Food Labeling: Revision of the Nutrition and Supplement Facts Labels
Federal RegisterMay 27, 2016
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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.
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
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 B
12
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 B
12
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 § 101.9(c)(8)(iii) To Provide Instructions for Rounding Percent DVs
5. Miscellaneous Changes
T. Miscellaneous Comments
III. Effective and Compliance Dates
IV. Economic Analysis of Impacts
V. Paperwork Reduction Act of 1995
A. Recordkeeping Requirements
B. Reporting Requirements
C. Third-Party Disclosure Requirements
D. Third-Party Disclosure Burden for Manufacturers
VI. Analysis of Environmental Impact
VII. Federalism
VIII. References
Executive Summary
Purpose of the Regulatory Action
We are amending our regulations for the nutrition labeling of conventional foods and dietary supplements to help consumers maintain healthy dietary practices. Section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)) specifies certain nutrients to be declared in nutrition labeling, and authorizes the Secretary of Health and Human Services to require other nutrients to be declared if the Secretary determines that a nutrient will provide information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices. The Secretary also has discretion under section 403(q) of the FD&C Act to remove, by regulation and under certain circumstances, nutrient information that is otherwise explicitly required in food labeling under this section.
The final rule revises our regulations to provide updated nutrition information on the label and to improve how the nutrition information is presented to consumers.
Summary of the Major Provisions of the Regulatory Action in Question
The final rule revises the Nutrition Facts label by:
• Removing the declaration of “Calories from fat” because current science supports a view that the type of fat is more relevant than overall total fat intake in increased risk of chronic diseases;
• Requiring the declaration of the gram amount of “added sugars” in a serving of a product, establishing a Daily Reference Value (DRV), and requiring the percent Daily Value (DV) declaration for added sugars;
• Changing “Sugars” to “Total Sugars” and requiring that “Includes `X' g Added Sugars” be indented and declared directly below “Total Sugars” on the label;
• Updating the list of vitamins and minerals of public health significance. For example, the final rule requires the declaration of vitamin D and potassium and permits, rather than requires, the declaration of vitamins A and C;
• Updating certain reference values used in the declaration of percent DVs of nutrients on the Nutrition Facts and Supplement Facts labels;
• Revising the format of the Nutrition Facts and Supplement Facts labels to increase the prominence of the term “Calories;”
• Removing the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets;
• Requiring the maintenance of records to support the declarations of certain nutrients under specified circumstances. For example, because there are no analytical methods that can distinguish between dietary fiber (soluble and insoluble fiber) and nondigestible carbohydrates that do not meet the definition of dietary fiber; added and naturally occurring sugars or the various forms of vitamin E; or folate and folic acid, the final rule requires manufacturers to make and keep certain written records to verify the declarations of dietary fiber, added sugars, vitamin E, and folate and folic acid in the labeling of the food associated with such records. The final rule requires these records to be kept for at least 2 years after introduction or delivery for introduction of the food into interstate commerce. A similar requirement exists with respect to added sugars in foods subject to non-enzymatic browning and fermentation because there are no analytical methods that can determine the amount of added sugar in specific foods containing added sugars alone or in combination with naturally occurring sugars, where the added sugars are subject to non-enzymatic browning and fermentation. However, for manufacturers of such foods who are unable to reasonably approximate the amount of added sugars in a serving of food to which the records requirements apply, the final rule allows manufacturers to submit a petition to request an alternative means of compliance; and
• Establishing a compliance date of 2 years after the final rule's effective date, except that manufacturers with less than $10 million in annual food sales have a compliance date of 3 years after the final rule's effective date. (For more details, see part III.)
The final rule is the result of significant stakeholder engagement. We received nearly 300,000 comments, conducted several consumer studies and made those studies publicly available, and, in light of new scientific recommendations (particularly for added sugars), issued a supplemental notice of proposed rulemaking.
Elsewhere in this issue of the
Federal Register
, we have published a final rule that amends the definition of a single-serving container, requires dual column labeling for certain containers, updates the reference amounts customarily consumed and serving sizes for several food product categories, and amends the serving size for breath mints.
Costs and Benefits
We have developed one final regulatory impact analysis (FRIA) for this final rule as well as the final rule entitled “Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments.” The FRIA discusses key inputs in the estimation of costs and benefits of the changes finalized by the rules and assesses the sensitivity of cost and benefit totals to those inputs. The two nutrition labeling rules—which have a compliance date of 2 years after the final rule's effective date for manufacturers with $10 million or more in annual food sales, and 3 years after the final rule's effective date for manufacturers with less than $10 million in annual food sales—have impacts, including the sign on net benefits, that are characterized by substantial uncertainty. The primary sensitivity analysis shows benefits having the potential to range between $0.2 and $2 or $5 billion,
and costs ranging between $0.2, $0.5 and $0.8 billion (annualized over the next twenty years, in 2014 dollars, at seven percent interest).
1
1
There is substantial uncertainty regarding the impacts of the two nutrition labeling rules. For a full discussion of the uncertainty, please see the Welfare Estimates—Primary Sensitivity Analysis section of the regulatory impact analysis.
Table 1—Summary of the Primary Sensitivity Analysis of the Costs and Benefits of the Final Rules
[in billions of 2014$]
Benefits
(Low)
Benefits
(Mean)
Benefits
(High)
Costs
(Low)
Costs
(Mean)
Costs
(High)
Present Value
3%
$2.8
$33.1
$77.7
$2.3
$4.8
$8.6
7%
1.9
22.3
52.5
2.2
4.5
8.3
Annualized Amount
3%
0.2
2.2
5.2
0.2
0.3
0.6
7%
0.2
2.1
5.0
0.2
0.4
0.8
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 § 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 §§ 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 § 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
§ 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
-α-tocopherol acetate and RRR-α-tocopherol, we are requiring manufacturers to make and keep written records to verify the amount of
all rac
-α-tocopherol acetate added to the food and RRR-α-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 § 101.9(g)(10) and (11), would result in the food being misbranded under sections 403(q) and 403(a)(1) of the FD&C Act.
B. Need To Update the Nutrition Facts and Supplement Facts Labels
We first issued regulations related to the Nutrition Facts label in 1993 and amended them in 1995 (to establish new DVs and to update the DVs (60 FR 67164, December 28, 1995)) and in 2003 (to address the declaration of
trans
fats (68 FR 41434, July 11, 2003)). From July 2003 to November 2007, we also issued three advance notices of proposed rulemaking (ANPRMs) seeking public comment on issues relevant to updating the Nutrition Facts label. These ANPRMs sought comment on:
• Data that could be used to establish new nutrient content claims about
trans
fatty acids; to establish qualifying criteria for
trans
fat in nutrient content claims for saturated fatty acids and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol raising lipids; and, in addition, to establish disclosure and disqualifying criteria to help consumers make heart healthy food choices. We also requested comments on whether we should consider statements about
trans
fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts label or as a disclosure statement in conjunction with claims to enhance consumer understanding about cholesterol-raising lipids and how to use the information to make healthy food choices (68 FR 41507, July 11, 2003). We later extended the comment period (69 FR 20838, April 19, 2004) to receive comments that considered the information in the 2004 meeting of the Nutrition Subcommittee of the Food Advisory Committee which addressed whether the available scientific evidence supported listing the percent DV for saturated fat and
trans
fat together or separately on the Nutrition Facts label and what the maximal daily intake of
trans
fat may be;
• The prominence of calories on the food label (70 FR 17008, April 4, 2005) (the 2005 ANPRM). We took this action in response to recommendations from the Obesity Working Group established by the Commissioner of Food and Drugs to develop an action plan to address the growing incidence of obesity in the United States. The 2005 ANPRM, in part, requested comments on whether giving more prominence to the declaration of calories per serving would increase consumer awareness of the caloric content of the packaged food and whether providing a percent DV for total calories would help consumers understand the caloric content of the packaged food in the context of a 2,000 calorie diet. We also requested comments on questions concerning the declaration of “Calories from fat;” and
• The revision of reference values and mandatory nutrients (72 FR 62149, November 2, 2007) (the 2007 ANPRM). The 2007 ANPRM requested comment on various aspects of nutrition labeling, including new reference values we should use to calculate the percent DV in the Nutrition Facts and Supplement Facts labels and factors we should consider in establishing such new reference values. We also requested comments on whether we should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels.
Additionally, between 1993 and 2013, we received 12 citizen petitions asking us to make various changes to the Nutrition Facts and Supplement Facts labels. For example, some petitions asked us to permit the use of a different term on the Nutrition Facts label, while others sought changes in definitions, values (such as caloric values or the DV for a specific nutrient), or the inclusion of more information on the Nutrition Facts label.
Yet, as we considered the issues raised in the ANPRMs and the citizen petitions, the public health profile of the U.S. population changed, and new
information became available about nutrient definitions, reference intake values, and analytical methods. New dietary recommendations also were published. We reconsidered what nutrients we should require or permit to be listed on the Nutrition Facts label and what nutrient reference intake values we should use as a basis for calculating the percent DVs in food labeling. We also considered corresponding changes to the Supplement Facts labels. Consequently, in the
Federal Register
of March 3, 2014 (79 FR 11879), we issued a proposed rule to amend our labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label and to help consumers maintain healthy dietary practices. The preamble to the proposed rule discussed, in some detail, the reasons why we felt it necessary to update the Nutrition Facts and Supplement Facts labels (see 79 FR 11879 at 11884 through 11889). In brief, the preamble to the proposed rule discussed:
• Rates of chronic disease, such as cardiovascular disease, diabetes, and cancer, and changes in obesity rates (79 FR 11879 at 11885);
• Dietary recommendations, consensus reports, and national survey data, such as the Institute of Medicine (IOM) Dietary Reference Intakes Reports (which resulted in the development of a set of reference values known collectively as Dietary Reference Intakes (DRIs) (id. at 11885 through 11887). The DRIs themselves consist of four categories of reference values: (1) The Estimated Average Requirement (EAR); (2) Recommended Dietary Allowance (RDA); (3) Adequate Intake (AI); and (4) Tolerable Upper Intake Level (UL) (id.). The preamble to the proposed rule explained that the EAR is the average daily nutrient intake level that is estimated to meet the requirements of half of the healthy individuals in a particular life stage and gender group and that EARs are used for assessing the statistical probability of adequacy of nutrient intakes of groups of people. The RDA is an estimate of the average intake level that meets the nutrient requirements of nearly all (97 to 98 percent) healthy individuals in a particular life stage and gender group and is set using the EAR. In general, the RDA is the EAR plus two times the standard deviation of the EAR. The RDA is used to plan nutrient intakes for individuals to ensure a low probability of inadequacy. The AI is the level determined for an essential nutrient or a nutrient that is beneficial for human health when there is insufficient evidence to calculate an EAR for that nutrient, and therefore insufficient evidence on which to establish an RDA. AIs can be based on a variety of data, including scientific evidence about the essentiality of a nutrient (
i.e.,
choline, biotin, fluoride), experimental data on risk reduction of chronic disease (
i.e.,
dietary fiber, potassium), and median intakes of a nutrient using national survey data (
i.e.,
vitamin K, pantothenic acid, chromium, manganese, linoleic acid, and α-linolenic acid). Although there is less certainty about an AI value than about an RDA value, the AI is similarly designed to cover the needs of nearly all individuals. The UL is the highest average daily intake level likely to pose no risk of adverse health effects for nearly all people in a particular group. The UL is not intended to be a recommended level of intake, but is used to assess the risk of adverse health effects from excessive nutrient intake. As intake above the UL increases, so does the potential for risk of adverse health effects (id. at 11885 through 11886). The preamble to the proposed rule also discussed the Dietary Guidelines for Americans (DGA); the DGA is developed jointly by the U.S. Department of Agriculture and the U.S. Department of Health and Human Services and provides key recommendations on dietary patterns and quantitative intake recommendations with respect to micronutrients and macronutrients (id. at 11886). Although the preamble to the proposed rule discussed the DGA that was issued in 2010, in February 2015, the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (DGAC Report) became publicly available. While the DGAC Report is not a DGA itself (because the Federal government must determine how to use the information in the DGAC Report to develop the 2015-2020 version of the DGA), the DGAC Report contains scientific information on specific nutrients and vitamins as well as a review of the underlying scientific evidence. For example, the DGAC Report contains scientific evidence related to a daily intake recommendation for added sugars. In the
Federal Register
of July 27, 2015 (80 FR 44303), we issued a supplemental proposed rule with respect to the scientific evidence in the DGAC Report pertaining to added sugars and the possible inclusion of added sugars to the Nutrition Facts and Supplement Facts labels.
• Consumer use and understanding of the Nutrition Facts label (79 FR 11879 at 11887). The preamble to the proposed rule discussed, among other things, the frequency at which consumers use food labels and the purposes for which they consulted food labels (id.). The preamble to the proposed rule also noted that consumer research data suggested that, despite widespread use of food labels, certain elements of the Nutrition Facts label “may need improvement” (such as consumer understanding of the concept of percent DVs) (id.). We also stated that we intended to continue performing research during the rulemaking process to evaluate how variations in label format may affect consumer understanding and use of the Nutrition Facts label as well as to help inform consumer education (id.).
• Other considerations, including the focus of the Nutrition Facts label itself and practical limitations (id. at 11887 through 11888). For example, we noted that the Nutrition Facts label information is to help consumers make more informed choices to consume a healthy diet and not intended for the clinical management of an existing disease. However, we also said that we were considering the large proportion of the U.S. population that is at risk for chronic disease as we proposed changes to the Nutrition Facts label's content and format (id. at 11887). Simultaneously, we recognized that there is not room on the label for all information that may be related to maintaining healthy dietary practices and that space constraints on the label of most foods make it impractical to declare all essential nutrients (id. at 11888). We added that having a large amount of information on the label could interfere with consumers' abilities to use the information that has the greatest public health significance and that, given the amount and format of information that we require on the label, limits to the voluntary information on the label are necessary so that voluntary information does not clutter the label, does not mislead, confuse, or overwhelm the consumer, and does not take away prominence of and emphasis on the required information (id.).
The preamble to the proposed rule also discussed the citizen petitions and ANPRMs (id. at 11888 through 11889) as influencing our development of the proposed rule. Additionally, as stated earlier in part I.B, in the
Federal Register
of July 27, 2015 (80 FR 44303), we issued a supplemental proposed rule to establish a DRV of 10 percent of total energy intake from added sugars, require the declaration of the percent DV for added sugars on the label, and to provide text for the footnotes to be used on the Nutrition Facts label. The
supplemental proposed rule also provided additional data and information to support the declaration of added sugars on the label and made our consumer research regarding the footnote text and added sugars declarations publicly available.
II. Comments to the Proposed Rule and the Supplemental Proposed Rule, Our Responses, and a Description of the Final Rule
A. Introduction
The proposed rule would amend our labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label. In brief, the proposed rule would (among other things):
• Require the declaration of “Added Sugars” on the label. “Sugars” include both “added sugars” and sugars that are naturally occurring in food. The proposed rule would require the declaration of “Added Sugars” indented under “Sugars” so that both would be listed;
• Remove the requirement for declaring “Calories from fat.” Current research shows that the total fat in the diet is less important than the type of fat. In addition, our consumer research shows that removal of the declaration of “calories from fat” has no effect on consumers' ability to judge the healthfulness of a product;
• Revise the nutrients of public health significance that must be declared on the label. The proposed rule would require the declaration of vitamin D and potassium. Vitamin D is important for its role in bone development and general health, and intakes among some population groups are inadequate. Adequate potassium intake is beneficial in lowering blood pressure, and intakes of this nutrient are also low among some population groups. The proposed rule also would no longer require mandatory labeling for vitamin C or vitamin A because data indicate that deficiencies are not common. Voluntary labeling for vitamins C and A would be allowed; and
• Revise DVs for certain nutrients that are either mandatory or voluntary on the label. Examples include calcium, sodium, dietary fiber and vitamin D. Some DVs are intended to guide consumers about maximum intake—saturated fat, for example—while others are intended to help consumers meet a nutrient requirement—iron, for example. DVs are used to calculate the percent Daily Value (% DV) on the label, which helps consumers understand the nutrient information on the product label in the context of the total diet. We considered revisions to the DVs based on scientific evidence related to recommendations published by the IOM and other reports such as the DGA. In addition to changing some DVs, the proposed rule would change the units used to declare vitamins A, E, and D from “international units,” or “I.U.” to a metric measure, milligrams or micrograms, and also would include the absolute amounts in milligrams or micrograms of vitamins and minerals, in addition to the % DV, on the label.
The proposed rule also would change the appearance of the label itself by highlighting key parts of the label that are important in addressing current public health problems. For example, the proposed rule would:
• Highlight the caloric content of foods by increasing the type size and placing in bold type the number of calories and servings per container;
• Shift to the left of the label % DV. The % DV is intended to help consumers place nutrient information in the context of a total daily diet;
• Declare the actual amount, in addition to % DV, for all vitamins and minerals when they are declared;
• Change “Amount Per Serving” to “Amount per ___”, with the blank filled in with the serving size in common household measures, such as “Amount per 1 cup”;
• Replace the listing of “Total Carbohydrate” with “Total Carbs” and add an indented listing of “Added Sugars” directly beneath the listing for “Sugars;”
• Right justify the actual amounts of the serving size information;
• Reverse the order of “Serving Size” and “Servings Per Container” declarations; and
• Remove the existing footnote that describes the DVs for 2,000 and 2,500 calories to provide more space to better explain the percent dietary value.
The proposed label changes were intended to help consumers maintain health dietary practices, and we based the updated information on current data on associations between specific nutrients and chronic diseases or health-related conditions in the United States and on new information regarding consumer understanding of the label and consumption patterns.
We provided a 90-day comment period for the proposed rule. In the
Federal Register
of May 27, 2014 (79 FR 30055), we extended the comment period by 60 more days after receiving multiple requests to extend the comment period. In the
Federal Register
of May 29, 2014 (79 FR 30763), we announced a public meeting to discuss the proposed rule, as well as the proposed rule on serving size requirements, and to solicit oral stakeholder and public comments and to respond to questions about the proposed rules. Additionally, as we stated in part I.B, in the
Federal Register
of July 27, 2015 (80 FR 44303), we issued a supplemental proposed rule to establish a DRV of 10 percent of total energy intake from added sugars, to require the declaration of the percent DV for added sugars, and to provide text for the footnotes to be used on the Nutrition Facts label. The supplemental proposed rule also provided additional information to support the declaration of added sugars on the label and made our consumer research regarding added sugars declarations and the footnote text publicly available. We also reopened the comment period for the purpose of inviting public comment on two consumer studies we added to the administrative record (80 FR 44302). The two consumer studies pertained to proposed changes to the format of the Nutrition Facts label and to consumers' interpretations of information on the Nutrition Facts label. Collectively, with respect to the proposed rule, the supplemental proposal, and the related
Federal Register
documents, we received nearly 300,000 comments from consumers, foreign governments, industry, trade associations, professional societies, academia, health professionals, and other government agencies.
We discuss the issues raised in the comments on the proposed rule and supplemental proposed rule and also describe the final rule, in part II. We preface each comment discussion with a numbered “Comment,” and each response by the word “Response” to make it easier to identify comments and our responses. We have numbered each comment to help distinguish among different topics. The number assigned is for organizational purposes only and does not signify the comment's value, importance, or the order in which it was received.
Incorporation by Reference
Additionally, the final rule incorporates by reference the “Official Methods of Analysis of the AOAC International,” 19th Edition. The “Official Methods of Analysis of AOAC International” (AOAC Methods) is a comprehensive collection of chemical and microbiological methods of analysis. The AOAC Methods have undergone rigorous scientific review and validation to determine the performance characteristics for the intended analytical application and
fitness for purpose. Each method includes specific instructions for performing the chemical analysis of a substance in a particular matrix.
Although the 19th Edition of the AOAC Methods was available for purchase from AOAC when we drafted the proposed rule, the reference has since been sold out at AOAC INTERNATIONAL. Copies, however, can be obtained or downloaded from secondary sources, and the final rule identifies one such source. However, we do not endorse any particular secondary source or reseller and note that other resellers also may have the 19th Edition of the AOAC Methods for sale.
B. General Comments
Some comments raised issues that were general in nature or affected multiple parts of the rule.
Additionally, one foreign government agency, Health Canada, provided factual information and comments on various aspects of its review and update of nutritional information on the Canadian food label. Health Canada did not advocate a particular outcome or did not provide comments on possible changes or suggestions to our proposed rule.
1. Comments Seeking an Education Campaign or Program
(Comment 1) Several comments suggested that we develop a well-funded, coordinated, multi-component consumer education campaign to promote and explain the new Nutrition Facts label, the changes to the label, and the use of the label to help consumers to make healthier food and beverage choices. Many comments suggested that we coordinate our consumer education campaign with other Federal government Agencies including the Centers for Disease Control and Prevention (CDC), other parts of the Department of Health and Human Services, the U.S. Department of Agriculture (USDA), State health departments, and non-government entities, including food manufacturers, retailers, and non-profit organizations with an interest in nutrition and health.
Several comments suggested that our education campaign emphasize calories because knowledge of calories is important for rolling back the obesity epidemic. Other comments would focus on sodium because of its contribution to cardiovascular disease or on nutrients (such as added sugars) that would be on the Nutrition Facts label for the first time and nutrients (such as total fat) for which the science has changed significantly.
Several comments noted that, although some revisions (such as the declaration of
trans
fatty acids and the declaration of food allergens) have been made to nutrition labeling since implementation of the NLEA, there have not been changes to the label of the magnitude in the proposed rule. The comments said, therefore, that public outreach, through avenues such as Webinars, town hall meetings, and social media, will be a key component of the nutrition labeling modernization effort. A few comments suggested that the consumer education program should be informed by any relevant consumer research. Several comments noted that there is consumer confusion over the meaning of percent DV and consumer research had found that consumers do not understand or know how to use the DVs; thus, the percent DV should be a key area in which to focus consumer education efforts. One comment specifically stated that percent DV/added sugars disclosure will create substantial consumer confusion that does not exist today and that we would need to provide consumer education in attempt to overcome the confusion. Several comments stated that education is needed to help consumers understand the meaning of percent DVs, with inclusion of a brief footnote on packages, but additional consumer education should be done online.
Several comments suggested that, although the education campaign is important for all consumers to know about, understand, and use the revised Nutrition Facts label, an education campaign should primarily be designed to reach consumers who are least likely to understand and use the label, including lower income consumers, communities with diverse languages and literacy levels who are also more likely to suffer from many obesity- and nutrition-related chronic diseases than those with higher incomes and education. The comments stated that we should use multiple and culturally relevant communication channels and messengers, and we should field test our messages to ensure they are relevant and compelling for audience segments. One comment noted that a Canadian study (Ref. 1) found that participants were significantly less likely to correctly assess the Nutrition Facts label for calorie and nutrient information if they reported lower educational attainment, lower income, or non-white ethnicity. The comment also stated that the 2012 IOM report on front-of-pack labeling (Ref. 2) found that “a lack of nutrition knowledge is a major barrier to effective use of the [Nutrition Facts label] and may actually lower the motivation of some consumers to use the nutrition information on the label,” and that “some racial groups . . . are less likely . . . to use and understand nutrition labels, primarily because of lack of time to read labels and lack of understanding of the nutrition information.” The comment stated that working with other health departments and organizations could help extend our educational resources to all rural and urban communities. Another comment suggested that, to be most effective, we should incorporate lessons learned on how individuals from various subpopulations interpret the new label design. The comment noted that such education needs to accommodate individuals at various levels of educational achievement and with cultural and ethnic diversity.
A few comments suggested that we conduct the education campaign after the final rule's publication and before the rule's compliance date. One comment suggested that our recommendations be publicized to groups who interact with the public at least 3 months before implementation of the new Nutrition Facts label style and elements to allow for preparation of curricula and development of local educational and media efforts.
One comment suggested that, similar to our earlier public service campaigns such as “The Real Cost” campaign targeting youth tobacco use, we have a unique ability to get the attention of the public and shape understanding about the risks of lifestyles habits and choices. Other comments suggested that we integrate the education campaign with preexisting consumer education programs and initiatives, including the USDA's Supplemental Nutrition Assistance Program Education (SNAP-Ed) (the nutrition promotion and obesity prevention component of SNAP), school-based nutrition education programs, and grocery store labeling and education initiatives, such as the Boston Public Health Commission's “Re-Think Your Drink” campaign. One comment suggested that we develop a similar outreach campaign as “Read the Label” to enable Americans to understand the revised label and its uses.
One comment noted that, while nutrition education has been shown to have a positive impact on consumers' dietary choices and patterns, multiple studies suggest that education alone is not adequate to change consumer behavior around healthy eating for a sustained amount of time. The comment suggested that, for education efforts to be effective and sustainable, they should be combined with policy, systems, and environmental changes that support healthful choices. For example, food
environmental changes, such as increased availability of and access to healthful foods, combined with education efforts, have been found to be significantly more effective in changing consumer behavior in the long run.
(Response) We agree that a consumer education and outreach campaign will assist in making the new food label a successful tool in continuing to help consumers to make healthy food and beverage choices. Currently, we have available a collection of various educational materials (
e.g.,
videos, an array of public education materials and brochures (in English and Spanish)) on numerous nutrition topics, including materials on the Nutrition Facts label (
e.g.,
“Read the Label,” Make Your Calories Count, Sodium: Look at the Label) (Ref. 3). These materials are intended for educators, teachers, health professionals (
e.g.,
dietitians, physicians, and nurses) as well as for general consumers. Our intent is to update our existing educational materials and create new educational opportunities to explain how to use the label to help consumers make healthy dietary choices, with an emphasis on each of the new changes of the label. We intend to continue to work on and to create new partnership opportunities with other Federal government Agencies including other parts of the Department of Health and Human Services, USDA, State health departments, health professional organizations, food manufacturers, retailers, and non-profit organizations that have an interest and responsibilities in nutrition education and health promotion. These partnerships will help us develop and disseminate our educational materials that will ease the transition to the revised nutrition label and help consumers to understand and use the label to make well-informed dietary choices. Through our work with both government and non-government entities, our continued goal is to increase consumers' knowledge and effective use of the new Nutrition Facts label and to ensure that consumers have accurate and adequate resources, materials, and information for making healthy food and beverage choices. Furthermore, we intend to continue a variety of activities such as conduct and report on existing and planned food labeling research; to develop education initiatives at the national and local levels; to build labeling education exchanges; and to integrate food labeling education into existing programs (
e.g.,
USDA-school-based nutrition education programs). We plan to continue to build partnerships capable of developing and evaluating labeling education targeted to the dietary needs of diverse populations, such as low literacy consumers, lower incomes, minorities, and various subpopulations (
e.g.,
children, older subpopulation, women of childbearing age) as well as to the general public.
As for the comments stating that the percent DV should be a key area to focus consumer education efforts, and that the disclosure of “% DV/Added sugars” will create substantial consumer confusion, we will continue to provide education and outreach to consumers about using the Nutrition Facts label to make healthful dietary choices. (We also note that the comments' use of the term “confusion” is, itself, misplaced; a more appropriate characterization would be whether some consumers we tested “understand” or “misunderstand” the declaration of added sugars. However, because the comments used the term “confusion,” for convenience, we will use the same term in this response as well as in other responses on the subject of added sugars, consumer research, and education, in reference to the findings that some consumers we tested seemed to misunderstand that the term “added sugars” referred to a subcomponent of total sugars on the label.) The changes in the “new” label will be highlighted and clarified through these education and outreach endeavors. We are not planning to focus educational activities on the “% DV/Added Sugars” disclosure of the Nutrition Facts label in isolation. Instead, education and outreach will focus on a number of aspects of the label to enhance its use and understanding by consumers.
As for the comment stating that education efforts should be combined with policy, systems, and food environmental changes that support healthy dietary choices, we understand that combining the Nutrition Facts label education efforts with other policies may be more effective in supporting healthy dietary choices; however, many policies, such as consumer access to or increased availability of healthful foods, are not under our purview and are outside the scope of this rulemaking. As part of supporting access to healthy foods, we continue to encourage food product reformulation, such as reducing sodium content in the food supply.
2. Comments Linking the Nutrition Facts Label to Specific Diseases
(Comment 2) Many comments recommended mandatory declaration of specific nutrients (
e.g.,
phosphorous, added sugars, potassium) on the Nutrition Facts label because, according to the comments, these nutrients are or may be helpful to persons with an existing acute or chronic disease (
e.g.,
heart disease, chronic kidney disease, diabetes). According to the comments, mandatory declaration of the specific nutrient would be helpful for the management of specific diseases or conditions.
(Response) While the Nutrition Facts label information has never been, nor is it now, targeted to individuals with acute or chronic disease (
e.g.,
diabetes, chronic kidney disease or cardiovascular disease (CVD)), consumers with these types of diseases may be able to use quantitative information on the label to follow advice they have received from a health care professional concerning their conditions. However, the nutrient declaration and percent DVs on the label are to help consumers make more informed choices to consume a healthy diet and not intended for the clinical management of an existing disease.
3. Use of Household Measures
(Comment 3) Many comments recommended that the amount of total fat, carbohydrate, sugars, added sugars, protein, and sodium be declared in common household measurements (
e.g.
teaspoons) instead of or in addition to grams (g). The comments said that the metric system has not been widely adopted in the United States, and the average consumer is more familiar with household measurements than with grams. The comments also said that, if the purpose of the information on the label is to help consumers understand the actual amount of nutrients in a food product, the declaration of these nutrients in grams defeats the intended purpose of the label because consumers cannot conceptualize gram amounts. One comment suggested that we include an icon that would allow the consumer to visualize a gram and that we could use a teaspoon for such an icon. Another comment suggested using ounces instead of or in addition to grams because consumers can understand this information more easily than gram amounts. The comment also recommended stating on the label that there are 28 grams in an ounce and 448 grams in a pound.
(Response) We decline to require the declaration of total fat, carbohydrate, sugars, added sugars, protein, and sodium in household measurements or in ounces. Using a volume measure rather than a weight measurement for total fat, carbohydrate, sugars, added sugars, and protein would provide inaccurate information. The gram is a measure of mass or weight while a teaspoon is a measure of volume. The
gram weight of different carbohydrates, fats, and proteins is different. For example, a teaspoon of sucrose or table sugar weighs 4.2 grams, but a teaspoon of corn syrup weighs 7.3 grams (Ref. 4) and has 1.5 grams of water and 5.1 grams of sugar.
Additionally, many ingredients provide multiple nutrients, so it may not be possible for manufacturers to determine the volume contribution that each ingredient provides towards the various macronutrients. For example, salt is composed of sodium and chloride. Other ingredients, such as baking soda, contain sodium. It would be very difficult for a manufacturer to determine the volume of sodium contributed by both salt and baking soda in a food such as a cookie.
We also reiterate that the gram weight is a more precise measurement. When it comes to some nutrients, particularly added sugars and sodium, most products contain a fraction of a teaspoon.
Additionally, dietary recommendations for total fat, total carbohydrate, sugars, added sugars, protein, and sodium are provided in grams and milligrams (mg) (Ref. 5). The declaration of these nutrients in household measurements would make it more difficult for consumers to compare the amount of the nutrient in a serving of a product to current dietary recommendations.
As for the comments suggesting the declaration of teaspoon amounts in addition to grams, there is limited space available on the label, especially for small packages and dual column labeling (see part II.Q). Adding a teaspoon amount before or after the gram declaration of the nutrients could make it more difficult to read the information on the label. Therefore, we decline to allow for voluntary declaration of household measurements of total fat, carbohydrate, sugars, added sugars, protein, and sodium.
Finally, with respect to declaring nutrients in ounces or pounds, we decline to revise the rule as suggested by the comment. Many products contain an ounce or less of food per serving. If ounces or pounds were declared on the label for these nutrients, fractions would have to be declared. The gram weight of a nutrient is a more precise measurement than ounces or pounds.
4. Impact on Other Regulations
(Comment 4) Several comments expressed concern that revision of the RDIs would necessitate revisions to other regulations for nutrient content claims and health claims. Several comments noted that many products (such as juices and dairy products) that are now eligible to make nutrient content claims for nutrients that are increasing (such as potassium, calcium, vitamin D, and vitamin C) would no longer be able to do so. Other comments expressed concern that standards of identity for yogurt, milk, and cheeses might need to be updated. Other comments noted that food additive regulations for the addition of calcium and vitamin D to juice would need to be reevaluated; some comments suggested that we delay finalizing the rule until we update our rules on nutrient content claims.
(Response) We will address, as appropriate and as time and resources permit, the impact on our other regulations that are outside the scope of this rulemaking in separate rulemaking actions. While we do intend to revisit our regulations for nutrient content claims at a later date to determine if changes are necessary, we recognize that changes to the list of nutrients declared on the Nutrition Facts label or the RDIs or DRVs of nutrients could affect the ability of some products to bear certain nutrient content or health claims. We also recognize that changes to the RDIs for calcium, for example, may impact certain other regulations, including our food additive regulations in § 172.380 (21 CFR 172.380), where the use of vitamin D is based on a product containing a certain percentage of the RDI for calcium.
We also do not agree to delay finalizing this rule until we provide any updates to our rules on nutrient content claims. The RDIs are based on how much of a nutrient should be consumed to meet nutrient needs and not based on eligibility to make a nutrient content claim.
(Comment 5) One comment said we should try to finalize all the anticipated changes to the food package labels simultaneously, including Nutrition Facts label, a front-of package panel, and health claims so that a consumer education program about the revised Nutrition Facts label also could explain all changes at one time, thereby minimizing consumer confusion and maximizing resources available for education.
(Response) We do not agree that the rule should be delayed until we provide any updates to rules on health claims or any possible rule on front of pack labeling. The pace at which each individual rulemaking activity proceeds may be affected by our resources and other priorities; consequently, it would be impractical to defer action on this final rule until we complete other possible regulatory actions.
5. Consumer Research
In the preamble to the supplemental proposed rule (80 FR 44303 at 44305 through 44306), we discussed, among other things, information on two consumer studies (80 FR 44303), and in the
Federal Register
of July 27, 2015 (80 FR 44302), we reopened the comment period for the proposed rule for inviting public comments on two additional consumer studies. These four consumer studies, conducted in 2014 and 2015, were randomized controlled experimental studies with English-speaking adult consumers: (1) The Experimental Study on Consumer Responses to Nutrition Facts Labels with Declaration of Amount of Added Sugars (“the added sugars study”); (2) the Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats (“the footnote study”); (3) the Experimental Study of Proposed Changes to the Nutrition Facts Label Formats (“the format study”); and (4) the Eye-tracking Experimental Study on Consumer Responses to Modifications to the Nutrition Facts Label Outlined in the Food and Drug Administration's Proposed Rulemaking (“the eye-tracking study”). All study participants were adults 18 years of age or older. The overarching purpose of these studies was to explore how and to what extent different presentations of the label and its components (
e.g.,
different formats of the entire Nutrition Facts label or different formats of how added sugars may be declared on the label) may affect consumer responses to the presentations. In addition, the added sugars study was conducted to enhance our understanding of how inclusion of added sugars declarations on the Nutrition Facts label may affect how consumers perceive a product or a label and how to better educate people in using the Nutrition Facts label in general. In the following paragraphs, we briefly describe the methodology and key findings of each study and discuss the characteristics and proper use of the study data and findings.
The added sugars study was a randomized, controlled, Web-based experiment conducted in July and August of 2014 to enhance our understanding of how inclusion of added sugars declarations on the Nutrition Facts label may affect how consumers perceive a product or a label and how to better educate people in using the Nutrition Facts label in general. At the time the research was designed, we were not aware of any previous studies of consumer responses to added sugars information. We
engaged in this research to help inform our potential consumer education efforts if added sugars were declared on the Nutrition Facts label. The research design did not include a percent Daily Value for added sugars on the food label or the ingredient listing that will appear on packages and therefore did not provide data on how those pieces of information would affect consumer responses to an added sugars declaration. Nevertheless, the study achieved its intended objectives of providing an initial understanding of potential consumer reactions to added sugars declarations on Nutrition Facts labels.
Participants (n = 6,480) self-administered the study on their own computers and were randomly assigned to view mock-ups of one of three formats of the current Nutrition Facts label: (1) The “Added Sugars” format, in which an added sugars declaration was indented below a “Sugars” declaration; (2) the “Total Sugars + Added Sugars” format, in which an added sugars declaration was indented below a “Total Sugars” declaration; and (3) the “Current” format, in which “Sugars,” but not added sugars, was declared on the label. While viewing their assigned label images, participants answered questions on their ability to recognize and compare nutrient amounts on the Nutrition Facts label and their judgments about the foods' overall healthfulness and relative nutrient levels. The Nutrition Facts label images were accompanied by a product identity caption (
e.g.,
“Frozen Meal” or “Cereal”), but no front panel or brand name, either fictitious or real. The study was designed as a controlled experimental study that employed random assignment in order to establish causal relationships between test conditions and consumer responses. Because the study was not intended to generate population estimates, participants were selected from members of an online consumer panel in the United States. To recruit a diverse study sample, quotas were constructed with the aim of making the sample's distributions of age, gender, education, race/ethnicity, and census region resemble that of the U.S. population as closely as possible.
The added sugars study found that, while added sugars declarations increased the ability of some participants to identify those products with less added sugars and to determine the quantity of added sugar in a food, the declarations decreased the ability of some participants to correctly identify the quantity of total sugars in a food. The “Total Sugars + Added Sugars” format appeared to help participants better comprehend the total amount of sugars in a food than the “Added Sugars” format. More details about the study methodology, tested label formats, and results can be found in an Administrative File entitled “Experimental Study on Consumer Responses to Nutrition Facts Labels with Declaration of Amount of Added Sugars (OMB No. 0910-0764)” (Docket FDA-2012-N-1210).
The footnote study was a randomized, controlled, Web-based experiment conducted concurrently with the added sugars study. The footnote study included 3,866 participants who were different participants from those in the added sugars study but selected from the same online consumer panel using the same sampling methodology as that used in the added sugars study. The purpose of the footnote study was to explore consumer responses to various formats for the footnote area of the Nutrition Facts label, including those that provide information such as various definitions for percent Daily Value, a succinct statement about daily caloric intake, and general guidelines for high and low nutrient levels. Participants self-administered the study on their own computers and were randomly assigned to view a mock-up of one of seven Nutrition Facts label formats. Five of these Nutrition Facts formats included modified footnotes; one included the current footnote, and one included no footnote at all. The footnotes displayed variations of information such as a description of percent Daily Value, a succinct statement about daily caloric intake, or a general guideline for interpreting percent Daily Values, or noted nutrients whose daily intake should be limited. While viewing a label, participants answered questions about their judgments of the foods' overall healthfulness and levels of vitamin A, vitamin C, dietary fiber, fat, and sodium. After rating the product's nutritional attributes, participants who viewed labels that included one of the five modified footnotes or the current footnote were asked to rate the footnote statement's understandability, usefulness, believability, and helpfulness for the following dietary tasks: Comparing products, planning a healthy diet, determining the healthfulness of a food, and deciding how much of a food to eat.
The footnote study found that all five footnote options produced similar perceptions and judgments relative to the current footnote and the no-footnote control. Nevertheless, all five modified footnotes were rated as easier to understand than the current footnote. Footnote 1 was perceived to be more believable than the current footnote. Footnote 1 stated the following: “2,000 calories a day is used for general nutrition advice. * The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet.” More details about the study methodology, tested label formats, and results can be found in an Administrative File entitled “Experimental Study on Consumer Responses to Nutrition Facts Labels with Various Footnote Formats (OMB No. 0910-0764)” (Docket FDA-2012-N-1210).
The format study was a Web-based study conducted in February-March, 2015, to explore consumer responses to: (1) Three different formats of the Nutrition Facts label (the Current format, the Proposed format, and the Alternative format discussed in the proposed rule) (80 FR 11879), with each format embodying all current label elements or most of the potential changes to them as outlined in the proposed rule (
e.g.,
the prominence of the calorie declaration, the position of the percent Daily Value column); (2) the location of the percent Daily Value column (right or left side of the label); (3) column type (single-column, dual-column, and dual-calorie); (4) location of sodium declaration on the Proposed single column label; and (5) the declaration of voluntary vitamins and fats (voluntary vitamins, voluntary fats, and both vitamins and fats). A total of 5,430 consumers participated in the format study; they were recruited from the same online consumer panel with the same sampling methodology as in the added sugars and the footnote studies. As in the added sugars study and the footnote study, participants were randomly assigned to view different Nutrition Facts label mock-ups and answer questions about their: (1) Perceptions of the healthfulness and levels of nutrients of a product; (2) identification of which product in a pair of products was considered healthier; (3) accuracy of identifying the amount of nutrients per serving and per container and number of servings per container; and (4) perceptions of the understandability, usefulness, believability, and helpfulness of the label for various dietary tasks such as comparing products and deciding how much of a food to eat.
We did not find many significant or consistent effects of these label variations on the answers to the questions we asked. However, there were some notable and statistically significant differences when comparing
the current, single-column Nutrition Facts label with the % DV on the right (the “Current label”), the single-column Nutrition Facts label with the % DV on the left (which we had proposed (the “Proposed label”)), and an alternative, single-column label with the % DV on the left (the “Alternative label”). Respondents were more accurate in identifying the grams of saturated fat and the % DV for sodium using the single-column Proposed label (% DV left) compared to the single-column Current label (% DV right). Respondents were more accurate in identifying the grams of sugars per serving using the single-column Current label (% DV right) compared to the single-column Proposed (% DV left) or single-column Alternative label (% DV left), and they were more accurate in identifying the grams of sugars per container using the single-column Current label (% DV right) compared to the single-column Proposed label (% DV left). Finally, respondents were more accurate in identifying the grams of added sugars with the single-column Proposed label (% DV left) as compared to the single-column Alternative label (% DV left) (respondents assigned to view the Current label were not asked this question). Among the Proposed labels with % DV on the left (single-column, dual-column, and dual-calorie), we found that dual-column labeling significantly improved respondents' ability to identify the amount of nutrients in the entire container. More details about the study methodology and results can be found in an Administrative File entitled “Experimental study of proposed changes to the Nutrition Facts label formats (OMB No. 0910-0774)” (Docket FDA-2012-N-1210).
The eye-tracking study, conducted in January-March, 2015, was to explore whether and to what extent most of the potential label changes as outlined in the proposed rule (80 FR 11879), in their totality, may increase consumer attention to various label elements (
e.g.,
calories, number of servings) and lessen consumer effort in searching for specific label information. In addition, the eye-tracking study explored how the difference in the location of the percent Daily Value column may cause any changes in consumer attention to various label elements. A total of 160 English-speaking adult consumers in four cities (Washington, DC, Chicago, IL, Boston, MA, and San Francisco, CA) participated in the eye-tracking study. They were recruited by telephone and the sample was composed of some degree of diversity in socio-demographic characteristics and experience with the Nutrition Facts label. Due to an unexpected issue during recruiting, the eye-tracking study did not include any participants who were 35 years of age or younger. We asked study participants to come to a central location in each city to view mock-ups of three label formats (the Current format, the Proposed format and the Alternative format) (80 FR 11879) on a computer screen, recorded participants' eye-movement data to examine and compare the degree of attention paid to some of the possible label changes and the level of effort participants used to perform three categories of task (browsing a label, searching for specific information on a label such as the amount of sodium per serving in a product, and identifying which of a pair of products they would choose for a given purpose such as if they were to buy a healthier product for themselves). Labels used in this study were borrowed or adapted from the format study.
The eye-tracking study showed few statistically significant differences between the Current and the Proposed formats or between their variants. Among these differences, no one single format or variant consistently stood out as the “best” format in terms of degree of participant attention to label information, level of effort in using label information, or accuracy of information search or dietary choices. Many of the format differences pertained to two specific label components: (1) Sodium, carbohydrate, and protein; and (2) vitamins and minerals. There was little evidence that the Proposed format led participants to re-allocate their attention to or effort spent on different label components while browsing a label or making the dietary choices. More details about the study methodology and results can be found in an Administrative File entitled “Eye-tracking experimental study on consumer responses to modifications to the Nutrition Facts label outlined in the Food and Drug Administration's proposed rulemaking (OMB No. 0910-0774)” (Docket FDA-2012-N-1210).
For all four studies, we employed a randomized controlled experimental approach. According to the Office of Management and Budget (OMB), when Federal Agency research questions involve trying to determine whether there is a causal relationship between two variables or whether a program caused a change for participants, the Agency will need to employ an experimental or quasi-experimental design (rather than other approaches such as population surveys) to demonstrate how the study design will allow the Agency to determine causality (Ref. 6).
We chose to conduct the added sugars, the footnote, and the format studies using a Web-based approach with mock-ups of the Nutrition Facts label and footnote. The Web-based approach is quicker in administration and data collection and more efficient in including participants from many different parts of the country than other modes of data collection such as in-person interviews. The approach also reduces administrative errors in terms of assignment of labels for different participants. We used mock-ups of the label and footnote rather than real food packages because the approach helps the studies accomplish their goal of exploring consumer responses to differences in the presentation of the label rather than of a food package, which includes other components such as the front panel, the ingredient list, and imageries. The presence of these other label elements can weaken a study's ability to obtain key information on the label and the footnote to answer its research questions.
All studies used non-probability samples recruited from either members of the public at selected geographic locations with a certain degree of diversity in sociodemographic characteristics (
i.e.,
age, gender, education, race/ethnicity), as in the eye-tracking study, or members of a commercial online consumer panel with the sample's sociodemographic characteristics matched to that of the general population, as in the added sugars, the footnote, and the format studies; in all these cases, an individual's probability of being selected into a sample was unknown. In particular, the online panel recruitment methodology was based on the opt-in approach, a non-probability sampling technique. In contrast to probability sampling in which every individual has some chance of being selected to participate in a study, not all individuals have some chances of being selected in a study. To ensure representativeness of selected participants of the population, it is necessary that everyone has a known probability and that no one is left out (Ref. 7). In addition, according to OMB's Guidance on Agency Survey and Statistical Information Collections, for the purpose of making estimates with measurable sampling error that represent a population, the sample must be selected using probability methods, where a subset of the population is chosen randomly such that each unit has a known nonzero probability of
selection (Ref. 6). Therefore, none of the studies could provide nationally representative population estimates of consumer understanding, behaviors, or perceptions, nor could their data be considered nationally representative.
The samples of our studies were not selected using a probability sampling method and the samples came from consumers in selected locations or an opt-in online consumer panel. Therefore, based on the AAPOR and OMB guidelines, we do not consider the findings of any of the four studies projectable to the general population.
The overarching purpose of our research was to explore how and to what extent different presentations of the label and its components may affect consumer responses to the presentations. The added sugars study also was conducted to enhance our understanding of how inclusion of added sugars declarations on the Nutrition Facts label may affect how consumers perceive a product or a label and how to better educate people in using the Nutrition Facts label in general. We did not aim to use these studies to help us develop a label that will be understood by all consumers. We recognize that, regardless of how well a label is designed, there is always a certain proportion of consumers who encounter challenges in understanding and using the label.
In the
Federal Register
of July 27, 2015 (80 FR 44302), we added a description and our findings of these four studies to the administrative record, and we reopened the comment period for the sole purpose of inviting public comments on the eye-tracking and the format studies. We also published a supplemental proposed rule that discussed, among other things, information on the added sugars and the footnote studies (80 FR 44303). In response, many comments discussed our studies' findings, methodologies, and implications. Some comments provided new consumer research information related to issues examined in our studies, particularly the added sugars declaration. To the extent that the comments pertained to general issues involving our study results and methodologies, we address them here. We respond to comments related to research implications that are specific to the added sugars declaration or to format issues, such as the footnote, elsewhere in this document (see,
e.g.,
part II.H.3, “Added Sugars,” and part II.Q, “Format”).
(Comment 6) While many comments referred to our research findings as part of the evidence used to support their positions, some comments suggested that we conduct additional consumer research on selected changes outlined in the proposed rule. The comments felt further research is needed because it is difficult to examine the effects of individual proposed changes based on our studies.
(Response) One of our missions is to assist in providing the public with the accurate, science-based information it needs to use medicines and foods to maintain and improve health (Ref. 8). The objective of the Nutrition Facts label is to provide nutrition information about products to help consumers in maintaining healthy dietary practices. Therefore, as part of our continuing effort to enable consumers to make informed dietary choices and construct healthful diets, we intend to, subject to program priorities and resource availability, conduct more consumer research to help enhance the usefulness and understandability of the label.
In the format and the eye-tracking experimental studies, we chose to examine the combined effects of most of the changes outlined in the proposed rule, in totality. Nevertheless, in both studies, we also examined selected individual changes where we thought original consumer research would be helpful. For example, we were interested in the effect of the location of the percent Daily Value (left or right) independent of other format elements and therefore studied that change on all three label formats (Current, Proposed, and Alternative) (in both the format and the eye-tracking studies). We also were interested in the effect of column type (single-column, dual-column, and dual-calorie) independent of other label format changes and therefore studied that on all three label formats (in the format study). We also were interested in some other possible label format changes and therefore chose to study the effects of moving the location of sodium declaration on the Proposed single column label (in the format study), as well as the declaration of voluntary vitamins and fats (voluntary vitamins, voluntary fats, and both vitamins and fats) (in both the format and the eye-tracking studies). We believed the original consumer research on these topics was more useful than on other topics. Therefore, we took a hybrid approach of studying the differences between the Current, Proposed, and Alternative formats in totality and as well as in isolation for selected individual changes.
(Comment 7) Some comments questioned whether participants in our studies generally or as assigned in individual conditions were representative of the consumers in the nation. The comments stated that such representativeness was important for assessing the effects of the proposed label format changes on consumer understanding and use of the label. In particular, the comments were concerned that the lack of such representativeness, for example, the absence of participants 35 years of age and younger in the eye-tracking study, would render results imprecise or misleading. Some comments also encouraged us to obtain nationally representative samples of the population for future consumer research studies.
(Response) While we recognize that our study samples are not nationally representative, we disagree that the use of such samples would render our findings imprecise or misleading. The purpose of our studies was to investigate and compare how different presentations of label information may cause different responses by consumers. In other words, we sought to understand the causal relationships between the label presentations and consumer response rather than develop nationally representative estimates of the prevalence or extent of various responses. Therefore, our primary consideration in the study design was internal validity (
i.e.,
the validity of the causal relationships) rather than external validity (
i.e.,
the extent that the results can be generalized to the population or to presentations other than those studied). Even though we focused on internal validity, we recognized that, to make the study findings more robust, it was important that the studies included participants from different segments of the population in terms of education, gender, race/ethnicity, and geographic regions. Moreover, the causal relationships we examined were not necessarily particular to certain segments of the population, and our samples included consumers with a wide range of label reading and use practices.
We doubt the absence of study participants aged 35 years and under in the eye-tracking study, which was due to an unexpected issue in recruiting participants from this segment, would have led us to reach noticeably different conclusions about the label formats. While all of the eye-tracking participants were over age 35, they were diverse in many other important factors that the literature suggests may be related to label viewing and use, such as gender, education, race/ethnicity, label reading practices, attitudes toward the label, and nutritional interest (Refs. 9-11).
(Comment 8) One comment said that the use of terms such as “healthy” and “healthier” in our studies represented a misuse of a defined nutrient content claim. The comment also noted that consumers have different interpretations of the term “healthy” and that these interpretations may be based on considerations that are different from those defined for the claim “healthy” in FDA regulations. In addition, the comment said that the use of the term “healthy” in the eye-tracking study was a cue to participants that there is a correct answer and the criterion was “healthy.”
(Response) In the consumer studies we conducted for informing this rulemaking, research participants were presented with and asked to respond to a Nutrition Facts label. Neither the front panel of a package nor the ingredient list was provided to participants. In our studies, the questions that asked participants to assess products' healthfulness served as one type of measure of potential consumer reactions to the tested Nutrition Facts label formats and content modifications. These questions were not connected to the regulatory meaning of a “healthy” claim, which usually appears on the front panel of a package, and we disagree that the healthfulness questions in our studies reflect “a misuse,” as asserted in the comments, which mischaracterize the purpose of the healthfulness questions in the studies we conducted.
We agree, in part, and disagree, in part, that the use of the term “healthy” in the eye-tracking study was a cue to participants that there was a correct answer and the criterion was “healthy.” We agree that this term was used in the study to prompt participants to use “healthy” as the criterion in deciding their response to the task of choosing which of two products they thought was healthier for themselves. The primary purpose of this design was to examine whether and how different label presentations would lead to differences in participant attention to various parts of a label if participants were considering a healthy dietary choice. The accuracy of choice was of less interest in this design. In addition, one of the products presented to the participants always had lower content of calories, total fat, saturated fat, sodium and sugars than the other, so the “correct” choice was unambiguous. Therefore, we do not believe that the study design would have biased the answers participants gave in this task.
(Comment 9) One comment suggested that we conduct studies that are not electronically based so that we may have more reliable data that can contribute to a more successful solution.
(Response) The comment did not explain why data collected non-electronically are more reliable than data collected electronically. We believe the Web-based approach is appropriate for the purposes of our studies. Furthermore, the comment did not assert that our study results were necessarily flawed because we collected data electronically.
(Comment 10) One comment asked us to clarify a conclusion reported in the preamble to the supplemental proposed rule that when participants viewing Nutrition Facts labels without added sugars declarations could not accurately determine the amount of added sugars in the products and that many participants who viewed Nutrition Facts labels without added sugars declarations assumed that the more nutritious products in the study had less added sugars (80 FR 44303 at 44306). The comment asked us to clarify the preceding statement because it further noted that another document, namely, “Experimental Study of Proposed Changes to the Nutrition Facts Label Formats,” stated that “respondents assigned to view the Current label were not asked to identify the grams of added sugars.” The comment questioned how we were able to arrive at the conclusion referenced in the supplemental proposed rule, reasoning that the two statements appear contradictory, as participants in the format study who viewed the Current label were not asked questions regarding the amount of added sugars.
(Response) The two statements are not contradictory because the two statements refer to different studies. Due to the different purposes of the studies, the format study did not ask participants who were assigned to the Current label about the amount of added sugars, whereas the added sugars study did. We used results from the added sugars study, rather than findings from the format study, to arrive at the conclusion stated in the supplemental proposed rule.
(Comment 11) One comment asked if we balanced the sample for demographic characteristics in the added sugars and format studies.
(Response) In the added sugars and format studies, we did balance our samples on key demographic characteristics. We selected our samples by matching their key demographic characteristics (
i.e.,
age, gender, education, race/ethnicity, and census region) to that of the U.S. population.
(Comment 12) Some comments said that the order in which we assigned label formats to participants in the eye-tracking study could have affected the participants' responses. The comments attributed the concern to the design that showed all participants the Current label in the first set of tasks and showed the Proposed or Alternative labels randomly in the second set of tasks, rather than showing the three labels to three randomly assigned groups of participants in one set of tasks. The comments further stated that the design choice was not explained.
(Response) We acknowledge that the design could potentially have yielded different results than a design that randomly assigned participants to the three formats. We chose our design because the Current Nutrition Facts label has been on products for approximately 20 years and most, if not all, consumers have had exposure to or used the label. Consumers have likely developed their own patterns of reading and use of the Current label. Furthermore, the objective of the study was to explore whether and how much the two label formats outlined in the proposed rule would help raise consumer attention to certain label elements and reduce reading efforts. The design we chose recognized that participants would carry their own patterns of reading and using the Current label into tasks based on the Proposed and the Alternative labels. To the extent that the patterns could have varied between participants, each participant's responses to the Current label in the first set of tasks was used as her/his own baseline when we examined the responses to the Proposed or the Alternative labels in the second set of tasks. This approach, in turn, could minimize the within-subject differences between study participants and help reveal the true differential effects of label format on attention and efforts. Correspondingly, we applied the difference-in-difference analysis for this purpose. Therefore, although our design could have produced different results than a design that randomly assigned participants to the three label formats, we believe our design is appropriate under the particular circumstances.
(Comment 13) One comment said that the sample size of the eye-tracking study was too small to produce reliable empirical evidence. The comment also said that, despite the study's claim that the sample represented a wide variety of demographics, the claim is misleading because the South and Midwest regions were not included and 69 percent of the sample had a college or advanced degree.
(Response) We disagree with the comment. Our sample size calculations
suggested that the numbers of participants included in various statistical tests were sufficient to achieve the conventional degree of statistical power of at least a medium effect size for the non-parametric analyses we conducted. This is particularly true in terms of key outcome measures during label browsing (proportion of participants who noticed a label component at least once, length of time it took participants to notice a label component for the first time, proportion of total label viewing time spent on a label component, proportion of total number of notices spent on a label component), during information search (proportion of participants who identified target information, length of time it took participants to find target information, number of notices of target information before it was found), and during product identification (length of time it took participants to enter a choice, proportion of participants who selected a given label, proportion of participants who noticed a label component at least once on either of a pair of labels, proportion of total number of notices spent on a label component, and proportion of total label viewing time spent on a label component). Additionally, as shown in the study report, the participants varied in education attained, gender, race/ethnicity, and geographic locations. Thus, contrary to what the comment said, the sample did include a wide variety of demographics.
(Comment 14) Some comments questioned certain design aspects of how the format experimental study tested the different Nutrition Facts label formats. In particular, some comments said that the overall study design was complex and that 29 labels were too many to test at once and recommended a simpler design. One comment said that questions related to calories per serving and number of servings were comparatively less important because they appeared later in the questionnaire. In addition, the comment asked why the subjective numeracy questions, which asked participants to self-rate their aptitude for working with fractions and percentages, appeared at the beginning of the questionnaire.
Other comments questioned why certain topics were not included as part of the questionnaire. For example, one comment noted that, although the term “% DV” was used in place of “% Daily Value” in the Proposed and Alternative label formats, there were no questions specific to this change in the study. The comment also asked why there were not more direct questions about serving size. In addition, one comment said that the study report did not include respondents' perceptions of each label's “helpfulness.”
(Response) The main purpose of the format study was to compare consumer use and understanding of Current, Proposed, and Alternative label formats (in their totality). Additionally, the study was designed to test the effects of the location of Percent Daily Value, column type (single- vs. dual-column vs. dual-calorie), location of sodium declaration on the Proposed single-column label, and declaration of voluntary vitamins and fats on the Proposed label. Given the priorities chosen, we carefully designed the study, including the necessary number of test labels, to ensure that the study could provide adequate statistical power to test hypotheses related to the priority topics. Thus, the overall study design and number of labels were appropriate.
Moreover, we disagree with the comment stating the questions about calories per serving and number of servings appeared later in the questionnaire and were less important. These questions appeared in the first half of the questionnaire. In addition, with respect to the comment on the order of questions related to subjective numeracy, we conducted the cognitive interviews with the subjective numeracy questions at the beginning of the study and found that the overall flow of the questionnaire was working well. We did not use these questions to screen participants in or out of the study.
With respect to comments related to questions not included in the format study, we narrowed our questions to the purpose of the study. For example, although we did not include specific questions to assess consumer understanding of the terms “% DV” and “% Daily Value, ” we assessed the effects of the location of Percent Daily Value through a question that used the definition of % Daily Value as part of the question. Specifically, we included a question asking respondents the percentage of sodium for the day in a serving of a product to see how the labels compared in helping respondents find the % Daily Value. In addition, the focus of this study was not on consumer use and understanding of the meaning of serving size and therefore did not include a specific question about it. Instead, we focused on how the label formats affected consumers': (1) Perceptions of the healthfulness and levels of nutrients of a product; (2) identification of which product in a pair of products was considered healthier; (3) accuracy of identifying the amount of nutrients per serving and per container and number of servings per container; and (4) perceptions of the understandability, usefulness, believability, and helpfulness of the label for various dietary tasks such as comparing products and deciding how much of a food to eat.
Lastly, we disagree with the comment that we did not report on respondents' perceptions of label “helpfulness.” We reported on respondents' perceptions of “helpfulness” for each set of label comparisons in the “Label preference” rating.
(Comment 15) Some comments asked us to conduct additional analyses with the format experimental study on the Nutrition Facts label formats data. Some comments requested that we provide an analysis specifically comparing the single-column Current label format to the dual-column Proposed label format. Another comment asked us to provide the results related the effect of adding absolute values to the vitamins and minerals as was found on the Proposed and Alternative labels. One comment asked why we did not include an analysis of the number of servings per container.
(Response) In the notice on Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Reopening of the Comment Period as to Specific Documents (80 FR 44302), we reported on the results of our consumer study “Experimental Study of Proposed Changes to the Nutrition Facts Label Formats” related to key aspects of the changes we proposed to the format of the nutrition label. The comparisons suggested by the comments could be made through additional analyses of the data we collected. While we reported the effects of the format types within the same column type and the column-type within the same format type, we did not report the comparison between the Current single-column format and Proposed dual-column format. Such an analysis would not have provided us with information on the differences in formats in which we were most interested. However, for our own interest, we have since conducted that analysis and the results do not provide any new information related to our consideration of the format of the nutrition label. The results of this analysis seem to corroborate our main finding related to the effects of dual-column labeling compared to single-column labeling as described in table 7 of our June 30, 2015 memo to the file (Ref. 12). As reported in that memo, the Proposed dual-column label (% DV left) scored higher than the Proposed single-column label (% DV left) on the Total correct per container measure.
Similarly, in the new comparison, the Proposed dual-column label (% DV left) scored higher than the Current single-column label (% DV right) on that same measure. The new comparison demonstrates that the Proposed dual-column (% DV left) also scored higher on the Total Correct per serving measure than the Current single-column (% DV right) label.
In addition, the purpose of our evaluation of consumer views about how high or low the product is in a vitamin or mineral when absolute values were provided, compared to a label without this information, was to understand how some consumers perceive different numbers associated with various units of measure. In response to the comment on our findings on absolute amounts, we did complete a review of that aspect of the data, and the results do not provide any new information related to our consideration of the declaration of absolute amounts for some or all nutrients (Ref. 13)). The study did not address how consumers use or understand absolute amounts for following dietary advice. Participants who viewed the different label conditions were asked to rate on a 5-point scale (1 = none or very little; 5 = a lot) how much of various nutrients they thought were in one serving of the product. Because the questions asked participants to offer their subjective perception, rather than report the absolute amount for a nutrient, no rating offered could be judged as correct or incorrect. Instead, the ratings simply provided information about how pairing the correct absolute nutrient amount with the correct % DV affected participants' perceptions.
Further analysis found that there was no difference in correctly identifying the number of servings per container between the single-column labels, the dual-column labels, or between the Current single-column (% DV right), and the Proposed dual-column (% DV left) (Ref. 13). Thus, none of these formats had any influence on how participants identified the number of servings per container, and therefore, did not provide any new information related to our consideration of the servings per container.
(Comment 16) One comment mentioned an eye-tracking study that the comment did to examine and compare participants' attention to the Nutrition Facts label either in its current format or in the proposed format. The comment stated that the study did not find significant differences between the two formats either in attention to the label in its totality or in terms of the vitamins and mineral section nor in healthful food choices made. The comment also stated that moving the percent Daily Value column to the left side of the label reduced participants' attention to the percent Daily Value information. In addition, the comment suggested that more noticeable changes to the label format, such as using traffic light colors, or descriptors, such as “high” or “low,” may have a greater impact on attention and choice than the changes we proposed.
(Response) We decline to comment on the findings because the comment did not provide sufficient details about how the study was designed and analyzed.
As for other possible changes of the label that the comment speculated might affect consumer attention and food choices,
e.g.,
traffic light colors or text descriptors, such issues are outside of the scope of this rulemaking.
(Comment 17) One comment said that FDA's added sugars study seemed to be unduly focused on whether consumers could correctly identify added sugars and how identification of added sugars affected overall judgment of the product. The comment also stated that the study design steered participants to think specifically about added sugars throughout the survey, potentially leading them to judge the labels on the amount of added sugars.
(Response) We disagree that the design of the added sugars study unduly emphasized, or otherwise steered participants to focus on, added sugars beyond a level necessary to meet the key objectives of the study. A primary focus of FDA's added sugars study was to explore participants' understanding of Nutrition Facts labels that include added sugars declarations relative to participants' understanding of Nutrition Facts labels that do not include added sugars declarations. Although the primary objectives of the study pertained to added sugars declarations, we used a variety of measures to assess a range of participant reactions to the different labels. For example, we asked participants to evaluate foods' overall healthfulness as well as the levels of various nutrients such as saturated fat, sodium, dietary fiber, and others, in addition to added sugars.
(Comment 18) One comment noted that the added sugars study varied the experimental conditions in an unbalanced way, making it difficult to make inferences about the experimental conditions. The comment also said that we did not keep the caloric value consistent across products and, therefore, did not isolate the effect of the added sugars declarations separately from the effect of calories. The comment also noted that, in Appendix A of the FDA study report about the results of the added sugars study (Ref. 14), the “most nutritious” frozen meal had more calories, sodium, fat, and saturated fat, and lower iron and vitamin C than the “least nutritious” frozen meal.
(Response) Because the comment does not specify what was “unbalanced” in the experimental conditions and what specific inferences were therefore precluded, we do not have sufficient information to respond to this comment. We disagree that the study did not isolate the effect of added sugars declarations separately from the effect of calories because that is in fact what the experimental design achieved. In other words, by randomly assigning participants to different experimental conditions, we were able to compare participant responses in experimental conditions that were treated identically in all respects other than the display of added sugars information, thus isolating the effect of added sugars declarations from the effect of other experimental factors, such as calorie information.
Regarding Appendix A of the FDA study report (Ref. 14), there was a typographic error on the nutrition profiles for the frozen meals. Meal 1 should have been labeled the “least nutritious,” whereas Meal 3 should have been labeled the “most nutritious.” This typographic error, however, did not in any way affect the rest of the study description or reported findings.
(Comment 19) One comment noted that in table 8 of the added sugars study report (Ref. 14), the mean “usefulness” score for those viewing the control format was 3.93, whereas the mean “usefulness” score for those viewing the added sugars declaration format was 3.97. The comment stated that the report noted a significant difference between these scores and requested clarification.
(Response) The comment is incorrect. The report indicated that there was no statistically significant difference between the two means in question.
(Comment 20) One comment stated that the voluntary responses from study participants during the debriefing phase of the eye-tracking study showed that consumers had difficulties using the Current label and did not understand terms such as saturated fat and
trans
fat.
(Response) We disagree that the indicated responses showed that consumers have difficulties using the Current label and do not understand terms such as saturated fat and
trans
fat. The comment did not interpret this finding in context. The full statement in our study report is “When asked, most participants did not report having difficulties using the Current format as
long as they knew what to look for on the label (table 25) (Ref. 15). Some, however, mentioned that they did not understand some of the information on the label, such as fats and
trans
fat, or had problems with the small font size of the information” (eye-tracking study memo in the re-opener, July 27, 2015, p. 25). Contrary to the comment, the report states that most of the study participants did not have difficulties using the Current label, and only some said they did not understand fats and
trans
fat.
C. Comments on Legal Issues
Several comments addressed legal issues. Some comments asserted that FDA cannot compel an added sugars declaration in nutrition labeling under the First Amendment. We also received comments that questioned whether our proposed requirement for an added sugars declaration and certain other proposed requirements are consistent with the requirements in the Administrative Procedure Act (APA) and our authority under the FD&C Act. In addition, we received comments questioning our authority to require and access records related to the declarations for added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E, and folate/folic acid. Other comments raised miscellaneous legal issues.
1. First Amendment
Many comments on the proposed requirement to include an added sugars declaration on food labels related to our ability to compel such speech under the First Amendment. Some comments supported our proposed requirement for the declaration of added sugars as factual, uncontroversial information, based on the application of the First Amendment test set forth in
Zauderer
v.
Office of Disciplinary Counsel of Supreme Court,
471 U.S. 626 (1985). Most comments raising First Amendment arguments did not support the proposed declaration, but differed in their assertion of the applicable First Amendment test. Many comments asserted that the proposed declaration did not satisfy the Zauderer test, while other asserted that it failed under the test set forth in
Central Hudson Gas & Electric Corp.
v.
Public Service Comm'n,
447 U.S. 557 (1980). Still others asserted that the proposed declaration was subject to, and failed to satisfy, strict scrutiny review.
(Comment 21) Some comments said the added sugars declaration is not subject to the test in
Zauderer,
or, even if subject, does not meet such test. Specifically, one comment stated that
Zauderer
does not apply to misleading statements or statements that are subject to misinterpretation. Other comments said that because there is already a declaration for total sugars and there is no material difference, or scientific rationale, for distinguishing between added and intrinsic sugars, including no “sufficient nexus to consumer health,” the declaration of added sugars is not purely factual and uncontroversial information for which the First Amendment test in
Zauderer
would apply. One comment stated that because added sugars are not chemically distinct from natural sugars and do not have different health effects, the declaration of added sugars would be false and misleading and the Agency could not compel it under the First Amendment. Several comments stated there are no physiological distinctions between added and naturally occurring sugars, and therefore, no connection to consumer health on which to compel such speech.
(Response) The disclosure of added sugars is factually accurate nutrition information and industry's interest in not disclosing such factual information is minimal. In
Zauderer,
the Supreme Court explained that “[b]ecause the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides, [a speaker's] constitutionally protected interest in not providing any particular factual information in his advertising is minimal” (see 471 U.S. at 651 (internal citations omitted)). Providing consumers the amount of added sugars in a serving of food “does not offend the core First Amendment values of promoting efficient exchange of information” and “furthers, rather than hinders, the First Amendment goal of the discovery of the truth and contributes to the efficiency of the `marketplace of ideas' ” (
Nat'l Elec. Mfrs. Ass'n
v.
Sorrell,
272 F.3d 104, 113 through 114 (2d Cir. 2001). As a result, government requirements to disclose factual commercial speech are subject to a more lenient constitutional standard than that set forth under the Central Hudson framework (
Zauderer,
471 U.S. at 651). Under
Zauderer,
the government can require disclosure of factual information in the realm of commercial speech as long as the disclosure provides accurate, factual information; is not unjustified or unduly burdensome; and “reasonably relate[s]” to a government interest (id.).
The required added sugars declaration readily satisfies the
Zauderer
test. First, the declaration of added sugars, which is being finalized in this rule, provides accurate disclosures of factual commercial information about the amount of added sugars contained in a food. The required disclosure requires only facts about the product (
Am. Meat Inst.
v.
United States,
760 F.3d 18 (D.C. Cir. 2014) (“country-of-origin labeling qualifies as factual, and the facts conveyed are directly informative of intrinsic characteristics of the product AMI is selling”)). This required labeling will help facilitate the free flow of commercial information by providing a declaration of added sugars on food labels, and does not “prescribe what shall be orthodox in politics, nationalism, religion, or other matters of opinion” (
Zauderer,
471 U.S. at 651 (quoting
W. Va. State Bd. of Educ.
v.
Barnette,
319 U.S. 624, 642 (1943))).
As for the comments stating that there is no material difference or scientific rationale for distinguishing between total sugars and added sugars, or between added sugars and naturally occurring sugars, these comments relate to our rationale for why an added sugars declaration will assist consumers to maintain healthy dietary practices and not to whether the declaration is factual and accurate information. We address these comments in part II.H.3.i. The added sugars declaration conveys factual and accurate information about the amount of added sugars in a serving of food.
Second, the required added sugars declaration is not unduly burdensome. Factual nutrition information for a number of other nutrients is currently required to be provided on packaged foods. The space that is occupied by the indented line for the “Includes `XX' g Added Sugars” declaration, below the “Total Sugars” declaration does not increase the size of the existing Nutrition or Supplement Facts label, given changes made elsewhere to the label, such as reducing the size of the footnote in the label. We also note that, as discussed in our economic analysis (Ref. 16), the cost to manufacturers is reduced from that in the proposed rule under the compliance timelines in the final rule which will allow most manufacturers to make revisions to the label during regularly scheduled label changes for their products.
Third, the required added sugars declaration is reasonably related to our government interests in promoting the public health, preventing misleading labeling, and providing information to consumers to assist them in maintaining healthy dietary practices, and thus amply satisfies the remaining element of the
Zauderer
test. Providing consumers with information about the added sugars content of food would promote the
public health by ensuring they have information to assist them in meeting nutrient needs within calorie limits and to assist them in constructing a healthy dietary pattern that is limited in added sugars to reduce the risk of CVD. As explained in the preamble to the proposed rule (79 FR 11879 at 11903), Americans consume too many calories from 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
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.
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 § 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
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
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 ba
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