisions of the FD&C Act.
    (Comment 73) Some comments stated that we did not need records 
access to enforce the nutrition declarations because companies are 
already required to ensure that their labels are not false or 
misleading under section 403(a)(1) of the FD&C Act and Sec.  101.9(g).
    (Response) While we agree with the comment that manufacturers are 
already required to ensure that their labels are not false or 
misleading, we are requiring that records be maintained that can 
specifically support certain declarations required under Sec.  101.9(g) 
because without access to those records, we are not able to verify the 
accuracy of the required declared amounts.
    (Comment 74) Some comments argued that, even if we had the 
authority to access records, we did not have the authority to copy 
records, stating that copying of records is not required for the 
efficient enforcement of the FD&C Act and that inspectors should be 
able to inspect and evaluate records onsite at the manufacturing 
facility without copying them.
    (Response) We disagree with this comment. As we stated in the 
preamble to the proposed rule (79 FR 11879 at 11957), in order 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. Without the authority to 
access the records supporting the declarations, the nutrient 
declarations that we have determined to be necessary to assist 
consumers in maintaining healthy dietary practices would be 
unenforceable. While we understand the concerns with confidentiality of 
certain corporate information, and we discuss safeguards for such 
information in part II.R.3, practically, we need to be able to copy the 
records and access them at FDA headquarters in order to fully evaluate 
them to determine compliance or the need for any further regulatory 
action or enforcement proceedings (see FDA Regulatory Procedure Manual, 
section 4-1-4, regarding Center concurrence for labeling violations). 
Such full evaluation by us is not possible onsite at the facility.
    (Comment 75) One comment suggested that the inspectional authority 
in section 704 of the FD&C Act did not provide for access to these 
records.
    (Response) Section 704 of the FD&C Act states that the inspection 
``shall'' extend to records when section 414 of the FD&C Act applies. 
We do not interpret this as an exclusive extension. Section 414 of the 
FD&C Act specifically states that it does not limit the authority of 
the secretary to inspect records under other provisions of the FD&C 
Act. This specific grant of authority applies to a single specific 
statutory provision regarding food safety, and does not address false 
and misleading labeling. It does not prevent us from accessing records 
that we can require by other regulations.
5. Miscellaneous Comments
    Several comments raised other legal issues with respect to various 
parts of the rule.
Dietary Fiber
    (Comment 76) One comment stated the definition of dietary fiber, 
which requires a dietary fiber to have a physiological effect 
beneficial to health, would ``prohibit the use of accurate, well 
substantiated dietary fiber determinations in nutrition labeling for 
many foods.'' The comment said that the restriction is not adequately 
justified to advance FDA's labeling objectives, nor is adequately 
tailored, to satisfy the First Amendment.
    (Response) We disagree that, by defining ``dietary fiber,'' we are 
prohibiting the use of ``accurate, well substantiated dietary fiber 
determinations'' as the comment suggests. As we explain in our response 
to comment 252, the definition includes dietary fibers that have been 
shown to have a physiological effect beneficial to human health, and 
therefore, the declared amount of dietary fiber will include 
information about the amount of fibers in a serving of food that are 
necessary to maintain healthy dietary practices, consistent with our 
authority in section 403(q)(2) of the FD&C Act. Manufacturers will be 
able to petition

[[Page 33779]]

FDA to request that we amend the definition to include additional 
fibers, as appropriate. If a substance is a fiber, but not a ``dietary 
fiber'' that has a physiological effect beneficial to human health 
(such that the fiber is not eligible to be, and not listed as, a 
``dietary fiber'' in the codified definition of ``dietary fiber''), a 
manufacturer may still declare the substance as part of total 
carbohydrate. Furthermore, a manufacturer may make a statement about 
the amount of these other fiber substances in the food, provided the 
statement is truthful and not misleading. The comment did not provide 
further explanation for why our definition for dietary fiber is not 
adequately justified or adequately tailored under the First Amendment 
and, based on the reasons we provide, we are not making any changes in 
response to this comment.

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

    The preamble to the proposed rule (79 FR 11879 at 11890 through 
11891) discussed the factors that we primarily considered in requiring 
the declaration of most non-statutory nutrients or providing for the 
voluntary declaration of such nutrients. Our discussion of these 
factors in the proposed rule related to the nutrients for which there 
is an independent relationship between the nutrient and risk of a 
chronic disease, health-related condition, or physiological endpoint. 
We did not consider these factors for added sugars because our 
rationale for the declaration of added sugars differs and is not based 
on an independent relationship between added sugars and risk of chronic 
disease, health-related condition, or physiological endpoint. Thus, to 
help clarify when we refer to a nutrient for which there is such an 
independent relationship, we refer to the nutrient as ``this type of'' 
or ``this category of'' or, if plural, ``these types of'' nutrient(s), 
or similar phrase. We discuss our rationale for requiring added sugars 
separately because our rationale for added sugars is distinct from the 
factors that applied more generally to these other types of nutrients. 
In general, we continue to consider mandatory declaration appropriate 
for these types of nutrients when there is public health significance 
and a quantitative intake recommendation that can be used for setting a 
DV (DRV or RDI). However, we also have considered mandatory declaration 
based, in part, on evidence highlighting the role of a nutrient (e.g., 
trans fat) in chronic disease risk. The preamble to the proposed rule 
(79 FR 11879 at 11889) explained that, under section 403(q)(1)(C) and 
(D) of the FD&C Act, nutrition information in food labeling must 
include the total number of calories, derived from any source and 
derived from the total fat, and the amounts of total fat, saturated 
fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, 
sugars, dietary fiber, and total protein. We referred to the nutrients 
that are explicitly required by the FD&C Act to be declared on the 
Nutrition Facts label as ``statutorily required nutrients.'' Section 
403(q)(2)(B) of the FD&C Act permits us to remove a statutorily 
required nutrient from the label or labeling of food, by regulation, if 
we determine the information related to that nutrient is not necessary 
to assist consumers in maintaining healthy dietary practices.
    Section 403(q)(2)(A) of the FD&C Act also gives us the authority to 
require, by regulation, other nutrients to be declared if the we 
determine that a nutrient will provide information regarding the 
nutritional value of such food that will assist consumers in 
maintaining healthy dietary practices. The preamble to the proposed 
rule explained that we consider such nutrients that are not statutorily 
required, but subject to our discretion under section 403(q)(2)(A) of 
the FD&C Act, to be ``non-statutory nutrients'' to distinguish them 
from the ``statutorily required nutrients'' (79 FR 11879 at 11889). 
Thus, insofar as ``non-statutory nutrients'' are concerned, previously 
we have: (1) Required the declaration of certain essential vitamins and 
minerals (such as vitamins A and C, iron, and calcium) for which an RDI 
was established and that were determined to have public health 
significance; and (2) permitted the declaration of the remaining 
essential vitamins and minerals for which there was an established RDI 
or DRV (i.e., vitamin E) or that had public health significance, and 
permitted the declaration of certain subcategories of macronutrients 
for which a DRV was not established (including monounsaturated fat, 
polyunsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and 
other carbohydrate) (id.).
    The preamble to the proposed rule (id. at 11890) explained that, to 
help us determine whether a non-statutory nutrient, for which there is 
an independent relationship between the nutrient and risk of chronic 
disease, health-related condition, or physiological endpoint, should be 
a required or permitted declaration, we consider: (1) The existence of 
quantitative intake recommendations; and (2) public health 
significance. Quantitative intake recommendations are reference intake 
levels provided in consensus reports that can be used to set a DRV or 
RDI. We expect these consensus reports to be published for the purpose 
of setting quantitative intake recommendations (e.g., the IOM DRI 
reports), but, if DRIs are not available for nutrients, other than 
essential vitamins and minerals, then we consider the scientific 
evidence from other U.S. consensus reports or the DGA. Public health 
significance refers to two elements. First, we consider whether there 
is evidence of a relationship between the nutrient and a chronic 
disease, health-related condition, or health-related physiological 
endpoint. This can be demonstrated either by well-established evidence 
(in the form of U.S. consensus reports) or, for essential vitamins and 
minerals, the health consequences of inadequacy of the nutrient. 
Second, we consider whether there is evidence of a problem related to 
health in the general U.S. population. This is demonstrated by both 
evidence of a problem with the intake of the nutrient in the general 
U.S. population and evidence of the prevalence of the chronic disease, 
health-related condition, or health-related physiological endpoint that 
is linked to that nutrient in the general U.S. population.
    For mandatory declaration of this type of non-statutory nutrient, 
in general, we consider mandatory declaration appropriate when there is 
public health significance and scientific evidence to support a 
quantitative intake (which, for purposes of convenience, we will refer 
to as ``a quantitative intake recommendation'') that can be used for 
setting a DV (DRV or RDI). However, we have also considered mandatory 
declaration based, in part, on evidence highlighting the role of a 
nutrient (e.g., trans fat) in chronic disease risk.
    For voluntary declaration of a non-essential vitamin or mineral 
(e.g., fluoride, soluble and insoluble fiber, monounsaturated fatty 
acids and polyunsaturated fatty acids), we consider voluntary 
declaration to be appropriate when the nutrient either has a 
quantitative intake recommendation, but does not have public health 
significance, or does not have a quantitative intake recommendation 
available for setting a DRV but has public health significance. In 
addition, we permit voluntary declaration for essential vitamins or 
minerals that we determine do not fit within our considerations for 
mandatory declaration, but that have an RDI.
    The preamble to the proposed rule also noted that we continue to be 
mindful of factors such as the number

[[Page 33780]]

of nutrients that can be listed in nutrition labeling, the possibility 
that some individuals could interpret a long list of nutrients as 
implying that a food has greater nutritional significance than is the 
case, and that there is limited space for nutrition information on the 
label (id.).
    (Comment 77) The preamble to the proposed rule (id. at 11891) 
invited public comment on our factors for mandatory and voluntary 
declarations of these types of nutrients. Some comments supported the 
factors. One comment, however, also suggested that, if the 2015-2020 
DGA is released before we publish a final rule, the vitamins and 
minerals considered to be of public health significance should be based 
on the most recent version of the DGA.
    (Response) As discussed in the preamble to the proposed rule (79 FR 
11879 at 11890 and 11918), the factors that we consider for determining 
the essential vitamins and minerals with the greatest public health 
significance to be those for which the IOM based DRIs on a chronic 
disease risk, or health related condition, or a nutrient deficiency 
with clinical significance. Additionally, we consider whether nutrient 
intake data, and/or, when available, biomarkers of nutrient status, 
provide evidence of inadequate intakes in the general healthy U.S. 
population (ages 4 years and older) and whether a substantial 
prevalence of a disease, or health related condition or a nutrient 
deficiency with clinical significance exists that was linked to the 
particular nutrient. Our intake and status biomarker analysis is 
conducted for the U.S. general population, ages 4 years and older, 
which is the focus of the label, while the DGA focuses on the U.S. 
population ages 2 years and older. The 2015 DGAC (Ref. 19) used a 
three-pronged approach similar to our factors for determining the 
nutrients of public health concern, including analysis of intake data, 
available valid biochemical indices from NHANES dietary survey, and 
data on the prevalence of health condition in the U.S. population. 
Based on the scientific evidence in the 2015 DGAC approach, vitamin D, 
calcium, potassium, iron, and fiber were considered as nutrients of 
public health concern for under consumption.
    (Comment 78) Another comment agreed with the factors, but suggested 
that we use the 2010 DGA or the 2015-2020 DGA (if it became available) 
when a quantitative intake recommendation by the IOM is not available 
and can be supported by a ``Nutrition Evidence Library Review system.''
    (Response) We agree that it is often appropriate to consider the 
scientific information in the DGA when the IOM does not provide a 
quantitative intake recommendation. The preamble to the proposed rule 
stated that we will consider quantitative intake recommendations from 
the IOM report, but if DRIs are not available for nutrients (other than 
essential vitamins and minerals), we will consider science-based 
recommendations from other U.S. consensus reports or the DGA policy 
reports (id. at 11890).

E. Calories

    Under section 403(q)(1)(C)(i) of the FD&C Act, nutrition 
information in food labels or labeling must include the total number of 
calories derived from any source. Our preexisting regulations require 
the total caloric content of a food to be declared on the Nutrition 
Facts label (Sec.  101.9(c)(1)), and the proposed rule would not modify 
the requirement to declare total calories. However, in the preamble to 
the proposed rule (79 FR 11879 at 11891), we stated that we were 
reconsidering a number of other requirements related to the declaration 
of information about calories. The other requirements related to 
``Calories from fat,'' ``Calories from saturated fat,'' the 2,000 
reference calorie intake level, a percent DV for calories, and 
requirements related to prominence of the calorie declaration and the 
footnote statement and table of DVs for 2,000 and 2,500 calorie diets.
1. Calories From Fat
    Our preexisting regulations, at Sec.  101.9(c)(1)(ii), require the 
declaration of ``Calories from fat'' on the label. This requirement 
stems from section 403(q)(1)(C)(ii) of the FD&C Act which, in turn, 
requires total calories from fat to be declared on the label or 
labeling of food. However, section 403(q)(2)(B) of the FD&C Act gives 
us the discretion to remove the requirement by regulation if we 
determine that the requirement is not necessary to assist consumers in 
maintaining healthy dietary practices. The preamble to the proposed 
rule (79 FR 11879 at 11891) explained that we reviewed current 
scientific evidence and consensus reports in determining whether 
information on calories from fat is necessary to assist consumers in 
maintaining healthy dietary practices. Current dietary recommendations 
no longer emphasize total fat. Certain fatty acids are understood to be 
beneficial, while others are understood to have negative health 
effects, particularly related to cardiovascular disease. Consequently, 
the proposed rule would no longer require, nor would it allow 
voluntarily, the declaration of ``Calories from fat'' on the Nutrition 
Facts label. In the preamble to the proposed rule (79 FR 11879 at 
11891), we acknowledged that eliminating the declaration of ``Calories 
from fat'' may appear to be a loss of information on the amount of fat 
being consumed, but noted that the amount of fat being consumed can 
still be obtained from the total fat declaration elsewhere on the 
Nutrition Facts label, and consumers can still use the percent DV for 
total fat to put fat content in the context of a total daily diet, 
compare products, and plan diets. Thus, the proposed rule would remove 
Sec.  101.9(c)(1)(ii), which requires declaration of calories from fat, 
and redesignate Sec.  101.9(c)(1)(iii) as Sec.  101.9(c)(1)(ii).
    (Comment 79) Several comments supported removing the declaration of 
``Calories from fat'' because current dietary recommendations emphasize 
that the intake of total calories and the type of fat consumed are more 
important than information on calories from fat in maintaining healthy 
dietary practices.
    Many comments opposed removing the declaration of ``Calories from 
fat'' because of the importance of knowing this information for 
consumers who are diabetic, overweight, have high blood pressure, or 
are at risk of heart disease. Several comments also noted that, in 
general, the information was useful to monitor the amount of calories 
from fat consumed in packaged foods. These comments noted that some 
people use the ``Calories from fat'' information to make a choice 
between similar products and that, because of fat's caloric density, 
consumers need to be informed regarding the amount of calories they 
were getting from fat. Other comments also suggested that we require 
the declaration of ``Percent of calories from fat,'' and some comments 
supported removing the ``Calories from fat'' declaration if a 
declaration of monounsaturated and polyunsaturated fats was mandatory.
    A few comments opposed to removing the ``Calories from fat'' 
declaration stated that this information remains useful to consumers; 
the comments, however, did agree that the total number of calories and 
types of fatty acids consumed are more important than total fat 
consumption in maintaining healthy dietary practices and reducing 
cardiovascular risk. One comment stated that it is important for total 
fat consumption to be within the acceptable range (i.e., 20 to 35 
percent of daily caloric intake) established by the IOM, and that 
``Calories from fat'' provides valuable information to help consumers 
put the Dietary Guidelines into action. Another comment disagreed

[[Page 33781]]

with our assessment that removing ``Calories from fat'' does not 
constitute a loss of information to consumers because there is 
presently no other means for conveying differences in nutrient density 
between macronutrients on the Nutrition Facts label. One comment 
indicated that, as long as the ``Calories from fat'' declaration is 
truthful and not misleading, the information is protected commercial 
speech under the First Amendment and that there is no legal basis to 
prohibit it. The comment said that ``Calories from fat'' should 
continue to be allowed on the Nutrition Facts label on a voluntary 
basis.
    (Response) We disagree that the labeling of ``Calories from fat'' 
is required for specific health conditions or that it is necessary for 
consumers to monitor their calories from total fat. The Nutrition Facts 
label is intended to provide nutrition information to the general U.S. 
population and not for specific populations with specific diseases. 
Current dietary recommendations no longer emphasize total fat. 
Consumers already have information on the quantitative amount of total 
fat on the label as well as information of its DV on the label. The 
extra emphasis of calories from fat is not needed based on the new 
science for total fat. As we stated in the preamble to the proposed 
rule (79 FR 11879 at 11891), U.S. consensus reports recognized that 
there are benefits to consuming moderate amounts of fat and that 
different types of fat have different roles in chronic disease risk, so 
the additional emphasis of ``Calories from fat'' is not warranted. The 
results of these reports and dietary recommendations also establish why 
a declaration of ``Percent of Calories from Fat'' is not necessary to 
assist consumers in maintaining healthy dietary practices, because the 
reports emphasize the intake of ``total calories'' and the type of fat 
consumed. We also note that the information required for fats in the 
Nutrition Facts label, in the absence of a declaration of ``Calories 
from Fat,'' provides consumers with the information to compare similar 
products and make healthy dietary choices.
    Information on monounsaturated and polyunsaturated fats is 
voluntary on the Nutrition Facts label due to their role in health, and 
information on saturated fat will still be required. Ultimately, we do 
not think mandatory information on the amounts of monounsaturated and 
polyunsaturated fats is necessary to help consumers maintain healthy 
dietary practices because information on the quantitative amount and 
the percent DV of total fat and saturated fat will still be required on 
the Nutrition Facts label. We discuss monounsaturated and 
polyunsaturated fats in greater detail in part II.F.4.
    We disagree that the declaration of ``Calories from fat'' should be 
voluntary on the Nutrition Facts label. Based on current scientific 
evidence and dietary recommendations, we have concluded that the 
declaration of ``Calories from fat'' is not necessary to assist 
consumers in maintain health dietary practices. Information on total 
calories, the quantitative and percent DVs for total fat and saturated 
fat, and quantitative amount of trans fat provides consumers with 
information to maintain healthy dietary practices and to put total fat 
and saturated fat in the context of a total daily diet, to compare 
products, and to plan diets.
    (Comment 80) Some comments supporting the continued declaration of 
``Calories from fat'' suggested requiring a declaration only for 
certain foods that contained above a specified level of total fat or if 
the food contained more than a certain amount of saturated and trans 
fat.
    (Response) We decline to revise the rule as suggested by the 
comments. To require a declaration for ``Calories from fat'' only on 
certain products would not be consistent with our conclusion that 
information on ``Calories from fat'' is not necessary to help consumers 
in maintaining healthy dietary practices. Furthermore, the quantitative 
amounts and percent DV for total fat and saturated fat are already 
provided, as well as the quantitative amount of trans fat. Finally, the 
DGAs and other consensus reports emphasize the importance of total 
calories rather than the amount of calories from any particular 
macronutrient.
2. Calories From Saturated Fat
    Under our preexisting regulations at Sec.  101.9(c)(1)(iii), the 
declaration of ``Calories from saturated fat'' is voluntary. The 
preamble to the proposed rule noted that saturated fat is known to 
increase the risk of cardiovascular disease and, unlike ``Calories from 
fat,'' which could include calories attributable to fatty acids that 
decrease or increase the risk of certain diseases, ``Calories from 
saturated fat'' would provide information about calories from a source 
known to increase disease risk (79 FR 11879 at 11892). Although we 
tentatively concluded that mandatory declaration of ``Calories from 
saturated fat'' is not necessary because the amount of saturated fat 
being consumed can be obtained from the total saturated fat declaration 
elsewhere on the Nutrition Facts label and because consumers can still 
use the percent DV for saturated fat to put saturated fat content in 
the context of a total daily diet, compare products, and plan diets, we 
decided that, due to the strong evidence associating higher intakes of 
saturated fat with higher low-density lipoprotein (LDL) cholesterol 
levels, information on ``Calories from saturated fat'' can assist 
consumers in maintaining healthy dietary practices. Therefore, the 
proposed rule would not change the current voluntary labeling of 
``Calories from saturated fat'' in the Nutrition Facts label as 
specified in Sec.  101.9(c)(1)(iii). However, considering our proposal 
to eliminate the declaration of ``Calories from fat'' on the Nutrition 
Facts label (see part II.E.1.), the proposed rule would revise Sec.  
101.9(c)(1)(iii) and (d)(5) to specify that the statement ``Calories 
from saturated fat,'' when declared, must be indented under the 
statement of calories. In addition, the proposed rule would redesignate 
Sec.  101.9(c)(1)(iii) as proposed Sec.  101.9(c)(1)(ii).
    We did not receive comments on this topic and have finalized the 
revisions without change.
3. Two Thousand Calories as the Reference Caloric Intake Level
    Our preexisting regulations, at Sec.  101.9(c)(9), establish a 
reference calorie intake level of 2,000 calories to set DRVs for total 
fat, saturated fat, total carbohydrate, protein, and dietary fiber. In 
addition, the preexisting regulation requires a footnote on the 
Nutrition Facts label that states, ``Percent Daily Values are based on 
a 2,000 calorie diet. Your daily values may be higher or lower 
depending on your calorie needs,'' followed by a table with certain DVs 
based on 2,000 and 2,500 calorie diets.
    The preamble to the proposed rule (79 FR 11879 at 11892) discussed 
recommendations from the IOM macronutrient report that provided 
estimated energy requirements (EERs) and the IOM labeling report (Refs. 
24-25), as well as comments (Ref. 26) received in response to the 2007 
ANPRM, in which we asked whether 2,000 calories should continue to be 
used as the reference calorie intake level and asked questions related 
to the use of the EERs. The preamble to the proposed rule explained 
that an EER is a DRI set by the IOM for energy intake and is defined as 
the dietary energy intake that is predicted to maintain energy balance 
in a healthy adult of defined age, gender, weight, height, and level of 
physical activity consistent with good health. The IOM set EERs for all

[[Page 33782]]

life-stage and gender groups and based these EERs on normal weight 
individuals (i.e., Body Mass Index (BMI) < 25) (Ref. 24). The IOM 
Labeling Committee considered whether there was a basis to use the EERs 
for developing a new reference calorie intake level for macronutrients 
in nutrition labeling. The IOM Labeling Committee found that the data 
necessary to use the EER concept as the basis for a reference calorie 
intake level for nutrition labeling were incomplete and that retaining 
the current 2,000 reference calorie intake level would be the best 
approach as it would provide continuity and would not encourage higher 
calorie intake and overconsumption of energy (Ref. 25). The proposed 
rule would not suggest any changes to the current use of 2,000 
reference calorie intake level as the basis for setting DRVs for total 
fat, saturated fat, total carbohydrate, dietary fiber, and protein.
    (Comment 81) Many comments supported using 2,000 calories as the 
reference caloric intake levels based on the same rationale provided by 
U.S. consensus reports and the IOM labeling report mentioned in the 
preamble to the proposed rule and agreed that the EER was not an 
appropriate way to set a reference caloric intake level.
    In contrast, many other comments opposed using 2,000 calories as a 
reference caloric intake level. The comments said that many individuals 
do not consume 2,000 calories (i.e., individuals may need more or less 
depending on age, sex, weight, height and physical activity level). 
Other comments wanted us to use a different reference calorie intake 
level (i.e., 1,400 calories, 1,800 calories or more than 2,000 
calories) or to eliminate the concept of a reference calorie intake 
level because, according to the comments, it is not useful or accurate 
because all individuals do not consume 2,000 calories per day.
    (Response) We agree that an individual's caloric needs can vary; 
however, we disagree that the reference caloric intake level should be 
a value other than 2,000 calories or that there should not be one at 
all. As we stated in the preamble to the proposed rule, the reference 
calorie intake level is not used as a target for caloric intake, but 
rather to set DVs for total fat, saturated fat, total carbohydrate, 
protein, and dietary fiber (see 79 FR 11879 at 11892). We agree with 
the IOM labeling report (Ref. 25) that a reference caloric intake level 
of 2,000 calories provides continuity and would not encourage higher 
calorie intake and overconsumption of energy (id.).
    We also use 2,000 calories because a rounded value is easier for 
other consumers to use and is less likely suggest an inappropriate 
level of precision as would 1,500 calories, 1,800 calories, or 2,350 
calories. The comments supporting a different reference caloric intake 
level did not provide evidence to support these values for our 
consideration; consequently, we do not have sufficient information to 
determine the advantages or disadvantages associated with a different 
value or how the values compare against the 2,000 calorie value used 
now.
4. Percent DV Declaration for Calories
    Our preexisting regulations do not provide for a DRV for calories. 
The preamble to the proposed rule (79 FR 11879 at 11892 through 11893) 
explained that setting a DRV for calories would necessitate determining 
a quantitative intake recommendation for calories, but also noted that 
there is no appropriate quantitative intake recommendation and that we 
were not aware of any other data or information on which a DRV for 
calories could be determined. Thus, the proposed rule would not set a 
DRV for calories and, as a result, neither require nor permit a percent 
DV declaration for calories.
    (Comment 82) Many comments agreed with our rationale for not 
providing a percent DV for calories. Some comments said that a percent 
DV for calories would be misleading, not accurate, or not useful 
because not all individuals consume 2,000 calories a day.
    In contrast, other comments supported a declaration for percent DV 
because, according to the comments, this information would be useful to 
consumers by allowing them to learn about the relationship between 
portion size and calorie intake. Another comment noted that an optional 
declaration of a percent DV for calories would allow consumers to make 
more informed decisions regarding selection of processed foods. Some 
comments suggested having different percent DVs for calories (i.e., one 
for men and woman, or one for growing children and adults, or two DVs 
of 1,500 and 2,000 calories).
    (Response) We do not agree that a DV for calories, for purposes of 
nutrition labeling, should be set at any caloric level. We continue to 
believe that, to provide a DV, a DRV based on quantitative intake 
recommendations for calories would need to be set. Quantitative intake 
recommendations for calories are called estimated energy requirements 
(EERs), and they are based on normal weight healthy individuals of 
defined age, gender, weight, height, and level of physical activity. It 
would be difficult to combine the EERs into a single reference calorie 
level applicable to the general population because calorie needs vary 
based on many factors.
    As for the comments suggesting that a DV could help consumers with 
the relationship between portion size and calorie intake and to make 
informed food selections, we note that the declaration of ``Calories'' 
can by itself alert consumers to the amount of calories in a serving of 
a food and assist consumers to make informed decisions about their food 
selections based on the calorie content.
    As for the comments suggesting different percent DVs for calories, 
the comments did not indicate what those DVs would be or how we might 
calculate them. Therefore, for the same reasons we expressed earlier in 
this response, we do not have sufficient information to set a DV or 
multiple DVs, and so the final rule does not establish a percent DV for 
calories. However, we consider that a statement about daily calorie 
intake (2,000 calories) should be a necessary part of the footnote in 
the Nutrition Facts label because 2,000 calories is consistent with 
widely used food plans and will serve as a basis for menu labeling (79 
FR 71156, December 1, 2014). Likewise, the second sentence of the 
footnote will state: ``2,000 calories a day is used for general 
nutrition advice'' (see part II.Q.11).

F. Fat

    The preamble to the proposed rule (79 FR 11879 at 11893 through 
11899) discussed considerations related to definitions, declaration, 
and DRVs for total fat, saturated fat, trans fat, monounsaturated fat, 
and polyunsaturated fat.
1. Total Fat
    a. Definition. Our preexisting regulations at Sec.  101.9(c)(2) 
define ``fat, total'' or ``total fat'' as a statement of the number of 
grams (g) of total fat in a serving defined as total lipid fatty acids 
and expressed as triglycerides.
    In the preamble to the proposed rule (79 FR 11879 at 11893), we 
discussed a 1997 citizen petition submitted by Nabisco, Inc. (Docket 
No. FDA-1997-P-0476) asking us to amend the definitions of ``total 
fat'' and ``saturated fat'' to clarify that acetic, propionic, and 
butyric acids may be excluded when calculating the amount of fat in a 
food product. We tentatively concluded that the petitioner did not 
provide a scientific basis on which we could rely to propose to exclude 
acetic, propionic,

[[Page 33783]]

and butyric acids from the definition of total fat based on differences 
in chemical composition. We therefore, did not propose any changes to 
the definition of ``total fat'' found in Sec.  101.9(c)(2).
    To clarify what we consider to be a fatty acid, we proposed to 
define ``fatty acids'' in Sec.  101.9(c)(2) as ``aliphatic carboxylic 
acids consisting of a chain of alkyl groups and characterized by a 
terminal carboxyl group.'' We explained that this definition is 
consistent with other similar definitions found in nutrition and 
chemistry references (79 FR 11879 at 11893).
    (Comment 83) Several comments supported our current definition of 
``total fat'' and our proposed definition of ``fatty acids.'' The 
comments also agreed with our tentative conclusion that acetic, 
propionic, and butyric acids should continue to be included in the 
definition of total fat because they are short-chain fatty acids and 
that the basic chemical group (i.e., the terminal carboxyl group 
attached to a chain of alkyl groups containing carbon atoms) should 
remain the main defining factor of a fatty acid.
    However, one comment suggested that acetic and propionic acids 
should not be considered fatty acids, but that butyric acid should be 
considered both a fatty acid and a saturated fatty acid. The comment 
cited the International Union of Pure Applied Chemistry (IUPAC) 
definition of fatty acids, which indicates that ``natural fatty acids 
commonly have a chain of 4 to 28 carbons'' (Ref. 27). The comment noted 
that acetic and propionic acid have 2 and 3 carbon chains, 
respectively, so the comment said extending the definition of fatty 
acids to these two substances is unjustified. Furthermore, the comment 
said that acetic and proprionic acids are not functionally fatty acids 
because acetic acid is a primary component of vinegar and propionic 
acid is most commonly used as a food stabilizer or anti-microbial agent 
in the form of sodium or ammonium salts, and is also used in its free 
form as a taste additive.
    (Response) We agree that butyric acid should be considered both a 
fatty acid and a saturated fatty acid. However, we disagree that acetic 
acid and propionic acid should be excluded from the declaration of 
total fat based on their carbon chain length. The IUPAC definition 
provided says that fatty acids ``commonly'' have a chain length of 4 to 
28 carbons, but this definition does not exclude the possibility that 
there may be fatty acids with carbon chain lengths of less than 4 
carbons. Furthermore, other definitions of fatty acids include 
monocarbonic acids with chain lengths between 1 and nearly 30 carbon 
atoms (79 FR 11879 at 11893). The final rule, therefore, does not 
change our pre-existing definition of ``total fat.''
    The comment noted that acetic acid is most commonly found in the 
human diet in vinegar, either separately or as an ingredient, and is 
responsible for its distinctive odor and taste. The comment noted that 
propionic acid is used in food as a stabilizer, anti-microbial agent, 
and as a taste additive. The comment used this information to explain 
why these acids are not functionally fatty acids rather than explaining 
how the function of acetic and propionic acids differ from those of 
other fatty acids. Therefore, the comment did not provide sufficient 
information for us to consider in determining whether acetic and 
propionic acid should be excluded from the declaration based on their 
functional attributes, and we have finalized the definition of ``fatty 
acids'' in Sec.  101.9(c)(2) without change.
    (Comment 84) One comment recommended that consumer education is 
warranted to make consumers aware that the physiological effects of 
acetic, propionic, and butyric acids are different from the health 
effects that have been linked to longer-chain fatty acids.
    (Response) The health effects of acetic, propionic, and butyric 
acids have not been well established in the scientific literature. 
Therefore, it would be premature to provide consumer education on 
acetic, propionic, and butyric acids until more is known about these 
acids.
    b. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act 
requires the declaration of the amount of total fat on food labels. 
Consequently, the Nutrition Facts label includes the mandatory 
declaration of the gram amount for total fat in Sec.  101.9(c)(2).
    The preamble to the proposed rule (79 FR 11879 at 11893) stated 
that the 2010 DGA recognizes that the types of fatty acids consumed are 
more important in influencing the risk of CVD than the total amount of 
fat in the diet. It also stated that current dietary recommendations 
and clinical guidelines encourage replacing saturated and trans fatty 
acids with beneficial fats, such as polyunsaturated and monounsaturated 
fatty acids, and that a high intake of most types of saturated fatty 
acids, trans fatty acids, and cholesterol can increase LDL cholesterol 
levels, which in turn may increase the risk of CHD (id.). Although we 
concurred with the 2010 DGA that consuming a diet low in saturated 
fatty acids and cholesterol is more important for reducing CVD risk 
than consuming a diet low in total fat, we tentatively concluded in the 
preamble to the proposed rule that mandatory declaration of total fat 
on the Nutrition Facts label continues to be necessary to assist 
consumers in maintaining healthy dietary practices (id.) for the 
following reasons:
     Total fat is a calorie-yielding macronutrient and an 
important piece of the macronutrient profile of a food;
     Consumption of a low fat, high carbohydrate diet can 
increase the risk of chronic diseases such as CHD and type 2 diabetes; 
and
    Increased fat intake, as a result of increased saturated fat 
intake, has been shown to increase LDL cholesterol concentrations, and 
therefore risk of CHD.
    (Comment 85) Several comments supported the mandatory declaration 
of total fat on the Nutrition Facts label. The comments suggested that 
retaining the declaration of total fat also would help consumers who 
are trying to consume foods with a lower calorie density because foods 
higher in fat have a higher caloric density. (Caloric density is the 
amount of calories per unit of food weight.) Some comments provided 
evidence to show that consumption of a lower-fat, lower-calorie diet 
promotes weight loss, weight maintenance, and the reduction in risk of 
diabetes. Other comments stated that consumers can use a food's total 
and saturated fat content to estimate its unsaturated fat content. As 
discussed in part II.F.4, replacing saturated fats with unsaturated 
fats can lower LDL cholesterol levels and the risk of CVD.
    Other comments disagreed with our conclusion and suggested that, 
rather than listing total fat on the label, we should require the 
declaration of the amount of each type of fat (i.e., saturated fat, 
trans fat, polyunsaturated fat, and monounsaturated fat). The comments 
noted that total fat consumption is no longer emphasized in the DGA. 
Instead consumers are advised to limit their consumption of saturated 
and trans fats, and replace them with monounsaturated and 
polyunsaturated fats. One comment questioned whether including total 
fat on the label may inadvertently discourage consumers from selecting 
foods that appear to be high in fat without regard to the source of 
fat.
    (Response) We agree, in part, and disagree, in part, with the 
comments. As we stated in the preamble to the proposed rule (79 FR 
11879 at 11893), we agree with the recommendations of the 2010 DGA that 
the types of fatty acids consumed are more important in influencing the 
risk of CVD than the total amount of fat in the diet. However,

[[Page 33784]]

we decline to remove the declaration of total fat from the label as 
some comments suggested. Total fat continues to be associated with the 
risk of chronic disease and so a declaration of total fat provides 
important information about the nutrient profile of a food (79 FR 11879 
at 11893). Increased fat intake, as a result of increased saturated fat 
intake, has been shown to increase LDL cholesterol concentrations, and 
therefore risk of CHD.
    As for the comment asserting that including total fat on the label 
may inadvertently discourage consumers from selecting healthful foods 
because of the amount of total fat declared on the label, the comment 
did not provide any data or other information to support the assertion. 
We recognize that how a total fat declaration may be understood and 
used by consumers could have important implications for how we focus 
our consumer education.
    c. DRV. The DRV for total fat is 30 percent of calories (65 grams/
day) (Sec.  101.9(c)(9)). The proposed rule would not change the DRV. 
The preamble to the proposed rule (79 FR 11879 at 11894) discussed the 
absence of an AI and RDA for total fat and how the IOM established an 
AMDR for total fat intake of 20 to 35 percent of energy for adults and 
an AMDR of 25 to 35 percent of energy for children age 4 to 18 years. 
(The AMDRs are associated with reduced risk of chronic diseases, such 
as CHD, while providing for adequate intake of essential nutrients.) We 
noted that the 2010 DGA acknowledged the IOM's AMDR and indicated that 
total fat intake should fall within the AMDRs set by the IOM. We 
explained that the IOM Labeling Committee recommended a population-
weighted midpoint of the AMDR because AMDRs vary with age; thus, a 
population-weighted mid-point of the AMDR for adults, i.e., 20 to 35 
percent, yields a DRV of 28 percent or 62 grams of total fat. However, 
we declined to adjust the DRV because we concluded, in the preamble to 
the proposed rule (79 FR 11879 at 11894), that the upper level of the 
AMDR of 35 percent of 2,000 calories as the basis for a DRV would 
provide no meaningful health benefit and that a population-weighted 
mid-point of 28 percent of the AMDR (28 percent of calories) as the 
basis for the DRV is not significantly different from a public health 
outcome standpoint than the current value of 30 percent of calories.
    (Comment 86) One comment agreed that we should not change the DRV 
for total fat. The comment noted that there is little or no advantage 
to making a change on this basis because the actual change in the DRV 
amount is minimal compared to the cost and effort required to educate 
consumers about the rationale for the change and its significance 
related to dietary choices.
    One comment said we should reduce the DRV for total fat to 40 
grams/day (18 percent of calories based on a 2,000 calorie diet), but 
the comment did not provide a rationale or other information to support 
the recommended change.
    Another comment suggested that we eliminate the DRV for total fat 
to allow consumers to focus on replacing saturated fats with 
unsaturated fats. The comment stated that the types of fat consumed are 
more important in influencing the risk of heart disease than is the 
total amount of fat. The comment noted that current dietary 
recommendations and clinical guidelines recommend replacing saturated 
and trans fats with polyunsaturated and monounsaturated fats to reduce 
the risk of heart disease.
    (Response) Since we published the proposed rule in the Federal 
Register, new information and evidence has become available that 
corroborates the position that the types of fats consumed are more 
important in influencing the risk of heart disease than is the total 
amount of fat. The 2015 DGAC concluded that strong and consistent 
evidence from randomized controlled trials shows that replacing 
saturated fatty acids with unsaturated fats, especially polyunsaturated 
fatty acids, significantly reduces total and LDL cholesterol. The 2015 
DGAC also concluded that there is strong evidence that dietary patterns 
that are lower in saturated fat, cholesterol, and sodium and richer in 
fiber, potassium, and unsaturated fats are beneficial for reducing CVD 
risk. The 2015 DGAC noted that, in low-fat diets, fats are often 
replaced with refined carbohydrates and this is of particular concern 
because such diets are generally associated with changes in blood 
cholesterol levels associated with an increased risk of disease. The 
2015 DGAC suggested that dietary advice should put the emphasis on 
optimizing types of dietary fat consumed and not on reducing total fat 
intake. The 2015-2020 DGA did not include a recommendation that 
Americans should reduce their intake of total fat, but did recommend 
that sources of saturated fat should be replaced with unsaturated fat, 
particularly polyunsaturated fatty acids (Ref. 28). These 
recommendations and conclusions are supported by the Lifestyle 
Management Report and the evidence reviewed for the NHLBI Lifestyle 
Evidence Review (Refs. 17-18).
    We disagree with the comment recommending the elimination of the 
declaration of the percent DV for total fat because we have concluded 
that the declaration of the amount of total fat is necessary to assist 
consumers in maintaining healthy dietary practices and the percent DV 
declaration can help consumers put the gram amount of total fat 
declared on the label into the context of their total daily diet. 
Furthermore, the comment did not explain how removing the declaration 
of the percent DV for total fat from the label will help consumers 
focus on replacing saturated fats with monounsaturated fats, especially 
if the total gram amount of total fat in a serving of a product is 
still declared on the label. Therefore, we decline to remove the 
declaration of the percent DV for total fat from the label.
    We also disagree that the DRV for total fat should be decreased 
from 65 grams/day to 40 grams/day. The comment did not provide a basis 
for the change, so, absent data or evidence to support decreasing the 
DRV, we do not have sufficient information to support the change and 
also are unable to determine if the change would be appropriate.
    Although we disagree with the comment suggesting that we eliminate 
the percent DV declaration for total fat, we are reconsidering our 
position that increasing the DRV for total fat to 35 percent, which is 
the upper end of the AMDR range, would provide no meaningful health 
benefit. The scientific community continues to focus on the types of 
fats consumed and less on the total amount of fat consumed. Current 
clinical guidelines and dietary recommendations do not include guidance 
or recommendations to limit total fat. We do not place limitations on 
the total amount of fat. We are concerned that keeping the DRV for 
total fat of 30 percent of calories may be misinterpreted as advising 
consumers to limit their intake of total fat to 30 percent or less. It 
is also conceivable that consumers could view foods which are good 
sources of mono and polyunsaturated fats negatively because their 
percent DV declaration for total fat is high. Given that current 
dietary recommendations and clinical guidelines corroborate our action 
to not place limitations on the total amount of fat which should be 
consumed and acknowledge that replacing total fat in the diet with 
carbohydrates can have negative health effects, we have reconsidered 
our statement that the upper level of the AMDR of 35 percent would 
provide no meaningful health benefit compared to the current value of 
30 percent calories. Thus, we are increasing the DRV for total fat from 
30 percent of calories to 35 percent of

[[Page 33785]]

calories, which results in a DRV of 78 grams.
    d. Declaration of total fat. The proposed rule would not change the 
preexisting requirement for mandatory declaration of total fat on the 
Nutrition Facts label.
    (Comment 87) Several comments recommended decreasing the prominence 
of total fat on the label while increasing the prominence of saturated 
and trans fatty acids because the scientific evidence shows that the 
type of fat consumed is more important than the total amount consumed. 
The comments stated that more emphasis on saturated and trans fatty 
acids could help consumers reduce their intake of these types of fats. 
One comment recommended that the total fat declaration should be listed 
right after protein and carbohydrate on the label to reduce its 
prominence. The comment suggested that this change is necessary because 
high fat diets have been proven to reduce body weight, normalize blood 
sugars for diabetics, improve cardiac risk profiles, and reduce the 
risk for other comorbidities, such as the risk of stroke.
    (Response) We decline to change the order of nutrients on the label 
to decrease the prominence of total fat. Fat is one of three major 
macronutrients in the diet. The listing of the amount of total fat in a 
product provides valuable information to the consumer about the 
nutrient profile of a food. While we agree that it is important for 
consumers to consider the amount of saturated and trans fat in a 
product, these fatty acids are components of total fat. They are 
indented and listed below total fat on the Nutrition Facts label so 
that consumers can see that they are part of the total fat declaration. 
If the declaration of the amount of total fat in a product is separated 
from the declaration of its components, as suggested in the comment 
recommending its placement below carbohydrate and protein, it could 
appear as though saturated and trans fat are not part of the total fat 
declaration.
    As for the comment suggesting that high fat diets have been proven 
to be beneficial for weight loss and to have other beneficial health 
effects, the comment did not provide evidence related to how the order 
of nutrients on the label may impact consumers wishing to follow a high 
fat diet. Without such evidence, we are unable to evaluate the impact 
of the suggested change in the order of nutrients declared on the 
label.
    (Comment 88) Some comments recommended declaring total fat as a 
percentage of the total weight of a product or as a percentage of 
calories in a serving of the product. One comment expressed concern 
that some manufacturers are making false claims about the percentage of 
fat in a product, and the comment suggested that knowing the percentage 
attributed to the total weight of the food by the fat in the product 
would be beneficial for consumers. The comment also stated that most 
calculations of body fat and daily intakes are expressed as 
percentages.
    (Response) We decline to require the declaration of total fat as a 
percentage of the weight of the food or as a percentage of calories in 
a serving of the product.
    We disagree that declaration of the amount of fat as a percentage 
of weight or as a percentage of calories would be helpful to consumers 
in maintaining healthy dietary practices. Information found on the 
label can be used to determine the amount of a nutrient in a food so 
that it can be used for product comparison or to determine how the food 
contributes towards recommended amounts of nutrients (see part I.B). 
The declaration of a percentage of weight that is attributable to the 
total fat content of a food product would not allow for easy product 
comparison and would not allow a consumer to determine how the product 
compares to dietary recommendations for total fat. Dietary 
recommendations for total fat are provided in grams rather than in 
percentages (Ref. 29).
    Additionally, as discussed in part II.E.1, we are removing calories 
from fat from the label because the type of fat consumed is more 
relevant in reducing the risk of CHD than overall total fat intake. 
Therefore, the declaration of a percentage of calories from fat also is 
unwarranted.
2. Saturated Fat
    a. Definition. Our preexisting regulations define ``Saturated fat'' 
in Sec.  101.9(c)(2)(i) as the sum of all fatty acids containing no 
double bonds. We did not propose to change the definition.
    (Comment 89) Most comments supported our decision not to revise the 
definition of saturated fat. However, one comment argued that we should 
exclude the short-chain fatty acids, acetic acid and proprionic acid, 
from the definition of both total fat and saturated fat, but another 
short-chain fatty acid, butyric acid, could remain in the definitions. 
The comment argued that both acetic acid and proprionic acid have 
carbon chains shorter than four carbons and that the International 
Union of Pure Applied Chemistry (IUPAC) has a definition of fatty acids 
which indicates that ``natural fatty acids commonly have a chain of 4 
to 28 carbons'' (Ref. 27).
    (Response) We decline to exclude acetic and propionic acid from the 
declaration of saturated fat based on the length of the carbon chains 
for reasons already discussed in part II.F.1.
    b. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act 
requires the declaration of the amount of saturated fat on food labels. 
Accordingly, our preexisting regulations require mandatory declaration 
of the gram amount for saturated fat (Sec.  101.9(c)(2)). We did not 
propose any changes to the mandatory declaration of the gram amount for 
saturated fat.
    (Comment 90) Most comments supported our decision not to change the 
mandatory declaration of saturated fat.
    Other comments opposed listing saturated fats because, the comments 
said, saturated fats are not detrimental to health. One comment that 
suggested we should break down saturated fat further into medium chain 
and long chain saturated fatty acids because medium chain saturated 
fatty acids are beneficial to health, while long chain saturated fatty 
acids are not.
    (Response) We disagree that the Nutrition Facts label no longer 
needs to list saturated fats and also decline to break down saturated 
fat further into medium chain and long chain saturated fatty acids. 
Section 403(q)(1)(D) of the FD&C Act requires the declaration of the 
amount of saturated fat on food labels, and, in the preamble to the 
proposed rule (79 FR 11879 at 11895), we described how dietary 
recommendations continue to recognize the well-established relationship 
between consumption of saturated fat, which include all saturated fatty 
acids chain lengths, and its effect on blood cholesterol levels. In 
addition, the 2010 DGA provided scientific evidence supporting a 
quantitative intake recommendation for saturated fat which likewise, 
include all saturated fatty acid chain lengths.
    The comments suggesting that saturated fat did not need to be 
declared or should be further broken down by chain length did not 
provide any information that could be used to contradict the dietary 
recommendations, nor did they provide information that would enable us 
to determine that the nutrient information is no longer necessary to 
assist consumers in maintaining healthy dietary practices (as section 
403(q)(2)(B) of the FD&C Act requires when removing nutrient 
information). Thus, based on the science and dietary recommendations 
and the absence of evidence indicating that the

[[Page 33786]]

information is no longer necessary to assist consumers in maintaining 
healthy dietary practices, we are retaining the declaration of 
saturated fat in the Nutrition Facts label.
    c. DRV. Under our preexisting regulations at Sec.  101.9(c)(9), the 
DRV for saturated fat is 20 grams, which is 10 percent of calories 
based on a 2,000 reference calorie intake level. In the preamble to the 
proposed rule (79 FR 11879 at 11895), we discussed how current 
consensus reports, such as the IOM DRIs, the 2010 DGA, and a 2002 
report from the National Cholesterol Education Program of the NIH 
National Heart, Lung, and Blood Institute, continue to recommend 
saturated fat intakes of no more than 10 percent of calories, based on 
risk of CVD. Additionally, the scientific evidence in the 2015-2020 DGA 
supports limiting calories from saturated fat which corroborates the 
consensus reports. Consequently, we did not propose to change the DRV 
for saturated fat in Sec.  101.9(c)(9).
    (Comment 91) Many comments supported our decision to keep the 
existing saturated fat DRV of 20 grams, but some comments would have us 
lower the DRV to 6 or 7 percent of calories. The comments indicated 
that this range would calculate to a DRV of approximately 13 to 15 
grams of saturated fat. Other comments noted that recent guidelines 
published by the American Heart Association and American College of 
Cardiology, in collaboration with the National Heart, Lung, and Blood 
Institute, concluded that no more than 5 to 6 percent of calories 
should come from saturated fat. One comment also argued that the 
saturated fat DRV was too low and that human diets, both historical and 
among different cultures, are consistent with diets higher in saturated 
fat and that current science supports higher levels of intake.
    Two comments suggested that we remove stearic acid from any 
calculation of the percent DV. The comments argued that the DRV is 
based on adverse physiological effect and that each saturated fatty 
acid should be considered individually regarding these effects. The 
comments suggested that a percent DV for saturated fat of an individual 
food could be calculated using different weighting factors for 
saturated fatty acids dependent on the level of adverse effect of each 
individual fatty acid. The comments also argued that, because stearic 
acid is neutral in regard to effects on levels of serum total and LDL-
cholesterol compared to other saturated fatty acids, stearic acid would 
end up being left out of the calculation for the percent DV.
    (Response) We decline to revise the DRV for saturated fat. As we 
discussed in the preamble to the proposed rule (79 FR 11879 at 11895), 
current consensus reports reviewing the scientific evidence related to 
saturated fatty acid intake continue to support saturated fat intakes 
of no more than 10 percent of calories, based on risk of CVD. For 
example, the scientific evidence in the 2010 DGA (Ref. 30) supports 
reducing saturated fatty acid intake to less than 10 percent of 
calories, and the scientific evidence in the 2015 DGAC supports 
retaining the 10 percent upper limit for saturated fat intake. These 
guidelines apply to intake levels for the general population. Other 
guidelines that support lower than 10 percent of calories do exist for 
therapeutic uses, which would apply to specific populations in need of, 
for example, lowering of LDL cholesterol levels in the blood (Ref. 31). 
These are specific populations such as those with diagnosed heart 
disease or type 2 diabetes, those with family histories of high blood 
cholesterol, and others with high risk for CVD (Ref. 32).
    As for the comment claiming that the DRV for saturated fat is too 
low, the comment did not provide evidence for increasing the DRV, and 
we are unaware of current scientific information that would support an 
increase. The current dietary recommendations for intake of saturated 
fatty acids, of less than 10 percent of calories, are still applicable 
to the general U.S. population. Thus, the existing DRV of 20 grams is 
consistent with the scientific evidence supporting a maximum intake 
level that covers the general U.S. population.
    We also disagree with comments that would exclude stearic acid from 
the calculation of an individual food's percent DV for saturated fat. 
The scientific evidence supporting the current dietary recommendations 
for saturated fat, does not differentiate among the individual 
saturated fatty acids. The scientific evidence relates to the intake of 
all saturated fatty acids combined, and this would include stearic 
acid. We note that the 2015-2020 DGA recommendation to consume less 
than 10 percent of calories from saturated fatty acids makes no 
specific exclusion of stearic acid and, instead, relates to the intake 
of total saturated fatty acids (Ref. 28). Because the DRV is based on 
the intake of all saturated fatty acids, determination of percent DV is 
also based on content of all saturated fatty acids in the individual 
food.
3. Trans Fat
    a. Definition. Our preexisting regulations, at Sec.  
101.9(c)(2)(ii), define ``Trans fat'' or ``Trans'' as the sum of all 
unsaturated fatty acids that contain one or more isolated (i.e., non-
conjugated) double bonds in a trans configuration. The proposed rule 
would not change the definition.
    (Comment 92) Most comments supported our decision to retain the 
definition of trans fat.
    One comment, however, said that the physiological effects of trans 
fat from ruminant sources differs from the effects of trans fat from 
industrial sources (i.e., partially hydrogenated oils). The comment 
said we should exclude trans fat from ruminant sources from the 
definition of trans fat.
    (Response) We decline to exclude trans fat from ruminant sources 
from the definition of trans fat. Trans fat is generally understood to 
be any unsaturated fatty acid that contains a double bond, regardless 
of source (Ref. 29). Additionally, as we stated in the preamble to the 
proposed rule (79 FR 11879 at 11896), the chemical definition is 
consistent with how we define polyunsaturated fat as cis, cis-
methylene-interrupted (Sec.  101.9(c)(2)(ii)).
    We also note that, in the Federal Register of June 17, 2015 (80 FR 
34650), we issued a declaratory order making a final determination that 
there is no longer a consensus among qualified experts that partially 
hydrogenated oils (PHOs), which are the primary dietary source of 
industrially produced trans fatty acids (IPTFA) are generally 
recognized as safe (GRAS) for any use in human food. The major 
provisions of our declaratory order were that:
     PHOs are not GRAS for any use in human food;
     Any interested party may seek food additive approval for 
one or more specific uses of PHOs with data demonstrating a reasonable 
certainty of no harm of the proposed use(s); and
     For the purposes of the declaratory order, FDA defined 
PHOs as those fats and oils that have been hydrogenated, but not to 
complete or near complete saturation, and with an iodine value (IV) 
greater than 4.
    We established a compliance date of June 18, 2018 for the 
declaratory order.
    b. Mandatory declaration. Our preexisting regulations, at Sec.  
101.9(c)(2)(ii), require the declaration of trans fat on the Nutrition 
Facts label (Sec.  101.9(c)(2)(ii)). In the preamble to the proposed 
rule (79 FR 11879 at 11896), we tentatively concluded that information 
on the amount of trans fat in food products allows consumers to

[[Page 33787]]

reduce their intake of trans fat, and thus, reduce the risk of CHD, so 
we did not propose to change this requirement. However, we also stated 
that, in the Federal Register of November 8, 2013 (78 FR 67169), we had 
published a tentative determination that partially hydrogenated oils 
(PHOs), the source of industrially produced trans fat, may not be 
generally recognized as safe (GRAS), and we invited comment on whether 
mandatory labeling of trans fat would still be necessary if we 
finalized our determination (79 FR 11879 at 11896).
    (Comment 93) Regarding the mandatory declaration of trans fat, all 
comments supported our decision to continue requiring the declaration 
of trans fats.
    With respect to the GRAS determination of PHOs, the comments were 
divided. Some comments supported requiring the declaration of trans 
fats on the label regardless of the final GRAS determination; other 
comments supported removing the declaration of trans fat from label if 
PHOs are no longer GRAS.
    The comments supporting the declaration of trans fat on the label, 
even if PHOs are no longer declared GRAS, discussed the continued 
presence of trans fat in products even after PHOs are removed from 
foods. The comments explained that trans fat could come from both 
natural sources, such as the trans fat in dairy products, and from uses 
of oils that are either currently allowed as food additives or could 
potentially be permitted in the future. The comments said that trans 
fat content is still information that consumers need even if total 
overall presence in the food supply is reduced.
    Other comments supporting removal of the trans fat declaration if 
PHOs are no longer GRAS said that, if PHOs are no longer GRAS, most 
foods would not have any trans fat, except for the trans fat that comes 
from animal sources. Thus, to these comments, few foods would have 
declarable levels of trans fat, and most foods would indicate a trans 
fat content of zero. Because so few foods would contain trans fat, the 
comments stated, a trans fat declaration would no longer be needed on 
the label. Some comments also noted that animal products, such as 
dairy, are considered part of normal, healthful diets, and trans fat 
information on those products is not necessary. Some comments, however, 
did suggest that if trans fat from animal sources exceeded a certain 
level, such as 1.0 g per serving, then we should require its disclosure 
on the label.
    (Response) Based on the available scientific evidence and the 
findings of expert scientific panels, in the Federal Register of June 
17, 2015 (80 FR 34650), we published a declaratory order stating that 
PHOs are not GRAS for any use in human food. Although we have made this 
determination regarding PHOs, some trans fats will continue to be 
present in foods. For example, the declaratory order provided a 
compliance date of June 18, 2018; this gives manufacturers up to 3 
years to remove PHOs, and the accompanying trans fats in PHOs, from 
foods. The 3 years also provides time for manufacturers to petition us 
for approval of PHOs as food additives, which could allow PHOs to be 
included in food in certain circumstances. Moreover, trans fat will 
always be naturally present in foods from ruminant sources (e.g., beef 
products and dairy foods). Using the latest data from the Gladson 
database (data current as of March 2015), we calculate that, based on 
the Gladson values, there could potentially be more than 5,000 foods 
remaining with declarable levels of trans fat, after removal of PHOs. 
Thus, it is premature to consider removing trans fat from the Nutrition 
Facts label at this time. We expect there to be a great deal of 
reformulation of products over the next 3 years, and we will need to 
evaluate the remaining trans fat content in foods, both from approved 
or potentially approved food additive uses of PHOs and from naturally 
occurring trans fat, after the expected reformulations have occurred. 
We will then be able to consider whether, in light of any remaining 
trans fat content in foods, declaring trans fat on the label continues 
to assist consumers in maintaining healthy dietary practices. Until 
such time, however, the scientific evidence continues to support the 
need to inform consumers about the continued presence of trans fat in 
foods.
    c. DRV. Our preexisting regulations do not provide a DRV for trans 
fat. In the preamble to the proposed rule (79 FR 11879 at 11896 through 
11897), we described various efforts (such as the use of ANPRMs) to 
consider determining a DRV for trans fat, including the use of food 
composition data, menu modeling and data from dietary surveys, and a 
potential joint percent DV for trans fat and saturated fat. We 
described how a number of evaluations of the existing scientific 
evidence were not able to set a definitive quantitative intake 
recommendation for trans fat. We tentatively concluded that there was 
not a basis for setting a DRV for trans fat, and so we did not propose 
a DRV for trans fat.
    (Comment 93a) Most comments agreed that the scientific evidence is 
insufficient to set a DRV. In contrast, two comments said we should set 
a DV for trans fat, but did not provide information that would enable 
us to establish a DRV.
    (Response) We decline to revise the rule to establish a DV for 
trans fat. The comments did not provide information that would enable 
us to establish a DV, and, as we discussed in the preamble to the 
proposed rule (id.), consensus reports were unable to determine a 
specific level of trans fat intake that would likely pose no risk of 
adverse health effects. The IOM, for example, said that a DV for trans 
fat could not be established because ``any increase in trans fat intake 
increases CHD risk but because trans fats are unavoidable in ordinary 
diets, consuming zero percent of calories would require significant 
changes in dietary intake patterns that may introduce undesirable 
effects and unknown and unquantifiable health risks'' (Ref. 29). We 
continue to adhere to the recommendation from the IOM that trans fatty 
acid consumption be as low as possible while consuming a nutritionally 
adequate diet.
    d. Declaring the amount of trans fat. Our preexisting regulations, 
at Sec.  101.9(c)(2)(ii), state that, if the serving contains less than 
0.5 grams, the content declared on the Nutrition Facts label must be 
expressed as zero. For most nutrients, the maximum amount permitted for 
a zero declaration is governed by the limitations associated with 
analytical methods available, and, in the preamble to the proposed rule 
(79 FR 11879 at 11896), we said that validated analytical methodologies 
that provide sensitive and reliable estimates of trans fatty acids in 
all foods at levels below 0.5 grams per serving are currently not 
available. Thus, we did not propose to change the requirements for a 
zero declaration of trans fat.
    (Comment 94) Several comments asked us to lower the maximum amount 
permitted for a zero declaration. The comments provided several 
different values, such as 0.0 grams, 0.05 grams, 0.1 grams, and 0.2 
grams, as alternatives to the preexisting value of 0.5 grams. The 
comments argued that even very small amounts of trans fat in a food 
(i.e., less than 0.5 grams) could be harmful to consumers' health, and 
consumers should know if foods contained any trans fat at all. Most 
comments did not address the issue of a lack of validated analytical 
methodologies. One comment did, however, state that a validated 
analytical methodology did exist to detect trans fat below 0.5 grams 
per

[[Page 33788]]

serving and cited AOAC 996.06 (Ref. 33).
    (Response) We agree that consumers should be informed of trans fat 
content in foods. With the current analytical methodologies, however, 
quantification of trans fat content in foods is limited. When 
determining the maximum amount permitted for a zero declaration, we 
need to consider, for compliance purposes, whether the trans fat 
content at those low levels can be reliably and accurately measured in 
all foods by an analytical method(s) that has been validated to do so. 
Currently, there are no validated analytical methods to determine trans 
fat content at levels less than 0.5 grams for all foods.
    With respect to the comment that cited AOAC 996.06 as a methodology 
to detect trans fat, AOAC 996.06 does not provide validation data for 
trans fatty acids. AOAC 996.06 does provide validation data for total 
fat, saturated fat, and monounsaturated fat (Ref. 33). We are aware of 
ongoing efforts for validation of improved analytical methods for trans 
fat (Ref. 34), and if new validated methods become available, we may 
reevaluate the threshold for a zero declaration of trans fat.
4. Monounsaturated Fat and Polyunsaturated Fat
    a. Voluntary declaration. Our preexisting regulations, at Sec.  
101.9(c)(2)(iii) and (iv), permit, but do not require, the declaration 
of monounsaturated fat (defined as cis-monounsaturated fatty acids 
(e.g., oleic acid)) and the declaration of polyunsaturated fat (defined 
as cis, cis-methylene-interrupted polyunsaturated fatty acids) on the 
Nutrition Facts label.
    The preamble to the proposed rule (79 FR 11879 at 11897 through 
11899) described how we considered recommendations in current consensus 
reports, as well as comments received in response to the 2007 ANPRM in 
which we requested comment on whether declaration of monounsaturated 
fat and polyunsaturated fat should remain voluntary or be made 
mandatory. We noted that we have been unable to set a DRV for 
monounsaturated fat and polyunsaturated fat due to the absence of DRIs 
for both (id.)
    Consistent with the 2010 DGA, the 2015-2020 DGA recommends that 
foods high in saturated fats should be replaced with foods high in 
unsaturated fats (Ref. 28).
    (Comment 95) One comment supported voluntary declaration of 
monounsaturated and polyunsaturated fats and said that omitting 
unsaturated fats would reduce label clutter.
    (Response) While it is possible that omitting unsaturated fats 
would reduce label clutter, our reason for not requiring the 
declaration of monounsaturated or polyunsaturated fats is due to the 
lack of a DRV and our consideration of the factors for mandatory and 
voluntary declaration for these types of nutrients. We consider 
voluntary declaration to be appropriate when the nutrient either has a 
quantitative intake recommendation, but does not have public health 
significance or does not have a quantitative intake recommendation 
available for setting a DRV, but has public health significance.
    (Comment 96) Some comments supported voluntary declaration of 
monounsaturated and polyunsaturated fats because, according to the 
comments, they were a key recommendation in the 2010 DGA, ``Consume 
less than 10 percent of calories from saturated fatty acids by 
replacing them with monounsaturated and polyunsaturated fatty acids.''
    Other comments supporting mandatory declaration of monounsaturated 
and polyunsaturated fats also referred to the 2010 DGA recommendation. 
Some comments asserted that being a key recommendation was sufficient 
for mandatory listing of added sugars and claimed that we were being 
inconsistent with the use of dietary guidance recommendations, 
especially because the scientific evidence is stronger for 
monounsaturated and polyunsaturated fats than for added sugars.
    (Response) We proposed to retain the voluntary declaration of 
monounsaturated and polyunsaturated fats based on the factors 
identified for the mandatory and voluntary listing of these types of 
non-statutory nutrients. While added sugars is not a statutory 
nutrient, we are requiring the declaration of added sugars based on the 
need for consumers to have this information, which relates to a dietary 
pattern, to assist consumers to maintain healthy dietary practices and 
not based on a specific relationship of added sugars to chronic disease 
risk. Thus, the basis for requiring the declaration of added sugars 
differs from that for monounsaturated and polyunsaturated fats. We 
acknowledge that the 2010 DGA provided a key recommendation for 
monounsaturated and polyunsaturated fats because of the strong evidence 
(79 FR 11879 at 11898); however, some evidence supporting this is 
replacing saturated fat with monounsaturated and polyunsaturated fats. 
Because saturated fat is on the label, we believe consumers can use 
that information in addition with total fat DV to maintain healthy 
dietary practices. The scientific evidence for added sugars (and solid 
fats) is based on the modeling of dietary patterns to ensure adequate 
consumption of nutrient dense foods and avoidance of excess empty 
calories that can lead to weight management issues and obesity.
    (Comment 97) One comment supporting mandatory declaration noted 
that the 2010 DGA stated that there is well established evidence that 
replacing saturated fat with monounsaturated and polyunsaturated fat 
lowers LDL cholesterol and has health benefits.
    (Response) We agree that there is well established evidence that 
replacing saturated fat with monounsaturated and polyunsaturated fats 
lowers LDL cholesterol and therefore reduces the risk of heart disease, 
and the preamble to the proposed rule (79 FR 11879 at 11897 through 
11898) discussed how replacing saturated fatty acids with 
monounsaturated or polyunsaturated fats reduced blood LDL cholesterol 
levels. A quantitative intake recommendation, however, is not available 
for either monounsaturated or polyunsaturated fat. Therefore, in 
considering the factors for mandatory or voluntary declaration, we 
determined that monounsaturated and polyunsaturated fat warrants 
voluntary declaration.
    An FDA health claim is available for the labeling of foods: 
``Replacing saturated fat with similar amounts of unsaturated fats may 
reduce the risk of heart disease. To achieve this benefit, total daily 
calories should not increase'' (see ``Health Claim Notification for the 
Substitution of Saturated Fat in the Diet with Unsaturated Fatty Acids 
and Reduced Risk of Heart Disease'') (Ref. 35).
    (Comment 98) One comment supported mandatory declaration of 
polyunsaturated fat because, according to the comment, polyunsaturated 
fat includes essential nutrients.
    (Response) We agree that polyunsaturated fat includes essential 
fatty acids (i.e., linoleic and alpha linolenic acid). We disagree, 
however, that the listing of polyunsaturated fat should be mandatory 
for this reason. Essentiality of a nutrient is not factor considered 
for the mandatory or voluntary labeling of these types of non-statutory 
nutrients, other than essential vitamins and minerals. The basis for 
proposing voluntary declaration of polyunsaturated fat was because of 
its role in reducing the risk of CVD when replacing saturated fat, 
which has public health significance.

[[Page 33789]]

    (Comment 99) One comment supporting mandatory declaration noted 
that the 2002 IOM report (Ref. 29) concluded that the type of fat, 
rather than total fat, was relevant to health and the 2010 DGA shifted 
the focus from total fat to the type of fat. Another comment noted that 
we were no longer requiring ``Calories from fat'' because the focus is 
more on the type of fat. Several comments supporting mandatory 
declaration of monounsaturated and polyunsaturated fats noted that it 
is not possible to identify these types of fats which have health 
benefits, and, therefore, it is not possible to differentiate from 
unhealthy fats. One comment said that listing these fats can help 
people distinguish between fatty foods that can be eaten more often 
compared to those with higher saturated fat content to be eaten less 
often.
    Other comments supporting mandatory declaration claimed that 
consumers need to be able to compare products and select foods that are 
not only lower in saturated fat but contain monounsaturated and 
polyunsaturated fats.
    (Response) We agree that the four chemically defined categories of 
type of fat (i.e., saturated, trans, monounsaturated fat, and 
polyunsaturated fat), rather than total fat, are relevant to health, 
specifically CVD risk. Current dietary recommendations no longer 
emphasize total fat. Certain categories of fatty acids are beneficial, 
while others categories have negative health effects, particularly 
related to CVD (see 79 FR 11879 at 11891). We recognize that 
monounsaturated and polyunsaturated fat have public health relevance 
when they replace saturated fat (id. at 11898). There is not a 
quantitative intake recommendation available, however, that identifies 
how much monounsaturated and polyunsaturated fat must replace saturated 
fat, and there is no dose-response relationship between mono- and 
polyunsaturated fats to risk of CHD, independent of saturated fat, 
similar to the relationship between trans fat and risk of CHD. 
Therefore, we decline to require the declaration of monounsaturated and 
polyunsaturated fat. A quantitative intake recommendation is a factor 
we considered for mandatory declaration of these types of non-statutory 
nutrients (79 FR 11879 at 11890).
    b. DRV. The proposed rule would not establish DRVs for either 
monounsaturated or polyunsaturated fat because quantitative intake 
recommendations are not available for setting DRVs (79 FR 11879 at 
11897, 11899).
    (Comment 100) One comment agreed with not setting a DRV for 
monounsaturated or polyunsaturated fat because there is no agreed upon 
scientific basis for establishing a DV due to diverse nature of these 
fatty acids.
    (Response) We maintain that there is an insufficient basis to set a 
DRV for either monounsaturated or polyunsaturated fat, so the final 
rule does not establish a DRV for either monounsaturated or 
polyunsaturated fat.
    c. Declaration of individual polyunsaturated fatty acids. 
Polyunsaturated fats represent two general categories: n-6 and n-3 
polyunsaturated fatty acids. The most common n-6 and n-3 
polyunsaturated fatty acid in food is linoleic acid and [alpha]-
linolenic acid, respectively. Other n-3 fatty acids found in foods, 
particularly in fish, are the long chain fatty acids, eicosapentaeneoic 
acid (EPA) and docosahexaenoic acid (DHA).
    The preamble to the proposed rule (79 FR 11879 at 11898) discussed 
the possibility of establishing separate DRVs for linoleic acid and 
[alpha]-linolenic acid, and, if so, whether the declaration of these 
nutrients should be voluntary or made mandatory. We decided that, 
because of the lack of well-established evidence for a role of n-3 or 
n-6 polyunsaturated fatty acids in chronic disease risk and the lack of 
a quantitative intake recommendation, the declarations of n-3 and n-6 
polyunsaturated fatty acids are not necessary to assist consumers to 
maintain healthy dietary practices. Thus, the proposed rule would not 
provide for the individual declaration of either n-3 or n-6 
polyunsaturated fatty acids on the Nutrition Facts label. Similarly, 
because of the lack of well-established evidence for a role of EPA and 
DHA in chronic disease risk and the lack of a quantitative intake 
recommendation, the proposed rule would not provide for the 
declarations of EPA and DHA.
    (Comment 101) Although some comments agreed with our decision not 
to require the declaration of n-3 or n-6 polyunsaturated fatty acids, 
other comments would revise the rule to allow for the voluntary 
declaration of the n-3 polyunsaturated fatty acids, eicosapentaeneoic 
acid (EPA), and docosahexaenoic acid (DHA). One comment supported the 
voluntary declaration of EPA and DHA because humans have a limited 
capability to synthesize, elongate, and desaturate [alpha]-linolenic 
acid (ALA) to EPA and DHA.
    (Response) While humans may have a limited capability to elongate 
and desaturate ALA to EPA and DHA, we do not have evidence to 
demonstrate that biosynthesis of EPA and DHA is insufficient in the 
general population such that EPA and DHA are essential in the diet. 
Therefore, there is no basis on which we can rely to support a 
voluntary declaration.
    (Comment 102) Other comments supporting the voluntary declaration 
of n-3 and n-6 polyunsaturated fatty acids noted that monounsaturated 
fat, polyunsaturated fat, sugars, soluble fiber, insoluble fiber, sugar 
alcohols, and added sugars are being allowed or required on the label 
but do not have a DV. Therefore, the comments argued, we should treat 
n-3 and n-6 polyunsaturated fatty acids in the same manner.
    (Response) There is well-established evidence for the role of 
sugars, monounsaturated fat, polyunsaturated fat, soluble fiber, 
insoluble fiber, and sugar alcohols in reducing the risk of chronic 
disease or providing a beneficial physiological effect. Therefore, 
these nutrients have public health relevance, which is the basis for 
voluntary labeling. Specifically, there is strong evidence for sugars 
increasing the risk of dental caries (see 79 FR 11879 at 11902), as 
well as reducing the risk of dental caries when sugar alcohols replace 
sugar in the diet (id. at 11908). There also is well established 
evidence that replacing saturated fat with monounsaturated and 
polyunsaturated fat reduces the risk of CVD (Ref. 35). There is strong 
evidence that soluble fibers reduce the risk of CHD (see 79 FR 11879 at 
11911). There is well established evidence that insoluble fibers can 
improve laxation, a beneficial physiological effect (Ref. 36). 
Moreover, the scientific evidence for added sugars differs from that 
for n-3 and n-6 polyunsaturated fatty acids. There is a strong 
association between a healthy dietary pattern characterized by a lower 
intake of sugar sweetened foods and beverages, as compared to less 
healthy dietary patterns, and a reduced risk of CVD. A DV is being 
provided for added sugars (see part II.H.3).
    In contrast, there is supportive, but not conclusive, evidence to 
suggest that n-3 polyunsaturated fatty acids reduce the risk of CHD 
(Ref. 37). Furthermore, there is no conclusive evidence for an 
independent role of n-6 polyunsaturated fatty acids in reducing blood 
cholesterol levels, and consequently, risk of CHD (see 79 FR 11879 at 
11898). Therefore, we disagree that there is a sufficient basis to 
treat n-3 and n-6 polyunsaturated fatty acids the same as

[[Page 33790]]

the other nutrients discussed in the comment, so the final rule does 
not provide for voluntary declaration of n-3 and n-6 polyunsaturated 
fatty acids.
    (Comment 103) One comment supporting the voluntary declaration of 
n-3 polyunsaturated fatty acids said that we could have reached the 
same conclusion for n-3 polyunsaturated fatty acid in the same way that 
we did for vitamin D. The 2010 DGA recommendation to increase the 
amount and variety of seafood in place of some meat and poultry was 
made to increase EPA and DHA in the American diet, as well as the total 
package of benefits seafood provides, including vitamin D.
    (Response) We disagree that n-3 polyunsaturated fatty acids were 
handled differently than vitamin D. There is strong evidence for a 
relationship between vitamin D intake and risk of osteoporosis (see 79 
FR 11879 at 11921). Furthermore, the IOM provided a quantitative intake 
recommendation (i.e., RDA) for vitamin D (Ref. 38). We considered the 
scientific evidence for this recommendation when setting an RDI (see 
our response to comment 372). In contrast, the evidence for n-3 
polyunsaturated fatty acids is not well-established, and a quantitative 
intake recommendation is not available (see 79 FR 11879 at 11897 
through 11899).
    (Comment 104) Several comments supporting the voluntary declaration 
of n-3 polyunsaturated fatty acids stated that not providing 
information on n-3 polyunsaturated fatty acids affords the consumer 
little opportunity to apply important dietary guidance as in the 2010 
DGA. The comments said that, while the IOM did not set a DRI for EPA 
and/or DHA, this is an insufficient reason for disallowing the 
voluntary declaration of these essential fatty acids on the Nutrition 
Facts label. The comments said that the DGA concluded that moderate 
evidence indicates that 250 mg EPA and DHA daily is associated with 
reduced cardiac deaths among individuals with and without preexisting 
CVD and this recommendation contributes to prevention of heart disease. 
The comments also noted that, while we have not authorized a health 
claim regarding EPA and DHA and CVD risk, we have allowed the use of 
qualified health claims for 10 years.
    (Response) The 2010 DGA concluded that moderate evidence shows that 
the consumption of 8 ounces per week of a variety of seafood, which 
provides an average consumption of 250 mg per day of EPA and DHA, is 
associated with reduced cardiac deaths among individuals with and 
without preexisting CVD. A DGA key recommendation was not provided for 
EPA and DHA, but rather for seafood. It is not clear whether EPA and 
DHA per se, or other substances in fish contribute to cardiac deaths. 
The qualified health claim on EPA and DHA and CVD risk is supportive, 
but not conclusive, evidence to suggest that n-3 polyunsaturated fatty 
acids reduce the risk of CHD (Ref. 37). The factors for mandatory and 
voluntary labeling of these types of non-statutory nutrients on the 
Nutrition Facts label depend on strong (rather than moderate or 
inconclusive) evidence. Therefore, we disagree that the information 
provided in the 2010 DGA report is sufficient to warrant the voluntary 
declaration of EPA and DHA.
    (Comment 105) One comment supporting the voluntary declaration of 
n-3 polyunsaturated fatty acids noted that an article on a summary of a 
workshop stated that, ``National public health initiatives to increase 
n-3 fatty acid consumption are needed: The working group believes that 
data are currently sufficient to indicate that intake of n-3 fatty 
acids is suboptimal and a national and international initiative should 
be launched to shift n-3 fatty acid intake upward'' (Ref. 39). Another 
comment cited a paper which concluded that a large percentage of the 
U.S. adult population is not meeting recommendations for omega-3 fatty 
acid consumption set forth by the 2010 DGA (Ref. 40). One comment cited 
an article that evaluated intakes of ALA, EPA, and DHA intake in 
children 4 to 8 years of age (Madden et al., 2009).
    (Response) We disagree with the comments' interpretation of the 
cited articles. With respect to the cited articles, we note that the 
Akabas and Decklebaum article did not provide information to explain 
the basis for concluding that the intake of n-3 polyunsaturated fatty 
acids is suboptimal. The Papanikolaou article used 250 mg/day to assess 
adequacy of intake, however, the value was not a recommendation put 
forth by the 2010 DGA. The article by Madden et al. (2009) used the AI 
of 900 mg/day to assess adequacy of ALA, and 10 percent of this value 
(90 mg/day) was used to assess intake adequacy for EPA and DHA. We 
disagree with how Madden (Ref. 41) assessed nutrient intake for EPA and 
DHA because the IOM did not set an AI or EAR for EPA and DHA. The IOM 
only noted that EPA and DHA contribute approximately 10 percent of the 
total n-3 polyunsaturated fat intake (Ref. 29). There is no 
quantitative intake recommendation (i.e., EAR) available for assessing 
inadequate intake in populations. Furthermore, there are a number of 
nutrients for which there is suboptimal intake which was considered as 
part of the factors for mandatory or voluntary declaration. However, we 
did not rely on suboptimal intake alone for such voluntary declarations 
in the Nutrition Facts label.
    (Comment 106) Other comments supporting the voluntary declaration 
of n-3 polyunsaturated fats cited published articles or gave Web site 
addresses to discuss the health benefits of these fatty acids.
    (Response) We have reviewed the articles and Web sites and, based 
on our review, decline to revise the rule to provide for the voluntary 
declaration of n-3 polyunsaturated fats.
     Many articles were review articles or meta-analyses that 
included studies that tested individuals who had a previous coronary 
event; therefore, the studies were evaluating the effect of the n-3 
polyunsaturated fatty acids on secondary prevention of CVD (Refs. 42-
47). Furthermore, some articles included observational studies on the 
association between the intake of polyunsaturated fatty acids and CVD 
risk. Scientific conclusions from such studies are not sufficient to 
support conclusions about the causal role of these n-3 polyunsaturated 
fatty acids on CHD risk in the general population.
     One article (Ref. 48) was a one-page abstract from a 
meeting. The Web site address that was cited (http://www.goedomega3.com/healthcare) is a general resource for health care 
professionals. Another Web site provided a list of organizations that 
have intake recommendations for EPA and DHA (http://www.goedomega3.com/index.php/files/download/304). None of the citations provided 
information that we would consider for voluntary declaration of EPA and 
DHA related to a relationship between these nutrients and risk of CHD.
     One article (Ref. 49) evaluated the relationship between 
plasma phospholipid EPA and DHA as a biomarker of intake and mortality. 
Figure 2 of this article showed that the dose-response relationship 
between EPA and DHA intake and plasma phospholipid EPA and DHA was not 
linear and plateaued at around 0.5 grams/day. Therefore, plasma 
phospholipid EPA and DHA is not a reliable indicator of EPA and DHA 
consumption, and scientific conclusions could not be drawn from such as 
study.
     One article (Ref. 50) was on an animal study that tested 
the effect of DHA on melanoma. The article did not present the totality 
of the evidence on DHA and risk of melanoma.

[[Page 33791]]

Furthermore, we would not rely on animal data for evaluating the 
efficacy of DHA to reduction of risk to melanoma in humans to establish 
a nutrient declaration.
     One article (Ref. 51) was a meta-analysis on EPA and DHA 
intake and blood pressure. There are several limitations of this meta-
analysis including: (1) Not providing all of the relevant studies on 
EPA and DHA and blood pressure; (2) including studies that lacked an 
appropriate control group; and (3) including studies that conducted 
inappropriate statistical analyses.
     One article (Ref. 52) was an European Food Safety 
Association (EFSA) scientific opinion on a labeling reference value for 
n-3 and n-6 polyunsaturated fatty acids in which EFSA provided a 
recommended intake level of 250 mg/day of EPA and DHA. The article did 
not discuss the scientific evidence in detail to show how this 
quantitative intake recommendation was determined. Furthermore, while 
the scientific opinion cited several references to support 250 mg/day, 
a number of these included observational data in which information was 
obtained on fish consumption. The IOM did not set a DRI for EPA or DHA 
because much of the observational evidence measured fish or fish oil 
intake as a proxy for n-3 polyunsaturated fat intake, and other 
components in fish may have effects that are similar to n-3 fatty acids 
and therefore may confound the results of the observational studies 
(Ref. 29).
    (Comment 107) Some comments supporting the voluntary declaration of 
individual polyunsaturated fatty acids discussed consumer use or 
consumer understanding as reasons for allowing voluntary declaration.
    One comment cited the 2014 IFIC Food and Health survey data to 
assert that the data suggests that voluntary declaration of individual 
polyunsaturated fatty acids is necessary for the consumer to make the 
purchase decisions that they intend. The comment indicated that 21 
percent of consumers are looking to increase their omega-3 intake.
    Some comments stated that a distinction between the different n-3 
polyunsaturated fatty acids is necessary so that consumers seeking 
specifically EPA or DHA are not misled by voluntary declaration of 
polyunsaturated fat, because the levels are inflated by the presence of 
n-6 polyunsaturated fatty acids and ALA. The comments said that, while 
85 percent of Americans are aware the n-3 polyunsaturated fatty acids 
reduce the risk CHD, not all n-3 polyunsaturated fatty acids are equal.
    Other comments said that, while manufacturers may express the 
content of EPA and DHA in a product bearing a claim, doing so outside 
the Nutrition Facts label denies the consumer an opportunity to 
recognize if a meaningful amount of these fatty acids are provided 
relative to the other fats in the product.
    (Response) We recognize that the 2014 IFIC survey concluded that 21 
percent of consumers are trying to increase their consumption of omega-
3 fats. We also recognize that the majority of polyunsaturated fats in 
foods are in the form of n-6 polyunsaturated fatty acids and that not 
all n-3 polyunsaturated fatty acids have the same effect on CHD risk. 
However, because of the lack of well-established evidence for a role of 
n-3 or n-6 polyunsaturated fatty acids in chronic disease risk and the 
lack of a quantitative intake recommendation, the declarations of n-3 
and n-6 polyunsaturated fatty acids are not necessary to assist 
consumers to maintain healthy dietary practices. Because neither of 
these factors for voluntary declaration for these types of nutrients 
has been met, and the comments provided no scientific basis on which we 
could rely to support the declaration, we disagree that meaningful 
amounts of EPA and DHA should be voluntarily listed to provide its 
amount relative to the other fats in the product.
    (Comment 108) Some comments supporting the voluntary declaration of 
n-3 polyunsaturated fatty acids stated that the recognition of only 
polyunsaturated fat may have unintended consequences of consumers 
failing to understand differences in biopotency of n-3 long-chain 
polyunsaturated fatty acids compared to other polyunsaturated fatty 
acids. According to the comments, not declaring n-3 polyunsaturated 
fatty acids may confuse consumers who are not aware of differences 
among individual polyunsaturated fatty acids with respect to their 
ability to reduce heart disease risk.
    (Response) We disagree that potential differences in biopotency of 
n-3 polyunsaturated fatty acids is a basis for voluntary declaration. 
While there may be differences in biopotency with respect to CHD risk, 
there is insufficient scientific evidence and information to warrant 
voluntary declaration.
    With respect to possible consumer confusion and unintended 
consequences, the comments did not describe the extent to which 
consumers might be confused or what the unintended consequences might 
be, so we do not have sufficient information to evaluate those aspects 
of the comments.

G. Cholesterol

1. Mandatory Declaration
    Section 403(q)(1)(D) of the FD&C Act requires the declaration of 
the amount of cholesterol on food labels, and cholesterol content must 
be declared on the Nutrition Facts label in accordance with Sec.  
101.9(c)(3). In the preamble to the proposed rule (79 FR 11879 at 
11899), we explained that current dietary recommendations continue to 
recognize the well-established relationship between consumption of 
cholesterol and its effect on blood cholesterol levels, which are a 
surrogate endpoint for CHD risk and that we were unaware of evidence 
that would support a change to the requirement for mandatory 
declaration of cholesterol on the Nutrition Facts label in Sec.  
101.9(c)(3). Consequently, we did not propose any changes to the 
requirement for mandatory declaration of cholesterol.
    Relying on information provided in the NHLBI Lifestyle Evidence 
Review (Ref. 17), the 2015 DGAC Report concluded that cholesterol is 
not a nutrient of public health concern (Ref. 19). The 2015-2020 DGA 
noted that, while adequate evidence is not available for a quantitative 
limit for dietary cholesterol specific to the Dietary Guidelines, 
individuals should eat as little dietary cholesterol as possible while 
consuming a healthy dietary pattern that includes eggs and shellfish 
(Ref. 28).
    Much of the published evidence, as was analyzed and reported by the 
IOM (Ref. 53), has demonstrated a positive association between 
cholesterol intake and total cholesterol in the blood. The IOM 
conducted a dose-response analysis of clinical trials to evaluate the 
relationship between dietary cholesterol and blood total cholesterol 
because most of the available evidence was on total cholesterol (Ref. 
53). From this IOM analysis, it was concluded that, on average, an 
increase of 100 mg/day of dietary cholesterol is predicted to result in 
a 0.05 to 0.1 mmol/L increase in total serum cholesterol, of which 
approximately 80 percent is in the LDL fraction. The IOM cited evidence 
showing that the majority of the increase in serum total cholesterol 
with increased dietary cholesterol was due to an increase in LDL 
cholesterol (rather than HDL) concentration, therefore adversely 
affecting the cholesterol profile. The IOM analysis was the basis for 
the IOM concluding that cholesterol consumption should be as low as

[[Page 33792]]

possible while consuming a nutritionally adequate diet.
    Data from NHANES (2007-2010) show that, for all individuals over 1 
year of age, 32 percent consume cholesterol in excess of the DRV of 300 
mg. For men and women 19 years of age and older, 59 percent and 17 
percent consume in excess of 300 mg/day of cholesterol, respectively. 
These findings are indicative that a significant portion of the U.S. 
population consumes amounts of cholesterol in excess of the DRV of 300 
mg.
    We do not consider there to be new information that alters the 
conclusions of the 2002 IOM report. Therefore, we conclude that the 
declaration of cholesterol on the Nutrition Facts label can assist 
consumers in maintaining healthy dietary practices and therefore should 
remain mandatory.
    (Comment 109) One comment supporting mandatory declaration of 
cholesterol noted that the 2002 IOM report (Ref. 53) showed a strong 
positive relationship between cholesterol intake and increased LDL 
cholesterol levels. The comment cited a meta-analysis of clinical 
studies in which people consumed eggs or a cholesterol-free egg 
substitute found that LDL cholesterol rose by 2 mg/dL for every 100 mg 
of cholesterol consumed (Ref. 54).
    (Response) While the 2002 IOM report provided its own analysis that 
evaluated the relationship between dietary cholesterol and cholesterol 
levels, it specifically evaluated total cholesterol levels, rather than 
LDL cholesterol levels. The IOM reported a positive association between 
change in cholesterol intake and change in total cholesterol levels 
which supports our position for mandatory listing. We recognize that 
the meta-analysis cited in the comment (Weggemans et al. 2001 (Ref. 
54)) estimated that each additional 100 mg of dietary cholesterol would 
increase serum LDL cholesterol by 0.036 (1.4 mg/dL) in the studies with 
a background diet low in saturated fat and by 0.061 (2.4 mg/dL) in the 
studies with a background high in saturated fat (P = 0.03). However, 
this study only evaluated the effect of cholesterol from eggs rather 
than total dietary cholesterol. Thus, this meta-analysis, by itself, is 
insufficient to evaluate the effect of total cholesterol intake on 
blood cholesterol levels, and therefore CVD risk.
    (Comment 110) Some comments opposed mandatory declaration of 
cholesterol because, the comments said, saturated fat has the biggest 
negative impact on blood cholesterol. The comments said that the EFSA 
concluded that, ``Although there is a positive-dose-dependent 
relationship between the intake of dietary cholesterol with blood LDL 
cholesterol concentrations, the main dietary determinant of blood LDL 
cholesterol concentrations is saturated fat.'' Other comments said 
there is not enough evidence on the effect of dietary cholesterol on 
blood cholesterol, the relationship between cholesterol consumption and 
blood cholesterol levels is weak and has been overestimated, and 
cholesterol intake does not raise blood cholesterol levels. Some 
comments cited several meta-analyses that concluded that there were 
small, modest reductions in serum cholesterol with reductions (e.g., 
100 mg/day) in dietary cholesterol (Refs. 55-57).
    (Response) We agree that saturated fat has a larger impact on 
raising blood cholesterol levels. We disagree that there is not enough 
evidence or that the evidence for the cholesterol-raising effects of 
dietary cholesterol is weak or does not exist. Numerous clinical 
studies have reported a cholesterol-raising effect of dietary 
cholesterol (Ref. 53). Using such studies, the IOM illustrated a 
curvilinear relationship between change in dietary cholesterol and 
change in serum total cholesterol levels ranging from 0 to 4,500 mg/
day, with the greatest change (increase) in serum cholesterol occurring 
with an increased cholesterol intake of up to 50 mg/day.
    The comments about EFSA support mandatory listing of both 
cholesterol and saturated fat because EFSA recognizes that intake of 
both nutrients have a positive association with blood cholesterol 
levels.
    The final rule, therefore, does not change the pre-existing 
requirement for mandatory declaration of cholesterol.
    (Comment 111) Some comments opposed to mandatory declaration of 
cholesterol noted that the NHLBI Lifestyle Evidence Review (Ref. 17) 
states that there is insufficient evidence to determine whether 
lowering dietary cholesterol reduced LDL cholesterol in the blood.
    (Response) While we recognize the conclusion of the NHLBI Lifestyle 
Evidence Review in addition to blood LDL cholesterol being a surrogate 
endpoint for CHD risk, blood total cholesterol is also considered a 
valid predictor of CHD risk as approximately 80 percent of total 
cholesterol is LDL cholesterol (Ref. 29). The NHLBI Lifestyle Evidence 
Review did not review the findings for blood total cholesterol. Much of 
the evidence, as was analyzed and reported by the IOM (2002), 
demonstrated a positive association between cholesterol intake and 
total cholesterol in the blood. While the 2015 DGAC concluded that 
there was no appreciable relationship between the consumption of 
dietary cholesterol and serum cholesterol, the only information the 
DGAC considered was that in the NHLBI Lifestyle Evidence Review, which 
was specific to studies that measured LDL cholesterol.
    (Comment 112) One comment opposed to mandatory declaration of 
cholesterol stated that clinical trials have identified individuals 
across all ages who have very limited or no increase in plasma 
cholesterol as a result of additional dietary cholesterol. The comments 
said that, even among hyper-responders (high response in blood 
cholesterol to dietary cholesterol), the response is an increase in 
both LDL and HDL cholesterol levels, such that the LDL/HDL ratio, a key 
marker of CHD risk, does not change (Refs. 58-61). Furthermore, the 
comments said, the amounts of cholesterol provided in clinical trials 
are well in excess of normal consumption.
    (Response) We agree that individual's blood cholesterol levels 
respond differently to dietary cholesterol; this difference in 
individual response is true for most nutrients when they are associated 
with chronic disease risk. We disagree that differences in individual 
response is a basis for not considering the numerous studies showing 
that cholesterol intake raises average blood cholesterol levels. The 
reported findings on blood cholesterol levels from clinical trials 
usually represent the averages of these blood levels of the study 
subjects, including those who respond and those who do not respond. 
Assessment of the average findings from clinical studies is more 
relevant because the Nutrition Facts label is intended for the general 
U.S. population.
    We also disagree that the ratio of LDL cholesterol to HDL 
cholesterol is a key marker of CHD risk. We do not consider HDL 
cholesterol, and therefore the LDL:HDL cholesterol ratio, to be a key 
marker (i.e., surrogate endpoint) of CHD risk. Blood HDL cholesterol 
has not been qualified as being a strong predictor of CHD risk. 
Therefore, the evidence on LDL cholesterol outweighs any evidence on 
the LDL:HDL cholesterol ratio with respect to evaluating the role of 
cholesterol in CHD risk.
    (Comment 113) Some comments opposed to the mandatory declaration of 
cholesterol said that the 2010 DGA stated that an egg a day does not 
increase blood cholesterol levels, that eggs are not associated with 
greater risk of CVD, and that eggs are nutrient-dense. Other comments 
cited a number

[[Page 33793]]

of studies and meta-analyses (Refs. 62-66) concluding that there was 
not an association between egg consumption and CVD or CHD risk.
    (Response) We recognize that the 2010 DGA noted that evidence 
suggests that one egg (i.e., egg yolk) per day does not result in 
increased blood cholesterol levels, nor does it increase the risk of 
cardiovascular disease in healthy people. The 2010 DGAC, however, noted 
that, while eggs are a major source of cholesterol in the American 
diet, eggs and egg mixed dishes provide 25 percent of total cholesterol 
intake. Therefore, we do not consider studies involving only eggs to be 
sufficient to understand the role of total cholesterol intake on CVD 
risk.
    As for the comments stating that eggs are nutrient-dense, the 
mandatory declaration of cholesterol relates to the relationship 
between cholesterol intake from consumption of all food sources, as 
part of the total daily dietary intake, and risk of CHD. Therefore, the 
comment does not change our conclusion about the scientific basis for 
the mandatory declaration of cholesterol. As we stated in the preamble 
to the proposed rule (79 FR 11879 at 11899), current dietary 
recommendations continue to recognize the well-established relationship 
between consumption of cholesterol and its effect on blood cholesterol 
levels, which are a surrogate endpoint for CHD risk. We continue to 
believe that information regarding cholesterol is necessary to assist 
consumers in maintaining healthy dietary practices.
    As for the studies cited in the comments, the studies do not imply 
that total cholesterol intake (from all dietary sources) does not 
contribute to CHD risk. Consequently, rather than view eggs and 
cholesterol content in eggs in isolation, our Nutrition Facts label 
provides information to help the consumer understand the ``relative 
significance'' of eggs and their cholesterol content in the context of 
a ``total daily diet'' (see section 2(b)(1)(A) of the NLEA).
    (Comment 114) Some comments opposed to mandatory declaration of 
cholesterol stated that dietary cholesterol has been proven to be 
unrelated to CVD and CVD mortality. The comments cited review articles 
(Refs. 67-68) to assert such studies do not support a connection 
between dietary cholesterol and CHD events. The review articles 
summarized observational studies, as well as some clinical trials, that 
questioned an association between cholesterol intake and risk of CHD.
    (Response) We agree that some observational studies have failed to 
support an association between dietary cholesterol and CHD events. 
However, we put greater reliance on clinical trials when substantiating 
nutrient and disease relationships. Observational studies measure 
associations between foods/nutrients and diseases without demonstrating 
that the food or nutrient caused, in part, the change in risk of a 
chronic disease. The IOM (2002) (Ref. 29) noted that the lack of 
consistency in observational studies on dietary cholesterol may be due 
to many factors, including inaccuracies of dietary intake data, and to 
the limited ability to distinguish the effects of dietary cholesterol, 
independent of energy intake and other dietary variables that may be 
positively (e.g., saturated fat) or negatively (e.g., dietary fiber 
intake) associated with dietary cholesterol and heart disease risk. 
Individual studies, as well as an analysis of a number of these studies 
(Ref. 29), have demonstrated a positive association between cholesterol 
intake and total cholesterol, which is a risk factor of CHD. Therefore, 
we rely on the best available data and use clinical trial data more 
heavily than observational data when they are available for evaluating 
the role of dietary cholesterol in CHD risk. These two review articles 
(Refs. 67-68) also cited clinical trial data and noted that, while 
dietary cholesterol raises LDL cholesterol, it also raises HDL 
cholesterol and therefore does not change the LDL:HDL ratio. While LDL 
cholesterol is considered a surrogate endpoint for CHD risk, HDL is 
not. Therefore, the LDL:HDL ratio is not relied on for evaluating CHD 
risk.
    (Comment 115) One comment opposed to the mandatory declaration of 
cholesterol stated that the evidence is questionable for an association 
between cholesterol intake and risk of type 2 diabetes.
    (Response) Whether or not the evidence supporting cholesterol's 
role in type 2 diabetes risk may be questionable, the basis for 
mandatory declaration of cholesterol on the label is because of its 
role in CHD risk.
    (Comment 116) One comment opposed to the mandatory declaration of 
cholesterol said that overconsumption of cholesterol is not a concern 
in the United States. The comment said that the average dietary 
cholesterol intake reported by CDC is 307 mg/day for men and 225 mg/day 
for women and that, among men, the average consumption exceeds 300 mg/
day by only 2 percent while, among women, the average consumption is 25 
percent below 300 mg/day (NHANES 1999-2000).
    (Response) We disagree with the comment. Data from NHANES (2007-
2010) show that, for all individuals over 1 year of age, 32 percent 
consume cholesterol in excess of 300 mg/day. For men and women 19 years 
of age and older, 59 percent and 17 percent consume in excess of 300 
mg/day of cholesterol, respectively. These findings are indicative that 
a significant portion of the U.S. population consumes amounts of 
cholesterol in excess of the DRV of 300 mg. Therefore, we decline to 
make changes in response to this comment.
    (Comment 117) Other comments opposed the mandatory declaration of 
cholesterol for several reasons. The comments said that:
     Consumers who want to take care of their blood cholesterol 
levels may orient their food choices only towards foods that contain 
low amounts of cholesterol, regardless of their saturated fat content. 
A focus on saturated fat may lead to better results in terms of public 
health.
     Listing cholesterol could have a negative impact on 
protein intake. According to the comments, because most meat and other 
protein rich foods also contain cholesterol, cholesterol declaration 
will likely dissuade consumers from eating protein-rich foods. The 
result will be an increase in the consumption of carbohydrate-rich 
foods, causing delayed satiety and contributing to increased caloric 
consumption.
    (Response) We require declaration of cholesterol on the Nutrition 
Facts label pursuant to section 403(q) of the FD&C Act. Cholesterol 
intake is related to the risk of CHD. The comments did not provide 
information on the impact of the mandatory declaration of cholesterol 
on the consumer's intake of saturated fat, protein or carbohydrate-rich 
foods. We are not aware of information indicating that mandatory 
listing of cholesterol over the past 20 years has resulted in more 
focus on cholesterol, less focus on saturated fat, and reduced intake 
of protein-rich foods. We consider the declaration of cholesterol is 
necessary to assist consumers maintain healthy dietary practices and 
are making no changes in response to this comment.
    (Comment 118) One comment said that mandatory declaration of 
cholesterol was not necessary because cholesterol consumption has not 
been a concern for a long time in treating patients with high 
cholesterol levels.
    (Response) The Nutrition Facts label is intended for the general 
U.S. population, and nutrient declarations and percent DVs on the label 
are to help consumers make more informed choices to consume a healthy 
diet and there is a strong relationship between dietary cholesterol 
intake and total serum

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cholesterol which is a marker of CVD risk (see 79 FR 11879 at 11887 and 
part II.C.).
    (Comment 119) One comment opposed to the mandatory declaration of 
cholesterol said that the U.S. government's advice to reduce 
cholesterol intake is unusual compared to other countries in focusing 
on dietary cholesterol. The comment said that dietary recommendations 
in other countries, such as Canada, do not have an upper limit for 
cholesterol intake and, instead, focus on saturated and trans fat.
    (Response) There is a strong relationship between dietary 
cholesterol intake and total serum cholesterol which is a marker of CVD 
risk. Section 403(q)(2)(B) of the FD&C Act authorizes us to remove, by 
regulation and under certain circumstances, nutrient information. We 
would need a scientific basis about the relationship between total 
cholesterol intake and CVD risk to no longer require the mandatory 
declaration of cholesterol. While other countries may not require the 
listing of cholesterol on their food labels, section 403(q)(1)(D) of 
the FD&C Act requires the declaration of the amount of cholesterol on 
the food label. The fact that other countries lack cholesterol 
recommendations is, alone, an insufficient reason for us to no longer 
require the mandatory listing of cholesterol.
2. DRV
    Our preexisting regulations, at Sec.  101.9(c)(9), provide a DRV 
for cholesterol of 300 mg. In the preamble to the proposed rule (79 FR 
11879 at 11899), we discussed how the IOM Labeling Committee had 
recommended that the DV for cholesterol (along with saturated fat and 
trans fat) be set at a level that is as low as possible in keeping with 
an achievable health-promoting diet and how, in the 2007 ANPRM, we 
asked for public comment on whether the current DRV for cholesterol of 
300 mg should be retained. We also noted that, although the 2010 DGA 
recommended that cholesterol intake levels should be less than 200 mg/
day for individuals at high risk of CVD, we considered the DGA 
recommendation of 300 mg/day for maintaining normal blood cholesterol 
levels as an appropriate basis for setting a DRV because it represents 
the maximum intake level that covers the general U.S. population 4 
years of age and older (id.). Consequently, we did not propose changes 
to the DRV for cholesterol of 300 mg specified in Sec.  101.9(c)(9).
    (Comment 120) One comment did not support a DRV for cholesterol 
because cholesterol is made in the body.
    (Response) We agree that cholesterol is made in the body and is 
therefore not essential in the diet. However, the basis for the DRV is 
an intake level not to exceed to reduce the risk of CHD, rather than an 
intake level to achieve (e.g., a DV for essential vitamins and 
minerals). Therefore, we decline to revise Sec.  101.9(c)(9) insofar as 
a DRV for cholesterol is concerned.

H. Carbohydrate

1. Total Carbohydrate
    a. Calculation of total carbohydrate. Under our preexisting 
regulations, at Sec.  101.9(c)(6), total carbohydrate content is 
calculated by subtracting the sum of protein, total fat, moisture, and 
ash from the total weight of the food. This calculation method is 
called ``carbohydrate by difference'' and is described in A.L. Merrill 
and B.K. Watt, ``Energy Value of Foods--Basis and Derivation,'' in the 
USDA Handbook No. 74 (Ref. 69). Total carbohydrate includes starch, 
sugars, sugar alcohols, and dietary fiber.
    We did not propose to change the method for calculating 
carbohydrate content.
    (Comment 121) While some comments agreed with our decision to 
retain the calculation method for total carbohydrate content, other 
comments suggested that dietary fiber should not be included in the 
declaration of total carbohydrate. The comments stated that a 
significant number of consumers, especially individuals who have 
diabetes, want to know the amount of carbohydrates excluding dietary 
fiber (also known as ``net carbs'') because it is helpful to know when 
trying to control blood glucose. One comment recommended that 
carbohydrate should be calculated by difference, but that moisture, 
fat, protein, dietary fiber, and ash should be excluded from the 
declaration of carbohydrate. The comment suggested that the benefits of 
such an approach include easy comparison of carbohydrates between food 
choices that do or do not contain dietary fiber, easy calculation of 
calories from carbohydrates with a value of 4 calories per gram, and 
easy calculation of calories from dietary fiber with a value of 
approximately 2 calories per gram. In addition, the comment stated that 
such an approach would encourage manufacturers to increase the dietary 
fiber content of their product without increasing the carbohydrate 
content of their product and that it would simplify consumer education 
and understanding. The comment further stated that nutrient databases 
can easily exclude dietary fiber from the calculation of carbohydrate 
because analytical laboratories are easily able to determine total 
carbohydrate by excluding protein, total fat, moisture, dietary fiber, 
and ash from the total weight of the food and nutrient composition 
tables will continue to change on a regular basis to provide new and 
updated data.
    (Response) We decline to change the current method of calculating 
carbohydrate by difference. Total carbohydrate is one of the 
macronutrients and includes starch, sugars, sugar alcohols, and fiber. 
As discussed in the preamble to the proposed rule (79 FR 11879 at 
11900), dietary fibers, with the exception of lignin, are considered 
carbohydrates and are listed as a subset of total carbohydrate on the 
label. Individuals who are interested in knowing the amount of 
carbohydrate in a serving of a product less the amount of dietary fiber 
may determine this information based on what is currently declared on 
the label. Because dietary fibers are a type of carbohydrate, to 
maintain consistency with how components of macronutrients are declared 
on the label, we decline to remove dietary fiber from the calculation 
of total carbohydrate, as suggested by the comments.
    With respect to comments suggesting that dietary fiber should be 
excluded from the calculation of total carbohydrate because such a 
change would be helpful to diabetics when managing their blood sugar 
levels, we disagree that this should be a reason to remove dietary 
fiber from the declaration of carbohydrate. The information found in 
the Nutrition Facts and Supplement Facts labels is not targeted to 
individuals with acute or chronic diseases, such as diabetics (see part 
II.B.2; 79 FR 11879 at 11887).
    We also disagree that removal of dietary fiber from the declaration 
of total carbohydrate would allow consumers to compare products that do 
and do not contain dietary fiber more easily. It is not clear how the 
comparison would be made easier by removal of dietary fiber from the 
total carbohydrate declaration because, if the consumer is interested 
in knowing how much dietary fiber is in a product, the consumer can 
take that information into consideration by looking for the declaration 
of the amount of dietary fiber on the label.
    Calories from total carbohydrate may be declared voluntarily on the 
label. We discuss calculation of calories from total carbohydrate in 
greater detail later in

[[Page 33795]]

this part. We agree that additional steps are necessary to calculate 
calories from total carbohydrates when dietary fiber is included in the 
declaration. However, we did not receive any comments that the 
calculation of total carbohydrate when dietary fiber is included in the 
declaration would be unnecessarily burdensome or difficult for 
manufacturers to perform. The calculation would not require additional 
laboratory analysis or expense.
    We disagree that exclusion of dietary fiber from the declaration of 
total carbohydrate would encourage manufacturers to raise dietary fiber 
values independent from raising carbohydrate values. So long as the 
dietary fiber added to a product meets our definition of dietary fiber, 
the additional fiber added by the manufacturer would be reflected in 
the dietary fiber declaration. Consumers who are interested in 
consuming more dietary fiber may use the dietary fiber declaration to 
determine which products they purchase. Therefore, it is not clear how 
removing dietary fiber from the declaration of carbohydrate on the 
label would encourage manufacturers to add dietary fiber to their 
products.
    With respect to the assertion that exclusion of dietary fiber from 
the calculation of total carbohydrate simplifies the education process 
and understanding for consumers, absent additional information, we are 
unable to judge whether such a change would lead to better 
understanding of the total carbohydrate and/or dietary fiber 
declaration on the label, and thus, whether consumers would benefit 
from such a change in how carbohydrate is calculated.
    With respect to the comment asserting that nutrient databases can 
easily exclude dietary fiber from the calculation of carbohydrate, we 
disagree that this is a reason to exclude dietary fiber from the 
calculation of total carbohydrate. Although nutrient databases may be 
updated, we decline to exclude dietary fiber from the calculation of 
total carbohydrate because dietary fiber is a carbohydrate and should 
be declared as such to maintain consistency with how other 
macronutrients are determined and declared on the label.
    (Comment 122) One comment encouraged us to conduct consumer studies 
to examine if the separation of dietary fiber from total carbohydrate 
on the label would benefit the overall use of the Nutrition Facts label 
as a tool for nutrition literacy and education.
    (Response) We are always interested in understanding how consumers 
interpret and use information on the label. However, we are not aware 
of a specific need, and the comment did not specify how this 
information could aid consumers. Therefore, we decline to conduct these 
studies. We will consider conducting such studies if we have 
information showing that there is a need for these studies and we have 
the resources available to conduct such studies.
    b. Classification of carbohydrates based on a chemical definition 
or physiological effect. The preamble to the proposed rule (79 FR 11879 
at 11900 through 11901) discussed how the 2007 ANPRM invited comment on 
whether carbohydrates should be classified and declared in nutrition 
labeling based on their chemical definition (which is the current 
method) or on their physiological effect (e.g., attenuation of blood 
sugar or laxation), and whether additional types of carbohydrates 
(e.g., starch) should be listed separately on the Nutrition Facts 
label. We explained that carbohydrates include starch, sugars, sugar 
alcohols, and dietary fibers and that different carbohydrates have 
different physiological effects (id. at 11901). Within the different 
types of carbohydrate (i.e., starch, sugars, sugar alcohols, and 
dietary fibers), too, specific carbohydrates may have different 
physiological effects (e.g., different types of dietary fibers) making 
it difficult to apply a definition that is based on physiological 
effects across a category of carbohydrates. Furthermore, analytical 
methods for measuring different types of carbohydrates are based on 
chemical structure rather than physiological effect. Given the various 
components of total carbohydrate and different types of physiological 
effects of each, we decided not to change our provisions for the 
classification or declaration of carbohydrates specified in Sec.  
101.9(c)(6).
    (Comment 123) One comment recommended that complex carbohydrates 
should be listed separately under total carbohydrate on the label. The 
comment stated that people do not understand that they have to subtract 
in order to get an idea of how much good carbohydrates are in a food 
product.
    (Response) We decline to list complex carbohydrates separately on 
the label. The comment did not provide any information to explain what 
is considered to be a ``complex'' or ``good carbohydrate,'' and it did 
not explain what subtraction method can be used to calculate ``good'' 
or ``complex'' carbohydrates from information found on the label.
    We have allowed for voluntary declaration of ``other carbohydrate'' 
on the Nutrition Facts label (Sec.  101.9(c)(6)(iv)). Our regulations 
define ``other carbohydrate'' as the difference between total 
carbohydrate and the sum of dietary fiber, sugars, and sugar alcohol, 
except that if sugar alcohol is not declared, ``other carbohydrate'' is 
defined as the difference between total carbohydrate and the sum of 
dietary fiber and sugars (Sec.  101.9(c)(6)(iv)). Thus, the category of 
``other carbohydrate'' includes what are typically considered to be 
complex carbohydrates. As discussed in part II.H.6, the final rule does 
not permit the category of ``other carbohydrate'' to be declared on the 
label.
    c. Separate declaration of additional individual types of 
carbohydrates. In the preamble to the proposed rule (79 FR 11879 at 
11901), we discussed how the 2007 ANPRM asked whether additional types 
of carbohydrates (e.g., starch) should be listed separately on the 
Nutrition Facts label. We stated that the comments we received in 
response to the 2007 ANPRM did not support the declaration of 
additional types of carbohydrates (e.g., starch). Thus, the proposed 
rule would not require the separate declaration of additional types of 
individual carbohydrates, such as starch, on the Nutrition Facts label.
    (Comment 124) Several comments discussed Allulose. Allulose (also 
known as psicose) is a monosaccharide that is derived from fructose. 
According to the comments, Allulose is approximately 70 percent as 
sweet as sucrose, but contributes less than 0.2 calories/gram to the 
diet. The comments said that Allulose is added to foods and beverages 
as a partial replacement for sugars and/or high-fructose corn syrup 
because of its low, near zero, calorie content and other organoleptic 
properties (e.g. mouthfeel, texture, etc.).
    One comment said we should not include Allulose in the declaration 
for total carbohydrate and added sugar. In contrast, another comment 
said Allulose should be included in the declaration of ``total 
carbohydrate'' for nutrition labeling purposes, but should not be 
included in the declaration of ``sugars'' or ``added sugars.'' The 
comments suggested that Allulose does not have the metabolic properties 
of fructose or other sugars and does not contribute calories or raise 
blood sugar levels like other sugars do. The comments said that, upon 
ingestion, approximately 70 percent of Allulose is unabsorbed in the 
small intestine, passes into the bloodstream and is then excreted in 
the urine, without significant metabolism; the other 30 percent that is 
not absorbed

[[Page 33796]]

is transported to the large intestine where it is not fermented. 
Allulose is then excreted without being absorbed (Refs. 70-71).
    One comment stated that, when Allulose is used in food, there 
should be a reduction in the amount of calories declared of 4 calories/
gram.
    (Response) On April 10, 2015, we received a citizen petition from 
Tate & Lyle Ingredients Americas LLC (Docket Number FDA-2015-P-1201) 
requesting that Allulose be exempt from being included as a 
carbohydrate, sugars, or added sugar in the Nutrition Facts label on 
foods and beverages. The petition provided data and other information 
suggesting that Allulose is different from other sugars in that it is 
not metabolized by the human body, has negligible calories (0.2 
calories per gram or less), does not contribute to increases in blood 
glucose or insulin levels, and, if included as carbohydrates and sugars 
(added sugars) on the Nutrition Facts label, would lead to consumer 
confusion, particularly consumers with diabetes or consumers otherwise 
concerned with accurately monitoring blood glucose. The petition, which 
was submitted after the comment period for the proposed rule had ended, 
provided new evidence that was not previously submitted in comments to 
the proposed rule. We need additional time to fully consider the 
information provided in the comments and the citizen petition. 
Therefore, the final rule does not reach a decision as to whether 
Allulose should be excluded from the labeling of carbohydrate, sugars 
and/or added sugars, and Allulose, as a monosaccharide, must be 
included in the declaration of each pending any future rulemaking that 
would otherwise exclude this substance from the declaration.
    d. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act 
requires the declaration of total carbohydrate, and our preexisting 
regulations, at Sec.  101.9(c)(6), require the declaration of the 
amount of total carbohydrate on the Nutrition Facts label. In the 
preamble to the proposed rule (79 FR 11879 at 11901), we said that 
carbohydrates are an essential part of the diet because they provide 
energy to the cells in the body, especially the brain, which is 
dependent on carbohydrate for proper functioning, and we tentatively 
concluded that the declaration of carbohydrates on the Nutrition Facts 
label continues to be necessary to assist consumers in maintaining 
healthy dietary practices.
    (Comment 125) Many comments supported the continued mandatory 
declaration of total carbohydrates; some comments stated that the 
reason that total carbohydrates should continue to be declared on the 
label is because the information is used by individuals who have 
diabetes to ``count carbs.''
    (Response) While we agree that total carbohydrates should continue 
to be declared on the label, we disagree with the comments' rationale 
for the continued mandatory labeling of total carbohydrates. As 
discussed in part II.B.2, the information on the label is intended for 
the general healthy population rather than individuals with chronic 
diseases such as diabetes. In the preamble to the proposed rule (79 FR 
11879 at 11901), we explained that carbohydrates are an essential part 
of the diet because they provide energy to the cells in the body, 
especially the brain, which is dependent on carbohydrate for proper 
functioning. Thus, the declaration of carbohydrates on the Nutrition 
Facts label continues to be necessary to assist consumers in 
maintaining healthy dietary practices, and so the final rule does not 
change the requirement in Sec.  101.9(c)(7) for mandatory labeling of 
total carbohydrate.
    e. DRV. The DRV for total carbohydrate is 300 grams (Sec.  
101.9(c)(9)). Consistent with calculating total carbohydrate ``by 
difference,'' the proposed rule would not change the approach to 
calculate the percent DV for carbohydrate ``by difference'' as well. In 
addition, the proposed rule would not change the DRVs for fat or 
protein (see parts II.F.1.c, II.F.2.c, II.F.3.c, II.F.4.b, and II.I.3), 
which are used to derive the DRV for total carbohydrate. The DRV for 
total carbohydrate would remain at 300 grams/day. We note that the RDA 
for carbohydrate for men and women 19 years of age and older is 130 
grams/day. Therefore, the DRV should not be viewed as an intake 
requirement, but as a reference amount.
    (Comment 126) One comment said we should no longer require a 
percent DV declaration for total carbohydrate because consumption of 
some carbohydrates, such as naturally occurring sugars from fruit and 
milk, are not a public health concern.
    (Response) We disagree with the comment that the percent DV 
declaration for total carbohydrate should no longer be required. Total 
carbohydrate is one of the three major macronutrients in the diet. It 
provides basic information about a food's nutrient profile. The percent 
DV declaration for total carbohydrate helps consumers put the amount of 
total carbohydrate in a serving of a food into the context of their 
total daily diet.
    (Comment 127) One comment supported maintaining the current DRV for 
total carbohydrate of 300 grams. The comment stated that it falls 
within the AMDR range. In addition, the comment said, although there is 
an EAR and RDA for total carbohydrate, neither is appropriate or needed 
to serve as the basis for the DRV because relevant public health 
concerns are the ratio of carbohydrate to total fat and the source and 
type of carbohydrate in the diet.
    Other comments suggested that the DRV of 300 grams is too high and 
that we should take a different approach to setting the DRV for total 
carbohydrate. One comment stated that, even though the DRV should not 
be viewed as an intake requirement, but rather as a reference amount, 
consumers often perceive it as recommended amount. The comment 
recommended using the population-weighted mid-point of the AMDR for 
adults and children of 275 grams to encourage reduction in carbohydrate 
consumption. The comment suggested that the current DRV of 300 grams is 
excessive given that the RDA for carbohydrate for adults 19 years of 
age and older is 130 grams/day, and that excessive carbohydrate intake 
is a central cause of the American obesity epidemic.
    Another comment recommended reducing the DRV for total carbohydrate 
because the American population is sedentary and prone to metabolic 
syndrome. The comment also referred to the current DRV of 300 grams as 
a recommended intake level for a daily energy intake of 2,000 calories.
    (Response) We agree with the comments recommending a reduction in 
the DRV for total carbohydrate, but for different reasons. We disagree 
with the comment that recommended decreasing the DRV for total 
carbohydrate because the American population is sedentary and prone to 
metabolic syndrome. It is unclear, based on the comment, what the 
comment is suggesting regarding the relationship between consumption of 
carbohydrates and a sedentary lifestyle or risk of metabolic syndrome. 
Furthermore, we disagree with the comment that the current DRV is a 
recommended intake level. As stated in the preamble to the proposed 
rule (79 FR 11879 at 11901), the DRV should not be viewed as an intake 
requirement, but as a reference amount.
    We agree that neither the EAR or RDA values for total carbohydrate 
are appropriate to serve as the basis for a DRV, but we agree for 
different reasons than those stated in the comment. As discussed in the 
preamble to the proposed rule (79 FR 11879 at 11901), the EAR and RDA 
values set by the IOM

[[Page 33797]]

do not include sugar alcohols or dietary fiber. Our calculation of 
total carbohydrate, for the purposes of nutrition labeling, accounts 
for all types of carbohydrates, including sugar alcohols and dietary 
fiber. Therefore, using the EAR and RDA to set a DRV for total 
carbohydrate would result in a reference value that is based on 
recommendations specifically for sugars and starches. As we stated in 
the preamble to the proposed rule (id.), if the midpoint of the AMDR 
range is used as the basis for the DRV, there would be a discrepancy in 
what carbohydrates are encompassed in the information provided on the 
label for the absolute gram amount versus the percent DV.
    The current DRV for total carbohydrate of 300 grams is calculated 
based on 60 percent of a 2,000 calorie diet ((0.60 x 2,000 calories)/4 
calories per gram of carbohydrate = 300 grams). The percentage of 
calories contributed by total fat, total carbohydrate, and protein add 
up to 100 percent on the label. The DRV for carbohydrate of 60 percent 
of a 2,000 calorie diet is determined by the difference of what is left 
over by the DRVs for total fat and protein and 100 percent. As 
discussed in part II.F.1, we are increasing the DRV for total fat from 
30 to 35 percent. Therefore, in order for the percentages of calories 
contributed by total fat, total carbohydrate, and protein to add up to 
100 percent, either the percentage of calories contributed by the DRV 
for total carbohydrate or protein needs to decrease. Some comments 
suggested that the DRV for total carbohydrates be decreased, and the 
DRV for total carbohydrate is significantly greater than the RDA for 
carbohydrate for adults 19 years of age and older of 130 grams/day. 
Reducing the DRV for protein to 5 percent of calories to account for 
the 5 percent increase in the DRV for fat would result in a DRV value 
of 25 grams of protein, which is below the RDA for protein for children 
and adults 9 years and older. Therefore, we conclude that the DRV for 
total carbohydrate should be decreased from 60 percent of calories to 
55 percent of calories for a DRV of 275 grams.
    f. How total carbohydrates appears on the label.
    (Comment 128) Several comments discussed the placement of 
carbohydrates on the label itself. One comment said that consumers need 
to be made aware of the fact that carbohydrates are sugars chemically 
because, according to the comment, most consumers believe that 
carbohydrates and sugars are two distinct nutrients. The comment would 
place the word ``sugars'' in parentheses next to ``Total Carbs'' or 
place ``Total Carbs'' in parentheses next to ``Total Sugars.''
    (Response) We disagree that carbohydrates are chemically sugars. 
Although the body converts carbohydrates to sugars, the chemical 
structure of some carbohydrates (e.g., starches) differs from the 
chemical structure of sugars. Sugars are a subset of carbohydrates and 
are declared as such on the label. Some examples of carbohydrates 
include sugars, such as sucrose and lactose, and polysaccharides, such 
as cellulose, glycogen, and starch. Therefore, we decline to change the 
label's format as suggested by the comment.
    (Comment 129) Some comments would move ``Total Carbohydrates'' to 
the top of the list of declared nutrients on the label. The comments 
cited the significant rise in diabetes and the need to make the 
declared amount of total carbohydrates more prominent on the label.
    (Response) We disagree that the increase in diabetes in the United 
States is a reason to move total carbohydrates to the top of list of 
declared nutrients on the label. As stated in part II.B.2, the intended 
purpose of information on the Nutrition Facts label is to assist the 
general healthy population in maintaining healthy dietary practices.
    (Comment 130) One comment recommended listing the amount of total 
carbohydrate in a product in teaspoons rather than grams. The comment 
said that people do not understand what gram of carbohydrate would look 
like and providing the information in teaspoons would be more helpful 
for consumers.
    (Response) We decline to revise the rule as suggested by the 
comment. We address arguments regarding the use of household measures, 
rather than in gram amounts on the label, in part II.B.3.
    g. Calculation of calories from carbohydrate. Our preexisting 
regulations, at Sec.  101.9(c)(1)(i)(C), require that the calories from 
total carbohydrate be calculated by using the general factor of 4 
calories/gram of carbohydrate less the amount of insoluble dietary 
fiber. The proposed rule also would revise the definition of dietary 
fiber so that only those dietary fibers that we have determined to have 
a physiological effect that is beneficial to human health would be 
considered to be ``dietary fiber'' on the Nutrition Facts label. For 
the purposes of calculating calories from carbohydrate, when it is 
voluntarily declared, all soluble and insoluble non-digestible 
carbohydrates should be excluded from the calculation, not just those 
known to meet the definition of dietary fiber. To ensure that all 
soluble and insoluble non-digestible carbohydrates are excluded from 
the calculation of calories from carbohydrate, we proposed to amend 
Sec.  101.9(c)(1)(i)(C) to require that calories from carbohydrate be 
calculated using a general factor of 4 calories/g of total carbohydrate 
less the amount of non-digestible carbohydrates and sugar alcohols, and 
the caloric value of each (the non-digestible carbohydrates and sugar 
alcohols) is then added to the sum of the carbohydrates.
    We did not receive any comments on this proposed amendment, and so 
we have finalized the rule without change.
2. Sugars
    a. Definition. Our preexisting regulations, at Sec.  
101.9(c)(6)(ii), define sugars as a statement of the number of grams of 
sugars in a serving. They are the sum of all free mono and 
disaccharides (e.g., glucose, fructose, lactose, and sucrose). We 
considered whether we should continue to require mandatory declaration 
of sugars on the label in the proposed rule, but tentatively concluded 
that the declaration of sugars continues to be necessary to assist 
consumers in maintaining healthy dietary practices, and thus did not 
propose to change the current requirement for mandatory declaration of 
sugars (79 FR 11879 at 11902).
    As discussed in the total carbohydrates section at part II.H.1, 
some comments and a citizen petition said we should exclude Allulose 
from the declaration of sugars. We discuss those comments in part 
II.H.1 (see comment 124).
    b. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act 
requires the declaration of sugars, and our preexisting regulations, at 
Sec.  101.9(c)(6)(ii), require the declaration of sugars on the 
Nutrition Facts label. We did not propose to change this requirement.
    (Comment 131) Several comments supported the continued mandatory 
declaration of sugars. One comment stated that sugars should continue 
to be labeled as part of total carbohydrate because they are a type of 
carbohydrate. The comment added that the amount of declared sugar is 
possible to quantify, easy to verify using analytical methods, and is 
information that is easily understood by consumers, nutritionists, and 
health professionals.
    In contrast, other comments asked us to remove sugars from the 
label or replace it with a declaration of added sugars or ``fruit & 
milk sugars.'' The

[[Page 33798]]

comments recommending replacement of sugars with added sugars said that 
consumers, including individuals who have diabetes, focus on the sugars 
instead of the total carbohydrate amount declared on the label. One 
comment suggested that, when registered dietitians provide Medical 
Nutrition Therapy for diabetics, the sugars line is not valuable and 
contributes to information overload. The comment also stated that the 
sugars declaration makes consumers reluctant to eat foods, such as 
fruit and milk, which contain sugars as their source of carbohydrates.
    One comment would replace sugars with fruit and milk sugars and 
place the new heading directly under dietary fiber; the comment said 
this change would clearly distinguish added sugars from naturally 
occurring sugars in whole fruit and from sugars from dairy ingredients 
and also eliminate the need for a double indentation (for declaration 
of added sugars) under the ``Total Carbs'' heading. The comment cited 
data from an online survey of 500 participants showing that, when 
``Sugars'' is replaced with ``Fruit & Milk Sugars'' on the Nutrition 
Facts label, significantly more individuals were able to correctly 
identify the amount of naturally occurring sugars in one serving of the 
food (Ref. 72).
    (Response) We decline to remove the declaration of sugars from the 
label because consumption of sugars continues to be associated with an 
increased risk of dental caries; thus, the information continues to be 
necessary to assist consumers in maintaining healthy dietary practices. 
We agree that sugars should continue to be labeled as part of total 
carbohydrate and that the amount of total sugars can be quantified 
using existing analytical methods.
    Similarly, we disagree with the comments suggesting that the total 
sugars declaration should be removed from the label because consumers, 
especially individuals with diabetes, focus on the sugars declaration 
rather than the total carbohydrate declaration and may be overwhelmed 
by the information. The comments did not provide data or other 
evidence, nor are we aware of such data or evidence, to support this 
assertion. The total carbohydrate and sugars declaration has been on 
the label for over 20 years. Furthermore, as noted in part II.B.2, the 
information on the label is intended for the general healthy population 
and not for individuals with chronic diseases, such as diabetes.
    Likewise, we are unable to evaluate whether the sugars declaration 
results in a reluctance to consume foods, such as fruit or milk, which 
are natural sources of sugars because the comment did not provide data 
or information, and we are not aware of such data or information, to 
support this assertion.
    We disagree with the comment which would replace ``Sugars'' with 
``Fruit & Milk Sugars'' on the Nutrition Facts label. Total sugars 
continue to be associated with risk of dental caries. Furthermore, our 
definition of added sugars includes (see part II.H.3.n) some fruit and 
milk sugars, such as sugars found in concentrated fruit juice that is 
not reconstituted to 100 percent fruit juice.
    c. Changing ``Sugars'' to ``Total Sugars''. In the preamble to the 
proposed rule (79 FR 11879 at 11902), we said that we were considering 
whether to use the term ``Total Sugars'' instead of ``Sugars'' on the 
label if we finalize a declaration of added sugars. We also said that 
we planned to conduct consumer research that would include, among other 
things, questions regarding the declaration of added sugars on the 
Nutrition Facts label in order to help or enhance our understanding of 
how consumers would comprehend and use this new information, and to 
inform education efforts (id.). In the supplemental proposed rule (80 
FR 44303 at 44306, 44308), we discussed the results of our consumer 
research which showed that when an ``Added Sugars'' declaration was 
indented below a ``Total Sugars'' declaration on the label, 
participants appeared to be better able to comprehend the total amount 
of sugars in a food than if an ``Added Sugars'' declaration was 
indented below a ``Sugars'' declaration. In the supplemental proposed 
rule (id. at 44304), we asked for comment on whether the term ``Total 
Sugars'' should be declared on the label instead of ``Sugars.''
    The final rule uses the term ``Total Sugars'' to replace the 
declaration of ``Sugars.'' We explain our rationale and respond to 
comments on this change in part II.H.3.
    d. DRV. Our preexisting regulations do not specify a DRV for 
sugars. In the preamble to the proposed rule (79 FR 11879 at 11902), we 
explained that consensus reports did not set dietary reference values 
based on which we could derive an appropriate DRV for total sugars. 
Therefore, we did not propose to establish a DRV for total sugars.
    (Comment 132) Some comments submitted in response to the proposed 
rule agreed that there is insufficient information to establish a DRV 
for sugars. However, others comments recommended establishing a DRV and 
requiring mandatory declaration of a percent DV for sugars. One comment 
stated that such information would help consumers choose food and 
beverages that are low in sugar. Another comment said that, with 
``skyrocketing'' overweight, obesity, and their co-morbidities, a 
percent DV for sugar would be a useful tool for informing consumers of 
sugar content and would help consumers make better choices. The comment 
said that the declaration could help consumers to visually understand 
approximately how much sugar they should be getting each day and how 
much sugar they are actually consuming. One comment suggested that a 
declaration of a percent DV for sugars would allow consumers to compare 
products more easily.
    Other comments said that a DRV for sugars could be based on 
recommendations from the World Health Organization or the American 
Heart Association. One comment said that the National Institutes of 
Health should ask the IOM to set a suggested limit on how much sugar 
one should consume on a daily basis.
    (Response) We decline to set a DRV for sugars or to require the 
declaration of a percent DV for sugars. We are not aware of data or 
information related to a quantitative intake recommendation for sugars 
that we could use as the basis for a DRV for total sugars.
    With respect to the comments suggesting that the World Health 
Organization (WHO) or the American Heart Association (AHA) could give 
us a basis to establish a DRV, we acknowledge that the WHO recently 
released guidelines for sugars intake for adults and children (Ref. 
73). The WHO recommends reducing the intake of free sugars to less than 
10 percent of total energy intake in both children and adults. It also 
provided a conditional recommendation which suggested further reduction 
of the intake of free sugars to below 5 percent of total energy intake. 
The WHO defines ``free sugars'' as monosaccharides and disaccharides 
added to foods and beverages by the manufacturer, cook, or consumer, 
and sugars naturally present in honey, syrups, fruit juices and fruit 
juice concentrates (Ref. 73). The WHO definition of ``free sugars'' is 
not consistent with our definition of ``sugars'' because the WHO 
definition does not include all free mono and disaccharides. It 
excludes some naturally occurring sugars, such as lactose. Therefore, 
we disagree that the WHO's recommendations could be used to establish a 
DRV for sugars. The AHA recommended limits for intake of added sugars 
and not total sugars (Ref. 74). Therefore, it would not be appropriate

[[Page 33799]]

to use the AHA recommendations to establish a DRV for total sugars.
    As for the comment suggesting that the IOM could set a maximum 
intake recommendation, the IOM reviewed the evidence on this topic in 
the Macronutrient report (Ref. 75). As discussed in the preamble to the 
proposed rule (79 FR 11879 at 11902), the IOM found an association 
between sugar consumption and risk of dental caries, but, due to the 
various factors that contribute to dental caries, the IOM could not 
determine an intake level of sugars that is associated with increased 
risk of dental caries and, therefore, did not have sufficient evidence 
to set a UL for sugars.
    e. Seasonal variation in sugars content.
    (Comment 133) One comment noted that, depending on the time of 
year, the sugar content of fruit changes, which could impact the sugar 
content of products to which fruit is added. The comment questioned 
whether the product labels have to change throughout the year to 
reflect the seasonal variation in sugar content of the fruit or fruit 
juice in a product. The comment also questioned if the seasonal 
variation in the sweetness of fruit is compensated for by adjusting the 
amount of sugar alcohols in the product and whether a label change 
would be required. Another comment suggested that sugars may be added 
to fruits and vegetables to achieve a standard flavor profile and said 
that the amount of sugars added to the food may change throughout the 
year.
    (Response) Our compliance requirements in Sec.  101.9(g)(5) state 
that a food with a label declaration of calories, sugars, total fat, 
saturated fat, trans fat, cholesterol, or sodium shall be deemed to be 
misbranded under section 403(a) of the FD&C Act if the nutrient content 
of the composite is greater than 20 percent in excess of the value for 
that nutrient declared on the label. However, no regulatory action will 
be based on a determination of a nutrient value that falls above this 
level by a factor less than the variability generally recognized for 
the analytical method used in that food at the level involved. This 
approach takes into account seasonal variability as well as variability 
due to the analytical method used. Therefore, so long as the 
variability in the sugars content of the fruit does not cause the total 
sugars comment to be greater than 20 percent in excess of the declared 
value, the manufacturer of a product containing fruit would not be in 
violation of the regulation. The manufacturer is in the best position 
to determine if and when a label change is needed based on the total 
sugar content and the amount of sugars or sugar alcohols added to 
standardize the flavor profile of the food.
    The declaration of the amount of sugar alcohols on the Nutrition 
Facts label is voluntary, so if a manufacturer uses sugar alcohols to 
account for the variation in the sugar content of the product, the 
label would only need to change if the amount of sugar alcohol is 
voluntarily declared on the label. However, if a food product does not 
typically contain a certain sugar alcohol which is added to adjust for 
the sugars content of fruit, that sugar alcohol would need to be 
declared in the ingredient list.
3. Added Sugars
    In the preamble to the proposed rule, we explained that current 
regulations neither define the term ``added sugars'' nor require or 
permit the declaration of added sugars on the label. We considered 
requiring the declaration of added sugars taking into account new 
information. We tentatively concluded that the declaration of added 
sugars on the label is necessary to assist consumers to maintain 
healthy dietary practices, and we proposed to require the declaration 
of the amount of added sugars in a serving of a product (79 FR 11879 at 
11905). We are finalizing the requirement for mandatory labeling of 
added sugars in Sec.  101.9(c)(6)(iii), and our rationale for doing so 
is discussed in this section below.
    We have requirements for label statements that must be made if a 
product contains an insignificant amount of many nutrients on the label 
such as carbohydrate, sugars, and dietary fiber. We also have 
requirements for when the nutrient content can be expressed as zero. We 
proposed that a statement of added sugars content would not be required 
for products that contain less than 1 gram of added sugars in a serving 
if no claims are made about sweeteners, sugars, or sugar alcohol 
content and we are finalizing this requirement, as proposed, in Sec.  
101.9(c)(6)(iii). We proposed to require that the phrase ``Not a 
significant source of added sugars'' be placed at the bottom of the 
table of nutrient values if a statement of the added sugars content is 
not required, and as a result, is not declared. Alternatively, we 
proposed to permit the use of the alternative statements ``Contains 
less than 1 g'' and ``less than 1 g'' to be declared. We also proposed 
to permit the added sugars content to be expressed as zero if a serving 
of food contains less than 0.5 grams of added sugars. We are finalizing 
the requirements for when label statements if a product contains an 
insignificant amount of added sugars and for when the added sugars 
content may be expressed as zero, as proposed, in Sec.  101.9(c)(6).
    Because our preexisting regulations do not define ``added sugars,'' 
the proposed rule would define ``added sugars'' as sugars that are 
added during the processing of foods, or are packaged as such, and 
include sugars (free, mono- and disaccharides), syrups, naturally 
occurring sugars that are isolated from a whole food and concentrated 
so that sugar is the primary component (e.g. fruit juice concentrates), 
and other caloric sweeteners. A summary of the comments regarding our 
proposed definition of added sugars, and our responses to those 
comments, can be found in part II.H.3.a.
    In February 2015, the 2015 DGAC submitted the 2015 DGAC Report to 
the Secretaries of the U.S. Department of Health and Human Services and 
the U.S. Department of Agriculture. The 2015 DGAC reaffirmed 
recommendations in the 2010 DGA, which included recommending the 
reduction of added sugars intake. For the first time, the 2015 DGAC 
conducted a systematic review of the evidence related to dietary 
patterns and health outcomes, including cardiovascular disease (CVD), 
body weight and type 2 diabetes, cancer, congenital abnormalities, 
neurological and psychological illness, and bone health. The 2015 DGAC 
concluded that there is strong and consistent evidence that healthy 
dietary patterns characterized, in part, by lower intakes of sugar-
sweetened foods and beverages relative to less healthy patterns, are 
associated with a reduced risk of CVD. We considered the evidence that 
the 2015 DGAC relied upon in making its determinations, and tentatively 
concluded, in the preamble to the supplemental proposed rule (80 FR 
44303), that this information provides further support for our proposal 
to require the mandatory declaration of the amount of added sugars in a 
serving of a product on the label.
    The proposed rule would not establish a DRV for added sugars. We 
explained, in the preamble to the proposed rule (79 FR 11879 at 11906), 
that the USDA Food Patterns specify the maximum amount of calories from 
solid fats and added sugars that can be consumed at each calorie level, 
while staying within calorie limits. A 2,000 calorie diet could contain 
approximately 260 calories from solid fats and added sugars (id.). The 
limit of 260 calories served as a reference to ensure the selection of 
a nutrient dense

[[Page 33800]]

diet without excess discretionary calories from added sugars and solid 
fats. These limits established for calories from solid fats and added 
sugars in the USDA Food Patterns are based on food pattern modeling. 
Because the limits are not based on any biomarker of risk of disease 
from an independent relationship between a nutrient and chronic disease 
risk we stated that we did not have a quantitative intake 
recommendation upon which a DRV for added sugars could be derived. The 
statement was not intended to suggest a limitation for when we can 
mandate a nutrient declaration in the nutrition label, as some comments 
seem to suggest. The 2015 DGAC further evaluated limits for added 
sugars in the diet based, in part, on food pattern modeling and 
recommended that Americans limit their intake of added sugars to a 
maximum of 10 percent of total daily caloric intake. The 2015 DGAC said 
that its recommendation was supported by a food pattern modeling 
analysis conducted by the 2015 DGAC and the scientific evidence review 
on added sugars and chronic disease risk. In the preamble to the 
supplemental proposed rule (80 FR 44303 at 44308), we reconsidered our 
tentative conclusion that a DRV for added sugars could not be 
established and proposed to establish a DRV for added sugars of 10 
percent of total energy intake from added sugars and to require the 
declaration of the percent DV for added sugars on the label.
    Thus, we have scientific evidence to support a limit for added 
sugars that can serve as the basis for a DRV for added sugars. The 
limit for calories from added sugars to less than 10 percent of 
calories is a reference value that is appropriate for use as a DRV for 
added sugars. The DRV is used to calculate the percent DV, and a 
percent DV provides information that Americans can use to determine how 
the amount of added sugars in a serving of food contributes to his or 
her individual total daily diet. The food pattern modeling used to 
support a limit in the intake of added sugars to less than 10 percent 
of calories was used to create the USDA Food Patterns. The USDA Food 
Patterns provide suggested amounts of food to consume from the basic 
food groups, subgroups, and oils to meet recommended nutrient intakes 
at 12 different calorie levels. They can be used by Americans to 
construct a healthful dietary pattern that is consistent with current 
recommendations. We have concluded that evidence on dietary patterns 
and health outcomes showing that healthy dietary patterns 
characterized, in part, by lower amounts of sugar-sweetened foods and 
beverages are associated with a reduced risk of CVD supports a 
mandatory declaration of added sugars. Both the USDA Food Patterns and 
the dietary patterns and health outcomes analysis that were discussed 
in the 2015 DGAC Report provide information about healthy dietary 
patterns. Therefore, the DRV of 10 percent of calories and the 
mandatory declaration of the amount of added sugars in a serving of 
food are related to providing information that will assist consumers in 
constructing a healthy dietary pattern.
    On January 7, 2016, the Secretaries of the U.S. Department of 
Health and Human Services and the U.S. Department of Agriculture 
released the 2015-2020 DGA (Ref. 28). The 2015-2020 DGA focuses on 
eating patterns in addition to nutrients and foods because healthy 
dietary patterns may be more predictive of overall health status and 
disease risk than individual foods or nutrients. A key recommendation 
of the 2015-2020 DGA is to limit calories from added sugars and 
saturated fats and reduce sodium intake. In order to achieve this 
recommendation, the 2015-2020 DGA says that Americans should consume an 
eating pattern that is low in added sugars. Another key recommendation 
of the 2015-2020 DGA is to consume less than 10 percent of calories per 
day from added sugars. The 2015-2020 DGA is consistent with the 
recommendations and the science presented in the 2015 DGAC Report. We 
considered the scientific evidence in the 2015 DGAC Report related to 
dietary patterns, as well as evidence related to limiting calories from 
added sugars that served as our basis for proposing a DRV for added 
sugars of 10 percent of total calories.
    Throughout this part, we refer to the underlying scientific 
evidence that we have reviewed and considered which supports our basis 
for the mandatory declaration of the amount of added sugars in a 
serving of a product, the DRV, and the declaration of the percent DV 
for added sugars. The need for a mandatory declaration of added sugar 
is supported by strong and consistent evidence that dietary patterns 
characterized by higher consumption of vegetables, fruits, whole 
grains, low-fat dairy, and seafood, and lower consumption of red and 
processed meat, and lower intakes of refined grains, and sugar-
sweetened foods and beverages relative to less healthy dietary 
patterns; regular consumption of nuts and legumes; moderate consumption 
of alcohol; lower in saturated fat, cholesterol, and sodium and richer 
in fiber, potassium, and unsaturated fats are associated with a 
decreased risk of CVD. The scientific evidence from the 2010 DGA 
supporting that consumption of excess calories from added sugars can 
lead to a less nutrient-dense diet, current consumption data showing 
that Americans are consuming too many calories from added sugars, and 
the strong evidence that greater intake of sugar-sweetened beverages is 
associated with increased adiposity in children also support mandatory 
declaration of added sugars.
    We reviewed and considered the evidence that the 2015 DGAC relied 
upon for its conclusion that healthy dietary patterns characterized, in 
part, by lower intakes of sugar-sweetened foods and beverages are 
associated with a decreased risk of CVD relative to less healthy 
dietary patterns, which included an existing review from the NEL 
Dietary Patterns Systematic Review Project as well as the NHLBI 
Lifestyle Evidence Review and the associated Lifestyle Management 
Report (Refs. 17-18). We have concluded that it is appropriate to rely 
on evidence that considered not only added sugars but also sugar-
sweetened foods and beverages to support the mandatory declaration of 
added sugars on the label because sugars are added to sugar-sweetened 
foods and beverages and provide extra calories in those foods. When 
those foods are consumed in excess, they are not consistent with 
healthy dietary patterns. We also note that the strong and consistent 
association with CVD risk was seen when healthy dietary patterns were 
compared with less healthy dietary patterns. As discussed in the 2015 
DGAC Report, dietary patterns of the American public are suboptimal and 
are causally related to poor individual and population health and 
higher chronic disease rates. On average, the U.S. diet is low in 
vegetables, fruits, and whole grains, and high in sodium, calories, 
saturated fat, refined grains, and added sugars. Underconsumption of 
the essential nutrients vitamin D, calcium, potassium, and fiber are 
public health concerns for the majority of the U.S. population, and 
iron intake is of concern among adolescents and premenopausal females 
(Ref. 19).
    There were many statements made in the 2010 DGA related to 
consuming a dietary pattern that is nutrient dense. Those statements 
included the concepts that added sugars displace other nutrient-dense 
foods in the diet and that as the amount of solid fats and added sugars 
increase in the diet, it becomes more difficult to also eat foods with 
sufficient dietary fiber and essential vitamins and minerals, and still 
stay

[[Page 33801]]

within calorie limits. The 2010 DGA relied on food pattern modeling 
done for the USDA Food Patterns to support statements in the 2010 DGA 
related to nutrient density. We considered these statements and 
evidence from the IOM macronutrient report (Ref. 75) showing that 
decreased intake of some micronutrients occurs when individuals consume 
in excess of 25 percent of calories from added sugars.
    The 2015 DGAC said that current intake of added sugars remains high 
at 268 calories, or 13.4 percent of total calories per day among the 
total population ages 1 year and older (Ref. 19). Intake data from the 
What We Eat In America, 2007-2010 (Ref. 76), the dietary component of 
NHANES was used by the 2015 DGAC to answer questions related to current 
intake of added sugars. We also considered how this current intake data 
relates to recommendations from the 2015 DGAC when concluding that 
Americans are consuming too many calories from added sugars.
    We considered the scientific evidence in the 2010 DGAC Report 
supporting the conclusion related to consumption of sugar-sweetened 
beverages and adiposity in children when determining that the evidence 
supports the mandatory declaration of added sugars. The 2010 DGAC 
conducted a full NEL search to evaluate the association between sugar-
sweetened beverages and adiposity in children. Results of this review, 
covering 2004-2009 were supplemented by the findings of prospective 
studies included in an earlier evidence review conducted by the 
American Dietetic Association (ADA) (1982-2004). Although we have 
concluded that this body of evidence provides further support for a 
mandatory declaration of added sugars on the label, it is limited to 
children. Therefore, we refer to the general population, which includes 
both children and adults, when we discuss the evidence on dietary 
patterns characterized, in part, by lower intakes of sugar-sweetened 
foods and beverages and decreased risk of CVD because the healthy 
dietary pattern components described in the literature for adults are 
reaffirmed with the USDA Food Patterns, which aim to meet nutrient 
needs across the lifespan, including children 2 years of age and older.
a. Declaration
(i) Comments on the Rationale for Requiring Mandatory Declaration of 
Added Sugars
    In the preamble to the proposed rule, we identified the factors 
that we considered when determining which non-statutory (those that are 
not explicitly required by the FD&C Act) nutrients should be declared 
on a mandatory and voluntary basis on the label (79 FR 11879 at 11889). 
We considered whether a quantitative intake recommendation existed and 
whether there is public health significance when determining which 
nutrients should be declared on the label. We considered mandatory 
declaration to be appropriate when there is public health significance 
and a quantitative intake recommendation that can be used for setting a 
DV for a nutrient (79 FR 11879 at 11890). For nutrients that are not 
essential vitamins and minerals, we considered voluntary declaration to 
be appropriate when the nutrient either has a quantitative intake 
recommendation but does not have public health significance, or does 
not have a quantitative intake recommendation available for setting a 
DRV but has public health significance (79 FR 11879 at 11891). We also 
considered the scientific evidence from the 2010 DGA related to the 
intake of added sugars in the diet and the role of such information in 
assisting consumers to maintain healthy dietary practices. We noted 
that our review for added sugars was not based on the factors we have 
traditionally considered for mandatory declaration that are related to 
an independent relationship between the particular nutrient and a risk 
of chronic disease, health-related condition, or health-related 
physiological endpoint.
    (Comment 134) Many comments addressed our rationale for requiring 
the declaration of added sugars on the label in relation to the risk of 
chronic disease. One comment recognized that our rationale for 
proposing to require the mandatory declaration of added sugars is 
atypical and is not based on a traditional nutrient health-outcome 
linkage. In contrast, other comments suggested that we not require the 
declaration of added sugars on the label because they do not meet the 
factors outlined in our criteria for mandatory labeling. One comment 
also objected to voluntary declaration of added sugars because, 
according to the comment, it does not meet either of our proposed 
factors. Another comment said that we have not shown that a public 
health significance exists for added sugars labeling through well-
established scientific evidence. The comments also noted that our 
rationale for requiring the declaration of added sugars differs from 
our rationale for declaring other nutrients on the label.
    (Response) Our determination under section 403(a)(2)(A) of the FD&C 
Act of whether a nutrient is necessary to assist consumers in 
maintaining healthy dietary practices is not limited to the factors we 
have used when assessing nutrients for which there is an independent 
relationship between the nutrient and risk of disease, a health-related 
condition, or a physiological endpoint (see our response to comment 
45). Our rationale for requiring the mandatory declaration of added 
sugars is different from that of nutrients for which such an 
independent relationship exists. Rather than basing a declaration of 
added sugars on an association with risk of chronic disease, a health-
related condition, or a physiological endpoint, for the purposes of the 
general population (see part II.H.3), we are considering a declaration 
of added sugars in the context of how it can assist consumers in 
maintaining healthy dietary practices by providing information to help 
them limit consumption of added sugars, and to consume a healthy 
dietary pattern. Instead of considering an association with risk of 
chronic disease, for the purposes of the general population, our review 
for the proposed rule was based on information which supported the need 
for further information about added sugars on the label to assist 
consumers to maintain healthy dietary practices and the need for 
consumers to be able to readily observe and comprehend the information 
and to understand its relative significance in the context of a total 
daily diet (79 FR 11879 at 11891). We relied on multi-faceted evidence 
showing that added sugars consumption in the United States is a public 
health concern. We cited information from the 2010 DGA indicating that 
a high intake of calories from excess solid fats and added sugars can 
decrease the intake of nutrient-dense foods in the diet and can 
increase the overall caloric intake, which could lead to weight 
management issues (79 FR 11879 at 11904). We considered evidence 
related to excess consumption of calories from added sugars. For many 
years, added sugars have contributed a significant amount of calories 
to the American diet. The 2010 DGA cited intake data showing that 
Americans consumed approximately 16 percent of calories from added 
sugars (Ref. 77). More recent data shows that consumption of added 
sugars has decreased to approximately 13.4 percent of calories in 
recent years; however, the intake still remains high and exceeds 10 
percent of total calorie intake. In the preamble to the proposed rule, 
we also

[[Page 33802]]

cited to the strong evidence reviewed by the 2010 DGAC that shows that 
children who consume sugar-sweetened beverages have increased adiposity 
(increased body fat) (79 FR 11879 at 11904).
    The evidence we considered when determining that the amount of 
added sugars in a serving of a product must be declared on the label 
includes the scientific evidence from the 2010 DGA and the 2015 DGAC 
Report related to limiting calories from added sugars. The 2015-2020 
DGA also includes this scientific evidence.
    A recommendation to limit the intake of added sugars has been long-
standing in the various editions of the DGA, although the terminology 
and specificity of the guidance has evolved over time. In fact, we 
considered requiring the declaration of added sugars on the label in 
the January 6, 1993 final rule for the Mandatory Status of Nutrition 
Labeling and Nutrient Content Revision, Format for Nutrition Label (58 
FR 2079 at 2098). The comments that we received to a 1990 proposed rule 
recommended mandating the declaration of added sugars only, rather than 
total sugars, because dietary recommendations urged the use of sugar in 
moderation, while at the same time recommending increased consumption 
of fruits, which are sources of naturally occurring sugars. Though the 
terminology ``added sugars'' was not introduced into the DGA until 
2005, when Americans were advised to ``choose and prepare foods and 
beverages with little added sugars or caloric sweeteners, such as 
amounts suggested by the USDA Food Guide and the DASH eating plan,'' 
the DGA has included key recommendations advising Americans to limit 
their intake of ``sugar'' since the first report in 1980 (Refs. 30, 78-
83). Even in the 1980 DGA, Americans were advised to ``avoid excessive 
sugars'' by using less of all sugars, including white sugar, brown 
sugar, raw sugar, honey, and syrups. Consumers were also advised to 
reduce their consumption of foods containing these sugars such as 
candy, soft drinks, ice cream, cakes, and cookies. All of the 
ingredients that consumers were advised to limit in their diet in the 
1980 DGA would meet our current definition of an added sugars, and the 
foods that Americans were advised to limit are some of the largest 
contributors to added sugars intake today.
    Over the past century the health profile of Americans has changed. 
Deficiencies of essential nutrients have dramatically decreased, and 
chronic diseases that are related to poor quality dietary patterns and 
physical inactivity, such as obesity, CVD, type 2 diabetes, and diet-
related cancers, have become much more prevalent in the population 
(Ref. 19). Dietary patterns and their food and nutrient characteristics 
were at the core of the conceptual model that guided the 2015 DGAC's 
work and resulted in scientific evidence supporting the recommendations 
from both the 2015 DGAC Report and the 2015-2020 DGA related to healthy 
dietary patterns (Refs. 19, 28). For the first time, the 2015 DGAC 
completed a systematic review to examine the relationship between 
dietary patterns and health outcomes. The data related to dietary 
patterns and health outcomes, which was reviewed by the 2015 DGAC, 
focused on specific health outcomes including: CVD, measures of body 
weight or obesity, type 2 diabetes, cancer, congenital anomalies, 
neurological and psychological illnesses, and bone health. The 2015 
DGAC concluded that the overall body of evidence examined by the 2015 
DGAC identifies that a healthy dietary pattern is higher in vegetables, 
fruits, whole grains, low- or non-fat dairy, seafood, legumes, and 
nuts; and moderate in alcohol (Ref. 19). The 2015 DGAC also concluded 
that dietary patterns characterized, in part, by lower consumption of 
sugar-sweetened foods and beverages relative to less healthy dietary 
patterns were strongly and consistently associated with a reduced risk 
of CVD (Ref. 19). Evidence for dietary patterns and the other health 
outcomes that were included in the analysis was moderate or limited. 
The new evidence from the systematic review examining the relationship 
between dietary patterns and health outcomes provide further support 
for a mandatory declaration of added sugars because consumers need to 
know how much added sugars are in their foods in order for them to 
construct an overall healthy dietary pattern and to limit consumption 
of added sugars. The scientific evidence also was included in the 2015-
2020 DGA. Furthermore, consumers need to know how much added sugars are 
in a serving of a product so that they can avoid consuming excess 
calories from added sugars, at the expense of calories from other 
components as part of a healthy dietary pattern within calorie limits, 
such as fruits, vegetables, fat-free and low-fat dairy, grains, protein 
foods, and oils.
    We disagree with the comment that added sugars should not be 
required on the label because we have not shown that a public health 
significance exists for added sugars labeling through well-established 
scientific evidence. The comment is considering the guidance we have 
given related to determining public health significance in our proposed 
factors for mandatory and voluntary labeling, which are focused on 
nutrients for which there is a relationship with a risk of a chronic 
disease, a health-related condition, or a physiological endpoint. 
However, we are using a different paradigm for the labeling of added 
sugars for the general population (see part II.H.3) than has been used 
traditionally. We have established that there is public health 
significance of added sugars through other evidence and recommendations 
related to a healthy dietary pattern low in sugar-sweetened foods and 
beverages that is associated with reduced risk of CVD, through 
consumption data showing that Americans are consuming too many calories 
from added sugars, through evidence showing that it is difficult to 
meet nutrient needs within calorie limits if one consumes too many 
added sugars, and through evidence showing that increased intake of 
sugar-sweetened beverages is associated with greater adiposity in 
children.
    We disagree with the comments that suggested that added sugars 
should not be required to be declared on the label because they do not 
meet the factors we consider for mandatory labeling of nutrients for 
which there is an independent relationship between the nutrient and a 
risk of chronic disease, a health-related condition, or a physiological 
endpoint. We must evaluate the current nutrition science and determine 
whether a nutrient will assist consumers in maintaining healthy dietary 
practices. We are not bound by certain factors when determining if any 
and all nutrients should be declared on the label now or in the future 
(see part II.C.3).
    The final rule, therefore, at Sec.  101.9(c)(6)(iii), requires the 
mandatory declaration of added sugars.
    (Comment 135) Many comments said we should not require the 
declaration of added sugars on the label because they do not have a 
unique role in causing weight gain or increasing the risk of chronic 
disease when compared to other macronutrients. Many comments cited the 
2010 DGA's conclusion that added sugars are no more likely to 
contribute to weight gain or obesity than any other source of calories 
(Ref. 30). Some comments also cited the conclusion in the IOM DRI 
report for macronutrients that there is no clear and consistent 
association between increased intake of added sugars and BMI (Ref. 75). 
The comments noted that studies have shown that with respect to weight 
loss, reducing total caloric intake is more

[[Page 33803]]

important than the source of calories. The comments asserted that 
excess energy in any form will promote body fat accumulation.
    (Response) We agree that excess calories from any source can 
contribute to weight gain. However, Americans are consuming too many 
calories from added sugars, and those calories typically are not 
accompanied by other beneficial nutrients. The comments are considering 
the evidence that we have used to support a declaration of added sugars 
against our proposed factors for mandatory and voluntary declaration of 
non-statutory nutrients for which there is an independent relationship 
between the nutrient and a risk of chronic disease, a health-related 
condition, or a physiological endpoint. Rather than considering a 
direct relationship between consumption of added sugars and risk of a 
chronic disease, health-related condition, or physiological endpoint, 
for the purposes of the general population (see part II.H.3), we have 
focused on how added sugars found in sugar-sweetened foods and 
beverages contribute to a dietary pattern, and how the contribution of 
added sugars to the total diet impacts health. The evidence points to 
the need for consumers to know how much added sugars are in a serving 
of a product to assist them in achieving a healthy dietary pattern and 
maintaining healthy dietary practices.
(ii) Evidence on Added Sugars and Risk of Chronic Disease
    (Comment 136) Many comments suggested that, if we are using the 
traditional relationship between a nutrient and risk of chronic 
disease, a health-related condition, or a physiological endpoint when 
determining if added sugars should be declared on the label, there is 
specific scientific evidence on added sugars and risk of disease that 
we should consider. Many comments suggested that a declaration of added 
sugars is necessary because consumption of added sugars is associated 
with an increased risk of chronic disease or markers for chronic 
disease. Some comments provided evidence that increased consumption of 
sugar-sweetened beverages, which are the primary source of added sugars 
in the American diet, is associated with increased body weight, an 
increase in body mass index (BMI), adiposity (body fat), increased 
blood pressure leading to increased incidence of hypertension, and in 
increased risk of metabolic syndrome, type 2 diabetes, and gout. Other 
comments provided evidence that high intakes of fructose-containing 
sugars can raise levels of triglycerides, visceral fat, liver fat, 
blood glucose, insulin, and LDL cholesterol. The comments suggested 
that the findings indicate that diets high in fructose increase markers 
or risk factors for heart disease, diabetes, non-alcoholic fatty liver 
disease, and metabolic syndrome. The comments noted that randomized, 
controlled clinical trials to test the hypothesis that added sugars 
increase disease risk would violate ethical standards, and therefore, 
are impossible to conduct.
    In contrast, many comments argued that there is no association 
between consumption of added sugars and risk of chronic disease, and 
therefore, there is a lack of a scientific basis to require the 
mandatory declaration of added sugars on the label. One comment stated 
that evidence available since the 2010 DGA is conflicting and 
inconclusive. In reference to the evidence showing that all sugars 
contribute to dental caries, one comment suggested that there are many 
factors that can contribute to dental caries, including oral bacteria, 
salivary flow, oral hygiene behavior, and susceptibility of the tooth. 
The comment stated that it was not aware of any evidence showing that 
added sugars presents a unique risk for causing dental caries.
    Some comments criticized studies on added sugars and risk of 
disease. The comments suggested that scientific consensus groups have 
found difficulty in determining any relationship between added sugars 
intake and health outcomes due to a variety of complex reasons. The 
reasons cited included lack of harmonization within the scientific 
literature of the definition and inclusion of ingredients considered to 
be added sugars, difficulty comparing studies where the primary health 
outcomes measured are not consistent across studies, systematic reviews 
draw conclusions across multiple studies with various inclusion 
criteria and designs, excess energy intake may not be controlled for in 
the analysis, much of the information about added sugar content of 
products is proprietary, and methodological problems with observational 
studies which have suggested detrimental associations of added sugars 
intake with health outcomes. The comments also noted that sugar-
sweetened beverages are often inappropriately used as a proxy or 
surrogate for total added sugars intake.
    (Response) Added sugar in the diet is an area that is of particular 
interest in the nutrition community. A substantial amount of research 
has been conducted on the association between consumption of sugar-
sweetened beverages and risk of chronic disease, as noted in the 
comments. The 2010 DGAC concluded that an increased intake of sugar-
sweetened beverages is associated with greater adiposity in children. 
Since 2010, additional evidence on sugar-sweetened beverages and their 
association with risk of disease has emerged. The 2015 DGAC concluded 
that there is strong and consistent evidence that intake of added 
sugars from foods and/or beverages is associated with excess body 
weight in children and adults (Ref. 19). We note that the majority of 
the evidence that the 2015 DGAC relied on for this conclusion was from 
studies on the relationship between intake of sugar-sweetened beverages 
and body weight. Although the evidence on sugar-sweetened beverages and 
body weight/adiposity is strong and consistent, sugar-sweetened 
beverages represent only 39 percent of food sources of added sugars. As 
noted in the comments, sugar-sweetened beverages may not be an 
appropriate proxy or surrogate for total added sugars intake.
    Research on the health effects of total added sugars continues to 
emerge. One difficulty that researchers face when designing studies on 
added sugars from all food sources is that there are many ingredients 
containing added sugars by different names, and no single definition of 
added sugars has been adopted by the scientific community. In Sec.  
101.9(c)(6)(iii) of the final rule, we are establishing a regulatory 
definition of added sugars. We expect that, by requiring the 
declaration of the amount of added sugars in a serving of a product on 
the label, and by establishing a definition of added sugars, additional 
research on the health effects of added sugars from food and beverages 
will be conducted in the future that will further clarify the direct 
relationship of added sugars with risk of chronic diseases, health-
related conditions, and physiological endpoints.
    Although we are not basing a mandatory declaration of added sugars 
for the general population on an independent relationship between added 
sugars and risk of chronic disease, we are, instead, basing an added 
sugars declaration on the need to provide consumers with information to 
construct a healthy dietary pattern that is low in added sugars. We 
intend to monitor the evidence in this area and will consider how any 
new evidence may impact our regulations in the future.
    (Comment 137) In the preamble to the proposed rule (79 FR 11879 at 
11904), we suggested that the disclosure of saturated fat and trans fat 
on the label not only provides information to consumers for managing 
their risk of

[[Page 33804]]

CVD, but the declaration of these nutrients also could provide a marker 
for foods that contain solid fats (fats which are solid at room 
temperature and contain a mixture of saturated and unsaturated fatty 
acids but tend to contain a high percentage of saturated and trans 
fats). We suggested that there is not currently information on the 
label that could serve as a marker for added sugars.
    Some comments took issue with comparisons made between fats and 
sugars in the proposed rule. The comments noted that there are 
significant health differences between fats in general and solid fats. 
The comments asserted that those differences provide a defensible basis 
for delineating the types of fats on the label, and there are no 
similar functional health differences between sugars and added sugars. 
Therefore, the comments said we do not have a basis for requiring a 
separate declaration for added sugars on the label.
    (Response) Our basis for requiring the declaration of added sugars 
for the general population (see part II.H.3) is not related to an 
independent relationship between added sugars and a risk of chronic 
disease, but rather on the contribution of added sugars to an overall 
dietary pattern. Added sugars consumption among the general U.S. 
population exceeds what can reasonably be consumed within calorie 
limits and can have a negative impact on health. The declaration of 
added sugars will assist consumers in maintaining healthy dietary 
practices. In the preamble to the proposed rule, we were not making a 
comparison between the level of evidence related to an independent 
relationship between the intake of fats and sugars and chronic disease 
risk. Instead, we were describing whether information on the label for 
certain fats and sugars would allow the consumer to use the label to 
reduce their consumption of calories from solid fats and added sugars.
    (Comment 138) Some comments likened the public interest in added 
sugars to that in total fat in previous years and suggested that we 
consider the unintended consequences associated with a single nutrient-
type approach.
    (Response) We disagree with the comment's suggestion that we are 
taking a single nutrient-type approach to the labeling of added sugars. 
We are considering how added sugars interact with other components in 
the diet and make it difficult for individuals to meet nutrient needs 
within calorie limits and to construct a healthful dietary pattern. As 
noted in the 2015 DGAC Report, added sugars are not intended to be 
reduced in isolation; in fact, sodium and saturated fats are also 
recommended to be reduced in order to achieve a healthy dietary pattern 
that is balanced, as appropriate, in calories (Ref. 19). These 
considerations have led us to conclude that consumers need information 
on the amount of added sugars in a serving of a product as well as a 
percent DV declaration to help them maintain healthy practices and 
determine how a serving of a product fits into the context of their 
total daily diet. Furthermore, the declaration of added sugars will be 
included with other nutrient declarations on the label. This is one of 
many pieces of nutrition information that consumers should use when 
making food choices.
(iii) New Evidence Presented in the 2015 DGAC Report
    After publication of the 2010 DGA, the USDA NEL completed a 
systematic review project examining the relationships between dietary 
patterns and several health outcomes, including CVD, body weight, type 
2 diabetes, and dental caries. In addition, the DGAC reviewed the NHLBI 
Lifestyle Evidence Review and the Lifestyle Management Report. Based on 
the information provided in the NEL report, the 2015 DGAC made 
conclusions about the association of healthy dietary patterns and the 
risk of the named health outcomes. In particular, the 2015 DGAC 
concluded that strong and consistent evidence demonstrates that dietary 
patterns characterized by higher consumption of vegetables, fruits, 
whole grains, low-fat dairy, and seafood, and lower consumption of red 
and processed meat, and lower intakes of refined grains, and sugar-
sweetened foods and beverages relative to less healthy patterns; 
regular consumption of nuts and legumes; moderate consumption of 
alcohol; lower in saturated fat, cholesterol, and sodium, and richer in 
fiber, potassium, and unsaturated fats is associated with a decreased 
risk of CVD. We reviewed and considered the evidence that the DGAC 
relied on for making this conclusion, and determined that it supports 
our basis for requiring the mandatory declaration of the gram amount of 
added sugars on the label. We requested comment on this new information 
in the supplemental proposed rule.
    (Comment 139) Some comments supporting our inclusion of the new 
information on dietary patterns and CVD risk in our rationale for the 
declaration of added sugars said that the U.S. population should be 
encouraged and guided to consume dietary patterns that are rich in 
vegetables, fruit, whole grains, seafood, legumes, and nuts; moderate 
in low- and non-fat dairy products and alcohol (among adults); lower in 
red and processed meat; and low in sugar-sweetened foods and beverages 
and refined grains. One comment noted that the dietary patterns that 
are now recommended for CVD reduction by the American Heart Association 
and the American College of Cardiology and the new part 2 
recommendations of the National Lipid Association all refer to a 
dietary pattern low in sweets and sugar-sweetened beverages.
    Many comments supported the 2015 DGAC's recommendation that 
Americans reduce their intake of added sugars and said that the 
recommendation is consistent with the American Cancer Society's 
nutrition and physical activity guidelines, the recent guidelines from 
the World Health Organization on added sugars intake, and recent 
lifestyle guidelines from the American Heart Association and the 
American College of Cardiology.
    (Response) We have reviewed and considered the data and information 
underlying the 2015 DGAC's recommendations and have concluded that the 
declaration of added sugars is necessary to assist consumers in 
maintaining healthy dietary practices. The declaration would enable 
consumers to limit added sugars as part of a healthy dietary pattern.
    (Comment 140) Although we did not propose to rely on the analysis 
conducted by the 2015 DGAC (Ref. 84) on the relationship between the 
intake of added sugars and CVD, body weight/obesity, type 2 diabetes, 
and dental caries, some comments addressed the analysis and whether it 
supports a mandatory declaration of added sugars.
    Some comments said that it is appropriate for us to rely on 
information from the 2015 DGAC Report as well as the robust science 
upon which that report is based regarding the health risks of added 
sugars. The comments said that the DGAC comprehensively reviewed the 
current scientific literature and concluded that added sugars increase 
the risk of multiple health outcomes, including excess body weight, 
type 2 diabetes, CVD and dental caries. According to the comments, the 
evidence, which was graded either as ``strong'' or ``moderate'' by the 
DGAC, further supports the mandatory declaration of added sugars on the 
label and supports the addition of a percent DV declaration on the 
label. The comments cited additional scientific evidence supporting an 
association between consumption of added sugars and/or sugar-sweetened 
beverages and

[[Page 33805]]

the risk of the health outcomes named in the 2015 DGAC Report or 
endpoints such as serum triglycerides, LDL cholesterol, and blood 
pressure.
    Other comments suggested that the existing evidence related to 
consumption of added sugars and the risk of various chronic diseases 
and health-related conditions is limited and does not demonstrate a 
clear, causative relationship or direct contribution of added sugars to 
obesity, heart disease, or other diseases or conditions.
    Some comments questioned why we are relying on evidence related to 
dietary patterns and risk of disease to support a mandatory declaration 
of added sugars when a review was done by the DGAC that specifically 
looked at consumption of added sugars and risk of CVD and the DGAC 
concluded that the evidence was moderate rather than strong. The 
comments noted that the evidence reviewed by the DGAC in chapter 6 
(clinical trials and observational studies on sources of added sugars 
and CVD risk) provides a more direct and specific evaluation on added 
sugars and CVD risk than from data on dietary patterns and CVD risk.
    (Response) As discussed in part II.H.3.a, we are requiring an added 
sugars declaration so that consumers can limit calories from added 
sugars as part of a healthy dietary pattern lower in sugar-sweetened 
foods and beverages which is associated with a reduced risk of chronic 
disease and can meet nutrient needs within calorie limits. We do not 
need to limit our review of the science to the moderate evidence 
related to an independent relationship between added sugars and risk of 
chronic disease; instead, we can include in our review the strong and 
consistent association between the healthy dietary pattern with lower 
amounts of sugar-sweetened foods and beverages, compared to less 
healthy dietary patterns, and reduced risk of CVD (see added sugars 
introduction). Although the 2015 DGAC concluded that strong and 
consistent evidence shows that intake of added sugars from food and/or 
sugar-sweetened beverages are associated with excess body weight in 
children and adults, the evidence reviewed by the 2015 DGAC was 
primarily on sugar-sweetened beverages, which only represent 39 percent 
of food sources of added sugars. The consumption of added sugars and 
their impact on health continues to be an area of great interest to the 
scientific community and to consumers. We intend to monitor future 
research that may impact the labeling of added sugars.
    (Comment 141) Some comments suggested that our review is 
inconsistent and selective. The comments said that the particular 
dietary pattern related to CVD was singled out from the DGAC Report of 
dietary patterns and other chronic diseases (e.g. cancer, type 2 
diabetes) in the supplemental proposed rule because it was the only 
chronic disease for which the evidence was considered to be strong and, 
as such, we consider strong evidence to be necessary for requiring 
added sugars on nutrients in the proposed rule.
    (Response) We have strong and consistent evidence that dietary 
patterns associated with a decreased risk of CVD are characterized by 
higher consumption of fruits, vegetables, whole grains, low-fat dairy, 
and seafood, and lower consumption of red and processed meats, and 
lower intakes of refined grains and sugar-sweetened foods and beverages 
relative to less healthy dietary patterns. The dietary pattern approach 
focuses on components of the diet and how they contribute to an overall 
healthy dietary pattern that is associated with a decreased risk of 
disease. Although this is the first time that the 2015 DGAC has 
conducted a systematic review of the evidence related to dietary 
patterns and health outcomes, analysis of diet quality using scoring 
indices is an accepted scientific method that has been used for years 
to assess diet quality. The evidence that the 2015 DGAC considered 
related to dietary patterns and CVD risk adds to information that we 
provided in the proposed rule to support an added sugars declaration 
and is not the only evidence that we are relying on to support the 
declaration. Evidence related to an independent association between 
consumption of added sugars and risk of chronic disease continues to 
emerge. Although science related to the independent relationship 
between total added sugars and risk of chronic disease is not 
conclusive at this point, it does not mean that we cannot and should 
not rely on the evidence that we currently have related to healthy 
dietary patterns characterized, in part, by a reduced intake of sugar-
sweetened foods and beverages and reduced risk of CVD, which is strong 
and consistent.
    (Comment 142) Some comments cited reasons why the type of analysis 
which was conducted to examine the relationship between healthy dietary 
patterns and health outcomes cannot be used to make conclusions 
regarding single nutrients, food components, or foods. The comments 
noted that we have stated that we do not accept this type of 
extrapolation from an association of a complex mixture with disease 
risk to determine the association between a single component of the 
mixture to disease risk in our Guidance on Evidenced Based Review (Ref. 
85). The comments said that the extrapolation does not establish a 
public health endpoint to justify mandatory declaration added sugars. 
Some comments also said that the evidence on dietary patterns is not 
nutrient specific and a dietary pattern is defined as the quantities, 
proportions, variety or combinations of different foods and beverages 
in diets, and the frequency with which they are habitually consumed.
    (Response) This type of analysis that was conducted to examine the 
relationship between healthy dietary patterns and health outcomes is 
appropriate to answer questions about how dietary patterns, as a whole, 
impact disease risk. This type of analysis also takes into account 
relationships between components of a healthy dietary intake, which 
cannot be determined when looking at specific associations with a 
nutrient and risk of disease. Other analyses are more appropriate for 
answering questions related to a direct cause and effect relationship 
between a nutrient and the risk of a disease or health-related 
endpoint.
    The evidence considered by the 2015 DGAC related to dietary 
patterns and CVD risk provides us with information about the components 
of a healthy dietary pattern and how those components, when taken in 
combination, make up a dietary pattern that is associated with the 
reduced risk of CVD. As noted by the 2015 DGAC, it is often not 
possible to separate the effects of individual nutrients and foods. The 
2015 DGAC Report says that the components of the eating pattern can 
have interactive and potentially cumulative effects on health (Ref. 
19). The 2015-2020 DGA also says that people do not eat food groups and 
nutrients in isolation but rather in combination, and the totality of 
the diet forms an overall eating pattern.
    The dietary pattern analysis as well as information from the USDA 
food patterns showing how much added sugars individuals can reasonably 
consume in their diet while meeting nutrient needs, and consumption 
data showing that consumption of added sugars among Americans remains 
high supports limiting consumption of added sugars. In order for 
consumers to limit consumption of added sugars in the diet, it is 
necessary for information to be provided on the label that allows 
consumers to determine how much added sugars is in a serving of food, 
so

[[Page 33806]]

they can determine whether and how that food fits into their total 
daily diet. Therefore, information about what constitutes a healthy 
dietary pattern that is associated with a decreased risk of disease 
supports a label declaration of added sugars even though conclusions 
about a nutrient-specific association with risk of disease cannot be 
drawn from this type of evidence.
    (Comment 143) Some comments noted that the 2010 DGA said that 
individuals can achieve a healthy diet in multiple ways and preferably 
with a wide variety of foods and beverages. Optimal nutrition can be 
attained by many different dietary patterns, and a single dietary 
pattern approach or prescription is unnecessary. The comments said that 
dietary patterns other than those evaluated in Chapter 2 of the 2015 
DGAC Report might not have necessarily shown that reduced added sugars 
intake was associated with increased risk of CVD.
    (Response) While individuals can follow a number of different 
healthful dietary patterns, the NEL review on dietary patterns and CVD 
risk did not specifically look at studies where individuals were placed 
on a particular diet or were instructed to follow a specific diet. The 
2015 DGAC did consider evidence from DASH trials where participants 
were placed on the DASH diet. With the exception of the DASH trials, 
the analyses included free-living individuals who were following many 
dietary patterns. Certain scoring indices were then applied to intake 
data to look at how closely the diets of study participants matched 
certain types of healthy dietary patterns. Scores were then given based 
on adherence to the dietary pattern of interest. The dietary quality 
analyses included individuals that did not closely adhere to a 
particular dietary pattern of interest. In looking at all reports, 
which included an analysis of adherence to multiple types of healthy 
dietary patterns, the 2015 DGAC concluded that closer adherence to the 
healthy dietary patterns of interest, which tended to include less 
sugar-sweetened foods and beverages, resulted in a decreased risk of 
CVD. Therefore, the analysis included individuals who followed a wide 
variety of dietary patterns, some of which were determined to be more 
strongly associated with chronic disease risk than others. Although it 
is possible that some dietary patterns including substantial amounts of 
sugar-sweetened foods and beverages are associated with a decreased 
risk of CVD, research conducted across cohorts using multiple dietary 
pattern indices show that there is a high degree of correlation 
(highest quintile of scores) across scoring indices, and that higher 
diet quality is significantly and consistently associated with a 
reduced risk of death due to all causes, CVD, and cancer compared to 
the lowest quintile of scores (Ref. 86). Therefore, it is very unlikely 
that the majority of the population can consume a high quality diet 
that incorporates the proper amounts from food groups to meet nutrient 
needs as well as a significant amount of added sugars and still stay 
within calorie limits. The research suggests that there is a high level 
of consistency between different scoring indices in what is considered 
to be a healthy diet. Furthermore, as shown in the USDA Food Patterns 
for three patterns of health eating (a Healthy U.S.-Style Eating 
Pattern, a Healthy Mediterranean-Style Eating Pattern, and a Healthy 
Vegetarian Eating Pattern (Ref. 19)), in order to eat a dietary pattern 
that includes the amounts of other healthy dietary components, it is 
not possible to consume large amounts of empty calories.
b. The 2015 DGAC Analysis of Dietary Patterns and Health Outcomes
    (Comment 144) In the analysis of dietary patterns and health 
outcomes, dietary quality indices were used to evaluate adherence to 
certain dietary patterns. An individual's score is derived by comparing 
and quantifying their adherence to the criterion food and/or nutrient 
component of the index and then summed over all components (Ref. 19). A 
population's average mean and individual component scores can be 
similarly determined. Some examples of the dietary quality scores used 
for the analysis include: The Health Eating Index (HEI)-2005 and 2010, 
the Alternate HEI (AHEI) and updated AHEI-2010, the Recommended Food 
Score (RFS), the Mediterranean Diet Score (MDS), and the Alternate 
Mediterranean Diet Score (aMed).
    Some comments took issue with the various scoring algorithms used 
to evaluate adherence to certain dietary patterns as well as with the 
studies included in the analysis. One criticism of the scoring 
algorithms was that the majority of dietary pattern index studies cited 
by the 2015 DGAC did not include an added sugars criterion. The 
comments noted that the MDS, the aMed, the AHEI, and the RFS do not 
include a ``sweets or sugar products'' component. The comments said the 
HEI-2005 included sugar in a combined category of solid fats, alcoholic 
beverages and added sugars, the AHEI-2010 included sugar-sweetened 
beverages and fruit juice, and the Dietary Approaches to Stop 
Hypertension adherence index included soda, sugar sweetened beverages 
or a broader ``sweets'' category depending on the scoring method used. 
The comments said that none of these indices specifically address added 
sugars independently. One comment stated that not one of the 
Mediterranean dietary pattern studies cited by the DGAC had a sugars or 
added sugars criterion.
    Other comments singled out studies from the 55 that were included 
in the NEL review based on whether they included a measure of added 
sugars in the study. The comments suggested that studies with scoring 
indices that did not include a measure of added sugars should be 
excluded from our analysis. Some comments suggested that, when only the 
studies in which dietary pattern scoring indices were used that 
included a measure of added sugars are considered, the evidence related 
to CVD risk is not strong and consistent. The comments noted that the 
2015 DGAC Report says that ``certain scores also included added sugars 
or sugar-sweetened beverages as negative components.''
    (Response) While a number of index studies did not include a direct 
measure of added sugars or sugar-sweetened foods and/or beverages, the 
scoring systems in the study were measuring adherence to an overall 
dietary pattern, such as the Mediterranean diet, that is typically low 
in added sugars. Furthermore, research shows that there is consistency 
in scoring as well as association with health outcomes across dietary 
quality indices, including two that do not typically include a sugar-
sweetened food and beverages component (i.e. aHEI and AMED) (Ref. 86).
    The Dietary Patterns Methods Project conducted standardized and 
parallel analyses of the prospective association of select dietary 
patterns characterized by dietary quality indices and mortality 
outcomes in three large cohort studies conducted in the United States. 
The investigators selected four commonly used dietary quality indices 
including the HEI-2010, the AHEI-2010, the aMED, and the DASH (Ref. 
86). The comments noted that the AHEI and aMED dietary quality indices 
do not have a specific measure of added sugars. Liese et al. found that 
the indices were highly correlated, which means that individuals with 
the highest scores of adherence were likely to be scored similarly 
across all of the four dietary quality indices. They also found that 
higher diet quality (highest quintile of scores) was associated with 
lower all-

[[Page 33807]]

cause, CVD, and cancer mortality when compared to lower diet quality 
(lowest quintile of scores) across the diet quality indices. Similar 
findings have been seen across dietary quality scoring indices and 
large prospective cohort studies (Refs. 87-89). These results suggest 
that dietary quality scoring indices consistently determine diet 
quality, regardless of whether they include a component for sugar-
sweetened foods and/or beverages. The research also suggests that, 
because the diet quality indices are so comparable in what they measure 
as a high quality diet, it is very likely that the diets of individuals 
with higher diet quality scores will have a lower intake of sugar-
sweetened foods and/or beverages. Furthermore, it is very unlikely that 
participants with high diet quality scores across the various scoring 
indices would be able to consume enough of the other components of a 
healthy dietary pattern to receive a high score if they were consuming 
large amounts of sugar-sweetened foods and beverages.
    We also note that the dietary pattern scoring indices were modified 
by study investigators, so it is necessary to review each study to 
determine whether the diet quality index used in a particular study 
included a component that measured added sugars. Table 4-B-I-1 from the 
2015 DGAC Report shows a comparison of the dietary components across 
some of the major diet scoring indices (Ref. 19). The comment noting 
that the MDS, the aMed, the AHEI, and the RFS do not include a ``sweets 
or sugar products'' component was likely referring to the information 
in Table 4-B-I-1. However, to determine if the scoring index used in a 
particular index study included a measure of sugars-sweetened foods or 
beverages, it is necessary to go to the study report because 
investigators did include measures of types of sugar-sweetened foods 
and/or beverages in most of the studies included in the analysis. For 
example, Trichopoulou et al. evaluated adherence to a Mediterranean 
diet by using the MDS, but included sweets as a component of the 
scoring algorithm.
    (Comment 145) One comment noted that, if a company wanted to make a 
voluntary claim that there is a strong association between diets low in 
added sugars and a decreased risk of CVD, we would not consider the 
underlying evidence that the DGAC relied upon as sufficient to support 
such a claim, yet we are relying on this same level of evidence to 
require that companies include a mandatory claim on their labels that 
is potentially false and misleading for certain foods which undergo 
chemical processes that reduce the amount of sugar in a product.
    (Response) To the extent that the comments are suggesting that it 
is not appropriate for us to rely on evidence related to dietary 
patterns and health outcomes to support a mandatory declaration of 
added sugars, we disagree. The scientific evidence related to dietary 
patterns and health outcomes that was presented in the 2015 DGAC 
Report, and more specifically the evidence related to a healthy dietary 
pattern that is associated with a decreased risk of CVD relative to 
less healthy dietary patterns does show that there are certain 
characteristics of a healthy dietary pattern that consumers need when 
selecting foods to eat and when determining how much of those foods 
they should eat. The information that we are relying upon related to 
healthy dietary patterns characterized, in part, by lower amounts of 
sugar-sweetened foods and beverages and CVD risk is directly related to 
the need for consumers to have information on the label, which they do 
not currently have in the case of added sugars, so that they can 
construct a healthy dietary pattern that is associated with a decreased 
risk of disease and maintain healthy dietary practices.
    In response to the comment's suggestion that an added sugars 
declaration is potentially false and misleading for certain foods which 
undergo chemical processes that reduce the amount of sugar in a 
product, we have concluded that, generally, manufacturers of foods that 
undergo non-enzymatic browning and fermentation are able to determine a 
reasonable approximation of the amount of added sugars in a serving of 
their finished product (see part II.H.3.k). Therefore, added sugars 
declarations on foods that undergo non-enzymatic browning and 
fermentation are not potentially false and misleading.
    (Comment 146) Some comments noted that the studies that did include 
an assessment of sugar sweetened foods and/or beverages did not include 
an assessment of everything that we would consider to be added sugars. 
One comment said that some of the studies only assessed 
sugars[hyphen]sweetened beverage intake, and some considered fruit 
juices to be sugar-sweetened beverages. The studies included no 
assessment of intake of sugar-containing foods.
    Other comments noted that the scoring algorithms used to evaluate 
dietary pattern adherence may differ and may affect the results of 
studies examining specific health outcomes. The comments said that this 
factor may hamper cross-study comparisons and limit reproducibility.
    (Response) Some studies included only sugar-sweetened beverages, 
while others included ``sugar'' or ``sweets.'' The scoring algorithms 
also did vary from study to study. However, research shows that 
different dietary quality indices are very comparable in what they 
consider to be a high quality versus a low-quality diet (Ref. 86). The 
different dietary quality indices also are very consistent in their 
association with health outcomes (Ref. 86). Although the studies 
included different types of added sugars as components of their 
analysis, when taken as a whole, the data generally shows that healthy 
dietary patterns that are associated with a decreased risk of CVD 
relative to less healthy dietary patterns are characterized, in part, 
by lower amounts of sugar-sweetened foods and beverages. Additionally, 
it would be extremely difficult for individuals consuming large amounts 
of empty calories from sugar-sweetened foods and beverages to be able 
to consume enough of the other components of a healthy dietary pattern 
to be able to receive a high diet quality score.
    We also recognize that the scoring algorithms used in the studies 
included in the analysis differ from study to study. However, despite 
having different ways to evaluate many different types of healthy 
diets, a strong and consistent pattern emerged from the evidence. We 
view the variety of scoring algorithms to be a strength of the review 
because, despite the differences in scoring algorithms, there was 
consistency in what constituted a diet that would receive a high 
dietary quality score and there was consistency in the association 
between higher dietary quality scores and CVD risk versus lower diet 
quality scores.
    (Comment 147) Some comments noted that none of the definitions of 
added sugars used in the studies included in the analysis of dietary 
patterns and CVD risk are consistent with our proposed definition since 
it was not released until 2014 and the studies were conducted prior to 
that date. One comment suggested that many more sources of sugar are 
included in our proposed definition than in the studies cited in the 
2015 DGAC Report.
    (Response) The studies included in the analysis on dietary patterns 
and CVD risk assessed the intake of foods that are part of an eating 
pattern rather than intake of specific nutrients. Therefore, we would 
not expect, nor would it be necessary for, our proposed definition of 
added sugars to be consistent with how sugar-sweetened

[[Page 33808]]

foods and beverages were defined for the purposes of this type of 
analysis. Furthermore, we would not anticipate that researchers would 
have used our proposed definition as a guide when determining what 
foods include added sugars because, at the time the studies were 
conducted, we had not finalized the rule.
    (Comment 148) One comment cited several epidemiological studies 
which evaluated the DASH dietary scoring pattern and CVD outcomes. The 
comment said that, in one study included in the 2015 DGAC analysis 
(Ref. 90), the range of sweetened beverage intake across the DASH score 
quintile was narrow (0.3 servings per day in the lowest quintile and 
0.2 servings per day in the highest quintile). The comment noted that 
the authors of the study concluded that a diet that resembles the DASH 
eating plan was significantly associated with lower risk of CHD and 
stroke, but they made no mention of reduced consumption of sweetened 
beverages as part of the diet. The comment also referred to a 
subsequent study in the Women's Health Study cohort which evaluated the 
relationship between adherence to a DASH dietary pattern score and risk 
of CVD. In this study, an apparently strong association of adherence to 
the DASH diet with incidence of CVD was attenuated upon control for 
confounding variables. The comment noted that, Folsom et al. found that 
adherence to the DASH diet, where sweets were evaluated as a broad 
category, did not have an independent long-term association with 
hypertension or CVD mortality after adjustment for confounding 
variables in a cohort of women (Ref. 91).
    (Response) Although study authors may not have mentioned sweetened 
beverages as part of the DASH eating plan, the DASH diet is typically 
lower in the category of food called ``sweets.'' Therefore, it is 
appropriate to rely on studies where a DASH scoring index was used 
because the scoring algorithm is based on a diet that is low in sweets.
    We considered all 55 articles reviewed by the NEL, which summarized 
evidence from 52 prospective cohort studies and 7 randomized-controlled 
trials (RCTs), and the NHLBI Lifestyle Evidence Review and the 
associated Lifestyle Management Report, which included primarily RCTs. 
Although some studies where a DASH dietary quality scoring index was 
used did not show an association with CVD risk, and some DASH dietary 
quality scoring indices did not include a direct measure of sugar-
sweetened foods and beverages, as noted in the comments, when taken 
together with other studies included in the analysis, the body of 
evidence supports the conclusion that there is strong and consistent 
evidence dietary patterns characterized by higher consumption of 
vegetables, fruits, whole grains, low-fat dairy, and seafood, and lower 
consumption of red and processed meat, and lower intakes of refined 
grains, and sugar-sweetened foods and beverages relative to less 
healthy patterns; regular consumption of nuts and legumes; moderate 
consumption of alcohol; lower in saturated fat, cholesterol and sodium 
and richer in fiber, potassium, and unsaturated fats are associated 
with decreased CVD risk.
    (Comment 149) Some comments cited a number of studies where an 
association with higher adherence scores and CVD risk, CHD risk, or 
ischemic stroke was found, but when an analysis of sugar sweetened 
foods and/or beverages was done in the same data set, an association 
with the outcome of interest was not found. The comments referred to 
component analyses that were conducted as part of some of the studies 
included in the analysis of the evidence related to dietary patterns 
and CVD risk. In these component analyses, the data for intake of 
certain dietary components, such as fruits and vegetables, were looked 
at more closely to see if they were associated with the outcome of 
interest (CVD risk) when looked at in isolation. The comments said that 
``added sugars'' intake was not a factor in the observed differences in 
CVD risk in some of the studies where component analyses were 
performed. Additionally, the comments said that sugars are only one of 
many dietary factors included in the scoring indexes, and interplay 
between multiple factors in the dietary patterns cannot be excluded. 
Some comments said that the analysis is limited because not all of the 
studies included in the NEL review included a component analysis. The 
comments pointed to the statement in the 2015 DGAC Report which says 
``although a large number of the studies assessed food group components 
and their association with CVD outcomes, many did not, and more precise 
determination of the benefits and risks of individual components (e.g., 
alcohol) would be helpful for policy recommendations. One comment noted 
that the 2015 DGAC Report fails to mention all of the individual 
components that were tested that had no effect on CVD (e.g., added 
sugars). Another comment noted that throughout the studies, the impact 
of dairy on the association between a dietary pattern and a health 
outcome was inconsistent, which shows that the methodology used is 
imprecise.
    (Response) For the first time, the 2015 DGAC conducted a systematic 
review of the evidence related to dietary patterns and health outcomes. 
The analysis was included because people do not eat nutrients or foods 
in isolation. Rather than focusing on specific nutrients, the 2015 DGAC 
and the 2015-2020 DGA focused on eating patterns and shifts that 
Americans need to make in order to move towards a healthier diet that 
is associated with a decreased risk of chronic disease. The 2015-2020 
DGA said that the key recommendations for healthy eating patterns 
should be applied in their entirety, given the interconnected 
relationship that each dietary component can have with others (Ref. 
28). The 2015 DGAC Report said, and we agree, that it is often not 
possible to separate the effects of individual nutrients and foods and 
that the totality of the diet-the combinations and quantities in which 
foods and nutrients are consumed may have synergistic and cumulative 
effects on health and disease (Ref. 19). It is with this information in 
mind that we reviewed the evidence related to dietary patterns and 
health outcomes presented in the 2015 DGAC Report.
    We disagree with the comments stating that studies that included a 
component analysis for added sugars and CVD risk that did not show a 
favorable association cannot be used to support an added sugars 
declaration. Investigators use component analyses as an exploratory 
measure to see if the result seen is mainly due to one component or 
another. How these component analyses are conducted varies from study 
to study because there is not consensus within the scientific community 
yet on what methods should be used for component analyses. For example, 
in some studies, the effects of individual components of the diet are 
looked at separately without controlling for the effects of other 
components of the diet, while in other studies investigators control 
for other variables in the diet when looking at the effect of an 
individual dietary component. Because the methodology related to 
dietary pattern component analyses is still evolving and there is a 
great deal of variability between studies in how the component analyses 
are performed, we believe that it would not be appropriate to conclude 
that sugar-sweetened beverages have no responsibility for the overall 
relationship that is seen with CVD risk just because a component 
analysis indicates that there is no

[[Page 33809]]

independent effect of sugar-sweetened beverage consumption on CVD risk 
in the data set. Instead, we have considered the evidence related to 
the totality of the dietary pattern. By considering the makeup of the 
entire healthy dietary pattern, we can take into account connections 
that foods and dietary components may have with one another.
    As noted in the 2015 DGAC Report, the analysis of dietary patterns 
and health outcomes captures the relationship between the overall diet 
and its constituent foods, beverages and nutrients in relationship to 
outcomes of interest and quality, thereby overcoming the collinearity 
(closely aligned relationship) among single foods and nutrients (Ref. 
19). Therefore, we agree with the comment that said that interplay 
between multiple factors in dietary patterns cannot be excluded. The 
dietary pattern should be looked at as a whole rather than a sum of its 
parts because there is interplay between the multiple factors. When 
certain nutrients or foods are looked at individually without taking 
into account the relationships that the nutrient or food component has 
with other pieces of the dietary pattern, the effects of those 
relationships are lost. Information that would allow consumers to 
understand how a food fits into their overall dietary pattern is 
therefore important to be declared on the label.
    In addition, investigators often analyze data using different 
methods, depending on the research question, and not all articles 
include a report of all of the study findings. Therefore, it is 
possible that sugar-sweetened foods and beverages could have been 
measured or that a component analysis was conducted for sugar-sweetened 
foods and/or beverages, but the findings were not reported in a 
particular published article.
    (Comment 150) Some comments said that the evidence related to 
healthy dietary patterns characterized, in part, by lower intakes of 
sugar-sweetened foods and beverages is not strong and questioned 
whether we relied on the DGAC's analysis and conclusion rather than 
doing our own analysis of the studies.
    (Response) We reviewed and considered the evidence that was 
considered by the 2015 DGAC when making their conclusions in Chapter 2 
of the 2015 DGAC Report. We concluded based on that review and 
consideration of the evidence that strong and consistent evidence 
demonstrates that healthy dietary patterns are characterized by higher 
consumption of vegetables, fruits, whole grains, low-fat dairy, and 
seafood, and lower consumption of red and processed meat, and lower 
intakes of refined grains, and sugar-sweetened foods and beverages.
    The comments that said that the data does not support a strong and 
consistent relationship with CVD risk were looking at the data in more 
limited way than we have. They focused their review on a specific 
nutrient-disease relationship whereas we considered the whole of the 
dietary pattern. Some comments included conclusions from their own 
review of the evidence. In those comments, studies were excluded based 
on whether the dietary quality index used in each study included a 
measure of added sugars, whether the studies were conducted in the 
United States, whether a component analysis for a measure of added 
sugars was conducted, and whether that analysis showed an association 
with CVD risk. As previously discussed in our responses to comments 147 
and 148, we do not agree that it is appropriate to discount studies 
from the body of evidence considered based on these factors and have 
looked at the data and the dietary pattern as a whole rather than a sum 
of its parts.
    (Comment 151) One comment questioned the scientific validity of 
using hypothesis-based dietary pattern scores for determining health 
outcomes. The comment said that the use of adherence scores, cluster or 
factor analysis as a science-based measure for predicting health 
outcomes is flawed and not an accepted scientific methodology. The 
comment provided an example where an analysis based on dietary pattern 
scores showed that individuals with higher adherence to the dietary 
pattern of interest compared to individuals with lower adherence 
actually had an almost 300 percent increased chance of dying from CVD, 
which is an incorrect conclusion (Ref. 92).
    (Response) The use of this type of scientifically valid approach to 
looking at complex relationships between dietary patterns at health 
endpoints is being used by well-established scientific bodies. In fact, 
some of the dietary quality scoring indices were developed by Federal 
Agencies (e.g., the HEI). Although this is the first time that the DGAC 
has conducted a systematic review of the evidence related to dietary 
patterns and health outcomes, the use of diet quality indexes to look 
at an association between dietary patterns and health outcomes is not 
new. For example, the USDA's Center for Nutrition Policy and Promotion 
created the HEI in 1995. Dietary pattern analysis is becoming more 
widely accepted in the scientific community because there has been a 
shift in recent years from focusing on nutrients and their association 
with disease risk to a dietary pattern approach that considers the fact 
that individuals do not eat nutrients or foods in isolation. The 2015 
DGAC based their conclusions and recommendations on the results of this 
type of analysis to look at dietary patterns as a whole rather than 
specific nutrient and disease relationships, and the DGAC uses 
scientifically valid approaches that are widely accepted in the 
scientific community.
    Other comments suggested that the use of dietary pattern indices to 
assess the relationship between dietary patterns and health outcomes is 
flawed for specific reasons. We address those issues in our responses 
to comment 143.
    (Comment 152) Several comments cited a number of limitations of how 
the dietary intake data was collected in studies included in the 
analysis. The comments cited a number of criticisms of the use of Food 
Frequency Questionnaires (FFQs), which were used in the observational 
studies included in the analysis to assess adherence to scoring 
patterns. The comments suggested that added sugars are poorly measured 
by FFQs. Another limitation of FFQs mentioned in comments is that they 
are based on self-report and may introduce levels of report bias that 
can attenuate diet-health relationships. The comments stated that the 
extent to which data from FFQs are valid measures of dietary patterns 
is not well established. One comment said that FFQs are not designed to 
assess absolute intakes of foods, and when used only at baseline, the 
assumption is that intake does not change over several years, when 
health outcome is measured. The comment also said that FFQs provide 
little information on how the food was prepared.
    Other comments said that the dietary patterns do not assess the 
frequency of meal and snack consumption, specific combinations of foods 
consumed together, and aspects of food purchase and preparation, all of 
which may influence an overall dietary pattern.
    One comment said that fats and oils are spread across food groups, 
making them difficult to account for.
    (Response) FFQs are a relatively efficient and cost effective way 
to collect information about usual intakes in a large population study, 
which is why they are often used to assess intake in large-scale cohort 
studies. FFQs are often used in studies because they are inexpensive, 
can be self-administered, take less time for participants to

[[Page 33810]]

complete compared to other dietary assessment methods, and can be read 
by machines rather than being hand-entered and analyzed (Ref. 93). 
Although there may be more precise ways to assess dietary intake 
patterns, other intake methods, such as multiple 24-hour recalls are 
often less practical for use in large population studies. There are 
many advantages to having a larger sample size when evaluating habitual 
intake, which can provide robust results (Ref. 94). FFQs have been 
shown to be reasonably accurate in reporting food use (Ref. 93). FFQs 
also provide a better estimate of usual intakes that can be used to 
assess dietary patterns because they assess intake over a longer period 
of time than other dietary assessment techniques, such as 24-hour 
recalls, diet histories, and dietary records. FFQs are also almost 
always used in retrospective reports about diet (Ref. 95). We accept 
the use of data from FFQs in observational studies used to support an 
association between a substance and a disease or health-related 
condition for health claims (Ref. 85).
    We recognize that there are some limitations to the use of FFQs, 
and that one limitation is that in many of the studies FFQs were only 
administered at baseline. FFQs do not assess the frequency of meal and 
snack consumption, specific food combinations, and food preparation. 
Dietary pattern analysis considers combinations of foods and how they 
relate to health outcomes, but questions about the frequency of meal 
and snack consumption, specific food combinations, and food preparation 
would require a more specific analysis. Like other types of dietary 
assessment, this type of analysis can only be used to draw general 
conclusions about what components are included in a dietary pattern 
that is associated with risk of disease and the relative contribution 
(higher or lower) of that dietary component to the overall dietary 
pattern. Further analyses would be required to answer questions related 
to frequency of meal and snack consumption, specific food combinations 
that may associated with disease risk, and specific aspects of food 
preparation.
    Fats and oils are spread across food groups, which make them more 
difficult to account for; however, we are most interested in sugar-
sweetened food and beverages and how they fit into the dietary pattern. 
Sugar-sweetened foods and beverages can be isolated from the diet by 
the dietary assessment tools used in the studies included in the 
dietary pattern and health outcomes analysis.
    (Comment 153) One comment said that the observational data used in 
these studies, and the way that they are analyzed, make the findings 
highly subjected to residual confounding (error that can occur when 
either the categories of the variables related to the outcome of 
interest (e.g. CVD risk), called confounding variables, are too broad 
or when some confounding variables are not accounted for). The comment 
said that even with adjustment for confounders, residual confounding 
cannot be eliminated from observational studies. More specifically, 
higher/better dietary index scores were associated with a number of 
factors, such as higher education, increased physical activity, 
non[hyphen]smoker, multivitamin use, hormone therapy (women), and being 
married vs. single.
    (Response) Residual confounding is a general limitation of all 
observational studies and is not specific to just this type of 
analysis. The comment did not provide specifics about individual 
studies for which confounders were not appropriately adjusted. 
Therefore, the comment does not change our consideration of the data.
    (Comment 154) Some comments said that the patterns may be 
population-specific and therefore, are not generalizable. The comments 
also noted that some studies were not conducted in the United States 
and suggested that these studies cannot be used to draw conclusions 
about the general U.S. population.
    (Response) We agree that patterns may be population-specific; 
however, care was taken to include studies conducted in populations 
that were very similar to the U.S. population (e.g. countries in the 
E.U.) and that data was collected in populations that would be 
generalizable to the U.S. population (Ref. 19).
    (Comment 155) Some comments said that the NEL project based its 
conclusions only on those studies where score adherence was associated 
with decreased CVD risk, leaving all of the studies showing no effect 
out of the analysis.
    (Response) We disagree with the comment that the NEL and the 2015 
DGAC based their conclusions only on studies where score adherence was 
associated with decreased CVD risk. As stated in the 2015 DGAC Report, 
after the exclusion criteria were applied, a total of 55 studies met 
the inclusion criteria for the systematic review. The NEL found that 
the majority of the 55 studies that assessed CVD incidence or mortality 
reported an inverse association between increased adherence to a 
healthy dietary pattern and decreased risk of CVD. The NEL considered 
the results of all 55 studies rather just a subset where score 
adherence was associated with a decreased CVD risk.
c. Authority for Labeling
(i) Statutory Authority
    (Comment 156) Many comments addressed our authority to require the 
mandatory declaration of added sugars on the label. We discuss our 
authority under the FD&C Act and our recordkeeping authority in parts 
II.C.3 and C.4.
    Many other comments questioned our authority to require added 
sugars on the label because the purpose of the Nutrition Facts label is 
to help consumers reduce their risk of diet-related disease and added 
sugars are not associated with risk of disease. One comment noted that 
each of the nutrients currently on the label relate to a disease or 
serious health condition. Other comments said that we lack the 
authority to require the disclosure of added sugars because our 
rationale for requiring labeling, which is related to encouraging 
consumers to eat a more nutrient-dense diet or dietary planning, is by 
our own admission not related to a disease or health-related condition, 
such as obesity.
    One comment suggested that, because there is no scientifically 
supported quantitative intake recommendation for added sugars upon 
which a DRV can be derived and because no authoritative scientific body 
has found a public health need to set an Upper Level (UL) for added 
sugars intake, we have not sufficiently shown that there is a public 
health need to monitor added sugars intake through labeling for 
consumers to maintain healthy dietary practices. The comment further 
stated that our admission in the proposed rule that we cannot establish 
a DV for added sugars further indicates that added sugars is not the 
type of nutrition disclosure that Congress intended for the Agency to 
require on the label.
    (Response) As discussed in part II.C.3, under section 403(q)(2)(A) 
of the FD&C Act, the Secretary of the Department of Health and Human 
Services may require, by regulation, that information related to 
additional nutrients be included in the label or labeling of food, if 
the Secretary determines that providing information regarding the 
nutritional value of such food will assist consumers in maintaining 
healthy dietary practices. The FD&C Act requires that nutrition 
information on

[[Page 33811]]

the label be conveyed to the public in a manner which enables the 
public to readily observe and comprehend such information and to 
understand its relative significance in the context of the total daily 
diet. There is evidence that excess consumption of added sugars is a 
public health concern. Healthy dietary patterns characterized, in part, 
by lower intakes of foods and beverages which contain added sugars are 
associated with a decreased risk of CVD. Current scientific evidence 
supports limiting consumption of added sugars. Without a label 
declaration of added sugars, consumers are unable to determine how much 
added sugars a serving of a particular food would contribute to their 
diet and how to fit that food within an overall healthy eating pattern. 
We have concluded that the declaration of added sugars will assist 
consumers in maintaining healthy dietary practices, as required under 
the FD&C Act.
    We disagree with the comment that asserted that added sugars is not 
the type of nutrient disclosure Congress intended for FDA to require 
because there is no scientifically supported quantitative intake 
recommendation for added sugars upon which a DRV can be derived. We are 
not limited to establishing a quantitative intake recommendation to 
circumstances in which there is a biomarker of risk of disease. 
Instead, we are relying on other evidence to support a mandatory 
declaration of added sugars for the general population which is not 
based on an independent relationship with a chronic disease, health-
related condition, or physiological endpoint, but is based, instead, on 
constructing an overall healthy eating pattern that is low in added 
sugars.
    As discussed in part II.H.3.o.(i), new evidence has become 
available since publication of the proposed rule in March 2014 related 
to limiting intake of added sugars to less than 10 percent of calories 
(Ref. 19). We have considered the underlying scientific evidence in the 
2015 DGAC Report and have determined that the evidence supports 
establishing a DRV of 10 percent of total calories. The DRV for added 
sugars of 10 percent of calories is based on the amount of added sugars 
that can be reasonably accommodated within a healthy dietary pattern. 
As discussed in part II.H.3, the evidence that we are relying on for a 
mandatory declaration of added sugars for the general population and 
for the DRV is based on information related to healthy dietary 
patterns. Therefore, the comment's concern about a lack of a 
quantitative intake recommendation for added sugars has been addressed.
    (Comment 157) Some comments said that a stronger case can be made 
for including whole grains or stearic acid on the label.
    (Response) The FD&C Act gives us the authority to add and remove 
nutrients from the label based on whether we determine the nutrients 
are necessary to assist consumers in maintaining healthy dietary 
practices. We did not consider whether it would be appropriate to 
consider whole grains as a nutrient, nor propose a declaration of whole 
grains on the nutrition label, in the context of this rulemaking. Whole 
grains are made up of a variety of different grains (e.g. amaranth, 
barley, buckwheat, whole kernel corn, millet, oats, quinoa, rice, rye, 
sorghum, teff, triticale, wheat, and wild rice), and we would need to 
give further consideration about whether it would be appropriate to 
consider whole grains as a nutrient for purposes of nutrition labeling.
    In the preamble to the proposed rule (79 FR 11879 at 11894), we 
considered whether the labeling of stearic acid should be mandatory or 
voluntary on the label and concluded that the evidence for a role of 
stearic acid in human health (e.g. changes in plasma LDL cholesterol 
levels) is not well-established. We tentatively concluded that the 
individual declaration of stearic acid is not necessary to assist 
consumers in maintaining healthy dietary practices. We also have 
declined to exclude stearic acid from the calculation of an individual 
food's percent DV for saturated fat elsewhere in this document (see 
part II.F.2) because current dietary recommendations for saturated fat, 
such as those of the DGA, do not differentiate among the individual 
saturated fatty acids in providing the recommended intake levels. In 
addition, the DGA recommendation to consume less than 10 percent of 
calories from saturated fatty acids makes no specific exclusion of 
stearic acid, and instead, relates to the intake of total saturated 
fatty acids. Therefore, we have determined that stearic acid should not 
be specifically listed on the label and should not be excluded from the 
calculation of an individual food's percent DV for saturated fat.
    (Comment 158) One comment discussed how the declaration of the 
amount of added sugars in a product ``could compromise legitimate trade 
secrets'' based on the declared amount being made public.
    (Response) To the extent that the comment argued that the 
declaration of the amount of added sugars could compromise legitimate 
trade secrets, we disagree. We are not requiring the public disclosure 
of formulations or recipes. We are requiring, for all products, the 
declaration of specific nutrients that have been determined to assist 
consumers to maintain healthy dietary practices (cf. Philip Morris, 
Inc. v. Reilly, 312 F.3d 24 (1st Cir. 2002)). It would be unreasonable 
for manufacturers to expect that the nutrients on the Nutrition Facts 
label would never change based on updated scientific evidence and the 
need to provide information that will assist consumers to maintain 
healthy dietary practices (see, e.g., Ruckelhaus v. Monsanto Co., 467 
U.S. 986 (1984), Corn Products Refinery Co. v. Eddy, 249 U.S. 427 
(1919)).
(ii) Material Fact
    (Comment 159) Some comments said that a declaration of added sugars 
is not a material fact because a declaration does not appear to be 
necessary for consumers to make healthy dietary choices and that, 
absent a declaration of added sugars, the label is not false or 
misleading to consumers.
    (Response) Under section 403(a)(1) of the FD&C Act, a food is 
misbranded if its labeling is false or misleading in any particular. 
Section 201(n) of the FD&C Act further defines misleading labeling. In 
determining whether labeling is false or misleading, we take into 
account representations made or suggested in the labeling and the 
extent to which the labeling fails to reveal facts material in light of 
the representations or with respect to consequences that may result 
from the use of the food to which the labeling relates under the 
conditions of use prescribed in the labeling, or under such conditions 
of use as are customary or usual (id.). In the context of nutrition 
labeling, we have considered the declaration of meaningful sources of 
calories or nutrients to be a material fact (see 55 FR 29487 at 29491 
through 29492, July 19, 1990 and 68 FR 41434 at 41438, July 11, 2003). 
Nutritive value cannot be determined without a declaration. Thus, the 
final rule will ensure that information that relates to the added 
sugars content of a serving of food, which is fundamental to people's 
food choices, is available on the food label. The added sugars 
declaration will provide consumers with information that is material 
with respect to the consequences of consuming a particular food (see 55 
FR 29487 at 29491 through 29492).
    We have determined that there is adequate evidence to demonstrate 
that consumption of added sugars is a public health concern because 
evidence shows that heathy dietary patterns associated

[[Page 33812]]

with a decreased risk of chronic disease are lower in sugar-sweetened 
foods and beverages that have been sweetened with added sugars, 
consumption of too much added sugars can impact the nutrient density of 
the diet, and consumption of sugar-sweetened foods and beverages is 
associated with increased adiposity in children. Furthermore, the 
scientific evidence supports that consumers limit their intake of added 
sugars to less than 10 percent of total calories. Without information 
on the amount of added sugars in a serving of a food, consumers would 
not have the information they need to construct a healthy dietary 
pattern that contains less than 10 percent of calories from added 
sugars. Therefore, we have concluded that this evidence is adequate to 
compel a label declaration of added sugars on the Nutrition and 
Supplement Facts labels.
(iii) Regulations Must Bear a Reasonable Relationship to the 
Requirements and Purposes of the Statute
(A) Consumers Are Eating Too Many Added Sugars
    (Comment 160) Some comments suggested that an added sugars 
declaration would be beneficial for consumers because evidence shows 
that Americans are consuming too many added sugars. The comments cited 
survey data showing that from 2003 to 2006, added sugars, on average, 
provided about 14 percent of total calories in the American diet, and 
25 percent or more of total calories for over 36 million Americans. The 
comments argued that Americans consume an average of 152 pounds of 
sugar per year, the average 6- to 11-year-old American boy consumes 22 
teaspoons of added sugars per day, and the average girl of that age 
consumes 18 teaspoons of added sugars per day. The comments also cited 
data on the average per-capita loss-adjusted food availability data 
from 2012 showing that, on average, Americans consumed between 18 to 23 
teaspoons (about 300 to 390 calories worth) of added sugars per day.
    Other comments suggested that the declaration of added sugars is 
not necessary because current evidence shows that consumption of added 
sugars is declining in the United States. One comment noted that the 
American public is already reducing its consumption of sugar-sweetened 
beverages, especially carbonated sweetened beverages, and it is doing 
so without having an added sugars declaration on the Nutrition Facts 
label. Some comments provided evidence that the decrease in the intake 
of added sugars has been pronounced with an approximate decrease of 
about 25 percent on a per person basis between 1999 and 2010 (Ref. 96). 
One comment noted that sugar/sucrose consumption has declined by 33 
percent in the United States and that per capita added sugars 
consumption has declined since 1970 when obesity was not a public 
health concern.
    One comment suggested that the contribution from added sugars to 
the increase in total calories over the past 30 years is relatively 
minor. The comment cited evidence from USDA that between 1970 and 2009 
there was an increase of 425 calories per person per day, and added 
sugars contributed less than 10 percent (38 calories) of this increased 
caloric intake.
    One comment suggested that the problem of increasing added sugars 
consumption has mainly been a problem with beverages, not food. The 
comment said that almost all of the increase in consumption of sugars 
between the late 1970s and about 2005 has been in beverages. The total 
amount of added sugars consumed in sweet pastry, dairy and non-dairy 
desserts, candy, and other sugars-containing foods has remained almost 
constant, but the added sugars contributed by sweetened beverages has 
doubled. Total sugars consumption increased from about 59 grams per 
person per day to about 84 grams per person per day, and added sugars 
in sweetened beverages increased from about 17.5 to 41.5 grams per 
person per day. Twenty-four of the twenty-five grams of increase were 
in sweetened beverages.
    (Response) Although added sugars consumption has decreased in 
recent years, consumption of added sugars still remains high at an 
average of 13.4 percent of calories among the U.S. population (Ref. 
19). The scientific evidence supports Americans limiting their intake 
of added sugars to no more than 10 percent of calories (Ref. 19). The 
scientific evidence also is included in the 2015-DGA. Current 
consumption exceeds the recommended limit for added sugars. Usual 
intake data shows that added sugars consumption among some populations, 
especially children and young adults, is even higher. Based on food 
intakes in the U.S. population from 2007 to 2010, the usual median 
intake of added sugars exceeded 15 percent of calories and 300 calories 
for males 4 to 50 years old. For males 14 to 18 years old, the usual 
median intake was 22.2 teaspoons per day and 492.3 calories per day. 
The usual median intake of added sugars for males 19 to 30 years was 
21.2 teaspoons per day and 454.6 calories per day. Consumption is also 
high in females. The usual median intake exceeds 15 teaspoons and 300 
calories per day in females aged 9 through 30 years (Ref. 97). At the 
highest calorie level of 3,200 calories per day in the USDA Food 
Patterns described in the 2015 DGAC Report, the empty calorie limit 
available for added sugars is 275 calories (Ref. 98). This means that 
the median usual intake for most age groups based on 2007 to 2010 
intake data exceeds the highest empty calorie limits available for 
added sugars in the USDA Food Intake Patterns. This information shows 
that added sugars intake in the U.S. population continues to be 
excessive. Knowing the amount of added sugars in the foods that we eat 
may help Americans limit their intake of calories from added sugars and 
reduce their overall consumption of calories.
(B) Comments on Whether an Added Sugars Declaration Is Necessary To 
Assist Consumers in Limiting Their Added Sugars Consumption
    (Comment 161) Many comments supported mandatory declaration of 
added sugars on the label because the information is necessary to 
assist consumers in limiting their intake of added sugars. The comments 
argued that consumers have no way of knowing the quantity of added 
sugars in a product unless they are listed on the label, and such a 
declaration would help consumers avoid the consumption of too much 
added sugars. The comments stated that, in reading ingredient labels, 
consumers may not know all forms of added sugars that can be in a food, 
such as concentrated fruit juice, and they may not understand that 
ingredients are listed in order of predominance. One comment noted 
that, for many programs across the country in schools and other 
institutions, the preexisting label makes it difficult for those 
developing program guidelines to follow the DGA's recommendations and 
limit the amount of added sugars in provided foods. To date, limiting 
total sugars has been the only option, which results in complex 
standards with detailed exemptions for foods with naturally occurring 
sugars, such as fruit and dairy.
    In contrast, many other comments opposed to the mandatory 
declaration of added sugars on the label argued that a label 
declaration of the amount of added sugars is not necessary because it 
does not convey information that consumers cannot already obtain from 
total sugars and calorie declarations or from the ingredient list. One 
comment said that we are already addressing how to help consumers 
maintain appropriate caloric

[[Page 33813]]

balance through increasing the prominence of calories on the Nutrition 
Facts label, and the DGAs are already providing consumers with 
recommended food choices to increase consumption of nutrient dense 
foods. Other comments stated that we did not show how an added sugars 
declaration would provide consumers with any additional information to 
help consumers maintain healthy dietary practices or enhance the 
information that the Nutrition Facts label already provides, and 
therefore, the added sugars declaration fails to assist consumers in 
maintaining healthy dietary practices. One comment suggested that an 
added sugars declaration will not help consumers select a nutrient-
dense diet because information on total calories and nutrient content 
already allows for the identification of other nutrient-dense foods. 
Other comments noted that foods that are major sources of added sugars 
are products for which all or virtually all sugar is added and the 
current sugars declaration already reflects the amount of added sugars.
    (Response) The calorie declaration, the total sugars declaration, 
and the ingredient list do not provide the consumer with the amount of 
added sugars in a serving of a product. An added sugars declaration is 
necessary to provide consumers with a measure to assess the relative 
contribution of the added sugars from a serving of food as part of a 
healthy dietary pattern and enable consumers to avoid a dietary pattern 
containing excess calories from added sugars. In some foods that are 
high in added sugars, such as sugar-sweetened beverages, virtually all 
sugars in the products are added sugars. In these types of foods, it 
would be possible for the consumer to determine the amount of added 
sugars in the product by looking at the (total) sugars declaration. 
However, many other foods contain a mixture of naturally occurring and 
added sugars. Based on information that is currently declared on the 
label, the consumer is unable to determine what portion of the total 
sugars declaration is naturally occurring and what portion of the total 
sugars declaration is added sugars. Small amounts of added sugars found 
in many different foods and ingredients can add up throughout the day 
and can contribute empty calories in the diet at levels that exceed 
what would otherwise be reasonable within recommended calorie limits. 
Therefore, an added sugars declaration allows consumers to better 
compare products and assess whether a particular product fits into a 
healthy diet. Furthermore, the calorie declaration reflects calories 
from all macronutrients, and the total sugars declaration would only be 
a reflection of the amount of added sugars in a product if all of the 
sugars are added rather than naturally occurring.
    Consumers would not be able to determine the relative amount of 
added sugars in a serving of a product from the ingredient list for 
several reasons. There are many different types and forms of sugar that 
may be added to a food during processing and preparation. Consumers 
also may not recognize the names of some types of sugars to be a sugar 
(e.g. trehelose). Finally, consumers may also not know that the 
ingredients are listed in order of predominance by weight, and no 
quantitative information is provided in the ingredient list.
    Although the DGA already provides information on recommended food 
choices to increase consumption of nutrient dense foods, the DGA does 
not provide the amount of added sugars in a serving of food that 
nutritional labeling provides. While some added sugars can be part of a 
healthy dietary pattern, without a label declaration for added sugars, 
consumers will not have the information they need to limit added sugars 
to less than 10 percent of calories. Information about the amount of 
added sugars in a serving of food and how to put that amount of added 
sugars into the context of the total daily diet can further assist 
consumers in reducing their intake of calories from added sugars.
    With respect to the comments that suggested we did not show how 
added sugars would provide consumers with any additional information to 
help them maintain healthy dietary practices or enhance what the 
Nutrition Facts label already provides, we are not required to show 
that consumers will use new information on the label to change their 
behaviors or dietary practices before requiring the declaration of 
information on the label. Furthermore, our consumer research shows that 
without an added sugars declaration, consumers are unable to determine 
the amount of added sugars in a serving of a product (Ref. 14). 
Further, the current label provides only information on total 
carbohydrates and total sugars. A declaration of added sugars on the 
label would provide the needed information about the added sugars 
content of a food.
    A declaration of the amount of added sugars in a serving of a 
product will provide more specific quantitative information about the 
amount of all added sugars found in a serving of a product that is not 
currently available on the label. We anticipate that providing a 
declaration of the amount of added sugars in a serving of a product 
would assist government programs, schools, and other institutions in 
limiting the amount of added sugars in foods they provide.
    (Comment 162) Some comments suggested that added sugars should be 
declared on the label because this is information that consumers have 
the right to know.
    (Response) While we appreciate consumers' interests, the statutory 
framework for the declaration of a nutrient under section 403(q)(2) of 
the FD&C Act is whether the declaration will provide information that 
will assist consumers in maintaining healthy dietary practices, not 
whether consumers want access to the information. Furthermore, consumer 
interest or demand alone does not constitute a material fact under 
section 201(n) of the FD&C Act and is not a sufficient basis upon which 
we can require additional labeling for foods (see, e.g., Stauber v. 
Shalala, 895 F. Supp. 1178, 1193 (W.D. Wisc. 1995) and Alliance for 
BioIntegrity v. Shalala, 116 F. Supp. 2d 166, 179 (D.D.C. 2000)).
    Although consumer interest alone is not sufficient to require 
mandatory labeling, we have discussed in part II.C that the amount of 
added sugars in a serving of food is a declaration that meets the 
statutory framework in section 403(q)(2) of the FD&C Act and, 
furthermore, it is a material fact because added sugars is a public 
health concern and knowing the amount of added sugars in a serving of 
food will assist consumers in maintaining healthy dietary practices.
    (Comment 163) In our Preliminary Regulatory Impact Analysis (PRIA), 
we extrapolated from the welfare effects estimated in a retrospective 
study on the impact of the Nutrition Labeling and Education Act of 1990 
(Ref. 99) to quantify benefits of the proposed rule. Some comments 
suggested that it was inappropriate for us to rely on a paper written 
by a graduate student, which was not peer-reviewed, as the basis for 
our proposal to require the mandatory declaration of added sugars. 
Another comment argued that we provided no basis to require the 
mandatory declaration of added sugars on the label other than the 
Abaluck paper.
    (Response) We note that we did not rely on the information provided 
in the Abaluck paper as the basis for our proposal to require the 
mandatory declaration of added sugars on the label. The information in 
the Abaluck paper was used to estimate economic benefits

[[Page 33814]]

of our proposal for the PRIA. We are relying on information related to 
overconsumption of added sugars, the reduction of the nutrient density 
of the diet when substantial amounts of added sugars are present, 
evidence showing the consumption of sugar-sweetened beverages is 
associated with increased body weight and adiposity, and evidence 
showing that consumption of health dietary patterns characterized, in 
part, by lower consumption of sugar-sweetened foods and beverages is 
associated with a decreased risk of CVD.
    (Comment 164) One comment noted that the FD&C Act only gives us the 
authority to add nutrients to the Nutrition Facts label to help 
consumers maintain healthy dietary practices, but our definition of 
``healthy'' excludes any consideration of sugars content.
    (Response) The comment is referring to our regulation for implied 
nutrient content claims (Sec.  101.65). Section 101.65(d)(1)(ii)(2) 
provides requirements for the use of the term ``healthy'' or related 
terms on the label or in the labeling of foods. The regulation requires 
that a food must meet requirements for fat, saturated fat, cholesterol, 
and other nutrients, but does not include limitations on the amount of 
total or added sugars that a food may have if it bears an implied 
``healthy'' nutrient content claim. Our authority in section 403(r) of 
the FD&C Act to define a term, by regulation, to characterize the level 
of a nutrient in the label or labeling is distinct from our authority 
in section 403(q) of the FD&C Act to require the declaration of a 
nutrient in nutrition labeling. As previously discussed in part II.B.4, 
we intend to revisit our other regulations for nutrient content claims 
at a later date to determine if changes are necessary.
    (Comment 165) One comment said that sources of sugar contribute the 
same number of calories per gram weight of food, and calories should be 
the principal nutrient of concern of a population striving to achieve 
desired weight and control obesity. The comment suggested that giving 
consumers a false impression that reducing added sugars without 
reducing calories may actually delay finding a real solution to the 
problem.
    (Response) We have increased the prominence of calories on the 
label because of its importance for consumers to consider for the 
purposes of weight management. We are not suggesting that consumers 
should ignore or consider information about the amount of calories in a 
serving of a food to be secondary to the amount of added sugars in a 
serving of food. Instead, we are requiring the declaration of added 
sugars on the label to provide one additional piece of information to 
consumers to assist them in selecting foods that contribute to a 
healthy dietary pattern. Therefore, we do not agree that an added 
sugars declaration is unnecessary because the total amount of calories 
in a serving of a food is already displayed on the label.
    (Comment 166) One comment stated that by mandating declaration of 
both total sugars and added sugars, we are creating an arbitrary 
distinction between two types of sugars which will not lead to any 
nutritional differences for consumers.
    (Response) We do not agree with the comment that the distinction 
between total and added sugars is arbitrary and will not lead to any 
nutritional differences in the foods that consumers select. The 
addition of added sugars to foods provides additional calories which 
can make it difficult for consumers to meet nutrient needs within 
calorie limits and can lead to issues with weight management. Sugars, 
added in excess, do not provide any health benefits. In addition, foods 
high in added sugars tend to be lower in beneficial nutrients. By 
providing a declaration of added sugars on the label, consumers will 
have additional information about a product that can assist them in 
determining how much sugars have been added to a food. Moreover, the 
intake of added sugars from sugar-sweetened foods and beverages needs 
to be reduced as part of a healthy dietary pattern. A healthy dietary 
pattern, when compared to less healthy dietary patterns, such as the 
dietary pattern of the current U.S. general population, is strongly 
associated with a reduced risk of CVD. The intake of foods with 
naturally occurring sugars, such as fresh fruits and vegetables, is 
encouraged as part of a healthy dietary pattern and not recommended to 
be reduced.
(C) Comments on a Lack of a Chemical or Physiological Distinction 
Between Naturally Occurring and Added Sugars
    (Comment 167) In the preamble to the proposed rule (79 FR 11879 at 
11905), we recognized a lack of a chemical or physiological distinction 
between added and naturally occurring sugars. Many comments agreed that 
naturally occurring and added sugars are the same and argued that, 
because there is no chemical or physiological distinction, we should 
not require the mandatory labeling of added sugars. One comment cited a 
paper by Murphy and Johnson (2003) that discusses added sugars in the 
context of the 2000 DGA and suggested that it would be challenging to 
require a declaration of added sugars on the label because they are not 
chemically or physiologically distinct from naturally occurring sugars 
(Ref. 100).
    However, other comments suggested that there is evidence that not 
all sugars are chemically the same. The comments suggested that 
different sugars are metabolized differently in the body. One comment 
stated that naturally occurring sugars have more nutritional value than 
those added to foods. Another comment stated that sugars that are found 
naturally in foods are consumed in combination with all other 
ingredients and nutrients in that food and that the body reacts to 
inherent sugars in such combinations. The comment noted that emerging 
studies suggest that inherent sugars in combination with plant 
nutrients, for example, behave differently in the body than added 
sugars without such accompanying nutrients. These comments indicated 
that it is important for consumers to know how much added sugars are in 
their products because they are inherently different from naturally 
occurring sugars.
    (Response) A physiological or chemical distinction between added 
and naturally occurring sugars is not a prerequisite to mandatory 
declaration under section 403(q)(2)(A) of the FD&C Act. We explained in 
the preamble to the proposed rule that our scientific basis for the 
added sugars declaration, in fact, differed from our rationale to 
support other mandatory nutrients related to the intake of a nutrient 
and risk of chronic disease, a health-related condition, or a 
physiological endpoint (see 79 FR 11879 at 11904). Rather than relying 
on a causal relationship between added sugars to obesity or heart 
disease, we considered, in the preamble to the proposed rule (79 FR 
11879 at 11902 through 11908) and the preamble to the supplemental 
proposed rule (80 FR 44303 at 44307 through 44309), the contribution of 
added sugars as part of healthy dietary patterns and the impact to 
public health from such patterns for the purposes of the general 
population. Thus, the comments did not focus on added sugars as a 
component of sugar-sweetened foods and beverages that have been found 
to have health implications as part of a dietary pattern, or as a 
nutrient that provides a source of empty calories consumed by the U.S. 
population in excess, which make it difficult for consumers to meet 
nutrient needs within calorie limits. Providing consumers with 
information about the amount of added sugars in a serving of a product 
will assist consumers in

[[Page 33815]]

planning a healthy diet. We have concluded that the consumption of 
added sugars is related to health for a number of reasons, and 
consumers will benefit from information about the added sugars content 
of a food on the label.
    (Comment 168) Many comments did not support an added sugars 
declaration because added sugars are not chemically or physiologically 
distinct from naturally occurring sugars, and a separate declaration of 
added sugars implies that there is a distinction. The comments 
suggested that an added sugars declaration would arguably be false and 
misleading because it would convey to the reasonable consumer that 
added sugars are chemically different than naturally occurring sugars 
and/or that added sugars has different health effects than naturally 
occurring sugars. One comment further asserted that implying 
superiority of one source of a nutrient versus another, when they are 
not materially different and are chemically, nutritionally, and 
functionally equivalent, is inherently misleading. Another comment 
suggested that a separate declaration for added sugars could cause 
consumers to believe that naturally occurring sugars are more 
beneficial.
    (Response) As we explained in our response to comment 167, a 
physiological or chemical distinction between added and naturally 
occurring sugars is not a prerequisite to mandatory declaration under 
section 403(q)(2)(A) of the FD&C Act. In fact, some nutrients currently 
declared on separate lines in the Nutrition Facts label may be related 
to the same chronic disease risk or physiological endpoint (e.g., 
saturated fat and trans fat and risk of CVD). Therefore, we disagree 
that a separate declaration necessarily implies a chemical or 
physiological distinction. Furthermore, the comments may not have 
considered the basis for why the declaration of added sugars is 
necessary to assist consumers in maintaining healthy dietary practices. 
A dietary pattern characterized, in part, by larger amounts of sugar-
sweetened foods and beverages is associated with greater risk of CVD 
than a healthy dietary pattern that includes less sugar-sweetened foods 
and beverages. Moreover, added sugars provide excess calories in the 
U.S. diet (see our responses to comment 29 and comment 177), and these 
additional empty calories make it difficult for consumers to meet 
nutrient needs within their calorie limits and can lead to issues with 
weight management. Therefore, the intake of added sugars in the current 
U.S. dietary pattern is a public health concern. The declaration of 
added sugars provides factual, accurate information about the amount of 
added sugars in a serving of food, and we are requiring the declaration 
consistent with our authority in section 403(q) of the FD&C Act. The 
added sugars declaration is not inherently misleading as the comments 
suggest, as is addressed further in part II.C.3.
    (Comment 169) Some comments suggested that we are being 
inconsistent in our treatment of the evidence for nutrients because we 
are considering whether certain dietary fibers have a beneficial 
physiological effect, but we are not considering whether added sugars 
have a separate and distinct physiological effect in our determination 
that added sugars should be declared on the label.
    (Response) In the case of dietary fiber, we are requiring that a 
dietary fiber have a beneficial physiological effect to human health 
for the purposes of declaration because there are dietary fibers 
currently present in foods that are being declared on the label 
indicating to consumers that they have the same beneficial 
physiological effects to human health as other fibers, when in fact, 
they do not. We previously have discussed in this section that added 
sugars, independent of sugars naturally present in foods, can have a 
negative impact on health. A decision to not require a separate 
declaration of added sugars on the label would not allow consumers to 
determine the additional sugars which have been added above and beyond 
what is naturally present in a food which are contributing extra 
calories to their diet and could also contribute to a dietary pattern 
that is associated with disease risk.
    (Comment 170) One comment stated that the Nutrition Facts label 
must remain a source of information about nutrients that are chemically 
distinct based on analysis. The comment asserted that we have not 
provided a reasonable basis for defining added sugars based on source 
rather than chemical composition.
    (Response) We disagree with the comment that a chemical distinction 
must be a requirement for declaration of a nutrient on the label. 
Section 403(q)(2)(A) of the FD&C Act provides discretion to the 
Secretary, and by delegation, to FDA, to determine whether providing 
nutrition information regarding a nutrient will assist consumers in 
maintaining healthy dietary practices and when to require information 
relating to such additional nutrient be included in the label or 
labeling of the food. This section does not include limitations on 
chemical distinctions.
(D) Comments Questioning our Reliance on Conclusions and Information 
From the 2010 DGA and the 2015 DGAC
    (Comment 171) Many comments questioned our reliance on conclusions 
and information in the 2010 DGAC Report and 2010 DGA. One comment 
asserted that it is a gross expansion of the law governing the DGA to 
use selective dietary guidance from a single edition to promulgate food 
labeling regulations. Some comments suggested that the evidence cited 
by the 2010 DGAC and 2010 DGA was not strong enough to support a 
declaration of added sugars. One comment stated that neither the 2010 
DGA nor the 2010 DGAC Report provided a preponderance of scientific 
information or conclusive, documented, or strong scientific evidence to 
support these suppositions. The comments asserted that we did not 
address the strength of the evidence that the 2010 DGAC reviewed as the 
basis for their recommendations. One comment also noted that the 2010 
DGAC addressed few or limited questions related to impact of added 
sugars on health due to lack of available evidence. The comment stated 
that what evidence there was at the time that the 2015 DGAC Report was 
published was not conclusive.
    (Response) We note that we did not specifically rely on conclusions 
or recommendations made by the 2010 DGAC Report or in the 2010 DGA. We 
considered the information and underlying data presented in the 2010 
DGAC Report and 2010 DGA that was used as the basis for their 
conclusions and recommendations and determined that, for the purposes 
of nutrition labeling, the evidence in the 2010 DGAC and 2010 DGA, 
along with other data and information we considered, supports the 
declaration of added sugars on the Nutrition and Supplement Facts 
labels (79 FR 11879 at 11902 through 11908). The DGAs have recommended 
that Americans reduce their intake of what we are defining to be added 
sugars since the early 1980s, so the recommendation to limit 
consumption of added sugars is not new. Since publication of the 2010 
DGA and 2010 DGAC Report, new evidence has become available on added 
sugars and dietary patterns that we have considered. We have determined 
that this evidence further supports a declaration of added sugars on 
the label.
    The comment suggesting that the evidence on added sugars is not 
conclusive, documented, or strong is referring to the factors that we 
considered for mandatory declaration of nutrients on the label for 
which there is

[[Page 33816]]

an independent relationship between the nutrient and chronic risk of 
disease. Our determination that added sugars should be declared on the 
label for the general population (see part II.H.3) was not based on the 
factors used to determine mandatory or voluntary declaration for these 
other non-statutory nutrients that have an independent relationship 
related to a chronic disease, a health-related condition, or health-
related physiological endpoint. Instead, our review is based on the 
need for the declaration of nutrient information on the labels to 
assist consumers in limiting their consumption of calories from added 
sugars found in sugar-sweetened foods and beverages and consuming a 
healthy dietary pattern that is associated with a reduce risk of CVD.
    (Comment 172) Many comments took issue with the 2010 DGA's use of 
food pattern modeling to support the recommendation to reduce the 
intake of calories from added sugars. One comment stated that the 
amount of solid fats and added sugars in the USDA food patterns is the 
outcome of using the remaining calories in that pattern rather than the 
evidence-based research. Other comments said that the USDA Food 
Patterns lack the scientific underpinning on which to base official 
recommendations.
    Some comments said that the same issues that prevent FDA from using 
food consumption data, menu modeling, and dietary survey data to 
determine DRVs are also applicable when considering the mandatory 
declaration of non-statutory nutrients. One comment noted that we have 
concluded that menu modeling is not related to disease risk and is not 
suitable for determining recommended intakes.
    Some comments also noted that the 2010 DGA clearly states that the 
USDA Food Patterns are only one example of suggested eating patterns 
and that the USDA Food Patterns have not been specifically tested for 
health benefits. Another comment said that the extremely low suggested 
intakes of 6 to 12 teaspoons of added sugars in the USDA Food Patterns 
have no historical basis and lack context.
    (Response) We disagree with comments that questioned the use of 
evidence based on food pattern modeling to support the added sugars 
declaration so that consumers can use the information to reduce 
calories from solid fats and added sugars. While the food pattern 
modeling used to create the USDA Food Patterns was used to compare 
current consumption data with recommended intakes from the USDA Food 
Patterns, the 2010 DGA also considered information about the impact of 
added sugars on nutrient density and on their implications for weight 
management (Ref. 77). Furthermore, the fact that the USDA food patterns 
were not studied for health effects until recently, does not lessen our 
reliance on the information as part of our basis for a mandatory 
declaration of added sugars. Since publication of the proposed rule, 
the USDA Food Patterns have been studied for their association with 
disease risk (Ref. 101). We also have evidence that dietary patterns 
characterized, in part, by lower intakes of sugar-sweetened foods and 
beverages are associated with a reduced risk of CVD that further 
supports a mandatory declaration of added sugars on the label for the 
general U.S. population. It is not clear what is meant by the comment 
which stated that the extremely low suggested intakes of 6 to 12 
teaspoons of added sugars in the USDA Food Patterns have no historical 
basis and lack context. To the extent the comment disagrees with the 
suggested intakes of 6-12 teaspoons of added sugars, we note that there 
is evidence showing that Americans are consuming too many calories from 
added sugars as well as evidence that it is difficult to meet nutrient 
needs within calorie limits when excessive amounts of added sugars are 
consumed.
    (Comment 173) In the preamble to the proposed rule (79 FR 11879 at 
11890), we discussed the factors that we considered for mandatory and 
voluntary declaration of non-statutory nutrients. We considered the 
scientific evidence from other U.S. consensus reports or DGA policy 
reports (79 FR 11879 at 11890). We also listed the DGA policy reports 
among other reports that we would consider to be U.S. consensus 
reports.
    One comment questioned whether the DGA is a consensus report 
because it is a report that is issued jointly every 5 years by the USDA 
and HHS. The comment said that the DGAC Report is an advisory report, 
and the Secretaries of USDA and HHS have sole responsibility and 
discretion as to the final content of the DGA. The comment also noted 
that the DGAC Report does not undergo independent external review.
    (Response) In the preamble to the proposed rule (79 FR 11879 at 
11885 through 11887), we listed new dietary recommendations, consensus 
reports, and national survey data as sources of information that we 
considered when developing the proposed amendments to the regulations. 
Furthermore, our review of the scientific evidence in the 2010 DGA 
relates to the intake of added sugars and the role of such information 
in assisting consumers to maintain healthy dietary practices and the 
need for consumers to be able to readily observe and comprehend the 
information and to understand its relative significance in the context 
of a total daily diet (79 FR 11879 at 11891). Therefore, whether the 
2015 DGAC Report is or is not a consensus report is not relevant for 
the added sugars declaration. Furthermore, we considered the underlying 
evidence related to added sugars that supported the recommendation to 
limit consumption of calories from solid fats and added sugars and did 
propose to require a declaration of the amount of added sugars in a 
serving of a product on the label because of the 2010 DGA 
recommendation related to calories from solid fats and added sugars. We 
considered the evidence in the 2010 DGAC Report and 2010 DGA, along 
with other data and information in the proposed rule to support a 
declaration of added sugars on the Nutrition Facts and Supplement Facts 
labels (79 FR 11879 at 11902 through 11908).
    (Comment 174) One comment said that the proposed rule incorrectly 
assumes that reduced consumption of added sugars will reduce the 
problem of obesity, but noted that we acknowledged in the proposed rule 
that solid fats and added sugars do not contribute to weight gain any 
more than another source of calories.
    (Response) We have not changed our position with regard to the 
effect of calories from solid fats and added sugars on weight gain. 
However, as noted in the 2010 and 2015-2020 DGAs, consumption of excess 
solid fats and added sugars make it difficult to meet nutrient needs 
within calorie limits (Refs. 28, 30). Because sugars added to foods 
during processing increase the calorie content of the food without 
increasing other nutrients in the food, added sugars as an ingredient 
could conceivably lead to weight gain if a consumer striving to meet 
their nutrient needs does so by consuming foods containing too many 
added sugars. Further, we stated in the proposed rule that we know that 
foods containing solid fats and added sugars make up a significant 
percentage of the American diet and are a source of excess calories (79 
FR 11879 at 11904).
    (Comment 175) Some comments said that we are not being consistent 
with the dietary recommendations we use for requiring nutrients on the 
label because the 2010 DGA also recommended replacing saturated fats 
with mono and polyunsaturated fats, yet the labeling of mono and 
polyunsaturated fats is voluntary on the label.

[[Page 33817]]

    (Response) We do not rely on the 2010 DGA recommendation to reduce 
calories from solid fats and added sugars. Instead, we examined the 
underlying evidence and concluded that added sugars should be declared 
on the label. Furthermore, the 2010 DGA recommendations related to mono 
and polyunsaturated fats are about replacing saturated fats with the 
mono and polyunsaturated fats, because reduction of saturated fats is 
associated with reductions in blood LDL cholesterol and, therefore, the 
risk of CVD. The 2015 DGA corroborates this finding. Saturated fats are 
already declared on the label, so consumers have the information they 
need to reduce their intake of saturated fat. In addition, current 
evidence does not show that there is an inherent benefit to consumption 
of mono and polyunsaturated fats by themselves. The benefit comes from 
reduction of saturated fats in the diets by way of replacement. 
Furthermore, the scientific evidence supports consuming a healthy 
dietary pattern that is low in saturated fats. A healthy eating pattern 
limits saturated fats, and the scientific evidence supports consumption 
of added sugars to to less than 10 percent of calories per day from 
saturated fats (Ref. 19). Therefore, Americans currently have the 
information on the label which will allow them to limit saturated fats 
in their diet.
d. Nutrient Density
    (Comment 176) Many comments suggested that including a declaration 
of the amount of added sugars in a serving of a product can help 
consumers select foods that contribute to a more nutrient-dense diet. 
The comments noted that the 2010 DGA suggested that reduced intake of 
added sugars allows for increased intake of nutrient-dense foods which 
may help individuals to control their total caloric intake and better 
manage their weight. The comments also said that sugars intrinsic to 
foods are accompanied by nutrients, whereas added sugars are not. The 
comments referred to the discussion in the proposed rule related to 
intake of added sugars and its association with a lower intake of 
essential nutrients (79 FR 11879 at 11903) and suggested that most 
major sources of added sugars are high in calories and fats, but lack 
meaningful amounts of dietary fiber, essential vitamins or minerals. 
The comments said that, when added sugars intake is 10 to 15 percent of 
calories, the median intakes of nine nutrients (vitamin A, vitamin E, 
vitamin C, folate, magnesium, potassium, vitamin K, fiber, and total 
choline) are significantly lower than the median intakes of those 
nutrients for someone consuming 0 to 5 percent of their calories from 
added sugars (Ref. 102). Another comment noted that IOM recommends that 
the intake of added sugars not exceed 25 percent of energy to ensure 
adequate intake of essential micronutrients that are typically not 
present in foods high in added sugars (Ref. 75). One comment said that 
consumers who eat less added sugars consume fewer calories and more 
foods rich in essential nutrients.
    In contrast, many comments said that a declaration of added sugars 
on the label will not assist consumers in constructing a more nutrient 
dense diet. The comments said that there is a lack of science to 
support the contention that added sugars intake displaces nutrients or 
causes a decrease in the intake of nutrient-rich foods in the diet of 
the general population, at current intake levels. One comment cited the 
2010 DGA conclusion that added sugars replace nutrient-dense foods and 
beverages and make it difficult for people to achieve the recommended 
nutrient intake while controlling their calorie intake, but noted that 
no evidence-based review was conducted on this topic, and no 
conclusive, documented, or strong evidence was cited to support that 
added sugars intake causes nutrient displacement, or decreased 
consumption of nutrient-rich foods. Another comment noted that although 
a recent analysis of NHANES data (Ref. 102) reaffirmed the conclusion 
of the 2002 IOM report (Ref. 75), individuals with intakes of greater 
than 25 percent of calories from added sugars appear to be at greater 
risk for nutrient inadequacy based on comparison with the DRIs. The 
comment said that the authors of the study also clarify the real-world 
impact from these higher intake amounts, and stated ``However, high 
levels of added sugars intake occur among only a small proportion of 
the population and cannot explain the existing problem of poor nutrient 
intake in the U.S. population as a whole.''
    (Response) We agree that a declaration of the amount of added 
sugars can assist consumers in selecting foods that contribute to a 
more nutrient dense diet. The IOM did not establish a UL for sugars or 
added sugars, however they did conclude that increased consumption of 
added sugars can result in decreased intakes of certain micronutrients 
based on their review of the evidence available at the time that the 
IOM Dietary Reference Intakes for energy, carbohydrate, fiber, fat, 
fatty acids, cholesterol, protein, and amino acids were published (Ref. 
103). As noted in comments, additional evidence has become available 
since the IOM DRI reports were published, which supports their 
conclusion (Ref. 102). Therefore, although the 2010 DGAC did not 
conduct an evidence-based review on this topic, there is documented 
evidence that increased consumption of added sugars can make it 
difficult for individuals to meet nutrient needs.
    We disagree with the suggestion added sugars consumption is not 
contributing to poor nutrient intake in the U.S. population as a whole 
and thus should not be required on the label because only a small 
proportion of the population is consuming large amounts of added 
sugars. The 2015 DGAC found that the general U.S. population is 
consuming 13.4 percent of its calories from added sugars. As the 
comments noted, Marriott et al. found that median nutrient intakes were 
lower when added sugars intake was 10 to 15 percent of calories (Ref. 
102). Therefore, even at intake levels below 25 percent of calories, 
nutrient intake can be negatively impacted by increased consumption of 
added sugars. Furthermore, based on NHANES data from 2007 to 2010, 
males aged 9 to 50 are consuming more than 300 calories per day from 
added sugars, and females aged 9 to 30 are consuming more than 250 
calories per day from added sugars (Ref. 104). Males between the ages 
of 14 to 18 years old consumed almost 400 calories per day from added 
sugars (Ref. 104). Although these subpopulations may not make up a 
majority of the population, these groups include children and young 
adults who are growing and need nutrients for proper growth. Therefore, 
the impact of added sugars consumption on nutrient density in these 
specific populations is an important consideration for the declaration 
of added sugars.
    As for the comment which said that consumers who eat less added 
sugars consume fewer calories and more foods rich in essential 
nutrients, the comment did not provide evidence to support this 
statement. Therefore, we are unable to determine if this information 
adds to other evidence we have, which suggests that added sugars can 
decrease the nutrient density of the diet.
    (Comment 177) Many comments suggested that the added sugars 
declaration does not assist consumers in constructing a nutrient dense 
diet because there are nutrient dense foods which contain added sugars, 
and the declaration may obscure the fact that some foods with added 
sugars may actually be good sources of beneficial nutrients. One 
comment argued that the added sugars declaration does not meet

[[Page 33818]]

the proposed rule's stated goal to convey information necessary to meet 
recommendations to construct diets containing nutrient-dense foods 
because the declaration does not provide consumers with any means to 
differentiate between foods that will contribute phytonutrients to 
their diet from foods with empty calories. The comments provided 
examples of nutrient-dense foods, such as yogurt, cranberries, tart 
cherries, and cereal, which contain added sugars.
    Some comments from the cranberry industry asked that we make an 
exception to added sugars labeling for cranberries, which require 
sweetening for palatability. The comments noted that cranberries are a 
nutrient-dense fruit with many known health benefits. Unlike other 
fruits, cranberries have little natural sugar and, therefore, have a 
uniquely tart taste. The comments expressed concern that cranberry 
products would be considered ``unhealthy'' based solely on their added 
sugars content. The comments said that the evidence shows that 
cranberries are rich in polyphenols, specifically flavonoids, and have 
a positive impact on urinary health. The comments also cited evidence 
that the addition of sugar to cranberry products does not decrease the 
polyphenol content. Furthermore, according to the comments, the calorie 
content of each serving of dried cranberries is similar to that of 
other dried fruits, and cranberry juice cocktail (27 percent juice) is 
the standard equivalent to other 100 percent juices with similar total 
calorie and sugar levels. The comments also noted that they contribute 
to recommended fruit intake amounts in the DGA.
    The comments said that requiring the declaration of added sugars on 
cranberry products may mislead consumers to believe that nutrient-dense 
foods, such as cranberries, with their proven health benefits, are 
somehow less nutritious than foods with the same amount of naturally 
occurring sugar, or even those with more total sugars. The comments 
expressed concern that a focus on added sugars may have the unintended 
consequence of driving consumers away from nutrient dense products with 
moderate amounts of sugar.
    Many comments said that a mandatory declaration of added sugars 
could be damaging for the cranberry industry or for the tart cherry 
industry. One comment noted that the drying operation used by the tart 
cherry industry reduces the moisture content while simultaneously 
increasing the percentage of sugar. The use of sugar as a natural 
preservative combats the threat of mold and yeast contamination.
    Several comments noted that USDA grants an exemption, which is 
similar to that which the comments requested for the labeling of added 
sugars on cranberry products, for cranberry products offered for sale 
in our nation's schools. One comment noted that the IOM, in its report 
titled ``Nutrition Standards for Foods in Schools: Leading the Way 
Toward Healthier Youth,'' made recommendations for nutrition standards 
for competitive foods offered in schools, and has made an exception for 
yogurt from its recommended general sugar standard of 35 percent or 
less of calories from total sugars.
    One comment suggested that the added sugars declaration will not 
help consumers select foods that contribute to a nutrient dense diet 
because information on total calories and nutrient content (e.g. fiber 
plus vitamins and minerals) already allows for the identification of 
nutrient-dense foods.
    (Response) Consumers now have access to nutrient information 
provided on the nutrition label that they can use to plan a nutrient 
dense diet. We have required those nutrients that are of the greatest 
public health significance be declared in nutrition labeling (58 FR 
2079, 2107). An added sugars declaration is an important piece of 
information because consumers need to ensure their diet does not 
contain excess calories from added sugars which can make it difficult 
for consumers to meet nutrient needs within calorie limits and can lead 
to issues with weight management.
    As mentioned in the 2010 DGA, many foods that contain added sugars 
often supply calories, but few or no essential nutrients, and no 
dietary fiber (Ref. 77). However, there are some foods, such as dried 
fruits, yogurt, and cereal, that contain significant amounts of 
beneficial nutrients as well as added sugars. The declaration of added 
sugars will enable consumers to understand the relative significance of 
the added sugars content in a serving of dried fruit, yogurt, cereal, 
and other foods that may contribute beneficial nutrients to the diet 
and determine how to incorporate those foods into a healthy dietary 
pattern and meet their nutrient needs within calorie limits. As 
discussed in the 2015 DGAC report, there is room for Americans to 
include limited amounts of added sugars in their eating patterns, 
including to improve the palatability of some nutrient-dense foods, 
such as fruits and vegetables that are naturally tart (e.g. cranberries 
and rhubarb). Healthy eating patterns can also accommodate other 
nutrient dense foods with small amounts of added sugars, such as whole-
grain breakfast cereals or fat-free yogurt, as long as the calories 
from added sugars do not exceed 10 percent per day, total carbohydrate 
intake remains within the AMDR, and total calorie intake remains within 
limits (Ref. 19).
    The added sugars declaration is just one piece of information that 
consumers can use to help them construct a healthful dietary pattern 
that may include some added sugars. We acknowledge that some consumers 
may focus in on the amount of added sugars in a product and may judge 
it to be a less nutritious product even though it contains beneficial 
nutrients. The added sugars declaration on the label is new information 
that consumers will not have seen before. In collaboration with Federal 
and other partners, we plan to engage in educational and outreach 
activities for consumers and health professionals about the use of 
information on the Nutrition Facts and Supplement Facts labels. Part of 
that education will include information about added sugars. A key 
message related to added sugars will be that consumers should consider 
all of the information on the label when constructing a healthful 
dietary pattern and not focus in on one specific nutrient, such as 
added sugars. The message related to consumption of added sugars is not 
to eliminate added sugars or foods high in added sugars from the diet; 
instead, the message is to limit overall consumption of added sugars in 
the diet to less than 10 percent of total calorie intake. Therefore, if 
consumers choose to eat foods with sugars added to them for 
palatability, such as cranberries, they may do so in moderation, and 
cut back on added sugars elsewhere in the diet.
    We decline to exempt certain nutrient dense foods containing added 
sugars from the requirement to declare the amount of added sugars in a 
serving of a product on the label. If such products are exempt from 
added sugars labeling, consumers may assume incorrectly that they 
contain no added sugars. Providing added sugars information on the 
label for all foods allows consumers to compare foods and make informed 
choices. It allows them to also make trade-offs in their diet to 
achieve an overall healthy dietary pattern that contains less than 10 
percent of total calories from added sugars. As part of our education 
and outreach activities, we plan to educate consumers that the amount 
of added sugars in a serving of a product should be considered along 
with other information on the label

[[Page 33819]]

when constructing a healthy dietary pattern.
    While other government programs and consensus bodies have excluded 
cranberries and yogurt from their programs or recommended limits on 
sugars, the purpose of those programs and reports are different than 
the purpose of the information on the Nutrition and Supplement Facts 
labels. The purpose of the Nutrition and Supplement Facts labels is to 
provide nutrition information to consumers to allow them to make 
informed choices about the foods that they eat. Therefore, although 
some nutrient-dense foods containing added sugars have been excluded 
from government programs or recommendations, the same approach does not 
apply to the Nutrition and Supplement Facts labels.
    With regard to the comment that said that the drying operation used 
by the tart cherry industry reduces the moisture content while 
simultaneously increasing the percentage of sugar, we would not 
consider sugars that naturally exist in the tart cherries prior to the 
drying process to be added sugars. Only sugars that have been added to 
the fruit would be required to be declared as added sugars on the 
label.
e. Reformulation
    (Comment 178) While some comments said that an added sugars 
declaration will be an incentive for food manufacturers to reformulate, 
other comments said that reformulation of products to reduce the added 
sugars content may not result in products that are healthier. Some 
comments said that an added sugars declaration may lead to 
reformulation or changes in consumer behavior that would not improve 
overall nutritional profile or nutrient density of the diet and may 
result in overconsumption of other macronutrient sources (e.g. fat) 
without a reduction of calories. The comments said that added sugars 
could be replaced with bulking agents, which provide calories and 
carbohydrate. Another comment said that reformulation of products 
containing added sugars could result in an increased use of artificial 
sweeteners (i.e. low calorie sweeteners), which could be bad for 
health. Other comments noted that consumers have many food and beverage 
choices that are reduced in total and added sugars.
    (Response) Absent data, we do not know whether manufacturers will 
reformulate their products if we require the declaration of added 
sugars on the label. Likewise, absent data, we do not know whether 
consumers will select reformulated products that may be higher in fat, 
calories, or low-calorie sweeteners. In our efforts to educate 
consumers and health professionals about the use of the label, we 
intend to encourage consumers to consider all of the information on the 
label when making decisions about what foods to eat and how much rather 
than focusing on one specific nutrient, such as added sugars. If 
consumers take all label information into consideration when making 
dietary choices, they will recognize when a product is low in added 
sugars, but still contains a significant amount of calories and 
carbohydrate or fat per serving. They can also see if low-calorie 
sweeteners have been added to a product by looking at the ingredient 
list.
    With respect to the comment which suggested that low-calorie 
sweeteners may be harmful to health, as noted in our Overview of Food 
Ingredients, Additives & Colors, there is no convincing evidence of a 
cause and effect relationship between these sweeteners and negative 
health effects in humans. We have monitored consumer complaints of 
possible adverse reactions for more than 15 years (Ref. 105).
    (Comment 179) One comment asked what studies we used to suggest 
that declaring added sugars on the label will result in firms reducing 
the amount of added sugars in products and result in an overall 
reduction of sugar consumption.
    (Response) In the preamble to the proposed rule (79 FR 11879 at 
11904), we said that the mandatory declaration of added sugars may 
prompt product reformulation of foods high in added sugars like what 
was seen when trans fat labeling was mandated. We do not know whether 
or how manufacturers will reformulate their foods as the result of a 
mandatory added sugars declaration.
f. Calories From Solid Fats and Added Sugars
    (Comment 180) The 2010 DGA provided a key recommendation that 
Americans should reduce their intake of calories from solid fats and 
added sugars (SoFAS). In the preamble to the proposed rule (79 FR 11879 
at 11904), we concluded that the disclosure of saturated fat and trans 
fat on the label not only provides information to consumers which can 
be used to reduce their intake of these nutrients, and thus reduce 
their risk of CVD, but the declaration of saturated and trans fats on 
the label could also provide a marker for foods that contain solid fats 
that are abundant in the diets of Americans and contribute 
significantly to excess calorie intake. We stated that similar 
information is not available on the label for calories from added 
sugars (id.).
    Several comments disagreed that the declared amounts of saturated 
and trans fats can be used as markers for solid fats in the diet. The 
comments stated that the calculation of calories from SoFAS is not 
feasible based on the information that is proposed for the label, and 
the nature of the calculation that consumers would need to perform 
would not be consistent with our objectives to make the label more 
usable and understandable for consumers. The comments noted that it is 
not feasible to determine the amount of solid fats from the saturated 
and trans fat declarations alone because the label does not provide the 
quantity of solid fat that USDA used in its menu modeling analysis. The 
comments further stated that, while saturated fat and trans fat may be 
components of solid fats, those values alone cannot be used to 
determine the solid fat content of a food because it is not known what 
portion of these declarations would be identified in the menu modeling 
program used by USDA.
    One comment said that the declaration of saturated and trans fat 
declarations are for the purposes of lowering risk of CVD and not for 
estimating the SoFAS content of a food. The identification of SoFAS is 
for the purposes of developing the USDA Food Patterns and is not a 
suitable approach for mandating an added sugars declaration.
    Another comment suggested that the sugars declaration on the label 
can serve as a marker for added sugars in the same way that saturated 
fats serves as a marker for solid fats. The comment also suggested that 
saturated fats in certain foods are not solid fats (such as in nuts) in 
the same way that sugars in certain foods are not added sugars (such as 
fruit juice and milk).
    (Response) We used the term ``marker'' in the preamble to the 
proposed rule to mean that the amount of saturated and trans fats on 
the label would give consumers a very good idea or a reasonable 
estimate of the quantity of solid fats in a serving of a food. Although 
many fat containing foods have a mixture of fats, such as nuts and oils 
that may contain some solid fats and some unsaturated fats, the 
saturated fat and trans fat declarations would account for these 
differences. In addition, even though one would need more information 
on how saturated fats were quantified for the development of the USDA 
Food Patterns to determine the exact amount of calories from solid 
fats, such specificity would not be needed to obtain a reasonable 
estimate of solid fats using the declared value of

[[Page 33820]]

saturated fat and trans fat combined. Furthermore, unlike solid fats, 
there is no information currently on the label that could give 
consumers an estimate of the amount of added sugars in a serving of 
food when the food contains both naturally occurring and added sugars. 
In such a case, the amount of total carbohydrate or total sugars in a 
serving of a food cannot be used as a reasonable estimate of the amount 
of added sugars in a serving of the food.
    We disagree with the comment suggesting that the total sugars 
declaration can serve as a marker of added sugars in the same way that 
the saturated fat and trans fat declaration can serve as a marker for 
solid fat. When both naturally occurring and added sugars are present 
in a food, the consumer has no way of knowing from the total sugars 
declaration what portion of that total sugars declaration represents 
the amount of added sugars in a serving of the food.
    Since the publication of the proposed rule, the 2015 DGAC Report 
became available. In that report, the solid fats and added sugars were 
divided within the ``empty calories'' category with 45 percent of the 
empty calorie allowance allocated to added sugars and 55 percent of the 
empty calorie allowance allocated to solid fats. Furthermore, the 
scientific evidence in the 2015 DGAC Report for limiting calories from 
added sugars is separate from that for limiting saturated fats, which 
are a key contributor of solid fats to the diet. There is adequate 
information available to consumers on the label to assist them in 
meeting the key recommendation to limit calories from saturated fats to 
less than 10 percent of total calories; however, there is no such 
information on the label to help consumers limit their consumption of 
added sugars to no more than 10 percent of total calories. Whether 
there is adequate information on the label to assist consumers in 
limiting solid fats is not related to an added sugars declaration.
    (Comment 181) The comments were divided on whether calories from 
added sugars should be declared on the label. One comment said that, if 
added sugars are declared on the label, we should require the 
declaration of calories from added sugars. Another comment stated that 
concerns about the scientific evidence on the health effects of added 
sugars and the usefulness of a declaration to improve food choices 
apply to whether the declaration of added sugars is in gram units or 
declared as calories from added sugars. Other comments suggested that a 
declaration of calories from added sugars is unnecessary and not 
beneficial. The comments noted that the total number of calories in a 
serving of food is prominently displayed in the proposed format. The 
comments said that a declaration of calories from added sugars could 
cause consumer confusion, particularly for consumers who are unable to 
readily understand the distinction between a gram value and calories 
from added sugars. The comments noted that consumers are already 
familiar with the gram unit from the total sugars declaration. The 
comments said there is no evidence from consumer research that a 
declaration of calories from added sugars in lieu of grams would lead 
consumers to greater reductions in intake of added sugars.
    (Response) Evidence shows that heathy dietary patterns associated 
with a decreased risk of chronic disease are lower in sugar-sweetened 
foods and beverages. Consumption of too much added sugars can impact 
the nutrient density of the diet, and consumption of sugar-sweetened 
beverages are associated with increased adiposity in children. Thus, 
the added sugars declaration is information that is necessary for 
consumers to construct a healthy dietary pattern lower in added sugars 
and that is less than 10 percent of calories from added sugars. The 
information on the label includes the gram amount of added sugars in a 
serving of a food product and the percent DV declaration for added 
sugars. There is no need for consumers to be able to determine the 
amount of calories from added sugars in a serving of a food because we 
are establishing a DV that is based on 10 percent of total calories (50 
grams in children and adults 4 years of age and older and 25 grams for 
foods purported to be for children 1 through 3 years of age). Consumers 
can use the percent DV declaration to determine what percentage of 
total calories a serving of a food contributes. They can also use the 
gram declaration of added sugars to construct a diet that is low in 
added sugars by comparing the amount of added sugars between products 
and by using trade-offs in the diet if they choose to include certain 
foods which have a large amount of added sugars.
g. Consumer Research and Consumer Use of Added Sugars Declaration
    (Comment 182) One comment said that research does not substantiate 
a causal effect between including added sugars information on the 
Nutrition Facts label and decreased added sugars intake. The comment 
cited a study in which data from the 1994-96 Continuing Survey of Food 
Intakes by Individuals (CSFII) was used to model total consumption of 
added sugars and the Diet and Health Knowledge Survey conducted by the 
USDA was used to determine usage of labeling information on total 
sugars (Ref. 106).
    (Response) Although the results of the study showed that regular 
use of sugar information on nutrition labels is associated with a 
significantly lower density of added sugar in the diet, the results of 
this study cannot be used to determine whether there is a causal effect 
between including added sugars information on the Nutrition Facts label 
and decreased added sugars intake. The study did not assess use of 
labeling information on added sugars, but rather use of information on 
total sugars.
    (Comment 183) One comment noted that the use of the ``no added 
sugars'' or ``without added sugars'' nutrient content claim focuses on 
ingredients used in a product (Sec.  101.60(c)). The comment said that 
manufacturers must put a disclaimer on the label of their product if 
the food is not low or reduced in calories so that consumers are not 
misled about the calories associated with such products. The comment 
suggested that consumers could potentially be misled because when the 
amount of added sugars in a serving of a product is declared on the 
label, manufacturers who are currently using a ``no added sugars'' or 
``without added sugars'' claim would be less likely to use the claim 
because the amount of added sugars is stated on the label, and thus, a 
disclaimer with regard to the calorie content of a product would not be 
declared.
    (Response) We do not have data or information about whether 
manufacturers may elect to use a voluntary nutrient content claim once 
they are required to declare the amount of added sugars in a serving of 
their product. Consequently, we also cannot determine whether consumers 
might be misled, so we decline to revise the rule in response to this 
comment.
    (Comment 184) Several comments addressed additional consumer 
research on Nutrition Facts labels that include added sugars 
declarations. One comment included two reports that described methods 
and results of two studies, including one controlled experiment and one 
cross-sectional survey study, both on cranberry and other fruit 
products. Both studies included, among other formats of the Nutrition 
Facts labels, Nutrition Facts labels with declarations of the gram 
amount of added sugars in a serving of the product and the percent 
Daily Value for added sugars displayed below a ``Total Sugars'' 
declaration. Regarding

[[Page 33821]]

the experiment on cranberry and other fruit products, the comment 
described an online study conducted in a sample of 1,448 adults age 18 
or older in the United States At the start of the study, participants 
were shown a set of five statements, including two statements that 
referred to added sugars: ``Americans should reduce consumption of 
sodium, saturated fat, refined grains and added sugars;'' and ``Too 
much added sugar in a person's diet can be bad for them and their total 
added sugar intake should not exceed 10 percent of their total calorie 
intake.''
    The comment described selected results including, but not limited 
to, findings related to study participants who viewed a single 
Nutrition Facts label, in FDA's proposed format, either for cranberry 
juice cocktail or 100 percent grape juice. The cranberry juice cocktail 
label showed 110 calories, 28 grams of total sugars, and 25 grams (50 
percent DV) of added sugars. The 100 percent grape juice label showed 
140 calories, 36 grams of total sugars, and 0 grams (0 percent DV) of 
added sugars. The comment noted that when both groups of participants 
were asked to describe ``the amount of sugar'' that the product 
contains on a scale of 1 to 10, where 10 equaled ``extremely high,'' 
the average rating of the sugar content for the cranberry juice 
cocktail was statistically significantly higher than the average rating 
of the sugar content for the grape juice. The comment also described 
findings from a group of participants who viewed a single Nutrition 
Facts label, in FDA's proposed format, for dried cranberries, and 
another group of participants who viewed a single nutrition label, in 
FDA's proposed format, for raisins. The dried cranberries label 
showed130 calories, 3 grams (12 percent DV) of dietary fiber, 29 grams 
of total sugars, 26 grams (52 percent DV) of added sugars; 0 percent DV 
of vitamin D, calcium, and iron; and 1 percent DV of potassium in a 
serving of the product. The raisins label showed 130 calories, 2 grams 
(8 percent DV) of dietary fiber, 29 grams of total sugars, 0 grams (0 
percent DV) of added sugars, 0 percent DV of vitamin D, 2 percent DV of 
calcium, 6 percent DV of iron, and 9 percent DV of potassium. The 
comment said that when both groups of participants were asked to 
describe ``the amount of sugar'' and ``the amount of calories'' that 
the product contains by rating each item on a scale of 1 to 10, where 
10 equaled ``extremely high,'' the average ratings of the sugar and 
calorie content for the dried cranberries were statistically 
significantly higher than the average ratings of the sugar and calorie 
content for the raisins. In the same study, a subset of participants 
also completed a ``forced choice task'' in which they were shown 
Nutrition Facts labels for two products presented, displayed in FDA's 
proposed label format, side-by-side, and were asked to choose which of 
the two products was ``better described'' by eight different phrases. 
Some participants were shown a Nutrition Facts label for dried 
cranberries plus a Nutrition Facts label for raisins, both in FDA's 
proposed format. The report submitted in the comment said that among 
those who completed this task, statistically significantly more 
participants selected the dried cranberries as being ``better 
described'' as containing ``more sugar'' and ``more calories,'' whereas 
statistically significantly more participants selected the raisins as 
being ``better described'' as ``healthy.''
    The same comment described selected results from a cross-sectional 
survey study on cranberry products. The survey was conducted online in 
September 2015 and included 1,000 adults of 18 and over in the United 
States. The study participants were asked how likely they are to 
consume or purchase cranberry juice cocktail, apple juice, and grape 
juice for their household on a regular basis. Participants were then 
asked how strongly they agreed or disagreed with four statements: (1) 
``Too much added sugar in a person's diet can lead to obesity and risk 
of chronic health problems;'' (2) ``Many Americans do not meet dietary 
recommendations for servings of fruit;'' (3) ``One should reduce 
consumption of sodium, saturated fat, refined grains and added sugar;'' 
and (4) ``Dried fruits and fruit juices can form a nutritious part of a 
well-balanced diet and help provide nutrients and servings of fruit.'' 
Participants were then shown nutrition information for three juice 
products, displayed in FDA's proposed label format, in a rotating 
order. One product was cranberry juice cocktail of which label showed 
110 calories, 28 grams of total sugars, and 25 grams (50 percent DV) of 
added sugars. One product was grape juice of which the label showed 140 
calories, 36 grams of total sugars, and 0 grams (0 percent DV) of added 
sugars. One product was apple juice of which the label showed 120 
calories, 24 grams of total sugars, and 0 grams (0 percent DV) of added 
sugars. As each product label was shown, participants were asked, ``How 
does the information on this label affect your likelihood to consume or 
purchase [name of juice] for your household?'' The comment said that 39 
percent of participants were less likely to consume or purchase the 
cranberry juice cocktail after viewing the FDA-proposed nutrition 
label, versus 29 percent for the grape juice and 18 percent for the 
apple juice. Participants were also asked to identify ``how many grams 
of sugar'' were in each juice. The comment said that 30 percent of 
participants could not answer the question correctly when viewing the 
label for cranberry juice cocktail, versus 7 percent for the grape 
juice and 7 percent for the apple juice. After answering questions 
about the grams of sugar in each juice, participants who indicated that 
they would be less likely to consume or purchase cranberry juice 
cocktail were asked, ``Why do you say that?'' The comment said that the 
``main reason'' for most of the participants who answered this question 
was ``sugar content.'' The comment reported similar research findings 
for participants who viewed Nutrition Facts labels, in our proposed 
format, for dried cranberries versus raisins.
    Based on the research findings from the two cranberry studies, the 
comment said that consumers misunderstood the sugar content of 
cranberry juice cocktail and dried cranberries, and believed that 
cranberry products contain more calories and more sugars and are less 
healthy than competitive products, when presented with FDA-proposed 
labels for each, both alone and as compared to competitive products. 
Therefore, the comment said that requiring a naturally unpalatable 
fruit product that has been sweetened to label the gram amount and 
percent DV for added sugars, in comparison with naturally sweetened 
fruit products labeled as having zero grams and zero percent DV for 
added sugars, is misleading because it implies that a sweetened 
unpalatable fruit with the same or fewer total calories and sugars as 
the naturally sweetened fruit product is less nutritious and 
``generally unhealthy.''
    Both cranberry studies also tested an alternative label format in 
which the declaration of the grams and percent DV for added sugars was 
replaced by a double asterisk symbol on the declaration of ``Total 
Sugars,'' (instead of ``Sugars''), and a footnote placed at the bottom 
of the label that stated, ``** Total sugars include sugars added for 
fruit palatability.'' The comment said that the alternative label 
format alleviated the confusion regarding the sugar content of 
cranberry juice cocktail compared to grape juice and the confusion 
regarding the sugar content of dried cranberries compared to raisins.
    Another comment described a separate, online experiment that tested

[[Page 33822]]

Nutrition Facts labels for fictitious products without any product 
identities. The study, co-sponsored by five trade associations, was 
conducted in October, 2015, among a sample of 2,014 U.S. adult 
consumers aged 18 years or older. Half of the sample saw ``Control 
labels'' that included only gram amounts of ``Sugars.'' The other half 
of the sample saw ``Added Sugars labels'' that featured gram amounts of 
added sugars and the percent Daily Value for added sugars displayed 
below a ``Total Sugars'' declaration. All participants performed two 
product comparison tasks. In the first product comparison task, 
participants who saw the ``Control labels'' were shown two labels side-
by-side that displayed identical nutrition profiles, whereas 
participants who saw ``Added Sugars labels'' saw two labels side-by-
side which were almost nutritionally identical, except that one 
declared 4 grams of added sugars whereas the other declared 0 grams of 
added sugars. All participants were asked to indicate which of the two 
products was: (1) The ``healthier'' choice and (2) the ``best choice 
for maintaining weight.'' The comment said that the results showed that 
compared to those who saw two ``Control labels'' side-by-side, 
participants who saw two ``Added Sugars labels'' side-by-side were less 
likely to say that the product declaring 4 grams of added sugars was 
equally healthy to, or equally helpful in maintaining a healthy weight 
as, an identical product that declared 0 grams of added sugars. In the 
second product comparison task, participants were shown two labels 
side-by-side that displayed different nutrition profiles. One product 
contained 190 calories, 2 grams (3 percent DV) of total fat, 37 grams 
(12 percent DV) of total carbohydrates, 7 grams (28 percent DV) of 
dietary fiber, 16 grams of total sugars, and, in the ``Added Sugars 
labels'' but not the ``Control labels,'' 0 grams (0 percent DV) of 
added sugars. The other product contained 190 calories, 3 grams (5 
percent DV) of total fat, 35 grams (12 percent DV) of total 
carbohydrates, 10 grams (40 percent DV) of dietary fiber, 8 grams of 
total sugars, and, in the ``Added Sugars labels'' but not the ``Control 
labels,'' 8 grams (16 percent DV) of added sugars. All other nutrients 
were declared in identical amounts for both products. In this case, the 
comment said that of the participants who saw ``Control labels,'' 56 
percent selected the product with 10 grams (40 percent DV) of dietary 
fiber and 8 grams of total sugars as the healthier choice, versus 32 
percent of participants who saw the ``Added Sugars labels.''
    Many comments referenced a study that was initially submitted as a 
comment and report to the proposed rule and subsequently published in 
2015 (Ref. 107). The report provided qualitative and quantitative 
results of a study conducted with 1,088 U.S. adults recruited from an 
online consumer panel. The report said that study participants 
generally did not understand the term ``added sugars'' and had 
difficulty correctly identifying the amount of ``sugars'' on the label 
when ``added sugars'' were declared. Some study participants perceived 
that products with an ``Added Sugars'' declaration had a higher sugar 
content than was actually present. The published paper of the study 
also said that participants were shown three Nutrition Facts labels, 
side-by-side, for three products that were nutritionally identical, 
except that two of the three labels included ``Added Sugars'' 
declarations whereas one of the three included only a ``Sugars'' 
declaration. The paper said that, when participants were asked to rank 
in order of descending preference which product they would buy based on 
the label information, 76 percent of the participants gave the highest 
preference to the label that included only a ``Sugars'' declaration.
    (Response) The findings from the research submitted in the comments 
and from our own added sugars study suggest more limited conclusions 
than the comments assert. Regarding the findings that some study 
participants appeared to have overestimated the sugar content of the 
products included in the study as a result of summing total and added 
sugar amounts, we address this issue in our response to comment 188. 
Regarding the comments' assertions that the study findings demonstrate 
that our proposed label declaration of the percent Daily Value and 
grams of added sugars would ``mislead'' consumers based on study 
participants' responses to questions posed (which reflect participant 
perceptions), we disagree that the results support such a conclusion 
(see our response to comment 35).
    Our consumer study on added sugars was conducted to help inform our 
consumer education. In particular, we were interested in better 
understanding how the inclusion of added sugars declarations on the 
Nutrition Facts label might influence consumer perceptions of various 
products and comprehension of the label. A consumer's belief, opinion, 
or previous exposure to information about added sugars and the impact 
added sugars may have on health may affect how a consumer may view a 
label with an added sugars declaration, whether the belief, opinion, or 
information is grounded in scientific evidence or not. These factors 
can influence how a consumer perceives information on a label and may 
result in some consumer confusion and misunderstanding, e.g., when a 
consumer thinks a food, which can be part of a healthy dietary pattern 
for the day, is not ``healthful'' simply because it has a certain 
amount of added sugars. We want to ensure, through our consumer 
education, that consumers understand how to include a variety of foods 
in their diet as part of a healthy dietary pattern and focus on 
providing consumers the tools they need to understand how to include 
added sugars in their diets and where calories from added sugars can be 
included within calorie limits. FDA's consumer research on added sugars 
suggests that in comparison to participants who saw the current label 
without any added sugars declarations, some study participants' 
perceptions of the healthfulness of a given product varied when added 
sugars declarations were included on the Nutrition Facts label. 
Specifically, the study showed that when participants compared two 
products that declared added sugars, and the more nutritious product 
had more added sugars, some participants had difficulty assessing the 
relative healthfulness of the more nutritious product. This variation 
in healthfulness perceptions suggests that, when presented with 
Nutrition Facts labels that included added sugars declarations, some 
FDA study participants may have applied their own understanding of 
added sugars in deciding how to evaluate this new information, relative 
to other, more familiar nutrients shown on the label, which may have, 
in turn, affected these participants' perceptions about the 
healthfulness of a given food. A variety of factors may account for 
some of the product perceptions (e.g., healthfulness of a product) 
found in our research, including but not necessarily limited to: (1) 
Dietary advice disseminated since 1980 about limiting ``sugar'' intake, 
particularly from sources of added sugars; (2) preexisting perceptions 
and knowledge (both correct and incorrect) about ``sugars'' and ``added 
sugars;'' and (3) potential confusion among some consumers about the 
fact that the existing ``Sugars'' declarations on the current Nutrition 
Facts label refers to the components of ``sugars,'' which include both 
naturally occurring and added sugars.
    The information on the Nutrition Facts label provides consumers 
with

[[Page 33823]]

information they need to maintain healthy dietary practices. Our 
consumer research on added sugars was informative with respect to the 
need for information about the amount of added sugars in a serving of 
food to enable consumers to incorporate added sugars into a healthy 
eating pattern. Our consumer research on added sugars demonstrated 
that, without the added sugars declaration, consumers will not have 
information they need to construct a dietary pattern that is low in 
added sugars. Not all consumers understand the distinction between 
``Sugars'' and ``Added Sugars,'' and, therefore, some consumers do not 
understand that added sugars, along with naturally occurring sugars, 
are components of ``Sugars.'' We found that some study participants 
think a food with added sugars is less ``healthful,'' even though the 
food could be included as part of a healthy dietary pattern.
    Without the factual information about the amount of added sugars in 
a serving of food and percent DV declaration, consumers would not be 
able to choose from a variety of foods for a healthy dietary pattern 
and would not be provided with information about appropriate limits on 
calories from added sugars in their diet. It is important to provide 
consumers with the information on the amount of added sugars in a 
serving of food so they can better manage their daily intake of added 
sugars, rather than having consumers avoid foods with added sugars in 
the ingredient list or conversely consume excess amounts of added 
sugars because they are uninformed about the contribution of added 
sugars in a serving of food. Information about added sugars on the 
nutrition label will provide material information to the consumer to 
better enable them to construct a healthy dietary pattern from a 
variety of foods.
    In addition to our consumer study on added sugars, the comments 
provided consumer research on added sugars related to consumer 
perceptions. The research provided in the comments was designed to show 
differences in how people view added sugars on the label, but did not 
discuss the need for the added sugars declaration and its importance in 
enabling consumers to construct healthy dietary patterns. If we do not 
include added sugars on the label, based on how consumers may 
misperceive added sugars or be confused about how to include it as part 
of a healthy dietary pattern on intake, consumers could be harmed by 
not having critical information needed to maintain healthy dietary 
practices.
    The studies submitted in comments demonstrate the same issue we 
have noted with respect to some consumers adding total and added sugar 
declarations together, which led to our revisions to the final 
declaration of added sugars to clarify that added sugars is a 
subcomponent of total sugars (``included'' in total sugars). 
Furthermore, due to a number of deficiencies in the information 
provided about the cranberry studies as well as in the described study 
methodologies, we are not able to assess the merits of any conclusions 
described in the comments related to cranberry products. For example, 
in the cranberry experiment, one dietary statement that participants 
were shown at the beginning of the study about added sugars said: ``Too 
much added sugar in a person's diet can be bad for them and their total 
added sugar intake should not exceed 10 percent of their total calorie 
intake.'' A DRV for added sugars of less than 10 percent calories 
suggests that some added sugars can be part of a healthy diet. In fact, 
the food pattern modeling that was part of the basis for establishing 
the DRV for added sugars included 4 to 9 percent of calories from added 
sugars. Therefore, some study findings in the cranberry experiment may 
be attributable to participants having seen the negative dietary 
statement before evaluating the label formats tested in the study.
    Additionally, it is not clear whether the cranberry experiment 
tested how participants would have evaluated the cranberry juice 
cocktail versus grape juice, or dried cranberries versus raisins when 
using the current Nutrition Facts label and, more importantly, the 
proposed Nutrition Facts label without the proposed declaration of 
added sugars. Without such test results, it is not possible to 
ascertain whether the reported results could be attributed, as the 
comment asserted, to the added sugars declaration or were influenced by 
other label elements. Moreover, although the comment said that the 
cranberry experiment reduced confusion with an alternative label in 
which the declaration of the grams and percent DV for added sugars was 
replaced by a footnote that stated, ``** Total sugars include sugars 
added for fruit palatability,'' based on findings from eye-tracking 
studies (Refs. 15, 108), we suspect that the reduced confusion is 
related more to participants overlooking the information in the 
footnote, which is located at the bottom of the label. Regardless of 
the findings described in the comment, the alternative label format 
included in the cranberry experiment would not provide consumers with 
essential information about the quantity of added sugars in a food or 
what that amount of added sugars contributes to a daily diet. Without 
this information, consumers will not be able to consume less added 
sugars or put the added sugars declaration in the context of their 
daily diet. Finally, although we acknowledge that the cranberry 
experiment showed that statistically significantly more participants 
selected raisins as being ``better described'' as ``healthy'' in 
comparison to the dried cranberries, we note that there were other 
differences between the dried cranberries and the raisins besides the 
amount of added sugars. For example, the raisins contained more 
protein, iron, potassium and calcium than cranberries. It is unclear 
from the study results if the participants solely chose raisins based 
on their lack of added sugars or if the increased levels of these other 
nutrients may have impacted the participant's choice for the 
``healthy'' product.
    In the cranberry survey study, selective reporting of the verbatim 
results that were used to identify the reported reasons for the 
decreases in purchase or consumption intentions, the absence of a 
baseline assessment of how participants would respond to the study 
questions using the current Nutrition Facts label, and the sequence and 
nature of the questions described preclude a determination of the 
extent to which the findings produced in the study are attributable to 
the FDA-proposed label or to added sugars declarations. For example, 
the cranberry survey study first asked participants to express 
agreement or disagreement with a statement, ``Too much added sugar in a 
person's diet can lead to obesity and risk of chronic health 
problems.'' Given that 91 percent of the study sample said that they 
strongly or somewhat agreed with this statement, it is reasonable to 
infer that the study participants' preconceived beliefs and/or 
heightened attention on added sugars may account for many of the 
cranberry survey study findings reported in the comment, rather than 
the declaration of added sugars. Given that study participants have 
various preconceived perceptions about added sugars, it is not 
surprising that participants have different purchase intentions or 
perceptions. Furthermore, because the cranberry survey study led 
participants through a sequence of questions where they answered 
questions about grams of sugar in the products before viewing an 
alternative label that was advocated by the authors of the comment, the 
study methods

[[Page 33824]]

deliberately led participants to focus on information that they may not 
have naturally focused on in other circumstances, therefore calling 
into question whether the alternative label would produce less 
confusion while also producing better comprehension about the added 
sugars content of the tested foods if a different set or sequence of 
questions had been employed.
    In the experiment that was co-sponsored by five trade associations, 
we are unable to conclude that added sugars declarations were the 
reason for the findings in the second product comparison task because 
the experimental conditions included variations in total fat and 
dietary fiber values, in addition to varying added sugars. For example, 
in the second product comparison task, in which respondents viewed 
``nutritionally different'' products, 50 percent of participants who 
selected the product that declared 0 grams of added sugars as ``better 
for maintaining healthy weight'' indicated ``it was low in fat'' as a 
reason for their selection; in addition, our analysis of the raw data 
submitted by the commenter shows that, 36 percent indicated ``has no 
grams of added sugars'' as a reason for their selection. On the other 
hand, our analysis of the raw data shows that among participants who 
selected the product that declared 8 grams of added sugars as ``better 
for maintaining healthy weight,'' 55 percent indicated ``is higher in 
fiber'' as a reason for their selection, and 39 percent indicated 
``contains less sugar'' as a reason. As for the findings from the first 
comparison task, in which participants viewed two labels that were 
almost nutritionally identical, we do not agree that participants 
``misjudged'' the healthfulness or weight-related attributes of the 
foods in the presence of added sugars information, because the 
difference in added sugars content between the foods meant that the two 
foods were, in fact, nutritionally different. Without added sugars 
declarations, participants were unable to discern that such a 
difference existed. Similarly, in the paper by Laquatra et al., 
participants who expressed a purchase preference for the label that 
included only a ``Sugars'' declaration may not have understood that the 
food contained added sugars and may have based their preference on that 
mistaken understanding.
    Some research referenced different approaches for the labeling of 
added sugars for certain nutrient-dense fruit products that are high in 
acid. The proposed alternative approach to added sugars labeling for 
dried unpalatable fruit and juices made with at least 27 percent juice 
of an unpalatable fruit includes a proposed definition for an 
unpalatable fruit. We note that there are other fruits, such as lemons 
and limes, which contain nutrients, but have a low Brix value. When the 
juices of such fruits are consumed, they typically have sugar added to 
them for palatability. It is not clear what the impact of this approach 
suggested in the comment, which includes a definition of dried 
unpalatable fruit as well as use of a Brix-to-acid ratio that is not 
defined by regulation, would have on other dried fruit products or 
products made from juices of other fruits that typically have sugars 
added to them. An alternative approach provided in comments includes 
the use of a footnote in the Nutrition Facts box to explain that added 
sugars are added to increase the palatability of the food. However, we 
are concerned about the use of the Nutrition Facts label to convey this 
type of information and the precedent such an approach may set for 
other possible statements related to a nutrient declared on the label, 
such as the purpose for its addition, and information related to the 
characteristics or use of the nutrient. We consider it important to 
maintain the consistency of the information contained within the 
Nutrition Facts label, which provides factual information about the 
amount of a nutrient in a serving of food. This ensures that consumers 
can continue to readily use the Nutrition Facts label to make 
comparisons across all packaged foods. Manufacturers who are interested 
in communicating, through labeling, how products made from fruits that 
have sugars added to them in order for the product to be acceptable to 
consumers are free to make a statement elsewhere on the label or in 
labeling, outside of the Nutrition Facts box, to explain the purpose 
for which the sugars has been added, provided the information is 
consistent with other labeling requirements, e.g., is truthful and not 
misleading. Thus, for example, manufacturers could include a truthful 
and not misleading statement explaining that total sugars include 
sugars added for fruit palatability.
    (Comment 185) One comment described a reanalysis of the raw data 
from our added sugars study, the availability of which we announced in 
the Federal Register of September 10, 2015 (80 FR 54446). The 
reanalysis confirmed some of the findings reported in an FDA memo (see 
part II.H.3.g), but also found that participant perceptions of the 
products in the study were inconsistent depending on race, education 
level, or both. Based on the findings from the reanalysis and prior 
published research that has examined how nutrition label use varies 
with education level and ethnic minority status, the comment said that 
the presence of added sugars information on the label produced 
misperceptions and confusion, and that low-education consumers and 
ethnic minorities seemed especially prone to ``unintended 
consequences'' when added sugars was displayed on the label. The 
comment said that more research is needed to thoroughly understand how 
the provision of added sugars on the Nutrition Facts label would affect 
``at-risk segments'' of the population.
    (Response) We agree that some findings suggest the potential for 
consumer responses to labels vary depending on race, ethnicity, and 
education level; this type of variation has been shown in prior 
published research. On the other hand, because the reanalysis ventured 
beyond the primary objectives of what the study was designed to explore 
and because some findings reported in the comment were based on fewer 
than five participants, many findings of the reanalysis are unreliable. 
We also disagree with the comment's basis for asserting a need for 
additional research as discussed in our response to comment 40. Due to 
the limitations of the sample, limitations which the comment 
acknowledged, we view the reanalysis as exploratory and inconclusive, 
although potentially informative for future education efforts. 
Furthermore, as addressed in our responses to comments 1 and 244, we 
have considered, and will continue to consider, a variety of 
educational efforts to assist consumers in comprehending and using the 
Nutrition Facts label to maintain healthy dietary practices.
    h. Voluntary labeling. In the preamble to the proposed rule (79 FR 
11879 at 11905), we considered the appropriateness of the voluntary 
declaration of added sugars. However, we said that we were concerned 
that voluntary declaration of added sugars may not ensure that 
consumers have the information that will allow them to follow the 
current dietary recommendations (id.). We also said that added sugars 
declared voluntarily by manufacturers could be confusing to consumers 
and would not provide consumers with the information they need to plan 
their dietary pattern to reduce consumption of calories from added 
sugars (id.).
    (Comment 186) Several comments disagreed with our tentative 
conclusion that the labeling of added sugars should be mandatory and 
provided a number of

[[Page 33825]]

reasons why the declaration of added sugars should be voluntary rather 
than mandatory. Most comments suggested that labeling of added sugars 
should be voluntary rather than mandatory for the same reasons that 
they opposed mandatory labeling of added sugars. The comments, and our 
responses to the comments, are provided in part II.H.3.a. Other 
comments, which recommended that if we determine that added sugars 
should be declared on the label, the label declaration should be 
voluntary rather than mandatory, provided the following reasons:
     One comment referred to our discussion of voluntary 
labeling of added sugars in the proposed rule (79 FR 11879 at 11905), 
and said that whether declaration of a nutrient on the Nutrition Facts 
label is mandatory or voluntary does not correspond to its bearing on 
maintaining healthy dietary practices;
     The sole macronutrient made mandatory by regulation is 
trans fat due to its established relationship to risk of chronic 
diseases and health-related conditions;
     Other voluntary nutrients, such as polyunsaturated fat, 
monounsaturated fat, potassium, soluble fiber, and sugar alcohol, are 
the subject of authorized health claims;
     Executive Order 13563 requires us to consider less 
burdensome alternatives;
     Consumers' understanding of the differences between added 
and naturally present sugars should be determined before becoming 
mandatory;
     Voluntary labeling would be consistent with the labeling 
of added sugars in the United Kingdom, Canada, Australia, and New 
Zealand, and would not run afoul of the World Trade Organization's 
Agreement on Technical Barriers to Trade (``TBT Agreement''); and
     Manufacturers of foods containing a significant amount of 
added sugars would likely be disinclined to declare added sugars if 
labeling is voluntary, however manufacturers of foods containing an 
insignificant amount of added sugars would likely use the added sugars 
declaration to highlight the added sugars content by juxtaposing sugars 
and added sugars declarations on the label.
    (Response) Since the publication of the proposed rule, additional 
evidence has become available that further supports the need for a 
mandatory declaration of added sugars. The scientific evidence supports 
Americans limiting their calories from added sugars by consuming an 
eating pattern low in added sugars. We explained that consumers need to 
know how much added sugars is in a serving of a product in order to 
consume a healthy dietary pattern that is low in added sugars because 
we have evidence that healthy dietary patterns characterized, in part, 
by lower intakes of sugar-sweetened foods and beverages when compared 
to less healthy dietary patterns are associated with a decreased risk 
of CVD. We have the authority to require the declaration of a nutrient 
on the label if we determine the declaration will assist consumers in 
maintaining healthy dietary practices. Our discretion includes whether 
to permit the voluntary declaration or require the mandatory 
declaration of a nutrient (56 FR 60366, November 27, 1991).
    With respect to the comment which noted that the only nutrient 
which has been added to the label by regulation is trans fat, which was 
based on its relationship to CVD risk, our basis for requiring the 
declaration of added sugars for the general population is not its 
independent association with the risk of chronic disease, a health-
related condition, or a physiological endpoint. Instead, we are 
requiring the mandatory declaration of added sugars because evidence 
shows that heathy dietary patterns associated with a decreased risk of 
chronic disease are lower in added sugars, consumption of too much 
added sugars can impact the nutrient density of the diet, and 
consumption of sugar-sweetened beverages are associated with increased 
adiposity in children.
    With respect to the comment that suggested that a declaration of 
added sugars should be voluntary because it is not the subject of an 
authorized health claim, our authority to add additional nutrients to 
the label under section 403(q) of the FD&C Act is distinct from our 
authority to authorize health claims.
    With respect to the comment suggesting that we should consider less 
burdensome alternatives as directed by Executive Order 13563, we did 
consider voluntary labeling of added sugars in the preamble to the 
proposed rule (79 FR 11879 at 11905) and determined that a voluntary 
declaration would not provide the information consumers need to 
understand the relative contribution of added sugars from all food in 
the context of a total daily diet and achieve a healthy dietary pattern 
that is associated with a reduced risk of chronic disease. The 2015 DGA 
provides further support for this conclusion.
    With respect to the comment that consumers' understanding of the 
differences between added and naturally present sugars should be 
determined before we can require the declaration of added sugars, that 
is not consistent with our authority for when we can require a nutrient 
declaration, as discussed in our response to comment 156.
    Concerning the comments raised with the TBT Agreement, the comments 
have not explained why we would be acting inconsistently with our WTO 
obligations if we require the declaration of added sugars, as compared 
to other countries that allow for the voluntary declaration of added 
sugars on their labels. As we have explained, our objectives will not 
be fulfilled by voluntary labeling. Rather, the scientific evidence 
supports the mandatory disclosure of the amount of added sugars in the 
nutritional labeling of food. The dietary pattern of the general United 
States population contains excessive calories from solid fats and added 
sugars. The consumption of excess calories above calorie needs can lead 
to overweight and obesity. There is public health need to reduce excess 
calories from solid fats and added sugars to ensure that nutrient needs 
are met within calorie limits. Moreover, a healthy dietary pattern that 
is characterized, in part, by lower intakes of sugar-sweetened foods 
and beverages relative to less healthy dietary patterns is associated 
with a reduced risk of CVD. Thus, we have determined that there is a 
public health need for Americans to be able to determine the amount of 
added sugars in a serving of foods and to be able to put that amount 
into the context of their total daily diet so that they can consume a 
healthy dietary pattern that is lower in added sugars. We have a 
legitimate regulatory objective to provide nutrition information to 
consumers that includes the added sugars content in a serving of food 
to protect the health of United States consumers. The scientific 
evidence indicates that requiring disclosure of added sugar content is 
necessary to achieving this objective. We address comments related to 
international trade in part II.H.3.m.
    We have considered the comment about the possible inclination of 
manufacturers to declare added sugars on their labels as a basis for 
determining whether to require or permit the declaration of added 
sugars on the label and consider the required declaration of added 
sugars to be necessary to assist consumers in maintaining healthy 
dietary practices. If consumers do not have information on the amount 
of added sugars in foods available in the marketplace, they will not be 
able to compare products so that they can avoid excess calories from 
added sugars and

[[Page 33826]]

construct an overall healthy dietary pattern that has less than 10 
percent of calories from added sugars.
    i. How added sugars are declared. Many comments provided 
recommendations for how information about added sugars in products 
should be conveyed to consumers on the label.
(i) Changing ``Sugars'' to ``Total Sugars''
    In the preamble to the proposed rule (79 FR 11879 at 11902), we 
said that we were considering whether to use the term ``Total Sugars'' 
instead of ``Sugars'' on the label if we finalize a declaration of 
added sugars. We also said that we planned to conduct consumer research 
that would include, among other things, questions regarding the 
declaration of added sugars on the Nutrition Facts label in order to 
help or enhance our understanding of how consumers would comprehend and 
use this new information, and to inform our education activities and 
outreach. In the preamble to the supplemental proposed rule (80 FR 
44303 at 44306), we discussed the results of our consumer research 
which showed that when an ``Added Sugars'' declaration was indented 
below a ``Total Sugars'' declaration on the label, participants 
appeared to be better able to comprehend the total amount of sugars in 
a food than if an ``Added Sugars'' declaration was indented below a 
``Sugars'' declaration. In the preamble to the supplemental proposed 
rule (id. at 44304), we asked for comment on whether the term ``Total 
Sugars'' should be declared on the label instead of ``Sugars.''
    (Comment 187) Many comments to both the proposed rule and the 
supplemental proposed rule addressed this topic. The comments generally 
preferred the term ``Total Sugars'' rather than ``Sugars'' on the 
label. Although some comments did not support a declaration of added 
sugars on the label, the comments said that, if we require the 
declaration of added sugars in the final rule, the term ``Total 
Sugars'' should be used on the label rather than ``Sugars.'' The 
comments said that such a change to the terminology used will likely 
increase consumer understanding that ``Added Sugars'' are included in 
the ``Total Sugars'' declaration. The comments would change the 
``Sugars'' declaration to ``Total Sugars'' to provide a clearer 
distinction between total and added sugars and to prevent consumers 
from adding the ``Added Sugars'' and ``Sugars'' declarations together. 
The comments said that this change would be consistent with the 
declarations for ``Total Fat'' and ``Total carb.'' Other comments 
suggested that using the heading ``Total Sugars'' would provide 
interpretive data that is consistent with the need to make information 
clearer for consumers with lower levels of health literacy, numeracy, 
and English language limitations. One comment said that an analysis of 
our research indicates that replacing the term ``Sugars'' with ``Total 
Sugars'' on the label will enhance the consumers' ability to discern 
the overall nutritional value and compare nutrient density of food 
products at the point of selection (Ref. 109).
    Other comments provided evidence that consumer's understanding of 
label information about sugars is improved when the ``Sugars'' term is 
replaced with ``Total Sugars.'' One comment provided the results of a 
qualitative and quantitative study that it conducted showing that, when 
``Total Sugars'' was declared on a label rather than ``Sugars,'' 
participants were more likely to understand that the sugars in an 
``Added Sugars'' line would be included in a ``Total Sugars'' line 
(Ref. 107). These results are consistent with our findings. Another 
comment cited a study by Laquatra et al., which the comment said 
suggests that consumers' understanding of the amount of sugar indicated 
on a food label was improved when the term ``total sugars'' was used 
rather than ``sugars'' (Ref. 107).
    One comment said that our consumer research results are ambiguous, 
and requested that we undertake sufficient education activities to 
ensure that consumers understand that ``Added Sugars'' are included in 
the ``Total Sugars'' declaration. Another comment also said that it is 
premature to comment on using the term ``Total Sugars'' instead of 
``Sugars'' on the label because additional consumer research that 
includes a label format that represents our proposed added sugars 
labeling declarations (including a percent DV declaration) is needed to 
gauge consumer understanding and usage of the new label information.
    (Response) Since the publication of the supplemental proposed rule, 
our finding that participants appear have better comprehension of the 
total amount of sugars in a food when ``Sugars'' is replaced with 
``Total Sugars'' on the label has been replicated by others, as noted 
in some comments. We disagree that additional consumer research testing 
the proposed label format with a percent DV declaration for added 
sugars is needed before we can finalize a change to the label which 
replaces the term ``Sugars'' with ``Total Sugars.'' ``Total Sugars'' 
will help improve comprehension of information on the label related to 
total and added sugars (see part II.H.2.c). Therefore, we are replacing 
``Sugars'' with ``Total Sugars'' throughout Sec. Sec.  101.9 and 
101.36.
    (Comment 188) Many comments raised concerns about our proposal to 
require added sugars declarations due to findings from consumer 
research conducted by FDA and others. The comments said consumer 
research showed that added sugars declarations decreased the ability of 
some participants to correctly identify the quantity of total sugars in 
a food. Specifically, FDA's studies as well as other studies cited in 
the comments showed that when viewing nutrition labels with added 
sugars declarations, some participants mistakenly summed the value for 
total sugars and the value for added sugars when they were asked to 
identify the total amount of sugars in a serving of a product. Some 
comments also said that the research suggests that the proposed label 
is more likely than the current label to mislead or confuse consumers 
with regard to total grams of sugars in the product; the comments would 
exclude an added sugars declaration from the label. Another comment 
suggested that FDA should conduct additional research to find other 
ways to present added sugars and total sugars declarations to reduce 
consumer confusion.
    (Response) We acknowledge that our consumer research and those 
referenced in the comments showed statistically significant decreases 
in participants' understanding of total sugars in a serving of a 
product when a label included an added sugars declaration, either with 
or without the corresponding percent Daily Value of added sugars, 
compared to when a label did not include an added sugars declaration. 
Our study showed that the most common error was for our study 
participants to overestimate the quantity of total sugars in the 
product by summing the product's ``total sugars'' (or just ``sugars,'' 
depending on which label format was used) and ``added sugars.'' We 
note, however, that in our study and in a study conducted by IFIC, 
including ``total'' in front of ``sugars'' helped study participants 
better comprehend the total amount of sugars in a serving of a product. 
Therefore, the final rule includes ``total'' in front of ``sugars'' to 
better enable consumers to correctly assess the quantity of total 
sugars in a product.
    We also note that in our research, when compared to the control 
group viewing the current label with no ``added sugars'' declaration, 
some study participants still did not report the correct amount of 
``sugars'' in one serving of the product, even when the

[[Page 33827]]

word ``total'' was included in front of ``sugars.'' It is also 
important to note that when using the sugars declaration on the current 
label, some participants were unable to determine the total amount of 
sugars, even when only ``sugars'' was listed on the label. 
Additionally, our research found that the majority of study 
participants could not identify the correct amount of ``added sugars'' 
on the label when it was not declared, thereby not giving participants 
a key piece of information needed to maintain healthy dietary 
practices.
    We plan to include ``added sugars'' in our consumer education and 
outreach efforts on the Nutrition Facts label. This will address some 
consumer confusion. However, to the extent some confusion was 
identified in the studies, we want to correct this potential confusion 
by adding the word ``includes'' in front of added sugars. The added 
sugars declaration will now read ``Includes X g Added Sugars'' below 
the ``Total Sugars'' line. The addition of ``includes'' will enable 
consumers to understand that ``added sugars'' are a sub-component of 
``total sugars.'' We also are minimizing the hairline between total 
sugars and added sugars to help denote that ``added sugars'' are a 
subcomponent of ``total sugars.'' Minimizing the hairline between the 
two sugars will ``chunk'' the sugars together instead of them being 
distinct and separate. We base our decision on the expert opinion of 
two scientists in the fields of consumer research and risk 
communication and a review of literature as explained below surrounding 
the use of connecting words to clarify relationships between subject 
matter.
    We enlisted the aid of two independent FDA experts, one whose 
expertise is in consumer research and the other whose expertise is in 
risk communication. These experts were not affiliated with our current 
consumer studies work on added sugars and were asked to evaluate 
whether using the word ``includes'' as well as minimizing the line 
between ``total sugars and ``added sugars'' are likely to ameliorate 
the consumer confusion found in our consumer research as well as the 
research of others. The experts independently agreed that these changes 
should help consumers better understand that ``added sugars'' is a 
subcomponent of ``total sugars'' (Refs. 110-111). The consumer research 
expert noted that including the word ``total'' in front of ``sugars'' 
should be particularly helpful to regular label users since this format 
is consistent with what is used for ``total fat'' and ``total 
carbohydrate.'' The expert also suggested that use of the word 
``includes'' should reinforce for consumers that ``added sugars'' is a 
component of ``total sugars'' and not merely a complement. The expert 
also noted that any lingering confusion with the format related to 
determining total amount of sugars in a serving of a product should 
dissipate over time as users of the Nutrition Facts label become 
accustomed to the new label.
    The second expert in risk communication noted that the presence of 
the word ``includes'' provides clarity that she expects will reduce 
confusion among those consumers who summed ``Added Sugars'' and ``Total 
Sugars'' and allow consumers to determine the total amount of sugars in 
one serving of a product.
    In addition to the expert opinion, some literature suggests linking 
terms (words or phrases that reveal relationships between ideas in 
content) are useful for increasing comprehension, indicating that using 
the word ``includes'' may help consumers understand that ``added 
sugars'' are a subcomponent of ``total sugars.'' Comprehension of 
information in text takes place when the reader can identify new text 
information and relate it to the information already given or known. 
The more information that coincides with what readers already know, the 
easier it will be for them to integrate new information into their 
existing knowledge base, hence coming to understand the material 
presented in the information (Ref. 112). One principle commonly used to 
facilitate comprehension is to make each sentence explicitly related to 
the next. One possible approach to implement this principle is to use 
sentence connectors to clarify relationships between sentences. 
Similarly, Spyridakis 1989 (Ref. 113) suggested that because 
comprehension of text requires readers to make inferences, a text that 
provides clues to the links between discrete units of information can 
help readers make appropriate inferences and therefore contribute to 
overall learning of the content of the text. There are different types 
of ``connector'' or ``signal'' words, phrases, or statements that 
preannounce content and/or reveal a relationship between ideas in 
content (Ref. 114). The latter, sometimes called logical connectors, 
can be words or phrases such as ``first,'' ``moreover,'' ``because,'' 
``for example,'' and ``in other words.'' The literature has 
demonstrated that logical connectors can be helpful in improving text 
comprehension (Refs. 113-115). We acknowledge that text and tables are 
different formats of presentation, however the understanding of tabular 
information and understanding of textual information share similar 
psychological processes (Ref. 116). The literature thus lends support 
that a linking word such as ``includes'' may help consumers better 
comprehend that ``added sugars'' are a sub-component of ``total 
sugars.''
    Furthermore, in the previous final rule implementing the NLEA (57 
FR 32070 at 32071), we noted that several comments suggested using 
terms such as ``includes,'' ``including,'' and ``of which,'' before the 
subcomponent for fats and carbohydrates to indicate that the 
subcomponent is a part of a broader classification. We agreed that 
these words would add clarity to the label but declined to include them 
at that time because they could ``clutter'' the label. While label 
clutter is a concern, decreasing potential consumer confusion outweighs 
any cluttering of the label that would result from the addition of a 
word before ``added sugars.'' We also note that the European Union, in 
its new nutritional labeling requirements, is requiring ``of which'' to 
help denote the sub-components of fats and carbohydrates, which is a 
similar linking phrase.
    With regard to the comment that asked us to conduct further 
consumer research on this topic, we decline to do so at this time. 
While we may consider additional consumer research in the future to 
help inform consumer education regarding the ``added sugars'' or other 
declarations, we have incorporated changes intended to minimize 
consumer confusion regarding the ``added sugars'' declaration on the 
label and have finalized this requirement. We have sufficient 
information to move forward with the requirement for the added sugars 
declaration based on a review of the scientific evidence and other 
available data and information which support the need for added sugars 
information to be available to the consumer as part of the nutrition 
label.
(ii) Declaration of Added Sugars in Teaspoons
    (Comment 189) While one comment said that a gram disclosure for 
added sugars would be more readily understood by consumers because it 
is consistent with the manner in which total sugars are disclosed on 
the label, a number of comments suggested that added sugars should be 
declared in teaspoons or in teaspoons as well as grams. The comments 
said Americans understand household measures better than they do the 
metric system because they use household measures at home.

[[Page 33828]]

The comments said that listing the amount of added sugars in both grams 
and teaspoons would improve the clarity of the information provided 
about added sugars. The comments also suggested that a gram and 
teaspoon declaration for added sugars would help consumers readily 
observe and comprehend the information on sugars and to understand its 
relative significance in the context of a total daily diet.
    The comments provided the results of survey data to support an 
added sugars declaration in teaspoons. One comment provided the results 
of a 2010 telephone survey which it said showed that 72 percent of 
respondents favored listing teaspoons of sugar on the label. Another 
comment referenced the results of a 2012 survey of readers by Consumer 
World, an Internet-based publisher of a consumer resource guide. The 
comment said that, when exposed to label information in which the 
amount of added sugars in a product was expressed in grams, up to 80 
percent of survey participants could not accurately say how much sugar 
was contained in a product, and many participants underestimated the 
actual amount of sugar in the product.
    (Response) We decline to revise the rule as suggested by the 
comments. We address issues regarding the use of household measures 
(such as teaspoons) in part II.B.3.
    Additionally, we note that there are many ingredients that supply 
added sugar, so it would be difficult, if not impossible, for a 
manufacturer to determine the volume contribution that each ingredient 
provides towards the added sugars declaration. For example, a cookie 
made with white chocolate chips and dried fruit would have added sugars 
in the form of sugar in the batter as well as in the white chocolate 
chips and the dried fruit.
    Because many products would not have amounts of added sugars in a 
serving of a product that would result in the declaration of an even 
teaspoon or multiple thereof, the requirement to declare added sugars 
in teaspoons rather than in grams would result in fractional 
declarations of teaspoons of added sugars. Indeed, under Sec.  
101.9(c)(6)(iii) of the final rule, a statement of added sugars content 
is not required for products that contain less than 1 gram of added 
sugars in a serving if no claims are made about sweeteners, sugars, or 
sugar alcohol content. The final rule also states that if a product 
contains an insignificant amount of added sugars, the added sugars 
content may be expressed as zero.
    Additionally, the USDA Food Patterns provide limits for added 
sugars that can be reasonably consumed while meeting all other nutrient 
and food group requirements that are listed in grams rather than in 
teaspoons. The declaration of added sugars in teaspoons rather than in 
grams would make it difficult for consumers to determine how their 
consumption of added sugars relates to the recommended limits in the 
USDA Food Patterns.
    There is limited space on the label, so the declaration of both 
gram and teaspoon amounts of added sugars on the label could cause 
clutter and make the label more difficult to read. We have determined 
that the amount of other nutrients on the label should not be declared 
in teaspoons, so if added sugars were declared in both grams and 
teaspoons, it could draw the reader's attention to the added sugars 
declaration and make it appear as though the information should be more 
important or considered in a different way than declarations of other 
nutrients when the declarations of other nutrients are just as 
important to consider when constructing a healthful dietary pattern.
    While we take into consideration consumer preference, manufacturers 
must provide information on the label that is as accurate as possible. 
Although consumers may prefer the declaration of added sugars in 
teaspoons because household measures are more familiar to them than 
gram amounts, the need for accurate labeling of added sugars is of 
greater importance.
    We have conducted our own research, and that research showed that 
when the gram amount of added sugars is declared on the label, study 
participants are able to determine the amount of added sugars in a 
serving of a product. Furthermore, the percent DV declaration for added 
sugars is also required. Therefore, we disagree that consumers are 
unable to determine the amount of added sugars when the gram amount is 
declared on the label.
(iii) Distinguishing Between Naturally Occurring and Added Sugars on 
the Label
    (Comment 190) Some comments thought that we proposed to require 
both a declaration for naturally occurring and added sugars. Other 
comments suggested that the Nutrition Facts label include separate 
declarations for naturally occurring and added sugars so that consumers 
could clearly identify the amount of both naturally occurring and added 
sugars on the label.
    (Response) We did not propose to require separate declarations for 
naturally occurring and added sugars on the label. The comments did not 
provide a basis upon which we can rely to support a separate 
declaration of naturally occurring sugars, and so we decline to revise 
the rule as suggested by the comments.
    (Comment 191) One comment recommended that we propose a Nutrition 
Facts label format that clearly distinguishes added sugars from 
naturally occurring sugars in whole fruit and from sugars from dairy 
ingredients. The comment also recommended replacing ``sugars'' with 
``fruit & milk sugars''.
    (Response) We address this comment in part II.H.2.
(iv) Replacing ``Sugars'' With ``Added Sugars''
    (Comment 192) Some comments would replace ``Sugars'' with ``Added 
Sugars.'' One comment said that foods like fruits have natural sugars 
in them, but when people see the amount of sugars they may think the 
food is bad for them.
    (Response) We decline to revise the rule as suggested by the 
comment. The consumption of sugars continues to be associated with an 
increased risk of dental caries (Ref. 75); thus, a declaration of the 
total amount of sugars in a serving of a product continues to be 
necessary to assist consumers in maintaining healthy dietary practices.
(v) Distinguishing Between Different Types of Sugars or Sweeteners
    (Comment 193) One comment suggested listing all sugars separately 
on the label.
    (Response) We decline to revise the rule as suggested by the 
comment. There are many different kinds of sugars and ingredients 
containing sugars. The declaration of the amount of each type of sugar 
in a serving of a product would result in a very large and cluttered 
Nutrition Facts label. While all nutrient declarations are important to 
build healthy dietary patterns, current science focuses on added sugars 
in total rather than focusing on specific sugars. If consumers are 
interested in knowing whether certain sugars are in a product, specific 
sugars are listed in the ingredient list.
    (Comment 194) One comment requested that we allow the inclusion of 
``nutritive sweetener'' in a parenthetical after added sugars so 
manufacturers could identify the name of the added sugar. The comment 
also requested that, if the added sugar is high fructose corn syrup, we 
allow manufacturers to identify the percentage of fructose on the 
Nutrition Facts label (e.g., high fructose corn syrup-42 or high 
fructose

[[Page 33829]]

corn syrup-55). The comment said that listing ``nutritive sweetener,'' 
the name of the added sugar, and the percentage of fructose in high 
fructose corn syrup is essential for the consumer to make a fully 
informed choice about the caloric contribution of sweeteners and the 
composition of ingredients in the product they are consuming.
    Other comments supported the declaration of the amount of fructose 
in a serving of a product on the label. One comment said that the 
information is needed because metabolizing fructose puts an extra load 
on the liver. The comment suggested that adding fructose and deleting 
added sugars in the quantitative information would add value without 
adding complexity.
    (Response) We decline to revise the rule as suggested by the 
comments. Added sugars are nutritive sweeteners, so it is not clear why 
``nutritive sweetener'' needs to be declared in parentheses behind the 
words ``added sugars'' on the label. As previously discussed in our 
response to comment 193, current science focuses on added sugars in 
total rather than focusing on specific sugars.
    (Comment 195) One comment objected to the use of the term ``added 
sugars'' because, according to the comment, it improperly combines 
compositionally and metabolically distinct caloric sweeteners.
    (Response) We are not basing our declaration of added sugars on an 
independent relationship between added sugars, or different types of 
added sugars, and risk of chronic disease. To the extent that the 
comment is suggesting that different types of sugars are chemically 
distinct, so the term added sugars is inappropriate, there are 
different types of naturally occurring sugars as well as different 
types of carbohydrates, but we use the terms ``total sugars'' and 
``total carbohydrate'' to capture all sugars and all carbohydrates 
respectively. Therefore, using one broad term to capture all sugars 
that have been added to a food is consistent with the approach that we 
have taken for other nutrients. Furthermore, caloric sweeteners that 
have been added to a food are added sugars, therefore we do not agree 
that it is inappropriate to use the term added sugars to include 
caloric sweeteners that have different chemical structures.
(vi) Warning Statements
    (Comment 196) Several comments suggested that we require various 
warning statements on the label related to added sugars to warn 
consumers of the negative health effects of added sugars. One comment 
suggested that we require a warning statement that says ``WARNING: THIS 
PRODUCT CONTAINS A SIGNIFICANT AMOUNT OF ADDED TEASPOONS OF SUGAR WHICH 
STUDIES HAVE LINKED TO OBESITY, TYPE II DIABETES, CARDIOVASCULAR 
DISEASE AND CERTAIN CANCERS. CONSULT YOUR PHYSICIAN ABOUT AN 
APPROPRIATE DIET WITH A REDUCED AMOUNT OF ADDED SUGAR.'' Another 
comment suggested that we should require a warning label that says ``IT 
[added sugar] IS ADDICTIVE. IT CAN LEAD TO OBESITY. OBESITY CAN LEAD TO 
DIABETES, HEART DISEASE, ETC.''
    One comment suggested that we require, or offer an incentive for, a 
disclaimer about added sugars and sodium. The disclaimer would explain 
the health effects on the body and connections to disorders such as 
diabetes and hypertension. The comment said that, similar to cigarette 
packets, consumers should be warned of the health effects of added 
sugars.
    (Response) We decline to revise the rule as suggested by the 
comments. The statements are not consistent with our review of the 
evidence (see our response to comments 136 and 137), and we do not 
require warning labels or disclaimers for other nutrients on the label. 
Furthermore, some added sugars can be included as part of a healthy 
dietary pattern.
    (Comment 197) Several comments suggested that we use wording to 
convey that the DRV of 10 percent of calories from added sugars is a 
maximum amount rather than a recommended amount. One comment would 
include language to state that ``no consumption is recommended. But if 
you choose to consume, then this absolute maximum should be observed to 
avoid increasing adverse health exposure.'' Another comment would 
require a statement on the label that the average woman should consume 
no more than 24 grams of sugar per day, and the average man should 
consume no more than 34 grams of sugar per day.
    (Response) We decline to revise the rule as suggested by the 
comments. In response to the comment that would include language to 
convey that the DRV is a maximum amount rather than a recommended 
amount, such language would not be appropriate because we do not 
require this information for other nutrients with DRVs or RDIs that are 
based on an amount not to exceed.
    As for a statement regarding ``no consumption,'' the current 
evidence does not support a need to eliminate all added sugars from the 
diet. In fact, the USDA Food Patterns show that one can carefully 
construct a healthful diet that includes calories from added sugars.
    Finally, regarding a statement on the label with limits for the 
amount of added sugars that the average man or woman should consume, we 
do not provide this information for any other nutrients which are to be 
limited in the diet, and it is not clear what the scientific basis is 
for the suggested limits.
    j. Variability in sugar content.
    (Comment 198) One comment noted that manufacturers may add varying 
amounts of sugars due to variation in maturity of a fruit or vegetable 
ingredient during the course of a growing season to attain a consistent 
level of soluble solids and a consistent taste profile of the food. The 
comment further said that food manufacturers and marketers would not 
prepare multiple labels for different batches, so the declared amount 
would reflect the highest possible amount of added sugars and may 
overstate the actual amount.
    (Response) Variation in the sugar content of fruits and vegetables 
due to growing conditions is something that manufacturers have had to 
take into account with their labeling of total sugars since 1993. 
Manufacturers are in the best position to determine how much of a 
nutrient is in their product given the variability of the nutrients in 
their product. They are also in the best position to determine when a 
label change is needed because the declaration would no longer be in 
compliance with our requirements under Sec.  101.9(g).
    k. Non-enzymatic browning and fermentation. In the preamble to the 
proposed rule (79 FR 11879 at 11906), we recognized that sugars in some 
foods may undergo changes mediated by chemical reactions from non-
enzymatic browning (i.e. Maillard reaction and caramelization) and 
fermentation that would result in compounds that are no longer 
recognizable or detectable as sugars through conventional analytical 
methods. We tentatively concluded that the amount of added sugars 
transformed during non-enzymatic browning reactions is insignificant 
relative to the initial levels of sugars. We also tentatively concluded 
based on the information available to us that the amount of added 
sugars present in foods prior to undergoing fermentation, with the 
exception of yeast-leavened bakery products, wines with less than 7 
percent alcohol by volume, and beers that do not meet the definition of 
a ``malt beverage'' as defined by the Federal Alcohol Administration 
Act (27 U.S.C. 211(a)(7)) with sugars added during the formation 
process, will not be

[[Page 33830]]

significantly affected by virtue of the food having undergone 
fermentation (79 FR 11879 at 11907). We acknowledged that we do not 
have adequate information to assess the degradation of added sugars 
during fermentation for yeast-leavened bakery products, wine with less 
than 7 percent alcohol by volume, and beers that do not meet the 
definition of a malt beverage with sugars added before fermentation. We 
requested the submission of available data and information on our 
tentative conclusions as well as the submission of data on the amount 
of variability that occurs among various types of products where added 
sugars are transformed into other compounds as a result of chemical 
reactions during food processing.
    The proposed rule, at Sec.  101.9(g)(10)(v), would require a 
manufacturer of yeast-leavened bakery products, wines with less than 7 
percent alcohol by volume, and beers that do not meet the definition of 
a malt beverage with sugars added before and during the fermentation 
process to make and keep records of added sugars necessary to determine 
the amount of added sugars present in the finished food. The proposed 
rule would require manufacturers of such foods to make and keep records 
of all relevant scientific data and information relied upon by the 
manufacturer that demonstrates the amount of added sugars in the food 
after fermentation and a narrative explaining why the data and 
information are sufficient to demonstrate the amount of added sugars 
declared in the finished food, provided the data and information used 
is specific to the type of fermented food manufactured. Alternatively, 
under the proposed rule, manufacturers would be able to make and keep 
records of the amount of added sugars added to the food before and 
during the processing of the food and, if packaged as a separate 
ingredient, as packaged. We said that the amount of added sugars 
declared should not exceed the amount of total sugars on the label (79 
FR 11879 at 11908).
    (Comment 199) One comment said that we have not demonstrated why 
distinguishing between a fermented added sugar and a fermented 
naturally occurring sugar or why the type of sugar that participates in 
reactions due to heat treatment improves the health of consumers. The 
comment questioned what the compelling government interest is in 
knowing which molecule of sugar participates in these reactions.
    (Response) To the extent that the comment is suggesting that our 
focus on added sugars is misplaced because added sugars are not 
chemically distinct from naturally occurring sugars and are not 
associated with health or the risk of disease, we respond to such 
issues in part II.H.3.i. We also have stated, in part II.H.3.a, that 
added sugars consumption is a significant public health concern which 
warrants mandatory declaration.
    (Comment 200) Several comments suggested that there are a wide 
variety of fermented foods (e.g., fermented vegetables, beverages, 
fruits, condiments, products made with grains and/or pulses, dairy 
replacement products, and meat products) and ingredients (e.g., 
vinegars, enzymes, vitamins, and amino acids in pure form or in 
mixtures) to which sugars are added, and where the sugars content is 
significantly diminished or entirely removed through fermentation. The 
comments also disagreed with our tentative conclusion that the amount 
of added sugars transformed by fermentation will be insignificant 
relative to the initial levels of sugars in foods and ingredients other 
than yeast-leavened bakery products, wines with less than 7 percent 
alcohol by volume, and beers that do not meet the definition of a malt 
beverage. The comments noted that the effect of fermentation is 
variable. According to the comments, the net effect can depend on 
details of the starting materials, fermentation process, and length of 
fermentation.
    Several comments noted that there are many processing and 
ingredient variables that influence the fermentation process in yeast-
leavened bakery products. The comments said that our assumption that 
manufacturers have information about reduction of added sugars in 
yeast-leavened bakery products is incorrect. One comment stated that, 
because manufacturers would be unable to determine the amount of added 
sugars consumed during fermentation in yeast-leavened bakery products, 
manufacturers would have to declare the amount of sugars added before 
leavening under the proposed rule, resulting in an overstatement of the 
amount of added sugars in the finished product, which is false and 
misleading.
    Other comments suggested that added sugars that are converted 
through fermentation to other compounds should be subtracted from the 
added sugars declaration, and any sugars produced during fermentation 
should be omitted from the declaration of added sugars.
    One comment suggested that proposed Sec.  101.9(g)(10)(v), which 
would permit manufacturers of yeast-leavened bakery products, wines 
with less than 7 percent alcohol by volume, and beers that do not meet 
the definition of a malt beverage to make and keep records of 
scientific data and information to demonstrate the amount of added 
sugars remaining in the finished food, when that amount is less than 
the initial amount of added sugars, be extended to all food 
manufacturers that must declare added sugars in the labeling of their 
products.
    Other comments disagreed with our tentative conclusion that the 
amount of added sugars transformed by non-enzymatic browning reactions 
will be insignificant relative to the initial levels of sugars. One 
comment provided the example of the manufacture of caramel. The comment 
suggested that this process converts sugars into thousands of new 
chemical compounds that include oligomers, dehydration and hydration 
products, disproportionation products, and colored aromatic products. 
The comment noted that the decrease in added sugars in a wide variety 
of products undergoing such chemical reactions may depend on the 
ingredients, moisture levels, presence of acids or bases, exposure to 
heat, etc., but that the decrease is not uniformly insignificant.
    (Response) Although comments said that the amount of added sugars 
converted to other compounds during fermentation and non-enzymatic 
browning is significant in a wide variety of foods, few comments 
provided data to support their conclusions. One comment provided 
information about the amount of sugars which are converted to other 
compounds in kimchi, a fermented vegetable product (Refs. 117-118). 
Another comment provided information about caramel candy (Ref. 119). In 
a memo to the file for the proposed rule (Ref. 120), we tentatively 
concluded that the amount of added sugars which are converted to other 
compounds through Maillard browning, a type of non-enzymatic browning, 
is insignificant. Although the comments generally disagreed with our 
conclusion that all products participating in non-enzymatic browning 
have an insignificant reduction in the amount of added sugars, no 
comments specifically disagreed with our conclusion about products that 
participate in Maillard browning. Therefore, in products affected by 
Maillard browning, the amount of sugars added before Maillard browning 
is a reasonable approximation of the amount of added sugars in the 
finished product in most, if not all, products.
    With the exception of the comment which cited caramelization as an

[[Page 33831]]

example of a non-enzymatic browning process where the reduction in the 
amount of added sugars present in a finished food could be significant, 
we did not receive any other specific data or information about foods 
that undergo non-enzymatic browning to support the comments' position 
that the amount of added sugars converted to other compounds is 
significant. Therefore, we expect that the amount of sugars added 
before non-enzymatic browning in these foods would be a reasonable 
approximation of the amount of added sugars in the finished product. We 
also expect that manufacturers of such products would be able to make 
and keep documentation to show a reasonable basis for how they 
determined the declared value for added sugars.
    We recognize that there may be a larger amount of variability in 
fermented products with respect to the amount of added sugars that are 
converted to other compounds. Although the comments provided examples 
of products that participate in fermentation, the comments provided 
very little data or information to support the assertion that the added 
sugars content is significantly reduced in a large number of fermented 
foods. We are aware of only a small number of fermented foods where the 
reduction in added sugars may significant (where the reduction in added 
sugars after fermentation may be significant enough to impact the label 
declaration for added sugars) after fermentation. Therefore, we expect 
that the majority of manufacturers would be able to use the amount of 
added sugars added as an ingredient as a reasonable approximation of 
the amount of added sugars in a serving of their product.
    If a manufacturer has a basis on which to support a declaration of 
added sugars based on the amount of added sugars present in a food 
after non-enzymatic browning or fermentation, the label declaration 
must be supported by records demonstrating the accuracy of the declared 
amount. The records should include all relevant scientific data and 
information relied upon by the manufacturer that demonstrates the 
amount of added sugars in the food after non-enzymatic browning and/or 
fermentation and a narrative explaining why the data and information 
are sufficient to demonstrate the amount of added sugars declared in 
the finished food.
    There may be a small number of foods which undergo non-enzymatic 
browning and/or fermentation for which manufacturers have reason to 
believe that the amount of added sugars in a serving of the finished 
food product is significantly less (i.e., where the reduction in added 
sugars after fermentation may be significant enough to impact the label 
declaration for added sugars) than the amount added prior to non-
enzymatic browning and/or fermentation, and the manufacturer has no way 
to reasonably approximate the amount of added sugars in a serving of 
the finished food. Therefore, we have revised Sec.  101.9(g)(10)(v)(C) 
to state that manufacturers may submit a petition, under Sec.  10.30 
(21 CFR 10.30), to request an alternative means of compliance. The 
petition must provide scientific data or other information for why the 
amount of added sugars in a serving of the product is likely to have a 
significant reduction in added sugars compared to the amount added 
prior to non-enzymatic browning and/or fermentation. A significant 
reduction would be where reduction in added sugars after non-enzymatic 
browning and/or fermentation may be significant enough to impact the 
label declaration for added sugars by an amount that exceeds the 
reasonable deficiency acceptable within current good manufacturing 
practice under Sec.  101.9(g)(6). In addition, the scientific data or 
other information must include the reason that the manufacturer is 
unable to determine a reasonable approximation of the amount of added 
sugars in a serving of their finished product and a description of the 
process that they used to come to that conclusion.
    We recognize that labeling of added sugars in products that undergo 
fermentation and non-enzymatic browning may not be exact, but 
manufacturers of most products that participate in these reactions 
should be able to provide a reasonable approximation of the amount of 
added sugars in a serving of their product based on information in the 
literature and their own analyses. Most manufacturers should be able to 
provide documentation to support the value that they declare on the 
label. Therefore, the majority of manufacturers of such foods will be 
able to provide a reasonable approximation of the amount of added 
sugars in a serving of their product as well as documentation showing a 
reasonable basis for how they determined the declared value.
    As some comments recommended, we agree that it is appropriate to 
allow manufacturers of all products which undergo non-enzymatic 
browning and/or fermentation to make and keep records of the type that 
we proposed. Therefore, we have revised Sec.  101.9(g)(v) to say that 
when the amount of sugars added to food products is reduced through 
non-enzymatic browning and/or fermentation, manufacturers must:
     Make and keep records of all relevant scientific data and 
information relied upon by the manufacturer that demonstrates the 
amount of added sugars in the food after non-enzymatic browning and/or 
fermentation and a narrative explaining why the data and information 
are sufficient to demonstrate the amount of added sugars declared in 
the finished food, provided the data and information used is specific 
to the type of food manufactured; or
     Make and keep records of the amount of sugars added to the 
food before and during the processing of the food, and if packaged as a 
separate ingredient, as packaged (whether as part of a package 
containing one or more ingredients or packaged as a single ingredient) 
and in no event shall the amount of added sugars declared exceed the 
amount of total sugars on the label; or
     Submit a petition, under Sec.  10.30, to request an 
alternative means of compliance. The petition must provide scientific 
data or other information for why the amount of added sugars in a 
serving of the product is likely to have a significant reduction in 
added sugars compared to the amount added prior to non-enzymatic 
browning and/or fermentation.
    A significant reduction would be where reduction in added sugars 
after non-enzymatic browning and/or fermentation may be significant 
enough to impact the label declaration for added sugars by an amount 
that exceeds the reasonable deficiency acceptable within current good 
manufacturing practice under Sec.  101.9(g)(6). In addition, the 
scientific data or other information must include the reason that the 
manufacturer is unable to determine a reasonable approximation of the 
amount of added sugars in a serving of their finished product and a 
description of the process that they used to come to that conclusion.
    (Comment 201) One comment noted that sugar content of products can 
be increased through hydrolysis and enzymatic reactions using 
carbohydrate containing ingredients. The comment questioned what the 
classification would be of the sugars (natural or added) produced by 
such reactions during food processing. The comment also noted that the 
possibility of having sugars produced ``in situ'' (meaning in place or 
in position) shows the difficulty of drawing a clear line between the 
two types of sugars.
    (Response) Sugars content can be increased through acid, heat, or

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enzymatic hydrolysis of complex carbohydrates (e.g. starch). Sometimes, 
the increase is incidental as a consequence of other food manufacturing 
processes, such as acidification, heating, and/or fermentation. For 
example, during yeast bread fermentation, natural enzymes present in 
the flour can hydrolyze starch into maltose. Other than sugar syrup 
types of products where the sugars are specifically and purposely 
produced via hydrolysis, we do not have information suggesting that 
sugars produced through incidental hydrolysis of complex carbohydrates 
results in a significant increase in the sugar content of foods. Sugars 
which are produced through incidental hydrolysis would be captured in 
the total sugars declaration, but we do not have any comments or other 
information suggesting that these sugars should be captured under the 
added sugars declaration. Therefore, they are not included in our 
definition of added sugars and would not be declared as added sugars on 
the label. In the previous example of the enzymatic hydrolysis of 
maltose from starch during bread fermentation, we would not require the 
maltose formed during this process to be declared as added sugar. 
However, sugar present in corn syrup produced from hydrolysis of corn 
starch would be considered added sugar because the hydrolysis was 
specifically done to generate mono- and di-glycerides. In addition, if 
a manufacturer purposely employs a hydrolysis step as part of a food 
manufacturing process to increase the sugar content of a food product 
(e.g. enzymatic hydrolysis of corn starch to make corn syrup in the 
same facility as part of the cookie-making process), we would consider 
the sugar generated from the hydrolysis step to be added sugars, since 
hydrolysis was purposely used by the manufacturer to increase the sugar 
content of the product.
    l. Impact on nutrient databases.
    (Comment 202) One comment said that we failed to provide a 
framework and/or an approved database that harmonizes implementation 
across industry. The comment also said that it is unclear how FDA-
approved databases would be revised in order to be used to calculate 
added sugars or to distinguish between amounts of naturally occurring 
sugars and added sugars, such as how to calculate the varying sugar 
content of a food that contains naturally occurring and added sugars 
given the common fluctuations in foods containing naturally occurring 
sugars.
    (Response) Under Sec.  101.9(g)(8), we allow for compliance with 
Sec.  101.9(g)(1) through (g)(6) by use of an FDA approved database 
that has been computed following FDA guideline procedures and where 
food samples have been handled in accordance with current GMPs to 
prevent nutrition loss. Our Guidance for Industry: Nutrition Labeling 
Manual--A Guide for Developing and using Data Bases, the manual 
provides generic instructions for developing and preparing an 
acceptable database, as well as the recommended statistical methodology 
to develop nutrition label values. The guide is based on doing 
laboratory analyses of food samples. Because added sugars and naturally 
occurring sugars are not chemically distinct, it is not possible to do 
a laboratory analysis to determine the amount of added sugars in a 
product that contains both naturally occurring sugars and added sugars. 
If a product contains only added sugars, the procedures outlined in our 
guidance could be used by manufacturers to develop a database of values 
for added sugars. However, if both naturally occurring and added sugars 
are present, manufacturers will have to use other information that they 
have to determine a label value. They will also have to make and keep 
records to support the declared value, as discussed in part II.H.3.p.
    With respect to calculating the varying sugar content of foods that 
contain naturally occurring and added sugars given seasonal variability 
and variability due to other growing conditions in products containing 
naturally occurring sugars, such as fruits and vegetables, 
manufacturers should know how much sugars they add to a product to 
account for the variability in the sugars naturally present in a food. 
They should be able to use the amount that they add to determine the 
value that they declare on the label. The variability in naturally 
occurring sugar content would not be a new variable for manufacturers 
to consider.
    m. International labeling guidelines.
    (Comment 203) Some comments noted that Codex Alimentarius 
Guidelines on Nutrition Labeling require the labeling of total, but not 
added sugars (Ref. 121). The comments said that our proposal to require 
the mandatory declaration of added sugars is not in line with 
international guidelines on nutrition labeling. The comments said that 
a revision of the Guidelines was undertaken by a working group within 
the Codex Committee on Food Labeling (CCFL) and discussed at the 38th 
Session of the CCFL (2010). The comments also said that, based on 
reports from that CCFL meeting, the Codex Committee considered the 
following evidentiary support for labeling only total sugars: (1) The 
body cannot differentiate between added sugars and total sugars in 
physiologic response; (2) the absence of any analytical differentiation 
between added and inherent sugars, which would create difficulties for 
enforcement; and (3) the importance of declaration of total sugars for 
certain populations including diabetics. The comment also said that the 
WHO advised that ``total sugars is the only practical way of labeling 
the sugars content of food since sugars cannot be distinguished 
analytically from intrinsic sugars.''
    Other comments said that no other country has adopted mandatory 
added sugars declarations as part of nutrition labeling of foods and 
beverages. The comments noted that the purpose of the Codex Guidelines 
on Nutrition Labeling is to promote fair trade through international 
harmonization in the approach to nutrition labeling.
    Other comments said that we need to be in compliance with the TBT 
Agreement, which insures that technical regulations ``do not create 
unnecessary obstacles to international trade.''
    Some comments referred to previous positions that we have taken 
with respect to Codex and said that our proposal to require the 
mandatory declaration of added sugars is a total reversal from those 
previous positions.
    (Response) The Codex standards are recommendations for voluntary 
application by countries. For nutrition labeling, the Codex Guidelines 
on Nutrition Labeling provide that where a nutrient declaration is 
applied, the declaration of total sugars should be mandatory. Although 
Codex does not state or imply that the declaration of added sugars 
should be mandatory, the guidelines provide for mandatory declaration 
when ``The amount of any other nutrient [is] considered to be relevant 
for maintaining a good nutritional status, as required by national 
legislation or national dietary guidelines.'' ((Ref. 121) at section 
3.2.1.4). We have determined that the declaration of added sugars in 
necessary to assist consumers in maintaining healthy dietary practices, 
consistent with our authority in section 403(q) of the FD&C Act for 
when the labeling of a nutrient is required. The provision of such 
information is necessary to achieve our legitimate objective of 
protecting human health. We have established elsewhere in this section 
that the mandatory declaration of the amount of added sugars in a 
serving of a product is necessary to protect human health because 
scientific evidence supports that healthy dietary patterns

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characterized, in part, by lower intakes of added sugars are associated 
with a decreased risk of CVD, sugar-sweetened beverage consumption is 
associated with adiposity in children, added sugars can lead to 
displacement of nutrient-dense foods in the diet, and intake data shows 
that Americans, on average, are exceeding the recommended limit for 
added sugars consumption. As such, our requirements to include the 
declaration of added sugars in nutrition labeling and for manufacturers 
to make and keep records of the amount of sugars they add to their 
products do not constitute an unnecessary obstacle to trade. Firms, 
whether domestic or foreign, must include an added sugars declaration 
on the label and must make and keep records, as appropriate, to verify 
the amount of added sugars in a product.
    Manufacturers already know how much sugar is added to their product 
based on the formulation or should be able to reasonably estimate the 
amount of sugars added in products that undergo non-enzymatic browning 
and fermentation. We also do not consider that the records we are 
requiring would be unnecessarily burdensome for manufacturers to make 
and keep (see part II.C.1).
    Our position on requiring the labeling of added sugars has 
developed in response to additional information that we did not have in 
the past. At the time that previous statements with respect to our 
official position on labeling of added sugars were made, the 2010 DGA 
and 2015 DGAC Report were not yet available. Based on information 
provided in the 2010 DGA and the 2015 DGAC Report, such as the 
underlying evidence used to support the 2015 DGAC conclusion that there 
is strong evidence that healthy dietary patterns characterized, in 
part, by lower intakes of sugar-sweetened foods or beverages are 
associated with a decreased risk of CVD and evidence that it is 
difficult to meet nutrient needs within calorie limits when individuals 
consume large amounts of added sugars, we had reason to revisit the 
requirement for a declaration of added sugars on the Nutrition and 
Supplement Facts labels in the proposed rule and in the supplemental 
proposed rule. We considered comments to the proposed rule and the 
supplemental proposed rule and have concluded that the evidence 
supports the mandatory declaration of added sugars on the label to 
fulfill the legitimate objective of protecting human health.
    With respect to the comments that suggest no other country has 
adopted mandatory labeling of added sugars, we note that the comments 
do not address the relevance of these circumstances with respect to our 
objectives and the scientific evidence before us.
    With respect to the comments on the evidentiary support considered 
by the CCFL on the reporting of added sugars, we have addressed these 
points in response to comments in this final rule. Furthermore, we 
require records, as appropriate, to verify the declaration of added 
sugars, and do not rely on analytical methods, as addressed by the WHO. 
In the six years since that decision, the evidence that has developed 
indicates that reporting of added sugars is of clear benefit in terms 
of public health.
    n. Definition of added sugars. Added sugars are not currently 
defined by regulation. We proposed to define added sugars in Sec.  
101.9(c)(6)(iii) as sugars that are either added during the processing 
of foods, or are packaged as such, and include sugars (free, mono- and 
disaccharides), syrups, naturally occurring sugars that are isolated 
from a whole food and concentrated so that sugar is the primary 
component (e.g. fruit juice concentrates), and other caloric 
sweeteners. We also clarified in preamble to the proposed rule (79 FR 
11879 at 11906) that the definition would include single ingredient 
foods such as individually packaged table sugar, and that sugar 
alcohols are not considered to be added sugars. We provided the 
following examples of names for added sugars: Brown sugar, corn 
sweetener, corn syrup, dextrose, fructose, fruit juice concentrates, 
glucose, high-fructose corn syrup, honey, invert sugar, lactose, 
maltose, malt sugar, molasses, raw sugar, turbinado, sugar, trehalose, 
and sucrose. We note that this is not an exhaustive list of all added 
sugars.
    Although some comments supported the proposed definition, other 
comments said that the proposed definition is ambiguous, confusing, and 
will lead to inconsistent application across the food industry. As 
discussed in the following responses to comments on the definition of 
added sugars, the final rule revises the definition of added sugars in 
Sec.  101.9(c)(6)(iii) that is specific and provides clarity on issues 
raised in the comments. As such, the definition of added sugars can be 
applied by the food industry in a consistent manner.
(i) Fruit and Vegetable Juice Concentrates
    (Comment 204) Many comments related to the inclusion of juices and 
juice concentrates in the definition of added sugars. Some comments 
suggested that the definition include sugars from fruit juice as well 
as fruit juice concentrate. However, many other comments disagreed with 
the inclusion of both fruit juices and fruit juice concentrates in the 
definition of added sugars. The comments said that 100 percent fruit 
juices, and 100 percent juice reconstituted from concentrate should not 
be considered to be added sugars. The comments suggested that fruit 
juice concentrates should be considered an added sugar only if they are 
not brought back to single strength by dilution with water in the 
product or by the end-user. One comment stated that 100 percent juice 
from concentrate and 100 percent juice not from concentrate are 
nutritionally identical, and there is no reason to require declaration 
of the added sugar content differently. One comment questioned why we 
are proposing to require different labeling for fruit juice depending 
upon whether it is a stand-alone product or an ingredient in another 
product. Another comment stated that a juice product formulated with 
juice that is reconstituted from a juice concentrate would appear as if 
it is making a greater calorie contribution because the juice 
concentrate would be deemed an ``added sugar'' when in fact, the 
calorie contribution of these two products is exactly the same. The 
comments argued that, if a juice product is sweetened with added 
sugars, the underlying juice before sweetening should not be considered 
an added sugar.
    (Response) Single strength or 100 percent fruit juices (which, for 
purposes of this document, we will refer to collectively as 100 percent 
fruit juice) contribute calories from sugars as well as nutrients. The 
comments did not provide data or other information to demonstrate that 
exclusion of information on sugars from fruit juices would be 
scientifically unjustified, potentially disadvantageous for consumers, 
and inconsistent with growing expert opinion and international 
approach. We note that sugars from 100 percent fruit juices have never 
been considered to be added sugars in the DGA. In fact, the USDA Food 
Patterns include 100 percent fruit juices in the fruit group, and the 
DGA has recommended increased consumption of fruits for many years 
(Refs. 28, 30, 78-83). It was not our intent to include the sugars from 
100 percent fruit and vegetable juices in the definition of added 
sugars in the proposed rule. Therefore, the final rule does not include 
100 percent fruit or vegetable juices in the added sugars definition.
    While fruit or vegetable juice concentrates can supply the same

[[Page 33834]]

nutrients as single strength or 100 percent fruit juice, they are a 
highly concentrated source of sugar. They may be used in small 
quantities for purposes other than to sweeten a food; however they are 
increasingly added to foods for sweetening purposes. They are 
identified in the ingredient list as concentrated fruit or vegetable 
juice. Some consumers could assume that the sugars that a concentrated 
fruit or vegetable juice contributes to a product are beneficial 
because they come from fruits or vegetables rather than from a more 
refined source. While foods sweetened with concentrated fruit or 
vegetable juices can be a part of a healthful diet, the sugars 
contributed by the concentrated fruit or vegetable juice provide 
additional calories to a product just as another source of refined 
sugar would provide additional calories. Over the course of the day, 
small amounts of calories in sugar-sweetened foods and beverages can 
add up and can make it difficult to balance the amount of calories 
consumed with the amount of calories expended. We consider foods 
sweetened with concentrated fruit or vegetable juices to be sugar-
sweetened foods. The 2015 DGAC concluded that healthy dietary patterns 
characterized, in part, by lower intakes of sugar-sweetened foods and 
beverages are associated with a reduced risk of CVD. Therefore, it is 
important for consumers to be aware that when products are sweetened 
with concentrated fruit or vegetable juices; the extra sugars and 
calories that they contribute to products are like any other source of 
added sugars. When added to foods for the purpose of sweetening, we 
consider the sugars in a fruit juice concentrated which are used for 
sweetening purposes to be added sugars.
    We recognize that juice concentrates may be added to food products 
in varying levels of concentration. For example, a product may use 
juice concentrate as an ingredient to achieve equivalent juice 
percentage as discussed in this section (e.g. a juice drink with 50 
percent juice) or at 100 percent juice (e.g. 100 percent juice, from 
concentrate) based on our juice percentage declaration regulation in 
Sec.  101.30 (also see our response to comment 205). An applesauce may 
have concentrated fruit juice added which has not been reconstituted at 
all. Because the nutrient profiles of fruit juice concentrates are the 
same as 100 percent fruit juices, we consider the amount of sugars 
above and beyond what would be contributed by the same volume of the 
same type of juice which is reconstituted to 100 percent juice to be 
added sugars. For example, if 15 grams of concentrated apple juice, 
which has 6 grams of sugars, is added to sweeten an applesauce and the 
same amount (15 grams) of 100 percent apple juice contains 1.7 gram of 
sugar, we would consider 4.3 grams of the sugars contributed to the 
applesauce (6 grams sugar in 15 grams apple juice concentrate 1.7 gram 
sugar in 15 grams 100 percent apple juice = 4.3 grams added sugars) by 
the apple juice concentrate to be added sugars. Another example to 
consider is an apple juice concentrate added to 100 percent pear juice 
for the purposes of sweetening. If 30 grams of apple juice concentrate, 
which contributes 10 grams of sugars is present in a serving of the 
finished product, the amount of added sugars which should be declared 
can be calculated by subtracting the amount of sugars present in 30 
grams of 100 percent apple juice (3.4 grams) from the amount of sugars 
present in 30 grams of the fruit juice concentrate (10 grams of sugar 
in 30 grams apple juice concentrate 3.4 grams sugar in 30 grams 100 
percent apple juice = 6.6 grams added sugars).
    Fruit juice concentrates made from 100 percent juice that are sold 
directly to consumers (e.g. in grocery stores or on the Internet) are 
typically reconstituted with water by consumers before consumption. The 
packaging of these fruit juice concentrates typically provides 
information about the amount of water that consumers should use to 
reconstitute the juice. Concentrated juice products must bear a 
percentage juice declaration and that declaration may not be greater 
than 100 percent (Ref. 122). The label may explain that when the 
product is diluted according to label directions, the product yields a 
``__ percent juice from concentrate,'' with the blank being filled in 
with the correct percentage based on the Brix values set out in 21 CFR 
101.30(h)(1), as applicable (Ref. 122). We expect that consumers will 
reconstitute these types of fruit juice concentrates to 100 percent 
juice based on the instructions provided on the label for 
reconstituting frozen fruit juice. Therefore, we do not consider 100 
percent juice concentrate sold directly to consumers as added sugar.
    Accordingly, we have revised the definition of added sugars to 
exclude frozen fruit juice concentrates from 100 percent juice and to 
include only additional sugars contributed by fruit juice concentrates 
not reconstituted to full strength to be declared on the label. This 
approach is consistent with our position that only the amount of sugar 
which is above and beyond what would be expected in the same type of 
100 percent juice is considered added sugar. However, concentrated 
juice cocktails, drinks, or beverages do not reconstitute to 100 
percent juice and often contain sweeteners, such as sugar and syrup. 
For these types of products, all sugar except the sugar from the juice 
ingredients should be declared as added sugar on the label.
    We note that we are also excluding fruit juice concentrates which 
are used to formulate the fruit component of jellies, jams, or 
preserves in accordance with the standard of identities set forth in 
Sec.  150.140 and Sec.  150.160 as discussed in our response to comment 
211.
    As for juice concentrates, juice concentrates may be added for many 
different purposes and they may have multiple functions in a food. For 
example, an orange juice concentrate could be added to a muffin batter 
to give it orange flavor, to add vitamin C, and to provide sweetness. 
If one purpose of adding the juice concentrate to a product is to 
provide sweetness, manufacturers should declare the amount of sugar 
provided from the juice which is in excess of what would be provided 
from the same volume of the same type of 100 percent juice as added 
sugars on the label.
    We are aware that there are syrup-like products made by 
concentrating fruit juice that has been processed specifically to 
remove organic acid, minerals, and insoluble fruit materials. These 
types of products are not fruit juice concentrates, but are fruit 
syrups. All of the sugar contents in these types of ingredients should 
be declared as added sugars on the label.
    We proposed to require manufacturers to make and keep records to 
verify the amount of added sugars in a serving of a product when the 
product contains both naturally occurring and added sugars. If a juice 
concentrate is added to a food and is not brought back to 100 percent 
juice, we are unable to determine how much of the sugars provided by 
the juice is in excess of what would be expected for the same volume of 
the same type of 100 percent juice, therefore, manufacturers of such 
products must include a calculation of how they determined the amount 
of sugars from the juice concentrate that contribute to the added 
sugars declaration. Because juice concentrates contain naturally 
occurring sugars, all manufacturers of products containing juices that 
are not brought back to 100 percent strength in the finished food must 
make and keep records to verify how they arrived at their determination 
of the amount of added sugars which are contributed by the concentrated 
juice.

[[Page 33835]]

    (Comment 205) Some comments noted that juice concentrates are 
commonly used to adjust the Brix levels of directly expressed juice, 
and these juice concentrates are not required to be reflected in the 
common or usual name of such juices under the regulation for beverages 
that contain fruit or vegetable juice (Sec.  102.33(g)(2)). The 
comments said that fruit juice concentrates are not added sugars if 
they qualify to be included in the percent juice declaration found on 
beverage labels. The comments asked us to clarify that added sugars do 
not include fruit or vegetable juice concentrates used to formulate 100 
percent juice or 100 percent juice blends, or dilute juice beverages, 
and do not include juice concentrates that are added to juices and 
dilute juice beverages to adjust soluble solids content in accordance 
with Sec.  102.33 (21 CFR 102.33) and the standards of identity in 
parts 146 and 156 (21 CFR parts 146 and 156).
    (Response) We do allow for the use of juice concentrates in the 
formulation of 100 percent juice, 100 percent juice blends, and diluted 
juice beverages under Sec.  101.30 (percentage juice declaration for 
foods purporting to be beverages that contain fruit or vegetable 
juice), Sec.  102.33 (beverages that contain fruit or vegetable 
juices), part 146 (requirements for specific standardized canned fruit 
juices and beverage), and part 156 (vegetable juices). For consistency 
with our current regulations, we agree that juice concentrates should 
be exempt from the definition of added sugars if they are: (1) Counted 
towards percentage juice declaration in accordance with Sec.  101.30 
for 100 percent juice and juice beverages (Sec.  102.33); and (2) used 
to standardize the Brix values of a single species juice consisting 
juice directly expressed from a fruit or vegetable in accordance with 
Sec.  102.33(g)(2). Therefore, we have revised the definition of added 
sugars to make an exception for juice concentrates which contribute to 
the percentage juice label declaration under Sec.  101.30 and for Brix 
value standardization under Sec.  102.33(g)(2).
    (Comment 206) One comment noted that, under the proposed definition 
for added sugars, a fruit juice concentrate that is 45 percent sugar, 
50 percent water, and 5 percent other components would not be 
considered an added sugar because sugar would not be the primary 
component. The comment said that this is a potential loophole that 
manufacturers could exploit.
    (Response) The comment is referencing the language in our proposed 
added sugars definition which would state that ``naturally occurring 
sugars that are isolated from a whole food and concentrated so that 
sugar is the primary component (e.g., fruit juice concentrates)'' are 
added sugars. We recognize that there could be fruit juice concentrates 
that do not have sugar as the primary component. Therefore, we have 
revised the definition of added sugars to remove the language regarding 
naturally occurring sugars that are isolated from a whole food and 
concentrated so that sugar is the primary component (e.g., fruit juice 
concentrates), and instead specifically listing the types of fruit 
juice concentrates that we consider to be added sugars.
(ii) Intended Purpose of Sweetening
    (Comment 207) Many comments argued that sugars are an ingredient 
which may have multiple functions in a food. The comments recommended 
that we exclude certain ingredients which are not added for the 
intended purpose of sweetening a food. Most comments suggested defining 
added sugars based on the intended use of the sugar which has been 
added and not exclusively on the nature of the product. The comments 
would define added sugars as the sum of all mono- and disaccharides 
that are added to a food for purposes of sweetening the food.
    Other comments said that, even when added as an ingredient in foods 
(as opposed to beverages), fruit juice concentrates are not always used 
for a sweetening purpose. One comment stated that apple juice 
concentrates can be added to produce a browning color as the food is 
heated and the sugars in the concentrate are caramelized. Many yogurt 
manufacturers, for example, use small amounts of fruit juice 
concentrates (such as carrot juice concentrate) in their yogurt 
products for purposes of coloring or flavoring. The comments suggested 
that fruit juice concentrates which are not used to sweeten a food not 
be counted as ``added sugars'' given that they: (1) Are not being used 
as a sweetener; (2) do not materially sweeten the product when used in 
the amounts necessary for their intended purpose of coloring or 
flavoring; and (3) only contain naturally occurring sugars derived from 
fruit.
    (Response) We acknowledge that fruit juice concentrates, sugars, 
honey, or syrups may be added for many reasons to a food, and they may 
have many affects in a food other than adding sweetness. As previously 
discussed in this part, we have evidence that excess calorie 
consumption from added sugars is a public health concern. In 
determining which sugars should be included in the definition of added 
sugars, we have considered the presence of added sugars as a component 
of dietary intake and whether it is consistent with the concept of 
empty calories, as discussed in the 2015 DGAC Report.
    (Comment 208) One comment recommended that mono and disaccharides 
from any pure (i.e. with no added sugars) fruit ingredient, such as 
juices, concentrates, fruit pieces, pulps, and purees should not count 
as added sugars if these ingredients are not added for sweetening 
purposes.
    (Response) We decline to revise the rule as suggested by the 
comment. We agree that whole fruit, fruit pieces, pulps, purees, 100 
percent fruit juices, and certain fruit juice concentrates should not 
be considered added sugars because they are nutrient rich and maintain 
the basic properties of a fruit, which is not considered to be an added 
sugar. We have, in the final rule's definition of added sugars, 
excluded whole fruits, fruit pieces, pulps, purees, and certain 
concentrated fruit juices that are reconstituted to full strength or 
that may be added to other fruit juices, jellies, jams, and preserves 
under our standards of identity. However, we consider other mono and 
disaccharides from fruit ingredients to be added sugars. Sugars from 
fruits as well as fruit juices can be isolated (removed from the 
fruit), concentrated (decreased in volume by removing water), and 
stripped of nutrients such that they are essentially sugars that 
provide a concentrated source of calories to a food without other 
redeeming qualities (e.g. fruit syrups). Therefore, we are not 
excluding all mono and disaccharides from any pure fruit ingredient.
    (Comment 209) Many comments opposed the inclusion of dried and 
concentrated dairy ingredients in the definition of added sugars. The 
comments explained that a number of dairy-based ingredients are 
isolated from milk and concentrated such that lactose, the naturally 
occurring sugar in milk, is the primary component. Examples of such 
ingredients include non-fat dry milk powder, dry whole milk, some forms 
of concentrated whey and dried whey, and milk and whey permeate. 
According to the comments, under the proposed definition of added 
sugars, the lactose in these dried and concentrated dairy ingredients 
would be considered an added sugar because it is the ``primary 
ingredient.''
    The comments also explained that lactose is not added to foods for 
the purpose of sweetening, and is instead added for other functional 
properties. Lactose contributes viscosity and mouthfeel, serves as a 
fermentation

[[Page 33836]]

source in yogurt, increases shelf-life, provides foaming properties 
which are beneficial for cakes and frozen desserts, and serves as an 
emulsifier in sausages, soups, sauces, beverages, and salad dressing. 
Milk and whey protein concentrates, some of which contain lactose as 
the primary component, are typically used to increase the protein 
content of foods or as salt replacers to reduce the amount of sodium in 
a broad range of foods because of their unique salt enhancement 
characteristics.
    The comments said that it would not be possible to make foods if 
lactose were used as the sole sweetener in the formulation, replacing 
the traditional sugar (e.g., sucrose). Lactose has about one sixth of 
the sweetness of sucrose. The amount of lactose required to achieve the 
same level of sweetness would compromise basic attributes of the 
product itself. For example, if lactose were added to a typical ice 
cream, the amount of lactose that would have to be added to sweeten the 
product would either depress the freezing point of the ice cream mix 
such that the product would not be able to freeze under normal 
conditions, or if it did freeze, would result in an extremely gritty 
texture defect which would make the product unacceptable to consumers.
    One comment said that the common and usual names for dairy 
ingredients would cause confusion with added sugars declarations. For 
example, according to the comment, we allow manufacturers to identify 
skim milk, concentrated skim milk, and nonfat dry milk as ``skim milk'' 
or ``nonfat milk'' in an ingredients listing. In addition, two nonfat 
yogurt products could be formulated to the same final product 
composition, and the ingredient statements for both could read ``nonfat 
milk and culture.'' However, under the proposed definition of added 
sugars, a yogurt made using fluid skim milk as the sole dairy 
ingredient would have no added sugars, while a yogurt made using nonfat 
dry milk powder as the sole source of dairy solids would have to 
declare added sugars on the Nutrition Facts label.
    One comment said that, when dry milk ingredients are added, 
consumers may be confused about the source of added sugar in the food 
if the food contains no obvious sweetener. For example, if a food with 
a dairy-based ingredient, such as nonfat dry milk or whey protein 
concentrate, would be required to declare the inherent lactose as added 
sugars on the Nutrition Facts label and the food contained no easily 
identifiable source of added sugars, consumers reading the ingredient 
list likely would not expect or recognize dairy ingredients as sources 
of ``added sugars.''
    The comments noted that dairy ingredients containing lactose may be 
added so that a dairy product meets the standards for identity. One 
comment stated that California's standard for fluid milk mandates 
higher milk solids than the Federal standard of identity, requiring the 
addition of nonfat dried milk or condensed skim milk containing 
lactose. The comment said that the lactose in these milk solids should 
not be considered an added sugar because it is not added for sweetening 
purposes. The comments also noted that for standardized dairy products 
such as milk and yogurt, current regulations do not require that a 
sweetener be added. The comments said that the exclusion of dairy-based 
ingredients as sweeteners in the standards is acknowledgement by FDA 
that the lactose in these dairy-derived ingredients is not primarily 
added to provide sweetness.
    (Response) Lactose is a major component of milk solids. Many common 
concentrated or dried dairy ingredients, such as nonfat dry milk and 
whey powder contain lactose as the primary component. We agree that 
many dairy ingredients, even though high in lactose, are not considered 
a source of added sugars. Dairy ingredients and nutritive carbohydrate 
sweeteners are often considered to be in two separate ingredient 
categories during food formulation. The proposed definition of added 
sugars captured such dairy ingredients because it included naturally 
occurring sugars that are isolated from a whole food and concentrated 
so that sugar (in this case lactose) is the primary component. We did 
not intend to capture dairy ingredients under this portion of the 
definition. Therefore, we have removed the language from the definition 
of added sugars stating that naturally occurring sugars that are 
isolated from a whole food and concentrated so that sugar is the 
primary component are added sugars.
    FDA regulations, at Sec.  168.122, establish a standard of identity 
for lactose. The standard of identity for lactose states that it must 
contain not less than 98 percent lactose, mass over mass (m/m), 
calculated on a dry basis. We have historically considered purified 
lactose as a sweetener as it is included in 21 CFR part 168 under 
sweeteners and table syrups. We consider lactose as defined in Sec.  
168.122 to be an added sugar. Lactose, as defined under Sec.  168.122 
would be captured under the definition of added sugars because it is a 
free disaccharide. Therefore, with the revised definition, dairy 
ingredients, except lactose as defined in Sec.  168.122, are not 
included in the definition of added sugars.
(iii) The ``No Added Sugars'' Nutrient Content Claim
    (Comment 210) Many comments argued that the proposed definition is 
inconsistent with the regulation for the ``no added sugars'' nutrient 
content claim in Sec.  101.60(c)(2) because the regulation recognizes 
that ingredients that contain sugars do not preclude the use of the 
claim unless the ingredients ``functionally substitute for added 
sugars.'' The comments noted that, if the definition of added sugars is 
not consistent with the ``no added sugars'' nutrient content claim 
regulation, products could conceivably bear ``no added sugars'' claims 
but have a gram amount of added sugars declared on the Nutrition Facts 
label, which would be confusing and misleading. One comment provided 
the example of a juice that is reconstituted from juice concentrate 
which meets the Brix standard for single-strength juices. The comment 
said that such a product can factually claim that it is 
``unsweetened'', but the manufacturer would have to disclose the amount 
of added sugars under the proposed rule.
    Other comments noted that in the 1993 preamble to our rule defining 
the ``no added sugars'' nutrient content claim, we clarified that 
sugars inherent in a product, such as those found in fruit juices, 
would not disallow a no added sugars claim. One comment further noted 
that we advised that ``the addition of water to a juice concentrate to 
produce a single strength juice would not preclude the use of a ``no 
added sugar'' claim; however the other conditions for the claim must 
still be met'' (see 58 FR 2328). The comment said that this statement 
makes it clear that the presence of a fruit juice concentrate in a food 
does not prevent the use of a no added sugar claim. Another comment 
suggested that, in addition to fruit juice concentrates that are 
reconstituted to single strength in 100 percent juices, juice blends, 
juice drinks, and juice drink blends also should be excluded from the 
definition of added sugars because doing so would align with the 
current definition of no added sugars.
    (Response) The comments expressed concern that fruit juice 
concentrates added to a single strength juice or dairy ingredients that 
are not added for the intended purpose of sweetening can currently bear 
the ``no added sugars'' claim, but sugars from the concentrated fruit 
juice or dairy ingredient would have to be declared as added sugars

[[Page 33837]]

under the proposed definition. We have revised the rule to exclude 
certain fruit juice concentrates that are added to juices and that 
dilute juice beverages to adjust soluble solids content in accordance 
with Sec.  102.33 and the standards of identity in parts 146 and 156. 
We are also excluding fruit juice concentrates that are reconstituted 
to 100 percent single strength juice. In addition, we have removed the 
language from the definition of added sugars which states that 
naturally occurring sugars that are isolated from a whole food and 
concentrated so that sugar is the primary component are added sugars. 
Therefore, dairy ingredients containing lactose, except lactose as 
defined in Sec.  168.122, are no longer captured under the definition 
of added sugars. With these revisions to the definition of added 
sugars, there is no longer a conflict between the definition of added 
sugars and the requirements for use of the ``no added sugars'' nutrient 
content claim.
    We decline to define added sugars based on the intended purpose of 
the ingredient as suggested by the comments because we are providing 
specifics of what we consider to be added sugars in the definition. In 
addition, in determining which sugars should be included in the 
definition of added sugars, we have considered the presence of added 
sugars as a component of dietary intake and whether it is consistent 
with the concept of empty calories, as discussed in the 2015 DGAC 
Report.
(iv) Fruit Jellies, Jams, and Preserves
    (Comment 211) Several comments suggested that fruit jellies, jams, 
and preserves not be considered as added sugars. The comments noted 
that fruit jellies, jams, and preserves are subject to standards of 
identity set forth in Sec.  150.140 and Sec.  150.160 and are 
manufactured using certain fruit and fruit juice ingredients in 
combination with added sugars. One comment suggested that it is 
appropriate for such ingredients, regardless of whether they are 
derived from cane sugar, fruit juice syrup, fruit juice concentrates, 
etc., to count towards an added sugars declaration when used as 
sweeteners. The comment said that characterizing fruit and fruit juices 
in jellies, jams, and preserves (before the addition of sweeteners) 
should be excluded from the definition of added sugar because they do 
not serve as sugar substitutes, and are not ``added'' to a food for 
purposes of sweetening a food.
    (Response) The definition of added sugars excludes fruits and 100 
percent fruit juices. However, sugars from certain fruit juice 
concentrates fall within what we consider to be added sugars. Because 
fruit juice concentrates may be used as ingredients in fruit jellies, 
jams, and preserves, we have excluded those fruit juice concentrates 
that are used in accordance with the standards of identity in Sec.  
150.140 and Sec.  150.160 from the definition of added sugars. However, 
any additional sugars that are added to the jelly, jam, or preserve 
would need to be declared as added sugars on the label.
(v) Dried Fruits
    (Comment 212) Some comments said that dried fruit added to a 
product should not be considered to be an added sugar.
    (Response) We agree that dried fruits which have not had any sugar 
added to them should not be considered to be an added sugar because 
they are essentially a dehydrated whole fruit and still retain the 
nutrients and other components of a whole fruit. However, if additional 
sugar is added to a dried fruit, the sugar added to the dried fruit 
must be declared on the label as added sugars.
(vi) Other Sugars/Sweeteners
    (Comment 213) One comment would exempt isomaltulose and D-tagatose 
from labeling as added sugars due to their effect on reducing the risk 
of dental caries. The comment said that the proposed declaration for 
added sugars would not allow for adequate information to be provided to 
the consumer about carbohydrates such as isomaltulose (a disaccharide) 
and D-tagatose (a monosaccharide) that are ``sugars'' from a regulatory 
standpoint, but at the same time have very different and beneficial 
physiological properties than traditional ``sugars.'' The comment noted 
that isomaltulose and D-tagatose are noncariogenic carbohydrate 
sweeteners, and products containing these sweeteners can bear the 
dietary noncariogenic carbohydrate sweeteners and dental caries health 
claim if they meet the requirements of Sec.  101.80. The comment also 
stated that these dental health benefits of isomaltulose and D-tagatose 
can also be the subject of a health claim under EU regulation 432/2012. 
The comment said that, aside from the dental health benefits, 
isomaltulose and D-tagatose are low-glycemic carbohydrate(s) resulting 
in a reduced blood glucose response and that this health effect is the 
subject of EU health claim 432/2012. The comment argued that such a 
health benefit provides the basis for a structure-function claim under 
the FD&C Act.
    (Response) We have recognized through our health claim for 
noncariogenic carbohydrate sweeteners and dental caries that the sugars 
D-tagatose and isomaltulose may reduce the risk of dental caries (tooth 
decay). However, D-tagatose and isomaltulose are chemically sugars. 
Because these sweeteners are chemically sugars, and other substances 
are included or excluded from the definition of sugars and added sugars 
based on whether they are a free mono or disaccharide rather than on 
their physiological effects, including D-tagatose and isomaltulose is 
consistent with how we have characterized other sugars. As such, we are 
not excluding D-tagatose and isomaltulose from the added sugars 
declaration. However, manufacturers may still use the noncariogenic 
carbohydrate sweeteners and dental caries health claims on their 
products to make consumers aware that sugars contained in a food may 
reduce the risk of dental caries.
    (Comment 214) Some comments would exclude Allulose (psicose) from 
the definition of added sugars because ketohexose sugars, such as 
Allulose, do not provide calories, are not metabolized, and do not 
raise blood sugar levels.
    (Response) As discussed in our response to comment 124, we received 
a petition on this subject after the comment period closed. We intend 
to address this issue at a later date when we have had time to consider 
the information presented in the petition.
    (Comment 215) Some comments stated that the proposed language, 
which states that ``other caloric sweeteners'' are considered added 
sugars, is confusing and unclear. One comment provided the example of 
applesauce, which can be used to replace oil in baking. In this 
example, unsweetened applesauce contains no added sugars, but can be 
used to both replace an oil and sweeten baked goods.
    (Response) We agree that the language that states that ``other 
caloric'' sweeteners are considered to be added sugars may not be clear 
to manufacturers or consumers. We have removed this language from the 
definition of added sugars because caloric sweeteners, which are 
chemically sugars, are free mono or disaccharides and are captured 
elsewhere in the definition.
(vii) Other Comments
    (Comment 216) Some comments noted that ingredients such as fruit 
juice concentrates, high fructose corn syrup, honey, and molasses 
contain significant amounts of water (e.g., 30 percent). The

[[Page 33838]]

ingredients may contain a range of naturally occurring constituents 
besides sugars (e.g., polysaccharides, anthocyanins, vitamins, 
minerals, etc.). Therefore, to avoid overstating the amounts of added 
sugars, the comments said that it is important to take into account the 
actual ``sugars'' content of the ingredients. The comments suggested 
adding language to clarify that the quantity of added sugars declared 
in labeling will include only the actual ``sugars'' portion of the 
ingredient.
    (Response) We agree that some ingredients containing sugars, such 
as syrups, contain water and other components that are not sugars, and 
that those components should not be considered as part of the added 
sugars declaration. Therefore, when such ingredients are included in 
foods, only the sugar portion of the ingredient should be declared on 
the label. The definition of added sugars states that free mono and 
disaccharides are considered added sugars, thus water and other 
components of sugar-containing ingredients are not added sugars and 
should not be declared as such. We have also revised the definition to 
say ``sugars from syrups'' to clarify that only the sugars component of 
the product should be declared as added sugars.
    (Comment 217) Several comments would not consider natural sources 
of sugar (e.g., honey or maple syrup) to be added sugars. One comment 
would exempt natural, unrefined honey and other natural liquid or semi-
liquid, unrefined, un-concentrated, whole-food sweetening agents 
because they are whole food products in an unrefined, un-concentrated, 
whole-food form. Conversely, the comment suggested that other 
sweeteners which are extracted, refined, and concentrated such as agave 
syrup, maple syrup, and evaporated cane juice syrup should be 
considered added sugars.
    (Response) We disagree that all natural sources of sugar which have 
not been processed or refined should not be considered added sugars. In 
determining which sugars should be included in the definition of added 
sugars, we have considered the presence of added sugars as a component 
of dietary intake and whether it is consistent with the concept of 
empty calories, as discussed in the 2015 DGAC Report. The processing 
history (e.g., concentration or refinement) does not entirely determine 
whether or not sugar in an ingredient is added sugar. For example, 
natural sources of sugar present in foods, such as whole fruits, 100 
percent juice, and dried fruits, are not considered added sugars 
because these foods are nutrient rich. However, products such as maple 
syrups or honey are included in the ``empty calories'' or ``calories 
for other uses'' category in the USDA Food Patterns. Therefore, we 
decline to exclude sugars from honey and maple syrup from the added 
sugars definition.
    (Comment 218) One comment stated that consistency is needed in the 
definition of added sugars across Federal Agencies as well as by 
scientists, health professionals, manufacturers, and others. The 
comment identified fruit juice concentrate as one example of 
inconsistency among Federal Agencies. The comment cited a paper on the 
development of USDA estimates of added sugars (Ref. 123).
    (Response) When establishing a regulatory definition for the 
purposes of nutrition labeling, we consider other regulatory aspects 
such as the impact on other regulations. We expect that establishing a 
regulatory definition of added sugars for the purpose of nutrition 
labeling will help other Federal Agencies and the scientific community 
in determining a definition for added sugars for Federal guidelines, 
programs, and research.
    (Comment 219) One comment would not consider incidental additives 
or flavors containing sugars, such as dextrose, which are not added for 
sweetness as added sugars.
    (Response) The comment did not explain what ``incidental 
additives'' are. However, we disagree that dextrose should be excluded 
from the definition of added sugars. Dextrose is a sugar, and, when 
added to a food, it acts in the same manner as other types of added 
sugars.
    (Comment 220) Some comments said it will be difficult for 
manufacturers to obtain information about added sugars content of 
sourced ingredients that they get from suppliers. The comments 
questioned whether ingredients used in the formulation that are not an 
isolated sugar but are part of a compound ingredient must be labeled. 
One comment noted that, aside from the ingredients used in traditional 
food processing, there are ingredients that are used in ``better for 
you'' formulated foods that would be required to be listed on the 
label.
    (Response) The added sugars declaration in the finished product 
includes added sugars present as sub-ingredients. For example, if a 
cookie product uses strawberry jams as an ingredient, the added sugar 
present in the strawberry jam would count towards the added sugars 
declaration for the finished cookie product. Manufacturers need to 
collect nutrient information for ingredients in their products from 
suppliers. Manufacturers have the ability to select which suppliers 
they use. If a supplier is not willing or able to provide information 
about the added sugars content of an ingredient, the manufacturer may 
wish to consider another supplier.
    With respect to the comment suggesting that manufacturers may have 
difficulty obtaining information about the added sugars content of 
``better for you'' formulated foods, manufacturers need to obtain 
information about the added sugars content of all ingredients in order 
to provide accurate labeling, regardless of whether they are used to 
formulate ``better for you foods.''
    (Comment 221) One comment would expand the added sugars definition 
to encompass all added sweeteners.
    (Response) It is not clear from the comment which sweeteners that 
the comment is suggesting are not included in an added sugars 
declaration. Therefore, we are not revising the added sugars definition 
in response to the comment.
    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
    (Comment 222) Many comments both to the proposed rule and the 
supplemental proposed rule discussed establishing a DRV that can be 
used to calculate a percent DV for added sugars as well as a mandatory 
declaration of a percent DV for added sugars on the label. Most 
comments favored establishing a DRV and requiring the percent DV 
declaration of added sugars. Many comments to the proposed rule 
recommended establishing a DRV for added sugars of 10 percent of 
calories, and provided several rationales to justify the suggested DRV. 
The comments said that, since the 1977 Dietary Goals, health officials 
have consistently recommended an upper limit of 10 percent of calories 
from added sugars. The comments referred to the WHO recommended limit 
of 50 grams or 10 percent of total calories from added sugars and the 
American Heart Association recommendation to limit added sugars 
consumption to 25 grams per day for women and 37.5 grams per day for 
men. The comments also noted that the 1992 USDA Food Guide Pyramid 
suggested an upper limit of 6, 12, and 19 teaspoons of sugars, 
respectively, for diets of 1,600, 2,200, and 2,800 calories, 
respectively. This comes to 7, 10, and 13 percent of calorie

[[Page 33839]]

intake, respectively, for an average of 10 percent of total calories 
from added sugars. One comment said that the 2010 DGA stated that no 
more than 5 to 15 percent of calories should come from a combination of 
solid fats and added sugars. The comment stated that this implies that 
added sugars should be less than 10 percent of calories. Another 
comment quoted a pediatric endocrinologist who says that a ``dose'' of 
added sugars of up to 50 grams a day poses little risk for metabolic or 
chronic disease, but that the amount consumed by Americans is toxic.
    One comment to the proposed rule suggested that the discretionary 
calorie allowance from the USDA Food Patterns presented in the 2005 DGA 
could serve as a basis for a DRV. The comment suggested that, using the 
food patterns provided in the 2005 DGA at the 2,000 calorie level, one 
would have a limit of 267 discretionary calories to use on solid fats 
and added sugars (assuming no alcohol consumption). The discretionary 
calorie allowance could be divided equally between solid fats and added 
sugars resulting in a limit of no more than 133 calories, 33 grams, or 
8 teaspoons of added sugars per day. This would result in a DRV for 
added sugars of 6 percent of total calories.
    Other comments in favor of a percent DV declaration suggested that 
a percent DV declaration is necessary for consumers to be able to put 
the amount of added sugars in a serving of a food into the context of 
their total daily diet. The comments said that, without a DV, consumers 
could only compare the relative amounts of added sugars among products, 
but would not know how much of a day's worth of added sugars a food 
contains. The comments said that the percent DV advises the consumer of 
how much of a recommended intake of that nutrient is provided by a 
particular food. The comments also suggested that a percent DV 
declaration could help parents and other caregivers make informed 
decisions about the food products children consume and be more 
confident that their intake of added sugars does not exceed healthy 
daily limits. One comment provided survey data showing that consumers 
would like to have a DV for added sugars on the label.
    Many comments supporting a mandatory declaration of a percent DV of 
added sugars also suggested that the information is necessary because 
added sugars consumption is associated with the risk of chronic 
diseases and health-related conditions such as diabetes, CVD, and 
metabolic syndrome.
    One comment noted that the 2014 IOM workshop summary on Health 
Literacy and Health Numeracy documents that most Americans have limited 
numeracy skills, and disparities exist in those skills. The comment 
further stated that providing simpler, clearer food labeling 
information is needed to reach a larger segment of the population, and 
suggested that providing a percent DV declaration may be an easier way 
for consumers with limited numeracy skills to understand an added 
sugars declaration.
    In contrast, many comments opposed establishing a DRV for added 
sugars and the mandatory declaration of a percent DV for added sugars. 
The comments said there is no scientific basis upon which to base a DRV 
for added sugars. Other comments said that we should not establish a 
DRV for added sugars or require the percent DV declaration for added 
sugars because the declaration of any information related to added 
sugars is not scientifically supported. The comments' rationale relates 
to our basis for requiring an added sugars declaration, and we address 
those topics are provided elsewhere in this part.
    The comments also opposed the mandatory declaration of a percent DV 
for added sugars because sugars are converted to other products during 
processing (caramelization, Maillard browning, and fermentation), and 
thus the amount declared on the label may be inaccurate for some 
products. (We respond to comments pertaining to non-enzymatic browning 
and fermentation in part II.H.3.k and have determined that it is 
possible for manufacturers of products which undergo these chemical 
reactions to provide a reasonable approximation of the amount of added 
sugars in a serving of their product.)
    Many comments also said that added sugar is not a necessary 
nutrient and should be avoided or should not be consumed in any amount. 
The comments said that it is inappropriate for us to recommend the 
consumption of any amount of added sugars in the diet. One comment 
suggested that added sugars should be viewed similarly to trans fats 
because they are not essential in the diet and are detrimental to 
health. The comment said that we should not set a recommended level of 
added sugars because, like trans fats, Americans should be consuming as 
little added sugars as possible in their diet.
    One comment said that a percent DV declaration for added sugars 
just confuses the public, many of whom have diabetes, and should be 
focused on their intake on total carbohydrates rather than sugars or 
added sugars. Another comment said that, because there are no studies 
which support the proposed value, if the value is determined to be 
incorrect at a future date, it will remain in the public's mind long 
after it has been proven to be incorrect.
    (Response) Consumers need to know how much added sugars are in a 
serving of a product in order to maintain healthy dietary practices. As 
discussed in part II.H.3, our rationale for the declaration of added 
sugars for the general U.S. population is focused on assisting 
consumers in maintaining healthy dietary practices by providing the 
information that consumers need to construct a healthful dietary 
pattern that meets nutrient needs within calorie limits and is 
associated with a decreased risk of chronic disease. While the gram 
declaration for added sugars gives consumers the information that they 
need to construct a healthy dietary pattern that is low in added 
sugars, it does not provide the information that they need in order to 
put the amount of added sugars in a serving of a product in the context 
of their total daily diet. The gram amount of added sugars also does 
not give consumers the information that they need to determine if a 
food is relatively high or relatively low in added sugars or a frame of 
reference that they can use to determine how to include a food in their 
overall diet. The percent DV declaration provides that missing piece of 
information that will allow consumers to more easily compare products 
and determine the relative contribution that a serving of a food will 
provide towards their diet.
    After publication of the proposed rule, the 2015 DGAC recommended 
that Americans limit their consumption of added sugars to a maximum of 
10 percent of total calories (Ref. 19). The 2015 DGAC based this 
recommendation on modeling of dietary patterns, current added sugars 
consumption data, and a published meta-analysis on sugars intake and 
body weight. We considered the evidence that the 2015 DGAC relied on in 
making this recommendation, and tentatively concluded in the 
supplemental proposed rule that limiting consumption of added sugars to 
10 percent of daily calories is a reasonable goal for consumers to 
achieve and would assist consumers in choosing and maintaining a 
healthful dietary pattern. We proposed to require the mandatory 
declaration of a percent DV for added sugars, and we proposed a DRV of 
50 grams for added sugars for children and adults 4 years of age and 
older from which the percent DV can be calculated. The DRV of 50 grams 
is determined by first multiplying the 2,000 reference calorie intake 
by 10

[[Page 33840]]

percent (2,000 x 0.1 = 200 calories) and then by dividing the resulting 
200 calories by 4 calories per gram for carbohydrates (200 / 4 = 50 
grams). We proposed a DRV of 25 grams of added sugars for children 1 
through 3 years of age. A 1,000 calorie reference amount would be used 
to calculate the DRV for children under the age of 4 (1,000 calories x 
0.1 = 100 calories and 100 calories / 4 calories per gram for 
carbohydrates = 25 grams).
    Before proposing a DRV for added sugars, we considered the 
approaches suggested in comments to the proposed rule for establishing 
a DRV of 10 percent of total calories for added sugars, but declined to 
accept the comments' various approaches for supporting a DRV of 10 
percent of calories from added sugars because the approach provided a 
recommended limit for added sugars, which was not based on total added 
sugars information (e.g. the WHO recommendations which are based on 
``free sugars'' and include fruit juices), because it is not clear how 
the recommended limits were derived and whether they were based on any 
scientific data or evidence (i.e., AHA recommendation and 
recommendation from an endocrinologist), or because the 2015 DGAC 
provided updated USDA Food Patterns that are specific to added sugars, 
unlike previous editions of the USDA Food Patterns included in the 
1992, 2005, and 2010 DGAs.
    With respect to the comments suggesting that we do not have a 
scientific basis to establish a DRV for added sugars, we have a 
recommended limit for added sugars of no more than 10 percent of total 
calories that was developed using food pattern modeling. We address 
these issues later in this part.
    We want to clarify that the DRV for added sugars should not be 
viewed as a recommended amount for consumption. The percent DV 
declaration for nutrients, which is calculated based on the DRV or RDI, 
represents a reference value that serves as a general guide to 
consumers. It would be inappropriate to view all DRVs and RDIs as 
recommended amounts to consume because some are based on amounts to 
limit (e.g., sodium and saturated fat) while others are based on 
amounts that individuals should strive to consume (e.g., calcium and 
potassium). Furthermore, individuals have varying nutrient and calorie 
needs, so consumers may need more or less of a particular nutrient 
based on their specific nutrient needs. As such, consumers with higher 
calorie needs can consume more added sugars in their diet relative to 
individuals with lower calorie needs.
    While consumers are interested in seeing a DV for added sugars on 
the label, as discussed in part II.C.1, consumer interest alone cannot 
be used to justify a label declaration. There is a need for a percent 
DV declaration for added sugars so that consumers can put the amount of 
added sugars in a serving of a product into the context of their total 
daily diet so that they can meet nutrient needs within calorie limits 
and construct a healthy dietary pattern that is associated with a 
reduced risk of CVD.
    We disagree with the comment suggesting that we should take the 
same approach that we have taken with trans fat and not establish a DRV 
for added sugars because Americans should be consuming as little added 
sugars in their diets as possible. The current evidence on added sugars 
does not show a linear relationship with chronic disease risk, and 
therefore, the evidence does not support limiting added sugars to as 
little in the diet as possible, similar to current recommendations for 
trans fat. In fact, individuals can carefully incorporate limited 
amounts of added sugars into a healthy diet. The USDA Food Patterns 
suggest that individuals who need between 1,000 and 3,200 calories per 
day can reasonably consume between 4 to 9 percent of their calories 
from added sugars and still meet their nutrient needs within calorie 
limits.
    As for the assertion that a percent DV declaration for added sugars 
will confuse the public, the comments did not provide evidence to 
support the assertion. Some comments submitted consumer research that 
included a percent DV declaration for added sugars in the labels, and 
the participants were shown the percent DV declaration. However, the 
research did not isolate the effect of the percent DV declaration from 
that of the gram amount declaration, so it is not possible to determine 
if the effects seen in those studies were due to confusion about a 
percent DV declaration for added sugars or more generally about 
information on the label related to added sugars. Other consumer 
research showed that participants reported similar responses about 
percent DV declarations for saturated fat and for added sugars, which 
suggests that a percent DV declaration for added sugars may not have 
specifically caused the confusion shown in the research. In both cases, 
it is unclear what conclusions related to confusion about a percent DV 
declaration for added sugars can be drawn from the evidence provided in 
comments.
    With respect to the suggestion that, if the DRV for added sugars is 
determined to be incorrect later, the DRV will remain in the public's 
mind long after it has been proven to be incorrect, a change in the 
science related to added sugars in the future should not prevent us 
from establishing a DRV at this time that is based on currently 
available evidence. Science evolves over time, and it is possible that 
we could have additional evidence in the future that would lead us to 
re-evaluate the DRV for added sugars. In fact, we are updating DRVs and 
RDIs for a number of different nutrients on the label based data and 
information that has become available since 1993.
    (Comment 223) Some comments to the proposed rule recommended that 
we commission the IOM to review the evidence and recommend a figure 
that could be used as the basis for a DV. The comments suggested that a 
quantitative limit will help consumers reduce added sugars by giving 
them a specific target or goal to work towards.
    (Response) We have evidence that added sugars are a public health 
concern, and a percent DV declaration that is calculated based on a DRV 
for added sugars will assist consumers in putting the amount of added 
sugars in a serving of a product into the context of the total daily 
diet. We also have scientific evidence to support limiting calories 
from added sugars to less than 10 percent of calories that can be used 
to establish a DRV. We are acting on the evidence that we currently 
have available to us because a percent DV declaration for added sugars 
is important to assist consumers in maintaining healthy dietary 
practices.
    (Comment 224) Some comments opposed establishing a DRV and 
requiring the mandatory declaration of a percent DV for added sugars 
when we have not established a DRV for total sugars. The comments said 
that establishing a DRV and requiring the percent DV declaration for 
added sugars without a DRV or percent DV declaration for total sugars 
will cause confusion. One comment questioned our conclusion that there 
is adequate evidence to establish a DRV for added sugars but not total 
sugars, especially when much data used to support the declaration of 
added sugars was based on research looking at total sugars. Another 
comment said that a percent DV declaration for total sugars is more 
important than one for added sugars because a percent DV for added 
sugars does not represent the true caloric or metabolic contributions 
of sugars to a food product.

[[Page 33841]]

    (Response) As discussed in the preamble to the proposed rule (79 FR 
11879 at 11902), we do not have a reference value upon which we can 
derive an appropriate DRV for total sugars. The IOM has not set a UL 
for sugars. We also do not have scientific evidence to support a 
reference value for total sugars from another U.S. consensus report. 
However, we have considered the scientific evidence that supports the 
2015 DGAC recommendation (which we note is also included in the 2015-
2020 DGA) to limit calories from added sugars to no more than 10 
percent of calories. Although this reference level is different than 
other scientifically supported quantitative intake recommendations that 
have been used to establish DRVs and RDIs for other nutrients, it was 
derived from food pattern modeling of a healthy dietary pattern that is 
low in added sugars. We are focusing on what healthy dietary patterns 
look like and what information is needed for consumers to construct a 
healthy dietary pattern. The USDA Food Patterns that support limiting 
consumption of calories from added sugars to less than 10 percent of 
calories per day, are examples of the type of healthy dietary pattern 
that consumers could use to reduce their risk of disease. Therefore, 
although a limit of calories to no more than 10 percent of calories 
provides a reference value that is different than other scientifically 
supported quantitative intake recommendations, it was derived using a 
dietary pattern approach, which is consistent with our basis for 
requiring the declaration of added sugars on the label.
    In response to the comments suggesting that consumers will be 
confused if there is a percent DV declaration for added but not total 
sugars, the comments did not provide data or other information to 
support this assertion. A declaration of the gram amount of sugars has 
been on the label for over 20 years without a declaration of a percent 
DV for sugars, so consumers are familiar with the information that will 
be on the label for total sugars.
    With respect to the comment stating that it is more important to 
require a percent DV declaration for total rather than added sugars 
because a percent DV for added sugars would not represent the true 
caloric or metabolic contributions of sugars to a food product, we have 
concluded that consumption of too many added sugars has health 
implications. Consumers need specific information on how much added 
sugars is in a serving of a product and the contribution that a serving 
of a product makes towards the total daily diet.
    To the extent that comments are suggesting that we should be able 
to establish a DRV for total sugars because much evidence which is 
being used to support an added sugars declaration is on total sugars, 
we disagree. Total sugars includes both naturally occurring and added 
sugars. Although a small number of the studies that we are relying on 
to support an added sugars declaration included fruit juices, which 
contain naturally occurring sugars, the vast majority of the evidence 
was on only added sugars, or on foods and beverages to which sugars 
have been added. Furthermore, we are basing the DRV on food pattern 
modeling and not on the Chapter 2 analysis related to dietary patterns 
and health outcomes.
    Although we do not currently have a reference value that can be 
used to establish a DRV for total sugars, information could become 
available in the future that may cause us to reconsider.
    (Comment 225) One comment said that we should not require a percent 
DV declaration for added sugars because other countries have evaluated 
added sugars and have concluded that the declaration of added sugars 
should not be mandatory as there is little evidence to support such 
identification.
    (Response) We address similar comments related to the declaration 
of the gram amount of added sugars on the label in part II.H.3.
    (Comment 226) Some comments suggested that additional research 
needs to be conducted to determine how much added sugars is harmful 
before establishing a DRV for added sugars or requiring a percent DV 
declaration on the label.
    (Response) We disagree that additional research on added sugars 
should be conducted before we establish a DRV for added sugars or to 
require a percent DV declaration on the label. Although a linear 
relationship has not been established between added sugars intake and 
risk of disease upon which a UL can be based, we do have evidence 
showing that consumption of too much added sugars is harmful to health. 
We also have scientific evidence that supports limiting added sugars 
consumption to less than 10 percent of calories that includes modeling 
of healthy dietary patterns.
    (Comment 227) One comment, as part of its argument that the 
declaration of added sugars information is not material and provides no 
added importance to consumer product purchase or use decisions, stated 
that, based on its own research of our eye-tracking study data, 
participants spent statistically significantly less time on added 
sugars than on carbohydrate on the Proposed label and spent 
statistically the same amount of time on carbohydrate and added sugars 
on the Proposed label as that on carbohydrate on the Current label. The 
comment also asked how we made the distinction between participants' 
attention on carbohydrate and on added sugars on the proposed label. 
Another comment questioned whether adding percent DV for added sugars 
will increase consumer attention to the added sugars declaration, 
including the percent DV for added sugars. The comment stated that, 
although percent DV for added sugars was not specifically tested in our 
eye-tracking study, the study showed that: (1) There were no 
statistically significant differences between the current and the 
proposed formats in the proportion of participants who noticed percent 
DV information or the share of time they spent on the information; and 
(2) the added sugars declaration received relatively little attention 
(on the proposed label). The comment concluded that these results 
suggest that the percent DV information receives low priority from 
consumers or the information is not prominent or easy to understand and 
it is not clear if including the percent DV for added sugars will 
enhance consumer attention to the added sugars declaration.
    (Response) We disagree that our eye-tracking study findings on the 
percent DV information and on added sugars declaration mean that adding 
percent DV for added sugars will not increase consumer attention to the 
added sugars declaration. Our study did not include a percent DV for 
added sugars on any labels tested, did not compare participants' 
responses to a label with a percent DV declaration for added sugars and 
responses to a label without such a declaration, and did not examine 
participants' attention to this percent DV information. Therefore, the 
cited findings cannot be used to infer the amount of attention the 
percent DV for added sugars would receive by consumers if and when it 
is present on labels. We also disagree that one can infer from our eye-
tracking study findings that an added sugars declaration, including the 
percent DV, is of no value to consumers. Our decision to require the 
declaration is not determined by how much attention it receives from 
the study participants. Instead, we are requiring the declaration of 
added sugars on the label because consumers need the information in 
order to maintain healthy dietary

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practices. We clarify that, in our eye-tracking study, the label 
element ``carbohydrate'' on the Proposed label included these areas of 
the label: Total carbohydrate, dietary fiber, sugars and protein. 
``Added sugars'' was considered in the study as a separate area on the 
label.
(ii) DRV of 10 Percent of Total Calories From Added Sugars
    In the supplemental proposed rule, we proposed to establish a DRV 
for added sugars of 10 percent of total calories (50 grams for children 
and adults 4 years of age and older and 25 grams for children 1 through 
3 years of age). The scientific evidence from the 2015 DGAC Report 
supports Americans keep added sugars intake below 10 percent of total 
energy intake, based on modeling of dietary patterns, current 
consumption data, and a published meta-analysis on sugars intake and 
body weight (80 FR 44303 at 44308). We concluded that the scientific 
information from the 2015 DGAC Report provides a basis for FDA to 
establish a DRV for added sugars. The 2015 DGAC relied on both food 
pattern modeling information from the USDA Food Patterns as well as 
information from the Te Morenga et al. paper for their recommendation 
to limit added sugars to a maximum of 10 percent of total daily caloric 
intake.
    (Comment 228) One comment cited work sponsored by ILSI North 
America that suggests a lack of strong evidence for a dietary 
recommendation to limit added sugars to no more than 10 percent of 
calories. The comment cited reviews by ILSI North America related to 
dental caries and BMI which led it to conclude that frequency of 
consumption of fermentable carbohydrates is a driver of dental caries 
along with oral hygiene, exposure to fluoride, and salivary flow and 
composition and that sustained overconsumption of energy, irrespective 
of the energy sources, leads to weight gain. The comment concluded from 
the evidence reviewed that the scientific evidence is lacking with 
respect to quantifying a level of sugar or added sugar relative to 
health outcomes.
    (Response) The comment provided a review of the evidence related to 
a specific relationship between intake of added sugars and risk of 
disease. As discussed in our response to comment 224, we are 
establishing a DRV for added sugars using a different type of intake 
recommendation than what has been used for other nutrients with a 
linear relationship with disease risk, which was developed primarily by 
food pattern modeling. Our rationale for requiring the mandatory 
declaration of added sugars relates to consuming a healthy dietary 
pattern that meets nutrient needs within calorie limits and is 
associated with a decreased risk of chronic disease. The food pattern 
modeling that was done for the USDA Food Patterns provides a conceptual 
framework for selecting the kinds and amounts of foods of various 
types, which together, provide a nutritionally satisfactory diet. 
Therefore, the scientific evidence that supports limiting calories from 
added sugars to less than 10 percent of calories per day that was 
derived from food pattern modeling is related to our basis for 
requiring the mandatory declaration of added sugars for the general 
population, which is focused on consumption of a healthy dietary 
pattern.
    (Comment 229) Several comments recommended that the IOM re-evaluate 
the added sugars intake recommendations. The comments said that the IOM 
is the appropriate body to establish a DRI upon which to base a DRV for 
added sugars because:
     The scope of work for the IOM DRI committees is 
specifically to develop the DRIs, which are intended to inform 
nutrition labeling;
     The DRI process provides a rigorous and methodological 
process to determine nutrient values used in nutrition labeling and 
includes guidance on when a percent DV may be established;
     The IOM DRI considers the risks of adverse effects 
associated with low as well as high nutrient intakes;
     The IOM adheres to a structured risk assessment approach 
to ensure that the evidence is systematically and consistently 
evaluated; and
     The IOM ensures and fosters transparency in decision-
making.
    The comments said that we have based all other DRVs on the IOM DRI 
reports. The comments noted that more than a decade has passed since 
IOM concluded in 2005 that, based on the data available on dental 
caries, behavior, cancer, risk of obesity, and risk of hyperlipidemia, 
there is insufficient evidence to set a daily intake for total and 
added sugars or to set an upper limit for added sugars. The comments 
said that the process the DGAC used to develop its recommendations did 
not have the scientific rigor of the IOM process. The comments 
recommended that we defer any final rule, especially changes related to 
the declaration of added sugars, until the IOM can review the available 
evidence and develop a DRI for added sugars.
    (Response) While the IOM has been the source of data that we have 
relied upon when setting other DVs, it is not the only source of 
information on which we can rely. While we recognize that a DRV that is 
derived primarily based on food pattern modeling is different from a UL 
that is determined by IOM, a DRV based on food modeling is a valid 
approach that provides consumers with a tool that they can use to help 
them put the amount of added sugars in a serving of a product into the 
context of their total daily diet. In response to the comments 
suggesting that the process that is used by the IOM to set ULs is more 
scientifically rigorous than food pattern modeling, the IOM process is 
different than food pattern modeling, but we have the ability to use 
different approaches to set DRVs based on the information we have 
available to us if the information will assist consumers in maintaining 
healthy dietary practices.
    We also disagree with the comment stating that all other DRVs were 
established based on IOM DRI reports. Some DRVs were set based on 
scientific evidence from consensus reports or by other means. In the 
Reference Daily Intakes and Daily Reference Values proposed rule, we 
proposed to establish eight DRVs for persons 4 or more years of age 
based on information presented in the ``Diet and Health: Implications 
for Reducing Chronic Disease Risk report,'' the ``Surgeon General's 
Report on Nutrition and Health,'' and the ``Report of the Expert Panel 
on Population Strategies for Blood Cholesterol Reduction'' (55 FR 29476 
at 29483). The DRVs were finalized in the 1993 Reference Daily Intakes 
and Daily Reference Values final rule (58 FR 2206, Jan. 6, 1993).
    As new evidence emerges, we will consider whether we need to update 
the DRV. In the future, there may be more information available that 
would allow us to establish a DRV for added sugars that is based on a 
linear relationship with the risk of disease. We intend to monitor the 
evidence related to added sugars and consider whether changes need to 
be made to the label based on the evidence in the future.
    (Comment 230) One comment referred to the DGA recommendation that 
Americans consume fatty fish due to their omega-3 fatty acid content, 
but noted that there is no reference value for omega-3 fatty acids. The 
comment said that added sugars are no different than omega-3 fatty 
acids and suggested that added sugars can be reduced in the diet, even 
while there is not sufficient evidence to recommend that they be 
limited to a particular intake level.
    (Response) We do not agree that omega-3 fatty acids are an 
appropriate comparison to added sugars. For

[[Page 33843]]

example, we do not have scientific evidence to support a reference 
value for omega-3 fatty acids. We include a reference value for added 
sugars in the final rule to provide information that allows consumers 
to put the amount of the nutrient into the context of the total daily 
diet.
(iii) Food Pattern Modeling
    (Comment 231) Food pattern modeling was used to support the 2015 
DGAC recommendation that Americans should limit added sugars to a 
maximum of 10 percent of total caloric intake. For the 2015 DGAC, USDA 
used a modeling process to develop new USDA Food Patterns based on 
different types of evidence: The ``Healthy Vegetarian Pattern,'' which 
takes into account food choices of self-identified vegetarians, and the 
``Healthy Mediterranean-style Pattern,'' which takes into account food 
group intakes from studies using a Mediterranean diet index to assess 
dietary patterns. The USDA Food Patterns provide suggested amounts of 
foods to consume from the basic food groups, subgroups, and oils to 
meet recommended nutrient intakes at 12 different calorie levels. They 
also show the number of calories from solid fats and added sugars that 
can be accommodated within each calorie level, in addition to the 
suggested amounts of nutrient-dense forms of foods in each food group.
    Many comments questioned the use of food pattern modeling to 
establish a DRV for added sugars. The comments noted that, when we 
considered establishing a DRV for trans fat using menu modeling, we 
said that we continue to adhere to the approach of determining DRVs for 
a nutrient based on the nutrient's association with a specific health 
outcome (e.g., LDL cholesterol levels), yet we proposed to use food 
pattern modeling to establish a DRV for added sugars rather than data 
on an association with a health outcome. The comment noted that we 
stated previously in the proposed rule, as well as in 1993, that we do 
not consider the use of food composition data, menu modeling, or 
dietary survey data as a suitable approach to determine DRVs. The 
comments explained that menu modeling involves individual foods, 
whereas food pattern modeling involves food group composites, but the 
process for menu and food pattern modeling is similar. The comments 
said that the issues that we raised for not using menu modeling for 
setting a DV for trans or saturated fat are the same for a food pattern 
modeling approach and would therefore apply to added sugars.
    (Response) Although we have stated in the past that use of food 
composition data, menu modeling, or dietary survey data is not a 
suitable approach to determine DRVs, these statements were made in the 
context of establishing DRVs for nutrients where a causal relationship 
between consumption of the nutrient and risk of disease exists. Added 
sugars are different than trans fats in that there is a linear 
relationship between consumption of trans fats and LDL cholesterol 
whereas, for added sugars we do not have the type of direct association 
with risk of disease, based on the evidence we are using to support a 
mandatory declaration of added sugars for the general U.S. population, 
that we do with trans fats. When a linear relationship with disease 
risk is present, there are other, more appropriate, ways to establish a 
DRV for the nutrient. Because the current evidence supports more of a 
dietary pattern approach than a specific nutrient-disease approach, it 
is appropriate to use methods for the development of a DRV for added 
sugars that are based on constructing a healthy dietary pattern that is 
low in added sugars. The food pattern modeling that was done when 
developing the healthy U.S.-style, the healthy Mediterranean-style, and 
healthy vegetarian patterns provides a model of what a healthy dietary 
pattern should look like at different calorie levels. Therefore, the 
use of food pattern modeling to support a DRV for added sugars is 
closely aligned with our rationale for requiring the mandatory 
declaration of added sugars for the general U.S. population on the 
label.
    (Comment 232) Some comments noted that the 2010 DGA states that the 
USDA Food Patterns are only one example of suggested eating patterns 
and that the USDA Food Patterns have not been scientifically tested for 
health benefits.
    (Response) We acknowledge that the USDA Food Patterns are only one 
example of a healthy eating pattern and that it is possible for 
individuals to consume other patterns that are associated with a 
decreased risk of disease. However, analyses using diet quality index 
scores show that there is a great deal of consistency in what is 
considered a healthy dietary pattern that is associated with a 
decreased risk of disease (Ref. 86). Although it is possible to eat 
other healthy dietary patterns, it would be very difficult to meet 
nutrient needs within calorie limits by consuming enough of the other 
components of a healthy dietary pattern while consuming high levels of 
added sugars.
    We also recognize that individuals may be able to accommodate more 
or less than 10 percent of calories in their diet while meeting 
nutrient needs within calorie limits. The purpose of a percent DV is to 
provide context to consumers so that they can determine how a food fits 
within their diet. The percent DV declaration can also allow for 
consumers to determine if a product is relatively high or low in a 
nutrient based on a reference amount. Therefore, a DRV of 10 percent of 
total calories should not be viewed as a recommended consumption level, 
but rather a reference amount that consumers can use as a guide.
    We disagree with the comment that the USDA Food Patterns have not 
been scientifically tested for health benefits. Schroeder et al. 
assessed the effects of a diet based on the USDA Food Patterns used in 
the 2010 DGA, a Korean diet, and a typical American diet on blood lipid 
(fat) levels and blood pressure in overweight, non-Asian individuals in 
the United States with elevated LDL cholesterol (Ref. 101). They found 
that total cholesterol and LDL cholesterol significantly decreased when 
subjects were on fed a diet that is consistent with the USDA Food 
Patterns. Although the USDA Food Patterns in the 2015 DGAC Report 
differ slightly from those included in the 2010 DGA, they were designed 
in a very similar manner with the goal of meeting nutrient needs within 
calorie limits.
    (Comment 233) Some comments objected to the use of food pattern 
modeling to establish a DRV for added sugars because, according to the 
comments, it lacks a scientific basis. The comments said that the 
reference value of 10 percent of total calories that the 2015 DGAC 
produced using modeling is a mathematical calculation of empty calories 
``left over'' after the recommendations for food groups and nutrients 
in the different dietary patterns have been met. It does not signify a 
level at which negative metabolic effects occur. The comments asserted 
that the calories available for solid fats or added sugars in the 
``empty calories'' category would completely change based on one 
addition or deletion of a serving of food.
    The comments cited a number of limitations of food pattern 
modeling, such as:
     It is not evidence-based or nutrient specific so 
conclusions cannot be drawn with respect to health-related outcomes;
     It was designed to study the impact of an overall diet, 
not to evaluate the effect of a single nutrient;
     The nutritional adequacy was derived from a limited number 
of

[[Page 33844]]

representative foods, limiting the ability to extrapolate the 
nutritional adequacy of the food patterns beyond these ``representative 
foods;''
     Table sugar was used as a surrogate for added sugar in the 
USDA Food Patterns. As such, the model only identifies how much pure 
sugar can be consumed after achieving nutrient requirements, and not 
how to incorporate foods with added sugars into a dietary pattern;
     The modeling is based on a misperception that added sugars 
provide no additional nutritional value and are merely ``empty 
calories.'' Sugars are added to many nutrient-dense foods;
     The contribution of the representative foods to total 
daily added sugar intake was not considered or reported;
     It presents one modeling scenario with one set of 
assumptions and presents no uncertainty around their assumptions. 
Micronutrient requirements in the USDA Food Pattern are not always 
based on established intakes i.e., the USDA Food Patterns calcium 
intakes can range from 110 percent of the RDA at the lower calorie 
range to 138 percent of the RDA at the highest, the RDA range for iron 
is 110 to 265 percent. As caloric levels increase, there is a disregard 
for the percent adequacy of micronutrients;
     The model did not test if nutritional adequacy could be 
achieved at added sugar intake levels above 10 percent and was not 
tested to assess efficacy or sensitivity;
     The USDA food modeling (with few exceptions) does not take 
into consideration fortification in the food supply, which could 
dramatically reduce the number of food servings in the USDA Food 
Patterns and increase the calories designated as leftover; and
     Food formulations and food consumption is continually 
changing. With continuing changes to food composition databases, 
information derived from food pattern modeling could change frequently. 
Using such changing information to update daily values could be costly 
to manufacturers for frequent changes to labels especially when based 
on an approach that has no public health relevance. The comment said 
that we chose, in part, to not use similar type data (i.e., census 
data) for using a population weighted approach for setting daily values 
for vitamins and minerals.
    (Response) As previously noted in our response to comment 224, we 
do not have the type of quantitative intake recommendation for added 
sugars that we have for other nutrients that have an independent 
association with the risk of chronic disease. However, we do have 
evidence that added sugars are a public health concern, and that 
consumers need information about of added sugars in a serving of food 
to maintain healthy dietary practices. Consumers also need to know how 
that amount of added sugars in a serving of food fits into the context 
of their total daily diet. Although we do not have the same type of 
reference amount for added sugars that we do for other nutrients that 
are associated with chronic disease risk, the scientific evidence 
supporting a limit in consumption of added sugars to a maximum of 10 
percent of total calories provides a reference value that can be used 
to give context to the gram declaration for added sugars. The DRV, in 
general, should not be viewed as a precisely defined limit, but rather 
a guide to help consumers when selecting foods and determining how much 
of those foods they can eat within a healthful diet.
    We recognize that empty calories allotment in the USDA Food 
Patterns represents an amount that is left over once all other 
requirements of the diet are met. We also recognize that conclusions 
related to health outcomes cannot be drawn from food pattern modeling. 
However, the dietary patterns approach to setting a DRV is consistent 
with the dietary pattern approach that we are taking to the evidence 
that we have considered to support the mandatory declaration of added 
sugar. Rather than basing the declaration on a nutrient-disease 
relationship, we are considering how a dietary pattern that is lower in 
added sugars is characterized, in part, by lower intakes of sugar-
sweetened foods and beverages.
    We disagree with the comment that said that the USDA Food Patterns 
were designed to study the impact of an overall diet and not to 
evaluate the effect of a single nutrient. The USDA Food Patterns were 
not designed to study nutrient or diet/disease relationships. They 
provide a conceptual framework for selecting the kinds and amounts of 
foods of various types, which together, provides a nutritionally 
satisfactory diet. The USDA Food Patterns assist Americans in meeting 
their nutrient requirements based on different caloric needs. In 
general, food patterns, such as the USDA food patterns, translate 
recommendations on nutrient intake into recommendations on food intake 
based on selective nutrient-dense foods.
    During the modeling of the USDA intake patterns, 292 representative 
foods were chosen in order to provide healthy food intake patterns to 
meet nutrient needs for various age/sex groups of Americans ages 2 
years and older within their calorie limits. We disagree with the 
comment stating that the contribution of the representative foods to 
total daily added sugar intake was not considered or reported. About 7 
percent of these representative foods contain some added sugars (Ref. 
124). For all added sugars in the USDA food patterns, the nutrients in 
granulated white sugar were used for the nutrient profile; however, 
this does not limit the application of the information for use as a 
DRV. While sugars are added to many nutrient-dense foods, and the 
assumption is made for the purposes of the USDA Food Patterns that the 
sugars do not come along with other nutrients, they provide a way to 
identify how much added sugars one could consume in various forms in 
the diet while meeting nutrient needs within calorie limits. The empty 
calorie allotment in the USDA Food Patterns gives Americans a general 
sense of how many calories from added sugars they can incorporate into 
a nutrient-dense diet without exceeding calorie limits. It is up to 
each individual to determine if he or she wants to consume those extra 
calories in the form of a food that is nutrient dense (e.g., cereal, 
yogurt, or dried fruit with sugar added to them) or whether to consume 
it in a less nutrient-dense form such as a cola. The Nutrition Facts 
label also provides factual information that consumers can use to make 
choices about their diet.
    With respect to the suggestion that micronutrient requirements in 
the USDA Food Patterns are not always based on established intakes, we 
agree. Instead, they are based on nutrient requirements for specific 
age and sex groups. However, the nutrient profiles of the food groups 
and subgroups used to construct the USDA Food Patterns are calculated 
and weighted by consumption of the U.S. population. It is not clear 
what the comment meant when it said that, as caloric levels increase in 
the USDA Food Patterns, there is a disregard for the percent adequacy 
of micronutrients. To the extent that the comment is suggesting that at 
higher calorie levels, the amounts of nutrients provided in the USDA 
Food Patterns exceed nutrient recommendations, as long as the food 
pattern does not exceed the UL for nutrients, it should not be a 
concern if the USDA Food Patterns exceed nutrient recommendations.
    In developing the dietary intake patterns, USDA built nutrient 
adequacy in its dietary pattern by selecting a nutrient-dense food to 
represent each item cluster (Ref. 19). The selection of item clusters 
is based on the

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consumption amount of the U.S. population (more than 1 percent of the 
weighted amount). A limited number of the representative foods for an 
item cluster were fortified foods. These fortified representative foods 
were selected when fortification of the food is mandatory, such as 
folate in enriched cereal grains, the food is typically fortified, or 
when the market leader for the food is fortified and its consumption in 
the population was consistent over time. Most nutrients in the USDA 
Food Patterns come from non-fortified food sources. It is possible 
that, if other fortified foods are used as representative foods in the 
model, the quantities of foods in the USDA Food Patterns may increase 
or decrease thereby increasing or decreasing the empty calorie 
allotment. The USDA Food Patterns are a theoretical model that is used 
to help Americans put the dietary recommendations into practice. The 
amount of added sugars that could be reasonably consumed while eating a 
healthy dietary pattern may be slightly more or less depending on the 
foods included when modeling the dietary patterns; however, they show 
that, across calorie levels, it would be very difficult to consume 
significantly more than 10 percent of calories as added sugars while 
still consuming enough foods from the food groups to meet nutrient 
needs within calorie limits.
    We agree that nutrient intake data can be affected due to factors 
such as nutrient database changes, reformulation, or change of dietary 
behaviors. This is a limitation with the use of all intake data, and 
affects evidence that we rely on for other label declarations as well 
(e.g., assessment of nutrient adequacy when determining what the 
nutrients of public health concern are). The DRV of 10 percent of 
calories from added sugars is based on the data that we have available 
to us at this time. We plan to monitor intake data and other evidence 
and information on added sugars and will consider whether and how it 
affects both an added sugars declaration and a DRV for added sugars in 
the future.
    (Comment 234) The 2015 DGAC Report explains that, for purposes of 
the USDA Food Pattern Food Groups, the term solid fats and added sugars 
is an analytic grouping, but the 2015 DGAC elected to use the term 
``empty calories'' for the food grouping in the USDA Food Patterns 
which includes solid fats and added sugars. The empty calorie allowance 
in the USDA Food Patterns is 8 to 19 percent of calories, and, based on 
current consumption patterns, 45 percent of empty calories were 
allocated to limits for added sugars with the remainder (55 percent) 
allocated to solid fats.
    Some comments opposed the assignment of 45 percent of empty 
calories to added sugars based on current consumption data. The 
comments said that consumption data changes, so the assignment of 45 
percent of calories to added sugars could change. Furthermore, the 
comments noted that Americans are consuming too many calories from 
added sugars, so using current consumption data to set a limit for 
added sugars consumption is inappropriate. One comment said that 
current intake of solid fats and added sugars has no relevance to the 
intended use of the USDA Food Patterns (e.g., nutrient density). The 
intent is for these leftover calories to be used at the discretion of 
the individual as to how they consume these calories all added sugars, 
all solid fats, or a combination. The comments also said that the 
assignment of 45 percent of calories to added sugars in the USDA Food 
Patterns is not linked to a health-related outcome or a healthy diet.
    (Response) We agree that consumption data changes and the 
designation of 45 percent of empty calories to added sugars could 
change. Consumption of added sugars could change in the future, which 
may prompt a change to the recommendations and the how empty calories 
from solid fats and added sugars are divided in the USDA Food Patterns. 
If changes are made to the USDA Food Patterns in the future related to 
added sugars, we will consider whether and how those changes impact the 
DRV for added sugars. We also acknowledge that Americans are currently 
consuming too much added sugars, so the assignment of 45 percent of the 
empty calories allotment could reflect overconsumption. However, 
Americans also are consuming too many solid fats, so the relative 
proportion of empty calories assigned to both solid fats and added 
sugars reflects overconsumption of both components of the diet. 
Although the empty calorie allotment is intended to be used by 
Americans based on their discretion, using consumption data to provide 
a percentage of empty calories from solid fats and added sugars can be 
consumed within a healthy dietary pattern reflects how Americans 
currently are using those left over calories. The modeling of dietary 
patterns for the USDA Food Patterns is done for a different reason than 
to evaluate a dietary pattern for health-related outcomes, so the 
assignment of 45 percent of calories to added sugars is not expected to 
be linked to a health-related outcome. However, we disagree that the 
assignment of 45 percent of calories to added sugars is not associated 
with a healthy diet. The purpose of the USDA Food Patterns is to assist 
consumers in putting intake recommendations for nutrients, foods, and 
food groups into practice so that they can construct a healthful diet. 
After nutrient needs are met, the left over calories are empty calories 
which Americans can choose to consume in the form of solid fats and/or 
added sugars. Therefore, how the empty calorie allowance was derived 
was based on getting adequate amounts of nutrients from a variety of 
foods in the diets to make up a healthy diet.
    (Comment 235) One comment said that we should not base a DRV for 
added sugars on the USDA Food Patterns because they have not been 
validated. The comment noted that, although the 2015 DGAC Report states 
that an extensive effort was made to validate the food patterns, the 
DGAC did not actually test the patterns in a clinical study. Instead, 
it plotted the USDA food groups against those found in published 
hypothesis-based dietary pattern studies on a graph. The comment 
questioned whether the data provided by USDA to support a validation of 
the USDA food patterns is empirical evidence that the USDA food 
patterns are evidence-based guides for food consumption because, the 
comment said, the majority of food group intakes from the USDA Food 
Patterns do not actually fall within the range of intakes in the 
published dietary pattern study recommendations and because the 
majority of dietary pattern index studies used for the exercise did not 
included added sugars criteria.
    (Response) The comment is suggesting that the USDA Food Patterns 
are not evidence based guides for food consumption and have not been 
validated because it is comparing them to dietary pattern studies where 
dietary quality indices are used to evaluate dietary patterns and 
health outcomes. Comparing the USDA Food Patterns, which have been 
developed through the process of menu modeling, to studies evaluating 
certain dietary patterns and health outcomes is not an appropriate way 
to assess the validity of the USDA Food Patterns. The USDA Food 
Patterns have been developed to be used as an example of a 
nutritionally adequate and balanced diet. Although the purpose is not 
to provide an example of a diet that is associated with decreased risk 
of disease, Schroeder et al. did assess the effects of the USDA Food 
Patterns from the 2010 DGA and found that total and LDL cholesterol 
were significantly lower in participants on the 2010 DGA diet

[[Page 33846]]

compared to typical American diet (Ref. 101). The proper assessment of 
the USDA Food Patterns is to consider whether they meet current dietary 
recommendations. The 2015 DGAC evaluated the Healthy U.S.-style, 
Mediterranean-style, and Vegetarian-style Patterns and determined that 
they meet nutritional goals without excess calories, and use a variety 
of foods (Ref. 19).
    (Comment 236) In the preamble to the supplemental proposed rule (80 
FR 44303 at 44307 through 44308), we noted that the 2015 DGAC based its 
recommendation that Americans limit their added sugars intake to no 
more than 10 percent of total energy intake, in part, on current 
consumption data. For many of the same reasons that comments opposed 
the use of current consumption data to allocate 45 percent of available 
empty calories in the USDA Food Patterns to added sugars, some comments 
generally opposed the use of current consumption data to support a DRV 
of 10 percent of total calories. The comments noted that consumption of 
added sugars has been declining in recent years although the prevalence 
of overweight and obesity have increased. One comment said that intake 
data do not support ``added sugars'' intake as a major source of 
increased caloric intake. The comment said that, in the past 40 years, 
U.S. per capita consumption of sugar/sucrose declined by 33 percent as 
obesity and other serious diseases increased. The comment noted that a 
recent analysis of U.S. National Health and Nutrition Examination 
Survey (NHANES) data found that ``added sugars'' consumption has 
declined to 14.6 percent of energy, which is a decrease of 19.3 percent 
over a period of 8 years (2000 to 2008) and as the 2015 DGAC noted 
intake continues to decrease and current intake is now 13.4 percent of 
energy. The comment also said that, according to USDA data, Americans 
are consuming 425 more calories per person per day than they did in 
1970 and of these 425 calories only 38 calories are attributed to 
``added sugars'' intake (2009).
    Other comments said that a maximum limit for added sugars should 
not be based on consumption data but rather on science with meaningful 
endpoints. While current intake of added sugars (13 percent of 
calories) is above but near a maximum level of 10 percent of calories, 
suggesting that this current intake makes 10 percent a reasonable goal 
is also not a health-based approach for setting a maximum intake level. 
The comments noted that current average intake of sodium is 
approximately 3,400 mg/day, but that the IOM panel set the upper level 
at 2,300 mg/day based on a public health outcome, even though they said 
it is generally agreed this is not a reasonable intake level that can 
be achieved in the near future. The comments said that current intakes 
are used to estimate prevalence of overconsumption by comparing to a 
maximum intake level tied to an adverse outcome rather using current 
intake to set the maximum intake level.
    (Response) Americans are still consuming 13.4 percent of their 
calories from added sugars, which is a significant proportion of 
calories. Despite the fact that consumption of added sugars may have 
declined in recent years, consumption among the U.S population remains 
high. While current consumption data was a consideration in the 2015 
DGAC's recommendation, it was used more to show that limiting calories 
from added sugars is a reasonable goal for Americans to strive for than 
it was to establish a precise limitation. Furthermore, current 
consumption data was not the only information that was used by the 2015 
DGAC to support a recommendation to limit added sugars to a maximum of 
10 percent of total calories. Information from the USDA Food Patterns 
showing that one can reasonably accommodate approximately 4 to 9 
percent of calories in a diet that meets nutrient needs within calorie 
limits as well as data information from a published meta-analysis, also 
supported the 2015 DGAC's recommendation.
    We explain, in our response to other comments in part II.H.3.o, 
that we are considering how added sugars interact with other components 
of a healthy dietary pattern. When too many added sugars are consumed, 
it makes it difficult to meet nutrient needs within calorie limits and 
it also makes it difficult for one to consume the recommended amount of 
other foods that make up a healthy dietary pattern that is associated 
with a decreased risk of CVD. Because our basis for requiring the 
mandatory declaration of added sugars on the label for the general U.S. 
population is related to consumption of a healthy dietary pattern that 
is low in added sugars, it is appropriate to establish a DRV that is 
based, in part, on information derived from modeling of healthy dietary 
patterns. The IOM has not set a UL for added sugars so we do not have a 
maximum intake level tied to an adverse outcome to which we can compare 
current intake levels. The USDA Food Patterns show that it would be 
difficult for Americans to consume a nutritionally adequate diet within 
calorie requirements if they are consuming more than 4 to 9 percent of 
their calories from added sugars. Because Americans are consuming 
approximately 13.4 percent of their calories, or even more in some 
segments of the population, the evidence supports that Americans are 
consuming too many calories from added sugars.
    (Comment 237) Some comments questioned our reliance on findings and 
recommendations in the 2015 DGAC Report for establishing a DRV for 
added sugars. The comments asked whether we took the conclusions and 
recommendations from the 2015 DGAC at face value or whether we 
conducted our own rigorous review of the scientific evidence. The 
comments (which were submitted in response to the proposed rule before 
the 2015 DGAC Report became available) said that the DGAC Report has 
not yet been sanctioned by the Secretaries of Health and Human Service 
and the U.S. Department of Agriculture, which are under Congressional 
mandate to ensure that the general dietary guidance for the American 
public in the DGA is based on the preponderance of scientific and 
medical knowledge at the time of the report. The comments noted that 
the Secretaries not only consider the recommendations in this advisory 
report to ensure the Dietary Guidelines are based on the preponderance 
of science and medical knowledge, but also take into consideration 
public comment, a process that has not yet been completed. The comments 
said that our reliance on information and conclusions from the DGAC 
Report is setting a new precedent.
    Other comments said that the DGAC was not convened with the purpose 
and intent of establishing specific reference values for labeling. The 
comments noted that the 2015 DGAC did not include a carbohydrate and/or 
``added sugars'' expert. The comments suggested that a robust review by 
carbohydrate and sugars experts familiar with the entire body of high-
quality scientific literature is necessary for establishing a reference 
value for added sugars. The comments said that the lack of ``added 
sugars'' expertise on the DGAC not only calls into question the 
legitimacy of the DGAC's ``added sugars'' upper daily intake limit 
intake recommendation, but also disputes the validity of the 2015 DGAC 
Report as a ``consensus report'' from which we can establish a DRV.
    One comment said that the IOM recommendations are based on thorough 
and systematic reviews of the scientific literature; a process that 
usually takes 2 to 3 years to complete by experts in the field of 
investigation. The comment said that the DGAC did not conduct a

[[Page 33847]]

thorough review of the evidence to determine its recommendation to 
limit consumption of added sugars to less than 10 percent of calories. 
The comment said that the DGAC did not convene the Added Sugars Working 
Group until a few months before the DGAC process concluded. The comment 
suggested that, because the Added Sugars Working Group was not 
established earlier on, the DGAC had only 90 days to collect, review, 
synthesize and formulate conclusions on the extensive body of 
literature on sugars, with no experts in carbohydrate metabolism on the 
2015 DGAC.
    (Response) Since the publication of the supplemental proposed rule, 
the Secretaries of the U.S. Department of Health and Human Services and 
the U.S. Department of Agriculture released the 2015-2010 DGA (Ref. 
28). During the process of developing the 2015-2020 DGA, government 
officials considered the recommendations from the 2015 DGAC as well as 
comments from the public. The scientific evidence in the 2015-2020 DGA 
related to added sugars corroborates the scientific evidence in the 
2015 DGAC. The scientific evidence supports limiting calories from 
added sugars and saturated fats and reducing sodium intake. Americans 
can achieve this by consuming an eating pattern low in added sugars, 
saturated fats, and sodium as well as by cutting back on foods and 
beverages higher in these components to amounts that fit within healthy 
eating patterns. A healthy eating pattern accounts for all foods and 
beverages within an appropriate calorie level and limits saturated fats 
and trans fats, added sugars, and sodium. The scientific evidence, from 
the 2015 DGAC (that is corroborated by the 2015-2020 DGA) supports the 
recommendation from the 2015 DGAC for Americans to consume less than 10 
percent of calories per day from added sugars. Therefore, because the 
2015-2020 DGA is in agreement with the 2015 DGAC, the concern related 
to us basing an added sugars declaration on the evidence from the 2015 
DGAC have been addressed.
(iv) The Te Morenga et al. Meta-Analysis
    (Comment 238) The 2015 DGAC reported that its recommendation to 
limit added sugars to a maximum of 10 percent of total daily caloric 
intake is supported by scientific evidence on added sugars and chronic 
disease risk conducted by the DGAC. The 2015 DGAC Report also says that 
the data analyzed by Te Morenga et al. supports limiting added sugars 
to no more than 10 percent of daily total energy intake based on lowest 
versus highest intakes from prospective cohort studies (Ref. 125). The 
Te Morenga et al. study is a systematic review and meta-analysis of 
randomized controlled trials and prospective cohort studies that was 
commissioned by the WHO to look at the relationship between dietary 
sugars and body weight (Ref. 125). Several comments criticized the Te 
Morenga paper, stating that:
     It is a meta-analysis commissioned by the WHO and not a 
U.S. consensus report;
     Although Te Morenga et al concluded that among free living 
people consuming ad libitum diets, intake of free sugars or sugar-
sweetened beverages is a determinant of body weight, the comments noted 
that in the WHO report on sugars intake for adults and children, they 
graded their own evidence for free sugars intake and body weight for 
both adults and children to be of moderate quality at best;
     The Te Morenga et al. interpretation did not establish a 
reference value for intake of free sugars and body weight;
     The definition of free sugars differs from our proposed 
definition of added sugars. The WHO defines ``free sugars'' as all 
monosaccharides and disaccharides added to foods by the manufacturer, 
cook or consumer, plus the sugars that are naturally present in honey, 
syrups and fruit juices. In particular, the definition of free sugars 
includes natural sugars from fruit juices which are not included in our 
proposed definition of added sugars;
     Te Morenga et al. investigates the relationship between 
added sugars intake and body weight rather than CVD risk;
     The authors' conclusion that any role of sugars on body 
weight results from alteration in energy balance rather than a 
physiological or metabolic consequence of monosaccharides or 
disaccharides. The paper further stated that ``the extent to which 
population-based advice to reduce sugars might reduce risk of obesity 
cannot be extrapolated from present findings'' because few studies 
lasted longer than 10 weeks;
     Many studies in the meta-analysis fail to provide any 
comparative associations between total sugar intakes and metrics of 
obesity (i.e., BMI, adiposity measures) in comparison with their 
analyses of free sugar intakes. The comments said that this may be a 
source of bias for their conclusions that only ``free sugars'' 
contribute to weight gain and fatness;
     Of the 77 studies evaluated for full review, only 11 
isoenergetic studies were identified and composite results from those 
studies provided ``no evidence of difference in weight change as a 
result of difference in sugar intakes when energy intakes were 
equivalent.'' The comments concluded that it cannot be assumed that 
``free sugars'' is linked to fatness when excess energy intake was not 
taken into consideration in the meta-analysis for non-isoenergetic 
studies;
     The authors noted significant heterogeneity (the studies 
included in the meta-analysis were not undertaken in the same way using 
the same experimental design) and potential bias in some of the trials 
examined;
     The authors concluded that comparison of the lowest to 
highest intakes in cohort studies was compatible (not supportive as the 
2010 DGAC Report indicates) with a recommendation to restrict intake to 
below 10 percent of total energy. However, there is no evidence of a 
dose-response relationship, a key component of elucidating potential 
mechanisms, was provided through the array of research studies 
evaluated;
     The findings are consistent with the 2010 DGA advice that 
states, ``Foods containing solid fats and added sugars are no more 
likely to contribute to weight gain than any other source of calories 
in an eating pattern that is within calorie limits; and
     The research included in Te Morenga et al. is not current. 
Less than 10 percent of the studies included in the report were 
published after 2010, more than 50 percent of the studies are over 10 
years old, more than 70 percent of the trials (in children and adults) 
are over 10 years old, and 80 percent of the randomized trials on 
adults are over 10 years old.
    Other comments questioned our reliance on the Te Morenga et al. 
paper due to a number of factors and suggested that the results of this 
study should not be extrapolated to nutrient-dense foods and beverages 
with small amounts of added sugars.
    The comments questioned our reliance on a meta-analysis for the 
proposed DRV of 10 percent of calories from added sugars and said that 
a meta-analysis does not provide sufficient scientific support to make 
an intake recommendation of 10 percent of energy.
    One comment noted that the Te Morenga et al. paper was published 
and available to us at the time of the March 2014 proposed rule, but we 
said, in the preamble to the proposed rule (79 FR 11879 at 11906), that 
we reviewed scientific evidence and recommendations of consensus 
reports

[[Page 33848]]

and concluded that we could not propose to establish a DRV for added 
sugars. The comment questioned why we now have determined that the Te 
Morenga et al. paper provides suitable evidence to establish a DRV, but 
not when we developed the proposed rule.
    (Response) We are relying on information from the USDA Food 
Patterns showing that it would be difficult for one to consume more 
than 10 percent of their calories from added sugars and still be able 
to consume enough of the other components of a healthy dietary pattern 
to meet nutrient needs within calorie limits to support a DRV for added 
sugars. We are also relying on consumption data showing that, on 
average, Americans are consuming 13.4 percent of calories from added 
sugars. Therefore, because we are not relying on the Te Morenga et al. 
paper to support a DRV for added sugars, we need not address specific 
comments on the merits of the Te Morenga et al. paper. We have 
determined that, because we are focusing on a healthy dietary pattern, 
the interactions that sugar-sweetened foods and beverages have with 
other components of a healthy dietary pattern, and how that healthy 
dietary pattern is associated with health outcomes, and basing a DRV 
for added sugars on data that takes into consideration the whole of a 
healthy dietary pattern, we do not need to rely on evidence related to 
a direct association between added sugars and risk of disease for a 
DRV. It also suggests that a DRV for added sugars of 10 percent of 
total calories is not an unrealistic reference value. We note that the 
2015-2020 DGA also bases the recommendation to limit intake of calories 
from added sugars to less than 10 percent per day on food pattern 
modeling and national intake data on intakes of calories from added 
sugars that demonstrate the public health need to limit calories from 
added sugars to meet food group and nutrient needs within calorie 
limits. The 2015-2020 DGA states that, for most calorie levels in the 
USDA Food Patterns, there are not enough calories available after 
meeting food group needs to consume 10 percent of calories from added 
sugars and 10 percent of calories from saturated fats and still stay 
within calorie limits.
    (Comment 239) One comment said that our scientific justification 
for proposing a DRV for added sugars of 10 percent of total energy is 
not clear because it is based on menu-modeling and is not included in 
the meta-analysis conducted by Te Morenga et al.
    (Response) We proposed to establish a DRV for added sugars of 10 
percent of total calories (50 grams for children and adults 4 years of 
age and older and 25 grams for children 1 through 3 years of age). We 
said that the 2015 DGAC Report recommended that Americans keep added 
sugars intake below 10 percent of total energy intake, and that 
recommendation was based on modeling of dietary patterns, current 
consumption data, and a published meta-analysis on sugars intake and 
body weight (80 FR 44303 at 44308). We concluded that the scientific 
information from the 2015 DGAC report provides a basis for FDA to 
establish a DRV for added sugars. The 2015 DGAC relied on both food 
pattern modeling information from the USDA Food Patterns as well as 
information from the Te Morenga et al. paper for its recommendation to 
limit added sugars to a maximum of 10 percent of total daily caloric 
intake.
    After further consideration, we are establishing a DRV for added 
sugars of 10 percent of total calories, and are relying on information 
from the USDA Food Patterns as well as current consumption data for 
this determination.
    (Comment 240) Some comments said it would be inappropriate to base 
a DRV for added sugars on recommendations from the WHO. The comments 
said that the WHO recommendation to limit intake of free sugars to 10 
percent of energy intake was based on evidence for dental caries and 
not body weight or CVD risk. In reference to the Te Morenga et al. 
paper, the comments said that there was no effect of sugar and measures 
of weight found in children based on the reviews of randomized 
controlled trials and only a minor effect was found in cohort studies 
with intake of sugar-sweetened beverages but no other sugar-containing 
foods.
    Other comments referred to the new WHO conditional recommendation 
to further reduce free sugars intake to 5 percent of total calories and 
said that this recommendation appears to be based solely on data from 
several studies that are more than 50 years old. The comments noted 
that the findings of the evidence-based review are described by the 
review authors as of ``very low quality'' (Ref. 126).
    (Response) Although the WHO commissioned a systematic literature 
review to answer a series of questions relating to the effects of 
sugars on excess adiposity that resulted in the Te Morenga et al. 
paper, the 2015 DGAC considered the evidence discussed to the Te 
Morenga et al. paper and concluded that the evidence reviewed by Te 
Morenga et al., as well as food pattern modeling analysis conducted by 
the 2015 DGAC and consumption data supported a recommendation to limit 
added sugars to a maximum of 10 percent of total daily caloric intake. 
We did not propose to establish a DRV based on recommendations from the 
WHO, nor are we finalizing a DRV for added sugars based on 
recommendations from the WHO.
(v) The Iom Suggested Maximum Intake Level of 25 Percent or Less of 
Energy From Added Sugars
    (Comment 241) Some comments noted that the 2005 IOM Macronutrient 
Committee concluded that ``based on the data available on dental 
caries, behavior, cancer, risk of obesity, and risk of hyperlipidemia, 
there is insufficient evidence to set a UL for total or added sugars. 
Although a UL is not set for sugars, a maximum intake level of 25 
percent or less of energy from added sugars is suggested based on the 
decreased intake of some micronutrients of American subpopulations 
exceeding this level'' (Ref. 75). The comments asked why we did not use 
this 25 percent level as the basis for a DRV for added sugars because 
it was determined using an evidence-based approach.
    (Response) We have concluded that using the IOM suggested maximum 
intake level of 25 percent or less of energy from added sugars to set a 
DRV for added sugars would be inappropriate. As noted in the IOM 
macronutrient report, the IOM could not establish a UL for total or 
added sugars based on the evidence, and the less than 25 percent of 
total energy recommendation should not be viewed as a UL. Setting a DRV 
for added sugars that is one quarter of a 2,000 calorie diet would 
result in a DRV for added sugars of 125 grams (2,000 x 0.25 = 500 
calories and 500 / 4 = 125 grams). Such a DRV for added sugars would be 
greater than the DRV for protein and fat, and would be approximately 42 
percent of the DRV for total carbohydrate. Although DRVs are reference 
values rather than precise recommended intake levels, the percent DV 
declaration, which is calculated based on the DRV, gives the consumer a 
general idea of how much of a nutrient should be consumed (79 FR 11879 
at 11926). A DRV of 25 percent of calories would indicate to consumers 
that foods containing a significant amount of added sugars are 
relatively low in added sugars. Such a DRV also would send the message 
to the American public that consuming one fourth of one's calories in 
the form of added sugars is appropriate. If a consumer chooses to eat 
those added sugars in the form of foods that contain few or little 
other nutrients, it would be very difficult, if

[[Page 33849]]

not impossible, to consume a healthful dietary pattern that includes 
adequate amounts from food groups, meets nutrient needs, and is within 
calorie limits. As such, a DRV for added sugars that is 25 percent of 
total calories could have negative public health implications. 
Therefore, we are not setting a DRV for added sugars based on the IOM 
suggested maximum level of 25 percent of total calories.
(vi) DRV of 10 Percent of Total Calories
    Many comments to the supplemental proposed rule discussed whether a 
DRV of 10 percent of total energy intake is appropriate or whether 
another number should be chosen.
    (Comment 242) Many comments suggested that the DRV for added sugars 
should be lower than 10 percent of calories. The comments referred to 
the 2015 WHO Guideline for Sugars intake for adults and children which 
recommends reducing the intake of free sugars to less than 10 percent 
of total energy intake. In the report, the WHO also suggested a further 
reduction of the intake of free sugars below 5 percent of total energy 
intake as a ``conditional recommendation.'' The comments also 
recommended that we follow the recommendation of the Scientific 
Advisory Committee on Nutrition in the United Kingdom that added sugars 
should account for no more than 5 percent of daily energy intake. The 
comments said that the American Heart Association (AHA) also recommends 
limiting added sugars consumption to no more than 5 percent of total 
energy intake. The comments also said that a DRV of 5 percent of total 
energy intake would align with AHA's recommendation that no more than 
one-half of discretionary calories should come from added sugars. The 
AHA recommends that most women consume no more than 100 calories (6 
teaspoons) from added sugars per day and no more than 150 calories (9 
teaspoons) per day for most men. The comments suggested that a DRV of 5 
percent of total energy intake would be more appropriate than a DRV of 
10 percent of total energy intake because the 2,000[hyphen]calorie 
``Healthy U.S.[hyphen]Style,'' ``Healthy Mediterranean[hyphen]Style,'' 
and ``Healthy Vegetarian'' dietary patterns developed for the DGAC 
Report included only 6 or 7 percent of calories from added sugars.
    (Response) We disagree that the DRV for added sugars should be 
lower than 10 percent of calories or that there is adequate evidence at 
this time to set a DRV for added sugars of less than 5 percent of 
calories. While the WHO and other health organizations have recommended 
that individuals should consume 5 percent or less of total calories 
from added sugars, those recommendations are not consistent with those 
of U.S. consensus reports. Furthermore, current consumption data shows 
that Americans, on average, are consuming 13.4 percent of calories from 
added sugars, and the USDA Food Patterns show that it is possible to 
construct a healthful dietary pattern that includes more than 5 percent 
of calories from added sugars. The USDA Food Patterns were developed 
using representative foods with very little or no added sugars or solid 
fats. Even with using representative foods with little or no added 
sugars, the amount of calories left over that consumers can use to 
incorporate added sugars into their diet was 5 percent or more for all 
but two calorie levels (Ref. 19). A DRV of 10 percent of total calories 
provides a value that is more realistic considering current consumption 
of added sugars in the United States as well added sugars in the food 
supply.
    (Comment 243) Several comments recommended lowering the added 
sugars DRV for children. The comments said that a DRV of 50 grams of 
added sugars for children 4 years of age and older which is based on 
the 2,000 reference value is too high. The comments said that according 
to USDA, 4 year olds should be consuming 1,400 calories per day, 
assuming moderate activity. The comments said that under our proposal, 
a 4 year old could consume more than 14 percent of calories from added 
sugars and still be within the guidelines. The comments noted that this 
disparity does not align with the 2015 DGAC's or WHO's recommendations 
for added sugars accounting for no more than 10 percent of total 
calories until age 11 for boys and age 12 for girls. The comments 
suggested changing the DRV to 25 grams of added sugars for children 
aged 1 to 11years, and no more than 50 grams of added sugars for 
individuals 12 and older. The comments said that this change would 
bring our recommendations more in line with the stated goal of 
consuming less than 10 percent of total calories from added sugars. The 
comments also said that for products marketed to children between the 
ages of 1 to 11 years old, we should require the use of a DRV of 25 
grams for added sugars. The comments suggested criteria that could be 
used to identify products marketed to children.
    One comment noted that in the United Kingdom health authorities 
further stratify recommendations for children to include no more than 
19 grams for children ages 4 to 6 and no more than 24 grams for 
children ages 7 to 10.
    (Response) We decline to revise the rule as suggested by the 
comments. DRVs should be viewed as reference amounts that consumers can 
use to determine how a serving of a food fits within their total daily 
diet. A DRV for children between the ages of 4 through 11 or 7 through 
10, as the comments suggested, could clutter the label, cause 
confusion, and draw attention to the added sugars declaration because 
more space would be required for two separate percent DV declarations 
on the label. In addition, the approach we have taken for setting a DRV 
for added sugars for children and adults 4 years of age and older is 
consistent with that of total and saturated fat where the DRVs are 
based on an amount not to exceed.
(vii) Education
    (Comment 244) Many comments discussed the need for consumer 
education to help consumers understand the addition of an added sugars 
disclosure to the Nutrition Facts label and to help consumers use this 
information to make healthy food choices. Other comments suggested that 
education should focus on total calories, total sugars, and the 
ingredient list--information which can already be found on the current 
Nutrition Facts label. One comment suggested that we educate consumers 
about the fact that sugars are included in total carbohydrates, instead 
of requiring an added sugars declaration on the label. Many comments 
also said that Nutrition Facts labels that declare added sugars in 
addition to total sugars will be confusing to consumers, suggest to 
consumers that added sugars are more harmful than naturally occurring 
sugars, or suggest that consumers should focus on added sugars more 
than on other nutrients.
    One comment argued that consumer responses to added sugars 
declarations could lead to unintended consequences, citing studies that 
have found that ``low-fat'' labels may reduce consumers' experience of 
guilt associated with excess consumption of foods bearing such labels 
or may increase what consumers perceive to be an appropriate serving 
size of such foods. Many comments said that requiring a new line for 
added sugars could suggest to consumers that they should give increased 
attention to added sugars whereas current U.S. dietary guidelines do 
not support an overemphasis on added sugars. One comment said that an 
added sugars declaration could call undue attention to added sugars as 
a source of calories when it is no different from other caloric 
sources. This

[[Page 33850]]

comment said that emphasis on reducing individual macronutrients, in 
lieu of reducing total energy intake defeats the primary goals of our 
Calories Count report (Ref. 127). Another comment said that the 
addition of added sugars declarations to the label may lead consumers 
to opt for foods of equal total sugar content but lesser nutrition, and 
to overlook health benefits that some foods have to offer.
    In contrast, some comments said that listing added sugars on the 
Nutrition Facts label would provide vital information on the amount of 
added sugars in a food and help consumers eat less added sugars.
    Some comments also said that public education on the food sources 
and health consequences of excessive added sugars intake is needed. One 
comment suggested that we develop materials to explain that consuming 
foods high in added sugars makes it difficult to meet nutritional needs 
and stay within calorie limits. The comment also suggested that we 
emphasize that naturally occurring sugars in fruits, vegetables, and 
dairy products do not pose any health problem, and that people should 
consume more fruits, vegetables, and low-fat dairy products.
    One comment said that an industry-sponsored reanalysis of FDA's 
added sugars consumer study and a consumer study commissioned by a 
group of national food and beverage associations showed that the ``% 
DV/Added Sugars'' information will create consumer confusion that does 
not exist today. The comment said that we would face education campaign 
challenges such as confusion related to the concept of percent DV, 
possible misinterpretation of the new term ``Added Sugars,'' and 
``unintended effects'' of placing a percent DV next to ``Added Sugars'' 
and not ``Total Sugars.'' The comment also said that when 
misperceptions of ``% DV/Added Sugars'' arise in the marketplace, it 
will be difficult to correct those misperceptions, particularly given 
that the new rule and label changes would be interpreted and defined by 
many other communicators outside FDA. The comment cited examples of 
other campaigns that faced similar obstacles, and concluded that any 
campaign FDA undertook related to added sugars would not succeed. Some 
comments said that some segments of the population may be more 
susceptible to misunderstanding added sugars information than the 
general population. Another comment suggested explaining ``daily 
values'' better and to clarify that the daily value for added sugars 
does not represent a suggested amount one should eat, but rather, 
represents a ``conservative estimate'' of the highest amount one should 
consume of added sugar. The comment also said that if subsequent 
research were to show that the current daily value for added sugars is 
too high or too low, the ``incorrect'' value may remain in the public 
mind long after it has been proven to be incorrect.
    One comment included information from a consumer study that sampled 
1,088 participants aged 18 years and older from an online respondent 
panel. The comment described results including, but not limited to, 
participants' understanding of the term ``Added Sugars'' as displayed 
on Nutrition Facts labels used in the study. Respondents' answers 
reflected a range of interpretations, including, but not limited to, 
beliefs that added sugars refer to specific types of sugars (e.g., 
``white sugar'') or artificial sweeteners. The comment said that 30 
percent of participants said they ``don't know'' what added sugars are 
or provided no answer. The comment said that the study findings 
indicated that there is confusion among consumers regarding what added 
sugars are and that ``consistent, coordinated communication efforts'' 
will be needed to educate consumers about the Nutrition Facts label and 
added sugars.
    (Response) Increased consumer education about nutrition and healthy 
dietary practices would likely benefit a number of consumers in the 
United States. The updated Nutrition Facts label promulgated by this 
rule is an important foundational tool for that consumer education. As 
noted in part II.B.1, we are committed to increasing understanding and 
use of the Nutrition Facts label to improve healthy dietary patterns 
through consumer education, in collaboration with key Federal partners 
such as USDA and CDC, health professionals, and the broader public 
health community, as well as with industry partners. One aspect of 
those education and outreach activities will be increasing 
understanding of new components to the label including added sugars 
(e.g., definition, relationship to total sugars), considerations for 
how to interpret the information on added sugars in the context of a 
healthy diet, and how all of the information provided on the Nutrition 
Facts label is important to consider when constructing a healthy 
dietary pattern--not only information on added sugars, but the 
nutrients declared, the percent Daily Value, and the importance of 
being mindful of total caloric intake. Attention to calories is 
highlighted by the substantially increased font size of the calorie 
declaration per serving of a product discussed in part II.Q. Focusing 
on the totality of nutrition information on the label in education 
activities will enable consumers to identify foods that are nutrient 
rich and may contain some added sugars, and reinforces the 
recommendations of the 2015 DGAC Report and 2015-2020 DGA to increase 
fruit and vegetable consumption, decrease saturated fat and sodium, and 
to limit added sugar intake to less than 10 percent of total calories.
    With regard to the comment stating that no education initiative can 
be successful in helping consumers understand added sugars, and 
therefore implying that added sugars should not be on the Nutrition 
Facts label, we disagree. The requirement to declare added sugars on 
the label is important public health information based on the latest 
science. Not requiring this important information to be declared would 
be detrimental to public health and run counter to our mandate to 
promote healthy dietary practices, even if not all consumers understand 
and use the information immediately.
    With regard to the comments questioning the addition of added 
sugars to the label, we have determined that there is a public health 
need for this declaration and that it is necessary to assist consumers 
in maintaining healthy dietary practices (see part II.H.3.a). We have 
the legal authority to require this declaration (see part II.C.3). 
Moreover, we are not aware of any data or information suggests that 
consumers will focus undue attention on added sugars as a source of 
calories any more than other nutrients on the label that are a source 
of calories. Our determination that added sugars should be declared on 
the label is consistent with the intent of our Calories Count report 
because the information an assist consumers in limiting their total 
energy intake.
    With regard to the comments questioning the confusion about a 
percent DV relating to added sugars and not total sugars, we address 
the need for a percent DV for added sugars and why it is not 
appropriate for total sugars (see part II.H.3).
    Regarding the question about consumer confusion about the concept 
of the percent DV, we have updated the footnote explaining the percent 
DV (see part II.Q.11).
    With regard to the question about consumer confusion on the 
relationship between total and added sugars, as described in our 
response to comment 188, we have modified the format of the added 
sugars declaration to appear indented under total sugars using the 
phrasing: ``Includes X g Added Sugars.''

[[Page 33851]]

    p. Records. When a mixture of naturally occurring and added sugars 
is present in a food, the proposed rule, at Sec.  101.9(g)(10)(iv), 
would require manufacturers to make and keep written records of the 
amount of added sugars added to the food during the processing of the 
food, and if packaged as a separate ingredient, as packaged (whether as 
part of a package containing one or more ingredients or packaged as a 
single ingredient) to verify the amount of added sugars present in the 
food. We also proposed specific recordkeeping requirements specific to 
yeast-leavened bakery products, wines with less than 7 percent alcohol 
by volume, or beer that does not meet the definition of a ``malt 
beverage,'' as defined by the Federal Alcohol Administration Act (27 
U.S.C. 211(a)(7)), if the amount of added sugars in those products is 
reduced through the process of fermentation.
    Several comments addressed the proposed recordkeeping requirements 
for added sugars. We discuss those comments in part II.R.3.
    As discussed in part II.H.3.n, we are requiring manufacturers of 
products containing fruit and vegetable juice concentrates as an 
ingredient that have not been reconstituted to 100 percent juice in the 
finished food to provide documentation that shows how they determined 
how much of the sugars provided by the juice concentrate should be 
declared as added sugars.
    Also, as discussed in part II.H.3.k, when the amount of added 
sugars in a product is reduced through non-enzymatic browning and/or 
fermentation, we are requiring manufacturers to make and keep records 
to demonstrate the amount of amount of added sugars after non-enzymatic 
browning and/or fermentation, make and keep records of the amount of 
sugars added to the food before and during the processing of the food, 
or the submission of a citizen petition requesting an alternative means 
of compliance if the manufacturer has reason to believe that the amount 
of added sugars in the finished product is significantly less than the 
amount added prior to non-enzymatic browning and fermentation but they 
have no way to determine a reasonable approximation of the amount in 
the finished food.
4. Sugar Alcohols
    Our preexisting regulations, at Sec.  101.9(c)(6)(iii), define 
sugar alcohols, in part, as the sum of saccharide derivatives in which 
a hydroxyl group replaces a ketone or aldehyde group (e.g., mannitol or 
sorbitol).
    a. Voluntary declaration. Our preexisting regulations, at Sec.  
101.9(c)(6)(iii), permit the voluntary declaration of sugar alcohols on 
the Nutrition Facts label. The preamble to the proposed rule (79 FR 
11879 at 11908) discussed how, in reaction to a citizen petition and in 
the 2007 ANPRM, we considered whether to make the declaration of sugar 
alcohols on the Nutrition Facts label mandatory. We tentatively 
concluded that the declaration of sugar alcohols should remain 
voluntary, and so the proposed rule would not revise the requirement 
but would, because of other changes, renumber the provision as Sec.  
101.9(c)(6)(iv).
    We did not receive any comments regarding the voluntary declaration 
of sugar alcohols, and so the final rule continues to provide for their 
voluntary declaration.
    b. Use of the term ``sugar alcohols''. In the preamble to the 
proposed rule (79 FR 11879 at 11908), we discussed our consideration of 
a citizen petition and comments to the 2007 ANPRM regarding the use of 
the term ``polyols'' (a contraction of the term ``polyalcohol'' instead 
of ``sugar alcohols''). We determined that ``polyols'' could be 
potentially more confusing to consumers than the term ``sugar 
alcohol,'' but acknowledged that consumers also may not be familiar 
with the term ``sugar alcohol.'' Nevertheless, we continued to support 
the term ``sugar alcohols'' rather than ``polyols'' because we stated 
that ``sugar alcohols'' more accurately describes the group of 
substances encompassed in the definition in Sec.  101.9(c)(6)(iii) (79 
FR 11879 at 11908). We explained that ``polyols'' includes non-
carbohydrate polyalcohols, such as polyesters, whereas ``sugar 
alcohols,'' as defined by FDA, includes only carbohydrates, and so the 
proposed rule would not change the term ``sugar alcohols'' when used on 
the Nutrition Facts label.
    (Comment 245) Several comments supported using the term ``polyols'' 
instead of ``sugar alcohols.''
    Some comments said that sugars are mono- and disaccharides, whereas 
most sugar alcohols are pentoses and hexoses. The comments said that 
the chemical structures of sugars are rings, and the chemical structure 
of sugar alcohols are chains. The comments also said that sugars and 
sugar alcohols have different calorie contributions. Therefore, the 
comments said that the term ``polyols'' is more appropriate in 
reference to carbohydrate-based polyalcohols.
    (Response) We disagree with the comments. Both sugars and sugar 
alcohols contain saccharides. Sugars are defined as mono- and 
disaccharides (Sec.  101.9(c)(6)(ii)). Sugars alcohols are defined as 
the ``sum of saccharide derivatives in which a hydroxyl group replaces 
a ketone or aldehyde group'' (Sec.  101.9(c)(6)(iv)). The presence of 
the hydroxyl group is the basis for these modified sugars being called 
``sugar alcohols.'' The term ``sugar alcohols'' more accurately 
reflects the chemical composition of these compounds than ``polyols.'' 
Because of the difference in chemical composition, they are metabolized 
differently and have different caloric contributions. Analytical 
methods are available to measure sugar alcohols based on their chemical 
composition and structure (79 FR 11879 at 11901), and they are listed 
separately in the Nutrition Facts label. ``Sugar alcohols'' more 
accurately describes the group of substances encompassed in the 
definition in Sec.  101.9(c)(6)(iii). ``Polyols'' includes non-
carbohydrate polyalcohols, such as polyesters, whereas ``sugar 
alcohols,'' as defined by FDA, includes only carbohydrates (see 79 FR 
11879 at 11908). Thus, we decline to revise Sec.  101.9(c)(6)(iii) to 
use the term ``polyols.''
    (Comment 246) One comment supporting use of the term polyols noted 
that our explanation in the preamble to the proposed rule, that polyols 
only cover non-carbohydrate polymers while sugar alcohols include only 
carbohydrates, is not supported. The comment said that polyols are low-
digestible carbohydrates and the only sugar alcohols used in foods are 
also considered polyols.
    (Response) We disagree that polyols only pertain to non-digestible 
carbohydrate polymers. We consider polyols to include low-digestible 
carbohydrates (i.e., sugar alcohols) that are used in foods, as well as 
non-carbohydrate polyalcohols (see 79 FR 11879 at 11908). Therefore, 
``sugar alcohols'' is a more specific description of the listing of 
these ingredients in the Nutrition Facts label.
    (Comment 247) One comment said that ``sugar alcohol'' may be 
confusing to consumers and that ``polyols'' is less likely to cause 
confusion. The comment said that ``sugar alcohol'' may mislead the 
consumer regarding health effects, given the negative health 
connotations of the terms ``sugar'' and ``alcohol'' separately. The 
comment said that we, at the very least, should conduct consumer 
testing of the term ``polyols'' and ``sugar alcohols.''
    Another comment cited a 1995 survey provided to FDA in a citizen 
petition in 1995, stating that there is strong evidence that ``sugar 
alcohols'' is a term widely misunderstood by consumers, with most 
consumers mistakenly

[[Page 33852]]

believing that foods containing sugar alcohols contain both sugar and 
alcohol. Another comment cited a 2012 survey, ``Adults Remain Confused 
about `Sugar Alcohol'--and Whether It Contains Sugar and/or Alcohol,'' 
which observed that a majority of the 1,000 adults polled believed that 
``sugar-free'' products containing ``sugar alcohols'' contained sugar 
(74 percent) or alcohol (64 percent).
    (Response) We previously considered the use of the term ``polyol'' 
and determined that it could be potentially more confusing to consumers 
than ``sugar alcohols.'' However, we acknowledge that consumers may not 
be familiar with the term ``sugar alcohol'' (see 79 FR 11879 at 11908). 
Therefore, we allow for the listing of the name of the specific sugar 
alcohol instead of ``sugar alcohols,'' provided that only one sugar 
alcohol is present in the food, because many sugar alcohols are listed 
as ingredients (e.g., sorbitol, mannitol, and xylitol) and therefore 
may be more recognizable to consumers.
    (Comment 248) One comment supporting use of the term ``polyols'' 
said that the EU has introduced optional declaration for ``polyols'' 
(Ref. 128) (``on the provision of food information to consumers'').
    (Response) We acknowledge that the EU provides for the option to 
declare ``polyols'' which is defined as ``alcohols containing more than 
two hydroxyl groups.'' The EU, however, does not allow for the optional 
listing of specific sugar alcohols. ``Sugar alcohols'' more accurately 
reflects the chemical composition of these ingredients than 
``polyols.'' Furthermore, unlike the EU, we allow for the listing of 
specific sugar alcohols because consumers may not be familiar with the 
term ``sugar alcohol.''
    c. DRV. Our preexisting regulations do not provide a DRV for total 
sugar alcohols or for individual sugar alcohols. The preamble to the 
proposed rule (79 FR 11879 at 11908) explained that a quantitative 
reference intake recommendation for sugar alcohols is not available 
from current consensus reports, so we have no basis on which to 
consider setting an appropriate DRV. Therefore, we did not propose to 
set a DRV for sugar alcohols.
    (Comment 249) One comment agreed that there was no scientific basis 
to establish a DRV for ``sugar alcohols.''
    (Response) Because we continue to lack a basis to set an 
appropriate DRV for sugar alcohols, the final rule does not establish a 
DRV for sugar alcohols.
    d. Caloric value. The caloric value for carbohydrates, other than 
insoluble fiber, is 4 kcal/gram (Sec.  101.9(c)(1)(i)(C)). Sugar 
alcohols have been shown to have a caloric value lower than 4 kcal/gram 
(Refs. 129-130). In the preamble to the proposed rule (79 FR 11879 at 
11908 through 11909), we explained that we considered revising the 
energy contribution of sugar alcohols and also considered relevant 
caloric values recommended by the Life Sciences Research Office (LSRO). 
The LSRO expert panel reports provided the following caloric values for 
individual sugar alcohols: Isomalt (2.0 kcal/gram), lactitol (2.0 kcal/
gram), xylitol (2.4 kcal/gram), maltitol (2.1 kcal/gram), sorbitol (2.6 
kcal/gram), hydrogenated starch hydrolysates (3.0 kcal/gram), and 
mannitol (1.6 kcal/gram). Consequently, we proposed to amend Sec.  
101.9(c)(1)(i)(F) to establish the following general factors for 
caloric values of sugar alcohols, using the values recommended by LSRO: 
Isomalt--2.0 kcal/gram, lactitol--2.0 kcal/gram, xylitol--2.4 kcal/
gram, maltitol--2.1 kcal/gram, sorbitol--2.6 kcal/gram, hydrogenated 
starch hydrolysates--3.0 kcal/gram, and mannitol--1.6 kcal/gram. We 
also proposed to amend Sec.  101.9(c)(1)(i)(C) such that the 4 kcal/
gram value is not applied to sugar alcohols.
    (Comment 250) Several comments supported the proposed caloric 
values. Some comments, however, noted that we did not identify a 
caloric value for erythritol. Some comments noted that a caloric value 
of 0.2 kcal/gram was consistent with the EU and Health Canada, while 
other comments supported 0 kcal/gram as a value consisted with the EU. 
One comment provided a review of the evidence, including a publication 
by Livesey (1992) (Ref. 131) and more recent evidence from human (Ref. 
132) and rat studies to support of a caloric value of 0 kcal/gram for 
erythritol.
    (Response) We agree that a caloric value for erythritol should be 
considered. We generally do not consider animal studies for determining 
the caloric contribution of nutrients. Livesey (1992) determined that 
the caloric value for erythritol was 0.2 kcal/gram in humans. Applying 
the factors that Livesey (1992) used for determining the caloric value 
for erythritol and considering the newer evidence using radiolabelled 
erythritol in humans (Ref. 132), the review submitted as part of the 
comment concluded that erythritol is a substrate that is readily 
absorbed, and undergoes no metabolism, therefore providing 0 calories. 
These methods are consistent with those used for establishing caloric 
values for the other sugars alcohols determined by LSRO (79 FR 11879 at 
11909). Therefore, the final rule provides a caloric value of 0 kcal/
gram for erythritol.
5. Dietary Fiber
    a. Dietary fiber.
(i) Definition
    Our preexisting regulations do not establish a definition for 
dietary fiber. Dietary fiber represents a heterogeneous group of 
compounds that vary in their carbohydrate composition, linkages between 
carbohydrates, and molecular weight. Therefore, there is no specific 
chemical definition for dietary fiber. The amount of dietary fiber that 
is currently declared is based on analytical methods such as the AOAC 
analytical methods.
    In the preamble to the proposed rule (79 FR 11879 at 11909), we 
explained how the IOM had issued a report defining ``total fiber'' as 
the sum of ``dietary fiber'' and ``added fiber,'' where ``dietary 
fiber'' consists of non-digestible carbohydrates and lignin that are 
intrinsic and intact in plants, and ``added fiber'' (referred to as 
``functional fiber'' in the IOM Macronutrient Report) consists of 
isolated, non-digestible carbohydrates that have beneficial 
physiological effects in humans. We proposed to adopt a definition for 
dietary fiber that is equivalent to the IOM's definition of ``total 
fiber'' and therefore would include fibers that the IOM defines as 
``dietary fiber'' and ``functional fiber.'' Both ``dietary fiber'' and 
``functional fiber,'' as defined by the IOM, are considered to have 
beneficial health effects, so there is little benefit for consumers in 
distinguishing between these two types of fiber on the Nutrition Facts 
label. In addition, the IOM recognized analytical limitations in 
distinguishing between ``dietary fiber'' and ``functional fiber'' and 
noted that the labeling of ``total fiber'' would be more practical than 
labeling ``dietary fiber'' and ``functional fiber'' separately (79 FR 
11879 at 11909). Specifically, the proposed rule would amend Sec.  
101.9(c)(6)(i) to include the definition for dietary fiber. The 
proposed definition would include: (1) Non-digestible soluble and 
insoluble carbohydrates (with 3 or more monomeric units) and lignin 
that are intrinsic and intact in plants; (2) isolated and synthetic 
non-digestible carbohydrates (with 3 or more monomeric units) that we 
have granted be included in the definition of dietary fiber, in 
response to a citizen petition we received demonstrating that such 
carbohydrates have a physiological effect(s) that is beneficial to 
human health; or (3) isolated and synthetic non-digestible 
carbohydrates (with 3 or more monomeric units) that are the subject of 
an authorized health claim. Our

[[Page 33853]]

proposed definition for total fiber also would include a minimum degree 
of polymerization (DP) greater or equal to 3 monomeric units.
    In the preamble to the proposed rule (79 FR 11879 at 11909 through 
11910), we proposed to list isolated and synthetic non-digestible 
carbohydrates with beneficial physiological effect(s) in the definition 
of dietary fiber. In the proposed codified language, we identified two 
ways the list of dietary fibers could be amended to include new fibers 
in the definition. Specifically, we identified the existing citizen 
petition process in Sec.  10.30 that a manufacturer could use to 
request an amendment to the definition of dietary fiber and the 
petition process for the authorization of a health claim (21 CFR 
101.70) where a fiber that is the subject of an authorized claim would 
be considered a dietary fiber that we could add to the list of fibers 
in the definition. We would consider an isolated or synthetic non-
digestible carbohydrate that meets the significant scientific agreement 
standard in section 403(r)(3) of the FD&C Act, for which a health claim 
is authorized, to be a dietary fiber with a beneficial physiological 
effect to human health. Two dietary fibers, for which an authorized 
health claim exists, i.e., [beta]-glucan soluble fiber and barley 
[beta]-fiber, were included in the proposed definition. The two types 
dietary fibers, for which an authorized health claim exists (i.e., 
[beta]-glucan soluble fiber and psyllium husk), are included in the 
codified definition for dietary fiber in this final rule.
    (Comment 251) Some comments stated that it would be a burden to us 
to maintain and update an approved list of dietary fibers.
    (Response) We consider a listing of dietary fibers that provide a 
beneficial physiological effect to be an efficient way to ensure the 
use of a common definition on which all manufacturers can rely to 
evaluate the fiber content of their products for purposes of the 
dietary fiber declaration and that we can use to evaluate compliance. 
Therefore, we decline to revise the rule in response to this comment.
    (Comment 252) Some comments expressed concern about using the 
citizen petition process in Sec.  10.30 to amend the listing of 
isolated and synthetic non-digestible carbohydrates in the definition 
of dietary fiber. Some comments considered this aspect of the 
definition as creating an approval process for dietary fiber and stated 
that we did not have legal authority for such a process. The comments 
said our pre-approval authority is limited to the premarket review of 
food additives, color additives, and health and nutrient/content claims 
and that section 403(q) of the FD&C Act does not provide a legal basis 
to support premarket approval. The comments also asserted that, under 
the Administrative Procedure Act, our actions must be consistent with 
the authority given to us under the FD&C Act and cannot be arbitrary or 
capricious.
    (Response) We disagree that defining the term ``dietary fiber'' to 
include the identification of specific isolated and synthetic non-
digestible carbohydrates is a pre-approval process for dietary fibers 
like that for food additives, color additives, and health or nutrient 
content claims. First, the listing of isolated and synthetic dietary 
fibers in the definition of dietary fiber does not constitute a pre-
approval process related to the safety of the food as an ingredient. We 
are defining dietary fiber under our authorities in sections 403(q), 
403(a), 201(n) and 701(a) of the FD&C Act and not under the food 
additive approval provisions in section 409 of the FD&C Act (21 U.S.C. 
348). Moreover, the definition of dietary fiber does not prevent the 
use of an isolated or synthetic non-digestible carbohydrate to be used 
as an ingredient in the manufacture of a food. The use of such an added 
fiber as an ingredient must be lawful under the relevant provisions in 
the FD&C Act. Second, our definition of dietary fiber for a label 
declaration does not constitute a health claim or a nutrient content 
claim under the provisions to authorize such claims in section 403(r) 
of the FD&C Act. By defining the term dietary fiber, based on 
beneficial physiological effects in human health rather than by 
chemical definition, we will ensure that the dietary fiber declared 
amount will assist consumers to maintain healthy dietary practices, 
consistent with our labeling authorities under section 403(q) the FD&C 
Act.
    To avoid confusion in the final rule about the citizen petition 
process at Sec.  10.30, we removed the language that referred to 
dietary fibers ``that FDA has granted be included in the definition of 
dietary fiber, in response to a petition submitted to FDA under Sec.  
10.30 demonstrating that such carbohydrates have a physiological effect 
that is beneficial to health.'' The language is not necessary. Any 
interested person may seek to amend the listing of added fibers through 
the existing citizen petition process in Sec.  10.30. We do not need to 
cite to that process within the codified definition of dietary fiber 
for that process to be available or used to amend the definition of 
dietary fiber.
    (Comment 253) Some comments expressed concern about the citizen 
petition process with respect to the time for FDA to respond and about 
the priority of review. Several comments said that, if we did not 
respond to a citizen petition after 180 days, the dietary fiber should 
be considered to be officially recognized. One comment would change the 
deadline for responding to a petition to 30 days or to 90 days.
    (Response) Under Sec.  10.30(e)(2), the Commissioner is to provide 
a response to a petitioner within 180 days of receipt of the petition 
to approve the petition, deny the petition, or provide a tentative 
response. In addition, under Sec.  10.30(e)(3), the Commissioner may 
grant such other relief or take other action as the petition warrants. 
The comment that requests a shorter time period for review under Sec.  
10.30 would require a substantive amendment to the existing regulation 
in Sec.  10.30 and is outside the scope of this rule. Therefore, we 
decline to revise the rule in response to this comment.
    (Comment 254) Several comments asked how we would handle more than 
one petition on the same added non-digestible carbohydrate. For 
example, if two petitions were submitted on the same added non-
digestible carbohydrate, but for different endpoints, and the added 
non-digestible carbohydrate meets the dietary fiber definition based on 
one endpoint, but not the other endpoint, would the added non-
digestible carbohydrate meet the dietary fiber definition? Another 
comment stated that it is unlikely that a single dietary fiber source 
will produce all of the potential health outcomes anticipated for 
dietary fiber consumption. Some comments questioned whether all 
manufacturers would have to submit a citizen petition for the same 
fiber.
    (Response) We recognize that different isolated or synthetic non-
digestible carbohydrates can have different beneficial physiological 
effects. An isolated or synthetic non-digestible carbohydrate only 
needs to demonstrate one beneficial physiological effect. Therefore, 
for example, if the non-digestible carbohydrate attenuates blood 
glucose levels, but not blood cholesterol levels, it would meet the 
definition of dietary fiber. As long as one of the petitions provided 
sufficient evidence for a beneficial physiological effect, we could add 
the dietary fiber to the regulation. After an isolated or synthetic 
non-digestible carbohydrate is included in the list of such fibers in 
the definition of dietary fiber in Sec.  101.9(c)(6)(i), all 
manufacturers must list the dietary fiber

[[Page 33854]]

as part of the total dietary fiber declaration if it is present in 
their product. Manufacturers would not have to individually submit a 
citizen petition for the same fiber already listed before being subject 
to the mandatory declaration for that fiber.
    (Comment 255) One comment said we should authorize only specific 
formulations of an isolated or synthetic non-digestible carbohydrate. 
The comment said that generic approval of many added fibers would be 
inappropriate because companies produce a wide variety of each fiber.
    (Response) We recognize that companies may produce a wide variety 
of specific formulations of isolated or synthetic non-digestible 
carbohydrates, and we would, as appropriate, provide the needed 
specificity in a list of isolated or synthetic non-digestible 
carbohydrates in the definition, including their source and chemical 
structure to ensure clarity in what fibers must be declared as 
``dietary fiber'' if present as an ingredient in food. We intend to 
issue a guidance document on the information we recommend be provided 
to us for scientific review, the approach we intend to use to evaluate 
the studies, including the approach for our evaluation of the strength 
of the scientific evidence, if a company petitions us to amend the 
definition of dietary fiber to include an additional fiber in the 
definition.
    (Comment 256) One comment suggested that we use a voluntary pre-
notification process, such as that used for FDAMA health claims, to 
substantiate an added non-digestible carbohydrate. Other comments 
suggested the use of a voluntary GRAS notification process that 
involves submitting a detailed summary of a determination for safety 
or, for companies that have self-determined their ingredient as GRAS, 
their self-determination process. Other comments said that added non-
digestible carbohydrates that are GRAS should meet the dietary fiber 
definition. Many comments suggested that we use a pre-market 
notification process, such as that used for structure/functions claims, 
where the evidence is on file and the evidence is publically available.
    (Response) We decline to revise the rule as suggested by the 
comments. A voluntary process, such as the GRAS notification program, 
is not consistent with ensuring that there is a singular definition of 
dietary fiber for purposes of the declaration in the Nutrition Facts 
label. Furthermore, the GRAS review system evaluates ingredients for 
their safety, rather than beneficial physiological effects. A dietary 
fiber that is GRAS does not necessarily meet the definition of dietary 
fiber for purposes of a nutrient declaration. A non-digestible 
carbohydrate that is added to a food by a manufacturer must be approved 
as a food additive under section 409 of the FD&C Act or be GRAS under 
the conditions of its intended use (see sections 201(s) and 409 of the 
FD&C Act). The lawfulness of the use of various fibers added to food is 
outside the scope of this rule.
    Moreover, a process whereby a firm retains the evidence that its 
fiber meets the definition of dietary fiber would not ensure that there 
is a singular definition of dietary fiber for purposes of the 
declaration in the Nutrition Facts label. By including a list of all 
isolated or synthetic dietary fibers that meet the definition of 
dietary fiber, manufacturers will know that, when they use those fibers 
as an ingredient in their product, they must include the fibers in the 
declaration of dietary fiber. Consumers will have a consistent basis on 
which the declared values for dietary fiber are derived and can use 
that information in making healthy dietary choices and for comparing 
products. We are establishing a definition for dietary fiber that 
includes isolated or synthetic non-digestible carbohydrates that have a 
beneficial physiological effect to human health and are to be included 
in the declaration for dietary fibers on the Nutrition Facts label. 
Without a consistent regulatory definition, we would not be able to 
determine the veracity of a dietary fiber declaration on the Nutrition 
Facts label for purposes of compliance, and consumers would not be 
assured that the fibers declared as dietary fiber on the label are 
those that will assist them in maintaining healthy dietary practices.
    Furthermore, although we consider an isolated or synthetic fiber 
that is the subject of an authorized health claim to meet the 
definition of dietary fiber, we are not able to make the same 
determination for such a fiber if subject of a health claim 
notification submitted under section 403(r)(3)(C) of the FD&C Act. (We 
refer to this health claim as a ``FDAMA health claim'' based on the 
statutory language enacted as part of the Food and Drug Administration 
Modernization Act of 1997, Pub. L. 105-115, 111 Stat. 2296 (1997).) A 
FDAMA health claim relates to an authoritative statement made by a 
scientific body of the U.S. Government with official responsibility for 
public health protection or research directly relating to human 
nutrition (section 343(r)(3)(C)(i)) of the FD&C Act). A FDAMA health 
claim may be used on food in the market within 120 days of a 
submission; however, there are certain circumstances under which we may 
object to the content of the submission. For FDAMA health claims in 
use, for which the 120-day period has passed, we must issue a 
regulation to prohibit or modify the claim or make other findings to 
prevent the use of the claim (section 343(r)(3)(D) of the FD&C Act). 
There are a number of factors we must evaluate during the 120-day 
period of review that could raise questions about the use of the claim. 
For example, we may have questions about the source of the statement 
and whether the statement is a health claim, whether the notification 
contains a balanced representation of the scientific literature about 
the health claim and whether the claim is misleading. Thus, unlike the 
540-day period available to publish a final rule to authorize a health 
claim (section 403(r)(4)(A)(i) of the FD&C Act), we may not have 
adequate time during a FDAMA health claim review period to address 
additional questions about the fiber as it relates to our authority in 
section 403(q) of the FD&C Act for purposes of nutrient declaration. 
Therefore, we plan to consider, on a case-by-case basis, whether the 
scientific evidence for a fiber that is the subject of a FDAMA health 
claim notification is sufficient to amend the list of dietary fibers in 
the dietary fiber definition for nutrient declaration.
    (Comment 257) One comment asked us to clarify that, when a company 
makes a structure/function claim (e.g., fiber helps maintain healthy 
digestive function), the substantiation for that claim would need to be 
based on a physiological effect. The comment said that companies 
already must substantiate all claims on the label and said we could 
issue a guidance document to clarify how substantiation of a claim 
should be done.
    (Response) Structure or function claims are outside the scope of 
this rule. Therefore, we are making no clarifying statements with 
respect to structure or function claims in this final rule.
    (Comment 258) One comment that objected to the proposed rule's 
mention of citizen petitions stated that the evidence for meeting the 
dietary fiber definition should meet the significant scientific 
agreement (SSA) standard for health claims and that small, short-term 
studies of varying quality with conflicting results would not suffice. 
The comment also said that a health claim authorization would require 
us to consider whether levels of an added non-digestible carbohydrate 
in foods are sufficient to cause the physiological effect. Other 
comments said we should only require evidence needed to

[[Page 33855]]

demonstrate the physiological effect of the added non-digestible 
carbohydrate, regardless of the amount in the finished food.
    Another comment said that we should not expect the evidence to be 
equivalent to the significant scientific agreement (SSA) standard 
required for an authorized health claim. Instead, the comment said the 
evidence considered could include animal and in vitro studies or else 
the evidentiary standard would be the same as for structure function 
and health claims. The comment said we should provide the evidentiary 
standard in the final rule.
    (Response) The comments express concern about the level and 
sufficiency of the scientific evidence necessary to demonstrate a fiber 
provides a beneficial physiological benefit to health and whether a 
certain level of such a fiber in food is needed in order to be 
considered a ``dietary fiber'' for purposes of a Nutrition Facts label 
declaration. A health claim and a nutrient declaration are distinct 
from each other. A health claim is a statement about the relationship 
between a food or a food component and risk of chronic disease or a 
health-related condition. A nutrient declaration on a food label is a 
statement of the amount of the nutrient in a serving of a food that is 
necessary to assist consumers to maintain healthy dietary practices. A 
beneficial physiological effect to human health for purposes of 
nutrition labeling may be based on a relationship between the nutrient 
(e.g., dietary fiber) and a risk of chronic disease or a health-related 
condition, but that is not a prerequisite. Not all beneficial 
physiological effects are specific to chronic disease risk (e.g., 
attenuation of postprandial blood glucose, improved bowel function). 
Thus, for purposes of the Nutrition Facts label, the evidence to 
support a beneficial physiological effect on human health may differ 
from that required for a health claim that relates to a relationship 
between an isolated or synthetic non-digestible carbohydrate and a risk 
of chronic disease. As part of the factors for mandatory declaration, 
the evidence for a relationship between the nutrient and a health-
related physiological endpoint should be ``well-established'' which 
includes conclusive or strong evidence (79 FR 11879 at 11890). For 
evidence submitted as part of a citizen petition, we consider that the 
strength of the total evidence should demonstrate a specific beneficial 
physiological effect and that the beneficial effect should be 
replicated (Ref. 133), consistent with generally accepted scientific 
evidence to competent authorities in the Codex definition of dietary 
fiber in 2010 (79 FR 11879 at 11909). Accordingly, we do not consider 
animal or in vitro data to be sufficient. The physiology of animals is 
different than that of humans. In vitro studies are conducted in an 
artificial environment and cannot account for a multitude of normal 
physiological processes such as digestion, absorption, distribution, 
and metabolism that affect how humans respond to the consumption of 
foods and dietary substances (Ref. 134). Animal and in vitro studies 
can be used to generate hypotheses, investigate biological plausibility 
of hypotheses, or explore a mechanism of action of a specific food 
component through controlled animal diets; however, these studies do 
not provide information from which scientific conclusions can be drawn 
regarding the beneficial physiological effects of a food component, 
such as added non-digestible carbohydrates.
    If a dietary fiber is the subject of an authorized health claim, we 
would consider the relationship between the fiber and the chronic 
disease risk or health-related condition, to provide a beneficial 
physiological benefit to health. In fact, we proposed, and include in 
this final rule, two dietary fibers in the definition of dietary fiber 
that are the subject of an authorized health claim. Prospectively, if 
we issue a final rule authorizing a health claim for a dietary fiber, 
we intend to modify the dietary fiber definition accordingly.
    Moreover, we are not including a requirement that an isolated or 
synthetic non-digestible carbohydrate that has beneficial physiological 
benefit be included at or above a certain level in food in order to be 
declared as dietary fiber on the Nutrition Facts label. The dietary 
fiber declaration is not a health claim. We do not consider it 
necessary to titrate an amount of a dietary fiber in a food with the 
beneficial physiological effect of the fiber for purposes of a nutrient 
declaration. We recognize that dose-response relationships may exist 
between certain isolated or synthetic non-digestible carbohydrates and 
a beneficial physiological endpoint. We also recognize that the amount 
of an isolated or synthetic non-digestible carbohydrate will vary in 
similar and different marketed food products. The scientific evidence 
from a clinical study to support a beneficial physiological effect 
should provide an amount of the fiber that is a reasonable level to be 
expected in a food and relevant based on typical consumption of dietary 
fiber.
    (Comment 259) Several comments said we should accept functional 
fibers (i.e., isolated or synthetic non-digestible carbohydrates) 
identified in the IOM macronutrient report (Ref. 5) that summarizes the 
scientific evidence and where sufficient data documents their 
beneficial physiological effect. The comments said that the 2002 IOM 
report already included inulin and oligofructose as dietary fibers in 
table 7-1 and pages 345 through 346.
    (Response) We disagree with the comments. The IOM (Ref. 5) did not 
consider whether the scientific evidence is sufficient to support a 
beneficial physiological effect to human health for specific isolated 
or synthetic non-digestible carbohydrates, but rather identified or 
classified which non-digestible carbohydrates would be considered to be 
a functional fiber and, therefore, would need to demonstrate a 
beneficial physiological effect to fall within the dietary fiber 
definition. For example, the IOM report states that inulin, 
oligofructose, and fructooligosaccharides ``could be classified as 
functional fibers where there are sufficient data to show positive 
physiological effects in humans'' (Ref. 135). Table 7-1 of the IOM 
report simply provides the general characteristics of what could 
qualify as a dietary fiber. The IOM did not evaluate the beneficial 
physiological effects of the individual non-digestible carbohydrates 
for the purpose of identifying those that meet the dietary fiber 
definition. Instead, the IOM provided a brief science review rather 
than an indepth review for the various physiological endpoints. The IOM 
stated that it is important to note that the discussions on the 
potential benefits of what might eventually be classified as functional 
fibers should not be construed as endorsements of those fibers.
    (Comment 260) One comment said our consideration of physiological 
effects was arbitrarily limited to three endpoints. Many comments said 
we should use and incorporate into a guidance document the endpoints 
identified at the Vahouny Fiber Symposium, besides the three endpoints 
listed in the IOM report (and the proposed rule).
    (Response) We disagree that we limited the physiological effects to 
three endpoints. In the preamble to the proposed rule (79 FR 11879 at 
11910), we identified examples of physiological effects that are 
beneficial to human health, such as attenuation of postprandial blood 
glucose concentrations, attenuation of blood cholesterol 
concentrations, and improved laxation. The terms ``such as'' indicate 
that the subsequent list of items is merely an illustration rather than 
an exhaustive list.

[[Page 33856]]

    As for the comments' reference to Vahouny endpoints, at the 9th 
Vahouny Fiber Symposium, nine physiological health effects were 
identified: (1) Total/LDL cholesterol; (2) post-prandial glucose and 
insulin; (3) increased fecal bulk and laxation; (4) colonic transit 
time; (5) blood pressure; (6) colonic fermentation and short chain 
fatty acid production; (7) modulation of the colonic microflora; (8) 
weight loss, weight maintenance, and reduction in satiety; and (9) 
increased satiety (Ref. 136). We agree that lowering total/LDL levels, 
lowering post-prandial glucose levels, reducing gut transit time and 
improving laxation (fecal output), reduced blood pressure, and 
increased satiety associated with reduced energy intake and with 
possible associated outcomes on body weight are beneficial to human 
health. We consider colonic fermentation and short chain fatty acid 
production and modulation of the colonic microflora to be processes 
that may be associated with a physiological endpoint, rather than 
physiological endpoints themselves.
    (Comment 261) One comment said that requiring added non-digestible 
carbohydrates to have a beneficial physiological effect will require 
research, and funds to support such research, to demonstrate such an 
effect. The comment said this would be a burden to firms who seek to 
develop new fibers. Another comment said we should accept the existing 
body of evidence as an appropriate demonstration of benefit, in many 
cases, without requiring new substantiation for a beneficial ingredient 
already in common use.
    (Response) The final rule does not require a firm to demonstrate 
that there is a beneficial physiological effect before it can add an 
isolated or synthetic non-digestible carbohydrate to a food and declare 
it as part of the Total Carbohydrate declaration. We recognize that 
firms may develop new fibers and that we may not be aware of all of the 
added fibers that a manufacturer may be using as an ingredient in its 
products. For example, there may be some fibers that a manufacturer has 
self-determined to be GRAS for which we did not receive a GRAS 
notification. In addition, isolated or synthetic added fibers may be 
approved for use as a food additive. Moreover, even if a manufacturer 
self-determines that a fiber is GRAS, or there is a food additive 
approval for the fiber, whether the fiber has a beneficial 
physiological effect to health is a separate question. Therefore, given 
the potential uncertainties and possible inconsistencies in what fibers 
may be declared as dietary fiber, we define dietary fiber to include a 
listing of isolated or synthetic non-digestible carbohydrate that will 
provide a beneficial physiological effect. In this way, there is 
transparency in what added fibers are included in the definition that 
will assist consumers in maintaining healthy dietary practices and 
certainty in what must be declared for compliance purposes.
    Numerous studies have already been conducted on many different 
types of isolated or synthetic non-digestible carbohydrates. We 
reviewed the publically available studies for various non-digestible 
carbohydrates. Based on our review, we found that a number of isolated 
or synthetic fibers have a demonstrated beneficial physiological effect 
to health (Ref. 137), and we include such fibers in the definition for 
dietary fiber (Sec.  101.9(c)(6)(i)). We consider the totality of the 
evidence when evaluating the beneficial physiological effect(s) of an 
isolated or synthetic non-digestible carbohydrate. We reviewed several 
non-digestible carbohydrates for which the publically available 
scientific evidence indicated mixed results, or appears to be 
insufficient. It is not clear whether there may be additional data or 
information concerning the beneficial health effects of these non-
digestible carbohydrates that interested persons have and are not yet 
publically available. Therefore, we decline to make a determination on 
whether these non-digestible carbohydrates meet the definition of 
``dietary fiber'' without first providing an opportunity for comment on 
the available scientific evidence for these non-digestible 
carbohydrates. We intend to publish a separate notice to seek comment 
on the available scientific data on these non-digestible carbohydrates 
to determine if we should consider additional non-digestible 
carbohydrates to be added to the list of dietary fibers. We also intend 
to publish a guidance document on the type of evidence we recommend be 
provided and the approach we plan to use to evaluate the beneficial 
physiological effect of a non-digestible carbohydrate.
    If a manufacturer wants to add an isolated or synthetic non-
digestible carbohydrate to the listing of fibers in the dietary fiber 
definition, it can petition us to amend the definition to include that 
fiber in the dietary fiber listing for these types of carbohydrates. 
Under Sec.  10.30(b), the citizen petition must include all relevant 
information and views on which the petitioner relies, as well as 
representative information known to the petitioner which is unfavorable 
to the petitioner's position. Thus, any petition to request an 
amendment to the definition to include an additional dietary fiber 
should include all publically available evidence relevant to the review 
about a beneficial effect of the isolated or synthetic added non-
digestible carbohydrate.
    (Comment 262) The proposed definition of dietary fiber would 
mention citizen petitions submitted to us pursuant to Sec.  10.30. One 
comment said that requiring a citizen petition to seek approval of 
currently used fibers will cause disruption in the food supply. The 
comment said there could be a backlog of petitions.
    Several comments raised concerns that a review of new fibers that 
manufacturers want to include as part of a listing of fibers within the 
definition of dietary fiber will result in lag time resulting in 
manufacturers dropping the extrinsic fiber they use in products. With a 
label compliance period of 2 years, the comments questioned whether we 
could review and respond to citizen petitions within this time period 
and allow manufacturers to design and secure new packaging. Some 
comments said that, once we begin implementing the final rule, the time 
for review of subsequent petitions may be unreasonable and that some 
added non-digestible carbohydrates that are currently declared as 
dietary fiber may have to come off the Nutrition Facts label. The 
comments said that a lengthy petition process undermines the overall 
purpose to promote the healthful consumption of dietary fibers and that 
industry would have to make the other label changes in response to the 
final rule without knowing the amount of dietary fiber to declare and 
could lose dietary fiber health claims. Some comments said that 
premarket review should only apply to those fibers that we did not 
identify as dietary fiber. One comment said that we should issue the 
guidance document along with the listing of the dietary fibers, 
including the commonly used added non-digestible carbohydrates that we 
have determined to have a beneficial effect without submission of 
formal petitions.
    (Response) We recognize that there may be uncertainty about whether 
certain isolated or synthetic non-digestible carbohydrates, currently 
in use by manufacturers and declared as dietary fiber, meet the dietary 
fiber definition. We proposed to list isolated or synthetic non-
digestible carbohydrates that we have been determined to have a 
physiological effect that is beneficial to human health in Sec.  
101.9(c)(6)(i), and the final rule includes additional dietary fibers 
in the definition based on the review of

[[Page 33857]]

publically available evidence (Ref. 137). These reviews identify a 
number of isolated or synthetic non-digestible carbohydrates for which 
the publically available scientific evidence supports a beneficial 
physiological effect to human health.
    With respect to the concern about a possible backlog in petitions, 
we did not receive any comment about numbers of specific isolated or 
synthetic fibers used as an ingredient in food that would not otherwise 
have been included in our review of publically available evidence. Our 
review was necessarily limited to the publically available evidence on 
such fibers. Therefore, to the extent there are uses of isolated or 
synthetic fibers that are specific to a particular manufacturer, we 
will need to consider those case-by-case in the context of petition 
submitted under Sec.  10.30 and consider the resources needed to 
evaluate such requests as we receive them.
    (Comment 263) Several comments said that certain added non-
digestible carbohydrates meet the dietary fiber definition. Some 
comments would add psyllium husk to the list of approved fibers and 
said that there is a wealth of clinical trial data on inulin which met 
the dietary fiber definition based on the 2002 IOM report and that 
there were data to support galactooligosaccharides (GOS) as a dietary 
fiber.
    Other comments supported the inclusion of bamboo fiber, soy fiber, 
pea fiber, wheat fiber, cellulose, cotton seed fiber, sugar cane fiber, 
sugar beet fiber, and oat fiber. One comment said that cellulose is 
GRAS under a ``prior sanctioned category.''
    (Response) We agree that psyllium husk meets the dietary fiber 
definition (Sec.  101.81(c)(2)(B)) and have revised the definition 
accordingly. We have reviewed the publicly available scientific 
evidence for some of the isolated or synthetic non-digestible 
carbohydrates, including cellulose (Ref. 137). Based on our review, we 
determined that the scientific evidence supports a showing of a 
beneficial physiological effect to human health from the following 
fibers: Cellulose, guar gum, pectin, locust bean gum, and 
hydroxypropylmethylcellulose. Cellulose was determined to improve bowel 
function. Guar gum, pectin, locust bean gum and 
hydroxypropylmethylcellulose were determined to lower blood total and/
or LDL cholesterol levels. Therefore, we include these isolated or 
synthetic dietary fibers in the final rule's definition of dietary 
fiber.
    As for the other carbohydrates mentioned in the comments, the 
comments did not provide data on beneficial physiological effects, so 
we are unable to conduct a scientific review. However, we intend to 
publish a separate notice to seek comment on the available scientific 
data on non-digestible carbohydrates to assist us in the review of the 
scientific evidence. Publically available clinical trial data will be 
identified and summarized for non-digestible carbohydrates, including 
inulin, bamboo fiber, soy fiber, pea fiber, wheat fiber, cotton seed 
fiber, sugar cane fiber, sugar beet fiber, and oat fiber.
    (Comment 264) Several comments stated that we should provide 
guidance to industry on submissions to demonstrate physiological 
effects that are beneficial to humans before we issue the final rule so 
that meaningful comments can be provided on the process. The comments 
said that our failure to provide notice and an opportunity to comment 
on a guidance document would violate the Administrative Procedure Act. 
Other comments stated that, once we have identified the dietary fibers, 
we should reopen the dietary fiber section of the proposed rule for 
public comment, including the requirements for defining dietary fiber.
    (Response) We intend to issue guidance concerning the evidence to 
submit and our approach to reviewing the science in a request to amend 
the dietary fiber definition to support a fiber's beneficial 
physiological effect to human health. We do not consider it necessary 
to publish the draft guidance before the final rule is published. There 
will be an opportunity to submit comments to the guidance, consistent 
with our good guidance practices regulation at 21 CFR 10.115.
    To the extent the comment asserts a failure to receive comment on 
the draft guidance before the publication of the final rule violates 
the Administrative Procedure Act (APA), we disagree. The publication of 
a draft guidance document is not a general notice of proposed 
rulemaking to which the APA requirements under 5 U.S.C. 553 would 
otherwise apply. Furthermore, we provided adequate notice and 
opportunity to comment on our proposed definition of dietary fiber and 
provided the Codex definition that includes isolated or synthetic non-
digestible carbohydrates that have been shown to have a beneficial 
physiological effect to health as demonstrated by generally accepted 
scientific evidence to competent authorities (79 FR 11879 at 11909). We 
provided examples of beneficial physiological effects (e.g., 
attenuation of blood glucose and cholesterol levels and improved 
laxation) and the reference to the IOM reports (Ref. 138) (id.). We 
also asked for comment on the IOM definition of dietary and functional 
fibers dating back to the 2007 ANPRM (id.). Therefore, we decline to 
delay issuance of the final rule as suggested by the comments. 
Furthermore, the administrative process for submitting a request to 
amend the definition of dietary fiber is in Sec.  10.30. We have not 
proposed changes to that regulation in the context of this rulemaking, 
and, therefore, comments to Sec.  10.30 are outside the scope of this 
rule.
    (Comment 265) Many comments supported the proposed definition of 
dietary fiber, but for different reasons. Some comments supported the 
proposed definition because, according to the comments, dietary fibers 
should show a physiological benefit, and the proposed definition would 
facilitate the development of healthier products. Other comments said 
the proposed definition aligns with the IOM and Codex definitions for 
dietary fiber.
    Several comments, however, asked us for clarification. Some 
comments asked us to clarify what we meant by ``intact and intrinsic in 
plants'' and ``isolated and synthetic.''
    (Response) Consistent with the IOM fiber report (Ref. 138), we 
consider ``intact'' as having no relevant component removed or 
destroyed and ``intrinsic'' as originating and included wholly within a 
food. Intact and intrinsic fibers are naturally present such that they 
are integrated within the plant matrix and contain other nutrients 
naturally present in proportions that exist in the plant cell. For 
example, brans, which are obtained by grinding, are anatomical layers 
of the grain consisting of intact cells and substantial amounts of 
starch, protein and other nutrients. Non-digestible carbohydrates that 
are created during normal food processing (e.g., cooking, rolling, or 
milling) are intrinsic and intact (e.g., non-digestible (resistant) 
starch in flaked corn cereal). However, a resistant starch that has 
been extracted and isolated from the flaked corn cereal, such that it 
is no longer part of the food matrix (intrinsic) and no longer consists 
of relevant food components (intact), often with an increased 
concentration of non-digestible carbohydrates, would be considered an 
isolated non-digestible carbohydrate. The term ``isolated'' is used to 
describe isolated non-digestible carbohydrates that are isolated from 
plant sources such that they are no longer intrinsic or intact. Some of 
these isolated fibers can be further modified. The term ``synthetic'' 
is used to describe

[[Page 33858]]

synthetic non-digestible carbohydrates that are not isolated from plant 
sources, but rather chemically synthesized.
    We note that the distinction between ``intrinsic and intact'' and 
``isolated or synthetic'' is important because foods that contain 
intrinsic and intact fibers include naturally occurring dietary fibers 
that contain other nutrients normally found in foods that may be 
associated with beneficial physiological effects. Such beneficial 
physiological effects, associated with natural dietary fibers, cannot 
be assumed to exist when non-digestible carbohydrates are isolated from 
foods, and especially when synthesized. We note that the IOM (2002) 
cited an earlier IOM report (Ref. 139), which stated that, while 
dietary fiber intake is associated with decreased risk or improvements 
in several chronic diseases, there is no conclusive evidence that 
dietary fiber, rather than the other components of vegetables, fruits, 
and cereal products, reduces the risk of those diseases. Furthermore, 
the IOM stated that there are many constituents of whole grains, in 
addition to dietary fiber, that may reduce the risk of CHD. These 
statements emphasize the inherent benefits of intact and intrinsic non-
digestible carbohydrates.
    (Comment 266) Several comments would change ``intact and intrinsic 
in plants'' to ``intact or intrinsic.'' The comments said that, without 
this change, the definition would exclude almost all fiber ingredients.
    (Response) We disagree with the comment. These two terms 
collectively require that the non-digestible carbohydrate is naturally 
present such that it is integrated within the plant matrix and contains 
other nutrients naturally present in proportions that exist in the 
plant cell. These conditions (integration in the plant matrix and 
providing proportional nutrients that are present naturally in the 
plant cell) are considered to be inherent in the health benefits 
associated with naturally occurring dietary fibers. The definition of 
dietary fiber includes these intact and intrinsic fibers in addition to 
isolated or synthetic fibers that have a beneficial physiological 
effect. Therefore, we disagree that the definition of dietary fiber 
would ``exclude almost all fiber ingredients'' if we retained 
``intrinsic and intact in plants'' in the definition. We decline to 
revise the definition as suggested by the comment.
    (Comment 267) One comment suggested changing ``isolated and 
synthetic'' to ``isolated or synthetic.''
    (Response) We agree with the comment. Non-digestible carbohydrates 
that are added to foods are either isolated from foods or synthesized, 
and so we have revised the rule as suggested by the comment.
    (Comment 268) One comment stated that brans, obtained by mechanical 
action (grinding), are a layer of grains and therefore should be a 
dietary fiber.
    (Response) We agree that brans that are obtained by mechanical 
actions are unique and, unlike other fibers subject to mechanical 
actions, are intact and intrinsic and therefore meet the dietary fiber 
definition. Bran is the hard outer layer of cereal grain and is 
obtained by mechanical processing. Bran is rich in dietary fiber, as 
well as other nutrients including starch, protein, vitamins, and 
minerals. Furthermore, naturally occurring dietary fiber is part of the 
matrix in bran. Therefore, dietary fiber in bran is intact and 
intrinsic.
    (Comment 269) One comment opposed to the proposed definition of 
dietary fiber stated that, as is the case for most dietary components, 
the health benefits of dietary fiber have only been studied in clinical 
trials in isolated forms rather than in their intrinsic and intact 
forms. The comment said it is nearly impossible to separate out any 
associated health outcome from other bioactive components within the 
food matrix.
    (Response) We agree that the health benefits of non-digestible 
carbohydrates have been studied in numerous clinical trials in isolated 
forms. These clinical trials have been used to identify those added 
non-digestible carbohydrates that meet the dietary fiber definition 
(Ref. 137). Fiber-containing fruits, vegetable, and grain products have 
been shown to have beneficial health effects via such clinical trials, 
as well as observational studies on chronic disease risk (e.g., CHD). 
The collective information from such studies has been used to 
substantiate the evidence for the relationship between soluble fibers 
and CHD risk (e.g., Sec. Sec.  101.77 and 101.81), as well as the 
establishment of an AI for dietary fiber (Ref. 36). Thus, the health 
benefits of foods that contain naturally occurring dietary fibers have 
already been substantiated.
    (Comment 270) Several comments asked us to clarify the meaning of a 
``physiological effect that is beneficial to human health.''
    (Response) In the preamble of the proposed rule (79 FR 11879 at 
11909), we explained that a regulatory definition for dietary fiber, 
such as those consistent with the IOM and Codex, should be one that 
emphasizes its physiological effect that is beneficial to human health 
to assist consumers in maintaining healthy dietary practices. We also 
identified, in the preamble to the proposed rule (id. at 11910), 
physiological effects that are beneficial, such as attenuation of blood 
glucose and cholesterol levels (i.e., total or LDL). We also would 
consider the lowering of blood pressure to be a beneficial 
physiological effect. The attenuation/lowering of these biomarkers 
(lowering of blood glucose and cholesterol levels and lowering of blood 
pressure) are associated with reduced risk of type 2 diabetes or CVD. 
Another outcome we consider a beneficial physiological effect is 
increased satiety, where an isolated or synthetic non-digestible 
carbohydrate is associated with a reduced energy intake. A reduced 
energy intake can reduce the risk of being overweight or obese. In 
addition, improved laxation and bowel function is a beneficial 
physiological effect where an isolated or synthetic non-digestible 
carbohydrate shows a reduced intestinal transit time or an increase in 
the passage of stools. These outcomes result in an increased rate of 
defecation to improve bowel function. Increased absorption of minerals, 
such as calcium, are considered to provide beneficial physiological 
effects because increased absorption of calcium is associated with 
increased bone mineral density which may reduce osteoporosis. For the 
purposes of Nutrition Facts labeling, we do not consider processes and 
mechanisms (e.g., fermentation) per se as beneficial physiological 
effects for determining whether an isolated or synthetic non-digestible 
carbohydrate meets the definition of dietary fiber. Fermentation is not 
a physiological benefit; rather, it is a process associated with the 
digestion of the non-digestible carbohydrate itself. Unless there is 
information to support a beneficial physiological effect, such non-
digestible carbohydrates would not assist consumers in maintaining 
healthy dietary practices. As stated in the IOM Diet and Health report 
(Ref. 139), while dietary fiber intake is associated with decreased 
risk or improvements in several chronic diseases, there is no 
conclusive evidence that it is dietary fiber, rather than the other 
components of vegetables, fruits, and cereal products, that reduces the 
risk of those diseases. There are many constituents in whole grains, in 
addition to dietary fiber, that may reduce the risk of CHD. Therefore, 
unlike the inherent benefits of intact non-digestible carbohydrates, 
isolated or synthetic non-digestible carbohydrates must be 
independently shown to have physiological health benefits, and not all 
such fibers have these types of benefits. One example of a process that 
is not considered to be a

[[Page 33859]]

beneficial physiological effect is fermentation. Another example is 
changes in the microbiota in the large intestine as a result of the 
consumption of non-digestible carbohydrates. Physiological effects that 
are beneficial (e.g., satiety) may be an outcome of a process, such as 
fermentation and changes in the colonic microbiota.
    (Comment 271) One comment said that the food industry will be able 
to demonstrate at least one physiological effect for each type of 
isolated or synthetic non-digestible carbohydrate and those effects may 
be less significant than the benefits from intact fiber. For example, 
the comment said, referring to EFSA, reduced post-prandial glycemic 
response would apply for all isolated or synthetic non-digestible 
carbohydrates (compared to sugar). The comment also said that the 
evidence showing that isolated or synthetic non-digestible 
carbohydrates are beneficial is often inconsistent and based on poorly 
established biomarkers. Thus, according to the comment, added fiber may 
have less benefit than its intact counterpart.
    (Response) Without reviewing the evidence on the beneficial 
physiological effects of non-digestible carbohydrates, it is premature 
for us to state whether or not at least one physiological effect for 
each type of isolated or synthetic non-digestible carbohydrate can be 
demonstrated. We disagree with the comment, referring to EFSA, that 
reduced post-prandial glycemic response would apply for all isolated or 
synthetic non-digestible carbohydrates. As an example, EFSA concluded 
that a relationship has not been established between acacia gum and 
reduced postprandial glycemic response (Ref. 140). While some studies 
may have used poorly established biomarkers, our science reviews have 
included endpoints that are reliable measurements of physiological 
effects (e.g., total and LDL cholesterol levels, and intestinal transit 
time and frequency of bowel movements as a measure of laxation) (Ref. 
137).
    (Comment 272) One comment said there is an insufficient 
understanding of the complex interactions among and between gut 
microbiota and the human host. The comment said these interactions are 
affected by total fiber intake, but the effects of specific fiber 
components can be difficult to define. Another comment said that we 
should indicate that the list of beneficial physiological effects is 
not exhaustive and is evolving.
    (Response) We agree that scientific knowledge of beneficial 
physiological effects to human health is evolving. The physiological 
endpoints that we have considered in our science reviews include those 
that are supported by the current scientific evidence (Ref. 137). We 
recognize that, as the science evolves, the list of dietary fibers in 
the definition may change. Thus, our list is not exhaustive.
    (Comment 273) One comment presumed that, based on the proposed 
factor of 2 kcal/gram, ``non-digestible carbohydrates'' includes 
partially and totally digested carbohydrates. The comment said that, 
for this reason, we should define ``non-digestible carbohydrate'' to 
mean ``carbohydrates that are partially or totally fermentable by 
colonic microflora.''
    (Response) As provided in the IOM fiber report (Ref. 138), ``non-
digestible'' is an adjective that implies a substance is not broken 
down to simpler chemical compounds in the living body chiefly through 
the action of secretion-containing enzymes such as the saliva and the 
gastric, pancreatic, and intestinal juices in the alimentary canal. 
Thus, non-digestible carbohydrates are not digested by human enzymes 
and pass into the colon where they may or not be fermented by colonic 
microflora, and so we decline to revise the rule as suggested by the 
comment.
    (Comment 274) Many comments disagreed with the proposed definition 
of dietary fiber. Several comments said that the amount of dietary 
fiber declared in the Nutrition Facts label should continue to be based 
on AOAC methods because the measured amount aligns more closely to the 
chemical composition and structure and is more feasible and practical. 
The comments also said that natural and isolated fibers are chemically 
identical.
    Other comments argued that using the more recently developed 
methods (e.g., AOAC 2011.25) allows for a comprehensive isolation and 
quantitation of all dietary fiber ingredients, without relying on a 
definition. The comments said that the newer AOAC methods capture the 
more highly soluble non-digestible carbohydrates (i.e., non-digestible 
oligosaccharides) that were not captured in the methods available at 
the time when the IOM considered the definitions for dietary fiber and 
therefore not considered in the 2002 IOM report.
    (Response) We disagree with the comments. While the AOAC methods 
may be more feasible, practical, and inclusive in measuring non-
digestible carbohydrate compared to the amount of non-digestible 
carbohydrates that meets the dietary fiber definition, these methods 
are not able to distinguish and measure non-digestible carbohydrates 
that do not provide a beneficial physiological effect. Therefore, 
relying on AOAC methods can overestimate the amount of non-digestible 
carbohydrates that can assist consumers in maintaining healthy dietary 
practices.
    We agree that the newer methods that can measure lower molecular 
weight non-digestible carbohydrates were not available when the IOM was 
developing the dietary fiber definitions. However, the availability of 
analytical methods had no bearing on the IOM's definitions, and the IOM 
definition included the lower molecular weight non-digestible 
oligosaccharides as part of the definition of dietary fiber. The focus 
was on ensuring that all added non-digestible carbohydrates that meet 
the dietary fiber definition have a beneficial physiological effect. 
Even though natural and isolated fibers can be identical chemically, 
they may not provide the same beneficial physiological effect.
    (Comment 275) Several comments supported using the American 
Association of Cereal Chemist International (AACCI) definition because 
the AACCI definition was consistent with the Codex definition and would 
support global harmonization. The AACCI definition is:

    Dietary fiber is the edible parts of plants or analogous 
carbohydrates that are resistant to digestion and absorption in the 
human small intestine with complete or partial fermentation in the 
large intestine. Dietary fiber includes polysaccharides, 
oligosaccharides, lignin, and associated plant substances. Dietary 
fibers promote beneficial physiological effects including laxation, 
and/or blood cholesterol attenuation, and/or blood glucose 
attenuation.

    (Response) We decline to revise the rule as suggested by the 
comment. While the AACCI definition distinguishes between natural and 
isolated or synthetic non-digestible carbohydrates, it does not specify 
the need for isolated or synthetic non-digestible carbohydrates to 
demonstrate a beneficial physiological effect. Foods that contain 
naturally occurring dietary fibers are usually a mixture of 
polysaccharides that are integral components of the plant cell wall or 
intercellular structure. Naturally occurring dietary fibers have the 
three-dimensional plant matrix that is responsible for some of the 
physicochemical properties attributed to dietary fiber (Ref. 138). 
Furthermore, foods that contain naturally occurring dietary fibers 
contain other nutrients normally found in foods that may be associated 
with beneficial physiological effects. Such beneficial physiological

[[Page 33860]]

effects, associated with natural dietary fibers, cannot be assumed to 
exist when non-digestible carbohydrates are isolated from foods, and 
especially when synthesized.
    We also disagree that the AACCI definition is consistent with the 
Codex definition. The Codex definition includes the need for isolated 
or synthetic fibers to have been shown to have a physiological effect 
of benefit to health.
    (Comment 276) One comment said we should establish a definition 
that is consistent with other long-recognized definitions regardless of 
whether that definition is based on clinical evidence or to include 
greater than DP >3. The comment, however, did not identify any other 
definitions.
    (Response) To the extent the comment suggests that we should not 
consider clinical evidence of beneficial physiological effect or length 
of monomeric units in the dietary fiber definition, we disagree. 
Consistent with the IOM, we recognize that those non-digestible 
carbohydrates that have been isolated from foods or synthesized need to 
demonstrate a physiological benefit in humans and may include a DP of 
>=3. Evidence of such a benefit is obtained primarily through human 
clinical studies that have evaluated the effect of isolated or 
synthetic non-digestible carbohydrates on individual physiological 
effects.
    (Comment 277) Several comments stated that, for the sake of 
harmonization, we should adopt the Codex definition, but without 
footnote 2. Footnote 2 states that the decision on whether to include 
carbohydrates from 3 to 9 monomeric units should be left to national 
authorities.
    (Response) We decline to revise the rule as suggested by the 
comments. Codex defines dietary fiber to mean carbohydrate polymers 
with ten or more monomeric units, which are not hydrolyzed by the 
endogenous enzymes in the small intestine of humans and belong to the 
following categories:
     Edible carbohydrate polymers naturally occurring in the 
food as consumed;
     carbohydrate polymers, which have been obtained from food 
raw material by physical, enzymatic, or chemical means and which have 
been shown to have a physiological effect of benefit to health as 
demonstrated by generally accepted scientific evidence to competent 
authorities; and
     synthetic carbohydrate polymers which have been shown to 
have a physiological effect of benefit to health as demonstrated by 
generally accepted scientific evidence to competent authorities.
    The Codex and IOM definitions are consistent with our definition in 
that they specify that isolated or synthetic non-digestible 
carbohydrates that are added to foods need to show a beneficial 
physiological effect. The footnote is left up to competent authorities, 
such as FDA, and we have chosen to include non-digestible 
oligosaccharides with a DP of 3 to 9 monomeric units as part of the 
dietary fiber definition to include fibers with beneficial physiologic 
effects regardless of size.
    (Comment 278) One comment stated that the dietary fiber definition 
should include non-digestible carbohydrates with a DP = 2 (e.g., non-
digestible disaccharides such as galacto-oligosaccharides (GOS)) to 
capture all added non-digestible carbohydrates that have a beneficial 
physiological effect.
    (Response) Non-digestible oligosaccharides, such as GOS, vary in 
size. GOS is a mixture of [beta]-linked polymers in various 
configurations and the DP ranges from 2 to 8 (Ref. 141). The currently 
available AOAC methods measure non-digestible carbohydrates at a DP 
>=3. Furthermore, non-digestible monosaccharides and disaccharides meet 
the definition of sugar (see part II.H.3.n). Therefore, we disagree 
that non-digestible mono- and disaccharides should be considered as 
dietary fiber.
    (Comment 279) One comment said that the IOM definition could be 
enhanced by including other minor substances that are intrinsic in 
plant fibers to make it more compatible with a variety of other 
definitions, such as those issued by Codex and AACCI.
    (Response) The IOM (and Codex) definition did not address minor 
components such as waxes, cutin, and suberin, that are intrinsic in 
plant fibers. However, like lignin, waxes, cutin, and suberin are not 
carbohydrates that are closely associated with non-digestible 
carbohydrates within plants. Therefore, like lignin, these minor 
components are included in the amount of intact and intrinsic fibers 
that would be declared as dietary fiber. Newer methods, such as AOAC 
2011.25, include waxes, cutin, and suberin in the measurement of non-
digestible carbohydrates.
    (Comment 280) Several comments said that the proposed requirement 
to demonstrate a physiological benefit is a drastic shift from the 
analytical-based approach and dietary fiber would be the only nutrient 
listed in the Nutrition Facts label that requires a physiological 
benefit. The comments said our approach contradicts with the rationale 
(chemical composition) for not excluding certain fatty acids (i.e., 
stearic acid) from the definition of total fat.
    (Response) We disagree with the comments. The definition for 
saturated fat in Sec.  101.9(c)(2)(i) includes all fatty acids without 
double bonds, and the accepted analytical methods capture all of the 
saturated fatty acids, including stearic acid. In adopting this 
definition, we addressed the issue of the inclusion or exclusion of 
individual saturated fatty acids and determined that a chemical 
definition which includes all fatty acids containing no double bonds 
was the appropriate approach to define saturated fat (see 79 FR 11879 
at 11894). The scientific evidence to recommend that saturated fatty 
acids provide no more than 10 percent of total calories does not 
exclude stearic acid. As we discussed in the preamble to the proposed 
rule (79 FR 11879 at 11894), the scientific evidence in the 2010 DGA to 
consume less than 10 percent of calories from saturated fatty acids 
makes no specific exclusion of stearic acid and, instead, relates to 
the intake of total saturated fatty acids. Therefore, the DRV that is 
based on 10 percent of calories includes stearic acid. The DV of 28 
grams for dietary fiber is based on the AI set by the IOM for total 
fiber (Ref. 36). The DV reflects the IOM definition for dietary fiber 
which excludes those isolated or synthetic non-digestible carbohydrates 
that do not provide a beneficial physiological effect. Furthermore, the 
listing of individual nutrients based on physiological effect is not 
new. Soluble and insoluble dietary fibers can be voluntarily listed 
separately because of their distinct physiological effects.
    (Comment 281) One comment that objected to the proposed definition 
said that the criteria for listing dietary fiber differ from the 
criteria used for protein. The comment said there are many sources of 
protein (soy protein) that are used as ingredients, but they are not 
reviewed individually for their health benefits.
    (Response) Protein is listed because it is a major macronutrient 
category, as is the case for total carbohydrate. Protein contains amino 
acids that are essential in the diet. Dietary fiber is not essential in 
the diet and is listed because of its beneficial physiological effects, 
rather than essentiality. The DV for protein is based on providing a 
certain percent of calories, relative to total fat and carbohydrate, 
whereas the DV for dietary fiber is based chronic disease risk. 
Therefore, the basis for declaring protein, including protein 
ingredients, is not comparable to dietary fiber.
    As for the comment's mention of soy protein, soy protein that is 
naturally

[[Page 33861]]

present in a food is an intact and intrinsic protein, and thus, is a 
protein for purposes of nutrient declaration.
    (Comment 282) One comment that objected to the proposed definition 
of dietary fiber said that vitamins naturally present in food and those 
added through fortification can work effectively together to fulfill 
nutrient needs in the same manner that added fibers can interact with 
intrinsic fibers to meet the requirement.
    (Response) We agree that different forms of naturally occurring and 
isolated or synthetic non-digestible carbohydrates that meet the 
dietary fiber definition can work together to assist consumers in 
maintaining healthy dietary practices, but this fact does not 
necessitate a change to the definition. The comparison of different 
sources of fibers to different sources of the same vitamin, as the 
comment suggests, is not accurate. Fibers represent a heterogeneous 
group of compounds, and not all isolated or synthetic non-digestible 
carbohydrates may provide a beneficial physiological effect.
    (Comment 283) One comment said that we should base the listing of 
dietary fiber on physicochemical properties instead of physiological 
benefit. The comment would define dietary fiber as ``non-digestible 
soluble and insoluble carbohydrates (with 3 or more monomeric units) 
and lignin.'' The comment said this definition would allow any review 
or consideration of dietary fiber to be predicated on its 
physicochemical characteristics.
    (Response) We disagree that the declaration of dietary fiber should 
be based on physicochemical properties. Although a physiochemical 
property, such as viscosity (degree of thickness and resistance to 
flow), is linked to health benefits, it is not known at what level of 
viscosity a dietary fiber begins to have a physiological effect (see 79 
FR 11879 at 11911). Moreover, there are no scientifically valid methods 
available that we could use to measure the amount of various dietary 
fibers defined by their physicochemical properties in various food 
matrices, whereas scientifically valid methods to measure soluble and 
insoluble fiber are available.
    (Comment 284) One comment stated that, instead of using the 
proposed dietary fiber definition, we should require the listing of 
soluble and insoluble fiber and conduct an education campaign to 
understand the difference which might prove to be more beneficial for 
consumers.
    (Response) We disagree that soluble and insoluble fiber should be 
listed instead of the dietary fiber definition. Both soluble and 
insoluble fibers should provide a beneficial physiological effect to 
assist consumers in maintaining healthy dietary practices. Under Sec.  
101.9(c)(6)(i) of the final rule, soluble fiber and insoluble fiber 
that meet the dietary fiber definition may be declared voluntarily.
    As for education campaigns, we address such issues in part II.B.1.
    (Comment 285) One comment said that all insoluble non-digestible 
carbohydrates should meet the proposed fiber definition. The comment 
said that cellulose and lignin do not dissolve in water and are not 
digested by bacteria in the colon adding bulk to the stool for improved 
laxation. Furthermore, the comment said that the IOM noted that the 
body of evidence indicates that non-fermentable fiber sources (often 
isolated as insoluble fiber) promote laxation and that improved 
laxation is an established physiological effect that is beneficial to 
human health.
    (Response) We agree that if the scientific evidence for a 
particular isolated or synthetic non-digestible carbohydrate 
demonstrates improved laxation, the fiber would meet the dietary fiber 
definition because improved laxation is a beneficial physiological 
effect. However, we are not able to conclude that all isolated or 
synthetic non-digestible carbohydrates improve laxation and therefore 
meet the dietary fiber definition. Cellulose is a fiber for which the 
science supports its role in improved laxation (Ref. 138). Therefore, 
we are listing cellulose in the definition of dietary fiber.
    With respect to lignin, and as we stated in the preamble to the 
proposed rule (79 FR 11879 at 11900), all dietary fibers, with the 
exception of lignin, are carbohydrate polymers. Although lignin is not 
a carbohydrate, it is tightly bound to other dietary fibers and cannot 
be easily isolated using AOAC or other reliable and appropriate 
analytical procedures. It is, therefore, included in the declaration of 
dietary fiber.
    (Comment 286) One comment stated that fiber-containing ingredients 
can have a variety of physiological effects that do not depend on 
whether they are characterized as intrinsic and intact or isolated and 
synthetic. The comment said that requiring added non-digestible 
carbohydrates demonstrate a physiological benefit falsely implies a 
nutritional superiority of fibers that have not been separated from 
their natural source. The comment added that such a distinction that is 
not factual from a food chemistry or physiological perspective. Other 
comments noted that the dietary fiber definition has the potential to 
be exclusionary and limit the benefits that consumers realize from 
certain fiber sources that may not meet the dietary fiber definition. 
One comment stated that all non-digestible carbohydrates have a 
physiological effect by virtue of not being digested and present in the 
colon. Another comment questioned why there is not a call to 
demonstrate physiological benefits of natural dietary fibers.
    (Response) We agree that some fiber-containing ingredients may have 
a variety of physiological effects that do not depend on whether they 
are characterized as intrinsic and intact or isolated or synthetic. The 
presence of a fiber in the colon alone is not necessarily beneficial. 
While one comment did not provide an example of how non-digestible 
carbohydrates have a physiological effect by virtue of not being 
digested and present in the colon, not all measurements in a study 
necessarily demonstrate a physiological effect, much less a beneficial 
physiological effect. For example, fermentation and changes in the 
colonic microflora is a process rather than a physiological effect.
    Moreover, unlike foods that contain only isolated or synthetic non-
digestible carbohydrate as a fiber source, foods that contain intrinsic 
and intact fibers contain other nutrients normally found in foods, and 
the foods with these fibers are associated with beneficial 
physiological effects. Such beneficial physiological effects cannot be 
assumed to exist when non-digestible carbohydrates are isolated from 
foods and thereby separated from other nutrients found in the food. The 
same is true for synthetic fibers which do not have other nutrients 
present that are found in the food.
    (Comment 287) One comment stated that isolated plant fibers are 
chemically identical to intrinsic fibers and have no similarity with 
synthetic fibers. The comment said that we should not hold isolated 
fibers to the same standards as synthetic fibers.
    (Response) While some isolated non-digestible carbohydrates may be 
chemically identical or similar to the forms (including molecular 
weight) that occur naturally in food, the basis for isolated non-
digestible carbohydrates showing a beneficial effect is not chemical 
composition. Isolated or synthetic fibers are similar in that they are 
not part of the three-dimensional plant matrix that is responsible for 
some physicochemical properties attributed to dietary fiber (Ref. 138) 
or in foods that contain other nutrients normally found in foods that 
may be associated with beneficial physiological effects.
    (Comment 288) Some comments objecting to the proposed definition of

[[Page 33862]]

dietary fiber stated that consumers will not easily understand our 
dietary fiber and functional fiber definition, and these definitions 
will cause consumer confusion. One comment said that changing the 
declaration of dietary fiber could cause consumer confusion when a 
product no longer lists dietary fiber.
    (Response) The comments may have misinterpreted the rule. The rule 
does not change the term ``dietary fiber'' on the Nutrition Facts 
label, nor does it use the term ``functional fiber'' on the Nutrition 
Facts label. Consumers generally view dietary fiber as being a 
beneficial nutrient (Ref. 142). Including fibers in the definition of 
dietary fiber that do not have a beneficial physiological effect would 
be misleading in that the fiber listed would not assist consumers in 
maintaining healthy dietary practices. Therefore, ensuring that all 
non-digestible carbohydrates that are declared as dietary fiber have a 
beneficial physiological effect will provide a consistent benchmark 
with respect to the types of fibers included in the declaration so that 
consumers can understand the relative significance of the amount of 
dietary fiber declared in a product in the context of a total daily 
diet. We expect that some dietary fiber label declarations will need to 
change to comply with the definition of dietary fiber. Consumers may 
have questions about fiber ingredients based on changes in dietary 
fiber declarations and will be better informed as to the dietary fiber 
content of a product that provides a beneficial nutrient.
    (Comment 289) One comment said that our rule would prevent 
consumers from knowing how much fiber in many foods has been linked to 
a lower risk of disease and how much fiber has some ``physiological 
benefit'' that may be far less consequential.
    (Response) While there can be a distinction between physiological 
benefit and lower chronic disease risk, a number of the endpoints for a 
physiological benefit also are surrogate endpoints for chronic disease 
risk (e.g., fasting blood cholesterol and glucose levels, blood 
pressure). Furthermore, requiring that an added non-digestible 
carbohydrate meet the dietary fiber definition will better identify 
those dietary fibers that have a beneficial role in human health than 
the current process of declaring dietary fiber solely based on 
analytical methods. A dietary fiber is not necessarily limited to one 
physiological health benefit, and there may be multiple types of 
dietary fibers present in a particular food. Thus, to the extent the 
comment suggests the Nutrition Facts label needs to list individual 
dietary fibers so that consumers can match particular beneficial 
physiological effects with each, we disagree and consider such an 
approach to be unwieldy.
    (Comment 290) One comment said that the proposed definition of 
dietary fiber, insofar as it states that non-digestible carbohydrates 
have a physiological effect that is beneficial to human health, will 
reduce the availability of high fiber products and reduce their use as 
ingredients. The comment said that regulatory hurdles will discourage 
manufacturers from innovating fiber containing products and reduce the 
intake of dietary fiber. Another comment stated that these ingredients 
are used as thickeners, bulking agents, or anti-caking agents, in 
addition to fiber fortification.
    (Response) We agree that many non-digestible carbohydrates are 
added to foods for a technical effect other than as a source of dietary 
fiber. There are numerous non-digestible carbohydrates approved as 
foods additives and GRAS notifications submitted to FDA about 
manufacturers' determinations that certain non-digestible carbohydrates 
added to food provide a technical effect and are safe. The final rule 
does not prohibit isolated or synthetic non-digestible carbohydrates 
from being added to foods.
    Manufacturers have a responsibility to ensure that the ingredients 
they use are safe and do not adulterate the food and to obtain FDA pre-
market approval as appropriate. Innovative non-digestible carbohydrate-
containing products have been shown to provide a variety of technical 
effects. If the isolated or synthetic non-digestible carbohydrate is 
included in the listing of fibers in the definition of dietary fiber, 
then the dietary fiber must be included in the declaration of declared 
as dietary fiber in addition to the declaration of Total Carbohydrate. 
If the added fiber is not included in the listing of dietary fibers in 
the definition, the added fiber is not a dietary fiber and must not be 
part of the declaration of dietary fiber; instead, the added fiber 
would only need to be included in the declaration of Total 
Carbohydrate.
    (Comment 291) Some comments said that there may be a need to make 
significant product changes to maintain current dietary fiber label 
values. The comments explained that a dietary fiber that is now a 
significant source may no longer be a significant source if we change 
the definition of dietary fiber. The comments said that companies would 
lose their ability to make fiber claims that have been marketed for 
years and that significant reformulation would be needed to be eligible 
for claims.
    (Response) We recognize that some non-digestible carbohydrates 
added to foods may not meet the dietary fiber definition in the final 
rule, resulting in a lower amount of dietary fiber being declared on 
the Nutrition Facts label. We also recognize that the definition may 
affect the number of foods that voluntarily make a nutrient content or 
health claim. However, we disagree that this is a sufficient basis for 
not requiring added non-digestible carbohydrates to meet the dietary 
fiber definition; the declaration of dietary fiber should assist 
consumers in maintaining healthy dietary practices.
    (Comment 292) One comment said that the dietary fiber definition 
would encourage the food industry to market cookies, candies, ice 
cream, refined grains, and other highly processed and relatively non-
nutritious foods that would compete with the fiber-rich fruits, 
vegetables, beans, and whole grains that are linked to a lower risk of 
disease.
    (Response) We disagree with the comment. The comment did not 
provide, and we are not aware of, evidence to suggest that the dietary 
fiber definition would encourage the food industry to market cookies, 
candies, ice cream, refined grains, and other highly processed and 
relatively non-nutritious foods that would compete with the fiber-rich 
fruits, vegetables, beans, and whole grains that are linked to a lower 
risk of disease. Furthermore, the current process of relying solely on 
analytical methods does not ensure that isolated or synthetic non-
digestible carbohydrates provide any beneficial physiological effect. 
While we do have a fortification policy in place (see Sec.  104.20), 
manufacturers can and currently do add these non-digestible 
carbohydrates to a variety of foods that may or may not have a 
beneficial physiological effect. The final rule's definition of dietary 
fiber would prevent the declaration of isolated or synthetic non-
digestible carbohydrates that have no beneficial physiological effect 
as dietary fiber. If there were to be a change in the marketing of 
snack foods, it would more likely result in a reduction of the use of 
isolated or synthetic non-digestible carbohydrates that do not meet the 
dietary fiber definition.
    (Comment 293) One comment said that the definition could result in 
unintended consequences (i.e., reduced dietary fiber intake) because 
only dietary fibers would be based on physiological function.
    (Response) We disagree with the comment. Those dietary fibers that

[[Page 33863]]

occur naturally in food must be declared as dietary fiber. Information 
on the amount of isolated or synthetic non-digestible carbohydrates 
that demonstrate a beneficial physiological effect to human health can 
assist consumers in maintaining healthy dietary practices. While the 
dietary fiber declaration may need to be revised to a lower value in 
some foods based on the definition of dietary fiber, that does mean 
that consumption of the various carbohydrates will change or that 
consumers will not seek out other foods to achieve a desired dietary 
fiber intake.
    (Comment 294) One comment stated that some added fibers have 
adverse effects (flatulence, exacerbation of irritable bowel syndrome) 
that outweigh their benefits.
    (Response) While the comment did not provide information as to 
which isolated or synthetic non-digestible carbohydrates have adverse 
effects, the overall health implications of fibers in the context of 
the daily diet have been considered. While the safety of added fibers 
is outside the scope of this rule, we have approved many isolated or 
synthetic non-digestible carbohydrates as food additives, and there 
have been determinations that certain non-digestible carbohydrates 
added to food provide a technical effect and are safe. Furthermore, 
natural dietary fibers also can cause flatulence.
    (Comment 295) One comment asked whether dietary fibers that are 
currently declared in the Nutrition Facts label would have to be 
removed until approved. The comment said we should allow industry to 
continue using and labeling fibers already on the market during the 
authorization process.
    (Response) The compliance date for the final rule is 2 years after 
the effective date, except that the compliance date for manufacturers 
with less than $10 million in annual food sales is 3 years after the 
final rule's effective date. After the compliance date, foods must 
declare dietary fiber in accordance with the requirements of the final 
rule. Thus, if fibers are included as an ingredient in a food and do 
not meet the definition of dietary fiber after that date, the 
declaration of dietary fiber must not include those fibers. We are not 
aware of how many isolated or synthetic fibers may be used as an 
ingredient in food that we have not already evaluated and that are not 
already included in the definition of dietary fiber. Thus, we have no 
information to suggest that we would receive numerous petitions or 
that, if we were to receive petitions, our review would extend beyond 
the compliance dates.
    (Comment 296) Several comments said we should allow isolated or 
synthetic non-digestible carbohydrates identified by other governmental 
organizations to meet the dietary fiber definition. The comments 
further stated that our isolated or synthetic non-digestible 
carbohydrates that meet the dietary fiber definition should be 
harmonized with those approved by Canada (e.g., inulin) or Europe so as 
to not hinder trade. Some comments noted that EFSA mentions 
physiological endpoints such as improved bowel function, colonic 
fermentation, maintenance of cholesterol levels, and lowered glycemic 
response. Other comments said we should consider Health Canada and EFSA 
decisions to grandfather in our isolated or synthetic non-digestible 
carbohydrates that meet the dietary fiber definition.
    (Response) We decline to revise the rule as suggested by the 
comments.
    Health Canada provides a list novel fibers that are ingredients 
manufactured to be sources of dietary fiber and consist of 
carbohydrates with a DP of 3 or more that are not digested and absorbed 
by the small intestine. Novel fibers are synthetically produced or are 
obtained from natural sources which have no history of safe use as a 
dietary fiber or which have been processed so as to modify the 
properties of the fiber. Health Canada considers the following to be 
beneficial effects: (1) Improved laxation or regularity by increasing 
stool bulk; (2) reduced blood total and/or low-density lipoprotein 
cholesterol levels; (3) reduced post-prandial blood glucose and/or 
insulin levels; and (4) energy-yielding metabolites through colonic 
fermentation. There are distinct differences between how novel fibers 
are identified and our definition of dietary fiber. First, a novel 
fiber need only show a physiological effect, rather than a beneficial 
physiological effect. We do not consider energy-yielding metabolites 
(e.g., short chain fatty acids) to be a beneficial physiological effect 
but rather an end product of fermentation that may result in a 
physiological effect that may be beneficial. Second, Health Canada does 
not require that all added non-digestible carbohydrates demonstrate a 
physiological effect. Isolated or synthetic non-digestible 
carbohydrates that have a history of safe use are considered to be 
traditional fibers rather than novel fibers and do not have to 
demonstrate a physiological effect. We have determined that a fiber 
must have beneficial physiological effects to human health to assist 
consumers in maintaining healthy dietary practices, consistent with 
section 403(q) of the FD&C Act.
    As for the comments' reference to EFSA, in response to evidence 
submitted in a petition, EFSA conducts premarket reviews of added non-
digestible carbohydrates and their role in beneficial physiological 
effects for health claims (claims that are similar to our structure 
function claims). Simply adopting isolated or synthetic non-digestible 
carbohydrates approved by other countries or organizations without 
determining if they have a beneficial physiological effect would not 
ensure that there is a consistent basis for an isolated or synthetic 
non-digestible carbohydrate meeting the definition of dietary fiber for 
purposes of the declaration in the Nutrition Facts label.
(ii) Mandatory Declaration
    Section 403(q)(1)(D) of the FD&C Act specifies, in part, that for 
each serving size or other unit of measure of a food, the amount of 
dietary fiber must be provided. Accordingly, our preexisting 
regulations, at Sec.  101.9(c)(6)(i), require the declaration of 
dietary fiber on the Nutrition Facts label.
    In the preamble to the proposed rule (79 FR 11879 at 11910), we 
mentioned that the 2007 ANPRM did not ask any questions about the 
mandatory labeling of dietary fiber and that we received no comments on 
this subject. Dietary fiber is not an essential nutrient, although it 
has physiological effects that are beneficial to human health, such as 
attenuation of postprandial blood glucose concentrations, attenuation 
of blood cholesterol concentrations, and improved laxation. The 
consumption of certain dietary fibers, particularly those that are 
poorly fermented (i.e., insoluble fiber), improve fecal bulk and 
laxation and ameliorate constipation, and soluble fiber plays a 
beneficial role in reducing the risk of heart disease (id.). Given the 
health benefits of dietary fiber, we did not propose any changes to our 
current requirement for the mandatory declaration of dietary fiber in 
Sec.  101.9(6)(i).
    We received no comments on this topic, and so no changes to the 
final rule, with respect to mandatory declaration of dietary fiber, are 
necessary.
    With respect to the term used to declare dietary fiber content on 
the Nutrition Facts label, the preamble to the proposed rule (79 FR 
11879 at 11910) said that the term ``dietary fiber'' has been listed on 
the Nutrition Facts label since 1993. Thus, we did not propose to 
change the current requirement to declare dietary fiber

[[Page 33864]]

using the term ``dietary fiber,'' as specified in Sec.  101.9(f).
    (Comment 297) One comment supported the current single disclosure 
of dietary fiber because, according to the comment, all fibers have a 
beneficial effect.
    (Response) We agree that there should be a single disclosure for 
dietary fiber. While it is premature to know whether all isolated or 
synthetic non-digestible carbohydrates have a beneficial physiological 
effect, and therefore are a ``dietary fiber'' as defined in the final 
rule, the final rule does not affect the preexisting requirement to use 
the term ``dietary fiber.''
    (Comment 298) Several comments supported a separate disclosure 
(e.g., subcategory) of added fiber. Some comments said that consumers 
should know the amount of added (processed) versus natural 
(unprocessed) non-digestible carbohydrates in a product so that 
consumers who want to increase their intake of only intact fiber are 
able to do so. Other comments noted that the 2010 DGA stated that it is 
unclear whether added fibers provide the same health benefits as 
naturally occurring dietary fiber. Other comments said that a separate 
declaration of added non-digestible carbohydrates would exclude non-
digestible carbohydrates that do not have a demonstrated health 
benefit.
    One comment supporting a separate listing of added non-digestible 
carbohydrates stated that, although the IOM concluded that functional 
(added) fiber should be included in total fiber, the IOM clearly had 
more confidence in the benefits of foods rich in intact fiber than in 
the benefits of added fiber. The comment said that, in the years since 
the IOM report was issued, the evidence that dietary fiber lowers the 
risk of heart disease, diabetes, and diverticular disease continues to 
come from studies of people who consume foods rich in intact fiber, 
especially whole grains and wheat bran. The comment said that allowing 
labels to combine intact and added fiber misleads consumers into 
believing that added fiber has the same health benefits as intact 
fiber. The comment said we have tentatively concluded that there is 
little benefit for consumers in distinguishing between intact and added 
fiber on the Nutrition Facts label because ``both have beneficial 
health effects.'' However, the comment said that the two types of fiber 
do not necessarily have equivalent health effects, as labels would 
imply.
    (Response) We agree that intact and intrinsic (naturally occurring) 
dietary fibers may have different health effects than isolated or 
synthetic non-digestible carbohydrates. For example, some soluble 
naturally occurring dietary fibers are associated with CVD risk, 
whereas insoluble naturally occurring dietary fiber, such as some forms 
of cellulose, is associated with improved laxation. However, we 
disagree that the differences in health effects warrant separate 
declarations on the Nutrition Facts label when both categories are 
composed of a heterogeneous group of compounds with variable health 
effects, all of which assist consumers to maintain healthy dietary 
practices. We have no basis on which we could rely, nor has the comment 
provided one, to separate the dietary fiber declaration in the 
Nutrition Facts label into two separate listings; one for intact and 
intrinsic fibers, and the other for isolated or synthetic non-
digestible fibers that provide a physiological benefit to human health. 
Therefore, we disagree that the declaration of dietary fiber, as 
proposed, would mislead consumers, and we decline to revise the rule in 
response to this comment.
(iii) Analytical Methods
    Under our preexisting regulations, at Sec.  101.9(g)(2), compliance 
with the requirement for declaration of dietary fiber is determined 
using appropriate AOAC analytical methods. In the preamble to the 
proposed rule (79 FR 11879 at 11910), we discussed comments to the 2007 
ANPRM regarding the use of analytical methods and our review of other 
analytical methods. We noted that while some AOAC methods, such as AOAC 
985.29, 991.43 and 994.13, measure soluble and insoluble 
polysaccharides, lignin, higher molecular weight non-digestible 
oligosaccharides (DP >12), and some measure resistant starch, inulin 
and low molecular weight non-digestible oligosaccharides (DP <10), they 
do not measure all non-digestible carbohydrates with a DP <10 (id.). In 
contrast, newer methods (AOAC 2009.01 and AOAC 2011.25) measure all low 
molecular weight non-digestible carbohydrates (i.e., non-digestible 
oligosaccharides) in addition to the higher molecular weight non-
digestible carbohydrates, and we said that the newer, more inclusive 
AOAC methods would be more consistent with our proposed definition of 
dietary fiber (id.). We acknowledged, however, that there is no 
analytical method that can distinguish non-digestible carbohydrates 
that have a beneficial physiological effect from those that do not 
(id.).
    Thus, we proposed to amend Sec.  101.9(c)(6)(i) to indicate that 
dietary fiber content may be determined by subtracting the amount of 
non-digestible carbohydrates added during processing that do not meet 
the definition of dietary fiber (in proposed Sec.  101.9(c)(6)(i)) from 
the value obtained using AOAC 2009.01, AOAC 2011.25 or an equivalent 
AOAC method of analysis as given in the ``Official Methods of Analysis 
of the AOAC International'' 19th Edition. If a product contains only 
non-digestible carbohydrates that meet the proposed definition of 
dietary fiber, using AOAC 2009.01, AOAC 2011.25, or an equivalent 
method would be sufficient to quantify the dietary fiber content of a 
food. However, if the product contains both dietary fiber that is 
included in the proposed definition (e.g., naturally occurring fibers) 
and non-digestible carbohydrates not included in the definition (e.g., 
synthetic fibers without a physiological effect that is beneficial to 
human health), neither AOAC 2009.01 or AOAC 2011.25 nor an equivalent 
AOAC method would accurately quantify the dietary fiber that could be 
declared on the Nutrition Facts label, because the determination of 
fiber by these methods would include the non-digestible carbohydrates 
that do not meet the proposed definition of dietary fiber.
    To verify that the quantity of dietary fiber declared on the 
Nutrition Facts label includes only those fibers that meet the 
regulatory definition of dietary fiber, when a food contains a mixture 
of non-digestible carbohydrates that meet the proposed dietary fiber 
definition and those that do not, we also proposed, in Sec. Sec.  
101.9(c)(6) and (g)(10), to require manufacturers to make and keep 
written records to verify the amount of added non-digestible 
carbohydrates that do not meet the proposed definition of dietary 
fiber. The amount of non-digestible carbohydrate measured by AOAC 
2009.01 or AOAC 2011.25 (or an equivalent AOAC method) minus the amount 
of added non-digestible carbohydrate which is not included in the 
definition of ``dietary fiber'' would reflect the amount of dietary 
fiber lawfully declared on the label. Only those fibers that have been 
determined by FDA to have a physiological effect that is beneficial to 
human health would be included in the definition of ``dietary fiber.''
    (Comment 299) One comment stated that AOAC 2009.01 is suitable to 
measure low molecular weight non-digestible oligosaccharides, as well 
as the higher molecular weight non-digestible carbohydrates and 
quantitatively cover inulin and oligofructose while the older methods 
did not. Another comment supported acceptance of the ``all-inclusive'' 
methods of analysis, AACCI 32-45

[[Page 33865]]

(AOAC 2009.01) and AACCI 32-50 (AOAC 2011.25), as well as other 
equivalent and validated AACCI and AOAC Approved or Official methods. 
Several comments stated that AOAC 2009.01 and 2011.25 are not the only 
methods that can be used to measure dietary fiber. Some comments 
suggested that we allow for other dietary fiber analytical methods, 
such as AOAC 985.29, AOAC 991.43 and AOAC 2001.03. One comment would 
revise the rule to allow the use of alternative methods provided they 
have been sufficiently validated (e.g., if they are noted in USP or CFR 
citations). The comment said that test methods may evolve to 
incorporate superior measurement technologies and will better keep pace 
with the science and understanding of dietary fiber. Several comments 
stated that we should allow the use of methods that measure specific 
non-digestible carbohydrates such as GOS, [beta]-glucan, fructans, 
polydextrose, trans galactose oligosaccharides, and resistant starch.
    (Response) The proposed rule did not specify the use of AOAC 
2009.01 and AOAC 2011.25 for measuring and declaring dietary fiber. We 
stated that dietary fiber content may be determined by subtracting the 
amount of non-digestible carbohydrates added during processing that do 
not meet the definition of dietary fiber from the value obtained using 
AOAC 2009.01, AOAC 2011.25, or an equivalent method of analysis as 
given in the ``Official Methods of Analysis of the AOAC International, 
19th Ed., 2012 (see 79 FR 11879 at 11968). The methods used must 
support the dietary fiber definition and therefore must measure lower 
molecular weight non-digestible oligosaccharides (DP 3-9) if present in 
a food.
    (Comment 300) One comment stated that AOAC 2009.01 and 2011.25 do 
not capture all types of resistant starch (RS) (e.g., RS4).
    (Response) We agree that AOAC 2009.01 and 2011.25 do not measure 
all forms of RS4, such as cross-linked wheat starch (Ref. 143). In 
these cases, when submitting a citizen petition or a health claim 
petition, a more appropriate method can be identified that can measure 
all of the RS4.
(iv) DRV
    The DRV for dietary fiber is 25 grams (Sec.  101.9(c)(9)). In the 
preamble to the proposed rule (79 FR 11879 at 11911), we noted that, in 
2002, the IOM set an AI of 14 grams/1,000 kcal for ``total fiber'' and 
that the AI was primarily based on the intake level that was associated 
with the greatest reduction in the risk of CHD. Therefore, we proposed 
to use 14 grams/1,000 kcal as the basis for a DRV for dietary fiber and 
to amend Sec.  101.9(c)(9) to set a DRV of 28 grams (14 grams/1,000 
kcal x 2,000 kcal/day) for dietary fiber.
    (Comment 301) Some comments supported the proposed DV (also a DRV) 
of 28 grams based on most recent findings by the IOM and current 
dietary recommendations. One comment supported increasing the DV from 
25 to 28 grams after we have a better understanding of consumer and 
shopper dynamics.
    In contrast, one comment objected to a DV of 28 grams; the comment 
said that the AI is based on observational data rather than clinical 
trial data.
    (Response) We proposed the DV of 28 grams based on the current 
scientific evidence evaluated by the IOM. The comments objecting to a 
DV of 28 grams did not provide a basis on which we could rely that 
would cause us not to use the current DRIs provided by the IOM. The AI 
was set by the IOM based on three prospective cohorts that consistently 
demonstrated that the greatest reduction in CVD risk could be achieved 
when consuming 14 grams/1,000 kcal of dietary fiber. We agree that 
observational data alone are insufficient for evaluating the causal 
relationship between a nutrient and a health endpoint, such as CVD. The 
IOM noted that there are a large number of intervention trials on blood 
lipid concentrations that alter the risk of CHD (Ref. 29). In our 
science review of the evidence to authorize a health claim for dietary 
fiber-containing fruits, vegetables and grain products and CVD (Sec.  
101.77), numerous intervention studies were cited that showed a 
cholesterol-lowering effect (58 FR 2552 at 2552 through 2559). 
Furthermore, our recent review of intervention studies on some added 
fibers (e.g., pectin, guar gum, hydroxypropylmethylcellulose and locust 
bean gum) has shown a cholesterol-lowering effect (Ref. 138) Because of 
the available underlying evidence from intervention studies to support 
a cholesterol-lowering effect of dietary fibers, we disagree that a 
quantitative intake recommendation based on observational data related 
to CVD risk is inadequate for setting a DV, and the final rule sets a 
DRV of 28 grams for dietary fiber.
    (Comment 302) Several comments supported retaining the DV of 25 
grams rather than the proposed DV of 28 grams for dietary fiber. One 
comment stated that 28 grams is based on an AI of 14 grams/1,000 
calories and is tied to calories rather than reflecting the energy 
needs of children and women. The comment said that recommendations to 
reduce calorie intake will make it more difficult to increase dietary 
fiber intake and to increase the DV to 28 grams will require consumers 
to increase their calorie intake.
    (Response) We disagree with the comments' assertion that an AI 
based on calories is not a sufficient basis for setting the DV. There 
have been a number of DVs based on calories other than dietary fiber 
(e.g., total fat and saturated fat). Furthermore, the AI was not set 
based on energy needs but rather on energy intake. While there may be 
recommendations to reduce calorie intake for some individuals, the 2010 
DGA encourages consumption of fruits, vegetables and whole grains which 
are sources of dietary fiber.
    (Comment 303) Several comments opposed a DV of 28 grams because, 
according to the comments, some foods that are a good source of dietary 
fiber would no longer qualify if the DV was set at 28 grams.
    (Response) We will address, as appropriate, the impact on our other 
regulations that are outside the scope of this rulemaking, such as the 
regulations for nutrient-content claims, in separate rulemaking 
actions. While some foods may no longer qualify as a good source of 
dietary fiber, the DV is based on evidence linking dietary fiber to 
reduced risk of chronic disease. Therefore, this DV and nutrient-
content claims based on this DV can assist consumers in maintaining 
healthy dietary practices.
    (Comment 304) One comment opposed to setting the DV at 28 grams 
said that increasing the level of dietary fiber to meet the increased 
DV will present many technical and economic hurdles to ingredient 
suppliers and manufacturers. The comment said manufacturers would be 
deterred from developing products that help consumers close the dietary 
fiber intake gap.
    (Response) While it is unclear how an increased DV would present 
technical and economic hurdles or deter the development of products, 
the DV of 28 grams is a quantitative intake recommendation set by the 
IOM (14 grams/1,000 calories) based on reducing the risk of CVD and 
therefore should inform the consumer on the contribution of a food to 
dietary fiber to assist the consumer in maintaining healthy dietary 
practices. Increasing the DV for dietary fiber (which may result in a 
corresponding reduction in the percent DV for some foods) tells the 
consumer how much that food contributes to the overall dietary fiber 
intake as part of a healthy diet.

[[Page 33866]]

Consumers attempting to meet a certain percent DV could increase their 
dietary fiber intake based on the new DV and based on the dietary fiber 
definition are assured that the percent DV reflects beneficial 
physiological effects.
    (Comment 305) One comment would keep the DV at 25 grams and noted 
that WHO/FAO and EFSA recommend 25 grams/day as an amount needed for 
healthy laxation.
    (Response) We disagree that a DV of 25 grams should be set based on 
laxation. The WHO/FAO (Ref. 144) did not provide a recommendation for 
dietary fiber, but stated that the recommended intake of fruits and 
vegetables is likely to provide greater than 25 grams/day of total 
dietary fiber. This amount would only reflect dietary fiber that is 
naturally occurring in food.
    While EFSA set a Nutrient Reference Value of 25 grams/day based on 
laxation, EFSA also noted that there is evidence of benefit to health 
associated with the consumption of dietary fiber intakes greater than 
25 grams/day (e.g., reduced risk of CHD) (Ref. 145).
    (Comment 306) One comment opposed to a DV of 28 grams stated that 
this value represents intact dietary fiber only because the IOM relied 
on evidence from studies of intact fiber to set the AI.
    (Response) We disagree with the comment. The AI of 28 grams/day (14 
grams/1,000 calories) set by the IOM represents total dietary fiber 
which includes both naturally occurring and added dietary fiber (IOM).
    b. Soluble and insoluble fiber. Dietary fibers can be classified as 
being soluble or insoluble. Soluble fibers, such as pectin and gums, 
dissolve in water and are digested by the bacteria in the large 
intestine. Insoluble fibers, such as some forms of cellulose and 
lignin, do not dissolve in water and are not digested by bacteria in 
the large intestine, adding bulk to the stool for improved laxation.
(i) Definition
    Our preexisting regulations do not define soluble or insoluble 
fiber. In the preamble to the proposed rule (79 FR 11879 at 11911), we 
explained that, because soluble and insoluble fibers are components of 
dietary fiber, they must meet the proposed definition of dietary fiber. 
Therefore, we proposed, in Sec.  101.9(c)(6)(i)(A) and (c)(6)(i)(B), 
that soluble fiber and insoluble fiber, respectively, must meet the 
definition of dietary fiber in Sec.  101.9(c)(6)(i).
    (Comment 307) One comment said that the terms soluble and insoluble 
fiber did not clearly identify physiological or nutritional functions.
    (Response) We agree that the terms soluble and insoluble fiber do 
not necessarily reflect physiological or nutrition functions. In the 
preamble to the proposed rule (79 FR 11879 at 11911), we considered 
physicochemical terms such as ``viscous'' or ``fermentable.'' The 
standardization of the characterization of such terms, however, has not 
yet occurred. Furthermore, the viscosity of a fiber does not 
necessarily predict fermentability, and it is not known at what level 
of viscosity a fiber begins to have a physiological effect. Therefore, 
we did not propose to change the terms soluble and insoluble fiber.
    The final rule, at Sec.  101.9(c)(6)(i)(A) and (c)(6)(i)(B), 
requires soluble fiber and insoluble fiber, respectively, to meet the 
definition of dietary fiber in Sec.  101.9(c)(6)(i).
(ii) Voluntary Declaration
    Our preexisting regulations permit, but do not require, the 
declaration of soluble fiber (Sec.  101.9(c)(6)(i)(A)) and insoluble 
fiber (Sec.  101.9(c)(6)(i)(B)) on the Nutrition Facts label. We did 
not propose any changes to these provisions with respect to voluntary 
declaration.
    (Comment 308) One comment supported voluntary declaration of 
soluble and insoluble fiber. The comment said consumers may not know 
the difference between these two categories of dietary fiber.
    In contrast, another comment supported mandatory declaration of 
soluble and insoluble fiber. The comment said that, while the IOM did 
not provide DRIs for each category of dietary fiber, there is a 
recommendation of a 3:1 ratio of insoluble fiber to soluble fiber. 
Furthermore, the comment said, there is little burden to measure both, 
consumers may make more informed choices that offer a balance of 
soluble and insoluble fiber, and the solubility relates to 
physiological benefit.
    (Response) We decline to revise the rule to provide for the 
mandatory declaration of soluble and insoluble fiber. We are unaware of 
a recommended ratio for insoluble to soluble fiber intake, and, 
therefore, we do not know on what basis such a declaration would allow 
consumers to make more informed choices on an appropriate balance of 
soluble and insoluble fibers. However, to meet the dietary fiber 
definition, all non-digestible carbohydrates declared as dietary fiber 
should assist consumers in maintaining healthy dietary practices, 
regardless of the ratio of such fibers. While there is evidence to 
suggest that, in general, solubility relates to physiological benefit, 
we consider it important to evaluate the physiological benefits of 
individual isolated or synthetic non-digestible carbohydrates.
(iii) Analytical Methods
    Our preexisting regulations, at Sec.  101.9(g)(2), state that 
compliance with any declaration of soluble or insoluble fibers is to be 
determined using appropriate AOAC analytical methods. In the preamble 
to the proposed rule (79 FR 11879 at 11911), we said that there are a 
number of traditional AOAC methods available for measuring soluble 
fiber (e.g., AOAC 991.43 and 993.19) and insoluble fiber (e.g., AOAC 
991.42 and 991.43), but that, as is the case with dietary fiber, these 
methods cannot measure all non-digestible carbohydrates with a DP <10. 
Similarly, a newer method, AOAC 2011.25, can measure low molecular 
weight non-digestible carbohydrates and separately measure soluble and 
insoluble non-digestible carbohydrates, but AOAC 2011.25 cannot 
distinguish soluble and insoluble non-digestible carbohydrates that 
have a physiological effect that is beneficial to human health from 
those that do not (id.).
    The proposed rule would amend Sec.  101.9(c)(6)(i)(A) and 
(c)(6)(i)(B) to indicate that the soluble and insoluble non-digestible 
carbohydrate content may be calculated by first using AOAC 2011.25, or 
an equivalent AOAC method of analysis. If a food contains only non-
digestible carbohydrates that meet the proposed definition of dietary 
fiber (e.g., contains naturally occurring fiber only), then AOAC 
2011.25 or an equivalent AOAC method would measure the amount of 
soluble or insoluble fiber that can be declared on the Nutrition Facts 
label. If a food contains a mixture of non-digestible carbohydrates 
that do and do not meet the proposed dietary fiber definition, and the 
label of the food declares soluble or insoluble fiber content, proposed 
Sec.  101.9(c)(6)(i)(A) and (c)(6)(i)(B) would require manufacturers to 
make and keep records to verify the amount of soluble or insoluble non-
digestible carbohydrates that do not meet the proposed definition of 
dietary fiber that have been added to the food product during 
processing.
    (Comment 309) Some comments said that other analytical methods 
(e.g. AOAC 991.43) are cited in a health claim regulation for soluble 
fiber from certain foods and risk of CHD (Sec.  101.81). One comment 
further stated that there is an opportunity to incorporate HPLC 
analysis to quantify the DP 3-9 fraction which previously has not been 
detected by the health claim-mandated method for psyllium husk.

[[Page 33867]]

    (Response) We recognize that Sec.  101.81(c)(G)(2)(ii) states that 
[beta]-glucan soluble fiber from the whole oat and barley sources will 
be determined by AOAC 992.28 and that we will determine the amount of 
soluble fiber provided by psyllium husk by using a modification of AOAC 
991.43. We intend to update this regulation in the future such that 
these soluble fibers would be required to be measured by methods that 
meet the dietary fiber definition (DP >3). However, the final rule no 
longer refers to AOAC methods in Sec.  101.9(c)(6)(i), (i)(A), and 
(i)(B). We discuss the omission of the AOAC methods in these provisions 
in our response to comment 524.
(iv) DRV
    Our preexisting regulations do not establish DRVs for soluble fiber 
or insoluble fiber. In the preamble to the proposed rule (79 FR 11879 
at 11912), we explained that no DRIs were established for soluble or 
insoluble fiber during the IOM's evaluation of a DRI for dietary fiber, 
so we have no basis on which to derive an appropriate DRV. Therefore, 
we did not propose to set a DRV for either soluble fiber or insoluble 
fiber.
    We did not receive any comments on a DRV for soluble or insoluble 
fiber. The final rule, therefore, does not establish a DRV for soluble 
or insoluble fiber.
(v) Caloric Value
    Under our preexisting regulations, at Sec.  101.9(c)(1)(i)(C), the 
caloric content of a food may be calculated by, among other methods, 
using the general factors of 4, 4, and 9 kcal/gram for protein, total 
carbohydrate less the amount of insoluble dietary fiber, and total fat, 
respectively. Soluble fiber, which is encompassed within ``total 
carbohydrate,'' is assigned a general factor of 4 kcal/gram. In the 
preamble to the proposed rule (79 FR 11879 at 11912), we explained how 
comments to the 2007 ANPRM and a citizen petition supported a caloric 
value of 2 kcal/gram for soluble fiber, and so we proposed to amend 
Sec.  101.9(c)(1)(i)(C) to establish a general factor of 2 kcal/gram as 
the caloric value of soluble non-digestible carbohydrates. Insoluble 
non-digestible carbohydrates are not included in the caloric 
calculation.
    We also proposed a corresponding change to the introductory text in 
Sec.  101.9(c)(1)(i)(C) to reflect the caloric value of total 
carbohydrate based on the new caloric contribution of soluble fiber. We 
explained that our regulations require that the calories from total 
carbohydrate be calculated by using the general factor of 4 kcal/gram 
of carbohydrate less the amount of insoluble dietary fiber (Sec.  
101.9(c)(1)(i)(C)) (79 FR 11879 at 11912). Because the proposed rule 
would establish a new definition of dietary fiber that only allows for 
the declaration of dietary fibers that are added to foods that we have 
determined to have a physiological effect that is beneficial to human 
health, the proposed definition of dietary fiber would exclude soluble 
and insoluble non-digestible carbohydrates that do not meet the 
proposed definition of dietary fiber. Thus, to calculate calories from 
soluble and insoluble non-digestible carbohydrate, the proposed factor 
of 2 kcal/gram and 0 kcal/gram, respectively, would apply to those 
soluble and insoluble non-digestible carbohydrates that both do and do 
not meet the proposed definition of dietary fiber. To ensure that 
soluble non-digestible carbohydrates that do and do not meet the 
proposed definition of dietary fiber are considered in the caloric 
contribution of total carbohydrate, such that a general factor of 2 
kcal/gram is applied to these non-digestible carbohydrates, we proposed 
to amend Sec.  101.9(c)(1)(i)(C) to require that calories from 
carbohydrate be calculated using a general factor of 4 kcal/gram of 
total carbohydrate less the amount of non-digestible carbohydrates, 
which includes soluble (2 kcal/gram) and insoluble (0 kcal/gram) non-
digestible carbohydrates that do and do not meet the definition of 
dietary fiber. The calorie contribution of soluble non-digestible 
carbohydrate would be added to that sum to determine the total 
carbohydrate calorie contribution.
    (Comment 310) Several comments agreed with a caloric value of 2 
kcal/gram for soluble, non-digestible carbohydrates. Some comments, 
however, said the final rule should provide for exceptions when the 
difference in energy value would be significant and has been 
established by science.
    (Response) We decline to revise the rule to provide for exceptions. 
We recognize that fermentation of fibers can yield different caloric 
values and that a fermentable fiber is not equivalent to a soluble 
fiber. We agree that exceptions could be considered for changing the 
caloric value of a soluble non-digestible carbohydrate when the 
difference in energy value is significant and when we determine that 
the evidence is established by science. We would need to evaluate any 
requests for exceptions case-by-case in a request to amend Sec.  
101.9(c)(1)(i)(C) to include the greater caloric value of the fiber in 
the total carbohydrate calorie amount. Thus, the final rule retains a 
general factor of 2 calories per gram for soluble non-digestible 
carbohydrates.
    (Comment 311) One comment supported a caloric value of 1 kcal/gram 
for polydextrose. The comment said that, in 1981, FDA recognized that 
polydextrose has a biocalorie value of 1 kcal/gram and that the science 
supporting this value has been reviewed (Ref. 146).
    (Response) The comment is referring to a 1981 letter from the 
Bureau of Foods, Division of Food and Color Additives that did not 
object to the caloric value of 1 kcal/gram from polydextrose. This 
letter was in reference to food additive petition 9A3441. We disagree 
that the 1981 FDA letter related to polydextrose is a basis for 
establishing a caloric value for polydextrose for the Nutrition Facts 
label. Polydextrose is a synthetic, non-digestible carbohydrate. We are 
establishing, in this final rule, a definition for dietary fiber that 
does not include polydextrose as a listed dietary fiber. Thus, 
polydextrose would be considered a component of total carbohydrate 
subject to the calculation of the value for total carbohydrate in Sec.  
101.9(c)(1)(i)(C) and not as a dietary fiber.
    As for the comment's reference to a specific scientific article, 
the publication was a review article on studies that had evaluated the 
caloric contribution of polydextrose in humans and animals (Ref. 146). 
We have not considered all of the caloric values of individual 
components of total carbohydrate as part of this rule, and all are 
subject to Sec.  101.9(c)(1)(i)(C) for total carbohydrate, unless 
otherwise specified.
6. Other Carbohydrate
    Our preexisting regulations, at Sec.  101.9(c)(6)(iv), define 
``other carbohydrate'' as the difference between total carbohydrate and 
the sum of dietary fiber, sugars, and sugar alcohol, except that if 
sugar alcohol is not declared, ``other carbohydrate'' is defined as the 
difference between total carbohydrate and the sum of dietary fiber and 
sugars. Examples of ``other carbohydrate'' include starch and 
oligosaccharides. Our preexisting regulations, at Sec.  
101.9(c)(6)(iv), also provide for the voluntary declaration of the 
amount of ``other carbohydrate'' on the Nutrition Facts label.
    The preamble to the proposed rule (79 FR 11879 at 11912) explained 
that we were reconsidering the voluntary declaration of ``Other 
carbohydrate'' on the Nutrition Facts label based on the factors we 
consider for the mandatory

[[Page 33868]]

and voluntary declaration. We stated that ``other carbohydrate'' 
represents different types of carbohydrate, and, unlike sugars and 
dietary fiber, carbohydrates covered under this category have no shared 
physiological effects and that there is no well-established evidence to 
support the role of particular types of carbohydrate that fall within 
the ``Other carbohydrate'' category, such as starch and 
oligosaccharides, in human health that is based on reliable and valid 
physiological or clinical endpoints (id.). We also noted that a 
quantitative intake recommendation for ``Other carbohydrate'' is not 
available from relevant consensus reports, and so, given the lack of 
public health significance or a quantitative intake recommendation for 
``other carbohydrate'' as a category, we tentatively concluded that 
``Other carbohydrate'' should no longer be permitted to be declared on 
the Nutrition Facts label (id.). Thus, the proposed rule would remove 
the provision that allows for the voluntary declaration of ``Other 
carbohydrate'' on the Nutrition Facts label, and we would make a 
corresponding revision to Sec.  101.9(g)(4) and (g)(6) to remove 
references to ``Other carbohydrates.''
    (Comment 312) Several comments supporting the removal of ``Other 
carbohydrate.'' Some comments agreed that there is no quantitative 
intake recommendation and the scientific evidence does not demonstrate 
public health significance. Other comments said that retaining ``Other 
carbohydrate'' may be confusing and that most consumers are not likely 
to understand what the term ``Other carbohydrate'' represents. One 
comment said it was not aware of any data or other factual information 
around consumer understanding of the term.
    In contrast, some comments said we should retain the voluntary 
declaration of ``Other carbohydrate'' because, according to the 
comments, consumers use the information to determine the carbohydrate 
content of foods that are not attributable to sugars and dietary fiber 
or because removing the voluntary declaration could confuse consumers. 
Some comments said that the ``Other carbohydrate'' declaration allows 
consumers to better understand the total carbohydrates portion of the 
Nutrition Facts label because the various components that constitute 
``Total carbohydrate'' approximates the sum when ``Other carbohydrate'' 
is included.
    (Response) The comments did not provide data or information, nor 
are we aware of any, to support their view that consumers use, are 
confused by, or do not understand the ``Other carbohydrate'' 
declaration.
    In any case, the declaration of ``Other carbohydrate'' was 
voluntary, so most products did not contain the declaration. The FDA 
Food Label and Package Survey (FLAPS) (2006-2007) estimated that about 
4 percent of products list ``Other carbohydrate.'' As a result, 
consumers had limited ability to be informed about the components of 
total carbohydrate on most products. The contribution of ``Other 
carbohydrate'' can be determined by subtracting dietary fiber and 
sugars from the ``Total carbohydrate'' declaration. The declaration of 
``Total carbohydrate,'' is mandatory, so the total carbohydrate content 
is available on all products that must bear a Nutrition Facts label. 
Consequently, the final rule removes the provision that allows for the 
voluntary declaration of ``Other carbohydrate'' on the Nutrition Facts 
label, and we also have revised Sec.  101.9(g)(4) and (g)(6) to remove 
references to ``Other carbohydrates.''

I. Protein

1. Mandatory and Voluntary Declaration
    Section 403(q)(1)(D) of the FD&C Act requires food labeling to bear 
nutrition information about protein, and so our preexisting 
regulations, at Sec.  101.9(c)(7)(i), require the declaration of the 
amount of protein by weight and provide for voluntary declaration of 
the percent DV for protein on the Nutrition Facts label (Sec.  
101.9(c)(7)(i)). In the preamble to the proposed rule, we stated that 
there is strong evidence, based on valid physiological and clinical 
endpoints, that protein is an essential nutrient that is necessary for 
human health and growth and that the declaration of protein content 
remains necessary to assist consumers in maintaining healthy dietary 
practices. We also stated that, because protein intake in the U.S. 
population continues to be adequate when compared to the EAR, absent a 
mandatory percent DV declaration, the declaration of protein as a 
percent DV should remain voluntary (id.). Consequently, we did not 
propose any changes to the requirement for declaration of the 
quantitative amount of protein and the voluntary declaration of this 
amount as a percent DV on the Nutrition Facts label.
    (Comment 313) Several comments supported the continued mandatory 
declaration of protein on the label.
    (Response) Because we did not propose to change the preexisting 
requirement to declare the amount of protein by weight, no changes to 
the final rule are necessary.
2. Analytical Methods
    Our preexisting regulations, at Sec.  101.9(c)(7), state that 
protein may be calculated on the basis of 6.25 times the nitrogen 
content of the food determined by the appropriate method of analysis as 
given in the Official Methods of Analysis of AOAC International, 15th 
ed. (1990), except when the official procedure for a specific food 
requires another factor. The preamble to the proposed rule discussed a 
citizen petition that asked us to consider other methods of analysis as 
set forth in a newer edition of the Official Methods of Analysis of 
AOAC International, and we agreed that we should update the version of 
the Official Methods of Analysis of the AOAC International that we use 
for compliance purposes because newer, and sometimes better, analytical 
methods for many nutrients are included in new or revised versions of 
the methods (79 FR 11879 at 11913). The proposed rule, therefore, would 
amend Sec.  101.9(c)(7) to incorporate by reference the Official 
Methods of Analysis of the AOAC International, 19th ed. (2012) by 
removing ``15th Ed. (1990)'' and adding in its place ``19th Ed. 
(2012).''
    We did not receive any comments on the AOAC methods for the 
determination of protein. The Official Methods of Analysis of AOAC 
International, 20th Edition was published in 2016. The 20th Edition 
includes a number of new methods of analysis as well as changes to 
current methods. We need additional time to consider the additions and 
changes, and to determine if additional public comment is necessary on 
the 20th Edition of the AOAC Methods of Analysis. Therefore, we are 
finalizing the regulation as proposed, and are incorporating the 19th 
Edition of the Official Methods of Analysis of the AOAC International 
by reference. Consequently, we have finalized Sec.  101.9(c)(7), 
insofar as the AOAC methods are concerned, without change.
    (Comment 314) Although we did not propose any changes to how the 
gram amount of protein in a serving of a food product is calculated, 
several comments addressed this subject. Our preexisting regulations, 
at Sec.  101.9(c)(7), require that protein content be calculated using 
a factor of 6.25 times the nitrogen content of the food as determined 
by the appropriate method of analysis in the ``Official Methods of 
Analysis of the AOAC International'' (15th Ed.), except when the 
official procedure for a specific food requires another factor. We also 
state in Sec.  101.9(c)(7)(ii) that the protein digestibility-corrected 
amino

[[Page 33869]]

acid score (PDCAAS) must be determined by methods given in sections 
5.4.1, 7.2.1, and 8.00 in ``Protein Quality Evaluation, Report of the 
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,'' 
Rome, 1990 (which we also proposed changing the publication year to 
1991; hereafter referred to as the 1991 FAO/WHO Protein Quality 
Report), except that when official AOAC procedures described in Sec.  
101.9(c)(7) require a specific food factor other than 6.25, that 
specific factor shall be used.
    One comment noted that the language related to use of nitrogen to 
protein conversion factors in Sec.  101.9(c)(7) and (c)(7)(ii) is 
inconsistent. The comment suggested that the term ``official 
procedure'' is vague, and the term ``food'' does not allow for the 
differentiation between single foods like peas, or a blend like beans 
and rice. The comment suggested revising both Sec.  101.9(c)(7) and 
(c)(7)(ii) to say ``or if another scientifically supported factor is 
generally accepted.'' The comment said that this change would allow for 
the use of nitrogen to protein conversion factors other than 6.25 that 
are commonly used throughout industry. The comment noted that a number 
of sources have suggested that the factor of 6.25 does not reflect an 
accurate nitrogen level for all foods, particularly non-meat items and 
that other commodity-specific nitrogen-to-protein conversion factors 
are included in reports from USDA (Ref. 69).
    (Response) We agree, in part, with the comment and disagree, in 
part, with the comment. We agree that the language in Sec.  101.9(c)(7) 
and (c)(7)(ii) should be consistent and have revised Sec.  101.9(c)(7) 
to say ``except that when official AOAC procedures described in 
paragraph (c)(7) require a specific factor other than 6.25, that 
specific factor shall be used'' and have made a corresponding edit to 
Sec.  101.9(c)(7)(ii). We also agree that the generally accepted 
factors (i.e., the Jones' factors) should be used when specified in 
official AOAC procedures. We decline to allow for the use of other 
factors for the reasons discussed in this response.
    For purposes of nutrition labeling, among others, protein is 
estimated by determining the nitrogen content of an ingredient and 
multiplying it by a nitrogen-to-protein conversion factor. A number of 
Jones factors cited in the USDA references provided in the comment have 
been in use for a wide variety of foods for about 75 years. These 
conversion factors for calculating protein from nitrogen content for 43 
foods were published in 1973 by USDA (Ref. 69). Use of Jones' factors 
provides a value for ``crude protein'' since the factors are derived by 
applying the appropriate factor to the total nitrogen present. For 
groups of foods for which a conversion factor is not provided, a 
general factor of 6.25 is used. This general conversion factor is 
derived from observations that many commonly occurring proteins contain 
about 16 percent nitrogen (i.e., (100/16 = 6.25)) (Ref. 69). A single 
nitrogen-to-protein conversion factor may be sufficient if the aim is 
to indicate the amount of nitrogen present and to present it as an 
average protein content. In contrast, specific conversion factors 
rather than a single general factor provide a more accurate indication 
of dietary amino acids in a food (Ref. 147).
    As for the comment's assertion that the word ``food'' does not 
allow for differentiation between single foods or a blend of foods, we 
disagree. Food is defined in section 201(f) of the FD&C Act as articles 
used for food or drink for man or other animals, chewing gum, and 
articles used for components of any such article. Therefore, ``food'' 
refers to both single-ingredient foods, such as peas, and blends such 
as beans and rice. We note, however, that all of the Jones' factors 
were determined for specific single foods and not for blends of foods 
as suggested in the comment (Ref. 69). We are not aware of any 
conversion factors that have been developed for blends of foods (e.g. a 
mixture of beans and rice).
    With respect to the comment's assertion regarding other, more 
accurate food factors, we note that, in the 1993 Final Rule for 
Mandatory Nutrition Labeling, we responded to a comment requesting that 
food-specific conversion factors used by AOAC be allowed for 
calculating the PDCAAS whenever such factors are available (58 FR 2079 
at 2102). The PDCAAS is an amino acid scoring procedure that takes into 
account digestibility of a protein. The PDCAAS provides a reasonable 
measure of protein quality. We acknowledged that the method for 
calculating PDCAAS described in the 1991 FAO/WHO Protein Quality Report 
specifies a conversion factor of 6.25, but agreed to allow for the use 
of other food-specific conversion factors when the official AOAC 
procedures require them (58 FR 2079 at 2102). When amending our 
regulations to allow for use of such conversion factors, we intended to 
allow for the use of food-specific conversion factors that are 
specified in official AOAC procedures. The conversion factors specified 
in official AOAC procedures are commodity-specific Jones' factors.
    In recent years, a number of conversion factors have been 
recalculated based on the best available data, including the amino acid 
composition of foods rather than the nitrogen content. Conversion 
factors calculated from the nitrogen content provide a measure of the 
``crude protein'' content (Refs. 147-152). However, the amino acid 
composition rather than the nitrogen content of a protein is 
increasingly viewed as the more important quality of a protein for 
nutrition purposes. This is because ``protein'' is increasingly taken 
to mean ``amino acids,'' which is the focus of greatest concern to 
those interested in human nutrition (Ref. 147). Theoretically, these 
newer factors may provide a more nutritionally relevant way to estimate 
protein quantity and quality. As discussed in our response to comment 
317, other comments have raised issues related to the determination of 
protein for the purposes of nutrition labeling which require additional 
review and consideration. We need to evaluate the use of methods which 
include conversion factors other than those specified in official AOAC 
procedures to determine if they are appropriate and in context with 
other changes to how protein is determined for the purposes of 
nutrition labeling before amending the regulation. We therefore decline 
to allow for the use of conversion factors other than those specified 
in the official AOAC procedures at this time, but will continue to 
monitor future developments in the determination of protein and will 
consider amendments to our requirements for protein labeling, as 
appropriate.
    In the future, it may be possible to accept factors other than 
Jones' factors if there is a description of methods used for their 
determination (e.g. complete amino acid determination) and a 
description of the foods to which such new factors are applicable. 
Because a nitrogen-to-protein conversion factor can be ``calculated'' 
by simply dividing 100 by the total nitrogen content of a food, it will 
be critical that newer factors be accompanied by publicly available 
documentation of the amino acid analyses by which they were developed 
and the specific foods to which the new factors apply. Continued use of 
Jones' factors other than 6.25 (e.g., 5.7 for wheat, 6.38 for milk, 
5.46 for peanuts and Brazil nuts, 5.18 for almonds) in AOAC Official 
Methods is appropriate. These factors are used in commodity-specific 
analytical methods which have been replicated in

[[Page 33870]]

numerous laboratories and, as a result, have achieved Official Method 
status.
    (Comment 315) One comment stated that, because the regulation says 
that ``protein content may be calculated on the basis of the factor 
6.25 times the nitrogen content of the food,'' manufacturers are using 
various practices in calculating protein for the labeling of foods 
(e.g., breakfast cereal, meal replacement products, and dietary 
supplements) that contain protein combined with non-protein sources of 
nitrogen such as free amino acids and non-proteinogenic nitrogen 
compounds (e.g., L-carnitine, creatine, D-phenalalanine, adenosine, 
niacinamide, etc.). Two comments recommended that we revise the rule so 
that the declared content of protein in grams does not include non-
protein nitrogen sources and to define protein as ``a chain of amino 
acids connected by peptide bonds.'' One comment suggested that, if 
these changes are made, there are two means by which the appropriate 
label declaration for protein may be determined. The first is by 
subtracting the quantity of non-protein nitrogen sources from the total 
protein calculated based on the nitrogen content. The second is by 
measuring the total amino acids in the food and subtracting the free 
amino acids present. The comment acknowledged that methods for various 
non-protein nitrogen sources may not exist or may not be valid for a 
given food matrix. The comment recommended that we should give 
manufacturers greater flexibility to select an appropriate test method 
or to rely on recordkeeping to determine the quantities of non-protein 
nitrogen sources.
    Another comment noted that Sec.  101.36(b)(2) states that protein 
shall not be declared on labels of products that, other than 
ingredients added solely for technological reasons, contain only 
individual amino acids. The comment argued that this requirement does 
not prevent foods from containing non-amino acid nitrogen compounds as 
the only source of nitrogen (e.g., a dietary supplement containing 
vitamins or nucleotides, but no amino acids) from being labeled as 
containing protein.
    (Response) We agree with comments that the term ``may'' in Sec.  
101.9(c)(7) could be interpreted to mean that a variety of different 
practices could be used to determine the amount of protein in a serving 
of food. However, we decline to replace the term ``may'' with other 
terms that would require manufacturers to calculate the amount of 
protein in a serving of a product on the basis of 6.25 times the 
nitrogen content of the food, except when the official procedure 
requires another factor. Replacement of the term ``may'' with other 
terms in Sec.  101.9(c)(7) would prevent the use of all other means of 
protein determination. Manufacturers are permitted to use other means, 
such as databases, to determine the amount of protein in a serving of 
their product, and the suggested change would not permit such 
practices. Therefore, the final rule does not prohibit the use of 
values derived from databases or other methods, but the protein value 
declared in labeling must meet the value that we obtain using our 
compliance criteria for the product to not be misbranded. Regardless of 
the means used to determine the amount of protein, a manufacturer is 
responsible for the accuracy and compliance of the information 
presented on the label. We will determine whether a product complies 
with Sec.  101.9(g) by laboratory analysis.
    We also agree that methods for the determination of non-protein 
nitrogen sources may not yet be available or may not be valid for a 
given food matrix. We are currently aware of such methods for milk, but 
not for other matrices. For example, a number of AOAC Official Methods 
are available, including a method for TCA-precipitated protein nitrogen 
in milk (AOAC Official Methods 991.20, 991.21, and 991.22). These 
methods have been validated for milk and are considered to be adequate 
to determine true protein and non-protein nitrogen in milk. It may be 
possible to extend these methods or to develop analogous methods for 
other food matrices in the future.
    We disagree with the comments that we should define protein as ``a 
chain of amino acids connected by peptide bonds;'' such a definition is 
overly simplistic and would not prevent the declaration of compounds, 
such as di- and tri-peptides, from being declared as protein on the 
label.
    Methods for the determination of such compounds may not be widely 
available. There is also no definition of protein that is generally 
accepted by the scientific community that could be applied to a 
regulatory framework. The development of validated analytical methods 
for the determination of non-protein nitrogen containing compounds to 
match a scientifically sound regulatory definition of protein will take 
time. Therefore, we plan to revisit the determination of protein on the 
label once validated analytical methods and/or a regulatory definition 
for protein can be established.
    (Comment 316) We did not propose any changes to how the quality of 
a protein is determined, yet some comments addressed this subject. Our 
preexisting regulations, at Sec.  101.9(c)(7), require the use of a 
PDCAAS for determining whether a food contains a significant amount of 
protein per serving and for calculating the percent DV for protein. 
When the protein in foods represented or purported to be for adults and 
children 4 or more years of age has a PDCAAS of less than 20 expressed 
as a percent, or when the protein in a food represented or purported to 
be for children greater than 1 but less than 4 years of age has a 
PDCAAS of less than 40 expressed as a percent, a statement must be 
placed on the label indicating that the food is not a significant 
source of protein or the percent DV for protein must be declared.
    We also require, in Sec.  101.9(c)(7)(ii), that the PDCAAS be 
multiplied by the actual amount of protein in grams to determine the 
``corrected amount of protein (gram) per serving''. Under our 
preexisting regulations, at Sec.  101.9(c)(7)(i), the corrected amount 
of protein per serving must then be used to calculate a percentage of 
the RDI or DRV for protein, as appropriate. The PDCAAS must be 
determined by methods given in the 1991 FAO/WHO Protein Quality Report, 
which is incorporated by reference in Sec.  101.9(c)(7)(ii).
    Some comments expressed support for continued use of the PDCAAS for 
calculation of the percent DV for protein. However, other comments 
recommended replacing the PDCAAS method with the Digestible 
Indispensable Amino Acid Score (DIAAS) in Sec.  101.9(c)(7) because the 
comments believed the DIAAS to be a more accurate method of evaluating 
protein quality (Ref. 153). DIAAS is defined as: DIAAS percent = 100 x 
[(mg of digestible dietary indispensable amino acid in 1 g of the 
dietary protein/(mg of the same dietary indispensable amino acid in 1 g 
of the reference protein)] (Ref. 154). Indispensable or ``essential'' 
amino acids are those that the body cannot make and that can only be 
obtained from the diet. The comments referred to conclusions and 
recommendations from the FAO Expert Consultation on Dietary Protein 
Quality Evaluation in Human Nutrition (Ref. 154). The 2013 FAO Protein 
Quality Report states that for regulatory purposes, DIAAS is the 
recommended method for dietary protein quality assessment. A key 
recommendation by the FAO Expert Consultation was to replace PDCAAS 
with DIAAS because DIAAS more accurately reflects protein digestion and 
amino acid absorption compared to the single fecal crude

[[Page 33871]]

protein values used as part of the PDCAAS calculation. Some comments 
noted that the 2013 FAO Protein Quality Report states that DIAAS should 
optimally be based on known values of ileal amino acid digestibility 
for human foods, and such data are currently lacking. According to the 
comments, the FAO Expert Consultation suggested that, until such data 
become available, DIAAS values could be calculated by applying fecal 
crude protein digestibility values to dietary amino acid contents.
    (Response) We agree that the DIAAS is an important new method of 
evaluating protein quality when true ileal amino acid digestibility 
data are used. However, we decline to replace the PDCAAS with DIAAS in 
the final rule because there are insufficient data available to 
implement the DIAAS. The digestibility of protein has traditionally 
been determined from fecal digestibility, which does not take into 
account metabolism of protein in the colon. Unabsorbed amino acids are 
largely metabolized by bacteria in the colon and then converted into 
other compounds that can be absorbed; therefore, determination of fecal 
digestibility may provide inaccurate measurements of amino acids 
absorbed from the small intestine (Refs. 153, 155-156). Digestibility 
measured at the terminal ileum (that is, at the end of the intestine) 
has been suggested by some in the scientific community (Ref. 153) to be 
more accurate than fecal digestibility for determination of dietary 
amino acid digestibility. The difference between DIAAS and PDCAAS is 
that true ileal amino acid digestibility for the dietary indispensable 
amino acids is used for the calculation of DIAAS rather than a single 
fecal crude protein digestibility value.
    As mentioned in the comments, a key finding of the 2013 FAO Protein 
Quality Report is that digestibility should be based on the true ileal 
digestibility of each amino acid, preferably determined in humans. If 
collection of human data is not possible, the true ileal digestibility 
can be determined in growing pigs or in growing rats, in that order. 
However, the report noted that, after assessment of the ileal amino 
acid digestibility dataset, the FAO Expert Consultation concluded that 
currently available data are insufficient to implement true ileal amino 
acid digestibility in the calculation of DIAAS. Furthermore, until such 
time that a dataset of true ileal amino acid digestibility for human 
foods becomes available, the report suggested that values for fecal 
crude protein digestibility should be used in the calculation of DIAAS 
(Ref. 154).
    Notes from the Sub-Committee Report (Ref. 157) express the 
conclusions of the Sub-Committee members that, while there is a sound 
scientific case for using ileal digestibility, it derives almost 
entirely from work with animals. Based on limitations and the nature of 
data currently available, a case cannot be made for changing from fecal 
to ileal digestibility. The Sub-Committee also concluded that, ``For an 
organization like the FAO representing the whole World, a change will 
produce confusion. Before the change is made, sufficient data on 
comparisons across animal species and humans are needed'' (Ref. 157). 
Therefore, we decline to propose to replace PDCAAS with DIAAS until 
such time that a database of true ileal amino acid digestibility for 
humans that is widely accepted by the scientific community has been 
developed. We will continue to monitor future developments in the 
evaluation of dietary protein quality, and will consider amendments to 
our requirements for protein labeling based on new information, as 
appropriate.
    (Comment 317) One comment recommended replacing the scoring pattern 
for PDCAAS found in the 1991 FAO/WHO Protein Quality Report, which is 
incorporated by reference in Sec.  101.9(c)(7)(ii), with the scoring 
patterns found in the 2007 WHO/FAO/UNU Report ``Protein and Amino Acid 
Requirements in Human Nutrition, Report of a Joint WHO/FAO/UNU Expert 
Consultation'' (Ref. 158). Specifically, the comment would amend Sec.  
101.9(c)(7)(ii) by removing the incorporation by reference of the 
determination of PDCAAS by methods in sections 5.4.1, 7.2.1, and 8.00 
of the 1991 Protein Quality Report and incorporating by reference 
sections 6.2 and 6.3, section 8.3 (including Table 23), section 9.4.2 
(including Table 36), and section 14.7 (including Tables 49 and 50) 
from the 2007 Protein and Amino Acid Requirements Report. Specifically, 
section 5.4 of the 1991 Protein Quality Report provides recommended 
procedures for methods for the determination of all amino acids, 
partial amino acid analysis, and recommendations regarding the use of 
published amino acid data. Section 7 of the Protein Quality Report 
identifies digestibility methods and provides a detailed description of 
the in vivo rat assay for true protein digestibility. This section also 
describes the composition of experimental diets to be used, rat feeding 
protocol, collection of food and feces, and calculations to be 
performed. Section 8.00 of the Protein Quality Report describes how the 
PDCAAS is determined, describes the analyses needed for test foods, the 
amino acid scoring pattern, and calculation of amino acid scores. The 
four sections from the 2007 Protein and Amino Acid Requirements Report 
include the following information: Current concerns about the PDCAAS 
approach (sections 6.2 through 6.3), summary of adult indispensable 
amino acid requirements (section 8.3), summary of indispensable amino 
acid requirements for older infants and children (section 9.4.2.) and 
summaries of requirements for various age groups (section 14.7). The 
comment recommended these changes because it said there have been 
advances in science since the 1991 FAO/WHO Protein Quality Report was 
published. The comment said that the 2007 Protein and Amino Acid 
Requirements Report provides updated adult indispensable amino acid 
requirements as well as corrections to the calculation of the PDCAAS 
for food mixtures.
    (Response) We decline to amend Sec.  101.9(c)(7)(ii) as suggested 
by the comment. The amendment sought by the comment would eliminate 
important information that identifies and describes the methods and 
procedures for determination of the PDCAAS, would remove the current 
preschool child scoring pattern used for PDCAAS, and would replace the 
scoring patterns with newer ones that were developed in a different 
manner than those in the 1991 FAO/WHO Protein Quality Report.
    None of this methods-related and procedural information is included 
in the 2007 Protein and Amino Acid Requirements Report, including those 
sections mentioned specifically for inclusion (i.e., sections 6.2 and 
6.3, section 8.3, section 9.4.2 and section 14.7).
    In addition to removing important methods-related information for 
the calculation of PDCAAS, replacement of the 1991 FAO/WHO Protein 
Quality Report with specific sections of the 2007 Protein and Amino 
Acid Recommendations Report would remove the current preschool child 
scoring pattern for the PDCAAS and replace it with an adult scoring 
pattern. The amino acid scoring pattern currently in use by FDA is that 
for the preschool child (age 2 to 5 years), as recommended in the 1991 
FAO/WHO Protein Quality Report. This scoring pattern was established by 
FAO/WHO/UNU in 1985 for preschool children 2 to 5 years of age 
(``Energy and protein requirements: Report of a Joint FAO/WHO/UNU 
Expert Consultation'' (Ref. 159). The 1985 Report suggested separate 
amino acid scoring patterns for

[[Page 33872]]

infants, pre-school children 2 to 5 years of age, and adults, implying 
that protein quality varies with the age of the individual. The 1985 
Report stated that protein and diets containing essential amino acids 
that met the greater needs of young children were also adequate for 
older children and adults, whereas the reverse may not be true (Ref. 
159).
    In 1991, the FAO/WHO Consultation evaluated the 1985 Report and 
recommended that the FAO/WHO/UNU amino acid scoring pattern for 
preschool children be used to evaluate protein quality for all age 
groups except infants (Ref. 160). The FAO Expert Consultation also 
concluded that the PDCAAS is the most suitable regulatory method for 
evaluating protein quality of foods (Ref. 160). We reviewed the 1991 
FAO/WHO Protein Quality Report, tentatively accepted its conclusions, 
and proposed to require the use of PDCAAS as the method for determining 
protein quality for food intended for children over 1 year of age and 
adults in the 1991 proposed rule for Reference Daily Intakes and Daily 
Reference Values; Mandatory Status of Nutrition Labeling and Nutrient 
Content Revision (56 FR 60366 at 60370).
    We responded to comments on this subject in the 1993 final rule for 
Mandatory Status of Nutrition Labeling and Nutrient Content Revision, 
Format for Nutrition Label (58 FR 2079 at 2104) and concluded that the 
proposed amino acid scoring pattern for preschool age children was the 
most suitable pattern for use in the evaluation of dietary protein 
quality for all age groups, except infants.
    We also decline to replace the incorporation by reference of 
information from the 1991 FAO/WHO 1991 Protein Quality Report with the 
information cited in the comment from the 2007 Protein and Amino Acid 
Requirements Report. The use of the 2007 Report's scoring pattern for 
adults would provide significantly lower amounts of specific 
indispensable amino acids (i.e., histidine, lysine, phenylalanine + 
tyrosine, and tryptophan) than those provided by use of the scoring 
pattern in the 1991 FAO/WHO Protein Report. The scoring patterns in the 
2007 Protein and Amino Acid Requirements Report were based on amino 
acid requirement values divided by the mean protein requirement while 
the scoring patterns provided in the 1991 FAO/WHO Protein Quality 
Report were estimated by dividing amino acid requirements by what was 
considered a safe level of protein intake (Refs. 158, 160). Further 
evaluation of the two approaches used to derive scoring patterns is 
necessary before we can determine which approach provides a better 
estimation determination of protein quality. We will continue to 
monitor future developments in the determination of protein quality and 
will consider amendments to our requirements for protein labeling based 
on new information, as appropriate.
    (Comment 318) One comment recommended that, in Sec.  101.9(c)(7), 
when the protein in foods represented or purported to be for adults and 
children 4 or more years of age has a PDCAAS of less than 20 expressed 
as a percent, or when the protein in a food represented or purported to 
be for children older than 1 but less than 4 years of age has a PDCAAS 
of less than 40 expressed as a percent, the statement ``not a 
significant source of protein'' should be changed to ``not a source of 
complete protein'' for products that supply a non-trivial amount of 
protein but which have a low PDCAAS. The comment explained that many 
consumers, especially vegetarians, are familiar with the concept of 
complete vs. incomplete protein and, even for consumers who are 
unfamiliar with the concept, the statement ``not a source of complete 
protein'' provides notice that the food in question cannot be relied 
upon as the sole source of protein in the diet. (Complete proteins are 
those that contain all of the ``essential'' amino acids, or those amino 
acids that cannot be made by the body. An incomplete protein is one 
that is low in one or more of the essential amino acids (Ref. 161).
    The comment stated that the label for a product that contains 10 
grams of protein per serving (which would provide 20 percent of the DRV 
for adults) from low-PDCAAS proteins such as gelatin or collagen as the 
sole source of amino acids will often have ``10 g of protein'' declared 
and a ``not a significant source of protein'' declaration as well. The 
comment suggested that such a situation is confusing and misleading to 
the consumer.
    The comment further stated that amino acids deficient in one food 
or meal can be supplied by another, so that dietary needs are met over 
the course of the day. Therefore, according to the comment, foods with 
a low PDCAAS are a valuable source of protein in the context of the 
overall diet, and the labeling regulations should not completely 
discount their value.
    (Response) We decline to amend Sec.  101.9(c)(7) to replace the 
statement ``not a significant source of protein'' with ``not a source 
of complete protein'' when a product contains protein with a low 
PDCAAS. We agree that amino acids that are deficient in one food or 
meal can be supplied by another so that dietary needs are met over the 
course of the day. However, it is not clear, based on the information 
provided in the comment, if the general public would understand what a 
``complete'' protein is and, even if consumers did understand, whether 
the statements would be viewed differently. Therefore, we are not 
replacing the statement ``not a significant source of protein'' with 
``not a source of complete protein'' when a product contains protein 
with a low PDCAAS.
3. DRV
    Our preexisting regulations, at Sec.  101.9(c)(9), set the DRV for 
protein at 50 grams, and this represents 10 percent of the 2,000 
reference calorie intake level. The preamble to the proposed rule (79 
FR 11879 at 11913 through 11914) discussed scientific recommendations 
for setting the DV for protein and comments we received in response to 
the 2007 ANPRM. The preamble to the proposed rule (79 FR 11879 at 
11913) explained how using the IOM Labeling Committee's recommended 
approach for setting the DV for protein would result in no change to 
the DRV for protein and how the DRV of 50 grams for protein falls 
within the range of the RDAs calculated using reference weights.
    We did not propose to change the DRV of 50 grams for protein.
    (Comment 319) Several comments supported maintaining the current 
DRV of 50 grams for protein. However, other comments recommended 
increasing the DRV for protein. One comment suggested that the DRV for 
protein should be 23 percent of calories, which is the median of the 
IOM's Acceptable Macronutrient Distribution Range (AMDR) range (Ref. 
5). Taking into account the average actual weight of people in the 
United States, which is 195.5 pounds (lbs) for men and 166.2 lbs for 
women based on data from the Centers for Disease Control and Prevention 
National Center for Health Statistics (Ref. 162), the comment said an 
individual would need to eat 66 grams/day of protein to meet the 
recommended grams/kilogram of protein. The comment suggested that 
increasing the DRV for protein would help people lose weight because it 
would allow people to increase their muscle mass. However, the comment 
did not provide scientific support for this statement.
    Other comments recommended increasing the DRV for protein from 10 
percent to 15 percent or a minimum 15 percent of calories. The comments 
suggested that the current DRV of 10

[[Page 33873]]

percent of energy from protein is too low considering the IOM's AMDR 
for protein is 10 to 35 percent of energy intake for adults. One 
comment stated that Americans typically consume 15 to 17 percent of 
calories from protein, so increasing the DRV for protein to 15 percent 
would be consistent with protein intakes in the United States. One 
comment expressed concern that a DRV of 10 percent of energy from 
protein could lead to overconsumption of calories from other 
macronutrients, such as carbohydrates or fats.
    Another comment compared the current DRV for protein to the IOM's 
RDAs. The comment acknowledged that our DRV for protein is not based on 
the RDA for protein, but said it is less than the RDA for adolescent 
and adult men. The comment further stated that, because protein is an 
essential nutrient and because the RDA is set based on grams/kilogram 
of body weight, protein needs may exceed the RDA for some men, 
especially for men who are taller than average and/or have increased 
muscle mass. The comment expressed concern that we are not determining 
the DRV for protein in a similar manner to that for vitamins and 
minerals (i.e., the population coverage approach).
    One comment suggested that the DRV for protein should reflect 
dietitian-suggested values (e.g., 60 grams/day), but did not provide 
any basis for the change.
    (Response) We decline to increase the DRV for protein and are not 
making any changes to the existing DRV for protein of 50 g. The 
preamble to the proposed rule discussed comments we had received in 
response to an ANPRM and explained why we declined to change the DRV 
(79 FR 11879 at 11913). In brief, we considered basing the DRV for 
protein on the midpoint of the AMDR for protein 22.5 grams (79 FR 11879 
at 11913), but declined to base the DRV for protein on the midpoint of 
the AMDR range because we had no data to show that protein intakes in 
the United States were inadequate or that setting a higher DRV that is 
based on the midpoint of the AMDR is needed to reduce the risk of 
chronic diseases. Furthermore, the DRV of 10 percent of calories from 
protein falls within the AMDR range of 10 to 35 percent of calories 
from protein (id.).
    We also disagree that the DRV for protein should be increased to 15 
percent of calories from protein. The only basis provided in comments 
for increasing the DRV for protein to 15 percent of calories from 
protein is consumption data indicating that Americans typically consume 
15 to 17 percent of calories from protein. In reference to the concern 
that the established DRV for protein does not cover the needs of 
adolescent and adult men, recent consumption data shows that, on 
average, males 19 years and older are exceeding the RDA for protein, 
and thus a DRV of 10 percent has not had a negative impact on protein 
consumption (Ref. 163). The mean protein intake from foods and 
beverages in males 20 years of age and older is 98.8 grams/day and 
ranges from 80 grams/day to 110.0 grams/day. Four percent or less of 
males 19 years of age and older are consuming below the EAR for 
protein. Therefore, regardless of the current DRV, males 19 years of 
age and older are consuming well above the RDA for protein.
    We also disagree that the DRV should reflect suggested values from 
a dietitian. There is a range of values that could be recommended by a 
dietitian depending on the individual or group that a dietitian is 
counseling. Dietitians work in a variety of settings such as hospitals, 
long-term care facilities, wellness or rehabilitation centers, food 
industry, and non-profit organizations. They provide recommendations 
based on the patient or client's needs. The protein recommendations 
provided by dietitians vary greatly depending on the audience. 
Therefore, a DRV based on values suggested by dietitians would not 
necessarily be reflective of the needs of the general population.
4. Miscellaneous Comments
    (Comment 320) One comment recommended reorganizing Sec.  
101.9(c)(7) so that the regulated industry can more easily understand 
its provisions. The comment stated that the regulation is written in a 
manner that is convoluted and confusing, such that many readers have a 
hard time understanding its requirements. For example, the comment said 
that readers are often confused as to when, how, and to what the PDCAAS 
correction is to be applied in labeling, and when declaration of the 
percent DV is required, prohibited, or optional. The comment also 
stated that there is also confusion regarding the most appropriate 
method to determine the declared quantity of protein.
    The comment suggested revisions to the codified text, which 
included: (1) Removal of the discussion related to protein quality and 
when the statement ``not a significant source of protein'' must be 
declared from Sec.  101.9(c)(7); (2) removal of the discussion of how 
protein content may be determined from Sec.  101.9(c)(7) and placement 
of this information underSec.  101.9(c)(7)(i); (3) addition of ``(The 
quantity of protein in grams shall not be corrected based on protein 
quality values as described in paragraph (c)(7)(vii) of this 
section.)'' to Sec.  101.9(c)(7); (4) addition of the statement ``for 
foods in which the only significant source of nitrogen is from protein 
(i.e., chains of amino acids linked by peptide bonds) followed by 
information related to the calculation of protein content (moved from 
Sec.  101.9(c)(7)) to Sec.  101.9(c)(7)(i)); (5) addition of a new 
Sec.  101.9(c)(7)(ii) which includes requirements for foods containing 
non-protein sources of nitrogen; (6) replacement of the proposed 
language in Sec.  101.9(c)(7)(iii) related to the DRV and RDI values 
for protein with information related to the protein quality of foods 
purported to be for children and adults 4 years of age and older and 
new requirements for when the statement ``not a source of complete 
protein'' or a calculated percent DV for protein can be declared; (7) 
addition of a new Sec.  101.9(c)(7)(iv), which includes requirements 
for when the statement ``not a significant source of protein'' or the 
percent DV for protein must be declared on foods represented or 
purported to be for children greater than 1 but less than 4 years of 
age; (8) addition of a new Sec.  101.9(c)(7)(v), which includes 
requirements for when the statement ``not a significant source of 
protein'' must be declared and the prohibition of the declaration of 
the percent DV for foods represented or purported to be specifically 
for infants 7 through 12 months of age; (9) addition of a new Sec.  
101.9(c)(7)(vi) which includes information related to the voluntary 
declaration of a percent DV for protein, except that the percent DV 
declaration is prohibited if a food is represented or purported to be 
for infants 7 through 12 months of age; (10) addition of a new Sec.  
101.9(c)(7)(vii), which includes all of the information in proposed 
Sec.  101.9(c)(7)(ii) related to the calculation of the ``corrected 
amount of protein (gram) per serving''; and (11) addition of a new 
Sec.  101.9(c)(7)(viii), which includes all of the information in 
proposed Sec.  101.9(c)(7)(iii) related to the proposed DRVs and RDIs 
for protein.
    The comment also recommended revising Sec.  101.36(b)(2)(iii)(B) to 
state that the percent DV of all dietary ingredients declared under 
Sec.  101.36(b)(2)(i) must be listed, except that the percent for 
protein may ``or shall'' be omitted as provided in Sec.  101.9(c)(7). 
In addition, the comment recommended clarifying Sec.  
101.36(b)(2)(iii)(B) so that the percent DV for protein, when present, 
be calculated using the corrected amount of protein as specified in 
Sec.  101.9(c)(7).
    (Response) We decline to revise Sec.  101.9(c)(7) based on the 
comment. It is

[[Page 33874]]

not clear that the suggested reorganization of the codified makes it 
easier for the reader to understand the requirements related to when, 
how, and to what the PDCAAS correction is to be applied, and when the 
declaration of the percent DV is required, prohibited, or optional.
    We do agree, however, that Sec.  101.36(b)(2)(iii) should be 
revised for clarity to explicitly state that the percentage of the RDI 
for protein shall be omitted when a food is purported to be for infants 
through 12 months of age, and we have revised the rule accordingly. (We 
explain, in our response to comment 441, our reasons for changing 
``infants 7 through 12 months of age'' to ``infants through 12 months 
of age.'')
    We also agree to clarify, in Sec.  101.36(b)(2)(iii), that the 
percent DV for protein should be calculated using the corrected amount 
of protein as specified in Sec.  101.9(c)(7). Therefore, we have 
revised Sec.  101.36(b)(2)(iii) to state that the percent DV for 
protein, when present, shall be calculated using the corrected amount 
of protein as specified in Sec.  101.9(c)(7)(ii).

J. Sodium

    The preamble to the proposed rule discussed key consensus reports 
and recommendations that we reviewed in reconsidering the DRV (79 FR 
11879 at 11914 through 11915). After we published the proposed rule in 
March 2014, three new reports were issued that provided corroborative 
evidence to our proposal to set a DRV of 2,300 mg.
    The first report was the ``NHLBI Lifestyle Interventions to Reduce 
Cardiovascular Risk: Systematic Evidence Review from the Lifestyle Work 
Group'' (Ref. 17). In 2013, the Lifestyle Work Group evaluated evidence 
on the role of specific dietary patterns, nutrient intake (e.g., 
macronutrients, sodium, and potassium), and levels and types of 
physical activity, through effects on such modifiable CVD risk factors 
as high BP and lipids, in reducing CVD risk. The results of this 
systematic review were intended to be used to establish clinical 
recommendations that are directed at patients with CVD risk factors 
(i.e., abnormal lipids and/or prehypertension and hypertension). The 
Lifestyle Work Group evaluated evidence statements on the: (1) Overall 
effect of dietary intake of sodium on blood pressure; (2) comparison of 
different levels of dietary intake of sodium on blood pressure; (3) 
sodium and blood pressure in subpopulations defined by sex, race/
ethnicity, age, and hypertension status; (4) sodium intake and blood 
pressure in the context of dietary pattern changes; (5) sodium and 
blood pressure in the context of other minerals; and (6) effect of 
dietary intake of sodium on CVD outcomes. The Lifestyle Workgroup found 
that the strength of the evidence was high and that, in adults 25 to 80 
years of age with blood pressure 120 to 159/80 to 95 mm HG, reducing 
sodium intake lowers blood pressure. The Lifestyle Work Group found 
moderate evidence that, in adults 25 to 75 years of age with blood 
pressure 120 to 159/80 to 95 mm HG, reducing sodium intake that 
achieves a mean 24-hour urinary sodium excretion of approximately 2,400 
mg/day relative to approximately 3,300 mg/day lowers blood pressure by 
2/1 mm HG and reducing sodium intake that achieves a mean 24-hour 
urinary sodium excretion of approximately 1,500 mg/day lowers blood 
pressure by 7/3 mm Hg. There was low evidence that a reduction in 
sodium by approximately 1,000 mg/day reduces CVD events by about 30 
percent and that higher sodium intake is associated with greater risk 
for fatal and nonfatal stroke and CVD. The Lifestyle Work Group did not 
find sufficient evidence to determine the association between sodium 
intake and the development of heart failure.
    The second report was the 2015 DGAC. The DGAC informs the Federal 
government of current scientific evidence on topics related to diet, 
nutrition, and health. The 2015 DGAC considered the 2010 DGAC reviews, 
the 2013 NHLBI Lifestyle Evidence Review, the 2013 IOM Sodium in 
Populations report, and new evidence released since 2013 for sodium 
intake and blood pressure and CVD outcomes. The 2015 DGAC recommended 
that the general population, ages 2 years and older, rely on the 
recommendations in the 2005 IOM DRI Electrolytes report that set the UL 
at 2,300 mg/day based on evidence showing associations between high 
sodium intake, high blood pressure, and subsequent risk of heart 
disease, stroke, and mortality. The committee also noted that, given 
the well-documented relationship between sodium intake and high blood 
pressure, sodium intake should be reduced and combined with a healthful 
dietary pattern (Ref. 19).
    The third report was the 2015-2020 Dietary Guidelines for Americans 
(Ref. 28). The 2015-2020 DGA made a key recommendation to limit 
calories from added sugars and saturated fats and reduce sodium intake 
and to consume an eating pattern low in added sugars, saturated fats, 
and sodium. Cutting back on foods and beverages higher in these 
components will help people achieve diets that fit into healthy eating 
patterns. The 2015-2020 DGA also made a key recommendation to consume 
less than 2,300 mg of sodium per day. This recommendation was based on 
the UL for individuals ages 14 years and older set by the IOM (Ref. 
28)).
1. Mandatory Declaration
    Under section 403(q)(1)(D) of the FD&C Act, nutrition information 
in food labels or labeling must include, among other things, the amount 
of sodium, and our preexisting regulations, at Sec.  101.9(c)(4), 
require the declaration of sodium content on the Nutrition Facts label. 
The preamble to the proposed rule (79 FR 11879 at 11914) explained that 
Americans 4 years and older consume an average of approximately 3,650 
mg sodium/day, which is more than twice the amount required to meet 
their adequate intake (1,500 mg/day for individuals 9 to 50 years old). 
We also noted that evidence continues to support the association 
between increased sodium consumption and increased blood pressure 
(id.). Consequently, the preamble to the proposed rule indicated that 
we would continue to require mandatory declaration of sodium at Sec.  
101.9(c)(4).
    (Comment 321) Several comments supported the ongoing mandatory 
declaration of sodium content on the Nutrition Facts label. Some 
comments noted that providing this information will assist consumers in 
maintaining healthy dietary practices by helping them identify products 
with less sodium and to follow the advice of their health care 
professionals, specifically those consumers who are at higher risk of 
cardiovascular disease (CVD) (e.g., people with chronic kidney disease, 
African Americans, people 51 years and older, and those with 
hypertension). One comment stated that consumer research indicates that 
sodium is one of the top three food components Americans consider when 
making decisions about buying packaged foods or beverages (Ref. 164). 
Another comment suggested that mandatory declaration along with the 
declaration of potassium would encourage food manufacturers to reduce 
sodium that is added to foods. However, the comment did not provide 
data to support these assertions.
    (Response) We agree that the declaration of sodium on the food 
label will provide consumers with information on sodium content that 
can help them make appropriate food choices to help them maintain 
healthy dietary practices. However, with respect to the comment 
suggesting that mandatory declaration of sodium, along

[[Page 33875]]

with the declaration of potassium, would encourage food manufacturers 
to reduce sodium addition to foods, the extent that mandatory 
declaration of sodium and potassium will encourage reformulation is 
unknown.
    The final rule also requires disclosure of potassium. We discuss 
comments regarding the mandatory declaration of potassium at part 
II.L.3.b.
    (Comment 322) One comment opposed mandatory declaration of sodium 
and asked us to look critically at the science behind the dietary 
sodium recommendations and to consider removing sodium from the list of 
mandatory nutrients. However, the comment recognized that, given the 
2010 DGA (Ref. 30) and the 2010 IOM Sodium Strategies Report (Ref. 
165), FDA may feel that eliminating sodium as a mandatory nutrient is 
not possible at the current time.
    (Response) We decline to remove sodium from the list of mandatory 
nutrients. We note that section 403(q) of the FD&C Act expressly lists 
sodium as one of the nutrients to appear on the Nutrition Facts label. 
While the FD&C Act also provides a mechanism for us to remove nutrients 
from the label or labeling of food, we would have to determine that the 
information related to that nutrient is not necessary to assist 
consumers in maintaining healthy dietary practices. In the case of 
sodium, evidence continues to support the association between increased 
sodium consumption and blood pressure. In 2005, the IOM DRI 
Electrolytes Report noted a direct relationship between sodium intake 
and increased blood pressure (Ref. 166). The 2010 DGAC (Ref. 30) and 
the 2013 IOM report on Sodium Intake in Populations, Assessment of the 
Evidence (Ref. 167) concluded that a strong body of evidence has been 
documented in adults that blood pressure decreases as sodium intake 
decreases. The 2015 DGAC Report corroborates our position in the 
proposed rule because it also concluded that there is a strong body of 
evidence linking increased sodium intake to increased blood pressure 
(Ref. 19). Thus, the evidence continues to support mandatory 
declaration of sodium on the Nutrition Facts label.
2. DRV
    We proposed to revise Sec.  101.9(c)(9) to reduce the DRV for 
sodium from 2,400 mg to 2,300 mg. The preamble to the proposed rule (79 
FR 11879 at 11914 through 11915) explained that new scientific data and 
consensus reports on sodium highlighted the need to reconsider the DRV.
    (Comment 323) Several comments supported a DRV of 2,300 mg and 
agreed that the UL established by the IOM in 2005 is an appropriate 
basis for setting a DRV. The comments also noted that the 2013 IOM 
Sodium Intake in Populations, Assessment of the Evidence report (Ref. 
167) concluded that evidence on direct health outcomes is not 
consistent and insufficient to conclude that lowering sodium intakes 
below 2,300 mg/day either increases or decreases risk of CVD outcomes 
or all-cause mortality for the general population. The comments also 
noted that the IOM concluded there was no evidence on health outcomes 
to support treating subpopulation groups differently from the general 
U.S. population. A few comments noted that a recent meta-analysis by 
Graudal et. al (2014) showed that there is a U-shaped relationship 
between sodium intake and health outcomes (Ref. 168). (A U-shaped curve 
indicates that, at low levels of intake, there is a risk of inadequacy 
and, at high levels of intake, there is a risk of adverse events.) The 
comments noted that the Graudal et al. study extends the IOM report by 
identifying a specific range of sodium intake, 2,645 to 4,945 mg, 
associated with the most favorable health outcomes, within which 
variation in sodium intake is not associated with variation in 
mortality. The comments stated that this analysis underscores the 
conclusions of the 2013 IOM Sodium Intake in Populations, Assessment of 
the Evidence report (Ref. 167) and supports setting a DRV of 2,300 mg 
and does not support reducing the DV to 1,500 mg.
    Other comments supporting a DRV of 2,300 mg argued that a DRV based 
on a UL (rather than an RDI based on an AI) is consistent with our 
current and proposed approach for other nutrients (e.g., saturated fat 
and cholesterol) that should be limited in the diet and for which there 
are concerns of excess intake and risk of chronic-disease or health-
related conditions.
    Some comments supporting a DRV of 2,300 mg said that this value is 
consistent with the 2010 DGA recommendation for the general population. 
Another comment stated that scientific evidence and Federal nutrition 
policy do not support recommending that the general public reduce their 
daily intake of sodium to 1,500 mg/day. The comment noted that 2005 DGA 
report's statement for specific population groups to ``consume no more 
than 1,500 mg'' inadvertently implied that the 2005 DGA had defined a 
new UL for these groups. Furthermore, the comments said that the 
NHLBI's Lifestyles Evidence Review recommended no more than 2,400 mg/
day and that a further reduction to 1,500 mg/day would be even more 
beneficial for adults with pre-hypertension and hypertension who could 
benefit from blood pressure lowering. While the NHLBI report found 
strong evidence for reducing sodium intake and lower blood pressure, 
the comment said that the evidence for specifying an optimal intake 
level for sodium intake was moderate, and the evidence for sodium 
intake and CVD events was low.
    (Response) We agree with the comments supporting a DRV of 2,300 mg 
for sodium. The DRV is consistent with the scientific evidence from 
consensus reports, such as the 2005 IOM DRI Electrolytes report (Ref. 
166) and the 2013 IOM Sodium Intake in Populations, Assessment of the 
Evidence (Ref. 167), as well as our approach for other nutrients (such 
as saturated fat and cholesterol) that should be limited in the diet. 
The final rule, therefore, establishes a DRV of 2,300 mg for sodium.
    To the extent the comment suggests that the 2005 DGA implied that 
1,500 mg was the new UL for specific subgroups, we disagree. While the 
2010 DGA recommended reducing sodium intake to the AI of 1,500 mg/day 
for certain subpopulations at increased risk of the blood-pressure 
raising effects of sodium (e.g., older persons, African-Americans, and 
individuals with hypertension, diabetes or chronic kidney disease), the 
2005 IOM Electrolytes report concluded that there was insufficient 
scientific evidence to set a separate UL for these groups (see 79 FR 
11879 at 11914 through 11915). The AI for sodium of 1,500 mg/day was 
based on meeting essential needs of sodium (e.g., replacing sweat 
losses) and not blood pressure. We note that the NHLBI Lifestyles 
Evidence Review recommendations apply to adults with pre-hypertension 
and hypertension who would benefit from blood pressure lowering.
    (Comment 324) Some comments stated that, while intake below 2,300 
mg/day of sodium is desirable for some individuals, particularly those 
at risk of hypertension, the 2,300 mg/day recommendation seems most 
achievable given the current food supply and intake levels in the 
general U.S. population. The comments said that sodium targets below 
2,300 mg/day would make it hard to meet other nutrient needs, 
particularly potassium. In addition, one comment said that 
substantially lowering the current DV to 1,500 mg would reduce the 
palatability of foods that can be labeled as ``low sodium'' (e.g., 
assuming, as FDA

[[Page 33876]]

recognized, the eligibility criteria of 140 mg/RACC) used to define low 
sodium would likely be adjusted to remain consistent with current cut 
points for ``low'' nutrient content claims which are set at levels 
around 5 percent DV or less).
    (Response) The DRV of 2,300 mg is based on clinical data on sodium 
and blood pressure that is applicable to the general U.S. population 
and represents an amount not to exceed. The DRV for sodium is not based 
on the levels of sodium in the food supply or eligibility requirements 
for nutrient content claims. However, we recognize that revisions of 
other regulatory requirements, such as nutrient content claims (e.g., 
low sodium), would be less likely if the DV were updated to 2,300 mg 
(see 79 FR 11879 at 11916) and that there may be fewer technological 
barriers and product acceptance issues (e.g., palatability) for 
products that meet the current definition of ``low'' sodium.
    (Comment 325) A few comments supported establishing a DRV of 2,300 
mg, but suggested that we should consider the 2015-2020 DGA before 
issuing a final rule. Other comments suggested that we ask the IOM to 
re-evaluate the DRI for sodium or conduct our own re-evaluation to 
determine a sodium intake range. The comments stated that a new 
reevaluation should consider data on biomarkers, clinical outcomes as 
well as the sodium and potassium ratio.
    (Response) Given the extensive reviews already conducted by the 
IOM, the 2010 DGA, and the 2015 DGAC, we decline to ask the IOM to re-
evaluate the existing evidence for sodium or to conduct our own re-
evaluation. The UL set by the IOM in 2005 was based on clinical studies 
on sodium intake and blood pressure. Additionally, the 2005 IOM 
Electrolytes report evaluated the data on the sodium and potassium 
ratio and concluded that the data were insufficient to be used to set 
requirements. The 2013 IOM report, Sodium Intake in Populations, 
evaluated the evidence on sodium intake and CVD outcomes, and the 
report's conclusions support the UL of 2,300 mg/day. Furthermore, the 
2015 DGAC reviewed the evidence for blood pressure and clinical 
outcomes and recommended that the general population, 2 years and 
older, should rely on the UL of 2,300 mg/day based on evidence showing 
associations between increased sodium intake, increased blood pressure, 
and subsequent risk of heart disease, stroke, and mortality (Ref. 166). 
Therefore, we continue to consider the UL of 2,300 mg/day to be 
appropriate for the DRV for sodium. However, if significant changes in 
the science occur in the future, we would re-evaluate the evidence. We 
also note that the 2015-2020 DGA also supported a UL of 2,300 mg/day 
for individuals ages 14 years and older.
    (Comment 326) Some comments stated that consumers recognize that 
sodium is a nutrient to limit and that it is appropriate to use the UL 
of 2,300 mg/day to establish a DRV because the UL is the dietary intake 
level of a nutrient that is recommended not to exceed during any given 
day. Some comments noted that setting a DRV of 2,300 would result in 
less consumer confusion than changing to an RDI of 1,500 mg because 
consumers already understand that sodium is a nutrient to limit (Ref. 
164).
    (Response) Results from the FDA Health and Diet Surveys (Refs. 169-
171) have shown that consumers are aware that sodium is a nutrient to 
limit in the diet. As we noted in the preamble to the proposed rule (79 
FR 11879 at 11916), this awareness would suggest that consumer 
acceptance of a DV based on a level not to exceed would be consistent 
with a DRV of 2,300 mg.
    (Comment 327) Several comments objected to a DRV of 2,300 mg and 
supported a different level instead. Some comments supported using 
1,500 mg and said that lowering the DV for sodium from 2,400 mg to 
1,500 mg/day would align with the 2010 DGA recommendation for the 
majority of Americans, including persons who are 51 years or over, 
African-Americans, or individuals who have hypertension, diabetes, or 
chronic kidney disease.
    (Response) We decline to establish an RDI for sodium of 1,500 mg. 
We note that the 2010 DGA recommended 2,300 mg/day for the general 
population. While the 2010 DGA recommended reducing sodium intake to 
the AI of 1,500 mg/day for certain subpopulations at increased risk of 
the blood-pressure raising effects of sodium (e.g., older persons, 
African-Americans, and individuals with hypertension, diabetes or 
chronic kidney disease), the 2005 IOM Electrolytes report concluded 
that there was insufficient scientific evidence to set separate UL for 
these groups (see 79 FR 11879 at 11914 through 11915). The AI for 
sodium of 1,500 mg/day was based on meeting essential needs of sodium 
(e.g., replacing sweat losses) and not blood pressure. The UL of 2,300 
mg/day applies to the majority of the U.S. population (persons aged 14 
years and older) and is the highest daily nutrient intake level that is 
likely to pose no risk of adverse health effects to almost all 
individuals in the general population (79 FR 11879 at 11914). More 
recently, the 2013 IOM Sodium Intake in Populations (Ref. 167) report 
concluded that evidence was insufficient and inconsistent to recommend 
sodium intake levels below 2,300 mg/day for the general U.S. population 
based on the direct outcomes of CVD or all-cause mortality. In 
addition, the IOM concluded that the evidence on both benefit and harm 
is not strong enough to indicate that these subgroups should be treated 
differently from the general U.S. population. Thus, the evidence on 
direct health outcomes does not support recommendations to lower sodium 
intake within these subgroups to or even below 1,500 mg/day (see 79 FR 
11879 at 11915). We also note that the 2015-2020 DGA recommended 
limiting sodium intake to less than 2,300 mg/day for individuals ages 
14 years and older.
    (Comment 328) Some comments supporting a DV of 1,500 mg noted that 
the 2010 IOM Strategies to Reduce Sodium Intake in the U.S. report 
recommended that we lower the DV for sodium to 1,500 mg based on the 
AI.
    (Response) In the preamble to the proposed rule (79 FR 11879 at 
11916, 11917), we recognized that the 2010 IOM report recommended that 
we base the DV for sodium on the AI of 1,500 mg/day, and we invited 
comment on whether an RDI of 1,500 mg would be more appropriate and 
why. We also noted that the IOM said that using the AI would be 
consistent with the approach used for all other essential nutrients, 
where the DV is based on a reference value of adequacy rather than a 
reference value of safety (79 FR 11879 at 11916). However, the 2010 IOM 
report did not focus on reviewing the scientific evidence between 
sodium intake and health or with reevaluating the dietary guidance 
levels of sodium that should be consumed. The AI is a level to achieve 
in the diet to meet essential needs and is not an UL. Thus, we continue 
to consider that the 2005 IOM DRI Electrolytes report and 2013 IOM 
Sodium in Populations report, which conducted extensive reviews of the 
literature on sodium intake and blood pressure and/or CVD outcomes, are 
the most appropriate basis for a DRV of 2,300 mg.
    (Comment 329) Some comments stated that a DV of 1,500 mg would be 
consistent with recommendations of the 2010 DGAC, CDC, the American 
Public Health Association, and the American Heart Association.
    (Response) In the preamble to the proposed rule (79 FR 11879 at 
11890), we explained the factors we consider for nutrients of this 
type: (1) Existence of

[[Page 33877]]

quantitative intake recommendations, particularly reference intake 
levels provided in consensus reports that can be used to set a DRV or 
RDI; and (2) public health significance, as demonstrated by either 
well-established evidence or evidence of a problem with the intake of 
the nutrient in the general U.S. population and evidence of the 
prevalence of the chronic disease, health-related condition, or health-
related physiological endpoint that is linked to that nutrient in the 
general U.S. population. While the 2010 DGAC Report recommended that 
sodium be reduced over time to 1,500 mg/day, the 2010 DGA did not 
recommend 1,500 mg/day for the general population. The CDC 
recommendations are consistent with the 2010 DGA. The recommendations 
of the American Heart Association and the American Public Health 
Association of 1,500 mg/day did not persuade us to adopt a lower value 
as the DRV for sodium for the general U.S. population. We determined 
that the data and information on sodium intake and health from U.S. 
consensus reports that support a quantitative intake recommendation for 
sodium of 2,300 mg/day provide an adequate basis on which we can rely 
to establish 2,300 mg/day as the DRV for sodium.
    (Comment 330) Several comments said we should not use the 
``flawed'' 2013 IOM Sodium Intake in Populations report to set dietary 
policy. According to the comments, the IOM did not consider 
hypertension itself as a health outcome despite the relationship 
between blood pressure and cardiovascular disease. The comments also 
said that there are methodological concerns with some studies that the 
IOM considered, such as unreliable measures of sodium intake and 
results that are not generalizable to the general population. The 
comments also said that the IOM based its conclusions, in part, on a 
study with suspect evidence that focused on people with heart failure 
who received an aggressive treatment that is not used in the United 
States. The comments said that these methodological issues limit the 
IOM report's usefulness in setting dietary recommendations that are 
applicable to the general population and that we should base the DV for 
sodium on a robust body of evidence linking sodium intake with elevated 
blood pressure and on the few existing trials of sodium reduction and 
CVD. One comment stated that among those population trials is the 
Trials of Hypertension Prevention Study (TOHP I and II). The comment 
noted that the observational followup study showed a 30 percent 
reduction in the risk of CVD even among those in the reduced sodium 
group that decreased sodium intake by 20 to 30 percent (Refs. 172-173). 
The followup study found a continued decrease in CVD events among those 
with sodium levels as low as 1,500 mg/day with no evidence of a J-
shaped curve (increased risk of CVD at upper and lower levels of sodium 
intake) (Ref. 174). Those who excreted less than 2,300 mg/day had a 32 
percent reduction in risk; however, this reduction was not 
statistically significant (Ref. 174).
    (Response) We based the DRV of 2,300 mg primarily on the UL 
established in the 2005 IOM DRI Electrolytes report. The UL is, itself, 
based on clinical studies on sodium intake and blood pressure. 
Moreover, the 2013 IOM Sodium Intake in Populations report conclusions 
that are based mostly on observational studies on intake of sodium and 
outcomes for CVD and all-cause mortality are consistent with a DRV of 
2,300 mg. While the IOM included studies in patients with Congestive 
Heart Failure (CHF), it did consider the other subgroups separately. 
The IOM concluded that, while the current literature provides some 
evidence for adverse health effects of low sodium intake among 
individuals with diabetes, chronic kidney disease (CKD), or preexisting 
CVD, the evidence on both benefit and harm is not strong enough to 
indicate that these subgroups should be treated differently from the 
general U.S. population. Thus, the IOM concluded that the evidence on 
direct health outcomes does not support recommendations to lower sodium 
intake within these subgroups to or even below 1,500 mg/day.
    As for the comment regarding the use of a ``robust body of 
evidence,'' our decision to use the DRV of 2,300 mg is based on a 
robust body of evidence. Both IOM consensus reports were comprehensive 
reviews on the evidence between sodium intake and blood pressure and/or 
CVD outcomes. Additionally, the TOHP I and TOHP II trials and the 
followup observational study (Ref. 172) cited by the comment were 
included in the IOM's comprehensive review in 2013. The 2013 IOM report 
noted that Cook et al. 2007 (Ref. 172), an observational followup of 
the TOHP I and II sodium reduction trials, found a 25 percent reduction 
in CVD incidence (RR = 0.75, [Confidence Interval [CI]: 0.57 to 0.99], 
P = 0.04) when average sodium intake decreased from approximately 3,600 
to 2,300 mg/day in the intervention group in TOHP I and from 4,200 to 
3,200 mg/day in TOHP II (Refs. 167, 172). Further adjustment for 
baseline sodium excretion and body weight found a 30 percent lower risk 
(RR = 0.70 [CI: 0.53, 0.94], P = 0.02). The recent additional analysis 
conducted by Cook et al., 2014 (Ref. 174) on a subset of the TOHP 
participants not in the sodium reduction intervention group and 
stratified based on sodium intake (<2,300 mg, 2,300 to <3600 mg, 3,600 
to <4,800 mg, and 4,800 mg and higher) was published after the 2013 IOM 
report. This additional analysis showed a significant P for trend; 
however, CIs for CVD risk were not statistically significant between 
the lower daily intake levels (<2,300 mg; 2,300 to <3,600 mg) and the 
reference intake level (of 3,600 mg to <4,800 mg) for the three models 
used in the analysis. Many studies analyze for the statistical 
significance of the linear relationship (P for trend) between the 
substance and the disease. While this trend may be significant (P 
<0.05), the difference in risk between subjects at the various levels 
of intake (e.g., tertiles, quartiles or quintiles of intake) may not be 
significant (Ref. 85). In this case, because the CIs are not 
significant, the Cooke et al., 2014 study shows no effect for the 
association of sodium intake and risk of CVD when stratified by intake 
levels. When establishing a DRV, we consider the totality of the 
scientific evidence and do not consider it appropriate to rely on one 
observational study in lieu of a larger body of evidence that includes 
intervention studies on sodium and blood pressure and other 
observational studies on sodium and CVD outcomes. Therefore, we 
consider the UL of 2,300 mg/day appropriate for establishing a DRV.
    (Comment 331) Some comments supporting a DRV of 1,500 mg stated 
that this value would be consistent with what we had proposed for other 
nutrients (e.g., vitamin K, biotin, pantothenic acid, manganese) where 
the IOM had established an AI, but not an RDA.
    (Response) We disagree that the DRV for sodium should be consistent 
with vitamins and other minerals. Unlike vitamins and other minerals, 
the majority of the population consumes sodium at levels that exceed 
the AI and the UL. There is not a concern with overconsumption of these 
vitamins and other minerals. This makes sodium unique in comparison to 
other vitamins and minerals for which people generally strive to meet 
their daily needs.
    (Comment 332) Some comments opposed to a DRV of 2,300 mg stated 
that using the UL might confuse consumers into thinking that it is a 
recommended intake level.

[[Page 33878]]

    (Response) The comment provided no data to support its position, 
and we are not aware of data indicating that consumers would be 
confused with using a DRV based on an intake level not to exceed. The 
current DRV for sodium has been listed on food labels for the past 20 
years and represents an amount not to exceed. Additionally, the FDA 
Health and Diet Surveys (Refs. 169-171) have shown that consumers are 
aware that sodium is a nutrient to limit in the diet. Furthermore, our 
approach for sodium is consistent with the approach we use for other 
nutrients, such as saturated fat and cholesterol, that should be 
limited in the diet (see 79 FR 11879 at 11915 through 11916).
    (Comment 333) One comment said that we had indicated that consumers 
would find it difficult to reduce their sodium consumption to 1,500 mg/
day because of the high-sodium content in the food supply and because 
of taste preferences. The comment said that tastes can change as sodium 
levels are reduced and that lowering the DV for sodium would give 
manufacturers greater incentive to reduce the sodium content of their 
foods.
    (Response) We are establishing a DRV of 2,300 mg/day for reasons 
unrelated to the sodium content in the food supply and taste 
preferences. Therefore, the issues the comment raises are no longer 
relevant, and we are not making changes in response to this comment. We 
note that we are considering other ways to support the reduction of 
sodium in the food supply that take into account technological 
challenges to sodium reduction (see 76 FR 57050, September 15, 2011).
    (Comment 334) One comment said that not setting the DV at 1,500 mg 
would be arbitrary and capricious. The comment said that Agency action 
is arbitrary and capricious if the action departs from prior Agency 
policy without explanation or with disregard for factual determinations 
that we made in the past. The comment acknowledged that we had 
presented several alternatives to the DV of 2,300 mg, including 
alternative DVs of 1,500 and 1,900 mg and a ``tiered approach,'' but 
said that our proposal ``lacks an adequate basis in the record'' and 
that a DV of 2,300 mg is not protective of vulnerable populations. The 
comment cited the preamble to the proposed rule to indicate that most 
DRVs have been based on a quantitative intake recommendation associated 
with chronic disease risk of a health-related condition (79 FR 11879 at 
11892) and that, in the case of iron, we set a DV to protect population 
subgroups that require more iron, such as young children (1 to 4 years 
of age), women of childbearing age (12 to 49 years old), and pregnant 
women. It contrasted the DV for sodium as being a ``UL for all of the 
population over 14 years of age and substantially in excess of that for 
younger children.'' The comment said that we acknowledged that roughly 
one-half of the adult population, namely African Americans, individuals 
ages 51 years or older, and individuals with hypertension, chronic 
kidney disease, or diabetes, should be consuming lower levels of sodium 
(Ref. 175). For those subgroups, 1,500 mg/day is the recommended 
maximum intake for sodium (Ref. 30). The comment claimed that the DV 
``will affirmatively mislead the most affected but suggesting a much 
higher target for their consumption than is healthy or medically 
appropriate.''
    The comment referred to the preamble to the proposed rule where we 
discussed using 1,500 mg as a possible DV for sodium (79 FR 11879 at 
11914 through 11915) and said we focused inappropriately on a 
``flawed'' 2013 IOM report to arrive at a DV of 2,300 mg for sodium.
    (Response) We disagree with the comment. The preamble to the 
proposed rule discussed, at some length, the options we considered for 
updating the DV for sodium and why we proposed to set a DRV of 2,300 mg 
for sodium based on the UL for individuals aged 4 years and older and 
how a DRV of 2,300 mg for sodium is the most appropriate DV (79 FR 
11879 at 11914 through 11917). For example, we stated that:
     A DRV of 2,300 mg represents the UL for the majority of 
the population (persons 14 years of age and older) and is consistent 
with both the 2005 and 2010 DGA recommendations for sodium intake in 
the general population as the 2013 IOM report on Sodium Intake in 
Populations (id. at 11914);
     Setting the DV at 2,300 mg would classify the level as a 
DRV (rather than an RDI) and represent a reference intake level not to 
exceed. This would be consistent with our approaches to using DRVs for 
other nutrients that should be limited in the diet and for which there 
are concerns of excess intake and risk of chronic or health-related 
conditions (id.). Thus, although the comment claimed that a DV of 2,300 
mg would mislead consumers into believing they should consume more 
sodium, we reiterate that, as a DRV, it is a reference intake level not 
to exceed. Moreover, as we stated in the preamble to the proposed rule, 
if we were to adopt a DV of 1,500 mg, we anticipate that consumer 
education efforts would be needed to help consumers understand that the 
updated DV for sodium is a level to achieve rather than a level to 
consume less than and also that consuming in excess of this level would 
not be helpful (id. at 11916);
     Although the comment said we used a different approach for 
iron, the comment's comparison is misplaced. As the preamble to the 
proposed rule noted, iron deficiency is a concern (see id. at 11919), 
so the DV for iron represents a level that is to be achieved. Sodium, 
in contrast, is a concern due to overconsumption, so the DV for sodium 
is based on a reference intake level that should not be exceeded. As we 
stated in the preamble to the proposed rule, unlike the consumption of 
other vitamins and minerals, the majority of the population consumes 
sodium at levels that exceed the AI and the UL, and this makes sodium 
unique in comparison to the other vitamins and minerals for which 
people generally must strive to meet their daily needs (id. at 11916);
     As for the comment's depiction of the 2013 IOM report as 
``flawed,'' as discussed in our response to comment 330, we disagree. 
Furthermore, we stated, in the preamble to the proposed rule, that a 
DRV of 2,300 mg, which represents the UL, would be consistent with the 
2005 and 2010 DGA recommendations for sodium intake in the general 
population (id. at 11915). (We also note that it is consistent with the 
2015-2020 DGA and that the ``Scientific Report of the 2015 Dietary 
Guidelines Advisory Committee'' maintains a goal of less than 2,300 mg 
dietary sodium per day for the general population);
     We disagree that the UL is ``substantially in excess of 
that for younger children.'' The UL for children 4 to 8 years is 1,900 
mg/day and 2,200 mg/day for adolescents 9 to 13 years. (We note that 
these values are the same in the 2015-2020 DGA.) The IOM derived these 
ULs for these age groups by extrapolating downward from the adult UL of 
2,300 mg/day based on mean energy intakes because the evidence for 
sodium reduction on blood pressure in children is limited and 
inconsistent and was therefore insufficient to directly set a UL. We 
reiterate that the DRV for sodium is an amount not to exceed and not a 
recommended intake level. Therefore, it is appropriate to use the UL 
that represents the majority of the population as the basis for setting 
the DRV; and
     We also disagree with the comment's assertion that for 
subgroups the DV ``will affirmatively mislead the most affected by 
suggesting a much higher target for their consumption than

[[Page 33879]]

is healthy or medically appropriate.'' The 2013 IOM Sodium in 
Populations report concluded that the evidence on both benefit and harm 
is not strong enough to indicate that these subgroups should be treated 
differently from the general U.S. population. Thus, the evidence on 
direct health outcomes does not support recommendations to lower sodium 
intake within these subgroups to or even below 1,500 mg/day (see 79 FR 
11879 at 11915). Additionally, the 2005 IOM Electrolytes report 
concluded that there was insufficient scientific evidence to set a 
separate UL for these groups (see 79 FR 11879 at 11914 through 11915). 
Furthermore, consumers in these subgroups may be able to use 
quantitative information on the label to follow advice they have 
received from a health care professional concerning their conditions 
(see 79 FR 11879 at 11887).
    Thus, we disagree that a DV of 2,300 mg for sodium is ``arbitrary 
and capricious,'' departs from our past practice, or lacks an adequate 
basis in the record.
    (Comment 335) Several comments supported retaining a DV of 2,400 
mg. Some comments said experts disagree what the recommended daily 
amount for sodium should be and said that the 2013 IOM report on Sodium 
Intake in Populations did not recommend an intake level. Some comments 
cited a meta-analysis by Graudal et al. (Ref. 168) that included over 
250,000 participants; the comment said that there is a u-shaped 
relationship between sodium intake and health outcomes (Ref. 168). One 
comment noted that this relationship could enable a more precise 
determination of intake levels to be achieved rather than relying on 
dietary modeling and a somewhat arbitrary cutoff on a continuous scale. 
Therefore, the comment said we should convene a panel to review the 
evidence, examine the scientific evidence associating sodium intake to 
measurable health outcomes, or wait for the publication of the 2015-
2020 DGA report to be published for consideration.
    (Response) We disagree that there is not agreement on a sodium 
intake level among experts. The 2005 IOM DRI Electrolytes report, a 
U.S. consensus report, set a UL of 2,300 mg/day based on clinical 
trials that evaluated the dose-response relationship between sodium 
intake and blood pressure. Retaining the existing DRV of 2,400 mg would 
exceed the UL for sodium for the majority of the population (persons 14 
years of age and older) (see 79 FR 11879 at 11915). While the 2013 IOM 
Report on Sodium Intake in Populations Assessment of the Evidence was 
not given the task to set a target intake level, the conclusions of 
this review that examined the benefits and adverse outcomes of reducing 
sodium intake primarily in observational studies are consistent with 
the UL of 2,300 mg/day. Furthermore, all of the individual studies in 
the Graudal meta-analysis (2014) cited by the comments have been 
considered in the IOM reports (Refs. 166-168). In addition, this meta-
analysis does not represent the totality of the scientific evidence. 
Given the extensive reviews already conducted by the IOM, we do not 
agree that it is necessary to convene a panel to re-review the existing 
evidence at this time. The scientific evidence from the 2005 IOM DRI 
Electrolytes report, the 2013 IOM Sodium in Populations report, and the 
2010 DGA report that we relied on in the proposed rule are a sufficient 
basis to establish a DRV of 2,300 mg. Furthermore, the 2015-2020 DGA 
conclusions corroborate a DRV of 2,300 mg.
    (Comment 336) The preamble to the proposed rule discussed the 
possibility of using a ``tiered approach'' whereby we would set an 
interim DRV of 2,300 mg and lower to an RDI of 1,500 mg over time (79 
FR 11879 at 11916 through 11917). We explained that a tiered approach 
would give companies more time to manufacture new foods or reformulate 
existing products, would help gradually achieve an adequate intake 
level of 1,500 mg/day, and would be consistent with the 2010 DGAC 
recommendation, but we stated that there was inadequate justification 
for proposing a tiered approach.
    A few comments agreed with our conclusion that there is inadequate 
justification in consensus reports to use a tiered approach. The 
comments noted that a tiered approach would be an unprecedented process 
and inconsistent to the approach used for other nutrients, such as 
saturated fat and cholesterol, to limit in the diet. Another comment 
noted that a tiered approach may not help consumers adjust their taste 
preferences for sodium (Ref. 176).
    Other comments, however, recommended that we consider the tiered 
option if an RDI of 1,500 mg is not used. The comments said a tiered 
approach would provide food manufacturers with more time to 
reformulate, allow consumer taste preferences to adjust, and be 
consistent with the 2010 DGAC recommendation to reduce sodium intake to 
1,500 mg/day over time. Some comments said a phased-in approach also 
would be consistent with the 2010 IOM Strategies to Reduce Sodium 
Intake in Populations report which recommended reducing sodium content 
in a stepwise manner (Ref. 165).
    (Response) We decline to amend the rule to adopt a tiered approach. 
As we explain in our response to comment 325, we have set a DV of 2,300 
mg based on a UL. We also maintain that DVs are based on scientific 
data supporting healthy dietary practices rather than the levels of a 
nutrient present in the food supply (see 79 FR 11879 at 11914). 
However, we are working on efforts to reduce sodium content in various 
foods and encourage manufacturers to take steps towards reducing sodium 
content.
    (Comment 337) One comment suggested that reference to any daily 
nutritional intake or requirement for sodium is misleading and that we 
should halt any further consideration of regulations on the sodium 
content of food. The comment said that neither the AI nor the UL 
established by the IOM should be used to recommend intake levels of 
sodium because they are inconsistent with results from populations 
studies on sodium intake (Refs. 177-178). The comment also said that 
using the AI and UL would violate the National Nutrition Monitoring and 
Related Research Act, 7 U.S.C 5301 et seq. The comment added that the 
2013 IOM report concluded that there is no consistent evidence 
supporting any association between sodium intake and health outcomes 
and the Dietary Guideline of 1,500 mg sodium per day and could increase 
health risk for certain population groups. The comment asserted that 
the range of sodium intake at which there is the least negative health 
outcomes based on mortality and measureable feedback responses (renin, 
aldosterone, catecholamines, cholesterol and triglycerides) is above 
130 mmol (approximately 3,000 mg/day) and that this is the level that 
most people around the world already consume (Ref. 179). The comment 
stated that restriction of sodium intake stimulates the renin-
angiotensin-aldosterone (RAS) response and may lead to insulin 
resistance, increased mortality from diabetes, increased congestive 
heart failure risk, negative blood chemistry and increased overall 
mortality (Refs. 179-182). The comment also stated that the IOM had 
agreed to re-evaluate the DRIs for sodium.
    (Response) We disagree that any reference to any daily intake is 
misleading, that there should be no reference to an intake 
recommendation for sodium, and that we should stop working on ways to 
reduce the sodium content of food. While we agree that the AI for 
sodium, which was based on

[[Page 33880]]

meeting essential needs, is not a suitable basis for establishing a 
DRV, we disagree that the UL should not be used to establish a DRV for 
sodium. There is well-established evidence from consensus reports on 
the relationship between sodium intake and blood pressure (Ref. 166). 
The UL of 2,300 mg/day was based on clinical trials that evaluated the 
dose-response relationship between sodium intake and blood pressure 
(Ref. 166). In addition, the 2013 IOM Sodium Intake in Populations 
report concluded that clinical outcomes primarily from observational 
studies are consistent with the UL of 2,300 mg/day. One observational 
population study cited by the comment (Ref. 177) was reviewed by the 
IOM in 2005 and 2013 and another study done by Powles et al., 2013 
(Ref. 178) did not evaluate sodium intake to CVD outcomes or blood 
pressure and only estimated sodium intakes around the world.
    We also disagree with the comment that suggests there should be no 
restriction of sodium below current intake levels of 3,000 mg/day 
because of concerns of negative health outcomes. The 2005 IOM 
Electrolytes report reviewed the evidence on low sodium intake and 
blood lipid concentrations and insulin resistance and noted that the Al 
of 1,500 mg/day exceeds the levels of sodium intake (typically less 
than 700 mg/day) that have been associated in some studies with adverse 
effects of blood lipid concentrations and insulin resistance (Ref. 
166). The 2005 IOM Electrolytes report reviewed the evidence for plasma 
renin and concluded that, in contrast to blood pressure, there is no 
consensus on the interpretation of plasma renin activity and its role 
in guiding therapy for high blood pressure (Ref. 166). Similar to 
plasma renin activity, the evidence for the role of sympathetic nerve 
activity (e.g., release of catecholamines) and aldosterone is limited, 
and neither catecholamines, aldosterone, plasma renin, or triglycerides 
are recognized as validated surrogate endpoints for predicting CVD risk 
(see 79 FR 11879 at 11916). Furthermore, while consumers with acute or 
chronic disease, such as obesity, CVD (including CHF), or diabetes, may 
be able to use quantitative information on the label to follow advice 
they have received from a health care professional concerning their 
conditions, the nutrient declarations and percent DVs on the label are 
to help consumers make more informed choices to consume a healthy diet 
and are not intended for the clinical management of an existing disease 
(see 79 FR 11879 at 11887 and part II.B.2). In addition, while sodium 
was nominated as part of the DRI nomination process that was developed 
to help Federal Agencies prioritize which nutrients are reviewed, the 
IOM has not been asked to undertake a re-evaluation of the DRI for 
sodium as asserted by the comment (Ref. 183). To our knowledge, the IOM 
also has not agreed to reevaluate the DRI for sodium as asserted by the 
comment.
    Lastly, in response to the comment asserting that using the AI and 
UL would violate the National Nutrition Monitoring and Related Research 
Act (NNMRRA), to the extent the comment suggests our establishment of a 
DRV of 2,300 mg/day for sodium for purposes of labeling is somehow not 
consistent with nutritional monitoring and related research activities 
related to the NNMRRA, we disagree. We are requiring a DRV of 2,300 mg/
day for sodium consistent with our authority in section 403(q) of the 
FD&C Act to assist consumers to maintain healthy dietary practices and 
to enable consumers to observe and comprehend the information and to 
understand the relative significance of the information in the context 
of a total daily diet. We also note that the NNMRRA was enacted on 
October 22, 1990 and that the NLEA was enacted on November 8, 1990. 
Nothing in the NLEA states or even suggests that the NNMRRA imposes 
limits or conditions on the declaration of nutrients on food labeling 
or on our statutory obligations under the NLEA.
    (Comment 338) A few comments said that food labels should 
distinguish the amount of sodium that is added to food from the amount 
that is naturally occurring. The comments said we proposed a similar 
result for added sugar and that both sodium and added sugar cause 
serious health problems.
    (Response) We decline to require the amount of added sodium to be 
declared separately from the amount that occurs naturally in food. The 
comment did not explain why we should consider a distinction between 
naturally occurring and added sodium for purposes of the sodium 
declaration or provide a scientific rationale for that distinction. (In 
contrast, the preamble to the proposed rule (79 FR 11879 at 11902 
through 11905) discussed why we were proposing to require the 
declaration of added sugars, and the preamble to the supplemental 
proposed rule (80 FR 44303 at 44307 through 44309) explained why we 
were proposing to establish a DRV of 10 percent of total energy intake 
from added sugars and to require a percent DV for added sugars.) We are 
not aware of any scientific evidence to support a distinction for added 
sodium in labeling. Therefore, we are not making changes in response to 
this comment.
    (Comment 339) One comment said we should require disclosure of 
``salt'' instead of ``sodium.'' The comment said that consumers 
understand ``salt,'' but may not know what ``sodium'' means. The 
comment also noted that most sodium we consume is in the form of salt 
and that other countries use the term ``salt.'' The comment stated that 
requiring use of the term ``salt'' would mean that consumers would see 
a larger number on food labels and that could deter consumers from 
eating high sodium foods.
    (Response) We decline to revise the rule to replace ``sodium'' with 
``salt.'' We note that section 403(q)(1)(D) of the FD&C Act expressly 
refers to ``sodium'' (rather than a specific form of sodium) as a 
nutrient and that ``sodium'' has been in the Nutrition Facts label 
since 1993 (see 58 FR 2079). We also note that our surveys suggest that 
consumers are aware that too much sodium is unhealthy (see 79 FR 11879 
at 11916 (referring to results from the FDA Health and Diet Surveys)).
    Furthermore, while most sodium consumed in the diet comes from 
sodium chloride (which is the compound associated most with ``salt''), 
other forms of sodium, such as sodium bicarbonate (e.g. baking soda) 
and monosodium glutamate (MSG), used in foods contribute to the intake 
of sodium and can also raise blood pressure.

K. Fluoride

1. Voluntary Declaration
    Our preexisting regulations do not require or permit the 
declaration of fluoride on the Nutrition Facts label. Fluoride is a 
nonessential nutrient, but there is well-established evidence for the 
role of fluoride in reducing the risk of dental caries. As we said in 
the preamble to the proposed rule (79 FR 11879 at 11917), the 
declaration of fluoride content of a food can provide consumers with 
information to assist them in maintaining healthy dietary practices. 
However, because the evidence available to us did not allow us to 
establish a DRV for fluoride, we proposed to amend Sec.  101.9(c)(5) to 
provide for voluntary declaration of fluoride. In addition, consistent 
with existing provisions for voluntary declaration of other nutrients, 
we proposed that the declaration of fluoride would be mandatory when a 
claim about fluoride is made on the label or in labeling of foods and 
that, when fluoride content is declared, it must be expressed as zero 
when a serving

[[Page 33881]]

contains less than 0.1 mg of fluoride, to the nearest 0.1 mg increment 
when a serving contains less than or equal to 0.8 mg of fluoride, and 
the nearest 0.2 mg when a serving contains more than 0.8 mg of 
fluoride, consistent with how we have approached incremental values for 
other nutrients that are present in food in small amounts.
    (Comment 340) Several comments supported voluntary fluoride 
labeling and agreed that there is well-established evidence for the 
role of fluoride in reducing the risk of dental caries.
    One comment suggested that manufacturers of foodstuffs/beverages 
voluntarily label fluoride content if levels do not exceed 0.2 ppm from 
fluoride-contaminated materials during product preparation or are less 
than 2 ppm if fluoride is present naturally. The comment would require 
foodstuffs/beverages to be labeled if fluoride is intentionally added 
to the product.
    (Response) Under the final rule, declaration of a product's 
fluoride levels is voluntary whether intentionally added or present 
naturally. As we stated in the preamble to the proposed rule (79 FR 
11879 at 11917), a DRV cannot be established for fluoride based on the 
available quantitative intake recommendations. Therefore, while 
fluoride is a nutrient with public health significance, consistent with 
the factors we considered for declaration of non-statutory nutrients 
such as this, fluoride declaration is voluntary in the Nutrition Facts 
label. The final rule also states how fluoride content must be 
expressed, depending on the amount of fluoride in a specified serving.
    As for the comment suggesting that the declaration of fluoride be 
mandatory if it is added intentionally to a product, we disagree. The 
comment did not provide, nor do we have, a basis to require labeling of 
fluoride content when intentionally added. The addition of fluorine 
compounds to foods that would be subject to a voluntary fluoride 
declaration in the Nutrition Facts label includes fluoride in water 
that is used as an ingredient in food from fluoridation of public water 
supplies and fluoridation of bottled water within the limitations set 
forth in Sec.  165.110(b)(4)(ii) (see Sec.  170.45). We are not aware 
of added fluorinated compounds to other foods and would consider such 
an addition to be subject to a food additive approval under section 409 
of the FD&C Act. Moreover, mandatory declaration is required if a claim 
about fluoride content is made on the label or in the labeling of foods 
(see Sec.  101.9(c)(5)). Thus, we decline to revise the rule as 
suggested by the comment.
    (Comment 341) One comment stated that declaration of fluoride 
should be mandatory because fluoride consumption is one of the safest 
and most effective ways to help prevent tooth decay. The comment said 
that most bottled waters contain negligible amounts of fluoride or are 
fluoride-free, so displaying the fluoride content of bottled water on 
Nutrition and Supplement Facts labels will help consumers make informed 
decisions about their choice of drinking water. The comment noted that, 
without such labeling, individuals who use bottled water as their 
primary water source could unknowingly be missing the decay preventive 
effects of optimally fluoridated water available from their community 
water supply.
    (Response) We decline to amend the rule as suggested by the 
comment. There are already quantitative limits for fluoride with 
respect to bottled water. Furthermore, labeling of fluoride on bottled 
water would not be sufficient to inform a consumer about whether to 
consume water from the local municipal water supply. The consumer would 
need to understand the fluoride content of the local municipal water 
supply (or well water, if applicable) to understand the relative 
contribution of fluoride from each. Therefore, we do not consider it 
necessary to require labeling on the fluoride content of bottled water.
    We also do not expect fluorination of food. To the extent fluoride 
is approved for use as an ingredient in a food, its form must be listed 
in the ingredient list, and so one can determine if there is fluoride 
in food by checking the ingredient list (Sec.  101.4(a)(1)).
    (Comment 342) One comment agreed with the proposed requirements for 
voluntary declaration of fluoride and for mandatory declaration of 
fluoride if a claim is made about fluoride content or the label 
includes a FDA health claim for fluoride and dental caries. However, 
the comment objected to the need for a fluoride nutrient content 
declaration on bottled water when the product bears a statement of 
``added fluoride'' as part of the statement of identity with an 
accompanying quantitative declaration elsewhere on the label. The 
comment said that declaring fluoride in the Nutrition Facts label in 
such a situation would not help consumers. The comment stated that 
including a statement about fluoride in the statement of identity 
(e.g., spring water with fluoride added) under the bottled water 
standard should not be treated as a fluoride claim that triggers 
mandatory nutrition labeling as long as the amount of fluoride is 
otherwise declared on the label. The comment said that the proposed 
rule would impose a burden without any consumer benefit because 
fluoride is already declared and all other nutrients would be declared 
as zero. The comment added that, if we required Nutrition Facts labels 
on all foods that are otherwise exempt from nutrition labeling, labels 
on these foods would have to increase in size.
    (Response) We agree that a declaration of fluoride would not be 
required on the label for bottled water if statements such as 
``fluoridated,'' fluoride added,'' or ``with added fluoride,'' 
consistent with Sec.  101.13(q)(8), are included. The use of these 
statements would, however, require use of a simplified format for 
nutrition labeling. In the preamble to the final rule establishing the 
standard of identity and standard of quality for bottled water (60 FR 
57076 at 57079; November 13, 1995), we recognized that bottled water 
may be used by some consumers as an alternative to community drinking 
water and that the Surgeon General's Report on Nutrition and Health 
recommends that community water systems contain fluoride at optimal 
levels to prevent tooth decay. Therefore, we included, as part of the 
standard of identity for bottled water (Sec.  165.110(a)(1)), the 
optional addition of fluoride to bottled water within the limitations 
established in the quality standard (Sec.  165.110(b)(4)(ii)). We 
stated that a bottled water with added fluoride would be a multi-
ingredient food and, as such, its label must bear ingredient labeling 
(21 CFR 101.4(a)(1)) (id.). We also stated that we provided for the use 
of terms ``fluoridated,'' ``fluoride added,'' or ``with added 
fluoride'' on the label or in labeling of bottled water that contains 
added fluoride in 21 CFR 101.13(q)(8) (id.). By doing so, we did not 
define a nutrient content claim for fluoride, and, instead, provided 
that a statement indicating the presence of added fluoride could be 
used, but that the claim cannot include a description of the level of 
fluoride present (e.g., ``good source'' or ``high'') (58 FR 2302 at 
2314). We also stated, in the preamble to another final rule (58 FR 
2079 at 2149), that we considered the identity statement ``fluoridated 
water'' to be misleading if the product is derived from a source 
naturally containing fluoride. We concluded that the term 
``fluoridated'' should be used to describe only products to which 
fluoride has been added in the manufacturing process and that such 
products must bear nutrition labeling that complies with the simplified 
format (id.). Thus, fluoride that is added to bottled water consistent 
with the

[[Page 33882]]

standard of quality in Sec.  165.119(b)(4)(ii) and that bears a 
statement consistent with Sec.  101.13(q)(8) must comply with the 
simplified format for labeling in Sec.  101.9(f). However, we did not 
require any inclusion or declaration of fluoride in the simplified 
format for Nutrition Facts label because of the regulatory status of 
fluoride declarations and fluoride claims at the time. The terms 
``fluoridated,'' ``fluoride added,'' or ``with added fluoride'' were 
not provided for use as nutrient content claims (which would require 
declaration of fluoride if defined as such), but rather as statements 
regarding the presence of added fluoride, which were declared exempt 
from the nutrient content claim general requirements (Sec.  101.13(q)). 
Moreover, even if the terms ``fluoridated,'' ``fluoride added,'' or 
``with added fluoride'' were defined as nutrient content claims at that 
time, fluoride had not been included in Sec.  101.9 as a nutrient for 
inclusion in Nutrition Facts label and would not have been able to be 
included in the simplified format for Nutrition Facts label even if 
those claims were used.
    Through this final rule, we provide for the voluntary declaration 
of fluoride in the Nutrition Facts label, but, under the preexisting 
regulations, statements on the presence of added fluoride remain exempt 
from the nutrient content claim general requirements. We may evaluate 
our regulations for nutrient content claims (and health claims) for any 
necessary changes after publication of this final rule and the final 
rule on serving sizes. To be clear, with respect to labeling 
requirements when statements are made on the label about added fluoride 
in bottled water consistent with Sec.  101.13(q)(8), we are not 
requiring the mandatory declaration of fluoride for bottled water that 
bears a statement about added fluoride. We are, however, including 
additional language in Sec.  101.9(c)(5) to make clear that bottled 
water that bears a statement about added fluoride, as permitted by 
Sec.  101.13(q)(8), must bear nutrition labeling that complies with 
requirements for the simplified format in Sec.  101.9(f). If any other 
fluoride claim is used on the label (e.g., the FDAMA health claim for 
fluoride or an amount statement under Sec.  101.13(i)(3)), the 
declaration of fluoride would be mandatory on the Nutrition Facts 
label.
    (Comment 343) One comment would revise the rule to require the 
declaration of fluoride if the amount of fluoride exceeds 0.5 mg per 
serving. The comment said that fluoride is a dangerous neurotoxin and 
that consumption of over 2 mg/day of fluoride in drinking water would 
cause widespread, significant dental fluorosis. The comment said that 
athletes or others who drink twice the average intake of water could 
easily consume more than 2 mg of fluoride per day.
    (Response) The level of fluoride in public drinking water is 
outside the scope of this rulemaking.
    With respect to community water sources, we note that, on April 27, 
2015, the U.S. Public Health Service (PHS) recommended an optimal 
fluoride concentration of 0.7 mg/L for community water systems that add 
fluoride (see Department of Health and Human Services, ``HHS Issues 
Final Recommendation for Community Water Fluoridation,'' dated April 
27, 2015; ``U.S. Public Health Service Recommendation for Fluoride 
Concentration in Drinking Water for the Prevention of Dental Caries,'' 
Public Health Reports, vol. 130, pages 1 through 14 (July-August 2015) 
(``PHS Recommendation'') (accessed on the Internet at http://www.publichealthreports.org/documents/PHS_2015_Fluoride_Guidelines.pdf)). PHS indicated that this fluoride 
concentration, which replaces the previous recommended range of 0.7 to 
1.2 mg/L, would maintain caries prevention benefits while reducing the 
risk of dental fluorosis (PHS Recommendation at 2). It also noted that 
the Environmental Protection Agency (EPA) is in the process of 
reviewing the maximum amount of fluoride allowed in drinking water 
(id.).
    As for bottled water, although we have regulations establishing a 
quality standard for bottled water (Sec.  165.110), we issued a letter 
on April 27, 2015, based on the PHS recommendation, advising 
manufacturers, distributors, and importers of bottled water to not add 
fluoride to bottled water at concentrations greater than a maximum 
final concentration of 0.7 mg/L (see Letter from Susan T. Mayne, Ph.D., 
F.A.C.E., Director, Center for Food Safety and Applied Nutrition, to 
Manufacturer, Distributor, or Importer of Bottled Water, dated April 
27, 2015 (available on the Internet at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/BottledWaterCarbonatedSoftDrinks/ucm444373.htm)). We intend to revise 
our quality standard for fluoride added to bottled water (at Sec.  
165.110(b)(4)(ii)) to be consistent with the PHS recommendation.
    As for the comment's mention of dental fluorosis, the majority of 
dental fluorosis in the United States is the very mild form, and severe 
dental fluorosis is not common in the United States (Ref. 184). The 
prevalence of severe dental fluorosis could not be estimated in U.S. 
adolescents due to few cases in the participants in a national survey 
(Ref. 184). The PHS stated that ``to lower the fluoride concentration 
for community water fluoridation should decrease fluoride exposure 
during the time of enamel formation (birth through 8 years of age) for 
most permanent teeth, and further lessen the chance for children's 
teeth to have dental fluorosis, while keeping the decay prevention 
benefits of fluoridated water'' (Ref. 184). The PHS and FDA 
recommendations or advice should reduce the risk of dental fluorosis 
while still preserving the benefit of caries prevention.
2. DRV
    Our preexisting regulations do not provide an RDI or DRV for 
fluoride, and, in the preamble to the proposed rule (79 FR 11879 at 
11917), we stated that we were not proposing to establish a DRV for 
fluoride.
    (Comment 344) Some comments agreed with our decision to not 
establish a DRV for fluoride.
    (Response) The final rule does not establish a DRV for fluoride.
3. Miscellaneous Comments
    Several comments raised additional issues regarding fluoride.
    (Comment 345) One comment said the fluoride declaration should be 
in units of mg per liter (mg/L) rather than mg/serving. The comment 
stated that that the FDAMA health claim is in mg/L, that we mandated 
the amount of fluoride in bottled water in mg/L, and that consumers are 
accustomed to seeing fluoride as mg/L on bottles. Therefore, according 
to the comment, to facilitate consumer understanding and comparisons 
between the amount of fluoride in bottled water or other products and 
the recommended intake levels, we should adopt mg/L as the unit for 
fluoride declarations. The comment further stated that if mg/serving 
were to be used as the unit, some servings of bottled water would need 
to be declared as 0 mg fluoride, despite containing a meaningful amount 
of fluoride from a public health perspective on a mg/L basis and that 
consumers may be confused if the label said ``with fluoride added'' but 
the Nutrition Facts label declared 0 mg of fluoride.
    (Response) We decline to require the declaration of fluoride in the 
Nutrition Facts label to be in units of mg/L. The declaration of 
fluoride in the Nutrition Facts label is comparable to the other 
nutrients which are declared in absolute amounts per serving. Reporting 
mg per serving gives consumers an accurate amount of fluoride in a 
serving of the

[[Page 33883]]

product. Providing the amount of fluoride per liter may confuse 
consumers because the consumer may not be aware how much fluoride will 
be in the amount per serving (e.g., 12 ounces of bottled water which is 
equal to about 360 mL).
    As for the comment's mention of the FDAMA health claim and our 
bottled water regulation, the FDAMA health claim language did not 
mention a specific quantity of fluoride nor did it use a specific unit 
of measure; the claim language is ``Drinking fluoridated water may 
reduce the risk of [dental caries or tooth decay].'' We acknowledge 
that the bottled water regulation uses units in mg/L, yet we also note 
that the bottled water regulation is directed at manufacturers, 
distributors, and importers of bottled water and establishes a standard 
of identity and standard of quality for bottled water and includes 
maximum levels of fluoride in bottled water. In contrast, the Nutrition 
Facts label information declares nutrient content in a serving of a 
product to assist consumers in maintaining healthy dietary practices. 
Thus, we decline to amend the rule to require the declaration of 
fluoride to be in mg/L.
    Finally, regarding the comment's claim that consumers would be 
confused if the label said ``with fluoride added'' and the Nutrition 
Facts label declared fluoride content as 0 mg, we note that the use of 
a statement, consistent with Sec.  101.13(q)(8) would not require 
fluoride be declared on the label as ``0 mg.'' We are not aware of, and 
think it would be unlikely for, a manufacturer to voluntarily declare 
``0 mg'' for fluoride if the level of added fluoride is at a level that 
must be declared as zero when making statements on its product 
consistent with Sec.  101.13(q)(8). Any labeling must be truthful and 
not misleading, within the meaning of sections 403(a) and 201(n) of the 
FD&C Act.
    (Comment 346) One comment interpreted the proposed rule as allowing 
fluoride claims for dental caries on all food labels. The comment asked 
if these health claims will be permissible, beyond fluoride in bottled 
water products, for conventional foods and dietary supplements of any 
matrix because we have evidence acknowledging fluoride's health 
benefits and whether we will update the current qualified health claim 
for fluoridated water and reduced risk of dental caries. Alternatively, 
the comment asked if claims for the reduction in dental caries in the 
labels for conventional food products (other than bottled water) and 
dietary supplements would lead us to regulate those products under a 
different category (such as an unapproved drug). The comment said that, 
if our evidence suggests benefits of dietary fluoride exposure in 
preventing dental caries, it is reasonable to conclude that the 
qualified health claim should be expanded to allow the claim in 
conventional foods and dietary supplements, labeled with dietary 
fluoride, and in all forms (capsule, tablet, liquid).
    (Response) The proposed rule did not set forth a qualified claim 
with respect to fluoride. In the preamble to the proposed rule (79 FR 
11879 at 11917), we explained that we received a FDAMA notification in 
2006 for a health claim for fluoride in bottled water and that we did 
not object to the claim. The FDAMA health claim is limited to bottled 
water and does not extend to other foods. Under the FDAMA health claim, 
the food eligible to bear the claim is bottled water meeting the 
standards of identity and quality set forth in Sec.  165.110, and 
general requirements for health claims in Sec.  101.14 with the 
exception of the minimum nutrient contribution (Sec.  101.14 (e)(6)). 
For a health claim to be expanded to more foods, a health claim 
petition (Sec.  101.70) or a FDAMA notification must be submitted for 
our review (section 403(r)(3)(C) of the FD&C Act).
    (Comment 347) One comment suggested that, when fluoride is 
intentionally added to foods/beverages for ingestion by consumers, the 
following disclaimer/label appear before the listed amount: ``Fluoride 
is not a mineral nutrient, has no daily allowance, and is not FDA 
approved for ingestion particularly for women who are pregnant. 
Fluoride is recognized by U.S. EPA as a water contaminant.'' One 
comment stated that voluntary labeling could help because those who add 
fluoride and claim it as a ``dietary ingredient'' will show fluoride 
content. The comment noted that consumers who understand that fluoride 
is unsafe to add to food can avoid buying the product.
    (Response) We decline to revise the rule to include the comment's 
suggested language. While we agree that fluoride is a non-essential 
nutrient, there is well-established evidence for the role of fluoride 
in reducing the risk of dental caries, and the IOM set a quantitative 
intake recommendation (AI) based on its role in the reduction of risk 
of dental caries, but a DRV for fluoride has not been established. 
Furthermore, we have a standard of identity and a standard for quality 
for bottled water that allows voluntary addition of fluoride within the 
limitation established in Sec.  165.110, and, as we stated in our 
response to comment 343, the PHS recently recommended an optimal 
fluoride concentration of 0.7 mg/L for community water systems that add 
fluoride. Based on the PHS recommendation, we advised manufacturers, 
distributors, and importers of bottled water to not add fluoride to 
bottled water at concentrations greater than a maximum final 
concentration of 0.7 mg/L.
    As for the comment's suggestion to include language that the EPA 
has recognized fluoride as a water ``contaminant,'' the fact that EPA 
has a maximum contaminant level for fluoride in public drinking water 
does not mean bottled water or other products containing fluoride 
should state that fluoride is recognized by U.S. EPA as a water 
contaminant. Fluoride, as a contaminant to public drinking water, is 
outside the scope of this rule.
    (Comment 348) One comment stated that labeling could promote the 
false notion that fluoride is a nutrient and said that any accompanying 
claim that fluoride has ``nutritional value'' or is a ``dietary 
ingredient'' would constitute false labeling and would violate the FD&C 
Act.
    (Response) We disagree with the comment. We consider fluoride to be 
a nutrient (specifically, a mineral) (Ref. 185) for purposes of 
nutrition labeling in section 403(q) of the FD&C Act. We consider a 
nutrient that is subject to nutrition labeling under section 403(q)(1) 
or (q)(2) of the FD&C Act also to be a dietary ingredient in section 
201(ff) of the FD&C Act.
    (Comment 349) One comment suggested that, when fluoride is declared 
over 0.5 grams per serving, the manufacturer declare the form of 
fluoride present. The comment said that this information is highly 
relevant given the well-known differences between the bioavailability 
and pharmacokinetic profiles of artificial fluorides (e.g. hydrosilicic 
acid, sodium monofluorophosphate) as compared with naturally occurring 
ones (principally calcium fluoride).
    (Response) If a nutrient is added to a food, the form that is added 
must be declared in the ingredients list (Sec.  101.4(a)(1)). Moreover, 
under Sec.  101.4(a)(1), if the ingredient is a dietary ingredient, the 
form would be in the ingredient list, unless already labeled in 
accordance with Sec.  101.36. Under the Supplement Facts label 
requirements at Sec.  101.36(d), the source ingredient may be 
identified within the nutrition label in parenthesis immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the word ``as'' or

[[Page 33884]]

``from''. Therefore, we decline to revise the rule as suggested by the 
comment.
    (Comment 350) One comment rejected the notion that fluoride is a 
safe ingredient that only provides benefit and no harm. The comment 
said that ingested fluoride is toxic and that we should cite references 
that address the harm of ingested fluoride. Another comment stated that 
all synthetic industrial fluorides (e.g., hydrosilic acid, sodium 
monofluorophosphate) are toxic calcium chelators that are assimilated 
well. The comment said that fluoride is incorporated permanently in the 
bone during lifelong consumption, contributes to osteoporosis, 
accentuates hypothyroidism and dysfunctional kidneys, and can cause 
dental fluorosis in children and other effects. The comment said that 
natural calcium fluoride is not well assimilated and is the fluoride 
source for which labeling could be voluntary. The comment added that 
EPA's maximum contaminant level (MCL) for fluoride in drinking water (2 
ppm) is derived for calcium fluoride in natural sources in public water 
supplies and that there is no established MCL for synthetic fluoride 
where toxicity can vary under differing environmental conditions and 
disease conditions of the consumers.
    (Response) The preamble to the proposed rule highlighted the 
adverse impacts of high fluoride consumption set by IOM (Ref. 185) and 
U.S. EPA report (Ref. 186) (see 79 FR 11879 at 11917 through 11918). We 
also stated that other FDA regulations (Sec. Sec.  165.110 and 170.45) 
have limited what foods contain added fluoride. We reiterate that we 
recently advised manufacturers, distributors, and importers of bottled 
water to not add fluoride to bottled water at concentrations greater 
than a maximum final concentration of 0.7 mg/L.
    As for the comment regarding synthetic and natural forms of 
fluoride, the final rule does not restrict itself to a specific source 
of fluoride. Absent data or information, we do not have a sufficient 
basis in the administrative record on which to distinguish ``natural'' 
forms of fluoride from ``synthetic'' forms and to base the fluoride 
declaration in the Nutrition Facts label on a particular form of 
fluoride.
    We have not made any changes to the rule in response to these 
comments.

L. Essential Vitamins and Minerals of Public Health Significance

    In addition to sodium, a statutorily required nutrient, our 
preexisting regulations, at Sec.  101.9(c)(8)(ii), require the 
declaration of four essential vitamins and minerals, namely, vitamin A, 
vitamin C, calcium, and iron. Vitamins and minerals that may be 
declared voluntarily are vitamin D, vitamin E, vitamin K, vitamin 
B6, vitamin B12, thiamin, riboflavin, niacin, 
folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, 
selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium.
1. General Comments
    (Comment 351) One comment opposed the mandatory declaration of any 
vitamins or minerals other than sodium and potassium. The comment noted 
that all vitamins and minerals are required in the diet and said that 
singling out a few nutrients on the label encourages unnecessary 
fortification and overconsumption. The comment stated that labeling 
potassium would encourage food manufacturers to reduce sodium to 
achieve a better balance.
    (Response) The comment did not provide data or information to 
support its argument that the inclusion of a vitamin or a mineral on 
the Nutrition Facts label will encourage fortification or 
overconsumption. With respect to fortification, we encourage 
manufacturers to follow the principles in our fortification policy at 
Sec.  104.20 if they add nutrients to food. We issued the fortification 
policy to promote the rational addition of nutrients to foods and to 
preserve a balance of nutrients in the U.S. diet. In addition, our food 
additive regulations or GRAS status of some nutrients (e.g., vitamin D 
and folic acid) may limit which foods may be fortified and at what 
level. For example, the food additive regulations on folic acid (21 CFR 
172.345) and vitamin D (Sec.  172.379 (21 CFR 172.379); Sec.  172.380) 
stipulate which foods may be fortified and at what level.
    As for the mandatory declaration of vitamins and minerals, as we 
stated in the preamble to the proposed rule (79 FR 11879 at 11918 
through 11922), we determined that iron, calcium, vitamin D, and 
potassium are nutrients of public health significance and their 
mandatory declaration on the label can help consumers maintain healthy 
dietary practices. We mentioned how we considered several factors, such 
as intake and/or biomarker data, IOM setting a quantitative intake 
recommendation for a nutrient based on its relationship to a chronic 
disease, or a health-related condition to determine whether a 
particular nutrient was of public health significance for the general 
U.S. population (id.). The comment did not dispute our assessment of 
the data or provide information that would cause us to reconsider our 
analysis of the factors supporting mandatory declaration. Thus, we 
decline to revise the rule as suggested by the comment.
    (Comment 352) Some comments said that our nutrients of public 
health significance (e.g., calcium and vitamin D) are similar to 
nutrients of public health concern as determined by the 2010 DGA 
recommendations. The comments suggested that we wait for the 2015-2020 
DGA decision on nutrients of public health concern, so we can be 
consistent with the 2015-2020 DGA.
    (Response) We note that our nutrients of public health significance 
are the same as the 2010 DGA and the 2015 DGAC recommendations. The 
2015 DGAC used a three pronged approach similar to our factors for 
determining whether nutrients that have a specific relationship to 
chronic disease risk or a health-related condition are nutrients of 
public health concern, including an analysis of intake data, available 
valid biochemical indices from NHANES dietary survey, and data on the 
prevalence of health condition in the U.S. population. Based on the 
2015 DGAC approach, vitamin D, calcium, potassium, iron, and fiber were 
considered as nutrients of public health concern for under-consumption.
    We also note that the 2015-2020 DGA identifies calcium, potassium, 
dietary fiber, vitamin D, and iron as nutrients of public health 
concern.
2. Essential Vitamins and Minerals That Are Mandatory
    a. Calcium. Our preexisting regulations, at Sec.  101.9(c)(8)(ii), 
require the declaration of calcium content as a percent DV on the 
Nutrition Facts label. We require the declaration of calcium in 
nutrition labeling because: (1) There were a limited number of calcium-
rich foods in the food supply; (2) calcium intakes in the United States 
were generally marginal; (3) adequate calcium intakes are needed to 
allow for optimal bone mass development during childhood and young 
adulthood; and (4) calcium was identified as a nutrient of public 
health significance in the 1990 IOM report and in other consensus 
reports (58 FR 2079 at 2106).
    In the preamble to the proposed rule (79 FR 11879 at 11918 through 
11919), we discussed the benefits of adequate calcium intake on bone 
health, the relatively low intakes of calcium, and the high prevalence 
of osteoporosis and osteopenia among the U.S. population. We decided to 
continue requiring the declaration of calcium on the Nutrition Facts 
label, and so the proposed rule would not change Sec.  101.9(c)(8)(ii).

[[Page 33885]]

    (Comment 353) Most comments supported mandatory declaration of 
calcium on the Nutrition Facts label.
    However, some comments supported mandatory declaration for 
different reasons. Some comments focused on calcium's role in bone 
health, but most comments said that calcium is important for dialysis 
and renal patients.
    (Response) While a mandatory calcium declaration may help patients 
who have chronic kidney disease, this was not a factor we considered in 
mandating the declaration of calcium. The Nutrition Facts label is not 
intended to focus on individuals with a specific acute or chronic 
disease (see part II.B.2). To evaluate the public health significance 
of essential vitamins and minerals, we considered several factors in 
determining the mandatory declaration of vitamins and minerals in the 
Nutrition Facts label. We considered the essential vitamins and 
minerals with the greatest public health significance to be those for 
which IOM based DRIs on chronic disease risk (e.g., osteoporosis), a 
health-related condition (e.g., high blood pressure), or a nutrient 
deficiency with clinical significance (e.g., low iron storage leading 
to iron deficiency anemia) for which inadequate intake of these 
nutrients are likely to have important clinical consequences. We also 
considered whether the national survey data on nutrient intake and/or, 
when available, biomarkers of nutrient status, provide evidence of 
inadequate intake of the nutrient in the general healthy U.S. 
population, and whether a substantial prevalence of health consequences 
that was linked to the particular nutrient exists in the general 
healthy U.S. population (see 79 FR 11879 at 11890). In setting DRIs for 
calcium, the IOM reviewed various endpoints (i.e., bone health, cancer, 
cardiovascular disease and diabetes), and bone health was the only 
endpoint with sufficient scientific evidence to set a DRI (Ref. 38). 
Therefore, given the benefits of adequate intake on bone health, 
reflected in the IOM's DRIs, relatively low intake of calcium (about 49 
percent of individuals ages 4 years and older have usual calcium intake 
from conventional foods below the EAR and 37 percent have intakes from 
both conventional foods plus supplements below the EAR), and the high 
prevalence of osteoporosis and osteopenia among the U.S. population, we 
concluded that calcium is a nutrient of public health significance, and 
its declaration continues to be necessary to assist consumers in 
maintaining healthy dietary practices. Our preexisting regulation, at 
Sec.  101.9(c)(8)(ii), continues to require the declaration of calcium 
content as a percent DV on the Nutrition Facts label, so the final rule 
does not affect the requirements for the declaration of calcium.
    (Comment 354) One comment noted that adding calcium (plus vitamin D 
and potassium) to the Nutrition Facts label will be ``nice'' for those 
who understand these details, but, for most consumers (except perhaps 
those with Chronic Kidney Disease), information regarding calcium is 
just more information to sift through on an already-confusing food 
label.
    (Response) We consider that a vitamin or mineral of public health 
significance should continue to be the key factor in deciding when to 
require mandatory declaration in labeling. Available quantitative 
evidence suggests that the declaration of nutrient of public health 
significance, including vitamins and minerals, can help consumers 
maintain healthy dietary practices (Refs. 187-188). Additionally, we 
intend to work with other Federal Agencies and organizations on 
communication and education for health professionals and consumers 
regarding the revised Nutrition Facts and Supplement Facts labels after 
we issue the final rule.
    b. Iron. Our preexisting regulations, at Sec.  101.9(c)(8)(ii), 
require the declaration of iron as a percent DV on the Nutrition Facts 
label. We require the declaration of iron because: (1) Iron was 
identified as a nutrient of public health significance in a 1990 IOM 
report and in other consensus reports; and (2) iron deficiency was a 
risk for certain segments of the U.S. population (i.e., young children, 
adolescents and women of childbearing age and pregnant women, 
especially those with low incomes) (58 FR 2079 at 2106). In the 
preamble to the proposed rule (79 FR 11879 at 11919), we discussed our 
analysis of NHANES intake data showing that 3.5 percent of the 
population ages 4 years and older (excluding pregnant and lactating 
women) have inadequate iron intakes from conventional foods (i.e., an 
intake below the EAR), and about 3.3 percent have inadequate iron 
intakes from conventional foods and dietary supplements. We also stated 
that about 11.2 and 10.4 percent of women of childbearing age (12 to 49 
years old) continue to have iron intakes below the EAR, from 
conventional foods and conventional foods plus dietary supplements, 
respectively. We also considered data for several status biomarkers 
related to iron nutrition. Analyses of these data showed that about 14 
percent of women of childbearing age (12 to 49 years) had serum 
ferritin concentration (the major iron storage compounds) less than 15 
ng/mL, while 10 and 14.5 percent of women had inadequate stores of body 
iron based on the body iron model or ferritin model, respectively (see 
79 FR 11879 at 11920). Additionally, about 3.76 million of these women 
of childbearing age are considered to have iron deficiency anemia, so 
that iron continues to be of public health significance among women of 
childbearing age and pregnant women, who account for 26 percent of the 
general U.S. population (id.).
    We noted that iron continues to be identified as a nutrient of 
public health significance in consensus reports such as Healthy People 
2020 and the 2010 DGA (see 79 FR 11879 at 11920). Thus, we did not 
propose any changes to the mandatory declaration of iron under Sec.  
101.9(c)(8)(ii).
    (Comment 355) Most comments supported the mandatory declaration of 
iron on the Nutrition Facts label.
    One comment suggested that, instead of declaring iron as ``iron,'' 
we should require the declaration of specific forms, such as ``reduced 
iron'' or ``ferrous sulfate,'' on the label. The comment said that some 
people have an allergic reaction to added iron, but do not react to 
natural iron.
    (Response) We decline to revise the rule as suggested by the 
comment. Based on our regulations, only iron can be used on the food 
labels (Sec.  101.9(c)(8)(iv)), but the specific form that is added to 
the food, (e.g., ferrous sulfate) must be listed in the ingredient list 
(Sec.  101.4). Individuals with allergic reactions to added iron in 
food are advised to check the ingredient list.
    Under the Supplement Facts label requirements at Sec.  101.36(d), 
the source ingredient may be identified in parenthesis immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the word ``as'' or ``from.'' When a source ingredient is 
not identified within the nutrition label, it must be listed in an 
ingredient statement in accordance with Sec.  101.4(g). However, when a 
source ingredient is identified in the nutrition label, it will not be 
listed again in the ingredient statement.
    Our preexisting regulation, at Sec.  101.9(c)(8)(ii), continues to 
require the declaration of iron content as a percent DV on the 
Nutrition Facts label, so the final rule does not affect the 
requirements for the declaration of iron.
    c. Vitamin A and Vitamin C. Our preexisting regulations, at Sec.  
101.9(c)(8)(ii), require the declaration of vitamins A and C as percent 
DVs on the Nutrition Facts label.

[[Page 33886]]

    With respect to vitamin A, we require the declaration of vitamin A 
because: (1) It was found in a limited number of foods within the food 
supply; and (2) a 1990 IOM labeling report identified vitamin A as a 
nutrient of potential public health significance and stated that 
certain subpopulations (children under 5 years of age) were still at 
risk of deficiency for this vitamin (see 58 FR 2079 at 2106). In the 
preamble to the proposed rule (79 FR 11879 at 11920), we mentioned 
that, in response to the 2007 ANPRM, several comments recommended 
retaining the mandatory declaration of vitamin A, but we also said 
that, even though vitamin A intakes appear to be low, vitamin A 
deficiency based on an assessment of vitamin A status is rare in the 
U.S. population. Consequently, we tentatively concluded that vitamin A 
is no longer a nutrient of public health significance for the general 
U.S. population, and, consistent with the factors for declaration of 
these types of non-statutory nutrients, we proposed to amend Sec.  
101.9(c)(8)(ii) to permit, but no longer require, the declaration of 
vitamin A on the Nutrition Facts label. However, vitamin A declaration 
would remain mandatory when vitamin A is added as a nutrient supplement 
or claims are made about it on the label or in labeling of foods. The 
proposed rule also would not change the current provision for voluntary 
declaration of the percent of vitamin A that is present as [beta]-
carotene, as specified in Sec.  101.9(c)(8)(vi). The preamble to the 
proposed rule (79 FR 11879 at 11920) did, however, invite comment on 
whether there is an appropriate alternative analysis to application of 
the factors regarding the mandatory declaration of vitamin A.
    As for vitamin C, we require the declaration of vitamin C because: 
(1) A 1990 IOM labeling report identified vitamin C as a nutrient of 
potential public health significance and stated that certain 
subpopulations were considered at risk of deficiency (such as elderly 
individuals on inadequate diets and infants fed cow's milk 
exclusively); and (2) vitamin C was thought to play a role in promoting 
the intestinal absorption of non-heme iron, meaning that vitamin C in 
the same food as iron was considered to help prevent iron deficiency 
anemia, while excess vitamin C was considered to increase the risk of 
excessive iron absorption (55 FR 29487 at 29501). In the preamble to 
the proposed rule, we noted that, in response to the 2007 ANPRM, 
several comments recommended retaining the mandatory declaration of 
vitamin C, but we also noted that, while the prevalence of inadequate 
intake of vitamin C is high, prevalence of vitamin C deficiency is not 
apparent in the U.S. population as only about 6 percent of the general 
population had serum vitamin C concentrations below 11.4 micromoles 
([micro]mol)/L, a cutoff level that is used as an indicator of vitamin 
C deficiency (79 FR 11879 at 11921). We further noted that the effects 
of vitamin C on risk of chronic diseases, such as cardiovascular 
disease or cancer, are not conclusive, that, in a letter of enforcement 
discretion on qualified health claims for vitamin C supplement intake 
and reduced risk of cancers, we concluded that there was no credible 
evidence on the risk reduction from vitamin C for most cancers 
(squamous cell cancer of the esophagus, colorectal, laryngeal, lung, 
oral cavity, pancreatic, pharyngeal, renal cell, and salivary gland 
cancers), and very limited evidence for an association between vitamin 
C supplement intake and gastric cancer, and that the 2010 DGA does not 
include vitamin C among the list of nutrients of public health concern 
for the general U.S. population (id.). Consequently, we tentatively 
concluded that, while vitamin C intakes are low, vitamin C deficiency 
is uncommon, and vitamin C is no longer a nutrient of public health 
significance for the general U.S. population. Therefore, consistent 
with the factors we consider for declaration of these types of non-
statutory nutrients, we proposed to amend Sec.  101.9(c)(8)(ii) to 
permit, but no longer require, the declaration of vitamin C on the 
Nutrition Facts label. However, vitamin C declaration would remain 
mandatory when vitamin C is added as a nutrient supplement or claims 
are made about it on the label or in labeling of foods. The preamble to 
the proposed rule (79 FR 11879 at 11920) invited comment about whether 
there is an appropriate alternative analysis to the application of the 
factors regarding the mandatory declaration of vitamin C.
    (Comment 356) Several comments agreed with our proposal to amend 
Sec.  101.9(c)(8)(ii) to allow for the voluntary declaration of 
vitamins A and C. Although we invited comment on whether there is an 
appropriate alternative analysis to the application of factors 
regarding the mandatory declaration of vitamin A and vitamin C, we did 
not receive any comments on that topic other than general agreement 
with the factors we applied.
    Most comments, however, disagreed with voluntary declaration. Many 
comments did not explain why they felt that mandatory declaration of 
vitamins A and C is necessary, but some comments provided a rationale. 
A few comments agreed that vitamins A and C deficiencies are not common 
in the general population, but said vitamins A and C are extremely 
important and that the public will benefit from seeing them on the 
label. The comments suggested that removing vitamins A or C from the 
label would prevent consumers from determining the amount of each 
vitamin in their diet. Other comments suggested keeping vitamins A and 
C on the label because we also proposed eliminating other portions of 
the Nutrition Facts label; thus, the comments said there should be 
adequate room for mandatory declaration of vitamins A and C.
    (Response) We decline to amend the rule to require the disclosure 
of vitamins A and C. We base the mandatory listing of vitamins and 
minerals on public health significance relative to inadequate dietary 
intakes and biomarkers of nutrient status, as well as the possible 
association between the nutrients and the risk of chronic disease. 
Consistent with the factors set for the declaration of essential 
vitamins and minerals, we concluded that vitamins A and C are no longer 
considered nutrients of public health significance for mandatory 
declaration on the label, and the final rule removes vitamins A and C 
from the list of nutrients in Sec.  101.9(c)(8)(ii) for which the 
quantitative amount by weight and percent of the RDI are required in 
nutrition labeling. However, manufacturers can declare these vitamins 
on the label voluntarily, and if vitamin A or vitamin C is added as a 
nutrient supplement or claims are made about the vitamin on the label 
or in labeling of foods, then they must be declared on the Nutrition 
Facts label.
    As for the comment referring to other information that would be 
removed from the Nutrition Facts label, space constraints on the label 
were not the reason behind the removal of these vitamins from the 
Nutrition Facts label.
    (Comment 357) One comment stated that vitamins A and C are markers 
for fruit and vegetable intake, and so declaring vitamins A and C on 
the label will promote increased intake of fruits and vegetables. 
Another comment noted that having vitamins A and C on the label will 
help consumers to figure out how much real fruits and vegetables are in 
a food product.
    (Response) We consider whether a vitamin or mineral is of public 
health significance (rather than its possible role as a marker for 
certain food groups) to be a key factor in deciding whether to require 
mandatory declaration on the Nutrition Facts label. However, the four 
selected mandatory vitamins and minerals plus fiber represent various

[[Page 33887]]

food categories, such as fruits and vegetables. For example, potassium 
and fiber are found in fruits and vegetables and could be used as 
markers for fruits and vegetables, and non-heme iron sources come from 
plant foods, such as beans and lentils and some vegetables such as 
spinach. Paying particular attention to nutrients of public health 
significance on the Nutrition Facts label can help consumers in 
selecting a variety of foods in the diet and help the U.S. population 
make healthy dietary choices.
    (Comment 358) One comment suggested that the reason why vitamin A 
and vitamin C deficiencies are rare is because they are on the 
Nutrition Facts label. The comment said that if we remove the vitamins 
from the label, there might be deficiencies in the future because 
manufacturers would not fortify the foods. Another comment stated that 
food fortification is a significant contributor to the intakes of both 
vitamins A and C and is instrumental for controlling vitamins A and C 
deficiency. The comment said we should consider the impact on the 
fortification and consumer access to vitamins A and C in foods if we do 
not require declaration of these vitamins. The comment said that 
presence of these vitamins on the Nutrition Facts label has encouraged 
fortification by the food industry and that a large percentage of 
vitamins A and C in the diet is supplied through food fortification. 
Thus, if declaration of vitamins A and C is not required, the comment 
said that the industry may reconsider fortifying foods with those 
vitamins. The comment stated that there are no data to indicate the 
impact that removing the requirement for vitamins A and C from the 
Nutrition Facts label will have on the practice of food fortification 
or on the adequacy of those vitamins in the U.S. population.
    One comment stated that it is misleading and incorrect 
scientifically to consider any essential nutrient as being ``no longer 
of public health significance.'' Rather than removing two nutrients 
from the mandatory declaration list to make way for two new ones, the 
comment said it is important for consumers to know as much as possible 
about the micro-nutritional content of the foods they choose to 
purchase and consume. One comment asked whether one can really judge 
which vitamins and minerals are more important to people or whether 
vitamin D and potassium are more beneficial to people than vitamins A 
and C. The comment said that all vitamins and minerals play an 
important role in the healthy functioning of the human body. The 
comment suggested that, to determine which vitamins and minerals to 
list in the Nutrition Facts label, we should study which vitamins or 
minerals are more difficult for the body to synthesize or make on its 
own, and we should list those vitamins or minerals because consumers 
need to find other sources of those vitamins or minerals help their 
body function.
    (Response) The preamble to the proposed rule invited comments, 
including the submission of data and information on whether the 
mandatory listing of vitamins and minerals impacts food fortification 
practices. We did not receive any comments providing data or 
information that inclusion of mandatory vitamins and minerals on the 
label will increase or decrease fortification practices. The comments 
also did not provide data to substantiate the claim that removing 
vitamins A and C from the label will change the industry fortification 
practices, although one comment suggested that such data does not 
exist. Consequently, we do not have evidence that would let us 
determine whether removing these nutrients from the Nutrition Facts 
label will affect fortification.
    As for the claim that removing vitamins A and C from the Nutrition 
Facts label may cause deficiencies in the U.S. population, we have 
evaluated all essential vitamins and minerals intake (including 
vitamins A and C) in the U.S. population for purposes of determining 
the nutrients of public health significance, and we will continue 
monitoring vitamins A and C (among other nutrients) intake and the 
status (to determine both deficiency and excess) of the U.S. population 
after the final rule becomes effective. We also intend to monitor the 
marketplace to determine the impact of requiring the declaration of 
nutrients on the Nutrition Facts label or removing nutrients from the 
label on fortification practices.
    As for the comment stating that it is misleading and incorrect 
scientifically to consider any essential nutrient as being ``no longer 
of public health significance,'' the fact that we do not require the 
declaration of a particular vitamin or mineral on the Nutrition Facts 
label should not be interpreted as saying that these vitamins and 
minerals are no longer essential nutrients or do not need to be 
consumed in adequate amounts each day. We base the mandatory listing of 
vitamins and minerals on several factors that link public health 
concerns relative to inadequate dietary intakes and status biomarker 
levels as well as the association between the nutrients and the risk of 
chronic disease and the prevalence of disease in the general U.S. 
population.
    (Comment 359) One comment stated that, while frank vitamin C 
deficiency may not be common, almost 20 percent of individuals 6 years 
of age and older have serum vitamin C concentrations indicative of 
being at moderate risk for developing vitamin C deficiency and cited a 
published article as support (Ref. 189). The comment also said that 
individuals who smoke or who are in lower income categories may be more 
likely to be deficient in vitamin C (Ref. 189), which may put these 
vulnerable populations at higher risk for vitamin C deficiency and 
associated morbidity.
    (Response) We disagree with the comment. Based on our data analysis 
(NHANES 2003-2006), we determined that about 6 percent of people ages 6 
years and older (including smokers) have serum vitamin C concentrations 
below 11.4 [micro] mol/L. This cutoff level is used as indictor of 
vitamin C deficiency (Refs. 190-191). The CDC analysis of NHANES 2003-
2006 showed the same results as ours (Ref. 190).
    As for the article cited by the comment, Schleicher et al., 2009 
(Ref. 189), we note that the authors reported that 7.1 percent of the 
total population in NHANES 2003-2004 were deficient (using cutoff of 
less than 11.4 [micro] mol/L). Additionally, in establishing the 
nutrients of public health significance, while nearly 35 percent of the 
general healthy U.S. population (4 years and older) have vitamin C 
intakes below the EAR from conventional foods, and nearly 28 percent of 
the general healthy U.S. population (4 years and older) have vitamin C 
intakes below the EAR from conventional foods plus dietary supplements, 
vitamin C deficiency is uncommon. Thus, it is no longer considered a 
nutrient of public health significance for the general U.S. population. 
Similar to our findings, vitamin C was not considered to be a nutrient 
of public health concern by the 2010 DGA and the 2015 DGAC, but these 
reports considered vitamin C to be a shortfall nutrient because intakes 
are below the recommended intake. (The 2015 DGAC states that 
``shortfall nutrients'' are ``those that may be underconsumed either 
across the population or in specific groups relative to the IOM-based 
standards, such as the Estimated Average Requirement (EAR) or the 
Adequate Intake (AI)'' (Ref. 192).
    We will continue monitoring all nutrient intake (including vitamins 
A and C) and the status of the U.S. population (to determine both 
deficiency and excess) after the final rule becomes effective.

[[Page 33888]]

    (Comment 360) One comment said that segments of U.S. population 
have inadequate intakes of both vitamins A and C, so we should not 
remove vitamins A and C from the label. The comment said that 
provitamin A carotenoids provide approximately 26 and 34 percent of 
vitamin A consumed by men and women, respectively. Because recent data 
indicate a much lower conversion rate of carotenoids to vitamin A, the 
comment said that many reports of vitamin A intake have been over-
estimated (Ref. 193). The comment also said that 45 percent of American 
males and females over the age of 2 years (excluding pregnant/lactating 
women) consume less than the EAR for vitamin A from food and that, even 
when dietary supplements were considered, 34 percent of Americans did 
not meet the EAR for vitamin A (Ref. 194). The comment also said that 
vitamin A intake from any source (naturally in foods, fortified in food 
and dietary supplement) were below the EAR in 25 percent of 9- to 13-
year-old girls, and over 50 percent of 14 to 18 year olds failed to 
meet the EAR (Ref. 195). The comment added that 37 and 25 percent of 
Americans consume less than the EAR for vitamin C from food or from 
food plus dietary supplements, respectively (Ref. 194).
    The comment said, similar to vitamin A, vitamin C intakes are poor 
in children (2 to 18 years old) (Ref. 195). Another comment stated 
that, given increased awareness and knowledge about the importance of 
nutrient interactions (e.g., between calcium and magnesium, sodium, 
potassium, iron, copper, and vitamins D, K, and A), the best approach 
to providing informed choice to consumers is to require a declaration 
of all essential vitamins and minerals when present in a serving over a 
predetermined significant amount, for instance between 10 and 20 
percent of the DV.
    (Response) We considered whether a vitamin or mineral is of public 
health significance to be a key factor in deciding whether to require 
mandatory declaration of that vitamin or mineral on the Nutrition Facts 
label. We have done our own analyses of both intake and status (using 
biomarker data when available in NHANES with a valid cutoff) data from 
NHANES for those ages 4 years and older (excluding pregnant women) for 
all vitamins and minerals (including vitamins A and C). Based on the 
factors considered in establishing a nutrient of public health 
significance (see 79 FR 11879 at 11899 through 11891), we concluded 
that, while vitamins A and C intakes are low, their deficiency based on 
assessment of vitamin A or vitamin C status is not common in the 
general healthy U.S. population. Furthermore, the IOM did not set a 
quantitative intake recommendation for vitamins A or C based on a 
public health endpoint (see 79 FR 11879 at 11920 through 11921).
    We also note that, similar to our findings, vitamins A and C were 
not considered to be nutrients of public health concern in the 2010 DGA 
(Ref. 30) and the 2015 DGAC (Ref. 19). However, both 2010 DGA and 2015 
DGAC considered these vitamins to be shortfall nutrients because their 
intakes are below the recommended intake level.
    As for the comment regarding declaration of all essential vitamins 
and minerals when present over a predetermined significant amount (10 
to 20 percent of DV), we must be selective with regard to the 
information to be listed on the label. Therefore, we emphasize only the 
essential vitamins and minerals that meet our factors for determining 
nutrients with the greatest public health significance to be declared 
on the Nutrition Facts label in order to assist consumers in 
maintaining healthy dietary practices. We permit voluntary declaration 
of other vitamins and minerals on the Nutrition Facts label. However, 
the declaration of these vitamins and minerals will be mandatory when 
they are added as a nutrient supplement or claims are made about them 
on the label or in labeling of foods.
    Thus, we decline to revise the rule as suggested by the comments.
    (Comment 361) One comment said we were being inconsistent in our 
evaluation of non-statutory nutrients for mandatory declaration. The 
comment said that the intake data for vitamin A and calcium are very 
comparable, and so our proposal to include calcium on the label, while 
removing vitamin A, is inconsistent. The comment compared vitamin A to 
calcium consumption; it stated, for example, that 45 and 34 percent of 
Americans consume less than the EAR for vitamin A from food, or food 
plus dietary supplements, respectively, while 48.9 and 38 percent of 
Americans consume less than the EAR for calcium from food or food plus 
dietary supplements, respectively.
    One comment said that removing vitamins A or C from the Nutrition 
Facts label will lead consumers to believe these vitamins are not 
nutrients of concern. The comment said the removal also may cause USDA 
nutrition programs, such as MyPlate, to reconsider their emphasis on 
vitamins A and C.
    One comment said that consumers are still looking for vitamins A 
and C and, in fact, are trying to purchase more products containing 
these vitamins. The comment said that a study done by NPD reveals that 
50 percent of shoppers are trying to get more vitamin C, and 40 percent 
are trying to get more vitamin A. Additionally, the 2013 HealthFocus 
Trend Report, A National Study of Public Attitudes and Actions, found 
that the importance of numerous label claims remains relatively steady 
with more than 40 percent of shoppers looking for ``good source 
claims.'' Specifically, the comment said, 40 percent are looking for 
food products that are a ``good source of antioxidants'' (e.g., vitamin 
C).
    (Response) Besides looking at only intake data, we also looked at 
biomarker data (when available) as well as the endpoints upon which the 
IOM based a DRI and the disease prevalence associated with that 
nutrient in order to determine public health significance of nutrients. 
For example, in view of the benefits of adequate calcium intake on bone 
health (established in the IOM's DRIs), low intakes of calcium, and the 
higher prevalence of osteoporosis and osteopenia among the U.S. 
population, we concluded that calcium is a nutrient of public health 
significance and its declaration continues to be necessary to assist 
consumers in maintain healthy dietary practices.
    For vitamin A, although our analysis showed that vitamin A intakes 
appears to be low, vitamin A deficiency based on assessment of vitamin 
A status is rare in the U.S. population. The IOM did not set a 
quantitative intake recommendation for vitamin A based on a public 
health endpoint (Ref. 193). Thus, we concluded that vitamin A is no 
longer a nutrient of public health significance. We do not necessarily 
consider a high prevalence of nutrient intake inadequacy by itself as a 
sufficient justification of being a nutrient of public health 
significance and warranting mandatory declaration on the Nutrition 
Facts label (Ref. 196).
    Vitamins A and C were not also considered to be nutrients of public 
health concern in the 2010 DGA (Ref. 30) and the 2015 DGAC (Ref. 19). 
However, both the 2010 DGA and the 2015 DGAC considered these vitamins 
to be shortfall nutrients because their intakes are below the 
recommended intake level.
    As for the comment pertaining to MyPlate, MyPlate is based on the 
USDA food intake patterns, which provide a recommended daily selection 
of foods that is generally adequate in essential nutrients and moderate 
in food

[[Page 33889]]

components often consumed in excess. The USDA food intake patterns 
emphasize eating the recommended intake of all essential vitamins and 
minerals, regardless of whether those vitamins and minerals are on the 
Nutrition Facts label.
    As for consumer interest or shopping patterns, we agree that many 
consumers may be interested about the levels of vitamins A and C, among 
other nutrients, on the label, but not all nutrient information can be 
mandated on the Nutrition Facts label. We consider mandatory 
declaration appropriate, for a nutrient that has a specific 
relationship to chronic disease risk or a health-related condition, 
when there is public health significance and a quantitative intake 
recommendation that can be used for setting a DV (DRV or RDI). We 
consider voluntary declaration to be appropriate when such a nutrient 
either has a quantitative intake recommendation, but does not have 
public health significance, or does not have a quantitative intake 
recommendation available for setting a DRV but has public health 
significance. For vitamins A and C, the final rule provides for 
voluntary declarations, and, if the nutrient is added to a food or a 
claim is made on the label or in the labeling of food (e.g., good 
source of vitamin C), the nutrient must be declared on the label.
    (Comment 362) Some comments suggested that vitamin A can be toxic 
in high levels and can cause birth defects, so consumers need to know 
the amount of vitamin A on the label.
    (Response) Consumption of vitamin A (as preformed vitamin A 
(retinol)) above the UL may pose risk of toxicity in the population. 
The IOM set a UL for preformed vitamin A based on teratogenicity in 
women of childbearing age or liver abnormalities in all other adults 
(Ref. 193). If a vitamin A is present at very high levels in a 
conventional food, it is most likely in the added form, therefore, it 
must be declared on the label, and the forms added must be listed in 
the ingredient list (Sec.  101.4). Consumers can check the ingredient 
list to learn about the forms of vitamin A added in the food. 
Furthermore, the amount of added vitamin A and its form must be 
reported either on the Supplements Facts label or the ingredient list 
of a dietary supplement (Sec.  101.36).
    (Comment 363) One comment suggested that vitamin A is important in 
eye vision, immune function, and the prevention of other diseases, so 
we should continue to require the declaration of vitamin A on the 
Nutrition Facts label.
    Another comment noted that scurvy is a big problem in the homeless 
population and in youth due to poor diet. The comment said it would be 
difficult for people to consume adequate amounts of vitamin C if we no 
longer required the declaration of vitamin C on the Nutrition Facts 
label.
    (Response) We agree that adequate vitamin A intake is important for 
normal vision and immune function (Ref. 193). However, the IOM set the 
DRIs (EAR/RDA) based on the amount of dietary vitamin A required to 
maintain adequate liver stores in well-nourished subjects, rather than 
on normal vision or immune function (Ref. 193). Furthermore, there is 
no clear evidence that suggests a protective association between 
dietary vitamin A or [beta]-carotene and reduction of risk for chronic 
disease, such as cardiovascular disease and cancer (Ref. 193). Instead, 
consistent with the factors we set forth regarding mandatory and 
voluntary declaration, we have determined that vitamin A is no longer a 
nutrient of public health significance and so the final rule does not 
require declaration of vitamin A on the Nutrition Facts label.
    As for the comment regarding vitamin C and scurvy, the comment did 
not provide evidence to support the proposition that scurvy is high 
among homeless individuals and among youth. We do note that our 
regulations have required the declaration of vitamin C declaration on 
the Nutrition Facts label for over 20 years, so if we were to accept 
the comment's premise that scurvy is high among the homeless and youth, 
then it does not appear that declaring vitamin C on the Nutrition Facts 
label has affected the purchasing behavior of these subpopulations to 
buy products higher in vitamin C. Instead, based on the factors 
considered in determining mandatory declaration of essential vitamins 
and minerals, vitamin C was no longer considered as a nutrient of 
public health significance for the general U.S. population.
    (Comment 364) One comment said that mandatory declaration of 
vitamins A and C is crucial for government food programs and that there 
might be an unintended consequence if we stopped requiring mandatory 
declaration of vitamin C. The comment said that the IOM recommended 
increasing vitamin C levels for women of reproductive age as a priority 
in the revision of food packages under the Special Supplemental 
Nutrition Program for Women, Infants, and Children (WIC), that vitamin 
C intake is important in reducing the risk of iron deficiency in women 
of child bearing age, and that the 2010 DGA emphasized vitamin C's 
importance in improving iron absorption. The comment also said that the 
WIC program has been successful in decreasing iron-deficiency anemia, 
and this may be, in part, because of nutrition education and the 
provision of easily identified vitamin C-rich foods, which aid in the 
absorption of iron. The comment said that WIC benefits for qualifying 
juices are issued monthly to 2.05 million pregnant and postpartum women 
who receive benefits for up to 144 fluid ounces of juice each month, 
and 4.58 million children ages 1 to 4 who receive benefits for 128 
fluid ounces of juice each month. The comment said that, to be 
authorized for WIC purchase, juices must contain 30 mg of vitamin C per 
100 mL of juice, which translates to 120 percent of vitamin C per eight 
ounce serving using the RDA for women. The comment said that consumers 
can identify WIC-authorized juices by reading the Nutrition Facts label 
to determine if the juice contributes 120 percent of vitamin C per 
serving. Thus, according to the comment, eliminating mandatory 
declaration of vitamin C on food labels removes the mechanism for WIC 
clients to readily identify WIC-approved juices while shopping. This 
may result in WIC clients forgoing this important benefit rather than 
risk potential product rejection and the associated embarrassment upon 
checkout.
    The comment added that, if we no longer require declaration of 
vitamin C content in the Nutrition Facts label, State agencies will 
have to review all potential eligible juices from multiple 
manufacturers to meet regulation each time the food list is updated, 
and this process would create an unnecessary administrative burden for 
both the WIC State agencies and manufacturers.
    (Response) We consider whether a vitamin or mineral is of public 
health significance to be the key factor in deciding when to require 
mandatory declaration in labeling. As we explained in the preamble to 
the proposed rule (79 FR 11879 at 11921), while vitamin C intakes are 
low, vitamin C deficiency is uncommon, so we no longer find vitamin C 
to be a nutrient of public health significance for the general U.S. 
population. Juice manufacturers who would like their products to be 
authorized for WIC purchase can declare vitamin C voluntarily on their 
product labels.
    All juices under the WIC authorization must meet the vitamin C 
minimum (at least 30 mg of vitamin C per 100 mL), either naturally or 
via fortification (Ref. 197). However, many eligible juices (e.g., 
pineapple, apple, or grape juice) have to be fortified with

[[Page 33890]]

vitamin C to be authorized by WIC; so, because vitamin C is added to 
those juices, the declaration of vitamin C would be mandatory on the 
label.
    As for the comment's statements regarding the rule's potential 
impact on WIC clients and the WIC program, such issues are outside the 
scope of this rulemaking.
    (Comment 365) One comment supported voluntary declaration of 
vitamins A and C, but said that, because these two nutrients are linked 
to the minimum nutrient contribution requirements for the nutrient 
content claim ``healthy'' and for health claims, we should make any 
changes to the nutrient content and health claim regulations at the 
same time when we finalize the rule.
    (Response) We decline to adopt the comment's suggestion. As we 
stated in the preamble to the proposed rule (79 FR 11879 at 11889), we 
plan to evaluate the final rule's impact on other FDA regulations and 
to address, as appropriate, the impact on other FDA regulations in 
future separate rulemakings. Issues related to nutrient content claims 
and health claims are outside the scope of this rulemaking (see part 
II.B.4).
3. Essential Vitamins and Minerals That Are Voluntary
    a. Vitamin D. Our preexisting regulations, at Sec.  
101.9(c)(8)(ii), provide for the voluntary declaration of vitamin D 
content on the Nutrition Facts label, unless vitamin D is added as a 
nutrient supplement or claims are made about it. In 1993, we determined 
that vitamin D was not of particular public health significance in the 
United States because the human requirement for vitamin D could be met 
with sufficient exposure to sunlight and consumption of milk and other 
foods that were fortified with vitamin D; as a result, deficiencies in 
this vitamin were very rare (58 FR 2079 at 2107). In the preamble to 
the proposed rule (79 FR 11879 at 11921), however, we described how 
comments responding to the 2007 ANPRM recommended vitamin D for 
mandatory declaration citing vitamin D inadequacy; the relationship of 
vitamin D to chronic disease risk (e.g., rheumatoid arthritis, multiple 
sclerosis, and cancers, such as prostate, breast, lung, colon, and 
colorectal cancers); and the 2005 DGA, which identified vitamin D as a 
nutrient of concern for certain subpopulations (e.g., older adults, 
people with dark skin, and those exposed to insufficient ultraviolet 
band radiation). We also mentioned that the IOM set age and gender 
specific DRIs (EAR and RDA) for vitamin D at a level that would achieve 
and maintain serum 25-hydroxy vitamin D (25(OH)D) concentrations above 
a defined level (40 to 50 nanomoles per liter (nmol)/L) to maintain 
bone health and how, in 2008, we authorized a health claim for calcium 
and vitamin D intake and reduced risk of osteoporosis (Sec.  101.72), 
signifying vitamin D's critical role in the risk reduction of this 
chronic disease.
    Additionally, the preamble to the proposed rule (79 FR 11879 at 
11921) discussed how serum concentration of 25(OH)D is widely 
considered as a biomarker of total vitamin D nutritional status and is 
recommended to be used for assessing vitamin D total exposure from all 
sources, including conventional foods, dietary supplements, synthesis 
from sun, and conversion of vitamin D from adipose stores in the liver. 
We explained that our analysis of NHANES 2003-2006 data showed that 
about 18 percent of the U.S. population 4 years and older (excluding 
pregnant and lactating women) have serum 25(OH)D levels below the 40 
nmol/L (a level set by IOM as equivalent to EAR), which indicates an 
increased risk of inadequate vitamin D exposure, but that this analysis 
might underestimate the prevalence of low serum vitamin D levels in the 
U.S. population (id.). Analysis of NHANES 2005-2008 dietary data showed 
that, about 94 percent of the U.S. population have usual vitamin D 
intakes below the EAR from conventional foods only and 62 percent have 
intakes below the EAR from conventional foods and supplements (table 
1). The IOM set the DRIs (e.g., EAR) assuming minimal sun exposure 
(Ref. 38).
    We also noted that approximately 24 percent of the U.S. population 
ages 4 years and older have serum 25(OH)D concentrations between 30 and 
50 nmol/L, levels that indicate risk for inadequacy according to the 
IOM and CDC (79 FR 11879 at 11921). Approximately 32 percent of the 
U.S. population has serum 25(OH)D levels below 50 nmol/L (a level set 
by IOM as equivalent to RDA and associated with optimal benefit for 
nearly all the population) (id.). We stated that about 8 percent have 
serum 25(OH)D levels below IOM's cutoff of 30 nmol/L and may be at 
increased risk of vitamin D deficiency. Vitamin D deficiency results in 
inadequate bone mineralization or demineralization of the skeleton 
including rickets, osteomalacia, and osteoporosis. The 2010 DGA, too, 
highlighted vitamin D as a nutrient of concern for the U.S. population, 
in general, rather than for specific population groups alone.
    Thus, given the benefits of adequate vitamin D intakes on bone 
health, data indicating inadequate intakes, poor vitamin D status, and 
high prevalence of osteoporosis and osteopenia among the general U.S. 
population, we tentatively concluded that vitamin D is a nutrient of 
``public health significance,'' and so mandatory declaration of vitamin 
D is necessary to assist consumers in maintaining healthy dietary 
practices. Therefore, consistent with the factors we consider for 
mandatory declaration of non-statutory nutrients, we proposed to amend 
Sec.  101.9(c)(8)(ii) to require the mandatory declaration of vitamin D 
on the Nutrition Facts label, and we invited comment on whether there 
is an appropriate alternative analysis to the application of the 
factors regarding the mandatory declaration of vitamin D.
    (Comment 366) Most comments supported the mandatory declaration of 
vitamin D on the Nutrition Facts label, but did not explain the reasons 
for their support.
    One comment supported the mandatory declaration of vitamin D 
declaration on the label, but said that a food or beverage that is not 
a significant source of vitamin D should declare that fact as part of 
the ``Not a significant source of (listing the vitamins or minerals 
omitted)'' statement included at the bottom of the table of nutrient 
values.
    (Response) We agree with the comment. Under our preexisting 
regulations at Sec.  101.9(c)(8)(iii), if any mandatory essential 
vitamin or mineral is present in amounts less than 2 percent of the 
RDI, label declaration of the nutrient(s) is not required if the 
statement ``Not a significant source of . . . . (Listing the amount of 
vitamins and minerals)'' is placed at the bottom of the table of 
nutrient values. No changes to the rule, however, are necessary as a 
result of this comment, and the final rule requires the mandatory 
declaration of vitamin D on the Nutrition Facts label.
    (Comment 367) Some comments noted that vitamin D is used in 
fortification and that dietary supplements may be in various forms such 
as vitamin D2 (ergocalciferol) or vitamin D3 
(cholecalciferol). The comments said that the form of vitamin D added 
to foods may be important to vegetarians because the vitamin 
D3 commonly used in dietary supplements and in fortified 
foods is derived from lanolin from sheep's wool and is not considered 
to be vegan. Some comments said that foods and dietary supplements 
might list vitamin D without specifying the form. Thus, the comments 
said that requiring manufacturers to specify the

[[Page 33891]]

form of vitamin D would be helpful to vegans and to those who prefer to 
use a specific form of vitamin D.
    Another comment asked whether we consider the main two forms of 
vitamin D (D2 and D3) to be bioequivalent. The 
comment said it would be helpful if we could either define them as 
bioequivalent or list a potency conversion factor if we consider one 
form to be more bioactive than the other.
    (Response) We decline to revise the rule as suggested by the 
comments. We note that our GRAS affirmation regulation (Sec.  184.1950 
(21 CFR 184.1950)) includes both D2 and D3 and 
their resins. The food additive regulations are specific to one form or 
another (and even more specific, to the crystalline forms or vitamin 
D2 baker's yeast) because that is what the petitioner 
requested. With respect to the Nutrition Facts label, only vitamin D 
can be used on the food labels (see Sec.  101.9(c)(8)(iv)), but the 
specific form that is added to a food (e.g., ergocalciferol) must be 
listed in the ingredient list (Sec.  101.4). People who are interested 
in knowing the forms of vitamin D in the food should check the 
ingredient list.
    As for dietary supplements, under the Supplement Facts label 
requirements at Sec.  101.36(d), the source ingredient may be 
identified within the nutrition label in parenthesis immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the word ``as'' or ``from.'' When a source ingredient is 
not identified within the nutrition label, it must be listed in an 
ingredient statement in accordance with Sec.  101.4(g). However, when a 
source ingredient is identified in the nutrition label, it will not be 
listed again in the ingredient statement.
    (Comment 368) Some comments objected to the mandatory declaration 
of vitamin D on the label, although most comments did not explain why 
they opposed mandatory declaration.
    Other comments objecting to the mandatory declaration of vitamin D 
said there are not very many food sources that contain vitamin D, and 
they would prefer retaining other vitamins on the Nutrition Facts label 
instead. The comments noted that most vitamin D is produced by the body 
with the aid of exposure to the sun.
    Other comments suggested not permitting food companies to use 
statements such as ``fortified with Vitamin D'' or ``good source of 
Vitamin D'' because, the comments said, vitamin D is a hormone 
synthesized by the action of sunlight on skin, and so, for this reason 
alone, it does not belong on the food label.
    One comment suggested vitamin D fortification should be viewed as 
hormone replacement therapy and that it raises questions about 
efficacy, dose, and side effects that should be asked about all such 
therapies. The comment said it would be misleading, and possibly 
harmful, to the public to add this hormone to food and to promote it as 
something that promotes better health.
    (Response) We agree that vitamin D is synthesized by the body via 
sunlight exposure. However, the IOM set the DRIs for vitamin D based on 
minimal sun exposure because sun exposure is a risk factor for skin 
cancer (Ref. 38). Considering the factors for mandatory and voluntary 
declaration of vitamins and minerals, we determined that vitamin D is a 
nutrient of public health significance based on its contribution to 
bone health and because our analysis indicates that intake and status 
of vitamin D is inadequate in the U.S. population. Therefore, vitamin D 
met our factors for mandatory declaration, and its inclusion on the 
label will assist consumers in maintaining healthy dietary practices.
    As for the comment regarding vitamin D fortification and hormone 
replacement therapy, vitamin D is a vitamin (Ref. 198), and its 
rational addition to foods is allowed under our current food additive 
(Sec.  172.380) and GRAS (Sec.  184.1950) regulations. The use of 
vitamin D as a food additive is not considered as hormone replacement 
therapy. Under our preexisting regulations, vitamin D can be added in 
specific amounts to selected foods such as breakfast cereals, grain 
products and pastas, fluid milks and milk products, and calcium-
fortified juices.
    (Comment 369) Some comments objected to the mandatory declaration 
of vitamin D on the Nutrition Facts label because, according to the 
comments, mandatory declaration of vitamin D will increase vitamin D 
fortification of foods because vitamin D is found in few foods and 
because consumers cannot expect to see a significant vitamin D 
contribution on the vast majority of food labels. The comments said 
that if we require the declaration of vitamin D on the Nutrition Facts 
label, more food manufacturers would make their food sound more 
nutritious by fortifying with vitamin D and promoting that on the 
label. Some comments said that a similar outcome occurred with vitamin 
C and calcium; other comments said that vitamin D can easily reach 
toxic levels in the diet and that most consumers do not realize this.
    (Response) We disagree with the comments. To ensure that vitamin D 
is not added to the U.S. food supply at levels that could raise safety 
concerns, we affirmed vitamin D as GRAS with specific limitations as 
listed in Sec.  184.1950. Under Sec.  184.1(b)(2), an ingredient 
affirmed as GRAS with specific limitations may be used in food only 
within such limitations, including the category of food, functional use 
of the ingredient, and level of use. Any addition of vitamin D to food 
beyond those limitations set out in Sec.  184.1950 requires either a 
food additive regulation or an amendment of Sec.  184.1950. A 
manufacturer would have to submit a petition to amend our regulations. 
Several food additive petitions for vitamin D have been submitted to 
FDA, resulting in food additive regulations. (see Sec. Sec.  172.379, 
172.380, and 172.381.)
    Furthermore, while vitamin D can be produced in the body via 
sunlight, and there are a number of foods that can currently be 
fortified with vitamin D, total usual intakes for vitamin D from food 
and dietary supplements are below the EAR for the general U.S. 
population. The total usual intakes do not exceed the UL for any age 
group at the 90th percentile (Ref. 199). The percentage of the 
population that consumes vitamin D above the UL is very low (0.1 to 0.4 
percent). In addition, the prevalence of high serum 25-OH-D 
concentration (greater than 125 nmol/L) for the U.S. population aged 1 
year and older is 0.9 percent (NHANES 2003-2006) (Ref. 190). The IOM 
committee indicated that serum 25-OH-D concentration over 125 nmol/L 
may be reason for concern (Ref. 200). Thus, while some comments said 
that manufacturers would increase fortification of foods, we are not 
aware of evidence to support this statement. We do note that, in the 
preamble to the proposed rule (79 FR 11879 at 11923), we invited 
comment on whether the mandatory declaration of vitamins and minerals 
somehow impacts food fortification practices, and we did not receive 
any data to support an impact. We also do not have any data to 
determine whether there was an increase in vitamin C or calcium since 
the time they were first required to be listed on the label. However, 
we know that both vitamin C and calcium intake are not above the UL set 
by IOM (Ref. 199). We intend to continue monitoring the nutrients, 
including vitamin D, on the Nutrition Facts label, their intake, and 
status of the U.S. population (both deficiency and excess) through the 
national survey databases. We also intend to continue to monitor the

[[Page 33892]]

marketplace to determine if inappropriate fortification is occurring. 
If we find that there is an inappropriate fortification of foods with 
vitamin D or any other nutrients, we will take steps to help ensure 
that fortification does not result in the imbalance of essential 
nutrients in the diet of the U.S. population.
    (Comment 370) One comment objected to mandatory declaration of 
vitamin D because, according to the comment, vitamin D does not occur 
naturally in most foods and because other FDA regulations would not 
allow manufacturers to make a significant impact on the dietary intake 
of vitamin D.
    (Response) Considering the factors for mandatory and voluntary 
declaration of vitamins and minerals, we determined that vitamin D is a 
nutrient of public health significance based on its contribution to 
bone health and because our analysis indicates that intake and status 
of vitamin D is inadequate in the U.S. population. Therefore, we 
consider vitamin D to be a nutrient of public health significance and 
include vitamin D in the list of nutrients in Sec.  101.9(c)(8)(ii) for 
which a quantitative amount by weight and percent of the RDI are 
required in nutrition labeling to assist the consumers in maintaining 
healthy dietary practices.
    We note that, under our food additive and GRAS regulations (Sec.  
172.380 and Sec.  184.1950 respectively), vitamin D can be added in 
specific amounts to various foods such as breakfast cereals, grain 
products and pastas, fluid milks and milk products, and calcium-
fortified juices. In addition vitamin D can be obtained through dietary 
sources, such as fish (e.g., salmon, rockfish, and tuna) and shellfish, 
which are the primary natural food sources of vitamin D.
    (Comment 371) One comment said the lack of compelling research has 
permitted vitamin D to become ``trendy,'' such that vitamin D is 
advertised on boxes of fortified cereals, has its own pro-supplement 
advocacy group, and generates millions of dollars in dietary supplement 
sales annually. The comment suggested that, in the absence of stronger 
evidence for benefit from fortification and some evidence from possible 
adverse consequences, we should not contribute to further 
commercialization of ``this misnamed hormone'' by declaring vitamin D 
on food labels.
    (Response) The mandatory declaration of vitamin D on the Nutrition 
Facts label is not intended to promote or encourage excess 
fortification of foods with vitamin D. Given the benefits of adequate 
vitamin D intakes on bone health and calcium absorption, data 
indicating inadequate intakes, poor vitamin D status, and the high 
prevalence of osteoporosis and osteopenia (Ref. 201-202) among the 
general U.S. population, we concluded that this nutrient is a nutrient 
of public health significance and met the factors for mandatory 
declaration on the Nutrition Facts label. Furthermore, the 2010 DGA 
recommends increasing the amount and variety of seafood in place of 
some meat and poultry (Ref. 30). Fish/seafood is the primary source of 
naturally occurring vitamin D (Ref. 30). Data show that fish/seafood 
only provides 9 percent of the total vitamin D intake in the United 
States. Therefore, we conclude that mandatory declaration of vitamin D 
on the label would allow consumers to understand the relative 
significance of the contribution of vitamin D from natural food 
sources, in addition to fortified foods, in the context of the total 
daily diet and also is necessary to assist consumers in maintaining 
healthy dietary practices.
    Also, as we stated in our response to comment 368, vitamin D is a 
vitamin and its rational addition to foods is allowed under our current 
food additive (Sec.  172.380) and GRAS (Sec.  184.1950) regulations.
    (Comment 372) One comment stated that, beyond prevention of 
rickets, the importance of vitamin D and the optimum serum levels or 
dietary intake for chronic disease risk are hotly debated subjects, and 
it is premature to focus on this nutrient as being of particular 
concern. The comment said the U.S. Preventive Services Task Force 
concluded that the evidence is insufficient to determine how vitamin D 
supplementation (and, therefore, fortification) affects fracture 
incidence. The comment also noted that data from the Women's Health 
Initiative are consistent with largely inconclusive findings about 
hormone vitamin D supplements and bone health. The comment said that 
the IOM does not consider deficiency of vitamin D to be a serious 
problem in the United States, except among certain population groups. 
Instead, according to the comment, because of widespread fortification 
and supplementation, the IOM is concerned about the possibility of 
adverse consequences from over-consumption through supplementation or 
fortification.
    (Response) We disagree with the comment that the association of 
vitamin D to bone health is inconclusive. The consensus report by IOM 
set the dietary reference intake for vitamin D based on its role in 
bone health and calcium absorption and uptake by bones (Ref. 38). The 
IOM set age and gender specific DRIs (EAR and RDA) for vitamin D to 
maintain bone health (Ref. 38). Vitamin D deficiency results in 
inadequate bone mineralization or demineralization of the skeleton 
including rickets, osteomalacia, and osteoporosis (Ref. 203). In 
addition, in 2008, we authorized a health claim for calcium and vitamin 
D intake and reduced risk of osteoporosis (Sec.  101.72), signifying 
vitamin D's critical role in the risk reduction of this chronic 
disease. In view of the benefits of adequate vitamin D intakes on bone 
health, data indicating inadequate intakes, poor vitamin D status, and 
high prevalence of osteoporosis and osteopenia among the general U.S. 
population, we conclude that this nutrient is a nutrient of public 
health significance and meets our factors for mandatory declaration on 
the Nutrition Facts label.
    As for the comment's claims that fortification will result in 
adverse consequences, while vitamin D can be produced in the body via 
sunlight and there are a number of foods that can currently be 
fortified with vitamin D, current total usual intakes for vitamin D 
from food and dietary supplements do not exceed the UL for any age 
group at the 90th percentile (Ref. 199). The percentage of the 
population that consumes total vitamin D (food and supplement) above 
the UL is low (0.1 to 0.4 percent). As for fortification, we reiterate 
that our food additive and GRAS regulations create a regulatory 
structure that does not allow for unilateral fortification of food; the 
addition of vitamin D to food beyond those limitations set out in Sec.  
184.1950 requires either a food additive regulation or an amendment of 
Sec.  184.1950. The manufacturer has to formally petition FDA to amend 
the regulation.
    (Comment 373) One comment said that there is inconsistency in 
vitamin D assays, and individuals may be told that they are deficient 
when they are not.
    (Response) We recognize that there may be inconsistencies in serum 
vitamin D assays from various laboratories and that this inconsistency 
may cause variations in an individual's serum vitamin D analysis. 
However, for purposes of determining the nutrients of public health 
significance, our data indicating poor vitamin D status (through serum 
vitamin D analysis) were based on NHANES data. The serum data were 
analyzed by the same valid vitamin D method for the survey period (Ref. 
190).
    (Comment 374) One comment opposed the mandatory declaration of 
vitamin D because, according to the

[[Page 33893]]

comment, testing for vitamin D is very challenging and expensive. Other 
comments supported mandatory declaration of vitamin D, but said that 
limited data is available on the vitamin D content in many foods and 
ingredients, so manufacturers will need time and resources to obtain 
data for purposes of revising their Nutrition Facts labels. Some 
comments said that an analysis of the 7,189 foods in the USDA National 
Nutrient Database reveals that approximately one-third of those foods 
are missing values for vitamin D and that this does not take into 
account the thousands of other ingredients that are also missing 
vitamin D values.
    (Response) We acknowledge that performing an accurate vitamin D 
analysis requires some expertise, but there are commercial laboratories 
with expertise in the analysis. Having quality control food matrix 
material certified for vitamin D is important, and the National 
Institute of Standards and Technology (NIST) has worked and continues 
to work to come up with better standard reference material for quality 
control of vitamin D analysis. Under our preexisting regulations, 
declaration of vitamin D was mandatory when vitamin D was added as a 
nutrient supplement or claims are made about it on the label or 
labeling. Therefore, manufacturers who have added vitamin D to their 
products have already been using methods for testing and determining 
vitamin D content of foods, so, with respect to those manufacturers, 
additional time and resources to conduct analyses for vitamin D may not 
be necessary.
    As for other products whose manufacturers have not added vitamin D 
to the food, there is adequate methodology for determining vitamin D in 
the foods. However, an analysis may not be needed for vitamin D where 
reliable databases or scientific knowledge establish that a nutrient is 
not present in the food. For example, there might not be a need to 
analyze for vitamin D in foods that are not natural sources of vitamin 
D, and to which our regulations, at Sec.  172.380 and Sec.  184.1950, 
do not allow vitamin D to be added. Therefore, regarding the analytical 
burden, if a manufacturer has adequate and reliable reasons to believe 
that vitamin D is not present, there is no need to analyze for it: It 
can be declared as zero or the manufacturer can state at the bottom of 
the nutrition label ``not a significance source of vitamin D.'' Costs 
associated with nutrition labeling will be contained by not analyzing 
for a nutrient where there is no reasonable expectation that the 
nutrient occurs in the food.
    We also agree that USDA nutrient databases may be missing vitamin D 
values for nearly one-third of the products in those databases. Vitamin 
D occurs naturally in a limited number of foods, such as mushrooms 
exposed to UV light, egg yolks (often the feed is supplemented with 
D3 or 25(OH)D3), and meats or other animal 
products. There is usually a minimal amount of vitamin D in milk and 
cheese unless the food is fortified. Many foods that would be reporting 
vitamin D on labels greater than zero are fortified (with the exception 
of foods listed previously or foods that contain them) and already 
would have declarations. The USDA national nutrient database (standard 
reference (SR)) provides a complete set of all nutrients (including 
vitamin D) to use with NHANES database (Ref. 4). However, vitamin D may 
not be always required to be filled in the SR. USDA is working with 
various industries to determine the vitamin D values on meats and eggs, 
and it plans to have these data available in future SR releases. We 
intend to work with USDA to determine ways to have more values for 
vitamin D on the SR databases.
    b. Potassium. Under our preexisting regulations, at Sec.  
101.9(c)(5), the declaration of potassium content is voluntary, except 
when a claim is made about it. In the preamble to the proposed rule (79 
FR 11879 at 11922), we discussed how the scientific evidence regarding 
potassium had changed, such that we recognized potassium's importance 
in the risk reduction of certain chronic diseases. We also noted that 
the 2010 DGA concluded that potassium is a nutrient of concern for the 
general U.S. population. Given the benefits of adequate potassium 
intake in lowering blood pressure, reflected in IOM's DRIs, and data 
indicating low likelihood of potassium adequacy and high prevalence of 
hypertension among the general population, we tentatively concluded 
that potassium is a nutrient of public health significance for the 
general U.S. population and proposed to amend Sec.  101.9(c)(8)(ii) to 
require the mandatory declaration of potassium.
    (Comment 375) Almost all comments supported the mandatory 
declaration of potassium on the Nutrition Facts label.
    Some comments, however, supported mandatory declaration of 
potassium for different reasons. Many comments would require mandatory 
declaration of potassium because potassium is important for dialysis 
and renal patients.
    (Response) While mandatory labeling of potassium may help patients 
with chronic kidney disease, this was not a factor we considered when 
we proposed the mandatory declaration of potassium on the Nutrition 
Facts label. As we stated in the preamble to the proposed rule (79 FR 
11879 at 11890) and maintain in this final rule, we consider mandatory 
declaration appropriate for these types of nutrients when there is 
public health significance and a quantitative intake recommendation 
that can be used for setting a DV (DRV or RDI), although we also have 
considered mandatory declaration based, in part, on evidence 
highlighting the role of a nutrient in a specific relationship to 
chronic disease risk. For potassium, we concluded that potassium is a 
nutrient of public health significance for the general U.S. population 
and its declaration is necessary to assist consumers in maintaining 
healthy dietary practices. Therefore, the final rule, at Sec.  
101.9(c)(8)(ii), requires the mandatory declaration of potassium.
    (Comment 376) One comment stated that food manufacturers may start 
to fortify their foods with potassium in an attempt to offset the 
sodium content of a food product. The comment said we should monitor 
how food manufacturers respond to this new requirement. The comment 
also said that, as part of an overall consumer education campaign, we 
should encourage consumers to obtain potassium through a diet high in 
fruits and vegetables and recommend amounts of low-fat/fat-free dairy 
products rather than obtain potassium from dietary supplements or 
potassium fortified foods.
    (Response) The comment did not provide any evidence to suggest that 
mandatory declaration of potassium on the Nutrition Facts label will 
increase fortification of foods; consequently, we are unable to 
determine whether such fortification is likely or the extent to which 
it might occur. The final rule requires mandatory labeling of potassium 
and other essential vitamins and minerals on the Nutrition Facts label 
to assist consumers in maintaining health dietary practices.
    With respect to fortification, we note that we published a policy 
statement on the rational addition of nutrients to foods (Sec.  
104.20). We urge manufacturers, if they elect to add nutrients to a 
food, to follow the guidelines stated in the fortification policy for 
rational addition of nutrient to foods to preserve a balance of 
nutrients in the diet of the U.S. population. We intend to continue 
assessing the nutritional status

[[Page 33894]]

(inadequacy and excess) of potassium consumption, among other 
nutrients, in the general healthy U.S. population after the final 
rule's compliance dates. We also intend to monitor the market to assess 
fortification practices in response to the revised Nutrition Facts 
label. With respect to educational activities, we intend to work with 
other Federal Agencies and organizations to emphasize the changes to 
the Nutrition Facts label (see part II.B.1). However, consistent with 
our mission, our educational activities will focus on the Nutrition 
Facts label rather than fresh produce (i.e., fresh fruits and 
vegetables). The reason for the mandatory declaration of potassium and 
other essential vitamins and minerals on the Nutrition Facts label is 
to assist consumers in maintaining health dietary practices rather than 
to recommend consumption of specific foods or products.
    (Comment 377) Several comments suggested that potassium should 
appear on the Nutrition Facts label after sodium. The comments said 
that there is an association between potassium intake and reduced blood 
pressure in certain individuals, so potassium should appear below 
sodium. The comments said this placement will help consumers understand 
that these two nutrients and their respective amounts in a food are 
related.
    (Response) We decline to revise the rule as suggested by the 
comment. We stated in the preamble to the 1993 final rule (58 FR 2079 
at 2106) that, for essential vitamins and minerals, the decisions about 
mandatory or voluntary declarations were based on public health 
concerns relative to inadequate dietary intakes as well as the possible 
association between several of these nutrients and the risk of chronic 
disease. The main difference between the DRV and RDI nutrients was/is 
that DRV nutrients are: (1) Nutrients to limit (e.g., sat fat, 
cholesterol, and trans fat); or (2) based on a specific caloric intake 
(e.g., fat, carbohydrate, protein, and dietary fiber). However, RDIs 
have been and are being proposed based on age specific RDAs (and now 
AIs). In 1993, there were not age specific RDAs for potassium. 
Currently, there are age specific AIs for potassium that are based on 
chronic disease risk. Thus, because potassium is now being assigned an 
RDI, rather than a DRV, we are moving it down in the label with the 
other essential vitamins and minerals that have RDIs. Furthermore, the 
comment did not provide any evidence to support the claim that having 
sodium and potassium near each other on the label would help consumers 
understand that these two nutrients and their respective amounts in a 
food are related. Consequently, we cannot evaluate the comment's claim 
regarding placement and consumer understanding.
    (Comment 378) One comment said the mandatory declaration of 
potassium on the Nutrition Facts label will pose challenges for very 
small packages (because another line in the label would be needed). 
Additionally, some comments noted that beverages, such as plain 
unsweetened coffee and tea, are exempt from nutrition labeling (under 
Sec.  101.9(j)(4)) because they contain insignificant amounts of all 
nutrients required to be declared on the Nutrition Facts label. 
According to the comments, plain coffee and tea may have low, but 
declarable, levels of potassium, so the mandatory declaration of 
potassium would cause plain coffee and tea to lose their current 
exemption from nutrition labeling. The comments said we should examine 
Sec.  101.9(j)(4) and make any necessary adjustments. The comment 
suggested that, when levels of potassium are less than 5 percent of the 
DV and on small packs with limited space, declaration of potassium 
would be voluntary.
    (Response) We recognize the discrepancy between the exemption under 
Sec.  101.9(j)(4) and the labeling that would be required for products 
that have significant levels of nutrients. In the proposed rule, we did 
not ask for comments specifically about the continued applicability of 
this exemption from nutrition labeling provisions in light of what 
would be a changing level of nutrients that will be considered 
``insignificant'' as a result of this rule and 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'' (Serving Size final 
rule) published elsewhere in this issue of the Federal Register. 
Therefore, we intend to consider the future applicability of the 
exemption with respect to mandatory nutrition labeling on products that 
would have been exempt under Sec.  101.9(j)(4) prior to the effective 
date of this rule and the Serving Size final rule. After the effective 
date of this final rule, we intend to consider the exercise of 
enforcement discretion with respect to the use of mandatory nutrition 
labeling on such products that would have been exempt under Sec.  
101.9(j)(4).
    We understand that providing Nutrition Facts labels on packages 
with limited space may be challenging for manufacturers; thus, our 
preexisting regulation, at Sec.  101.9(j)(13), provides for special 
labeling provisions for packages with limited space.
    (Comment 379) Several comments said that manufacturers would need 
more than 2 years to gather nutrition data for potassium and to comply 
with the mandatory declaration of potassium on the Nutrition Facts 
label. Some comments said that the data are often lacking in many 
company and public databases, so time will be needed to collect the 
data.
    (Response) We disagree, in part, with the comments. There are 
public databases, such as USDA Nutrient Data Database, that can provide 
information regarding the potassium content of foods. For example, in 
the USDA Nutrient Data Database for current Standard Reference (SR 27), 
nearly 8,200 of the approximately 8,600 foods in the database, or 
approximately 95 percent of the foods, have potassium values.
    Additionally, the operations involved and equipment required for 
the methods for potassium determination are standard in analytical 
laboratories. Nevertheless, we have revised the compliance dates for 
the final rule (see part III).
    (Comment 380) One comment asked us to clarify the use of potassium 
in dietary supplement products. The comment said that many dietary 
supplement companies have been limiting potassium in their formulas to 
99 mg per serving and that 99 mg of potassium is not an appreciable 
fraction of the current (3,500 mg) or proposed (4,700 mg) reference 
daily intake for potassium. The comment said that this limitation is 
based on a position we took in 1975 that any capsule or coated tablet 
of a potassium salt intended for oral ingestion (without prior dilution 
with an adequate volume of liquid to preclude gastrointestinal injury) 
should carry a warning statement regarding small-bowel lesions related 
to the use of oral drug products containing 100 mg or more potassium. 
The comment said we have not established an upper limit for potassium 
in dietary supplement formulations, so the comment asked us to clarify 
how potassium might be used in solid oral dietary supplements.
    (Response) We have not established any limits on potency or 
recommended uses for dietary supplements that contain potassium salts. 
Under the FD&C Act, a manufacturer or distributor is responsible for 
ensuring that the dietary supplements are safe and meet other 
applicable requirements of the FD&C Act and its implementing

[[Page 33895]]

regulations. The safety of or need for a warning statement on dietary 
supplements with certain potencies of potassium are outside the scope 
of this rulemaking.
    (Comment 381) Several comments did not support mandatory 
declaration of potassium on the Nutrition Facts label. Some comments 
said that consumers do not know what potassium is, so the declaration 
of potassium on the label would not be helpful. The comments said it 
would be better to omit potassium from the label so that the Nutrition 
Facts label is less cluttered, can be better organized, and be less 
likely to overwhelm the consumer with information.
    (Response) We decline to revise the rule as suggested by the 
comments. We consider whether a vitamin or mineral is of public health 
significance to be the key factor in deciding when to require mandatory 
declaration on the Nutrition Facts label. Available quantitative 
evidence suggests that the declaration of nutrients of public health 
significance including vitamins and minerals can help consumers 
maintain healthy dietary practices. We consider potassium to be a 
nutrient of public health significance, and the final rule includes 
potassium in the list of nutrients in Sec.  101.9(c)(8)(ii) for which a 
quantitative amount by weight and percent of the RDI are required in 
nutrition labeling to assist the consumers in maintaining healthy 
dietary practices.
    As for the comment's mention of clutter, we consider clutter as a 
matter of graphic design, but possible clutter is not our basis for 
omitting or removing a nutrient of public health significance from the 
Nutrition Facts label.
    (Comment 382) One comment suggested that potassium should be a 
qualifying nutrient for ``Healthy'' claim criteria.
    (Response) Issues regarding labeling outside the Nutrition Facts 
and Supplement Facts labels, such as nutrient content claims, are 
outside the scope of this rulemaking (see part II.B.4).
4. Other Essential Vitamins and Minerals
    Under our preexisting regulations, at Sec.  101.9, several other 
essential vitamins and minerals, in addition to vitamin D and 
potassium, may be declared voluntarily on the Nutrition Facts label, 
i.e., vitamin E, vitamin K, vitamin B6, vitamin 
B12, thiamin, riboflavin, niacin, folate, biotin, 
pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, 
copper, manganese, chromium, molybdenum, and chloride. In the preamble 
to the proposed rule (79 FR 11879 at 11922 through 11923), we explained 
how we had considered comments to the 2007 ANPRM recommending mandatory 
declaration of vitamin E, folate, vitamin B12, magnesium, 
and phosphorus and how, based on our analysis of available data and 
using the factors we consider for mandatory and voluntary declaration 
of non-statutory nutrients, we did not propose any changes to the 
provisions for voluntary declaration of vitamin E, vitamin K, vitamin 
B6, vitamin B12, thiamin, riboflavin, niacin, 
folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, 
selenium, copper, manganese, chromium, molybdenum, and chloride.
    Several comments addressed the voluntary declaration of specific 
vitamins or nutrients, and we discuss those comments in this section.
    a. Phosphorus.
    (Comment 383) Most comments asked that we amend our regulations so 
that declaration of phosphorus is mandatory rather than voluntary.
    Most comments said that many people have kidney problems, and 
patients under dialysis have to watch their intake of phosphorous in 
addition to potassium and calcium. The comments said that it can be 
very difficult for individuals who are on a low potassium and 
phosphorous diet to calculate their daily intake. The comments said 
that dialysis patients are educated about foods high in phosphorus, but 
it is difficult to manage one's phosphorus intake when phosphorus is 
``in almost everything.'' The comments said that many dialysis patients 
have neither the motivation nor the resources to be diligent about 
monitoring phosphorus in their diet. One comment stated that phosphorus 
can occur naturally in various forms of food, or as a component in 
commonly used food additives, and that the processing of meat and fish 
products increases the phosphorus content above the naturally occurring 
levels in the protein itself. The comment said that the addition of 
phosphorous to the Nutrition Facts label will help kidney patients to 
be aware of the high amount of phosphorus in foods. The comment noted 
that, in determining mandatory or voluntary labeling, FDA considers 
whether there is evidence of a relationship between the nutrient and a 
chronic disease, health-related condition, or health-related 
physiological endpoint and whether there is evidence of a problem 
related to health in the general U.S population. Thus, the comment 
said, using these considerations, we should revise the rule to require 
the mandatory declaration of phosphorus on the Nutrition Facts label.
    (Response) While a mandatory phosphorous declaration may aid 
patients with chronic kidney disease and dialysis patients, the 
Nutrition Facts label is not targeted to individuals with a particular 
acute or chronic disease (see part II.B.2). The information on the 
label is meant for the general healthy U.S. population. For determining 
the nutrients of public health significance, we considered the factors 
that were discussed in the proposed rule and determined that 
phosphorous intakes are generally adequate and not of public health 
significance in the general, healthy U.S. population (Ref. 204). 
Furthermore, total intakes (food and supplement) among the general U.S. 
population were not found to be above the UL (Ref. 199). Based on these 
factors, we determined that phosphorous is considered a voluntary 
nutrient for the general healthy U.S. population, and are not making 
changes to the voluntary declaration of phosphorus in response to this 
comment. Therefore, manufacturers can declare phosphorus on the 
Nutrition Facts label voluntarily. However, if phosphorous is added as 
a nutrient supplement or claims are made about it on the label or in 
labeling of foods, then it must be declared on the label. All 
ingredients, including phosphate compounds, must be declared in the 
ingredient list on the label.
    b. Magnesium.
    (Comment 384) Several comments would revise the rule so that 
declaration of magnesium on the Nutrition Facts label would be 
mandatory instead of voluntary. Several comments stated that magnesium 
is needed for dialysis patients. One comment said that, instead of 
paying too much emphasis on calcium for adults, we should pay more 
attention to magnesium because, according to the comment, nearly 90 
percent of dialysis patients are deficient in magnesium.
    (Response) We decline to revise the rule as suggested by the 
comments. As we stated in part II.B.2, the Nutrition Facts label is not 
targeted to individuals who have a specific acute or chronic disease.
    (Comment 385) Some comments said that magnesium is an essential 
mineral and necessary for maintaining more than 300 essential metabolic 
reactions in the human body. One comment said that magnesium interacts 
with calcium and potassium and foods and that dietary supplements are 
frequently enriched with calcium. The comment

[[Page 33896]]

said that magnesium deficiency in the face of a normal calcium intake 
can lead to soft tissue calcification in animals (Refs. 205-206). The 
comment said that the most prominent feature of magnesium deficiency is 
the calcification predominantly of arteries (Refs. 207-209) and that 
magnesium inhibits the release of calcium ion from the sarcoplasmic 
reticulum, blocks the influx of calcium ion into the cell by 
inactivating the calcium channels in the cell membrane, and competes 
with calcium ions at binding sites on troponin C and myosin, thereby 
inhibiting the ability of calcium ions to stimulate myocardial tension 
(Refs. 210-212). The comment noted that magnesium, a calcium 
antagonist, substitutes itself for the calcium ions on hydroxyapatite, 
producing more soluble phosphate salts and thus inhibiting bone 
formation and perhaps aortic valve stenosis (Ref. 213).
    One comment stated that the absorption of calcium and magnesium may 
be altered depending upon the levels and ratio between them. The 
comment said that emerging evidence indicates that it may be better to 
optimize one's intake of calcium and magnesium rather than 
supplementing with either mineral alone. The comment said that the 
mandatory declaration of magnesium on the Nutrition Facts label will 
help consumers avoid an imbalance of calcium and magnesium by 
highlighting to the consumer how inadequate his or her magnesium intake 
is in relation to the calcium content of packaged foods (which the 
comment said are frequently supplemented with calcium). The comment 
also stated that the IOM has said that ``magnesium is necessary for 
sodium, potassium-ATPase activity, which is responsible for active 
transport of potassium'' (Ref. 214) and that magnesium regulates the 
outward movement of potassium in myocardial cells (Ref. 215). The 
comment further stated that magnesium inadequacy has a variety of other 
adverse health effects and that dietary magnesium intake was found to 
be inversely associated with mortality risk in individuals at high risk 
of cardiovascular disease (Ref. 216). In addition, the comment said, a 
higher dietary magnesium intake is associated with lower fasting 
glucose and insulin (Ref. 217), and dietary magnesium intake is 
inversely associated with plasma concentrations of the inflammation 
indicator C-reactive protein (CRP).
    One comment stated that national survey data indicate that dietary 
magnesium intake is inadequate in the general U.S. population, 
particularly among adolescent girls, adult women, and the elderly. One 
comment stated that the impact of adding another item to the label is 
minimal compared to overall costs. The comment said that, given that 
the costs are inevitable, it is better to add all mandatory 
declarations to the label at one time. In other words, if a 
manufacturer is already changing the label for potassium for example, 
there is a minimal incremental cost to add magnesium at the same time.
    One comment noted that, from a food processing perspective, given 
the label desirability of increasing potassium and reducing sodium 
levels, manufacturers might replace a portion of currently used sodium 
salts, such as sodium citrate and sodium phosphate, with the potassium 
salts with equivalent functional characteristics. Thus, the comment 
said, labeling of magnesium content becomes more important to avoid 
creating an imbalance of potassium and magnesium.
    (Response) We agree that magnesium is an essential nutrient and 
that it is important in many different pathways and functions of the 
body (Ref. 218). However, consistent with our consideration of the 
factors for mandatory and voluntary declaration of vitamins and 
minerals (see part II.D), while magnesium dietary intake is currently 
low, the IOM recommended intake is not set based on a public health 
endpoint (e.g., a chronic disease), and the overt symptoms of magnesium 
deficiency are rarely seen among general healthy U.S population. 
Consequently, we do not consider magnesium to be a nutrient of public 
health significance for the general U.S. population (Ref. 204). We 
consider whether a vitamin or mineral is of public health significance 
to be the key factor in deciding when to require mandatory declaration 
on the Nutrition Facts label, cost consideration was not a factor in 
determining nutrients of public health significant.
    In the case of magnesium, similar to our recommendation, the 2010 
DGA and 2015 DGAC did not include magnesium as a nutrient of public 
health concern for the general U.S. population. (The 2015-2020 DGA also 
does not include magnesium as a nutrient of public health concern.) 
Magnesium was considered as a shortfall nutrient. Although some 
comments cited published articles, most articles cited by the comments 
are either animal studies, not using valid surrogate endpoints (such as 
C-reactive protein), or are based on single studies and emerging 
evidence and the conclusions are not based on the totality of 
scientific data.
    (Comment 386) One comment noted that some manufacturers already 
include magnesium content on the Nutrition Facts label for their 
products. The comment said that, for example, Kelloggs includes 
magnesium content on Raisin Bran cereal (but not on its Corn Flakes), 
Nestle includes magnesium content on its Instant Breakfast products, 
and General Mills includes magnesium content on Cheerios cereal. The 
comment suggested that these steps are to be encouraged and broadened.
    (Response) We are not making changes to the voluntary declaration 
of magnesium in the final rule, and therefore, manufacturers may 
declare magnesium voluntarily on the Nutrition Facts label. However, if 
magnesium is added as a nutrient supplement or claims are made about it 
on the label or in labeling of foods, then it must be declared on the 
label.
    c. Vitamin K.
    (Comment 387) Several comments stated that declaration of vitamin K 
on the Nutrition Facts label is necessary for individuals who are on 
blood thinners.
    (Response) We decline to revise the rule as suggested by the 
comment, and vitamin K remains a voluntarily declared nutrient in the 
final rule. While information regarding vitamin K may help patients on 
blood thinners, as we stated in part II.B.2, the Nutrition Facts label 
is for the general, healthy U.S. population rather than for individuals 
with acute or chronic disease.
    d. Choline.
    (Comment 388) In general, comments regarding the declaration of 
choline on the Nutrition Facts label supported voluntary declaration.
    (Response) Because declaration of choline on the Nutrition Facts 
label is already voluntary, no changes to the rule are necessary.
    e. Vitamin B12.
    (Comment 389) One comment stated that fortified foods and dietary 
supplements are the only reliable way for individuals who avoid all 
animal products to obtain vitamin B12. The comment said that 
including the amount of vitamin B12 added to fortified foods 
and dietary supplements would enable these individuals to monitor their 
intake of this essential vitamin. The comment said that labeling also 
would help individuals aged 50 years and older who are advised to meet 
their RDA mainly by consuming foods fortified with crystalline vitamin 
B12 or vitamin B12-containing dietary 
supplements.
    (Response) Declaration of vitamin B12 on the Nutrition 
Facts or Supplement Facts label is mandatory when vitamin 
B12 is added as a nutrient supplement or

[[Page 33897]]

when claims are made about it on the label or in labeling of foods. 
Thus, because the information is already available to consumers under 
the circumstances described in the comment, no changes to the rule are 
necessary.

M. Reference Daily Intakes for Vitamins and Minerals

1. Need To Update RDIs
    Our preexisting regulations, at Sec.  101.9(c)(8)(iv), set forth 
RDIs used to calculate the percent DVs for vitamins and minerals that 
are required or permitted to be declared on the Nutrition Facts label. 
RDIs are intended as general food labeling reference values and are not 
intended to represent dietary allowances for individuals. They function 
as an overall population reference to help consumers judge a food's 
usefulness in meeting overall daily nutrient requirements or 
recommended consumption levels and to compare nutrient contributions of 
different foods.
    The preamble to the proposed rule discussed how new information 
caused us to reconsider the RDIs and our approach to setting RDIs (79 
FR 11879 at 11925 through 11928). In brief, the proposed rule would 
revise the existing RDIs for vitamins and minerals based on the DRIs 
set by the IOM (1997 to 2010) and would consider the RDAs, when 
available, as the basis for establishing RDIs, instead of the EAR. 
Using corresponding RDAs, proposed Sec.  101.9(c)(8)(iv) would update 
the RDIs for calcium, copper, folate, iodine, iron, magnesium, 
molybdenum, niacin, phosphorus, riboflavin, selenium, thiamin, vitamins 
A, B6, B12, C, D, and E and zinc (see 79 FR 11879 
at 11926 through 11927).
2. Approach To Setting RDIs: EAR Versus RDA
    In the preamble to the proposed rule (79 FR 11879 at 11926 through 
11927), we explained our approach to setting RDIs. In brief, the 
percent DV advises the consumer how much of the recommended intake of a 
particular nutrient is provided by the food. The DV for a nutrient is 
not to be interpreted as a precise recommended intake level for an 
individual; instead, it is a general guide or a reference value that 
the consumer can use to help judge a food's usefulness in meeting 
overall daily nutrient requirements or recommended consumption levels 
and to compare nutrient contributions of different foods (id. at 
11926). Two types of reference values, the Reference Daily Intakes 
(RDIs) for vitamins and minerals and Daily Reference Values (DRVs) for 
certain nutrients, are used to declare nutrient contents as percent DVs 
(id. at 11883, 11926), and the RDIs for vitamins and minerals have been 
based primarily on RDAs (or on other available quantitative intake 
recommendations if an RDA has not been established for a particular 
vitamin or mineral).
    The preamble to the proposed rule also stated that the RDA was 
developed as a target intake level for individuals and is designed to 
meet the nutrient needs of practically all (97 to 98 percent) 
individuals within a life stage and gender group (id. at 11926). RDAs 
are available for calcium, copper, folate, iodine, iron, magnesium, 
molybdenum, niacin, phosphorus, riboflavin, selenium, thiamin, vitamins 
A, B6, B12, C, D, and E, and zinc (id.).
    In contrast, the EAR is the median requirement that is most likely 
to be close to an individual's actual needs within a particular life 
stage and gender group (id.). The EAR is a quantitative intake 
recommendation that is used to derive target nutrient intake goals for 
the planning of diets for groups (such as planning diets in an assisted 
living facility for senior citizens or planning menus for a school 
nutrition program), but is not used as a target intake goal for 
individuals. The EAR is not intended to be a target intake level for 
individuals because an individual does not know how his or her needs 
relate to the EAR. Therefore, if the RDI were to be based on the EAR, 
the RDI would not meet the daily nutrient requirements for some 
consumers and would understate target intake levels. In contrast, an 
RDI that is based on a RDA would meet the daily nutrient requirements 
for most individuals 4 years of age and older. An RDI based on the RDA 
would mean that a product with 100 percent of the DV would have a 
higher probability of meeting an individual's nutrient needs than if 
the RDI was based on the EAR. As a result, in the preamble to the 
proposed rule (id. at 11927), we stated that RDAs, when available, 
provide the most appropriate basis for establishing RDIs and, using 
corresponding RDAs, we proposed, at Sec.  101.9(c)(8)(iv), to update 
the RDIs for calcium, copper, folate, iodine, iron, magnesium, 
molybdenum, niacin, phosphorus, riboflavin, selenium, thiamin, vitamins 
A, B6, B12, C, D, and E, and zinc.
    (Comment 390) Several comments supported using the RDA, rather than 
the EAR, as the basis for establishing RDIs.
    In contrast, one comment opposed using the RDA and supported using 
the EAR. The comment asserted that we should not dismiss the 
recommendations of the IOM Labeling report (Ref. 219) to use the EAR as 
the basis for setting DVs, in favor of the 2003 IOM Planning report 
(Ref. 220) recommendation to use RDAs to plan diets of individuals. The 
comment stated that there is no better reference value against which to 
appraise the nutritional contribution of a product than a DV based on a 
population weighted EAR and that any other basis for the DV will either 
understate or overstate the nutritional contribution of a food product 
when considered in comparison to the population weighted EAR. The 
comment said that we misinterpreted the purpose of the 2003 IOM 
Planning report recommendation to use the RDA to plan diets and that 
there is no reason to assume that the very specific notion of dietary 
planning for individuals (as described in the 2003 IOM Planning report) 
is what consumers mean when they say they use the label for planning 
purposes. The comment further stated that the DVs are not appropriate 
to use for planning an individual's entire diet because they do not 
represent the individual's age and sex, and that this nutrition 
information is only provided on packaged foods (not fresh fruits and 
vegetables, meat, poultry, fish). The comment also said that this 
information is only available for nutrients that are mandatory on the 
Nutrition Facts label.
    (Response) We continue to believe that the RDA is the most 
appropriate reference value to use to establish RDIs, considering the 
purpose of the DV. As we noted in the preamble to the proposed rule (79 
FR 11879 at 11926), the percent DV advises the consumer how much of the 
recommended intake of that nutrient is provided by the food. While the 
DV for a nutrient is not to be interpreted as a precise recommended 
intake level for an individual, it is a general guide or a reference 
value that the consumer can use to help judge a food's usefulness in 
meeting overall daily nutrient requirements or recommended consumption 
levels and to compare nutrient contributions of different foods (id.). 
The EAR is not intended to be a target intake level for individuals 
because an individual does not know how his or her needs relate to the 
EAR. While the RDA may not be the best estimate of any given 
individual's nutrient requirements, which are usually unknown, the RDA 
was developed as a target intake level for individuals. The RDA is 
designed to meet the needs of practically all (97 to 98 percent) 
individuals within a life stage and gender group. If the RDI was

[[Page 33898]]

based on the EAR, the RDI would not meet the daily nutrient 
requirements for some consumers and would understate target intake 
levels.
    We also disagree with the comment's characterization of the 2003 
IOM Planning report recommendations. The 2003 IOM Planning report noted 
that intake goals (i.e., RDAs) should be translated into dietary plans 
to help individuals choose foods that will make up a healthy diet. The 
2003 IOM Planning report gave several examples of dietary plans such as 
the Nutrition Facts label, the U.S. Food Guide Pyramid, and the Dietary 
Guidelines for Americans that are intended to help consumers choose 
foods that are part of a healthful diet (Ref. 220). The 2003 IOM 
Planning report noted that, when food guides are used, reference 
standards for nutrients such as the RDAs are implicitly used in 
planning individual diets (see 79 FR 11879 at 11926). Therefore, we 
disagree with the comment's suggestion that the 2003 IOM Planning 
report is somehow at odds with the use of the RDA as a reference value 
for establishing RDIs. Furthermore, we disagree with the comments' 
assertion that the DVs are not appropriate to use for planning an 
individual's entire diet because nutrition information is only provided 
on packaged foods (and not on fresh fruits and vegetables, meat, 
poultry, or fish). Retail stores that sell raw fruits, vegetables, and 
fish participate in the voluntary point-of-purchase nutrition 
information program (Sec. Sec.  101.42 through 101.45). Additionally, 
we have developed posters that provide nutrition information for the 20 
most commonly consumed fruits, vegetables and seafood that are 
available to consumers and industry (Ref. 221). Similarly, USDA 
requires that retail stores that sell meat and poultry to label 
products with nutrition information or to post point-of-purchase 
nutrition information. USDA also has developed posters for nutrition 
information for meat and poultry that are available for use by 
consumers and industry (75 FR 82148) (Ref. 222). For these reasons, we 
are making no changes to the rule based on the comment.
    We address comments on specific vitamins and minerals at parts 
II.M.6 and II.M.7.
3. Approach To Setting RDIs: Adequate Intake
    In the preamble to the proposed rule (79 FR 11879 at 11927), we 
explained that, in the absence of RDAs, AIs represent the best estimate 
of an adequate daily nutrient intake level based on available science 
and, as such, they provide an appropriate basis for selecting RDIs for 
those vitamins and minerals where available data are insufficient to 
determine RDAs. Consequently, we proposed to use the AI to set RDIs for 
biotin, chloride, choline, chromium, manganese, pantothenic acid, 
potassium, and vitamin K.
    (Comment 391) Several comments supported using the AI as the basis 
for establishing RDIs for those vitamins and minerals where data were 
insufficient to determine a RDA. However, other comments opposed using 
the AI for potassium to establish an RDI of 4,700 mg and recommended 
that we retain the current DRV of 3,500 mg. The comments stated that 
the AI is established at a level assumed to ensure nutritional adequacy 
in all members of a healthy population when there is insufficient 
scientific evidence to develop an RDA. The comments said that using a 
reference value based on inadequate quantity or quality science would 
be providing inconclusive information to consumers. A few comments 
noted that there is now additional evidence (Refs. 223-224) that is 
more reflective of the current state of the science and recognizes the 
sodium to potassium ratio. Some comments also suggested that the IOM 
should re-assess the DRI for potassium in light of the new data to 
determine if the current AI is truly reflective of the actual 
requirements. One comment suggested that increasing the RDI could 
result in increased reliance on fortification or use of dietary 
supplements.
    (Response) We agree with the comments that support the use of the 
AI to set the RDIs for nutrients that do not have a RDA. We disagree 
that we should not use the AI to set an RDI for potassium and that the 
existing DV of 3,500 mg should be retained. The existing DV for 
potassium was set in 1993 based on the 1989 Diet and Health report and 
no longer represents the most current recommendations for potassium 
intake. As discussed in the preamble to the proposed rule (79 FR 11879 
at 11927), while there is more uncertainty with an AI than an EAR or 
RDA, in the case of nutrients without established RDAs, the AI reflects 
the most current scientific recommendations for intake (id.). When 
establishing RDIs, we consider the quantitative intake recommendations 
from U.S. consensus reports (e.g., the IOM DRI reports) (see 79 FR 
11879 at 11890).
    We disagree that the sodium and potassium ratio should be used to 
set a DV for potassium. First, sodium is not presented on the label as 
a ratio of sodium and potassium. As discussed in part II.L.3.b, the 
final rule requires the declaration of potassium on the label. Thus, if 
consumers are interested in the sodium and potassium ratio, they will 
have both the absolute amounts as well as the percent DV for both 
nutrients. In addition, the Aburto et al., 2013 systematic review and 
meta-analysis cited by the comment concluded that daily potassium 
intakes in the range of 90 to 120 mmol (3,519 mg to 4,700 mg) were 
associated with lower risk of stroke (Ref. 223). This range is 
consistent with the AI of 120 mmol (4,700 mg/day) that was based on 
potassium's ability to blunt the effects of sodium intake on blood 
pressure and to reduce the risk of kidney stones. Furthermore, Aburto 
et al. 2013 noted their analysis of randomized trials that examined how 
sodium intakes influence potassium's effect on blood pressure shows 
there was no statistically different effect among subgroups based on 
sodium intake. A majority of the individual studies cited in the Aburto 
et al., 2013 meta-analysis were reviewed in the 2005 Electrolytes 
report which concluded that data on the sodium and potassium ratio was 
insufficient to be used to set requirements (Ref. 223). The other 
article cited in the comment (Ref. 224) is a review article that does 
not include the totality of the scientific evidence and does not 
provide sufficient information for FDA to review. While we recognize 
that the intakes of sodium and potassium are interrelated, we do not 
consider the evidence to be sufficient to set an RDI based on the 
sodium and potassium ratio, and we continue to consider that the AI set 
by the IOM is appropriate to use for setting the RDI. Additionally, 
given the extensive reviews already conducted by the IOM, we do not 
agree that it is necessary to ask the IOM to reevaluate the existing 
evidence for potassium.
    As for the comment regarding fortification, the comment did not 
provide any evidence, and we are not aware of any evidence, that 
suggests using the AI would lead to excessive fortification and 
increased use of dietary supplements. Currently, the adequacy of 
intakes for potassium is very low (see 79 FR 11879 at 11922). Only 1.9 
percent of the general population has usual potassium intake above the 
AI from conventional foods only, and 2.4 percent have intakes above the 
AI from conventional foods plus dietary supplements. RDIs which are 
expressed on the label as a percent DV, give a consumer a general idea 
how much of a nutrient they should consume. While RDIs may influence 
the vitamin or

[[Page 33899]]

mineral content of foods, FDA's principles of rational fortification 
are expressed in our fortification policy (Sec.  104.20). The addition 
of nutrients to foods is also governed by the requirements established 
in food standards of identity (21 CFR parts 130 to 169), nutrition 
quality guidelines (21 CFR part 104), substitute food regulations 
(Sec.  101.3(e)), and relevant specifications in food additive and food 
substance regulations (e.g., folic acid (Sec.  172.345) and vitamin D 
(Sec. Sec.  184.1950 and 172.380)). Consistent with our previous 
position (58 FR 2206 at 2210), we acknowledge that some manufacturers 
may fortify products to a specific percentage of the DV (e.g., 25 
percent) and, to the extent this practice continues, nutrient levels in 
these foods would be affected by updated RDI values. Manufacturers must 
comply with relevant regulations, and we urge them to follow the 
principles stated in our fortification policy. We conclude that the AIs 
set by the IOM provide an appropriate basis for selecting RDIs for 
those vitamins and minerals where available data are insufficient to 
determine RDAs and will not be making a change as a result of this 
comment.
4. Approach To Setting RDIs: Tolerable Upper Intake Level
    The preamble to the proposed rule (79 FR 11879 at 11928) explained 
that 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. As intake increases above the UL, potential risk of adverse 
effects may increase. The UL can be used to estimate the percentage of 
the population at potential risk of adverse effects from excess 
nutrient intake, but it is not intended to be a recommended level of 
intake for vitamins and minerals where excess intake is not a concern, 
as there is generally no established benefit for consuming amounts of 
nutrients above the RDA or AI. Thus, we do not consider the UL to be an 
appropriate basis for setting RDIs for vitamins and minerals.
    We did not receive comments on this topic.
5. Approach To Setting RDIs: Population-Weighted Versus Population-
Coverage
    In the preamble to the proposed rule (id.), we discussed how we 
considered recommendations of current consensus reports, scientific 
review articles, and comments to the 2007 ANPRM. We tentatively 
concluded that RDIs for vitamins and minerals should continue to be 
based on a population-coverage approach (rather than a population-
weighted approach), using the highest RDA and, where an RDA has not 
been established, the highest AI (79 FR 11879 at 11928). We explained 
that using a population-coverage approach would avoid a higher risk of 
nutrient inadequacy among certain segments of the population because 
the RDA/AI value is not derived from averaging the requirements for 
populations with lower needs (children and elderly) and those with 
greater needs (adolescents or adults). We acknowledged that, for some 
nutrients, the population-coverage RDA approach would result in RDIs 
that are higher than the nutrient requirements for some consumers, but 
said that the RDA, by definition, is the target intake goal for 
nutrient intakes for individuals (id.).
    We proposed to amend Sec.  101.9(c)(8)(iv) to update RDIs and to 
present the updated RDIs in a table.
    (Comment 392) Several comments supported the use of the population-
coverage approach, using the highest RDA or AI to set the RDIs. Other 
comments, however, said we should use the population-weighted approach. 
Comments supporting the use of a population-weighted approach asserted 
that a DV derived from the population-coverage RDA will result in 
setting target intakes for nutrients above the needs for the majority 
of the population, that the use of a population-weighted RDA would 
still result in an increase in the RDIs for calcium, vitamin D, and 
potassium, and that the RDI for iron would decrease from 18 mg to 11 
mg, but that this level would still exceed or meet the RDA for 80 
percent of the population.
    One comment supporting use of a population-weighted EAR disagreed 
with our rationale that using a population-coverage approach ensures 
that vulnerable groups are covered; the comment stated that, with the 
exception of iron, the highest RDAs are those for young men who are not 
vulnerable to nutrient inadequacies.
    A few comments suggested that using a population-coverage approach 
would set nutrient targets unnecessarily too high and would make it 
harder for consumers to meet their nutrient requirements while staying 
within energy needs. Another comment suggested that using a population-
coverage approach might lead to consumer confusion and frustration.
    (Response) As we discussed in the preamble to the proposed rule (79 
FR 11879 at 11928), using the highest age and gender group RDA/AI value 
(i.e., a population-coverage approach) would avoid a higher risk of 
nutrient inadequacy among certain segments of the population because 
such a value is not derived from averaging the requirements for 
populations with lower needs (children and elderly) and those with 
greater needs (adolescents or adults). While incidences of deficiency 
diseases, such as pellagra, are now rare, intakes and status biomarkers 
of certain nutrients continue to be inadequate and of public health 
significance. Furthermore, in addition to iron, the proposed RDIs for 
calcium and vitamin D were based on vulnerable groups. The RDI for 
calcium was based on the highest RDA of 1,300 mg/day for 9 to 18 year 
olds, and the proposed RDI of 20 mcg for vitamin D was based on the RDA 
for adults 70 years and older. All three nutrients have been identified 
as nutrients of public health concern (see 79 FR 11879 at 11918 through 
11922). We continue to use the population-coverage approach to set RDIs 
and decline to make a change based on this comment.
    As for the comment suggesting that using a population-coverage 
approach would set nutrient targets unnecessarily too high and would 
make it harder for consumers to meet their nutrient requirements while 
staying within energy needs, we acknowledge that, for some nutrients, 
the population-coverage RDA approach will result in RDIs that are 
higher than the nutrient requirements for some consumers. However, the 
RDA, by definition, is the target intake goal for nutrient intakes for 
individuals. In addition, unlike the population-weighted approach, the 
population-coverage approach would not be susceptible to changes in age 
demographics of the population. Therefore, any future revisions to RDIs 
would be based primarily on new scientific data related to nutrition or 
new dietary recommendations, and we would not need to revise RDIs 
solely based on the availability of new census data (see 79 FR 11879 at 
11928). Furthermore, because many of the new RDAs and AIs established 
by the IOM are now lower than the older RDAs or ESADDIs that were used 
in the past to develop RDIs, the new RDIs established in the final rule 
based on a population-coverage RDA for many nutrients will be lower. We 
are not aware of, nor did the comment provide, any evidence to suggest 
that retaining the population-coverage approach would make it harder 
for consumers to meet their nutrient requirements while staying within 
energy needs.
    As for the assertion that consumers confusion may result, the 
comments did not provide any data or information that such difficulties 
or consumer confusion exists or the extent to which such

[[Page 33900]]

difficulties or confusion exists, so we are unable to determine the 
nature or severity, if any, of such consumer difficulties or confusion. 
We do note that the current DVs on the label are based on a population-
coverage approach, and we are not aware of any data and information 
that the population-coverage approach, which we have used for decades, 
has caused consumer confusion.
    We conclude that setting RDIs based on a population-coverage 
approach is more appropriate than a population-weighted approach, and 
we are not making changes to the rule based on these comments. Thus, 
the final rule, at Sec.  101.9(c)(8)(iv), updates the RDIs for various 
nutrients and presents them in table form, although we have, on our own 
initiative, elected to use non-italicized numbers for RDI values that 
were italicized in the proposed rule and deleted the footnote regarding 
the declaration of a percent daily value for ``bolded'' (italicized) 
nutrients.
    (Comment 393) Some comments agreed that using the population-
coverage RDA does not lead to excessive intakes of nutrients due to 
over fortification of foods. The comments noted several recent analyses 
that support our analysis and conclusions that a population coverage 
RDA would not lead to excessive intakes of nutrients from fortified 
foods (Refs. 194-195, 225). One comment pointed out that RDIs would 
likely reset levels of vitamins and minerals in discretionary enriched/
fortified foods as manufacturers adjust absolute levels to maintain 
current label claims. The comment said that, based on diet modeling 
done by Murphy et al. that assumes that discretionary enrichment/
fortification levels reset, a population-coverage RDA would be likely 
to result in a greater percentage of Americas meeting their nutrient 
requirements compared to a population-weighted EAR (Ref. 225). 
Furthermore, the comment said, the results of diet modeling conducted 
by Murphy that assumed that discretionary enrichment/fortification 
levels would reset indicated that using a population-coverage approach 
would result in less than 1 percent of the total populations 4 years of 
age and older having intakes above the ULs (Ref. 225).
    Some comments suggested that the use of a population-coverage RDA 
could result in over-fortification of products. One comment noted that 
intakes of zinc exceed the UL for young children. The comment stated 
that we should not dismiss this finding by challenging the basis for 
the UL, because doing so fails to recognize the extent to which many 
American children's intakes currently exceed the UL. The comment stated 
that the proposed RDI (11 mg) is more than two times the RDA for 
children 4 to 8 years (5 mg/day) and almost four times the RDA for 
children 1 through 3 years (3 mg/day). The comment said that a product 
with 20 percent of the DV for zinc (e.g. 11 mg x 0.20 = 2.2 mg) 
declared on the label would provide almost 100 percent of the zinc RDA 
for a young child (3 mg/day).
    (Response) We disagree with the comment that stated that the use of 
a population-coverage RDA would lead to excessive fortification and 
intakes of nutrients. Instead, we agree with the comments that stated 
that a population-coverage RDA would not lead to excessive intakes of 
nutrients from fortified foods. As noted in the preamble to the 
proposed rule (79 FR 11879 at 11928) and the accompanying memorandum to 
the file (Ref. 199), intakes of vitamins and minerals generally do not 
exceed the ULs under current RDIs that are based on a population-
coverage RDA approach, except for zinc, vitamin A (preformed), iodine, 
and folic acid among children 4 to 8 years. In these few instances 
where total usual intakes of vitamins and minerals by children 4 to 8 
years exceed corresponding ULs, we have determined that such intakes 
are not of public health significance, and for some nutrients, are not 
as a result of fortification (Ref. 199). Analyses done by other groups 
also have determined that fortified foods contribute to the nutrient 
intakes and adequacy of many nutrients without leading to excessive 
intakes for most vitamins and minerals (Refs. 194-195, 225). 
Furthermore, because many of the new RDAs and AIs established by the 
IOM are now lower than the older RDAs or ESADDIs that were used in the 
past to develop RDIs, the final rule's RDIs, based on population-
coverage RDAs for many nutrients, will be lower. We consider that, from 
a public health perspective, it is more important for the DV of 
vitamins and minerals to cover the intake needs of most consumers than 
it is for certain age and gender groups to be covered by the DV based 
on their proportion of the overall population. As discussed in the 2014 
memo to the file, we acknowledge that total usual zinc intakes from 
conventional foods and dietary supplements exceed the UL for 
approximately 33 percent of children 4 to 8 years of age. The UL for 
zinc of 12 mg/day was extrapolated upward from the UL set for infants 
based on decreased copper absorption (Ref. 226). In addition to intake 
data, we considered whether there is public health significance to 
exceeding the UL. As noted in the 2014 memo to the file, no reports on 
adverse effects of zinc on copper absorption have been reported in 
children and adolescents (Ref. 199). A dose response intervention study 
published in 2013 found that supplementation with 5 to 15 mg/day of 
zinc for 4 months did not alter copper status in healthy Canadian boys 
aged 6 to 8 years (Ref. 227). Furthermore, the proposed RDI for zinc of 
11 mg, which is based on the highest new RDA, decreases by 27 percent 
from the current RDI of 15 mg. In addition, the proposed RDI for zinc 
of 11 mg does not exceed the UL for children 4 to 8 years of age. The 
RDIs are currently intended for adults and children 4 or more years of 
age and not younger children because children over the age of 4 years 
consume the same foods that the rest of the population consumes. 
However, as discussed in part II.O.6.k, we also are establishing a RDI 
of 3 mg for zinc for younger children 1 through 3 years of age.
    (Comment 394) Several comments opposed any revision to the RDIs 
that would lower the RDIs. The comments stated that Americans need more 
vitamins and minerals because toxin intake is increasing and nutrient 
intake is decreasing. The comments suggested that our goal was to 
harmonize our food laws to Codex standards and guidelines and stated 
that this has been specifically prohibited by Congress. The comments 
requested that we obey the law and withdraw the proposal rule for 
revision and bring it in line with modern science which, according to 
the comments, shows that we need higher daily intake of vitamin B and 
other vitamins as well as more minerals such as magnesium and selenium.
    (Response) We disagree that the RDIs should not be revised. As we 
discussed in the preamble to the proposed rule, we are revising the 
RDIs based on our consideration of the RDA or AI set in the most recent 
IOM DRI reports that are U.S. consensus reports (see 79 FR 11879 at 
11926). The comments did not provide any data, information, or 
explanation to support the various assertions made, including that 
Americans need more vitamins and minerals due to increased toxins, that 
the IOM DRI reports are incorrect, that our proposed actions are not 
consistent with the law and the proposed rule should be withdrawn, or 
that our goal is to harmonize food labeling with Codex standards and 
guidelines. We are unaware of new consensus research that would lead us 
to change our proposed approach to revise the RDIs. Therefore,

[[Page 33901]]

we are not making changes or taking any action in response to these 
comments.
    (Comment 395) Several comments objected to lowering the RDIs for 
specific nutrients such as biotin, niacin, pantothenic acid, 
riboflavin, thiamin, vitamin B6, chromium, copper, 
molybdenum, selenium, and zinc. One comment suggested that we did not 
outline our specific reasoning for lowering the RDIs for these 
particular nutrients. Another comment stated that we should reevaluate 
more recent science that evaluates the effects of high doses of 
nutrients from foods and supplements and look at clear differences 
between synthetic and naturally occurring vitamins. Another comment 
stated that the proposed changes will lead to consumer confusion and a 
drop in intake as consumers will now perceive foods and supplements to 
contain a much larger percentage of these nutrients when, in reality, 
the nutrient level is the same.
    (Response) We disagree that RDIs for biotin, niacin, pantothenic 
acid, riboflavin, thiamin, vitamin B6, chromium, copper, 
molybdenum, selenium, and zinc should not be revised. As discussed in 
the preamble to the proposed rule (see 79 FR 11879 at 11890), we are 
revising the RDIs based on our consideration of the RDA or AIs set in 
the IOM DRI reports that are U.S. consensus reports. We consider the 
quantitative intake recommendations from these reports when 
establishing RDIs.
    As for the comment suggesting that we consider new more recent 
science, the comment did not identify any new references for us to 
consider, and we are unaware of any new consensus from a body of 
research that would lead us to change the rule. However, with respect 
to synthetic and naturally occurring nutrients, in establishing RDAs or 
AIs, the IOM does consider the various sources of nutrients (synthetic 
and naturally occurring) when establishing the nutrient requirements.
    As for possible consumer confusion or lower intakes by consumers, 
we are not aware of any data or information about that outcome, nor did 
the comment provide any to support its assertions. Although the final 
rule lowers many RDIs, using the population-coverage RDA to set the 
RDIs would cover the needs of most individuals in the population. For 
these reasons, we are making no further changes to the rule based on 
these comments.
    (Comment 396) One comment stated that the current RDIs which are 
largely based on preventing deficiency diseases are out of date and do 
not consider nutrient intakes over the lifespan and do not provide 
consumers with information on optimal amounts of nutrients for good 
health. The comment cited a review by McCann and Ames that suggest 
modest deficiency of selenium my increase the risk of age-associated 
diseases (Ref. 228).
    (Response) We agree that the current RDIs are out of date and 
should be revised. The RDAs set by the IOM which are the basis for the 
new RDIs, did consider intakes over the lifespan and to the extent 
possible based on available data consider the relationship between 
optimal health and intakes of nutrients. The article cited by the 
comment was a review article and does not include the totality of the 
scientific evidence for FDA to review. The RDIs are based on our 
consideration of the RDA or AIs set in the IOM DRI reports that are 
U.S. consensus reports and we are not aware of any new consensus from a 
body of research that would lead us to change our proposed approach to 
revise the RDI for selenium. Therefore, we are not making changes or 
taking any action in response to this comment.
    (Comment 397) Some comments questioned why we are increasing the DV 
for vitamin C from 60 mg to 90 mg when we determined that the 
declaration of vitamin C on the Nutrition Facts or Supplement Facts 
label should no longer be mandatory. A few comments suggested that 
increasing the DV for vitamin C may negatively impact the consumer 
perception of this vitamin and result in consumer confusion. The 
comments suggested the percent DV declaration will be lower because the 
DV is higher for vitamin C, and so consumers may perceive that the 
product has changed when it has not. A few comments also suggested 
that, if the higher DV for vitamin C is adopted, we should engage in 
consumer education.
    (Response) The preexisting RDI of 60 mg was based on the 1968 RDA 
which is outdated and does not reflect current recommendations for 
intake of vitamin C. We disagree that the RDI for vitamin C should not 
be increased because we are no longer requiring mandatory declaration. 
As we stated in the preamble to the proposed rule (79 FR 11879 at 
11928), we are basing the RDIs for vitamins and minerals, including 
vitamin C, on the highest RDA set by the IOM. Thus, for vitamin C, we 
set the RDI at 90 mg. The RDIs, which are expressed on the label 
through the percent DV, give a consumer a general idea how much of a 
nutrient they should consume.
    We recognize that consumer education on the various changes to the 
label will be important (see part II.B.1). Furthermore, we are not 
aware of, nor did the comment provide, any data or information that 
increasing the RDI for vitamin C will lead to consumer confusion.
6. Declaration of Absolute Amounts of Vitamins and Minerals
    Our preexisting regulations, at Sec.  101.9(d)(7)(i), require the 
declaration of mandatory nutrients and, when declared, voluntary 
nutrients by their absolute amounts in weight on the Nutrition Facts 
label, except for vitamins and minerals (other than sodium and 
potassium). Thus, except when the linear label format is used (Sec.  
101.9(j)(13)(ii)(A)(2)), listings for sodium and potassium (when 
declared) appear above the third bar and include both weight amounts 
and percent DVs, while vitamins A and C, calcium, and iron appear below 
the third bar and include percent DVs only. In the case of dietary 
supplements, both the quantitative amount by weight and percent DV (if 
available) are required to be declared on the Supplement Facts label 
(Sec.  101.36(b)(2)(ii) and (iii)). The proposed rule would require 
that, similar to the requirement for dietary supplements (Sec.  
101.36(b)(2)(i)(A)), all vitamins and minerals declared on the 
Nutrition Facts label include their quantitative amounts (in addition 
to the requirement for corresponding percent DV declaration) (proposed 
Sec.  101.9(c)(8)). We address the comments to this proposed 
requirement in part II.Q.9.
    The proposed rule also would remove the specific requirements for 
the declaration of potassium in Sec.  101.9(c)(5) and provide, instead, 
for the declaration of fluoride. The proposed rule also would require 
that, when a product contains less than 2 percent of the RDI for a 
vitamin or mineral, the manufacturer must declare the quantitative 
amount of the vitamin or mineral and the percent DV in the same manner. 
For example, if a serving of the product contains less than 2 percent 
of the RDI for calcium, both the quantitative amount and the percent DV 
for calcium may be listed as zero or an asterisk (or symbol) directing 
the consumer to a statement at the bottom of the label may be used in 
place of both the quantitative amount and the percent DV declaration 
for calcium. We stated that we saw no reason to provide different 
declaration increments for the Nutrition Facts label than those that 
have already been established for the declaration of quantitative 
amounts of vitamins and minerals on the Supplement Facts label in Sec.  
101.36(b)(2)(ii).
    We also invited comment on whether quantitative amounts for 
nutrients with

[[Page 33902]]

RDI values that contain three or four digits should be rounded, what 
the rounding increments should be, and data to support rounding 
increments (79 FR 11879 at 11930, 11961).
    (Comment 398) For conventional foods, we specify in Sec.  
101.9(c)(8)(iii) that the percent DV declaration for vitamins and 
minerals present at less than 2 percent of the RDI is not required for 
nutrition labeling, but may be declared as zero or by the use of an 
asterisk (or other symbol) that refers to another asterisk (or symbol) 
that is placed at the bottom of the table and that is followed by the 
statement ``Contains less than 2 percent of the Daily Value of this 
(these) nutrient (nutrients).'' Alternatively, the statement ``Not a 
significant source of (listing the vitamins or minerals omitted)'' may 
be placed at the bottom of the table of nutrient values.
    One comment said that quantitative amounts less than 2 percent of 
the DV should be exempt from declaration as such amounts are 
nutritionally insignificant. Other comments suggested that we should 
not allow for the amount of a nutrient to be declared as zero. These 
comments suggested that, if there is even the smallest amount of the 
nutrient in a serving of the product, the amount should be declared.
    (Response) We decline to revise the rule to require the declaration 
of small, quantitative amounts of vitamins and minerals on the 
Nutrition Facts label. While it may be desirable to have a precise 
nutrient value on the label, such precision is impractical. There is 
variability inherent in the food supply. Nutrients found in foods can 
vary slightly due to many factors such as the season of the year, soil 
type, variety (cultivar), and weather conditions. The processing that a 
food undergoes also can alter its nutrient content. The rounding rules 
were established to avoid the impression of unwarranted accuracy as 
well as to make a label easier for the consumer to review and 
understand.
    Furthermore, very small quantities of nutrients in a food product 
do not contribute significantly to nutrient requirements for the total 
daily diet. A consumer would most likely exceed their calorie needs 
trying to obtain the recommended amount of a certain nutrient if their 
diet is made up of only foods that contribute less than 2 percent of 
the DV for that nutrient. To obtain the recommend amount of that 
nutrient for the day, the consumer would need to consume other foods 
containing larger quantities (at least more than 2 percent of the DV 
for that nutrient) of the nutrient.
    (Comment 399) We proposed to use the same declaration increments 
for the Nutrition Facts label as those that have already been 
established for the declaration of quantitative amounts of vitamins and 
minerals on the Supplement Facts label in Sec.  101.36(b)(2)(ii). The 
proposed rule, at Sec.  101.9(c)(8)(iii), would require that the 
quantitative amounts of vitamins and minerals on the Nutrition Facts 
label, excluding sodium, be the amount of the vitamin or mineral 
included in one serving of the product, using the units of measure and 
the levels of significance given in Sec.  101.9(c)(8)(iv), except that 
zeros following decimal points may be dropped, and additional levels of 
significance may be used when the number of decimal places indicated is 
not sufficient to express lower amounts (e.g., the RDI for zinc is 
given in whole milligrams, but the quantitative amount may be declared 
in tenths of a milligram).
    Several comments would change the rule's declaration increments. 
Two comments asked us to ensure that there is consistency between the 
rounded absolute amount and the declared percent DV. One comment stated 
that any declaration of quantitative amounts of vitamins and minerals 
should provide for declaration of a quantitative amount that 
corresponds to the nearest whole number of the percent DV beginning 
with 2 percent. Another comment said that most consumers will not do 
the math to convert the absolute amount of the percent DV, but 
providing both absolute amount and percentages could result in 
different values for similar products in the marketplace.
    (Response) We agree that the rounded absolute amount and the 
declared percent DV may be slightly inconsistent. For example, if the 
quantitative amount of the vitamin or mineral is rounded after the 
rounding rules for the percent DV declaration are applied, it could 
result in a rounded value that is significantly different than the 
actual amount of the nutrient in a serving of a food. For example, if a 
product is determined by analytical methods to have 1,550 mg of 
potassium per serving, the percent DV declaration would be determined 
by dividing 1,550 mg by the RDI of 4,700 mg for a value of 33 percent. 
After application of the rounding requirements for the percent DV 
declaration, the declared percent DV value would be rounded to 35 
percent. If the declared quantitative amount of potassium in a serving 
of the product is then multiplied by 35 percent by the RDI of 4,700, 
the declared quantitative amount of would be 1,645 mg of potassium. 
This is a difference of 95 mg between the value obtained before and 
after applying the rounding rules for the percent DV declaration.
    In addition, requiring a declaration of the amount of the nutrient 
that corresponds to the nearest whole number of the percent DV 
calculated before rounding could result in declared quantitative 
amounts that are different than what has been determined by analytical 
methods, but still not correspond with the rounded percent DV 
declaration. For example, if testing is done to determine that a 
product contains 300 mg of potassium per serving, the calculated 
percentage of the RDI for potassium of 4,700 is 6.4 percent. If that 
percentage is then rounded to the nearest whole number of 6 percent and 
then multiplied by the RDI for potassium, it would result in a declared 
value of 282 mg, which is different than the value which is determined 
by analytical methods.
    The approaches suggested by comments to make the quantitative 
amount of a vitamin or mineral declared on the label as close as 
possible to the quantitative amount calculated from the percent DV 
declaration would either result in a declared value that is either less 
accurate or no better that the proposed approach. Therefore, we decline 
to make changes to our label declaration increments.
    (Comment 400) One comment said that nutrients with ``equivalents,'' 
such as Vitamin A, folate, and niacin, make it impossible to simply 
convert a numerical value to a percentage and could create consumer 
confusion.
    (Response) We disagree with the comment. For those nutrients with 
``equivalents,'' the equivalent amount should already be determined for 
the purposes of the amount declared on the label. For calculation of 
the percent DV, the declared amount should be divided by the RDI for 
that nutrient and multiplied by 100. The equivalent amount should 
already be determined for the label declaration and would not prevent a 
manufacturer from determining the percent DV declaration for vitamin A, 
niacin, folate, or folic acid.
    (Comment 401) Some comments suggested that less precision is needed 
for declaration of quantitative amounts of nutrients declared on the 
label. One comment suggested that the declared amounts should be 
rounded to whole numbers because they are easier for consumers to 
understand.
    Another comment suggested that any nutrient in an amount greater 
than 10 units (e.g., 10 mg or 10 mcg) should be rounded to the nearest 
1 (unless a larger increment is specified in the proposed

[[Page 33903]]

rule, such as ``Calories from saturated fat '' for which 5 calorie 
increments are specified for amounts up to and including 50 calories), 
those in an amount greater than 100 units should be rounded to the 
nearest 10 units (unless a larger increment is specified in the rule), 
and those in amounts greater than 1,000 units should be rounded to the 
nearest 100 (unless a larger increment is specified in the rule). The 
comment suggested that rounding should be based on the declared 
quantity of a nutrient rather than on the RDI or DRV for the nutrient.
    One comment recommended that numbers ending in ``5'' should be 
rounded up. The comment suggested that we could consider alternatively 
allowing for numbers ending in 5 to be rounded to the nearest even 
number, but said this could be confusing and counterintuitive for most 
members of industry.
    Other comments suggested that more precision is needed for 
declaration of quantitative amounts of nutrients declared on the label. 
One comment recommended that quantitative amounts be rounded to the 
nearest tenth instead of to the nearest integer. The comment indicated 
that rounding errors can occur when quantitative amounts are rounded to 
the nearest integer.
    Another comment also recommended that nutrients be rounded to the 
nearest tenth of a gram for quantities under 10 grams per serving.
    (Response) We disagree that the same rounding increments should be 
used for quantitative amounts of all vitamins and minerals. Some 
nutrients, such as potassium, have a relatively large RDI value (4,700 
mg) while others, such as thiamin, have a relatively small RDI value 
(1.2 mg). The declaration of those nutrients with relatively smaller 
RDI values requires greater specificity than those with relatively 
larger RDI values. Furthermore, for some nutrients with relatively 
larger RDI values, it may not be possible, given current analytical 
methods, to determine the amount of the nutrient with precision when 
very small quantities are present (e.g., at a level of less than 1 mg).
    The comments recommending specific rounding increments of all 
nutrients based on the number of units in the RDI or DRV value did not 
explain why those increments are appropriate so that we might determine 
if the approaches suggested are merited. By using the levels of 
significance provided in the RDI table in Sec.  101.9(c)(8)(iv), 
allowing for zeros following decimal points to be dropped, and allowing 
for additional levels of significance to be used when the number of 
decimal places indicated is not sufficient to express lower amounts for 
those nutrients with small RDI values, we are giving manufacturers some 
flexibility to determine if the value should be rounded to the nearest 
whole number or to a fraction of a whole number based on the nutrient 
and the quantity present in a serving of the food.
    We recognize that determining the appropriate value to declare for 
quantitative amounts of vitamins and minerals could be confusing to 
manufacturers when the rule provides some flexibility based on the RDI 
and the quantity of the nutrient present in a serving of food, 
especially for nutrients with relatively small RDIs. For example, the 
rounding requirements allow a manufacturer to declare an amount of zinc 
as 2 mg or 2.4 mg per serving. Additionally, consumers use the 
information found on the label in different ways. Some may use it to 
get enough of certain nutrients whereas others may be more concerned 
with not exceeding a certain calorie level. There has always been built 
in variability in the label declarations due to variation in the food 
supply and variance in the analytical methods used to determine the 
amount of nutrients in a serving of a food. The amount of vitamins and 
minerals declared on a label is not always the exact amount of the 
nutrient in a serving of the food. Therefore, we decline to revise the 
increments used for declaration of quantitative amounts of vitamins and 
minerals as suggested by the comments.
    (Comment 402) One comment said that, if the final rule requires the 
declaration of quantitative amounts of vitamins and minerals, we should 
provide sufficient guidance regarding rounding rules and how to 
quantify amounts of naturally occurring substances that inherently are 
subject to variability (e.g., vitamins and minerals from plants that 
are subject to variable growing conditions that affect nutrient 
content).
    (Response) There may be different ways in which manufacturers may 
want to consider the variability in the foods they produce. 
Manufacturers should know how much variability to expect in the foods 
they produce based on adequate sampling. Manufacturers should consider 
the range of nutrients which may be in a finished food product and 
determine the label value which they think will best meet the 
requirements for class II nutrients in Sec.  101.9(g).
    (Comment 403) One comment suggested we should test any rounding 
rules which are adopted to ensure that consumers are not confused.
    (Response) We established the rounding rules to provide an accurate 
representation of the amount of a nutrient in the product so that 
consumers can determine how the nutrients in a serving of a food 
contribute to their total daily diet. The rounding rules also allow for 
natural variability in the nutrient content of foods, analytical 
variability in test methods, and statistical probability, and we have 
set practical limits of variation in nutrient levels since 1973 (see 38 
FR 2125 at 2128 (January 19, 1973) (final rule titled ``Regulations for 
the Enforcement of the Federal Food, Drug, and Cosmetic Act and the 
Fair Packaging and Labeling Act Nutrition Labeling'')). We appreciate 
the need for consumers to be able to understand the information on a 
product label, yet the comment did not provide information to show how 
our rounding rules have confused consumers nor did it suggest how such 
tests would be done. We do not consider the changes we are making to 
the rounding rules to require consumer testing.
    (Comment 404) Our preexisting regulations, at Sec.  101.9(c), 
provide for the rounding of quantitative amounts of calories and 
macronutrients declared on the Nutrition Facts label. The requirements 
vary based on the nutrient. For example, our regulations state that 
quantitative amounts in milligrams may be listed on the Nutrition Facts 
label for only two minerals: Sodium (Sec.  101.9(c)(4)) and potassium 
(Sec.  101.9(c)(5)). Our regulations state that, when a serving 
contains less than 5 mg of sodium or potassium, the value must be 
declared as zero; when a serving contains 5 to 140 mg of sodium or 
potassium, the declared value must be rounded to the nearest 5 
milligram increment; and when a serving contains greater than 140 mg of 
sodium or potassium, the declared value must be rounded to the nearest 
10 mg increment.
    We did not propose any changes to these requirements.
    One comment suggested that the amount of calories in a serving of a 
product should not be rounded because people who are counting calories 
need to know exactly how many calories are in the product.
    (Response) We disagree with the comment. As with quantitative 
amounts of nutrients, determining the exact amount of calories in a 
serving of a specific package of food is not possible or practical. The 
determination of calories is a somewhat imprecise measure. The exact 
amount of calories per serving in a given food may vary from package to 
package. Therefore, providing an exact amount of calories

[[Page 33904]]

on a food label would give the consumer the incorrect impression that 
the declared amount is a precise value. Furthermore, providing an exact 
amount of calories rather than a rounded value is unlikely to provide 
consumers who count their calories for weight management purposes more 
helpful information because consumption of an extra 5 or 10 calories in 
a given food is unlikely to have a significant impact on body weight 
when most adults need to consume well over 1,000 calories per day, even 
when trying to lose weight.
    (Comment 405) Our preexisting regulations, at Sec.  101.9(g)(5), 
state, in part, that a food with a label declaration of calories, 
sugars, total fat, saturated fat, trans fat, cholesterol, or sodium 
shall be deemed to be misbranded under section 403(a) of the FD&C Act 
if the nutrient content of the composite is greater than 20 percent in 
excess of the value for that nutrient declared on the label. The 
regulation goes on to say ``Provided, That no regulatory action will be 
based'' on a determination of a nutrient value that falls above this 
level by a factor less than the variability generally recognized for 
the analytical method used in that food at the level involved.
    The proposed rule would amend Sec.  101.9(g)(5) to insert ``added 
sugars'' after the word ``sugars'' and delete the words ``Provided, 
That.''
    One comment would revise Sec.  101.9(g)(5) to stipulate that 
products labeled in accordance with the rounding or increment 
requirements are not misbranded if the use of such rounding or 
increments causes the content of calories, sugars, total fat, saturated 
fat, trans fat, cholesterol, or sodium to be understated by more than 
20 percent. The comment explained that Sec.  101.9(g)(5) leaves 
companies vulnerable to lawsuits under state consumer protection laws 
because a company could be sued for selling a ``misbranded'' product 
labeled as containing 5 calories per serving when the actual caloric 
content is just over 6 calories per serving, despite the fact that the 
product's labeling meets our requirement to express the number of 
calories to the nearest 5 calories.
    (Response) We decline to revise the rule as suggested by the 
comment. Section 101.9(g)(6) states that reasonable deficiencies of 
calories under labeled amounts are acceptable within current good 
manufacturing practice. We continue to consider the variability 
generally recognized for the analytical method used and reasonable 
deficiencies of declared amounts acceptable within current good 
manufacturing practice when evaluating label compliance and making 
determinations regarding misbranding charges. We also recognize that 
Sec.  101.9(c)(1) provides several methods for determining calories, 
which also allows manufacturers flexibility in determining the declared 
calorie value. Thus, the regulations provide for variability that is 
acceptable under our regulations.
    (Comment 406) One comment recommended that fractions of quantities 
should be shown per serving for nutrients such as trans fat because 
some people consume multiple servings of a product at the same time and 
may not realize that they add up to greater than 1 gram per serving.
    (Response) We decline to revise the rule as suggested by the 
comment. We note that the requirements of Sec.  101.9(c) do require the 
declaration of total fat, saturated fat, trans fat, and monounsaturated 
fat be expressed using fractions, which are the nearest 0.5 gram 
increment below 5 grams. For many macronutrients, it is not possible 
for manufacturers to declare fractions of a gram or mg amount on the 
label due to the level of variability inherent in the analytical 
methods used to determine the amount of the nutrient.
    Similar comments recommended that we require manufacturers to 
declare amounts of trans fat when present at less than 0.5 grams per 
serving of a food. We address those comments in part II.F.3.d.
    (Comment 407) One comment suggested that we allow for grams of 
dietary fiber to be rounded to the nearest 0.5 grams. The comment noted 
that the proposed DV for children 1 through 3 years of age is 14 grams. 
Therefore, the comment said, 10 percent of the DV for that age group 
would be equivalent to 1.5 grams of dietary fiber, and 20 percent of 
the DV for that age group would be 2.5 grams. The comment also noted 
that 10 percent of the current DV for the general population of 25 g 
would be 2.5 grams. The comment suggested that allowing for fiber to be 
declared in 0.5 gram increments up to 5 grams could help facilitate 
consumer communication and help reduce any confusion with respect to 
claims.
    (Response) We decline to revise the rule as suggested by the 
comment. The declaration of dietary fiber is expressed in increments of 
1 gram due to the level of precision of analytical methods for dietary 
fiber. The level of precision of the methods for determining dietary 
fiber do not allow for the accurate determination of the amount of 
dietary fiber in increments of less than 1 gram per serving.
7. Issues Concerning Specific Vitamins and Minerals
    The preamble to the proposed rule discussed issues related to RDIs 
for vitamin K, chloride, potassium, choline, and vitamin B12 
(79 FR 11879 at 11930).
    a. Vitamin K. The preamble to the proposed rule noted that there 
are three general forms of vitamin K: Phylloquinone (vitamin 
K1), menaquinone (vitamin K2), and menadione 
(vitamin K3) (id.). For labeling purposes, there is no 
specific definition for vitamin K and the AI for vitamin K is based on 
the intake of phylloquinone, the major form of vitamin K in the diet. 
The proposed rule, at Sec.  101.9(c)(8)(iv), would establish 120 mcg as 
the RDI for vitamin K.
    (Comment 408) One comment supported using the AI for vitamin K 
which pertains only to phylloquinone.
    Other comments objected to limiting the RDI for vitamin K to 
phylloquinone (Vitamin K1). The comments stated that 
menaquinone contributes to the nutritional requirements for vitamin K 
and should be included in the definition. One comment stated that 
inclusion of menaquinone would be in line with other regulatory bodies 
such as EFSA and Health Canada. One comment also noted that dairy and 
meat products are important sources of menaquinone and contribute to 
the daily intake of vitamin K. The comment stated that the 
bioavailability of menaquinone has been demonstrated using both in 
vitro and in vivo studies. The comment also stated that menaquinone is 
rapidly absorbed intact from the gastrointestinal tract (Ref. 229) and 
is more bioavailable than phylloquinone, which is strongly bound to 
vegetable fiber (Refs. 229-230). The comment also noted that it has 
been well-established that dietary intake of phylloquinone meets the 
nutritional requirements necessary for coagulation through the 
activation of biochemical pathways in the liver. The comment also noted 
that menaquinone has similar activity as phylloquinone in the blood 
coagulation system (Ref. 229), and data also suggest an important role 
for menaquinone in extra-hepatic processes. The comment stated that 
menaquinone intake has been shown to have a protective effect against 
CHD (Ref. 231), helps regulate bone metabolism, and plays a role in 
reducing the risk of osteoporotic fractures (Refs. 229, 232). The 
comment pointed out that the USDA database (2014) now includes vitamin 
K2. The comment also requested that we include phytonadione, 
which is an additional

[[Page 33905]]

name for vitamin K1, in the definition of vitamin K.
    (Response) We agree that the AI should be used as the basis for the 
RDI for vitamin K. However, we disagree that the definition of vitamin 
K should include menaquinones. While the comment referred to actions by 
Health Canada, we note that Health Canada also is proposing using the 
AI for the RDI for vitamin K (Ref. 233). Furthermore, the EFSA review 
cited by the comment was a safety assessment for vitamin K2 
as a source of vitamin K added to foods and was not an assessment of 
the possible nutritional benefits of vitamin K2 (Ref. 229). 
One study (Ref. 232) submitted by a comment was a review article on 
menaquinone-4 and osteoporosis and did not provide data for us to 
evaluate. It does not represent the totality of the scientific evidence 
on menaquinones and does not provide sufficient information for FDA to 
review. The other two studies, Gast et al., 2009 and Geleijnse et al., 
2004, were prospective cohort studies that showed an association of 
menaquinone intake and reduced risk of CHD. Intakes for menaquinone in 
these two studies were estimated from food frequency questionnaires 
and, because food composition data for menaquinones is limited, the 
results of these studies should be interpreted with caution (Refs. 230-
231). As we stated in the preamble to the proposed rule (79 FR 11879 at 
11930), the AI for vitamin K does not account for the intake of 
menaquinone or menadione because: (1) The NHANES data that was used as 
the basis for the AI only included the phylloquinone content of foods; 
(2) the contribution of menaquinones, which can be produced by bacteria 
in the gut, to the maintenance of vitamin K status has not been 
established; and (3) menadione is a synthetic form of vitamin K that 
can be converted to a form of menaquinone in animal tissues. In 
addition, menaquinones are poorly understood in terms of vitamin K 
absorption and utilization (Refs. 234-236). Unlike phylloquinone, there 
have been no stable isotope studies conducted with menaquinones that 
are needed to improve the understanding of menaquinone bioavailability 
and metabolism (Ref. 235). While the USDA National Nutrient Database 
for Standard Reference Release 27 includes data on one form of 
menaquinones (menaquinone-4), there are limited food composition data 
available (490 foods out of 8,618 or <6 percent in USDA NND SR27) (Ref. 
4), and estimates of intakes of menaquinones are very limited. 
Furthermore, we generally consider U.S. dietary recommendations, 
consensus reports, and U.S. national survey data to develop our 
regulations.
    While we decline to include menaquinone in a definition of vitamin 
K, we note that information about menaquinones that might be added to a 
food may be listed in the ingredient list to alert consumers that other 
forms of vitamin K are present in the product. We also discuss the 
labeling of menaquinone as a dietary ingredient in part II.P (Dietary 
Supplements).
    We also disagree that the term phytonadione should be included in 
the definition for vitamin K. ``Phytonadione'' is U.S. Pharmacopeia 
Convention's (USP) nomenclature for ``phylloquinone,'' and both have 
the same structure (Ref. 237). In the Nutrition Facts label, 
phylloquinone is declared as vitamin K (Sec.  101.9(c)(8)). 
Furthermore, for dietary supplements, labeling representations that the 
source ingredient conforms to an official compendium may be included 
either in the nutrition label or the ingredient list (e.g., calcium (as 
calcium carbonate USP) (Sec.  101.36(d)(3)).
    Thus, the final rule establishes, in Sec.  101.9(c)(8)(iv), an RDI 
for vitamin K of 120 mcg based on the AI that pertains only to 
phylloquinone. We are making no changes to the rule based on these 
comments.
    b. Chloride. The preamble to the proposed rule (79 FR 11879 at 
11930) stated that, under our preexisting regulations, the RDI for 
chloride is 3,400 mg (Sec.  101.9(c)(8)(iv)) and is based on the 
midpoint of the range (1,700 to 5,100 mg/day) of the ESADDI. The 
proposed rule would have chloride remain a RDI, but based on a 
population-coverage AI of 2,300 mg/day.
    We did not receive comments on the RDI for chloride and have 
finalized it without change.
    c. Potassium. The preamble to the proposed rule (id.) explained 
that the DRV of 3,500 mg for potassium was established based on its 
beneficial health effects (e.g., reduction in blood pressure) and that 
we established a DRV rather than an RDI because an RDA for specific age 
and gender groups was not established in 1990 (when we issued various 
regulations related to nutrition information on food labels). However, 
because potassium is an essential mineral and because age- and gender-
specific AIs became available in 2005, we proposed to establish an RDI 
for potassium, instead of the DRV, and thus revise Sec.  
101.9(c)(8)(iv) to set the RDI for potassium at 4,700 mg.
    We did not receive comments directly on the RDI for potassium, 
although some comments opposed using the AI for potassium to establish 
an RDI of 4,700 mg. We address those comments in part II.M.3 (see 
comment 391). The final rule, at Sec.  101.9(c)(8)(iv), establishes an 
RDI of 4,700 mg for potassium.
    d. Choline. Our existing regulations do not establish a reference 
value for choline. The preamble to the proposed rule noted that the IOM 
established age- and gender-specific AIs for choline based on intakes 
necessary to maintain liver function and that, in 2001, we received a 
FDAMA notification under section 403(r)(2)(G) of the FD&C Act for the 
use of certain nutrient content claims for choline (79 FR 11879 at 
11930). The FDAMA notification identified the DV for choline as 550 mg, 
which was based on the population-coverage AI for choline. Thus, the 
proposed rule, at Sec.  101.9(c)(8)(iv), would set an RDI of 550 mg for 
choline based on the population-coverage AI.
    (Comment 409) Several comments agreed with the proposed RDI for 
choline.
    (Response) The final rule, at Sec.  101.9(c)(8)(iv), establishes an 
RDI of 550 mg for choline.
    e. Vitamin B12. The proposed rule would lower the RDI for Vitamin 
B12 from 6 mcg/day to 2.4 mcg/day to reflect the population-
coverage RDA for Vitamin B12 established by the IOM in 2000 
(Ref. 238). We acknowledged that lowering the RDI from 6 to 2.4 mcg 
could result in a reduction of the fortification level in foods, such 
as ready-to-eat breakfast cereals, thereby decreasing the overall 
amount of crystalline vitamin B12 in the food supply (see 79 
FR 11879 at 11930). (The preamble to the proposed rule (id.) also noted 
that individuals older than 50 years of age meet their RDA mainly by 
consuming foods fortified with crystalline vitamin B12 or 
vitamin B12-containing supplements.)
    (Comment 410) Some comments supported our use of the RDA set by the 
IOM to revise the RDI for vitamin B12. One comment noted 
that, if the proposed RDI was adopted, manufacturers of fortified 
ready-to-eat cereals and other products may adjust fortification levels 
of vitamin B12 to maintain their current DV claim levels, 
thereby reducing the amount of crystalline vitamin B12 in 
the food supply. However, the comment stated that, based on an analysis 
by Murphy et al., this change would not lead to a significant increase 
in the proportion of the population with inadequate dietary intakes of 
vitamin B12. The comment said that the Murphy study 
indicated that the difference in the proportion of the total population 
with usual intakes

[[Page 33906]]

of vitamin B12 less than the EAR would be about 3 percent 
regardless of whether the revised RDI was based on a population-
weighted EAR or a population-coverage RDA, and this would be within 2 
percentage points of the percentage calculated by using the current DV. 
The comment noted that the results for older adults and teenage girls 
were a little higher, but similar regardless of the approach. The 
comment recommended that we continue to promote vitamin B12 
intake in at-risk subpopulation groups and to continue monitoring 
population intake.
    Other comments opposed lowering the RDI for vitamin B12 
and said we should retain the RDI of 6 mcg for vitamin B12. 
The comments expressed concern that a substantial decrease in the RDI 
would result in lower amounts of crystalline vitamin B12 in 
food and dietary supplements. The comments stated that this decrease 
would make it more difficult for those at-risk for deficiency, 
including older adults, vegetarians, and vegans, to achieve adequacy 
for this nutrient. The comments noted that the IOM and DGA recommended 
these at-risk groups should consume the crystalline forms.
    (Response) The final rule adopts an RDI for vitamin B12 
of 2.4 mcg based on the RDA. The RDA was established by the IOM in 2000 
for all adults and can be met by consuming natural and crystalline 
forms. While the IOM noted that it is advisable that individuals older 
than 50 years of age meet their RDA mainly by consuming foods fortified 
with crystalline vitamin B12 or vitamin B12-
containing supplements, less than 1 percent of men and 6.4 to 7.5 
percent of women older than 50 years of age consume below the EAR for 
vitamin B12, while only 3 to 5 percent of men and women in 
this age group have serum vitamin B12 levels that are 
considered to be inadequate (2003-2006 NHANES) (see 79 FR 11879 at 
11930). Based on the data provided by the comment in support of 
lowering the RDI, it is unlikely that lowering the RDI will result in a 
significant increase in the proportion of the population with 
inadequate dietary intakes of vitamin B12. If we became 
aware that foods are formulated as a result of this final rule, leading 
to lower amounts of crystalline B12 are in the food supply, 
we would consider the need for consumer education, particularly for at-
risk individuals who may need to increase intake of certain foods to 
meet nutrient needs.

N. Units of Measure, Analytical Methods, and Terms for Vitamins and 
Minerals

    The preamble to the proposed rule (79 FR 11879 at 11931) discussed 
how the IOM set DRIs using new units of measure for vitamin A, vitamin 
E, and folate and provided recommendations on the use of International 
Units (IUs) and the expression of weight amounts for sodium, potassium, 
copper, and chloride. The new units of measure for vitamin A, vitamin 
E, and folate affect how total amount of each nutrient is measured.
1. General Comments
    (Comment 411) While we did not request comment on using teaspoons 
or tablespoons as units of measure, several comments supported using 
teaspoons (tsp) and tablespoons (tbsp) in addition to or instead of 
grams (g) for nutrients. The comments said that consumers use these 
common household measures in recipes and can visualize them.
    In contrast, other comments recommended using only metric units, 
such as grams, only because they are more precise and used by other 
countries.
    (Response) We address this issue in part II.B.3.
2. Sodium, Potassium, Copper, and Chloride
    Our preexisting regulations at Sec.  101.9(c)(9) and (c)(8)(iv) 
express the units of measurement for sodium, potassium, copper, and 
chloride in milligrams. Although the preamble to the proposed rule (79 
FR 11879 at 11931) discussed IOM recommendations to use grams rather 
than milligrams (mg) and how comments to the 2007 ANPRM supported 
retaining mg instead of using grams, we declined to propose any changes 
to the units of measure for these nutrients.
    (Comment 412) Several comments supported retaining the declaration 
of ``mg'' for sodium and potassium. Other comments recommended the use 
of ``mg'' for calcium and phosphorus, but did not explain their 
reasoning.
    (Response) For reasons stated in the preamble to the proposed rule 
(79 FR 11879 at 11931), we agree with retaining ``mg'' for the units of 
measure for sodium, potassium, copper, and chloride, so the units of 
measure in Sec.  101.9(c)(8)(iv) and (c)(9) remain unchanged.
    As for calcium and phosphorus, we did not propose changing the 
units of measure, and so the final rule continues to use ``mg'' as the 
unit of measure for calcium and phosphorus.
3. Folate and Folic Acid
    a. Units of measure. Our preexisting regulations, at Sec.  
101.9(c)(8)(iv), have the RDI for ``folate'' in micrograms. In the 
preamble to the proposed rule (79 FR 11879 at 11931 through 11932), we 
explained how, in 1998, the IOM set the RDA for folate expressed as 
microgram (mcg) Dietary Folate Equivalents (DFE) and how the IOM 
Labeling Committee recommended that the use of similar units of measure 
in nutrition labeling. The preamble to the proposed rule explained how 
the IOM developed the new term, DFE, to account for the greater 
bioavailability of synthetic folic acid that is added to fortified 
foods or dietary supplements than folate that occurs naturally in foods 
(food folate) and that mcg DFE is equivalent to mcg food folate + (1.7 
x mcg synthetic folic acid) (id. at 11932). The proposed rule would 
amend Sec.  101.9(c)(8)(iv) to use mcg DFE to declare the amount of 
total folate (food folate and synthetic folic acid) on the Nutrition 
Facts label. The proposed rule would make a similar change, at Sec.  
101.36(b)(2)(ii)(B), with respect to the declaration of folic acid on 
the Supplement Facts label.
    The preamble to the proposed rule (79 FR 11879 at 11932) also 
stated that we are aware that education efforts should be provided to 
help consumers understand the new ``equivalent'' units of measurement 
for folic acid. We said that one option to help ensure consumer 
understanding would be to allow the declaration of the mcg amount of 
folic acid in parentheses in addition to declaring the amount of folate 
in mcg DFE and percent DV based on mcg DFE.
    (Comment 413) Although one comment supported using DFEs as the unit 
of measure, many comments said we should retain the preexisting DV of 
400 mcg folate or folic acid and not adopt DFEs as the unit of measure.
    Several comments stated that using mcg DFE as the unit of measure 
will confuse the public, limit the ability to monitor folate/folic acid 
intake and safety, and could negatively impact birth outcomes. The 
comments said that entities such as the IOM, the Centers for Disease 
Control and Prevention, the U.S. Public Health Service (USPHS), and the 
March of Dimes have educated the public on the importance of women of 
child-bearing age consuming at least 400 mcg of synthetic folic acid 
daily to help prevent neural tube defects. The comments said that 
changing the unit of measure may promote suboptimal intake of the 
nutrient, especially if women do not understand the difference in the 
bioavailability of

[[Page 33907]]

naturally occurring folate versus synthetic folic acid.
    Other comments stated that an educational campaign would be 
necessary, especially for obstetricians and women of child-bearing age, 
to teach them how to achieve adequate dietary folate levels if we were 
to use mcg DFE as the unit of measure. The comments said we should 
continue to declare the amount of folic acid in micrograms along with 
the percent of DV (based on the PHS recommendation) in both the 
Nutrition and Supplement Facts.
    (Response) As we stated in the preamble to proposed rule (79 FR 
11879 at 11932), the IOM developed the DFEs to reflect the most current 
recommendation for folate/folic acid for the general healthy U.S. 
population. The DFE accounts for the differences in bioavailability 
between food folate (natural folate) and folic acid which is more 
bioavailable (about 1.7 times more bioavailable). Use of mcg DFE on the 
label is important to make sure that the consumer is aware of the total 
amount of folate in a serving of food. For example, assume that the 
level of total folate in a packaged cereal is approximately 200 mcg 
folate per serving. If all of the folate in the cereal is added folic 
acid, then the amount of folate would be 340 mcg DFE (200 mcg x 1.7) 
because folic acid is more bioavailable than folate. This value is 
higher than the RDA set by IOM for children 4 to 8 years of age (200 
mcg DFE). Thus, if we retained mcg as the only unit of measure for 
folate, we would not differentiate between folic acid and food folate 
in food, and we would underestimate the contribution of fortified foods 
to the folate requirement; consequently, consumers may think they need 
more folate/folic acid than they receive from a food that contains both 
folate and folic acid.
    As for the comment suggesting that we allow the use of both mcg and 
mcg DFE as units of measure, we agree that declaring the amount of 
folic acid in mcg will provide information that women of childbearing 
age need in order to understand the unique contribution of synthetic 
folic acid from a food, given the differences in bioavailability 
compared to folate and nutrition recommendations for risk reduction of 
neural tube defects (Ref. 238).
    With respect to dietary supplement labeling, if a dietary 
supplement has added synthetic folate or a claim is made about folate, 
the manufacturer must include the declaration of folate as a 
quantitative amount by weight of folate (mcg DFE folate), and the 
percent DV based on mcg DFE folate in the Supplement Facts label. If a 
dietary supplement has added folic acid (alone or in combination with 
natural or synthetic folate), or a claim is made about folic acid, the 
nutrient declaration must include folate as a quantitative amount by 
weight of folate (mcg DFE folate), and the percent DV based on mcg DFE 
folate, in addition to the quantitative amount by weight of folic acid 
(mcg folic acid) in parentheses. If a dietary supplement has naturally 
occurring folate (with no folic acid added) and a claim is not made 
about folate, the manufacturer may voluntarily declare folate as a 
quantitative amount by weight in mcg DFE and percent DV based on mcg 
DFE folate.
    With respect to conventional food labeling, if a conventional food 
has naturally occurring folate (with no folic acid added) and there is 
no claim made about folate, the manufacturer can voluntarily declare 
folate in the Nutrition Facts label. If the manufacturer voluntarily 
declares folate, the manufacturer may declare folate followed by the 
percent DV based on mcg DFE folate, or alternatively, can declare the 
quantitative amount by weight in mcg DFE folate followed by the percent 
DV based on mcg DFE folate. If a claim is made about folate, the 
manufacturer must declare folate either by declaring folate as the 
percent DV folate based on mcg DFE folate, or as the quantitative 
amount by weight in mcg DFE folate followed by the percent DV based on 
mcg DFE folate. If folic acid is added to the conventional food, the 
manufacturer must declare folate either by declaring folate as the 
percent DV folate based on mcg DFE, or as the quantitative amount by 
weight in mcg DFE folate followed by the percent DV based on mcg DFE 
folate, in addition to the quantitative amount of folic acid in mcg in 
parentheses. This will provide the needed information about the amount 
of folic acid in a conventional food or dietary supplement for women 
who are capable of becoming pregnant. Declaring folate, either as a 
quantitative amount in mcg DFE followed by the percent DV or only as a 
percent DV based on mcg DFE, and, mcg folic acid, in circumstances when 
folic acid is added or claims are made about folic acid, the 
declaration of folate/folic acid should provide adequate and correct 
information for the general U.S. population, including the women of 
childbearing age.
    As for the comments regarding the need for an educational campaign, 
we agree that it is important for changes to the labeling to be 
accompanied by education efforts to help consumers understand the new 
labels (see part II.B.1). We intend to coordinate education and 
outreach efforts with Federal Agencies and other organizations with an 
interest in nutrition and health to emphasize, among other things, the 
newly adopted units of measure for folate in mcg DFE, percent DV based 
on mcg DFE, and mcg of folic acid for the first time on the Nutrition 
Facts and Supplement Facts labels.
    (Comment 414) Several comments were concerned about the removal of 
mcg folic acid from the food label. Some comments stated that, by only 
reporting mcg DFE folate on the label, it would no longer be possible 
to measure the percentage of a subpopulation that consumes in excess of 
the UL for folic acid. The comments said that intake data is obtained 
through the NHANES, which uses food labels to collect information on 
the type and amount of micronutrients (including folic acid) contained 
in food products.
    Other comments stated that limiting the units of measure to mcg DFE 
would make it difficult for consumers to make an informed decision 
regarding their actual folic acid intake. The comments said that this 
is a particular concern for older adults who are at greater risk for 
developing macrocytic anemia due to a deficiency of vitamin 
B12 and that this condition could be masked by excessive 
intake of folic acid from fortified foods and/or supplements. Other 
comments stated that the introduction of mcg DFE as the unit of measure 
for folic acid may prompt some manufacturers (who currently provide 100 
percent of the DV for folic acid) to reduce the amount of folic acid in 
their products. For example, the manufacturer of a dietary supplement 
that currently contains 100 percent of DV for folic acid (400 mcg folic 
acid) may reduce the amount to 235 mcg folic acid or 400 mcg DFE to 
retain 100 percent DV.
    (Response) As stated in our response to comment 413, we are not 
limiting the units of measure for folic acid to mcg DFE folate on the 
Nutrition Facts label. If folic acid is added or claims are made about 
folic acid, the Nutrition Facts label must include the declaration of 
folic acid as a quantitative amount by weight in mcg folic acid.
    With respect to measuring the percentage of a subpopulation that 
consumes in excess of the UL for folic acid, we note that the rule was 
not intended nor designed to facilitate such research. The Nutrition 
Facts label provides information to assist consumers in maintaining 
healthy dietary practices. By having only mcg DFE or mcg of folic acid 
on the label,

[[Page 33908]]

it would not be possible to determine the percentage of a subpopulation 
that exceeds the UL for folic acid. To determine the percentage of a 
subpopulation with folic acid intake in excess of the UL, one would 
have to perform an analysis using the consumption data from NHANES and 
the UL set by IOM for various age and gender groups.
    As for the comment's statements regarding NHANES, What We Eat in 
America (WWEIA)/NHANES does not use only food labels to collect 
information on the type and amount of micronutrients contained in food 
products. The preexisting Nutrition Facts label declares folate in mcg 
which represents both natural folate and synthetic folic acid, without 
taking into account differences in bioavailability factors. The WWEIA/
NHANES currently reports the amount of folate consumed as mcg DFE, as 
well as folic acid (mcg), food folate (mcg), and total folate (mcg). 
Thus, the Nutrition Facts label is not the sole source of information 
for folate and folic acid for this database.
    As for older adults and the risk of developing macrocytic anemia 
due to a deficiency of vitamin B12, we disagree that using 
mcg DFE on the label will put older adults at greater risk. The current 
Nutrition Facts label does not differentiate between synthetic folic 
acid and naturally occurring folate in the food label. The folate RDA 
for individuals 19 years of age and older is 400 mcg DFE, and not 400 
mcg folic acid. The DFE accounts for the differences in bioavailability 
between food folate (natural folate) and folic acid (which is 
approximately 1.7 times more bioavailable than food folate). Therefore, 
by declaring folate as mcg DFE and percent DV based on mcg DFE folate, 
as applicable, on the Nutrition Facts label, the total folate will be 
reported and will provide the majority of the general, healthy U.S. 
population (including older individuals) a more accurate amount of 
their intake. Furthermore, by requiring the mandatory declaration of 
the amount of folic acid as mcg folic acid in parentheses, when folic 
acid is added or a claim is made about it, women of childbearing age 
will have the information they need to understand the unique 
contribution of synthetic folic acid from a food to adhere to nutrition 
recommendations to reduce the risk of neural tube defects. In addition, 
other consumers, such as older adults, can determine how much folic 
acid is in a serving of food.
    With respect to reformulation, the comment did not provide any 
evidence to suggest that reformulation would occur, and so we have no 
basis to determine the extent to which reformulation might occur or 
whether reformulation would present any potential issues with respect 
to consumption of folate. We note, however, that if manufacturers 
decrease the amount of folic acid from 400 mcg folic acid to 400 mcg 
DFE to retain the 100 percent DV, the needs of the majority of the U.S. 
population will be met. For the majority of U.S. population, the RDA 
and its unit of measure is mcg DFE folate and not mcg of folic acid. 
Therefore, reporting total folate as mcg DFE folate and percent DV 
based on mcg DFE is more accurate.
    (Comment 415) Several comments stated that, for a dietary 
supplement that is ingested on an empty stomach, 1 mcg DFE is 
equivalent to 0.5 mg folic acid and is therefore subject to the 
conversion factor of 2.0 not 1.7. The comment said we should clarify 
this in the final rule if we adopt DFEs as the unit of measure.
    (Response) We are not limiting the units of measure to DFEs in the 
final rule. The IOM defined DFE as follows: 1 mcg DFE = 1 mcg food 
folate; 1 mcg DFE = 0.6 mcg folic acid from fortified foods or dietary 
supplements consumed with foods; 1 mcg DFE = 0.5 mcg folic acid from 
dietary supplements taken on an empty stomach. We do not know how many 
people take a supplement containing folic acid on an empty stomach or 
with a meal. To ensure consistency in the labeling of conventional 
foods fortified with folic acid, dietary supplements containing folic 
acid, and dietary supplements containing folic acid that may also 
contribute calories and other nutrients, we conclude that using the 
conversion factor of 0.6 mcg (multiply by 1.7) for folic acid is 
appropriate. The final rule requires dietary supplements to include the 
declaration of the quantitative amount of folic acid, when added or 
when a claim is made about folic acid, in addition to folate in mcg DFE 
and percent DV based on mcg DFE. The final rule also states that 1 mcg 
DFE is equal to 1 mcg naturally occurring folate and equal to 0.6 mcg 
folic acid.
    (Comment 416) Some comments said that mcg DFE fails to take into 
consideration the higher bioavailability of synthetic folates compared 
with naturally occurring dietary folate and should not be used on 
labels. The comments said that added L-5-methyltetrahydrofolate (also 
known as L-5-MTHF or L-MTHF) would be assigned the same bioavailability 
as naturally occurring folate and would underestimate the true 
bioavailability of the folate in the food. The comments noted that both 
the calcium and glucosamine salts of L-5-MTHF have bioavailabilities 
similar to folic acid. The comments said we should support a conversion 
factor equivalent to that for folic acid (x 1.7) for the labeling of 
these synthetic folates in dietary supplements and conventional foods.
    (Response) The use of synthetic folates (i.e., calcium and 
glucosamine salts of L-MTHF) in dietary supplements, and the 
appropriate conversion factor for these substances, warrants further 
review. We are not aware of the use of any synthetic folates, including 
calcium and glucosamine salts of L-5-MTHF, in conventional food. We 
note that folic acid is regulated as a food additive under Sec.  
172.345; the additive is identified as (N-[4-[[(2-amino-1,4-dihydro-4-
oxo-6-pteridinyl) methyl]amino]benzoyl]-L-glutamic acid; CAS Reg. 59-
30-3) for use as a nutrient in foods and may be added to conventional 
foods subject to a standard of identity when the standard provides for 
the addition of folic acid; to breakfast cereal and corn grits at 
specified levels; and to infant formula according to applicable 
regulations (Sec.  172.345). Conditions of use of folic acid in medical 
foods, foods for special dietary use, and for meal-replacement products 
also are included in Sec.  172.345. Additional uses of folic acid as 
described in Sec.  172.345 would require submission of a food additive 
petition asking us to amend the regulations to allow for the additional 
use. Information on submitting a food additive petition is described in 
Sec.  171.1. Manufacturers of food products that contain other forms of 
folic acid or synthetic folate, such as calcium and/or glucosamine 
salts of L-5-MTHF should consult the Office of Food Additive Safety to 
determine the appropriate regulatory pathway for the lawful use of 
their products.
    Although we asked for comment in the 2007 ANPRM about whether the 
current DV units for folate (mcg folate) should be consistent with the 
IOM DRI reports for folate (mcg DFE) (72 FR 62149 at 62170), we did not 
ask about the use of synthetic folate, such as calcium and/or 
glucosamine salts of L-5-MTHF in food, including dietary supplements, 
or invite comment about the conversion factor for synthetic folate 
compared to that for folic acid. Therefore, we intend to consider the 
comparability of synthetic folates in dietary supplements and the need 
for a conversion factor for each in a separate rulemaking. Until such 
rulemaking is completed, we do not intend to object to a manufacturer 
using its own established conversation factors, provided that the 
declaration is truthful and not misleading. We would not

[[Page 33909]]

expect a conversion factor to exceed 1.7 (comparable to folic acid) 
when reporting mcg DFE on the Supplement Facts label. Any declaration 
of mcg DFE for a dietary supplement that represents in whole or in part 
the amount of synthetic folate present, for which a conversion factor 
was applied, must be truthful and not misleading under section 403(a) 
and 201(n) of the FD&C Act. We will be able to determine the conversion 
factor used through information obtained from records required by this 
final rule for natural folate, folic acid, and synthetic folate present 
in the product and the declared mcg DFE on the label.
    (Comment 417) The preamble to the proposed rule also stated that we 
are aware that education efforts should be provided to help consumers 
understand the new ``equivalent'' units of measure for folic acid (79 
FR 11879 at 11932). We also said that one option to help ensure 
consumer understanding would be to allow the declaration of the amount 
of folic acid in parentheses in addition to declaring the amount in mcg 
DFE, and we invited comment on this option (id.).
    Several comments stated that, if DFEs are to be included on food 
labels, the mcg of folic acid must be included in parentheses. The 
comments said that the IOM recommended that women who may become 
pregnant consume 400 mcg of folic acid in addition to the RDA. The 
comments also said that using mcg DFE alone as the unit of measure will 
make it difficult for women to discern how much of their daily intake 
is from folic acid and which foods would be best choices for ensuring a 
daily intake of 400 mcg folic acid a day. The comments added that this 
approach could put women at higher risk for having a neural tube defect 
affecting a pregnancy. Some comments also noted that there may also be 
conventional foods containing only added folic acid, such as meal 
replacement foods based on protein concentrates that do not contain 
significant levels of naturally occurring folate.
    (Response) We agree that including the mcg folic acid when added to 
a food or when a claim is made about folic acid is necessary to help 
women of childbearing age determine the amount of folic acid in each 
food. Thus, we have revised Sec.  101.9(c)(8)(iv) and (c)(8)(vii) to 
require the declaration of folic acid in mcg under such circumstances.
    (Comment 418) Some comments stated that we should retain the 
current DV of 400 mcg as folate or folic acid without adopting a DFE 
approach, along with the percent DV (based on the PHS recommendation) 
in both the Nutrition and Supplement Facts labels. One comment 
suggested that an educational campaign would be necessary, especially 
for obstetricians and women of child-bearing age, to teach them how to 
achieve adequate dietary folate levels if we adopt the mcg DFE unit of 
measure.
    (Response) We agree that consumer education regarding the new unit 
of measure will be helpful (see part II.B.1 for a discussion of 
educational activities). We disagree that we should retain the DV and 
the percent DV based on the amount of mcg of folic acid. The DV and the 
percent DV should be based on mcg DFE, which reflects the most current 
recommendation for folate/folic acid for the general U.S. population 
and takes into account the differences in bioavailability between food 
folate and folic acid which is more bioavailable.
    b. Analytical methods. The preamble to the proposed rule (79 FR 
11879 at 11932) noted that available analytical methods cannot 
distinguish between naturally occurring folate in conventional food and 
folic acid that is added to conventional food products. To calculate 
DFEs, the preamble to the proposed rule (id.) explained that it is 
necessary to know both the amount of folate and folic acid in the food 
product, and so proposed Sec.  101.9(g)(10) would require manufacturers 
to make and keep records to verify the amount of folic acid added to 
the food and folate in the finished food, when a mixture of both 
naturally occurring folate and added folic acid are present in the 
food.
    (Comment 419) We did not receive any comments with respect to 
scientifically valid methods for determining folate and folic acid 
separately. However, one comment objected to the proposed recordkeeping 
requirement.
    (Response) We decline to revise the rule to remove the 
recordkeeping requirement. In the absence of an analytical method that 
distinguishes between folate and folic acid, records are necessary to 
demonstrate compliance with the label declaration and include written 
records of the amount of folic acid added to the food (conventional 
food or dietary supplement), the amount of synthetic folate, if added 
to the dietary supplement, and naturally occurring folate in the 
finished product. Without such records, we would be unable to determine 
or verify the amounts and also would not be able to determine whether 
the mcg DFE value listed on the label is correct.
    (Comment 420) Proposed Sec.  101.9(g)(10)(vii) would require 
manufacturers to make and keep written records of the amount of folic 
acid added to the food and folate in the finished food when a mixture 
of folate and folic acid is present in that food. One comment would 
revise Sec.  101.9(g)(10)(vii) to state that, when folic acid and/or 
purified folate salts (e.g., L-methylfolate) is added to a food, 
manufacturers must make and keep written records of the amount of folic 
acid, and/or purified folate salt, added to the food, as well as the 
amount of naturally occurring folate if present. The comment noted that 
these records will be necessary any time folic acid or folate salt is 
added to food to justify the calculation of the declared mcg DFE, even 
if no naturally occurring folate is present.
    (Response) We agree that when folic acid is added to a conventional 
food or dietary supplement and synthetic folate (e.g., L-5-MTHF) is 
added to a dietary supplement, manufacturers must keep written records 
of the amount of synthetic folate added to a dietary supplement and the 
amount of folic acid added to the conventional food or dietary 
supplement as well as the amount of naturally occurring folate in the 
finished conventional food or dietary supplement. We have revised Sec.  
101.9(g)(10)(vii) accordingly.
    c. Terms to declare folate. Our preexisting regulations identify 
``folic acid'' and ``folacin'' as synonyms of folate and allow these 
terms to be added in parentheses after folate or listed without 
parentheses in lieu of ``folate'' on the Nutrition Facts label (Sec.  
101.9(c)(8)(v)) or on the Supplement Facts label (Sec.  
101.36(b)(2)(B)(2)).
    Consistent with the proposed amendments related to the units of 
measure for folate that take into account the differences between 
folate and folic acid, the proposed rule would: (1) Eliminate the 
synonym ``folacin'' specified in Sec. Sec.  101.9(c)(8)(v) and 
101.36(b)(2)(i)(B)(2); (2) require, in proposed Sec.  101.9(c)(8)(vii), 
that the term ``folate'' be used in the labeling of conventional foods 
that contain either folate only or a mixture of folate and folic acid; 
and (3) require that the term ``folic acid'' be used in the labeling of 
dietary supplements only. Thus, under the proposed rule, conventional 
foods would not be permitted to use the term ``folic acid.''
    (Comment 421) One comment supported eliminating the term 
``folacin'' from the Nutrition Facts and Supplement Facts labels. 
However, other comments asked that we continue to allow the use of the 
term ``folate'' on Supplement Facts labels. Several comments stated 
that the use of the term folate on dietary supplement labels

[[Page 33910]]

refers to dietary folates which are members of the folate group that 
can be found in food, including folinic acid (5-fomryltetrahyrofolate). 
For some dietary supplements, calcium L-methylfolate (L-5 MTHF), and 
various other tetrahydrofolates, as synthetic folate, may be added. In 
comparison, the comments said that folic acid is synthetically produced 
and refers to only one member of the folate group (pteroylmonoglutamic 
acid). The comments said it would be scientifically and chemically 
incorrect and misleading to consumers to refer to the reduced folate 
forms in dietary supplements as folic acid, given that folic acid 
represents only the monoglutamic form.
    Other comments noted there are a large number of dietary 
supplements that are ``whole food'' supplements containing naturally 
occurring folate rather than added folic acid (e.g., multivitamin 
capsules manufactured using powdered cultured yeast).
    (Response) We agree that there are dietary supplements that may 
contain natural folate from food or synthetic folate (e.g., L-5-MTHF). 
If synthetic folate is added to a dietary supplement, folate must be 
declared as mcg DFE folate and percent DV based on DFE. This will 
result in consistency in the nutrient terms used and units of measure 
for the declaration of folate on both conventional foods and dietary 
supplements, which will avoid confusion among consumers. We are not 
aware of a manufacturer choosing to voluntary declare naturally 
occurring folate in a dietary supplement ingredient, but if not added 
for the purpose of supplementation, the manufacturer is not required to 
declare the quantitative amount or the percent DV for naturally 
occurring folate. If a manufacturer chooses to voluntary declare 
naturally occurring folate, the manufacturer must declare both the 
quantitative amount in mcg DFE and the percent DV. In addition, if 
folic acid is added to the dietary supplement that has naturally 
occurring folate present, the quantitative amount of folate, the 
quantitative amount of folic acid, and the % DV must be declared. The 
terminology for the units of measure in the Supplement Facts label will 
be consistent with the terminology in the Nutrition Facts label. 
Therefore, the final rule removes ``folacin'' from the list of synonyms 
that may be used for folate in the Nutrition Facts label in Sec.  
101.9(c)(8)(v) and the Supplement Facts label in Sec.  
101.36(b)(2)(i)(B)(2)). In addition, the final rule removes the term 
``folic acid'' from the list of synonyms that may be added in 
parentheses immediately following ``folate'' on the Nutrition Facts 
label in Sec.  101.9(c)(8)(v) or in place of the term ``folate'' on the 
Supplement Facts label in Sec.  101.36(b)(2)(i)(B)(2) because we are 
now requiring that both the terms ``folate'' and ``folic acid'' be 
included, when declared, on both the Nutrition and Supplement Facts 
label.
    (Comment 422) Several comments suggested that not allowing the use 
of the term ``folate'' on Supplement Facts labels and not considering 
L-5 MTHF calcium (Metafolin) to be equivalent to folic acid would have 
devastating, negative effects on industry. The comments said that 
eliminating the term ``folate'' would prevent dietary supplement 
manufacturers from being able to use L-methylfolate in their products. 
Other comments said we should clarify how L-5 MTHF should be labeled.
    (Response) The final rule requires the use of the term ``folate'' 
on Supplement Facts labels and achieves consistency between the 
Supplement Facts and Nutrition Facts labels.
    We also intend to consider the comparability of synthetic folates 
(e.g., L-5-MTHF calcium (metafolin)) in dietary supplements and the 
need for a conversion factor for each in a separate rulemaking. In the 
interim, manufacturers of synthetic folates, such as calcium and/or 
glucosamine salts of L-5- MTHF may use their established conversation 
factors (not to exceed 1.7 (comparable to folic acid)) when reporting 
mcg DFE, and we can determine what conversion factor is being used 
through information obtained from records required by this final rule 
for natural folate, folic acid, and synthetic folate present in the 
product and the declared folate mcg DFE on the label.
    (Comment 423) Some comments stated that limiting the use of the 
term ``folate'' to conventional food only would effectively make drug 
companies the only source for people who have a genetic polymorphism in 
the MTHFR gene. Some comments stated that it is important and essential 
that the labeling of dietary supplements explicitly state the form or 
forms of folate they contain because many people are not able to 
convert folic acid to folate. The comments added that, although there 
is no agreement regarding the number of people whose bodies have 
difficulty converting folic acid to folate, there is agreement that it 
is a serious concern for many individuals. The comments said there is 
much knowledge available regarding defects in two deoxyribonucleic acid 
(DNA) sequences responsible for producing enzymes needed for the final 
stage of conversion of folic acid into the active form needed by the 
human body and that these defects relate to an enzyme called MTHFR and 
are very common, although the defects vary enormously between ethnic 
groups and regions. The comments said that the defects can be found in 
as many as 44 percent of North American Caucasians and over 50 percent 
of Italians and are more common among those predisposed to diseases 
such as cancer, heart disease, and autism. The comments said that these 
estimates do not account for mutations in other genes involved in 
folate metabolism, such as DHFR, where data have only been emerging 
recently. For individuals who have mutations impacting MTHFR or other 
genes relating to folate metabolism, the comments said there is a 
distinct possibility of building up too much un-metabolized folic acid 
thereby potentially increasing the risk of cancer, heart disease or 
stroke. Consequently, a substantial segment of the population needs to 
consume folate rather than folic acid and would not be able to process 
dietary supplements containing folic acid.
    Several comments stated that requiring dietary supplement labels to 
use the term ``folic acid,'' when the product only contains folates 
found in food, would mislabel the product.
    (Response) When folic acid is added to conventional food, the final 
rule requires the declaration of mcg folic acid in addition to the 
declaration of folate as a percent DV based on mcg DFE or as a 
quantitative amount by weight in mcg DFE and the percent DV based on 
mcg DFE. When folic acid is added to dietary supplements, the final 
rule requires the the quantitative amount by weight for folate (mcg DFE 
folate) and the percent DV based on mcg DFE for folate, in addition to 
the mcg folic acid in parentheses. This should address the comments' 
concerns.
    (Comment 424) One comment would revise the rule to state that the 
term ``folic acid'' should be used in the labeling of dietary 
supplements, but that the term ``folate'' should be used if the dietary 
supplement contains folates in food as opposed to folic acid. The 
comment said that conventional foods would not be permitted to use the 
term ``folic acid'' unless they are fortified with folic acid. The 
comment said this result would be consistent with our intent to 
distinguish between items containing folate and those that primarily 
contain synthetic folic acid.
    Another comment would revise footnote 3 in proposed Sec.  
101.9(c)(8)(iv). The proposed footnote would state that

[[Page 33911]]

folic acid ``must be used for purpose of declaration in the labeling of 
dietary supplements'' and ``must also be declared in mcg DFE.'' The 
comment would revise the footnote to say that folic acid ``must be used 
for foods that contain this nutrient solely in the form of added folic 
acid. Foods which supply both folate and folic acid must list the 
predominant form. Folate and folic acid must both be declared in mcg 
DFE. Additional information regarding the types(s) or sources(s) of the 
nutrients (e.g., folate, folic acid, or L5-MTHF) and or/relative 
amounts where more than one form is present, may be included in 
parentheses.'' The comment also would revise Sec.  101.9(c)(8)(vii) to 
require ``folate'' ``for products containing only or predominantly 
folate'' and ``folic acid'' for ``products containing only or 
predominantly folic acid.'' (The proposed rule would require, when the 
amount of folate is declared in the labeling of a conventional food, 
the use of the name ``folate'' for products containing either folate 
alone or a mixture of folate and folic acid and the use of the term 
``folic acid'' when the nutrient is declared in the labeling of a 
dietary supplement.) The comment also would revise the rule to say that 
additional information regarding the types(s) or sources(s) of the 
nutrients (e.g., folate, folic acid, or L-methylfolate) and or/relative 
amounts where more than one form is present, may be included in 
parentheses.
    (Response) The final rule requires the use of the term ``folate'' 
on Supplement Facts labels when folic acid or synthetic folate is added 
and must be declared and when naturally occurring folate is present and 
may be declared. The final rule also requires the use of the term 
``folic acid'' in mcg folic acid when folic acid is present. This 
achieves consistency in terminology between the Supplement Facts and 
Nutrition Facts labels. If folic acid is declared, manufacturers of 
dietary supplements must also declare the quantitative amount of 
folate. The mcg DFE reflects the higher bioavailability of folic acid 
and certain synthetic folate (e.g., L-5-MTHF) than that of food folate 
and is the basis of DV.
    Under the Supplement Facts label requirements at Sec.  101.36(d), 
the source ingredient may be identified in parentheses immediately 
following or indented beneath the name of a dietary ingredient and 
preceded by the word ``as'' or ``from.'' When a source ingredient is 
not identified within the nutrition label, it must be listed in an 
ingredient statement in accordance with Sec.  101.4(g). However, when a 
source ingredient is identified in the nutrition label, we do not 
require it to be listed again in the ingredient statement. With respect 
to conventional food, the only form that currently can be added to 
conventional food is folic acid under Sec.  172.345 and not any other 
forms. If folic acid is added to a conventional food, folic acid must 
be listed in the ingredient list (Sec.  101.4(a)).
    (Comment 425) Some comments stated that not allowing the term 
``folate'' on dietary supplement labels violates the First Amendment. 
The comments said we cannot require that labeling to refer to folate as 
folic acid because, according to the comments, such labeling would then 
be false.
    (Response) The final rule requires the use of the terms ``folate'' 
and ``folic acid,'' when declared, on Supplement Facts labels and 
achieves consistency between the terms used and units of measure in the 
Supplement Facts and Nutrition Facts labels. Therefore, the comments' 
First Amendment concerns are no longer applicable.
    (Comment 426) One comment said that there is sufficient theoretical 
and circumstantial evidence that could compel the informed consumer to 
seek dietary supplements containing methyl folate rather than folic 
acid. Other comments suggested putting the term ``folate'' on 
conventional foods and dietary supplement labels, and using ``folic 
acid'' on dietary supplement labels with the source in parentheses 
(e.g., Folic acid as calcium l-5 methyltetrahyrofolate).
    (Response) Under the Supplement Facts label requirements at Sec.  
101.36(d), the source ingredient may be identified in parentheses 
immediately following or indented beneath the name of a dietary 
ingredient and preceded by the word ``as'' or ``from'' (e.g., ``folate 
(as L-5-MTHF-calcium)).'' When a source ingredient is not identified 
within the Nutrition Facts label, it must be listed in an ingredient 
statement in accordance with Sec.  101.4(g). However, when a source 
ingredient is identified in the Nutrition Facts label, it will not be 
listed again in the ingredient statement. For conventional food, under 
Sec.  172.345, the only form that currently can be added to 
conventional food is folic acid and not any other forms. If folic acid 
is added to a conventional food, folic acid must be listed in the 
ingredient list (Sec.  101.4(a)).
    (Comment 427) One comment stated that it is reasonable not to 
permit the term folate to be used alone on dietary supplement labels 
because it is not sufficiently specific. The comment added that if DFE 
is used for foods, it should be used for dietary supplements as well, 
but that correct calculation is uncertain. The comment suggested using 
the term FAE (folic acid equivalent) instead of DFE because FAE is 
based on a well-defined compound, unlike folate naturally present in 
unspecified food. Furthermore, the comment said, when the folic acid 
dose is sufficiently small, the biological availability is much better 
defined than folate from unspecified food. The calculation of FAE would 
include contribution from all folates, which would include folic acid 
and L-5-MTHF salts. The comment also stated that, as understanding of 
folate naturally occurring in food improved, the calculation of its 
contribution to FAE can be improved.
    (Response) We address the requirements for labeling folate in our 
response to comment 413.
    We disagree that the term FAE should be used on the label instead 
of DFE. Based on the IOM report (IOM 1998), the correct terminology 
that is accepted by the scientific community is mcg DFE and not FAE. We 
will, however, monitor the science in this area and, if there are any 
major changes based on the future consensus report, we will consider 
whether further changes are needed.
    (Comment 428) One comment stated that, while there is consensus 
that pure folic acid is more bioavailable than naturally occurring 
folate in food, there is currently no scientific consensus as to the 
magnitude of this effect. The comment said that one recent review 
states that the bioavailability of food folate is commonly estimated at 
50 percent of folic acid bioavailability, but said this should be 
considered a rough estimate because the data on the bioavailability of 
food folate vary between 30 and 98 percent. The comment noted that, 
even if a dietary supplement's direction for use specifies taking the 
products with food or alone, many consumers may not comply. The comment 
also stated that the more precise estimates (i.e., based on consumption 
of the nutrient in fortified food or a supplement taken with food vs. 
supplement taken alone) are not justified by the available data. The 
comment said that our proposed definition, based on IOM recommendations 
dating to 1998, no longer represents current knowledge and developments 
in the formulation of foods and supplements accurately. The comment 
would revise the definition to assign a value to naturally occurring 
folate at 50 percent of the value of folic acid (as well as at 50 
percent of the value of L-MTHF salts on the equimolar basis to folic 
acid.
    The comment also would revise footnote 4 in Sec.  101.9(c)(8)(iv). 
As

[[Page 33912]]

proposed, the footnote would explain that DFE stands for ``Dietary 
folate equivalents'' and that 1 DFE equals 1 microgram food folate and 
equals 0.6 micrograms folic acid from fortified food or as a supplement 
consumed with food equals 0.5 micrograms of a supplement. The comment 
would revise the footnote to capitalize the first letters in ``folate 
equivalents'' and to state that ``1 DFE = 1 mcg naturally occurring 
folate = 0.5 mcg folic acid (anhydrous basis)* = 0.56 mcg of L-
methylfolate calcium salt (anhydrous basis, molecular weight of 
497.5))* = 0.93 mcg L-methylfolate glucosamine salt (anhydrous basis, 
molecular weight of 817.8))*. With respect to the asterisks, the 
comment said that, because these numbers will often be calculated 
rather than determined through testing, it is important to specify how 
water present in the ingredient is to be accounted for in the 
calculation.
    (Response) We disagree that we should assign the value of naturally 
occurring folate at 50 percent of the value of folic acid (folic acid 
multiply by 2 instead of 1.7). We agree that the bioavailability of 
food folate at 50 percent of the bioavailability of folic acid is 
considered a rough estimate, as data on the bioavailability of food 
folate may vary between 30 percent and 98 percent. While we recognize 
that the IOM recommendation dates to 1998, it remains the best 
scientific consensus report that is available now. We will monitor the 
science in this area and, if there are any changes based on the future 
consensus report, we will consider whether to make modifications.
    In regard to taking into account the weights of the salts in the 
formula weights of the available 5-MTHF derivatives, label values and 
requirements are presented on labels on a weight basis (e.g., mg of 
calcium, rather than molar equivalents of calcium). Manufacturers are 
responsible for calculating amounts of the salt forms that, when added, 
will provide accurate amounts of folate for the label declaration. This 
is routinely done with other compounds such as minerals (e.g., for 
calcium, the label states the amount of calcium, not the amount of 
calcium carbonate that is added).
    As for the footnote pertaining to DFE in Sec.  101.9(c)(8)(iv), we 
have revised it to read as follows: ``DFE = Dietary Folate Equivalents; 
1 DFE = 1 mcg naturally occurring folate = 0.6 mcg folic acid.''
4. Vitamins A, D, and E
    Our preexisting regulations, at Sec. Sec.  101.9(c)(8)(iv) and 
101.36(b)(2)(ii)(B), require the use of International Units (IUs) for 
the labeling of vitamins A, D, and E on the Nutrition and Supplements 
Facts labels. The preamble to the proposed rule (79 FR 11879 at 11932) 
described how changes in our understanding of vitamin activity, along 
with the IOM Labeling Committee's recommendation to change the units of 
measure for these nutrients to be consistent with the units in the new 
DRI reports, led us to propose amending Sec.  101.9(c)(8)(iv) to 
replace IUs for the RDIs for vitamin A, vitamin D, and vitamin E with 
mcg RAE for vitamin A, mcg for vitamin D, and mg [alpha]-tocopherol for 
vitamin E.
    a. General comments.
    (Comment 429) Several comments supported changing the units of 
measure for vitamin A, vitamin D, and vitamin E. One comment supported 
using mg because, the comment asserted, that is how most registered 
dietitians give recommendations. Another comment cited a study that 
reported that physicians typically prescribe vitamin and mineral 
intakes in mg (Ref. 239). Other comments asked us to retain IUs rather 
than change to mcg RAE, mcg vitamin D, and mg vitamin E. The comments 
said that consumers are familiar with IUs and would be confused by use 
of new units for these nutrients. Other comments seeking to retain IUs 
as the unit of measure for vitamin D noted that IUs are used on dietary 
supplements and by clinicians. Another comment requested that the unit 
of measure for vitamin D be consistent for foods and supplements. One 
comment supporting the continued use of IUs as a unit of measure noted 
that the IOM uses IUs for vitamin D.
    Other comments recommended that we develop an educational campaign 
to help consumers understand that changes in the units of measure. Some 
comments suggested that we make a gradual transition to the new units 
of measure, including a period during which the labels could use IUs in 
addition to the new units of measure to help consumer understanding.
    (Response) We acknowledge that consumers may need some time to 
adjust to the new units and consider educational activities important 
to assist consumers to understand the changes made. However, unlike for 
vitamins A and E, we have further considered the use of IUs for vitamin 
D and have determined there are good reasons, specific to vitamin D, to 
permit the voluntary labeling in IUs for vitamin D in addition to 
requiring the new mcg units. First, although the IOM Labeling Report 
(Ref. 25) recommended the use of mcg as the unit of measure for vitamin 
D, some other IOM materials such as the IOM report on calcium and 
vitamin D (Ref. 200) present both IUs and mcg as the unit of measure. 
Thus, we agree, in part, with the comment noting that the IOM uses IUs 
as the unit of measure. Second, we found that the majority of the U.S. 
population has usual intakes of vitamin D below the EAR from 
conventional foods alone, and even when combined with dietary 
supplements (79 FR 11879 at 11922). Moreover, certain segments of the 
U.S. population are at risk for inadequacy and may be at increased risk 
of deficiency. Inadequate intakes of vitamin D are associated with 
osteoporosis and osteopenia (id.). Third, there are not a wide variety 
of food sources of vitamin D (79 FR 11879 at 11921), and many 
individuals rely on vitamin D supplements labeled in IUs to achieve an 
optimal intake, often on the advice and prescription of a clinician. 
For these reasons, we have determined it is appropriate to permit the 
voluntary labeling of vitamin D in IUs, in parentheses, alongside the 
mandatory declaration in mcg units. In this way, the manufacturer can 
determine whether to include IUs on the label for its products, based 
on the use of the product and consumers who may be relying on the 
advice of a clinician who recommends or prescribes vitamin D in IUs 
alone, or combined with, mcg units. The reasons we provide for the need 
for voluntary labeling of IUs for vitamin D are not present with 
respect to vitamin A or E as the IOM is consistent in presenting units 
of measure for these nutrients and we have determined them not to be 
nutrients of public health significance. Therefore, we are replacing 
IUs with mcg which will be consistent with the IOM Labeling Committee's 
recommendation that the units of measure be consistent with the DRIs. 
We agree that the unit of measure for vitamin D should be consistent 
for foods and supplements. We note that the Supplement Facts label 
reflects the unit of measure for vitamin D required by Sec. Sec.  
101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B) thus will reflect mcg as the 
unit of measure for both conventional foods and dietary supplements.
    Furthermore, we provide for voluntary labeling of vitamin D in IUs 
on both conventional food and dietary supplements. Because we have 
determined that vitamin D is a nutrient of public health significance, 
we consider that voluntary labeling in IUs for vitamin D will assist 
consumers in maintaining healthy dietary practices. The voluntary 
listing of the amount of vitamin D in IUs should be listed in

[[Page 33913]]

parentheses next to the mcg amount for vitamin D.
    As for a transition period to the new units of measure, we note 
that the final rule has a compliance date of July 26, 2018, although 
the compliance date for manufacturers with less than $10 million in 
annual food sales is July 26, 2019. This should give manufacturers and 
consumers some time to convert to the new units of measure and also 
give us some time to educate consumers about the change.
    (Comment 430) Some comments urged that we use the symbol `[micro]g' 
instead of `mcg'.
    (Response) We decline to amend the rule as suggested by the 
comment. While the abbreviation ``[micro]g'' may also be used for 
micrograms, the use of ``mcg' instead of ``[micro]g'' may prevent 
consumers from misinterpreting the prefix [micro] as m (milli).
    b. Specific comments on the units of measure for individual 
vitamins. Several comments focused on the units of measure for 
individual vitamins.
    (Comment 431) We proposed to change the units of measure for 
vitamin A in Sec.  101.9(c)(8)(iv) by replacing ``IU'' with ``mcg,'' 
representing mcg Retinol Activity Equivalents (RAE). The preamble to 
the proposed rule explained that the IU for vitamin A does not reflect 
the carotene:retinol equivalency ratio, that the vitamin A activity of 
provitamin A carotenoids (such as [beta]-carotene) is less than pre-
formed vitamin A (retinol), and that RAEs consider 6 mcg of dietary 
[beta]-carotene to be equivalent to 1 mcg of purified [beta]-carotene 
in supplements (79 FR 11879 at 11932). We proposed a similar change 
dietary supplements in proposed Sec.  101.36(b)(2)(i)(B)(3).
    Several comments agreed with the change to mcg RAE. However, other 
comments opposed changing IUs to mcg RAE; the comments said that the 
change fails to distinguish between synthetic [beta]-carotene and 
naturally derived [beta]-carotene in foods and supplements and results 
in less vitamin A declared on supplements.
    One comment noted that we provided only RAE conversions for 
retinol, beta-carotene, alpha-carotene and beta-cryptoxanthin and said 
it would be incorrect to apply the same conversion factor to naturally 
occurring, as compared to synthetically derived, [beta]-carotene.
    (Response) We agree there is a difference in biological activity 
between synthetic and naturally derived [beta]-carotene. Information 
presented in Table 2 of the proposed rule (79 FR 11879 at 11931) 
inadvertently omitted a conversion for RAE from [beta]-carotene from 
supplements. The table in Sec.  101.9(c)(8)(iv) of the final rule 
includes the conversions for mcg RAE to mcg supplemental [beta]-
carotene:

1 retinol activity equivalent (mcg RAE) = 1 mcg retinol
    2 mcg supplemental [beta]-carotene
    12 mcg of dietary [beta]-carotene
    24 mcg of other dietary provitamin A carotenoids
    ([alpha]-carotene or [beta]-cryptoxanthin)

    (Comment 432) The proposed rule, at Sec.  101.9(c)(8)(iv), would 
change the units of measure for vitamin E by replacing ``IU'' with 
``mg,'' representing mg [alpha]-tocopherol. The preamble to the 
proposed rule (79 FR 11879 at 11932) explained that the new measure of 
vitamin E activity would account for the difference in activity between 
naturally occurring and synthetic vitamin E.
    Several comments supported the definition of vitamin E as mg 
[alpha]-tocopherol. However, other comments disagreed with mg [alpha]-
tocopherol and recommended that we include other forms, in addition to 
[alpha]-tocopherol, in the definition of vitamin E. The comments said 
that other forms of vitamin E have biological activity and that some 
forms are linked to cancer, stroke, and neurodegeneration. One comment 
cited several studies to support the assertion that other forms of 
vitamin E have bioactivities that are important to disease prevention 
and/or therapy (Refs. 240-245). One comment disagreed with the use of 
mg [alpha]-tocopherol for vitamin E and suggested we include different 
forms of vitamin E and relative amounts so that the vitamin E 
declaration is not misleading.
    (Response) We decline to include other forms in the definition of 
vitamin E. As we noted in the preamble to the proposed rule (79 FR 
11879 at 11926), RDIs for vitamins and minerals are based on the DRIs 
set by the IOM that reflect the most current science regarding nutrient 
requirements. The RDA for vitamin E was established for mg of [alpha]-
tocopherol because [alpha]-tocopherol is the only form of vitamin E 
that is maintained in blood and has biological activity (79 FR 11879 at 
11933). We acknowledge the studies submitted to support the assertion 
that other forms of vitamin E, such as gamma-tocopherol, have 
biological activity that may be pertinent to disease prevention and/or 
therapy. However, these individual studies measured outcomes other than 
induced human vitamin E deficiency assessed by the correlation between 
red blood cell lysis and plasma [alpha]-tocopherol on which the RDA was 
based (Ref. 246). Jiang et al. 2003 studied gamma tocopherol and its 
metabolite on markers of inflammation in rats (Ref. 241). Mahabir et 
al. 2008 studied the associations between 4 tocopherols ([alpha]-, 
[beta]-, c-, and d-tocopherol) in human diets and lung cancer risk 
(Ref. 243). The review article by Wolf discussed the biochemical 
mechanism by which [alpha]-tocopherol influences gamma-tocopherol (Ref. 
245). Christen et al. 1997 studied the effects of gamma-tocopherol on 
lipid peroxidation in vitro (Ref. 240). Jiang et al. 2008 studied the 
effect of different forms of vitamin E and their metabolites on enzyme 
reactions involved in the inflammation pathway (cyclooxygenase-
catalyzed reactions) in vitro (Ref. 242). The review article by Sen et 
al. 2007 discussed tocotrienols and their biological functions. While 
these animal studies and review articles may suggest biological 
activity of other forms of vitamin E, outcomes in humans are lacking, 
thus a totality of evidence for a role of other forms of vitamin E in 
human health is lacking (Ref. 246). We consider the totality of 
evidence, such as what is presented in consensus reports like those 
issued by the IOM, rather than individual studies, to establish the 
RDIs. Therefore, based on the information provided in the comment, we 
do not have a basis to include other forms of vitamin E in our 
definition.
    We note, however, that other forms of vitamin E can be listed in 
the ingredient statement for foods.
    (Comment 433) The proposed rule, at Sec.  101.9(g)(10), would 
require manufacturers to verify the declared amount of both all rac-
[alpha]-tocopherol acetate and RRR-[alpha]-tocopherol in the finished 
food product. The preamble to the proposed rule (79 FR 11879 at 11933) 
explained that the RDA for vitamin E is 15 mg/day of [alpha]-tocopherol 
and that [alpha]-tocopherol is the only form of vitamin E that is 
maintained in blood and has biological activity. The preamble to the 
proposed rule also explained that there are eight stereoisomers of 
[alpha]-tocopherol (RRR, RSR, RRS, RSS, SRR, SSR, SRS, SSS) and that 
only RRR [alpha]-tocopherol occurs naturally in foods. Commercially 
available vitamin E that is used to fortify foods and used in dietary 
supplements contains esters of either the natural RRR- or, more 
commonly, mixtures of the 8 stereoisomers (e.g., all rac-[alpha]-
tocopherol acetate). Four stereoisomers (SRR, SSR, SRS, and SSS) are 
not maintained in human plasma or tissues, so we proposed to limit the 
new RDA for vitamin E to the four 2R stereoisomeric forms (RRR, RSR, 
RRS and RSS) of [alpha]-tocopherol. We stated that these four forms of 
[alpha]-tocopherol are found in nonfortified and fortified

[[Page 33914]]

conventional foods and dietary supplements and that the all rac-
[alpha]-tocopherol acetate in fortified foods or dietary supplements 
has one-half the activity of RRR-[alpha]-tocopherol naturally found in 
foods or the 2R stereoisomeric forms of [alpha]-tocopherol (id.). 
However, because AOAC methods cannot individually measure the naturally 
occurring and synthetic forms of vitamin E, it is necessary to know the 
amount of both RRR-[alpha]-tocopherol and all rac-[alpha]-tocopherol in 
a food product to calculate vitamin E activity for declaration as mg 
[alpha]-tocopherol.
    One comment suggested that it is more practical for manufacturers 
of vitamin E esters to ascertain the RRR, RSR, RRS and RSS content in 
their ingredients and to disclose this information to finished food 
manufacturers for use in calculating the declared amount of vitamin E, 
instead of requiring finished food manufacturer to test the finished 
product to verify the amounts of various forms of vitamin E, especially 
since valid methods for many food matrices may not be available. The 
comment was concerned that, even if they can be identified, analytical 
methods may not be valid for a wide variety of food matrices and may be 
prohibitively expensive.
    Another comment asked that we affirmatively state that, if 
appropriate new methods become available to distinguish natural and 
synthetic vitamin E, manufacturers must declare the amount of vitamin E 
by appropriate and reliable analytical testing.
    Another comment disagreed with narrowing the definition of vitamin 
E to four stereoisomers and said it is burdensome to confirm which 
stereoisomer is present in synthetic vitamin E additives compared to 
simply confirming that the additive is, indeed, vitamin E.
    (Response) We decline to revise the rule as suggested by the 
comments.
    However, on our own initiative, we are correcting an inadvertent 
error that we made in the proposed rule. The proposed rule used the 
term ``all rac-[alpha]-tocopherol acetate'' when referring to the 
synthetic form of vitamin E in fortified foods or dietary supplements 
because esters of synthetic vitamin E are commonly used in fortified 
foods and dietary supplements. However, the correct term for synthetic 
vitamin E is all rac-[alpha]-tocopherol, just as the term for naturally 
occurring vitamin is RRR-[alpha]-tocopherol. Esters of synthetic 
vitamin E are not limited only to ``all rac-[alpha]-tocopherol 
acetate'' and also include ``all rac-[alpha]-tocopheryl succinate.'' We 
note that the term `all rac-[alpha]-tocopherol' is the correct term to 
refer to the synthetic form of vitamin E.
    With respect to analytical testing, we decline to speculate on the 
methods that manufacturers may deem practical to verify the declared 
amount of both RRR-[alpha]-tocopherol and all rac-[alpha]-tocopherol in 
finished food products. We acknowledge that it is a new requirement to 
verify the amount of both RRR-[alpha]-tocopherol in the finished food 
and all rac-[alpha]-tocopherol added to the food in finished food 
products when a mixture of both are present in a food. However, without 
AOAC methods to individually measure these two forms of vitamin E and 
the inability to determine the amount of RRR-[alpha]-tocopherol in a 
food by subtracting the amount of all rac-[alpha]-tocopherol from the 
total amount declared, we need to rely on recordkeeping to verify the 
amount of vitamin E in a product.
    As for the comment's statement that analytical methods may be 
prohibitively expensive, the practicality or feasibility of using new 
analytical methods can depend on a variety of factors. For example, a 
method that uses equipment or technology that is readily available may 
be less costly compared to a method that uses proprietary equipment or 
technology. The number of facilities that can use a new analytical 
method may influence cost. For example, if a large number of facilities 
are able to use a new analytical method, then testing costs between 
facilities may become competitive; in contrast, if there are few 
facilities that can use the analytical method, then testing costs may 
be less sensitive to competition. Consequently, because we do not know 
what new analytical methods may exist in the future or the market for 
those new methods, we cannot say whether those methods will be 
prohibitively expensive.
    We also decline to revise the rule to affirmatively state that 
manufacturers declare the amounts of vitamin E by appropriate and 
reliable analytical testing, if appropriate new methods become 
available. The comment did not explain how manufacturers would be able 
to determine whether a new method was ``appropriate'' or ``available'' 
or how differences in opinion as to whether a particular method is 
``appropriate'' or ``available'' might be resolved. Current AOAC 
methods cannot individually measure naturally occurring vitamin E (RRR-
[alpha]-tocopherol) and synthetic vitamin E (all rac-[alpha]-tocopherol 
and its esters) in food products. Nevertheless, we will continue to 
monitor developments regarding methods to distinguish natural and 
synthetic vitamin E.
    As for the comment objecting to narrowing the definition of vitamin 
E to four stereoisomers because it is burdensome to confirm which 
stereoisomer is present in synthetic vitamin E additives, we point out 
that providing information that a vitamin E additive is only present in 
a product (rather than confirming the stereoisomers present in the 
synthetic vitamin E additive) would provide an inaccurate estimation of 
the vitamin E activity in the body. We reiterate that the RDI for 
vitamin E is based on the RDA for vitamin E which is limited to the 
four 2R stereoisomeric forms (RRR, RSR, RRS, and RSS) of [alpha]-
tocopherol (79 FR 11879 at 11926). Because synthetic vitamin E, also 
referred to as all rac-[alpha]-tocopherol, contains both 2R- and 2S- 
stereoisomers of [alpha]-tocopherol and has one-half the activity of 
the RRR-[alpha]-tocopherol naturally found in foods or the other 2R 
stereoisomers of [alpha]-tocopherol, it is necessary to determine the 
stereoisomers present in a food to determine vitamin E activity.
    (Comment 434) One comment noted that the proposed rule did not 
mention other esters of both natural (d-[alpha]-tocopheryl acetate) and 
synthetic forms of vitamin E ([alpha]-tocopheryl succinate) and said we 
should revise the rule to include these forms.
    (Response) We agree that the ester forms of natural and synthetic 
vitamin E are considered as [alpha]-tocopherol forms of vitamin E. The 
RDA for [alpha]-tocopherol is limited to RRR-[alpha]-tocopherol 
(historically and incorrectly labeled d-[alpha]-tocopherol) the only 
form of [alpha]-tocopherol that occurs naturally in foods, and the 
other 2R-stereoisomeric forms of [alpha]-tocopherol (RSR-, RRS-, and 
RSS-[alpha]-tocopherol) that are synthesized chemically and found in 
fortified foods and supplements. Vitamin E compounds include RRR-
[alpha]-tocopherol (also referred to as d-[alpha]-tocopherol or 
natural) and its esters (i.e. RRR-[alpha] -tocopheryl acetate, RRR-
[alpha] -tocopheryl succinate) and all rac-[alpha]-tocopherol (also 
referred to as dl-[alpha]-tocopherol) and its esters (i.e., all rac-
[alpha]-tocopheryl acetate, all rac-[alpha]-tocopheryol succinate) 
(Ref. 247). We note that all of these vitamin E compounds may be 
present in fortified foods and multivitamins. We have revised the rule 
to include the ester forms of natural and synthetic vitamin E.
    (Comment 435) Another comment requested we provide a conversion in 
the final rule stating 1 mg [alpha]-tocopherol (label claim) = 1 mg 
RRR-[alpha]-tocopherol; 1 mg [alpha]-tocopherol (label claim) = 2 mg 
all rac-[alpha]-tocopherol.
    (Response) We agree with the comment. The final rule provides this

[[Page 33915]]

conversion as a footnote in the table in Sec.  101.9(c)(8)(iv): 1 mg 
[alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- 
[alpha]-tocopherol = 2 mg all rac- [alpha]-tocopherol.
    (Comment 436) Some comments objected to changing the units of 
measure for vitamin E. Several comments stated that there are no AOAC 
international official methods to distinguish between different forms 
of vitamin E in foods and supplements. One comment objected the change 
to mg [alpha]-tocopherol and said there is a lack of scientifically 
validated methods capable of individually measuring all rac-[alpha]-
tocopherol acetate and RRR-[alpha]-tocopherol.
    Another comment said that it is not possible to measure total 
vitamin E by subtracting all rac-[alpha]-tocopherol acetate from total 
vitamin E to determine RRR-[alpha]-tocopherol.
    (Response) We agree that current AOAC methods cannot individually 
measure naturally occurring vitamin E (RRR-[alpha]-tocopherol) and all 
rac-[alpha]-tocopherol in foods. We also agree that it is not possible 
to measure total vitamin E by subtracting all rac-[alpha]-tocopherol 
from total vitamin E to determine RRR-[alpha]-tocopherol. For this 
reason, the final rule, at Sec.  101.9(g)(10)(vi), requires 
manufacturers to make and keep written records of the amount of all 
rac- [alpha]-tocopherol added to the food and RRR-[alpha]-tocopherol in 
the finished food.
    We disagree with the comment objecting to changing the unit of 
measure to mg [alpha]-tocopherol because there is a lack of 
scientifically validated methods capable of individually measuring all 
rac-[alpha]-tocopherol and RRR-[alpha]-tocopherol. We consider the DRIs 
that reflect the most current science regarding nutrient requirements 
as the basis for establishing RDIs and, therefore, the declaration of 
vitamin E as mg [alpha]-tocopherol. The choice of unit of measure for 
vitamin E is not based on the availability of scientifically validated 
methods capable of individually measuring all rac-[alpha]-tocopherol 
and RRR-[alpha]-tocopherol.
5. Niacin
    (Comment 437) Our preexisting regulations, at Sec.  
101.9(c)(8)(iv), state that the RDI for niacin is 20 mg. The proposed 
rule would amend Sec.  101.9(c)(8)(iv), in relevant part, by changing 
the unit of measure from ``mg'' to ``milligrams NE'' where ``NE'' would 
stand for ``niacin equivalents,'' and a footnote to proposed Sec.  
101.9(c)(8)(iv) would explain that 1 milligram NE is equal to 1 
milligram niacin or also equal to 60 milligrams of tryptophan. The 
preamble to the proposed rule discussed updating the RDIs for various 
nutrients (including niacin) and compared the current RDI of 20 mg 
against the proposed RDI of 16 mg NE (79 FR 11879 at 11927, 11931).
    Several comments supported changing ``mg'' niacin to mg niacin 
equivalents (NE). The comments said the change would be consistent with 
the IOM's use of RDAs as the basis for establishing reference values 
for purposes of food labeling. Another comment referred to the footnote 
in proposed Sec.  101.9(c)(8)(iv) and noted that ``milligrams NE'' is 
different from the existing regulation's use of ``milligrams.'' The 
comment said that it assumed that compliance would be determined by 
testing the product using AOAC methods for both niacin and tryptophan 
and that this, if correct, would increase the burden on manufacturers 
because it will necessitate additional testing.
    In contrast, other comments would have us continue to use 
milligrams as the unit of measure for niacin.
    (Response) The RDA for niacin is expressed as niacin equivalents 
(NE) because the body's niacin requirement is met not only by preformed 
niacin (nicotinamide, nicotinic acid, and its derivatives) in the diet, 
but also from conversion from dietary protein containing tryptophan 
(Ref. 248).
    We agree with the comment that compliance with a voluntary 
declaration of niacin would be determined by analysis, using AOAC 
methods, for both niacin and tryptophan, or by reference to existing 
databases for both nutrients. Niacin equivalents would be calculated 
using the following conversion: NE (niacin equivalents): 1 mg NE = 1 mg 
preformed niacin = 60 milligrams of tryptophan. While the unit of 
measurement for the RDI for niacin is listed as mg NE in Sec.  
101.9(c)(8)(iv), only the amount ``mg'' will continue to be declared on 
nutrition and supplement facts labeling.
    (Comment 438) One comment asked how compliance will be determined 
and asked us to clarify whether a declaration of niacin content will be 
required for products that contain no actual niacin. The comment would 
revise the rule to include a provision specifying that products 
containing more than 19 mg of tryptophan (corresponding to 0.32 mg of 
niacin or 2 percent of the RDI) must declare niacin even if there is no 
actual niacin present or else the manufacturers of such products might 
not notice the revised requirements for niacin declaration. Another 
comment noted that, for many protein-containing products for which 
there is presently no information on tryptophan required, manufacturers 
would be required to determine niacin and tryptophan content, either 
through analytic testing or existing databases.
    (Response) The declaration of niacin is voluntary unless it is 
added as a nutrient supplement to the food or if the label makes a 
nutrition claim about it. Compliance may be determined by measuring 
niacin and tryptophan separately. The unit of measure (mg NE) includes 
both preformed niacin (from nicotinic acid and nicotinamide in the diet 
or niacin) and niacin resulting from the conversion of tryptophan (Ref. 
249), and AOAC methods exist for both niacin and tryptophan. Thus, a 
declaration of niacin content requires products to include 
contributions from preformed niacin as well as tryptophan, including 
those that may not contain preformed niacin.
    As for the comment's statement that manufacturers may not notice 
the revised requirements for niacin declaration, we decline to revise 
the rule as suggested by the comment. We note that Sec.  
101.3(e)(4)(ii) (regarding identity labeling of food in packaged form) 
states, in relevant part, that a measurable amount of an essential 
nutrient in a food shall be considered to be 2 percent or more of the 
Reference Daily Intake (RDI) of any vitamin or mineral listed under 
Sec.  101.9(c)(8)(iv) per reference amount customarily consumed. We 
recognize that manufacturers may be unaware of the requirement for 
niacin declaration in mg and plan to engage in education and outreach 
explaining the revised changes to units of measurement for vitamins and 
minerals.
    As for the comment that manufacturers would be required to 
determine niacin and tryptophan content, either through analytic 
testing or existing databases, we note we have not stated how a company 
should determine the nutrient content of their product for labeling 
purposes (Ref. 122). Regardless of its source, a company is responsible 
for the accuracy and the compliance of the information presented on the 
label. Use of a database that we have accepted may give manufacturers 
some assurance in that we have stated that we will work with industry 
to resolve any compliance problems that might arise for food labeled on 
the basis of a database that we have accepted. A manual entitled ``FDA 
Nutrition Labeling Manual: A Guide for Developing and Using Databases'' 
is available online.
    (Comment 439) One comment pointed out that the use of mg NE may not 
accurately reflect niacin contribution in

[[Page 33916]]

foods because the conversion of tryptophan to niacin is highly variable 
among individuals and because the body uses tryptophan primarily for 
its role in protein synthesis instead of niacin production. The comment 
said that using mg NE as the unit of measure could represent an over-
estimate of niacin intake in the diet. Another comment was concerned 
there could be an extra step in food labeling and another potential 
source of error.
    (Response) We disagree that using mg NE may lead to overestimates 
of niacin intake from foods. We acknowledge that the conversion of 
tryptophan to niacin may vary among individuals and that tryptophan has 
a role in protein synthesis. The conversion factor of 1 mg NE = 60 mg 
tryptophan is the mean of a wide range of individual values from human 
studies that measured the conversion of tryptophan to urinary niacin 
metabolites (Ref. 248).
    We acknowledge the concern that using mg NE involves an added step 
of measuring tryptophan, but note that tryptophan is converted to 
niacin by the body and using mg NE provides a more accurate estimation 
of available niacin in the body compared to mg of niacin.
    (Comment 440) The proposed rule, at Sec.  101.9(c)(8)(iv), would 
include a footnote stating that ``NE'' means niacin equivalents and 
that ``1 milligram niacin = 60 milligrams of tryptophan.'' One comment 
suggested that, for additional clarity and consistency, we should 
revise footnote 2 to say ``NE = Niacin equivalents, 1 NE = 1 milligram 
niacin = 60 milligrams of tryptophan.''
    (Response) We agree with the comment and have revised the footnote 
for NE as follows: NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 
milligrams tryptophan.''

O. Labeling of Foods for Infants, Young Children, and Pregnant or 
Lactating Women

    In the preamble to the proposed rule (79 FR 11879 at 11933), we 
explained that our general labeling requirements for foods in Sec.  
101.9(c) apply to foods for infants, young children, and pregnant and 
lactating women, with certain exceptions. For example, foods, other 
than infant formula, represented or purported to be specifically for 
infants and children less than 4 years of age are not permitted to 
include declarations of percent DV for the following nutrients: Total 
fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate 
and dietary fiber (Sec.  101.9(j)(5)(ii)(A)). As another example, 
foods, other than infant formula, represented or purported to be 
specifically for infants and children less than 2 years of age are not 
permitted to declare calories from fat, calories from saturated fat, 
saturated fat, polyunsaturated fat, monounsaturated fat and cholesterol 
on the Nutrition Facts label (Sec.  101.9(j)(5)(i)).
    The preamble to the proposed rule (79 FR 11879 at 11933) also 
mentioned that our regulations do not include DRVs or RDIs for 
nutrients, generally, for infants, children under 4 years of age, or 
pregnant and lactating women, but there are requirements for a DRV for 
protein for children 4 or more years of age and RDIs for protein for 
each of the following subpopulations: (1) Children less than 4 years of 
age; (2) infants; (3) pregnant women; and (4) lactating women (Sec.  
101.9(c)(7)(iii)).
1. Age Range for Infants and Young Children
    Our preexisting regulations, at Sec.  101.9(j)(5), use the age 
ranges ``less than 2 years of age'' and ``less than 4 years of age'' to 
establish labeling requirements for foods represented or purported to 
be specifically for infants and young children. The preamble to the 
proposed rule (79 FR 11879 at 11933 through 11934) stated that comments 
to our 2007 ANPRM recommended changing the age categories to infants 7 
to 12 months and young children 1 through 3 years (13 through 48 
months), consistent with the age ranges used in the IOM's age-specific 
DRI recommendations. In the preamble to the proposed rule (79 FR 11879 
at 11933 through 11934), we discussed why we considered it appropriate 
to adopt the same age categories as those used in the IOM DRIs for 
infants and children. In brief, we said:
     Our proposed DVs are based on these age-specific DRIs;
     Infants are transitioning to eating solid foods by 7 
through 12 months, and there are a number of foods in the marketplace 
identified for this age group;
     With respect to children 1 through 3 years of age, using 
the DRI age range would result in infants no longer being the lower end 
of the age range in the category of infants and children less than 2 
years and less than 4 years of age as specified in Sec.  101.9(j)(5);
     Assigning DVs for children 1 through 3 years of age would 
ensure consistency with the 1 through 3 year toddler age category 
established for RACCs specified in Sec.  101.12(a)(2); and
     Because the growth velocity in height is most similar for 
children 1 through 3 years of age, we consider it appropriate to revise 
the age range to include children of these ages into a single category 
for food labeling purposes.
    Therefore, we proposed to revise the exceptions for requirements 
for nutrition labeling provided in Sec.  101.9(j)(5)(i) and the 
exception to the requirement for the format used for nutrient 
information on food labeling in Sec.  101.9(d)(1) for foods represented 
or purported to be specifically for infants and children less than 4 
years of age. Specifically, we proposed to replace the current category 
of infants and children less than 4 years with infants 7 through 12 
months and children 1 through 3 years of age.
    (Comment 441) Several comments supported providing nutrition 
information for children less than 4 years because, according to the 
comments, these subgroups have different nutritional needs. Another 
comment recommended mandatory nutrition labeling for children less than 
12 months and children 1 through 3 years. One comment said that we 
should continue to allow labeling information on foods for infants less 
than 7 months, such as infant cereals, or, at a minimum, allow such 
labeling to remain voluntary.
    (Response) We agree, in part, with the comments that recommended 
mandatory nutrition labeling for infants less than 12 months. We 
decline to revise the age range for infants to infants less than 12 
months because using that age range would leave a 1 month gap as the 
age for children 1 through 3 years represents 13 through 48 months. We 
also agree that nutrition labeling on foods represented or purported to 
be for infants less than 7 months old such as infant cereals should 
continue to be mandatory. We proposed the age category for labeling of 
infants 7 through 12 months to be consistent with the age ranges used 
in the IOM's age-specific DRI recommendations as well as current 
breastfeeding recommendations for the first 6 months of life (79 FR 
11933). Optimally, infants should begin eating complementary foods at 
around 6 months of age (AAP Section on Breastfeeding 2012, WHO 
Complementary feeding 2010); however, some infants are being introduced 
to foods and beverages before then (siega-Riz JADA 2010). To ensure 
that nutrition labeling includes products for infants and allow for 
flexibility in timing of complementary food, we have amended Sec.  
101.9(j)(5)(i) and (ii) to refer only to ``infants'' as infants through 
12 months of age rather than infants less than 12 months (as suggested 
by the comment) or ``infants 7 through 12 months'' of age as we had 
proposed. (We have made similar edits in Sec.  101.9(c), (c)(7), 
(c)(8), (d)(1), (e), and (f) to refer to ``infants through 12 months of 
age.'')

[[Page 33917]]

    We note that, while nutrition labeling is mandatory for food for 
children less than 4 years, we are not establishing DVs for infants 
less than 7 months of age. Therefore, nutrition information on foods 
purported for infants less than 7 months would not reflect DVs for that 
age group.
    (Comment 442) One comment said that labeling of foods for infants 7 
through 12 months and children 1 through 3 years is overdue and 
important. The comment said, however, that separate labeling for these 
two ages is not necessary and could be confusing, so the comment 
recommended that we use a population approach to set single values for 
7 months through 3 years.
    Another comment noted that the proposed new age range to set 
labeling requirements for these foods (infants 7 through 12 months and 
children 1 through 3 years of age) did not take into account the 
definition of ``young children'' given in different Codex standards 
(e.g., 074-1981 Rev. 1-2006) whereby ``young children'' are ``persons 
from the age of more than 12 months up to the age of 3 years (36 
months).''
    (Response) We disagree with the comment suggesting an age range of 
7 months through 3 years of age. Providing one label for infants and 
children 7 months through 3 years of age is inappropriate because 
growth and nutrient needs differ for infants through 12 months of age 
and children 1 through 3 years of age (beginning at the start of the 
13th month through the end of 48th month of age). These differences in 
growth and development between infants and young children are reflected 
in the age categories established by the IOM (79 FR 11879 at 11933).
    As for the comment noting that we did not take into account the 
definition of ``young children'' used in certain Codex texts, we note 
that our age range of children 1 through 3 years of age includes 
``persons from the age of more than 12 months up to the age of 36 
months.'' We also note that our age range aligns with the age specific 
category used in the IOM's DRI recommendations for the purposes of 
establishing DRVs and RDIs for this subpopulation. Our purpose of 
establishing a DRV or RDI for use in nutrition labeling is distinct 
from a purpose related to defining the age range when infants and young 
children are fed processed cereal-based complementary foods (CODEX STAN 
074-1981, REV.1-2006). Furthermore, while certain Codex standards such 
as the Standard for Processed Cereal-based Foods for infants and young 
children (CODEX STAN 074-1981, REV.1-2006) provide minimum and maximum 
levels for the composition of processed cereal-based complementary 
foods, we note that the Codex Guidelines on Nutrition Labelling (CAC/GL 
2-1985) (Ref. 121) do not provide Nutrient Reference Value--
Requirements that are comparable to our proposed DRVs and RDIs for 
children 1 through 3 years. (Comment 443) Some comments asked that we 
require the declaration of cannabinoid content, nutritional values, 
and/or health risks pertaining to the consumption of 
tetrahydrocannabinol (THC) and/or marijuana edibles for all consumers, 
in particular, children under the age of 4 years as well as pregnant 
and lactating women.
    (Response) We decline to revise the rule as suggested by the 
comment. We note that section 403(q)(2)(A) of the FD&C Act authorizes 
the inclusion of nutrients on the label or labeling of food for 
purposes of providing ``information regarding the nutritional value of 
such food that will assist consumers in maintaining healthy dietary 
practices.'' General labeling requirements of products containing THC 
and/or marijuana edibles is outside the scope of this rule. Therefore, 
we are making no changes in response to this comment.
2. Mandatory Declaration of Calories and Statutorily Required Nutrients
    Currently, foods, other than infant formula, represented or 
purported to be specifically for infants and children less than 4 years 
must declare statutorily required nutrients, including calories, 
calories from fat, total fat, saturated fat, cholesterol, sodium, total 
carbohydrate, sugars, dietary fiber, and protein. For foods, other than 
infant formula, represented or purported to be for infants and children 
less than 2 years, the declaration of certain statutorily required 
nutrients, which include calories from fat, saturated fat, and 
cholesterol, is not required or permitted (Sec.  101.9(j)(5)(i)).
    a. Declaration of saturated fat and cholesterol. In the preamble to 
the proposed rule (79 FR 11879 at 11934), we tentatively concluded 
that, except for the declaration of calories from fat, the declaration 
of statutorily required nutrients that include saturated fat and 
cholesterol on the label of foods represented or purported to be 
specifically for infants 7 through 12 months and children 1 through 3 
years of age should be mandatory because: (1) The declaration of 
calories and these nutrients is mandated by section 403(q) of the FD&C 
Act, and we have no basis on which to not require or permit their 
declaration as discussed previously; and (2) these nutrients are 
essential in fostering growth and maintaining good health during a 
critical stage of human development and physiology and, therefore, 
their mandatory declaration can assist in maintaining healthy dietary 
practices. We proposed to remove Sec.  101.9(j)(5)(i) and revise and 
redesignate current Sec.  101.9(j)(5)(ii) as Sec.  101.9(j)(5)(i).
    Similarly, foods consumed by pregnant and lactating women must 
declare statutorily required nutrients, including calories, calories 
from fat, total fat, saturated fat, cholesterol, sodium, total 
carbohydrate, sugars, dietary fiber, and protein. Women of reproductive 
age consume the same foods as the general population and, in general, 
continue consuming similar foods during pregnancy and lactation. In the 
preamble to the proposed rule (79 FR 11879 at 11934), we tentatively 
concluded that, except for the declaration of calories from fat, the 
declaration of statutorily required nutrients should be mandatory 
because the declaration of calories and these nutrients is mandated by 
section 403(q) of the FD&C Act and we have no basis on which to not 
require or permit their declaration as discussed previously. Thus, we 
proposed to require the mandatory declaration of calories, and the 
amount of total fat, saturated fat, trans fat, cholesterol, sodium, 
total carbohydrate, dietary fiber, sugars, and protein for foods 
represented or purported to be specifically for infants 7 through 12 
months of age, children 1 through 3 years of age, and pregnant and 
lactating women, and permit the declaration of calories from saturated 
fat such that the declaration of these nutrients on foods for these 
populations would be subject to the same requirements applicable to 
foods for the general population.
    (Comment 444) Several comments supported the declaration of 
saturated fat and cholesterol on labeling for infants and children 1 
through 3 years old and agreed such labeling will help maintain 
healthful dietary practices. In response to our request for information 
on whether consumers may be confused by these changes, one comment said 
that its products have been labeled for children under 2 years as well 
as for children less than 4 years of age on the market for many years. 
The comment noted that these dual label formats include the declaration 
of both saturated fat and cholesterol and the company has received no 
comments or concerns about the inclusion of this information on its 
labels from either consumers or health care professionals. The comment 
said that declaring saturated fat and cholesterol in addition to trans 
fat on infant foods will be more helpful in

[[Page 33918]]

food selection than having trans fat alone. The comment said declaring 
saturated fat, cholesterol, and trans fat will provide more information 
on the fat composition of foods and their relationship to chronic 
disease risk. The comment also noted that some children as young as 12 
months, with a family history of obesity, dyslipidemia, or CVD, may 
benefit from a diet lower in saturated fat and that having saturated 
fat on food labels can assist families in choosing foods that are lower 
in saturated fat while maintaining total fat intakes.
    Another comment said we should not finalize the rule until we had 
conducted appropriate research, including consumer testing, to better 
understand the impacts of declaring saturated fat and cholesterol on 
the labels of products represented or purported to be specifically for 
infants and children 1 through 3 years of age and to determine if an 
explanatory footnote would assist in improving consumer understanding 
when accompanying any relative declaration. The comment also noted that 
relevant empirical research is not available to determine whether the 
declaration of saturated fat and cholesterol will result in restricted 
intakes for infants and children ages 1 through 3 years old. One 
comment would revise the rule to include a voluntary footnote stating 
that ``total fat should not be limited in the diets of children less 
than 2 years unless directed by a physician'' or similar wording to 
provide dietary guidance to parents and other caregivers to help assure 
total fat is not restricted in the diet of young children.
    (Response) We acknowledge that products dual labeled for children 
under 2 and children less than 4 years of age include the declaration 
of both saturated fat and cholesterol. We agree that declaration of 
saturated fat and cholesterol provides more nutrition information and 
can help consumers make informed choices and maintain a healthy diet, 
and the final rule requires the declaration of saturated fat and 
cholesterol on Nutrition Facts labeling for infants and children 1 
through 3 years of age.
    As for the comment regarding consumer testing, we disagree that 
consumer testing is necessary before we can require the declaration of 
saturated fat and cholesterol on Nutrition Facts labels for infants and 
children 1 through 3 years of age. Section 403(q) of the FD&C Act lists 
total fat, saturated fat, and cholesterol as nutrients required on 
nutrition labeling. These nutrients are essential for growth and 
development, thus their mandatory declaration can assist consumers in 
maintaining healthy dietary practices (79 FR 11879 at 11934). We 
considered the Integrated Guidelines for Cardiovascular Health and Risk 
Reduction in Children and Adolescents which suggest a diet with 
saturated fat less than 10 percent of calories and cholesterol intake 
less than 300 mg/day can safely and effectively reduce the levels of 
total and LDL cholesterol in healthy children (Ref. 250). This type of 
diet may have similar effects when started in infancy and sustained 
throughout childhood into adolescence (Ref. 250).
    We acknowledge, in general, that total fat should not be limited in 
the diets of young children less than 2 years of age unless directed by 
a health professional. In response to the comment noting that research 
is unavailable on whether declaration of saturated fat and cholesterol 
will result in restricted intakes for infants and children, we intend 
to monitor fat and cholesterol intakes in these age groups and will 
consider whether to revisit our requirements for this labeling, as 
appropriate.
    We also decline to include a voluntary footnote. We intend to 
monitor fat intakes and educate consumers on changes to the labeling of 
foods for infants through 12 months of age and children 1 through 3 
years of age.
    b. Percent DV declaration. In the preamble to the proposed rule (79 
FR 11879 at 11935), we explained that, under our preexisting 
regulations, the percent DV declaration is not permitted on the food 
label for foods, other than infant formula, represented or purported to 
be specifically for infants and children less than 4 years (which 
includes infants and children less than 2 years) for total fat, 
saturated fat, cholesterol, sodium, potassium, total carbohydrate, and 
dietary fiber (Sec.  101.9(j)(5)(ii)). Percent DV is required for 
protein and vitamin A, vitamin C, iron, and calcium. We tentatively 
concluded that it is appropriate to require declarations of percent DV 
for those nutrients for which we are establishing a DRV or RDI for 
infants 7 through 12 months, for children 1 through 3 years of age, and 
for pregnant and lactating women (except for a % DV for protein for 
pregnant and lactating women), and this change would be reflected in 
redesignated Sec.  101.9(j)(5)(i).
    (Comment 445) One comment would retain a requirement for the 
mandatory declaration of percent DV for protein on infant foods.
    In contrast, another comment would not require the mandatory 
declaration of the percent DV for protein on labels of foods for 
children aged 1 through 3 years. The comment cited dietary intake data 
suggesting that protein intakes are above 40 grams per day and from 
high quality sources. Another comment recommended allowing for the use 
of the PDCAAS for determining the percent DV for protein for all 
population groups, including infants. The comment asked us to clarify 
the acceptability of PDCAAS for determining protein quality for foods 
for infants and specify the specific amino acid pattern that should be 
used (i.e., IOM pattern) and to reference the pattern by Table number.
    (Response) The final rule requires the mandatory declaration of 
percent DV for protein on foods for infants though 12 months of age and 
children 1 through 3 years of age. While the evidence suggests that 
protein intake is adequate and of high quality, the level and quality 
of protein present in a food remain an important consideration in food 
selection for infants because infant diets are derived from a limited 
number of foods. Calculating the percent DV for protein incorporates a 
measure of protein quality. Thus, the percent DV declaration is a 
useful tool to indicate protein quality to the consumer. Because of the 
importance of adequate high quality protein in the diets of infants and 
young children, we conclude that the percent DV declaration for protein 
for infants though 12 months of age and children 1 through 3 years of 
age should remain mandatory.
    We disagree with the comment asking that we allow for the use of 
the PDCAAS to determine protein quality for infants. The PDCAAS allows 
evaluation of food protein quality based on the needs of humans as it 
measures the quality of a protein based on the amino acid requirements 
(adjusted for digestibility) of a 2- to 5-year-old child (considered 
the most nutritionally demanding age group), not infants (Ref. 251). 
Protein quality is important during infancy for growth and development. 
We established the protein efficiency ratio (PER) as the method of 
determining protein quality (see 79 FR 7934 at 8022) for infants based 
on recommendations from the 1991 WHO Protein Quality report. A protein 
source may contain the necessary amino acids, but they may be in a form 
that an infant cannot digest and absorb. The PER method, unlike 
chemical measures of protein composition, provides an estimate of the 
bioavailability or amount absorbed, of the protein.
    (Comment 446) One comment said that, if the percent DV for protein 
remains mandatory, we should provide

[[Page 33919]]

an exemption from the mandatory declaration of percent DV for protein 
for foods intended for infants and children aged 1 through 3 years that 
declare less than 1 gram of protein per serving, such as fruits, 
because these foods contain an insignificant amount of protein and are 
not expected to contribute meaningfully to protein intake. The comment 
also would revise the rule to allow the optional declaration of ``0% 
DV'' instead of the phrase ``not a significant source of protein'' on 
infant foods with a protein quality of less than 40 percent of casein 
as measured by PER or less than 40 percent by PDCAAS or other 
comparable method. The comment explained that these options will help 
save label space, especially on small packages, while still providing 
meaningful information on protein quantity relative to the DV.
    (Response) We decline to revise the rule as suggested by the 
comment. While we recognize that the protein quantity of some foods, 
such as fruits, may be small, we consider the mandatory declaration of 
percent DV to provide important information on protein quality to the 
consumer. In establishing mandatory declaration of percent DV for 
protein on foods intended for infants through 12 months of age and 
children aged 1 through 3 years and associated statements of ``less 
than 1 g of protein per serving'' or ``not a significant source of 
protein,'' we considered that: (1) Protein is of critical importance in 
maintaining good health because it supplies essential amino acids and 
is a principal source of calories along with fat and carbohydrate; and 
(2) calculating the percent DV for protein incorporates a measure of 
protein quality. Thus, the percent DV declaration is a useful tool to 
indicate protein quality to the consumer.
    While label space on small packages may be a concern, we decline to 
make the change requested by the comment that would allow the optional 
declaration of ``0% DV'' instead of the phrase ``not a significant 
source of protein'' on infant foods with a protein quality of less than 
40 percent of casein as measured by PER or less than 40 percent by 
PDCAAS or other comparable method. As explained in part II.I and in our 
response to comment 445, we concluded that the PDCAAS was the most 
suitable pattern for use in the evaluation of dietary protein quality 
for all age groups, except infants through 12 months of age. We 
established the PER as the method of determining protein quality for 
infants because infants cannot digest and absorb all forms of protein; 
thus, PDCAAS or another comparable method that scores the amino acid 
profile of the specific food protein after it has been digested is not 
appropriate.
3. Declaration of Non-Statutory Nutrients Other Than Essential Vitamins 
and Minerals
    In the preamble to the proposed rule (79 FR 11879 at 11935), we 
stated that foods, other than infant formula, represented or purported 
to be specifically for infants and children less than 2 years of age 
are not permitted to declare calories from saturated fat and the amount 
of polyunsaturated fat and monounsaturated fat (Sec.  101.9(j)(5)(i)), 
whereas soluble fiber, insoluble fiber, and sugar alcohols can be 
declared voluntarily. Polyunsaturated fat, monounsaturated fat, soluble 
fiber, insoluble fiber, and sugar alcohols can be declared voluntarily 
on the label of foods represented or purported to be specifically for 
children 2 through 4 years of age, and pregnant and lactating women.
    For foods represented or purported to be specifically for children 
1 through 3 years of age and pregnant and lactating women, we 
considered whether to propose the mandatory or voluntary declaration of 
non-statutory nutrients. In the preamble to the proposed rule (79 FR 
11879 at 11935), we said that most advisory consensus and policy 
reports on which we rely for the general population apply to children 2 
years of age and older and pregnant and lactating women, unless noted 
otherwise (e.g., 2010 DGAC and health claims (Sec.  101.14(e)(5)).
    a. Voluntary declaration of calories from saturated fat, and the 
amount of polyunsaturated and monounsaturated fat. Our preexisting 
regulations, at Sec.  101.9(j)(5)(i), state that foods, other than 
infant formula, represented or purported to be specifically for infants 
and children less than 2 years of age must bear nutrition labeling with 
certain, specific exceptions. Among the exceptions, the label is not to 
include polyunsaturated fat or monounsaturated fat.
    The proposed rule would remove the restriction regarding the 
declaration of polyunsaturated fat and monounsaturated fat on foods 
represented or purposed to be specifically for children less than 2 
years of age. In the preamble to the proposed rule (79 FR 11879 at 
11935 through 11936), we explained that, for infants 7 to 12 months, 
there are no specific recommendations provided about calories from 
saturated or polyunsaturated or monounsaturated fat. We also stated 
there is some evidence to suggest that reduction of total and LDL 
cholesterol levels can occur with reducing saturated fat intake to less 
than 10 percent of calories, beginning in infancy and sustained 
throughout childhood into adolescence, that there is no evidence to 
suggest that infants 7 through 12 months of age would be different than 
children 1 through 3 years of age, and that there is no basis to 
continue to provide an exception that does not permit the declaration 
of calories from saturated fat, or polyunsaturated and monounsaturated 
fats on foods represented or purported to be specifically for infants 
and children less than 2 years of age.
    (Comment 447) One comment argued the declaration of alpha linoleic 
acid (ALA) on foods for infants and children 7 months to 3 years of age 
should be considered for voluntary labeling using the AI as the basis 
for a DRV. The comment noted that much of the evidence for a health 
benefit of n-3 fatty acids derives from studies on infants, and 
labeling of ALA is consistent with FDA's criteria of encouraging health 
dietary practices. Another comment recommended that we examine NHANES 
data for ALA consumption to determine whether there is a public health 
risk from inadequate dietary intake.
    (Response) We decline to amend the rule to permit the voluntary 
labeling of ALA on labels or labeling for foods intended for infants 
though 12 months of age and children 1 through 3 years of age and to 
use the AI for ALA to establish a DRV.
    We agree with promoting healthy dietary practices in this 
subpopulation; however, well-established evidence for ALA and disease 
risk reduction in adulthood and infancy is lacking (Ref. 29). As 
discussed in part II.F.4, we decided that, because of the lack of well-
established evidence for a role of n-3 or n-6 polyunsaturated fatty 
acids in chronic disease risk and the lack of a quantitative intake 
recommendation, the declarations of [alpha]-linolenic acid as well as 
other n-3 and n-6 polyunsaturated fatty acids are not necessary to 
assist consumers to maintain healthy dietary practices. Because the 
declaration of ALA is not permitted on labeling, a DRV for this 
nutrient is unnecessary.
    We disagree with the analysis of NHANES data for ALA intake to 
determine public health risk from inadequate dietary intake. An 
analysis of dietary intake data alone does not meet our criteria of 
public health significance. Moreover, an analysis of ALA intakes from 
NHANES data cannot determine inadequacy of dietary intake

[[Page 33920]]

because an EAR has not been established for ALA. EARs, not AIs, are 
used for assessing the statistical probability of adequacy or nutrient 
intakes of groups of people (79 FR 11879 at 11885).
    (Comment 448) One comment noted that we proposed mandatory labeling 
of the quantitative amount of some nutrients (trans fatty acids for 
which there is no DRI) on foods for infants aged 7 through 12 months 
and children aged 1 through 3 years. The comment said we should provide 
for the voluntary declaration of docosahexaenoic acid (DHA) on these 
foods to encourage healthy dietary practices.
    (Response) We decline to revise the rule as suggested by the 
comment. Our regulations, at Sec.  101.9(c)(2)(ii), require the 
declaration of trans fat on nutrition labeling for people of all ages 
because the consumption of trans fats may affect their risk of CHD; 
therefore, the presence or absence of trans fat in a food product is a 
material fact that consumers need to know to make healthy choices and 
allow them to reduce risk of CHD. Trans fat continues to be a nutrient 
with public health significance because of its well-established role in 
chronic disease through its effect on blood cholesterol levels (79 FR 
11879 at 11896). However, DHA lacks well-established evidence for its 
role in chronic disease as well as growth or neural development (IOM 
Macro report). As discussed in part II.F, voluntary labeling of DHA is 
not permitted because of the lack of well-established evidence for 
DHA's role in chronic disease risk and lack of a quantitative intake 
recommendation (79 FR 11879 at 11898).
    (Comment 449) One comment cited a 2011 IFIC survey suggesting that 
45 percent of consumers were already eating foods containing n-3 fatty 
acids to benefit cognitive development, especially in children and 39 
percent were somewhat likely to begin eating n-3 fatty acids for this 
health benefit in the next 12 months. The comment said that continued 
allowance of ALA nutrient content claims, absent a voluntary 
declaration of DHA, increases the likelihood that consumers may 
purchase foods for a benefit that the food will not supply. The comment 
also said that allowing polyunsaturated fat labeling of foods for 
children younger than 2 years without allowance for labeling of 
individual polyunsaturated fatty acids creates a scenario where 
polyunsaturated fat values, inflated by ALA, may mislead consumers 
actually seeking DHA.
    (Response) The comments did not provide, and we are not aware of, 
data or information to support the claim that consumers seeking to 
consume DHA would be misled by the voluntary declaration of 
polyunsaturated fats or an ALA nutrient content claim on labeling for 
children less than 2 years of age. Therefore, we are not making changes 
in response to this comment.
    We acknowledge the 2011 IFIC survey conclusions suggesting that 
consumers eating foods containing n-3 fatty acids are somewhat likely 
to begin eating these foods to benefit cognitive development. We also 
recognize that total polyunsaturated fats in foods include both n-6 and 
n-3 polyunsaturated fatty acids and the n-3 polyunsaturated fatty acids 
content may include ALA and DHA.
    However, we are unable to determine, based on the information 
provided in the comment, if some consumers seeking to consume DHA may 
be confused or misled by the declaration of total polyunsaturated fats 
or the ALA nutrient content claim. Furthermore, we are unable to 
determine if consumers understand that ALA may be converted to DHA. 
Without knowledge of the conversion from ALA to DHA, consumers would 
not be able to distinguish between the level and type of n-3 fatty 
acids in the food.
    Thus, the final rule removes the restriction regarding the 
declaration of calories from saturated fat, polyunsaturated fat, and 
monounsaturated fat on foods represented or purposed to be specifically 
for infants through 12 months of age and children 1 through 3 years of 
age.
    b. Voluntary declaration of soluble fiber, insoluble fiber, and 
sugar alcohols. In the preamble to the proposed rule (79 FR 11879 at 
11936), we stated that, while quantitative intake recommendations are 
lacking for soluble fiber, insoluble fiber, and sugar alcohols, there 
is well-established evidence for the role of these nutrients in chronic 
disease risk, risk of a health-related or a beneficial physiological 
endpoint (i.e., CHD, improved laxation, or dental caries). We also said 
that there is no evidence to suggest that the role of these nutrients 
would be different among infants 7 through 12 months, children 1 
through 3 years of age, or pregnant and lactating women compared to the 
general population. As a result, we did not propose any changes to the 
provisions for the voluntary declaration of soluble fiber, insoluble 
fiber, and sugar alcohols on the label of foods represented or 
purported to be specifically for infants 7 to 12 months, children 1 
through 3 years of age, or pregnant and lactating women.
    We did not receive comments on this topic, so no changes to the 
rule are necessary.
    c. Mandatory declaration of trans fat. In the preamble to the 
proposed rule (79 FR 11879 at 11936), we stated that trans fat must be 
declared on the Nutrition Facts label and that our regulations do not 
provide exceptions for foods represented or purported to be 
specifically for infants, young children, or pregnant and lactating 
women. We noted that cardiovascular disease is known to begin in 
childhood (id.). Thus, we tentatively concluded that declaration of 
trans fat continues to be necessary to assist consumers in maintaining 
health dietary practices, including among infants, young children, and 
pregnant and lactating women, and we did not propose any changes to the 
mandatory declaration of trans fat on the label of foods represented or 
purported to be specifically for infants, children 1 through 3 years of 
age, or pregnant and lactating women.
    Trans fat declaration is voluntary when the total fat content of a 
food is less than 0.5 grams (Sec.  101.9(c)(2)(ii)). In addition, if a 
manufacturer does not declare the trans fat content because total fat 
amount is less than 0.5 grams, then the statement ``Not a significant 
source of trans fat'' must be placed at the bottom of the table of 
nutrient values.
    We did not receive comments on this topic and have finalized this 
provision without change.
    d. Mandatory declaration of added sugars. Our preexisting 
regulations do not provide for the declaration of added sugars on the 
Nutrition Facts label, but the proposed rule would require the 
mandatory declaration of added sugars on the Nutrition Facts label. 
Additionally, in the Federal Register of July 27, 2015 (80 FR 44303), 
we published a supplemental proposed rule that would, among other 
things, establish a Daily Reference Value (DRV) of 10 percent of total 
energy intake from added sugars and require the declaration of the 
percent DV for added sugars on the label.
    (Comment 450) Several comments supported mandatory declaration of 
added sugars. One comment stated that sugar is used as a means to 
attract children, and this practice should be discouraged.
    Another comment opposed the mandatory labeling of added sugars for 
infants and children aged 1 through 3 years and pregnant and lactating

[[Page 33921]]

women. The comment argued that scientific consensus is lacking for the 
health effects of added sugars alone versus sugars as a whole and 
recommended careful consideration of the totality of the scientific 
evidence, as well as consideration of compliance and other technical 
issues. The comment also noted that consumer testing is also highly 
important prior to any determination relative to added sugars being 
made.
    (Response) We disagree that added sugars should not be required on 
the label for infants and children aged 1 through 3 years and pregnant 
and lactating women. We discuss in part II.H.3 our rationale for 
requiring the declaration of added sugars on the label for the general 
population. We are also basing an added sugars declaration on labeling 
for infants, children 1 through 3 years of age, pregnant women, and 
lactating women on the need to provide consumers with information to 
construct a healthy dietary pattern that meets the dietary 
recommendations for added sugars.
    In response to the comment about the totality of evidence for the 
health effects of added sugars, we discuss in part II.H.3 that rather 
than basing a declaration of added sugars on an association with risk 
of chronic disease, a health-related condition, or a physiological 
endpoint, we are considering a declaration of added sugars in the 
context of how it can assist consumers in maintaining healthy dietary 
practices by providing information to help them limit consumption of 
added sugars, and to consume a healthy dietary pattern. We have 
established that there is public health significance of added sugars 
through other evidence related to a healthy dietary pattern low in 
sugar-sweetened foods and beverages that is associated with reduced 
risk of CVD, through consumption data showing that Americans are 
consuming too many calories from added sugars, through evidence showing 
that it is difficult to meet nutrient needs within calorie limits if 
one consumes too many added sugars, and through evidence showing that 
increased intake of sugar-sweetened beverages is associated with 
greater adiposity in children.
    The comment did not explain what compliance and other technical 
issues merit further consideration. In response to the comment noting 
the importance for consumer testing of a declaration of added sugars, 
we have received several comments on this topic and discuss responses 
in part II.H.3.g.
    While the declaration of added sugars is mandatory, we are not 
establishing a DRV for added sugars for infants through 12 months. 
Dietary recommendations for infants through 12 months suggest 
introducing complementary foods such as infant cereal, vegetables, 
fruits, meat, and other protein-rich foods modified to a texture 
appropriate (e.g., strained, pureed, chopped, etc.) for the infant's 
developmental readiness one at a time. A DRV for added sugars for 
infants through 12 months is not necessary as the infant diet is 
comprised primarily of breast milk and/or infant formula as well as 
complementary foods. As the food introduced does not comprise the 
majority of the infant diet, a DRV is not necessary to compare added 
sugars in the context of a daily diet. Mandatory declaration of added 
sugars for infants through 12 months of age can help consumers limit 
the added sugars in the limited complementary foods that are being 
introduced individually.
    (Comment 451) One comment would modify the definition of added 
sugars to exclude ingredients that are inherent in the food or are 
present for purposes other than sweetening the food and that this 
modified definition should apply for adults and children between 7 
months to 3 years of age, and pregnant and lactating women.
    (Response) We received many comments on the definition of added 
sugars and, in part II.H.3.n, discuss ingredients that are inherent in 
the food, such as naturally occurring sugars, and the intended purpose 
of sweetening. The comment did not explain why a regulatory definition 
for added sugars should be different for infants, children 1 through 3 
years of age, and pregnant women, and lactating women, so we decline to 
revise the rule as suggested by the comment.
    e. Voluntary declaration of fluoride. Our preexisting regulations 
do not provide for the declaration of fluoride on the Nutrition Facts 
label of any foods. The proposed rule would allow voluntary declaration 
of fluoride on the labeling of foods for the general population, and we 
also tentatively concluded that the declaration of fluoride on foods 
represented or purported to be specifically for children 1 through 3 
years of age and pregnant and lactating women can assist in maintaining 
healthy dietary practices. We stated, in the preamble to the proposed 
rule (79 FR 11879 at 11937 through 11938), that evidence on dental 
caries is lacking for infants 7 through 12 months of age, but we did 
not expect the role of fluoride in the protection against dental caries 
to be different from other age groups. Therefore, proposed Sec.  
101.9(c)(5) would permit the voluntary declaration of fluoride on foods 
represented or purported to be specifically for infants 7 through 12 
months of age, children 1 through 3 years of age, and pregnant and 
lactating women.
    We did not receive comments on this topic and have finalized the 
provision to permit the voluntary declaration of fluoride on foods 
represented or purported to be specifically for infants through 12 
months, children 1 through 3 years of age, pregnant women, and 
lactating women.
4. Declaration of Essential Vitamins and Minerals
    Our preexisting regulations require the declaration of vitamin A, 
vitamin C, calcium, and iron on the Nutrition Facts label, and there 
are no specific exceptions to this requirement for foods represented or 
purported to be specifically for infants and children less than 2 years 
and children less than 4 years of age, and pregnant and lactating 
women. In the preamble to the proposed rule (79 FR 11879 at 11937), we 
explained that the AIs for essential vitamins and minerals (and RDAs 
for iron and zinc) for infants 7 through 12 months of age are based on 
the average intake of nutrients that infants consumed from breast milk, 
complementary foods, and/or supplements with the understanding that 
these sources provided sufficient amounts of the nutrients to meet the 
infant's daily needs. The AIs (as well as the RDAs for iron and zinc) 
for infants were not based on endpoints related to chronic disease 
risk, or a health-related conditions or health-related physiology. 
Furthermore, because the AI represents intakes that are considered 
adequate and are based on average nutrient intakes from breast milk, 
foods, and/or supplements, the presence of an AI indicates that there 
is not a public health concern about adequate intake of that nutrient. 
So, rather than determine public health significance for a nutrient 
during infancy based on an AI for infants, we considered the importance 
of the nutrient in establishing healthy dietary practices during 
infancy for later in life, as well as the relevant available 
information for children 1 through 3 months of age that may also be 
applicable to infants. For nutrients with an RDA for infants 7 through 
12 months of age (i.e., iron and zinc), we considered the factors for 
mandatory and voluntary labeling described in section I.C to determine 
whether to propose mandatory or voluntary labeling for the nutrient.
    For the declaration of essential vitamins and minerals for children 
1

[[Page 33922]]

through 3 years of age and pregnant and lactating women, we said, in 
the preamble to the proposed rule (79 FR 11879 at 11937) that we would 
use the same considerations, based on the same rationale as we set 
forth and proposed for the general population, because scientific and 
policy considerations are generally the same and the DGA 
recommendations apply to Americans 2 years of age and older. We also 
explained that, while NHANES data were collected in lactating women, we 
did not include these data in our analysis because the sample size of 
lactating women was small, and we could not reliably estimate mean 
intake and status of this population (id.). However, we stated that the 
conclusions made about nutrient inadequacy during pregnancy are applied 
to lactating women since the needs of essential vitamin and minerals 
are increased for both pregnant and lactating women, and we proposed to 
remove the provision in Sec.  101.9(c)(8)(i) that requires separate 
declaration of percent DVs based on both RDI values for pregnant women 
and for lactating women in the labeling of foods represented or 
purported to be for use by both pregnant and lactating women.
    We did not receive comment on this topic and are removing the 
provision in Sec.  101.9(c)(8)(i) regarding separate declaration of 
percent DVs based on both RDI values for pregnant women and for 
lactating women in the labeling of foods represented or purported to be 
for use by both pregnant and lactating women.
    a. Mandatory declaration of calcium and iron. We did not propose 
any changes to the mandatory declaration of calcium on foods for the 
general population. In the preamble to the proposed rule (79 FR 11879 
at 11937), we stated that the AI for calcium for infants 7 through 12 
months of age is based on average calcium consumption of these 
nutrients, rather than chronic disease risk, health related-condition, 
or physiological endpoints and that, for children 1 through 3 years of 
age and pregnant and lactating women, the RDAs for calcium are based, 
in part, on bone health.
    Our analysis of NHANES 2003-2006 data estimated that infants ages 7 
to 12 months have usual calcium intakes above the AI and that about 12 
percent of children 1 through 3 years of age had usual intakes of 
calcium below the EAR, based on intakes from conventional foods only 
(see 79 FR 11879 at 11937). We said, in the preamble to the proposed 
rule (id.), that promoting the development of eating patterns that are 
associated with adequate calcium intake later in life is important 
given that calcium intakes are inadequate for the majority of the 
population. Intakes of calcium, which is necessary for growth and bone 
development, are inadequate among children. Similar to the general 
population, approximately 20 percent of pregnant women consumed less 
than the EAR for calcium from conventional foods as well as from 
conventional foods and supplements. Consequently, we tentatively 
concluded that calcium is a nutrient of public health significance for 
children 1 through 3 years of age and for pregnant and lactating women 
and that, because calcium is important for growth and development, 
calcium is of public health significance for infants 7 through 12 
months of age.
    With respect to iron, we stated, in the preamble to the proposed 
rule (id.) that, while the EAR and RDA are based on daily iron 
requirements and not directly on chronic disease risk, iron deficiency 
is associated with delayed normal infant motor function (i.e., normal 
activity and movement) and mental function (i.e., normal thinking and 
processing skills) and that our analysis of NHANES 2003-2006 data 
estimated that about 18 percent of infants ages 7 through 12 months 
have usual iron intakes below the EAR, based on intakes from 
conventional foods only and 4 percent of infants ages 7 through 12 
months have usual iron intakes below the EAR based on intakes from 
conventional foods and supplements. For children 1 through 3 years of 
age, about 1 percent of children have usual iron intakes below the EAR, 
based on intakes from conventional foods only and 0.4 percent of 
children have usual iron intakes below the EAR based on intakes from 
conventional foods and supplements. While total iron intakes appear 
adequate, the prevalence of iron deficiency in children ages 1 to 2 
years has been reported to be 14.4 percent and the prevalence of iron 
deficiency anemia in children younger than 5 years has been reported to 
be 14.9 percent (see 79 FR 11879 at 11937). We also stated that 
inadequate iron intakes during pregnancy are of public health 
significance because of the adverse effects for both the mother and the 
fetus (such as maternal anemia, premature delivery, low birth weight, 
and increased perinatal infant mortality) and that our analysis of data 
collected by NHANES 2003-2006 estimated that 5 percent of pregnant 
women 14 to 50 years of age had usual iron intakes below the EAR based 
on intakes from conventional foods and 4 percent of pregnant women 14 
to 50 years of age had usual iron intakes below the EAR based on 
intakes from conventional foods and supplements (see 79 FR 11879 at 
11937). Among pregnant women aged 12 to 49 years, 25 percent were iron 
deficient and 13 percent had iron deficiency anemia. While intakes 
appear adequate for most individuals, the prevalence of iron deficiency 
and iron deficiency anemia indicates that iron deficiency is of public 
health significance for pregnant women. Therefore, we tentatively 
concluded that iron is a nutrient of public health significance for 
lactating women as well.
    Thus, we proposed to amend Sec.  101.9(c)(8)(ii) to require the 
mandatory declaration of calcium and iron on foods represented or 
purported to be specifically for infants 7 to 12 months, children 1 
through 3 years of age, or pregnant and lactating women.
    We did not receive any comments with respect to mandatory 
declaration of calcium and iron for these populations, and so, other 
than replacing ``infants 7 to 12 months'' with ``infants through 12 
months,'' we have finalized the provisions without change.
    b. Mandatory declaration of vitamin D and potassium. We proposed to 
require the declaration of vitamin D on foods for the general 
population. With respect to infants, we stated, in the preamble to the 
proposed rule (79 FR 11879 at 11938), that the AI for vitamin D for 
infants was based on maintenance of serum 25(OH)D concentrations at a 
level to achieve and maintain serum 25(OH)D concentrations above a 
defined level (30 to 50 nmol/L) in order to meet the needs of the 
majority of the infants and support bone accretion and that DRIs (EAR 
and RDA) for vitamin D were established at a level to achieve and 
maintain serum 25(OH)D concentrations above a defined level (40 to 50 
nmol/L) to maintain bone health for children 1 through 3 years of age 
and pregnant women. Although serum 25(OH)D data were not available in 
NHANES 2003-2006 for infants ages 7 to 12 months, we noted that our 
analysis of NHANES 2003-2006 dietary data showed that 28.7 and 33.6 
percent of infants ages 7 to 12 months have usual vitamin D intakes 
above the AI from conventional foods and conventional foods plus 
supplements, respectively (see 79 FR 11879 at 11938).
    Our analysis of NHANES 2003-2006 data showed that about 3 percent 
of children 1 through 3 years of age had serum 25(OH)D levels below 40 
nmol/L, while an analysis of NHANES 2005-2008 dietary data showed that, 
assuming minimal sun exposure, about 82 percent of these children had 
usual vitamin D intakes below the EAR from

[[Page 33923]]

conventional foods only and 66 percent had usual intakes below the EAR 
from conventional foods and supplements (see 79 FR 11879 at 11938). For 
pregnant women, 15 percent had serum 25(OH)D levels below 40 nmol/L, 
while about 88 percent of pregnant women had usual vitamin D intakes 
below the EAR from conventional foods only and 48 percent had usual 
intakes below the EAR from conventional foods and supplements (id.). We 
tentatively concluded that vitamin D has public health significance in 
children 1 through 3 years of age and pregnant women based on the high 
prevalence of inadequate intakes of vitamin D and its important role in 
bone development and health and that vitamin D is of public health 
significance for infants 7 through 12 months of age based on its 
importance for growth and development during infancy.
    We also proposed, at proposed Sec.  101.9(c)(8)(ii), to require the 
declaration of potassium on foods for the general population. The AI 
for the general population is set at a level to maintain blood 
pressure, reduce the adverse effects of sodium chloride intake on blood 
pressure, and reduce the risk of recurrent kidney stones, but for 
infants, the AI is based on average potassium intake from breast milk 
and/or complementary foods (id.). Our analysis of NHANES 2003-2006 
showed that 99 percent of infants ages 7 to 12 months have usual 
potassium intakes above the AI and that only 7 percent of children 1 
through 3 years of age and 4 percent of pregnant women had usual 
potassium intakes above the AI from conventional foods or conventional 
foods plus dietary supplements, indicating that the adequacy of intakes 
is very low. We acknowledged, in the preamble to the proposed rule (79 
FR 11879 at 11938) that, as a result of a FDAMA notification for a 
health claim about potassium, blood pressure, and stroke, foods may 
bear the following claim ``Diets containing foods that are good sources 
of potassium and low in sodium may reduce the risk of high blood 
pressure and stroke,'' on the label or labeling of any food product 
that meets the eligibility criteria described in the notification and 
meets the general requirements for a health claim (Sec.  101.14(e)(6)). 
This health claim pertains to the general population 2 years of age and 
older. Thus, because potassium is important in the risk reduction of 
these chronic diseases for children 2 years of age and older, we 
tentatively concluded that potassium is of public health significance 
to children 1 through 3 years of age, pregnant women, and lactating 
women and that, because of the benefits of adequate potassium intake in 
lowering blood pressure, data indicating low likelihood of potassium 
adequacy, and importance of establishing healthy dietary practices for 
later life, potassium is a nutrient of public health significance for 
infants 7 through 12 months of age, children 1 through 3 years of age, 
pregnant women, and lactating women. Thus, we proposed to require the 
labeling of vitamin D and potassium on foods represented or purported 
to be specifically for infants 7 through 12 months of age, children 1 
through 3 years of age, or pregnant and lactating women based on the 
quantitative intake recommendations for vitamin D and potassium and the 
public health significance of these nutrients and did not provide for 
any exceptions for these subpopulations from the general requirement 
for declaration of vitamin D and potassium in proposed Sec.  
101.9(c)(8)(ii).
    We did not receive comments regarding potassium and these 
subpopulations, so, other than replacing ``infants 7 to 12 months'' 
with ``infants through 12 months,'' we have finalized those provisions 
without change.
    (Comment 452) One comment questioned the need for mandatory 
disclosure of vitamin D on the Nutrition Facts panel. The comment cited 
dietary intake data from food, beverages and supplements that suggests 
at least 75 percent of children ages 1 through 3 years have adequate 
intakes of vitamin D, not including sun exposure (Ref. 252). The 
comment said that mandatory declaration of vitamin D is not of value 
because relatively few foods have naturally occurring vitamin D, 
limitations on vitamin D addition to foods already exist, and vitamin D 
added to foods is already required on labeling. In addition, according 
to the comment, labeling can not necessarily help consumers achieve 
adequate intakes of vitamin D because it is not expected that all the 
required vitamin D will be provided by foods or supplements. Another 
comment noted that its products have many labels with very little label 
space and that using this label space for a declaration of 0 percent DV 
for vitamin D will limit its ability to provide other label information 
including information on other nutrients present in the products at 
significant levels.
    (Response) We disagree with comments arguing against the mandatory 
declaration of vitamin D. We have determined that vitamin D is a 
nutrient of public health significance (79 FR 11879 at 11921 and 
11938). The comment cited data that assessed usual intakes using the AI 
for vitamin D established in 1997 (Ref. 253). The IOM has since 
established an EAR for vitamin D (Ref. 38). Our analysis of NHANES data 
compared to the EAR showed 66 percent of children 1 through 3 years of 
age had inadequate intake of vitamin D from foods and supplements (79 
FR 11879 at 11938).
    We also disagree that mandatory declaration of vitamin D, including 
the declaration of zero percent DV, is not of value because few foods 
have naturally occurring vitamin D. As we discussed in the preamble to 
the proposed rule (79 FR 11879 at 11938) and part II.L, we identified 
vitamin D as a nutrient of public health significance for children 1 
through 3 years of age based on the high prevalence of inadequate 
intakes of vitamin D and its important role in bone development and 
health (Ref. 198). Our analysis also shows that vitamin D intakes and 
status remain inadequate in the general population (79 FR 11879 at 
11922). While limited label space may present challenges, the 
consideration for the mandatory declaration of vitamin D on the label 
is whether it will help consumers maintain healthy dietary practices.
    While we acknowledge that some, but not all, vitamin D needs can be 
met by the body's exposure to sunlight, we determined the mandatory 
declaration of vitamin D based on the high prevalence of inadequate 
intakes of vitamin D and its important role in bone development and 
health (see part II.L). The mandatory declaration of vitamin D is 
intended to help consumers maintain healthy dietary practices and make 
healthy choices in context of a daily diet. The mandatory declaration 
of vitamin D also provides information to consumers about what foods 
are good sources of vitamin D and what foods do not contain vitamin D. 
Therefore, we have finalized this provision without change.
    c. Voluntary declaration of vitamin A and vitamin C. We proposed to 
no longer require the declaration of vitamin A and vitamin C on foods 
for the general population. With respect to subpopulations, we noted, 
in the preamble to the proposed rule (79 FR 11879 at 11939) that our 
analysis of data from NHANES 2003-2006 showed that less than 2 percent 
of children 1 through 3 years of age had usual vitamin A intakes below 
the EAR from conventional foods or conventional foods plus dietary 
supplements and that, while 36 percent of pregnant women had usual 
intakes below the EAR from conventional foods and 22 percent had usual 
intakes below the

[[Page 33924]]

EAR for conventional foods plus dietary supplements, only 1 percent of 
these women had serum vitamin A levels that were considered to be 
indicative of a vitamin A deficiency. Furthermore, our analysis of data 
from NHANES 2003-2006 showed that neither vitamin A nor vitamin C is 
considered to have public health significance for children 1 through 3 
years of age and pregnant women. Therefore, we tentatively concluded 
that vitamin A and vitamin C are not of public health significance 
among infants 7 through 12 months of age, children 1 through 3 years of 
age, and pregnant and lactating women, but we proposed to permit, but 
not require, the declaration of vitamin A and vitamin C on foods 
represented and purported to be specifically for infants 7 through 12 
months, children 1 through 3 years of age, or pregnant and lactating 
women. As for other voluntary nutrients, the declaration of these 
nutrients would be required when these nutrients are added as nutrient 
supplements or claims are made about them (proposed Sec.  
101.9(c)(8)(ii)).
    We did not receive comments regarding the voluntary declaration of 
vitamins A and C for subpopulations, so, other than replacing ``infants 
7 to 12 months'' with ``infants through 12 months,'' we have finalized 
that provision without change.
    d. Voluntary declaration of other vitamins and minerals. For the 
general population, we proposed to permit the voluntary declaration of 
vitamin E, vitamin K, vitamin B6, vitamin B12, 
thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, 
phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, 
chromium, molybdenum, chloride, and choline (proposed Sec.  
101.9(c)(8)(ii)). In the preamble to the proposed rule (79 FR 11879 at 
11939), we said that vitamins and minerals other than iron, calcium, 
vitamin D and potassium for infants either have DRIs that are not based 
on chronic disease risk, heath-related conditions, or health-related 
physiological endpoints or are not shown to have public health 
significance due to the prevalence of a clinically relevant nutrient 
deficiency. For infants 7 to 12 months, children 1 through 3 years of 
age, and pregnant and lactating women, we tentatively concluded that 
the essential vitamins and minerals, other than iron, calcium, vitamin 
D and potassium, do not have public health significance and there is no 
basis for the declaration of these nutrients to be different from that 
proposed for the general population. Thus, proposed Sec.  
101.9(c)(8)(ii) would allow the voluntary declaration of vitamin E, 
vitamin K, vitamin B6, vitamin B12, thiamin, 
riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, 
iodine, magnesium, zinc, selenium, copper, manganese, chromium, 
molybdenum, chloride, and choline on foods represented or purported to 
be specifically for infants 7 to 12 months, children 1 through 3 years 
of age, pregnant women, or lactating women, under the requirements of 
this section, unless they are added to foods as a nutrient supplement 
or if the label or labeling makes a claim about them, in which case the 
nutrients would have to be declared.
    We did not receive comments regarding the voluntary declaration of 
vitamin K, vitamin B6, vitamin B12, thiamin, 
riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, 
iodine, magnesium, zinc, copper, manganese, chromium, molybdenum, and 
chloride on foods represented or purported to be specifically for 
infants through 12 months of age, children 1 through 3 years of age, 
pregnant women, or lactating women. Therefore, other than replacing 
``infants 7 to 12 months'' with ``infants through 12 months,'' we have 
finalized these provisions without change.
    (Comment 453) One comment requested we reconsider mandatory 
declaration of vitamin E on nutrition labeling for children 1 through 3 
years of age. The comment said that about 63 percent of children 12 to 
24 months and 37 percent of children 24 to 48 months have vitamin E 
intakes below the EAR (Ref. 252). The comment also noted that 
encouraging an adequate intake of vitamin E in the diets of young 
children may encourage adequate consumption of foods with higher levels 
of vegetable fat.
    (Response) We agree that vitamin E intakes are below the EAR and 
disagree that mandatory declaration of vitamin E is needed. Our 
analysis of NHANES data also has shown that intakes of children 1 
through 3 years of age are below the EAR (79 FR 11879 at 11944). 
However, low intakes of vitamin E have not been associated with 
clinically relevant nutrient deficiency (Ref. 246). Therefore, 
consistent with the factors for mandatory or voluntary declaration of 
non-statutory nutrients (79 FR 11879 at 11889 and 11918, and part 
II.D), we have determined that vitamin E is not a nutrient public 
health significance for children 1 through 3 years of age and the 
general population.
    The comment did not provide evidence to suggest that mandatory 
declaration of vitamin E may encourage adequate intake and consumption 
of foods with higher levels of vegetable fat, and we are not aware of 
any evidence to support that proposition. Therefore, we are not making 
changes in response to this comment.
    (Comment 454) One comment supported the voluntary declaration of 
choline for pregnant and lactating women. The comment noted that 
choline has a role in preventing neural tube defects in infants and 
high intakes improve placental function and ease babies' response to 
stress during pregnancy. Another comment suggested that some nutrients 
should be considered for mandatory labeling, e.g., choline and selenium 
as public health concerns. The comment also recommended that choline be 
considered for mandatory labeling on foods for pregnant and lactating 
women. The comment explained that mandatory labeling on foods in 
general, should be driven by the interest to reduce the risk of chronic 
diseases in adulthood, and should be revisited for foods for 7 months 
through 3 years to emphasize the role of nutrients in development.
    (Response) We disagree that the declaration of choline and selenium 
should be mandatory. As the comment suggested, we have considered the 
relationship of nutrients and chronic disease risk, health-related 
conditions, or a health-related physiological endpoints (i.e. growth 
and development) in infants, children, and pregnant and lactating women 
to determine its mandatory or voluntary declaration on labeling. Based 
on our analysis of dietary intakes, we found no evidence of inadequate 
intakes of choline and selenium in these subpopulations. We also found 
no evidence for a substantial prevalence of chronic disease, health-
related condition, or nutrient deficiency with clinical significance 
linked to choline and selenium in these subpopulations. Therefore, 
consistent with the factors for mandatory or voluntary declaration of 
these types of non-statutory nutrients (see part II.D), we have 
determined that choline and selenium are not nutrients of public health 
significance for infants through 12 months of age, children 1 through 3 
years of age and pregnant and lactating women and have finalized the 
provision regarding voluntary declaration.
5. DRVs and RDIs for Infants Through 12 Months of Age
    Our preexisting regulations do not include DRVs or RDIs for 
nutrients for infants, except for an RDI of protein of 14 grams. 
However, the proposed rule would establish a DRV or RDI for certain 
nutrients, and we explained, in the case

[[Page 33925]]

of polyunsaturated fat, monounsaturated fat, insoluble fiber, soluble 
fiber, added sugars, sugar alcohols, sodium, and fluoride, why we were 
not proposing to establish a DRV.
    a. General comments.
    (Comment 455) One comment recommended considering dietary intake 
data and public health need in addition to quantitative intake 
recommendations to determine appropriate RDIs for vitamins and minerals 
to be established for infants 7 months through 12 months of age and 
children 1 through 3 years of age. Another comment recommended that 
menu modeling and intake survey data should be a consideration in the 
establishment of certain DRVs as they provide insight on whether a DV 
is achievable, without compromising intake of another food group or 
nutrient and whether they align with dietary recommendations.
    (Response) We agree dietary intake data and public health 
significance are important considerations in determining appropriate 
RDIs for vitamins and minerals. We consider public health significance 
in the context of developing RDIs for vitamins and minerals to refer to 
the existence of ``well-established'' scientific evidence from U.S. 
consensus reports that there is a relationship between a nutrient and 
chronic disease risk, a health-related condition, or a health-related 
physiological endpoint and where the intake of such nutrient is of 
general importance in the general U.S. population, e.g., where intakes 
are generally too low or too high among the U.S. population. Thus, we 
established RDIs for vitamins and minerals based on the DRIs set by the 
IOM that reflect the most current science regarding nutrient 
requirements and associated disease risk, health-related condition, or 
health-related physiological endpoints (79 FR 11879 at 11926). While 
the DRI reports also consider dietary intake data, we also have 
analyzed more recent dietary intake data for these age groups (79 FR 
11879 at 11944).
    We acknowledge the comment suggesting that menu modeling and intake 
survey data could be a consideration in the establishment of certain 
DRVs. Dietary recommendations based on menu modeling may aim to achieve 
nutrient requirements, but are not the sole determining factor for 
establishing all DRVs. We agree that menu modeling can be considered in 
choosing a reference point for daily intake that is realistically 
achievable and practical in light of the current food supply and 
consumption patterns.
    b. Calories. The preamble to the proposed rule (79 FR 11879 at 
11939) stated that we have not established a reference calorie intake 
for infants. We noted that there is no quantitative intake 
recommendation for calories for infants and that we were not aware of 
scientific data and information on which we could rely to establish 
such a level (id.). Thus, we did not propose to establish a reference 
calorie intake level for infants 7 to 12 months.
    We did not receive comments on this issue. Consequently, the final 
rule does not establish a reference calorie intake for infants though 
12 months of age.
    c. Total fat. Regarding total fat, the IOM set an AI of 30 grams/
day for fat for infants 7 through 12 months of age based on the average 
intake of human milk and complementary foods. The AI provides a basis 
on which we can determine an appropriate DRV for total fat for infants 
7 through 12 months, so we proposed to amend Sec.  101.9(c)(9) to 
include a DRV of 30 grams for fat for infants 7 through 12 months of 
age.
    We did not receive comments regarding the proposed DRV for infants, 
so the final rule establishes a DRV of 30 grams for fat for infants 
though 12 months of age.
    d. Saturated fat, trans fat, cholesterol, dietary fiber, and 
sugars. Regarding saturated fat, trans fat, cholesterol, dietary fiber, 
and sugars, there are no quantitative intake recommendations from U.S. 
consensus reports available with respect to infants. Thus, we did not 
propose to establish DRVs for these nutrients for infants 7 through 12 
months of age.
    We did not receive comments on our decision not to establish DRVs 
for saturated fat, trans fat, cholesterol, and dietary fiber for 
infants. Thus, the final rule does not establish DRVs for infants 
though 12 months of age for these nutrients.
    (Comment 456) One comment recommended establishing a DRV for sugars 
for infants and children and suggested that we work with the IOM to 
establish a DRV for sugar for this population.
    (Response) We decline to establish a DRV for sugars for infants 
though 12 months of age and children 1 through 3 years of age. As 
discussed in part II.H.2, we are not aware of data or information 
related to a quantitative intake recommendation for sugars that we 
could use as the basis for a DRV for total sugars. The IOM reviewed the 
evidence on this topic in the Macronutrient report (IOM, 2002) and did 
not provide quantitative intake recommendations for infants and 
children.
    e. Polyunsaturated fat, monounsaturated fat, insoluble fiber, 
soluble fiber, added sugars, and sugar alcohols. For polyunsaturated 
fat, monounsaturated fat, insoluble fiber, soluble fiber, added sugars, 
and sugar alcohols, there are no quantitative intake recommendations 
from U.S. consensus reports available with respect to infants. Thus, we 
did not propose to establish DRVs for these nutrients for infants 7 
through 12 months of age.
    We did not receive comments on our decision not to establish DRVs 
for polyunsaturated fat, monounsaturated fat, insoluble fiber, soluble 
fiber, added sugars, and sugar alcohols. Thus, the final rule does not 
establish DRVs for infants though 12 months of age for these nutrients.
    f. Total carbohydrates. For total carbohydrates, the IOM set an AI 
of 95 grams/day for carbohydrates for infants 7 through 12 months of 
age based on the average intake of human milk and complementary foods; 
the AI provides a basis on which we can determine an appropriate DRV 
for total carbohydrate for this subpopulation that can assist consumers 
in maintaining healthy dietary practices among this subpopulation. 
Therefore, we proposed to amend Sec.  101.9(c)(9) to establish a DRV of 
95 grams for total carbohydrate for infants 7 through 12 months of age.
    We did not receive comments regarding the proposed DRV of 95 grams 
for total carbohydrates for infants. Consequently, the final rule 
adopts the DRV of 95 grams for total carbohydrates for infants though 
12 months of age.
    g. Protein. For protein, the DV for protein for infants is an RDI, 
rather than a DRV. The preexisting RDI for infants is 14 grams/day for 
infants, but, in the preamble to the proposed rule (79 FR 11879 at 
11940), we said we would revise the RDI to rely on current quantitative 
intake recommendations and that, in 2002, the IOM established an RDA 
for infants 7 through 12 months of 1.2 grams/kilogram/day based on 
nitrogen balance studies and using a reference body weight of 9 
kilograms. The value 1.2 grams/kilogram/day x 9 kg equals 10.8 grams/
day or a rounded value of 11 grams/day, yet we also noted that protein 
intakes are well above the current and proposed RDI. Mean protein 
intake for infants 6 to 11 months of age was 22 grams/day, well above 
the RDA of 11 grams/day. Thus, we proposed to revise Sec.  
101.9(c)(8)(iv) to establish an RDI of 11 grams for protein for infants 
7 through 12 months of age.
    We did not receive comments on our proposed RDI of 11 grams for 
infants, so the final rule, at Sec.  101.9(c)(7)(iii) and (c)(8)(iv), 
establishes a RDI for protein of 11 grams for infants though 12 months 
of age.

[[Page 33926]]

    h. Sodium. For sodium, we noted, in the preamble to the proposed 
rule (79 FR 11879 at 11940), that the IOM did not set a UL for sodium 
for infants 7 through 12 months of age due to insufficient data on 
adverse effects of chronic overconsumption in this age group. Thus, we 
did not propose a DRV for sodium for infants 7 through 12 months of 
age.
    We did not receive comments regarding a DRV for sodium for infants. 
Thus, the final rule does not establish a DRV for sodium for infants 
though 12 months of age.
    i. Fluoride. For fluoride, although the IOM set an AI for fluoride, 
the AI for infants 7 through 12 months is close to the EPA benchmarks 
for total fluoride intake. Additionally, we did not propose a DRV for 
fluoride for use in the labeling of foods for the general population 
because of a concern about excess intakes associated with dental 
fluorosis, and so, in the proposed rule, we tentatively concluded that 
a DRV for fluoride is not warranted for infants 7 through 12 months. 
Thus, we did not propose to establish a DRV for fluoride for infants 7 
through 12 months of age.
    We did not receive comments regarding establishment of DRVs for 
fluoride for infants. Thus, the final rule does not establish DRVs for 
fluoride for infants though 12 months of age.
    j. Other vitamins and minerals. For vitamins and minerals, we 
reviewed current quantitative intake recommendations for vitamins and 
minerals for infants to determine appropriate RDIs for vitamins and 
minerals to be established in regulations for infants 7 through 12 
months of age. In the preamble to the proposed rule (79 FR 11879 at 
11940), we explained that we considered it important to establish RDIs 
for infants 7 through 12 months of age because infants in this age 
range transition from a diet of mostly breast milk and infant formula 
to infant cereal and baby foods, and labeling foods for this 
subpopulation with percent DV declarations can help parents make 
nutritious food choices. The DRIs (AIs and RDAs) provide a basis on 
which to determine RDIs for vitamins and minerals for this 
subpopulation. We considered it appropriate to use RDAs and, in the 
absence of RDAs, AIs to determine appropriate micronutrient RDIs for 
infants. We also stated that the IOM established DRIs based on 
scientific knowledge that update and supersede previous RDA 
recommendations. Consequently, we proposed to amend Sec.  
101.9(c)(8)(iv) to include a listing of RDIs for vitamin A, vitamin C, 
vitamin D, vitamin E, vitamin K, vitamin B12, folate, 
choline, riboflavin, niacin, vitamin B6, calcium, iron, 
thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, 
zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium for infants 7 through 12 months of age.
    We did not receive comments regarding our proposed RDIs for vitamin 
A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B12, 
folate, choline, riboflavin, niacin, vitamin B6, calcium, 
thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, 
selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium for infants. Thus, the final rule adopts these RDIs for 
infants though 12 months of age without change.
    (Comment 457) One comment would have us retain a DV for iron of 15 
mg for infants given the importance of adequate iron in the diets of 
infants and young children and the prevalence of iron deficiency in 
children. The comment noted that published data reported 12 percent of 
infants aged 6 to 11 months have iron intakes from food, beverages, and 
supplements below the EAR (Butte 2010) and our analysis of NHANES data 
showed that 17.8 percent of infants aged 7 to 12 months have iron 
intakes from conventional foods only below the EAR.
    (Response) We decline to revise the rule as suggested by the 
comment. We recognize the importance of adequate iron in the diets of 
infants. We acknowledge the dietary intake data and prevalence of iron 
deficiency for infants cited by the comment and point out that our 
analysis of NHANES data showed that 3 percent of infants aged 7 to 12 
months have iron intakes below the EAR from food, beverages, and 
supplements. While we evaluated intakes, we consider that the DRI is 
the appropriate basis for establishing the DV for iron for infants 
because the DRI reports and its set of nutrient reference values are 
comprehensive reviews and applications of nutrition science research 
(79 FR 11879 at 11885).
    (Comment 458) One comment questioned how a decrease in the DV for 
iron would affect iron fortification of foods for infants. The comment 
said that such a decrease in the DV could cause manufacturers to reduce 
iron fortification of products for this population group.
    (Response) We disagree with the comment. The comment did not 
provide, and we are not aware of, any evidence to suggest that 
decreasing the DV for iron would impact iron fortification of foods for 
infants. DVs are established based on DRIs set by the IOM that reflect 
the most current science regarding nutrient requirements, not on 
potential changes in fortification of products. We recognize the 
importance of adequate iron intake in the diets of infants and intend 
to monitor the nutrient adequacy for this population and consider the 
need for consumer education.
    (Comment 459) One comment asked that we use the current DV of 5 mg 
for zinc for infants as the DV for infants because previous RDA panels 
have recommended intakes of up to 10 mg for children 1 through 3 years 
of age and now recommend a RDA of 3 mg for infants and children 1 
through 3 years of age. The comment also cited a study by Walravens et 
al. 1989 (Ref. 254) referenced by the IOM confirming the factorial 
approach and questioned the IOM's use of the Walraven baseline data 
minus 2 standard deviations to support for the EAR and suggested that 
reported dietary intake data, instead of standard deviations, maybe a 
more appropriate basis for EAR. The comment stated that lowering the DV 
to 3 mg/day may affect the availability and level of zinc fortification 
in foods and reduce intake levels without a full understanding of the 
potential impact in this sensitive population.
    (Response) We decline to revise the rule as suggested by the 
comment. We are changing the DVs to reflect the most recent 
comprehensive reviews and applications of nutrition science research 
provided by current DRI reports and its set of nutrient reference 
values (see 79 FR 11879 at 11885). Modifying the reference value for 
zinc provided by these consensus reports is not warranted based on the 
scientific evidence to support the DRI.
    We also disagree that using reported dietary intake data may be a 
more appropriate basis for the EAR infants. We note that the IOM 
established the EAR for zinc using a factorial approach and did not 
base the EAR on the growth data from the Walravens study (Ref. 226). We 
decline to comment on the IOM's rationale for the calculation used in 
confirming the factorial approach using the growth data cited by the 
Walraven study. We decline to speculate on how consumers may interpret 
% DV for zinc resulting from a recommended dietary pattern and whether 
they may inappropriately limit zinc intake. The comment did not 
provide, and we are not aware of, any evidence to suggest how consumers 
will react to the changes in percent DV as a result of changes to the 
DVs and whether they would inappropriately limit zinc intake. We 
recognize the importance of adequate zinc intake in

[[Page 33927]]

the diets of infants and intend to monitor the nutrient adequacy for 
this population and consider the need for consumer education.
    We also have no evidence to suggest how that decreasing the DV for 
zinc would impact zinc fortification of foods for infants and decline 
to speculate on how availability and level of zinc fortification may 
change. DVs are established based on DRIs set by the IOM that reflect 
the most current science regarding nutrient requirements and not on 
potential changes in the fortification of products.
6. DRVs and RDIs for Children 1 Through 3 Years of Age
    With respect to children 1 through 3 years of age, our preexisting 
regulations do not include DRVs or RDIs, except an RDI for protein of 
16 grams for children less than 4 years of age. In the preamble to the 
proposed rule (79 FR 11879 at 11940 through 11941), we explained that 
we reviewed scientific evidence and current recommendations, as well as 
comments in response to the 2007 ANPRM to consider establishing DRVs 
and RDIs for nutrients for this subpopulation and to consider revisions 
to the current RDI for protein.
    a. General comments.
    (Comment 460) Several comments supported establishing DVs for 
children 1 through 3 years (13 through 48 months) that are consistent 
with the IOM's DRI recommendations for children 1 through 3 years age 
ranges.
    In contrast, one comment suggested setting DVs specific for 4- to 
8-year-old children because, according to the comment, setting a single 
DV that groups 4- to 8-year-old children with adults could lead to 
excessive intakes of some fortified vitamins and minerals and 
potentially increase the risk of adverse health effects from ingesting 
too much. The comment pointed out that the updated DVs for two 
nutrients, vitamin A and niacin, are the same as or higher than the IOM 
Tolerable Upper Intake Levels (ULs) for 4-to-8-year-olds.
    Other comments suggested establishing RDIs and DRVs for children 4 
to 13 years of age because product labeling based on RDIs for adults, 
in most cases, exceed the nutritional needs for children 4 to 13 years 
of age. The comments also noted that setting RDIs for children would 
provide an opportunity for more companies to formulate children's 
products to age-specific RDAs (rather than adult values which may not 
be appropriate for children's nutritional needs) and communicate the 
information to consumers via product labeling. One comment recommended 
that declarations of percent DV should be required for products 
targeted to children 4 through 13 years of age that contain nutrients 
for which this age-specific DRV or RDI is established.
    (Response) We decline to revise the rule as suggested by the 
comments. While we recognize that nutritional needs of children aged 4 
to 8 or 4 to 13 years are different from adults, we disagree with 
establishing RDIs for children aged 4 to 8 or 4 to 13 years due to 
concerns about excessive intake of nutrients above the UL or 
recommended intakes for these age groups. As noted in the preamble to 
the proposed rule (79 FR 11879 at 11928) and the accompanying 
memorandum to the file rule (Ref. 199), intakes of vitamins and 
minerals generally do not exceed the ULs under current RDIs that are 
based on a population coverage approach, except for zinc, vitamin A 
(preformed), iodine and folic acid among children 4 to 8 years old. In 
these few instances where total usual intakes of vitamins and minerals 
by children aged 4 to 8 years exceed corresponding ULs, we have 
determined that such intakes are not of public health significance.
    With respect to the comment regarding niacin, the UL for niacin 
applies to niacin obtained from fortified foods and/or supplements and 
is based on flushing (burning, tingling sensation and reddening flush 
primarily on skin, arms and face) which is not considered a serious 
adverse effect. The UL for children was set by extrapolating downward 
from the UL for adults. While niacin intakes from fortified foods and 
dietary supplements may exceed the UL for children aged 4 to 8 years 
old (Refs. 194-195), no data were found to suggest that children have 
increased susceptibility to flushing effects from excess intake (Ref. 
249).
    We also disagree with establishing RDIs and DRVs for children 4 to 
13 years of age and mandatory declaration of percent DV for products 
targeted to children 4 through 13 years of age to provide an 
opportunity for companies to formulate children's products to age-
specific RDAs rather than adult values which may not be appropriate for 
children's nutritional needs. We recognize that RDAs for adults may be 
higher than the RDAs of children 4 through 8 years of age and 9 through 
13 years of age. RDIs are intended to help persons to understand the 
relative significance of nutrients in the context of a total daily 
diet, to compare foods, and to plan general diets. They are not 
intended to be used to decide whether a particular individual's 
consumption of nutrients is appropriate. While RDIs are not precise 
values for certain age and sex groups, they function as an overall 
population reference to help consumers judge a food's usefulness in 
meeting overall daily nutrient requirements or recommended consumption 
levels and to compare nutrient contributions of different foods.
    b. Calories. With respect to calories, we stated, in the preamble 
to the proposed rule (79 FR 11879 at 11940 through 11941), that several 
comments to the 2007 ANPRM supported establishing a DV for calories 
specifically for young children 1 through 3 years of age and that we 
considered it appropriate to establish a reference calorie intake level 
for children 1 through 3 years of age because we proposed to set DRVs 
using quantitative intake recommendations that are based on calories 
(e.g., total fat, saturated fat, and dietary fiber). Because 
recommendations from the IOM, AHA, AAP, and the 2010 DGA for caloric 
intake range from 800 to 900 calories/day for children 1 year old, 
approximately 1,000 calories/day for children 2 years of age, and from 
1,000 to 1,200 calories/day for children 3 years of age, we used an 
average of the range of these caloric intake recommendations (800 to 
1,200 calories/day), i.e., 1,000 calories/day, as a reasonable 
reference calorie intake level and proposed to amend Sec.  101.9(c)(9) 
to provide a reference calorie intake level of 1,000 calories/day for 
children 1 through 3 years of age.
    (Comment 461) One comment supported the reference calorie intake of 
1,000 calories/day for children 1 through 3 years of age.
    (Response) We agree with the reference calorie intake of 1,000 
calories/day for labeling represented or purported to be for children 1 
through 3 years of age. Thus, the final rule, at Sec.  101.9(c)(9), 
establishes a reference calorie intake of 1,000 calories/day for 
children aged 1 through 3 years.
    c. Total fat. In the preamble to the proposed rule (79 FR 11879 at 
11941), we noted that there is no DRV for total fat for children ages 1 
through 3 years, but a comment to the 2007 ANPRM recommended that 35 
percent of the recommended 1,050 calories or 41 grams/day of fat be 
used to as the DRV for fat because it is the midpoint of the AAP/AHA 
recommendation and the IOM Acceptable Macronutrient Distribution Range 
(AMDR) for 1 through 3 year olds. We agreed that 35 percent of calories 
from fat for children 1 through 3 years of age serves as an appropriate 
basis on which to set the DRV for total fat and would be consistent 
with AHA and AAP recommendations that 30 to 40 percent

[[Page 33928]]

of calories consumed by children 12 to 24 months of age and 30 to 35 
percent of calories consumed by children 24 through 48 months of age 
should come from fat. Therefore, we tentatively concluded that 35 
percent of total calories from fat (i.e., 39 grams using the proposed 
reference calorie intake level of 1,000 calories/day) is an appropriate 
DRV for total fat for children 1 through 3 years of age, and we 
proposed to amend Sec.  101.9(c)(9) to establish a DRV of 39 grams for 
fat for children 1 through 3 years of age.
    (Comment 462) One comment would increase the DRV for total fat for 
children 1 through 3 years of age to 41 grams, given the importance of 
an adequate intake of total fat in this population for healthy 
development and growth. The comment noted that this level of total fat 
would be 37 percent of total calories from fat (based on 1,000 
calories/day reference calorie intake level) which is within the AMDR 
of 30 to 40 percent total calories from fat. The comment cited dietary 
intake data suggesting that 23 percent (12 to 23 months) and 47 percent 
(24 to 48 months) of children are below the AMDR. The comment noted 
that it is important for the total fat DV to help encourage adequate 
fat intake.
    (Response) We decline to increase the DRV for total fat. In the 
preamble to the proposed rule (79 FR 11879 at 11941), we determined 
that 35 percent of calories from fat, based on a 1,000 calorie/day 
reference calorie intake level, is an appropriate basis for the DRV for 
total fat because it aligns with the AHA and AAP recommendations that 
30 to 40 percent of calories consumed by children 12 through 24 months 
of age and 30 to 35 percent of calories consumed by children 24 through 
48 months of age should come from fat and is consistent with our 
proposed approach to setting the DRV for total fat for the general 
population (Ref. 255). We acknowledge the dietary intake data 
suggesting the total fat intake of children is below the AMDR. This 
calculation yields a DRV of 39 grams.
    We disagree that the purpose of the total fat DV is to encourage 
fat intake. The DVs are intended to help persons to understand the 
relative significance of nutrients in the context of a total daily 
diet, to compare foods, and to plan general diets. They are not 
intended to be used to decide whether a particular individual's 
consumption of nutrients is appropriate.
    Thus, the final rule, at Sec.  101.9(c)(9), establishes a DRV of 39 
grams for total fat for children aged 1 through 3 years.
    d. Saturated fat, trans fat, and cholesterol. For saturated fat, 
trans fat, and cholesterol, we stated, in the preamble to the proposed 
rule (79 FR 11879 at 11941), that there are no DRVs for children 1 
through 3 years of age. Based on the scientific evidence in the 2010 
DGA to support that Americans 2 years of age and older consume less 
than 10 percent of calories from saturated fat and less than 300 mg/day 
of cholesterol, we tentatively concluded that it would be appropriate 
to set a DRV of 10 grams for saturated fat, based on 10 percent of 
total calories from saturated fat and using the proposed reference 
calorie intake level of 1,000 calories/day, which equals 11 grams, 
rounded down to 10 grams, and a DRV of 300 mg for cholesterol for 
children 1 through 3 years of age. We proposed to amend Sec.  
101.9(c)(9) to establish a DRV of 10 grams for saturated fat and a DRV 
of 300 mg for cholesterol for children 1 through 3 years of age. We 
declined to propose a DRV for trans fat because the scientific evidence 
from the IOM and the 2010 DGA did not provide any specific appropriate 
levels of intake.
    (Comment 463) One comment recommended using the DRV of 12 grams for 
saturated fat for children 1 through 3 years of age. The comment noted 
that this value represents 10.7 percent of calories from saturated fat 
based on a 1,000 calorie diet and is consistent with the diets of about 
25 percent of children between 12 and 47 months, an indication that 
this level of intake is achievable.
    (Response) We decline to change the DRV for saturated fat as 
suggested by the comment. In establishing the DRV for saturated fat, we 
considered that cardiovascular disease can begin in childhood and the 
scientific evidence in the 2010 DGA that support Americans 2 years of 
age and older consuming less than 10 percent of calories from saturated 
fat (79 FR 11879 at 11941). We disagree that the DRV for saturated fat 
should be based on dietary intake data that suggest that a level of 12 
grams is achievable. DVs are established based on DRIs set by the IOM 
that reflect the most current science regarding nutrient requirements, 
not on levels of intakes that are achievable. Thus, the final rule, at 
Sec.  101.9(c)(9), establishes a DRV of 10 grams for saturated fat for 
children aged 1 through 3 years. Additionally, on our own initiative, 
we have replaced ``saturated fatty acids'' in the table with 
``saturated fat'' for consistency in how we refer to saturated fat. We 
also have replaced ``Unit of measurement'' with ``Unit of measure'' in 
the table for consistency with the introductory sentence to Sec.  
101.9(c)(9).
    We did not receive comments regarding our tentative decision not to 
establish a DRV for trans fat or the proposed DRV of 300 mg for 
cholesterol for children aged 1 through 3 years. Thus, the final rule 
establishes a DRV of 300 mg for cholesterol for children aged 1 through 
3 years and does not establish a DRV for trans fat.
    e. Polyunsaturated fat, monounsaturated fat, sugars, insoluble 
fiber, soluble fiber, added sugars, and sugar alcohols. For 
polyunsaturated fat, monounsaturated fat, sugars, added sugars, 
insoluble fiber, soluble fiber, and sugar alcohols, we stated, in the 
preamble to the proposed rule (79 FR 11879 at 11941), that there are no 
DRVs for children 1 through 3 years of age. We recognized the essential 
nature of [alpha]-linolenic acid in the diet, but we said that, for 
children 1 through 3 years of age, DRIs or other data and information 
were not available on which we could rely to establish DRVs for 
polyunsaturated fat, monounsaturated fat, sugars, added sugars, 
insoluble fiber, soluble fiber, and sugar alcohols (id.). Therefore, we 
tentatively concluded that there was no basis for setting DRVs for 
these nutrients and did not propose DRVs for polyunsaturated fat, 
including n-3 or n-6 polyunsaturated fatty acids, monounsaturated fat, 
sugars, added sugars, soluble fiber, insoluble fiber, or sugar alcohols 
for children 1 through 3 years of age.
    We did not receive comments on our tentative decision not to 
establish DRVs for polyunsaturated fat, monounsaturated fat, sugars, 
insoluble fiber, soluble fiber, and sugar alcohols. Thus, the final 
rule does not establish DRVs for children 1 through 3 years of age for 
these nutrients.
    (Comment 464) Some comments agreed with not defining DVs for added 
sugars. One comment recommended establishing a DRV for added sugar for 
children.
    (Response) We received many comments on defining a DRV for added 
sugars and explain, in part II.H.3.o, that we are establishing a DRV 
for added sugars for children and adults 4 years of age and older of no 
more than 10 percent of total calories, or 50 grams using a 2,000 
calorie intake reference amount based on food pattern modeling. For the 
reasons discussed in part II.H.3.o, we are also establishing a DRV of 
25 grams of added sugars for children 1 through 3 years of age based on 
food pattern modeling. Using the 1,000 calorie intake reference amount 
for children 1 through 3 years of age and the DRV of no more than 10 
percent of total calories, the DRV for children 1 through 3 years of 
age is 25 grams (1,000

[[Page 33929]]

calories x 0.1 = 100 calories and 100 calories / 4 calories per gram 
for carbohydrates = 25 grams). Thus, the final rule, at Sec.  
101.9(c)(9), establishes a DRV of 25 grams for added sugars for 
children ages 1 through 3 years of age.
    f. Total carbohydrates. In the preamble to the proposed rule (79 FR 
11879 at 11941), we said that, for total carbohydrates, there is not a 
DRV for children 1 through 3 years of age. We noted, however, that we 
were proposing a DRV for total carbohydrate for the general population 
based on the percentage of calories in a 2,000 calorie diet remaining 
after the sum of the DRV for fat (30 percent) plus the DRV for protein 
(10 percent) have been subtracted and that we considered this method to 
be appropriate for setting a DRV for total carbohydrate for children 1 
through 3 years of age (id.). We also stated that total calories (100 
percent) minus the proposed DRV for total fat (35 percent of calories) 
and the proposed DRV for protein (5 percent of calories) equals 60 
percent of calories from total carbohydrate. A value of 60 percent of 
total calories from total carbohydrates also falls within the IOM AMDR 
recommendation of 45 to 65 percent of calories from carbohydrates for 
children 1 through 3 years of age. Therefore, we tentatively concluded 
that an appropriate DRV for total carbohydrate is 60 percent of 
calories (i.e., 150 grams using the proposed reference calorie intake 
level of 1,000 calories/day), and we proposed to amend Sec.  
101.9(c)(9) to set a DRV of 150 grams for total carbohydrate for 
children 1 through 3 years of age.
    We did not receive comments regarding the proposed DRV of 150 grams 
for children 1 through 3 years of age, so the final rule adopts this 
DRV without change.
    g. Dietary fiber. In the preamble to the proposed rule (79 FR 11879 
at 11941), we stated that there is not a DRV for dietary fiber for 
children 1 through 3 years of age, but we agreed with a comment to an 
ANPRM that an AI of 14 grams/1,000 calories for dietary fiber for 
children 1 through 3 years of age should be used to set a DRV for 
dietary fiber to be consistent with how other proposed DRVs are being 
set. Additionally, because we proposed a reference calorie intake level 
of 1,000 calories/d for this subpopulation, we proposed to amend Sec.  
101.9(c)(9) to establish a DRV of 14 grams for dietary fiber for 
children 1 through 3 years of age.
    We did not receive comments regarding the proposed DRV of 14 grams 
for fiber for children 1 through 3 years of age. Thus, the final rule 
adopts this DRV without change.
    h. Protein. Under our preexisting regulations, at Sec.  
101.9(c)(7)(iii), the RDI for protein for children younger than 4 years 
of age was based on the 1989 RDA for protein of 16 grams/day. Taking 
into account current recommendations and protein intakes, we noted, in 
the preamble to the proposed rule (79 FR 11879 at 11942), that protein 
intakes are well above the current RDI, with the mean protein intake 
for children 12 to 23 months of age being 44 grams/day, well above the 
RDA of 13 grams/day, and the midpoint of the AMDR of 5 to 20 percent 
calories from protein (i.e., 12.5 percent of calories from protein or 
31 grams/day). The protein AMDR for children 1 through 3 years of age 
is 5 to 20 percent of calories, and the RDA is approximately 5 percent 
of calories. Given the proposed reference calorie intake level and the 
approaches used for the proposed DRVs for fat and carbohydrate that are 
based on percent of calories, we tentatively concluded that, as with 
the general population, the DV for protein for children 1 through 3 
years of age should be a DRV, rather than an RDI (using the RDA) and 
that a DRV for protein should be based on 5 percent of 1,000 calories 
or 50 calories which equals 12.5 grams or, when rounded up, 13 grams. 
We proposed to amend Sec.  101.9(c)(7)(iii) and (c)(9) to establish a 
DRV for protein of 13 grams for children 1 through 3 years of age.
    (Comment 465) One comment recommended retaining the current DV of 
16 grams for protein or using 10 percent of calories from protein. The 
comment noted that children 24 to 47 months have 13 to 19 percent of 
energy intakes from protein, respectively. The comment said that the 
proposed DV of 13 grams appears to be low relative to the protein that 
would be expected to be contributed from a diet that supplies the 
appropriate servings of foods from the recommended food groups, 
including milk, meat/poultry and beans and other legumes.
    (Response) We decline to retain a DV of 16 grams for protein. In 
the preamble to the proposed rule (79 FR 11879 at 11942), we discussed 
a comment to the 2007 ANPRM recommending the DV for protein be 
maintained at 16 grams. We declined to keep the DV for protein at 16 
grams, in part, because protein intakes are well above the current RDI. 
Mean protein intake for children 12 to 23 months of age was 44 grams/
day, well above the RDA of 13 grams/day and the midpoint of the AMDR of 
5 to 20 percent calories from protein (i.e., 12.5 percent of calories 
from protein or 31 grams/day, which we rounded up to 13 grams). The 
protein AMDR for children 1 through 3 years of age is 5 to 20 percent 
of calories and the RDA is approximately 5 percent of calories. Thus, a 
DRV for protein should be based on 5 percent of 1,000 calories or 50 
calories which equals 12.5 grams or, when rounded up, 13 grams, and the 
final rule, at Sec.  101.9(c)(7)(iii) and (c)(9), establishes a DRV for 
protein of 13 grams for children 1 through 3 years of age.
    i. Sodium. In the preamble to the proposed rule (79 FR 11879 at 
11942), we noted that, for the general population, we proposed to 
establish a DRV based on the UL for sodium and that there is no DRV for 
sodium for children 1 through 3 years of age. We also noted that the 
IOM derived the UL for children 1 through 3 years of age by 
extrapolation from the adult UL of 2,300 mg/day based on observational 
studies showing that blood pressure increases with age into adulthood 
and the recognition that risk factors for CVD, such as high blood 
pressure and atherosclerosis, occur in childhood (id.). We proposed to 
amend Sec.  101.9(c)(9) to establish a DRV of 1,500 mg for sodium for 
children 1 through 3 years of age.
    We did not receive comments regarding the DRV of 1500 g for sodium 
for children 1 through 3 years of age. Thus, the final rule, at Sec.  
101.9(c)(9), establishes a DRV of 1,500 mg for sodium for children 1 
through 3 years of age.
    j. Fluoride. There is not a DV for fluoride for children 1 through 
3 years of age. In the preamble to the proposed rule (79 FR 11879 at 
11942), we said that, although the IOM recognized fluoride as a trace 
mineral that is important for public health by setting an AI based on 
evidence of its role in reducing the risk of dental caries, we 
tentatively concluded that a DRV should not be established for 
fluoride. The proposed rule did not contain a DRV for fluoride for 
children 1 through 3 years of age.
    We did not receive comments regarding the establishment of DRVs for 
fluoride for children 1 through 3 years of age. Thus, the final rule 
does not establish a DRV for fluoride for children 1 through 3 years of 
age.
    k. Other vitamins and minerals. In the preamble to the proposed 
rule (79 FR 11879 at 11942 through 11943), we stated that the IOM's 
quantitative intake recommendations (AIs and RDAs) provide a basis on 
which to determine RDIs for vitamins and minerals for children 1 
through 3 years of age. We explained that the RDA, when available, is 
the best estimate of an intake level that will meet the nutrient goals 
of practically all consumers who would use the Nutrition Facts label 
and that,

[[Page 33930]]

while AIs have less certainty than RDAs, AIs represent goals for 
nutrient intake for individuals and provide the best estimate based on 
current science for use in setting RDIs for such nutrients (see id.). 
Therefore, using the RDAs and AIs, we proposed to amend Sec.  
101.9(c)(8)(iv) to establish RDIs for vitamin A, vitamin C, vitamin D, 
vitamin E, vitamin K, vitamin B12, folate, choline, 
riboflavin, niacin, vitamin B6, calcium, iron, thiamin, 
biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, 
selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium for children 1 through 3 years of age.
    We did not receive comments regarding our proposed RDIs for vitamin 
A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B12, 
folate, choline, riboflavin, niacin, vitamin B6, calcium, 
thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, 
selenium, copper, manganese, chromium, molybdenum, and chloride for 
children 1 through 3 years of age. Thus the final rule adopts these 
RDIs for children 1 through 3 years of age without change.
    (Comment 466) One comment said that a DV for potassium of 3,000 mg 
for children aged 1 through 3 years is unrealistic and may promote an 
unbalanced diet. The comment said that the DV for potassium should be 
calculated using a 1,000 calorie diet instead of the 1,372 calorie 
factor used by the IOM for 1 through 3 year olds. The comment requested 
a DV of 2,300 mg given the reference caloric intake of 1,000 for 
children ages 1 through 3 years.
    Another comment expressed concern that, with a DV of 3,000 mg, 
several foods products would no longer be considered a ``good source'' 
of potassium.
    (Response) We decline to establish a DV of 2,300 mg for potassium, 
and we disagree with the comment regarding foods that would no longer 
be considered as a ``good source'' of potassium. In the preamble to the 
proposed rule (79 FR 11879 at 11942), we discussed how we had 
considered comments to the 2007 ANPRM suggesting that we use 1,800 or 
2,000 mg/day potassium as the basis for the RDI for potassium; we said 
that it would be inconsistent with the approach for the general 
population. Selecting a number other than a RDA or AI, when there is 
one, is inconsistent with our approach for establishing DVs. We rely on 
the DRI reports and its set of nutrient reference values for 
establishing the DVs because they are comprehensive reviews and 
applications of nutrition science research. We acknowledge that current 
potassium intakes are below the proposed DV of 3,000 mg. However, we 
disagree that the DV for potassium may promote an unbalanced diet. 
Dietary sources of potassium are found in all food groups, notably in 
vegetables and fruits, and milk and milk products (Ref. 30). Promoting 
the development of healthy eating patterns that will be associated with 
adequate potassium intake later in life is important because chronic 
conditions such as elevated blood pressure, bone demineralization, and 
kidney stones likely result from inadequate potassium intakes over an 
extended period of time, including childhood (Ref. 256).
    We disagree that DVs should be set based on realistic intakes or 
eligibility to make a nutrient content claim. The DVs are established 
based on DRIs set by the IOM that reflect the most current science 
regarding nutrient requirements, not on levels of intakes that are 
achievable or eligibility to make nutrient content claims.
    (Comment 467) One comment would have us retain a DV for iron of 10 
mg of children 1 through 3 years given the importance of adequate iron 
in the diets of infants and young children and the prevalence of iron 
deficiency in children. The comment noted that dietary intake data in 
children aged 12 to 24 months suggests that children may be consuming 
less heme iron than assumed in the determination of the IOM EAR so the 
EAR may be too low to achieve the requirement of absorbed iron. 
However, the comment did not provide an amount or percentage of heme 
iron being consumed from current intakes and also cited data from 
published and unpublished sources.
    (Response) We decline to revise the rule as suggested by the 
comment. We recognize the importance of adequate iron in the diets of 
infants and young children. As for the statement that children may be 
consuming less heme iron than assumed in the IOM's determination of the 
EAR, as the comment provided data from one published study reflecting 
dietary intake data from 2002 and did not provide estimates of the heme 
iron consumed or total iron absorbed, we cannot determine from the 
information provided by the comment that the EAR may be too low to 
achieve the requirement of absorbed iron.
    Furthermore, selecting a number other than a RDA or AI is 
inconsistent with our approach for establishing DVs. We rely on the DRI 
reports and its set of nutrient reference values for establishing the 
DVs because they are comprehensive reviews and applications of 
nutrition science research (79 FR 11879 at 11885).
    (Comment 468) One comment questioned how a decrease in the DV for 
iron would affect iron fortification of foods for toddlers. The comment 
said that such a decrease in the DV could cause manufacturers to reduce 
iron fortification of products for this population group.
    (Response) We disagree with the comment. The comment did not 
provide, and we are not aware of, any evidence to suggest that 
decreasing the DV for iron would impact iron fortification of foods for 
toddlers. DVs are established based on DRIs set by the IOM that reflect 
the most current science regarding nutrient requirements, not on 
potential changes in fortification of products. We recognize the 
importance of adequate iron intake in the diets of young children and 
intend to monitor the nutrient adequacy for this population and 
consider the need for consumer education.
    (Comment 469) One comment asked that we use the current DV of 5 mg 
for zinc for infants as the DV for children 1 through 3 years of age 
because previous RDA panels have recommended intakes of up to 10 mg for 
children 1 through 3 years of age and now recommend a RDA of 3 mg for 
infants and children 1 through 3 years of age. The comment also cited a 
study by Walravens et al. 1989 (Ref. 254) referenced by the IOM 
confirming the factorial approach and questioned the IOM's use of the 
Walravens baseline data minus 2 standard deviations to support for the 
EAR and suggested that reported dietary intake data, instead of 
standard deviations, maybe a more appropriate basis for EAR. The 
comment said that the zinc consumption from a recommended dietary 
pattern for children 1 through 3 years of age would be at least 6 mg, 
or 200 percent of the proposed DV and that consumers would likely be 
confused by these high amounts per serving and could take steps to 
inappropriately limit zinc intake. The comment stated that lowering the 
DV to 3 mg/day may affect the availability and level of zinc 
fortification in foods and reduce intake levels without a full 
understanding of the potential impact in this sensitive population.
    (Response) We decline to revise the rule as suggested by the 
comment. We are changing the DVs to reflect the most recent 
comprehensive reviews and applications of nutrition science research 
provided by current DRI reports and its set of nutrient reference 
values (see 79 FR 11879 at 11885).

[[Page 33931]]

    We also disagree that using reported dietary intake data may be a 
more appropriate basis for the EAR children 1 through 3 years of age. 
We note that the IOM established the EAR for zinc using a factorial 
approach and did not base the EAR on the growth data from the Walravens 
study (Ref. 226).
    The comment did not provide, and we are not aware of, any evidence 
to suggest how consumers will react to the changes in percent DV as a 
result of changes to the DVs and whether they would inappropriately 
limit zinc intake. We recognize the importance of adequate zinc intake 
in the diets of young children and intend to monitor the nutrient 
adequacy for this population and consider the need for consumer 
education.
    We also have no evidence to suggest how that decreasing the DV for 
zinc would impact zinc fortification of foods for toddlers and decline 
to speculate on how availability and level of zinc fortification may 
change. DVs are established based on DRIs set by the IOM that reflect 
the most current science regarding nutrient requirements and not on 
potential changes in the fortification of products.
7. DRVs and RDIs for Pregnant Women and Lactating Women
    The proposed rule would establish certain DRVs and RDIs for 
pregnant women and lactating women.
    a. Calories. The proposed rule would use the 2,000 reference 
calorie intake level for setting DRVs for pregnant women and lactating 
women (Sec.  101.9(c)(9)). In the preamble to the proposed rule (79 FR 
11879 at 11943), we explained that the calorie needs for pregnant women 
and lactating women are similar to the general population, and few 
products are purported for pregnant and lactating women. Thus, because 
the reference calorie intake for the general population is 2,000, we 
proposed to use the 2,000 reference calorie intake level for setting 
DRVs for pregnant women and lactating women (Sec.  101.9(c)(9)).
    We did not receive comments on our proposed 2,000 reference calorie 
intake level for setting DRVs for pregnant women and lactating women. 
Thus, we have finalized the provision without change on this point. 
However, on our own initiative, we have made a grammatical change to 
the rule's mention of ``pregnant and lactating women'' to refer, 
instead, to ``pregnant women and lactating women.'' We have made this 
change to clarify that the rule is referring to two groups (pregnant 
women and lactating women) instead of one group.
    b. Total fat, saturated fat, cholesterol, total carbohydrate, 
sodium, and dietary fiber. For total fat, saturated fat, cholesterol, 
total carbohydrate, sodium, and dietary fiber, we explained, in the 
preamble to the proposed rule (79 FR 11879 at 11943), that the 
quantitative intake recommendations for total fat, saturated fat, 
cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant 
and lactating women are generally similar to the general population. 
Thus, we tentatively concluded that the DRVs for total fat, saturated 
fat, cholesterol, total carbohydrate, sodium, and dietary fiber for 
pregnant and lactating women should remain the same as for the general 
population, and so we proposed to amend Sec.  101.9(c)(9) to establish 
DRVs for pregnant and lactating women using the proposed DRVs for the 
general population for total fat, saturated fat, cholesterol, total 
carbohydrate, sodium, and dietary fiber.
    We did not receive comments on our proposal to establish DRVs for 
total fat, saturated fat, cholesterol, total carbohydrate, sodium, and 
dietary fiber for pregnant and lactating women based on the DRVs for 
the general population for total fat, saturated fat, cholesterol, total 
carbohydrate, sodium, and dietary fiber. Thus, we have finalized these 
provisions without change.
    c. Trans fat, polyunsaturated fat, monounsaturated fat, insoluble 
fiber, soluble fiber, sugars, added sugars, and sugar alcohols. For 
trans fat, polyunsaturated fat, monounsaturated fat, soluble fiber, 
insoluble fiber, sugars, added sugars, and sugar alcohols, in the 
preamble to the proposed rule (79 FR 11879 at 11943), we said that we 
did not propose DRVs for these nutrients for the general population 
because of a lack of quantitative intake recommendations. Because 
quantitative intake recommendations are lacking for these nutrients for 
pregnant and lactating women, we did not propose to establish DRVs for 
trans fat, polyunsaturated and monounsaturated fat, soluble fiber, 
insoluble fiber, sugars, added sugars, or sugar alcohols for pregnant 
and lactating women.
    We did not receive comments on our proposal not to establish DRVs 
for trans fat, polyunsaturated and monounsaturated fat, insoluble 
fiber, soluble fiber, sugars, or sugar alcohols for pregnant and 
lactating women. Thus, the final rule does not establish DRVs for trans 
fat, polyunsaturated and monounsaturated fat, insoluble fiber, soluble 
fiber, sugars, or sugar alcohols for pregnant and lactating women.
    However, with respect to added sugars, we received many comments on 
defining a DRV for added sugars for children and adults 4 years of age 
and older and explain, in part II.H.3.o, that we are establishing a DRV 
for added sugars for children and adults 4 years of age and older of no 
more than 10 percent of total calories, or 50 grams using a 2,000 
calorie intake reference amount based on food pattern modeling. For the 
reasons discussed in part II.H.3.o, we also are establishing a DRV for 
added sugars for pregnant women and lactating women of no more than 10 
percent of total calories, or 50 grams using a 2,000 calorie intake 
reference amount based on food pattern modeling. Thus, the final rule 
at Sec.  101.9(c)(9), establishes a DRV of 50 grams for added sugars 
for pregnant women and lactating women.
    d. Protein. Our preexisting regulations, at Sec.  101.9(c)(7)(iii), 
establish RDIs of 60 grams of protein for pregnant women and 65 grams 
of protein for lactating women based on the highest 1989 RDAs for 
pregnant and lactating women. In the preamble to the proposed rule (79 
FR 11879 at 11943), we noted that the IOM established 71 grams/day 
protein as the RDA for pregnant and lactating women based on the needs 
for maternal and fetal development and human milk production. Because 
the RDA for protein during both pregnancy and lactation is the same, 
and given that most foods represented or purported to be specifically 
for pregnant women are also represented or purported to be specifically 
for lactating women, we tentatively concluded that it would be 
appropriate to establish a single RDI of 71 grams applicable to both 
pregnant and lactating women and that the DV for protein for pregnant 
and lactating women should remain an RDI (using the RDA) instead of a 
DRV because the DRV approach used to calculate protein for the general 
population based on 10 percent of 2,000 calories, which equals 50 grams 
of protein/day, falls short of the recommended protein needs of 
pregnant and lactating women of 71 grams/day. Thus, we proposed to 
amend Sec.  101.9(c)(7)(iii) to establish an RDI of 71 grams for 
protein for pregnant and lactating women.
    We did not receive comments on the proposed RDI of 71 grams for 
protein for pregnant and lactating women. Thus, we have finalized this 
provision without change.
    e. Fluoride. For fluoride, we did not propose to establish a DRV 
for pregnant or lactating women because we were not proposing a DRV for 
fluoride in the general population.
    We did not receive comments regarding the establishment of a DRV 
for fluoride for pregnant and lactating

[[Page 33932]]

women. Thus, the final rule does not establish a DRV for fluoride for 
pregnant and lactating women.
    f. Vitamins and minerals. For vitamins and minerals, in the 
preamble to the proposed rule (79 FR 11879 at 11943), we considered it 
appropriate to establish RDIs for pregnant and lactating women for 
vitamins and minerals that have DRIs, using population-coverage RDAs 
and AIs, instead of population-weighted EARs. We proposed to establish 
a single set of RDIs intended for both pregnant women and lactating 
women because nutrient needs during pregnancy and lactation are 
similar. Thus, we proposed to amend Sec.  101.9(c)(8)(iv) to establish 
RDIs as set forth previously for vitamin A, vitamin C, vitamin D, 
vitamin E, vitamin K, vitamin B12, folate, choline, 
riboflavin, niacin, vitamin B6, calcium, iron, thiamin, 
biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, 
selenium, copper, manganese, chromium, molybdenum, chloride, and 
potassium for pregnant and lactating women.
    We did not receive comments with respect to these DRVs and RDIs for 
pregnant and lactating women, and so we have finalized these provisions 
without change.

P. Dietary Supplements

    Our preexisting regulations specific to dietary supplement 
nutrition labeling appear in Sec.  101.36. Many requirements in Sec.  
101.36 are consistent with the requirements for the nutrition labeling 
of conventional foods in Sec.  101.9, and there are references 
throughout Sec.  101.36 to requirements established in Sec.  101.9.
    The proposed rule would amend both the content and format of the 
Supplement Facts label to correspond to the Nutrition Facts label.
1. Mandatory Dietary Ingredients
    Our preexisting regulations, at Sec.  101.36(b)(2), provide 
information on dietary ingredients that have an RDI or a DRV as 
established in Sec.  101.9(c)(8)(ii) and (c)(9). These dietary 
ingredients are known as the ``(b)(2)-dietary ingredients.'' Of these 
15 nutrients, vitamin A, vitamin C, calcium, and iron must be listed in 
the Supplement Facts label for a dietary supplement when the 
quantitative amount by weight exceeds the amount that can be declared 
as zero in the nutrition labeling of foods in accordance with Sec.  
101.9(c). Section 101.36(b)(2) states that any (b)(2)-dietary 
ingredients that are not present, or that are present in amounts that 
can be declared as zero in Sec.  101.9(c), must not be declared (e.g., 
amounts corresponding to less than 2 percent of the RDI for vitamins 
and minerals). The regulation also requires, in Sec.  101.36(b)(2), 
that calories from saturated fat and polyunsaturated fat, 
monounsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, 
other carbohydrate, and Sec.  101.9(c)(8)(iv) or (c)(9) vitamins and 
minerals other than vitamin A, vitamin C, calcium, and iron may be 
declared, but they must be declared when they are added to the product 
for purposes of supplementation, or when a claim is made about them.
    We proposed to update the list of (b)(2)-dietary ingredients to 
maintain consistency with the proposed requirements for nutrition 
labeling of foods in Sec.  101.9. Therefore, proposed Sec.  
101.36(b)(2)(i) would: (1) No longer require declaration of vitamin A, 
vitamin C, or Calories from fat; (2) require vitamin D and potassium; 
(3) require the declaration of added sugars; and (4) retain the other 
(b)(2)-dietary ingredients as mandatory declarations. We also proposed 
to amend Sec.  101.36(b)(2)(i), (b)(2)(i)(B)(1), and (b)(2)(iii)(G) to 
remove the requirement for declaration of ``Calories from fat.''
    We did not receive comments on these proposed changes to the 
Supplement Facts label, and so, with the exception of replacing 
``sugars'' with ``total sugars'' in Sec.  101.36(b)(2)(i), we have 
finalized the provisions without change.
    We note that we did receive comments, in general, on removing the 
declaration of vitamins A and C and on requiring the declaration of 
vitamin D and potassium; we discuss those comments in part II.L.2 and 
II.L.3. We also received comments on removing the requirement for 
declaration of ``Calories from fat;'' we discuss those comments in part 
II.E.1.
2. Folate and Folic Acid
    The preamble to the proposed rule (79 FR 11879 at 11947) explained 
that folate is a nutrient found in conventional foods, whereas folic 
acid is the synthetic form of folate that is added to fortified 
conventional foods and dietary supplements. Because of the difference 
in bioavailability between naturally occurring folate and synthetic 
folic acid, we proposed to:
     Amend Sec.  101.9(c)(8)(v) such that the term ``folate'' 
would be used in the labeling of conventional foods that contain either 
folate alone or a mixture of folate and folic acid;
     amend Sec.  101.36(b)(2)(i)(B) and (b)(2)(i)(B)(2) to 
specify that ``folic acid'' is the term used to declare folic acid 
content of dietary supplements; and
     remove ``folate'' and ``folacin'' from the list of 
synonyms that may be used to declare folic acid on the Supplement Facts 
label.
    (Comment 470) Many comments opposed allowing only the use of the 
term ``folic acid'' on dietary supplements. The comments said that 
dietary supplements can contain folate.
    (Response) As discussed in part II.N.3.b, the final rule requires 
that the Supplement Facts label declare folate in mcg DFE, a percent DV 
based on mcg DFE, and that the mcg of folic acid be stated in 
parenthesis when folic acid is added as a nutrient supplement to a 
dietary supplement. In doing so, there will be consistency with the use 
of the term folate in labeling of both conventional foods and dietary 
supplements. In addition, the mcg DFE reflects the fact that folic acid 
is more bioavailable than folate and is the basis of the DV. By 
requiring the declaration of the mcg DFE folate, a percent DV based on 
mcg DFE, and the mcg of folic acid in parentheses on dietary 
supplements when folic acid is added as a nutrient supplement, 
consumers will be aware of the type and amount of folate or folic acid 
in the dietary supplement.
    The final rule also removes ``folacin'' from the list of synonyms 
that may be used for folate in the Nutrition Facts label in Sec.  
101.9(c)(8)(v) and the Supplement Facts label in Sec.  
101.36(b)(2)(i)(B)(2)). In addition, the final rule removes the term 
``folic acid'' from the list of synonyms that may be added in 
parentheses immediately following ``folate'' on the Nutrition Facts 
label in Sec.  101.9(c)(8)(v) or in place of the term ``folate'' on the 
Supplement Facts label in Sec.  101.36(b)(2)(B)(2) because we are now 
requiring that the terms ``folate'' and ``folic acid'' be included, 
when declared, on both the Nutrition and Supplement Facts label.
3. Units of Measure
    The proposed rule would amend Sec.  101.9(c)(8)(iv) to replace 
``IU'' for the RDIs for vitamin A, vitamin D, and vitamin E with mcg 
RAE for vitamin A, mcg for vitamin D, and mg [alpha]-tocopherol for 
vitamin E. The proposed rule would quantify and declare folate and 
folic acid in ``mcg DFE'' instead of ``mcg.'' For consistency in 
nutrition labeling of foods and dietary supplements, the proposed rule 
also would amend Sec.  101.36(b)(2)(i)(B)(3) to require that, when 
[beta]-carotene is included in parentheses following the percent 
statement for vitamin A, it should be declared using ``mcg'' 
(representing mcg RAE) as the unit of measure. In addition, under Sec.  
101.36(b)(2)(ii)(B), the

[[Page 33933]]

proposed units of measure for vitamin D, vitamin E, and folate in Sec.  
101.9(c)(8)(iv) would be used in the declaration of vitamin D, vitamin 
E, and folic acid in the Supplement Facts label.
    (Comment 471) Some comments disagreed with our proposal to replace 
``IU'' for the RDIs for vitamin A, vitamin D, vitamin E with mcg RAE 
for vitamin A, mcg for vitamin D, and mg [alpha]-tocopherol for vitamin 
E.
    (Response) We address these comments in part II.N.4. The final 
rule, at Sec.  101.9(c)(8)(iv), revises the units of measure to be mcg 
RAE for vitamin A, mcg for vitamin D (with the allowance of voluntary 
declaration of IUs), and mg [alpha]-tocopherol for vitamin E, and Sec.  
101.36(b)(2)(ii)(B), therefore, adopts the same units of measure for 
vitamin D, vitamin E, and folate.
    Additionally, we did not receive comments on the proposed changes 
to the declaration of [beta]-carotene at Sec.  101.36(b)(2)(i)(B)(3), 
so we have finalized that provision without change.
    (Comment 472) One comment said we should adopt a unit of measure 
for fluoride of mg per liter (mg/L) rather than mg/servings.
    (Response) We address this comment in part II.K.3. The final rule 
does not adopt mg/L as the unit of measure for fluoride.
    (Comment 473) The proposed rule, at Sec.  101.36(b)(2)(ii)(A), 
would state that amounts must be expressed in the increments specified 
in Sec.  101.9(c)(1) through (c)(7), which includes increments for 
sodium. One comment said we should permit the use of additional units 
of measure for dietary ingredients to allow for use of more appropriate 
units of measure when metric weight is not the most accurate way to 
express the quantity of the dietary ingredient. The comment gave 
examples of ``colony forming unit'' (CFU) for probiotics and enzyme 
assay units (e.g. HUT, PC, SU, ALU) for enzymes. Another comment would 
amend Sec.  101.36(b)(2)(ii)(A) to state ``these amounts shall be 
expressed in metric or other appropriate units of measure.''
    (Response) We decline to permit the use of additional units of 
measure for dietary ingredients. The comment provided the examples of 
CFUs for probiotics and enzyme assay units for enzymes; however, the 
broader change suggested in the comment, by including ``other 
appropriate units of measure,'' would allow for the use of units of 
measure for dietary ingredients other than just probiotics and enzyme 
assay units.
    We recognize that manufacturers are using a number of different 
units of measure for probiotics, enzymes, and other dietary 
ingredients. We need to fully evaluate each unit of measure for dietary 
ingredients to determine if it is appropriate for use on the Supplement 
Facts label, and if there are any implications to allowing for the use 
of such units of measure on the label. Because of the complexity of 
these labeling concerns, we plan to issue information related to this 
subject at a later date. We have, therefore, finalized Sec.  
101.36(b)(2)(ii)(A) without change.
4. Order of Nutrients Declared on the Label
    For dietary supplements, Sec.  101.36(b)(2)(i)(B) specifies that 
vitamins and minerals must be declared in a specific order on the 
Supplement Facts label. The proposed rule would add choline to the list 
of ordered nutrients in Sec.  101.36(b)(2)(i)(B) and that, when 
declared, choline must follow potassium on the label.
    We proposed to amend Sec.  101.9(c)(5) to provide for the voluntary 
declaration of fluoride, unless a claim about fluoride, in which case 
fluoride would be mandatory on the label. We inadvertently did not 
propose to add fluoride to the list of ordered nutrients for 
declaration on the Supplement Facts label in Sec.  101.36(b)(2)(i)(B).
    We did not receive any comments on the proposed addition of choline 
to the list of nutrients on the Supplement Facts label. Therefore, the 
final rule adds choline to the list of nutrients in Sec.  
101.36(b)(2)(i)(B) and requires it to appear after pantothenic acid on 
the label because choline is a vitamin and pantothenic acid is the last 
vitamin in the list of nutrients provided in Sec.  101.36(b)(2)(i)(B). 
In addition, the final rule specifies that calcium and iron shall be 
declared after choline on the label because choline will now be 
declared after pantothenic acid on the label.
    As for fluoride, to enable manufacturers to know where to declare 
fluoride on the Supplement Facts label, we are adding fluoride to the 
end of the list of nutrients in Sec.  101.36(b)(2)(i)(B) such that, 
when it is declared, it should be placed below potassium on the 
Supplement Facts label.
5. Subpopulations
    The preamble to the proposed rule (79 FR 11879 at 11947) indicated 
that, to maintain consistency with the proposed requirements for 
nutrition labeling of foods in Sec.  101.9, we would revise portions of 
Sec.  101.36 pertaining to labeling requirements for foods, other than 
infant formula, that are represented or purported to be specifically 
for infants 7 through 12 months, children 1 through 3 years, and 
pregnant and lactating women. The proposed rule would amend Sec.  
101.36(b)(2)(iii) to state that the percent of the DV of all dietary 
ingredients declared under Sec.  101.36(b)(2)(i) must be listed, except 
that the percent DV for protein may be omitted as provided in Sec.  
101.9(c)(7) and that no percent DV is to be given for subcomponents for 
which DRVs have not been established.
    When the percent DV is declared for total fat, saturated fat, total 
carbohydrate, dietary fiber, or protein, our existing regulations 
require that a symbol be placed next to the percent DV declaration for 
these nutrients that refers the consumer to a statement at the bottom 
of the label that says ``Percent Daily Values are based on a 2,000 
calorie diet.'' This statement is only accurate for products meant for 
children and adults that are 4 years of age and older. In the preamble 
to the proposed rule (79 FR 11879 at 11947), we explained that the 
proposed DRVs for total fat, total carbohydrate, dietary fiber, and 
protein for children 1 through 3 years of age are based on a 1,000 
calorie diet, so, when a product that is represented or purported to be 
for children 1 through 3 years of age contains a percent DV declaration 
for total fat, total carbohydrate, dietary fiber, or protein, the 
proposed rule would require, in Sec.  101.36(b)(2)(iii)(D), that a 
symbol be placed next to the percent DV declaration that refers the 
consumer to a statement at the bottom of the label that says ``Percent 
Daily Values are based on a 1,000 calorie diet.''
    The proposed rule also would amend Sec.  101.36(b)(2)(iii)(E) to 
change the categories of infants and children less than 4 years of age 
to infants 7 through 12 months of age and children 1 through 3 years of 
age, and, because we are proposing DRVs for various nutrients for 
infants 7 through 12 months, children 1 through 3 years, and pregnant 
and lactating women, amend Sec.  101.36(b)(2)(iii)(F) such that the 
requirement for an asterisk noting that a DV has not been established 
would be applicable to foods for these subpopulations only when a DRV 
has not been established for a nutrient (i.e., for saturated fat, 
cholesterol, or dietary fiber for dietary supplements that are 
represented or purported to be for use by infants 7 through 12 months).
    We did not receive comments specific to subpopulations and the 
proposed changes to Sec.  101.36, and so, except as described in our 
response to comment 474, we have finalized those provisions without 
change. As discussed in our

[[Page 33934]]

response to comment 441, we are using the terminology ``infants through 
12 months of age'' throughout Sec.  101.36. As discussed in part 
II.O.7.a, we also have decided to use the terminology ``pregnant women 
and lactating women'' rather than ``pregnant and lactating women'' to 
clarify that the rule is referring to two groups (pregnant women and 
lactating women) instead of one group.
6. Footnote
    The Supplement Facts label can bear a footnote stating that the 
percent Daily Values are based on a 2,000 calorie diet. In the preamble 
to the proposed rule (79 FR 11879 at 11947 through 11948), we noted 
that we intended to modify the footnote on the Nutrition Facts label 
and to conduct consumer studies related to the footnote on the 
Nutrition Facts label. We also noted that the footnote for the 
Supplement Facts label differs from the footnote for Nutrition Facts 
label, yet we expected that consumers who buy dietary supplements would 
be more interested in information about the amount of specific 
micronutrients contained in dietary supplements and would be less 
focused on the caloric reference value used in determining the percent 
DV for macronutrients (id.). We said that, based on the results of the 
consumer study, we would consider whether it is necessary to make 
corresponding changes to the footnote used on the Supplement Facts 
label when certain macronutrients are declared, and we invited comment 
on whether we should change the footnote on the Supplement Facts label 
to be consistent with the footnote on the Nutrition Facts label.
    (Comment 474) One comment said there should be no footnote on the 
Supplement Facts label. The comment said that consumers do not receive 
their nutrition solely from a supplement, so, according to the comment, 
there is no need to refer to total calories. In addition, because all 
nutrition calculations are being made from the 2,000 calorie total, the 
comment said that the information provided by the footnote is already 
standardized across industry, so the footnote is unnecessary.
    (Response) We decline to remove the footnote from the Supplement 
Facts label. Our preexisting regulations, at Sec.  
101.36(b)(2)(iii)(D), require manufacturers to declare the footnote 
``Percent Daily Values are based on a 2,000 calorie diet'' only when 
total fat, saturated fat, total carbohydrate, dietary fiber, or protein 
are declared. The final rule amends Sec.  101.36(b)(2)(iii)(D)) to 
include added sugars in the list of macronutrients to be consistent 
with the final requirement to include a declaration for added sugars in 
the nutrition label. As with the declaration of the footnote statement 
on the Nutrition Facts label, the footnote statement on the Supplement 
Facts label provides context for the consumer and enables the consumer 
to better judge how the nutrients in the supplement contributes towards 
the total daily diet. Therefore, we decline to remove the footnote 
statement from the Supplement Facts label.
    When the food is purported to be for children 1 through 3 years of 
age, the final rule requires footnote to state that ``Percent Daily 
Values are based on a 1,000 calorie diet'' because a 1,000 calorie 
reference caloric value is used when calculating percent DVs for 
children 1 through 3 years of age. Therefore, the final rule amends 
Sec.  101.36(b)(2)(iii)(D) to require the footnote statement ``Percent 
Daily Values are based on a 2, 000 calorie diet'' on the Supplement 
Facts label when the percent DV for total fat, saturated fat, total 
carbohydrate, dietary fiber, protein, or added sugars is declared on 
the label, and to require the footnote statement ``Percent Daily Values 
are based on a 1,000 calorie diet'' if the product is represented or 
purported to be for use by children 1 through 3 years of age and, if 
the percent DV is declared for total fat, total carbohydrate, dietary 
fiber, protein, or added sugars.
7. Miscellaneous Comments
    Several comments raised other issues regarding dietary supplements 
and labeling.
    (Comment 475) One comment said that the current method of labeling 
dietary supplements causes confusion regarding which micronutrients, 
especially vitamins and minerals, are added to a product as opposed to 
those that are naturally occurring within the product. The comment 
suggested that the terminology ``naturally occurring'' be used when 
nutrients are naturally present in ingredients or products, and that 
other terms, such as ``added,'' be used when ingredients containing 
micronutrients have been added to a product.
    Another comment objected to the nomenclature we proposed for the 
declaration of certain vitamins and minerals, suggesting the 
limitations in nomenclature are unconstitutional under the First 
Amendment (citing Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999); 
reh'g, en banc, denied, 172 F.3d 72 (D.C. Cir. 1999)) and stating that 
the nomenclature prevents the dissemination of information helpful to 
the public in evaluating health implications of supplements. For 
example, the comment stated that calling tocotrienols vitamin E is not 
accurate because these forms of vitamin E differ from other forms of 
vitamin E. The comment also noted that the proposed rule does not 
distinguish between different forms of vitamin K, selenium, vitamin 
B12, vitamin B6, and vitamin B3 for 
purposes of identifying on the label the actual ingredient that is 
contained in a dietary supplement product. The comment suggested that 
the identification of the actual form of vitamin B3 that is 
included in the product is essential because of the physiological 
differences between these forms. For example, vitamin B3 
could be identified as niacin or niacinamide; and similarly, vitamin 
B12 could be methylcobalamin or cyanocobalamin; vitamin 
B6 could be pyridoxal 5-phosphate or pyridoxine; vitamin K 
could be phylloquinone or menaquione; selenium could be 
selenomethionine or sodium selenite or selenocysteine. The comment also 
cited references to suggest selenium in different forms has been 
reported to have different effects. Furthermore, the comment noted that 
the name of a nutrient ingredient in a dietary supplement may be a 
structure/function claim because the form of the molecule determines 
its function. For example, the comment stated that gamma-tocopherol 
denotes a particular structure of vitamin E that has a particular 
function because of its structure.
    (Response) With respect to the comment related to added versus 
naturally occurring micronutrients in dietary supplement products, we 
decline to revise the rule as suggested by the comment. In dietary 
supplement products, when terms such as ``naturally occurring'' are 
used to refer to micronutrients in dietary supplements, they may imply 
that there is an inherent difference in nutritional quality of the 
vitamin depending on its source. We are not aware of any evidence that 
this is the case. Typically, ``added'' nutrients are synthetic forms of 
the nutrient. As stated in Sec.  101.9(k)(4), a food is misbranded if 
its labeling suggests or implies that a natural vitamin is superior to 
an added or synthetic vitamin.
    With respect to the comment objecting to the nomenclature we 
proposed for the declaration of certain vitamins and minerals, the 
comment seems to misunderstand our requirements for the declaration of 
vitamins and minerals and for structure or function claims. We provide 
for the truthful, nonmisleading labeling of

[[Page 33935]]

nutrients in their varying forms on dietary supplements in Sec.  
101.36(b) and (d) and Sec.  101.9(c). Our regulation (21 CFR 
101.36(b)(2)) provides for the labeling on the nutrition label of 
dietary ingredients with RDIs such as vitamins or minerals listed in 
Sec.  101.9(c)(8)(iv), with the exception of vitamin B3. We 
discussed, in the preamble to the proposed rule (79 FR 11879 at 11925) 
and also in part II.M (Reference Daily Intakes for Vitamins and 
Minerals), the reference intakes for vitamins and minerals listed in 
the Nutrition Facts and Supplement Facts panels that are identified in 
Sec.  101.9(c)(8)(iv). The RDIs for vitamins and minerals are based on 
the IOM RDAs or AIs. In some cases, the RDA is based on the form of a 
vitamin or mineral recognized to meet human requirements (i.e., the 
[alpha]-tocopherol form of vitamin E) and the AI is based on intakes of 
a specific form of the vitamin or mineral (i.e., phylloquinone form of 
vitamin K). With the exception of vitamin B3, we note that 
Sec.  101.9(c)(8)(iv) lists the common and usual names of vitamins and 
minerals. The dietary supplement label requirements at Sec.  101.36(d) 
provide for labeling of the source ingredient that supplies a dietary 
ingredient (i.e. niacin, vitamin B12, vitamin B6, 
vitamin K, and selenium) within the nutrition label in parentheses 
immediately following or indented beneath the name of a dietary 
ingredient and preceded by the words ``as'' or ``from,'' e.g., 
``Calcium (as calcium carbonate).'' When a source ingredient is not 
identified within the nutrition label, it must be listed in an 
ingredient statement in accordance with Sec.  101.4(g). In addition, 
dietary ingredients, such as menaquinone, that are ``other dietary 
ingredients'' within the meaning of Sec.  101.36(b)(3) must be declared 
by their common or usual name when they are present in a dietary 
supplement in accordance with that section. Thus, the forms of vitamins 
and minerals contained in dietary supplements such as niacinamide; 
methylcobalamin or cyanocobalamin; pyridoxal 5-phosphate or pyridoxine; 
phylloquinone or menaquione; and selenomethionine, sodium selenite, or 
selenocysteine may be identified, as appropriate, in the Nutrition 
Facts label or the ingredient statement.
    Although we do not recognize the term vitamin B3 and 
instead list niacin in Sec.  101.9(c)(8)(iv), the term ``vitamin 
B3'' if identified in labeling, other than in the Nutrition 
Facts label, must be truthful and not misleading. Furthermore, we 
disagree that we are requiring misinformation by calling tocotrienols 
vitamin E and lumping these forms of vitamin E together. As we discuss 
in part II.M, we established the RDI for vitamin E based on [alpha]-
tocopherol Sec.  101.9(c)(8)(iv). In Sec.  101.36, we provide for 
dietary ingredients, such as tocotrienols for which we have not 
established RDI's or DRV's and that are not subject to regulation under 
paragraph (b)(2) of this section, as ``other dietary ingredients'' in 
Sec.  101.36(b)(3). If other statements are made about ``other dietary 
ingredients,'' the statements must be consistent with the all 
applicable statutory and regulatory requirements.
    To the extent the comment suggests that our regulations limit the 
information about the form of a nutrient on the label, we disagree. 
Although we have specific requirements related to nomenclature for the 
nutrient declarations, there are ways to convey the source of the 
nutrient in labeling, and thus, we do not restrict information about 
the source of the nutrient, provided the information presented is 
consistent with our statutory and regulatory requirements.
    With respect to the comment that the name of a nutrient may be a 
structure or function claim, a structure or function claim is described 
in section 403(r)(6)of the FD&C Act. Such a claim is a statement that 
describes the role of a nutrient or dietary ingredient intended to 
affect the structure or function in humans or that characterizes the 
documented mechanism by which a nutrient or dietary ingredient acts to 
maintain such structure or function (section 403(r)(6)(A) of the FD&C 
Act). Gamma-tocopherol is a name for a particular form of tocopherol. 
While the molecular form of a vitamin may result in a particular 
function, the name of the form does not describe the role of the 
dietary ingredient in affecting the structure or function in humans nor 
does it describe a documented mechanism by which the dietary ingredient 
acts to maintain such structure or function. Thus, structure or 
function claims are permitted for dietary ingredients provided they 
meet the applicable statutory and regulatory requirements for such 
claims.
    (Comment 476) One comment said there is confusion whether nutrient 
declarations on the Supplement Facts label represent only the added 
nutrients or the total amount of a nutrient based on analysis of the 
finished product in products where either micronutrients have been 
added or botanical ingredients are present that are natural sources of 
particular micronutrients. The comment suggested we could resolve the 
issue by ensuring that, where micronutrients are listed on the 
Supplement Facts and/or Nutrition Facts label, the information reflects 
those micronutrients that are typically present at the end of the 
shelf-life period in the finished product, taking into account 
industry-accepted overages/tolerances.
    (Response) The Supplement Facts label provides the nutrition 
information for nutrients that have a RDI or a DRV as established in 
Sec.  101.9(c). A (b)(2)-dietary ingredient may only be listed if it is 
a quantitative amount by weight that exceeds the amount that can be 
declared as zero in Sec.  101.9(c). We are aware that micronutrients 
are sometimes added to naturally occurring micronutrients. The value 
declared on the label should be the value that is supported by data 
that factors in variability generally recognized for the analytical 
method used for the finished dietary supplement product for the level 
involved. We disagree that the label declaration should be based on a 
shelf-life period because the Dietary Supplement Good Manufacturing 
Practices regulations do not require an expiration date, shelf-life 
date, or ``best if used by'' date (see 72 FR 34752 at 34912 and 34856). 
Therefore, not all products would have a shelf-life date that could be 
used when determining what the final value should be.
    (Comment 477) Several comments opposed decreasing the RDIs for 
vitamins and minerals because of the impact on the dietary supplement 
industry. The comments also stated that decreasing the RDIs for 
vitamins and minerals makes it difficult for consumers to get 
therapeutic dosages of vitamins and minerals in one supplement.
    (Response) We address these comments in part II.M.
8. Compliance Requirements for Dietary Supplements
    Compliance for dietary supplements is currently determined in 
accordance with Sec.  101.9(g)(1) through (g)(8), except that the 
sample for analysis must consist of a composite of 12 subsamples 
(consumer packages) or 10 percent of the number of packages in the same 
inspection lot, whichever is smaller, randomly selected to be 
representative of the lot. The regulation also says that the criteria 
on class I and class II nutrients given in Sec.  101.9(g)(3) and (g)(4) 
are applicable to other dietary ingredients.
    The proposed rule would require manufacturers to declare added 
sugars on the Supplement Facts label under Sec.  101.36(b)(2)(i). It 
would also require manufacturers to make and keep records to verify the 
amount of dietary fiber,

[[Page 33936]]

soluble fiber, insoluble fiber, added sugars, vitamin E, and folate, 
under certain circumstances for foods (79 FR 11879 at 11956). The 
proposed rule, at Sec.  101.9(g)(10) and (g)(11), also would establish 
recordkeeping requirements for foods that contain a mixture of dietary 
fiber and added non-digestible carbohydrate(s) that does not meet the 
definition of dietary fiber, foods that contain a mixture of soluble 
fiber and added non-digestible carbohydrate(s) that does not meet the 
definition of dietary fiber, foods that contain a mixture of insoluble 
fiber and added non-digestible carbohydrate(s) that does not meet the 
definition of dietary fiber, foods that contain a mixture of naturally 
occurring and added sugars, foods that contain added sugars that are 
reduced through non-enzymatic browning and/or fermentation, foods that 
contain a mixture of all rac-[alpha]-tocopherol and RRR-[alpha]-
tocopherol, and foods that contain a mixture of folate and folic acid.
    The same records requirements in Sec.  101.9(g)(10) and (g)(11) 
also should apply to dietary supplements. Therefore, the final rule 
revises Sec.  101.36(f)(1) to include the recordkeeping requirements 
for specific nutrients under Sec.  101.9(g)(10) and (g)(11).
    Manufacturers of dietary supplements may request an alternative 
means of compliance or additional exemptions under Sec.  101.36(f)(2) 
when it is technologically feasible, or some other circumstance makes 
it impracticable, for firms to comply with the requirements of the 
regulation. This allowance is the similar to what is made for 
conventional foods under Sec.  101.9(g)(9). Therefore, the final rule, 
at Sec.  101.36(f)(2), does not refer to Sec.  101.9(g)(9).

Q. Format

    Under our preexisting regulations (see, e.g., Sec.  101.9(d) 
through (f) and (j)), nutrition information must be presented on food 
labels in a specific format. The elements of format related to the 
Nutrition Facts label include such features and graphic design 
principles as the type style (i.e., font) and size of the type (i.e., 
point); use of boldface, lines, and bars; arrangement of information in 
one or more columns; column headings; presence of a footnote and use of 
a symbol (such as an asterisk) to designate a footnote; and whether 
nutrition information is listed as a percentage or in absolute (i.e., 
quantitative) amounts. The elements of format also include the 
alignment of information; whether indentations are used in listing 
nutrient data; and the use of white space (or negative space) where no 
image or text exists. The format may differ from package to package 
according to the amount of space on the package that is available for 
labeling, as described and detailed in the relevant sections in this 
document.
    The original format of the Nutrition Facts label was informed by a 
number of factors, including consumer research that we conducted; 
consideration of the environment in which consumers typically use the 
label (i.e., grocery stores); the diversity of consumers (i.e., with 
respect to education, age, socioeconomic status, etc.) for whom the 
label is intended; and comments and data received on this issue in 
response to rulemaking activities conducted in the 1990s. Research 
studies consistently confirmed that simple formats are easier to 
comprehend and require less consumer effort than complex information 
formats. A simple format is one that minimizes clutter and best meets 
the NLEA requirements that nutrition information should enable the 
public to readily observe and comprehend such information. In addition, 
a simple format allows consumers to search for accurate nutrition 
information with minimum effort, and provides information in a succinct 
manner that maximizes understanding (79 FR 11879 at 11948).
    In the preamble to the proposed rule (79 FR 11879 at 11948), we 
explained that we were not proposing an extensive reformatting of the 
Nutrition Facts label. We further explained that we were proposing to 
make changes based on graphic design principles (such as alignment, 
consistency, repetition, and contrast), highlight key nutrients and key 
information, and remove or modify parts of the label to assist 
consumers in maintaining healthy dietary practices. In brief, we 
proposed the following changes to the format of the Nutrition Facts 
label: (1) Increasing the prominence of calories and serving size; (2) 
reversing the order of the ``Serving Size'' declaration and the 
``Servings Per Container'' declaration and increasing the prominence of 
``Servings Per Container;'' (3) right-justifying the quantitative 
amounts of the serving size information; (4) changing the phrase 
``Amount Per Serving'' to ``Amount Per __'' with the blank filled in 
with the serving size; (5) removing the declaration of ``Calories from 
fat;'' (6) modifying the presentation of the ``% DV'' information by 
changing its position to the left of the name of the nutrient on 
certain labels and separating it from the list of nutrients with a 
vertical line; (7) declaring ``Added Sugars'' as an indented listing 
directly beneath the listing for ``Sugars''; (8) declaring the 
quantitative (or absolute) amounts (in addition to percent DVs) of 
mandatory vitamins and minerals and, when declared, voluntary vitamins 
and minerals; (9) requiring dual column labeling under certain 
conditions; (10) modifying the footnote; (11) requiring that all 
nutrients not currently highlighted in bold or extra bold type be 
highlighted in a type that is intermediate between bold or extra bold 
and regular (i.e., semi-bold) type; (12) adding a horizontal line 
directly beneath the ``Nutrition Facts'' heading; and (13) replacing 
the listing of ``Total Carbohydrate'' with ``Total Carbs.'' We also 
invited comments on other issues related to the Nutrition Facts label 
format, including the use of an alternative format design or requiring 
the use of a specific font.
    The preamble to the proposed rule also discussed certain 
modifications to be applied to other label formats to maintain 
consistency with the proposed Nutrition Facts label. These other 
modifications would pertain to formats for packages of products that 
contain two or more separately packaged foods that are intended to be 
eaten individually (e.g., variety packs of cereals and snacks) or that 
are used interchangeably for the same type of foods (e.g., round ice 
cream containers (Sec.  101.9(d)(13)); formats that apply to 
subpopulations (Sec.  101.9(e) and (j)(5)); the simplified format 
(Sec.  101.9(f)); the tabular display on packages that do not have 
sufficient continuous vertical space (Sec.  101.9(d)(11)(iii)); and the 
tabular display (Sec.  101.9(j)(13)(ii)(A)(1)) and linear display 
(Sec.  101.9(j)(13)(ii)(A)(2)) for small packages.
    Additionally, in the Federal Register of July 27, 2015 (80 FR 
44303), we proposed text for the footnotes to be used on the Nutrition 
Facts label and proposed to require the declaration of the percent DV 
for added sugars on the Nutrition Facts label. In a separate notice 
published 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 consumer studies: One using an experimental design 
methodology (the format study) and one using eye-tracking methodology 
(the eye-tracking study). The purpose of these studies was to examine 
the combined effects of most of the changes outlined in the proposed 
rule in their totality; however, both studies also examined certain 
individual changes, selected on the basis of priorities and resources 
available at that time.

[[Page 33937]]

1. General Comments
    To make a determination about the final format for the Nutrition 
Facts label, we considered many factors including: Comments we received 
about the proposed label format in response to our proposed rule (79 FR 
11879), the supplemental proposed rule (80 FR 44303) and the reopening 
of the comment period (80 FR 44302); graphic design principles; and 
results from consumer research conducted by ourselves and others. This 
is similar to the approach we took when determining the original 
Nutrition Facts label formats. At that time, our decisions about format 
elements drew on information collected from a variety of sources 
including focus groups and a professional package design firm, in 
addition to label research conducted by FDA and other organizations (57 
FR 32060).
    (Comment 478) Several comments stated that neither the results of 
our consumer studies nor those submitted by outside parties support the 
proposed label changes and that our proposed changes do not improve 
consumer understanding of nutrition information on the label over the 
current label format. One comment said that the proposed format changes 
do not offer ``enhanced value'' to the consumer that would justify a 
change from the preexisting label format.
    (Response) The consumer studies that we conducted focused mainly on 
comparing the Current, Proposed, and Alternative formats in their 
totality. We found that overall consumer preferences, understanding, or 
perceptions of product healthfulness (as indicated by the label) were 
comparable among the Current, Proposed, and Alternative label formats. 
In this final rule, we are making minor changes, such as highlighting 
certain specific features and characteristics of the label, to enhance 
the information or for other reasons. Our consumer research provided 
important information and insights about consumer perceptions, 
judgments, and understanding that will be useful in informing our 
future consumer education efforts. We acknowledged in our 1993 
nutrition labeling final rule that various considerations (i.e., in 
addition to consumer research) would bear on the selection of a final 
nutrition label format. We previously said that an essential criterion 
would be how well a format conveyed information that Congress expected 
a nutrition label to provide, such as information that would allow 
people to decide whether to buy a product or to understand the relative 
significance of the food in the context of the daily diet (58 FR 2079 
at 2115). In the consumer studies we conducted to determine the format 
for the original Nutrition Facts label, no single format emerged as 
being superior in every aspect that was investigated. We subsequently 
worked with graphic design experts to develop the new label, drawing on 
research that considered not only comprehension, but also legibility 
and literacy (Ref. 257).
    (Comment 479) One comment described a study designed to investigate 
the extent that consumers are able to quickly notice and understand 
label information, as they would during grocery shopping (Ref. 258). 
The study compared consumer reactions to FDA's current and proposed 
versions of four different Nutrition Facts label formats, each 
portraying a different food product, so that a total of eight different 
labels were examined. The current and proposed label formats, and the 
foods depicted, were: Standard format for single-serve yogurt; tabular 
format for frozen vegetables; dual-column label for breakfast cereal 
(per serving and with \1/2\ cup skim milk); and a dual-column label for 
a multi-serving snack mix package (per serving and per container). The 
comment recommended that we not implement the proposed changes in 
format for the Nutrition Facts label because, according to the comment, 
the study indicated that participants perceived few differences between 
the current and proposed label formats.
    (Response) The results of this study are difficult to interpret 
because a number of details were not provided. Among other things, the 
comment did not adequately describe or explain the demographic 
characteristics of the participants, the statistical methods that were 
used, how the survey instrument was validated, how the participants 
were selected and the study was administered, and why 90 percent 
confidence levels were chosen to indicate significant differences 
rather than the conventional 95 percent confidence interval. In 
addition, the manner in which some questions were worded could have 
affected the responses, and the full range of response options was not 
presented. Furthermore, the proposed snack mix label appeared to be 
inconsistent in how the ``per serving'' and ``per container'' values 
were listed for various nutrients. Although the label indicated ``3\1/
2\ servings per container'' for some nutrients (e.g., calories, 
carbohydrates, sodium, protein) the amounts that were listed on the 
label suggested that there were 4 servings per container, and the 
amount of dietary fiber shown on the label indicated there were only 
2\1/2\ servings per container. Therefore, we are not able to rely on 
the results of this study to inform our decisions regarding Nutrition 
Facts label formats.
    (Comment 480) Several comments said that we should not move forward 
with the proposed nutrition label format changes without conducting 
further consumer research.
    (Response) We disagree with comments suggesting that we should not 
finalize this rulemaking until we conduct further consumer research 
(see, also, our response to comment 6). We considered consumer research 
studies and public comments, and we also relied on graphic design 
principles (such as contrast, proximity, alignment, consistency, etc.) 
in deciding how the various Nutrition Facts label formats should appear 
in finalizing the requirements for the label format.
2. Increasing the Prominence of Calories and Serving Size
    The ability to determine the caloric content of packaged foods is 
important for all consumers, especially those who are trying to control 
their total caloric intake and manage their weight. Our preexisting 
regulations require ``Calories'' to be declared in a type size no 
smaller than 8 point (Sec.  101.9(d)(1)(iii)) and highlighted in bold 
or extra bold type or other highlighting (Sec.  101.9(d)(1)(iv)). While 
calorie information is mandatory on the Nutrition Facts label, 
modifying the Nutrition Facts label to give more prominence to calories 
may benefit consumers in weight control and maintenance, as noted by 
the OWG in its final report entitled ``Calories Count'' (Ref. 127).
    In the preamble to the proposed rule (79 FR 11879 at 11849 and 
11948 through 11949), we explained that the OWG recommended, in part, 
that we issue an ANPRM to solicit comments on how to give more 
prominence to calories on the food label. The OWG suggested possible 
changes to the Nutrition Facts label, such as increasing the prominence 
of ``Calories'' and ``Serving Size,'' providing a percent DV for 
calories, and eliminating the ``Calories from fat'' declaration, which 
may detract from the emphasis on total calories. The OWG recommended 
that we obtain information on the effectiveness of these options on 
consumer understanding and behavior related to calorie intake (Ref. 
127). In response to the 2005 ANPRM, several comments supported 
increasing the prominence of calories on the Nutrition Facts label. 
These comments suggested

[[Page 33938]]

various approaches for doing so and pointed out the need for additional 
research to fully understand the effects of potential label changes on 
consumer understanding and behavior (Ref. 26).
    We considered available data from consumer research and comments 
received in response to the ANPRMs and conducted our own research on 
food labels. We tentatively concluded that the proposed changes to the 
number of calories per serving and the number of servings per container 
would result in these declarations serving as an anchor to the 
Nutrition Facts label by focusing the reader's attention to this 
information and therefore would assist consumers to effectively use 
this information in the Nutrition Facts label (Ref. 259). The proposed 
rule would revise Sec.  101.9(d) to increase the type size for 
``Calories'' and the numeric value for ``Calories'' and also would 
require the numeric value for calories be highlighted in bold or extra 
bold type to draw attention to this information, emphasize the 
importance of calories on the label, and maintain consistency with the 
bolded declaration for ``Calories.''
    We also expressed a tentative view that the Supplement Facts label 
should have a format similar to the format being proposed for the 
Nutrition Facts label with respect to increasing the prominence of 
information for calories. We invited comment on whether any changes we 
proposed to the Nutrition Facts label also should be required for 
certain products with Supplement Facts labels, and if so, under what 
conditions and for which dietary supplement products should such 
labeling be required.
    (Comment 481) Most comments supported our proposal to increase the 
prominence of the calories declaration, indicating that giving more 
emphasis to calories on the Nutrition Facts label would likely benefit 
consumers in helping them to monitor their caloric intake and make 
healthier food choices. Several comments suggested that increasing the 
prominence of calories would help focus consumer attention on their 
total caloric intake because the information on the label would be more 
visible, readily accessible, and hard to ignore. Many comments noted 
that the larger, bolder font would draw attention to the calorie 
content of the product, encourage consumers to consider this 
information when selecting a product or deciding how much to eat, and 
help them to grasp the relative significance of a particular food in 
the context of their daily diet. Other comments said that increasing 
the prominence of calories also would help consumers compare products 
when shopping and perhaps encourage them to pay more attention to 
labels in general. Several comments pointed out that increasing the 
type size and visibility of calories would be especially helpful to 
people with impaired vision, including many older adults and diabetics, 
and even people with normal vision would benefit if shopping in a dimly 
lit grocery store. The comments said that, although information about 
other nutrients is important, information on calories is particularly 
important because of the prevalence of obesity and the association 
between obesity and chronic diseases and disabilities. The comments 
agreed that enlarging the calories information and making it bolder 
would be an important step, not only in fighting obesity, but also in 
controlling diabetes.
    Although most comments acknowledged the importance of calories and 
supported increasing the prominence to some extent, many comments 
opposed declaring the calorie information in a type size substantially 
larger than that of other information on the label. Many comments 
expressed concerns that the proposed format overemphasized calories at 
the expense of other nutrients declared on the label, and several 
comments suggested that the calorie information was 
``disproportionately large'' or consumed too much label space. Other 
comments included suggestions for improving the overall design and 
balance of the label by adjusting the relative type sizes for 
``Calories,'' the numeric value for calories, and other nutrition 
information on the label, including the ``Nutrition Facts'' heading. A 
few comments stated that there was no need to increase the prominence 
of calories because the Nutrition Facts label already provides calorie 
information and that increasing the prominence may not provide any 
additional benefits.
    Several comments said that there is no convincing data that 
enlarging the calorie information would help consumers choose healthier 
products and that additional consumer research would be essential for 
determining a format that improves consumer understanding of calorie 
information in the Nutrition Facts label. One comment pointed out that, 
although the FDA consumer study cited in the proposed rule failed to 
demonstrate that increasing the font size for calories lead to 
healthier choices, we nevertheless decided to proceed with our proposal 
to increase the prominence of calories on the label. The comment 
further stated that, because FDA's own consumer research suggested that 
a larger font size does not improve consumer awareness of the calorie 
information, we must provide another justification to increase the font 
size.
    Many comments also expressed concerns that overemphasizing calories 
could have the unintended consequence of suggesting that information 
about calories is much more important than information about other 
nutrients appearing on the label. For example, some comments said that 
the proposed Nutrition Facts label could give the impression that 
calorie counting is the most important consideration in managing 
health, when, in fact, reducing the risk of chronic diseases and other 
health-related conditions goes well beyond caloric intake. Other 
comments said that consumers might evaluate and compare food or 
beverage products based solely on their caloric content and choose the 
option having the fewest calories, without considering the product's 
total nutrient profile. Consequently, this could inadvertently result 
in consumers avoiding nutrient dense foods as recommended by the 
Dietary Guidelines for Americans.
    Several comments expressed concerns that making the calorie 
declaration so prominent could affect consumer use and understanding of 
other information on the Nutrition Facts label. For example, comments 
suggested that, because the ``Amount per __ (serving)'' declaration is 
relatively small compared to the proposed ``Calories'' and ``__servings 
per container'' declarations, consumers may mistakenly associate the 
numeric value for ``Calories'' with the contents of the entire 
container, rather than with only one serving. Several comments 
emphasized that consumer research is needed to further investigate 
formats that would facilitate consumer understanding of this label 
information and ensure that the format does not result in consumers 
misinterpreting the calories information. One comment suggested that as 
part of a consumer test, the ``Amount per __'' (i.e., serving size) 
listing and the numeric value for ``Calories'' could be shown in equal 
type sizes.
    (Response) We agree that giving more prominence to calories by 
increasing the type size and bolding of the ``Calories'' declaration 
and the numeric value for ``Calories'' would emphasize the importance 
of calories on the Nutrition Facts label.
    We disagree with the comments suggesting it is not necessary to 
increase the prominence of the calorie declaration or that the numeric 
value for calories should not be larger than the word ``Calories,'' 
because, as we explain later in this response, emphasizing this

[[Page 33939]]

information has potential benefits to consumers who read the label. 
However, we agree that the 24 point type size that was proposed for the 
numeric value for ``Calories'' on most label formats (excluding small 
packages and dual column labels using the tabular format) could be 
considered too large and that adequate prominence could still be 
achieved by slightly reducing the type size. Therefore, the final rule, 
at Sec.  101.9(d)(i)(iii), requires a type size of 22 point for the 
numerical value for ``Calories,'' (excluding labels for smaller 
packages that have a total surface area available to bear labeling of 
40 square inches or less) and a type size of 16 point for the word 
``Calories'' on all label formats (excluding labels on smaller 
packages, with a total surface area available to bear labeling of 40 
square inches or less and all tabular displays) and highlighting both 
pieces of information in bold or extra bold type. The requirements for 
smaller packages require a type size of no smaller than 14 point for 
the numerical value for ``Calories'' for the tabular display for small 
packages as shown in Sec.  101.9(j)(13)(ii)(A)(1) and the linear 
display as shown in Sec.  101.9(j)(13)(ii)(A)(2), a type size of no 
smaller than 10 point for the word ``Calories'' for the tabular 
displays as shown in Sec.  101.9(d)(11)(iii) and (e)(6)(ii) and for the 
tabular display for small packages as shown in Sec.  
101.9(j)(13)(ii)(A)(1) and the linear display as shown in Sec.  
101.9(j)(13)(ii)(A)(2). These type sizes will be sufficiently large to 
emphasize the importance of calories on the label and draw attention to 
this information while decreasing the size to address issues raised in 
the comments as well as accommodating size constraints for packages 
with a total surface available to bear labeling of 40 square inches or 
less (see our response to comment 517).
    We disagree with the comments suggesting that emphasizing calories 
would detract from information about other nutrients on the label, or 
would result in consumers avoiding nutrient dense foods. No evidence 
was submitted in support of these comments, and we are unaware of any 
data that emphasizing the calories declaration would encourage 
consumers to always choose the lower calorie option, result in poor 
nutritional practices, or lead to adverse health consequences. Although 
we also are unaware of any consumer studies demonstrating that 
increasing the prominence of calories information on the Nutrition 
Facts label would either help or hinder consumer use and understanding 
of this information, we explained in the preamble to the proposed rule 
(79 FR 11879 at 11949) that existing data from studies on warning label 
and drug label formats have demonstrated that increasing the prominence 
of label information such as warning statements increases consumer 
attention to such information. Furthermore, the OWG report suggested 
that we consider increasing the font size for calories on the Nutrition 
Facts label because of the critical importance of caloric balance in 
relation to overweight and obesity (Ref. 127). Similar to graphic 
design principles underlying the appearance of warning labels, 
increasing the prominence of calories would be expected to draw 
consumer attention to this information. The OWG report recommend 
mainitaining a healthy body weight and calorie balance is key factor 
for managing body weight. The OWG report concluded that obesity is 
positively associated with adult morbidity and mortality and has become 
a pervasive and urgent public health problem in the United States. The 
OWG report also emphasized the medical and health related costs that 
result from high rates of overweight and obesity. Moreover the 2015-
2020 DGA does not alter these conclusions and corroborates these 
findings. We agree with the OWG report's recommendations and 
conclusions particularly emphasizing calories, but we are sensitive to 
concerns about over-emphasizing the calories declaration on the label. 
An important goal in addressing concerns regarding nutrient density is 
education. Nutrition education, especially around the Nutrition Facts 
label should be multifactorial and highlight the importance of 
calories, but also the other nutrients that can affect health and 
chronic disease. Therefore, the final rule requires a smaller type size 
for the number of calories on all labels than what we had originally 
proposed (i.e., 22 point rather than 24 point for all displays except 
those for smaller packages), and even further decreased type size (14) 
requirements are permitted for small packages with a total surface area 
available to bear labeling of 40 square inches of surface area or less 
as described in Sec.  101.9(j)(13)(ii)(A)(1) and (2).
    (Comment 482) A few comments expressed concerns that excessively 
focusing on calories and drawing too much attention to the caloric 
content of a food product would likely have a negative impact on 
individuals who are at risk for an eating disorder, or who are already 
struggling with an eating disorder.
    (Response) The comments did not submit data or other evidence to 
show that eating disorders could be triggered or exacerbated by 
enlarging the ``Calories'' declaration on the Nutrition Facts label. We 
are unaware of the existence of such an association and remain 
convinced that the potential public health benefits of increasing the 
prominence of ``Calories'' would outweigh the risk of a possible 
negative impact on individuals struggling with eating disorders.
    (Comment 483) One comment stated that, because dietary supplement 
labels often contain a large amount of information on a small label, 
increasing the prominence of calories information would likely be 
difficult because of a lack of space. The comment stated that an 
increased prominence for ``Calories'' on Supplement Facts labels should 
be required only if consumption of the dietary supplement would make a 
major contribution to daily caloric intake (e.g., 50 or more calories 
per serving). However, the comment noted that, in most cases, dietary 
supplement products contribute insignificant amounts of calories to the 
overall diet.
    (Response) In the preamble to the proposed rule, we invited 
comments on whether any of the changes being proposed for the Nutrition 
Facts label should also apply to products with Supplement Facts labels 
that list calories and/or other macronutrients (79 FR 11879 at 11949). 
We did not propose increasing the prominence of calories on labels of 
dietary supplement products and did not display the calories 
information in a larger and bolder type size in any of the labels 
illustrated in the proposed rule in Sec.  101.36(e)(11) and Sec.  
101.36(e)(12). We agree with the comment that many dietary supplement 
products may contribute a negligible amount of calories. Therefore, the 
final rule does not require that information about calories be 
displayed in a larger type size or be highlighted in bold or extra bold 
type or other highlighting on any Supplement Facts labels.
    (Comment 484) Several comments pointed out that increasing the font 
size for ``calories'' and ``serving size'' on the Nutrition Facts label 
would affect the size of the percentage juice declaration that 
manufacturers are required to make on juice products. Under Sec.  
101.30(e)(2), the percent of juice declaration must be in a height not 
less than the largest type found on the information panel except that 
used for the brand name, product name, logo, universal product code, or 
the title for Nutrition Facts. Because information about ``Calories'' 
is not included among these exceptions, the type size of the juice 
declaration would have to be at least as large as the type size of the 
numeric value for ``Calories.''

[[Page 33940]]

Therefore, according to the comments, increasing the size of the 
``Calories'' information would mean increasing the size of the percent 
juice declaration significantly. The comments further suggested that we 
revise Sec.  101.30(e)(2) to clarify that the percent juice declaration 
does not have to be larger than the information about ``Calories'' or 
``Serving size.''
    (Response) We inadvertently omitted the corresponding correction to 
Sec.  101.30(e)(2) to include ``Serving size,'' ``Calories,'' and the 
numerical value for ``Calories'' in the list of exceptions for 
declarations in larger type to avoid requiring a type that would be too 
large for the declaration of the amount of juice. Therefore, we have 
made a technical correction in the final rule and revised Sec.  
101.30(e)(2) to state that the title phrase ``Nutrition Facts, the 
declaration of ``Serving size,'' ``Calories,'' and the numerical value 
for ``Calories'' appearing in the nutrition information must be in 
easily legible boldface print or type in distinct contrast to other 
printed or graphic matter, in a height not less than the largest type 
found on the information panel except that used for the brand name, 
product name, logo, or universal product code.
    (Comment 485) One comment said we should not require the calories 
information listed on labels of food products intended for infants and 
young children to have the same prominence as the calories information 
on product labels intended for people 4 or more years of age. The 
comment stated that decisions about food choices that are made for 
infants and young children should not be based on the number of 
calories per portion, but rather on the overall nutrient profile of the 
food. The comment explained that, by relying too much on a food's 
caloric content, parents may inadvertently restrict healthful foods or 
make inappropriate food choices for their young children and infants. 
The comment also said that, according to nutrition experts, children in 
this age range should be encouraged to self-regulate caloric intake and 
that parents and caregivers should feed children in response to the 
child's hunger and fullness cues rather than on the basis of a 
preconceived number of calories they believe the child should consume.
    (Response) We agree with the comment that food choices for infants 
through 12 months of age and children 1 through 3 years of age should 
focus primarily on a food's overall nutrient profile rather than on the 
number of calories per serving (Refs. 260-261). The IOM report 
advocated feeding children in response to their hunger and fullness 
cues, rather than providing foods for children based on the number of 
calories in a serving of the product. However, the IOM report also 
emphasized the importance of parents establishing healthful eating 
habits for their children early in life. The IOM report stated that 
children who consume a diet that restricts energy-dense foods high in 
sugar, fat, and salt, but that is rich in nutrient-dense foods, are 
less likely to become overweight or obese. Thus, although the IOM 
report did not explicitly recommend restricting children's foods based 
on calorie content, it suggested that parents and caregivers should at 
least be aware of the amount of calories (and other nutrients) in the 
foods they give their children, especially those over 2 years of age, 
in order to begin establishing good eating habits.
    The comment did not provide evidence that parents would restrict 
foods or make inappropriate food choices for their young children and 
infants based solely on the food's caloric content. We acknowledge that 
parents and caregivers would likely consider a variety of factors when 
making decisions about what to feed their young children and that 
increasing the prominence of calories information on the labels of 
foods intended for young children does not necessarily mean that 
parents would restrict these foods. Therefore, we do not consider it 
necessary for the calories information on products for infants through 
12 months of age and children 1 through 3 years of age to differ from 
that required on Nutrition Facts label formats for foods intended for 
individuals 4 years of age and older. To maintain consistency in label 
formats, the final rule requires that the calories information on 
labels of foods intended for infants through 12 months of age and 
children 1 through 3 years of age be displayed prominently, as 
indicated in the label mockups shown in Sec.  101.9(j)(5)(i) and (ii).
3. Changing the Order of the ``Serving Size'' and ``Servings Per 
Container'' Declarations and Increasing the Prominence of ``Servings 
Per Container''
    Our preexisting regulations specify that information on serving 
size, consisting of a statement of the serving size (Sec.  
101.9(d)(3)(i)) and the number of servings per container (Sec.  
101.9(d)(3)(ii)), must immediately follow the identifying heading of 
``Nutrition Facts.'' In addition, ``Serving Size'' and ``Servings Per 
Container'' must be in a type size no smaller than 8 point (Sec.  
101.9(d)(1)(iii)).
    In the preamble to the proposed rule (79 FR 11879 at 11949), we 
explained that, with respect to the Nutrition Facts label, an important 
consumer need is to identify the number of servings per container of a 
packaged food. Therefore, we proposed placing ``Servings Per 
Container'' above ``Serving Size'' to help consumers find the number of 
servings per container with less effort than is now needed. We also 
proposed that listing ``__ servings per container'' with the blank 
filled in with the actual number of servings directly beneath the 
``Nutrition Facts'' heading, and highlighting it in bold or extra bold 
type, would help increase awareness that the information presented in 
the Nutrition Facts label does not refer to the contents of the entire 
package when the label indicates that there is more than one serving 
per container. We explained that listing ``Serving size'' in the same 
proximity to where the actual nutrient information is located on the 
label (rather than directly beneath the Nutrition Facts heading as in 
our preexisting regulations, Sec.  101.9(d)(3)) would help consumers 
understand that this nutrient information pertains to the particular 
serving size that is declared. (According to the graphic design 
principle of proximity, items that are positioned closer together are 
perceived to be more closely related (Ref. 262)). Thus, we tentatively 
concluded that reversing the order of the declarations of ``Servings 
Per Container'' and ``Serving Size'' would help consumers more readily 
observe and comprehend the nutrition information appearing in the 
Nutrition Facts label, allow consumers to search for information with a 
minimum of effort, and assist consumers in their food purchasing 
decisions and in maintaining healthy dietary practices. We proposed to 
redesignate Sec.  101.9(d)(3)(i) as Sec.  101.9(d)(3)(ii), redesignate 
Sec.  101.9(d)(3)(ii) as Sec.  101.9(d)(3)(i), and to make changes in 
how the serving size information is capitalized on the label so that no 
capital letters are used, except for the first letter in ``Serving 
size.'' We also proposed to require that the declaration of 
``__servings per container'' (with the blank filled in with the actual 
number of servings) be highlighted in bold or extra bold type and be in 
a type size no smaller than 11 point (except for the tabular and linear 
displays for small packages) (proposed Sec.  101.9(d)(3)(i)), and that 
the information for ``Serving size'' be in a type size no smaller than 
8 point (except for the linear display for small packages) (proposed 
Sec.  101.9(d)(3)(ii)).
    We did not propose similar changes for serving size information for 
dietary supplements. In the preamble to the

[[Page 33941]]

proposed rule (79 FR 11879 at 11950), we said that, when taking dietary 
supplements, consumers need to know how much of the product to take 
(e.g., 1 capsule, 2 tablets, 1 packet) and that this information, which 
is currently provided in the ``Serving Size'' line of the Supplement 
Facts label, is more important for the consumer to know than the number 
of servings (e.g., 100 tablets) contained in the package.
    (Comment 486) Many comments supported changing the order of the 
``Serving Size'' and ``Servings Per Container'' declarations because 
the comments felt that this change would make the label easier to read 
and understand. The comments said consumers would be better able to 
compare products when shopping and make better buying decisions, which 
could ultimately lead to improved health for themselves and their 
families. Other comments suggested that the proposed changes could help 
consumers understand that nutrition information on the label is based 
on the serving size, which could increase awareness of the amount of 
food actually being consumed. In addition, comments said that the 
proposed change could help consumers monitor their caloric and nutrient 
intakes, compare products more easily, eat more moderate portions, and 
more easily grasp the relative significance of a food product in the 
context of their daily diet.
    Other comments said that reversing the order of serving size and 
the number of servings per container, especially in combination with 
increasing the prominence of information about calories, would make the 
relationship between the ``Calories'' and ``Serving size'' declarations 
clearer, lead to a better understanding of the calories information, 
and improve the flow of the label.
    In contrast, several comments opposed changing the order and said 
we should continue to list ``Serving size'' above ``__ servings per 
container.'' The comments suggested that information about a product's 
serving size was more important than the number of servings per 
container because the label's information is based on the serving size 
declaration. Many comments that opposed reversing the order of serving 
size and servings per container expressed a preference for us to 
increase the prominence of serving size instead. The comments said that 
putting the ``Serving size'' declaration in bold print and increasing 
its type size would emphasize its importance and increase awareness 
that the nutrition information on the label is based on the serving 
size.
    (Response) As we explained in the preamble to the proposed rule (79 
FR 11879 at 11949), reversing the order in which ``Serving Size'' and 
``Servings Per Container'' are listed would place the serving size 
information in closer proximity to where the actual nutrient 
information is located on the Nutrition Facts label. According to 
graphic design principles (i.e., the principle of ``proximity''), this 
would increase the perception that the serving size is closely related 
to the nutrition information that follows directly below it, and thus 
provide necessary context for helping consumers understand that this 
nutrition information pertains to the particular serving size that is 
declared. If the order of the ``Serving Size'' and ``Servings Per 
Container'' declarations was preserved as in our preexisting 
regulations and as preferred by some comments, the relationship between 
the nutrition information and the serving size might be less clear. 
Although some comments suggested that we put the serving size 
declaration in bold print rather than shift its position, it is 
unlikely that bold print, alone, would provide the necessary context 
for helping consumers to understand the association between serving 
size and the nutrient information because these pieces of information 
in the preexisting regulation would be lacking in proximity, and the 
contrast between the ``Serving size'' declaration and the ``Nutrition 
Facts'' heading directly above it would be reduced if both were in a 
bold or extra bold font. We address the comments concerns regarding 
increased emphasis of ``serving size'' instead of ``servings per 
container'' in our response to comment 488.
    Therefore, the final rule, at Sec.  101.9(d)(3)(ii), requires that 
``serving size'' be placed below ``_Servings per container.'' The final 
rule also requires the information to be highlighted in bold or extra 
bold and be in a type size no smaller than 10 point, except the type 
size must not be smaller than 8 point for the information for small 
packages as shown in Sec.  101.9(j)(13)(ii)(A)(1) and (2). Displaying 
both pieces of information related to serving size adjacent to each 
other should help consumers understand how the serving size relates to 
the nutrition information on the label and use the label to plan and 
maintain healthy dietary practices. It is important for consumers to 
understand the serving size and realize how it relates to the rest of 
the label's nutrition information.
    (Comment 487) Many comments supported inserting the actual number 
of servings at the beginning of ``servings per container'' statement 
because this could help consumers identify more readily the number of 
servings in a package and help consumers decide how many people a 
particular food item could serve or feed. The comments said that 
consumers would have a better idea of the total number of calories in 
the package as well as the number of calories they would actually 
consume if they eat the entire contents of a multi-serving package.
    (Response) We agree with the comments, and so the final rule, at 
Sec.  101.9(d)(3)(i), requires the actual number of servings at the 
beginning of the ``servings per container'' statement.
    (Comment 488) Many comments agreed that increasing the prominence 
and visibility of ``servings per container'' would enable consumers to 
notice and use this information. The comments further stated that 
individuals who did not previously or regularly use the label might 
begin to do so and that increasing the prominence of the ``servings per 
container'' declaration would not only be ``eye catching'' and ``hard 
to ignore,'' but also would be helpful to people with poor vision or 
those who shop in dimly lit grocery stores.
    Some comments suggested increasing the size and prominence of the 
``Serving Size'' declaration, as well as that of ``servings per 
container.'' One comment acknowledged that one intention of the 
proposed rule is to help consumers more easily recognize multi-serving 
packages, but said there was no valid justification for making the ``__ 
servings per container'' information more prominent than the ``Serving 
size'' declaration. Another comment suggested that increasing the 
prominence of both calories and serving size could be especially 
important on labels of some sugar-sweetened beverages, particularly on 
products that may contain more than one serving, but are often consumed 
during one eating occasion.
    Several other comments opposed increasing the prominence of 
``servings per container'' because, according to the comments, 
``serving size'' is the more important piece of information. The 
comments would emphasize ``Serving size'' in a larger and bolder font. 
Many comments said that making the serving size information easier for 
consumers to see and understand was important for properly interpreting 
the calorie information (in addition to increasing the prominence of 
``Calories'') and is also ``what consumers are used to'' seeing. 
Several comments said that the proposed font size of the ``__ servings 
per container'' statement was so large

[[Page 33942]]

that consumers might mistakenly think that the number of calories 
listed in the ``Calories'' declaration on the label pertained to the 
entire package; i.e., to all of the servings that appear in the ``__'' 
space. Another comment suggested reducing the type size for ``__ 
servings per container'' to a size smaller than the ``Amount per __'' 
statement. One comment suggested that the relative differences in type 
sizes in the listings for the number of servings per container, the 
amount per serving, and the numeric value for ``Calories'' could result 
in consumers mistakenly associating the number of calories with the 
total package because the ``Amount per __'' is relatively small 
compared to the other declarations. One comment said that giving 
increased prominence to ``Serving size'' would be a reasonable way to 
implement the recommendations of the OWG's Calories Count report and 
would be consistent with existing research data suggesting a lack of 
attention to this listing.
    (Response) The comments reflect the need to consider how much 
emphasis to provide for the ``Serving size'' declaration compared to 
the ``__ servings per container'' declaration. We agree with the 
comments that the serving size information was not prominent enough in 
our proposal and that consumers could potentially associate the calorie 
and nutrition information on the label with the ``servings per 
container'' declaration since it was more prominent compared to the 
serving size declaration. We also agree that the ``servings per 
container'' declaration should be more prominent and visible than on 
the preexisting label so consumers will be able to use this information 
if they consume all or a larger portion of a multi-serving container. 
Increasing the prominence of the ``Serving size'' information by 
bolding and slightly increasing the font size will emphasize the 
importance of the information and, along with its placement, would 
assist consumers in better understanding how to use the Nutrition Facts 
label to interpret accurately the calories and nutrient information on 
the label that is directly below the ``Serving size'' declaration. To 
provide prominence to ``Serving size,'' however, we need to reduce the 
prominence of ``servings per container.'' According to graphic design 
principles (e.g., contrast), alternating a larger and bolder type style 
with a smaller, regular type style on successive lines of the Nutrition 
Facts label will provide maximum visibility and optimal highlighting to 
the information that we wish to emphasize on the label (Ref. 262). 
Contrast is a graphic design principle that uses opposing elements 
(such as bolding) to differentiate objects in the same field of view, 
or to intensify the effect between objects that would otherwise look 
similar (Ref. 263). Thus, we are providing contrast in the first three 
lines of the Nutrition Facts label in the final rule (i.e., the 
Nutrition Facts heading, the ``__ servings per container'' declaration, 
and the ``Serving size'' declaration) by alternating the use of bold 
font with non-bold font for this information. We also realize that 
enlarging the ``__ servings per container'' declaration through bolding 
may pose space challenges if the word ``about'' is used in this 
statement, which is allowed under Sec.  101.9(b)(8)(i).
    Therefore, the final rule requires that the ``Serving size'' 
declaration, and the quantitative information associated with this 
declaration, be listed in a type size no smaller than 10 point (except 
on labels of smaller packages with a total surface area available to 
bear labeling of 40 square inches or less and all tabular formats where 
a type size of 9 point type is permissible due to space constraints) 
and be highlighted in bold or extra bold type. Additionally, if a 
product has a ``Serving size'' declaration with too many characters to 
fit in the provided space allocated for the ``Serving 
size''declaration, then a type size of 8 point is permissible for any 
size package (Sec.  101.9(d)(3)(ii)). To reduce the prominence of the 
``__ servings per container'' declaration, we are requiring that ``__ 
servings per container'' be listed in a regular type in a type size no 
smaller than 10 point (except on labels of smaller packages with a 
total surface area available to bear labeling of 40 square inches or 
less (Sec.  101.9(j)(13)(ii)(A)(1) and (2)) where a type size of 9 
point is permissible due to space constraints) directly beneath the 
Nutrition Facts heading, followed directly below by the ``Serving 
size'' declaration in bolder font.
    (Comment 489) One comment referred to a study suggesting that many 
consumers do not look at serving size information, but otherwise do 
refer to the Nutrition Facts label and ingredients list, as evidence 
that the serving size declaration needs to be made more prominent. 
Other comments suggested that we should more closely review previous 
consumer research studies or conduct additional studies to determine 
the effects of displaying ``Serving size'' and ``servings per 
container'' information more prominently, and determine the potential 
implications of increasing the prominence and changing the location of 
the ``__ servings per container'' information on the Nutrition Facts 
label.
    (Response) We disagree with the comment suggesting that many 
consumers do not look at serving size information, but otherwise do 
refer to the Nutrition Facts label and ingredients list. The comment 
apparently misinterpreted a published abstract (Ref. 264) of a study 
that investigated consumer perceptions and use of the serving size 
information, ingredient list, health claim information, and the 
Nutrition Facts label in general, particularly with regards to the 
extent that each of these impact purchasing decisions. The study, which 
drew on data from the 2005-2006 and 2007-2008 NHANES, was recently 
published in its entirety (Ref. 265). In contrast to what the comment 
said, the abstract stated that the study participants were more likely 
to use the Nutrition Facts label (in general) and the ingredient list 
in particular than information about serving size and health claims. In 
addition, according to data from the NHANES 2009-2010 cycle, 
approximately 64 percent of respondents (16+ years of age) reported at 
least ``sometimes'' using the serving size information on the food 
label when deciding to buy a food product, and 31 percent of the 
respondents reported that they used the serving size information either 
``always'' or ``most of the time'' (Ref. 266).
    As for the comments suggesting that we need to evaluate consumer 
research and conduct further research in regards to switching the order 
and increasing the prominence of ``Serving size'' and ``servings per 
container,'' we address these issues in our responses to comments 478 
and 480. We also note that we are finalizing the requirement to 
include, directly below ``Nutrition Facts,'' the ``servings per 
container'' declaration followed by the ``Serving size'' declaration. 
As we explain in our response to comment 488, the location of ``Serving 
size'' to where ``servings per container'' was formerly located places 
it in closer proximity to the nutrient information that pertains to the 
serving size of the product.
    (Comment 490) One comment said that ``__ servings per container'' 
is irrelevant information because the nutrition information on the 
label refers to the amount of nutrients and calories in a single 
serving. The comment would have the Nutrition Facts label emphasize the 
size of a serving (i.e., the serving size) rather than the number of 
servings that are in the container.
    (Response) The declaration of ``__ servings per container'' 
provides important information to the consumer

[[Page 33943]]

about how the information on calories and nutrients for one serving of 
food relate to the entire package of food. Consumers may consume more 
than one serving and need to know how the portions consumed relate to 
their total daily dietary intake. Therefore, we decline to revise the 
rule as suggested by the comment. However, we have revised Sec.  
101.9(d)(3) to clarify that both the ``__ servings per container'' and 
``Serving size'' declarations are components of the serving size 
information required on the label.
    (Comment 491) Other comments opposed increasing the prominence of 
``__ servings per container'' because, in combination with other 
proposed changes, it would increase the space requirements for the 
Nutrition Facts label. One comment said that, because of space 
limitations on the label, we should not require the words ``per 
container'' to be included in the ``__ servings per container'' 
statement. The comment further said that ``per container'' is not 
needed for consumers to identify the number of servings in the package. 
The comment cited data from an online consumer research study (Ref. 
267) to assert that 98 percent of the study participants correctly 
identified the number of servings per package and the serving size when 
the label did not include the words ``per container,'' while 92 percent 
of respondents who viewed the proposed Nutrition Facts label (i.e., 
``__ servings per container'') were able to correctly identify this 
information.
    (Response) We note in our response to comment 488 that we are 
requiring that ``__ servings per container'' be listed in a type size 
no smaller than 10 point (except on labels of smaller packages with a 
total surface available for labeling of 40 square inches or less, where 
the type size will be no smaller than 9 point) and in regular font in 
order to provide adequate contrast to the prominent information 
displayed directly above and below it (i.e., the ``Nutrition Facts'' 
heading and ``Serving size'' information, respectively). We disagree 
that the words ``per container'' should not be required to be included 
in the ``__ servings per container'' statement because ``per 
container'' would provide context and a frame of reference for the 
number of servings. Furthermore, the comment did not provide adequate 
details about its study design, methodology, and statistical analyses, 
and did not include data that would enable us to appropriately evaluate 
the survey results. Including the words ``per container'' would remove 
any potential ambiguity between servings per container and the serving 
size information, which would help clarify the number of servings to 
which the label refers. Although the survey findings reported in the 
comment indicated that respondents did not need to see ``per 
container'' on the label to correctly interpret information about 
serving size and the number of servings per container, it is difficult 
to evaluate the results without any data. Therefore, we decline to 
change our longstanding practice of including ``per container'' as part 
of the ``servings'' declaration, as this information is intended to 
help consumers accurately identify the number of servings in a package.
    (Comment 492) Many comments suggested that we explain that 
nutrition information is based on the serving size listed in the 
Nutrition Facts label or conduct an education program to help consumers 
understand that the label serving size is not a recommendation but is 
based on actual food intake data. Some comments also asked us to 
explain the difference between serving size and portion size. One 
comment stated that, because some consumers use the terms ``serving 
size'' and ``portion size'' interchangeably, we should clarify the 
label by either: (1) Denoting the serving size provided as a 
``typical'' serving size; or (2) including a footnote to clarify that 
``the serving size is based upon the amount typically consumed, and is 
not a recommended portion size.'' Other comments said it was important 
to educate consumers that, if one eats more than one serving of a food 
product, the amount of calories consumed will increase proportionally.
    (Response) We recognize the importance of providing consumers with 
more in-depth information about the meaning of the serving size and 
intend to make this a key component of our future nutrition education 
efforts for consumers. However, we decline to revise the rule to add a 
footnote to the Nutrition Facts label to indicate that the serving size 
is based on what is typically consumed, rather than what is 
recommended. Manufacturers can include a truthful and not misleading 
statement explaining the meaning of serving size elsewhere on the 
product label.
4. Right-Justifying the Quantitative Amounts Declared in the ``Serving 
Size'' Statement
    In the preamble to the proposed rule (79 FR 11879 at 11950), we 
said that we tentatively concluded, based on design considerations, 
that the label statement for ``Serving size'' in both household units 
(e.g., cups, tablespoons, teaspoons, pieces or slices, as explained in 
Sec.  101.9(b)(5)) and gram amounts must be right-justified on the same 
line that ``Serving size'' is listed. Under our preexisting regulations 
at Sec.  101.9(d)(12), this numerical information is stated immediately 
adjacent to the ``Serving Size'' declaration. By keeping the proposed 
``Serving size'' declaration left-justified while right-justifying the 
corresponding numerical values, the proposed change would create white 
space on the Nutrition Facts label that would result in a less 
cluttered appearance, heightened focus and emphasis, and improved 
readability (Ref. 268). This design feature would provide enhanced 
emphasis to the information about serving size, allowing this 
information to be more noticeable and thereby facilitating its access 
and use by consumers.
    (Comment 493) Some comments addressed the issue of right-justifying 
the quantitative amounts declared in the ``Serving size'' statement. 
One comment suggested that moving the serving size information to the 
right-hand side of the Nutrition Facts label would help emphasize the 
information, create white space leading to a less cluttered appearance, 
and would allow the eye to ``flow across the information.'' Another 
comment said that the proposed change would make it easier for readers 
to find the values for calories, serving size, number of servings per 
container, and percent Daily Values if all of these values were 
consistently placed in the same right-hand side of the label.
    One comment opposed to right-justifying the serving size 
quantitative information on the Supplement Facts label. The comment 
said that because the ``Serving size'' declaration must be left-
justified, the quantitative information for serving size should appear 
near this declaration, rather than on the other side of the panel where 
it would be separated by a large white space. The comment added that 
this may be a particular concern for dietary supplement products that 
use dual column labeling (e.g., with columns for ``Per Serving'' and 
``Per Day'').
    (Response) Keeping the ``Serving size'' declaration left-justified, 
while requiring the corresponding numerical value be right-justified, 
provided that adequate space is available, will make this information 
more noticeable and facilitate its access and use by consumers. 
Although we did not propose to right-justify quantitative amounts in 
the ``Serving size'' declaration in the Supplement Facts label, we 
agree that it would not be appropriate to do this. The ``Supplement 
Facts'' title in the Supplement Facts label requires more

[[Page 33944]]

space than the ``Nutrition Facts'' title in the Nutrition Facts label 
and (unless impractical) must span the full width of the label (Sec.  
101.36(e)(1)). Also, the Supplement Facts label is less likely than the 
Nutrition Facts label to be situated on the narrow side panel of a 
package. Therefore, because Supplement Facts labels are often wider 
than Nutrition Facts labels, right-justifying the serving size amount 
might leave too much white space between the words ``Serving size'' and 
the quantitative amount. It may not be apparent on some Supplement 
Facts labels that the quantitative amount per serving listed on the far 
right side of the label would refer to the serving size declaration, 
which would be left-justified. With dietary supplements in particular, 
it is important that consumers understand the serving size unit (e.g., 
1 tablet, 1 capsule) to minimize the possibility of taking an excessive 
amount of the product. The serving size amount also is important so 
that consumers can understand and follow instructions on dietary 
supplement labels for the suggested use of the product, which explain 
how, when, or how much of the product to take daily and (if applicable) 
the amount not to exceed. Therefore, the final rule only requires that 
quantitative amounts declared in the ``Serving size'' statement be 
right-justified on Nutrition Facts labels, provided that adequate space 
is available, and not on Supplement Facts labels.
5. Changing the ``Amount Per Serving'' Statement
    Our preexisting regulations require the Nutrition Facts label to 
include a subheading designated as ``Amount Per Serving'' and to 
separate this subheading from the serving size information by a bar 
(Sec.  101.9(d)(4)) and highlight the subheading in bold or extra bold 
type or other highlighting (Sec.  109(d)(1)(iv)). The proposed rule 
would change the ``Amount Per Serving'' declaration to ``Amount per 
____'', with the blank filled in with the actual serving size expressed 
in household units. We also proposed increasing the type size of this 
information and, to heighten contrast with the calories information, 
using semi-bold rather than bold or extra bold highlighting. We 
explained, in the preamble to the proposed rule (79 FR 11879 at 11950), 
that these changes would make it easier for label users to understand 
what the nutrition information in the Nutrition Facts label refers to, 
because it would eliminate the need to first locate the ``Serving 
size'' declaration to see what the serving size unit is. Because 
studies suggest that consumers often find serving size information 
difficult to interpret (Ref. 9) we stated that specifying the actual 
serving size in the ``Amount per ____'' declaration would likely help 
consumers to more readily observe and comprehend the nutrition 
information that is displayed in the label.
    (Comment 494) Some comments supported the proposed change and said 
that replacing ``Amount Per Serving'' with ``Amount per ____'' would 
reinforce the concept of serving size and help people realize how many 
calories are actually in a serving of the product. One comment said it 
was reasonable for the label to include duplicate information (i.e., in 
both the ``Serving size'' and ``Amount per ____'' declarations) about 
what constitutes a serving because it is important for consumers to 
understand that the nutrition information on the label is based on the 
serving size. Another comment suggested that both the ``Serving size'' 
and ``Amount per ____'' declarations should be bolded to increase their 
visibility.
    Many comments disagreed with the proposed change and said it would 
make the serving size information repetitive, create unnecessary 
clutter, and impose additional space constraints on the label. One 
comment said that including duplicative information about serving size 
would be distracting and ``slow down'' the comprehension process, 
especially if the serving size is listed as a fraction (e.g., \2/3\ 
cup). Another comment suggested that listing the serving size in the 
``Amount per ____'' statement is unnecessary because our proposal to 
reverse the order of ``Serving size'' and ``Servings Per Container'' 
and make the ``__ servings per container'' information more prominent 
already allows the serving size to be more easily identified. The 
comment said that only the ``Serving size'' declaration should be used 
to indicate the amount of food contained in a serving, and that doing 
so would maintain consistency with the current Nutrition Facts label.
    Another comment suggested improving the clarity of the label by 
moving the ``Amount per ____'' declaration directly above the list of 
percent Daily Values, listing the serving size after ``Calories '' 
(i.e., ``Calories per ____''), and using the same type size for the 
``Serving size'' and ``Amount per ____'' declarations. Another comment 
said that changing ``Amount Per Serving'' to ``Amount per ____'' should 
be voluntary for dietary supplement labels, but if the change is made 
mandatory, then manufacturers should have the option of using the 
abbreviation ``Amt Per ____'' on Supplement Facts labels when extra 
space is required for the quantity statement (e.g., ``2 capsules'').
    (Response) We recognize there are multiple viewpoints and potential 
advantages and disadvantages with respect to listing the actual serving 
size in the blank space of the ``Amount per ____'' declaration. We 
acknowledge that inserting the serving size in the blank space would 
essentially repeat the value for serving size that is listed directly 
above this statement. We further agree that this information would be 
duplicative and add to the amount of numerical information already 
present on the label. Therefore, we will retain the preexisting 
requirement to declare ``Amount per serving'' directly above the 
``Calories'' declaration rather than finalize a change to declare 
``Amount per ____'' with the blank filled in with the actual serving 
size expressed in household units. We also will retain the preexisting 
requirement to list ``Amount per serving'' in bold or extra bold type 
or other highlighting and in a type size no smaller than 6 point rather 
than finalize a change in type size and contrast.
    With respect to the comment that said changing ``Amount Per 
Serving'' to ``Amount per ____'' should be voluntary for dietary 
supplement labels, we did not propose this change for the Supplement 
Facts label. Consequently, there is no need to provide the option of 
using the abbreviation ``Amt Per ____'' on Supplement Facts labels as 
the comment requested.
6. Declaration of ``Calories From Fat''
    The proposed rule would eliminate the requirement for declaring 
``Calories from fat'' on the label.
    Most comments supported removing the requirement for declaring 
``Calories from fat,'' and we discuss those comments in part II.E.1.
7. Presentation of Percent DVs
    Our preexisting regulations at Sec.  101.9(d)(7) establish the 
format for listing nutrients with DRVs on the Nutrition Facts label, 
including the quantitative amount by weight and percent DV. The 
preamble to the proposed rule (79 FR 11879 at 11950 through 11951) 
explained that, when we established the requirements for percent DV 
declaration, we considered that the information would help consumers 
evaluate the nutrient characteristics of a single product (e.g., how 
high or low a particular product is in certain nutrients or the extent 
to which it contributes toward daily nutritional goals) and help

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consumers make choices between products. We also explained that 
consumer research back in 1992 indicated that the percent DV 
information improved consumers' abilities to make correct dietary 
judgments about a food in the context of a total daily diet and helped 
consumers to verify the accuracy of front panel claims (id.).
    The proposed rule would use ``% DV'' rather than ``% Daily Value'' 
as the column heading above the nutrient listings to provide 
consistency among the different label formats and to maintain the 
alignment of this heading over the DV column. For most labels, the 
proposed rule also would list percent DVs in a column to the left of 
the names of the nutrients and their quantitative amounts, with a thin 
vertical line separating the % DV column from the list of nutrients. On 
dual column labels and on labels using the aggregate display, we 
proposed to list the names of nutrients to the left of the % DV columns 
and the quantitative (weight) amounts of each nutrient to the right of 
the % DV column, to use thin vertical lines to separate the information 
in the ``% DV'' column from the information in the column containing 
the quantitative weights, and to use the same style of thin vertical 
lines to separate each of the dual columns and aggregate display 
columns from each other.
    We also invited comment on alternative terms that may be more 
readily understandable than Daily Value, such as Daily Guide or Daily 
Need; whether the word ``percent'' (or the % symbol) needs to precede 
whatever term is used in the column heading where the percent DVs are 
listed or if this would be redundant because the ``%'' symbol is 
already included next to the numerical values listed in this column; 
and the appropriate placement of percent DVs in the labeling of foods 
for infants 7 through 12 months, children 1 through 3 years of age, and 
pregnant and lactating women (id. at 11961).
    (Comment 495) Some comments supporting our proposal said that 
moving the percent DVs to the left would draw attention to this 
information and help people realize its importance. Some comments said 
that, because we read from left to right, people would be less likely 
to skip over the percent DVs. Furthermore, because the information 
would be more noticeable, consumers might find it more quickly and use 
it more often to judge the percent DV of a specific nutrient and to 
compare products when shopping, leading to healthier food choices. 
Other comments said that shifting the percent DV column to the left 
would be ``eye catching,'' create a cleaner design, and make the label 
more logical, better organized, and easier to read and comprehend. It 
also would improve the simplicity and visual clarity of the label, as 
recommended by the IOM.
    Many comments that opposed placing the percent DV column on the 
left side of the label said that, because we read from left to right, 
consumers would see the percent DV before knowing to which nutrient the 
value referred. The comments said it is more logical to list an item 
first and then its value. Some comments said that moving the percent DV 
information to the left of the nutrient name would be counter-intuitive 
and confusing to consumers. One comment included data from a study it 
had commissioned; the study indicated that, when the percent DV was on 
the left side of the label, there was no advantage in consumer 
comprehension of this information. The study found that a higher 
percentage of respondents answered a question about Daily Values 
correctly when the percent DV information was on the right versus the 
left side of the label (Ref. 269). Another comment noted that the 
proposed label would be awkward to read because consumers would need to 
first find the name of the nutrient in the middle of the label.
    Several comments agreed with the concern we expressed in the 
preamble to the proposed rule, that giving more prominence to the 
percent DV by listing it first could potentially make the Nutrition 
Facts label appear less user-friendly particularly to frequent users 
who are accustomed to its current format and could draw attention away 
from nutrients that do not have a DV (79 FR 11879 at 11951). Another 
comment said that shifting the percent DV to the left could hinder, 
rather than assist, individuals with lower levels of health literacy 
and numeracy in understanding the label.
    Several comments said that moving the percent DV information to the 
left might cause layout problems for certain formats, such as dual-
column labels, because of the difficulty in aligning the column 
headings with the information in the columns, and in differentiating 
the columns. Other comments expressed concerns that placing percent DVs 
on the left would be distracting because consumers are mainly 
interested in the quantitative values of nutrients and tend to look for 
that information rather than the percent DVs. Other comments said that 
increasing the focus on percent DVs would be misguided because the 
percent DVs are not relevant to people who do not eat 2,000 calories 
per day; moving the percent DVs to the left would make the label look 
``foreign'' and would be an unnecessary change having no benefits; and 
shifting the location of the percent DVs would not help consumers 
understand the information any better than they currently do. Many 
comments said that, because people are generally confused by the 
meaning of percent DV and do not know how to properly use this 
information, percent DVs should not be given a more prominent placement 
on the left side of the Nutrition Facts label. Several comments said it 
was premature to shift the percent DVs to the left based solely on 
theoretical design principles, and that we should not do this unless 
research data become available demonstrating that this change would 
assist consumers in maintaining healthy dietary practices.
    (Response) We acknowledge that the conventional way to display data 
would be to list the percent DV after the name of the nutrient, as 
shown in the preexisting Nutrition Facts label format, and that 
shifting the percent DVs to the left might present layout challenges 
with certain formats. We also note that the results of our consumer 
research study were equivocal, as we found that no significant benefit 
was achieved by shifting the percent DV column to the left side of the 
Nutrition Facts label (Ref. 270).
    We have no evidence that the placement of the percent DV 
information on the left would result in less comprehension by consumers 
who do not understand the meaning of percent DV, as suggested by some 
comments. Nevertheless, we have reconsidered how percent DV should be 
presented and have decided to retain the preexisting requirement to 
list the percent DV information on the right side of the label.
    We anticipate that an increased focus on percent DV through the 
introduction of a new footnote and enhanced consumer education efforts 
could help consumers who currently have some difficulty understanding 
percent DV become more comfortable using the percent DV information. 
Furthermore, we may study this issue, and other issues involving the 
DV, in the future.
    (Comment 496) Several comments suggested that the term ``Daily 
Need'' would be more helpful to consumers than ``Daily Value.'' Another 
comment suggested using the term ``Daily Requirement'' because it would 
be ``more in keeping with a DRV calculation.'' The comment cautioned 
that the term ``Need'' may have a

[[Page 33946]]

negative perception because it conveys a ``personal tone'' and 
therefore may be seen as prescriptive or patronizing. An additional 
comment suggested using ``% Ref'' instead of ``% DV.''
    (Response) In the preamble to the proposed rule, we said that we 
had previously provided our rationale for choosing the term Daily Value 
in the format final rule (58 FR 2079 at 2124, January 6, 1993) and had 
explained why we considered ``need'' and ``requirement'' to be 
misleading terms that might complicate nutrition education efforts. 
Although one comment suggested the use of the term ``% Ref.'' (which we 
interpret as meaning % Reference) instead of % DV, the comments, in 
general, did not suggest alternative terms or provide data or 
information to support why an alternative term would be more 
appropriate or preferable. Thus, we continue to believe that the term 
Daily Value is generally understood by consumers to be a point of 
reference (see 58 FR 2079 at 2125) and will continue to use Daily Value 
as an appropriate single term to refer to all reference values in the 
Nutrition Facts label.
    (Comment 497) Many comments opposed the use of the abbreviated term 
% DV, and suggested that spelling out the term Daily Value would be 
clearer and easier to comprehend, eliminate possible confusion about 
the meaning of DV, and not require an explanatory footnote. Some 
comments stated that, while abbreviating Daily Value would save space, 
the abbreviation would not be helpful if consumers did not understand 
the abbreviation, especially when consumer research has shown that the 
term Daily Value is not well understood. One comment noted that if ``% 
Daily Value'' was abbreviated to ``% DV,'' we might replace a concept 
that is already obscure with a shorthand designation that would be even 
more obscure to consumers.
    Another comment suggested that consumer research is needed to 
evaluate the impact that changing % Daily Value to % DV would have on 
consumer use and understanding of this information. Some comments 
supported using ``%'' rather than spelling out ``percent'' because, 
according to the comments, it would decrease the amount of clutter on 
the label, and the term ``percent'' requires more label space without 
providing additional information or benefits to consumers. Another 
comment questioned whether either ``percent'' or the ``%'' symbol 
should be used on the label because the comment said that many 
consumers have difficulty understanding the concept of percent.
    (Response) We acknowledge that the term % DV is spelled out on most 
labels (with the exception of some small packages) and therefore the 
term ``% Daily Value'' should be familiar to consumers. We also 
acknowledge that it would be desirable for the Nutrition Facts label to 
be able to ``stand alone'' as a source of information to assist 
consumers in maintaining healthy dietary practices, and that the label 
should be self-explanatory insofar as possible. By spelling out the 
words Daily Value instead of abbreviating them, the meaning of the 
nutrition information presented on the Nutrition Facts label would be 
less ambiguous to consumers, alleviate the need to explain the 
abbreviation, and improve the ability of the label to stand alone. 
Therefore, the % Daily Value, rather than % DV, should be used as the 
column heading for most formats if space is available. In order to 
provide flexibility to manufacturers when there are space constraints 
on packages and to facilitate alignment of the % Daily Value column 
heading with the nutrient information listed beneath it, particularly 
on formats in which there are multiple columns of information, we are 
retaining the provision in our preexisting regulations (Sec.  
101.9(d)(6)) that allows for the substitution of ``Percent Daily 
Value,'' ``Percent DV,'' or ``% DV'' for ``% Daily Value.''
    With respect to whether consumers may have difficulty understanding 
the concept of percent, our public education program will help 
consumers understand how to use the percent DV information and become 
more comfortable with the concept of percent. We will continue to use 
percentages on the Nutrition Facts label for presenting nutrition 
information because it is useful for assisting consumers in maintaining 
healthy dietary practices.
    (Comment 498) One comment requested clarification with regards to 
how the percent DV information should be displayed for the nutrients of 
public health significance when these nutrients are listed either 
vertically or horizontally in two columns (i.e., the side-by-side 
arrangement), as permitted in Sec.  101.9(d)(8). The comment said there 
was a discrepancy in how we described the vertical arrangement of 
nutrient information for vitamins and minerals in Sec.  101.9(d)(8) and 
how this information was displayed in the label format shown in 
proposed Sec.  101.9(d)(12). The comment further suggested that the 
phrase ``or may be listed in two columns'' should be clarified, 
particularly with regards to the placement of the nutrient name, the % 
Daily Value, and the quantitative amounts, and that an example of this 
label would be helpful.
    (Response) The description of the vertical array of vitamins and 
minerals in Sec.  101.9(d)(8), which the comment said was inconsistent 
with the associated mockup because the percent Daily Values were listed 
in parentheses in the regulation, was not meant to be a literal 
description of what was shown in the label mockup in proposed Sec.  
101.9(d)(12). However, we agree with the comment that the phrase ``or 
may be listed in two columns'' needs to be clarified, particularly with 
regards to where the percent Daily Values and the absolute amounts are 
displayed relative to the names of the respective vitamins and 
minerals. Therefore, we have now stated in Sec.  101.9(d)(8) that the 
name of the nutrient will be listed first, followed by the absolute 
amount and then by the percent Daily Value (which will be listed to the 
right of the absolute amount and without parentheses). Furthermore, as 
the comment suggested, we have provided a mockup showing the horizontal 
(i.e., side-by-side) display of the vitamins and minerals in Sec.  
101.9(d)(8). However, we also note that mockups are provided as 
examples of labels, and are meant to serve as illustrations rather than 
as indications of specific requirements. We have not provided mockups 
of all possible types of labels and we did not intend to state 
literally in the regulation what was shown in the various label 
mockups.
8. Placement of ``Added Sugars''
    The proposed rule would require the declaration of added sugars as 
an indented line item underneath the declaration of total sugars on the 
Nutrition Facts label. In the Federal Register of July 27, 2015 (80 FR 
44303), we issued a supplemental proposed rule that would, among other 
things, establish a DRV of 10 percent of total energy intake from added 
sugars and require the declaration of the percent DV for added sugars.
    We did not receive any comments regarding the indentation of the 
added sugars declaration. We discuss the requirements for the added 
sugars declaration in part II.H.3.
9. Declaration of Absolute Amounts of Vitamins and Minerals
    The proposed rule would require the declaration of quantitative 
amounts for all vitamins and minerals listed on the Nutrition Facts 
label (except on labels of smaller packages with a total surface area 
available for labeling of 40 square inches or less as described in 
Sec.  101.9(j)(13)(ii)(A)(1) and (2)), in addition to maintaining the 
current

[[Page 33947]]

requirement of declaring percent DVs. Because of space limitations, we 
proposed to require only the percent DV for vitamins and minerals 
(other than sodium) on labels of foods in small or intermediate-size 
packages having a total surface area available to bear labeling of 40 
or less square inches. As we explained in the preamble to the proposed 
rule (79 FR 11879 at 11928 through 11929), comments received in 
response to the 2007 ANPRM, as well as the 2003 IOM report (Ref. 219) 
supported declaring both the absolute amounts of mandatory and 
voluntary micronutrients on the Nutrition Facts label in addition to 
the percent DVs (when they exist). Among other reasons, the IOM report 
said that listing absolute amounts of all vitamins and minerals would 
make the Nutrition Facts label internally consistent and more aligned 
with the current requirements of the Supplement Facts labels (Sec.  
101.36(b)(3)(ii) and (iii)).
    We also considered previous research which indicated that both 
consumers and health professionals have difficulty understanding how 
percent DVs relate to the absolute amounts of nutrients listed on the 
Nutrition Facts label (Ref. 239). The previous research indicated that 
physicians, dietitians, and other health professionals found it easier 
to refer to absolute amounts of nutrients rather than to the percent 
DVs when advising patients. The results suggested that declaring both 
the absolute amount and the percent DV would improve understanding of 
the label.
    (Comment 499) Many comments agreed that we should require the 
declaration of absolute amounts of all vitamins and minerals on the 
Nutrition Facts label. Some comments said that people, especially those 
with low numeracy skills, have difficulty understanding the concept of 
``percentage'' (such as percent DV) and would prefer using nutrition 
information expressed in absolute amounts rather than in percentages to 
plan diets. The comments also suggested that people who want to follow 
a health professional's nutrition guidance, such as advice to consume a 
specific amount of a nutrient (e.g., 500 mg calcium/day), would find 
quantitative amounts on labels to be more useful than the percent DVs.
    Other comments from registered dietitians said they perceived 
percent DVs to be confusing and cumbersome and preferred to use 
absolute amounts of nutrients when counseling clients on how to use the 
Nutrition Facts label to build a healthy diet, compare food products, 
and establish dietary goals.
    In contrast, many comments expressed concerns that declaring 
absolute amounts of all vitamins and minerals, in addition to the 
percent DV, would make the label more confusing, cluttered, and 
difficult to read. The comments said that listing quantitative amounts 
of all vitamins and minerals would take up valuable label space and add 
complexity to the label without providing any tangible benefits to 
consumers. Several comments said that the percent DV listing already 
provides consumers with the information they need for choosing foods 
for a healthy diet, so it is not necessary to also list the absolute 
amounts for all nutrients on the Nutrition Facts label. The comments 
questioned whether consumers would understand how to use absolute 
amounts in conjunction with the percent DV and said there was little 
evidence that declaring absolute amounts on the Nutrition Facts label 
would help consumers maintain healthful dietary practices. Some 
comments expressed concerns that, because consumers in general are not 
familiar with metric system units such as grams, milligrams, and 
micrograms or the relative magnitude of differences between these 
units, they may not realize that a quantitative weight listed as a 
large number, but expressed in micrograms, can actually represent a 
small amount of the nutrient. Another comment said that, because some 
high DVs are based on small quantitative amounts and some small DVs are 
based on high quantitative amounts, the quantitative information could 
be confusing to consumers.
    (Response) In the past, we have stated that we must be selective 
with regard to the information we require to be listed on the label and 
that not all vitamins and minerals are of equal public health 
significance (58 FR 2206 at 2107). We have limited the mandatory 
declaration of vitamins and minerals to those of particular public 
health significance. These vitamins and minerals include vitamin D, 
calcium, iron, and potassium, which are ``shortfall'' nutrients in the 
general U.S. population that are often consumed in inadequate amounts. 
In addition, we are requiring the absolute amount for folic acid in mcg 
to be declared when folic acid is added as a nutrient supplement or 
claims are made about the vitamin on the label or in labeling of foods 
(Sec.  101.9(c)(8)(ii) in the final rule).
    As we stated in the preamble to the proposed rule, research 
suggests that consumers and health professionals have difficulty 
understanding how percent DVs relate to the absolute amounts of 
nutrients (79 FR 11879 at 11928 through 11929). We recognize that some 
consumers, particularly those with low numeracy skills, may be better 
able to understand and use the listed quantitative amounts of nutrients 
(e.g., milligrams of calcium) on the label when making dietary choices, 
rather than relying solely on the percent DV, because they would need 
to know the calculation for converting percent DV to milligrams. Thus, 
although some comments would not list absolute amounts because 
(according to the comments) the percent DV already gives consumers the 
information they need for choosing foods for a healthy diet, the 
percent DVs and absolute amounts, particularly for nutrients of public 
health significance, are useful because consumers receive information 
on the recommended intake of these vitamins and minerals in 
quantitative amounts (i.e., the advice is given in milligrams, 
micrograms, or International Units) through public sources and from 
health professionals (Refs. 219, 271-272). Furthermore, folic acid 
intake is related to the risk reduction of neural tube defects, and is 
generally provided in terms of mcg of folic acid. By requiring the 
mandatory declaration of folic acid as a quantitative amount by weight 
in mcg, when folic acid is added or when a claim is made about the 
vitamin in labeling, women of childbearing age can gain a better 
understanding of the unique contribution that synthetic folic acid from 
food provides in reducing the risk of neural tube defects and will have 
the information they need to improve their ability to adhere to 
nutrition recommendations with respect to folic acid.
    Thus, requiring both the quantitative amount and the percent DV 
will help to ensure that consumers are fully informed about the content 
of these products, similar to how these nutrients are declared in 
dietary supplement product labeling (56 FR 60366; November 27, 1991). 
Nevertheless, we have decided not to include in the final rule the 
proposed requirement to include the declaration of absolute amounts for 
all vitamins and minerals. We clarify, in Sec.  101.9(c)(8)(ii), that 
the declaration of voluntarily declared vitamins and minerals listed in 
paragraph (c)(8)(iv) may include the quantitative amount by weight and 
percent of the RDI. We also revised the preexisting requirement in 
Sec.  101.9(c)(8) to remove the requirement that the declaration for 
vitamins and minerals include a statement of the amount per serving as 
a percent DV. A requirement to compel absolute amounts for all vitamins 
and minerals could make it

[[Page 33948]]

difficult for consumers to use and read the label, particularly on 
fortified foods such as cereals where many vitamins and minerals may be 
listed. In addition, the public health need among the general U.S. 
population is not as great for listing quantitative amounts for 
voluntary vitamins and minerals, such as thiamin, riboflavin, or 
niacin, because deficiencies of these vitamins are rare and because 
enriched bread, rolls, and buns must be fortified with these nutrients. 
Requiring the declaration of absolute amounts of nutrients of public 
health significance, and folic acid when added as a nutrient supplement 
or claims are made about the vitamin, while providing voluntary 
declaration of absolute amounts for other vitamins and minerals, will 
provide manufacturers with flexibility in assessing how much voluntary 
information to provide on the Nutrition Facts label without creating 
unnecessary clutter. However, if one of these other vitamins or 
minerals is added as a nutrient supplement or there is a claim made 
about it, the manufacturer must include a declaration of the nutrient 
as a percent DV, or alternatively, as a quantitative amount by weight 
and percent DV (Sec.  101.9(c)(8)(ii) in the final rule).
    With respect to the comment expressing concern that quantitative 
information could be confusing to consumers, the comment discussed a 
situation where a product that contains 100 percent DV for vitamin D 
and lists only 20 mcg (a ``low'' amount) on the label also contains 5 
percent DV for potassium, which would correspond to an absolute amount 
of 235 mg (a ``high'' amount). However, only two of the four nutrients 
(vitamin D and potassium) are new nutrient declarations under the final 
rule, and we expect consumers to become familiar with these nutrients 
as part of the new label. Vitamin D is a shortfall nutrient that many 
health professionals discuss with their clients or patients as part of 
a healthy dietary intake. As noted elsewhere in part II.N.4, vitamin D 
must be listed in micrograms and may be listed voluntarily in 
International Units. In addition, although only the percent Daily 
Values for calcium and iron are currently listed on the Nutrition Facts 
label, consumers who take these nutrients as dietary supplements may be 
familiar with the corresponding quantitative amounts because these must 
be declared on Supplement Facts labels. Furthermore, the Nutrition 
Facts label has included metric units since its inception in 1993, so 
consumers have had considerable exposure to metric units such as grams 
and milligrams. To the extent consumers are less likely to be familiar 
with ``micrograms'' (mcg), we anticipate that consumers will become 
increasingly familiar and comfortable with this metric unit and others 
on the Nutrition Facts label. We plan to address the different 
nutrients of public health concern and their units of measure as part 
of our education efforts aimed at enhancing consumer understanding of 
the label.
    (Comment 500) Some comments said that for people who have special 
dietary requirements because of a medical condition, such as chronic 
kidney disease, the percent DV by itself may be inadequate for making 
decisions about food selections (e.g., kidney patients who monitor 
their phosphorus intake would find the phosphorus content expressed in 
milligrams to be more useful than the % DV of phosphorus).
    (Response) While the Nutrition Facts label information has never 
been, nor is it now, targeted to individuals with acute or chronic 
disease, consumers may be able to use quantitative information on the 
label to follow advice they have received from a health care 
professional concerning their conditions (see part II.B.2).
    (Comment 501) Several comments questioning the need for declaring 
absolute amounts of vitamins and minerals on the Nutrition Facts label 
said that people who meet their nutritional needs through conventional 
foods are less likely to be interested in quantitative amounts of 
vitamins and minerals compared to those who use dietary supplements to 
supplement their diets with specific amounts of such nutrients. The 
comments said that labels designed for conventional food products and 
for dietary supplements are not necessarily analogous because the two 
types of products have different purposes as reflected in their 
nutrient composition; e.g., nutrient levels in dietary supplements are 
often much higher than those in foods and beverages. The comments also 
noted that, because there is a greater potential for toxicity resulting 
from the use of dietary supplement products due to overconsumption 
compared to conventional food products, it is important that nutrient 
levels on Supplement Facts labels be expressed in absolute amounts so 
that this information is plainly visible to consumers.
    (Response) Requiring the absolute amounts of vitamins and minerals 
for the nutrients of public health significance and folic acid under 
the circumstances previously described will help ensure that consumers 
are fully informed about the content of conventional foods and will 
achieve parity in labeling for nutrients of public health significance 
in conventional foods and dietary supplements. We do not consider 
issues related to potential greater toxicity from consumption of 
nutrients in dietary supplements to negate the benefits of also 
providing for conventional foods the information on absolute amounts 
for these particular nutrients of public health significance that are 
considered shortfall nutrients.
    Requiring absolute amounts of vitamins and minerals of public 
health significance and folic acid under the circumstances previously 
described to be listed on the Nutrition Facts label will make it easier 
for both consumers and health professionals to understand and use the 
Nutrition Facts label and help consumers in maintaining healthy dietary 
practices. Furthermore, consumers can use the information to obtain 
these shortfall nutrients primarily through healthy eating patterns 
containing nutrient-dense conventional foods, as recommended by the DGA 
(Ref. 28).
    (Comment 502) Several comments expressed concerns that requiring 
the absolute amounts of all vitamins and minerals to be listed on the 
Nutrition Facts label would be problematic because FDA's established 
rounding rules only apply to percent DV declarations, and the proposed 
rounding rules for declaring quantitative amounts of vitamins and 
minerals are not clear. The comments said that different products 
having the same absolute amounts of a nutrient listed on the label may 
have different percent DVs associated with that nutrient due to 
rounding. Some comments also said that two different products having 
the same percent DV for a nutrient may declare different absolute 
amounts for that nutrient, which would lead to consumer confusion. In 
addition to such discrepancies, several comments said it is not 
feasible to require absolute amounts of vitamins and minerals to be 
listed because analytical assays for obtaining this information lack 
the necessary precision, resulting in considerable variability in 
results from assay to assay. Other comments said that levels of 
nutrients in foods and food products are naturally variable and due to 
this variability, declaring absolute amounts would imply greater 
precision than is currently required for the declaration of the percent 
DV. The comments also said it would be particularly difficult and 
costly to obtain information on vitamin D levels because this 
information was not

[[Page 33949]]

previously required for most conventional food products.
    (Response) The quantitative amount of sodium has always been 
required to be declared on the Nutrition Facts label, and dietary 
supplement products have required weight amounts to be declared since 
1993. Rounding rules for the Nutrition Facts label have been 
established for potassium (Sec.  101.9(c)(5)) and for other vitamins 
and minerals (Sec.  101.9(c)(8)(iii)) in the Nutrition Facts label and 
for vitamins and minerals declared on labels of dietary supplements 
(Sec.  101.36(b)(2)(ii)(B) and Sec.  101.36(b)(2)(iii)(B)). We discuss 
this topic further in part II.M.6. To declare the percent DV for 
vitamins and minerals on the Nutrition Facts label, manufacturers 
should already have information about the levels of nutrients in their 
products. Such information also can be obtained through laboratory 
analysis or by consulting standard nutrient databases, such as the USDA 
Nutrient Data Lab Standard Reference (http://www.ars.usda.gov/Services/docs.htm?docid=8964). Substituting vitamin D and potassium for vitamin 
A and vitamin C for the nutrient analysis should not result in a 
significant difference in cost to the manufacturer. Furthermore, we are 
not aware of problems in obtaining quantitative data related to 
variability and precision. Manufacturers already must address these 
issues to comply with the preexisting nutrition labeling regulations.
    (Comment 503) One comment included the results of a consumer study 
to suggest that it is more important for FDA to gain a better 
understanding of how consumers use percent DV information rather than 
understand how consumers would use information on absolute amounts. The 
comment said that, according to its research, declaring absolute 
amounts on the label would decrease consumer attention to the percent 
DV information and would present ``significant implementation 
challenges.''
    (Response) The comment refers to the study which we addressed in 
our response to comment 184. We are not aware of any evidence that 
including absolute amounts for the public health nutrients would 
detract from the percent DV information, and we intend to conduct 
consumer education on increasing the understanding of the percent DVs.
10. Single and Dual Column Labeling
    The preamble to the proposed rule (79 FR 11879 at 11952 through 
11953) noted that we have preexisting regulations for voluntary dual 
column labeling and that dual column labeling is mandatory for products 
that are promoted on the label, or in advertising, for a use that 
differs in quantity by twofold or greater from the use upon which the 
reference amount was based (e.g., liquid cream substitutes promoted for 
use with breakfast cereals) (Sec.  101.9(b)(11)). The proposed rule 
would require (under certain conditions) dual column labeling where 
nutrition information would be presented based both on the serving size 
and on the entire package or unit of food.
    We respond to comments on single and dual-column labeling in the 
final serving size rule.
    (Comment 504 and Response) We address comments regarding dual 
column labeling in the final rule on ``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'' which is published elsewhere in this issue 
of the Federal Register.
11. The Footnote
    Our preexisting regulations, at Sec.  101.9(d)(9)(i), require the 
Nutrition Facts label to bear an asterisk after the ``% Daily Value'' 
declaration; the asterisk refers to a footnote that reads: ``*Percent 
Daily Values are based on a 2,000 calorie diet. Your Daily Values may 
be higher or lower depending on your calorie needs.'' Our preexisting 
regulations also require, below the footnote, a table that lists DRVs 
for total fat, saturated fat, cholesterol, sodium, total carbohydrate, 
and dietary fiber based on 2,000 and 2,500 calorie diets (Sec.  
101.9(d)(9)(i)). However, the preamble to the proposed rule (79 FR 
11879 at 11953) explained that the percent DV is not described in the 
footnote or anywhere else on the Nutrition Facts label, and so we 
wondered if such a description would help improve consumer 
understanding of the percent DV information. We also noted that 
consumers did not understand what was being conveyed in the footnote or 
the DRV table (id.). Consequently, we proposed to remove the 
requirement for the footnote table and to reserve a subparagraph 
(proposed Sec.  101.9(d)(9)) for a future footnote. The preamble to the 
proposed rule (79 FR 11879 at 11953) also stated our tentative view 
that a new, simple footnote was needed to help consumers understand the 
meaning of the percent Daily Value. We said that the new footnote 
should have a larger type size, be more noticeable than the preexisting 
footnote, and include a statement that 2,000 calories a day is used for 
general nutrition advice (id.).
    We also stated in the preamble of the proposed rule (id. at 11953 
through 11954) that we would continue to conduct research during the 
rulemaking process to evaluate how variations in label format, 
including percent DV information in the footnote area, may affect 
consumer understanding and use of the Nutrition Facts label and that we 
would make the results of our study available for public review and 
comment.
    In the preamble to the supplemental proposed rule (80 FR 44303 at 
44306 and 44309), we described an experimental study on consumer 
responses to Nutrition Facts labels with various footnote formats. (We 
summarize the footnote study at part II.B.5.) The supplemental proposed 
rule would add language to the space reserved in proposed Sec.  
101.9(d)(9) to explain that the % Daily Value tells how much a nutrient 
in a serving of food contributes to a daily diet and that 2,000 
calories a day is used for general nutrition advice. The supplemental 
proposed rule also would create an exemption to the proposed footnote 
requirement in Sec.  101.9(d)(9) for the foods that can use the terms 
``calorie free,'' ``free of calories,'' ``no calories,'' ``zero 
calories,'' ``without calories,'' ``trivial source of calories,'' 
``negligible source of calories,'' or ``dietary insignificant source of 
calories'' on the Nutrition Facts label or in the labeling of foods as 
defined in Sec.  101.60(b) because such products would have little to 
no impact on the average daily 2,000 calorie intake, which the footnote 
addresses. The supplemental proposed rule also would amend Sec.  
101.9(j)(13)(ii)(C) to allow the footnote to be omitted on small or 
intermediate-size packages (Sec.  101.9(j)(13)(ii)(A)(1) and Sec.  
101.9(j)(13)(ii)(A)(2)) provided that an abbreviated footnote statement 
(that % DV = % Daily Value) is used. Although the preamble to the 
supplemental proposed rule discussed allowing the footnote proposed in 
Sec.  101.9(d)(9) to be omitted from products that qualify for a 
simplified format (Sec.  101.9(f)) (80 FR 44303 at 44309) provided that 
the abbreviated footnote statement is used, this provision was 
inadvertently omitted from the codified section of the supplemental 
proposed rule.
    With respect to the Supplement Facts label, our preexisting 
regulations, at Sec.  101.36(b)(2)(iii)(D), require that, if the 
percent DV is declared for total fat, saturated fat, total 
carbohydrate, dietary

[[Page 33950]]

fiber, or protein on the Supplement Facts label, a footnote state that 
``Percent Daily Values are based on a 2,000 calorie diet.'' The 
proposed rule would require, for a product that is represented or 
purported to be for children 1 through 3 years of age and contains a 
percent DV declaration for total fat, total carbohydrate, dietary 
fiber, or protein, that a symbol be placed next to the percent DV 
declaration that refers the consumer to a statement at the bottom of 
the label that says ``Percent Daily Values are based on a 1,000 calorie 
diet'' (79 FR 11879 at 11947). We illustrated this footnote in a mockup 
of a Supplement Facts label depicting a multiple vitamin product for 
children and adults (Sec.  101.36(e)(11)(ii)). In the preamble to the 
proposed rule, we invited comments on whether changes to the footnote 
statement on the Supplement Facts label should be consistent with any 
changes that are made to the footnote statement in the Nutrition Facts 
label (79 FR 11879 at 11948). In the preamble to the supplemental 
proposed rule, we invited comments on whether we should replace the 
preexisting footnote in the Supplement Facts label with a footnote 
comparable to what we would require for the Nutrition Facts label; 
i.e., ``2,000 calories a day is used for general nutrition advice'' (80 
FR 44303 at 44307).
    (Comment 505) Many comments supported removing the footnote table 
listing DRVs for certain nutrients based on 2,000 and 2,500 calorie 
diets. The comments said that the footnote table is confusing and 
difficult to read; consumers generally do not understand how to use it 
and probably derive little value from it; and the footnote occupies 
valuable label space that could be used for other information. However, 
other comments favored retaining the footnote table, indicating that it 
is useful for nutrition education purposes, may help consumers gain a 
perspective on their daily nutrient intake, and is a convenient 
reference for consumers who want this information.
    Other comments suggested that the footnote should contain 
additional information beyond what is currently included or proposed. 
For example, some comments said the footnote should continue to explain 
that percent DVs are based on a 2,000 calorie diet and that an 
individual's Daily Values may be higher or lower depending on one's 
particular calorie needs. Some comments expressed concern that, without 
context, the public will not know whether 2,000 calories represents too 
many or too few calories. In addition, some comments said we should 
require language in the footnote explaining that growing children and 
adolescents may need more or less than 2,000 calories per day, 
depending on their age, gender, size, and activity level.
    Other comments suggested that, because some consumers may view the 
label serving size as a recommended portion size, or use these terms 
interchangeably, we should include a footnote clarifying that ``serving 
size'' is based on the amount typically consumed and is not a 
recommended amount.
    Another comment said that the Nutrition Facts label should go 
beyond just providing factual information and be a ``tool'' to help 
consumers make healthier food and beverage choices. For example, the 
comment said we should use a footnote to provide consumers with 
information about nutrients on the label that are ``beneficial'' (such 
as dietary fiber) or ``harmful'' (such as saturated fat) to their 
health. Several comments also said that we should consider including a 
link to a Web page where consumers can find more information about 
nutrition, health and calorie needs.
    Several comments suggested that we seek a broader understanding of 
how consumers use the footnote. The comments emphasized that any 
revisions to the footnote should be based on research, and that the 
results of our consumer research should be made available to the public 
for review and comment. However, other comments would remove the 
footnote entirely, and some comments suggested that, as part of our 
consumer studies, we should evaluate whether a footnote is even needed. 
Several comments noted that the footnote itself is not an effective 
means for educating consumers and should not be used as an educational 
tool.
    Several comments said that, regardless of which footnote was 
ultimately decided upon, the footnote should be succinct, occupy little 
space, and fit on small packages. Many comments emphasized that, 
because the proposed rule did not specify the exact footnote text and 
the amount of space the new footnote would require, it would be 
difficult to submit meaningful comments until further details were 
provided.
    (Response) We agree with removing the footnote table listing DRVs 
for certain nutrients based on 2,000 and 2,500 calorie diets. As stated 
in the proposed rule (79 FR 11879 at 11953), we are aware of research 
suggesting that consumers do not understand what is being conveyed in 
the footnote table (Ref. 273). We also recognize that label space is 
limited and agree that eliminating the footnote table would free up 
space on the label that could be used for other purposes. Therefore, 
the final rule does not require the footnote table which lists the DRVs 
for total fat, saturated fat, cholesterol, sodium, total carbohydrate, 
and dietary fiber for 2,000 and 2,500 calorie diets.
    We disagree with comments suggesting that a footnote be used to 
explain that calorie needs vary among population groups (including 
children and adolescents) or to clarify the meaning of ``serving 
size.'' The footnote area of the label is not an appropriate place for 
providing this information because of limited space on the label. 
Furthermore, we do not agree that it would be appropriate to use a 
footnote to indicate ``beneficial'' or ``harmful'' nutrients that are 
declared on the label, as the comment suggested. We considered a 
similar concept in the alternative visual format that was discussed in 
the preamble to the proposed rule (79 FR 11879 at 11995), but, after 
reviewing the comments on the proposed rule, indicated that we did not 
intend to consider the alternative format for the Nutrition Facts label 
further (see 80 FR 44302).
    With respect to comments suggesting that we base revisions of the 
footnote (including the option of not having any footnote at all) on 
research and that our research results should be made available to the 
public for review and comment, we did conduct research on various 
footnote options and made those results publicly available (see 80 FR 
44302; 80 FR 44303).
    Finally, we do not agree with the comments stating that we should 
consider including a link to a Web page where consumers can find more 
information about nutrition, health and calorie needs. Information on 
the Nutrition Facts label should be available to the consumer at the 
time of product purchase or consumption.
    (Comment 506) Many comments to the supplemental proposed rule 
supported FDA's proposed footnote, ``*The percent DV tells you how much 
a nutrient in a serving of food contributes to a daily diet. 2,000 
calories a day is used for general nutrition advice,'' and generally 
agreed that the footnote should include both a definition of percent DV 
as well as a reference calorie level. The comments said that the 
proposed footnote conveys the information that consumers need to 
understand the significance of the percent DV declaration in the 
context of a daily diet and highlights factors (i.e., nutrient values 
and total calorie intake)

[[Page 33951]]

that are important in making dietary decisions. Several comments also 
pointed out that, because the footnote has been condensed (i.e., by 
removing the footnote table), it would help counterbalance the 
increased space requirements of the Nutrition Facts label.
    Other comments objected to the proposed footnote and suggested 
alternative footnote text. For example, one comment said that the first 
sentence in the footnote is confusing grammatically; the second 
sentence does not flow naturally from the first sentence; it is unclear 
how the two concepts expressed in the footnote are related; and the 
proposed footnote text is longer than that of the current footnote and 
will take up too much valuable label space. The comment suggested an 
alternative footnote, ``*The % Daily Value (DV) tells you how much a 
nutrient in a serving of food contributes to a 2,000 calorie daily 
diet.'' The comment said its suggested footnote is more concise and 
easier to follow.
    Another comment said that the footnote should specify that a 2,000 
calorie daily diet pertains to adults and suggested the following 
footnote text: ``The % Daily Value (DV) tells you how much a nutrient 
in a serving of food contributes to a daily diet. 2,000 calories a day 
is used for general nutrition advice for adults.'' Another comment that 
criticized the proposed footnote for being ``too verbose'' and provided 
six different, but similar, versions of a ``more succinct'' alternative 
footnote, with one option reading as: ``* %DV = %Daily Value, how much 
a nutrient in a serving contributes to a daily 2,000 calorie diet.''
    Several other comments either suggested modifications to the 
proposed footnote (e.g., expanding the term ``food'' to ``food or 
beverage'' to emphasize that beverages also contribute to one's daily 
nutrient intake) or opposed the footnote because, according to the 
comments, the footnote was not tested and was not supported by 
research. Furthermore, several comments said that, because no 
significant differences were found among the footnotes in our consumer 
study, we should give further consideration to some footnotes that were 
tested, but ultimately rejected. In particular, the comments said we 
should reconsider the footnote which included the statement, ``5% or 
less is a little, 20% or more is a lot'' after the % Daily Value 
description (experimental footnote 2). The comments said that this 
guideline for what constitutes a ``lot'' or a ``little'' of a nutrient 
may be helpful to consumers in judging the nutrient content of a 
particular product. One comment also expressed support for the footnote 
stating, ``These are nutrients to reduce in your diet,'' with the 
footnote symbol inserted to the left of the listings for saturated fat, 
trans fat, cholesterol, sodium, and sugars in the Nutrition Facts label 
(experimental footnote 5). The comment said that this footnote scored 
well in our consumer study and offers ``real value'' for consumers 
seeking information on nutrients in the diet that should be reduced.
    (Response) We appreciate the suggestions for modifying or refining 
the footnote. However, the alternative footnote statements do not offer 
a significant improvement over the footnote text that we have proposed. 
Furthermore, the comments did not provide any evidence or data 
indicating that any alternative footnote represented an improvement 
over the proposed footnote.
    The second statement of our proposed footnote, ``2,000 calories a 
day is used for general nutrition advice,'' is the same as the succinct 
statement that will be required on menus and menu boards under FDA's 
menu labeling final rule (79 FR 71156 (December 1, 2014)). Moreover, by 
including this statement as a separate, stand-alone sentence in the 
footnote text, we provide consistency between labels on packaged foods 
and those on foods sold in restaurants. Adding the words ``for adults'' 
at the end of this sentence, as one comment suggested, would undermine 
this consistency, take up additional space, and is not needed because 
the Nutrition Facts label is intended to apply to individuals 4 years 
of age and older (with the exception of labels on products other than 
infant formula represented or purported to be specifically for infants 
through 12 months of age and children 1 through 3 years of age). 
Furthermore, as we explain in part II.E.3, a 2,000 calorie reference 
intake level is applicable to the general population and is used as the 
basis for setting DRVs for total fat, saturated fat, total 
carbohydrate, dietary fiber, and protein, so there is no need to add 
the words ``for adults'' in the footnote text.
    Regarding the comment suggesting the modified footnote text, ``The 
% Daily Value (DV) tells you how much a nutrient in a serving of food 
contributes to a 2,000 calorie daily diet,'' the statement is brief and 
grammatically correct, but may not be technically correct because the 
daily values of some declared nutrients, such as sodium and 
cholesterol, do not depend on the caloric intake. Therefore, it would 
not be accurate to link the percent DV in a serving ``to a 2,000 
calorie daily diet,'' as stated in the modified footnote, rather than 
``to a daily diet'' as stated in our footnote.
    Although we agree that including ``5% or less is a little, 20% or 
more is a lot'' after the % Daily Value description (experimental 
footnote 2) can be helpful in judging the nutrient content of a 
particular product, we note that our consumer research study did not 
demonstrate that this footnote performed any better than the other 
footnotes that we investigated. As we explained in the preamble to the 
supplemental proposed rule (80 FR 44303 at 44306), our results 
indicated that none of the modified footnotes we tested significantly 
affected consumer perceptions of the products or judgments of nutrient 
levels; all five footnote options elicited similar perceptions and 
judgments relative to the current footnote and a no-footnote control. 
We also are concerned that including this qualifying phrase would 
increase the amount of space required for the footnote. However, as we 
stated in the preamble to the proposed rule (79 FR 11879 at 11954), the 
``5/20 rule'' can be used as a general frame of reference for 
evaluating the nutrient content of foods. We anticipate that explaining 
this approach for using the percent DV information will be a part of 
our future consumer education efforts, so it would not be necessary to 
include an explanation of the ``5/20 rule'' in the footnote.
    As for the comments that favored consideration of the footnote 
which indicated ``nutrients to reduce in your diet'' (footnote 5), we 
previously considered this concept in our ``alternative format'' (79 FR 
11879 at 11995), but found it offered no clear advantages over the 
current and proposed formats in helping consumers to identify specific 
information on the label or to make healthier food choices.
    We do not agree with the comment that said our proposed footnote is 
``confusing grammatically.'' We deliberately used language that was 
informal rather than grammatically rigid or technical. Our intent was 
to make the footnote consumer friendly. We also consider our footnote 
to be simple and brief in providing a description of the percent Daily 
Value, which is lacking in the preexisting footnote.
    Finally, we decline to include the word ``beverage'' in the 
footnote. The term ``food'' is defined in section 201(f)(1) of the FD&C 
Act as including articles used for both ``food or drink.'' Moreover, 
the Nutrition Facts label has

[[Page 33952]]

appeared on beverages for more than 20 years, so consumers should 
understand that the entire label, including the footnote, applies to 
foods that are beverages.
    We expect that our footnote, which explains the term ``% Daily 
Value'' and provides a reference calorie level, will assist consumers 
in better understanding the information on the Nutrition Facts label 
and in maintaining healthy dietary practices. Therefore, the final 
rule, at Sec.  101.9(d)(9), requires a footnote stating that, ``* The % 
Daily Value tells you how much a nutrient in a serving of food 
contributes to a daily diet. 2,000 calories a day is used for general 
nutrition advice,'' in all Nutrition Facts label formats except for the 
exemptions previously noted. The final rule also requires, on labels of 
products represented or purported to be for children 1 through 3 years 
of age, that the second sentence of the footnote substitute ``1,000 
calories'' for ``2,000 calories,'' so the footnote statement will read: 
``* The % Daily Value tells you how much a nutrient in a serving of 
food contributes to a daily diet. 1,000 calories a day is used for 
general nutrition advice.''
    (Comment 507) Many comments supported the exemption for a footnote 
on products containing a negligible amount of calories and that can use 
the term ``calorie free'' or one of its synonyms. The comments agreed 
that a footnote which addresses a 2,000 calorie intake is not relevant 
for these products, and the exemption would be a practical way of 
conserving label space for the nutrient declarations that are required.
    However, other comments opposed the exemptions because, according 
to comments, products that have little or no impact on calorie intake 
still may contain substantial amounts of nutrients such as vitamins and 
minerals. As an example, one comment said that fortified beverages may 
contain significant amounts of electrolytes as well as 100 percent of 
the DV of certain vitamins. The comment suggested that ``calorie free'' 
products include the first sentence of the footnote, ``The % Daily 
Value tells you how much a nutrient in a serving of food contributes to 
a daily diet'' because it would help consumers understand the vitamin 
and mineral content of these calorie-free foods.
    Other comments supported the use of an abbreviated footnote, such 
as ``% DV = % Daily Value'' on the simplified format label and on 
labels of small and intermediate-size packages. Some comments explained 
that an abbreviated footnote would save label space. However, one 
comment opposed allowing the abbreviated footnote to be used on small 
and intermediate-size packages because, according to the comment, such 
products are often high in added sugars and are routinely marketed to 
children and adolescents. The comment suggested that consumers would 
benefit by having the complete footnote appear on these food packages.
    (Response) As we explained in the preamble to the supplemental 
proposed rule (80 FR 44303 at 44309), we are applying the same 
rationale in this final rule that we used in the 1993 final rule with 
regards to exempting small and intermediate-size packages from some of 
the footnote language we required for larger products. The 1993 final 
rule gave manufacturers flexibility in using the complete footnote on 
all product labels. We recognized that the benefits of requiring this 
footnote were not relative to the specific product that carries the 
information and that the information would be available to consumers if 
it appeared on a significant percentage of food labels (58 FR 2079 at 
2129). Therefore, although the final rule does not require any footnote 
on these products, we will allow the voluntary use of the first part of 
the footnote statement, ``* The % Daily Value tells you how much a 
nutrient in a serving of food contributes to a daily diet'' on products 
that can use the terms ``calorie free,'' ``free of calories,'' 
``without calories,'' ``trivial source of calories,'' ``negligible 
source of calories,'' or ``dietary insignificant source of calories'' 
on the label or in the labeling of foods, as defined in Sec.  
101.60(b).
    We acknowledge that small and intermediate-size packages may be 
high in added sugars and marketed to children and adolescents. However, 
both the absolute amount and % DV of added sugars will be declared on 
labels of small packages, so this information will be available to 
consumers. We also recognize the need to conserve space on smaller 
packages, which is why we allow other adjustments, such as not 
requiring the declaration of absolute amounts of the public health 
nutrients and the use of the tabular (Sec.  101.9(j)(13)(ii)(A)(1)) and 
linear (Sec.  101.9(j)(13)(ii)(A)(2)) display on small packages and 
intermediate-size packages having a total surface area available to 
bear labeling of 40 or less square inches. Therefore, the final rule 
does not require the footnote in Sec.  101.9(d)(9) to be used on 
products in small packages as specified in Sec.  101.9(j)(13)(ii)(A)(1) 
and Sec.  101.9(j)(13)(ii)(A)(2), but manufacturers may voluntarily 
include the abbreviated footnote ``% DV = % Daily Value'' on these 
packages and in a type size no smaller than 6 point. Furthermore, the 
final rule does not require the footnote in Sec.  101.9(d)(9) to be 
used on products that qualify for using the simplified format, as 
explained in Sec.  101.9(f)(5), provided that the abbreviated footnote 
``% DV = % Daily Value'' in a type size no smaller than 6 point is used 
on these package labels when Daily Value is not spelled out in the 
column heading.
    Finally, in the preamble to the proposed rule (79 FR 11879 at 
11953), we recognized that the footnote, by appearing in a small type 
size at the bottom of the label, may be less noticeable to consumers 
and of less use than if it had been larger and otherwise more 
noticeable. Consequently, our tentative view was that increasing the 
type size of the footnote would assist consumers in using the 
information, and we requested comments on this issue. We did not 
receive any comments that supported increasing the type size of the 
footnote (although comments supported increasing the font size for 
certain other declarations, e.g., ``Calories'' and ``Serving size''), 
but some comments supported using as little space as possible for the 
footnote information. Therefore, the final rule does not affect the 
pre-existing requirement in Sec.  101.9(d)(1)(iii) that specifies that 
the information required in Sec.  101.9(d)(9) be in a type size no 
smaller than 6 point.
    (Comment 508) Many comments discussed whether there should be a 
footnote on the labels of foods represented for infants 7 to 12 months 
of age or children 1 through 3 years of age. Most comments supported 
having a footnote on the label of foods intended for these 
subpopulation groups. For example, one comment said that a voluntary 
footnote should be permitted for foods specifically marketed to 
children 1 through 3 years of age and that the footnote should state, 
``Percent Daily Values are based on a 1,000 calorie diet.'' Other 
comments said that both conventional foods and dietary supplement 
products marketed for these age groups should have a footnote (denoted 
by an asterisk) indicating the number of calories that the percent DVs 
listed on the labels is based on. One comment noted that this had 
already been proposed for dietary supplements (79 FR 11879 at 11947). 
The comment further suggested that information about percent DVs of 
nutrients for different age groups be made available online (arranged 
by age group) so that parents and others interested in nutrition would 
have ready access to this information.
    Another comment suggested that we allow a voluntary footnote 
stating ``Total fat and cholesterol should not be limited in the diets 
of children less than 2 years

[[Page 33953]]

unless directed by a physician'' to provide dietary guidance to parents 
and other caregivers to help assure total fat is not restricted in the 
diet of young children. The comment said that the American Academy of 
Pediatrics recommends not restricting fat or cholesterol for infants 
and children younger than 2 years of age, as rapid growth and 
development occur during this time, necessitating a high energy intake. 
Another comment said we should not finalize the rule until we had 
conducted appropriate research, including consumer testing, to better 
understand the impacts of declaring saturated fat and cholesterol on 
the labels of products represented or purported to be specifically for 
infants and children 1 through 3 years of age and if an explanatory 
footnote would assist in improving consumer understanding when 
accompanying any relative declaration.
    (Response) We recognize that the percent DVs of certain nutrients 
(e.g., fats, carbohydrates, protein) for foods specifically intended 
for children 1 through 3 years of age are based on a reference calorie 
intake of 1,000 calories/day. However, as explained in part II.O 
(Subpopulations), the IOM's quantitative intake recommendations (AIs 
and RDAs), rather than a calorie level, provide a basis on which to 
determine RDIs (and percent DVs) for vitamins and minerals for this 
subpopulation. Although the comments suggested including the footnote 
``Percent Daily Values are based on a 1,000 calorie diet'' on labels of 
foods specifically intended for children 1 through 3 years of age, this 
statement would not be accurate for all nutrients. Therefore, as 
illustrated in the label mockup in Sec.  101.9(j)(5)(ii), the final 
rule requires the labels of these food products to have a footnote that 
includes the statement ``1,000 calories a day is used for general 
nutrition advice;'' this information would parallel the footnote 
statement used on food labels for the general population (i.e., 4 years 
of age and older).
    With respect to the comment suggesting we allow a voluntary 
footnote stating that total fat should not be limited in the diets of 
children less than 2 years unless directed by a physician (or similar 
wording), we acknowledge, in general, that total fat should not be 
limited in the diets of young children less than 2 years of age unless 
directed by a health professional (as previously explained in part 
II.O, Subpopulations). Because the final rule requires the mandatory 
declaration of saturated fat and cholesterol on labeling for infants 
and children, we are continuing to consider how a voluntary footnote 
explaining that total fat should not be restricted in the diets of 
children less than 2 years of age may help caregivers maintain healthy 
dietary practices for these subgroups, and how the information can be 
conveyed effectively. Although, for this final rule, we decline to 
allow this voluntary statement to be located within the Nutrition Facts 
label, manufacturers may place this or a similar statement in another 
area of the package, provided the statement is truthful and not 
misleading. We intend to engage in education efforts to explain changes 
to the Nutrition Facts label and will include labeling of foods for 
infants and children 1 through 3 years of age in these efforts.
    (Comment 509) One comment said that the Supplement Facts label 
should be similar to the Nutrition Facts label used for conventional 
foods because different versions of the labels may decrease consumer 
use, understanding and trust. However, it was not clear if the comment 
was referring specifically to the footnotes of these labels. Another 
comment said there should not be a footnote on the Supplement Facts 
labels because consumers do not receive nutrition solely from these 
products, so a footnote referring to total calories would be 
unnecessary. The comment added that, because nutrition calculations are 
based on 2,000 calories, this information is already standardized 
across the industry, making the notation unnecessary.
    Another comment expressed concern that the statement ``2,000 
calories a day is used for general nutrition advice'' on Supplement 
Facts labels would not be useful to consumers in the absence of 
additional information. However, the comment said it would be difficult 
to include additional, explanatory text because of limited space, 
especially on small packages. Therefore, the comment would retain the 
preexisting footnote, ``Percent Daily Values are based on a 2,000 
calorie diet,'' on Supplement Facts labels.
    (Response) We agree that information about calories is not relevant 
for many dietary supplement products because the products contain only 
vitamins and minerals and do not contain nutrients that provide 
calories, such as total fat, saturated fat, total carbohydrate, and 
protein. Therefore, the footnote in previously required Sec.  
101.9(d)(9) would not be appropriate on Supplement Facts labels for 
products that do not contain these calorie sources. Furthermore, 
dietary supplements are intended to supplement the diet, and the 
information in the footnote for conventional foods that references 
2,000 calories as a basis for ``general nutrition advice,'' or explains 
percent DV in the context of what a serving contributes to a daily 
diet, is for a different use from that of dietary supplements.
    Although the intent of the comment regarding the need for 
consistency between the Nutrition Facts label and Supplement Facts 
label is not clear, we recognize the necessity of having different 
footnotes on labels of conventional foods and dietary supplements, 
consistent with how these products are used. Therefore, the final rule 
retains the preexisting footnote on Supplement Facts labels and amends 
the list of macronutrients, for when the footnote is required, to 
include added sugars. Therefore, the final rule requires a footnote if 
the percent of Daily Value is declared for total fat, saturated fat, 
total carbohydrate, dietary fiber, protein, or added sugars), stating 
that ``Percent Daily Values are based on a 2,000 calorie diet'' (Sec.  
101.36(b)(2)(iii)(D)) because that information is related to the 
calorie contribution of the calorie-containing ingredients. The 
footnote statement for Supplement Facts labels does not contain the 
statement required for conventional foods that states ``The % Daily 
Value tells you how much a nutrient in a serving of food contributes to 
a daily diet.'' In addition, if a product declares a percent DV for 
total fat, saturated fat, total carbohydrate, dietary fiber, protein, 
or added sugars, and is represented or purported to be for use by 
children 1 through 3 years of age, the final rule, at Sec.  
101.36(b)(2)(iii)(D), requires a footnote statement, ``Percent Daily 
Values are based on a 1,000 calorie diet.''
    (Comment 510) One comment asked us to clarify the footnote's width 
because the width requirements were not specified. The comment said 
that this issue would be particularly important when either the tabular 
format (Sec.  101.9(d)(11)(iii)) or the dual column tabular format 
(Sec.  101.9(e)(6)(ii)) was used because, without a specific width 
requirement, the footnote text could be wrapped in various ways, 
resulting in the footnote occupying space varying from being mostly 
horizontal (i.e., wide and short) to mostly vertical (i.e., narrow and 
tall). The comment suggested the possibility of specifying a minimum 
width that would require at least the words ``The % Daily Value'' to 
fit on a single line.
    (Response) Manufacturers have the flexibility, within certain 
parameters, in how they display the footnote to satisfy the 
configuration and design constraints of their packages. Therefore, we 
decline to specify a minimum number of words

[[Page 33954]]

per line for the footnote, as the comment suggested. However, we intend 
to monitor how firms comply with the format requirements, including the 
footnote display. If we determine that manufacturers are having 
difficulty fitting the footnote text and other required information 
within the Nutrition Facts label, we will consider whether further 
action, including rulemaking, is needed with regard to positioning the 
footnote.
12. Use of Highlighting With a Type Intermediate Between Bold or Extra 
Bold and Regular Type
    Under our preexisting regulations, only nutrients that are not 
indented (i.e., ``Calories,'' ``Total Fat,'' ``Cholesterol,'' 
``Sodium,'' ``Total Carbohydrate,'' and ``Protein'') on the Nutrition 
Facts label are required to be highlighted in bold or extra bold type 
or other highlighting (Sec.  101.9(d)(1)(iv)). In the preamble to the 
proposed rule (79 FR 11879 at 11954), we stated that, based on design 
considerations of using bold type to help differentiate the name of the 
nutrient from its absolute amount (Ref. 262), all of the other 
nutrients listed on the Nutrition Facts label, including those that are 
indented and the vitamins and minerals, should also be highlighted to 
help set the names of the nutrients apart from other information that 
appears on the label. The key nutrients that are not indented would 
still be highlighted in a font that is bolder than the indented 
nutrients, so the overall style of the Nutrition Facts label would not 
change. Thus, we proposed to amend Sec.  101.9(d)(1)(iv) to remove the 
restriction that prohibits any other information on the label to be 
highlighted and to require that all voluntary nutrients specified in 
Sec.  101.9(c), including the vitamins and minerals listed in Sec.  
101.9(c)(8)(iv), appear in a type intermediate between bold and regular 
type (if bold type is used) or between extra bold and regular type (if 
extra bold type is used) on the Nutrition Facts label.
    (Comment 511) One comment suggested that if too much information on 
the Nutrition Facts label was bolded, nothing would stand out. The 
comment also said that too much bolding would be especially problematic 
for small packages because it would be difficult to maintain legibility 
of the printed information. The comment said that small print that is 
bolded would be even more difficult to read, because the letters would 
appear to run together even more.
    Another comment suggested that, as an alternative to bolding, we 
might want to reconsider the restriction of using reverse highlighting 
(i.e., white text printed in a black box, also known as reverse 
printing) as a method of increasing prominence. The comment stated that 
since the Nutrition Facts label was introduced in 1993, vast 
improvements have been made in printing technologies and capabilities, 
which should help alleviate previous concerns with regards to whether 
reverse printing could meet minimum printing tolerances.
    (Response) We agree that too much bolding may reduce the contrast 
between information that is intended to be relatively more or less 
prominent on the Nutrition Facts label and that maintaining adequate 
resolution of printed information on labels of small packages might be 
particularly difficult. We also agree that it is more likely that 
letters or numbers may run together when information is highlighted, 
especially on labels of small packages, and we note that our 
preexisting regulations (Sec.  101.9(d)(1)(ii)(D)) specify that letters 
on the Nutrition Facts label should never touch. Therefore, based on 
the graphic design principle of using contrast to distinguish 
differences between adjacent items that would otherwise appear similar, 
and the importance of preserving adequate resolution to ensure the 
sharpness and clarity of the label information, the final rule does not 
amend the portion of proposed Sec.  101.9(d)(1)(iv) that would require 
the indented nutrients and the vitamins and minerals (except sodium) to 
be highlighted in a type intermediate between bold or extra bold type 
and regular type.
    As for the comment suggesting that we reconsider the use of reverse 
printing, we had concluded in the 1993 final rule (58 FR 2079 at 2137), 
based on comments and the professional literature at that time, that 
the use of reverse printing on the Nutrition Facts label would give 
rise to technical and legibility problems, especially on small 
containers, and therefore we declined to permit reverse printing as a 
form of highlighting (Sec.  101.9(d)(1)(iv)). While advances in 
technology may have removed some previous barriers that existed with 
this printing technique, we need to learn more about the technology 
before we consider revising the rule to address reverse printing.
13. Addition of a Horizontal Line Beneath the Nutrition Facts Heading
    Our preexisting regulations, at Sec.  101.9(d)(2), require that the 
Nutrition Facts heading be set in a type size larger than all other 
print size in the nutrition label (Sec.  101.9(d)(2)) but does not 
require that this heading be set apart from the rest of the label with 
a horizontal hairline rule, which is a thin line. Horizontal lines are 
used throughout the Nutrition Facts label as a key graphic element to 
divide space, direct the eye, and give the label a unique and 
identifiable look. The proposed rule would require that a thin 
horizontal line (i.e., a 0.25 point hairline rule) be inserted directly 
beneath the Nutrition Facts heading with the exception of the linear 
display for smaller packages in Sec.  101.9(j)(13)(ii)(A)(2).
    (Comment 512) One comment said that the hairline rule beneath the 
Nutrition Facts title improves the overall appearance of the Nutrition 
Facts label and its ``ease of use.'' Another comment said that the use 
of horizontal lines and other design elements (e.g., white space, bold 
fonts, etc.) are visual cues that draw attention to important 
information on the Nutrition Facts label, helping to improve 
readability and make the information easier to process and remember. 
Another comment said that a horizontal line beneath the Nutrition Facts 
heading would help separate the heading from the ``__ servings per 
container'' declaration, because all of the information in the first 
two lines of the label was presented in bold type.
    (Response) We agree that a thin horizontal line directly beneath 
the Nutrition Facts heading would make the heading more visually 
appealing. Our requirement in Sec.  101.9(d)(1)(v) to insert the 
horizontal line beneath the Nutrition Facts heading for all formats 
(except the linear display for smaller packages described in Sec.  
101.9(j)(13)(ii)(A)(2)) is based on graphic design principles and other 
design considerations previously discussed in the preamble to the 
proposed rule.
14. Replacing ``Total Carbohydrate'' With ``Total Carbs''
    Nutrition information declared on the Nutrition Facts label must be 
presented using the nutrient names specified in Sec.  101.9(c) or Sec.  
101.9(j)(13)(ii)(B). According to Sec.  101.9(c)(6), the nutrient name 
used for listing information about the carbohydrate content of a 
product is ``Total Carbohydrate.'' Certain abbreviations, as specified 
in Sec.  101.9(j)(13)(ii)(B), may be used on the Nutrition Facts label 
on packages that have a total surface area available to bear labeling 
of 40 or less square inches.
    In the preamble to the proposed rule (79 FR 11879 at 11954), we 
explained that replacing ``Total Carbohydrate,'' the nutrient name 
currently required on most formats, with the shorter term ``Total 
Carbs'' would maximize white space, maintain simplicity, and because

[[Page 33955]]

it is a commonly used term, help the public to readily observe and 
comprehend the nutrition information presented in the Nutrition Facts 
label.
    (Comment 513) Most comments objected to replacing ``Total 
Carbohydrate'' with ``Total Carbs'' on the Nutrition Facts label. 
Several comments referred to the term ``Total Carbs'' as being 
``jargon,'' ``slang,'' ``sloppy,'' or ``denigrating.'' Other comments 
stated that ``Total Carbohydrate'' is a term that is familiar to 
consumers, is frequently used in the media, and has appeared on the 
Nutrition Facts label for more than 20 years. The comments also noted 
that ``carbohydrate'' is the correct, scientifically accurate term 
specified in the FD&C Act and NLEA and is used in the DGA, IOM reports, 
and other government or scientific documents.
    One comment questioned whether any data exist suggesting that 
consumers are either confused by the word ``carbohydrate'' or would 
understand the term ``carbs'' any better. Another comment suggested 
that research is needed to evaluate whether the proposed change would 
affect consumer use and understanding of the carbohydrate information 
presented on the label.
    Many comments said that listing the total carbohydrate content in a 
serving of food as ``Total Carbs'' rather than ``Total Carbohydrate'' 
could have a negative impact on the ability of people with diabetes to 
accurately assess their carbohydrate intake and thus their ability to 
manage their disease. The comments explained that diabetics, who 
monitor their blood glucose levels and adjust their insulin 
requirements accordingly, must be able to accurately determine the 
carbohydrate content of their foods, such as through ``carbohydrate 
counting.'' Several comments pointed out that many diabetics, 
especially those who are newly diagnosed, recognize the term ``carb 
choice'' or ``carb serving'' as referring to a serving of food that 
contains 15 grams of total carbohydrate. The comments noted that, in 
this context, the word ``carb'' has a specific meaning, and that 
declaring ``Total Carbs'' on the Nutrition Facts label could cause 
confusion and result in diabetics taking the wrong dose of insulin.
    Other comments suggested that ``carb'' or ``carbs'' frequently 
carries a negative connotation when it is linked to a ``low carb'' 
diet, the ``net carbs'' of a product, or to ``carb loading'' before an 
athletic competition. The comments expressed concerns that the term may 
be used in a context that does not support healthy dietary practices. 
One comment noted that the term ``carbs,'' if perceived negatively, 
could inadvertently challenge advice to consume 65 percent of calories 
from carbohydrates, as recommended in the 2010 DGA. Another comment 
questioned why carbohydrates should be treated differently than other 
nutrients on the Nutrition Facts label because it would be the only 
abbreviated nutrient on most label formats.
    One comment said that, because previous research suggests that 
consumers have difficulty understanding acronyms and abbreviations, the 
term ``carbs'' may not be appropriate on the label, and may present an 
additional challenge on bilingual labels. Another comment indicated 
that if the final rule uses ``Total Carbs,'' the ``Added Sugars'' 
declaration would become more prominent, leading to consumer confusion 
and distracting from an overall focus of reducing calorie consumption 
from all macronutrient sources.
    Some comments supported replacing the term ``Total Carbohydrate'' 
with ``Total Carbs'' and said that ``carbs'' is a term that is part of 
the daily vocabulary of many people and the term would ``draw their 
attention'' which could be beneficial.
    (Response) We acknowledge that ``carbohydrate'' is the correct, 
scientifically accurate term used in government or scientific documents 
and that ``carbs'' may be perceived as jargon. We further recognize the 
possibility that some diabetics may have difficulty distinguishing 
between the terms ``Total Carbs,'' ``carb choice,'' and ``carb 
serving,'' but note that the Nutrition Facts label, and any associated 
changes in format resulting from this rulemaking, applies to the 
general healthy population rather than to those with a specific 
disease. We are unaware of any data suggesting that consumers would be 
confused by the abbreviation ``Carbs'' or that this term would 
adversely affect the ability of consumers to interpret other parts of 
the Nutrition Facts label, or adversely impact dietary advice, as 
suggested by some comments. Furthermore, we already permit the 
abbreviation ``carb.'' (singular) for ``carbohydrate'' on small 
packages having space constraints, as specified in Sec.  
101.9(j)(13)(ii)(B), and we note that the term ``carbohydrate'' is 
spelled out on the Nutrition Facts label of most food products and 
therefore is readily observable for consumers who might be confused by 
the abbreviated term on small packages. However, because ``carbs'' 
(plural) may be perceived as an informal term and may have a negative 
connotation for some individuals and because a ``Total Carbs'' 
declaration may be problematic on some bilingual labels when this term 
is used instead of ``Total Carbohydrate'' generally, we will continue 
to require that ``Total Carbohydrate'' be used as the nutrient name for 
carbohydrates, as specified in Sec.  101.9(c)(6), and that ``Total 
carb.'' continue to be the abbreviation for this term (e.g., as 
applicable on small packages) as specified in Sec.  
101.9(j)(13)(ii)(B).
15. Alternative Visual Formats/Fonts
    We did not propose any changes to the basic format of the Nutrition 
Facts label, as specified in Sec.  101.9(d)(12), because we were 
unaware of any evidence that would support an alternative format. 
However, the preamble to the proposed rule did contain a mockup of an 
alternative concept for the Nutrition Facts label format (79 FR 11879 
at 11955) that categorized nutrient declarations as ``quick facts'' 
about certain nutrients, nutrients to ``avoid too much'' of, and 
nutrients to ``get enough of,'' and we invited comment on whether we 
should require a specific type style for the Nutrition Facts label.
    After reviewing the comments on the proposed rule, we tentatively 
concluded that we did not intend to further consider the alternative 
format for the Nutrition Facts label (80 FR 44302). Most comments 
agreed with our tentative conclusion, and other comments raised 
questions that we may consider if we decide to conduct further research 
on this issue in the future. A review of the results of FDA's consumer 
research, which we made available in reopening of the comment period as 
to specific documents (80 FR 44302), did not provide information to 
change our tentative conclusion, so we are not giving further 
consideration to the alternative format as part of this rulemaking.
16. Miscellaneous Comments
    a. Size and space issues. The preamble to the proposed rule did not 
invite comments on whether our proposed format changes would affect the 
ability of small packages to accommodate the Nutrition Facts label. Our 
intention was to use graphic design principles to improve the overall 
visual appearance of the Nutrition Facts label formats without altering 
the labels' dimensions. However, several comments addressed this issue, 
particularly with regards to the use of the proposed linear format on 
small and very small food packages.

[[Page 33956]]

    (Comment 514) Many comments said the proposed Nutrition Facts label 
formats appeared to be larger than the preexisting label formats and, 
therefore, would take up too much space on food packages. The comments 
said that implementing many proposed changes, such as increasing the 
prominence of ``servings per container and the ``calorie'' information 
as well as adding a line for ``Added Sugars,'' would necessarily 
increase label size. One comment suggested that we did not adequately 
consider how the proposed Nutrition Facts labels would fit on actual 
food products and asked us to ``verify'' that the proposed formats 
would not result in larger labels. Several comments said that companies 
would need to redesign their packages to accommodate the increased 
amount of space that would be necessary for labels to comply with the 
proposed format changes and to fit on packages, resulting in 
significant costs to the industry.
    Other comments indicated that, for all of the required information 
to fit within the boundaries of certain proposed formats, some labels 
would be cluttered, difficult to read, and challenging for consumers to 
use. One comment said that the label's overall visual appearance would 
be dense, complex, cluttered, and contradict FDA's intent to maintain 
the NLEA requirements. The comment said that the Nutrition Facts label 
should have a simple format, minimize clutter, and enable consumers to 
observe and comprehend the information readily.
    Several comments emphasized that a larger nutrition label would 
occupy ``valuable'' package space that could be used for other 
purposes. One comment said that a larger Nutrition Facts label might 
reduce the available package space that could be used for marketing and 
promotional messages, and this would be of particular concern to small 
firms unable to afford advertising costs. Another comment said that the 
proposed format changes might limit the amount of space on packages 
that could be used for product recipes and cooking instructions (e.g., 
information about proper cooking times and temperature settings) which 
may be necessary for ensuring food safety.
    (Response) We disagree with the comments suggesting that the 
proposed formats would be significantly larger than the current 
formats. Each label was specifically designed to occupy the same amount 
of package space as the preexisting label. While some nutrient 
information will be declared in a larger font size and style compared 
to the preexisting format, and the final rule requires the declaration 
of ``Added Sugars'' information, we are also removing the requirement 
for the ``Calories from Fat'' declaration and reducing the amount of 
space that will be necessary for the footnote. In certain cases (e.g., 
on labels of foods represented or purported to be specifically for 
infants through 12 months of age or on labels of foods that can use the 
terms ``calorie free,'' ``free of calories,'' ``no calories,'' ``zero 
calories,'' ``without calories,'' ``trivial source of calories,'' 
``negligible source of calories,'' or ``dietary insignificant source of 
calories'' on the Nutrition Facts label or in the labeling of foods as 
defined in Sec.  101.60(b)), we are removing the footnote requirement 
altogether. We also note that we are reducing the type size of the 
numerical value for calories, from 24 point to 22 point, and 14 point 
for the tabular display and linear display for smaller packages with a 
total surface area available to bear labeling of 40 square inches or 
less in Sec.  101.9(j)(13)(ii)(A)(1) and (2). Taken together, these 
format modifications will not result in a significant change in the 
size of the labels. Therefore, we decline to ``verify'' that the 
revised formats will not be larger than the current ones and disagree 
that manufacturers will need to redesign packages extensively to 
accommodate the revised Nutrition Facts labels. Also, because we are 
not requiring that absolute amounts be listed for voluntary nutrients, 
we do not anticipate that excessive crowding will be problematic on 
labels with multiple columns, such as those on breakfast cereal 
packages which list nutrition information for the product as packaged, 
as served (e.g., with milk), and for a subpopulation (e.g., children 
less than 4 years of age). Although providing nutrition information for 
these categories is voluntary, if a manufacturer chooses to use such 
multiple columns and adequate space is not available on the side panel, 
the Nutrition Facts label may be placed on the back panel of the 
package (as provided for in Sec.  101.2(a)(1)) where more space is 
likely to be available.
    With respect to the comment regarding the need for small businesses 
to have adequate space on packages for promotional and marketing 
messages, we acknowledge the importance of communicating information 
about the product. Similarly, we recognize the importance of providing 
consumers with information about food preparation, recipes, and safety 
issues relative to the product. However, as specified in Sec.  
101.9(j)(17), non-mandatory label information on the package 
information panel (as described in Sec.  101.2(a)) is not considered to 
be a factor in determining the sufficiency of available space for the 
placement of the Nutrition Facts label. Therefore, all manufacturers, 
regardless of size, who are required to display the Nutrition Facts 
label on its products must follow the regulations with regards to 
general food labeling requirements and provisions as discussed in Sec.  
101.1 through 101.5.
    (Comment 515) Several comments noted that label space, which is 
already limited, would be further constrained on bilingual labels. The 
comments suggested that bilingual labels will become increasingly 
common and that we should provide examples of bilingual labels for 
further public comment.
    (Response) The use of bilingual Nutrition Facts labels is 
voluntary. We do not agree that our format changes will prevent 
manufacturers from using a bilingual label, as many options are 
available regarding where the label is located on a package (e.g., the 
back panel). We have provided an example of a bilingual Nutrition Facts 
label in ``A Food Labeling Guide: Guidance for Industry'' (Ref. 122). 
Manufacturers who use a bilingual label can review this guidance 
document. We anticipate that future updates will be made to ``A Food 
Labeling Guide: Guidance for Industry'' to correspond to format changes 
in the final rule.
    (Comment 516) One comment said that, because the standard format 
requires both percent DV and absolute amounts of mandatory vitamins and 
minerals to be declared, there would not be enough space on some 
packages to allow the nutrients of public health concern to be listed 
side by side in two columns (as specified in Sec.  101.9(d)(8)), which 
the comment called a ``space saving feature.'' The comment provided an 
example of a label demonstrating that it is not possible to list 
micronutrients in two columns because of layout constraints caused by 
the package's configuration. The comment said that although the 
proposed Nutrition Facts label changes were intended to have a minimum 
impact on product packages, layout constraints in some cases would 
necessitate significant package redesign to comply with the revised 
format. The comment suggested that we had not adequately considered 
certain package shapes where changes in format would have 
``consequential'' effects on package design.
    (Response) We acknowledge there are layout constraints with certain 
packages, but we have given manufacturers flexibility in how they apply 
the Nutrition Facts label on

[[Page 33957]]

products having significant size and space challenges. The comment's 
example used certain text sizes and bolding that were initially 
proposed, but are not included in the final rule, so the comment's 
example, under the final rule's requirements, would take up less space. 
In response to concerns of products that have significant size and 
space constraints we are removing the requirement for the footnote 
statements in Sec.  101.9(j)(13)(ii)(C) for the tabular format for 
small packages as shown in Sec.  101.9(j)(13)(ii)(A)(1) and the linear 
format as shown in Sec.  101.9(j)(13)(ii)(A)(2), however, the 
abbreviated footnote ``% DV = % Daily Value'' may be used on these 
packages. Because we are removing the requirement in Sec.  
101.9(j)(13)(ii)(C), we are redesignating Sec.  101.9(j)(13)(ii)(D) as 
Sec.  101.9(j)(13)(ii)(C). We also are allowing ``vitamin'' to be 
abbreviated as ``vit.'' and potassium to be abbreviated as ``Potas.'' 
in Sec.  101.9(j)(13)(ii)(B) which will further conserve space. 
Although we cannot predict all the different sizes and shapes of 
packages that may enter the marketplace, we permit various formats of 
the Nutrition Facts label and allow flexibility in order to accommodate 
packages having various design features.
    (Comment 517) Many comments said that the proposed linear display 
for small packages (illustrated in Sec.  101.9(j)(13)(ii)(A)(2) (79 FR 
11879 at 11979)) would not fit on many small packages, such as those 
for candy, chewing gum, and other confectionery products, because it 
occupies substantially more space than the current linear display 
format. Some comments included detailed mockups of complete small 
product packages demonstrating that, due to their shape or size, some 
packages would not be able to accommodate the proposed Nutrition Facts 
labels without obscuring some information on the package or label, even 
if a minimum legible font size of 6 point was used on the label. Other 
comments pointed out that the preexisting linear format was 
specifically designed to be flexible because it allows nutrition 
information to be presented as a wrapped string of text that can be 
adapted to fit the specific dimensions of a small package. The comments 
suggested that the proposed ``linear'' display is not accurate because 
it has a ``table'' format rather than an arrangement that is linear, 
and it cannot be displayed as a string of wrapped text. According to 
the comments, the proposed linear display would not fit on many small 
packages for which it was intended (i.e., packages that could not 
otherwise accommodate the tabular display for small packages, as 
provided in Sec.  101.9(j)(13)(ii)(A)(1) (79 FR 11879 at 11979)). Other 
comments said that the proposed linear format would be especially 
problematic for products having small labels (e.g., packages with 13 
square inches of available labeling space) but that are not small 
enough to qualify for the complete exemption under Sec.  
101.9(j)(13)(i), which exempts nutrition labeling when the total 
surface area available to bear labeling is less than 12 square inches 
and no claims are made in labeling or advertising. The comments asked 
us to propose a revised linear format that would fit on small packages 
(i.e., <12 square inches) or retain the preexisting linear format as an 
option when neither of the proposed small label formats would fit on a 
package. Other comments suggested that we broaden the criteria that 
would allow more labels to qualify for the linear and tabular formats 
(as provided in Sec.  101.9(j)(13)(ii)(A)); for example, by increasing 
the intermediate package size from <=40 square inches to <=50 square 
inches.
    (Response) We agree that the proposed linear format for small 
packages may not be able to fit on many small packages, such as those 
of confectionery products. We also acknowledge the advantage of the 
text wrapping feature of the preexisting linear format in providing 
flexibility for labels on small packages having various shapes and 
sizes. Consequently, we are not finalizing the requirements for the 
proposed linear format. Instead, we are retaining the text wrapping 
feature of the preexisting linear format, but adapting it to maintain 
consistency with the other format changes we are finalizing, i.e., 
increasing the prominence of ``Calories'' information, removing the 
``Calories from Fat'' declaration, changing ``Sugars'' to ``Total 
Sugars,'' including an ``Added Sugars'' declaration, modifying the 
mandatory vitamins and minerals, and making the abbreviated footnote 
``% DV = % Daily Value'' optional for small packages. We also are 
providing that the actual number of servings may be listed after the 
``__ servings per container'' declaration and note that ``Servings'' is 
an acceptable abbreviation for ``__ Servings per container'' (as 
provided in Sec.  101.9(j)(13)(ii)(B)). Additionally, on our own 
initiative, we have revised the rule so that ``Incl. Xg added sugars'' 
is an acceptable abbreviation for ``includes X g of added sugars.''
    However, we are concerned that some companies may be using the 
linear format inappropriately because we have seen the linear format 
used on packages that could accommodate the tabular display for small 
packages or on larger-size packages that could accommodate the standard 
format. Manufacturers should understand that the linear format is only 
to be used for certain size packages (as described in Sec.  
101.9(j)(13)(ii)(A)), and only if the label will not accommodate a 
tabular display. The linear format is more difficult to read than other 
formats and is not permitted for larger packages. We consider the use 
of a linear display as a last resort when the tabular display for small 
packages cannot be accommodated in the available label space (e.g., 
when small packages with a total surface area available to bear 
labeling of less than 12 square inches, or 40 square inches or less and 
the package shape or size cannot accommodate a standard vertical column 
or tabular display would otherwise have to take advantage of the 
exemption allowing use of an address or telephone number in lieu of 
nutrition information). Consumers would be expected to be more likely 
to take a few extra moments to read a linear nutrition label than to 
write a letter or call the manufacturer. We do not want the linear 
format to be misused, so we intend to monitor the marketplace to ensure 
that the proper Nutrition Facts label format is used on the correct 
size package.
    We have addressed the size and space concerns expressed in the 
comments for smaller packages by decreasing the prominence of the 
calorie declaration from our original proposal, by removing the 
requirement for a footnote, and permitting the abbreviated footnote ``% 
DV = % Daily Value'' to be optional, providing acceptable abbreviations 
for terms, and also permitting the text wrapping feature. Based on 
these spacing accommodations, we decline to increase the intermediate 
package size from <=40 square inches to <=50 square inches, as the 
comment suggested, because retaining the preexisting linear format and 
other space saving requirements would preclude the necessity of doing 
so.
    (Comment 518) One comment stated that because foods in small 
packages (i.e., less than 12 square inches) must bear the Nutrition 
Facts label if the food's label makes nutrition claims (e.g., ``sugar-
free'' gums), manufacturers need a Nutrition Facts label format that 
would fit on such packages. Otherwise, manufacturers would be 
prohibited from making a claim, which the comment suggested might be an 
unintended consequence of the final rule and adversely affect consumers 
(because the claim would not be available to them). Alternatively, the

[[Page 33958]]

comment suggested that we exempt foods in very small packages from 
bearing a Nutrition Facts label, even if a nutrient content claim is 
made or if the nutritional contribution of the food is minimal. The 
comment urged us to carefully consider the impact that the increase in 
certain type sizes and the additional ``Added Sugars'' information 
would have on the ability of the Nutrition Facts label to fit on very 
small packages.
    Several comments also asked us to consider additional label formats 
that would be appropriate for products in small and very small packages 
making nutrient content claims or health claims. Some comments offered 
suggestions that would enable the Nutrition Facts label to fit on small 
and intermediate-size packages, remain legible when printed with a 6 
point font size, and still ``embrace the spirit'' of our proposed rule. 
Specifically, the comments suggested allowing a proportional reduction 
of the tabular and linear formats to accommodate certain package shapes 
or sizes; an abbreviated format that lists fewer nutrients but would 
still allow a claim to be made (such as ``sugar free'' or ``calorie 
free''); the declaration of certain information to be voluntary; and 
either a telephone number, Web site, or mailing address that consumers 
could use to obtain more complete nutrition information (similar to the 
provision in Sec.  101.9(j)(13)(i)(A)) for very small packages (i.e., 
having less than 6 square inches of available space to bear labeling).
    (Response) While we appreciate the extensive amount of time and 
effort that manufacturers devoted to designing alternative labels for 
small product packages, we disagree that such products, in general, 
should not be required to display a Nutrition Facts label if claims are 
made for the product. Depending on the particular claim and product, a 
variety of information may be required on the label (e.g., a disclosure 
statement, as described in Sec.  101.13(h)(1)) to prevent the claim 
from being misleading. The packages described in the comment appear to 
be hypothetical, as we are not aware that such packages currently exist 
in the marketplace.
    We also decline to exempt foods in small packages that have a total 
surface area available to bear labeling of less than 12 square inches 
from bearing a Nutrition Facts label if a nutrition claim is made or if 
the nutritional contribution of the food is minimal. We also are 
continuing to allow the preexisting linear format for small packages, 
as described in Sec.  101.9(j)(13)(ii)(A), which we anticipate will fit 
on most small confectionery packages. Furthermore, we will retain the 
preexisting requirement in Sec.  101.9(j)(13)(ii)(A) that stipulates 
that the linear format may only be used if the label will not 
accommodate a tabular display.
    (Comment 519) Several comments pointed out that the proposed 
leading requirements (i.e., the vertical space between lines) differ 
from the preexisting leading requirements so that the proposed labels 
will take up more space. One comment said we could increase the amount 
of white space by enlarging the leading requirements. Another comment 
said that there was a lack of detail about the leading requirements for 
the information displayed in the Nutrition Facts label format shown in 
Sec.  101.9(d)(12).
    (Response) We agree with the comment and acknowledge an error in 
Sec.  101.9(d)(1)(ii)(C) in which the leading requirements were 
increased. This has now been corrected in the final rule so that the 
original leading requirements are retained, i.e., all information 
within the nutrition label shall utilize at least one point leading 
except that at least four points leading shall be utilized for the 
information required by paragraphs (d)(7) and (d)(8) of this section as 
shown in paragraph (d)(12). We allow manufacturers some degree of 
discretion and flexibility with respect to the leading requirements, 
and the label mockups that we have provided in this final regulation 
are for the purpose of illustration rather than to provide exact 
specifications. An underlying purpose of the Nutrition Facts label is 
to help consumers make healthful food choices, and we expect 
manufacturers to provide legible labels to help consumers do this.
    b. Calorie conversion factors. In the preamble to the proposed rule 
(79 FR 11879 at 11954), we requested comments and supporting data on 
the extent that consumers use the caloric conversion information (i.e., 
``Calories per gram: Fat 9, Carbohydrate 4, Protein 4'') that may 
voluntarily be declared at the bottom of the footnote area of the 
Nutrition Facts label under Sec.  101.9(d)(10). We stated that we may 
consider deleting this optional requirement in the final rule if we 
determine the information is not useful (id.).
    (Comment 520) Some comments would prohibit the voluntary listing of 
caloric conversion information. These comments stated that it is too 
much information for consumers; its purpose in relation to the rest of 
the Nutrition Facts label is not readily apparent; it would require 
``hands-on consumer education'' to be useful or understood; and the 
information is underused. One comment said that allowing the optional 
use of this information on the label may lead to consumer confusion 
because we have proposed new caloric conversion factors for certain 
carbohydrate sub-types.
    Another comment suggested that, if we retain the optional caloric 
conversion information, there should also be a ``disclaimer'' or 
``education statement'' indicating that the calorie values listed for 
fat, carbohydrate, and protein are not exact. The comment said that a 
disclaimer or education statement would help consumers understand that, 
if the grams of fat, carbohydrate, and protein that are listed on the 
Nutrition Facts label are multiplied by their respective caloric values 
(i.e., 9, 4 and 4), the total may not necessarily be the same as the 
number of calories listed near the top of the label in the ``Calories'' 
declaration. The comment further suggested that such a discrepancy 
might cause consumer confusion. Another comment suggested the caloric 
information for fat, carbohydrate, and protein should be provided on a 
``per ounce'' basis rather than on a ``per gram'' basis. Finally, one 
comment said that retaining the caloric conversion information could 
help consumers adjust their caloric intake if their individual calorie 
needs were above or below 2,000 calories per day.
    (Response) We previously recognized that 9, 4, and 4 calories per 
gram for fat, carbohydrates, and protein, respectively, are general 
factors that are applicable to the majority of foods, and displaying 
them on the label can help consumers better understand and use the 
nutrition information on the label and to apply the DGA recommendations 
(58 FR 2079 at 2131). For example, the calorie conversion information 
might be useful to consumers who want to keep track of the number (or 
percentage) of calories they consume derived from fat and carbohydrate, 
or who are following certain dietary recommendations, such as for 
weight loss or other health reasons. Furthermore, because we are no 
longer requiring the number of calories from fat to be declared on the 
label, consumers who want this information can do their own 
calculations using the caloric conversion factors. We are unaware 
whether the caloric conversion information is underused by consumers, 
as suggested by one comment, and disagree that it comprises too much 
information, as it is displayed succinctly and is listed voluntarily. 
However, given the comments' concerns related to the need to conserve 
space on the Nutrition Facts label, we will continue to allow the 
caloric conversion factors to be listed voluntarily.

[[Page 33959]]

    We disagree with the comment stating that the proposed caloric 
conversion factors for carbohydrate sub-types might lead to consumer 
confusion if the current caloric conversion information is retained. 
The comment did not explain this assertion. Although we proposed new 
caloric conversion factors for certain carbohydrate sub-types, 
including soluble fiber (2 calories per gram) and specific sugar 
alcohols (ranging from 1.6-3.0 calories per gram), consumers would not 
be expected to be aware of this information and would have no reason to 
use it because it is intended for manufacturers to use in developing 
product labels. Therefore, we disagree that retaining the caloric 
conversion information on the Nutrition Facts label would lead to 
consumer confusion. Furthermore, although the general conversion 
factors may not apply to all foods (but relatively few products would 
be expected to include caloric values for soluble fiber and sugar 
alcohols as part of the total calorie calculations), we do not consider 
that to be a reason to prohibit their use.
    We also decline to provide a ``disclaimer'' or ``education 
statement'' on the label to indicate that the caloric conversion 
factors are approximations. The reason that multiplying the grams of 
fat, carbohydrate, and protein listed on the label by 9, 4, and 4 
calories per gram, respectively, does not exactly add up to the number 
of calories listed on the label is due mainly to rounding rules that 
apply to the Nutrition Facts label. Rather than explain this in a 
footnote, however, we intend to include information about rounding as 
part of our planned nutrition education efforts and clarify why the 
caloric values of individual macronutrients may not add up to the total 
number of calories listed on the label.
    We also do not agree that the caloric conversion factors on the 
label should be listed on a ``per ounce'' basis, rather than on a ``per 
gram'' basis, as one comment suggested. The information, if present, 
must be provided on a per gram basis (Sec.  101.9(d)(10)), which is 
consistent with the units that are used for declaring amounts of fat, 
carbohydrate, and protein on the Nutrition Facts label and therefore 
most likely to be useful for consumers. Furthermore, the comment did 
not provide data to show that ounces would be better understood or 
would be more useful to consumers than grams, and we have no evidence 
to support listing the conversion factors on a ``per ounce'' basis. We 
also note that the final rule no longer amends Sec.  101.9(d)(10); we 
had proposed revising Sec.  101.9(d)(10) as part of the proposed rule 
when we also proposed removing and reserving Sec.  101.9(d)(9). Our 
proposed amendment to Sec.  101.9(d)(10) would have removed a cross-
reference to Sec.  101.9(d)(9) and referred, instead, to a part of the 
Nutrition Facts label. In the supplemental proposed rule, however, we 
suggested text that would become a new Sec.  101.9(d)(9) (thereby 
eliminating the need to reserve that paragraph). Thus, the proposed 
amendment to Sec.  101.9(d)(10) is no longer necessary, and the final 
rule does not amend Sec.  101.9(d)(10). (We have made a similar 
revision to Sec.  101.9(d)(11) to restore a cross-reference to Sec.  
101.9(d)(9).)
    With respect to the comment that said retaining the caloric 
conversion information could help consumers adjust their caloric intake 
if their individual calorie needs were above or below 2,000 calories 
per day, we acknowledge this is a reasonable assumption because 
understanding the relative amount of calories contributed by fat, 
carbohydrate, and protein may help consumers better comprehend and use 
the Nutrition Facts label, which may assist them in maintaining healthy 
dietary practices.

R. Compliance

    Section 101.9(g) provides information about how we determine 
compliance with our nutrition labeling requirements, including the 
methods of analysis used to determine compliance, reasonable excesses 
and deficiencies of nutrients, and acceptable levels of variance from 
declared values.
1. Level of Variance Allowed for the Label Declaration of Specific 
Nutrients
    Under our preexisting regulations, at Sec.  101.9(g)(5), a food 
with a label declaration of calories, sugars, total fat, saturated fat, 
trans fat, cholesterol, or sodium shall be deemed to be misbranded 
under section 403(a) of the FD&C Act if the nutrient content of the 
composite is greater than 20 percent in excess of the value for that 
nutrient declared on the label. The provision provides that no 
regulatory action will be based on a determination of a nutrient value 
that falls above this level by a factor less than the variability 
generally recognized for the analytical method used in that food at the 
level involved.
    The proposed rule would not change the level of variance allowed in 
Sec.  101.9(g)(5).
    (Comment 521) One comment suggested that we tighten the allowable 
variance to no more than 10 percent. The comment was concerned that the 
20 percent allowable variance could result in inaccurate and misleading 
information going to consumers. The comment said that modern 
manufacturing and testing methods should allow food manufacturers to 
provide a more accurate representation of the nutrient content of 
foods.
    (Response) As we stated in the preamble to the proposed rule (79 FR 
11879 at 11955), we received a similar comment to the 2007 ANPRM asking 
us to reevaluate the level of variance permitted for nutrient content 
declarations. When initially determining the allowances for 
variability, we considered the variability in the nutrient content of 
foods, analytical variability inherent to test methods used to 
determine compliance, and statistical probability (38 FR 2125 at 2128, 
January 19, 1973). We also evaluated compliance procedures and found 
them to be statistically sound and adequate.
    The comment provided no information for us to consider, such as 
information to show that the variability in the nutrient content of 
foods or analytical variability inherent in test methods used to 
determine compliance have decreased. Therefore, because we do not have 
a basis to change the level of variance permitted for the label 
declaration of nutrients, we decline to revise the rule as suggested by 
the comment.
2. Methods Used To Determine Compliance
    Under our preexisting regulations, at Sec.  101.9(g)(2), a 
composite of 12 subsamples, each taken from 12 different randomly 
chosen shipping cases are analyzed by appropriate methods as given in 
the ``Official Methods of Analysis of the AOAC International,'' 15th 
Ed. (1990) to determine compliance with the requirements in Sec.  
101.9, unless a particular method of analysis is specified in Sec.  
101.9(c). If no AOAC method is available or appropriate, we use other 
reliable and appropriate analytical procedures (see Sec.  101.9(g)(2)).
    The proposed rule would amend Sec.  101.9(g)(2) to update the 
reference to the 19th Edition of the ``Official Methods of Analysis of 
the AOAC International.'' The preamble to the proposed rule (79 FR 
11879 at 11913) explained that the 19th edition published in 2012 and 
that if a newer edition were published before we issued a final rule, 
we intended to finalize the rule to refer to the newer edition provided 
there are no substantive changes in the newer edition requiring 
additional comment. The Official Methods of Analysis of AOAC 
International, 20th Edition was

[[Page 33960]]

published in 2016. The 20th Edition includes a number of new methods of 
analysis as well as changes to current methods. We need additional time 
to consider the additions and changes, and to determine if additional 
public comment is necessary on the 20th Edition of the AOAC Methods of 
Analysis. Therefore, the final rule, at Sec.  101.9(g)(2), incorporates 
by reference the 19th Edition of the Official Methods of Analysis of 
the AOAC International.
    (Comment 522) Some comments supported incorporating the 19th 
Edition of the AOAC Methods by reference in the final rule. Other 
comments suggested other alternatives. Some comments suggested that a 
specific edition of the AOAC Methods should not be incorporated by 
reference to allow companies to use future editions of the reference to 
meet compliance requirements. One comment stated that, given the 
potential limitations of the two AOAC methods for fiber identified in 
the proposed rule (AOAC 2009.01 and AOAC 2011.25) and the inevitable 
delays between adoption by AOAC of the most relevant, updated, and 
appropriate methods, we should incorporate all appropriate, equivalent, 
and validated methods into the final rule.
    (Response) We decline to revise the rule to adopt the alternative 
approaches suggested by the comments. We note that, under the 
incorporation by reference regulations issued by the Office of the 
Federal Register, incorporation by reference of publication is limited 
to a specific edition and ``future amendments or revisions of the 
publication are not included'' (1 CFR 51.1(f)). Thus, under Federal 
regulations, we cannot incorporate by reference a specific AOAC method 
and all future editions of that method.
    (Comment 523) Some comments questioned what we mean by ``equivalent 
AOAC method,'' and whether the terms mean that any other AOAC method is 
acceptable for determining fiber content.
    (Response) We used the terminology ``equivalent AOAC method'' to 
mean a reliable and appropriate method which can be used for measuring 
dietary fiber, soluble fiber, and insoluble fiber. For example, the 
definition of dietary fiber requires that the fiber must contain 3 or 
more monomeric units. We would consider a reliable and appropriate 
method for dietary fiber to be one that can measure fibers with 3 or 
more monomeric units.
    (Comment 524) Several comments suggested that AOAC 2009.01 and AOAC 
2011.25 do not capture all dietary fibers. Many comments recommended 
that we allow for the use of all validated AOAC methods for the 
determination of dietary fiber. (We discuss issues related to AOAC 
methods in greater detail in our response to comment 299.)
    (Response) In proposed Sec.  101.9(c)(6)(i), we stated that dietary 
fiber content may be determined by subtracting the amount of non-
digestible carbohydrates added during processing that do not meet the 
definition of dietary fiber from the value obtained using AOAC 2009.01, 
AOAC 2011.25, or an equivalent method of analysis given in the 19th 
edition of the AOAC methods. We stated, in proposed Sec.  
101.9(c)(6)(i)(A), that soluble fiber may be determined using AOAC 
2011.25 or an equivalent method of analysis as given in the 19th 
edition of the AOAC Methods and stated, in proposed Sec.  
101.9(c)(6)(i)(B), that insoluble fiber may be determined using AOAC 
2011.25 or an equivalent method of analysis given in the 19th edition 
of the AOAC Methods. Although we intended that the terms ``other 
equivalent methods'' refer to other AOAC methods and their AACCI 
counterparts, to provide clarification, the final rule omits the 
incorporation by reference of the specific AOAC methods in Sec.  
101.9(c)(6)(i), (c)(6)(i)(A), and (c)(6)(i)(B). Any dietary fiber 
declared on the label would have to meet the new definition of dietary 
fiber and manufacturers can measure the amount of dietary fibers in 
their product accurately by using a method that can measure lower 
molecular weight nondigestible oligosaccharides with DP 3-9. We would 
determine compliance by using appropriate methods, as given in the 
``Official Methods of Analysis of the AOAC International,'' 19th Ed. 
(2012). We consider AOAC 2009.01 and AOAC 2011.25 to be reliable and 
appropriate methods to measure the amount of dietary fiber in a serving 
of a product. We consider AOAC 2011.25, as given in the ``Official 
Methods of Analysis of the AOAC International,'' 19th Ed. (2012), to be 
a reliable and appropriate method to measure the amount of soluble and 
insoluble fiber in a serving of a product, if separately declared. 
There may be other methods which manufacturers may use to measure 
certain fibers which can provide an accurate and consistent result. We 
will consider the method to use for purposes of determining compliance 
consistent with Sec.  101.9(g).
3. Records Requirements
    Our preexisting regulations, at Sec.  101.9(g)(2), set forth 
requirements for composite sampling and analysis to determine 
compliance with labeling declarations. Specifically, unless a specific 
analytical method is identified by regulation, composites are analyzed 
by the appropriate AOAC method or, if no AOAC method is available or 
appropriate, by other reliable and appropriate analytical procedures.
    In the preamble to the proposed rule (79 FR 11879 at 11956), we 
noted that, for certain nutrients subject to the proposed rule, there 
is no AOAC official method of analysis or other reliable or appropriate 
analytical procedure that is available for us to verify the amount of 
the declared nutrient on the Nutrition Facts label and ensure that the 
declared nutrient amount is truthful, accurate and complies with all 
applicable labeling requirements. The preamble to the proposed rule (79 
FR 11879 at 11956) stated that there is no suitable analytical 
procedure available to measure the quantity of: (1) Added sugars (when 
a food product contains both naturally occurring sugars and added 
sugars and for specific foods containing added sugars, alone or in 
combination with naturally occurring sugars, where the added sugars are 
subject to non-enzymatic browning and/or fermentation); (2) dietary 
fiber (when a food product contains both non-digestible carbohydrate(s) 
that meets the proposed definition of dietary fiber and non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber); 
(3) soluble fiber (when a mixture of soluble fiber and added 
nondigestible carbohydrate(s) that does not meet the definition of 
dietary fiber are present in a food); (4) insoluble fiber (when a 
mixture of insoluble fiber and non-digestible carbohydrate(s) that does 
not meet the definition of dietary fiber are present in a food); (5) 
vitamin E (when a food product contains both RRR- [alpha]-tocopherol 
and all rac-[alpha]-tocopherol acetate); and (6) folate (when a food 
product contains both folate and folic acid).
    Under our preexisting regulations, at Sec.  101.9(g)(9), we may 
permit the use of an alternative means of compliance or additional 
exemptions when it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of Sec.  101.9. Under Sec.  101.9(g)(9), firms must submit 
a written request to us for the use of an alternative means of 
compliance or for a labeling exemption.
    The proposed rule would establish an alternative approach for 
assessing compliance of the declared amount of certain nutrients when 
there is no suitable analytical method available to measure the 
nutrient's quantity as

[[Page 33961]]

declared on the label or in labeling. Specifically, the proposed rule, 
at proposed Sec.  101.9(g)(10) and (g)(11), would require the 
manufacturer to make and keep records that are necessary to verify the 
declaration of: (1) The amount of added sugars when both naturally 
occurring and added sugars are present in a food (in Sec.  
101.9(c)(6)(iii)); (2) the amount of added non-digestible 
carbohydrate(s) that does not meet the proposed definition of dietary 
fiber when the dietary fiber present in a food is a mixture of non-
digestible carbohydrates that do and that do not meet the definition of 
dietary fiber (in Sec.  101.9(c)(6)(i)); (3) the amount of added 
soluble non-digestible carbohydrate(s) that does not meet the proposed 
definition of dietary fiber when the soluble dietary fiber present in a 
food is a mixture of soluble non-digestible carbohydrates that do and 
that do not meet the definition of dietary fiber (in Sec.  
101.9(c)(6)(i)(A)); (4) the amount of added insoluble non-digestible 
carbohydrate(s) that does not meet the proposed definition of dietary 
fiber when the insoluble dietary fiber present in a food is a mixture 
of insoluble non-digestible carbohydrates that do and that do not meet 
the definition of dietary fiber (in Sec.  101.9(c)(6)(i)(B)); (5) the 
amount of all rac-[alpha]-tocopherol acetate added to the food and RRR-
[alpha]-tocopherol in the finished food when a mixture of both forms of 
vitamin E are present in a food (in Sec.  101.9(g)(10)(i)); and (6) and 
the amount of folic acid added to the food and the amount of folate in 
the finished food when a mixture of both forms are present in a food 
(in Sec.  101.9(g)(10)(ii)). In the preamble to the proposed rule (79 
FR 11879 at 11956), we explained that the manufacturer is in the best 
position to know which of its records provide the documentation 
required under the circumstances described for us to determine 
compliance. These records could include one or more of the following: 
Analyses of databases, recipes or formulations, or batch records. We 
stated that most manufacturers should already have the type of records 
needed to validate the declared amount of these nutrients and that the 
proposed records requirements provide flexibility in what records the 
manufacturer makes available to us to verify the declared amount of 
these nutrients for a particular marketed product (id.).
    The proposed rule, at proposed Sec.  101.9(g)(11), also would 
require that records be kept for a period of 2 years after introduction 
or delivery for introduction of the food into interstate commerce and 
that such records be provided to us upon request during an inspection 
for official review and copying or other means of reproduction. The 
proposed rule also stated that records could be kept either as original 
records, true copies (such as photocopies, pictures, scanned copies, 
microfilm, microfiche, or other accurate reproductions of the original 
records), or electronic records in accordance with 21 CFR part 11.
    (Comment 525) Many comments agreed with the proposed recordkeeping 
requirements. However, other comments objected to the proposed 
recordkeeping requirements. Some comments said that our compliance 
program for nutrition labeling should be based on the validation of 
nutrient declarations through analytical methods and not through 
recordkeeping. Other comments said that compliance should be based on 
objective, analytical measures to yield consistent labeling practices 
across the food industry. Others comments said that the proposed 
recordkeeping requirements could invite unethical manufacturers to 
provide inaccurate information about the quantity of nutrients in a 
serving of their product.
    (Response) As discussed in the preamble to the proposed rule (79 FR 
11879 at 11956), for certain nutrients, there are no official methods 
of analysis or other reliable or appropriate analytical procedures that 
are available to verify the amount of the declared nutrient on the 
Nutrition Facts label. In the absence of such methods, there needs to 
be some means for determining compliance, and so we proposed 
recordkeeping as an alternative approach for assessing compliance of 
the declared amount of certain nutrients. While the amount of most 
other nutrients in Nutrition Facts can be verified analytically, for 
those nutrients whose amounts cannot be determined analytically, 
recordkeeping enables FDA to determine compliance with Sec.  101.9(g). 
Regarding the potential for encouraging manufacturers to provide 
inaccurate information to FDA, we note that all nutrient declarations 
must be truthful and not misleading under sections 403(a)(1) and 201(n) 
of the FD&C Act. Thus, whether determined analytically or through 
calculations documented in appropriate records, manufacturers are 
obligated to provide nutrient information that is not false or 
misleading.
    (Comment 526) Several comments said that it would be very difficult 
to obtain and retain the information required by FDA. Some comments 
noted that the number of product formulations can be greater than 
20,000 for certain manufacturers and that they would need to create 
systems and dedicate additional resources to create and maintain 
appropriate records on a large scale. Other comments said that 
manufacturers typically get ingredients from suppliers in an extensive 
supply chain and that many ingredients also contain multiple 
ingredients themselves. Suppliers may not have the information 
themselves, or the information for the formulations could be 
proprietary. Additionally, nutrient information could be provided in 
ranges, and manufacturers would be unable to determine or verify the 
specific amounts of certain nutrients analytically.
    (Response) Although some manufacturers could have a large number of 
foods that contain nutrients that would necessitate recordkeeping to 
verify amounts, we do not agree that determining the nutrient 
composition of a food and recording that information would present 
undue difficulty for manufacturers. On the contrary, knowledge of what 
ingredients and nutrients are in a food and providing that information 
truthfully to consumers is a basic requirement for food producers. 
Manufacturers, even those who produce large amounts of food products, 
have experience with determining nutrient content of the food they 
produce, and the maintenance of records of nutrient content, either 
written or electronic. Regarding obtaining information from ingredient 
suppliers, manufacturers are well suited to work with suppliers to 
ensure that proper information is communicated throughout the supply 
chain. Ingredient suppliers are obliged to have knowledge of the 
contents of ingredients they provide to food manufacturers and this 
information will need to be properly communicated. Manufacturers may be 
able to choose suppliers that provide appropriate information as to the 
contents of their ingredients or be able to ask their ingredient 
suppliers for nutrient information.
    (Comment 527) Some comments suggested that the required approach 
should be flexible and not mandate a specific type of record. The 
comments indicated that manufacturers should be able to substantiate 
using the records they believe best accomplish the validity of nutrient 
information. The comments stated that we did not need access to 
manufacturing records and that other methods, such as database 
information or an explanation from a manufacturer, would suffice.
    (Response) Manufacturers will be responsible for the type of 
records they maintain and are not required to

[[Page 33962]]

produce any specific form or document for verification purposes. 
Records used to verify nutrient content could include various types of 
batch records providing data on the weight of certain nutrient 
contributions to the total batch, records of test results conducted by 
the manufacturer or an ingredient supplier, certificates of analysis 
from suppliers subject to initial and periodic qualification of the 
supplier by the manufacturer, or other appropriate verification 
documentation that provide the needed assurance that a manufacturer has 
adequately ensured the food or ingredients comply with labeling 
requirements. The records submitted for inspection by FDA would only 
need to provide information on the nutrient(s) in question. Information 
about other nutrients can be redacted if necessary to ensure 
confidentiality of a food product formulation.
    (Comment 528) Several comments addressed our legal authority to 
require recordkeeping as described in the proposed rule.
    (Response) We address these comments in part II.C.4.
    (Comment 529) Some comments expressed concern that proprietary 
information in recipes and formulations could be divulged and said that 
the ability to retain and claim the proprietary nature of product 
formulations is essential to staying competitive in the marketplace. 
Other comments suggested that we clarify that the recordkeeping 
requirements will not require access to proprietary information, such 
as recipes and formulations. In addition, the comments recommended that 
we specify what level of information and types of documents are 
required to meet the recordkeeping requirements. Several comments 
requested that manufacturers be permitted to develop a stand-alone 
document that articulates the basis for the declaration of added sugars 
in a product. Other comments recommended that, if we finalize the 
recordkeeping requirements and require the copying of records, we 
address the security of the information coming from inspections and the 
protection of confidential information.
    (Response) The final rule does not require a specific document to 
be retained nor does it require information on proprietary recipes or 
overall formulations. Instead, the recordkeeping requirements seek 
specific content information for certain nutrients, and this 
information can be provided in various forms. For example, information 
in some batch records could include data on the total batch weight of 
the production of a particular food and also provide data on the weight 
of certain nutrient contributions to the total batch. With these types 
of data, calculations can be made to determine nutrient content for 
individual foods or servings of a food. Documentation of this type 
would not reveal any proprietary recipes or formulations and would be 
limited to specific nutrient information. Information about the 
nutrient content of the ingredients of a food product could be acquired 
from ingredient suppliers subject to initial qualification and periodic 
requalification by the manufacturer, and this type of information on 
quantitative source amounts can be included in the batch records.
    Furthermore, even if a manufacturer's records contained 
confidential commercial information or trade secret information or a 
manufacturer believes that certain information should be protected from 
public disclosure, we note that there are safeguards to protect against 
public disclosure of that information and mechanisms that a 
manufacturer can use to assert that certain information should be 
protected from disclosure. As we stated in the preamble to the proposed 
rule (79 FR 11879 at 11957), we would protect confidential information 
from disclosure, consistent with applicable statutes and regulations, 
including 5 U.S.C. 552(b)(4), 18 U.S.C. 1905, and part 20 (21 CFR part 
20). For example, our regulations pertaining to disclosure of public 
information, at part 20, include provisions that protect trade secrets 
and commercial or financial information which is privileged or 
confidential. If a manufacturer keeps proprietary recipe information in 
its records, it should mark the information as such before providing 
the records to us upon request.
    (Comment 530) One comment expressed concerns that allowing for 
recordkeeping as a way to verify the amount of nutrients such as added 
sugar in some products would encourage those manufacturers to provide 
false reporting of the added sugar content of their products.
    (Response) We note that having a false declaration on the label is 
a violation of section 403(a)(1) of the FD&C Act. Providing false 
information in records to the Agency may also be a potential criminal 
violation under 18 U.S.C. 1001. Under 18 U.S.C. 1001, whoever, in any 
matter within the jurisdiction of the executive, legislative, or 
judicial branch of the Government of the United States, knowingly and 
willfully: (1) Falsifies, conceals, or covers up by any trick, scheme, 
or device a material fact; (2) makes any materially false, fictitious, 
or fraudulent statement or representation; or (3) makes or uses any 
false writing or document knowing the same to contain any materially 
false, fictitious, or fraudulent statement or entry may be subject to a 
fine or imprisonment.
    (Comment 531) Some comments disagreed with the proposed requirement 
to keep records for at least 2 years after a food's introduction into 
interstate commerce. The comments said manufacturers would have to keep 
track of an additional data point (the date on which the food is 
actually shipped) as opposed to the date on which it is manufactured. 
The comments said that shipping dates can vary, even for foods from the 
same batches, and could occur months after manufacture, and this could 
result in extremely divergent record maintenance timeframes for foods.
    Furthermore, some comments said that is unclear whether the term 
``food'' is intended to refer to a particular batch of food or to an 
individual food.
    Other comments suggested that 2 years is a long time for foods with 
very short shelf lives. Some comments noted that the Seafood Hazard 
Analysis and Critical Control Points (HACCP) regulations allow for a 1-
year record retention period for refrigerated products and a 2 year 
period for frozen, preserved, or shelf-stable products. The comments 
suggested that, similarly, the 2 year requirement for recordkeeping 
related to nutrition labeling should be limited to frozen, preserved, 
or shelf-stable products and that a shorter period of 1 year should be 
allowed for maintenance of records for refrigerated and perishable 
foods.
    (Response) We recognize that there can be a wide variation of 
manufacturing practices, shipping practices, and shelf lives among 
packaged foods. We believe, however, that it is more practical to 
establish a single recordkeeping period rather than establish different 
recordkeeping periods for different products or for different 
manufacturing or shipping practices. It would be more difficult for FDA 
to establish a compliance program for one segment of the regulated 
industry that starts the recordkeeping process when the food is made 
and a different compliance program for another segment of the industry 
that starts the recordkeeping process when the food is shipped. 
Likewise, for manufacturers who make several food products, it may be 
easier for them to use the same recordkeeping period for all products 
rather than use different recordkeeping periods for different products. 
Therefore, we have designed a

[[Page 33963]]

compliance program or strategy that involves a single recordkeeping 
period.
    As for the comment asking whether ``food'' referred to a particular 
batch or to an individual food, the term food refers to an individual 
food item, but there are not specific requirements on what type of 
documentation is required. If the same documentation addresses the 
declarations on an entire batch of food or an even greater quantity of 
food, those records may be sufficient.
    (Comment 532) Some comments suggested that manufacturers should be 
allowed to keep records at locations separate from factories (e.g., 
corporate headquarters) and that we allow a reasonable timeframe (e.g., 
72 hours or 15 days) to obtain the records and make them available.
    (Response) Records must be made available to us for examination or 
copying during an inspection upon request; this is consistent with our 
other recordkeeping regulations (see, e.g., 21 CFR 111.605 and 
111.610). The records would need to be reasonably accessible (access to 
records within 24 hours can be considered reasonable) to FDA during an 
inspection at each manufacturing facility (even if not stored onsite) 
to determine whether the food has been manufactured and labeled in 
compliance with labeling requirements. Records that can be immediately 
retrieved from another location by electronic means are considered 
reasonably accessible.
    (Comment 533) Some comments said that the recordkeeping 
requirements could present a barrier to trade. They stated that access 
to records of manufacturers of imported foods may not be possible 
unless reciprocal agreements are in place and that such agreements 
could pose a challenge to trade with certain countries.
    (Response) We disagree with the comments. As in the case of 
domestic manufacturers, foreign manufacturers of food produced for sale 
in the United States must follow all applicable laws and regulations 
related to nutrition labeling. The final rule establishes the same 
recordkeeping requirements for foreign and domestic firms. To the 
extent records are not available during a foreign facility inspection 
for imported products, that would certainly inform a determination 
about the admissibility of the food.
    (Comment 534) Several comments addressed recordkeeping as it 
pertained to added sugars. The comments said the proposed recordkeeping 
requirements were overreaching, especially when, according to the 
comments, we acknowledged that added sugars do not pose a safety issue 
and are not uniquely or directly related to a risk of chronic disease, 
a health-related condition, or a physiological endpoint. Some comments 
noted that previous FDA recordkeeping requirements involved 
pharmaceutical safety or potentially adulterated foods that pose safety 
hazards. Some comments stated that we have never required recordkeeping 
to support a mandatory disclosure on the Nutrition Facts label that 
does not involve risk of disease. A few comments explained that 
obtaining added sugar information, in particular, from ingredient 
suppliers is difficult because ingredients do not distinguish between 
naturally occurring and added sugars and manufacturers are unable to 
distinguish them analytically.
    (Response) We recognize that it may be difficult to determine the 
quantity of added sugars and intrinsically occurring sugars in a 
particular ingredient or food, and we stated this several times in the 
preamble to the proposed rule (see 79 FR 11879 at 11905, 11906, and 
11956). The recordkeeping requirement, in the absence of an analytical 
method that would distinguish between added and intrinsically occurring 
sugars in a food, is an alternative means of verifying compliance; 
contrary to the comments' statements regarding added sugars and safety 
hazards or chronic disease, the recordkeeping requirement was not based 
on or otherwise dependent on an independent relationship between added 
sugars and chronic disease. Instead, as we stated in the preamble to 
the proposed rule (79 FR 11879 at 11956), the information contained in 
manufacturers' records is an accurate and practical method for assuring 
that the nutrient declarations comply with section 403(q) of the FD&C 
Act.
    (Comment 535) Some comments suggested that we extend the 
requirement in proposed Sec.  101.9(g)(10)(v) to all foods declaring 
added sugar to allow food manufacturers to keep records to demonstrate 
the amount of added sugars remaining in the finished food when that 
amount is less than the initial amount of added sugars.
    (Response) We decline to revise the rule as suggested by the 
comment. Section 101.9(g)(10)(v) states that when the amount of added 
sugars is reduced through non-enzymatic browning and/or fermentation, 
the manufacturer must make and keep certain data, information, and 
records to document the differences in added sugar content between the 
unfinished and finished products. Not all foods undergo non-enzymatic 
browning and/or fermentation, so extending Sec.  101.9(g)(10)(v) to all 
foods is unnecessary.
    (Comment 536) One comment noted that we have described the new 
recordkeeping requirement for certain nutrients as analogous. The 
comment said that the recordkeeping for added sugars is different than 
those for other nutrients, such as fiber, folate, or vitamin E in that 
the recordkeeping requirement for added sugars is unavoidable due to 
the mandatory nature of the added sugars declaration.
    (Response) The new recordkeeping requirements are analogous based 
on the fact that inspection of records is the only method to evaluate 
compliance with the nutrition labeling regulations for a certain number 
of nutrients. For certain nutrients there are no AOAC official methods 
of analysis or other reliable or appropriate analytical procedures that 
are available for us to verify the amount of the declared nutrient on 
the Nutrition Facts label and ensure that the declared nutrient amounts 
are truthful, accurate and complies with all applicable labeling 
requirements. However, we agree that there are difference as to which 
manufacturers will need to keep records for nutrient content and which 
products will necessitate recordkeeping. Some manufacturers who 
voluntarily declare vitamin E content, for example, will have to keep 
records for vitamin E content but manufacturers who do not declare 
vitamin E will not need to maintain any records for vitamin E content. 
Conversely, most manufacturers will need to maintain records on added 
sugar content. As discussed in part II.H.3, however, we have concluded 
that the declaration of added sugars is necessary to assist consumers 
in maintaining healthy dietary practices. Thus, the added sugars 
declaration is required and, as is the case for any nutrient that does 
not have any analytical method available to assess compliance, the 
records described here will have to be maintained and made available 
for inspection.
    (Comment 537) One comment stated that we have said that requiring 
recordkeeping could spur reformulation, but also stated that we have 
not provided any evidence of this.
    (Response) We do not cite potential reformulation of food products 
as a reason for or a benefit resulting from recordkeeping requirements. 
The recordkeeping requirements are only being created to establish an 
alternative approach for assessing compliance of the declared amount of 
certain nutrients when there is no suitable analytical method available 
to measure the

[[Page 33964]]

nutrient's quantity as declared on the label or in labeling.
4. Inclusion of Potassium as a Mineral
    Potassium is specified as a Class I and Class II nutrient in our 
preexisting regulations at Sec.  101.9(g)(4)(i) and (g)(4)(ii), 
respectively and is the only vitamin or mineral that is specifically 
listed under the description of both Class I and Class II nutrients. 
Because the proposed rule (at Sec.  101.9(c)(8)(iv)) would establish an 
RDI for potassium and require declaration of the absolute amount along 
with a percent DV on the Nutrition Facts label, we also proposed to not 
list potassium separately under the description of Class I and Class II 
nutrients and to remove the term ``potassium'' from Sec.  101.9(g)(4), 
(g)(4)(i), (g)(4)(ii), and (g)(6). Instead, potassium would be covered 
under the term ``mineral'' that appears in each section, and any 
listing of potassium on the Nutrition Facts label would have to meet 
the specific compliance requirements for minerals under Sec.  
101.9(g)(4), (g)(4)(i), (g)(4)(ii), and (g)(6).
    We did not receive any comments regarding potassium and Sec.  
101.9(g)(4) or (g)(6). Therefore, we have finalized those provisions 
without change.
5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber, 
Added Sugars, and Sugar Alcohols
    Our preexisting labeling requirements for Class I and Class II 
nutrients are at Sec.  101.9(g)(4). Because the proposed rule would 
revise Sec.  101.9(c)(6)(iv) to remove the provision for voluntary 
declaration of ``Other carbohydrate,'' we proposed to remove the 
compliance requirements related to ``Other carbohydrate'' in Sec.  
101.9(g)(4) and (g)(6).
    We also proposed, when all of dietary fiber in a food product meets 
the proposed definition of dietary fiber, to include soluble and 
insoluble fiber as both Class I and Class II nutrients under Sec.  
101.9(g)(4); include added sugars within Sec.  101.9(g)(5) such that 
the label declaration of added sugars will be deemed misbranded under 
section 403(a) of the FD&C Act if the nutrient composite is greater 
than 20 percent in excess of the added sugars value declared on the 
label, and within Sec.  101.9(g)(6) such that reasonable deficiencies 
of added sugars would be permitted; and include soluble and insoluble 
fiber and sugar alcohols within Sec.  101.9(g)(6) such that reasonable 
excesses of these nutrients would be permitted.
    We did not receive comments with respect to the removal of other 
carbohydrate from Sec.  101.9(g)(4) and (6) or on the addition of 
soluble and insoluble fiber to Sec.  101.(g)(4) and (6), and so we have 
finalized those provisions without change. We address comments on the 
compliance requirements for added sugars in part II.H.3; however, we 
are finalizing the addition of added sugars to the compliance 
requirements of Sec.  101.9(g)(5) and (g)(6) as proposed.
6. Miscellaneous Comments
    Although we did not receive any comments on our proposed revisions 
to the compliance requirements in Sec.  101.9(g)(4), (g)(5), and 
(g)(6), we did receive a number of comments related to Class I and 
Class II nutrients.
    (Comment 538) We proposed to amend Sec.  101.9(g)(4)(i) to say 
that, when a vitamin, mineral, protein, or non-digestible 
carbohydrate(s) (when the food contains only non-digestible 
carbohydrates (soluble or insoluble) that meet the definition of 
dietary fiber) meets the definition of a Class I nutrient, the nutrient 
content of the composite must be formulated to be at least equal to the 
value for that nutrient declared on the label. Currently, our 
preexisting regulations, at Sec.  101.36(f)(1), state that compliance 
for dietary supplements will be determined in accordance with Sec.  
101.9(g)(1) through (g)(8) and that the criteria on Class I and Class 
II nutrients given in Sec.  101.9(g)(3) and (g)(4) also are applicable 
to other dietary ingredients.
    Two comments would revise the requirements for Class I nutrients in 
Sec.  101.9(g)(4)(i) and Sec.  101.36(f)(1) such that added nutrients 
in fortified or fabricated foods must contain at least 90 percent of 
the declared amount rather than the current requirement of 100 percent 
of the declared amount. The comments recommended that we allow for 
fortified and fabricated foods to contain less than the declared amount 
of a Class I nutrients because degradation of dietary ingredients is 
anticipated and can occur during the shelf life of the product. The 
comments said that degradation can occur faster in some nutrients than 
others with certain matrices. The comments expressed concern that firms 
may include large excesses (greater than 120 percent of the declared 
amount) to remain in compliance with requirements for Class I nutrients 
and other dietary ingredients over the shelf life of the product. One 
comment stated that a lower limit of 90 percent potency as in the U.S. 
Pharmacopeia (USP) should be permitted because DSHEA made it clear that 
Congress' intent was that the compendial standards should be the 
guiding influence where compendial standards exist and products are 
represented as complying with those standards (21 U.S.C. 343(s)(2)(D)).
    One comment also would revise Sec.  101.36(f)(1) to state that the 
food is also in compliance if it conforms to the specifications of an 
official compendium. The comment suggested that reasonable excesses of 
dietary ingredients over labeled amounts would still be acceptable 
within current good manufacturing practices.
    Another comment noted that jurisdictions outside of the United 
States, such as Denmark, Korea, and the United Kingdom, recognize a 
minimum value of 80 to 90 percent of the declared amount for added 
vitamins and minerals at the end of shelf life. The comment suggested 
that allowing for a minimum of 90 percent of the declared amount of an 
added vitamin or mineral in the Class I requirements would promote 
harmonization with other jurisdictions.
    One comment suggested that allowing for a minor loss of strength 
during the product shelf life for Class I nutrients and other dietary 
ingredients would be similar to what is allowed in drug monographs.
    (Response) We acknowledge the comments' arguments for revising our 
compliance requirements for Class I nutrients, but decline to revise 
the rule to allow for less than 100 percent of the amount declared on 
the label. We note that the USP compendial standards for label claims 
deviations vary from nutrient to nutrient and even vary with different 
dietary supplement formulations (e.g., high potency products). This is 
a complex issue that warrants further consideration. We need to further 
consider and review the available information and to make a 
determination whether to propose changes with respect the requirements 
for Class I nutrients and/or other requirements that may be affected.
    (Comment 539) One comment referred to a statement made in the 
preamble to the proposed rule (79 FR 11879 at 11958) that we expect 
that, when a food product contains added sugars, added dietary fiber, 
vitamin E as all rac-[alpha]-tocopherol acetate, and added folic acid, 
the declared amount must be at least equal to the amount of the 
nutrient added to the food. The comment noted that there are instances 
when the declared amount of vitamin E, fiber, or folic acid could be 
less than the amount added to the recipe as a result of process losses 
or losses over shelf life. The comment said it is incorrect to assume 
that the declared amount would be equal to at least the amount added to 
the recipe.

[[Page 33965]]

    (Response) We agree that there could be process losses or losses 
over shelf life for some nutrients added to a product. Product loss 
over the shelf-life of a product is a complex issue that warrants 
further review. We need additional time to review the available 
information and to make a determination whether to propose changes with 
respect the requirements for Class I nutrients and/or other 
requirements that may be affected.
    (Comment 540) The proposed rule, at Sec.  101.9(g)(3)(ii), would 
state that when a nutrient or nutrients are not naturally occurring in 
an ingredient added to a food, the total amount of such nutrient in the 
final food product is subject to Class I requirements. One comment 
supported the rule, but two comments asked us to clarify that this 
provision is referring to ingredients, such as vitamin premixes, that 
contribute to, but do not account for, the total declared amount of the 
nutrient. The comments expressed concern that the rule could be 
construed to apply to the use of ingredients such as enriched flour or 
vitamin A fortified milk which may not contribute substantially to the 
nutrient composition of foods. An example might be a mixed dish 
containing carrots and a small amount of milk with added vitamin A. 
Because the naturally occurring vitamin A in the carrots would be the 
primary source of vitamin A in the product rather than the added 
vitamin A in the milk, the comment would have us consider vitamin A to 
be a Class II nutrient.
    (Response) We decline to revise the rule to refer to ingredients 
that contribute to, but do not account for, the total declared amount 
of the nutrient. There are cases when fortified ingredients contribute 
significantly to the amount of a nutrient when the same nutrient also 
occurs naturally in the food. For example, enriched flour containing 
thiamin could be added to bread containing oats where oats are also a 
source of thiamin. Our intent in proposing to amend Sec.  
101.9(g)(3)(ii) was to clarify, rather than alter, the requirement for 
manufacturers so that, even if a small amount of a nutrient is added to 
a food, where the final food product also contains an ingredient with 
the same nutrient in a naturally occurring form, the final food product 
is subject to the Class I requirements. Thus, contrary to the comments' 
interpretation, we would not consider the vitamin A to be a Class II 
nutrient in the example provided by the comment.
    We note that manufacturers can choose to use ingredients that are 
not fortified when formulating their products. In the example provided 
in the comment, the manufacturer could use milk that is not fortified 
with vitamin A in formulating the product. In such case, the vitamin A 
in the finished food would be from a naturally occurring source, and 
the food would have to meet the requirements for Class II nutrients 
rather than Class I nutrients.

S. Technical Amendments

    The proposed rule also would make certain technical amendments, 
such as changing the name of the program office to reflect its current 
name and making non-substantive edits for purposes of plain language.
1. Changing the Name of the Program Office
    The proposed rule would update the name of the program office that 
is responsible for developing regulations and answering questions 
related to nutrition labeling as well as for maintaining some 
references discussed throughout Sec.  101.9. The program office's 
former name was the Office of Nutritional Products, Labeling and 
Dietary Supplements; at the time we issued the proposed rule, the 
program office's name was the Office of Nutrition, Labeling and Dietary 
Supplements. We proposed to update the name throughout Sec.  101.9.
    We did not receive any comments regarding the change in the program 
office's name. However, since we issued the proposed rule, the program 
office's name changed again, to be the Office of Nutrition and Food 
Labeling, and so we have revised Sec.  101.9 accordingly.
2. Changing the Publication Date of Report Incorporated by Reference
    Our preexisting regulations, at Sec.  101.9(c)(7)(ii), provide that 
the protein digestibility-corrected amino acid score must be determined 
by methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein 
Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on 
Protein Quality Evaluation,'' Rome, 1990, except that when official 
AOAC procedures described in Sec.  101.9(c)(7) require a specific food 
factor other than 6.25 to be used. We incorporated the ``Report of the 
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation'' by 
reference in Sec.  101.9(c)(7)(ii), but Sec.  101.9(c)(7)(ii) 
incorrectly uses 1990 as the publication date when the report actually 
was published in 1991. Thus, the proposed rule would change the 
publication date of the report that is incorporated by reference from 
1990 to 1991.
    We received no comments regarding this change and have revised 
Sec.  101.9(c)(7)(ii) by replacing ``1990'' with ``1991.'' However, 
with respect to this and other references that we incorporated by 
reference in the final rule, we have revised the incorporation-by-
reference language in the final rule to meet the current requirements 
at 5 CFR part 51. Consequently, much of the incorporation by reference 
language can be found at a new Sec.  101.9(l).
3. Plain Language Edits
    On October 13, 2010, the President signed the Plain Writing Act of 
2010 requiring that Federal Agencies use ``clear Government 
communication that the public can understand and use.'' On January 18, 
2011, the President issued Executive Order (E.O.) 13563, ``Improving 
Regulation and Regulatory Review'' (75 FR 3821 (January 21, 2011)); 
section 1 of E.O. 13563 sets forth ``General principles of 
regulation,'' and these principles include ensuring that regulations 
are ``accessible, consistent, written in plain language, and easy to 
understand.'' To make the requirements of Sec.  101.9 easier to 
understand, we proposed editorial changes that would not change the 
meaning or intent of the language in Sec.  101.9(g)(3)(ii); (g)(4)(i); 
(g)(4)(ii); (g)(5); and (g)(8). Specifically, the proposed rule would:
     Revise Sec.  101.9(g)(3)(ii) to clarify that when a 
nutrient or nutrients are not naturally occurring (exogenous) in an 
ingredient that is added to a food, the total amount of such 
nutrient(s) in the final food product is subject to Class I 
requirements rather than Class II requirements. We proposed this change 
because the existing rule did not explicitly state that such a nutrient 
would be subject to Class I requirements.
     Remove ``Class I'' and ``Class II'' from Sec.  
101.9(g)(4)(i) and (g)(4)(ii), and to state instead that when the list 
of nutrients provided in those sections meets the definition of a Class 
I or Class II nutrient provided for in Sec.  101.9(g)(3)(i) and 
(g)(3)(ii), the declaration of those nutrients must meet certain 
requirements. We explained that this change was intended to prevent 
confusion by having two different definitions of a ``Class I'' and 
``Class II'' nutrient for compliance with nutrition labeling 
requirements.
     Remove the words ``Provided, That'' from Sec. Sec.  
101.9(g)(4)(ii) and (g)(5) because the words do not provide further 
clarification and are unnecessary.
     Add the word ``Alternatively'' at the beginning of Sec.  
101.9(g)(8) to indicate that use of an FDA approved database

[[Page 33966]]

is an alternative to the type of nutrient analysis described in Sec.  
101.9(g)(1) and (g)(2).
    (Comment 541) One comment stated that the proposed rule does not 
meet the requirements of the Plain Writing Act of 2010 (Pub. L. 111-
274) and said it should be rewritten at a much lower literacy level.
    (Response) Although we strive to use plain language and to draft 
our regulations in a manner such that they are easy to understand, we 
disagree with the comment. The comment did not provide any specific 
examples or suggestions on how we should rewrite the rule, so we do not 
have an adequate basis to determine which parts of the rule, in the 
comment's view, should be rewritten or how they should be revised.
    We also note that, while we have made every effort to write the 
rule in plain language and in easily understood terms, the rule imposes 
requirements on firms who have Nutrition Facts or Supplement Facts 
labels on their products rather than on laymen. The intended 
``audience'' for the rule is an important consideration when it comes 
to plain language. As the Federal Plain Language Guidelines state:

    One of the most popular plain language myths is that you have to 
``dumb down'' your content so that everyone everywhere can read it. 
That's not true. The first rule of plain language is: Write for your 
audience. Use language your audience knows and feels comfortable 
with. Take your audience's current level of knowledge into account. 
Don't write for an 8th grade class if your audience is composed of 
Ph.D. candidates, small business owners, working parents, or 
immigrants. Only write for 8th graders if your audience is, in fact, 
an 8th grade class.

Federal Plain Language Guidelines, ``Think About Your Audience,'' p. 1 
(March 2011).
    Consequently, the final rule makes the plain language edits to 
Sec.  101.9(g)(4)(i), (g)(4)(ii), and (g)(8). However, we have made 
additional revisions to Sec.  101.9(g)(3)(ii) for clarification. In 
addition, upon further consideration, we decided to retain the words 
``Provided, That'' in Sec. Sec.  101.9(g)(4)(ii) and (g)(5). Removing 
the clause would no longer signal to the reader that no regulatory 
action will be taken based on a determination of a nutrient value that 
falls above a certain level by a factor less than the variability 
generally recognized for the analytical method used in that food at the 
level involved.
4. Correcting Sec.  101.9(c)(8)(iii) To Provide Instructions for 
Rounding Percent DVs
    (Comment 542) One comment noted that the first sentence in proposed 
Sec.  101.9(c)(8)(iii) did not provide clear instructions for how to 
declare the percent DVs for vitamins and minerals when the percent 
daily is between 2 to 10 percent, between 10 to 50 percent, or above 
50-percent.
    (Response) The text in first sentence in proposed Sec.  
101.9(c)(8)(iii) was inadvertently changed, and we did not mean to 
propose to amend this requirement. The text in the first sentence of 
Sec.  101.9(c)(8)(iii) should read ``The percentages for vitamins and 
minerals shall be expressed to the nearest 2-percent increment up to 
and including the 10-percent level, the nearest 5-percent increment 
above 10 percent and up to and including the 50-percent level, and the 
nearest 10-percent increment above the 50-percent level.''
5. Miscellaneous Changes
    The final rule also makes several non-substantive changes.
    The proposed rule would amend Sec.  101.9(c) to state that the 
requirements of Sec.  101.9(c) apply to the labeling of food ``for 
adults and children over the age of 4 years, and on foods (other than 
infant formula) purported to be specifically for infants through 12 
months, children 1 through 3 years of age, and pregnant women and 
lactating women.'' After further consideration, we have decided not to 
amend Sec.  101.9(c) as we had proposed because the additional language 
is not necessary. As discussed part II.O, we have the same requirements 
for mandatory and voluntary labeling for products represented or 
purported to be for pregnant women and lactating women because women of 
reproductive age consume the same foods as the general population and, 
in general, continue consuming similar foods during pregnancy. 
Therefore, the requirements for mandatory and voluntary labeling for 
children and adults 4 years of age and older also apply to products 
represented or purported to be for pregnant women and lactating women, 
and there is no reason to mention requirements for pregnant women and 
lactating women in Sec.  101.9(c). In addition, the requirements for 
mandatory and voluntary labeling for products purported to be for 
infants through 12 months of age and children 1 through 3 years of age 
are provided in Sec.  101.9(j)(5). Therefore, there is no reason to 
mention requirements for mandatory and voluntary labeling of nutrients 
on products represented or purported to be for infants through 12 
months or children 1 through 3 years in Sec.  101.9(c).
    The proposed rule also would make minor conforming changes to Sec.  
101.9(c)(1)(i)(D) and (E) by deleting the word ``or'' from the former 
and adding the word ``or'' to the latter. This change reflected the 
addition of a new subparagraph (F), such that we needed to move the 
conjunction to its correct place between the last two subparagraphs in 
Sec.  101.9(c)(1)(i). The final rule adopts these changes.

T. Miscellaneous Comments

    We also received comments on a variety of topics that were 
unrelated to the proposed rule. In brief, we received comments asking 
about:
     Declaring the presence of genetically modified organisms 
(GMOs) or GMO-related issues;
     Ingredient listing, particularly with respect to specific 
ingredients such as high-fructose corn syrup;
     Front-of-package labeling;
     Labeling of alcoholic beverages by another Federal Agency;
     Declaring whether a product contains caffeine, gluten, 
allergens, ``toxins'' (particularly from pesticides and food 
containers);
     Listing the glycemic index of foods and listing whole 
grains in a food;
     Health claim or nutrient content claim regulations;
     Expiration dates on food labels;
     Whether we should define the term ``natural'' on food 
labels;
     Issues related to our final rules on menu labeling and 
vending machine labeling; and
     Listing artificial sweeteners in the Nutrition Facts 
label.
    Generally speaking, these topics are distinct from the Nutrition 
Facts and Supplement Facts label requirements, and so they are beyond 
the scope of this rulemaking. We note, however, that we have issued 
regulations regarding ``gluten-free'' labeling (see 78 FR 47154 (August 
5, 2013) (now codified at 21 CFR 101.91), labeling of standard menu 
items in restaurants and similar retail food establishments (known 
informally as ``menu labeling'') (see 78 FR 71155 (December 1, 2014)) 
(now codified at 21 CFR 101.9), calorie labeling of articles of food in 
vending machines (78 FR 71259 (December 1, 2014) (also codified at 21 
CFR 101.9), and Small Entity Compliance Guides for the gluten-free 
labeling rule and the menu labeling rules (see 79 FR 36322 (June 26, 
2014) and 80 FR 13225 (March 13, 2015) respectively).
    We also have a longstanding policy for the use of the term 
``natural'' on labels of human food (see 56 FR 60421 at 60466 (November 
27, 1991) (proposed rule on food labeling, nutrient content claims, and 
general principles)), and, in the Federal Register of November 12,

[[Page 33967]]

2015 (80 FR 69905), issued a notice to receive information and comments 
on the use of the term ``natural'' in the labeling of human food 
products, including foods that are genetically engineered or contain 
ingredients produced through the use of genetic engineering and on 
specific questions we posed in the notice.

III. Effective and Compliance Dates

    In the preamble to the proposed rule (79 FR 11879 at 11959), we 
indicated that a final rule, as well as any final rule resulting from 
the proposed 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,'' would become effective 60 days after the date 
of the final rule's publication in the Federal Register (79 FR 11879 at 
11959). We also suggested that a final rule have a compliance date that 
would be 2 years after the effective date (id.). We explained that 
industry might need some time to analyze products for which there may 
be new mandatory nutrient declarations, make any required changes to 
the Nutrition Facts label (which may be coordinated with other planned 
label changes), review and update records of product labels, and print 
new labels.
    (Comment 543) Several comments asked that we provide for a longer 
compliance date. Some comments specifically requested more time for 
small businesses. Some comments said that there are a limited number of 
label printing facilities and that they anticipated that small firms 
would have to wait longer to have new labels printed. The comments 
indicated that printing facilities would work with larger companies 
before working with small businesses or that the large companies would 
be able to negotiate more quickly with printing facilities to fill 
their labeling orders first. Other comments stated that small 
businesses often order a 2-year supply of labels or packaging, so a 2-
year compliance date would force small businesses to discard inventory. 
One comment said that some manufacturers would need to work with design 
firms to revise or develop label designs.
    Another comment requested a longer compliance date because of other 
label changes that we or other nations are requiring or anticipated new 
labeling requirements. The comment mentioned our declaratory order 
regarding partially hydrogenated oils (80 FR 34650 (June 17, 2015)), a 
Vermont state law requiring labeling of genetically engineered foods 
and similar legislation in other States, and a possible change to the 
Nutrition Facts Table and ingredient statements in Canada. Some 
comments said that synchronizing compliance dates would reduce the 
economic impact of food manufacturers or that providing a longer 
compliance date would reduce the economic impact on manufacturers.
    Several comments also said that manufacturers may decide to 
reformulate products. One comment said that a longer compliance date 
would make it possible for more manufacturers to reformulate products 
to reduce added sugars, to qualify for nutrient content claims, or 
``otherwise meet FDA's public health objectives.'' Another comment said 
that a longer compliance period would give companies time to 
reformulate ``where appropriate.''
    Some comments said there would be environmental consequences or 
impacts if companies had to dispose of labels or could not use existing 
label stock.
    In general, the comments suggested different compliance dates, 
ranging from 3 to 5 years, and stressed the impact on small businesses.
    (Response) After considering the comments, we have maintained the 
compliance date of 2 years after the effective date, except that 
manufacturers with less than $10 million in annual food sales have a 
compliance date of 3 years after the effective date. Because the 
comments emphasized the rule's potential impact on small businesses, we 
agree that the impacts to smaller businesses may be more substantial 
than those on larger businesses, and so we have decided to provide a 3-
year compliance date for manufacturers with less than $10 million in 
annual food sales. Thus, for manufacturers with less than $10 million 
in annual food sales, the compliance date will be July 26, 2019.
    We take no position with respect to the comment's statements on 
label printing facilities and their interaction with large companies, 
but agree, generally, that small businesses may have fewer resources 
(both in terms of personnel and financial resources) to deal with 
regulatory changes and that an extended compliance date may mitigate 
the rule's impact on small businesses and reduce the need to dispose of 
potentially non-compliant labeling stock. Although the comments did not 
suggest any criteria to decide what constitutes a ``small business,'' 
for purposes of this rulemaking, we consider a small business to be a 
manufacturer with less than $10 million in annual sales, which we 
estimate using Nielsen data that covers approximately 95 percent of all 
food manufacturers and 48 percent of food UPCs.
    We also decline to extend the compliance date for small businesses 
to 4 or 5 years. We note that the Nutrition Facts label's principal 
purpose is to assist consumers in maintaining healthy dietary 
practices. In establishing the compliance date for the rule, we have 
tried to balance the label's principal purpose against the need for 
industry to analyze products and to review, update, change, and print 
labels (see 79 FR 11879 at 11959). If we were to extend the compliance 
date for small businesses to 4 or 5 years, we may inadvertently create 
consumer confusion because different versions of the Nutrition Facts 
label would exist in the market for a longer period of time. The more 
years that differences exist between label formats on different 
products due to extended compliance periods, the more concern we would 
have about these differences frustrating, rather than enhancing, the 
consumer's ability to maintain healthy dietary practices and 
potentially undermining public confidence in the Nutrition Facts label.

IV. Economic Analysis of Impacts

    We have examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4).
    Executive Orders 12866 and 13563 direct us to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). We are 
publishing two final rules on nutrition labeling in the Federal 
Register. We have developed one final Regulatory Impact Analysis (RIA) 
(Ref. 274) that assesses the impacts of the two final rules taken 
together; the RIA is available at http://www.regulations.gov (Docket 
No. FDA-2012-N-1210) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/. We believe that the 
final rules, taken as a whole, are an economically significant 
regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any

[[Page 33968]]

significant impact of a rule on small entities. Additional costs per 
entity from the final rules are small, but not negligible, and as a 
result we find that the final rules, taken as a whole, will have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (Section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $144 
million, using the most current (2014) Implicit Price Deflator for the 
Gross Domestic Product. These final rules, taken as a whole, would 
result in an expenditure that meets or exceeds this amount. The 
analysis that we have performed to examine the impacts of the final 
rules under Executive Order 12866, Executive Order 13563, the 
Regulatory Flexibility Act, and the Unfunded Mandates Reform Act of 
1995 are included in the RIA (Ref. 274) and is available at http://www.regulations.gov (Docket No. FDA-2012-N-1210).

V. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are 
subject to review by the OMB under the PRA. The title, description, and 
respondent description of the information collection provisions are 
shown in the following paragraphs with an estimate of the annual 
reporting and recordkeeping burden. Included in the estimate is the 
time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    Title: Record Retention, Reporting, and Third-Party Disclosure 
Requirements for the Declaration of Added Sugars, Dietary Fiber, 
Soluble Fiber, Insoluble Fiber, Vitamin E and Folate/Folic Acid.

A. Recordkeeping Requirements

    Description of Respondents: The likely respondents to this 
information collection are manufacturers of retail food products 
marketed in the United States, whose products contain: (1) A mixture of 
naturally occurring and added sugars; or (2) a mixture of non-
digestible carbohydrates that do and do not meet the definition of 
dietary fiber. The likely respondents to this information collection 
also include manufacturers of retail food products marketed in the 
United States, whose products contain: (1) Mixtures of different forms 
of vitamin E; or (2) both folate and folic acid.
    Description: The Nutrition Facts label rule requires that, under 
certain circumstances, manufacturers make and keep certain records to 
verify the amount of added sugars when a food product contains both 
naturally occurring sugars and added sugars, isolated or synthetic non-
digestible carbohydrates that do not meet the definition of dietary 
fiber, different forms of vitamin E, and folate/folic acid declared on 
the Nutrition Facts or Supplement Facts label, which is the amount in 
the finished food product. Manufacturers are required to provide such 
records to an appropriate regulatory official upon request during 
inspection. Manufacturers also are required to maintain the records to 
verify the label declaration of the aforementioned nutrients for a 
period of 2 years after introduction or delivery for introduction of 
the food into interstate commerce. Manufacturers of food products that 
contain an isolated or synthetic non-digestible carbohydrate that are 
not listed in the definition of dietary fiber will have the option of 
submitting a citizen petition to FDA asking us to amend the definition 
of ``dietary fiber'' to include the carbohydrate as a listed dietary 
fiber, by demonstrating the physiological benefits of the isolated or 
synthetic non-digestible carbohydrate to human health. In addition, if 
the isolated or synthetic non-digestible carbohydrate is the subject of 
an authorized health claim, FDA would consider the carbohydrate to be a 
dietary fiber with a beneficial physiological effect to human health 
and would amend the definition of ``dietary fiber'' to include the 
carbohydrate as a listed dietary fiber. If the citizen petition is 
granted, or if the isolated or synthetic non-digestible carbohydrate is 
the subject of an authorized health claim, then the non-digestible 
carbohydrate is considered to meet the definition of dietary fiber and 
the definition would be amended to include the dietary fiber in the 
listing of dietary fibers that must be included in the total amount of 
dietary fiber declared on the Nutrition or Supplement Facts label by 
food manufacturers who manufacture food products that contain the 
isolated or synthetic non-digestible carbohydrate. The record 
requirements are necessary because analytical methods are not available 
that would allow us to differentiate between naturally occurring and 
added sugars, non-digestible carbohydrates (soluble or insoluble) that 
do and do not meet the definition of dietary fiber, the various forms 
of vitamin E, and folate or folic acid in order to quantify the amount 
of added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin 
E, or folate/folic acid in the final food product. For the nutrients 
described in the preceding sentence for which there are no analytical 
methods available to verify the label declaration, we must rely on 
information known only to the manufacturer, e.g., analyses of nutrient 
databases, the food's formulation or recipe, batch records, or other 
records, to determine whether their product contains the declared 
amount of the nutrient and is in compliance with the requirements of 
Sec. Sec.  101.9(g) and 101.36(f).
    We require that firms make and keep certain records necessary to 
verify the amount of the nutrients in the finished food product. The 
Nutrition Facts label rule does not specify what records must be used 
to verify the amounts of these nutrients, but does specify the 
information that the records must contain. The Nutrition Facts label 
rule would require manufacturers to, upon request during an inspection, 
provide FDA with the records that contain the required information for 
each of these nutrients to verify the amount of the nutrient declared 
on the label. These records may include analyses of nutrient databases, 
recipes or formulations, information from recipes or formulations, 
batch records, or any other records that contain the required 
information to verify the nutrient content in the final product.
    We estimate the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Type of declaration/CFR section     Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Added Sugars/Sec.                         31,283               1          31,283               1          31,283
 101.9(c)(6)(iii) \2\...........

[[Page 33969]]

 
Dietary Fiber/Sec.                        31,283               1          31,283               1          31,283
 101.9(c)(6)(i) \2\.............
Soluble Fiber/Sec.                        31,283               1          31,283               1          31,283
 101.9(c)(6)(i)(A) \2\..........
Insoluble Fiber/Sec.                      31,283               1          31,283               1          31,283
 101.9(c)(6)(i)(B) \2\..........
Dietary Fiber/Sec.                            28               1              28               1              28
 101.9(c)(6)(i).................
Vitamin E/Sec.   101.9(c)(8) \3\          31,283               1          31,283               1          31,283
Folate/Folic Acid/Sec.                    31,283               1          31,283               1          31,283
 101.9(c)(8) \3\................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         187,726
                                 -------------------------------------------------------------------------------
    Total Initial Hours.........  ..............  ..............  ..............  ..............         187,726
                                 -------------------------------------------------------------------------------
New Products....................             216               1             216               1             216
                                 -------------------------------------------------------------------------------
    Total Recurring Hours.......  ..............  ..............  ..............  ..............             216
                                 -------------------------------------------------------------------------------
        Total Burden Hours......  ..............  ..............  ..............  ..............         187,942
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
  added sugars, dietary fiber, and soluble and insoluble fiber. Manufacturers will only need to keep records for
  products with both added and naturally occurring sugars and products with non-digestible carbohydrates
  (soluble or insoluble) that do and do not meet the definition of dietary fiber.
\3\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
  vitamin E and folate/folic acid. The declaration of vitamin E and folate/folic acid is not mandatory unless a
  health or nutrient content claim is being made or these nutrients are directly added to the food for
  enrichment purposes.

    Based on our experience with food labeling regulations, we believe 
that the new records that would be required to be retained by the final 
rules are records that a prudent and responsible manufacturer uses and 
retains as a normal part of doing business, e.g., analyses of nutrient 
databases, recipes or formulations, batch records, or other records. 
Thus, the recordkeeping burden of the final rules consists of the time 
required to identify and assemble the records for copying and 
retention. Based on our previous experience with similar recordkeeping 
requirements, we estimate the recordkeeping burden of the Nutrition 
Facts Label rule to be 1 hour per product as estimated in table 1.
    Under the Nutrition Facts label rule, the declarations for added 
sugars, dietary fiber, soluble fiber, and insoluble fiber are 
mandatory, and we conservatively estimate that all roughly 31,283 food 
manufacturers would incur this recordkeeping burden and that the 
required recordkeeping would be 1 hour per manufacturer. We estimate 
that there are approximately 28 isolated or synthetic non-digestible 
carbohydrates that do not meet the definition of dietary fiber. Once a 
citizen petition filed by a manufacturer related to a particular 
isolated or synthetic non-digestible carbohydrate is granted or denied, 
or the carbohydrate is the subject of an authorized health claim, and 
the dietary fiber is listed in the definition of dietary fiber, the use 
of the dietary fiber as an ingredient in any food product must be 
included in the total amount of dietary fiber declared in nutrition 
labeling for such product. Thus, it is estimated that 28 manufacturers 
would incur a recordkeeping burden associated with filing a citizen 
petition to amend the listing of dietary fiber related to an isolated 
and synthetic non-digestible carbohydrate that is not currently listed 
in the definition of dietary fiber and that the required recordkeeping 
would be 1 hour per manufacturer. The declaration of vitamin E and 
folate/folic acid is not mandatory unless a health or nutrient content 
claim is being made or these nutrients are directly added to the food 
for enrichment purposes. However, we conservatively estimate that all 
roughly 31,283 food manufacturers would incur this recordkeeping burden 
and that the required recordkeeping would be 1 hour per manufacturer.
    It is hard to predict with certainty the exact number of newly 
introduced products that would be covered under the Nutrition Facts 
label rule each year, but based on the industry growth rate estimated 
using U.S. Census Bureau Business and Industry data, we estimate that 
number to be about 216. Thus, we estimate that about 216 new products 
would be affected by the Nutrition Facts Label rule, and that the 
required recordkeeping would be 1 hour per product, for an annual 
recurring recordkeeping burden of 216 hours (216 x 1). Adding the 
burden from new products to the burden for existing products results in 
a total of 187,942 recordkeeping burden hours for the covered 
establishments under the Nutrition Facts Label rule, as reported in 
table 1.

B. Reporting Requirements

    Description of Respondents: The likely respondents to this 
information collection are manufacturers of retail food products 
marketed in the United States, whose products contain: (1) A 
combination of both naturally occurring and added sugars; or (2) a 
mixture of non-digestible carbohydrates that do and do not meet the 
definition of dietary fiber, soluble fiber, and insoluble fiber. The 
likely respondents to this information collection also include 
manufacturers of retail food products marketed in the United States, 
whose products contain: (1) Mixtures of different forms of vitamin E; 
or (2) both folate and folic acid if a health or nutrient content claim 
is being made or these nutrients are directly added to the food for 
enrichment purposes.
    Description: Under the Nutrition Facts label rule, we require that 
firms provide records upon request during an inspection that they use 
to verify the declared amounts of added sugars, dietary fiber, soluble 
fiber, insoluble fiber, vitamin E, and folate/folic acid on the 
Nutrition Facts or Supplement Facts label.
    The reporting requirement is necessary because, at the present 
time, analytical methods are not available that would allow us to 
differentiate between naturally occurring and added sugars, non-
digestible carbohydrates that both do and do not meet the definition of 
dietary fiber, soluble fiber, and insoluble fiber, the various forms of 
vitamin E, and folate or folic acid in order to quantify the amount of 
added sugars, dietary fiber, vitamin E, or

[[Page 33970]]

folate/folic acid in the final food product. For these foods, we must 
rely on information known only to the manufacturer to assess compliance 
with the qualifying amount of nutrient. The food manufacturer would 
assemble and provide the records to FDA regulatory officials upon 
request during an inspection. We would review the records to verify the 
label declaration and assess compliance.

                                 Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
 Type of declaration/CFR section     Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Added Sugars/Sec.                         31,283               1          31,283               1          31,283
 101.9(c)(6)(iii) \2\...........
Dietary Fiber/Sec.                        31,283               1          31,283               1          31,283
 101.9(c)(6)(i) \2\.............
Soluble Fiber/Sec.                        31,283               1          31,283               1          31,283
 101.9(c)(6)(i)(A) \2\..........
Insoluble Fiber/Sec.                      31,283               1          31,283               1          31,283
 101.9(c)(6)(i)(B) \2\..........
Vitamin E/Sec.   101.9(c)(8) \3\          31,283               1          31,283               1          31,283
Folate/Folic Acid/Sec.                    31,283               1          31,283               1          31,283
 101.9(c)(8) \3\................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         187,698
                                 -------------------------------------------------------------------------------
    Total Initial Hours.........  ..............  ..............  ..............  ..............         187,698
                                 -------------------------------------------------------------------------------
New Products....................             216               1             216               1             216
                                 -------------------------------------------------------------------------------
    Total Recurring Hours.......  ..............  ..............  ..............  ..............             216
                                 -------------------------------------------------------------------------------
        Total Burden Hours......  ..............  ..............  ..............  ..............         187,914
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
  added sugars, dietary fiber, and soluble and insoluble fiber. Manufacturers will only need to keep records for
  products with both added and naturally occurring sugars and products with non-digestible carbohydrates
  (soluble or insoluble) that do and do not meet the definition of dietary fiber.
\3\ These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for
  vitamin E and folate/folic acid. The declaration of vitamin E and folate/folic acid is not mandatory unless a
  health or nutrient content claim is being made or these nutrients are directly added to the food for
  enrichment purposes.

    Based on our experience with food labeling regulations, we believe 
that the records that would be required to be provided to FDA, upon 
request, are records that a prudent and responsible manufacturer uses 
and retains as a normal part of doing business, e.g., analyses of 
nutrient databases, recipes or formulations, batch records, or other 
records. Thus, the reporting burden to the food manufacturer consists 
of the time required to assemble and provide the records to appropriate 
regulatory officials. Based on our previous experience with similar 
reporting requirements, we estimate the reporting burden of the 
Nutrition Facts Label rule to be 1 hour per response, as estimated in 
table 2.
    We do not expect to request records from all covered manufacturers 
to assess compliance, but for the purpose of this analysis the number 
of respondents is conservatively estimated to be all covered 
establishments. We estimate the number of responses per record keeper 
to be 1 and the hourly burden per response to be 1 hour. Built into the 
estimate of 1 hour is the range from 0 hours, for some covered 
manufacturers that do not need to maintain records, to a larger number 
of hours for some covered manufacturers, such as those who produce 
fermented foods, which may require more time to gather or produce the 
necessary records. As shown in table 2, the initial reporting burden 
for covered establishments is 187,698 hours. Also, in accordance with 
our previous estimate of the number of newly introduced products that 
would be covered by the requirements to be 216, we estimate the 
recurring reporting burden hours to be 216. Adding the burden from new 
products to the initial hours results in a total of 187,914 reporting 
burden hours for the covered establishments under the Nutrition Facts 
Label rule, as estimated in table 2.

C. Third-Party Disclosure Requirements

    Description of Respondents: Respondents to this collection of 
information include manufacturers of food products. We estimate the 
burden of this collection of information as follows:

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of                                                          Total capital costs
              21 CFR section                   Number of      disclosures per     Total annual    Average burden    Total hours       (in billions of
                                              respondents        respondent       disclosures     per disclosure                           2014$)
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.9 and 101.36..........................          31,283                 26          813,358                2        1,626,716                  $2.47
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    We have estimated that the burden associated with the Nutrition 
Facts Label rule would be a burden created by the need for food 
manufacturers to revise their nutrition labels. We estimate that the 
third party disclosure burden would be approximately 2 hours per 
disclosure, for a total burden of 1,626,716 hours.

D. Third-Party Disclosure Burden for Manufacturers

    The incremental time burden for reviewing labels to assess how to 
bring them into compliance with the requirements of the Nutrition Facts 
label

[[Page 33971]]

rule has been estimated to be 1 hour per label. These requirements do 
not generate any recurring burden per label because establishments must 
already print packaging for food products as part of normal business 
practices, and must disclose required nutrition information under the 
NLEA.
    Each label redesign would require an estimated 1 additional hour, 
making the total burden hours to be 2 hours in burden per UPC.
    We estimate that about 31,283 manufacturers representing about 
813,358 UPCs, with an average disclosure of 26 (813,358/31,283), would 
be covered under the Nutrition Facts label rule. The total number of 
responses is equal to the total number of UPCs being changed. 
Multiplying the total number of responses by the hours per response 
gives the total burden hours (Table 3, Column 6). Based on the RIA, we 
have estimated the capital cost to be $2.47 billion (2014$).
    The information collection provisions in this final rule have been 
submitted to OMB for review as required by section 3507(d) of the 
Paperwork Reduction Act of 1995. Before the effective date of this 
final rule, we will publish a notice in the Federal Register announcing 
OMB's decision to approve, modify, or disapprove the information 
collection provisions in this final rule.
    An Agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information unless it displays a 
currently valid OMB control number.

VI. Analysis of Environmental Impact

    We have carefully considered the potential environmental effects of 
this action. We have concluded that the action will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required (Refs. 275-276). Our finding of no 
significant impact and the evidence supporting that finding, contained 
in an environmental assessment, may be seen in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday 
through Friday.

VII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires Agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.''
    Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express 
preemption provision. Section 403A(a) of the FD&C Act provides that no 
State or political subdivision of a State may directly or indirectly 
establish under any authority or continue in effect as to any food in 
interstate commerce with respect to any requirement for nutrition 
labeling of food that is not identical to the requirement of section 
403(q) of the FD&C Act.
    The express preemption provision of section 403A(a) of the FD&C Act 
does not preempt any State or local requirement respecting a statement 
in the labeling of food that provides for a warning concerning the 
safety of the food or component of the food (section 6(c)(2) of the 
Nutrition Labeling and Education Act of 1990, Public Law 101-535, 104 
Stat. 2353, 2364 (1990)). If this proposed rule is made final, the 
final rule would create requirements that fall within the scope of 
section 403A(a) of the FD&C Act.
    (Comment 544) One comment argued that our federalism analysis in 
the proposed rule should have included a discussion of the limits which 
the First Amendment places on Federal law. The comment also said that 
section 403A of the FD&C Act is limited to food in interstate commerce.
    (Response) It is correct that, as quoted in the proposed rule's 
Federalism section, section 403A of the FD&C Act applies to food in 
interstate commerce. We decline to change our Federalism section to 
include a First Amendment analysis. The Federalism section discusses 
the limitations on states or political subdivisions of a State with 
regard to requirements for food labeling.
    We address First Amendment arguments in part II.C.1.

VIII. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. Sinclair S., Hammon D., Goodman S. ``Sociodemographic Differences 
in the Comprehension of Nutrition Labels on Food Products''. Journal 
of Nutrition Education and Behavior. 2013;45:767-772.
2. Institute of Medicine (IOM) of the National Academies. ``Front-
of-Package Nutrition Rating Systems and Symbols: Promoting Healthier 
Choices'', Washington, DC: National Academies Press; 2012.
3. U.S. Food and Drug Administration. ``Resources for You'', 2016. 
Retrieved from: http://www.fda.gov/Food/ResourcesForYou.
4. U.S. Department of Agriculture. Agricultural Research Service--
Nutrient Data Laboratory. ``USDA National Nutrient Database for 
Standard Reference, Release 27'', 2014. Retrieved from: http://www.ars.usda.gov/ba/bhnrc/ndl.
5. Institute of Medicine (IOM) of the National Academies. ``Dietary 
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, 
Cholesterol, Protein, and Amino Acids (Macronutrients)'', 
Washington, DC: National Academies Press; 2002.
6. Graham J.D. ``Memorandum for the President's Management Council--
Guidance on Agency Survey and Statistical Information Collections'', 
2006.
7. American Association for Public Opinion Research. ``Why Sampling 
Works''. 2006.
8. U.S. Food and Drug Administration. ``What We Do'', 2016. 
Retrieved from: http://www.fda.gov/AboutFDA/WhatWeDo/default.htm.
9. Cowburn G., L.S., ``Consumer Understanding and Use of Nutrition 
Labeling: A Systematic Review''. Public Health Nutrition. 2005;8:21-
28.
10. Kim S.Y., Nayga R.M., Capps Jr O. ``Food Label Use, Self-
Selectivity, and Diet Quality''. The Journal of Consumer Affairs. 
2001;35:346-363.
11. Lin C.T.J., Lee J.Y. ``Who Uses Food Label Information--a Case 
Study of Dietary Fat''. Journal of Food Products Marketing. 
2004;10:17-37.
12. U.S. Food and Drug Administration. ``Memorandum to File: 
Experimental Study of Proposed Changes to the Nutrition Facts Label 
Formats (OMB No. 0910-0774)--Table 7'', 2015.
13. U.S. Food and Drug Administration. ``Memorandum to File: 
Experimental Study of Proposed Changes to the Nutrition Facts Label 
Formats--Additional Analyses (OMB No. 0910-0774)'', 2016.
14. U.S. Food and Drug Administration. ``Memorandum to File: 
Experimental Study on Consumer Responses to the Nutrition Facts 
Labels with Declaration of Amount of Added Sugars (OMB Control 
Number 0910-0764)'', 2015.
15. U.S. Food and Drug Administration. ``Memorandum to the File: 
Eye-Tracking Experimental Study on Consumer Responses to 
Modifications to the Nutrition Facts Label Outlined in the Food and 
Drug Administration's Proposed Rulemaking (Docket FDA-2012-N-
1210)'', 2015.
16. U.S. Food and Drug Administration. ``Regulatory Impact Analysis 
for Final

[[Page 33972]]

Rules On: ``Food Labeling: Revision of the Nutrition and Supplement 
Facts Labels'' (Docket FDA-2012-N-1210 and ``Food Labeling: Serving 
Sizes of Foods That Can Reasonably Be Consumed at One Eating 
Occasion; Dual-Column Labeling; Updating, Modifying, and 
Establishing Certain Reference Amounts Customarily Consumed; Serving 
Size for Breath Mints; and Technical Amendments'', 2016.
17. National Heart Lung and Blood Institute. ``Lifestyle 
Interventions to Reduce Cardiovascular Risk: Systematic Evidence 
Review from the Lifestyle Work Group'', Bethesda, MD; 2013.
18. Eckel R.H., Jakicic J.M., Ard J.D., et al. ``2013 AHA/ACC 
Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A 
Report of the American College of Cardiology/American Heart 
Association Task Force on Practice Guidelines''. Journal of the 
American College of Cardiology. 2014;63:2960-2984.
19. U.S. Department of Agriculture and U.S. Department of Health and 
Human Services. ``Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee'', Advisory Report to the Secretary of Health and 
Human Services and the Secretary of Agriculture. Washington, DC, 
2015. Retrieved from: http://health.gov/dietaryguidelines/2015-scientific-report/PDFs/Scientific-Report-of-the-2015-Dietary-Guidelines-Advisory-Committee.pdf.
20. U.S. Department of Agriculture and U.S. Department of Health and 
Human Services. ``Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee, Figure D1.36 Food Sources of Added Sugars'', 
Advisory Report to the Secretary of Health and Human Services and 
the Secretary of Agriculture. Washington, DC: U.S. Government 
Printing Office, 2015. Retrieved from: http://health.gov/dietaryguidelines/2015-scientific-report/PDFs/Scientific-Report-of-the-2015-Dietary-Guidelines-Advisory-Committee.pdf.
21. Centers for Disease Control and Prevention (CDC). National 
Center for Health Statistics (NCHS). ``National Health and Nutrition 
Examination Survey 2009-2010, Consumer Behavior Phone Follow-up 
Module-Adult, Question DBQ-750''. Hyattsville, MD, 2016. Retrieved 
from: https://wwwn.cdc.gov/Nchs/Nhanes/2009-2010/CBQPFA_F.htm#DBQ750.
22. Centers for Disease Control and Prevention (CDC). National 
Center for Health Statistics (NCHS). ``National Health and Nutrition 
Examination Survey 2009-2010, Consumer Behavior Phone Follow-up 
Module-Adult, Question DBQ-685''. Hyattsville, MD, 2016. Retrieved 
from: https://wwwn.cdc.gov/Nchs/Nhanes/2009-2010/CBQPFA_F.htm#CBQ685.
23. U.S. Food and Drug Administration. Center for Food Safety and 
Applied Nutrition. ``2014 FDA Health and Diet Survey''. 2016.
24. Institute of Medicine (IOM) of the National Academies. ``Dietary 
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, 
Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 5: 
Energy'', Washington, DC: National Academies Press; 2002.
25. Institute of Medicine (IOM) of the National Academies. ``Dietary 
Reference Intakes: Guiding Principles for Nutrition Labeling and 
Fortification'', Washington, DC: National Academies Press; 2003.
26. U.S. Food and Drug Administration. ``Memorandum to the File: 
Comments Considered in the Development of the Revision of the 
Nutrition and Supplements Facts Proposed Rule'', 2014.
27. IUPAC. Compendium of Chemical Terminology (the ``Goldbook''). 
2nd ed. Oxford: Blackwell Scientific Publications, 1997.
28. U.S. Department of Health and Human Services and U.S. Department 
of Agriculture. ``Dietary Guidelines for Americans 2015-2020'', 8th 
ed. Washington, DC: U.S. Government Printing Office, 2015-2020. 
Retrieved from: http://health.gov/dietaryguidelines/2015/guidelines/
.
29. Institute of Medicine (IOM) of the National Academies. ``Dietary 
Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, 
Cholesterol, Protein, and Amino Acids (Macronutrients), Chapter 8: 
Dietary Fats: Total Fat and Fatty Acids'', Washington, DC: National 
Academies Press; 2002.
30. U.S. Department of Agriculture and U.S. Department of Health and 
Human Services. ``Dietary Guidelines for Americans, 2010'', 7th ed. 
Washington, DC: U.S. Government Printing Office, 2010. Retrieved 
from: http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm.
31. Eckel R.H., Jakicic J.M., Ard J.D., et al. ``2013 AHA/ACC 
Guideline on Lifestyle Management to Reduce Cardiovascular Risk: A 
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List of Subjects in 21 CFR Part 101

    Food labeling, Incorporation by reference, Nutrition, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for part 101 continues to read as follows:

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

0
2. In Sec.  101.9:
0
a. Revise paragraphs (c)(1)(i)(A) through (E).
0
b. Add paragraph (c)(1)(i)(F).
0
c. Remove paragraph (c)(1)(ii), redesignate paragraph (c)(1)(iii) as 
(c)(1)(ii), and revise newly designated paragraph (c)(1)(ii).

[[Page 33979]]

0
d. Revise paragraphs (c)(2), (c)(5), (c)(6)(i) through (iv), (c)(7), 
(c)(8) introductory text, (c)(8)(i), (c)(8)(ii) introductory text, and 
(c)(8)(iii) through (v).
0
e. Add paragraph (c)(8)(vii).
0
f. Revise paragraphs (c)(9), (d)(1) introductory text, (d)(1)(iii) 
through (v), (d)(2) through (d)(5), (d)(7) introductory text, 
(d)(7)(i), (d)(8) through (d)(9), (d)(11)(ii), (d)(11)(iii), (d)(12), 
(d)(13)(ii), (e), (f) introductory text, (f)(2)(ii), (f)(4) and (5), 
(g) introductory text, (g)(2), (g)(3)(ii), (g)(4) through (6), and 
(g)(8).
0
g. Add paragraphs (g)(10) and (11).
0
h. Revise paragraphs (h)(3)(iv), (h)(4) introductory text, (j)(5)(i), 
(j)(5)(ii) introductory text, and (j)(5)(ii)(A) and (B).
0
i. Remove and reserve paragraphs (j)(5)(ii)(C) through (j)(5)(ii)(E); 
and
0
j. Add paragraph (j)(5)(iii).
0
k. Revise paragraphs (j)(13)(i), (j)(13)(ii)(A)(1) and (2), and 
(j)(13)(ii)(B).
0
l. Remove paragraph (j)(13)(ii)(C) and redesignate paragraph 
(j)(13)(ii)(D) as (j)(13)(ii)(C).
0
m. Revise paragraph (j)(18)(iv) introductory text.
0
n. Add paragraph (l).
    The revisions and additions read as follows:

Sec.  101.9  Nutrition labeling of food.

* * * * *
    (c) * * *
    (1) * * *
    (i) * * *
    (A) Using specific Atwater factors (i.e., the Atwater method) given 
in table 13, USDA Handbook No. 74 (slightly revised, 1973),
    (B) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate, and total fat, respectively, as described 
in USDA Handbook No. 74 (slightly revised, 1973) pp. 9-11;
    (C) Using the general factors of 4, 4, and 9 calories per gram for 
protein, total carbohydrate (less the amount of non-digestible 
carbohydrates and sugar alcohols), and total fat, respectively, as 
described in USDA Handbook No. 74 (slightly revised, 1973) pp. 9-11. A 
general factor of 2 calories per gram for soluble non-digestible 
carbohydrates shall be used. The general factors for caloric value of 
sugar alcohols provided in paragraph (c)(1)(i)(F) of this section shall 
be used;
    (D) Using data for specific food factors for particular foods or 
ingredients approved by the Food and Drug Administration (FDA) and 
provided in parts 172 or 184 of this chapter, or by other means, as 
appropriate;
    (E) Using bomb calorimetry data subtracting 1.25 calories per gram 
protein to correct for incomplete digestibility, as described in USDA 
Handbook No. 74 (slightly revised, 1973) p. 10; or
    (F) Using the following general factors for caloric value of sugar 
alcohols: Isomalt--2.0 calories per gram, lactitol--2.0 calories per 
gram, xylitol--2.4 calories per gram, maltitol--2.1 calories per gram, 
sorbitol--2.6 calories per gram, hydrogenated starch hydrolysates--3.0 
calories per gram, mannitol--1.6 calories per gram, and erythritol--0 
calories per gram.
    (ii) ``Calories from saturated fat'' or ``Calories from saturated'' 
(VOLUNTARY): A statement of the caloric content derived from saturated 
fat as defined in paragraph (c)(2)(i) of this section in a serving may 
be declared voluntarily, expressed to the nearest 5-calorie increment, 
up to and including 50 calories, and the nearest 10-calorie increment 
above 50 calories, except that amounts less than 5 calories may be 
expressed as zero. This statement shall be indented under the statement 
of calories as provided in paragraph (d)(5) of this section.
    (2) ``Fat, total'' or ``Total fat'': A statement of the number of 
grams of total fat in a serving defined as total lipid fatty acids and 
expressed as triglycerides where fatty acids are aliphatic carboxylic 
acids consisting of a chain of alkyl groups and characterized by a 
terminal carboxyl group. Amounts shall be expressed to the nearest 0.5 
(\1/2\) gram increment below 5 grams and to the nearest gram increment 
above 5 grams. If the serving contains less than 0.5 gram, the content 
shall be expressed as zero.
* * * * *
    (5) ``Fluoride'' (VOLUNTARY): A statement of the number of 
milligrams of fluoride in a specified serving of food may be declared 
voluntarily, except that when a claim is made about fluoride content, 
label declaration shall be required. Fluoride content shall be 
expressed as zero when the serving contains less than 0.1 milligrams of 
fluoride, to the nearest 0.1-milligram increment when the serving 
contains less than or equal to 0.8 milligrams of fluoride, and the 
nearest 0.2 milligram-increment when a serving contains more than 0.8 
milligrams of fluoride. Bottled water that bears a statement about 
added fluoride, as permitted by Sec.  101.13(q)(8), must bear nutrition 
labeling that complies with requirements for the simplified format in 
paragraph (f) of this section.
    (6) * * *
    (i) ``Dietary fiber'': A statement of the number of grams of total 
dietary fiber in a serving, indented and expressed to the nearest gram, 
except that if a serving contains less than 1 gram, declaration of 
dietary fiber is not required or, alternatively, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and 
if the serving contains less than 0.5 gram, the content may be 
expressed as zero. Dietary fiber is defined as non-digestible soluble 
and insoluble carbohydrates (with 3 or more monomeric units), and 
lignin that are intrinsic and intact in plants; isolated or synthetic 
non-digestible carbohydrates (with 3 or more monomeric units) 
determined by FDA to have physiological effects that are beneficial to 
human health. Except as provided for in paragraph (f) of this section, 
if dietary fiber content is not required, and as a result not declared, 
the statement ``Not a significant source of dietary fiber'' shall be 
placed at the bottom of the table of nutrient values in the same type 
size. The following isolated or synthetic non-digestible 
carbohydrate(s) have been determined by FDA to have physiological 
effects that are beneficial to human health and, therefore, shall be 
included in the calculation of the amount of dietary fiber: [beta]-
glucan soluble fiber (as described in Sec.  101.81(c)(2)(ii)(A)), 
psyllium husk (as described in Sec.  101.81(c)(2)(ii)(A)(6)), 
cellulose, guar gum, pectin, locust bean gum, and 
hydroxypropylmethylcellulose. The manufacturer must make and keep 
records in accordance with paragraphs (g)(10) and (11) of this section 
to verify the declared amount of dietary fiber in the label and 
labeling of food when a mixture of dietary fiber, and added non-
digestible carbohydrate(s) that does not meet the definition of dietary 
fiber, is present in the food.
    (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of 
grams of soluble dietary fiber in a serving may be declared voluntarily 
except that when a claim is made on the label or in labeling about 
soluble fiber, label declaration shall be required. Soluble fiber must 
meet the definition of dietary fiber in this paragraph (c)(6)(i). The 
manufacturer must make and keep records in accordance with paragraphs 
(g)(10) and (11) of this section to verify the declared amount of 
soluble fiber in the label and labeling of food when a mixture of 
soluble fiber and added non-digestible carbohydrate(s) that does not 
meet the definition of dietary fiber is present in the food. Soluble 
fiber content shall be indented under dietary fiber and expressed to 
the nearest gram, except that if a serving contains less than 1 gram, 
the statement ``Contains less than 1 gram'' or ``less than 1 gram''

[[Page 33980]]

may be used as an alternative, and if the serving contains less than 
0.5 gram, the content may be expressed as zero.''
    (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of 
grams of insoluble dietary fiber in a serving may be declared 
voluntarily except that when a claim is made on the label or in 
labeling about insoluble fiber, label declaration shall be required. 
Insoluble fiber must meet the definition of dietary fiber in this 
paragraph (c)(6)(i). The manufacturer must make and keep records in 
accordance with paragraphs (g)(10) and (11) of this section to verify 
the declared amount of insoluble fiber in the label and labeling of 
food when a mixture of insoluble and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food. Insoluble fiber content shall be indented under 
dietary fiber and expressed to the nearest gram, except that if a 
serving contains less than 1 gram, the statement ``Contains less than 1 
gram'' or ``less than 1 gram'' may be used as an alternative, and if 
the serving contains less than 0.5 gram, the content may be expressed 
as zero.
    (ii) ``Total Sugars'': A statement of the number of grams of sugars 
in a serving, except that the label declaration of sugars content is 
not required for products that contain less than 1 gram of sugars in a 
serving if no claims are made about sweeteners, sugars, or sugar 
alcohol content. Except as provided for in paragraph (f) of this 
section, if a statement of the total sugars content is not required 
and, as a result, not declared, the statement ``Not a significant 
source of total sugars'' shall be placed at the bottom of the table of 
nutrient values in the same type size. Total sugars shall be defined as 
the sum of all free mono- and disaccharides (such as glucose, fructose, 
lactose, and sucrose). Total sugars content shall be indented and 
expressed to the nearest gram, except that if a serving contains less 
than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 
1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero.
    (iii) ``Added Sugars'': A statement of the number of grams of added 
sugars in a serving, except that label declaration of added sugars 
content is not required for products that contain less than 1 gram of 
added sugars in a serving if no claims are made about sweeteners, 
sugars, added sugars, or sugar alcohol content. If a statement of the 
added sugars content is not required and, as a result, not declared, 
the statement ``Not a significant source of added sugars'' shall be 
placed at the bottom of the table of nutrient values in the same type 
size. Added sugars are either added during the processing of foods, or 
are packaged as such, and include sugars (free, mono- and 
disaccharides), sugars from syrups and honey, and sugars from 
concentrated fruit or vegetable juices that are in excess of what would 
be expected from the same volume of 100 percent fruit or vegetable 
juice of the same type, except that fruit or vegetable juice 
concentrated from 100 percent juices sold to consumers, fruit or 
vegetable juice concentrates used towards the total juice percentage 
label declaration under Sec.  101.30 or for Brix standardization under 
Sec.  102.33(g)(2) of this chapter, fruit juice concentrates which are 
used to formulate the fruit component of jellies, jams, or preserves in 
accordance with the standard of identities set forth in Sec. Sec.  
150.140 and 150.160 of this chapter, or the fruit component of fruit 
spreads shall not be labeled as added sugars. Added sugars content 
shall be indented under Total Sugars and shall be prefaced with the 
word ``Includes'' followed by the amount (in grams) ``Added Sugars'' 
(``Includes `X' g Added Sugars''). It shall be expressed to the nearest 
gram, except that if a serving contains less than 1 gram, the statement 
``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an 
alternative, and if the serving contains less than 0.5 gram, the 
content may be expressed as zero. When a mixture of naturally occurring 
and added sugars is present in the food, and for specific foods 
containing added sugars, alone or in combination with naturally 
occurring sugars, where the added sugars are subject to fermentation 
and/or non-enzymatic browning, the manufacturer must make and keep 
records in accordance with paragraphs (g)(10) and (11) of this section 
to verify the declared amount of added sugars in the label and labeling 
of food.
    (iv) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of 
grams of sugar alcohols in a serving may be declared voluntarily on the 
label, except that when a claim is made on the label or in labeling 
about sugar alcohol or total sugars, or added sugars when sugar 
alcohols are present in the food, sugar alcohol content shall be 
declared. For nutrition labeling purposes, sugar alcohols are defined 
as the sum of saccharide derivatives in which a hydroxyl group replaces 
a ketone or aldehyde group and whose use in the food is listed by FDA 
(e.g., mannitol or xylitol) or is generally recognized as safe (e.g., 
sorbitol). In lieu of the term ``sugar alcohol,'' the name of the 
specific sugar alcohol (e.g., ``xylitol'') present in the food may be 
used in the nutrition label provided that only one sugar alcohol is 
present in the food. Sugar alcohol content shall be indented and 
expressed to the nearest gram, except that if a serving contains less 
than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 
1 gram'' may be used as an alternative, and if the serving contains 
less than 0.5 gram, the content may be expressed as zero.
    (7) ``Protein'': A statement of the number of grams of protein in a 
serving, expressed to the nearest gram, except that if a serving 
contains less than 1 gram, the statement ``Contains less than 1 gram'' 
or ``less than 1 gram'' may be used as an alternative, and if the 
serving contains less than 0.5 gram, the content may be expressed as 
zero. When the protein in foods represented or purported to be for 
adults and children 4 or more years of age has a protein quality value 
that is a protein digestibility-corrected amino acid score of less than 
20 expressed as a percent, or when the protein in a food represented or 
purported to be for children greater than 1 but less than 4 years of 
age has a protein quality value that is a protein digestibility-
corrected amino acid score of less than 40 expressed as a percent, 
either of the following shall be placed adjacent to the declaration of 
protein content by weight: The statement ``not a significant source of 
protein,'' or a listing aligned under the column headed ``Percent Daily 
Value'' of the corrected amount of protein per serving, as determined 
in paragraph (c)(7)(ii) of this section, calculated as a percentage of 
the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as 
appropriate, for protein and expressed as a Percent of Daily Value. 
When the protein quality in a food as measured by the Protein 
Efficiency Ratio (PER) is less than 40 percent of the reference 
standard (casein) for a food represented or purported to be 
specifically for infants through 12 months, the statement ``not a 
significant source of protein'' shall be placed adjacent to the 
declaration of protein content. Protein content may be calculated on 
the basis of the factor 6.25 times the nitrogen content of the food as 
determined by the appropriate method of analysis as given in the 
``Official Methods of Analysis of the AOAC International,'' except when 
official AOAC procedures described in this paragraph (c)(7) require a 
specific factor other than 6.25, that specific factor shall be used.
    (i) A statement of the corrected amount of protein per serving, as 
determined in paragraph (c)(7)(ii) of this section, calculated as a 
percentage of the

[[Page 33981]]

RDI or DRV for protein, as appropriate, and expressed as Percent of 
Daily Value, may be placed on the label, except that such a statement 
shall be given if a protein claim is made for the product, or if the 
product is represented or purported to be specifically for infants 
through 12 months or children 1 through 3 years of age. When such a 
declaration is provided, it should be placed on the label adjacent to 
the statement of grams of protein and aligned under the column headed 
``Percent Daily Value,'' and expressed to the nearest whole percent. 
However, the percentage of the RDI for protein shall not be declared if 
the food is represented or purported to be specifically for infants 
through 12 months and the protein quality value is less than 40 percent 
of the reference standard.
    (ii) The ``corrected amount of protein (gram) per serving'' for 
foods represented or purported for adults and children 1 or more years 
of age is equal to the actual amount of protein (gram) per serving 
multiplied by the amino acid score corrected for protein digestibility. 
If the corrected score is above 1.00, then it shall be set at 1.00. The 
protein digestibility-corrected amino acid score shall be determined by 
methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Report of the 
Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,'' 
except that when official AOAC procedures described in paragraph (c)(7) 
of this section require a specific factor other than 6.25, that 
specific factor shall be used. For foods represented or purported to be 
specifically for infants through 12 months, the corrected amount of 
protein (grams) per serving is equal to the actual amount of protein 
(grams) per serving multiplied by the relative protein quality value. 
The relative protein quality value shall be determined by dividing the 
subject food protein PER value by the PER value for casein. If the 
relative protein value is above 1.00, it shall be set at 1.00.
    (iii) For the purpose of labeling with a percent of the DRV or RDI, 
a value of 50 grams of protein shall be the DRV for adults and children 
4 or more years of age, a value of 11 grams of protein shall be the RDI 
for infants through 12 months, a value of 13 grams shall be the DRV for 
children 1 through 3 years of age, and a value of 71 grams of protein 
shall be the RDI for pregnant women and lactating women.
    (8) ``Vitamins and minerals'': The requirements related to 
including a statement of the amount per serving of vitamins and 
minerals are described in this paragraph (c)(8).
    (i) For purposes of declaration of percent of Daily Value as 
provided for in paragraphs (d), (e), and (f) of this section, foods 
represented or purported to be specifically for infants through 12 
months, children 1 through 3 years, pregnant women, and lactating women 
shall use the RDIs that are specified for the intended group. For foods 
represented or purported to be specifically for both infants through 12 
months of age and children 1 through 3 years of age, the percent of 
Daily Value shall be presented by separate declarations according to 
paragraph (e) of this section based on the RDI values for infants 
through 12 months of age and children 1 through 3 years of age. When 
such dual declaration is used on any label, it shall be included in all 
labeling, and equal prominence shall be given to both values in all 
such labeling. The percent Daily Value based on the RDI values for 
pregnant women and lactating women shall be declared on food 
represented or purported to be specifically for pregnant women and 
lactating women. All other foods shall use the RDI for adults and 
children 4 or more years of age.
    (ii) The declaration of vitamins and minerals as a quantitative 
amount by weight and percent of the RDI shall include vitamin D, 
calcium, iron, and potassium in that order, for infants through 12 
months, children 1 through 3 years of age, pregnant women, lactating 
women, and adults and children 4 or more years of age. The declaration 
of folic acid shall be included as a quantitative amount by weight when 
added as a nutrient supplement or a claim is made about the nutrient. 
The declaration of vitamins and minerals in a food, as a quantitative 
amount by weight and percent of the RDI, may include any of the other 
vitamins and minerals listed in paragraph (c)(8)(iv) of this section. 
The declaration of vitamins and minerals shall include any of the other 
vitamins and minerals listed in paragraph (c)(8)(iv) of this section as 
a statement of the amount per serving of the vitamins and minerals as 
described in this paragraph, calculated as a percent of the RDI and 
expressed as a percent of the Daily Value, when they are added as a 
nutrient supplement, or when a claim is made about them, unless 
otherwise stated as quantitative amount by weight and percent of the 
Daily Value. Other vitamins and minerals need not be declared if 
neither the nutrient nor the component is otherwise referred to on the 
label or the labeling or advertising and the vitamins and minerals are:
* * * * *
    (iii) The percentages for vitamins and minerals shall be expressed 
to the nearest 2-percent increment up to and including the 10-percent 
level, the nearest 5-percent increment above 10 percent and up to and 
including the 50-percent level, and the nearest 10-percent increment 
above the 50-percent level. Quantitative amounts and percentages of 
vitamins and minerals present at less than 2 percent of the RDI are not 
required to be declared in nutrition labeling but may be declared by a 
zero or by the use of an asterisk (or other symbol) that refers to 
another asterisk (or symbol) that is placed at the bottom of the table 
and that is followed by the statement ``Contains less than 2 percent of 
the Daily Value of this (these) nutrient (nutrients)'' or ``Contains < 
2 percent of the Daily Value of this (these) nutrient (nutrients).'' 
Alternatively, except as provided for in paragraph (f) of this section, 
if vitamin D, calcium, iron, or potassium is present in amounts less 
than 2 percent of the RDI, label declaration of the nutrient(s) is not 
required if the statement ``Not a significant source of--(listing the 
vitamins or minerals omitted)'' is placed at the bottom of the table of 
nutrient values. Either statement shall be in the same type size as 
nutrients that are indented. The quantitative amounts of vitamins and 
minerals, excluding sodium, shall be the amount of the vitamin or 
mineral included in one serving of the product, using the units of 
measurement and the levels of significance given in paragraph 
(c)(8)(iv) of this section, except that zeros following decimal points 
may be dropped, and additional levels of significance may be used when 
the number of decimal places indicated is not sufficient to express 
lower amounts (e.g., the RDI for zinc is given in whole milligrams, but 
the quantitative amount may be declared in tenths of a milligram).
    (iv) The following RDIs, nomenclature, and units of measure are 
established for the following vitamins and minerals which are essential 
in human nutrition:

[[Page 33982]]

----------------------------------------------------------------------------------------------------------------
                                                                                RDI
                                                 ---------------------------------------------------------------
           Nutrient              Unit of measure    Adults and      Infants \1\     Children 1    Pregnant women
                                                   children >=4     through 12       through 3     and lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Vitamin A.....................  Micrograms RAE               900             500             300           1,300
                                 \2\ (mcg).
Vitamin C.....................  Milligrams (mg).              90              50              15             120
Calcium.......................  Milligrams (mg).           1,300             260             700           1,300
Iron..........................  Milligrams (mg).              18              11               7              27
Vitamin D.....................  Micrograms (mcg)              20              10              15              15
                                 \3\.
Vitamin E.....................  Milligrams (mg)               15               5               6              19
                                 \4\.
Vitamin K.....................  Micrograms (mcg)             120             2.5              30              90
Thiamin.......................  Milligrams (mg).             1.2             0.3             0.5             1.4
Riboflavin....................  Milligrams (mg).             1.3             0.4             0.5             1.6
Niacin........................  Milligrams NE                 16               4               6              18
                                 \5\ (mg).
Vitamin B6....................  Milligrams (mg).             1.7             0.3             0.5             2.0
Folate \6\....................  Micrograms DFE               400              80             150             600
                                 \7\ (mcg).
Vitamin B12...................  Micrograms (mcg)             2.4             0.5             0.9             2.8
Biotin........................  Micrograms (mcg)              30               6               8              35
Pantothenic acid..............  Milligrams (mg).               5             1.8               2               7
Phosphorus....................  Milligrams (mg).           1,250             275             460           1,250
Iodine........................  Micrograms (mcg)             150             130              90             290
Magnesium.....................  Milligrams (mg).             420              75              80             400
Zinc..........................  Milligrams (mg).              11               3               3              13
Selenium......................  Micrograms (mcg)              55              20              20              70
Copper........................  Milligrams (mg).             0.9             0.2             0.3             1.3
Manganese.....................  Milligrams (mg).             2.3             0.6             1.2             2.6
Chromium......................  Micrograms (mcg)              35             5.5              11              45
Molybdenum....................  Micrograms (mcg)              45               3              17              50
Chloride......................  Milligrams (mg).           2,300             570           1,500           2,300
Potassium.....................  Milligrams (mg).           4,700             700           3,000           5,100
Choline.......................  Milligrams (mg).             550             150             200             550
Protein.......................  Grams (g).......             N/A              11             N/A          \8\ 71
----------------------------------------------------------------------------------------------------------------
\1\ RDIs are based on dietary reference intake recommendations for infants through 12 months of age.
\2\ RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental [beta]-
  carotene, 12 micrograms [beta]-carotene, or 24 micrograms [alpha]-carotene, or 24 micrograms [beta]-
  cryptoxanthin.
\3\ The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition
  to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in
  parentheses after the declaration of the amount of vitamin D in mcg.
\4\ 1 mg [alpha]-tocopherol (label claim) = 1 mg [alpha]-tocopherol = 1 mg RRR- [alpha]-tocopherol = 2 mg all
  rac-[alpha]-tocopherol .
\5\ NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan.
\6\ ``Folate'' and ``Folic Acid'' must be used for purposes of declaration in the labeling of conventional foods
  and dietary supplements. The declaration for folate must be in mcg DFE (when expressed as a quantitative
  amount by weight in a conventional food or a dietary supplement), and percent DV based on folate in mcg DFE.
  Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a claim is
  made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.
\7\ DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid.
\8\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant women and lactating women.

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

Calories--Energy
Vitamin C--Ascorbic acid
Thiamin--Vitamin B1
Riboflavin--Vitamin B2
* * * * *
    (vii) When the amount of folate is declared in the labeling of a 
conventional food or a dietary supplement, the nutrient name ``folate'' 
shall be listed for products containing folate (natural folate, and/or 
synthetic folate as a component of dietary supplement, such as calcium 
salt of L-5-MTHF), folic acid, or a mixture of folate and folic acid. 
The name of the synthetic form of the nutrient ``folic acid'', when 
added or a claim is made about the nutrient, shall be included in 
parentheses after this declaration with the amount of folic acid. The 
declaration must be folate in mcg DFE (when expressed as a quantitative 
amount by weight in a conventional food or a dietary supplement) and 
the percent DV based on folate in mcg DFE, or for conventional food, 
may be expressed as folate and the percent DV based on folate in mcg 
DFE. When declared, folic acid must be in parentheses, mcg of folic 
acid as shown in paragraph (d)(12) of this section in the display that 
illustrates voluntary declaration of nutrition information.
    (9) The following DRVs, nomenclature, and units of measure are 
established for the following food components:

----------------------------------------------------------------------------------------------------------------
                                                    Adults and        Infants       Children 1    Pregnant women
        Food component           Unit of measure   children >= 4    through 12       through 3     and lactating
                                                       years          months           years           women
----------------------------------------------------------------------------------------------------------------
Fat...........................  Grams (g).......          \1\ 78              30          \2\ 39          \1\ 78
Saturated fat.................  Grams (g).......          \1\ 20             N/A          \2\ 10          \1\ 20
Cholesterol...................  Milligrams (mg).             300             N/A             300             300
Total carbohydrate............  Grams (g).......         \1\ 275              95         \2\ 150         \1\ 275

[[Page 33983]]

 
Sodium........................  Milligrams (mg).           2,300             N/A           1,500           2,300
Dietary Fiber.................  Grams (g).......          \1\ 28             N/A          \2\ 14          \1\ 28
Protein.......................  Grams (g).......          \1\ 50             N/A          \2\ 13             N/A
Added Sugars..................  Grams (g).......          \1\ 50             N/A          \2\ 25          \1\ 50
----------------------------------------------------------------------------------------------------------------
\1\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  for pregnant women and lactating women
\2\ Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.

    (d)(1) Nutrient information specified in paragraph (c) of this 
section shall be presented on foods in the following format, as shown 
in paragraph (d)(12) of this section, except on foods where the tabular 
display is permitted as provided for in paragraph (d)(11) of this 
section, on which dual columns of nutrition information are declared as 
provided for in paragraph (e) of this section, on those food products 
on which the simplified format is required to be used as provided for 
in paragraph (f) of this section, on foods for infants through 12 
months of age and children 1 through 3 years of age as provided for in 
paragraph (j)(5) of this section, and on foods in small or 
intermediate-sized packages as provided for in paragraph (j)(13) of 
this section. In the interest of uniformity of presentation, FDA 
strongly recommends that the nutrition information be presented using 
the graphic specifications set forth in appendix B to part 101.
* * * * *
    (iii) Information required in paragraphs (d)(7) and (8) of this 
section shall be in type size no smaller than 8 point. Information 
required in paragraph (d)(5) of this section for the ``Calories'' 
declaration shall be highlighted in bold or extra bold and shall be in 
a type size no smaller than 16 point except the type size for this 
information required in the tabular displays as shown in paragraphs 
(d)(11), (e)(6)(ii), and (j)(13)(ii)(A)(1) of this section and the 
linear display for small packages as shown in paragraph 
(j)(13)(ii)(A)(2) of this section shall be in a type size no smaller 
than 10 point. The numeric amount for the information required in 
paragraph (d)(5) of this section shall also be highlighted in bold or 
extra bold type and shall be in a type size no smaller than 22 point, 
except the type size for this information required for the tabular 
display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of 
this section, and for the linear display for small packages as shown in 
paragraph (j)(13)(ii)(A)(2) of this section no smaller than 14 point. 
The information required in paragraph (d)(9) of this section shall be 
in a type size no smaller than 6 point. When provided, the information 
described in paragraph (d)(10) of this section shall be in a type size 
no smaller than 6 point.
    (iv) The headings required by paragraphs (d)(2), (d)(3)(ii), 
(d)(4), and (d)(6) of this section (i.e., ``Nutrition Facts,'' 
``Serving size,'' ``Amount per serving,'' and ``% Daily Value*''), the 
names of all nutrients that are not indented according to requirements 
of paragraph (c) of this section (i.e., ``Calories,'' ``Total Fat,'' 
``Cholesterol,'' ``Sodium,'' ``Total Carbohydrate'' and ``Protein''), 
and the percentage amounts required by paragraph (d)(7)(ii) of this 
section shall be highlighted in bold or extra bold type or other 
highlighting (reverse printing is not permitted as a form of 
highlighting) that prominently distinguishes it from other information. 
No other information shall be highlighted.
    (v) A hairline rule that is centered between the lines of text 
shall separate ``Nutrition Facts'' from the servings per container 
statement required in paragraph (d)(3)(i) of this section and shall 
separate each nutrient and its corresponding percent Daily Value 
required in paragraphs (d)(7)(i) and (ii) of this section from the 
nutrient and percent Daily Value above and below it, as shown in 
paragraph (d)(12) of this section and in Appendix B to Part 101.
    (2) The information shall be presented under the identifying 
heading of ``Nutrition Facts'' which shall be set in a type size no 
smaller than all other print size in the nutrition label except for the 
numerical information for ``Calories'' required in paragraph (d)(5) of 
this section, and except for labels presented according to the format 
provided for in paragraphs (d)(11), (d)(13)(ii), (e)(6)(ii), 
(j)(13)(ii)(A)(1), and (j)(13)(ii)(A)(2) of this section, unless 
impractical, shall be set the full width of the information provided 
under paragraph (d)(7) of this section, as shown in paragraph (d)(12) 
of this section.
    (3) Information on servings per container and serving size shall 
immediately follow the heading as shown in paragraph (d)(12) of this 
section. Such information shall include:
    (i) ``__ servings per container'': The number of servings per 
container, except that this statement is not required on single serving 
containers as defined in paragraph (b)(6) of this section or on other 
food containers when this information is stated in the net quantity of 
contents declaration. The information required in this paragraph shall 
be located immediately after the ``Nutrition Facts'' heading and shall 
be in a type size no smaller than 10 point, except the type size for 
this information shall be no smaller than 9 point in the tabular 
display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of 
this section and the linear display for small packages as shown in 
paragraph (j)(13)(ii)(A)(2) of this section. For the linear display for 
small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, 
the actual number of servings may be listed after the servings per 
container declaration.
    (ii) ``Serving size'': A statement of the serving size as specified 
in paragraph (b)(7) of this section which shall immediately follow the 
``__servings per container'' declaration. The information required in 
this paragraph shall be highlighted in bold or extra bold and be in a 
type size no smaller than 10 point, except the type size shall be no 
smaller than 9 point for this information in the tabular displays as 
shown in paragraphs (d)(11) and (e)(6)(ii) of this section, the tabular 
display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of 
this section, and the linear display for small packages as shown in 
paragraph (j)(13)(ii)(A)(2) of this section. The serving size amount 
must be right justified if adequate space is available. If the 
``Serving size'' declaration does not fit in the allocated space a type 
size of no smaller than 8 point may be used on packages of any size.
    (4) A subheading ``Amount per serving'' shall be separated from the 
serving size information by a bar as shown in paragraph (d)(12) of this 
section, except this information is not required for the dual column 
formats

[[Page 33984]]

shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this section.
    (5) Information on calories shall immediately follow the subheading 
``Amount per serving'' and shall be declared in one line. If ``Calories 
from saturated fat'' is declared, it shall be indented under 
``Calories'' and shall be in a type size no smaller than 8 point.
* * * * *
    (7) Except as provided for in paragraph (j)(13)(ii)(A)(2) of this 
section, nutrient information for both mandatory and any voluntary 
nutrients listed in paragraph (c) of this section that are to be 
declared in the nutrition label, except for folic acid in conventional 
food and voluntarily declared vitamins and minerals expressed as a 
statement of the amount per serving calculated as a percent of the RDI 
and expressed as a percent Daily Value, shall be declared as follows:
    (i) The name of each nutrient, as specified in paragraph (c) of 
this section, shall be given in a column and followed immediately by 
the quantitative amount by weight for that nutrient appended with a 
``g'' for grams, ``mg'' for milligrams, or ``mcg'' for micrograms as 
shown in paragraph (d)(12) of this section. The symbol ``<'' may be 
used in place of ``less than.''
* * * * *
    (8) Nutrient information for vitamins and minerals (except sodium) 
shall be separated from information on other nutrients by a bar and may 
be arrayed vertically as shown in paragraph (d)(12) of this section 
(e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, 
Potassium 235 mg 6%) or may be listed horizontally. When listed 
horizontally in two columns, vitamin D and calcium should be listed on 
the first line and iron and potassium should be listed on the second 
line, as shown in paragraph (d)(12) of this section in the side-by-side 
display. When more than four vitamins and minerals are declared 
voluntarily as shown in paragraph (d)(12) of this section in the label 
which illustrates the mandatory plus voluntary provisions of paragraph 
(d) of this section, they may be declared vertically with percentages 
listed under the column headed ``% Daily Value.''
    (9) A footnote, preceded by an asterisk, shall be placed beneath 
the list of vitamins and minerals and shall be separated from the list 
by a bar, except that the footnote may be omitted from foods that can 
use the terms ``calorie free,'' ``free of calories,'' ``without 
calories,'' ``trivial source of calories,'' ``negligible source of 
calories,'' or ``dietary insignificant source of calories'' on the 
label or in the labeling of foods as defined in Sec.  101.60(b). The 
first sentence of the footnote: ``The % Daily Value tells you how much 
a nutrient in a serving of food contributes to a daily diet'' may be 
used on foods that can use the terms ``calorie free,'' ``free of 
calories,'' ``without calories,'' ``trivial source of calories,'' 
``negligible source of calories,'' or ``dietary insignificant source of 
calories'' on the label or in the labeling of foods as defined in Sec.  
101.60(b). The footnote shall state: ``*The % Daily Value tells you how 
much a nutrient in a serving of food contributes to a daily diet. 2,000 
calories a day is used for general nutrition advice.'' If the food 
product is represented or purported to be for children 1 through 3 
years of age, the second sentence of the footnote shall substitute 
``1,000 calories'' for ``2,000 calories.''
* * * * *
    (11) * * *
    (ii) If the space beneath the mandatory declaration of potassium is 
not adequate to accommodate any remaining vitamins and minerals to be 
declared or the information required in paragraph (d)(9) of this 
section, the remaining information may be moved to the right and set 
off by a line that distinguishes it and sets it apart from the 
nutrients and the percent DV information given to the left. The caloric 
conversion information provided for in paragraph (d)(10) of this 
section may be presented beneath either side or along the full length 
of the nutrition label.
    (iii) If there is not sufficient continuous vertical space (i.e., 
approximately 3 in) to accommodate the required components of the 
nutrition label up to and including the mandatory declaration of 
potassium, the nutrition label may be presented in a tabular display as 
shown in the following sample label.
[GRAPHIC] [TIFF OMITTED] TR27MY16.000

[[Page 33985]]

    (12) The following sample labels illustrate the mandatory 
provisions and mandatory plus voluntary provisions of paragraph (d) of 
this section and the side-by-side display.
[GRAPHIC] [TIFF OMITTED] TR27MY16.001

[[Page 33986]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.002

[[Page 33987]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.003

    (13) * * *
    (ii) Aggregate displays shall comply with the format requirements 
of paragraph (d) of this section to the maximum extent possible, except 
that the identity of each food shall be specified immediately to the 
right of the ``Nutrition Facts'' heading, and both the quantitative 
amount by weight (i.e., g/mg/mcg amounts) and the percent Daily Value 
for each nutrient shall be listed in separate columns under the name of 
each food. The following sample label illustrates an aggregate display.
[GRAPHIC] [TIFF OMITTED] TR27MY16.004

* * * * *
    (e) Nutrition information may be presented for two or more forms of 
the same food (e.g., both ``as purchased'' and ``as prepared'') or for 
common combinations of food as provided for in paragraph (h)(4) of this 
section, for different units (e.g., slices of bread or per 100 grams) 
as provided for in

[[Page 33988]]

paragraph (b) of this section, or for two or more groups for which RDIs 
are established (e.g., both infants through 12 months of age and 
children 1 through 3 years of age) as shown in paragraph (e)(5) of this 
section. When such dual labeling is provided, equal prominence shall be 
given to both sets of values. Information shall be presented in a 
format consistent with paragraph (d) of this section, except that:
    (1) Following the serving size information there shall be two or 
more column headings accurately describing the amount per serving size 
of the form of the same food (e.g., ``Per \1/4\ cup mix'' and ``Per 
prepared portion''), the combinations of food, the units, or the RDI 
groups that are being declared as shown in paragraph (e)(5) of this 
section.
    (2) The quantitative information by weight as required in paragraph 
(d)(7)(i) and the information required in paragraph (d)(7)(ii) of this 
section shall be presented for the form of the product as packaged and 
for any other form of the product (e.g., ``as prepared'' or combined 
with another ingredient as shown in paragraph (e)(5) of this section).
    (3) When the dual labeling is presented for two or more forms of 
the same food, for combinations of food, for different units, or for 
two or more groups for which RDIs are established, the quantitative 
information by weight and the percent Daily Value shall be presented in 
two columns and the columns shall be separated by vertical lines as 
shown in paragraph (e)(5) of this section.
    (4) Nutrient information for vitamins and minerals (except sodium) 
shall be separated from information on other nutrients by a bar and 
shall be arrayed vertically in the following order: Vitamin D, calcium, 
iron, potassium as shown in paragraph (e)(5) of this section.
    (5) The following sample label illustrates the provisions of 
paragraph (e) of this section:
[GRAPHIC] [TIFF OMITTED] TR27MY16.005

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

[[Page 33989]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.006

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

[[Page 33990]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.007

    (f) The declaration of nutrition information may be presented in 
the simplified format set forth herein when a food product contains 
insignificant amounts of eight or more of the following: Calories, 
total fat, saturated fat, trans fat, cholesterol, sodium, total 
carbohydrate, dietary fiber, total sugars, added sugars, protein, 
vitamin D, calcium, iron, and potassium; except that for foods intended 
for infants through 12 months of age and children 1 through 3 years of 
age to which paragraph (j)(5)(i) of this section applies, nutrition 
information may be presented in the simplified format when a food 
product contains insignificant amounts of six or more of the following: 
Calories, total fat, sodium, total carbohydrate, dietary fiber, total 
sugars, added sugars, protein, vitamin D, calcium, iron, and potassium.
* * * * *
    (2) * * *
    (ii) Any other nutrients identified in paragraph (f) of this 
section that are present in the food in more than insignificant 
amounts; and
* * * * *
    (4) If any nutrients are declared as provided in paragraphs 
(f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the 
simplified format or if any nutrition claims are made on the label or 
in labeling, the statement ``Not a significant source of ____'' (with 
the blank filled in with the name(s) of any nutrient(s) identified in 
paragraph (f) of this section that are present in insignificant 
amounts) shall be included at the bottom of the nutrition label.
[GRAPHIC] [TIFF OMITTED] TR27MY16.008

    (5) Except as provided for in paragraphs (j)(5) and (j)(13) of this 
section, nutrient information declared in the simplified format shall 
be presented in the same manner as specified in paragraphs (d) or (e) 
of this section, except that the footnote required in paragraph (d)(9) 
of this section is not required, and an asterisk shall be placed at the 
bottom of the label followed by the statement ``% DV = % Daily Value'' 
when ``Daily Value'' is not spelled out in the heading, as shown in 
paragraph (f)(4).
    (g) Compliance with this section shall be determined as follows:
* * * * *
    (2) The sample for nutrient analysis shall consist of a composite 
of 12 subsamples (consumer units), taken 1 from each of 12 different 
randomly chosen shipping cases, to be representative of a lot. Unless a 
particular method of analysis is specified in paragraph (c) of this 
section, composites shall be analyzed by appropriate methods as given 
in the ``Official Methods of Analysis of the AOAC International,'' or, 
if no AOAC method is available or appropriate, by other reliable and 
appropriate analytical procedures.
    (3) * * *
    (ii) Class II. Naturally occurring (indigenous) nutrients. When a 
nutrient is naturally occurring (indigenous) in a food or an ingredient 
that is added to a food, the total amount of such nutrient in the final 
food product is subject to class II requirements, except that when an 
exogenous source of the nutrient is also added to the final food 
product, the total amount of the nutrient in the final food product 
(indigenous and

[[Page 33991]]

exogenous) is subject to class I requirements.
    (4) A food with a label declaration of a vitamin, mineral, protein, 
total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, 
polyunsaturated or monounsaturated fat shall be deemed to be misbranded 
under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) unless it meets the following requirements:
    (i) When a vitamin, mineral, protein, or dietary fiber meets the 
definition of a Class I nutrient, the nutrient content of the composite 
must be formulated to be at least equal to the value for that nutrient 
declared on the label.
    (ii) When a vitamin, mineral, protein, total carbohydrate, 
polyunsaturated or monounsaturated fat, or dietary fiber meets the 
definition of a Class II nutrient, the nutrient content of the 
composite must be at least equal to 80 percent of the value for that 
nutrient declared on the label. Provided, That no regulatory action 
will be based on a determination of a nutrient value that falls below 
this level by a factor less than the variability generally recognized 
for the analytical method used in that food at the level involved.
    (5) A food with a label declaration of calories, total sugars, 
added sugars (when the only source of sugars in the food is added 
sugars), total fat, saturated fat, trans fat, cholesterol, or sodium 
shall be deemed to be misbranded under section 403(a) of the act if the 
nutrient content of the composite is greater than 20 percent in excess 
of the value for that nutrient declared on the label. Provided, That no 
regulatory action will be based on a determination of a nutrient value 
that falls above this level by a factor less than the variability 
generally recognized for the analytical method used in that food at the 
level involved.
    (6) Reasonable excesses of vitamins, minerals, protein, total 
carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugar 
alcohols, polyunsaturated or monounsaturated fat over labeled amounts 
are acceptable within current good manufacturing practice. Reasonable 
deficiencies of calories, total sugars, added sugars, total fat, 
saturated fat, trans fat, cholesterol, or sodium under labeled amounts 
are acceptable within current good manufacturing practice.
* * * * *
    (8) Alternatively, compliance with the provisions set forth in 
paragraphs (g)(1) through (6) of this section may be provided by use of 
an FDA approved database that has been computed following FDA guideline 
procedures and where food samples have been handled in accordance with 
current good manufacturing practice to prevent nutrition loss. FDA 
approval of a database shall not be considered granted until the Center 
for Food Safety and Applied Nutrition has agreed to all aspects of the 
database in writing. The approval will be granted where a clear need is 
presented (e.g., raw produce and seafood). Approvals will be in effect 
for a limited time, e.g., 10 years, and will be eligible for renewal in 
the absence of significant changes in agricultural or industry 
practices. Approval requests shall be submitted in accordance with the 
provisions of Sec.  10.30 of this chapter. Guidance in the use of 
databases may be found in the ``FDA Nutrition Labeling Manual--A Guide 
for Developing and Using Data Bases,'' available from the Office of 
Nutrition and Food Labeling (HFS-800), Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740 or by going to http://www.fda.gov.
* * * * *
    (10) The manufacturer must make and keep written records (e.g., 
analyses of databases, recipes, formulations, information from recipes 
or formulations, or batch records) to verify the declared amount of 
that nutrient on the Nutrition Facts label as follows:
    (i) When a mixture of dietary fiber, and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber, is 
present in the food, a manufacturer must make and keep written records 
of the amount of non-digestible carbohydrate(s) added to the food that 
does not meet the definition of dietary fiber.
    (ii) When a mixture of soluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must make and keep written records 
necessary to verify the amount of the non-digestible carbohydrate(s) 
added to the food that does not meet the definition of dietary fiber.
    (iii) When a mixture of insoluble fiber and added non-digestible 
carbohydrate(s) that does not meet the definition of dietary fiber is 
present in the food, a manufacturer must make and keep written records 
necessary to verify the amount of the non-digestible carbohydrate(s) 
added to the food that does not meet the definition of dietary fiber.
    (iv) When a mixture of naturally occurring and added sugars is 
present in the food, a manufacturer must make and keep written records 
of the amount of added sugars added to the food during the processing 
of the food, and if packaged as a separate ingredient, as packaged 
(whether as part of a package containing one or more ingredients or 
packaged as a single ingredient).
    (v) When the amount of sugars added to food products is reduced 
through non-enzymatic browning and/or fermentation, manufacturers must:
    (A) Make and keep records of all relevant scientific data and 
information relied upon by the manufacturer that demonstrates the 
amount of added sugars in the food after non-enzymatic browning and/or 
fermentation and a narrative explaining why the data and information 
are sufficient to demonstrate the amount of added sugars declared in 
the finished food, provided the data and information used is specific 
to the type of food that is subject to non-enzymatic browning and/or 
fermentation; or
    (B) Make and keep records of the amount of added sugars added to 
the food before and during the processing of the food, and if packaged 
as a separate ingredient, as packaged (whether as part of a package 
containing one or more ingredients or packaged as a single ingredient) 
and in no event shall the amount of added sugars declared exceed the 
amount of total sugars on the label; or
    (C) Submit a petition, under 21 CFR 10.30, to request an 
alternative means of compliance. The petition must provide scientific 
data or other information for why the amount of added sugars in a 
serving of the product is likely to have a significant reduction in 
added sugars compared to the amount added prior to non-enzymatic 
browning and/or fermentation. A significant reduction would be where 
reduction in added sugars after non-enzymatic browning and/or 
fermentation may be significant enough to impact the label declaration 
for added sugars by an amount that exceeds the reasonable deficiency 
acceptable within good manufacturing practice under paragraph (g)(6) of 
this section. In addition, the scientific data or other information 
must include the reason that the manufacturer is unable to determine a 
reasonable approximation of the amount of added sugars in a serving of 
their finished product and a description of the process that they used 
to come to that conclusion.
    (vi) When a mixture of all rac-[alpha]-tocopherol and RRR-[alpha]-
tocopherol is present in a food, manufacturers must make and keep 
written records of the amount of all rac-[alpha]-tocopherol added to 
the food and RRR-[alpha]-tocopherol in the finished food.

[[Page 33992]]

    (vii) When a mixture of folate and folic acid is present in a food, 
manufacturers must make and keep written records of the amount of 
synthetic folate and/or folic acid added to the food and the amount of 
naturally-occurring folate in the finished food.
    (11) Records necessary to verify certain nutrient declarations that 
are specified in paragraph (g)(10) of this section must be kept for a 
period of at least 2 years after introduction or delivery for 
introduction of the food into interstate commerce. Such records must be 
provided to FDA upon request, during an inspection, for official review 
and photocopying or other means of reproduction. Records required to 
verify information on the label may be kept either as original records, 
true copies (such as photocopies, pictures, scanned copies, microfilm, 
microfiche, or other accurate reproductions of the original records), 
or electronic records which must be kept in accordance with part 11 of 
this chapter. These records must be accurate, indelible, and legible.
    Failure to make and keep the records or provide the records to 
appropriate regulatory authorities, as required by this paragraph 
(g)(11), would result in the food being misbranded under section 
403(a)(1) of the act.
    (h) * * *
    (3) * * *
    (iv) Nutrition information may be provided per serving for 
individual foods in the package, or, alternatively, as a composite per 
serving for reasonable categories of foods in the package having 
similar dietary uses and similar significant nutritional 
characteristics. Reasonable categories of foods may be used only if 
accepted by FDA. In determining whether a proposed category is 
reasonable, FDA will consider whether the values of the characterizing 
nutrients in the foods proposed to be in the category meet the 
compliance criteria set forth in paragraphs (g)(3) through (6) of this 
section. Proposals for such categories may be submitted in writing to 
the Office of Nutrition and Food Labeling (HFS-800), Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740.
* * * * *
    (4) If a food is commonly combined with other ingredients or is 
cooked or otherwise prepared before eating, and directions for such 
combination or preparations are provided, another column of figures may 
be used to declare nutrition information on the basis of the food as 
consumed in the format required in paragraph (e) of this section; e.g., 
a dry ready-to-eat cereal may be described with the percent Daily Value 
and the quantitative amounts for the cereal as sold (e.g., per ounce), 
and the percent Daily Value and the quantitative amounts for the cereal 
and milk as suggested in the label (e.g., per ounce of cereal and \1/
2\cup of vitamin D fortified skim milk); and a cake mix may be labeled 
with the percent Daily Value and the quantitative amounts for the dry 
mix (per serving) and the percent Daily Value and the quantitative 
amounts for the serving of the final cake when prepared, as shown in 
paragraph (e)(5) of this section: Provided, that, the type and quantity 
of the other ingredients to be added to the product by the user and the 
specific method of cooking and other preparation shall be specified 
prominently on the label.
* * * * *
    (j) * * *
    (5)(i) Foods, other than infant formula, represented or purported 
to be specifically for infants through 12 months of age and children 1 
through 3 years of age shall bear nutrition labeling. The nutrients 
declared for infants through 12 months of age and children 1 through 3 
years of age shall include calories, total fat, saturated fat, trans 
fat, cholesterol, sodium, total carbohydrates, dietary fiber, total 
sugars, added sugars, protein, and the following vitamins and minerals: 
Vitamin D, calcium, iron, and potassium.
    (ii) Foods, other than infant formula, represented or purported to 
be specifically for infants through 12 months of age shall bear 
nutrition labeling, except that:
    (A) Such labeling shall not declare a percent Daily Value for 
saturated fat, trans fat, cholesterol, sodium, dietary fiber, total 
sugars, or added sugars and shall not include a footnote.
    (B) The following sample label illustrates the provisions of 
paragraph (j)(5)(ii) of this section.
[GRAPHIC] [TIFF OMITTED] TR27MY16.009

    (iii) Foods, other than infant formula, represented or purported to 
be specifically for children 1 through 3 years of age shall include a 
footnote that states: ``*The % Daily Value tells you how much a 
nutrient in a serving of

[[Page 33993]]

food contributes to a daily diet. 1,000 calories a day is used for 
general nutrition advice.''
    (A) The following sample label illustrates the provisions of 
paragraph (j)(5)(iii) of this section.
[GRAPHIC] [TIFF OMITTED] TR27MY16.010

    (B) [Reserved]
* * * * *
    (13)(i) Foods in small packages that have a total surface area 
available to bear labeling of less than 12 square inches, Provided, 
That the labels for these foods bear no nutrition claims or other 
nutrition information in any context on the label or in labeling or 
advertising. Claims or other nutrition information subject the food to 
the provisions of this section. Foods in packages subject to 
requirements of paragraphs (j)(13)(ii)(A)(1) and (2) of this section do 
not require the information in paragraphs (d)(9) and (f)(5) related to 
the footnote, however the abbreviated footnote statement ``% DV = % 
Daily Value'' may be used.
    (ii) * * *
    (A) * * *
    (1) The following sample label illustrates the tabular display for 
small packages.
[GRAPHIC] [TIFF OMITTED] TR27MY16.011

    (2) The following sample label illustrates the linear display.
    [GRAPHIC] [TIFF OMITTED] TR27MY16.012
    

[[Page 33994]]

    (B) Using any of the following abbreviations:

Serving size--Serv size
Servings per container--Servings
Calories from saturated fat--Sat fat cal
Saturated fat--Sat fat
Monounsaturated fat--Monounsat fat
Polyunsaturated fat--Polyunsat fat
Cholesterol--Cholest
Total carbohydrate--Total carb. This abbreviation can also be used on 
dual-column displays as shown in paragraphs (e)(5), (e)(6)(i), and 
(e)(6)(ii).
Dietary fiber--Fiber
Soluble fiber--Sol fiber
Insoluble fiber--Insol fiber
Sugar alcohol--Sugar alc
Vitamin--Vit
Potassium--Potas
Includes--Incl. This abbreviation can also be used on dual-column 
displays as shown in paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of 
this section.
* * * * *
    (18) * * *
    (iv) A notice shall be filed with the Office of Nutrition and Food 
Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740 and contain the following information, except that if the person 
is not an importer and has fewer than 10 full-time equivalent 
employees, that person does not have to file a notice for any food 
product with annual sales of fewer than 10,000 total units:
* * * * *
    (l) The standards required in this section are incorporated by 
reference into this section with the approval of the Director of the 
Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved 
material is available for inspection at the Office of Nutrition and 
Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 
20740, 240-402-2404 and is available from the sources indicated below. 
It is also available for inspection at the National Archives and 
Records Administration (NARA). For information on the availability of 
this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (1) AOAC Reseller. Techstreet, 6300 Interfirst Dr., Ann Arbor, MI 
48108, Toll free in United States: 1-800-699-9277, Outside United 
States: 1-734-780-8000, Fax: 1-734-780-2046, 
www.techstreet.com,techstreet.service@thomsonreuters.com. FDA does not 
endorse any particular reseller and notes that other resellers also may 
have the reference for sale. Consult FDA at 240-402-2404 for more 
information on additional resellers.
    (i) ``Official Methods of Analysis of the AOAC INTERNATIONAL,'' 
19th Edition, Volumes 1 and 2, 2012.
    (ii) [Reserved]
    (2) Food and Agriculture Organization of the United Nations/World 
Health Organization (FAO/WHO), Publications Division, Viale delle Terme 
di Caracalla, 00100 Rome, Italy
    (i) FAO Food and Nutrition Paper 51,''Report of the Joint FAO/WHO 
Expert Consultation on Protein Quality Evaluation,'' Rome, 1991. http://apps.who.int/iris/bitstream/10665/38133/1/9251030979_eng.pdf.
    (ii) [Reserved]
    (3) United States Department of Agriculture (USDA), Agricultural 
Research Service, Washington, DC, Nutrient Data Laboratory, Bldg. 005 
Room 105 BARC-West, Beltsville, MD 20705, 301-504-0630. http://www.ars.usda.gov/News/docs.htm?docid=9447.
    (i) USDA Handbook No. 74, Energy Value of Foods--basis and 
derivation, by A. L. Merrill and B. K. Watt, (slightly revised, 1973) 
http://www.ars.usda.gov/SP2UserFiles/Place/80400525/Data/Classics/ah74.pdf.
    (ii) [Reserved]
* * * * *

0
3. In Sec.  101.30, revise paragraph (e)(2) to read as follows:

Sec.  101.30  Percentage juice declaration for foods purporting to be 
beverages that contain fruit or vegetable juice.

* * * * *
    (e) * * *
    (2) In easily legible boldface print or type in distinct contrast 
to other printed or graphic matter, in a height not less than the 
largest type found on the information panel except that used for the 
brand name, product name, logo, universal product code, the title 
phrase ``Nutrition Facts,'' the declaration of ``Serving size,'' 
``Calories'' and the numerical value for ``Calories appearing in the 
nutrition information as required by Sec.  101.9.
* * * * *

0
4. In Sec.  101.36:
0
a. Revise paragraphs (b)(2)(i) introductory text, (b)(2)(i)(B), 
(b)(2)(ii)(A) and (B), (b)(2)(iii) introductory text, (b)(2)(iii)(D) 
through (G), (b)(3)(ii)(A), (c)(4), (e) introductory text, (e)(8), 
(e)(11)(i) through (viii), (e)(12), and (f).
0
b. Remove paragraph (i) introductory text.
0
c. Revise paragraph (i)(1).
    The revisions read as follows:

Sec.  101.36  Nutrition labeling of dietary supplements.

* * * * *
    (b) * * *
    (2) * * * (i) The (b)(2)-dietary ingredients to be declared, that 
is, total calories, total fat, saturated fat, trans fat, cholesterol, 
sodium, total carbohydrate, dietary fiber, total sugars, added sugars, 
protein, vitamin D, calcium, iron, and potassium, shall be declared 
when they are present in a dietary supplement in quantitative amounts 
by weight that exceed the amount that can be declared as zero in 
nutrition labeling of foods in accordance with Sec.  101.9(c). Calories 
from saturated fat, polyunsaturated fat, monounsaturated fat, soluble 
fiber, insoluble fiber, and sugar alcohol may be declared, but they 
shall be declared when a claim is made about them. Any (b)(2)-dietary 
ingredients that are not present, or that are present in amounts that 
can be declared as zero in Sec.  101.9(c), shall not be declared (e.g., 
amounts corresponding to less than 2 percent of the RDI for vitamins 
and minerals). Protein shall not be declared on labels of products 
that, other than ingredients added solely for technological reasons, 
contain only individual amino acids.
* * * * *
    (B) The names of dietary ingredients that are declared under 
paragraph (b)(2)(i) of this section shall be presented in a column 
aligned on the left side of the nutritional label in the order and 
manner of indentation specified in Sec.  101.9(c), except that calcium 
and iron shall follow choline, and sodium and potassium shall follow 
chloride. This results in the following order for vitamins and 
minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, 
thiamin, riboflavin, niacin, vitamin B6, folate and folic 
acid, vitamin B12, biotin, pantothenic acid, choline, 
calcium, iron, phosphorous, iodine, magnesium, zinc, selenium, copper, 
manganese, chromium, molybdenum, chloride, sodium, potassium, and 
fluoride. The (b)(2)-dietary ingredients shall be listed according to 
the nomenclature specified in Sec.  101.9 or in paragraph 
(b)(2)(i)(B)(2) of this section.
    (1) When ``Calories'' are declared, they shall be listed first in 
the column of names, beneath a light bar separating the heading 
``Amount Per Serving'' from the list of names. When ``Calories from 
saturated fat'' are declared, they shall be indented under 
``Calories.''
    (2) The following synonyms may be added in parentheses immediately 
following the name of these (b)(2)-

[[Page 33995]]

dietary ingredients: Vitamin C (ascorbic acid), thiamin (vitamin 
B1), riboflavin (vitamin B2), and calories 
(energy). Energy content per serving may be expressed in kilojoule 
units, added in parentheses immediately following the statement of 
caloric content.
    (3) Beta-carotene may be declared as the percent of vitamin A that 
is present as beta-carotene, except that the declaration is required 
when a claim is made about beta-carotene. When declared, the percent 
shall be declared to the nearest whole percent, immediately adjacent to 
or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-
carotene)''). The amount of beta-carotene in terms of micrograms (mcg) 
may be included in the parentheses following the percent statement 
(e.g., ``Vitamin A (90% (810 mcg) as beta-carotene)'').
    (ii) * * *
    (A) The amounts shall be expressed in the increments specified in 
Sec.  101.9(c)(1) through (7), which includes increments for sodium.
    (B) The amounts of vitamins and minerals, excluding sodium and 
potassium, shall be the amount of the vitamin or mineral included in 
one serving of the product, using the units of measurement and the 
levels of significance given in Sec.  101.9(c)(8)(iv), except that 
zeros following decimal points may be dropped, and additional levels of 
significance may be used when the number of decimal places indicated is 
not sufficient to express lower amounts (e.g., the RDI for zinc is 
given in whole milligrams (mg), but the quantitative amount may be 
declared in tenths of a mg). The amount of vitamin D may, but is not 
required to, be expressed in IUs, in addition to the mandatory 
declaration in mcg. Any declaration of the amount of vitamin D in IUs 
must appear in parentheses after the declaration of the amount of 
vitamin D in mcg.
* * * * *
    (iii) The percent of the Daily Value of all dietary ingredients 
declared under paragraph (b)(2)(i) of this section shall be listed, 
except that the percent Daily Value for protein, when present, shall be 
calculated using the corrected amount of protein as specified in Sec.  
101.9(c)(7)(ii); no percent of the Daily Value shall be given for 
subcomponents for which DRVs or RDIs have not been established (e.g., 
total sugars). Additionally, the percentage of the RDI for protein 
shall be omitted when a food is purported to be for infants through 12 
months of age.
* * * * *
    (D) If the percent of Daily Value is declared for total fat, 
saturated fat, total carbohydrate, dietary fiber, or protein, or added 
sugars, a symbol shall follow the value listed for those nutrients that 
refers to the same symbol that is placed at the bottom of the nutrition 
label, below the bar required under paragraph (e)(6) of this section 
and inside the box, that is followed by the statement ``Percent Daily 
Values are based on a 2,000 calorie diet.'' If the product is 
represented or purported to be for use by children 1 through 3 years of 
age, and if the percent of Daily Value is declared for total fat, total 
carbohydrate, dietary fiber, or protein, or added sugars, a symbol 
shall follow the value listed for those nutrients that refers to the 
same symbol that is placed at the bottom of the nutrition label, below 
the bar required under paragraph (e)(6) of this section and inside the 
box, that is followed by the statement ``Percent Daily Values are based 
on a 1,000 calorie diet.''
    (E) The percent of Daily Value shall be based on RDI or DRV values 
for adults and children 4 or more years of age, unless the product is 
represented or purported to be specifically for infants through 12 
months of age, children 1 through 3 years of age, pregnant women, or 
lactating women, in which case the column heading shall clearly state 
the intended group. If the product is for persons within more than one 
group, the percent of Daily Value for each group shall be presented in 
separate columns as shown in paragraph (e)(11)(ii) of this section.
    (F) For declared subcomponents that have no DRVs or RDIs, a symbol 
(e.g., an asterisk) shall be placed in the ``Percent Daily Value'' 
column that shall refer to the same symbol that is placed at the bottom 
of the nutrition label, below the last heavy bar and inside the box, 
and followed by a statement ``Daily Value not established.''
    (G) When calories or calories from saturated fat are declared, the 
space under the ``% DV'' column shall be left blank for these items. 
When there are no other (b)(2)-dietary ingredients listed for which a 
value must be declared in the ``% DV'' column, the column may be 
omitted as shown in paragraph (e)(11)(vii) of this section. When the 
``% DV'' column is not required, but the dietary ingredients listed are 
subject to paragraph (b)(2)(iii)(F) of this section, the symbol 
required in that paragraph shall immediately follow the quantitative 
amount by weight for each dietary ingredient listed under ``Amount Per 
Serving.''
    (3) * * *
    (ii) * * *
    (A) These amounts shall be expressed using metric measures in 
appropriate units.
* * * * *
    (c) * * *
    (4) The sample label shown in paragraph (e)(11)(v) of this section 
illustrates one method of nutrition labeling a proprietary blend of 
dietary ingredients.
* * * * *
    (e) Except as provided for small and intermediate sized packages 
under paragraph (i)(2) of this section, information other than the 
title, headings, and footnotes shall be in uniform type size no smaller 
than 8 point. A font size at least two points greater shall be used for 
``Calories'' and the heading ``Calories'' and the actual number of 
calories per serving shall be highlighted in bold or extra bold type. 
Type size no smaller than 6 point may be used for column headings 
(e.g., ``Amount Per Serving'' and ``% Daily Value'') and for footnotes 
(e.g., ``Percent Daily Values are based on a 2,000 calorie diet).
* * * * *
    (8) If the product contains two or more separately packaged dietary 
supplements that differ from each other (e.g., the product has a packet 
of supplements to be taken in the morning and a different packet to be 
taken in the afternoon), the quantitative amounts and percent of Daily 
Value may be presented as specified in this paragraph in individual 
nutrition labels or in one aggregate nutrition label as illustrated in 
paragraph (e)(11)(iii) of this section.
* * * * *
    (11) * * *

BILLING CODE 4164-01-P

[[Page 33996]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.013

[[Page 33997]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.014

[[Page 33998]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.015

[[Page 33999]]

[GRAPHIC] [TIFF OMITTED] TR27MY16.016

    (12) If space is not adequate to list the required information as 
shown in the sample labels in paragraph (e)(11) of this section, the 
list may be split and continued to the right as long as the headings 
are repeated. The list to the right must be set off by a line that 
distinguishes it and sets it apart from the dietary ingredients and 
percent of Daily Value information given to the left. The following 
sample label illustrates this display:
[GRAPHIC] [TIFF OMITTED] TR27MY16.017

    (f)(1) Compliance with this section will be determined in 
accordance with Sec.  101.9(g)(1) through (g)(8), (g)(10), and (g)(11), 
except that the sample for analysis shall consist of a composite of 12 
subsamples (consumer packages) or 10 percent of the number of packages 
in the same inspection lot, whichever is smaller, randomly selected to 
be representative of the lot. The criteria on class I and class II 
nutrients given in Sec.  101.9(g)(3) and (g)(4) also are applicable to 
other dietary ingredients described in paragraph (b)(3)(i) of this 
section. Reasonable excesses over labeled amounts are acceptable within 
current good manufacturing practice.
    (2) When it is not technologically feasible, or some other 
circumstance makes it impracticable, for firms to comply with the 
requirements of this section, FDA may permit alternative means of 
compliance or additional exemptions to deal with the situation in 
accordance with Sec.  101.9(g)(9). Firms in need of such special 
allowances shall make their request in writing to the Office of 
Nutrition and Food Labeling (HFS-800), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740.
* * * * *
    (i)(1) Dietary supplements are subject to the special labeling 
provisions specified in Sec.  101.9(j)(5)(i) for foods other than 
infant formula, represented or purported to be specifically for infants 
through 12 months of age and children 1 through 3 years of age.
* * * * *

    Dated: May 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-11867 Filed 5-20-16; 8:45 am]
 BILLING CODE 4164-01-P