Food Labeling: Revision of the Nutrition and Supplement Facts Labels

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2012-N-1210]

RIN 0910-AF22

Food Labeling: Revision of the Nutrition and Supplement Facts Labels

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule.

SUMMARY:

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

DATES:

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

ADDRESSES:

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

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

•

Mail/Hand delivery/Courier (for paper submissions):

Division of Dockets Management (HFA-305), Food and Drug Administration, 5360 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Instructions:

All submissions received must include the Agency name and Docket No. FDA-2012-N-1210 and RIN 0910-AF22 for this rulemaking. All comments received may be posted without change to

http://www.regulations.gov,

including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the

SUPPLEMENTARY INFORMATION

section of this document.

Docket:

For access to the docket to read background documents or comments received, go to

http://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Blakeley Fitzpatrick, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-5429, email:

NutritionProgramStaff@fda.hhs.gov.

With regard to the information collection:

Domini Bean, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, Rockville, MD 20850,

Domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

Executive Summary

I. Background

A. Legal Authority

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

1. Rates of Chronic Disease

2. Dietary Recommendations, Consensus Reports, and National Survey Data

3. Consumer Use and Understanding of the Nutrition Facts Label

4. Other Relevant Considerations

5. Citizen Petitions

6. Advance Notices of Proposed Rulemaking (ANPRMs)

7. Impact on Other Regulations

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

1. Factors Considered

2. Approach for Mandatory Declaration

3. Approach for Voluntary Declaration

II. The Proposed Rule

A. Calories

1. Calories From Fat

2. Calories From Saturated Fat

3. Two Thousand Calories as the Reference Caloric Intake Level

4. Percent DV Declaration for Calories

B. Fat

1. Total Fat

2. Saturated Fat

3.

Trans

Fat

4. Polyunsaturated Fat

5. Monounsaturated Fat

C. Cholesterol

1. Mandatory Declaration

2. DRV

D. Carbohydrate

1. Total Carbohydrate

2. Sugars

3. Added Sugars

4. Sugar Alcohols

5. Dietary Fiber

6. Other Carbohydrate

E. Protein

1. Mandatory and Voluntary Declaration

2. Analytical Methods

3. DRV

F. Sodium

1. Mandatory Declaration

2. DRV

G. Fluoride

1. Voluntary Declaration

2. DRV

H. Essential Vitamins and Minerals of Public Health Significance

1. Essential Vitamins and Minerals That Are Mandatory

2. Essential Vitamins and Minerals That Are Voluntary

3. Other Essential Vitamins and Minerals

4. Summary

I. Reference Daily Intakes for Vitamins and Minerals

1. Need To Update RDIs

2. Approach To Setting RDIs: EAR Versus RDA

3. Approach To Setting RDIs: Adequate Intake

4. Approach To Setting RDIs: Tolerable Upper Intake Level

5. Approach To Setting RDIs: Population-Weighted Versus Population-Coverage

6. Declaration of the Absolute Amounts of Vitamins and Minerals

7. Issues Concerning Specific Vitamins and Minerals

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

1. Sodium, Potassium, Copper, and Chloride

2. Folate and Folic Acid

3. Vitamins A, D, and E

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

1. Age Range for Infants and Young Children

2. Mandatory Declaration of Calories and Statutorily Required Nutrients

3. Declaration of Non-Statutory Nutrients Other Than Essential Vitamins and Minerals

4. Declaration of Essential Vitamins and Minerals

5. DRVs and RDIs for Infants 7 Through 12 Months of Age

6. DRVs and RDIs for Children 1 Through 3 Years of Age

7. DRVs and RDIs for Pregnant and Lactating Women

L. Dietary Supplements

1. Mandatory Dietary Ingredients

2. Folate and Folic Acid

3. Units of Measure

4. Order of Nutrients Declared on the Label

5. Subpopulations

6. Footnote

M. Format

1. Increasing the Prominence of Calories and Serving Size

2. Changing the Order of the “Serving Size” and “Servings Per Container” Declarations and Increasing the Prominence of “Servings Per Container”

3. Right-Justifying the Quantitative Amounts Declared in the “Serving Size”

Statement

4. Changing the “Amount Per Serving” Statement

5. Declaration of “Calories From Fat”

6. Presentation of Percent DVs

7. Placement of “Added Sugars”

8. Declaration of Absolute Amounts of Vitamins and Minerals

9. Single and Dual Column Labeling

10. The Footnote

11. Use of Highlighting With a Type Intermediate Between Bold or Extra Bold and Regular Type

12. Addition of Horizontal Line Beneath the Nutrition Facts Heading

13. Replacing “Total Carbohydrate” With “Total Carbs”

14. Alternative Visual Formats/Fonts

N. Compliance

1. Level of Variance Allowed for the Label Declaration of Specific Nutrients

2. Methods Used To Determine Compliance

3. Records Requirements

4. Inclusion of Potassium as a Mineral

5. Requirements for Other Carbohydrate, Soluble and Insoluble Fiber, Added Sugars, and Sugar Alcohols

O. Technical Amendments

1. Changing the Name of the Program Office

2. Changing the Publication Date of Report Incorporated by Reference

3. Plain Language Edits

III. Proposed Effective and Compliance Dates

IV. Analysis of Impacts

V. Paperwork Reduction Act of 1995

VI. Analysis of Environmental Impact

VII. Federalism

VIII. Comments

IX. References

Executive Summary

Purpose of the Regulatory Action

FDA is proposing to amend the regulations for the nutrition labeling of conventional foods and dietary supplements to assist consumers in maintaining healthy dietary practices.

Following the passage of the Nutrition Labeling and Education Act (NLEA) of 1990 (the 1990 amendments) (Pub. L. 101-535), which added section 403(q) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)), we issued various regulations related to nutrition information on food labels, including the declaration of nutrients, the format for nutrition labeling, reference values for use in declaring the nutrient content, and allowances for certain specified products to be exempt from nutrition labeling (§ 101.9 (21 CFR 101.9)). In addition, following the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Pub. L. 103-417 and 21 U.S.C. 321(ff)), we amended our food labeling regulations to establish requirements for nutrition labeling of dietary supplements (§§ 101.9(j)(6) and 101.36). Section 403(q) of the FD&C Act specifies certain nutrients to be declared in nutrition labeling, and authorizes the Secretary of Health and Human Services to require other nutrients to be declared if the Secretary determines that a nutrient will provide information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices. The Secretary also has discretion under section 403(q) of the FD&C Act to remove, by regulation and under certain circumstances, nutrient information that is otherwise explicitly required in food labeling under this section.

We are proposing to revise our regulations to provide updated nutrition information on the label and improve how the nutrition information is presented to consumers, in light of current scientific evidence, dietary recommendations of most recent consensus reports, and public comments received in response to advance notices of proposed rulemaking. FDA invites comment on its use of the most recent consensus reports and whether the information and data on which FDA relies from such reports for proposed changes is consistent with current scientific information.

Summary of the Major Provisions of the Regulatory Action in Question

We discuss the need to update the Nutrition Facts and Supplement Facts labels in section I.B., and our scientific considerations for mandatory and voluntary declaration of nutrients are presented in section I.C. In sections II.A. through II.K., we discuss provisions related to the declaration, reference values, analytical methods, and definitions of nutrients that are required or permitted to be declared on the Nutrition Facts label of conventional foods, whereas corresponding changes to the Supplement Facts label of dietary supplements are presented in section II.L. We present our considerations related to the format of the Nutrition Facts and Supplement Facts labels in section II.M., and discuss issues related to compliance with the proposed requirements in section II.N. Some of the key proposed actions and considerations of the proposed rule are highlighted in this document.

Among other amendments related to declaration of nutrients, we are proposing to remove the declaration of “Calories from fat” because current science supports a view that the type of fat is more relevant than overall total fat intake in increased risk of chronic diseases. In addition, removal of the “calories from fat” disclosure had no effect on consumers' judgments of product healthfulness, accuracy in identifying nutrient contents of products, or perceptions in FDA's consumer research.

Considering current science and recommendations related to added sugars, we are also proposing to require the declaration of “added sugars,” that will provide consumers with information they need to implement the dietary recommendations of the

Dietary Guidelines for Americans, 2010

(2010 DGA).

We are also proposing to update the list of vitamins and minerals of public health significance. We currently require the mandatory declaration of percent Daily Values (DVs) of vitamins A and C, calcium and iron. We analyzed the nutrient inadequacy for vitamins and minerals based on biomarker data and total dietary intake (conventional foods and dietary supplements) using National Health and Nutrition Examination Survey (NHANES) data and other factors for mandatory and voluntary declaration discussed in section I.C. to determine which essential vitamins and minerals should be included as nutrients of public health significance. Based on this analysis, we are not proposing any changes to the current requirement for mandatory declaration of calcium and iron. In addition, we are proposing to require the declaration of vitamin D and potassium, and to permit, rather than require, the declaration of vitamins A and C.

With respect to reference values used to declare percent DVs of nutrients, since 1993, new reports from the Institute of Medicine (IOM) and other consensus and policy reports (for example, the 2010 DGA and the

Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for

Americans

) have been published that update the quantitative intake recommendations of nutrients as well as their association with chronic disease and health-related conditions. We are using these new data to update, as appropriate, the reference values used in the declaration of percent DVs of nutrients on the Nutrition Facts and Supplement Facts labels.

Among other amendments to reference values, we are proposing an updated reference value for the declaration of percent DV for sodium from the current value of 2,400 mg (milligrams) to 2,300 mg based on a consideration of current science and IOM's report that set Dietary Reference Intakes (DRIs) for sodium, including a Tolerable Upper Intake Level of 2,300 mg/day (d) as a reference intake level not to exceed.

A primary change that we are proposing to the format of the Nutrition Facts and Supplement Facts labels is to increase the prominence of the “Calories,” numeric value of calories, “Servings per container,” and numeric value of servings per container declarations. Research suggests that these proposed changes may increase consumers' attention to the information, and in certain situations, help consumers to accurately identify the number of calories in a product. We are also proposing to move the “% DV” to the left side of the label in order to highlight the information for consumers. We are also proposing to remove the requirement for the footnote table listing the reference values for certain nutrients for 2,000 and 2,500 calorie diets. We intend to continue to perform consumer research during this rulemaking process to evaluate how variations in label format may affect consumer understanding and use of the Nutrition Facts label. We intend to publish the results of our research for public review and comment.

EP03MR14.001

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

may be kept as original records, as true copies, or electronically, and manufacturers must provide those records to us for inspection and copying upon request during an inspection.

We anticipate that consumer education efforts would be needed to help with consumer understanding and use of information presented under the changes to the Nutrition Facts and Supplement Facts labels proposed in this rule. We plan to use the results of our consumer research to help inform our future actions on this issue.

Finally, we are proposing an effective date of 60 days after the date of the final rule's publication in the

Federal Register

with a compliance date 2 years after the effective date. We invite comment on the proposed compliance date. In addition to the proposed compliance date, we invite comment on various other issues, as summarized in section XI.

Costs and Benefits

We have developed one comprehensive preliminary regulatory impact analysis that presents the benefits and costs of this proposed rule as well as the proposed rules entitled Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments taken together. The cumulative impact of these two nutrition labeling proposals, taken as a whole, is shown in the following table.

Summary of Costs and Benefits

[In billions of 2011 $]

Benefits

Costs

Net benefits

Present Value (PV):

3%

$31.4

$2.3

$29.1

7%

21.1

2.3

18.8

Annualized (3% PV Amount)

3%

2.0

0.2

1.8

Annualized (7% PV Amount)

7%

1.9

0.2

1.7

Notes:

Compliance period is 24 months. Costs include relabeling and reformulation costs, which are one-time costs, as well as recordkeeping costs, which recur. Present values of relabeling and reformulation costs are equivalent at 3 or 7 percent because we conservatively assume that these one-time costs are incurred upon publication of the rule instead of at the end of the compliance period. Recordkeeping costs, because of their recurring nature, differ by discount rate; however, such costs comprise a very small percentage of total costs.

I. Background

The 1990 amendments added section 403(q) to the FD&C Act, which specifies, in part and with certain exceptions, that food is deemed misbranded unless its label or labeling bears nutrition information for certain nutrients. To implement the 1990 amendments, on January 6, 1993, FDA issued several rules, including “Food Labeling: Mandatory Status of Nutrition Labeling and Nutrient Content Revision, Format for Nutrition Label (the 1993 nutrient content final rule)”; “Food Labeling; Reference Daily Intakes and Daily Reference Values (1993 RDI/DRV final rule)”; and “Food Labeling: Serving Sizes”, to modify how nutrition information is presented on food labels (58 FR 2079; 58 FR 2206; 58 FR 2229, respectively). FDA published regulations related to: (1) Declaration of nutrients on food labeling, including nutrients that are required or permitted to be declared and the format for such declaration; (2) label reference values for use in declaring the nutrient content of a food on its label or labeling; (3) two types of reference values, Reference Daily Intakes (RDIs) for vitamins and minerals and Daily Reference Values (DRVs) for certain nutrients, which are used to declare nutrient contents as percent DVs on the Nutrition Facts label; (4) exemptions for certain specified products; and (5) a simplified form of nutrition labeling and the circumstances in which such simplified nutrition labeling can be used. (See § 101.9.) Elsewhere in this issue of the

Federal Register

, we are publishing a proposed rule that will amend the definition of a single-serving container, require dual column labeling for certain containers, update the reference amounts customarily consumed and serving sizes for several food product categories and amend the serving size for breath mints.

In 1994, DSHEA became law. Among other things, DSHEA amended section 403(q)(5)(F) of the FD&C Act by adding specific requirements that relate to the labeling of dietary supplement products. Accordingly, we amended our food labeling regulations to establish requirements for nutrition labeling of dietary supplements (§§ 101.9(j)(6) and 101.36).

The regulatory history, our rationale for existing requirements, and FDA activities related to nutrition labeling of foods and dietary supplements are described in Reference 1.

A. Legal Authority

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

with current scientific knowledge about nutrients and health. We are proposing changes to DVs (RDIs and DRVs, as applicable) for some nutrients, which values are used to calculate the percent DV for use on food labels. The use of reference values based on current science and the use of such values to calculate the percent DV assists consumers in comprehending the nutrition information and its relative significance in a total daily diet. We are also proposing changes to the format pertaining to information on the percent DV value. Further, section 2(b)(1)(C) of the 1990 amendments stipulates that regulations “shall permit the label or labeling of food to include nutrition information which is in addition to the information required by such section 403(q) [of the FD&C Act] and which is of the type described in subparagraph (1)(or (2) of such section . . . .” We are proposing changes to the voluntary declaration of certain nutrients in the Nutrition Facts label consistent with such authority.

Other relevant authorities include sections 701(a), 403(a)(1) and 201(n) of the FD&C Act (21 U.S.C. 371(a), 21 U.S.C. 343(a)(1), and 21 U.S.C. 321(n), respectively). Under section 701(a) of the FD&C Act, the Agency may issue regulations for the efficient enforcement of the FD&C Act in order to “effectuate a congressional objective expressed elsewhere in the Act” (

Association of American Physicians and Surgeons, Inc.

v

FDA,

226 F. Supp. 2d 204 (D.D.C. 2002) (citing

Pharm. Mfrs. Ass'n.

v

FDA,

484 F. Sup. 1179, 1183 (D. Del. 1980).)

We are relying on our authority under sections 403(q), 403(a), 201(n) and 701(a) of the FD&C Act, to propose record requirements to support nutrient declarations in labeling for added sugars, dietary fiber, soluble fiber, insoluble fiber, vitamin E, and folate/folic acid, under certain circumstances, so that we can determine compliance with labeling requirements and take enforcement action, as needed. For these nutrients, as explained in section II.N., there is no AOAC official method of analysis of AOAC International or other reliable or appropriate analytical procedure, otherwise required by § 101.9(g), available for FDA to quantify the declared amount of the nutrient, under certain circumstances. Section 101.9(g) sets forth the standards for accuracy of the amount statements of nutrients on food labels. Failing to accurately state the amounts of nutrients on the label under § 101.9(g) would result in a product being misbranded. Under section 403(q) of the FD&C Act, a food must bear, in its label or labeling, the amount of the nutrient the food contains. Moreover, the nutrient declaration must be truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. Thus, when a food product contains dietary fiber (whether soluble, insoluble, or a combination of both) and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber, we are proposing to require manufacturers to make and keep certain written records to verify the amount of added non-digestible carbohydrate that does not meet the definition of dietary. When vitamin E is present in a food as a mixture of all

rac

-α-tocopherol acetate and

RRR

-α-tocopherol, we are proposing to require 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 proposing to require manufacturers to make and keep records to verify the amount of folic acid added to the food and folate in the finished food. When added sugars as well as naturally occurring sugars are present in a food, we are proposing to require manufacturers to make and keep records to verify the declared amount of added sugars in the food. Finally, we are proposing to require manufacturers to make and keep records to verify the declared amount of added sugars in specific foods, alone or in combination with naturally occurring sugars, where the added sugars are subject to fermentation.

The proposed record requirements for these nutrients, under the circumstances described, are designed to ensure that the nutrient declarations are accurate, truthful and not misleading, based on information known only to the manufacturer, and to facilitate efficient and effective action to enforce the requirements when necessary. Our authority to establish records requirements has been upheld under other provisions of the FD&C Act where FDA has found such records to be necessary (

National Confectioners Assoc.

v

Califano,

569 F.2d 690, 693-94 (D.C. Cir. 1978). The records we propose to require are only for foods for which an adequate analytical method is not available. The records would allow us to verify the declared amount of each of these nutrients and that such amount is truthful and not misleading. Thus, the proposed records requirements would help in the efficient enforcement of the FD&C Act.

The authority granted to FDA under sections 701(a), 403(q), 403(a)(1) and 201(n) of the FD&C Act not only includes authority to establish records requirements, but also includes access to such records. Without such authority, the nutrient declarations for these specific nutrients that FDA has determined are necessary to assist consumers in maintaining healthy dietary practices under section 403(q)(2)(A) of the FD&C Act are, practically speaking, not enforceable. Without access to such records, FDA would not know whether the amount declared on the label or in the labeling of each these nutrients, under the circumstances described, is truthful and not misleading under sections 403(a)(1) and 201(n) of the FD&C Act. The introduction or delivery for introduction into interstate commerce of a misbranded food is a prohibited act under section 301(a) of the FD&C Act (21 U.S.C. 331(a)). Thus, to determine whether the food is misbranded and the manufacturer has committed a prohibited act, we must have access to the manufacturer's records that we are requiring be made and kept under sections 403(q), 403(a)(1), 201(n) and 701(a) of the FD&C Act. Failure to make and keep records and provide the records to FDA, as described in proposed § 101.9(g)(10) and (g)(11), would result in the food being misbranded under sections 403(q) and 403(a)(1) of the FD&C Act.

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

FDA first issued regulations related to the Nutrition Facts label in 1993. We have not updated the Nutrition Facts label since the 2003

trans

fat rulemaking (68 FR 41434; July 11, 2003) or established new or updated DVs for nutrients since 1995 (60 FR 67164; December 28, 1995). Since that time, the public health profile of the U.S. population has changed (e.g., increase in obesity), new information has become available about nutrient definitions (e.g., vitamin E), reference intake values, and analytical methods, and new dietary recommendations (see section I.B.2.) have been published. As a result, we are reconsidering what nutrients we should require or permit to be listed on the Nutrition Facts label and what nutrient reference intake values we should use as a basis for calculating the percent DVs in food labeling. We also considered corresponding changes to the Supplement Facts labels. We discuss specific nutrient declarations in greater detail in section II. Section I.B. includes an overview of information we considered when forming our tentative conclusions, including scientific and technical data and recommendations, citizen petitions submitted to us, and public comments to previous requests

for comment in advance notices of proposed rulemaking on topics related to this proposed rule. We also considered the role of nutrition labeling to assist consumers in maintaining healthy dietary practices and consumers' use and understanding of the Nutrition Facts label.

1. Rates of Chronic Disease

Chronic diseases, such as heart disease, cancer and stroke are the leading causes of death and disability in the United States, and account for 70 percent of all deaths in the United States (Ref. 2). In 2005, 133 million Americans, almost one out of every two adults, had at least one chronic illness (Ref. 2). An estimated 37 percent of Americans suffer from cardiovascular disease (CVD) (Ref. 3), 11.3 percent of the population 20 years and older has diabetes, 35 percent of adults has pre-diabetes (Ref. 4), and 41 percent of the population is predicted to be diagnosed with cancer during their lifetime (Ref. 5). While the causes of these chronic diseases are multifactorial, poor diet is a contributing factor associated with morbidity and mortality (Ref. 6). Many nutrients are associated with chronic disease risk. For example, diets low in saturated fat and cholesterol, and/or sodium are associated with a decreased risk of CVD (58 FR 2739; January 6, 1993, and 58 FR 2820; January 6, 1993). Adequate or increased intake of calcium and vitamin D may decrease the risk of osteoporosis (73 FR 56477; September 29, 2008).

Obesity rates have increased dramatically over the last three decades. Between 1976 and 1980 and 2007 and 2008, obesity rates increased more than twofold (from 15 to 34 percent) in adults and more than threefold (from 5 to 17 percent) among children and adolescents (Refs. 6 to 8). Data published by the U.S. Centers for Disease Control and Prevention (CDC) indicate that 68 percent of adults and about 32 percent of children aged 2 to 19 years in the U.S. population are overweight or obese (Refs. 7 and 8). Excessive body weight is a risk factor for chronic diseases such as heart disease, some forms of cancer, and type II diabetes (Ref. 9). The 2010 DGA affirmed the role of over consumption of calories and physical inactivity as the primary risk factors contributing to an epidemic of overweight and obesity in this country, and urged for a focus on improved nutrition and physical activity choices among Americans (Ref. 6).

Elevated blood pressure, an important risk factor for CVD (Ref. 10), affects about one-third of the U.S. adult population (Ref. 2). High intakes of sodium are directly associated with elevated blood pressure (Ref. 10). Average sodium intake for the U.S. population 4 years of age and older is approximately 3,650 mg/d (Ref. 11). Almost all Americans consume more sodium than the levels recommended by the 2010 DGA (Ref. 12)

Furthermore, while concerns in recent years have largely shifted away from nutritional deficiencies, some population subgroups may consume excess calories but still consume inadequate amounts of certain micronutrients such as iron, vitamin D, calcium and potassium (see section II.H.).

The mandatory declaration of nutrients that have public health significance, the use of updated DVs based on current scientific evidence, and the use of a format for the Nutrition Facts label to assist with consumer use and understanding can help consumers make informed food choices to consume a nutritionally adequate diet while monitoring calorie intake and lowering their risk of some chronic diseases.

2. Dietary Recommendations, Consensus Reports, and National Survey Data

a. IOM Dietary Reference Intakes Reports (IOM DRI Reports)—In 1994, the Food and Nutrition Board (FNB) of the Institute of Medicine (IOM) identified principles for the development of a new set of reference values that could expand and replace the IOM's Recommended Dietary Allowances (RDAs) of 1989 (Refs. 13 and 14). A comprehensive review and application of a growing body of nutritional science research resulted in the development of a set of reference values, collectively known as DRIs, published from 1997 to 2010 (Ref. 15). The DRIs represent a shift in the way that reference values are established or intended for use. In contrast to previous editions of RDAs (e.g., the 1968 and 1989 RDAs), which involved establishing single values for each nutrient with appropriate adjustments for age, sex and physiological status, the new DRI framework consisted of four categories of reference values. These categories include the Estimated Average Requirement (EAR), RDA, Adequate Intake (AI) and Tolerable Upper Intake Level (UL). For macronutrients—carbohydrates, fats, and protein—the IOM developed a new set of reference values called the Acceptable Macronutrient Distribution Ranges (AMDRs).

The EAR is the average daily nutrient intake level that is estimated to meet the requirements of half of the healthy individuals in a particular life stage and gender group. EARs are used for assessing the statistical probability of adequacy of nutrient intakes of groups of people. The RDA is an estimate of the average intake level that meets the nutrient requirements of nearly all (97 to 98 percent) healthy individuals in a particular life stage and gender group. The RDA is set using the EAR. In general, the RDA is the EAR plus two times the standard deviation of the EAR. The RDA is used to plan nutrient intakes for individuals to ensure a low probability of inadequacy. Nutrients with EARs and RDAs include carbohydrate, protein, vitamin A, vitamin C, vitamin E, thiamin, riboflavin, niacin, vitamin B

6

, folate, vitamin B

12

, copper, iodine, iron, magnesium, phosphorus, selenium, zinc, calcium and vitamin D.

An AI is the level determined for an essential nutrient or a nutrient that is beneficial for human health when there is insufficient evidence to calculate an EAR for that nutrient, and therefore insufficient evidence on which to establish an RDA. AIs can be based on a variety of data, including scientific evidence about the essentiality of a nutrient (i.e., choline, biotin, fluoride), experimental data on risk reduction of chronic disease (i.e., dietary fiber, potassium), and median intakes of a nutrient using national survey data (i.e., vitamin K, pantothenic acid, chromium, manganese, linoleic acid, and [alpha]-linolenic acid). Although there is less certainty about an AI value than about an RDA value, the AI is similarly designed to cover the needs of nearly all individuals. The IOM Dietary Planning Report and Dietary Assessment Report noted that “the AI should be used with less confidence if it has not been established as the mean intake of a healthy group.”

The UL is the highest average daily intake level likely to pose no risk of adverse health effects for nearly all people in a particular group. The UL is not intended to be a recommended level of intake. The UL is used to assess the risk of adverse health effects from excessive nutrient intake. As intake above the UL increases, so does the potential for risk of adverse health effects. Nutrients with ULs include vitamin A, vitamin C, vitamin D, vitamin E, niacin, vitamin B

6

, folate, choline, calcium, copper, fluoride, iodine, iron, magnesium, manganese, molybdenum, phosphorus, selenium, zinc, sodium, and chloride.

Moreover, while the previous RDAs primarily focused on reducing the incidence of diseases of nutrient deficiency in the population, the DRIs

now take into consideration data on chronic disease risk, such as heart disease, and developmental abnormalities, such as teratogenicity, rather than only the signs of deficiency. Finally, where sufficient data exist, the DRIs take into account the potential benefit or risk to health of substances that are not essential (such as dietary fiber and fluoride) that are in addition to the macronutrients of total carbohydrate, protein, and fat, and the micronutrient vitamins and minerals permitted or required on the Nutrition Facts label (Ref. 15). Beginning in 1997, the IOM began publishing its DRIs for those vitamins, minerals, and macronutrients that are essential in humans or provide a beneficial role in human health (Refs. 16 to 22). In addition, the IOM also set AMDRs for carbohydrates, fat, and protein (Ref. 23). The AMDR for a macronutrient is based on the amount of the macronutrient that is associated with a reduced risk of chronic disease while providing adequate intakes of essential nutrients. The AMDR is expressed as a range of percent energy intake (e.g., 20 to 35 percent of calories from total fat for adults over 18 years of age). The DRIs and AMDRs were set for the following life stage groups: Infants (0 to 6 and 7 to 12 months); toddlers (1 to 3 years); boys and girls (4 to 8 years); adolescent boys and girls (9 to 13 and 14 to 18 years); adult men and women (19 to 30, 31 to 50, 51 to 70, and greater than 70 years); and pregnant and lactating women.

b. IOM Dietary Fiber Report—In 2001, the IOM Panel on the Definition of Dietary Fiber (the IOM Dietary Fiber Panel) responded to our request to provide definitions for dietary fiber based on its role in human physiology and health. The IOM Dietary Fiber Panel developed two categories of definitions of fiber: “Dietary Fiber” and “Added Fiber” in its report

Dietary Reference Intakes: Proposed Definition of Dietary Fiber

(the IOM Dietary Fiber Report) (Ref. 24).

c. IOM Dietary Assessment Report—In 2000, the IOM Subcommittee on Interpretation and Uses of Dietary Reference Intakes (IOM uses Committee) published the report, DRIs Application in Dietary Assessment (IOM Dietary Assessment report) on how to use the DRIs for dietary assessment of individuals and groups.

d. IOM Labeling Report—In 2003, the IOM Committee on nutrition labeling (IOM Labeling Committee) considered how the DRIs can be used to develop appropriate reference values for nutrition labeling and published its report, co-funded by FDA,

DRI Guiding Principles for Nutrition Labeling and Fortification

(the IOM Labeling Report) (Ref. 25), with the goal of having an updated nutrition label that consumers can use to make informed dietary choices.

e. IOM Dietary Planning Report—In 2003, the IOM Subcommittee on interpretation and uses of DRIs (IOM Uses Committee) published a report,

DRIs Application in Dietary Planning

(IOM Dietary Planning Report) (Ref. 26) on how to use the DRIs for planning intakes of individuals and groups. This report discusses the use of the DRIs for food and supplement labels.

f. IOM Sodium Strategies Report—In 2008, the IOM convened a Committee on Strategies to Reduce Sodium Intake in the United States to address a Congressional request for recommendations about various means that could be employed to reduce dietary sodium intake to levels recommended by the 2005 DGA (less than 2,300 mg/d and no more than 1,500 mg/d for African-Americans, people with hypertension, and middle-aged and older adults). The Committee's report,

Strategies to Reduce Sodium Intake in the United States

(IOM Sodium Strategies Report), published in 2010, among other strategies, discusses how the labeling of sodium on foods can serve as a supporting strategy for reducing sodium intake (Ref. 27).

g. IOM Front-Of-Package Nutrition Rating Systems and Symbols Phase I and Phase II Reports—In 2010, the IOM Committee on Front-of-Package (FOP) Nutrition Rating Systems and Symbols reviewed the existing FOP systems and their underlying nutrition criteria. In the Phase I report, the IOM identified the nutrients for which there was sufficient evidence of their role in chronic disease risk and which should be included in a FOP label (Ref. 28). In 2012, the IOM published its phase II report that recommended developing a single standardized FOP rating system and updated their recommendations for nutrients to be included on the FOP label (Ref. 29).

h. IOM Sodium Intake in Populations Report—In 2012 the IOM convened a Committee to review and assess the benefits and adverse outcomes (if any) of reducing the sodium intake in the population, particularly in the range of 1,500 to 2,300 mg/d. The Committee was also asked to specifically emphasize relevant subgroups in the analysis including those 50 years of age and older, African Americans, and those with diabetes, chronic kidney disease, and congestive heart failure. The Report was published in May of 2013 and focused its findings and conclusions on evidence for associations between sodium intake and the risk of CVD-related events and mortality.

i.

Dietary Guidelines for Americans

(DGA), 2010—The 2010 DGA, developed jointly by the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS), provide several key recommendations including recommendations about dietary patterns, as well as quantitative intake recommendations with respect to micronutrients and macronutrients, most of which are based on the IOM DRI reports (Ref. 6). In a few cases, the 2010 DGA provided quantitative intake recommendations for certain nutrients (i.e., cholesterol and saturated fat) that were not provided by the IOM DRI reports (Ref. 6). The 2010 DGA emphasized the importance of meeting food and nutrient recommendations while balancing calorie needs (Ref. 6). More information regarding the scientific basis that informed the development of the 2010 DGA can be found in the

Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans,

2010 (2010 DGAC) (Ref. 30). An important note related to the 2010 DGA is the specified intended audience for its recommendations (Ref. 6). From the 1980s until 1995, the DGAs were targeted toward healthy Americans and designed to provide advice to healthy individuals about food choices that promote health and prevent disease (Refs. 31 to 34). In 2000, the recommendations specified an audience of “healthy children ages 2 years and older and adults of any age,” and the 2005 DGA provided recommendations for the “general public age 2 years and older.” (Refs. 35 and 36). While the DGAs have always taken into account the needs of subpopulations, the most recent 2010 DGA goes beyond the traditional target of a “healthy” audience to provide chronic disease,” noting “the reality that a large percentage of Americans are overweight or obese and/or at risk of various chronic diseases” (Ref. 6).

j. National Health and Nutrition Examination Survey (NHANES)—The NHANES provides the primary source of information on the health and nutritional status of adults and children in the United States. The survey examines a nationally representative sample of about 5,000 persons each year. These persons are located in counties across the country. The survey combines interviews, which include demographic, socioeconomic, dietary, and health-related questions, and physical examinations, which consist of

medical, dental, and physiological measurements, as well as laboratory tests administered by highly trained medical personnel (Ref. 37).

3. Consumer Use and Understanding of the Nutrition Facts Label

The Nutrition Facts label is intended to help consumers make informed food choices and maintain healthy dietary practices. Consumers became increasingly aware of the new label in the years following implementation of the 1990 amendments, and reported using food labels more often in their purchasing decisions compared to their use before the introduction of the Nutrition Facts label (Ref. 38).

Data from a nationally representative sample of U.S. adults collected through FDA's Health and Diet Surveys suggest that the frequency of food label use among consumers progressively increased between 2002 and 2008 (Refs. 39 to 41). For example, the percentage of consumers reporting that they “often” read a food label the first time they purchase a food product rose from 44 percent in 2002 to 54 percent in 2008. Among those indicating they read food labels when purchasing a product for the first time, two-thirds of them in 2008 reported using the label to see how high or low the food was in calories, salt, vitamins or fat, while more than half said they used labels to get a general idea of the nutritional content of the product. A similar increase in reported use of food labels has also been shown using data from the National Health and Nutrition Examination Surveys 2007-2008 and 2009-1010. The percent of working age adults that reported using the Nutrition Facts Panel (NFP) always or most of the time when shopping for food increased to 42% in 2009-2010 from 34% in 2007-2008. Among older adults the percentage increased to 57% in 2009-2010 from 51% in 2007-2008. (Ref. 42).

Consumer research data suggest that, despite the widespread use of food labels, certain elements of the Nutrition Facts label may need improvement. For example, some consumers have difficulty understanding the concept of percent DV (Refs. 43 and 44) or are confused by the label footnote that lists DVs for certain nutrients based on a 2,000 and 2,500 calorie diet (Ref. 45).

Section 2(b)(1)(A) of the 1990 amendments mandated that FDA regulations implementing section 403(q) of the FD&C Act require that nutrition labeling must be conveyed to the public in a manner which enables the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet. In particular, the percent DV of a nutrient present in food is declared on food labels to help consumers understand the relative significance of nutrition information in the context of a total daily diet, compare the nutritional values of food products, and to plan general diets (58 FR 2206 at 2213; January 6, 1993). We also noted that the percent DV information advises the consumer how much of a recommended intake of that nutrient is provided by the food (58 FR 2079 at 2123; January 6, 1993). We developed the term “Daily Value” to refer to all reference values on the nutrition label (DRVs and RDIs). We noted that some of the reference values were intended to guide consumers relative to maximum intakes (DRVs) (e.g., saturated fat), while others were intended to serve as the basis for planning general diets to meet nutrient requirements (RDIs) (e.g., vitamin C) (58 FR 2079 at 2124). Our research at the time showed that the term “Daily Value” was generally understood by consumers as a point of reference (58 FR 2079 at 2125).

In order to determine a nutrition labeling format that could be used most effectively by consumers, we conducted consumer research and evaluated research conducted by others in considering requirements for the nutrition label format (58 FR 2079 at 2115-2121). When available, we used empirical data on how consumers use and understand the label in proposing what information should be declared on the label and how. We used focus group data to inform what we would test in experimental studies, but did not rely on such data to make policy decisions. Several comments to the ANPRMs submitted focus group data. However, we are not relying on focus group data for the proposed changes to the Nutrition Facts label because focus groups do not yield meaningful quantitative findings and are not able to support conclusions about the relationships between the presentation of label information and consumer responses. As such, they cannot be used to drive the development of policies, programs, and services. Policy makers and educators can use focus groups findings to test and refine their ideas, but should then conduct further research before making important decisions such as adopting new policies and allocating or redirecting significant resources to support these policies.

We have completed one study that examined dual-column labels and ways to increase prominence of certain label information, and intend to continue to perform research during this rulemaking process to evaluate how variations in label format may affect consumer understanding and use of the Nutrition Facts label. Issues to be addressed include how a declaration of “Added Sugars” and alternative footnote statement may influence consumer use of the label.

The overall goal of these studies is to assess a consumer's ability to use the Nutrition Facts label and assess a consumer's preferences related to proposed modifications of the Nutrition Facts label format. In addition, the studies will help us focus our efforts on consumer education as well as enhance our understanding of whether modifications to the Nutrition Facts label format could help consumers make more informed choices based on their perceptions of the nutritional attributes and overall healthfulness of a food product. (See also discussion in section II.M.)

4. Other Relevant Considerations

In developing this proposed rule, we considered changes that would assist consumers in maintaining healthy dietary practices and recognize that it is important for the updated Nutrition Facts label to be useful and relevant to the American population. While the Nutrition Facts label information has never been nor is it now targeted to individuals with acute or chronic disease, we are considering the large portion of the U.S. population that is at risk for chronic disease in proposing changes to the label's content and format. The population at risk for chronic disease includes those who are overweight, and therefore at increased risk of certain chronic diseases, or those who are obese, leading to a variety of complications including diabetes and CVD. This approach is consistent with the new IOM DRIs, which are for healthy individuals, including those at-risk of disease, but not for individuals with acute or chronic disease or nutrient deficiencies (Ref. 15). Similarly, the DGAs are for Americans ages 2 years and older, including those at risk of chronic disease. While consumers with acute or chronic disease, such as obesity, CVD, or diabetes, may be able to use quantitative information on the label to follow advice they have received from a health care professional concerning their conditions, the nutrient declarations and percent DVs on the label are to help consumers make more informed choices to consume a healthy diet and not intended for the clinical management of an existing disease. In addition, we recognize the importance of federal regulations reflecting the most current science. In developing this proposed rule, we

considered new scientific evidence and dietary recommendations about the relationship between nutrients and health.

Finally, we recognize that the goal of assisting consumers in maintaining healthy dietary practices requires that we consider certain practicalities. For example, as we noted in the 1993 nutrient content final rule (58 FR 2079 at 2107), while the 1990 amendments permit the Secretary of Health and Human Services to include in the Nutrition Facts label any information about a nutrient that will assist consumers in maintaining healthy dietary practices, there is not room on the label for all information that may be related to maintaining healthy dietary practices. Space constraints on the label of most foods make declaring all essential nutrients impractical. In addition, having a large amount of information on the label could interfere with consumers' abilities to use the information that has the greatest public health significance. Therefore, not only are we aware of the amount and format of mandatory information on the label, but we recognize that limits to the voluntary information are necessary, so that voluntary information does not clutter the label, does not mislead, confuse, or overwhelm the consumer, and does not take away prominence of and emphasis on the required information.

5. Citizen Petitions

Since 1993, we received a number of citizen petitions requesting that FDA make various changes to the Nutrition and Supplement Facts labels. We are addressing a number of issues raised in the following petitions within this proposed rule: (1) The Calorie Control Council submitted a citizen petition on April 13, 1995 (Docket No. FDA-1995-P-0142) requesting that FDA permit the use of the term “polyols” in lieu of sugar alcohols on the Nutrition Facts label (

http://www.regulations.gov/#!docketDetail;D=FDA-1995-P-0142

); (2) the American Cocoa Research Institute submitted a citizen petition on April 4, 1996 (Docket No. FDA-1996-P-0035) recommending the accurate communication of the scientific fact that stearic acid does not affect blood cholesterol (

http://www.regulations.gov/#!docketDetail;D=FDA-1996-P-0035

); (3) Nabisco, Inc. submitted a citizen petition on May 8, 1997 (Docket No. FDA-1997-P-0476) requesting that FDA amend the definition of “total fat” and “saturated fat” in its food labeling regulations to clarify that acetic, propionic, and butyric acids may be excluded when calculating the amount of fat in a food product (

http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0476

); (4) the Calorie Control Council submitted a citizen petition on February 13, 1998 (Docket No. FDA-1997-P-0232) requesting that the caloric value of soluble fiber be no more than 2kcal/g (

http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0232

); (5) the Center for Science in the Public Interest (CSPI) submitted a citizen petition on August 4, 1999 (Docket No. FDA-1999-P-0158) requesting that FDA establish a DV for added sugars and require the amount of added sugar, and the percent DV that represents, to be declared on food labels (

http://www.regulations.gov/#!docketDetail;D=FDA-1999-P-0158

); (6) Protein Technologies International, Inc. submitted a citizen petition on December 21, 2000 (FDA-2000-P-0569) requesting that FDA modify the reference to the method used to calculate protein content (

http://www.regulations.gov/#!docketDetail;D=FDA-2000-P-0569

); (7) the National Starch and Chemical Company (“National Starch”) submitted a citizen petition on July 8, 2004 (Docket No. FDA-2004-P-0094) requesting that dietary fiber content be excluded from the “total carbohydrate” declaration on the Nutrition Facts label (

http://www.regulations.gov/#!docketDetail;D=FDA-2004-P-0094

); (8) the Sugar Association submitted a citizen petition on August 15, 2005 (Docket No. FDA-2005-P-0373) requesting, in part, that FDA amend regulations related to the labeling of sugar and alternative sweeteners (

http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0373

); (9) CSPI submitted a citizen petition on November 8, 2005 (Docket No. FDA-2005-P-0196) requesting, in part, that FDA lower the DV for sodium from 2,400 to 1,500 mg/day (

http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196

); (10) an individual submitted a citizen petition on May 25, 2005 (Docket No. FDA-2005-P-0126) requesting that FDA preclude the declaration of β-carotene in supplements as vitamin A (

http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0126

); (11) an individual submitted a citizen petition on January 17, 2007 (Docket No. FDA-2007-P-0404) requesting that FDA amend the definition of trans fat in its food labeling regulations to express the value of “zero” for

trans

fat when there are “absolutely no trans fats at all” and require the use of a symbol (e.g., “~”) to indicate when there is “more than zero but less than 0.5 grams (g) of trans fat per tablespoon” (

http://www.regulations.gov/#!docketDetail;D=FDA-2007-P-0404

); and (12) CSPI submitted a citizen petition on February 13, 2013 (Docket No. FDA-2013-P-0217) requesting, in part, that FDA revise the “Sugars” line on the Nutrition Facts label to address “added sugars” (

http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-0217

).

We address the specific requests identified previously for each citizen petition related to the labeling of conventional foods and dietary supplements in the appropriate sections in this document. Requests in these citizen petitions that are unrelated to the content of the Nutrition Facts label are outside of the scope of this rulemaking and we will address those requests separately from this rulemaking.

6. Advance Notices of Proposed Rulemaking (ANPRMs)

We also published three ANPRMs seeking public comment on issues relevant to updating the Nutrition Facts label.

a. ANPRM on

Trans

Fat—In the

Federal Register

of July 11, 2003 (68 FR 41507), we published an ANPRM (the 2003 ANPRM) to solicit information and data that potentially could be used to establish new nutrient content claims about

trans

fatty acids; to establish qualifying criteria for

trans

fat in nutrient content claims for saturated fatty acids and cholesterol, lean and extra lean claims, and health claims that contain a message about cholesterol-raising lipids; and, in addition, to establish disclosure and disqualifying criteria to help consumers make heart-healthy food choices. We also requested comments on whether we should consider statements about

trans

fat, either alone or in combination with saturated fat and cholesterol, as a footnote in the Nutrition Facts label or as a disclosure statement in conjunction with claims to enhance consumer understanding about cholesterol-raising lipids and how to use the information to make healthy food choices. On March 1, 2004 (69 FR 9559), we reopened the comment period for the 2003 ANPRM to receive comments that considered the information in the IOM Labeling Report (Ref. 25) published in the interim that addressed the labeling of

trans

fat. On April 19, 2004 (69 FR 20838), we extended the comment period for the 2003 ANPRM to receive comments that considered the information in the 2004 meeting of the Nutrition Subcommittee of the Food Advisory Committee (Ref.

46), which addressed whether the available scientific evidence supported listing the percent DV for saturated fat and

trans

fat together or separately on the Nutrition Facts label and what the maximal daily intake of

trans

fat may be.

In response to the 2003 ANPRM, we received about 120 comments. We consider the comments related to determining a DV for

trans

fat in section II.B.3. (see also accompanying Ref. 47). Other issues raised by comments that are unrelated to the DV for

trans

fat will be addressed in a separate rulemaking at a future time.

b. ANPRM on Prominence of Calories—In the

Federal Register

of April 4, 2005 (70 FR 17008), we published an ANPRM on the prominence of calories on the food label (the 2005 ANPRM). The 2005 ANPRM was issued in response to recommendations from the Obesity Working Group created by the Commissioner of Food and Drugs to develop an action plan to address the growing incidence of obesity in the United States. The 2005 ANPRM, in part, requested comments on whether giving more prominence to the declaration of calories per serving would increase consumer awareness of the caloric content of the packaged food. We also sought comment on whether providing a percent DV for total calories would help consumers understand the caloric content of the packaged food in the context of a 2,000 calorie diet. In addition, we also requested comments on questions concerning the declaration of “Calories from fat” (70 FR 17008 at 17010).

We received about 400 comments to the 2005 ANPRM, each containing one or more issues, from industry, trade associations, consumer groups, individual consumers, government, and academia. We consider the comments in sections II.A. and II.M. (see also accompanying Ref. 47).

c. ANPRM on Food Labeling: Revision of Reference Values and Mandatory Nutrients—In the

Federal Register

of November 2, 2007 (72 FR 62149), we published an ANPRM regarding the revision of reference values and mandatory nutrients (the 2007 ANPRM). The 2007 ANPRM requested comment on various aspects of nutrition labeling, including what new reference values we should use to calculate the percent DV in the Nutrition Facts and Supplement Facts labels and what factors we should consider in establishing such new reference values. In addition, we requested comments on whether we should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels.

In response to the 2007 ANPRM, we received about 820 comments, from industry, trade associations, consumer groups, individual consumers, government, and academia. We consider these comments in each of the relevant individual nutrient sections in this document (see also accompanying Ref. 47).

7. Impact on Other Regulations

We recognize that changes to the list of nutrients declared on the Nutrition Facts label or the RDIs or DRVs of nutrients will likely affect other FDA regulations, including certain labeling requirements for foods in 21 CFR part 101. For example, the DVs are used to determine, in part, whether a food or dietary supplement is eligible to bear nutrient content claims or health claims (see for example §§ 101.14, 101.54, 101.76, 101.78, and 101.79). In addition, our fortification policy refers to RDIs and certain DRVs that are specified in § 101.9 in describing principles for the rational addition of nutrients to foods (§ 104.20 (21 CFR 104.20)). We plan to evaluate the impact of the proposed changes to the Nutrition Facts and Supplement Facts labels, if finalized, on other FDA regulations. We intend to address, as appropriate, the impact on other FDA regulations in future separate rulemakings. Thus, issues related to nutrient content claims and health claims are outside the scope of this rulemaking.

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

Under section 403(q)(1)(C) and (D) of the FD&C Act, nutrition information in food labeling must include the total number of calories, derived from any source and derived from the total fat, and the amounts of total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein. For purposes of this proposed rule, we consider the nutrients that are explicitly required by the FD&C Act to be declared on the Nutrition Facts label as “statutorily required nutrients.” Section 403(q)(2)(B) of the FD&C Act permits the Secretary, and by delegation, FDA, to remove a statutorily required nutrients from the label or labeling of food, by regulation, if the Secretary determines the information related to that nutrient is not necessary to assist consumers in maintaining healthy dietary practices. FDA regulations require the declaration of the following statutorily required nutrients: Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrates, sugars, dietary fiber, and total protein (See Ref. 1 for information on regulatory history). As part of the effort to update the Nutrition Facts label, we reconsidered the declaration of these statutorily required nutrients. Our considerations and tentative conclusions on these nutrients are presented within the discussion of individual nutrients in section II.

Section 403(q)(2)(A) of the FD&C Act provides that the Secretary (and by delegation FDA) may, by regulation, require other nutrients to be declared if the Secretary determines that a nutrient will provide information regarding the nutritional value of such food that will assist consumers in maintaining healthy dietary practices. For purposes of this proposed rule, we consider such nutrients that are not statutorily required but subject to our discretion under section 403(q)(2)(A) of the FD&C Act, as “non-statutory nutrients” to distinguish such nutrients from those expressly required by the statute. In the 1993 nutrient content final rule (58 FR 2079), we considered the existence of a quantitative intake recommendation highlighted in U.S. consensus reports and the public health significance of the nutrient in exercising our discretion to determine which non-statutory nutrients to require or permit on the Nutrition Facts label. Based on these considerations, with respect to non-statutory nutrients, we (1) required the declaration of certain essential vitamins and minerals for which an RDI was established and that were determined to have public health significance (i.e., vitamins A and C, iron, and calcium); and (2) permitted the declaration of the remaining essential vitamins and minerals for which there was an established RDI or DRV (i.e., vitamin E)

or

that had public health significance, as well as permitted the declaration of certain subcategories of macronutrients for which a DRV was not established (including monounsaturated fat, polyunsaturated fat, soluble fiber, insoluble fiber, sugar alcohol, and other carbohydrate) (58 FR 2079).

In this section, we describe our current thinking related to considerations used to determine whether a non-statutory nutrient should be required or permitted to be declared on the Nutrition Facts label. Applying this current thinking, in section II, we are proposing the mandatory declaration of certain non-statutory nutrients, voluntary declaration of others, and proposing to remove the mandatory declaration of another nutrient. For purposes of this proposed rule, we use the term “nutrient” to refer to

substances that are currently included or that we are considering for inclusion on the Nutrition Facts label, including carbohydrate, fat, and protein and their subcomponents (e.g., added sugars, sugar alcohols, saturated fat), micronutrients (vitamins and minerals), and to calories, including calories from fat.

1. Factors Considered

We updated the information that we consider for determining whether the declaration of a non-statutory nutrient should be mandatory or voluntary. This update responds to several developments. Since the 1993 nutrient content final rule was published, (1) new scientific data have provided additional evidence of the role of certain nutrients in chronic disease risk, health-related conditions, or health-related physiological endpoints and, in some cases, based on the review of this evidence, DRIs are now available from the IOM that can be used as quantitative intake recommendations (i.e., RDA and AI), as well as for assessing the inadequacy and adequacy of essential vitamins and minerals in the U.S. population (i.e., EAR and AI); (2) the rates of certain diseases or health-related conditions have either changed or remained high; and (3) the process for evaluating the relationship between a nutrient and chronic disease risk, a health-related condition, or a health-related physiological endpoint has been refined based on the use of systematic evidence-based reviews for a number of nutrients (e.g., 2010 DGA, FDA health claims).

We continue to be mindful of past factors we considered as part of our deliberations related to the Nutrition Facts label, such as the number of nutrients that could be listed in nutrition labeling, that some individuals could interpret a long list of nutrients as implying that a food has greater nutritional significance than is the case, and that there is limited space for nutrition information on the label (55 FR 29487 at 29493; July 19 1990).

To help us determine whether a non-statutory nutrient should be a required or permitted declaration, we are considering the same general types of information used in 1993 when the nutrient content final rule was published: (1) Existence of quantitative intake recommendations; and (2) public health significance. We discuss each of these factors in greater detail in this document.

a. Quantitative Intake Recommendations—Quantitative intake recommendations are reference intake levels provided in consensus reports that can be used to set a DRV or RDI. We expect these consensus reports to be published for the purpose of setting quantitative intake recommendations (e.g., the IOM DRI reports). If DRIs are not available for nutrients, other than essential vitamins and minerals, then we consider science-based recommendations from other U.S. consensus reports or the DGA policy reports. Such recommendations may be identified as a conclusion, key recommendation, or reported in the executive summary of the consensus report.

b. Public Health Significance—For the purposes of nutrition labeling of foods and dietary supplements, we consider public health significance to refer to two elements. First we consider whether there is evidence of a relationship between the nutrient and a chronic disease, health-related condition, or health-related physiological endpoint. This can be demonstrated either by well-established evidence or, for essential vitamins and minerals, recommendations regarding the health consequences of inadequacy of the nutrient. Second we consider whether there is evidence of a problem related to health in the general U.S. population. This needs to be demonstrated by both evidence of a problem with the intake of the nutrient in the general U.S. population and evidence of the prevalence of the chronic disease, health-related condition, or health-related physiological endpoint that is linked to that nutrient in the general U.S. population. We consider public health significance to refer to the following: (1) Existence of “well-established” scientific evidence from U.S. consensus reports that there is a relationship between a nutrient and chronic disease risk, a health-related condition, or a health-related physiological endpoint and where the intake of such nutrient is of general importance in the general U.S. population, e.g., where intakes are generally too low or too high among the U.S. population. U.S. consensus reports are those reports that provide consensus conclusions or recommendations by a group of experts as requested by U.S. Government Agencies (e.g., IOM reports, the DGAs, National Institutes of Health (NIH) consensus reports). We generally consider scientific evidence to be “well-established” when such consensus reports have determined the evidence to be “conclusive,” “documented,” or “strong.” Evidence that meets the significant scientific agreement standard in section 403(r)(3)(B)(i) of the FD&C Act in support of those nutrients and disease or health-related conditions for which we have authorized a health claim would be considered “well-established” evidence for the purposes of what public health significance refers to in this proposed rule; or (2) nutrients for which there are DRIs set by the IOM (i.e., RDA or AI) that are based on chronic disease risk (e.g., osteoporosis), a health-related condition (e.g., blood pressure) or a nutrient deficiency with clinical significance (e.g., low iron storage leading to iron deficiency anemia) for which inadequate intakes of these nutrients are likely to have important clinical consequences. The nutrients for which this may occur are essential vitamins and minerals; and

(3) for all nutrients, there is evidence of inadequate or excess intake of the nutrient based on national nutritional survey data or U.S. consensus reports, and that a substantial prevalence exists in the general U.S. population of the chronic disease, health-related condition, or health-related physiological endpoint that was linked to the particular nutrient (e.g., soluble fiber and coronary heart disease (CHD) risk, calcium and risk of osteoporosis). Because we remain concerned about the large number of nutrients that could be listed as mandatory or voluntary, for essential vitamins and minerals, we are proposing for mandatory declaration, those for which inadequacy has the greatest impact on public health because of their association with a risk of chronic disease, a health-related condition, or a nutrient deficiency with clinical significance (e.g., iron deficiency anemia).

The methods used in the evaluation of public health significance of essential vitamins and minerals are discussed in greater detail in section II.H. and the accompanying reference document (Ref. 48).

2. Approach for Mandatory Declaration

In general, we continue to consider mandatory declaration appropriate when there is public health significance and a quantitative intake recommendation that can be used for setting a DV (DRV or RDI). However, we have also considered mandatory declaration based, in part, on evidence highlighting the role of a nutrient in chronic disease risk. For example, in 2003, we published a final rule requiring

trans

fat declaration on the Nutrition Facts label (68 FR 41434). We considered data and information related to the risk of coronary heart disease from consumption of

trans

fat. In addition, we considered the public health significance of

trans

fat intake

based on consensus reports and federal policy statements.

Information related to nutrient intake and its effect on health is not static. Recommendations from various scientific bodies of the U.S. Government that are responsible for public health protection or research directly relating to human nutrition may change or evolve over time. We include, as part of our review of nutrient information in this proposed rule, the current recommendations from such scientific bodies. In section D.3, we specifically consider recommendations from the 2010 DGA related to the intake of added sugars in the diet and the role of such information in assisting consumers to maintain healthy dietary practices. Our review is not based on the factors we have traditionally considered for mandatory declaration that are related to chronic disease, health-related condition, or health-related physiological endpoint linked to the particular nutrient. Instead, our review is based on the need for nutrient information for consumers to implement key dietary recommendations to assist consumers to maintain healthy dietary practices and the need for consumers to be able to readily observe and comprehend the information and to understand its relative significance in the context of a total daily diet.

3. Approach for Voluntary Declaration

For nutrients that are not essential vitamins and minerals (e.g., fluoride, soluble and insoluble fiber, monounsaturated fatty acids and polyunsaturated fatty acids), we consider voluntary declaration to be appropriate when the nutrient either has a quantitative intake recommendation but does not have public health significance, or does not have a quantitative intake recommendation available for setting a DRV but has public health significance. In addition, we consider that voluntary declaration should be permitted for essential vitamins or minerals that we determine do not fit within our considerations for mandatory declaration, but that have an RDI.

We invite comment on the factors for considering mandatory and voluntary declaration of non-statutory nutrients.

II. The Proposed Rule

In this proposed rule, we address issues related to the information declared on the Nutrition Facts label, i.e., declaration of nutrients, definitions, analytical methods, RDIs and DRVs, format, and compliance with declared values. Sections II.A. through II.E. discuss issues related to calories and macronutrients (including fat, fatty acids, cholesterol, carbohydrates, sugars, fiber, and protein), whereas sections II.F. through II.J. discuss issues related to vitamins and minerals, and sections II.K. and II.L. discuss nutrition labeling requirements applicable to certain population subgroups and dietary supplements, respectively. Section II.M. covers issues related to the format of the Nutrition Facts label, followed by section II.N., which focuses on provisions related to compliance and verification. Finally, section II.O. describes technical amendments to existing provisions in § 101.9.

As discussed in this document, our evaluation of these issues was informed by current scientific evidence, dietary recommendations, and conclusions of current consensus reports. We took into account any related requests from petitioners and public comments.

A. Calories

Section 403(q)(1)(C) of the FD&C Act requires the declaration of the total number of calories derived from any source. Correspondingly, FDA regulations require the total caloric content of a food to be declared on the Nutrition Facts label (§ 101.9(c)(1)). We are not proposing to modify the requirement to declare total calories. However, we are reconsidering a number of other requirements related to the declaration of information about calories. The requirements related to “Calories from fat,” “Calories from saturated fat,” the 2,000 reference calorie intake level, and a percent DV for calories are discussed in section II.A., whereas requirements related to prominence of the calorie declaration and the footnote statement and table of DVs for 2,000 and 2,500 calorie diets are discussed in section II.M.

1. Calories From Fat

The declaration of “Calories from fat” is mandatory (§ 101.9(c)(1)(ii)). Section 403(q)(1)(C)(ii) of the FD&C Act requires total calories from fat to be declared on the label or labeling of food. Section 403(q)(2)(B) of the FD&C Act provides the Secretary of Health and Human Services (and by delegation, FDA) with discretion to remove the requirement by regulation if the Secretary determines that it is not necessary to assist consumers in maintaining healthy dietary practices. We reviewed current scientific evidence and recommendations in current consensus reports in determining whether information on calories from fat is necessary to assist consumers in maintaining healthy dietary practices. We also considered comments (Ref. 47) to the 2005 and 2007 ANPRMs, in which we requested comment on various questions related to “Calories from fat” declared on the Nutrition Facts label. Unlike dietary recommendations that we relied on during the 1993 rulemaking, current dietary recommendations no longer emphasize total fat. Certain fatty acids are understood to be beneficial, while others are understood to have negative health effects, particularly related to cardiovascular disease (Refs. 6, 36, and 49). Accordingly, the 2005 DGA shifted its focus from total fat reduction to reduction in certain types of fatty acids and their influence on the risk of cardiovascular disease (Ref. 36). The 2002 IOM Macronutrient Report (Ref. 49) set an AMDR for total fat at 20 to 35 percent of calories, recognizing that there were some benefits to consuming moderate amounts of fat (Ref. 49). The 2002 IOM Macronutrient Report and the 2010 DGA (Refs. 6 and 49) concluded that the type of fat consumed was more relevant in reducing the risk of CHD than overall total fat intake.

Based on the these dietary recommendations and consensus reports that emphasize intake of total calories and the type of fat consumed, as well as comments to the 2005 and 2007 ANPRMs that supported eliminating the declaration of “Calories from fat” in order to place greater emphasis on total calories (Ref. 47), we tentatively conclude that declaration of “Calories from fat” is not necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are proposing to no longer require, and to not allow voluntarily, the declaration of “Calories from fat” on the Nutrition Facts label. While eliminating the declaration of “Calories from fat” may appear to be a loss of information on the amount of fat being consumed, as some comments suggested, the amount of fat being consumed can still be obtained from the total fat declaration elsewhere on the Nutrition Facts label, and consumers can still use the percent DV for total fat to put fat content in the context of a total daily diet, compare products, and plan diets. Therefore, we are proposing to remove current § 101.9(c)(1)(ii) to remove the requirement for declaration of calories from fat (and redesignate § 101.9(c)(1)(iii) as proposed § 101.9(c)(1)(ii)). We invite comment on the tentative conclusion to no longer require, and to not allow voluntarily the declaration of “Calories from fat” on the Nutrition Facts label.

2. Calories From Saturated Fat

The declaration of “Calories from saturated fat” is voluntary (§ 101.9(c)(1)(iii)). The 2010 DGA continues to recommend that Americans should consume less than 10 percent of calories from saturated fat (Ref. 6). Saturated fat is known to increase the risk of cardiovascular disease and, unlike “Calories from fat,” which could include calories attributable to fatty acids that decrease or increase the risk of certain diseases, “Calories from saturated fat” would provide information about calories from a source known to increase disease risk (Ref. 49). We considered the recommendations in current consensus reports as well as the comments (Ref. 47) received in response to the 2007 ANPRM requesting comment on whether the declaration of “Calories from saturated fat” should continue to be voluntary or whether it should be mandatory.

Based on the recommendations in current consensus reports and supported by many comments, we tentatively conclude that mandatory declaration of “Calories from saturated fat” is not necessary because the amount of saturated fat being consumed can still be obtained from the total saturated fat declaration elsewhere on the Nutrition Facts label. Additionally, as with total fat, consumers can still use the percent DV for saturated fat to put saturated fat content in the context of a total daily diet, compare products, and plan diets. However, because there is strong evidence associating higher intakes of saturated fat with higher low-density lipoprotein (LDL) cholesterol levels, information on “Calories from saturated fat” can assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing to change the current voluntary labeling of “Calories from saturated fat” in the Nutrition Facts label as specified in § 101.9(c)(1)(iii). However, considering our proposal to eliminate the declaration of “Calories from fat” on the Nutrition Facts label (see section II.A.1.), we are proposing to revise § 101.9(c)(1)(iii) and (d)(5) to specify that the statement “Calories from saturated fat,” when declared, must be indented under the statement of calories. In addition, we are proposing to redesignate § 101.9(c)(1)(iii) as proposed § 101.9(c)(1)(ii).

3. Two Thousand Calories as the Reference Caloric Intake Level

Per FDA regulations, a reference calorie intake level of 2,000 calories is used to set DRVs for total fat, saturated fat, total carbohydrate, protein, and dietary fiber (§ 101.9(c)(9)). In addition, we require a footnote on the Nutrition Facts label that states, “Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs,” followed by a table with certain DVs based on 2,000 and 2,500 calorie diets (§ 101.9(c)(9)). In reconsidering the 2,000 calories reference intake level, we considered relevant recommendations from the IOM macronutrient report that provided estimated energy requirements (EERs) and the IOM Labeling Report (Refs. 25 and 50). We also considered comments (Ref. 47) received in response to the 2007 ANPRM, in which we asked whether 2,000 calories should continue to be used as the reference calorie intake level and asked questions related to the use of the EERs.

An EER is a DRI set by the IOM for energy intake and is defined as the dietary energy intake that is predicted to maintain energy balance in a healthy adult of defined age, gender, weight, height, and level of physical activity consistent with good health. The IOM set EERs for all life-stage and gender groups and based these EERs on normal weight individuals (i.e., BMI < 25) (Ref. 50). The IOM Labeling Committee considered whether there was a basis to use the EERs for developing a new reference calorie intake level for macronutrients in nutrition labeling. The IOM Labeling Committee noted that using the EER to derive a reference calorie intake level would require making assumptions about height, weight, and physical activity level. Furthermore, the equations used to calculate the EERs were based on normal weight individuals; however, the American population has a high prevalence of overweight and obesity. Thus, the IOM Labeling Committee found that the data necessary to use the EER concept as the basis for a reference calorie intake level for nutrition labeling were incomplete and it could not recommend the approach (Ref. 25). The IOM Labeling Committee concluded that retaining the current 2,000 reference calorie intake level would be the best approach as it would provide continuity and would not encourage higher calorie intake and overconsumption of energy (Ref. 25).

We agree with the IOM Labeling Report and comments in response to the 2007 ANPRM (Ref. 47) that the EERs do not provide an appropriate basis for the derivation of a reference calorie intake level for the purpose of nutrition labeling. The EERs are influenced by various parameters such as age, gender, height, weight, and physical activity level (PAL), which makes it challenging to combine the EERs into a single reference calorie intake level applicable to the general population. Further, all of the comments supported the use of the 2,000 calorie reference intake level.

Therefore, we are not proposing any changes to the current use of 2,000 reference calorie intake level as the basis for setting DRVs for total fat, saturated fat, total carbohydrate, dietary fiber, and protein, as specified in § 101.9(c)(9).

4. Percent DV Declaration for Calories

Current regulations do not provide for a DRV for calories. Setting a DRV for calories would necessitate the determination of a quantitative intake recommendation for calories. To determine an appropriate DRV for calories, we reviewed recommendations in current consensus reports. We also considered comments (Ref. 47) received in response to the 2005 and 2007 ANPRMs, in which we asked whether providing a percent DV disclosure for total calories would assist consumers in understanding the caloric content of the packaged food in the context of a 2,000 calorie diet. The IOM macronutrient report is the most recent consensus report that provides quantitative intake recommendations for calories (Ref. 50), and those quantitative intake recommendations are the EERs. For the same reasons that EERs are not appropriate for setting the reference calorie intake level as described previously, these EERs are not appropriate for setting a DV for calories. First, the EERs do not apply to overweight individuals, and are therefore not applicable to a substantial portion of the general population. Second, combining the EERs into a single, meaningful reference value is challenging because they vary by age, gender, height, weight, and PAL. In addition, DRVs were established for those nutrients that are important in diet and health interrelationships and/or based on caloric intake (55 FR 29476 at 29479; July 19, 1990). Accordingly, most of the DRVs have been based on quantitative intake recommendations associated with chronic disease risk or a health-related condition (e.g., total fat, saturated fat, cholesterol, and dietary fiber). In contrast, the EERs are neither associated with chronic disease risk or a health-related condition, nor are they intended to be treated as a single recommended value that can be applied to the general U.S. population. Thus, we tentatively conclude that there is no appropriate quantitative intake recommendation and we are not aware of any other data or information on which a DRV for calories can be determined. Although a majority of

comments to the ANPRMs supported the addition of a percent DV for total calories, we are not persuaded to propose to require or permit such declaration due to the lack of an appropriate quantitative intake recommendation or other data or information on which FDA could rely to establish a DRV for calories. We invite comment on the tentative conclusion not to establish a DRV for calories and include a percent DV for the declaration of calories.

Therefore, we are not proposing to set a DRV for calories and, as a result, a percent DV declaration for calories would be neither required nor permitted.

B. Fat

In section II.B., we discuss considerations related to definitions, declaration, and DRVs for total fat, saturated fat,

trans

fat, monounsaturated fat, and polyunsaturated fat.

1. Total Fat

a. Definition—FDA defines “fat, total” or “total fat” in § 101.9(c)(2) as a statement of the number of g of total fat in a serving defined as total lipid fatty acids and expressed as triglycerides.

In 1997, we received a citizen petition from Nabisco, Inc. (Docket No. FDA-1997-P-0476) requesting that FDA amend the definitions of “total fat” and “saturated fat” in its food labeling regulations to clarify that acetic, propionic, and butyric acids may be excluded when calculating the amount of fat in a food product (

http://www.regulations.gov/# !docketDetail;D=FDA-1997-P-0476

). The petitioner's requests related to the definition and labeling of total fat are presented here and the petitioner's requests related to the definition of saturated fat are discussed in section II.B.2.

With respect to total fat, the petitioner requested that we amend § 101.9(c)(2) to read as follows: “Fat, total” or “Total fat”: A statement of the number of g of total fat in a serving defined as total lipid fatty acids, excluding acetic (C:2), propionic (C:3), and butyric (C:4) acids and expressed as triglycerides . . .” The petitioner stated that acetic, propionic, and butyric acids (“the acids”), which have very short two, three, and four carbon chains, respectively, are organic acids that should not be considered fatty acids for food labeling purposes for the following reasons: (1) The acids are chemically different from fatty acids because they are water soluble; (2) the digestion and absorption of the acids are distinctly different from those of fatty acids; (3) the acids are metabolized differently than fatty acids and are biochemically and physiologically more closely related to carbohydrates than to fat; and (4) the acids do not cause the adverse health effects associated with fat and may even have benefits that make them distinct from fat. The petitioner noted that excluding the acids from the definition of fat would not affect current labeling practices because they are found in such small amounts in the food supply. In addition, the petitioner asserted that analytical methods would not be affected because approved AOAC methods for total fat measurement do not detect the acids.

We disagree with the petitioner that the acids are chemically different from fatty acids because they are water soluble and that insolubility in water is the essential chemical property of a fat. Fatty acids are monocarbonic acids with chain lengths between 1 and nearly 30 carbon atoms (Ref. 51). The chain length of a fatty acid determines its physical properties (Ref. 51). Short-chain fatty acids are compounds that are soluble in water. As the chain length increases, water-solubility decreases (Ref. 51). Short chain acids such as acetic, propionic, and butyric acids are still considered fatty acids although they are water soluble. Furthermore, the characteristic feature of a fatty acid is a terminal carboxyl group attached to a chain of alkyl groups containing carbon atoms of which these short chain acids are composed (Ref. 52).

We determine the amount of the major macronutrients (carbohydrate, fat, and protein) in a food product by their chemical composition. We tentatively conclude that the petitioner did not provide a scientific basis on which we could rely to propose to exclude acetic, propionic, and butyric acids from the definition of total fat based on differences in chemical composition. Moreover, the petitioner did not explain why we should define total fat based on physiological differences identified for such fatty acids compared to other fatty acids, even if true, and not retain our current approach to define total fat based on chemical composition. Therefore, we are not proposing any changes to the current definition of “total fat.” We request comment on our tentative conclusion that acetic, propionic, and butyric acids should not be excluded from the definition of “total fat.”

To clarify what we consider to be a fatty acid, we are proposing to define “fatty acids” in § 101.9(c)(2) as “aliphatic carboxylic acids consisting of a chain of akyl groups and characterized by a terminal carboxyl group.” This definition is consistent with other similar definitions found in nutrition and chemistry references (Refs. 51 to 54). We request comment on the proposed definition of fatty acids.

b. Mandatory Declaration—Section 403(q)(1)(D) of the FD&C Act requires the declaration of the amount of total fat on food labels. Consequently, the Nutrition Facts label includes the mandatory declaration of the gram amount for total fat in § 101.9(c)(2).

The 2010 DGA recognizes that the types of fatty acids consumed are more important in influencing the risk of CVD than the total amount of fat in the diet (Ref. 6). Current dietary recommendations and clinical guidelines encourage replacing saturated and

trans

fatty acids with beneficial fats, such as polyunsaturated and monounsaturated fatty acids (Refs. 6 and 55). A high intake of most types of saturated fatty acids,

trans

fatty acids, and cholesterol can increase LDL cholesterol levels, which in turn may increase the risk of CHD (Ref. 49). While there is a significant amount of evidence showing that a diet high in saturated or

trans

fatty acids may be detrimental to health, there is also evidence that consumption of less than 20 percent of calories from fat can lead to an increased risk of insufficient intake of vitamin E and essential fatty acids (Ref. 49). In addition, consumption of a low fat diet that is high in carbohydrate can lead to a reduction in high density lipoprotein cholesterol concentration and an increase in blood triglycerides, which can result in an increased risk of CHD (Ref. 49).

We concur with the 2010 DGA that consuming a diet low in saturated fatty acids and cholesterol is more important for reducing CVD risk than consuming a diet low in total fat. This finding is consistent with the conclusions in the IOM Macronutrient Report (Ref. 49), as well as with current practice guidelines such as the National Heart, Lung, and Blood Institute (NHLBI) Third Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Ref. 55). Total fat is a calorie-yielding macronutrient and an important piece of the macronutrient profile of a food. However, consumption of inadequate amounts of total fat is also associated with an increased risk of impaired growth and consumption of excessive amounts of total fat is associated with an increased risk of chronic diseases, such as CHD and diabetes (Ref. 49). In addition, the IOM noted that high fat diets are usually accompanied by increased intakes of saturated fatty acids which can increase the risk of CHD (Ref. 49). Thus, we tentatively conclude that

mandatory declaration of total fat on the Nutrition Facts label continues to be necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing any changes to the current requirement for mandatory declaration of total fat on the Nutrition Facts label.

c. DRV—The DRV for total fat is 30 percent of calories (65 g/d) (§ 101.9 (c)(9)). In developing the DRIs for various nutrients, the IOM cited a lack of data sufficient to determine a defined level of fat intake at which no risk of inadequacy or prevention of chronic disease occurs, and therefore, decided to establish neither an AI nor an RDA for total fat (Ref. 49). Instead, the IOM established an AMDR for total fat intake of 20 to 35 percent of energy for adults and an AMDR of 25 to 35 percent of energy for children age 4 to 18 years. The AMDRs are associated with reduced risk of chronic diseases, such as CHD, while providing for adequate intake of essential nutrients. The 2010 DGA acknowledged the IOM's AMDR and noted that total fat intake should fall within the AMDRs set by the IOM (Ref. 6). The IOM Labeling Committee recommended that AMDRs should be the basis for DVs for protein, total carbohydrate, and total fat (72 FR 62149 at 62164). Accordingly, for total fat, the IOM Labeling Committee recommended a population-weighted midpoint of the AMDR since AMDRs vary with age. A population-weighted mid-point of the AMDR for adults, i.e., 20 to 35 percent, yields a DRV of 28 percent or 62 g of total fat. The use of the upper level (35 percent of energy) of the AMDR would increase the DRV from 65 g to 78 g for a 2,000 calorie diet.

Considering the recommendations of the IOM Labeling Committee, we requested comment, in the 2007 ANPRM, on: (1) Whether a population-weighted midpoint of the AMDR (e.g., 28 percent for adults) should be used, as suggested in the IOM Labeling Report and (2) whether the upper level of AMDR of 35 percent (78 g) should be used.

We reviewed the IOM Labeling Committee's recommendations, IOM DRIs, and comments in response to the 2007 ANPRM (Ref. 47). We tentatively conclude that changing the DRV for total fat to the lower end of 20 percent of 2,000 calories would not be appropriate because: (1) It would not be appropriate for children 4 to 18 years of age because it falls below the lower end of the AMDR (i.e., 25 to 35 percent of energy) and (2) scientific evidence supports consumption of greater than 20 percent of total calories from total fat for reduction in risk of chronic diseases, such as CHD and diabetes (Ref. 49).

We also conclude that the upper level of the AMDR of 35 percent of 2,000 calories as the basis for a DRV would provide no meaningful health benefit and that a population-weighted mid-point of 28 percent of the AMDR (28 percent of calories) as the basis for the DRV is not significantly different from a public health outcome standpoint than the current value of 30 percent of calories. Using the population-weighted AMDR midpoint approach would result in an insignificant reduction from the DRV of 65 g (rounded from 30 percent of a 2,000 calorie diet) to 60 g (rounded from 28 percent of calories), which may imply a greater level of precision in a DRV than is actually true.

Furthermore, the DRV for total fat is linked to the DRVs for total carbohydrate and protein. For reasons discussed in sections II.D. and II.E., we are not proposing to change the DRVs for carbohydrate or protein at this time. Because the DRV for carbohydrate is determined by difference, an increase in the DRV for fat would result in a decrease in the DRV for carbohydrate.

The DRV of 30 percent of calories fits within the AMDR and represents a moderate value that is not close to the upper or lower levels of the AMDR. A majority of comments supported maintaining the current DRV of 30 percent of calories. As noted previously, the DRV for total fat was calculated based on a 2,000 reference calorie intake and the dietary recommendation for fat intake at the time of 30 percent or less of total caloric intake, amounting to 66.7 g of fat, which was rounded down to 65 g. Current dietary recommendations for fat intake provide a range of acceptable intakes (i.e., between 20 and 35 percent of caloric intake) and encompass the 30 percent value that formed the basis for the existing DRV. Therefore, we are not proposing any changes to the current DRV for total fat of 30 percent of calories.

2. Saturated Fat

a. Definition—FDA regulations define “Saturated fat” in § 101.9(c)(2)(i) as the sum of all fatty acids containing no double bonds. We received a citizen petition from the American Cocoa Research Institute on April 3, 1996 (Docket No. FDA-1996-P-0035) requesting that the Agency exclude stearic acid from the definition of saturated fat because the petitioner claimed that stearic acid does not raise LDL-cholesterol levels or the risk of CHD (

http://www.regulations.gov/# !docketDetail;D=FDA-1996-P-0035

). In the 2007 ANPRM, we did not seek comments on the definition of saturated fat, but received a few comments that requested excluding stearic acid from the definition of saturated fat or permitting a separate listing for stearic acid below the line for saturated fat (Ref. 47).

We considered the comments to the 2007 ANPRM and the request by the American Cocoa Research Institute petition, and do not agree that stearic acid should be excluded from the definition of saturated fat. While there is evidence that there are potential differences in the physiological effects of different saturated fatty acids, including on LDL cholesterol levels, the definitions of nutrients for food labeling purposes have traditionally been based on chemical definitions, rather than on individual physiological effects. The definition for saturated fat in § 101.9(c)(2)(i) includes all fatty acids without double bonds and the accepted analytical methods capture all of the saturated fatty acids, including stearic acid. In adopting this definition, we addressed the issue of inclusion/exclusion of individual saturated fatty acids and determined that a chemical definition (which includes all fatty acids containing no double bonds) was the appropriate approach to define saturated fat (58 FR 2079 at 2088). We further note that the 2010 DGA recommendation related to saturated fat intake is based on scientific evidence related to the intake of all saturated fatty acids combined, which includes stearic acid. The DGA recommendation to consume less than 10 percent of calories from saturated fatty acids makes no specific exclusion of stearic acid and, instead, relates to the intake of total saturated fatty acids (Ref. 6). There are no quantitative intake recommendations for stearic acid.

The inclusion of stearic acid in the definition of saturated fat is consistent with our overall approach to rely on chemical definitions of nutrients as the basis for regulatory definitions for food labeling purposes. The American Cocoa Research Institute petition did not provide a basis for why we should deviate from this overall approach to rely on the chemical definition of nutrient as a basis for a regulatory definition. Thus, we are not proposing to exclude stearic acid from the definition of saturated fat.

Finally, we also considered voluntary declaration of stearic acid on the Nutrition Facts label, as recommended by a few comments. The effects of stearic acid on LDL cholesterol levels appear to vary depending on the macronutrient component that is replaced by stearic acid (Ref. 30).

Moderate evidence indicates that when stearic acid substitutes for other saturated fatty acids or

trans

fat, plasma LDL cholesterol levels decrease whereas when it replaces monounsaturated or polyunsaturated fatty acids, LDL cholesterol levels increase (Ref. 30). Considering such scientific data, the 2010 DGAC concluded that the potential effects of changes in dietary intake of stearic acid on the risk of CVD remain unclear. Thus, the evidence for a role of stearic acid in human health (e.g., changes in plasma LDL cholesterol levels) is not well-established. Furthermore, there is no quantitative intake recommendation available for stearic acid. Therefore, we tentatively conclude that the individual declaration of stearic acid is not necessary to assist consumers in maintaining health dietary practices, consistent with the factors we consider, discussed in section I.C., and therefore the declaration would not be permitted on the Nutrition Facts label.

As discussed in section II.B.1., we received a citizen petition from Nabisco, Inc. on May 7, 1997 (Docket No. FDA-1997-P-0476) requesting that FDA amend the definitions of “total fat” and “saturated fat” in its food labeling regulations to exclude acetic, propionic, and butyric acids (

http://www.regulations.gov/# !docketDetail;D=FDA-19970-P-0476

). With respect to saturated fat, the petition requested that FDA amend § 101.9(c)(2) to read as follows: (i) “Saturated fat,” or “Saturated”: A statement of the number of g of saturated fat in a serving defined as the sum of all fatty acids, excluding acetic (C:2), propionic (C:3), and butyric (C:4) acids, containing no double bonds.” For the same reasons discussed in section II.B.1. regarding total fat, we are not proposing to exclude acetic, propionic, and butyric acids from the definition of saturated fat.

b. Mandatory Declaration—Section 403(q)(1)(D) of the FD&C Act requires the declaration of the amount of saturated fat on food labels. Accordingly, FDA regulations require mandatory declaration of the gram amount for saturated fat (§ 101.9(c)(2)).

Dietary recommendations continue to recognize the well-established relationship between consumption of saturated fat and its effect on blood cholesterol levels (Refs. 6 and 49). In addition, the 2010 DGA provided a quantitative intake recommendation for saturated fat. We are unaware of evidence to support a determination that information relating to saturated fat on the Nutrition Facts label is no longer necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing to change the requirement for mandatory declaration of saturated fat on the Nutrition Facts label in § 101.9(c)(2)(i).

c. DRV—The DRV for saturated fat is 20 g, which is 10 percent of calories based on a 2,000 reference calorie intake level (§ 101.9(c)(9)). The IOM Labeling Committee recommended that the DV for saturated fatty acids (along with trans fatty acids and cholesterol) should be set at a level that is as low as possible in keeping with an achievable health-promoting diet and consistent with IOM DRIs (Ref. 25). The IOM Labeling Committee suggested that FDA use food composition data, menu modeling, and data from dietary surveys to estimate minimum intakes that are consistent with nutritionally adequate and health-promoting diets for diverse populations. In the 2007 ANPRM, we asked for public comment on (1) whether the current DRV for saturated fat of 20 g should be retained and (2) whether food composition data, menu modeling, and data from dietary surveys should be used to establish a DRV for saturated fat that is as low as possible while consuming a nutritionally adequate diet. We received several comments in response to these questions (Ref. 47).

Current consensus reports that reviewed scientific evidence related to saturated fatty acid intake continue to recommend saturated fat intakes of no more than 10 percent of calories, based on risk of CVD. Specifically, the IOM DRIs recommended that intakes of these fats should be as low as possible while consuming a nutritionally adequate diet (Ref. 49). In addition, confirming the relationship between high intakes of saturated fatty acids and increased risk of unhealthy blood lipid levels and CHD, the 2010 DGA reaffirmed the recommendation to reduce saturated fatty acid intake to less than 10 percent of calories and noted that lowering the intake even more, to 7 percent of calories, can further reduce the risk of CVD (Ref. 6). The 2002 report from the National Cholesterol Education Program of the NIH National Heart, Lung, and Blood Institute established saturated fat intakes of no more than 10 percent of calories as an optimal intake level for reduction of CHD risk while also establishing intakes of no more than 7 percent of calories as a therapeutic intake level for treating CHD (Ref. 55). Although some comments suggested reducing the DRV to 15 g and to lower the DRV to 7 percent of calories, we are not persuaded to do so because the current saturated fatty acid recommendation of less than 10 percent of calories is still appropriate for the general U.S. population and that the existing DRV of 20 g continues to conform to current dietary recommendations as a maximum intake level that covers the general U.S. population.

We do not consider the use of food composition data, menu modeling, or dietary survey data as a suitable approach to determine DRVs. We note that the majority of comments opposed the use of such alternative methods to determine the DRV for saturated fat.

We established the current DRVs based on quantitative intake recommendations and underlying science on the association between increased intakes and either reduced risk of chronic disease (e.g., dietary fiber and CHD) or increased risk of chronic disease (e.g., saturated fat and CHD). The approach to determine DRVs using food composition data, menu modeling, or dietary surveys has a number of deficiencies. Menu modeling is an approach, based on available foods in the marketplace, to design a set of food items for meals, which will meet certain nutrient or food intake pattern recommendations (Ref. 56). Menu modeling, by its very nature, would not permit the selection of DRVs that are based on scientific evidence related to actual public health outcomes. Furthermore, menu modeling permits the creation of model menus that may be able to meet certain nutrient thresholds through the inclusion of foods that are not representative of the type or quantity of foods eaten in the U.S. population or any specific population and, thus, may result in nutrient intake levels that do not reflect typical diets and, as such, may be unachievable or unreasonable. The use of menu modeling can be appropriate in other circumstances, such as the use of modeling to determine scenarios of highest possible nutrient intake levels or potential nutrient profiles of diets. Thus, food composition data and related models can help provide useful information about consumption trends and the general nutrient content of the food supply and can serve as an additional consideration in choosing a reference point for daily intake that is realistically achievable and practical in light of the current food supply and consumption patterns. However, these data cannot form the primary scientific bases for selecting DRVs. Another challenge with the use of the menu modeling approach is that numerous and rapid changes to food formulations can make it difficult for food composition databases to provide current and accurate estimates of nutrient intakes. Based on these inherent limitations of menu modeling

and the data sources used, we tentatively conclude that the menu modeling approach, as recommended in the IOM Labeling Report, is an unsuitable method for determining DRVs (or RDIs). Instead, we intend to continue using science-based recommendations to set DRVs and RDIs. In the case of saturated fat, as explained previously, the existing scientific evidence does not support a change to the current 20 g DRV. Therefore, we are not proposing any changes to the current DRV of 20 g for saturated fat as specified in § 101.9(c)(9).

3.

Trans

Fat

a. Definition—FDA defines “

Trans

fat” or “

Trans”

in § 101.9(c)(2)(ii) as the sum of all unsaturated fatty acids that contain one or more isolated (i.e., non-conjugated) double bonds in a

trans

configuration. In the 2007 ANPRM, we did not seek public comment on the definition of

trans

fat. However, we received a comment recommending the exclusion of a specific

trans

fat isomer, vaccenic acid (18:1 t11) from the definition of

trans

fat because, according to the comment, unlike other

trans

fat isomers, vaccenic acid may not have adverse health effects. As discussed in the preamble to the final rule regarding

trans

fat labeling (68 FR 41434 at 41461), we defined trans fatty acids by their chemical structure, not their physiological effects or functional attributes. While the comment provided us with some preliminary observational data suggesting that

trans

fat from ruminant sources, such as vaccenic acid, may not have the same effects on CHD risk as

trans

fat from industrial sources, such as partially hydrogenated oils, we do not agree that potential differences in physiological effects should be the basis for determining the specific isomers to be included in a regulatory definition of

trans

fat. The definition for

trans

fat is its chemical definition which captures all

trans

fat isomers that have isolated bonds and, thus, vaccenic acid would be measured by the analytical method used to determine

trans

fat content of foods. This chemical definition is consistent with how polyunsaturated fat is defined as

cis, cis

-methylene-interrupted (§ 101.9(c)(2)(ii)). Accordingly, we are not proposing to change the definition of

trans

fat in § 101.9(c)(2)(ii).

b. Mandatory Declaration—FDA regulations require the declaration of

trans

fat on the Nutrition Facts label (§ 101.9(c)(2)(ii). Dietary recommendations continue to recognize the well-established relationship between consumption of

trans

fat and its effect on blood cholesterol levels (Ref. 6). Furthermore, under section 403(r)(3)(C) of the FD&C Act, we did not object to a 2006 Food and Drug Administration Modernization Act of 1997 (FDAMA) notification for the health claim “Diets low in saturated fat and cholesterol, and as low as possible in

trans

fat, may reduce the risk of heart disease,” based on statements made in the 2005 DGA (Ref. 57). As such, because of its role in chronic disease,

trans

fat continues to be a nutrient with public health significance. We are unaware of evidence to support a determination that information relating to

trans

fat on the Nutrition Facts label is not necessary to assist consumers in maintaining healthy dietary practices. We tentatively conclude that information on the amount of

trans

fat in food products allows consumers to reduce their intake of

trans

fat, and thus, reduce the risk of CHD. Therefore, we are not proposing any changes to the requirement for mandatory declaration of

trans

fat on the Nutrition Facts label in § 101.9(c)(2)(ii). However the Agency recently published a tentative determination that partially hydrogenated oils, the source of industrially produced

trans

fat, may not be generally recognized as safe (78 FR 67169; November 8, 2013). We request comment on whether mandatory labeling of

trans

fat would still be necessary if this determination is finalized.

Per § 101.9(c)(2)(ii), if a food contains less than 0.5 g of trans fat per serving, the content, when declared, is to be expressed as zero. We received a citizen petition from an individual on January 17, 2007 (Docket No. FDA-2007-P-0404) which requested that FDA amend the definition of

trans

fat in its food labeling regulations to express the value of “zero” for

trans

fat only when there are “absolutely no

trans

fats at all” and require the use of a symbol (e.g., “~”) to indicate when there is “more than zero but less than 0.5g of

trans

fat per tablespoon” (

http://www.regulations.gov/# !docketDetail;D=FDA-2007-P-0404

). The petition claimed that the declaration of zero

trans

fats on the label is misleading to consumers because it does not denote the absence of

trans

fat (as “zero” is defined in Webster's Dictionary) and that people will consume a food incorrectly thinking that it has zero amount of

trans

fat. The petition stated that, because

trans

fat is associated with negative effects on heart health, this situation could be detrimental to people's health.

Validated analytical methodologies that provide sensitive and reliable estimates of

trans

fatty acids in all foods at levels below 0.5 g per serving are currently not available. For most nutrients declared on the nutrition label, the maximum amount permitted for a declaration of a zero value is governed by the limitations associated with analytical methods available to determine the content of a nutrient in a food. The analytical methods used to determine nutrient content for purposes of compliance are discussed in more depth in section II.N. The petition did not provide any information on alternative analytical methodologies that are more sensitive and reliable nor did the petition provide any evidence to support the claim that consumers are misled by the provisions for the declaration of zero

trans

fat. Thus, we are not proposing any changes to the requirement for the declaration of zero when

trans

fat content is less than 0.5 g per serving.

c. DRV—FDA regulations do not provide a DRV for

trans

fat. At the time of the issuance of the

trans

fat final rule, we concurrently issued the 2003 ANPRM in the same issue of the

Federal Register

(68 FR 41507) to solicit information and data on several

trans

fat labeling issues. In the 2007 ANPRM, we again requested comments on various issues related to the DV for trans fat, including the use of food composition data, menu modeling and data from dietary surveys, and a potential joint percent DV for

trans

fat and saturated fat. We received several comments in response to the 2007 ANPRM. We considered the recommendations in the IOM Labeling Report, available scientific evidence, and comments (Ref. 47) received in response to both the 2003 and 2007 ANPRMs.

i. Use of food composition data, menu modeling, and dietary surveys. FDA considered the approach recommended in the IOM Labeling Report to use food composition data, menu modeling, and dietary survey data to estimate a minimum

trans

fat intake within a nutritionally adequate diet.

As explained previously (see section II.B.2.c.), we do not consider food composition data, menu modeling, or dietary survey data suitable for determining DRVs. Furthermore, such an approach is not linked to a health outcome, which we have traditionally used as a basis for determining DRVs. As described in the IOM macronutrient DRI report (Ref. 49), the IOM reviewed the evidence for

trans

fat and was not able to set a UL for

trans

fat, which indicates that there is insufficient scientific evidence from which to determine a specific level of

trans

fat intake that would likely pose no risk of adverse health effects. We continue to

adhere to the approach of determining DRVs for a nutrient based on the nutrient's association with specific health outcomes (e.g., LDL cholesterol levels).

As an additional consideration, even if we were to use the menu modeling approach, it would be difficult to apply such an approach for

trans

fat. Current estimates of

trans

fat content in food composition databases are not comprehensive and do not include

trans

fat content for all foods. The levels of

trans

fat in foods have changed since the publication of the 2003

trans

fat final rule, in part due to reformulation of foods (Ref. 58). The numerous and rapid changes to food formulations can make it difficult for food composition databases to provide current and accurate estimates of the usual intake of

trans

fat.

Therefore, we tentatively conclude that the menu modeling approach, as recommended in the IOM Labeling Report, is an unsuitable method for determining an appropriate DRV for

trans

fat.

ii. Determining a DRV. The IOM did not set a UL for

trans

fat in the DRI macronutrient report. The IOM noted that any increase in

trans

fat intake increases CHD risk but because

trans

fats are unavoidable in ordinary diets, consuming zero percent of calories would require significant changes in dietary intake patterns that may introduce undesirable effects and unknown and unquantifiable health risks (Ref. 49). The 2005 and 2010 DGA and the FDA Food Advisory Committee (Refs. 6 and 36) likewise could not set a definitive quantitative intake recommendation for

trans

fat. Comments generally supported a single

trans

fat DRV and a single percent DV, but noted that such levels are not possible based on existing science. Although some comments supported a joint percent DV declaration for saturated and

trans

fat combined, the majority of comments opposed it due in large part to the chemical and physiological differences between these fats. We will consider determining a DRV for

trans

fat, if and when scientific evidence and relevant dietary recommendations become available. At that time, we will also consider whether a single DRV specific to

trans

fat or a provision for joint DV declaration for trans fat and saturated fat are appropriate. Thus, we tentatively conclude that there is no basis for setting a DRV for

trans

fat and, accordingly, we are not proposing a DRV for

trans

fat, a joint DRV declaration or joint percent DV declaration.

4. Polyunsaturated Fat

Polyunsaturated fats represent two general categories:

n

-6 and

n

-3 polyunsaturated fatty acids. The most common

n

-6 and

n

-3 polyunsaturated fatty acid in food is linoleic acid and α-linolenic acid, respectively. Other

n

-3 fatty acids found in foods, particularly in fish, are the long chain fatty acids, eicosapentaeneoic acid (EPA) and docosahexaenoic acid (DHA).

a. Voluntary Declaration—FDA regulations permit, but do not require, the declaration of polyunsaturated fat (defined as

cis, cis

-methylene-interrupted polyunsaturated fatty acids) on the Nutrition Facts label (§ 101.9(c)(2)(iii)).

To determine whether any changes are needed to the current provision for voluntary declaration, we considered recommendations of current U.S. consensus reports as well as comments received (Ref. 47) in response to the 2007 ANPRM, in which we requested comment on whether declaration of polyunsaturated fat should continue to be voluntary or made mandatory. Current dietary recommendations advise consumers to increase intakes of polyunsaturated fatty acids to replace saturated fatty acids in their diets (Ref. 6). The 2010 DGA recommends limiting the consumption of saturated fatty acids accompanied with replacing them with polyunsaturated and monounsaturated fatty acids (Ref. 6). However, as discussed in this document, the IOM did not set DRIs for total polyunsaturated fatty acids, but rather provided AIs and AMDRs each for two specific fatty acids, linoleic acid (an

n

-6 polyunsaturated fatty acid) and α-linolenic acid (an

n

-3 polyunsaturated fatty acid) based on median intakes of each fatty acid using NHANES data (Ref. 49).

We acknowledge that certain polyunsaturated fatty acids are essential and understand the interest expressed by some comments that there is a need to provide information on beneficial fats. However, the essentiality of a nutrient is not a factor considered for the mandatory or voluntary labeling of non-statutory nutrients, other than essential vitamins and minerals (see section I.C). Although certain polyunsaturated fatty acids are essential, an essential fatty acid deficiency is basically nonexistent in the United States and, therefore, is not of public health significance (Ref. 49).

A quantitative intake recommendation is not available from relevant U.S. consensus reports (see discussion in this document), but there is well-established evidence to indicate that replacing saturated fatty acids with polyunsaturated and monounsaturated fatty acids reduces blood LDL cholesterol levels and, therefore, the risk of CVD (Ref. 30). The prevalence of CVD in the U.S. population is substantial (Ref. 30). We are not proposing any changes to the requirement for mandatory declaration of saturated fat (see section II.B.2.). Because polyunsaturated fat has public health significance when it replaces saturated fat, consistent with the factors for voluntary declaration discussed in section I.C., we are proposing to continue to permit voluntary declaration of polyunsaturated fat, as provided in § 101.9(c)(2)(iii). We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the voluntary declaration of polyunsaturated fat.

b. DRV—FDA regulations do not provide a DRV for polyunsaturated fat. The IOM did not set a DRI or AMDR for polyunsaturated fat, but provided AIs and AMDRs for two specific essential fatty acids, linoleic acid (an

n

-6 polyunsaturated fatty acid) and α-linolenic acid (an

n

-3 polyunsaturated fatty acid) based on median intakes of each fatty acid using NHANES data (Ref. 49). The AIs for linoleic acid and α-linolenic acid are 17 and 1.6 micrograms (mcg)/d, respectively. The AMDRs for linoleic acid and α-linoleic acid are 5 to 10 percent of calories and 0.6 to 1.2 percent of calories, respectively. In the 2007 ANPRM, we asked: (1) Whether a DRV for total polyunsaturated fat should be derived based upon AIs for linoleic acid plus α-linolenic acid; and (2) whether a DRV for total polyunsaturated fat should be established using the AMDRs for

n

-6 and

n

-3 polyunsaturated fatty acids and, if so, should a midpoint be used. We received comments in response to these questions (Ref. 47).

We are not able to set an appropriate DRV for polyunsaturated fat at this time given the lack of established DRIs for total polyunsaturated fatty acids. We do not consider that the AMDRs or AIs for linoleic acid and α-linolenic acid provide a sufficient basis on which a DRV for polyunsaturated fat could be derived. The AIs for linoleic and α-linolenic acid were set based on U.S. median intake levels because there were insufficient experimental data to set an RDA (Ref. 49). Similarly, the AMDRs for linoleic acid and α-linolenic acid were based on the percent of calories needed to meet the AI for each fatty acid (lower range) and the percent of calories representing the highest intake level of each fatty acid (upper range). As such,

neither of these values provides an adequate basis on which to determine a DRV. For these reasons, we disagree with comments that supported using the sum of AIs or AMDRs to establish a DRV for total polyunsaturated fat.

Therefore, we tentatively conclude that there is no appropriate quantitative intake recommendation to form a basis for setting a DRV for polyunsaturated fat. Accordingly, we are not proposing a DRV for polyunsaturated fat.

c. Declaration of Individual Polyunsaturated Fatty Acids—The declaration of individual polyunsaturated fatty acids on the Nutrition Facts label is not permitted. The IOM did not set DRIs for total

n

-6 and

n

-3 polyunsaturated fatty acids, but established AIs and AMDRs for two specific fatty acids, linoleic acid (an

n

-6 polyunsaturated fatty acid) and α-linolenic acid (an

n

-3 polyunsaturated fatty acid) (Ref. 49). The 2007 ANPRM asked for public comment on whether separate DRVs for linoleic acid and α-linolenic acid should be established and, if so, whether the declaration of these nutrients should be voluntary or made mandatory. We received comments in response to these questions (Ref. 47).

Linoleic and α-linolenic acids are essential fatty acids that differ physiologically and compete metabolically. Based on a review of relevant scientific research, in 2004, FDA concluded in its qualified health claim review that there is supportive, but not conclusive, research to suggest that

n

-3 polyunsaturated fatty acids (EPA and DHA) reduce the risk of CHD (Ref. 59). Results of one clinical trial on the effects of EPA published since 2004 fail to demonstrate a significant reduction in the hazard ratio for the primary prevention of major coronary events (Ref. 60).

More recently, the 2010 DGAC concluded that moderate evidence shows that the consumption of two servings of seafood per week, which provides an average of 250 mg/d of long-chain

n

-3 polyunsaturated fatty acids (i.e., EPA and DHA), is associated with reduced cardiac mortality from CHD or sudden deaths, both in persons with and without CVD (Ref. 30). The DGAC also concluded that the evidence for plant-derived

n

-3 polyunsaturated fatty acids (i.e., α-linolenic acid) in reducing mortality among persons with existing CVD is limited (Ref. 30). Similarly, there is no conclusive evidence for an independent role of

n

-6 polyunsaturated fatty acids in reducing blood cholesterol levels and, consequently, the risk of CHD. Evidence suggests that the benefit of

n

-6 polyunsaturated fatty acids is observed only as a result of a reduction in saturated fatty acid intake (Refs. 6 and 59). The IOM noted that the evidence for a role of EPA and DHA in CHD risk is growing (Ref. 49), but set AIs and AMDRs for α-linolenic acid, not for EPA or DHA.

While a “healthy”

n

-6:

n

-3 ratio may be important in human health, such a ratio has not been defined and much of the available evidence is based on studies conducted in animals, infants, and patients on total parenteral nutrition and much of the evidence in adults has come from observational studies (Ref. 49).

Because of the lack of well-established evidence for a role of

n

-3 or

n

-6 polyunsaturated fatty acids in chronic disease risk and the lack of a quantitative intake recommendation, and consistent with the factors discussed in section I.C., we tentatively conclude that the declarations of

n

-3 and

n

-6 polyunsaturated fatty acids are not necessary to assist consumers to maintain healthy dietary practices. Accordingly, we are not proposing to provide for the individual declaration of either

n

-3 or

n

-6 polyunsaturated fatty acids on the Nutrition Facts label. Similarly, because of the lack of well-established evidence for a role of EPA and DHA in chronic disease risk and the lack of a quantitative intake recommendation, consistent with the factors discussed in section I.C., we tentatively conclude that the declarations of EPA and DHA are not necessary to assist consumers to maintain healthy dietary practices. Accordingly, we are not proposing to provide for the mandatory or voluntary declaration of EPA or DHA on the Nutrition Facts label. We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the individual declaration of

n

-3 or

n

-6 polyunsaturated fatty acids, as well as EPA or DHA.

5. Monounsaturated Fat

a. Voluntary Declaration—FDA regulations currently permit, but do not require, the declaration of monounsaturated fat (defined as

cis

-monounsaturated fatty acids (e.g., oleic acid)) on the Nutrition Facts label (§ 101.9(c)(2)(iii)). To determine whether any changes are needed to the provision for voluntary declaration, we considered recommendations in current consensus reports as well as comments received in response to the 2007 ANPRM (Ref. 47), in which we requested comment on whether declaration of monounsaturated fat should remain voluntary or be made mandatory.

In 2002, the IOM noted that there was no known independent role of monounsaturated fatty acids in preventing chronic disease (Ref. 49). The lack of an independent effect of monounsaturated fatty acids on heart disease risk was also substantiated in a 2004 FDA review of a qualified health claim regarding monounsaturated fatty acids from olive oil and CHD (Ref. 61). Upon review of data related to this qualified health claim, we concluded that there was no evidence to indicate that monounsaturated fatty acids from olive oil, independent of saturated fatty acid displacement, lower serum total and LDL cholesterol levels. Most recently, the 2010 DGAC (Ref. 30) noted that there was strong evidence indicating that monounsaturated fatty acids are associated with improved blood lipids related to CVD when they replace saturated fatty acids. Consequently, the 2010 DGA recommends that most fats should be consumed as polyunsaturated and monounsaturated fatty acids (Ref. 6). Current dietary recommendations advise consumers to increase intakes of monounsaturated fatty acids to replace saturated fatty acids in their diets.

We acknowledge that monounsaturated fatty acids are not essential in the diet (Ref. 49). However, a lack of essentiality is not a basis for determining whether a nutrient should be required to be declared (see section I.C.). Indeed, nonessential nutrients

trans

fat, saturated fat, and cholesterol are required to be declared on the label because of their public health significance. Scientific evidence points to the positive effects of increased monounsaturated fatty acid intake as a result of reduced intake of saturated fatty acids.

While a quantitative intake recommendation is not available from relevant U.S. consensus reports, there is well-established evidence to indicate that replacing saturated fatty acids with polyunsaturated and monounsaturated fatty acids reduces blood LDL cholesterol levels and, therefore, the risk of CVD, and that the prevalence of CVD is substantial in the United States (Ref. 30). We are not proposing any changes to the current requirement for mandatory declaration of saturated fat (see section II.B.2.). Because monounsaturated fat has public health significance when it replaces saturated fat, consistent with the factors we consider for voluntary declaration discussed in section I.C., we are proposing to continue to allow for voluntary declaration of

monounsaturated fat, as provided in § 101.9(c)(2)(iii). We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the voluntary declaration of monounsaturated fat.

b. DRV—FDA regulations do not provide a DRV for monounsaturated fat. Current consensus reports do not provide specific quantitative intake recommendations for monounsaturated fatty acids. The IOM did not set a DRI for monounsaturated fatty acids because these fatty acids are not essential in the diet and have no known independent role in preventing chronic diseases (Ref. 49). Therefore, we tentatively conclude that there is no scientific basis on which we can rely to set a DRV for monounsaturated fat and, therefore, we are not proposing to set a DRV for monounsaturated fat.

C. Cholesterol

1. Mandatory Declaration

Section 403(q)(1)(D) of the FD&C Act requires the declaration of the amount of cholesterol on food labels, and cholesterol content must be declared on the Nutrition Facts label in accordance with § 101.9(c)(3). Current dietary recommendations continue to recognize the well-established relationship between consumption of cholesterol and its effect on blood cholesterol levels, which are a surrogate endpoint for CHD risk (Ref. 6). In addition, the 2010 DGA provided a quantitative intake recommendation for cholesterol (Ref. 6) (see discussion in this document). Furthermore, FDA authorized a health claim for dietary saturated fat and cholesterol and risk of CHD, for which we evaluated the scientific evidence on the association between dietary cholesterol and serum cholesterol levels (§ 101.75).

We are unaware of evidence that would support a change to the requirement for mandatory declaration of cholesterol on the Nutrition Facts label in § 101.9(c)(3) and, therefore, we are not proposing any changes to the current requirement for mandatory declaration.

2. DRV

FDA regulations provide a DRV for cholesterol of 300 mg (§ 101.9(c)(9)). The IOM Labeling Committee recommended, based on the IOM DRIs, that the DV for cholesterol (along with saturated fat and

trans

fat) should be set at a level that is as low as possible in keeping with an achievable health-promoting diet (Ref. 25). The IOM Labeling Committee suggested that FDA use food composition data, menu modeling, and data from dietary surveys to estimate minimum intakes that are consistent with nutritionally adequate and health-promoting diets for diverse populations (Ref. 25). Acknowledging these IOM recommendations, in the 2007 ANPRM, we asked for public comment on (1) whether the current DRV for cholesterol of 300 mg should be retained; and (2) whether food composition data, menu modeling, and data from dietary surveys should be used to establish a DRV for cholesterol that is as low as possible while consuming a nutritionally adequate diet. We considered recommendations in current consensus reports as well as comments received (Ref. 47).

The 2010 DGA recommends consuming less than 300 mg/d of cholesterol to help maintain normal blood cholesterol levels and reducing intake to less than 200 mg/d for individuals at high risk of CVD (Ref. 6). The IOM also reported a relationship between increased cholesterol intake and increase in serum cholesterol, a surrogate endpoint for CHD risk (Ref. 62). The IOM macronutrient report recommended that cholesterol intakes should be as low as possible while consuming a nutritionally adequate diet, but did not set ULs for cholesterol (Ref. 62). Based on the reasons set forth previously, we disagree with the comments suggesting that a DRV of 300 mg is too low or that there is no strong association between cholesterol intake and CHD risk, or that current science justifies eliminating the percent DV declaration.

We do not agree with the IOM recommendation that food composition data, menu modeling, and data from dietary surveys offer a suitable approach for determining DRVs. Limitations inherent to menu modeling and food composition and dietary survey data sources are discussed in sections II.B.2.c. and II.B.3.c. We established the current DRV for cholesterol based on quantitative intake recommendations that considered specific effects on health outcomes (e.g., CHD) (58 FR 2206 at 2217). Use of menu modeling to determine a quantitative intake recommendation for cholesterol is inconsistent with this approach and may result in a reference intake level that is not based on scientific evidence related to actual public health outcomes.

Although the 2010 DGA recommends that cholesterol intake levels should be less than 200 mg/d for individuals at high risk of CVD, we consider the DGA recommendation of 300 mg/d for maintaining normal blood cholesterol levels as an appropriate basis for setting a DRV because it represents the maximum intake level that covers the general U.S. population 4 years of age and older. Therefore, we are not proposing any changes to the DRV for cholesterol of 300 mg specified in § 101.9(c)(9).

D. Carbohydrate

In this section, we discuss our consideration of provisions related to definitions, declarations, DRVs, and analytical methods for total carbohydrate, total sugars, added sugars, dietary fiber, soluble and insoluble fiber, sugar alcohols, and other carbohydrates.

1. Total Carbohydrate

a. Calculation of Total Carbohydrate—For the purposes of the Nutrition Facts label, total carbohydrate content is calculated by subtracting the sum of protein, total fat, moisture, and ash from the total weight of the food (§ 101.9(c)(6)). This calculation method is called “carbohydrate by difference” and is described in A.L. Merrill and B.K. Watt, “Energy Value of Foods—Basis and Derivation,” in the USDA Handbook No. 74 (Ref. 63). Total carbohydrate includes starch, sugars, sugar alcohols, and dietary fiber.

On July 8, 2004, the National Starch and Chemical Company (National Starch) submitted a citizen petition requesting that dietary fiber content be excluded from the calculation of total carbohydrate that is declared on the Nutrition Facts label (Docket No. FDA-2004-P-0094) (

http://www.regulations.gov/# !docketDetail;D=FDA-2004-P-0094

). The petition noted that consumers wishing to reduce their intake of carbohydrate may also be inadvertently decreasing their consumption of high fiber foods, such as whole grains, because dietary fiber is included in the definition of “Total Carbohydrate.” National Starch, therefore, requested an amendment to the second sentence in § 101.9(c)(6) to read as follows: “Total carbohydrate content shall be calculated by subtraction of the sum of the crude protein, total fat, moisture, ash, and dietary fiber from the total weight of the food.” The petition noted that excluding dietary fiber from the definition would be consistent with the way the IOM DRI report and Codex guidelines refer to carbohydrates and would be a more accurate representation of the amount of calories contributed by carbohydrates. To support this request, the petition presented study findings reported in the

New York Times

in 2004 and from research conducted on the Internet. In

addition, the petition discussed the use of the term “net carbs” in labeling and discussed inconsistencies in the way different manufacturers define the term “net carbs.” According to the petition, some manufacturers define “net carbs” as the amount of total carbohydrate excluding the amount of dietary fiber and sugar alcohols while others exclude sugar alcohols and “other carbohydrates,” as specified in § 101.9(c)(6)(iv), or sugar alcohols and “certain other carbohydrates.” The petition suggested that the varied approaches to describing carbohydrates have led to consumer confusion.

In the 2007 ANPRM, we asked for comment on whether the approach for calculating total carbohydrate by difference should be retained and, if not, which specific components should be included or excluded from the calculation of total carbohydrate. In addition, acknowledging the 2005 DGA recommendation to consume fiber-rich foods, we asked for comment on whether separating dietary fiber from the amount of total carbohydrate would affect consumer understanding and use of the information, particularly with respect to fiber consumption. We received several comments (Ref. 47).

We reviewed scientific evidence and considered the petition's requests and comments received. As explained in this document, we decline to change to the current method for calculating total carbohydrate by difference.

Under FDA regulations, compliance with certain nutrition labeling requirements may be achieved by the use of an FDA-approved database (§ 101.9(g)(8)). Nutrient databases include carbohydrate values that are determined by difference. Changing the way carbohydrate is calculated would either necessitate an analogous change to the way carbohydrate is calculated in major nutrient databases, such as the USDA National Nutrient Database for Standard Reference, or would substantially decrease the usefulness of these databases in assisting manufacturers in making nutrient content declarations.

We also considered an alternative approach of calculating total carbohydrates by summing individual carbohydrate measurements rather than calculating by difference, as suggested by a comment. There is variability and error that are introduced with each analytical test that is performed (Ref. 64). When summing the values from the various tests, the amount of variability and error would multiply and such an approach is likely to result in greater variability and error. As discussed in the documentation for USDA's National Nutrient Database for Standard Reference, Release 23, when the analyses of starch, sugars, sugar alcohol, and dietary fiber are performed separately, the result reflects the analytical variability inherent to each of those measurement processes (Ref. 65). Thus, such an approach does not provide any distinct advantage over measuring carbohydrate by difference.

With respect to removal of dietary fiber from the calculation of total carbohydrate, we agree that the IOM provided separate DRIs for carbohydrate (i.e., starch and sugars) and dietary fiber. However, the IOM DRI Report does not provide recommendations for nutrition labeling. Furthermore, the report defines dietary fiber as “non-digestible carbohydrates and lignin that are intrinsic and intact in plants” (Ref. 66). Thus, the report acknowledges that dietary fibers, with the exception of lignin, are carbohydrates. As discussed in section II.D.5., the definition of dietary fiber adopted by Codex in 2010 specifies that dietary fibers are carbohydrate polymers (Ref. 67). The Codex Guidelines on Nutrition Labeling, however, indicate that the nutrient declaration for carbohydrate should be “available carbohydrate,” which is the amount of dietary carbohydrate, excluding dietary fiber (Ref. 67).

The petition states that the inclusion of dietary fibers in the calculation of total carbohydrate is not fully aligned with the Codex Guidelines on Nutrition Labeling. Our rationale for including dietary fiber in the calculation of total carbohydrate is based on what is considered to be a carbohydrate. To the extent the petition is requesting the removal of dietary fiber from the total carbohydrate calculation due to its physiological effects, we consider in greater detail in this document the classification and declaration of carbohydrates based on their chemical definition or their physiological effects. As discussed in greater detail in this document, we find that inclusion of dietary fiber in the determination of the label declaration of total carbohydrate is scientifically sound based on our chemical definition of total carbohydrate and the analytical methods used to determine carbohydrate content, as well as being consistent with the way subcategories of other macronutrients, such as fat, are listed on the Nutrition Facts label. Dietary fiber is a subset of carbohydrates. All dietary fibers, with the exception of lignin, are carbohydrate polymers. Although lignin is not a carbohydrate, it is tightly bound to other dietary fibers and cannot be easily isolated using AOAC or equivalent methods. It is, therefore, included in the calculation of total carbohydrate.

Further, dietary fiber is a mandatory separate listing on the Nutrition Facts label. Therefore, for consumers who wish to know the carbohydrate content of a food that excludes dietary fiber, this information can be deduced by subtracting the declared amount of dietary fiber from the declared amount of total carbohydrate on the Nutrition Facts label.

In addition, a calculation based on eliminating dietary fiber content from the declared value of total carbohydrate would necessitate calculating total carbohydrate by difference using the current method and then subtracting from that number the amount of dietary fiber obtained from separate analysis. This option presents a challenge with respect to the use of existing databases in the United States, which include dietary fiber in the calculation of total carbohydrate.

Moreover, the petition provided no references to (and we could not locate) the studies identified in the petition. We have no data or information at this time to indicate that removal of dietary fiber from the declaration of total carbohydrate would promote consumption of dietary fiber due to lower amounts of carbohydrate contents declared in nutrition labeling. Finally, to the extent that the petition seeks to define the term “net carbs,” such a request is outside the scope of this rulemaking. In this proposed rule, we are considering whether to propose a change in how “total carbohydrate” is calculated. Therefore, to the extent the petitioner is requesting to remove “dietary fiber” from the total carbohydrate calculation to prevent consumer confusion from the term “net carb,” we decline to change the calculation of total carbohydrate by difference on that basis. We consider the calculation and declaration of “net carbs” and the total carbohydrate calculation and declaration on the label as separate and distinct. The declaration of total carbohydrate is required under section 403(q)(1)(D) of the FD&C Act.

For these reasons, we decline to change the method for calculating total carbohydrate by difference and, therefore, we are not proposing any changes to the method for calculating total carbohydrate by difference specified in § 101.9(c)(6).

b. Classification of Carbohydrates Based on a Chemical Definition or Physiological Effect—In the 2007 ANPRM, we asked for comment on whether carbohydrates should be classified and declared in nutrition labeling based on their chemical

definition (current method) or on their physiological effect (e.g., attenuation of blood sugar or laxation if dietary fiber were to be included in the total carbohydrate declaration), and whether additional types of carbohydrates (e.g., starch) should be listed separately on the Nutrition Facts label. We received several comments (Ref. 47) in response to these questions.

We considered this issue in light of the comments received. We agree with the comments that stated that classification of carbohydrates based on validated analytical techniques, which isolate and measure the individual carbohydrates based on their chemical structure rather than based on their physiological effects, is necessary for determining the accuracy of values declared on the label. Carbohydrates include starch, sugars, sugar alcohols, and dietary fibers. Different types of carbohydrates have different physiological effects. The effects of some carbohydrates are not fully understood and are the subject of debate in the scientific community. Within the different types of carbohydrate (i.e., starch, sugars, sugar alcohols, and dietary fibers), too, specific carbohydrates may have different physiological effects (e.g., different types of dietary fibers) making it difficult to apply a definition that is based on physiological effects across a category of carbohydrates. Furthermore, analytical methods for measuring different types of carbohydrates are based on chemical structure rather than physiological effect. Given the various components of total carbohydrate and different types of physiological effects of each, we disagree that a definition based on “physiological effects” would be a better approach than a chemical definition for total carbohydrate declaration. The use of a chemical definition is also consistent with the classification and declaration of fat on the Nutrition Facts label. Different types of fats identified in nutrition labeling are not classified based on their physiological effect but rather on their chemical definition.

Therefore, we are not proposing to use physiological effects of carbohydrates as a basis for classifying or declaring total carbohydrate. Accordingly, we are not proposing to change our provisions for the classification or declaration of carbohydrates specified in § 101.9(c)(6).

c. Separate Declaration of Additional Individual Types of Carbohydrates—In the 2007 ANPRM, we asked whether additional types of carbohydrates (e.g., starch) should be listed separately on the Nutrition Facts label. We considered comments received (Ref. 47), which, taken together, did not support declaration of additional types of carbohydrates. Some comments stated that such additional information could distract consumers from information that is important, such as dietary fiber. A few comments that supported the declaration of starch provided no evidence to support their assertions regarding the benefit of this declaration for diabetics. Moreover, there is no strong scientific evidence for us to consider related to the role of starch in human health. Therefore, we are not proposing to require the separate declaration of additional types of individual carbohydrates such as starch on the Nutrition Facts label.

d. Mandatory Declaration—Section 403(q)(1)(D) of the FD&C Act requires the declaration of total carbohydrate. Correspondingly, regulations require the declaration of the amount of total carbohydrate on the Nutrition Facts label (§ 101.9(c)(6)). Carbohydrates are an essential part of the diet because they provide energy to the cells in the body, especially the brain, which is dependent on carbohydrate for proper functioning (Ref. 68). We have no basis on which to reconsider the requirement for mandatory declaration of the amount of total carbohydrate on the Nutrition Facts label and comments in response to the 2007 ANPRM also supported this mandatory declaration. We tentatively conclude that the declaration of carbohydrates on the Nutrition Facts label continues to be necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing any changes to the current requirement for mandatory declaration of total carbohydrate, as specified in § 101.9(c)(6).

e. DRV—The DRV for total carbohydrate is 300 g (§ 101.9(c)(9)). The IOM established an AMDR for carbohydrate intake of 45 to 65 percent of energy for adults and an EAR of 100 g/d for adults and children (Ref. 69). In the IOM report, “carbohydrate” only included starch and sugars, not sugar alcohols or dietary fiber. The IOM also set the RDA for “carbohydrate” (i.e., starch and sugars) at 130 g/d for adults and children based on the average minimum amount of glucose utilized by the brain in adults, which was extrapolated to children ages 1 through 18 years. Subsequently, the IOM Labeling Committee recommended that, as in the case of protein and total fat, the AMDRs should be the basis for DVs for total carbohydrate (Ref. 25). Considering that AMDRs vary with age, the IOM Labeling Committee recommended a population-weighted midpoint of the AMDR. Under this approach, using a population-weighted mid-point of the AMDR for adults and children, i.e., 45 to 65 percent, the DV for total carbohydrate would amount to 55 percent or, based on a 2,000 calorie reference calorie intake, 275 g of carbohydrate.

However, as we noted in the 2007 ANPRM, the IOM's AMDR, EAR, and RDA values for carbohydrate do not include sugar alcohols or dietary fiber. In contrast, our calculation of total carbohydrates for the purposes of nutrition labeling accounts for all types of carbohydrates, including sugar alcohols and dietary fiber. Therefore, applying the IOM Labeling Committee's approach, in which a DV is derived from the AMDR, would result in a reference value based on recommendations specifically for sugars and starches, whereas the absolute gram amount of carbohydrates declared on the label includes all carbohydrates. Consequently, if the midpoint of the AMDR range is used as the basis for the DRV, there would be a discrepancy in what carbohydrates are encompassed in the information provided on the label for the absolute gram amount versus the percent DV. We did not ask any questions about the DRV for total carbohydrate in the 2007 ANPRM nor did we receive any comments on this issue. Consistent with calculating total carbohydrate “by difference” (discussed previously), we are proposing no changes to the approach to calculate the percent DV for carbohydrate “by difference” as well. In addition, we are not proposing to change the DRVs for fat or protein (see sections II.B. and II.E.), which are used to derive the DRV for total carbohydrate. Therefore, we are not proposing any changes to the DRV for total carbohydrate of 300 g/d. We note that the RDA for carbohydrate for men and women 19 years of age and older is 130 g/d. Therefore, the DRV should not be viewed as an intake requirement, but as a reference amount.

f. Calculation of Calories From Carbohydrate—FDA regulations require that the calories from total carbohydrate be calculated by using the general factor of 4 calories/g of carbohydrate less the amount of insoluble dietary fiber (§ 101.9(c)(1)(i)(C)). We are proposing a new definition of dietary fiber (see section II.D.5.a.i.) that only allows for the declaration of dietary fibers that we have determined to have a physiological effect that is beneficial to human health, as “dietary fiber” on the Nutrition Facts label. Therefore, the new definition of dietary fiber would exclude both soluble and insoluble non-digestible carbohydrates that do not meet the proposed definition. For the purposes of

calculating calories from carbohydrate, all soluble and insoluble non-digestible carbohydrates should be excluded from the calculation, not just those known to meet the definition of dietary fiber. To ensure that all soluble and insoluble non-digestible carbohydrates are excluded from the calculation of calories from carbohydrate, we are proposing to amend § 101.9(c)(1)(i)(C) to require that calories from carbohydrate be calculated using a general factor of 4 calories/g of total carbohydrate less the amount of non-digestible carbohydrates. As discussed in section II.D.5.b.v., a value of 2 calories/g of soluble non-digestible carbohydrates is then added to the calculation.

2. Sugars

a. Definition—Sugars are defined in § 101.9(c)(6)(ii) as a statement of the number of g of sugars in a serving. They are the sum of all free mono and disaccharides (e.g., glucose, fructose, lactose, and sucrose). We received a citizen petition on the term “sugars” and, as explained in this document, we are not proposing any changes to the term or its definition for the purpose of nutrition labeling.

b. Mandatory Declaration—Section 403(q)(1)(D) of the FD&C Act requires the declaration of sugars. FDA regulations require the declaration of sugars on the Nutrition Facts label (§ 101.9(c)(6)(ii)).

The Sugar Association submitted a citizen petition on August 16, 2005 (Docket No. FDA-2005-P-0373) requesting among other things that we eliminate “sugars” as a mandatory nutrient that is declared on the Nutrition Facts label or, alternatively, rename “sugars” as “sugars/syrup” and requi

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