Food Labeling: Revision of the Nutrition and Supplement Facts Labels

As Enacted ( Federal Register)

Cited authorities 13

Cited in

Federal Register, Volume 79 Issue 41 (Monday, March 3, 2014)

Federal Register Volume 79, Number 41 (Monday, March 3, 2014)

Proposed Rules

Pages 11879-11987

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2014-04387

Page 11879

Vol. 79

Monday,

No. 41

March 3, 2014

Part II

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 101

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

Docket No. FDA-2012-N-1210

RIN 0910-AF22

Food Labeling: Revision of the Nutrition and Supplement Facts Labels

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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

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

ADDRESSES: You may submit comments, identified by Docket No. FDA-2012-

N-1210, and/or Regulatory Information Number (RIN) 0910-AF22, by any of the following methods, except that comments on information collection issues under the Paperwork Reduction Act of 1995 must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see the ``Paperwork Reduction Act of 1995'' section of this document).

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Written Submissions

Submit written submissions in the following ways:

Mail/Hand delivery/Courier (for paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5360 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the Agency name and Docket No. FDA-2012-N-1210 and RIN 0910-AF22 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Blakeley Fitzpatrick, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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

Legal Authority
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
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
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
Fat

1. Total Fat

2. Saturated Fat

3. Trans Fat

4. Polyunsaturated Fat

5. Monounsaturated Fat
Cholesterol

1. Mandatory Declaration

2. DRV
Carbohydrate

1. Total Carbohydrate

2. Sugars

3. Added Sugars

4. Sugar Alcohols

5. Dietary Fiber

6. Other Carbohydrate
Protein

1. Mandatory and Voluntary Declaration

2. Analytical Methods

3. DRV
Sodium

1. Mandatory Declaration

2. DRV
Fluoride

1. Voluntary Declaration

2. DRV
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
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
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

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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
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
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
Technical Amendments

1. Changing the Name of the Program Office

2. Changing the Publication Date of Report Incorporated by Reference

3. Plain Language Edits

III. Proposed Effective and Compliance Dates

IV. Analysis of Impacts

V. Paperwork Reduction Act of 1995

VI. Analysis of Environmental Impact

VII. Federalism

VIII. Comments

IX. References

Executive Summary

Purpose of the Regulatory Action

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

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

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

Summary of the Major Provisions of the Regulatory Action in Question

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

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

Considering current science and recommendations related to added sugars, we are also proposing to require the declaration of ``added sugars,'' that will provide consumers with information they need to implement the dietary recommendations of the Dietary Guidelines for Americans, 2010 (2010 DGA).

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

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

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

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

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

GRAPHIC TIFF OMITTED TP03MR14.001

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

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

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

Finally, we are proposing an effective date of 60 days after the date of the final rule's publication in the Federal Register with a compliance date 2 years after the effective date. We invite comment on the proposed compliance date. In addition to the proposed compliance date, we invite comment on various other issues, as summarized in section XI.

Costs and Benefits

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

Summary of Costs and Benefits

In billions of 2011 $

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Benefits Costs Net benefits

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Present Value (PV):

3%.................................................... $31.4 $2.3 $29.1

7%.................................................... 21.1 2.3 18.8

Annualized (3% PV Amount)

3%.................................................... 2.0 0.2 1.8

Annualized (7% PV Amount)

7%.................................................... 1.9 0.2 1.7

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Notes: Compliance period is 24 months. Costs include relabeling and reformulation costs, which are one-time

costs, as well as recordkeeping costs, which recur. Present values of relabeling and reformulation costs are

equivalent at 3 or 7 percent because we conservatively assume that these one-time costs are incurred upon

publication of the rule instead of at the end of the compliance period. Recordkeeping costs, because of their

recurring nature, differ by discount rate; however, such costs comprise a very small percentage of total

costs.

I. Background

The 1990 amendments added section 403(q) to the FD&C Act, which specifies, in part and with certain exceptions, that food is deemed misbranded unless its label or labeling bears nutrition information for certain nutrients. To implement the 1990 amendments, on January 6, 1993, FDA issued several rules, including ``Food Labeling: Mandatory Status of Nutrition Labeling and Nutrient Content Revision, Format for Nutrition Label (the 1993 nutrient content final rule)''; ``Food Labeling; Reference Daily Intakes and Daily Reference Values (1993 RDI/

DRV final rule)''; and ``Food Labeling: Serving Sizes'', to modify how nutrition information is presented on food labels (58 FR 2079; 58 FR 2206; 58 FR 2229, respectively). FDA published regulations related to: (1) Declaration of nutrients on food labeling, including nutrients that are required or permitted to be declared and the format for such declaration; (2) label reference values for use in declaring the nutrient content of a food on its label or labeling; (3) two types of reference values, Reference Daily Intakes (RDIs) for vitamins and minerals and Daily Reference Values (DRVs) for certain nutrients, which are used to declare nutrient contents as percent DVs on the Nutrition Facts label; (4) exemptions for certain specified products; and (5) a simplified form of nutrition labeling and the circumstances in which such simplified nutrition labeling can be used. (See Sec. 101.9.) Elsewhere in this issue of the Federal Register, we are publishing a proposed rule that will amend the definition of a single-serving container, require dual column labeling for certain containers, update the reference amounts customarily consumed and serving sizes for several food product categories and amend the serving size for breath mints.

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

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

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

Other relevant authorities include sections 701(a), 403(a)(1) and 201(n) of the FD&C Act (21 U.S.C. 371(a), 21 U.S.C. 343(a)(1), and 21 U.S.C. 321(n), respectively). Under section 701(a) of the FD&C Act, the Agency may issue regulations for the efficient enforcement of the FD&C Act in order to ``effectuate a congressional objective expressed elsewhere in the Act'' (Association of American Physicians and Surgeons, Inc. v FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) (citing Pharm. Mfrs. Ass'n. v FDA, 484 F. Sup. 1179, 1183 (D. Del. 1980).)

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

alpha-tocopherol acetate and RRR-alpha-tocopherol, we are proposing to require manufacturers to make and keep written records to verify the amount of all rac-alpha-tocopherol acetate added to the food and RRR-

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

The proposed record requirements for these nutrients, under the circumstances described, are designed to ensure that the nutrient declarations are accurate, truthful and not misleading, based on information known only to the manufacturer, and to facilitate efficient and effective action to enforce the requirements when necessary. Our authority to establish records requirements has been upheld under other provisions of the FD&C Act where FDA has found such records to be necessary (National Confectioners Assoc. v Califano, 569 F.2d 690, 693-

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

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

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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
1. IOM Dietary Reference Intakes Reports (IOM DRI Reports)--In 1994, the Food and Nutrition Board (FNB) of the Institute of Medicine (IOM) identified principles for the development of a new set of reference values that could expand and replace the IOM's Recommended Dietary Allowances (RDAs) of 1989 (Refs. 13 and 14). A comprehensive review and application of a growing body of nutritional science research resulted in the development of a set of reference values, collectively known as DRIs, published from 1997 to 2010 (Ref. 15). The DRIs represent a shift in the way that reference values are established or intended for use. In contrast to previous editions of RDAs (e.g., the 1968 and 1989 RDAs), which involved establishing single values for each nutrient with appropriate adjustments for age, sex and physiological status, the new DRI framework consisted of four categories of reference values. These categories include the Estimated Average Requirement (EAR), RDA, Adequate Intake (AI) and Tolerable Upper Intake Level (UL). For macronutrients--carbohydrates, fats, and protein--the IOM developed a new set of reference values called the Acceptable Macronutrient Distribution Ranges (AMDRs).
  
  The EAR is the average daily nutrient intake level that is estimated to meet the requirements of half of the healthy individuals in a particular life stage and gender group. EARs are used for assessing the statistical probability of adequacy of nutrient intakes of groups of people. The RDA is an estimate of the average intake level that meets the nutrient requirements of nearly all (97 to 98 percent) healthy individuals in a particular life stage and gender group. The RDA is set using the EAR. In general, the RDA is the EAR plus two times the standard deviation of the EAR. The RDA is used to plan nutrient intakes for individuals to ensure a low probability of inadequacy. Nutrients with EARs and RDAs include carbohydrate, protein, vitamin A, vitamin C, vitamin E, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, copper, iodine, iron, magnesium, phosphorus, selenium, zinc, calcium and vitamin D.
  
  An AI is the level determined for an essential nutrient or a nutrient that is beneficial for human health when there is insufficient evidence to calculate an EAR for that nutrient, and therefore insufficient evidence on which to establish an RDA. AIs can be based on a variety of data, including scientific evidence about the essentiality of a nutrient (i.e., choline, biotin, fluoride), experimental data on risk reduction of chronic disease (i.e., dietary fiber, potassium), and median intakes of a nutrient using national survey data (i.e., vitamin K, pantothenic acid, chromium, manganese, linoleic acid, and alpha-
  
  linolenic acid). Although there is less certainty about an AI value than about an RDA value, the AI is similarly designed to cover the needs of nearly all individuals. The IOM Dietary Planning Report and Dietary Assessment Report noted that ``the AI should be used with less confidence if it has not been established as the mean intake of a healthy group.''
  
  The UL is the highest average daily intake level likely to pose no risk of adverse health effects for nearly all people in a particular group. The UL is not intended to be a recommended level of intake. The UL is used to assess the risk of adverse health effects from excessive nutrient intake. As intake above the UL increases, so does the potential for risk of adverse health effects. Nutrients with ULs include vitamin A, vitamin C, vitamin D, vitamin E, niacin, vitamin B6, folate, choline, calcium, copper, fluoride, iodine, iron, magnesium, manganese, molybdenum, phosphorus, selenium, zinc, sodium, and chloride.
  
  Moreover, while the previous RDAs primarily focused on reducing the incidence of diseases of nutrient deficiency in the population, the DRIs
  
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  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.
2. 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).
3. 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.
4. 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.
5. 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.
6. 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).
7. 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).
8. 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.
9. 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).
10. 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
  
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  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
  
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  considered new scientific evidence and dietary recommendations about the relationship between nutrients and health.
  
  Finally, we recognize that the goal of assisting consumers in maintaining healthy dietary practices requires that we consider certain practicalities. For example, as we noted in the 1993 nutrient content final rule (58 FR 2079 at 2107), while the 1990 amendments permit the Secretary of Health and Human Services to include in the Nutrition Facts label any information about a nutrient that will assist consumers in maintaining healthy dietary practices, there is not room on the label for all information that may be related to maintaining healthy dietary practices. Space constraints on the label of most foods make declaring all essential nutrients impractical. In addition, having a large amount of information on the label could interfere with consumers' abilities to use the information that has the greatest public health significance. Therefore, not only are we aware of the amount and format of mandatory information on the label, but we recognize that limits to the voluntary information are necessary, so that voluntary information does not clutter the label, does not mislead, confuse, or overwhelm the consumer, and does not take away prominence of and emphasis on the required information.
  
  5. Citizen Petitions
  
  Since 1993, we received a number of citizen petitions requesting that FDA make various changes to the Nutrition and Supplement Facts labels. We are addressing a number of issues raised in the following petitions within this proposed rule: (1) The Calorie Control Council submitted a citizen petition on April 13, 1995 (Docket No. FDA-1995-P-
  
  0142) requesting that FDA permit the use of the term ``polyols'' in lieu of sugar alcohols on the Nutrition Facts label (http://www.regulations.gov/#!docketDetail;D=FDA-1995-P-0142); (2) the American Cocoa Research Institute submitted a citizen petition on April 4, 1996 (Docket No. FDA-1996-P-0035) recommending the accurate communication of the scientific fact that stearic acid does not affect blood cholesterol (http://www.regulations.gov/#!docketDetail;D=FDA-1996-P-0035); (3) Nabisco, Inc. submitted a citizen petition on May 8, 1997 (Docket No. FDA-1997-P-0476) requesting that FDA amend the definition of ``total fat'' and ``saturated fat'' in its food labeling regulations to clarify that acetic, propionic, and butyric acids may be excluded when calculating the amount of fat in a food product (http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0476); (4) the Calorie Control Council submitted a citizen petition on February 13, 1998 (Docket No. FDA-1997-P-0232) requesting that the caloric value of soluble fiber be no more than 2 kcal/g (http://www.regulations.gov/#!docketDetail;D=FDA-1997-P-0232); (5) the Center for Science in the Public Interest (CSPI) submitted a citizen petition on August 4, 1999 (Docket No. FDA-1999-P-0158) requesting that FDA establish a DV for added sugars and require the amount of added sugar, and the percent DV that represents, to be declared on food labels (http://www.regulations.gov/#!docketDetail;D=FDA-1999-P-0158); (6) Protein Technologies International, Inc. submitted a citizen petition on December 21, 2000 (FDA-2000-P-0569) requesting that FDA modify the reference to the method used to calculate protein content (http://www.regulations.gov/#!docketDetail;D=FDA-2000-P-0569); (7) the National Starch and Chemical Company (``National Starch'') submitted a citizen petition on July 8, 2004 (Docket No. FDA-2004-P-0094) requesting that dietary fiber content be excluded from the ``total carbohydrate'' declaration on the Nutrition Facts label (http://www.regulations.gov/#!docketDetail;D=FDA-2004-P-0094); (8) the Sugar Association submitted a citizen petition on August 15, 2005 (Docket No. FDA-2005-P-0373) requesting, in part, that FDA amend regulations related to the labeling of sugar and alternative sweeteners (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0373); (9) CSPI submitted a citizen petition on November 8, 2005 (Docket No. FDA-2005-P-0196) requesting, in part, that FDA lower the DV for sodium from 2,400 to 1,500 mg/day (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196); (10) an individual submitted a citizen petition on May 25, 2005 (Docket No. FDA-2005-P-0126) requesting that FDA preclude the declaration of beta-carotene in supplements as vitamin A (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0126); (11) an individual submitted a citizen petition on January 17, 2007 (Docket No. FDA-2007-P-0404) requesting that FDA amend the definition of trans fat in its food labeling regulations to express the value of ``zero'' for trans fat when there are ``absolutely no trans fats at all'' and require the use of a symbol (e.g., ``~'') to indicate when there is ``more than zero but less than 0.5 grams (g) of trans fat per tablespoon'' (http://www.regulations.gov/#!docketDetail;D=FDA-2007-P-
  
  0404); and (12) CSPI submitted a citizen petition on February 13, 2013 (Docket No. FDA-2013-P-0217) requesting, in part, that FDA revise the ``Sugars'' line on the Nutrition Facts label to address ``added sugars'' (http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-0217).
  
  We address the specific requests identified previously for each citizen petition related to the labeling of conventional foods and dietary supplements in the appropriate sections in this document. Requests in these citizen petitions that are unrelated to the content of the Nutrition Facts label are outside of the scope of this rulemaking and we will address those requests separately from this rulemaking.
  
  6. Advance Notices of Proposed Rulemaking (ANPRMs)
  
  We also published three ANPRMs seeking public comment on issues relevant to updating the Nutrition Facts label.
11. 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.
  
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  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.
12. 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).
13. ANPRM on Food Labeling: Revision of Reference Values and Mandatory Nutrients--In the Federal Register of November 2, 2007 (72 FR 62149), we published an ANPRM regarding the revision of reference values and mandatory nutrients (the 2007 ANPRM). The 2007 ANPRM requested comment on various aspects of nutrition labeling, including what new reference values we should use to calculate the percent DV in the Nutrition Facts and Supplement Facts labels and what factors we should consider in establishing such new reference values. In addition, we requested comments on whether we should require that certain nutrients be added or removed from the Nutrition Facts and Supplement Facts labels.
  
  In response to the 2007 ANPRM, we received about 820 comments, from industry, trade associations, consumer groups, individual consumers, government, and academia. We consider these comments in each of the relevant individual nutrient sections in this document (see also accompanying Ref. 47).
  
  7. Impact on Other Regulations
  
  We recognize that changes to the list of nutrients declared on the Nutrition Facts label or the RDIs or DRVs of nutrients will likely affect other FDA regulations, including certain labeling requirements for foods in 21 CFR part 101. For example, the DVs are used to determine, in part, whether a food or dietary supplement is eligible to bear nutrient content claims or health claims (see for example Sec. Sec. 101.14, 101.54, 101.76, 101.78, and 101.79). In addition, our fortification policy refers to RDIs and certain DRVs that are specified in Sec. 101.9 in describing principles for the rational addition of nutrients to foods (Sec. 104.20 (21 CFR 104.20)). We plan to evaluate the impact of the proposed changes to the Nutrition Facts and Supplement Facts labels, if finalized, on other FDA regulations. We intend to address, as appropriate, the impact on other FDA regulations in future separate rulemakings. Thus, issues related to nutrient content claims and health claims are outside the scope of this rulemaking.
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

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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.
1. 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.
2. 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

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based on consensus reports and federal policy statements.

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

3. Approach for Voluntary Declaration

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

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

II. The Proposed Rule

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

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

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

1. Calories From Fat

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

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

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2. Calories From Saturated Fat

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

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

3. Two Thousand Calories as the Reference Caloric Intake Level

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

An EER is a DRI set by the IOM for energy intake and is defined as the dietary energy intake that is predicted to maintain energy balance in a healthy adult of defined age, gender, weight, height, and level of physical activity consistent with good health. The IOM set EERs for all life-stage and gender groups and based these EERs on normal weight individuals (i.e., BMI Edible carbohydrate polymers naturally occurring in the food as consumed,

Carbohydrate polymers, which have been obtained from food raw material by physical, enzymatic or chemical means and which have been shown to have a physiological effect of benefit to health as demonstrated by generally accepted scientific evidence to competent authorities, and

Synthetic carbohydrate polymers which have been shown to have a physiological effect of benefit to health as demonstrated by generally accepted scientific evidence to competent authorities.

As with the IOM definition of ``total fiber,'' the 2010 Codex definition for ``dietary fiber'' includes naturally occurring fibers and only those non-digestible carbohydrates added to food that have a physiological effect that is beneficial to human health.

Dietary fiber represents a heterogeneous group of compounds that vary in their carbohydrate composition, linkages between carbohydrates, and molecular weight. As stated previously, there is no specific chemical definition for dietary fiber. Therefore, considering the IOM and Codex definitions and comments received, as well as the role of the dietary fiber declaration on the Nutrition Facts label, we tentatively conclude that a regulatory definition for dietary fiber should be one that emphasizes its physiological effect that is beneficial to human health. The declaration of dietary fiber that accurately reflects the amount of fiber that provides a physiological effect that is beneficial to human health would assist consumers in maintaining healthy dietary practices.

We are proposing a single definition for dietary fiber that is equivalent to the IOM's definition for ``total fiber,'' rather than IOM's separate definitions of ``dietary fiber'' and ``functional fiber.'' Because both ``dietary fiber'' and ``functional fiber'' as defined by IOM are considered to have beneficial health effects, we tentatively conclude that there is little benefit for consumers in distinguishing between these two types of fiber on the Nutrition Facts label. In addition, the IOM itself recognized analytical limitations in distinguishing between ``dietary fiber'' and ``functional fiber'' and noted that the labeling of ``total fiber'' would be more practical than labeling ``dietary fiber'' and ``functional fiber'' separately (Ref. 24).

The Codex definition includes a minimum degree of polymerization (DP) for a carbohydrate of 10, and it also provides that the inclusion of non-digestible carbohydrates with 3 to 9 monomeric units should be left to national authorities. The IOM's definition for ``total fiber'' includes those non-digestible carbohydrates of 3 to 9 DP (Ref. 24).

Because we seek to include in our definition non-digestible carbohydrates with physiological effects that are beneficial to human health, regardless of size, we are proposing to adopt a definition for total fiber that includes a DP of >= 3, consistent with the IOM's definition.

Therefore, we are proposing to amend Sec. 101.9(c)(6)(i) to include the following definition for dietary fiber: (1) Non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants; (2) isolated and synthetic non-digestible carbohydrates (with 3 or more monomeric units) that FDA has granted be included in the definition of dietary fiber, in response to a petition submitted to FDA under Sec. 10.30 (21 CFR 10.30) demonstrating that such carbohydrates have a physiological effect(s) that is beneficial to human health; or (3) isolated and synthetic non-digestible carbohydrates (with 3 or more monomeric units) that are the subject of an authorized health claim. We invite comment on the proposed definition of dietary fiber.

As proposed, under provisions 2 and 3, manufacturers would be required to provide evidence to FDA to demonstrate

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the physiological effects that are beneficial to human health, of isolated and synthetic non-digestible carbohydrates added to food, and FDA would have to grant a petition or authorize a health claim before they can be considered as ``dietary fiber'' for declaration on the Nutrition Facts label. Manufacturers would use the citizen petition process in Sec. 10.30 or, in case of a related health claim, the health claims petition process in Sec. 101.70. We intend to issue guidance to industry on submissions to demonstrate physiological effects that are beneficial to human health.

Under these proposed provisions, both beta-glucan soluble fiber (Sec. 101.81(c)(2)(ii)(A)) and barley beta-fiber (Sec. 101.81(c)(2)(ii)(A)(6)) that are added to foods would meet the definition of dietary fiber and, therefore, would be included in the amount of dietary fiber declared on the Nutrition Facts label. We are proposing to list isolated and synthetic non-digestible carbohydrates that have been determined by FDA to have a physiological effect that is beneficial to human health, in Sec. 101.9(c)(6)(i). Accordingly, we are proposing to amend Sec. 101.9(c)(6)(i) to list beta-glucan soluble fiber and barley beta-fiber (as these substances are described in Sec. 101.81(c)(2)(ii)(A) and (c)(2)(ii)(A)(6), respectively) as isolated and synthetic non-digestible carbohydrates that have been determined by FDA to have a physiological effect that is beneficial to human health and, therefore, must be included in the declaration of dietary fiber. Under this process, we would amend Sec. 101.9(c)(6)(i) to list any additional isolated and synthetic non-

digestible carbohydrates that FDA determines have a physiological effect that is beneficial to human health, through either the citizen petition process or the health claims petition process.

ii. Mandatory declaration. Section 403(q)(1)(D) of the FD&C Act specifies, in part, that for each serving size or other unit of measure of a food, the amount of dietary fiber must be provided. Accordingly, FDA regulations require the declaration of dietary fiber on the Nutrition Facts label, as provided in Sec. 101.9(c)(6)(i).

We did not ask any questions about the mandatory labeling of dietary fiber in the 2007 ANPRM, and we received no comments on this subject. Dietary fiber is not an essential nutrient. However, it has physiological effects that are beneficial to human health, such as attenuation of postprandial blood glucose concentrations, attenuation of blood cholesterol concentrations, and improved laxation (Ref. 66). The IOM DRI report noted that consumption of certain dietary fibers, particularly those that are poorly fermented (i.e., insoluble fiber), improve fecal bulk and laxation and ameliorate constipation (Ref. 66). In addition, soluble fiber plays a beneficial role in reducing the risk of heart disease (Ref. 66). ``Dietary fiber'' is identified as a nutrient of public health concern in the 2010 DGA. The 2010 DGA also emphasized the consumption of whole grains, in part, because they are a source of dietary fiber, noting that choosing whole grains that are higher in dietary fiber has health benefits in addition to meeting nutrient needs (Ref. 6).

Given the health benefits of dietary fiber, we have no basis to conclude that the declaration of dietary fiber is no longer necessary to assist consumers in maintaining healthy dietary practices. Therefore, we are not proposing to change our current requirement for the mandatory declaration of dietary fiber in Sec. 101.9(6)(i).

With respect to the term used to declare dietary fiber content on the Nutrition Facts label, we considered comments received in response to the 2007 ANPRM (Ref. 47). The term ``dietary fiber'' has been listed on the Nutrition Facts label since 1993. One survey pointed out by comments suggests that both ``fiber'' and ``dietary fiber'' are similarly acceptable by consumers (Ref. 47). Alternative terms such as ``natural fiber'' or ``isolated fiber'' would not be appropriate to declare all dietary fiber given that we are proposing a definition of dietary fiber that includes both natural fiber and fiber that is added to food. Although the IOM used the term ``total fiber,'' there is no evidence to suggest that this term is preferable to the term ``dietary fiber.'' Therefore, we are not proposing to change the current requirement to declare dietary fiber using the term ``dietary fiber,'' as specified in Sec. 101.9(f). However, we request comment on this issue, including consumer understanding of the term ``dietary fiber'' relative to other relevant terms.

iii. Analytical methods. Per FDA regulations, compliance with the requirement for declaration of dietary fiber is determined using appropriate AOAC analytical methods (58 FR 2079 at 2113; Sec. 101.9(g)(2)). In the 2007 ANPRM, we noted the IOM Panel's consideration of analytical issues related to dietary fiber, and asked whether we should continue to use the AOAC International methods to determine the amount of dietary fiber and, if not, what other or additional methods should be used.

We reviewed comments (Ref. 47) received as well as current AOAC methods for dietary fiber and the various analytes measured by these methods in light of our proposed definition for dietary fiber. AOAC methods, such as AOAC 985.29, 991.43 and 994.13, measure soluble and insoluble polysaccharides, lignin, higher molecular weight non-

digestible oligosaccharides (DP > 12), and some resistant starch, inulin and low molecular weight non-digestible oligosaccharides (DP fat + DVcarbohydrate). The 2007 ANPRM requested comment on whether the DV for protein should be based on (1) the approach recommended in the IOM Labeling Report; (2) the midpoint of the AMDR for protein (i.e., 22.5 percent); or (3) the EAR or RDA for protein. We received comments on each of these approaches (Ref. 47). Overall, comments supported the approach recommended in the IOM Labeling Report and maintaining the DV of 50 g/d.

We considered current scientific recommendations and agree with the comments that supported the continued use of the current approach. First, as explained in sections II.B. and II.D., we are not proposing to change the DRVs for fat (30 percent of calories from fat or 65 g) or carbohydrate (60 percent of calories from carbohydrate or 300 g). Applying the IOM Labeling Committee's recommended approach, given our tentative conclusions on DRVs for fat and carbohydrates, that approach would result in no change to the DRV for protein, i.e., 10 percent (100 - (60 + 30)) of calories from protein.

Second, at 10 percent of caloric intake and using a reference energy intake of 2,000 calories, the DRV for protein is set at 50 g, which is relatively close to the IOM's RDAs for men and women. The RDAs, which represent values that meet the needs of almost all (97 to 98 percent) individuals in a group, are set at 0.80 g/kg for men and women who are 19 years and older, 0.85 g/kg for boys and girls 14 to 18 years of age, and 0.95 g/kg for boys and girls 4 to 13 years of age. Using reference weights established for age and gender groups, the resulting values are 56 g/d for males and 46 g/d for females who are 19 years of age or older (not including pregnant and lactating women), 52 g/d for males and 46 g/d for females between the ages of 14 through 18 years of age, 34 g/d for males and females between the ages of 9 and 13 years, and 19 g/d for males and females between the ages of 4 through 8 years. Thus, the DRV of 50 g for protein falls within the range of the RDAs calculated using reference weights.

We do not consider the midpoint of the AMDR of 22.5 percent of energy intake to provide the most appropriate basis for a DRV for protein. We have no data to show that protein intakes are inadequate or that setting a higher DRV that is based on the midpoint of the AMDR is needed to prevent chronic diseases such as cardiovascular disease, obesity, and sarcopenia, as asserted by some comments (Ref. 47). The AMDR is a range of intakes for a particular energy source that is associated with reduced risk of chronic diseases while providing adequate intakes of essential nutrients (Ref. 20). The DRV of 10 percent of calories from protein falls within the AMDR. Thus, the DRV for protein falls within a range of protein consumption that is associated with a reduced risk of chronic disease while providing essential nutrients.

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Finally, we consider the use of the population-weighted EAR to be inappropriate. First, as the comments pointed out (Ref. 47), using the population-weighted EAR could lead to inadequate consumption in some subpopulations, such as males 19 years and older. In addition, the EARs for protein are expressed in terms of g/kg of body weight and based on consumption of good quality or ``complete'' protein. In order to calculate a DRV from the population-weighted EAR for the purposes of nutrition labeling, a reference body weight would have to be selected. Although we could use the EER predictive equations included in the IOM's DRI macronutrient report (Ref. 50) to determine a reference body weight, these values may be inappropriate for the general U.S. population, which has a high percentage of overweight individuals. The IOM Labeling Report stated that deriving a label reference value for protein based on values from the EER predictive equations may not be appropriate for large segments of the North American population for the same reason (Ref. 25).

Therefore, we tentatively conclude that the DRV for protein should continue to be based on 10 percent of calories. Accordingly, we are not proposing to change the DRV of 50 g for protein.
Sodium

1. Mandatory Declaration

FDA regulations require the declaration of sodium content on the Nutrition Facts label (Sec. 101.9(c)(4)). The 2007 ANPRM did not ask any questions about the mandatory declaration of sodium, but one comment that recommended the declaration of sodium should remain mandatory because the information can help consumers who are concerned about sodium and salt make appropriate food choices.

Americans 4 years and older consume an average of approximately 3,650 mg sodium/d (NHANES 2003-2006), which is more than twice the amount required to meet their adequate intake (1,500 mg/day for individuals 9 to 50 years old). Evidence continues to support the association between increased sodium consumption and increased blood pressure. In 2005, the IOM noted the direct relationship between sodium intake and increased blood pressure (Ref. 10). The 2010 DGAC and the 2013 IOM committee on Sodium Intake in Populations (Ref. 87) concluded that a strong body of evidence has been documented in adults that as sodium intake decreases, so does blood pressure (Ref. 30). We agree with the comment that information about sodium content on the food label can help consumers make appropriate food choices.

Therefore, we tentatively conclude that declaration of sodium should remain mandatory so consumers are provided information necessary to assist them in maintaining healthy dietary practices. Accordingly, we are not proposing to amend the current requirement for declaration of sodium in Sec. 101.9(c)(4).

2. DRV
1. Need to update the DRV--The DRV for sodium is 2,400 mg (Sec. 101.9(c)(9)). New scientific data and consensus reports on sodium published since the 1993 final rule (58 FR 2206 at 2224) highlight the need to reconsider the DRV. Recent key consensus reports and recommendations that FDA reviewed in reconsidering the DRV are as follows:
2. IOM DRI Electrolytes Report. In 2005, the IOM established AIs and ULs for sodium (Ref. 10). The IOM found that data from dose-
  
  response trials for determining the daily requirement for sodium were insufficient to establish an EAR for sodium and, thus, an RDA could not be determined and an AI was set. The AIs for sodium are intake levels that meet or exceed the daily nutrient requirement, i.e., the recommended daily average intake levels that are needed to meet the sodium needs of most healthy and moderately active individuals, are 1,500 mg/d for individuals 9 to 50 years, 1,300 mg/d for individuals 51 to 70 years, and 1,200 mg/d for individuals older than 70 years and for children 4 to 8 years of age. AIs meet or exceed the intake levels required to meet nutrient needs and there is no benefit in consuming a nutrient in excess of its AI.
  
  Data available to the IOM showed that; (1) a carefully planned diet that provided an average of approximately 1,500 mg/d of sodium can meet recommended intakes of other nutrients; (2) 1,500 mg/d exceeds the levels of sodium intake that have been associated with effects of inadequacy, such as adverse effects on blood lipid concentrations and insulin resistance; and (3) 1,500 mg/d allows for sodium sweat losses in acclimatized individuals who are exposed to high temperatures or who become physically active. The AI does not apply to individuals who are highly active and workers who are exposed to heat stress that lose large volumes of sodium in sweat (Ref. 10).
  
  ULs are the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects to almost all individuals in the general population (Ref. 10). The major adverse and dose-dependent effect of increased sodium intake is elevated blood pressure and the IOM noted that the relationship between sodium intake and blood pressure is continuous, making it difficult to set a precise UL because other environmental factors (weight, exercise, potassium intake, dietary pattern, and alcohol intake) and genetic factors also affect blood pressure. The ULs for sodium are 2,300 mg/d for all individuals ages 14 years and older, 1,900 mg/d for children 4 to 8 years old, and 2,200 mg/d for adolescents 9 to 13 years old. The UL is not intended to be a recommended intake level to encourage, but rather a level not to exceed.
  
  The IOM stated that the UL may be lower than 2,300 mg/d among certain groups who are at increased risk of the blood pressure-raising effects of increased sodium intake (e.g., older individuals, African Americans, and individuals with hypertension, chronic kidney disease, or diabetes), but insufficient data prevented IOM from defining a specific UL for these groups. Instead, the IOM set the same UL for these population groups as the one for the general population (i.e., 2,300 mg/d), with the acknowledgment that the actual UL for this group may be lower.
  
  ii. IOM Report on the Strategies to Reduce Sodium Intake in the United States (IOM Sodium Strategies Report). After considering current trends in hypertension, sodium consumption, sodium content of the food supply, and existing strategies for sodium reduction, the IOM developed various strategies for reducing dietary sodium intake to levels recommended by the 2005 DGA. Among various recommendations to Government Agencies, food manufacturers, consumers, and other stakeholders, the IOM recommended that FDA adopt 1,500 mg as the DV for sodium, given that sodium is an essential nutrient and that, unlike in 1993 (58 FR 2206 at 2224), a reference value of adequacy is now available (i.e., the AI of 1,500 mg/d).
  
  iii. 2010 DGA. The 2005 DGA made a key recommendation for the general U.S. population to consume less than 2,300 mg/d of sodium and that individuals with hypertension, African-Americans, and middle-aged and older adults should aim to consume no more than 1,500 mg/d of sodium (Ref. 36). In 2010, the DGAC evaluated evidence considered in the 2005 DGAC report in addition to new research on the relationship between sodium intake and blood pressure, focusing on the strength of the scientific evidence (Ref. 30). The 2010 DGAC report noted that 1,500 mg/d should be the intake goal for the
  
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  general U.S. population. Further, the DGAC noted that, given the current U.S. marketplace and the resulting excessively high sodium intake, it will be challenging to achieve the lower level. The 2010 DGA, considering the 2010 DGAC conclusions, recommended a reduction in sodium intake to less than 2,300 mg/d and a further reduction to 1,500 mg/d among African Americans, individuals with hypertension, diabetes, or chronic kidney disease, and individuals ages 51 years or older.
  
  iv. IOM Report on Sodium Intake in Populations, Assessment of Evidence, 2013 (Ref. 87). The charge to the committee focused on literature published since 2003, therefore they reviewed literature between 2003 and 2012. The committee assessed the benefits and adverse outcomes (if any) of reducing sodium intake, particularly in the range of 1,500 to 2,300 mg/d, with an emphasis on the subgroups known to be at increased risk of the blood pressure-raising effects of increased sodium intake. Based on the review of studies that assessed cardiovascular events and mortality, the committee found that evidence from studies on direct health outcomes is inconsistent and insufficient to conclude that lowering sodium intakes below 2,300 mg/d will increase or decrease the risk of CVD outcomes or all-cause mortality in the general U.S. population. The committee also concluded that the evidence from direct health outcomes does not support recommendations for subgroups (people with diabetes, chronic kidney disease and pre-CVD) to lower their sodium intake to or even below 1,500 mg/d. No relevant evidence was found on health outcomes for the other population subgroups considered (i.e., African Americans and persons 51 years of age and older).
3. CSPI petition--In 2005, we received a citizen petition from CSPI (2005 CSPI petition) requesting, among other sodium related issues, that FDA initiate rulemaking to reduce the DRV for sodium from 2,400 to 1,500 mg (Docket No. FDA-2005-P-0196 (formerly Docket No. 2005P-0450)) (http://www.regulations.gov/#!docketDetail;D=FDA-2005-P-0196). Citing the 2005 DGA, the petition requested that FDA adopt a DV of 1,500 mg because that is the recommended maximum intake for roughly one-half of the adult population (i.e., people with hypertension, African-
  
  Americans, and middle-aged and older people). According to the petition, when recommended intake levels vary among population groups, FDA has typically been conservative, choosing a DV that is most protective. In this proposed rule, we are responding to the petition's request to reduce the DRV for sodium from 2,400 mg to 1,500 mg. The petition's other requests are outside the scope of this rulemaking.
4. Comments to 2007 ANPRM--In the 2007 ANPRM, we asked whether a new DV for sodium should be based on the UL or on the AI. We also asked whether the UL, were it to be used, should reflect the same approach (population-weighted or population-coverage) as the other DRIs. While a few comments supported retaining the current DRV of 2,400 mg, the majority of comments supported using the UL of 2,300 mg/d. Some other comments recommended setting a DV for sodium based on the AI of 1,500 mg/d. One comment urged that we adopt a tiered two-phase, step-down approach establishing an interim DRV of 2,000 mg in 2013 and a final revised DRV of 1,500 mg by 2020. See also (Ref. 47).
5. Options Considered--When the Nutrition Facts label was developed in the early 1990s, no RDA or Estimated Safe and Adequate Daily Dietary Intake (ESADDI) levels were available for consideration. While the National Academy of Sciences established 500 mg/d as an estimated minimum requirement for healthy adults in 1989, the Agency relied on the recommendation from 1989 National Research Council Report Diet and Health: Implications for Reducing Chronic Disease Risk (Ref. 88) that provided a quantitative intake recommendation for salt, based on blood pressure, that was equivalent to 2,400 mg/d as a value that consumers should not exceed (58 FR 2206 at 2223, 2224). There is debate in the scientific community about the appropriate DV for sodium, taking into account its essentiality in relatively small amounts as well as its association with increased blood pressure at greater but varying levels of intake.
  
  Current recommendations recognize the benefits of reduced sodium intake in the general population, despite the heterogeneity among individuals in blood pressure responses to changes in sodium intake. Although several factors influence inter-individual variability in blood pressure responses to changes in dietary sodium, certain population groups have been reported to have a higher prevalence of salt sensitivity and are considered to be most at risk of sodium-
  
  related chronic disease. Salt sensitivity is the extent of change in blood pressure in response to a change in salt intake (Ref. 10). Salt sensitivity differs among subgroups of the population as well as among individuals within a subgroup. Subgroups that have been reported to have a high prevalence of salt sensitivity include individuals 51 years of age and older, African Americans, and individuals with hypertension, diabetes or chronic kidney disease. The 2010 DGA recommended that Americans reduce sodium intakes and also noted that these population subgroups, representing nearly half of the U.S. population, would benefit from even greater reductions in sodium intake than the general population. We have considered the challenges related to lowering the DV for sodium. For example, lowering the value on which the percent DV declaration is based would likely require efforts to ensure consumer understanding of the new percent DV declaration of sodium on the Nutrition Facts label. Based on recent dietary recommendations from consensus reports, currently available scientific evidence, comments in response to the 2007 ANPRM, and the 2005 CSPI petition, we considered the following options for updating the DV for sodium:
  
  (1) A DRV of 2,300 mg which reflects the UL for individuals aged 14 years and older;
  
  (2) An RDI of 1,500 mg which reflects the AI for individuals 9 to 50 years of age; and
  
  (3) Alternative approaches such as retaining a DRV of 2,400 mg, using a tiered approach or setting a DRV of 1,900 mg based on the UL for children 4 to 9 years of age.
6. DRV of 2,300 mg/d. A DRV of 2,300 mg, which represents the UL for the majority of the population (persons 14 years of age and older), would be consistent with both the 2005 and 2010 DGA recommendations for sodium intake for the general population, as well as the 2013 IOM report on Sodium Intake in Populations. However, while a DRV of 2,300 mg would reflect the UL that is applicable to 88 percent of the U.S. population, including those who are susceptible to the blood pressure-
  
  raising effects of sodium, it would exceed the UL for children 4 to 13 years of age which is 1,900mg/day for children 4-8 years of age and 2,000mg/day for children 9-13 years of age.
  
  Setting the DV at 2,300 mg would classify the level as a DRV (rather than an RDI) and represent a reference intake level not to exceed. As such, it would be consistent with our current and proposed approach to using DRVs for other nutrients that should be limited in the diet and for which there are concerns of excess intake and risk of chronic disease or health-related conditions, for example, saturated fat
  
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  and cholesterol. The current and proposed DRVs for saturated fat and cholesterol are based on quantitative intake recommendations and underlying science that links the excess intake of these nutrients to specific adverse health effects (Ref. 6) (see sections II.B.2 and II.C.). We do note, however, that unlike saturated fat and cholesterol, sodium is an essential nutrient and, in the DRI Electrolytes report, the IOM established an AI for sodium.
  
  Results from the FDA Health and Diet Surveys have shown that consumers are aware that too much sodium is unhealthy (Refs. 39 to 41) and this awareness would suggest consumer acceptance of a DV based on a level not to exceed would be consistent with a DRV of 2,300 mg. Changing the DRV from 2,400 mg to 2,300 mg would likely result in less consumer confusion than changing the DRV to an RDI (a level to achieve) of 1,500 mg. Moreover, we have no data to suggest that lowering the reference value for the percent DV could result in consumer confusion, as claimed by a commenter (Ref. 47).
  
  ii. RDI of 1,500 mg. An RDI of 1,500 mg, based on the highest AI (i.e., among adults aged 19 to 50 years), would provide a daily average intake level that would reflect a low prevalence of inadequate sodium intakes of healthy and moderately active individuals while allowing for adequate intakes of other essential nutrients. As opposed to 2,300 mg, a DV of 1,500 mg would classify the level as an RDI representing a reference intake level to achieve. The 2005 IOM electrolytes report reviewed the evidence on low sodium intake and blood lipid concentrations and insulin resistance and noted that the AI of 1,500 mg/d exceeds the levels of sodium intake (typically less than 700 mg/d) that have been associated in some studies with adverse effects of blood lipid concentrations and insulin resistance (Ref. 10). The 2005 IOM electrolytes report reviewed the evidence for plasma renin and concluded that, in contrast to blood pressure, there is no consensus on the interpretation of plasma renin activity and its role in guiding therapy for high blood pressure (Ref. 10). Similar to plasma renin activity, the evidence for the role of sympathetic nerve activity and aldosterone is limited, and therefore neither is recognized as surrogate endpoints for CVD risk. Therefore, the AI of 1,500 mg/d exceeds the levels associated with low sodium intake and the previously discussed adverse effects.
  
  Using the population-coverage AI to set the RDI for sodium would be consistent with the proposed RDIs for other essential vitamins and minerals for which AIs are established (e.g., vitamin K and choline) (see section II.I.). AIs are similar to RDAs in that they meet the needs of essentially all members of the population. Thus, using an AI as a quantitative intake recommendation for setting an RDI would be consistent with the proposed RDIs for other essential minerals that have AIs or RDAs, such as potassium and calcium. Traditionally, we have based the RDI for essential nutrients on quantitative intake recommendations that reflect the intake level necessary to meet the daily physiological needs for that nutrient. However, unlike the consumption of other vitamins and minerals, the majority of the population consumes sodium at levels that exceed the AI and the UL. This makes sodium unique in comparison to other vitamins and minerals for which people generally must strive to meet their daily needs.
  
  In addition, an RDI of 1,500 mg would be consistent with the 2010 IOM Sodium Strategies Report (Ref. 89). The IOM recommended that FDA base the DV for sodium on the AI of 1,500 mg/d. First, the IOM stated that using the AI is consistent with the approach used for all other essential nutrients, where the DV is based on a reference value of adequacy rather than a reference value of safety. Second, although consumer data were not provided, the IOM strategies report argued that the use of the AI could better inform consumers of the actual contribution of sodium content to total sodium needs as an essential nutrient. Third, the IOM stated that adopting the AI would avoid misleading consumers into thinking that the sodium content of foods is more favorable than is actually the case. As such, from a public health perspective, the AI would provide a truer picture for the consumer of the contribution of the particular foods in assembling a healthful diet and is preferable for this purpose over the UL. Finally, the IOM opined that lowering the DV might act as an incentive for companies to reduce the sodium content of their foods because reducing the DV would result in a higher value of percent DV declared on the label if sodium content remained unchanged.
  
  The 2013 IOM Sodium Intake in Populations Committee concluded that the evidence was insufficient and inconsistent to recommend sodium intake levels below 2,300 mg/d for the general U.S. population based on the direct outcomes of CVD or all-cause mortality. While this recommendation does not address blood pressure or essentiality, it provides a level that the general population should seek to reduce their consumption to and therefore is a consideration in our proposal.
  
  ANPRM comments pointed out challenges related to the feasibility of achieving a DV of 1,500 mg given the current marketplace and patterns of sodium consumption as well as changes in our nutrient content claims. If we were to adopt a DV of 1,500 mg, we anticipate that consumer education efforts would be needed to help consumers understand that the updated DV for sodium is a level to achieve rather than a level to consume less than and also that consuming in excess of this level would not be helpful. Additionally, the IOM set the AI, in part, at a level that would allow individuals to meet the recommended intakes of other nutrients if they adopted a carefully planned diet (Ref. 10) and consumer education efforts would need to communicate that 1,500 mg/
  
  d is a level that consumers should achieve rather than not exceed. While the Agency is considering ways to support the reduction of sodium in the food supply (76 FR 57050), significant changes in the food supply would be needed to achieve this goal.
  
  An updated DV for sodium based on 1,500 mg/d would perhaps necessitate revising other relevant regulatory requirements such as nutrient content claims, however such revisions would be less likely if the DV was updated to 2,300 mg. Previously, our decision to retain the sodium level for a ``healthy'' claim (Sec. 101.65) at 480 mg/reference amount customarily consumed (RACC) was based, in part, on technological barriers and product acceptance issues by consumers with the more restrictive level of 360 mg/RACC (70 FR 56828; September 29, 2005). We acknowledge concerns from comments that consumers may find it difficult to reduce dietary sodium levels to 1,500 mg/d.
  
  iii. Alternative approaches.
  
  A few comments suggested retaining 2,400 mg as the DRV for sodium. Retaining the DRV of 2,400 mg would exceed the UL for sodium for the entire population and there is no scientific evidence to support this level. Therefore, we do not consider 2,400 mg an appropriate DRV for sodium going forward. Also, based on ANPRM comments, we considered setting an interim DRV of 2,300 mg that would be further lowered to an RDI of 1,500 mg over time, providing companies a longer time to manufacture new foods or reformulate existing products to lower the sodium content. This approach would address concerns regarding the feasibility of individuals being able to meet an RDI of 1,500 mg given taste
  
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  preferences and sodium content of foods in the current marketplace. A tiered approach would help to gradually achieve the adequate intake level of 1,500 mg/d and would give manufacturers time to develop lower sodium products and for consumers to adjust their taste preferences. In addition, this approach would be consistent with the 2010 DGAC recommendations which suggested that reduction in sodium intakes to 1,500 mg/d among Americans should occur gradually over time to allow for adjustments in taste perceptions and to accompany changes in the sodium content of foods in the marketplace.
  
  We tentatively conclude that there is inadequate justification in consensus reports or arguments presented by comments (Ref. 47) to propose a tiered option. While levels of sodium intake may need to decrease gradually due to time needed for modifications to the sodium content of the food supply and consumer taste preferences, the DV for sodium should reflect an amount that will assist consumers in maintaining healthy dietary practices and in understanding the relative significance of the percent DV for a particular food in the context of the total daily diet. Moreover, DVs are based on scientific data supporting healthy dietary practices, not on the levels of a nutrient present in the food supply.
  
  We also considered using 1,900 mg/d, the UL for children 4 to 8 years of age, to set the DRV for sodium. Using the lowest UL for a population above 4 years of age is consistent with the population-
  
  coverage approach discussed in section II.1.5. In this case, it is a population-coverage approach that is protective for the age and gender subpopulation with the lowest relative UL, providing an intake level that is likely to pose no risk for any age or gender subpopulations. This is in contrast to the population-coverage approach, using the RDA or AI for other essential vitamins and minerals, to ensure that all age and gender subpopulations consume adequate amounts. However, a DRV of 1,900 mg is not aligned with any recommendations from consensus reports including the 2010 IOM Sodium Intake in Populations and was not suggested by any comments.
7. Proposed DV--After considering the options discussed previously, we are proposing to set a DRV of 2,300 mg for sodium based on the UL for individuals ages 4 years of age and older (proposed Sec. 101.9(c)(8)(iv)). First, a DRV of 2,300 mg would be consistent with the current sodium intake recommendations from consensus reports. Second, a DRV of 2,300 mg would be consistent with our current and proposed approach for other nutrients that should be limited in the diet and for which there are concerns of excess intake and risk of chronic disease and health-related conditions. Third, consumers are generally aware that too much sodium is not healthy and therefore the current consumer education messaging is consistent with a DRV of 2,300 mg.
  
  For the reasons explained previously, we tentatively conclude that a DRV of 2,300 mg for sodium is the most appropriate DV to assist consumers in maintaining healthy dietary practices and in understanding the relative significance of the sodium content within the context of a total daily diet. We invite comment on our consideration of various options and tentative conclusions presented in this section. In particular, we invite comment on: (1) The rationale for the proposed DRV of 2,300 mg of sodium; (2) whether an RDI of 1,500 mg would be more appropriate and why; and (3) whether any alternative approaches for selecting a DV for sodium and their public health bases for these approaches could be more appropriate and why. We are also interested in data and factual information on consumer understanding, interpretation, and use of the percent DV of sodium declared on food labels, including the understanding and potential influences of a DV that reflects an RDI based on an AI (an intake level to not consume less of), instead of a DRV based on a UL (an intake level not to exceed).
Fluoride

1. Voluntary Declaration

FDA regulations do not require or permit the declaration of fluoride on the Nutrition Facts label. In 1993, no U.S. consensus report had set a quantitative intake recommendation for fluoride. The 2007 ANPRM did not ask questions regarding the declaration of fluoride, but several comments supported the voluntary declaration of fluoride in mg or mcg amounts (Ref. 47). We are considering in this proposed rule whether fluoride should be required or permitted to be declared or whether the lack of provisions should be maintained.

Fluoride is a nonessential nutrient, but there is well established evidence for the role of fluoride in reducing the risk of dental caries (Ref. 90). The IOM set a quantitative intake recommendation for fluoride based on its role in the reduction of risk of dental caries. Additionally, in 2006, a FDAMA notification for a health claim for fluoride in bottled water and dental caries was submitted to us under section 403(r)(2)(G) of the FD&C Act (Ref. 91). We did not object to the notification, indicating that we considered the evidence submitted to be sufficient for bottled water that meets the standards of identity and quality set forth in Sec. 165.110 and the general requirements for health claims in Sec. 101.14 to bear the claim (Ref. 91). Given that the positive health effects of fluoride are well-established, we tentatively conclude that declaration of fluoride content of a food can provide consumers with information to assist them in maintaining healthy dietary practices. However, as discussed in section II.G.2., a DRV cannot be established based on available quantitative intake recommendations. Thus, while fluoride is a nutrient with public health significance, an appropriate quantitative intake recommendation is not available for setting a DRV.

Therefore, consistent with the factors we consider for declaration of non-statutory nutrients discussed in section I.C., we are proposing to amend Sec. 101.9(c)(5) to provide for voluntary declaration of fluoride. In addition, consistent with existing provisions for voluntary declaration of other nutrients, we are proposing that the declaration of fluoride would be mandatory when a claim about fluoride is made on the label or in labeling of foods. We are also proposing that when fluoride content is declared, it must be expressed as zero when a serving contains less than 0.1 mg of fluoride, to the nearest 0.1 mg increment when a serving contains less than or equal to 0.8 mg of fluoride, and the nearest 0.2 mg when a serving contains more than 0.8 mg of fluoride, consistent with how we have approached incremental values for other nutrients that are present in food in small amounts.

2. DRV

FDA regulations do not provide an RDI or DRV for fluoride. The 2007 ANRPM discussed the DRIs for fluoride and asked whether we should establish a DV, given the availability of an AI. We considered current recommendations and scientific evidence as well as comments received (Ref. 47).

In 1997, the IOM established DRIs (AIs and ULs) for fluoride (Ref. 90). The AI was set at 3 mg/d for women 19 years and older and 4 mg/d for men 19 years or older, to represent the intake value that reduces the occurrence of dental caries maximally in a group of individuals without causing unwanted side effects. AIs for children are 0.7 mg/d (1 through 3 years), 1 mg/d (4 through

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8 years), and 2 mg/d (9 through 13 years). In addition, the IOM set a UL for fluoride at 10 mg/d (0.1 mg/kg/d) for individuals older than 8 years, based on data that suggest that increased risk of developing early signs of skeletal fluorosis is associated with fluoride intakes greater than 10 mg/d. The UL for children 4 through 8 years is 2.2 mg/d based on risk of developing moderate enamel fluorosis.

A recent report highlighted the potential adverse impact of excess fluoride intake (Ref. 92). These adverse impacts include moderate enamel fluorosis in children up to 8 years and skeletal fluorosis for individuals older than 8 years. In 2010, the Environmental Protection Agency (EPA) published a report on exposure of fluoride from various sources. This report provided a benchmark of no more than 0.08 mg/kg/d of total fluoride intake to protect 99.5 percent of the population from severe dental fluorosis (Ref. 92). These benchmark levels (e.g., 1.68 mg/d for 4 to 7 years; 2.56 mg/d for 7 to 11 years; 4.08 mg/d for 11 to 14 years of age; and 5.6 mg/d for adults) are considerably lower than the ULs set by IOM in 1997.

Thus, although the IOM set AIs for fluoride based on its role in reducing the risk of dental caries, more recent conclusions have highlighted concern about dental fluorosis associated with excess intakes. Because an RDI of 4 mg, using the population-coverage AI of 4 mg/d, exceeds or is equivalent to EPA's benchmark values for children 4 to 14 years of age (1.68 to 4.08 mg/d), we are not proposing to set a DRV for fluoride.

We considered concerns expressed by comments that a DRV should not be established because fluoride is not an essential nutrient. That fluoride is not essential is not, in itself, a justification for not establishing a DV for fluoride, because there is evidence demonstrating that dietary fluoride exposure is beneficial to public health owing to its ability to inhibit the development of dental caries in both children and adults (Ref. 90). However, we are not proposing to set a DRV for fluoride for other reasons as explained previously. We also do not consider that the DRV for fluoride should be set at zero because of concerns with adverse health effects and toxicity, as suggested by a comment. The IOM established an AI for fluoride based on risk reduction of dental caries. In addition, the ULs for children and adults that are set based on dental and skeletal fluorosis are greater than zero. Moreover, FDA regulations other than those related to nutrition labeling are intended to prevent excessive addition of fluoride in foods (Sec. Sec. 165.110 and 170.45).
Essential Vitamins and Minerals of Public Health Significance

In addition to sodium, a statutorily required nutrient, FDA regulations require the declaration of four essential vitamins and minerals, namely, vitamin A, vitamin C, calcium, and iron (Sec. 101.9(c)(8)(ii)). Vitamins and minerals that may be declared voluntarily are vitamin D, vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and potassium. In 1993, we identified vitamins A and C, calcium, and iron for mandatory declaration because we considered them to be nutrients of public health significance based on their inadequate dietary intakes among specific segments of the U.S. population and because they were identified as nutrients of potential public health significance in consensus reports (Refs. 88, 93 to 95) (58 FR 2079 at 2106). We continue to consider, consistent with the rationale put forth in 1993, that a vitamin or mineral's public health significance should be the key factor in mandatory labeling (58 FR 2079 at 2106).

In this section of the proposed rule, we discuss essential vitamins and minerals that are not expressly required to be declared by statute (referred to as ``non-statutory''). We are using our discretion, as described in this document, to propose mandatory declaration of certain non-statutory essential vitamins and minerals and voluntary declaration of others. Our tentative conclusions are based on an assessment of scientific data available for these nutrients, and consideration of the factors discussed in section I.C. (explained in this document). The RDIs that we are proposing for the declaration of vitamins and minerals are discussed in section II.I.

We conducted an analysis of available data to determine the public health significance of non-statutory essential vitamins and minerals. The 2010 DGA identified nutrients of public health concern for the general U.S. population using criteria that are similar to factors that FDA considered in its own analysis (Ref. 6). The factors and the evaluation process used in our analysis, discussed in greater detail in Ref. 48, incorporate whether a DRI (i.e., RDA or AI) is based on a chronic disease risk (e.g., osteoporosis), a health-related condition (e.g., high blood pressure), or a nutrient deficiency with clinical significance (e.g., low iron storage leading to iron deficiency anemia) and whether national survey data on nutrient intake, and/or, when available, biomarkers of nutrient status, provide evidence of inadequate intakes in the general healthy U.S. population (4 years of age and older). Furthermore, we consider whether a substantial prevalence exists in the general population of a chronic disease, health-related condition, or nutrient deficiency with clinical significance that was linked to the particular nutrient (e.g., potassium and risk of high blood pressure).

To estimate the prevalence of nutrient adequacy or inadequacy in the U.S. population, we compared dietary intake data with the EAR or AI (whichever is established by the IOM for a particular nutrient) (Ref. 96) and, when reliable biomarkers of nutritional status were available, we compared the biomarker survey data with the data on adequacy of nutrient intake. The use of reliable status biomarker data provides assessments of nutrient status, independent of subjective factors associated with assessing nutrient intake, such as underreporting of food intake (Ref. 97 pp. 373, 513, 534, 602, and 606). In the 2007 ANPRM, we sought input on whether vitamin A, vitamin C, calcium, and iron are still considered to be of public health significance; and (2) whether there are other micronutrients of public health significance. We received several comments in response to these questions (Ref. 47).

Based on our analysis of data, and considering the factors for mandatory and voluntary declaration discussed in section I.C. and the comments received, as discussed in this document, we are proposing to: (1) With respect to essential vitamins and minerals that are currently required to be declared, retain mandatory declaration of calcium and iron and provide for voluntary declaration of vitamins A and C; and (2) with respect to essential vitamins and minerals that are permitted to be declared, require the declaration of potassium and vitamin D and retain voluntary declaration of others. We discuss these proposed changes in this document.

1. Essential Vitamins and Minerals That Are Mandatory
1. Calcium--Calcium content must be declared as a percent DV on the Nutrition Facts label (Sec. 101.9(c)(8)(ii)). In 1993, we required the declaration of calcium in nutrition labeling because: (1) There were a limited number of calcium-rich foods in the food supply; (2) calcium intakes in the United States were generally marginal; (3) adequate calcium intakes are needed to allow for
  
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  optimal bone mass development during childhood and young adulthood (55 FR 29487 at 29501); and (4) calcium was identified as a nutrient of public health significance in the 1990 IOM report (Ref. 95) and in other consensus reports (Refs. 88,93,94) (58 FR 2079 at 2106). In response to the 2007 ANPRM, many comments maintained that calcium is still considered a nutrient of public health significance, especially in bone development, and therefore should be retained as a mandatory nutrient on the Nutrition Facts label.
  
  Our analysis of NHANES (2003-2006) data shows that usual calcium intakes among the U.S. population continue to be low. About 49 percent of individuals ages 4 years and older have usual calcium intakes from conventional foods below the EAR, and 37 percent have intakes from both conventional foods plus supplements below the EAR (table 1). The 2010 DGA, too, recognized that low intakes of calcium are a public health concern for the general U.S. population (Ref. 6). We are unable to consider biomarker data because sensitive biochemical indicators reflecting calcium nutritional status are lacking.
  
  In setting DRIs for calcium, the IOM reviewed various endpoints (e.g., bone health, cancer, cardiovascular disease and diabetes), and bone health was the only endpoint with sufficient evidence to set a DRI (Ref. 22). Therefore, the IOM set age- and gender-specific DRIs based on the level of calcium intake consistent with bone accretion, achieving and maintaining bone calcium balance, minimizing the degree of bone loss, and reducing the risk of fracture in later stages of life (Ref. 22). The DRIs for calcium assume adequate intakes of vitamin D, a nutrient which is essential for promoting calcium absorption in the gut and for maintaining adequate calcium levels in the blood (Ref. 22). Building strong bones during childhood and adolescence can help prevent osteoporosis (the most common bone disease) later in life. Adequate calcium intakes are needed to allow for optimal bone mass development during childhood and young adulthood and to decrease rate of bone loss in adults (Ref. 22). An estimated 10 million Americans over 50 years of age have osteoporosis, while another 34 million are at risk and an estimated 1.5 million people suffer an osteoporotic-related fracture each year (Ref. 98). Furthermore, based on 2005-2006 NHANES data, about 5.3 million older men and women in the United States have osteoporosis at the femur neck, and 34.5 million more have osteopenia (low bone mass) in the femur neck (Ref. 99).
  
  In addition, we independently reviewed data related to calcium intake and risk reduction of osteoporosis (Sec. 101.72) and authorized two health claims for this association, signifying calcium's critical role in the reduction of risk of this chronic disease in the general healthy population.
  
  In view of the benefits of adequate calcium intake on bone health, reflected in the IOM's DRIs, relatively low intakes of calcium, and the high prevalence of osteoporosis and osteopenia among the U.S. population, we tentatively conclude that calcium is a nutrient of public health significance and its declaration continues to be necessary to assist consumers in maintaining healthy dietary practices. Therefore, consistent with the factors we consider for mandatory declaration of non-statutory nutrients (see section I.C.), we are not proposing any changes to the current requirement for declaration of calcium on the Nutrition Facts label, as specified in Sec. 101.9(c)(8)(ii).
2. Iron--Iron must be declared as a percent DV on the Nutrition Facts label (Sec. 101.9(c)(8)(ii)). In 1993, we required the declaration of iron because (1) iron was identified as a nutrient of public health significance in a 1990 IOM report (Ref. 95) and in other consensus reports (Refs. 88,93,94); and (2) iron deficiency was a risk for certain segments of the U.S. population (i.e., young children, adolescents and women of childbearing age and pregnant women, especially those with low incomes) (58 FR 2079 at 2106). In response to the 2007 ANPRM, comments suggested retaining the mandatory declaration of iron because it is a nutrient of concern for women of childbearing age identified by the 2005 DGA (Ref. 36) and substantial numbers of adolescent females and women of childbearing age are iron deficient.
  
  Our analysis of NHANES (2003-2006) intake data shows that about 3.5 percent of the population ages 4 years and older (excluding pregnant and lactating women) have inadequate iron intakes from conventional foods (i.e., an intake below the EAR), and about 3.3 percent have inadequate iron intakes from conventional foods and dietary supplements (table 1). Subpopulation analyses of these NHANES 2003-2006 data shows that about 11.2 percent of women of childbearing age (12 to 49 years of age) continue to have intakes below the EAR, from conventional foods only and 10.4 percent continue to have intakes below the EAR from conventional foods plus dietary supplements (table 1).
  
  We also considered data for several status biomarkers related to iron nutrition, in addition to intake data. Serum ferritin is the major iron-storage compound and its concentration declines in the early stages of the development of iron deficiency (Refs. 100 and 101). Although low serum ferritin concentration is an indicator of early iron deficiency, it does not necessarily reflect the severity of iron depletion as it progresses (Ref. 101). In addition to determining serum ferritin, when relevant NHANES data were available, we also considered iron deficiency based on estimating stored body iron using the ferritin model and the body iron model (Ref. 102). Compared to the ferritin model, the body iron model is reported to produce lower estimates of prevalence of iron deficiency, better predict anemia, and be less affected by inflammation, although this model has some limitations (Ref. 103). Data from NHANES 1999-2002 for the general U.S. population showed a prevalence of iron deficiency, based on serum ferritin concentration (less than 15 nanograms (ng)/mL), body iron stores (based on the ferritin model), and iron deficiency anemia (defined as having iron deficiency and a low hemoglobin value) of 8.3, 6.5 and 1.9 percent, respectively (table 1). The IOM set age and gender specific DRIs (EARs and RDAs) based on factorial modeling, which included basal iron losses, menstrual losses, fetal requirements in pregnancy, increased requirements during growth for the expansion of blood volume, and/or increased tissue and storage iron (Ref. 100). Although the DRIs were not based directly on a chronic disease risk, iron deficiency and low iron stores over time will lead to iron deficiency anemia, an advanced stage of iron deficiency (Ref. 100). Anemia is associated with poor cognitive function, lower work performance, and low endurance in the general population; delayed psychomotor development in infants; and adverse pregnancy outcome (Ref. 100).
  
  Relevant biomarker data were available from NHANES 2003-2006 for certain subpopulations such as women of childbearing age (12 to 49 years old). Analyses of these data showed that about 14 percent of women of childbearing age (12 to 49 years) had serum ferritin concentration less than 15 ng/mL, while 10 and 14.5 percent of women had inadequate stores of body iron based on the body iron model or ferritin model, respectively (table 1). In addition, about 4.7 percent of these women had iron deficiency anemia. Based on these prevalence rates, the absolute numbers of individuals with iron deficiency in women of
  
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  childbearing age using 2010 projected U.S. Census data translate into 7.2 or 11.6 million women of childbearing age (12 to 49 years of age) with inadequate iron stores based on body iron model or ferritin model, respectively. About 3.76 million of these women are considered to have iron deficiency anemia. Thus, iron continues to be of public health significance among women of childbearing age and pregnant women, who account for 26 percent of the general U.S. population.
  
  Iron is also identified as a nutrient of public health significance in consensus reports. For example, Healthy People 2020 identified iron as a nutrient of public health significance among young children (1 to 4 years of age), women of childbearing age (12 to 49 years of age), and pregnant women, and announced an objective of a ten percent reduction in iron deficiency (using the body iron model) by the year 2020 (Ref. 104). Similarly, the 2010 DGA identified iron as a nutrient of concern among women capable of becoming pregnant and recommends choosing foods that supply heme iron, which is more readily absorbed by the body, additional iron sources, and enhancers of iron absorption such as vitamin C-rich foods (Ref. 6).
  
  Given the importance of the role of iron in public health and continued significance of inadequate intakes and deficiency among women of childbearing age, a significant portion of the general healthy population, we tentatively conclude that iron is a nutrient of public health significance and its declaration continues to be necessary to assist consumers in maintaining healthy dietary practices. Therefore, consistent with the factors used for mandatory declaration of non-
  
  statutory nutrients (see section I.C.), we are not proposing any changes to the current requirement for declaration of iron on the Nutrition Facts label, as specified in Sec. 101.9(c)(8)(ii).
3. Vitamin A--Vitamin A must be declared as a percent DV on the Nutrition Facts label (Sec. 101.9(c)(8)(ii)). In 1993, we required the declaration of vitamin A in nutrition labeling because (1) it was found in a limited number of foods within the food supply, and (2) a 1990 IOM labeling report (Ref. 95) identified vitamin A as a nutrient of potential public health significance and stated that certain subpopulations (children under 5 years of age) were still at risk of deficiency for this vitamin (58 FR 2079 at 2106). In response to the 2007 ANPRM, several comments recommended retaining the mandatory declaration of vitamin A, with some noting that the 2005 DGA identified it as a nutrient of concern (Ref. 36). Our analysis of intake data from NHANES 2003-2006 estimated that about 45 percent of the general U.S. population has usual vitamin A intakes from conventional foods below the EAR, and 34 percent have intakes from conventional foods plus dietary supplements below the EAR (table 1). However, the prevalence of vitamin A deficiency is not apparent. Only about 0.3 percent of those ages 6 years and older (excluding pregnant and lactating women) have a serum retinol concentration (a biomarker of vitamin A status) below 20 mcg/dL, a cutoff level that is used as an indicator of vitamin A deficiency (table 1) (Refs. 6 and 105). Because serum retinol levels are tightly regulated (homeostatically controlled) and do not always reflect total body status, using serum vitamin A for assessment of vitamin A status of individuals may not be useful (Ref. 101). However, the distribution of serum retinol levels in a population plus the prevalence of individuals with serum retinol levels below a given cutoff point may offer a better picture of the vitamin A status of a population (Ref. 101). Based on the analysis of distribution of serum retinol (NHANES 2003-2006), and the prevalence of those below the cutoff of 20 mcg/dL (0.3 percent), we estimated that the prevalence of vitamin A deficiency in the general U.S. population is not apparent.
  
  The IOM recognized that vitamin A deficiency is rarely seen in the healthy U.S. population (Ref. 105). Furthermore, the specific age and gender DRIs (EAR and RDA) set by the IOM were based on the amount of dietary vitamin A required to maintain adequate liver stores in well-
  
  nourished subjects, rather than on a specific adverse public health endpoint (Ref. 105). The DRIs represent an amount that will assure vitamin A reserves to cover periods of increased needs such as stress and low vitamin A intake (Ref. 105). In addition, the 2010 DGA does not include vitamin A among the list of nutrients of public health concern for the general U.S. population (Ref. 6).
  
  We also considered whether any changes are necessary to the provision for voluntary declaration of the portion of vitamin A activity derived from beta-carotene, including whether its mandatory declaration is appropriate, as suggested by a comment. One comment noted that beta-carotene intake, in particular, needs to be increased, but the comment provided no further explanation. The IOM did not set DRIs for beta-carotene and other carotenoids due to limited scientific data (Ref. 18). The only known function of provitamin A carotenoids (i.e., alpha-carotene, beta-carotene, and beta-
  
  cryptoxanthin, which can be converted into vitamin A (retinol) in the body) in humans is to act as a source of vitamin A in the diet (Ref. 18). Furthermore, there is no clear evidence that suggests a protective association between dietary vitamin A or beta-carotene and risk reduction of chronic diseases, such as cardiovascular disease and cancers (Ref. 105). In addition, evidence from large clinical trials suggests that beta-carotene supplementation increases the incidence of lung cancer in a high-risk population (e.g., current or former smokers, asbestos workers) (Refs. 106 and 107). Further, the IOM introduced mcg of RAEs (retinol activity equivalents) as a new unit for expressing vitamin A activity to account for the reduced absorption for provitamin A carotenoids, including beta-carotene (Ref. 105). This new unit, which would be the appropriate unit for declaring vitamin A on the Nutrition Facts label, takes into consideration vitamin A from all sources as well as the bioavailability of beta-carotene and other provitamin A carotenoids (see section II.J.3.).
  
  Our analysis demonstrates that, even though vitamin A intakes appear to be low, vitamin A deficiency based on an assessment of vitamin A status is rare in the U.S. population. The IOM did not set a quantitative intake recommendation for vitamin A based on a public health endpoint. Thus, we tentatively conclude that vitamin A is no longer a nutrient of public health significance for the general U.S. population. Therefore, consistent with the factors for declaration of non-statutory nutrients (see section I.C.), we are proposing to amend 101.9(c)(8)(ii) to no longer require, but to permit voluntary declaration of vitamin A on the Nutrition Facts label. However, vitamin A declaration would remain mandatory when vitamin A is added as a nutrient supplement or claims are made about it on the label or in labeling of foods. We are also not proposing to change the current provision for voluntary declaration of the percent of vitamin A that is present as beta-carotene, as specified in Sec. 101.9(c)(8)(vi). We request comment about whether there is an appropriate alternative analysis to application of the factors in section I.C. regarding the mandatory declaration of vitamin A.
4. Vitamin C--Vitamin C must be declared as a percent DV on the Nutrition Facts label (Sec. 101.9(c)(8)(ii)). In 1993, we required the declaration of vitamin C because (1) a 1990 IOM labeling report (Ref. 95) identified vitamin C as a nutrient of potential
  
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  public health significance and stated that certain subpopulations were considered at risk of deficiency (such as elderly individuals on inadequate diets and infants fed cow's milk exclusively) (58 FR 2079 at 2106), and (2) vitamin C was thought to play a role in promoting the intestinal absorption of non-heme iron, meaning that vitamin C in the same food as iron was considered to help prevent iron deficiency anemia, while excess vitamin C was considered to increase the risk of excessive iron absorption (55 FR 29487 at 29501, July 19, 1990). In response to the 2007 ANPRM about whether vitamin C is still a nutrient of public health significance, several comments recommended retaining the mandatory declaration of vitamin C, with some stating that vitamin C should be retained because it is a nutrient of concern identified by the 2005 DGA (Ref. 36), and is an enhancer of iron absorption for women of childbearing age.
  
  Our analysis of NHANES 2003-2006 estimated that about 35 percent of the general U.S. population has usual vitamin C intakes below the EAR, from conventional foods only and 27.5 percent have intakes below the EAR from conventional foods and supplements (table 1). While the prevalence of inadequate intake is high, prevalence of vitamin C deficiency is not apparent in the U.S. population. Only about 6 percent of the general population had serum vitamin C concentrations below 11.4 micromoles (mumol)/L, a cutoff level that is used as an indicator of vitamin C deficiency (Ref. 97 p.534; Ref. 101). The EAR for vitamin C is based on estimates of body pool or tissue levels of vitamin C that are required for antioxidant protection with minimal urinary loss, not on a public health endpoint (Ref. 18).
  
  The effects of vitamin C on risk of chronic diseases, such as cardiovascular disease or cancer, are not conclusive at this time (Ref. 18). We issued a letter of enforcement discretion on qualified health claims for vitamin C supplement intake and reduced risk of cancers, in which we concluded that there was no credible evidence on the risk reduction from vitamin C for most cancers (squamous cell cancer of the esophagus, colorectal, laryngeal, lung, oral cavity, pancreatic, pharyngeal, renal cell, and salivary gland cancers), and very limited evidence for an association between vitamin C supplement intake and gastric cancer (Ref. 108).
  
  The 2010 DGA does not include vitamin C among the list of nutrients of public health concern for the general U.S. population (Ref. 6). However, the 2010 DGA recommends that women capable of becoming pregnant choose foods that are enhancers of iron absorption, such as vitamin C-rich foods (Ref. 6). While we agree that vitamin C enhances iron absorption, the prevalence of vitamin C deficiency in this subpopulation is not apparent. Only about 6 percent of this subgroup had serum vitamin C concentrations below 11.4 mumol/L (table 1).
  
  Based on the previous analysis and information, we tentatively conclude that while vitamin C intakes are low, vitamin C deficiency is uncommon and vitamin C is no longer a nutrient of public health significance for the general U.S. population. Therefore, consistent with the factors we consider for declaration of non-statutory nutrients (see section I.C.), we are proposing to amend Sec. 101.9(c)(8)(ii) to no longer require, but to permit voluntary declaration of vitamin C on the Nutrition Facts label. However, vitamin C declaration would remain mandatory when vitamin C is added as a nutrient supplement or claims are made about it on the label or in labeling of foods. We request comment about whether there is an appropriate alternative analysis to the application of the factors in section I.C. regarding the mandatory declaration of vitamin C.
  
  2. Essential Vitamins and Minerals That Are Voluntary
5. Vitamin D--The declaration of vitamin D content in nutrition labeling is voluntary, unless vitamin D is added as a nutrient supplement or claims are made about it (Sec. 101.9(c)(8)(ii)). In 1993, we determined that vitamin D is not of particular public health significance in the United States because the human requirement for vitamin D could be met with sufficient exposure to sunlight and milk and other foods that were fortified with vitamin D. As a result, deficiencies in this vitamin were very rare (58 FR 2079 at 2107). In response to the 2007 ANPRM about what, if any, other micronutrients are of public health significance, several comments recommended vitamin D for mandatory declaration citing vitamin D inadequacy; relationship of vitamin D to chronic disease risk (e.g., rheumatoid arthritis, multiple sclerosis, and cancers, such as prostate, breast, lung, colon, and colorectal cancers); and the 2005 DGA, which identified vitamin D as a nutrient of concern for certain subpopulations (e.g., older adults, people with dark skin, and those exposed to insufficient ultraviolet band radiation) (Ref. 36).
  
  The IOM set age and gender specific DRIs (EAR and RDA) for vitamin D at a level that would achieve and maintain serum 25-hydroxy vitamin D (25(OH)D) concentrations above a defined level (40 to 50 nanomoles (nmol)/L) in order to maintain bone health (Ref. 22). Vitamin D has a role in bone health through calcium absorption and uptake by bones (Ref. 22). In addition, in 2008, we authorized a health claim for calcium and vitamin D intake and reduced risk of osteoporosis (Sec. 101.72), signifying vitamin D's critical role in the risk reduction of this chronic disease.
  
  Vitamin D can be obtained through dietary sources, such as fish (e.g., salmon, rockfish, and tuna) and shellfish, which are the primary natural food sources of vitamin D. FDA affirmed certain uses of vitamin D food ingredients as Generally Recognized as Safe (GRAS) with specific limitations as listed in Sec. 184.1950. Under Sec. 184.1(b)(2), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food, functional use, and level of use. Any addition of the ingredient to food beyond the limitations set out in Sec. 184.1950 requires either a food additive regulation or an amendment of Sec. 184.1950. In this way, FDA can ensure that the vitamin D ingredients are added to food at safe levels. For detail on estimating dietary intake of substances in food, see FDA's Guidance for Industry: Estimating Dietary Intake of Substances in Food (Ref. 109). Under FDA regulations (Sec. Sec. 172.380 (21 CFR 172.380) and 184.1950), vitamin D can be added in specific amounts to foods such as breakfast cereals, grain products and pastas, fluid milks and milk products, and calcium-fortified juices. As for any vitamin or mineral, when vitamin D is added to a food, the total amount per serving must be declared in the Nutrition Facts label. In addition to dietary sources of vitamin D from conventional foods and dietary supplements, vitamin D is synthesized in the skin following direct exposure to the sun. Therefore, sunlight exposure is an important source of vitamin D.
  
  Serum concentration of 25(OH)D is widely considered as a biomarker of total vitamin D nutritional status and is recommended to be used for assessing vitamin D total exposure from all sources, including conventional foods, dietary supplements, synthesis from sun, and conversion of vitamin D from adipose stores in liver (Ref. 22). Our analysis of NHANES 2003-2006 data showed that about 18 percent of the U.S. population 4 years and older (excluding pregnant and lactating women) have serum 25(OH)D levels below the 40 nmol/L (a level set by IOM as equivalent to EAR), which indicates an increased risk of inadequate vitamin D exposure.
  
  Page 11922
  
  NHANES data collection normally does not include serum levels in the northern regions of the United States in the winter months, when one would expect a lower serum vitamin D level. Therefore, analysis of NHANES data may underestimate the prevalence of low serum vitamin D levels in the Unites States population. Analysis of NHANES 2005-2008 dietary data showed that, about 94 percent of the U.S. population have usual vitamin D intakes below the EAR from conventional foods only and 62 percent have intakes below the EAR from conventional foods and supplements (table 1). The IOM set the DRIs (e.g., EAR) assuming minimal sun exposure (Ref. 22).
  
  Furthermore, approximately 24 percent of the U.S. population ages 4 years and older have serum 25(OH)D concentrations between 30 and 50 nmol/L, levels that indicate risk for inadequacy according to the IOM and CDC (Refs. 22 and 101). Approximately 32 percent of the U.S. population have serum 25(OH)D levels below 50 nmol/L (a level set by IOM as equivalent to RDA and associated with optimal benefit for nearly all the population) (Ref. 22). Also, about 8 percent have serum 25(OH)D levels below IOM's cutoff of 30 nmol/L and may be at increased risk of vitamin D deficiency. Vitamin D deficiency results in inadequate bone mineralization or demineralization of the skeleton including rickets, osteomalacia, and osteoporosis (Ref. 22). The 2010 DGA, too, highlighted vitamin D as a nutrient of concern for the U.S. population, in general, rather than for specific population groups alone (Ref. 6).
  
  We do not agree with some comments that suggested that vitamin D intake should be mandatory on the label because of its relationship to disease risk reduction, generally. The IOM did not set DRIs for vitamin D based on its protective effect against diseases, such as cancers, cardiovascular disease, and diabetes, because the scientific evidence does not support a role other than that associated with bone health (Ref. 22).
  
  In view of the benefits of adequate vitamin D intakes on bone health, reflected in the IOM's DRIs, data indicating inadequate intakes, poor vitamin D status, and high prevalence of osteoporosis and osteopenia (discussed previously in the calcium section, (Refs. 98 and 99) among the general U.S. population, we tentatively conclude that vitamin D is a nutrient of ``public health significance,'' as described in section I.C., and its mandatory declaration is necessary to assist consumers in maintaining healthy dietary practices. Therefore, consistent with the factors we consider for mandatory declaration of non-statutory nutrients (see section I.C.), we are proposing to amend Sec. 101.9(c)(8)(ii) to require the mandatory declaration of vitamin D 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 mandatory declaration of vitamin D.
6. Potassium--The declaration of potassium content is voluntary, except when a claim is made about it (Sec. 101.9(c)(5)). In 1993, potassium did not meet our considerations for inclusion as a mandatory element of nutrition labeling because no quantitative intake recommendations were available in national consensus reports (58 FR 2079 at 2095). In response to our question in the 2007 ANPRM about what, if any, other micronutrients are of public health significance, several comments supported mandatory declaration of potassium on the Nutrition Facts label because the 2005 DGA identified it as a nutrient of concern (Ref. 36). One comment also pointed out that scientific evidence from three meta-analyses of over 30 clinical trials shows that high potassium intake is associated with reduced blood pressure in non-
  
  hypertensive and hypertensive individuals (Refs. 110 to 112).
  
  Our analysis of data from NHANES 2003-2006 shows that the usual mean intakes of potassium from conventional foods only (2,644 mg/d) and from conventional foods plus dietary supplements (2,651 mg/d) are below the population-weighted AI of 4,622 mg/d. Where the mean usual intake is at or above the AI, we consider that there is probably a low prevalence of nutrient inadequacy in the population assessed. However, where the mean usual intake is below the AI, the population's prevalence of inadequacy cannot be estimated (Ref. 96). Therefore, the likelihood of nutrient inadequacy cannot be estimated. Only about 1.9 percent of the general population has usual potassium intakes above the AI from conventional foods only and 2.4 percent has intakes above the AI from conventional foods plus dietary supplements (table 1), indicating that the adequacy of intakes is very low. In the absence of a sensitive biochemical indicator of potassium nutritional status, we could not consider biomarker data to inform the determination of prevalence of potassium deficiency. However, the IOM set age- and gender-specific AIs for potassium based on risk of chronic disease. The AI was set at a level that would maintain blood pressure, reduce the adverse effects of sodium chloride intake on blood pressure, and reduce the risk of recurrent kidney stones (Ref. 21). According to the CDC, about one out of three U.S. adults has high blood pressure (Ref. 113).
  
  In 2000, a FDAMA notification for a health claim about potassium, blood pressure, and stroke was submitted to us under section 403(r)(2)(g) of the FD&C Act (Ref. 114). We did not object to the notification and this meant that manufacturers could include the following claim ``Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke,'' on the label or labeling of any food that meets the eligibility criteria described in the notification and meets the general requirements for health claims (Sec. 101.14(e)(6)). Thus, we recognize the importance of potassium in the risk reduction of these chronic diseases. The 2010 DGA also concluded that potassium is a nutrient of concern for the general U.S. population (Ref. 6).
  
  In view of the benefits of adequate potassium intake in lowering blood pressure, reflected in IOM's DRIs, and data indicating low likelihood of potassium adequacy and high prevalence of hypertension among the general population, we tentatively conclude that potassium is a nutrient of public health significance for the general U.S. population and its declaration is necessary to assist consumers in maintaining healthy dietary practices. Therefore, consistent with the factors we consider for mandatory declaration of non-statutory nutrients (see section I.C.), we are proposing to amend Sec. 101.9(c)(8)(ii) to require the mandatory declaration of potassium.
  
  3. Other Essential Vitamins and Minerals
  
  Several other essential vitamins and minerals, in addition to vitamin D and potassium, may be declared on the Nutrition Facts label, i.e., vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, and chloride. In response to the 2007 ANPRM about what, if any, other micronutrients are of public health significance, several comments recommended mandatory declaration of these voluntarily declared essential vitamins and minerals: Vitamin E, folate, vitamin B12, magnesium, and phosphorus. The reasons cited in
  
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  comments included: (1) The 2005 DGA identification of these nutrients as nutrients of concern (Ref. 36); (2) the need to provide information to patients; (3) the need to heighten consumer awareness; and (4) the intakes of these nutrients are inadequate in the U.S. population or subpopulations (Ref. 47).
  
  Based on FDA's analysis of available data using the factors we consider for mandatory and voluntary declaration of non-statutory nutrients (see section I.C.) and comments received on essential vitamins and minerals that are currently voluntarily declared, we are not proposing any changes to the current provisions for voluntary declaration (for detailed information and the analysis of each of the vitamins and minerals see Ref. 115). We reviewed data related to the intake and status of nutrients where available standards allow for such calculations (table 1). Consistent with the factors (see section I.C.), essential vitamins and minerals (with the exception of potassium and vitamin D discussed previously) that are voluntarily declared should continue to be permitted to be voluntarily declared (Ref. 115). Therefore, we are not proposing any changes to the provisions for voluntary declaration of vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, and chloride.
  
  In addition, several comments recommended mandatory declaration of choline, which is currently not permitted to be declared on the Nutrition Facts label. Based on the factors we consider (see section 1.C.) and comments that asked us to provide for its declaration on the Nutrition Facts label (Ref. 115), we tentatively conclude that the voluntary declaration of choline is consistent with the factors we consider for voluntary declaration (table 1) and, therefore, we are proposing to permit the voluntary declaration of choline on the Nutrition Facts label.
  
  4. Summary
  
  In summary, based on an analysis of the factors FDA considered (as described in section I.C.), comments received, and other data and information set forth previously, FDA tentatively concludes that calcium, iron, vitamin D and potassium are nutrients of public health significance and their declarations on the Nutrition Facts label are necessary to assist consumers in maintaining healthy dietary practices. Calcium is considered a nutrient of public health significance due to the benefits of adequate calcium intake on bone health, and the relatively low intakes of calcium and the high prevalence of osteoporosis and osteopenia among the U.S. population. Iron is considered a nutrient of public health significance due to the continued inadequate intakes and deficiency (using relevant biomarker data) among women of childbearing age, who comprise a significant portion of the general healthy U.S. population. Although the DRIs for iron were not based on a chronic disease risk, iron deficiency and low iron stores over time will lead to iron deficiency anemia, an advanced stage of iron deficiency. Anemia is associated with poor cognitive function, lower work performance, and low endurance in the general population; delayed psychomotor development in infants; and adverse pregnancy outcome. Vitamin D is considered a nutrient of public health significance due to the benefits of adequate vitamin D intake on bone health, data indicating inadequate intakes and status (both from total exposure (serum data) and dietary intake data), and the high prevalence of osteoporosis and osteopenia among the U.S. population. Adequate intake of vitamin D is essential for promoting calcium absorption in the gut and for maintaining adequate calcium levels in the blood and thus promoting bone health. Potassium is considered a nutrient of public health significance due to the benefit of adequate intake of potassium in lowering blood pressure, reducing the adverse effects of sodium chloride intake on blood pressure and reducing the risk of recurrent kidney stones, and due to data indicating a low likelihood of potassium adequacy and a high prevalence of hypertension among the general U.S. population.
  
  Although we continue to consider, consistent with our rationale put forth in 1993, that a vitamin or mineral's public health significance should be the key factor in mandatory labeling (58 FR 2079 at 2106), the proposed vitamins and minerals of public health significance (i.e., potassium, calcium, vitamin D, and iron) and dietary fiber (listed on the label as a nutrient to increase) do represent various food groups. For example, potassium is found in most food groups, especially vegetables, fruits, and milk and milk products. Milk and milk products contribute substantially to calcium intake. Sources of heme iron include lean meat, poultry and seafood, while the non-heme sources of iron come from plants foods, such as beans, lentils and spinach. Although vitamin D is mostly found in fortified foods in the United States, such as fluid milk and some milk products (e.g., yogurt), its natural sources include seafood. Dietary fiber is generally found in most fruits and vegetables, whole grains and beans.
  
  The 2010 DGA recommends increasing the amount and variety of seafood in place of some meat and poultry (Ref. 6). As mentioned, fish/
  
  seafood is the primary source of naturally occurring vitamin D (Ref. 6). Data shows that fish/seafood only provides 9 percent of the total vitamin D intake in the United States (Ref. 116). Therefore, we tentatively conclude that the proposed mandatory declaration of vitamin D on the label would allow consumers to understand the relative significance of the contribution of vitamin D from natural food sources, in addition to fortified foods, in the context of the total daily diet and also is necessary to assist consumers in maintaining healthy dietary practices.
  
  We are not aware of any unintended consequences of mandatory listing, in general, of vitamins and minerals. We invite comment, including the submission of data and information on whether the mandatory listing of vitamins and minerals somehow impacts food fortification practices. We invite comment on the proposed mandatory declaration of vitamin D, potassium, calcium and iron on the label, including how we consider the public health significance of each. We also invite comment on whether the presence of these nutrients presents concerns related to label space or the need for consumer education.
  
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  Table 1--Prevalence of Adequacy and Inadequacy (From Conventional Foods and Water) and Total Intake (Conventional Foods, Water, and Supplement) and
  
  Status Biomarkers for Essential Vitamins and Minerals Among the U.S. Population, Ages 4 Years and Older
  
  Excluding pregnant and lactating women \1\
  
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  
  Usual nutrient intake \2\ Status biomarkers
  
  --------------------------------------------------------------------------------------------------------
  
  % Below weighted EAR \4\ % above weighted AI \5\ (mean
  
  Nutrients Weighted EAR/AI ------------------------------------ intake)
  
  \3\ ----------------------------------- Biomarker % Below cutoff
  
  Food Food plus Food plus cutoff
  
  supplement Food supplement
  
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  
  Vitamins
  
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  
  Choline (NHANES 2005-2008)... 460 mg (AI)..... ................ ................ 10 (mean = 311 10 (mean = 312 NA............. NA
  
  mg). mg).
  
  Folate....................... 304 mcg DFE..... 8.7............. 7.3............. ................ ............... Serum folate 6, B12, C, D, and E, and zinc (Refs. 16 to 19,22).
  
  The EAR, by definition, is the median requirement that is most likely to be close to an individual's actual needs within a particular life stage and gender group, with the needs of half of the individuals within that group falling above or below the EAR. The EAR is a quantitative intake recommendation that is used to derive target nutrient intake goals for the planning of diets for groups, but is not used as a target intake goal for individuals. Examples of planning for groups include planning diets in an assisted living facility for senior citizens or planning menus for a school nutrition program (Ref. 26). However, the EAR is not intended to be a target intake level for individuals because an individual does not know how their needs relate to the EAR. While the RDA may not be the best estimate of any given individual's nutrient requirement, which is usually unknown, the RDA was developed as a target intake level for individuals and is designed to meet the nutrient needs of practically all (97 to 98 percent) individuals within a life stage and gender group. Therefore, if the RDI were to be based on the EAR, the RDI would not meet the daily nutrient requirements for some consumers and understate target intake levels. In contrast, an RDI that is based on a RDA would meet the daily nutrient requirements for the majority of all individuals 4 years of age and older. As we explained during the NLEA rulemaking, while RDIs are not precise values for specific age and sex groups, they function as an overall population reference to help consumers judge a food's usefulness in meeting overall daily nutrient requirements or recommended consumption levels and to compare nutrient contributions of different foods (55 FR 29476). An RDI based on the RDA would mean that a product with 100 percent of the DV would have a higher probability of meeting an individual's nutrient needs than if the RDI was based on the EAR.
  
  In addition, consumers have indicated that they use the label, among other things, to make dietary judgments about a food and to plan meals. Our 2008 Diet and Health Survey reported that, among consumers who use the label when they buy a product for the first time, 62 percent often or sometimes use the label to help in meal planning; 85 percent often or sometimes use the label to get a general idea of the nutritional content of the food; and 90 percent often or sometimes use the label to see how high or low the food is in things like calories, salt, vitamins, or fat (Ref. 41). A series of surveys conducted by the
  
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  International Food Information Council over the past several years also showed that approximately 65 percent of respondents used the Nutrition Facts label to decide whether to purchase or consume a food, and different individuals focus on different aspects of the label (e.g., calories, fat, or sodium) (Refs. 127 to 130).
  
  We recognize that the recommendations of the 2003 IOM Labeling Report (Ref. 25) differ from the conclusions of the 2003 IOM Planning Report (Ref. 26). The IOM Labeling Report recommends using the EAR as the basis for developing DVs, whereas the IOM Planning Report indicated that the RDAs are appropriate targets for nutrient intakes for individuals. Inadequate intakes of some nutrients continue to be of public health significance, as noted by the 2010 DGA, which identified potassium, calcium, and vitamin D as nutrients of public health concern for general U.S. population and iron, folic acid, and vitamin B12 for certain segments of the population (Ref. 6). Based on these concerns of inadequate nutrient intakes, we find that the IOM Dietary Planning Report discussion supports the use of RDAs as the basis for establishing reference values for the purposes of food labeling. We continue to believe that given the greater coverage provided by the RDAs compared to the EARs, more individuals who use the percent DV information to select foods, compare foods, or plan diets will have greater assurance that their nutrient needs are being met (58 FR 2206 at 2213). RDAs and AIs, not EARs, are also cited in both the 2010 DGA and the USDA's Food Patterns, which were formerly known as the MyPyramid Food Patterns (Refs. 6 and 131). It is important to reiterate, however, that the RDIs are not the same as RDAs. The RDAs are recommended intake levels set for different age and gender groups, whereas the RDIs are intended to provide an overall population reference value for use in calculating the percent DV for the food label that can help consumers understand the nutritional content of foods in the context of the total daily diet (55 FR 29476 at 29481 and 58 FR 2206 at 2213).
  
  Finally, we considered the potential for the RDIs to influence the vitamin or mineral content of foods, as suggested by several comments (Ref. 47). We are not persuaded that using an EAR will promote rational fortification and that using the RDA as the basis for the RDI will lead to overconsumption of vitamins and minerals, as was suggested by a comment (Ref. 47). FDA's principles of rational fortification are expressed in our fortification policy (Sec. 104.20). The addition of nutrients to foods is also governed by the requirements established in food standards of identity (21 CFR parts 130 to 169), nutrition quality guidelines (21 CFR part 104), substitute food regulations (Sec. 101.3(e)), and relevant specifications in food additive and food substance regulations (for example, folic acid (Sec. 172.345) and vitamin D (Sec. Sec. 184.1950 and 172.380)). Consistent with our previous position (58 FR 2206 at 2210), we acknowledge that some manufacturers may fortify products to a specific percentage of the DV (e.g., 25 percent) and, to the extent this practice continues, nutrient levels in these foods would be affected by updated RDI values. Changing the basis from the current RDA approach to EARs would lower RDIs for many important nutrients. Regardless of whether the basis for the RDI is the RDA or EAR, manufacturers must comply with relevant regulations, and we urge them to follow the principles stated in our fortification policy. With respect to the concern for risk of excessive intakes of vitamins and minerals, we conducted a thorough analysis of available data to determine whether intakes of vitamins and minerals from both foods and dietary supplements exceed established ULs. An analysis of NHANES (2003-2006) data showed that usual total nutrient intakes (from both conventional foods and dietary supplements) at the 90th percentile do not exceed the ULs for most vitamins and minerals at any age group, except for zinc intake, vitamin A (preformed), iodine intake and folic acid intake among children 4 to 8 years (Ref. 132).
  
  While there were a few exceptions, we have determined that such intakes are not of public health significance, and for some nutrients, are not a result of discretionary fortification. Therefore, we do not consider that the existing approach of using RDAs as the basis for RDIs leads to widespread overconsumption of vitamins and minerals. Moreover, about half of the proposed RDIs decrease when compared to the current RDIs (table 2) because many of the new RDAs and AIs established by the IOM are now lower than previously set RDAs or ESADDIs. Most of the RDIs proposed in this rulemaking that would increase (i.e., calcium, vitamin D, dietary fiber, and potassium) have also been proposed by FDA to be nutrients of public health significance for the general U.S. population (see section II.H.). Furthermore, none of the RDIs proposed in this rulemaking exceed the ULs for children 4 to 8 years of age (see tables 11a and 11b of the 2007 ANPRM).
  
  Therefore, we tentatively conclude that RDAs, when available, provide the most appropriate basis for establishing RDIs. Using corresponding RDAs, proposed Sec. 101.9(c)(8)(iv) would update the RDIs for calcium, copper, folate, iodine, iron, magnesium, molybdenum, niacin, phosphorus, riboflavin, selenium, thiamin, vitamins A, B6, B12, C, D, and E, and zinc, as shown in table 2. We request comment on our analysis and request data and factual information, including any additional data on what role, if any, the basis of the DV (EAR or RDA) has in consumption of nutrients above the UL and in discretionary fortification of foods.
  
  3. Approach to Setting RDIs: Adequate Intake
  
  We consider that, in the absence of RDAs, AIs represent the best estimate of adequate daily nutrient intake level based on available science and, as such, they provide an appropriate basis for selecting RDIs for those vitamins and minerals where available data are insufficient to determine RDAs. While the prevalence of inadequacy of a nutrient with an AI cannot be determined, AIs, like RDAs, are goals for nutrient intakes and AIs are expected to meet the nutrient needs of most healthy people. The IOM noted that usual individual intakes for a nutrient that are equal to or above the AI can be assumed adequate (Ref. 25). We acknowledge that there is more uncertainty with an AI than an EAR or RDA. However, in the case of nutrients without established RDAs, AIs reflect the most current scientific recommendations for intake (Ref. 25).
  
  Moreover, using the AIs (where RDAs are not available) would ensure consistency in the basis of setting RDIs. We agree with comments to the ANPRM that RDIs for vitamins and minerals and consequently, percent DVs declared on the label, should have comparable meanings in order to enable consistent use. RDIs should not be based on average requirements (i.e., EAR) for some nutrients, but goals for intakes (i.e., RDAs) for others. AIs, in the absence of RDAs, would provide uniformity in setting RDIs for vitamins and minerals based on goals for their intakes. Most of the comments in response to the 2007 ANPRM supported the AI as the basis for the DV for those nutrients for which no EARs or RDAs have been established (i.e., biotin, chloride, choline, chromium, manganese, pantothenic acid, potassium, and vitamin K) (Ref. 47).
  
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  Therefore, we tentatively conclude that AIs provide an appropriate basis for selecting RDIs for those vitamins and minerals where available data are insufficient to determine RDAs. Accordingly, we are proposing to use AIs to set the RDIs for biotin, chloride, choline, chromium, manganese, pantothenic acid, potassium, and vitamin K.
  
  4. Approach to Setting RDIs: Tolerable Upper Intake Level
  
  The UL is the highest average daily intake level likely to pose no risk of adverse health effects for nearly all people in a particular group. As intake increases above the UL, potential risk of adverse effects may increase (Ref. 96). The UL can be used to estimate the percentage of the population at potential risk of adverse effects from excess nutrient intake (Ref. 25). However, the UL is not intended to be a recommended level of intake for vitamins and minerals where excess intake is not a concern, as there is generally (with the exception of folate in the prevention of neural tube defects) no established benefit for consuming amounts of nutrients above the RDA or AI (Ref. 96). Therefore, we do not consider the UL to be an appropriate basis for setting RDIs. However, as the IOM noted, ULs can be used to plan diets to ensure usual intakes of vitamins and minerals are below the UL for individuals or to plan diets for groups to minimize the proportion of the population at risk of excess nutrient intake (Ref. 25).
  
  Therefore, we tentatively conclude that the UL does not provide an appropriate basis for establishing RDIs for vitamins and minerals. As noted previously (sections II.I.2. and II.I.3.), we tentatively conclude that the RDAs and, for nutrients where an RDA has not been established, AIs are the most appropriate quantitative intake recommendations for setting RDIs that can help consumers to plan general diets and understand the nutritional content of the foods they buy in the context of the total daily diet.
  
  5. Approach to Setting RDIs: Population-Weighted Versus Population-
  
  Coverage
  
  As discussed in the 2007 ANPRM, we set the RDIs based on a population-coverage approach, after concluding that this approach was more appropriate than a population-weighted approach, in part, so that vulnerable or at-risk groups would be sufficiently covered by the DV (72 FR 62149 at 62150). In determining an approach for setting RDIs in this proposed rule, we considered recommendations of current consensus reports, scientific review articles, and comments to the 2007 ANPRM. We presented a comparison of potential RDIs based on the various established DRIs and applying the population-coverage versus population-weighted approaches (see tables 11A and 11B of the 2007 ANPRM). As discussed in this document, we tentatively conclude that RDIs for vitamins and minerals should continue to be based on a population-coverage approach, using the highest RDA and, where an RDA has not been established, the highest AI.
  
  We continue to agree with the rationale we set forth in 1993 that the population-coverage approach would sufficiently cover the vulnerable or at-risk groups (58 FR 2206 at 2211). Using the highest age and gender group RDA/AI value (i.e., a population-coverage approach) would avoid a higher risk of nutrient inadequacy among certain segments of the population because such a value is not derived from averaging the requirements for populations with lower needs (children and elderly) and those with greater needs (adolescents or adults). While incidences of deficiency diseases, such as pellagra, are now rare, intakes and status biomarkers of certain nutrients continue to be inadequate and of public health significance (see section II.H.). Although, for some nutrients, the population-coverage RDA approach would result in RDIs that are higher than the nutrient requirements for some consumers, RDA, by definition, is the target intake goal for nutrient intakes for individuals. In addition, as noted by one comment, unlike the population-weighted approach, the population-coverage approach would not be susceptible to changes in age demographics of the population. Therefore, any future revisions to RDIs would be based primarily on new scientific data related to nutrition or new dietary recommendations, and we would not need to revise RDIs solely based on the availability of new census data.
  
  We also considered concerns that the population-coverage approach may lead to excessive intakes of nutrients. As in the case of the RDA approach (discussed previously), we find such concerns unfounded. Intakes of vitamins and minerals generally do not exceed the ULs under current RDIs that are based on a population-coverage RDA approach. In a few instances where total usual intakes of vitamins and minerals by children 4 to 8 years exceed corresponding ULs, we have determined that such intakes are not of public health significance, and for some nutrients, are not as a result of fortification (see accompanying Ref. 115). Furthermore, because many of the new RDAs and AIs established by the IOM are now lower than previously set RDAs or ESADDIs, the RDIs based on a population-coverage RDA for many nutrients will decrease (see table 2). We consider that, from a public health perspective, it is more important for the DV of vitamins and minerals to cover the intake needs of most consumers than it is for certain age and gender groups to be covered by the DV based on their proportion of the overall population. We are also not aware of any data indicating that use of a population-coverage approach versus a population-weighted approach results in increases in nutrient consumption. Therefore, we tentatively conclude that the population-coverage approach using the highest RDA or, in its absence, the highest AI continues to provide an appropriate basis for setting RDIs for vitamins and minerals. We are proposing to amend Sec. 101.9(c)(8)(iv) to update RDIs as presented in table 2.
  
  6. Declaration of Absolute Amounts of Vitamins and Minerals
  
  Currently, mandatory nutrients and, when declared, voluntary nutrients must be declared by their absolute amounts in weight on the Nutrition Facts label, except for vitamins and minerals (other than sodium and potassium) (see Sec. 101.9(d)(7)(i)). Thus, except when the linear label format is used (Sec. 101.9(j)(13)(ii)(A)(2)), listings for sodium and potassium (when declared) appear above the third bar and include both weight amounts and percent DVs, while vitamins A and C, calcium, and iron appear below the third bar and include percent DVs only. In the case of dietary supplements, both the quantitative amount by weight and percent DV (if available) are required to be declared on the Supplement Facts label (Sec. 101.36(b)(2)(ii) and (iii)). The 2007 ANPRM invited comment on whether the absolute amounts (e.g., grams or milligrams) of mandatory and voluntary vitamins and minerals should be included on the Nutrition Facts and Supplement Facts labels (72 FR 62149 at 62170). Most comments supported including the absolute amounts of these nutrients in addition to the requirement of listing percent DVs.
  
  Research suggests that consumers, in general, and physicians who prescribe nutrient supplements for specific medical reasons have difficulty understanding how percent DVs relate to the absolute amounts of nutrients listed on the Nutrition Facts label (Ref.
  
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  133). More recently, in a report on labeling and fortification, the IOM recommended listing both absolute amounts (e.g., mg/serving) and percent DVs to assist consumers who have difficulty understanding how to interpret the percent DV declaration (Ref. 25). This IOM report also stated that absolute amounts declaration for all micronutrients would maintain consistency in how nutrients are declared on the Nutrition Facts label.
  
  Based on the IOM's recommendation, research findings, and comments received, we are proposing to require that, similar to the requirement for dietary supplements (Sec. 101.36(b)(2)(i)(A)), all vitamins and minerals declared on the Nutrition Facts label must include their quantitative amounts (in addition to the requirement for corresponding percent DV declaration) (proposed Sec. 101.9(c)(8)). We request comments on this tentative conclusion, and seek input on the appropriate placement of the quantitative amounts of nutrients on the Nutrition Facts label.
  
  Further, with the proposed requirement for declaration of absolute amounts of vitamins and minerals, it is necessary to establish when a vitamin or mineral is present in an insignificant amount as well as increments for declaration of the quantitative amounts of vitamins and minerals on the Nutrition Facts label. In determining requirements for vitamins and minerals present in insignificant quantities, as well as increments for declared vitamins and minerals, we looked to requirements that have already been established for declaration of quantitative amounts of sodium and potassium, vitamins and minerals declared on the Supplement Facts label, and percent DVs.
  
  Quantitative amounts in milligrams may currently be listed on the Nutrition Facts label for only two minerals: Sodium, a mandatory nutrient (Sec. 101.9(c)(4)) and potassium (Sec. 101.9(c)(5)), which may be voluntarily declared on the Nutrition Facts label. We require in Sec. 101.9(c)(4) and (c)(5) that when a serving contains less than 5 mg of sodium or potassium, the value shall be declared as zero; when a serving contains 5 to 140 mg of sodium or potassium, the declared value shall be rounded to the nearest 5 milligram increment; and when a serving contains greater than 140 mg of sodium or potassium, the declared value shall be rounded to the nearest 10 mg increment. We are now proposing to establish an RDI for potassium. Since potassium will now have an RDI, rather than a DRV, we are proposing to remove the specific requirements for the declaration of potassium in Sec. 101.9(c)(5), and replace the section with requirements for the declaration of fluoride. Requirements for the declaration of quantitative amounts of other nutrients with an established RDI discussed in this document will apply to potassium, if finalized.
  
  The quantitative amounts by weight per serving of vitamins and minerals are also required to be declared on the Supplement Facts label (Sec. 101.36(b)(2)(ii)). The amounts of vitamins and minerals, excluding sodium and potassium, that are declared on the Supplement Facts label are the amount of the vitamin or mineral included in one serving of the product, using the units of measurement and levels of significance given in Sec. 101.9(c)(8)(iv). Section 101.36(b)(2)(ii)(B) also specifies that for declaration of vitamins and minerals on the Supplement Facts label, zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole mg, but the quantitative amount may be declared in tenths of a mg).
  
  For conventional foods, FDA specifies in Sec. 101.9(c)(8)(iii) that the percent DV declaration for vitamins and minerals present at less than 2 percent of the RDI is not required for nutrition labeling, but may be declared as zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement ``Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).'' Alternatively, the statement ``Not a significant source of (listing the vitamins or minerals omitted)'' may be placed at the bottom of the table of nutrient values.
  
  For the purpose of determining when a vitamin or mineral is present in an insignificant amount, we tentatively conclude that the cutoff used for declaration of percent DV of less than 2 percent of the RDI (Sec. 101.9(c)(8)(iii)) can reasonably be applied to the declaration of quantitative amounts of vitamins and minerals on the Nutrition Facts label. We find that, if a product contains less than 2 percent of the RDI per serving, it is appropriate to express the declared vitamin or mineral quantitative amount as zero. The manufacturer may choose to use an asterisk (or other symbol), instead of a declaration of zero, that refers to another asterisk (or symbol) placed at the bottom of the table and that is followed by the statement ``Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients).'' Alternatively, the statement ``Not a significant source of (listing the vitamins or minerals omitted)'' (``not a significant source'' statement) may be placed at the bottom of the table of nutrient values.
  
  As previously discussed, manufacturers have the option of using an asterisk (or symbol), instead of a declaration of zero, that directs the consumer to a statement indicating that the product is not a significant source of certain vitamins or minerals found at the bottom of the table of nutrient values when the calculated percent DV is less than 2 percent. We are concerned that it may be confusing to consumers if the manufacturer chooses to declare the quantitative amount of a vitamin or mineral as zero, and also chooses to use an asterisk referring the reader to a statement at the bottom of the label instead of in the percent DV column on the Nutrition Facts label. Therefore, we are proposing to require that, when a product contains less than 2 percent of the RDI for a vitamin or mineral, the manufacturer must declare the quantitative amount of the vitamin or mineral and the percent DV in the same manner. For example, if a serving of the product contains less than 2 percent of the RDI for calcium, both the quantitative amount and the percent DV for calcium may be listed as zero or an asterisk (or symbol) directing the consumer to a statement at the bottom of the label may be used in place of both the quantitative amount and the percent DV declaration for calcium.
  
  We see no reason to provide different declaration increments for the Nutrition Facts label than those that have already been established for the declaration of quantitative amounts of vitamins and minerals on the Supplement Facts label in Sec. 101.36(b)(2)(ii). Therefore, we tentatively conclude that, as with the declaration of quantitative amounts of vitamins and minerals on the Supplement Facts label, the levels of significance given in Sec. 101.9(c)(8)(iv) should be used. Zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole mg, but the quantitative amount may be declared in tenths of a mg).
  
  We acknowledge that for some vitamins and minerals with RDIs that contain three or four digits (e.g., phosphorous has a proposed RDI of 1,250 mg), a difference of 1 mg per serving may not be meaningful in terms
  
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  of health impacts. We request comment on whether quantitative amounts for nutrients with RDI values that contain three or four digits should be rounded, what the rounding increments should be, and data to support suggested rounding increments for such vitamins and minerals.
  
  7. Issues Concerning Specific Vitamins and Minerals
  
  In this section, we address issues related to RDIs for specific vitamins and minerals, including those received in comments to the 2007 ANPRM. We discussed the declaration of these vitamins and minerals in section II.H. (and in accompanying Ref. 115).
7. Vitamin K--There are three general forms of vitamin K: Phylloquinone (vitamin K1), menaquinone (vitamin K2), and menadione (vitamin K3). For labeling purposes, there is no specific definition for vitamin K. The AIs for vitamin K are based on median intakes from NHANES data, which specifically represents the intake of phylloquinone, the major form of vitamin K in the diet (Ref. 134). The AI for vitamin K does not account for the intake of menaquinone or menadione because (1) NHANES data only includes phylloquinone content of foods, (2) the contribution of menaquinones, which can be produced by bacteria in the gut, to the maintenance of vitamin K status has not been established, and (3) menadione is a synthetic form of vitamin K that can be converted to a form of menaquinone in animal tissues. Because the AI for vitamin K is specific to phylloquinone, our proposed RDI for vitamin K, 120 mcg in proposed Sec. 101.9(c)(8)(iv), that is based on the AI pertains only to phylloquinone.
8. Chloride--The RDI for chloride of 3,400 mg/d (Sec. 101.9(c)(8)(iv)) was established in 1995 and is based on the midpoint of the range (1,700 to 5,100 mg/d) of the ESADDI set in the 1980 RDA report (Ref. 135; 59 FR 427). The RDI for chloride is proportional to the DRV for sodium, considering that chloride losses tend to parallel losses of sodium and almost all dietary chloride comes from sodium chloride (60 FR 67164). The IOM set AIs and ULs for chloride on an equimolar basis to the AI and UL for sodium (Ref. 10). The 2007 ANPRM requested comment on whether (1) the DV for chloride should continue to be an RDI, or should be a DRV like the current DV for sodium and (2) the DV for chloride should be based on the same DRI (AI versus UL) as used to set a DV for sodium.
  
  A few comments supported setting a DRV for chloride on an equimolar basis to the UL for sodium. We disagree because the UL for chloride was not based on adverse effects associated with excess intake of chloride. Furthermore, the UL was not based on a public health endpoint specific to chloride intake, which is a basis for setting a DRV. Because chloride is an essential mineral and has age- and gender-specific AIs, we tentatively conclude that chloride should remain a RDI and be based on population-coverage AI (see section II.I.5.). Therefore, we are proposing to set an RDI for chloride using the population-coverage AI of 2,300 mg/d (proposed Sec. 101.9(c)(8)(iv)).
9. Potassium--The DRV of 3,500 mg/d for potassium was established based on its beneficial health effects (e.g., reduction in blood pressure) (55 FR 29487 at 29500). We established a DRV rather than an RDI because an RDA for specific age and gender groups was not established at that time. In 2005, the IOM established age- and gender-
  
  specific AIs for potassium based on data showing that potassium lowers blood pressure, blunts the adverse effects of sodium chloride intake on blood pressure, reduces the risk of recurrent kidney stones, and possibly decreases bone loss (Ref. 136). Because potassium is an essential mineral and age- and gender-specific AIs are available, we tentatively conclude that an RDI should be established in place of the DRV. Therefore, using the population-coverage AI, we are proposing to establish an RDI for potassium of 4,700 mg/d (proposed Sec. 101.9(c)(8)(iv)).
10. Choline--FDA regulations do not establish a reference value for choline. In 1998, the IOM established age- and gender-specific AIs for choline based on intakes necessary to maintain liver function (Ref. 137). In 2001, we received a FDAMA notification under section 403(r)(2)(G) of the FD&C Act for the use of certain nutrient content claims for choline (Ref. 138). The FDAMA notification identified the DV for choline as 550 mg, which was based on the population-coverage AI for choline. Because the IOM established age- and gender-specific AIs for choline, we tentatively conclude that an RDI should be established. Thus, we are proposing in Sec. 101.9(c)(8)(iv) to set an RDI of 550 mg for choline based on the population-coverage AI.
11. Vitamin B12--We are proposing to lower the RDI for Vitamin B12 from 6 to 2.4 mug/day which reflects the population-coverage RDA for Vitamin B12. The RDAs for Vitamin B12 were established by the IOM in 2000. The IOM noted that 10 to 30 percent of individuals older than 50 years of age are estimated to have atrophic gastritis with low stomach acid secretion which can decrease the bioavailability of naturally occurring vitamin B12 in food (Ref. 17). The bioavailability of crystalline vitamin B12 that is added to food is not altered in people with this condition. While the IOM set an RDA of 2.4 mug/d that can be met by consuming natural and crystalline forms of vitamin B12 and is for all adults, it was noted that it is advisable that individuals older than 50 years of age meet their RDA mainly by consuming foods fortified with crystalline vitamin B12 or vitamin B12-containing supplements. If the RDI is lowered from 6 to 2.4 mug, it is possible that the fortification level in foods, such as ready-to-eat breakfast cereals, may be lowered, decreasing the overall amount of crystalline vitamin B12 in the food supply. Given the current level of fortification in food, less than 1 percent of men and 6.4 to 7.5 percent of women older than 50 years of age consume below the EAR for vitamin B12, while only 3 to 5 percent of men and women in this age group have serum vitamin B12 levels that are considered to be inadequate (2003-2006 NHANES) (table 1). Reflecting the current food supply and regulations, data from NHANES (2003-2006) indicate that ready-to-eat cereal is the primary source of crystalline B12 added to food, providing approximately 14.6 percent of the total vitamin B12 consumed by individuals 51 years of age and older (Ref. 139). Dietary supplements appear to be an important contributor of vitamin B12 for this age group because the mean increase in vitamin B12 intake ranged between 2.5 and 4.7 mug/d when comparing intake from food only compared to food plus dietary supplements (NHANES 2003-2006) (table 1). We request comment and data on lowering the RDI for vitamin B12 to 2.4 mug.
  
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  Table 2--Current and Proposed RDIs for Nutrition Labeling
  
  Based on a 2,000 calorie intake for adults and children 4 or more years of age
  
  ----------------------------------------------------------------------------------------------------------------
  
  Nutrient Current RDIs Proposed RDIs
  
  ----------------------------------------------------------------------------------------------------------------
  
  Vitamins:
  
  Biotin............................ 300 micrograms................ 30 micrograms.
  
  Choline........................... 550 \1\ milligrams............ 550 milligrams.
  
  Folate............................ 400 micrograms................ 400 micrograms DFE.
  
  Niacin............................ 20 milligrams................. 16 milligrams NE.
  
  Pantothenic acid.................. 10 milligrams................. 5 milligrams.
  
  Riboflavin........................ 1.7 milligrams................ 1.3 milligrams.
  
  Thiamin........................... 1.5 milligrams................ 1.2 milligrams.
  
  Vitamin A......................... 5,000 International Units..... 900 micrograms RAE.
  
  Vitamin B6........................ 2.0 milligrams................ 1.7 milligrams.
  
  Vitamin B12....................... 6 micrograms.................. 2.4 micrograms.
  
  Vitamin C......................... 60 milligrams................. 90 milligrams.
  
  Vitamin D......................... 400 International Units....... 20 micrograms.
  
  Vitamin E......................... 30 International Units........ 15 milligrams.
  
  Vitamin K......................... 80 micrograms................. 120 micrograms.
  
  Minerals:
  
  Calcium........................... 1,000 milligrams.............. 1,300 milligrams.
  
  Chloride.......................... 3,400 milligrams.............. 2,300 milligrams.
  
  Chromium.......................... 120 micrograms................ 35 micrograms.
  
  Copper............................ 2.0 milligrams................ 0.9 milligrams.
  
  Iodine............................ 150 micrograms................ 150 micrograms.
  
  Iron.............................. 18 milligrams................. 18 milligrams.
  
  Magnesium......................... 400 milligrams................ 420 milligrams.
  
  Manganese......................... 2.0 milligrams................ 2.3 milligrams.
  
  Molybdenum........................ 75 micrograms................. 45 micrograms.
  
  Phosphorus........................ 1,000 milligrams.............. 1,250 milligrams.
  
  Potassium \2\..................... 3,500 milligrams.............. 4,700 milligrams.
  
  Selenium.......................... 70 micrograms................. 55 micrograms.
  
  Zinc.............................. 15 milligrams................. 11 milligrams.
  
  ----------------------------------------------------------------------------------------------------------------
  
  RAE = Retinol activity equivalents; 1 RAE = 1 mcg retinol, 12 mcg beta-carotene, or 24 mcg alpha- carotene,
  
  or 24 mcg beta-cryptoxanthin.
  
  NE = Niacin equivalents, 1 mg niacin = 60 mg of tryptophan.
  
  DFE = Dietary folate equivalents; 1 DFE = 1 mcg food folate = 0.6 mcg of folic acid from fortified food or as a
  
  supplement consumed with food.
  
  \1\ A notification was submitted under section 403(r)(2)(G) of the FD&C Act in 2001 for the use of certain
  
  nutrient content claims for choline. These statements identify the daily value for choline as 550 mg. This
  
  value is based on the AI set by the IOM of the NAS in 1998 (Refs. 138 and 137).
  
  \2\ These minerals currently have a DRV and we are proposing to establish an RDI.
Units of Measure, Analytical Methods, and Terms for Vitamins and Minerals

As discussed in this document, the IOM set DRIs using new units of measure for vitamin A, vitamin E, and folate, as well as provided recommendations on the use of International Units (IUs), and expression of weight amounts for sodium, potassium, copper, and chloride (Refs. 17 to 19,25). The new units of measure for vitamin A, vitamin E, and folate affect how total amount of each nutrient is measured. The 2007 ANPRM asked several questions about these issues. We discuss our reconsideration of the units of measure, analytical methods, and terms used in declaration of specific vitamins and minerals in this section.

1. Sodium, Potassium, Copper, and Chloride

The absolute amount declaration for sodium, potassium, copper, and chloride must be expressed in mg (Sec. 101.9(c)(8)(iv) and (c)(9)). However, in the DRI reports for these nutrients, these nutrients are expressed as grams (sodium, potassium, chloride) or micrograms (copper) (Refs. 21,140). The IOM Labeling Committee recommended that the current requirement for units of measurement used in the declaration of these nutrients should be changed to be consistent with the units used in the new DRI reports. In response to the 2007 ANPRM that asked about whether the units of measure should be changed for these nutrients, we received comments that generally supported maintaining the current units of measure.

We considered the IOM Labeling Committee recommendations and comments received. When expressed as ``g'' units, rather than in ``mg'' units, significant differences in the amounts of sodium or potassium could appear inconsequential or less significant. For example, amounts declared as 0.2 g and 0.5 g may not seem as significantly different as 200 mg and 500 mg. Furthermore, units of measure for these nutrients have been in use since 1993 and consumers may be already familiar with the units used on the label. In addition, the use of milligrams for sodium and potassium is consistent with the 2010 DGA, which provides recommendations for sodium and potassium in milligram units (Ref. 6). We tentatively conclude that there is no advantage to change the units of measure for sodium, potassium, copper, or chloride from those currently in use. Thus, we are not proposing any changes to the units used for declaring these nutrients on the Nutrition Facts label.

2. Folate and Folic Acid
1. Units of Measure--The RDI for ``folate'' is listed in ``micrograms'' (Sec. 101.9(c)(8)(iv)). Folate represents the sum of naturally occurring folate and synthetic folic acid that has been added to foods. In 1998, the IOM set the RDA for folate expressed as mcg Dietary Folate Equivalents (DFE) (Ref. 141). The IOM Labeling Committee recommended that the units used for folate (mcg) in nutrition labeling should be consistent with the units in the new DRI report (mcg DFE) (Ref. 25). In response to the 2007 ANPRM, in which we asked for comment on this issue, a few comments supported retaining the current units (mcg) for folate and one comment noted
  
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  that the use of the term DFE on the label would be unfamiliar to consumers and could be confusing (Ref. 47). The IOM developed the new term, DFE, to account for the greater bioavailability of synthetic folic acid that is added to fortified foods or dietary supplements than folate that occurs naturally in foods (food folate). As defined by the IOM, mcg DFE is equivalent to mcg food folate + (1.7 x mcg synthetic folic acid) (Ref. 141). The current unit of measure (mcg) does not take into account the difference in the bioavailability of folate and folic acid. In addition, mcg DFE declaration would provide a more accurate representation of the amount of folate in foods that contain both naturally occurring folate and added folic acid. For example, the standards of identity for certain enriched foods require the addition of folic acid (21 CFR parts 136, 137, and 139) and, these foods contain both food folate and synthetic folic acid.
  
  Therefore, we are proposing to amend Sec. 101.9(c)(8)(iv) such that mcg DFE would be used to declare the amount of total folate (food folate and synthetic folic acid) on the Nutrition Facts label. Section 101.36(b)(2)(ii)(B) for the labeling of dietary supplements includes a reference to Sec. 101.9(c)(8)(iv), which, as proposed, designates the units of measure for declaration of folic acid as mcg DFE units (see section II.L.).
  
  We are aware that education efforts should be provided to assist with consumer understanding of the new ``equivalent'' units of measurement for folic acid. For example, using the new units, a dietary supplement that now declares 400 mcg of folic acid would declare the same amount as 680 mcg DFE or 170 percent of the proposed RDI. One option to help ensure consumer understanding would be to allow the declaration of the amount of folic acid in parenthesis similar to that permitted for the percent of vitamin A as beta-carotene (Sec. 101.9(c)(8)(vi)). For example, for a conventional food that contains both folic acid and folate, the total mcg DFE could be declared and in parenthesis indicate how much is from folic acid. We invite comment on this approach.
2. Analytical Methods--Because we are proposing to amend the units used for declaring the sum of folate and folic acid, we considered the availability and limitations of analytical methods necessary to measure each nutrient separately for calculating mcg DFE. Available analytical methods (e.g., AOAC 960.46, 944.12, and 2004.05) cannot distinguish between naturally occurring folate in conventional food and folic acid that is added to conventional food products. There is a difference in folate activity between naturally occurring folate and synthetic folic acid that is added to fortify foods. When a conventional food product contains a mixture of naturally occurring folate and synthetic folic acid that has been added, available analytical methods do not allow for verification of the declared amount of mcg DFEs on the Nutrition Facts label. To calculate DFEs, it is necessary to know both the amount of folate and folic acid in the food product. Therefore, proposed Sec. 101.9(g)(10) would require manufacturers to make and keep records to verify the amount of folic acid added to the food and folate in the finished food, when a mixture of both naturally occurring folate and added folic acid are present in the food. (See section II.N.) We invite comment on available scientifically valid methods that are capable of measuring folic acid and folate separately.
3. Terms to Declare Folate--''Folic acid'' or ``folacin'' are identified as synonyms of folate and can be added in parentheses after folate or can be listed without parentheses in lieu of ``folate'' on the Nutrition Facts label (Sec. 101.9(c)(8)(v)) or in the Supplement Facts label (Sec. 101.36(b)(2)(B)(2)).
  
  Consistent with the proposed amendments related to the units of measure for folate that take into account the differences between folate and folic acid, we are reconsidering appropriate terms for declaration of folate content in foods and dietary supplements. We are proposing to (1) eliminate the synonym ``folacin'' specified in Sec. Sec. 101.9(c)(8)(v) and 101.36(b)(2)(B)(2); (2) require, in proposed Sec. 101.9(c)(8)(vii), that the term ``folate'' be used in the labeling of conventional foods that contain either folate only or a mixture of folate and folic acid; and (3) require that the term ``folic acid'' be used in the labeling of dietary supplements only. As proposed, conventional foods would not be permitted to use the term ``folic acid.''
  
  3. Vitamins A, D, and E
  
  International Units (IUs) are used for the labeling of vitamins A, D, and E on the Nutrition and Supplements Facts labels (Sec. Sec. 101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B)). The IOM Labeling Committee recommended that the units for these nutrients should be changed to be consistent with the units in the new DRI reports, i.e., mug Retinol Activity Equivalents for vitamin A, mug for vitamin D, and mg alpha-tocopherol for vitamin E (Refs. 18,22,25,140). In response to the 2007 ANPRM, several comments supported replacing IUs with mcg RAE for vitamin A, mug for vitamin D, and mg alpha-tocopherol for vitamin E. We agree that IUs should be replaced with units that are consistent with the DRIs. In addition, because DRIs form the basis for the proposed RDIs for these vitamins (see section II.I.), using the new units would also correspond with the proposed RDIs for vitamins A, D, and E. We discuss issues relevant to vitamin A and vitamin E units of activity in this document.
4. Units of Vitamin A Activity--The RDI for vitamin A is 5,000 IU (Sec. 101.9(c)(8)(iv)). Because the vitamin A activity of provitamin A carotenoids (e.g., beta-carotene) is less than pre-formed vitamin A (retinol), the following conversions were developed: One mcg retinol = 3.33 IU vitamin A activity from retinol (Ref. 105) and 10 IU beta-
  
  carotene = 3.33 IU retinol (Ref. 105). Because the vitamin A activity of beta-carotene in dietary supplements is greater than beta-
  
  carotene in food, ten IU of beta-carotene is based on 3.33 IU of vitamin A activity x 3 (the relative vitamin A activity of beta-
  
  carotene in supplements versus diets). The RDA in mcg Retinol Equivalents (RE) for vitamin A is equivalent to 1 mcg retinol or 6 mcg of beta-carotene (i.e., carotene:retinol equivalency ratio of 6:1) and considers 3 mcg of dietary beta-carotene to be equivalent to 1 mcg of purified beta-carotene in supplements (i.e., a carotene:retinol equivalency ratio of 3:1).
  
  A comment to the 2007 ANPRM noted that the IU for vitamin A does not take into account the recent information on the bioavailability of dietary provitamin A carotenoids that was used to define retinol activity equivalents (RAEs) for these carotenoids (Ref. 105). The unit of measure associated with the RDA for vitamin A is mcg RE. We agree that the IU for vitamin A does not reflect the carotene:retinol equivalency ratio. RAEs consider 6 mcg of dietary beta-carotene to be equivalent to 1 mcg of purified beta-carotene in supplements (i.e., a carotene:retinol equivalency ratio of 6:1) because more recent evidence suggests that the bioavailability of beta-carotene is approximately half of what was previously considered for setting mcg RE. A change in units does not present any challenges to AOAC methods used for measuring provitamin A carotenoids and vitamin A in foods or dietary supplements.
  
  Therefore, proposed Sec. 101.9(c)(8)(iv) would change the units of measure for vitamin A to replace ``IU'' with ``mcg,'' representing mcg RAE. In addition, because the difference in the bioconversion of beta-carotene to vitamin A will be accounted for with the proposed declaration of vitamin A content as ``mcg'' (representing mcg
  
  Page 11933
  
  RAE), we are not proposing to preclude the declaration of beta-
  
  carotene in conventional foods as vitamin A. A corresponding change for dietary supplements is made in proposed Sec. 101.36(b)(2)(i)(B)(3).
5. Units of Vitamin E Activity--The RDI for vitamin E is 30 IU (Sec. 101.9(c)(8)(iv)). Before 1980, one IU of vitamin E activity was defined as 1 mg of dl-alpha-tocopherol acetate by the U.S. Pharmacopeia (USP) (Ref. 142). After 1980, the IU was changed to the USP unit where one USP unit of vitamin E was still defined as having 1 mg of all rac-alpha-tocopherol acetate. Therefore there is no longer an IU for vitamin E (Ref. 142). One comment to the 2007 ANPRM said that the current RDI of 30 IU underestimates the amount of vitamin E naturally present in foods. We agree. The RDA for vitamin E is 15 mg/d of alpha-tocopherol (Ref. 143). alpha-Tocopherol is the only form of vitamin E that is maintained in blood and has biological activity. There are eight stereoisomers of alpha-tocopherol (RRR, RSR, RRS, RSS, SRR, SSR, SRS, SSS). Of the eight, only RRR alpha-tocopherol occurs naturally in foods. Commercially available vitamin E that is used to fortify foods and used in dietary supplements contains esters of either the natural RRR- or, more commonly, mixtures of the 8 stereoisomers (all rac alpha-tocopherol acetate). Four of the eight stereoisomers of alpha-tocopherol are not maintained in human plasma or tissues (SRR, SSR, SRS, and SSS). Thus, the new RDA for vitamin E is limited to the four 2R stereoisomeric forms (RRR, RSR, RRS and RSS) of alpha-tocopherol (Ref. 143). These four forms of alpha-tocopherol are found in nonfortified and fortified conventional foods and dietary supplements. The all rac-alpha-tocopherol acetate in fortified foods or dietary supplements has one-half the activity of RRR-alpha-
  
  tocopherol naturally found in foods or the 2R stereoisomeric forms of alpha-tocopherol. Unlike the IU, the new IOM measure of vitamin E activity, mg alpha-tocopherol accounts for this difference in activity between naturally occurring and synthetic vitamin E. Therefore, proposed Sec. 101.9(c)(8)(iv) would change the units of measure for vitamin E to replace ``IU'' with ``mg,'' representing mg of alpha-tocopherol. Section 101.36(b)(2)(ii)(B) for the labeling of dietary supplements includes a reference to Sec. 101.9(c)(8)(iv), which, as proposed, designates the units of measure for declaration of vitamin E as ``mg.''
  
  Because of the difference in vitamin E activity between all rac-
  
  alpha-tocopherol acetate and RRR-alpha-tocopherol, AOAC methods or other validated analytical methods would be needed for individually measuring naturally occurring vitamin E (RRR-alpha-tocopherol) and all rac-alpha-tocopherol acetate in food products. Current AOAC methods cannot individually measure these two forms of vitamin E. In addition, it is necessary to know the amount of both RRR-alpha-
  
  tocopherol and all rac-alpha-tocopherol acetate in a food product to calculate vitamin E equivalents for declaration as mg alpha-
  
  tocopherol. It is not possible to determine the amount of RRR-alpha-
  
  tocopherol in a food product by subtracting the amount of all rac-
  
  alpha-tocopherol acetate from the total amount of vitamin E declared. Therefore, when a conventional food contains a mixture of all rac-
  
  alpha-tocopherol acetate and RRR-alpha-tocopherol, we are proposing to require manufacturers to verify the declared amount of both all rac-
  
  alpha-tocopherol acetate and RRR-alpha-tocopherol in the finished food product (proposed Sec. 101. 9(g)(10)). (See section II.N.) We invite comment on available validated methods that are capable of individually measuring all rac-alpha-tocopherol acetate and RRR-
  
  alpha-tocopherol.
  
  For the reasons stated previously, we are proposing to amend Sec. 101.9(c)(8)(iv) to replace IUs for the RDIs for vitamin A, vitamin D, and vitamin E with mcg RAE for vitamin A, mug for vitamin D, and mg alpha-tocopherol for vitamin E.
Labeling of Foods for Infants, Young Children, and Pregnant or Lactating Women

The general labeling requirements for foods in Sec. 101.9(c) apply to foods for infants, young children, and pregnant and lactating women with certain exceptions. For example, foods, other than infant formula, represented or purported to be specifically for infants and children less than 4 years of age are not permitted to include declarations of percent DV for the following nutrients: Total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate and dietary fiber (Sec. 101.9(j)(5)(ii)(A)). There are additional exceptions to labeling for foods, other than infant formula, represented or purported to be specifically for infants and children less than 2 years of age. For example, these foods are also not permitted to declare calories from fat, calories from saturated fat, saturated fat, polyunsaturated fat, monounsaturated fat and cholesterol on the Nutrition Facts label (Sec. 101.9(j)(5)(i)).

FDA regulations do not include DRVs or RDIs for nutrients, generally, for infants, children under 4 years of age, or pregnant and lactating women. However, there are requirements for a DRV for protein for children 4 or more years of age, and an RDI for protein for each of the following subpopulations: (1) Children less than 4 years of age; (2) infants; (3) pregnant women; and (4) lactating women (Sec. 101.9(c)(7)(iii)). In the preamble to the 1993 DRV/RDI final rule, we included a table listing RDIs for various nutrients for these subpopulations, based on the 1968 NAS RDAs (58 FR 2206 at 2213). These RDIs also appear in FDA's Food Labeling Guide (Ref. 144) and we are aware that some manufacturers use these RDIs in labeling foods represented or purported to be specifically for these subpopulations.

We are reconsidering the requirements for the labeling of foods, other than infant formula, represented or purported to be specifically for infants, children under 4 years of age, and pregnant and lactating women, in light of current recommendations in consensus reports and proposed changes to the Nutrition Facts label discussed in sections II.A. to II.J., and comments to the 2007 ANPRM. We are proposing various changes, which we discuss in this document.

1. Age Range for Infants and Young Children

FDA regulations use the age ranges ``less than 2 years of age'' and ``less than 4 years of age'' to establish labeling requirements for foods represented or purported to be specifically for infants and young children (Sec. 101.9(j)(5)). The 2007 ANPRM did not ask for comments on this issue, but several comments (Ref. 47) recommended that we change the current age categories to infants 7 to 12 months and young children 1 through 3 years (13 through 48 months), consistent with the age ranges used in the IOM's age-specific DRI recommendations.

In general, we consider it appropriate to adopt the same age categories as those used in the IOM DRIs for infants and children because our proposed DVs are based on these age-specific DRIs. With respect to the infant category, the nutritional requirements of infants 0 to 6 months should be met almost exclusively by breast milk or infant formula (Refs. 145 and 146). Therefore, regulations for the labeling of foods, other than infant formula, represented or purported to be specifically for infants 0 to 6 months of age are not necessary or appropriate. However, infants are transitioning to eating solid foods by 7 through 12 months. There are a number of foods in the marketplace identified for this age group. Therefore, we are proposing a separate category of foods represented or purported to be

Page 11934

specifically for infants 7 through 12 months.

With respect to children 1 through 3 years of age, using the DRI age range would result in infants no longer being the lower end of the age range in the category of infants and children less than 2 years and less than 4 years of age as specified in Sec. 101.9(j)(5). Young children who are 1 year of age would be the lower end of the age range. Assigning DVs for children 1 through 3 years of age would ensure consistency with the 1 through 3 year toddler age category established for RACCs specified in Sec. 101.12(a)(2). Moreover, because the growth velocity in height is most similar for children 1 through 3 years of age, we consider it appropriate to revise the age range to include children of these ages into a single category for food labeling purposes (Ref. 15).

Therefore, we are proposing to revise the exceptions for requirements for nutrition labeling provided in Sec. 101.9(j)(5)(i) and the exception to the requirement for the format used for nutrient information on food labeling in Sec. 101.9(d)(1) for foods represented or purported to be specifically for infants and children less than 4 years of age. Specifically, we are proposing to replace the current category of infants and children less than 4 years with infants 7 through 12 months and children 1 through 3 years of age.

2. Mandatory Declaration of Calories and Statutorily Required Nutrients

Currently, foods, other than infant formula, represented or purported to be specifically for infants and children less than 4 years must declare statutorily required nutrients, including calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, sugars, dietary fiber, and protein. For foods, other than infant formula, represented or purported to be for infants and children less than 2 years, the declaration of certain statutorily required nutrients, which include calories from fat, saturated fat, and cholesterol, is not required or permitted (Sec. 101.9(j)(5)(i)).
1. Declaration of Saturated Fat and Cholesterol--One comment to the 2007 ANPRM noted that the diet of U.S. infants is nutritionally adequate with negligible risk of nutrient deficiency and recommended continuing to require the declaration of calories and the amount of total fat, total carbohydrate, dietary fiber, sugars, and total protein on the Nutrition Facts label of foods for infants. Another comment supported mandatory declaration of saturated fat on food products for children less than 2 years of age.
  
  As discussed in section II.K.1., we are proposing new categories of infants 7 through 12 months and children 1 through 3 years of age. We are considering, in this proposed rule, whether there is a need to require or permit the declaration of calories from fat, saturated fat, and cholesterol in the labeling for foods represented or purported to be specifically for these subpopulations. In section II.A.1., we discuss our intent to revise Sec. 101.9(c)(1)(ii) to no longer require and not permit the declaration of calories from fat on the Nutrition Fact label. Therefore, if these proposed changes are finalized, the exceptions in Sec. 101.9(j)(5)(i) would no longer be needed.
  
  With respect to saturated fat and cholesterol, we did not require or permit the labeling of any fat or fatty acid on foods represented or purported to be specifically for children less than 2 years because consensus reports noted the need for the higher percentage of calories from fat for this subpopulation and that nutrient guidelines on fats, cholesterol and calories for children less than 2 years of age is inappropriate (58 FR 2079 at 2150). A recent consensus report continues to recommend that fat intake in infants less than 12 months of age should not be restricted; however, there is no discussion or recommendation about not providing nutrient guidelines for fat and cholesterol to children under the age of 2 years (Ref. 146). While fat is still considered to be an important source of calories for infants and young children, recent evidence suggests that a diet with saturated fat less than 10 percent of calories and cholesterol intake less than 300 mg/d can safely and effectively reduce the levels of total and LDL cholesterol in healthy children (Ref. 146). This type of diet may have similar effects when started in infancy and sustained throughout childhood into adolescence (Ref. 146). Furthermore, the 2010 DGA recommended that Americans 2 years of age and older consume less saturated fatty acids and less than 300 mg/d of cholesterol (Ref. 6).
  
  We tentatively conclude that, except for the declaration of calories from fat, the declaration of statutorily required nutrients that include saturated fat and cholesterol on the label of foods represented or purported to be specifically for infants 7 through 12 months and children 1 through 3 years of age should be mandatory because: (1) The declaration of calories and these nutrients is mandated by section 403(q) of the FD&C Act and we have no basis on which to not require or permit their declaration as discussed previously; and (2) these nutrients are essential in fostering growth and maintaining good health during a critical stage of human development and physiology (Ref. 147 p. 71) and, therefore, their mandatory declaration can assist in maintaining healthy dietary practices. Therefore, we are proposing to remove current Sec. 101.9(j)(5)(i) and revise and re-designate current Sec. 101.9(j)(5)(ii) as Sec. 101.9(j)(5)(i).
  
  We request comment on our tentative conclusions and any available relevant empirical research as to whether the proposed declaration of saturated fat and cholesterol for these subpopulations is likely to be confusing to consumers or otherwise result in restriction of fat intakes among infants 7 through 12 months or children 1 through 3 years of age.
  
  Currently, foods consumed by pregnant and lactating women must declare statutorily required nutrients, including calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, sugars, dietary fiber, and protein. Women of reproductive age consume the same foods as the general population and, in general, continue consuming similar foods during pregnancy and lactation. We tentatively conclude that, except for the declaration of calories from fat, the declaration of statutorily required nutrients should be mandatory because the declaration of calories and these nutrients is mandated by section 403(q) of the FD&C Act and we have no basis on which to not require or permit their declaration as discussed previously.
  
  Accordingly, we are proposing to require the mandatory declaration of calories, and the amount of total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and protein on foods represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women, and permit the declaration of calories from saturated fat such that these nutrients would be subject to the same requirements applicable to foods for the general population.
  
  A comment to the 2007 ANPRM requested that we permit the use of a footnote statement about not limiting fat intake on foods represented or purported to be specifically for infants and children less than 2 years to enable consumers to make informed choices, should the Agency decide to propose the mandatory declaration of saturated fat for infants and children less than 2
  
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  years. The comment noted that saturated fat should not be limited in the diets of children less than 2 years of age. The comment provided no consumer data about such a footnote statement. At this time, we are not proposing to require a footnote stating that total fat and other types of fat should not be limited in infants and children less than 2 years in response to this comment. However, we request comments and information on how consumers would understand and use the amount of saturated fat and cholesterol declared on the Nutrition Facts label, as well as on the need for an explanatory footnote to accompany the declaration of saturated fat and cholesterol, on foods represented or purported to be specifically for infants 7 through 12 months or children 1 through 3 years.
2. Percent DV Declaration--Currently, the percent DV declaration is not permitted on the food label for foods, other than infant formula, represented or purported to be specifically for infants and children less than 4 years (which includes infants and children less than 2 years) for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber (Sec. 101.9(j)(5)(ii)). Percent DV is required for protein and vitamins and other minerals. We tentatively conclude that it is appropriate to require declarations of percent DV for those nutrients for which we are establishing a DRV or RDI for infants 7 to 12 months, for children 1 through 3 years of age, and for pregnant and lactating women (see the discussion in this document for the nutrients in each subpopulation for which FDA is establishing a DRV or RDI). This change is reflected in re-designated Sec. 101.9(j)(5)(i). The percent DV, as discussed in section II.B.3., provides information in a manner which enables consumers to understand the relative significance of nutrition information in the context of a total daily diet.
  
  One comment to the 2007 ANPRM suggested that the percent DV declaration for protein should be voluntary for all infant products, unless a claim is made for protein because protein intake and quality appear to be adequate for infants (Refs. 148 and 149). As we previously stated, protein is of critical importance in maintaining good health because it supplies essential amino acids and is a principal source of calories along with fat and carbohydrate (55 FR 29487 at 29499). Current evidence suggests that protein intake is adequate in infants and young children and the majority of protein sources in their diets constitute high quality protein sources (Ref. 150). However, the level and quality of protein present in a food remain an important consideration in food selection for infants because infant diets are derived from a limited number of foods (55 FR 29487 at 29499). For example, at 6 to 11 months of age, approximately 46 percent of the total protein intake comes from sources other than breast milk, formula, and cow's milk (e.g., baby foods and meats) (Ref. 149). The percentage increases at ages 12 to 24 months to 63 percent (Ref. 149). Calculating the percent DV for protein incorporates a measure of protein quality (e.g., a corrected protein amount obtained from the protein digestibility-corrected amino acid score) (Sec. 101.9 (c)(7)(i)). Thus, the percent DV declaration is a useful tool to indicate protein quality to the consumer. As such, we disagree that the percent DV declaration for protein should be voluntary. Because of the importance of adequate high quality protein in the diets of infants and young children, we tentatively conclude that the percent DV declaration for protein is necessary to assist consumers in maintaining healthy dietary practices among infants and young children 1 through 3 years of age.
  
  3. Declaration of Non-Statutory Nutrients Other Than Essential Vitamins and Minerals
  
  Foods, other than infant formula, represented or purported to be specifically for infants and children less than 2 years of age are not permitted to declare calories from saturated fat and the amount of polyunsaturated fat and monounsaturated fat (Sec. 101.9(j)(5)(i)), whereas soluble fiber, insoluble fiber, and sugar alcohols can be voluntarily declared. Polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohols can be voluntarily declared on the label of foods represented or purported to be specifically for children 2 through 4 years of age, and pregnant and lactating women.
  
  Section I.C. includes a discussion of the factors that we consider in proposing the requirements for declaration of non-statutorily required nutrients on the Nutrition Facts label of foods (e.g., polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohols). These factors include the availability of information from consensus reports, including evidence for the public health significance of a nutrient. Consensus reports that provide information about the relationship between nutrients and chronic diseases, heath-related conditions, or health-related physiological endpoints are generally not available for infants 7 to 12 months. Therefore, for foods represented or purported to be for these infants, we are not considering consensus reports in the way described in section I.C., but, rather, we are considering other types of information that are available from consensus reports applicable to this subpopulation. With respect to certain nutrition declaration requirements, we determined there was not sufficient evidence to propose a change to the regulations. In addition, we determined that, in some cases, there is not sufficient evidence to propose different requirements for foods represented or purported to be specifically for infants 7 through 12 months than for foods represented or purported to be specifically for children 1 through 3 years of age.
  
  For foods represented or purported to be specifically for children 1 through 3 years of age and pregnant and lactating women, we considered the factors in section I.C. to determine whether to propose the mandatory or voluntary declaration of non-statutory nutrients. Most advisory consensus and policy reports on which we rely for the general population apply to children 2 years of age and older and pregnant and lactating women, unless noted otherwise (e.g., 2010 DGAC and health claims (Sec. 101.14(e)(5)). While the recommendations in these reports are for 2 years of age and older, we are using the information in these consensus reports for considering the factors in section I.C. for children 1 through 3 years of age because it is not expected that the role of these nutrients in health would be markedly different between 1 and 2 year olds. Moreover, the IOM has established the DRI ranges for 1 to 3 year olds.
3. Voluntary Declaration of Calories From Saturated Fat, and the Amount of Polyunsaturated and Monounsaturated Fat--For infants 7 to 12 months, there are no specific recommendations provided about calories from saturated or polyunsaturated or monounsaturated fat. However, as discussed previously, there is some evidence to suggest that reduction of total and LDL cholesterol levels can occur with reducing saturated fat intake to less than 10 percent of calories, beginning in infancy and sustained throughout childhood into adolescence (Ref. 146). Furthermore, consensus reports provide no discussion or recommendation about not providing nutrient guidelines for fatty acids to children under the age of 2 years and there is no evidence to suggest that infants 7 through 12 months of age would be different than children 1
  
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  through 3 years of age. Therefore, we tentatively conclude that there is no basis to continue to provide an exception that does not permit the declaration of calories from saturated fat, or polyunsaturated and monounsaturated fats on foods represented or purported to be specifically for infants and children less than 2 years of age.
  
  Quantitative intake recommendations are not available from relevant U.S. consensus reports for monounsaturated and polyunsaturated fats for children 1 through 3 years of age or pregnant and lactating women. 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. 6). Because monounsaturated and polyunsaturated fats have public health significance when they replace saturated fat, consistent with the factors we consider for voluntary declaration discussed in section I.C., we tentatively conclude that not permitting the declaration of polyunsaturated and monounsaturated fat on foods represented or purported to be specifically for children less than 2 years of age in Sec. 101.9(j)(5)(i) is no longer necessary.
  
  Therefore, we are proposing to revise Sec. 101.9(j)(5)(i) to remove the exceptions for the declaration of calories from saturated fat, and the amount of polyunsaturated fat and monounsaturated fat on foods represented or purported to be specifically for children less than 2 years of age. If finalized, these declarations would be the same as the proposed voluntary declarations for foods for the general population (see sections II.A.2, II.B.4, and II.B.5., respectively).
4. Voluntary Declaration of Soluble Fiber, Insoluble Fiber, and Sugar Alcohols--As discussed in section II.D., while quantitative intake recommendations are lacking for soluble fiber, insoluble fiber, and sugar alcohols, there is well established evidence for the role of these nutrients in chronic disease risk, risk of a health-related or a physiological endpoint (i.e., CHD, laxation or dental caries) (Ref. 66 and Sec. Sec. 101.76, 101.77, 101.80, and 101.81). There is no evidence to suggest that the role of these nutrients would be different among infants 7 through 12 months, children 1 through 3 years of age, or pregnant and lactating women compared to the general population.
  
  Accordingly, we are not proposing any changes to the provisions for the voluntary declaration of soluble fiber, insoluble fiber, and sugar alcohols on the label of foods represented or purported to be specifically for infants 7 to 12 months, children 1 through 3 years of age, or pregnant and lactating women.
5. Mandatory Declaration of Trans Fat--Trans fat is required to be declared on the Nutrition Facts label and regulations do not provide exceptions for foods represented or purported to be specifically for infants, young children, or pregnant and lactating women. One comment to the 2007 ANPRM recommended eliminating mandatory trans fat labeling when total fat is declared as 0 g in the Nutrition Facts label of foods for infants.
  
  As explained in section II.B.3., we are not proposing any changes to the mandatory declaration of trans fat in the labeling of foods intended for the general population. The relationship between the consumption of trans fat and risk of CHD is well established (Refs. 6 and 49). Cardiovascular disease is also known to begin in childhood (Refs. 146 and 151). Thus, we tentatively conclude that declaration of trans fat continues to be necessary to assist consumers in maintaining health dietary practices, including among infants, young children, and pregnant and lactating women.
  
  Trans fat declaration is voluntary when the total fat content of a food is less than 0.5 g (Sec. 101.9(c)(2)(ii)). In addition, if a manufacturer does not declare the trans fat content because total fat amount is less than 0.5 g, then the statement ``Not a significant source of trans fat'' must be placed at the bottom of the table of nutrient values. This statement indicates why information that is required to be declared is omitted and provides necessary information to assist in making healthy dietary choices (55 FR 29487 at 29502). The statement is also helpful in minimizing space requirements for labels that do not meet the simplified label format requirements (58 FR 2079 at 2084).
  
  Therefore, we are not proposing any changes to the mandatory declaration of trans fat on the label of foods represented or purported to be specifically for infants, children 1 through 3 years of age, or pregnant and lactating women.
6. Mandatory Declaration of Added Sugars--Whereas FDA regulations do not provide for the declaration of added sugars on the Nutrition Facts label, as explained in section II.D.3., we are proposing to require the mandatory declaration of added sugars on the Nutrition Facts label. The 2010 DGA provides recommendations for consumption of added sugars for the U.S. population 2 years of age and older, but not for infants and children under age two. However, we would not expect the recommendations for added sugars for a 2 year old to be different from that of a 1 year old because we do not expect the role of added sugars in health to be markedly different between children 1 and 2 year olds. Moreover, the IOM has established DRI ranges for 1 through 3 year olds because growth velocity is most similar during this age range (Ref. 15). Further, mandatory declaration of added sugars would be important for foods for infants 7 through 12 months, as it is for the general population, to assist consumers in choosing nutrient-dense foods for infants 7 through 12 months during this phase of accelerated growth and development. Moreover, we do not have any information that providing added sugars information on the Nutrition Facts label of foods marketed to the subpopulations of infants 7 through 12 months and children 1 to 3 years of age would not assist in maintaining healthy dietary practices.
  
  Therefore, we are proposing the mandatory declaration of added sugars on the Nutrition Facts label of foods represented or purported to be specifically for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women. We request comment on our tentative conclusion.
7. Voluntary Declaration of Fluoride--FDA regulations do not provide for the declaration of fluoride on the Nutrition Facts label of any foods. For the reasons discussed in section II.G., we are proposing to permit voluntary declaration of fluoride on the labeling of foods for the general population based on the factors we consider in section I.C. and fluoride's role in reducing the risk of dental caries. Because fluoride provides protection against dental caries by strengthening the tooth enamel before and after teeth appear (Ref. 90) and because excessive fluoride intake can cause dental fluorosis in young children (Ref. 92), we tentatively conclude that the declaration of fluoride on foods represented or purported to be specifically for children 1 through 3 years of age, and pregnant and lactating women can assist in maintaining healthy dietary practices. While evidence on dental caries is lacking for infants 7 through 12 months of age, there is no reason to expect the role of fluoride in the protection against dental caries to be different from other age groups. Therefore, proposed Sec. 101.9(c)(5) would permit the voluntary declaration of fluoride on foods
  
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  represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women.
  
  4. Declaration of Essential Vitamins and Minerals
  
  The declarations of vitamin A, vitamin C, calcium, and iron are required on the Nutrition Facts label, and there are no specific exceptions to this requirement for foods represented or purported to be specifically for infants and children less than 2 years and children less than 4 years of age, and pregnant and lactating women. We considered the factors for mandatory and voluntary declaration of nutrients discussed in section I.C., as applicable, to determine whether to propose to require or permit certain vitamins and minerals in the labeling of foods for infants, children, and pregnant and lactating women.
  
  The AIs for essential vitamins and minerals (and RDAs for iron and zinc) for infants 7 to 12 months of age are based on the average intake of nutrients that infants consumed from breast milk, complementary foods, and/or supplements with the understanding that these sources provided sufficient amounts of the nutrients to meet the infant's daily needs (Refs. 18, 22, and 23). Therefore, the AIs (as well as the RDAs for iron and zinc) for infants were not based on endpoints related to chronic disease risk, or a health-related conditions or health-related physiology. Furthermore, because the AI represents intakes that are considered adequate and are based on average nutrient intakes from breast milk, foods, and/or supplements, the presence of an AI indicates that there is not a public health concern about adequate intake of that nutrient. Therefore, we could not determine public health significance for a nutrient during infancy based on an AI for infants. Instead, we considered the importance of the nutrient in establishing healthy dietary practices during infancy for later in life, as well as the relevant available information for children 1 through 3 months of age that may also be applicable to infants. For nutrients with an RDA for infants 7 through 12 months of age (i.e., iron and zinc), we considered the factors for mandatory and voluntary labeling described in section I.C. to determine whether to propose mandatory or voluntary labeling for the nutrient.
  
  For the declaration of essential vitamins and minerals for children 1 through 3 years of age and pregnant and lactating women, we propose the same considerations based on the same rationale as we set forth and proposed for the general population because scientific and policy considerations are generally the same and the DGA recommendations apply to Americans 2 years of age and older. While NHANES data were collected in lactating women, these data are not included in our analysis in this document because the sample size of lactating women was small and, thus, we could not reliably estimate mean intake and status of this population. However, the conclusions made about nutrient inadequacy during pregnancy are applied to lactating women since the needs of essential vitamin and minerals are increased for both pregnant and lactating women. Therefore, we are proposing the requirements related to essential vitamins and minerals in the labeling of foods for pregnant women and those for foods for lactating women should be the same. Accordingly, we are proposing to remove the provision in Sec. 101.9(c)(8)(i) that requires separate declaration of percent DVs based on both RDI values for pregnant women and for lactating women in the labeling of foods represented or purported to be for use by both pregnant and lactating women.
  
  We did not ask questions related to this issue in the 2007 ANPRM, but received some comments which we considered in reaching our tentative conclusions discussed in this document.
8. Mandatory Declaration of Calcium and Iron--We are not proposing any changes to the mandatory declaration of calcium on foods for the general population (see section II.H.1.). The AI for calcium for infants 7 through 12 months of age is based on average calcium consumption of these nutrients, rather than chronic disease risk, health related-condition, or physiological endpoints (Ref. 152). For children 1 through 3 years of age, and pregnant and lactating women, the RDAs for calcium are based, in part, on bone health (Ref. 22). One comment to the 2007 ANPRM recommended mandatory declaration of calcium and iron for labeling of foods for young children.
  
  Our analysis of NHANES 2003-2006 data estimated that infants ages 7 to 12 months have usual calcium intakes above the AI (table 3). Our analysis of NHANES 2003-2006 estimated that about 12 percent of children 1 through 3 years of age had usual intakes of calcium below the EAR, based on intakes from conventional foods only (table 4). The percentage did not change when supplements were included. We are unable to consider biomarker data because sensitive biochemical indicators reflecting calcium nutritional status are lacking. Promoting the development of eating patterns that are associated with adequate calcium intake later in life is important (Ref. 153) given that calcium intakes are inadequate for the majority of the population (see table 1). Intakes of calcium, which is necessary for growth and bone development, are inadequate among children. Similar to the general population, approximately 20 percent of pregnant women consumed less than the EAR for calcium from conventional foods as well as from conventional foods and supplements (table 5).
  
  Consistent with the factors we consider for essential vitamins and minerals (see section I.C.), we tentatively conclude that calcium is a nutrient of public health significance for children 1 through 3 years of age, and pregnant and lactating women. Because calcium is important for growth and development, we tentatively conclude that calcium is of public health significance for infants 7 through 12 months of age. As such, we agree with the comment that recommended mandatory declaration of calcium for foods purported to be specifically for young children.
  
  We are not proposing any changes to the mandatory declaration of iron on foods for the general population (see section II.H.1.). Although the EAR and RDA are based on daily iron requirements and not directly on chronic disease risk, iron deficiency is associated with delayed normal infant motor function (i.e., normal activity and movement) and mental function (i.e., normal thinking and processing skills) (Ref. 100). Our analysis of NHANES 2003-2006 data estimated that about 18 percent of infants ages 7 to 12 months have usual iron intakes below the EAR, based on intakes from conventional foods only and 4 percent of infants ages 7 to 12 months have usual iron intakes below the EAR based on intakes from conventional foods and supplements (table 3).
  
  For children 1 through 3 years of age, about 1 percent of children have usual iron intakes below the EAR, based on intakes from conventional foods only and 0.4 percent of children have usual iron intakes below the EAR based on intakes from conventional foods and supplements (table 4). The IOM set the EAR by modeling components of iron requirements. While total iron intakes appear adequate, the prevalence of iron deficiency in children ages 1 to 2 years has been reported to be 14.4 percent and the prevalence of iron deficiency anemia in children younger than 5 years has been reported to be 14.9 percent (Refs. 74 and 154). Therefore, we agree with the comment that recommended
  
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  mandatory declaration of iron in the labeling of foods for young children.
  
  Inadequate iron intakes during pregnancy are also of public health significance because of the adverse effects for both the mother and the fetus (such as maternal anemia, premature delivery, low birth weight, and increased perinatal infant mortality) (Ref. 15). Our analysis of data collected by NHANES 2003-2006 estimated that 5 percent of pregnant women 14 to 50 years of age had usual iron intakes below the EAR based on intakes from conventional foods and 4 percent of pregnant women 14 to 50 years of age had usual iron intakes below the EAR based on intakes from conventional foods and supplements (table 5). The EAR for iron for pregnant women was based on estimates of iron stores needed during the first trimester (Ref. 100). Our analysis of 2003-2006 NHANES data indicate that among pregnant women aged 12 to 49 years, 25 percent were iron deficient and 13 percent had iron deficiency anemia. For the purpose of this analysis, iron deficiency was based on two out of three cutoffs of iron deficiency variables (transferrin saturation, serum ferritin, and erythrocyte protoporphyrin) (Ref. 155). While intakes appear adequate for most individuals, the prevalence of iron deficiency and iron deficiency anemia indicates that iron deficiency is of public health significance for pregnant women. As discussed in section II.H.1., iron is of public health significance for women of childbearing age. Therefore, we tentatively conclude that iron is a nutrient of public health significance for lactating women as well.
  
  Because calcium and iron have quantitative intake recommendations and are considered to have public health significance for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women, we tentatively conclude that the declaration of calcium and iron is necessary to assist consumers in maintaining healthy dietary practices. Accordingly, proposed Sec. 101.9(c)(8)(ii) would require the mandatory declaration of calcium and iron on foods represented or purported to be specifically for infants 7 to 12 months, children 1 through 3 years of age, or pregnant and lactating women; we are not providing for any exceptions for these subpopulations from the requirement for declaration of calcium and iron applicable to foods for the general population.
9. Mandatory Declaration of Vitamin D and Potassium--We are proposing to require the declaration of vitamin D on foods for the general population (see section II.H.1.). The AI for vitamin D for infants was based on maintenance of serum 25(OH)D concentrations at a level to achieve and maintain serum 25(OH)D concentrations above a defined level (30 to 50 nmol/L) in order to meet the needs of the majority of the infants and support bone accretion (Ref. 22). DRIs (EAR and RDA) for vitamin D were established at a level to achieve and maintain serum 25(OH)D concentrations above a defined level (40 to 50 nmol/L) in order to maintain bone health for children 1 through 3 years of age and pregnant women (Ref. 22).
  
  Serum 25(OH)D data were not available in NHANES 2003-2006 for infants ages 7 to 12 months. Our analysis of NHANES 2003-2006 dietary data shows that 28.7 and 33.6 percent of infants ages 7 to 12 months have usual vitamin D intakes above the AI from conventional foods and conventional foods plus supplements, respectively (table 3).
  
  Our analysis of NHANES 2003-2006 data shows that about 3 percent of children 1 through 3 years of age had serum 25(OH)D levels below 40 nmol/L (a level set by IOM as equivalent to EAR, see section II.H.2.a). Analysis of NHANES 2005-2008 dietary data shows that, assuming minimal sun exposure, about 82 percent of these children had usual vitamin D intakes below the EAR from conventional foods only and 66 percent had usual intakes below the EAR from conventional foods and supplements (table 4). For pregnant women, 15 percent had serum 25(OH)D levels below 40 nmol/L, while about 88 percent of pregnant women had usual vitamin D intakes below the EAR from conventional foods only and 48 percent had usual intakes below the EAR from conventional foods and supplements (table 5). In addition to data on vitamin D status and intake, we considered other scientific and policy considerations, such as the importance of the nutrient in establishing healthy dietary practices for later life for children 1 through 3 years of age and pregnant and lactating women. Vitamin D has a role in bone health through calcium absorption and uptake by bones (Ref. 22). Deficiency results in inadequate bone mineralization or demineralization of the skeleton including rickets, osteomalacia, and osteoporosis (Ref. 22). Therefore, we tentatively conclude that vitamin D has public health significance in children 1 through 3 years of age and pregnant women based on the high prevalence of inadequate intakes of vitamin D and its important role in bone development and health (Ref. 22). In addition, in 2008, we authorized a health claim for calcium and vitamin D intake and reduced risk of osteoporosis (Sec. 101.72), signifying vitamin D's critical role in the risk reduction of this chronic disease for individuals 2 years of age and older. We also tentatively conclude that vitamin D is of public health significance for infants 7 through 12 months of age based on its importance for growth and development during infancy.
  
  We are proposing to require the declaration of potassium on foods for the general population (see proposed Sec. 101.9(c)(8)(ii) and section II.H.1.). The AI for infants is based on average potassium intake from breast milk and/or complementary foods. The AI for the other life-stage and gender groups is set at a level to maintain blood pressure, reduce the adverse effects of sodium chloride intake on blood pressure, and reduce the risk of recurrent kidney stones (Ref. 21).
  
  Our analysis of NHANES 2003-2006 shows that 99 percent of infants ages 7 to 12 months have usual potassium intakes above the AI (table 3). Only 7 percent of children 1 through 3 years of age (table 4) and 4 percent of pregnant women (table 5) had usual potassium intakes above the AI from conventional foods or conventional foods plus dietary supplements, indicating that the adequacy of intakes is very low. In the absence of a sensitive biochemical indicator of potassium nutritional status, we could not consider biomarker data to inform the determination of prevalence of potassium deficiency. In 2000, a FDAMA notification for a health claim about potassium, blood pressure, and stroke was submitted to us under section 403(r)(2)(g) of the FD&C Act (Ref. 114). Foods may bear the following claim ``Diets containing foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke,'' on the label or labeling of any food product that meets the eligibility criteria described in the notification and meets the general requirements for a health claim (Sec. 101.14(e)(6)). This health claim pertains to the general population 2 years of age and older. Thus, we recognize the importance of potassium in the risk reduction of these chronic diseases for children 2 years of age and older. Therefore, we tentatively conclude that potassium is of public health significance to children 1 through 3 years of age, and pregnant and lactating women. We have no basis to conclude that the public health significance of potassium among infants 7 through 12 months of age would be different than the science-based evidence for children 1 through 3 years of age and consider it important to
  
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  establish healthy dietary practices for later life. Because of the benefits of adequate potassium intake in lowering blood pressure, data indicating low likelihood of potassium adequacy, and importance of establishing healthy dietary practices for later life, we tentatively conclude that potassium is a nutrient of public health significance for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women.
  
  We are proposing to require the labeling of vitamin D and potassium on foods represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, or pregnant and lactating women based on the quantitative intake recommendations for vitamin D and potassium and the public health significance of these nutrients. Consequently, we are not providing for any exceptions for these subpopulations from the general requirement for declaration of vitamin D and potassium in proposed Sec. 101.9(c)(8)(ii).
10. Voluntary Declaration of Vitamin A and Vitamin C--We are proposing to no longer require the declaration of vitamin A and vitamin C on foods for the general population (see section II.H.1.). None of the DRIs (AIs or RDAs) for vitamin A were based on chronic disease risk, a health related-condition, or health-related physiological endpoints. One comment to the 2007 ANPRM stated that intakes of vitamins A and C among young children appear to be adequate (Ref. 148) and supported voluntary declaration of these nutrients in the labeling of foods for this subpopulation.
  
  Our analysis of data from NHANES 2003-2006 shows that less than 2 percent of children had usual vitamin A intakes below the EAR from conventional foods or conventional foods plus dietary supplements (table 4). While 36 percent of pregnant women had usual intakes below the EAR from conventional foods and 22 percent had usual intakes below the EAR for conventional foods plus dietary supplements, only 1 percent of these women had serum vitamin A levels that were considered to be indicative of a vitamin A deficiency (table 5).
  
  While quantitative intake recommendations are available for vitamins A and C, neither of these vitamins is considered to have public health significance for children 1 through 3 years of age and pregnant women. There is a very low prevalence of inadequate intakes of vitamins A and C or inadequate status among children 1 through 3 years of age or pregnant women, and we have no evidence to indicate that this would be different for infants or lactating women. Therefore, we tentatively conclude that vitamin A and vitamin C are not of public health significance among infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women. Thus, we agree with a comment that supported voluntary declaration of vitamins A and C in the labeling of foods for young children. An AI for older infants was provided by the IOM with the assumption that vitamin A and vitamin C intakes are adequate during infancy. Accordingly, similar to our proposal for voluntary declaration of vitamins A and C in the labeling of foods for the general population, we are proposing to permit, but not require, the declaration of vitamin A and vitamin C on foods represented and purported to be specifically for infants 7 through 12 months, children 1 through 3 years of age, or pregnant and lactating women. As for other voluntary nutrients, the declaration of these nutrients would be required when these nutrients are added as nutrient supplements or claims are made about them (proposed Sec. 101.9(c)(8)(ii)).
11. Voluntary Declaration of Other Vitamins and Minerals--As discussed in section II.H.3., for the general population, we are proposing to permit the voluntary declaration of vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and choline (proposed Sec. 101.9(c)(8)(ii)). Vitamins and minerals other than iron, calcium, vitamin D and potassium for infants either have DRIs that are not based on chronic disease risk, heath-
  
  related conditions, or health-related physiological endpoints or are not shown to have public health significance due to the prevalence of a clinically relevant nutrient deficiency. For infants 7 to 12 months, children 1 through 3 years of age, and pregnant and lactating women, we tentatively conclude that the essential vitamins and minerals, other than iron, calcium, vitamin D and potassium, do not have public health significance and there is no basis for the declaration of these nutrients to be different from that proposed for the general population. Accordingly, proposed Sec. 101.9(c)(8)(ii) would allow the voluntary declaration of vitamin E, vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, niacin, folate, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and choline on foods represented or purported to be specifically for infants 7 to 12 months, children 1 through 3 years of age, or pregnant and lactating women, under the requirements of this section, unless they are added to foods as a nutrient supplement or if the label or labeling makes a claim about them, in which case the nutrients would have to be declared.
  
  5. DRVs and RDIs for Infants 7 Through 12 Months of Age
  
  FDA regulations do not include DRVs or RDIs for nutrients for infants 7 through 12 months of age, except an RDI for protein of 14 g for infants. We reviewed scientific evidence and recommendations, as well as comments in response to the 2007 ANPRM to consider establishing DRVs and RDIs for nutrients for infants 7 through 12 months of age and to consider revisions to the current RDI for protein.
12. Calories--We have not established a reference calorie intake level for infants and children less than 2 years of age. For the general population, a reference calorie intake level is necessary when using a percent of calories approach to calculating the DRV for nutrients, such as total fat and carbohydrate. There is no quantitative intake recommendation for calories for infants and we are not aware of other scientific data and information on which we could rely to establish that level. Therefore, we are not proposing to establish a reference calorie intake level for infants 7 to 12 months.
13. Total Fat--The IOM set an AI of 30 g/d for fat for infants 7 through 12 months of age based on the average intake of human milk and complementary foods (Ref. 49). There was no AI available in 1993. The current AI provides a basis on which we can determine an appropriate DRV for total fat for this subpopulation that can assist consumers in maintaining healthy dietary practices among this subpopulation. Therefore, we are proposing to amend Sec. 101.9(c)(9) to include a DRV of 30 g for fat for infants 7 through 12 months of age.
14. Saturated Fat, Trans Fat, Cholesterol, Dietary Fiber and Sugars--There are no quantitative intake recommendations from U.S. consensus reports available for saturated fat, trans fat, cholesterol, dietary fiber, and sugars for infants. We are not aware of other scientific data and information on which we could rely to establish DRVs for these nutrients for infants 7 through 12 months of age. Accordingly, we are not proposing to establish DRVs for these nutrients for infants 7 through 12 months of age.
  
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15. Polyunsaturated Fat, Monounsaturated Fat, Insoluble Fiber, Soluble Fiber, Insoluble Fiber, Added Sugars, and Sugar Alcohols--
  
  Quantitative intake recommendations from U.S. consensus reports are not available for polyunsaturated fat, monounsaturated fat, insoluble fiber, soluble fiber, added sugars, or sugar alcohols for infants. We are not aware of other scientific data and information on which we could rely to establish DRVs for these nutrients for this subpopulation. Accordingly, we are not proposing to establish DRVs for these nutrients for infants 7 through 12 months of age.
16. Total Carbohydrate--The IOM has set an AI of 95 g/d for carbohydrates for infants 7 through 12 months of age based on the average intake of human milk and complementary foods (Ref. 68). There was no AI available in 1993. The current AI provides a basis on which we can determine an appropriate DRV for total carbohydrate for this subpopulation that can assist consumers in maintaining healthy dietary practices among this subpopulation. Therefore, we are proposing to amend Sec. 101.9(c)(9) to establish a DRV of 95 g for total carbohydrate for infants 7 through 12 months of age.
17. Protein--The DV for protein for infants is an RDI, rather than a DRV. Before 1993, we established the RDIs for protein for all age groups based on the 1989 RDA. In 1993, we changed the RDI for protein for the general population to a DRV in response to comments that suggested the DV for protein should be consistent with the ``percent of calories'' approach used for the other energy-yielding macronutrients, total fat and total carbohydrate (58 FR 2206 at 2216). However, we retained the RDI for infants, and based it on the highest 1968 RDA value (14 g/d for infants), to be consistent with a population-coverage approach (58 FR 2206 at 2216).
  
  We find no reason to change the approach of using the RDI for infants 7 through 12 months. However, we consider it appropriate to revise the RDI to rely on current quantitative intake recommendations. In 2002, the IOM established an RDA for infants 7 through 12 months of 1.2 g/kg/d based on nitrogen balance studies and using a reference body weight of 9 kg (Ref. 84). This reference body weight is also consistent with current growth charts for infants (Ref. 156). The value 1.2g/kg/
  
  gx9 kg equals 10.8 g/d or a rounded value of 11 g/d. In addition, protein intakes are well above the current and proposed RDI. Mean protein intake for infants 6 to 11 months of age was 22 g/d (Ref. 150), well above the RDA of 11 g/d. Accordingly, we are proposing to revise Sec. 101.9(c)(9) to establish an RDI of 11 g for protein for infants 7 through 12 months of age.
18. Sodium--For the general population, we are proposing to establish a DRV for sodium based on the IOM's UL (section II.F.). The IOM did not set a UL for sodium for infants 7 through 12 months of age due to insufficient data on adverse effects of chronic overconsumption in this age group (Ref. 10). We are not aware of other scientific data and information on which we could rely to establish a DRV for sodium for this subpopulation. Therefore, we are not proposing a DRV for sodium for infants 7 through 12 months of age.
19. Fluoride--As discussed in section II.G., although the IOM set an AI for fluoride, the AIs for infants 7 through 12 months and children 1 through 3 years are close to the EPA benchmarks for total fluoride intake (Ref. 92). We are not proposing a DRV for fluoride for use in the labeling of foods for the general population because of a concern about excess intakes associated with dental fluorosis (section II.G.). Therefore, we tentatively conclude that a DRV for fluoride is not warranted for infants 7 through 12 months. The use of such a DRV to calculate percent DV may have the unintended effect of consumers selecting foods with higher fluoride amounts, which are not necessary or advised. Accordingly, we are not proposing to establish a DRV for fluoride for infants 7 through 12 months of age.
20. Vitamins and Minerals--As noted previously in the introduction to section II.K., while not included in current regulations, the preamble to the 1993 DRV/RDI final rule provides a table listing RDIs for infants (58 FR 2206 at 2213), which is also provided in FDA's Food Labeling Guide (Ref. 144). We reviewed current quantitative intake recommendations for vitamins and minerals for infants and considered comments received in response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for vitamins and minerals to be established in regulations for infants 7 through 12 months of age.
  
  We consider it important to establish RDIs for infants 7 through 12 months of age because infants in this age range transition from a diet of mostly breast milk and infant formula to infant cereal and baby foods (Ref. 147 p. 71) and labeling foods for this subpopulation with percent DV declarations can assist parents in making nutritious food choices. The DRIs (AIs and RDAs) provide a basis on which to determine RDIs for vitamins and minerals for this subpopulation. We consider it appropriate to use RDAs and, in the absence of RDAs, AIs to determine appropriate micronutrient RDIs for infants. While there is more certainty with RDAs than AIs, both RDAs and AIs are sufficient for setting RDIs, because they both represent intake levels that are expected to meet or exceed the nutrient needs of the majority of infants (Ref. 157).
  
  We also considered and rejected an approach, as suggested by a comment, where the highest reference value available would be used for each nutrient, irrespective of whether it is an RDI based on the 1968 RDAs, a current RDA, or a current AI. The IOM established DRIs based on scientific knowledge that update and supersede previous RDA recommendations. Because DRIs are available for infants 7 through 12 months of age, we are proposing to use these current quantitative intake recommendations (i.e., AIs and RDAs) for setting RDIs for infants.
  
  Accordingly, we are proposing to amend Sec. 101.9(c)(8)(iv) to include a listing of RDIs for vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B12, folate, choline, riboflavin, niacin, vitamin B6, calcium, iron, thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and potassium for infants 7 months through 12 months of age.
  
  We invite comment on the adequacy of the proposed RDIs for vitamins and minerals for older infants.
  
  6. DRVs and RDIs for Children 1 Through 3 Years of Age
  
  FDA regulations do not include DRVs or RDIs for nutrients for children 1 through 3 years of age, except an RDI for protein of 16 g for children less than 4 years of age. We reviewed scientific evidence and current recommendations, as well as comments in response to the 2007 ANPRM to consider establishing DRVs and RDIs for nutrients for this subpopulation and to consider revisions to the current RDI for protein.
21. Calories--We have not established a reference calorie intake level for nutrition labeling for children ages 1 through 3 years. Several comments to the 2007 ANPRM supported establishing a DV for calories specifically for young children 1 through 3 years of age. Citing the IOM and AAP/AHA caloric intake recommendations (Refs. 50 and 71), one comment recommended 1,050 calories as the DV for calories and supported
  
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  rounding it down to 1,000 calories to facilitate use by consumers.
  
  We consider it appropriate to establish a reference calorie intake level for children 1 through 3 years of age because, as discussed in this document, we are proposing to set DRVs using quantitative intake recommendations that are based on calories (e.g., total fat, saturated fat, and dietary fiber). Current recommendations from the IOM, AHA, AAP, and the 2010 DGA for caloric intake range from 800 to 900 calories/d for children 1 year old, approximately 1,000 calories/d for children 2 years of age, and from 1,000 to 1,200 calories/d for children 3 years of age (Refs. 6, 50, and 71) . We consider that an average of the range of these caloric intake recommendations (800 to 1,200 calories/d), i.e., 1,000 calories/d, provides a reasonable reference calorie intake level. Therefore, we are proposing to amend Sec. 101.9(c)(9) to provide a reference calorie intake level of 1,000 calories/d for children 1 through 3 years of age.
22. Total Fat--There is no DRV for total fat for children ages 1 through 3 years. One comment to the 2007 ANPRM recommended that 35 percent of the recommended 1,050 calories or 41 g/d of fat be used to as the DRV for fat because it is the midpoint of the AAP/AHA recommendation and the IOM Acceptable Macronutrient Distribution Range (AMDR) for 1 through 3 year olds. We agree that 35 percent of calories from fat for children 1 through 3 years of age, the midpoint of the IOM AMDR of 30 to 40 percent, serves as an appropriate basis on which to set the DRV for total fat. This approach to calculating the DRV for total fat is consistent with our proposed approach to setting the DRV for total fat for the general population. Thirty-five percent is also consistent with AHA and AAP recommendations that 30 to 40 percent of calories consumed by children 12 through 24 months of age and 30 to 35 percent of calories consumed by children 24 through 48 months of age should come from fat (Ref. 71). Therefore, we tentatively conclude that 35 percent of total calories from fat (i.e., 39 g using the proposed reference calorie intake level of 1,000 calories/d) is an appropriate DRV for total fat for children 1 through 3 years of age. Accordingly, we are proposing to amend Sec. 101.9(c)(9) to establish a DRV of 39 g for fat for children 1 through 3 years of age.
23. Saturated Fat, Trans Fat, and Cholesterol--There are no DRVs for saturated fat, trans fat, or cholesterol for children 1 through 3 years of age. Once comment to the 2007 ANPRM suggested using the midpoint of 10 to 15 percent of calories for saturated fat, 2 percent of calories for trans fat based on estimates of mean trans fat intake for the U.S. population 3 years of age and older, and less than or equal to 300 mg/d for cholesterol based on the 2005 DGA recommendation.
  
  Cardiovascular disease is known to begin in childhood (Refs. 146 and 151). The 2010 DGA recommends that Americans 2 years of age and older consume less than 10 percent of calories from saturated fat and less than 300 mg/d of cholesterol (Ref. 6). Based on these recommendations, we tentatively conclude that it is appropriate to set a DRV of 10 g for saturated fat, based on 10 percent of total calories from saturated fat and using the proposed reference calorie intake level of 1,000 calories/d which equals 11 g, rounded down to 10 g, and a DRV of 300 mg for cholesterol for children 1 through 3 years of age. The comment provided no rationale for using an upper range of 15 percent of calories from saturated fat. We have no information to indicate that applying the level of 10 percent of calories from saturated fat to this subpopulation is restrictive, as the comment asserted. Accordingly, we are proposing to amend Sec. 101.9(c)(9) to establish a DRV of 10 g for saturated fat and a DRV of 300 mg for cholesterol for children 1 through 3 years of age.
  
  Current recommendations from the IOM (Ref. 49) and 2010 DGA (Ref. 6) recommend keeping trans fat intake as low as possible but do not provide any specific appropriate levels of intake. Thus, consistent with our discussion in section II.B.3., we disagree with the comment that suggested setting a DRV for trans fat and, therefore, we are not proposing to establish a DRV for trans fat in response to this comment.
24. Polyunsaturated Fat, Monounsaturated Fat, Sugars, Added Sugars, Insoluble Fiber, Soluble Fiber, and Sugar Alcohols--There are no DRVs for polyunsaturated fat, monounsaturated fat, sugars, added sugars, insoluble fiber, soluble fiber, or sugar alcohol for children 1 through 3 years of age. One comment to the 2007 ANPRM recommended establishing a DV for n-3 polyunsaturated fatty acids (alpha-linolenic acid) of 700 mg/d because alpha- linolenic acid is essential to the human diet and children 1 through 3 years of age are below recommended intake levels. We disagree that a DRV should be set for n-3 polyunsaturated fatty acids for children 1 through 3 years of age for the same reasons that we are not proposing a DRV for these fatty acids for the general population (see section II.B.). We recognize the essential nature of alpha-linolenic acid in the diet. The IOM based AIs for n-6 linoleic and n-3 alpha-linolenic acid on U.S. median intake levels because of the lack of linoleic and alpha- linolenic acid deficiency in non-
  
  institutionalized populations in the United States (Ref. 49).
  
  For children 1 through 3 years of age, DRIs or other data and information are not available on which we could rely to establish DRVs for polyunsaturated fat, monounsaturated fat, sugars, added sugars, insoluble fiber, soluble fiber, and sugar alcohols. Therefore, we tentatively conclude that there is no basis for setting DRVs for these nutrients. Accordingly, we are not proposing DRVs for polyunsaturated fat, including n-3 or n-6 polyunsaturated fatty acids, monounsaturated fat, sugars, added sugars, soluble fiber, insoluble fiber, or sugar alcohols for children 1 through 3 years of age.
25. Total Carbohydrate--There is not a DRV for total carbohydrate for children 1 through 3 years of age. One comment to the 2007 ANPRM suggested that we establish a DV for carbohydrates using 59 percent of calories from carbohydrates, or 154 g using the method of calculation by difference.
  
  As discussed in section II.D.1., we are proposing a DRV for total carbohydrate for the general population based on the percentage of calories in a 2,000 calorie diet remaining after the sum of the DRV for fat (30 percent) plus the DRV for protein (10 percent) have been subtracted. We also consider this method to be appropriate for setting a DRV for total carbohydrate for children 1 through 3 years of age. Total calories (100 percent) minus the proposed DRV for total fat (35 percent of calories) and the proposed DRV for protein (5 percent of calories) equals 60 percent of calories from total carbohydrate. A value of 60 percent of total calories from total carbohydrates also falls within the IOM AMDR recommendation of 45 to 65 percent of calories from carbohydrates for children 1 through 3 years of age. Therefore, we tentatively conclude that an appropriate DRV for total carbohydrate is 60 percent of calories (i.e., 150 g using the proposed reference calorie intake level of 1,000 calories/d). Accordingly, we are proposing to amend Sec. 101.9(c)(9) to set a DRV of 150 g for total carbohydrate for children 1 through 3 years of age.
26. Dietary Fiber--There is not a DRV for dietary fiber for children 1 through 3 years of age. One comment to the 2007 ANPRM recommended using 15 g/d as the basis of the DRV for dietary fiber, based on the AI of 14 g/1,000 calories and a 1,050 calorie diet. We agree that the AI of 14 g/1,000 calories for dietary fiber for children 1 through 3 years of
  
  Page 11942
  
  age (Ref. 66) should be used to set a DRV for dietary fiber to be consistent with how other proposed DRVs are being set. Given that we are proposing a reference calorie intake level of 1,000 calories/d for this subpopulation, we are proposing to amend Sec. 101.9(c)(9) to establish a DRV of 14 g for dietary fiber for children 1 through 3 years of age.
27. Protein--The RDI for protein for children less than 4 years of age was based on the 1989 RDA for protein of 16 g/d (Sec. 101.9(c)(7)(iii)). One comment to the 2007 ANPRM recommended maintaining the DV of 16 g for protein because the RDA for protein of 13 g/d for toddlers 1 through 3 years of age appears low relative to the amount of protein from a diet pattern consistent with dietary guidance from AAP/AHA.
  
  We consider it appropriate to determine whether changes are necessary to the current RDI taking into account current recommendations and protein intakes. Protein intakes are well above the current RDI. Mean protein intake for children 12 to 23 months of age was 44 g/d (Ref. 150), well above the RDA of 13 g/d and the midpoint of the AMDR of 5 to 20 percent calories from protein (i.e., 12.5 percent of calories from protein or 31 g/d) (Ref. 84). The protein AMDR for children 1 through 3 years of age is 5 to 20 percent of calories and the RDA is approximately 5 percent of calories (Ref. 84). While the RDA is lower than the amount of protein consistent with guidance from AAP/
  
  AHA, we explain in section II.B.2.c. that we do not consider the menu modeling approach used to develop this guidance appropriate to determine DRVs because it does not permit the selection of DRVs that are based on scientific evidence related to actual public health outcomes. In light of the proposed reference calorie intake level and the approaches used for the proposed DRVs for fat and carbohydrate that are based on percent of calories, we tentatively conclude that, as with the general population, the DV for protein for children 1 through 3 years of age should be a DRV, rather than an RDI (using the RDA). Therefore, we tentatively conclude that a DRV for protein should be based on 5 percent of 1,000 calories or 50 calories which equals 12.5 g or, when rounded up, is 13 g. Accordingly, we are proposing to amend Sec. 101.9(c)(7)(iii) to establish a DRV for protein of 13 g for children 1 through 3 years of age.
28. Sodium--For the general population, we are proposing to establish a DRV based on the UL for sodium (section II.F.). There is no DRV for sodium for children 1 through 3 years of age. Two comments to the 2007 ANPRM recommended basing the DRV for sodium on the IOM's UL of 1,500 mg/d for children 1 through 3 years of age to be consistent with recommendations from AAP and AHA (Ref. 71).
  
  The IOM derived the UL for children 1 through 3 years of age by extrapolation from the adult UL of 2,300 mg/d based on observational studies showing that blood pressure increases with age into adulthood and the recognition that risk factors for CVD, such as high blood pressure and atherosclerosis, occur in childhood (Ref. 10). We agree with the comments noting that 1,500 mg is an appropriate DRV for sodium for children 1 through 3 years of age. Consistent with the proposed approach for the general population, we are proposing to amend Sec. 101.9(c)(8)(iv) to establish a DRV of 1,500 mg for sodium for children 1 through 3 years of age.
29. Fluoride--There is not a DV for fluoride for children 1 through 3 years of age. One comment to the 2007 ANPRM suggested that fluoride should not have a DV because it is not found abundantly in food. We disagree with this comment. Whether a nutrient is found abundantly in food is not a consideration for FDA in setting DVs. The IOM recognized fluoride as a trace mineral that is important for public health by setting an AI based on evidence of its role in reducing the risk of dental caries.
  
  However, we tentatively conclude that a DRV should not be established for fluoride. Although the IOM set an AI for fluoride, the AI for children 1 through 3 years of age is close to the EPA benchmarks for maximum total fluoride intake (Ref. 92). In addition, we are not proposing a DRV for the general population because of concern about excess intakes associated with dental fluorosis (see section II.G.). The use of such a DRV to calculate percent DV may have the untoward effect of consumers selecting foods with higher fluoride amounts, which are not necessary or advised. Therefore, we tentatively conclude that a DRV for fluoride is not warranted for children 1 through 3 years of age. Accordingly, we are not proposing a DRV for fluoride for children 1 through 3 years of age.
30. Vitamins and Minerals--As explained earlier, while not included in our regulations, the preamble to the 1993 DRV/RDI final rule provides a table listing RDIs for children less than 4 years of age (58 FR 2206 at 2213), which is also provided in FDA's Food Labeling Guide (Ref. 144). We reviewed current quantitative intake recommendations for vitamins and minerals for infants and considered comments received in response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for vitamins and minerals for children 1 through 3 years of age.
  
  The IOM's quantitative intake recommendations (AIs and RDAs) provide a basis on which to determine RDIs for vitamins and minerals for this subpopulation. In addition, where data on functional indicators of nutritional status were available, the IOM relied on such data and determined that available evidence was sufficient to establish appropriate RDAs and AIs for vitamins and minerals for this subpopulation. Therefore, we disagree with a comment to the 2007 ANPRM that suggested that more population-specific data based on functional indicators of nutritional status are needed before establishing the RDIs for vitamins and minerals.
  
  We consider it appropriate to use RDAs and, in the absence of RDAs, AIs to determine appropriate micronutrient RDIs for children 1 through 3 years of age. As such, we agree with comments that suggested using RDAs to determine the RDIs for selenium and vitamin E and AIs to determine the RDIs for choline, vitamin K, and manganese, which do not have established RDAs. The RDA, when available, is the best estimate of an intake level that will meet the nutrient goals of practically all consumers who would use the Nutrition Facts label. AIs have less certainty than RDAs, but they represent goals for nutrient intake for individuals and provide the best estimate based on current science for use in setting RDIs for such nutrients.
  
  Finally, we disagree with comments suggesting we use 1,800 or 2,000 mg/d potassium as the basis for the RDI for potassium because it is inconsistent with the proposed approach for the general population. The comments did not explain why data collection on mean potassium intake should be the basis for the DV in lieu of the AIs and RDAs. In addition, promoting the development of eating patterns that will be associated with adequate potassium intake later in life is important because chronic conditions such as elevated blood pressure, bone demineralization, and kidney stones likely result from inadequate potassium intakes over an extended period of time, including childhood (Ref. 136). The AI for potassium is 3,000 mg/d and we consider it an appropriate basis for establishing a RDI for potassium for children 1 through 3 years of age.
  
  Therefore, using the RDAs and AIs, we are proposing to amend Sec. 101.9(c)(8)(iv) to establish RDIs as set forth previously for vitamin A, vitamin
  
  Page 11943
  
  C, vitamin D, vitamin E, vitamin K, vitamin B12, folate, choline, riboflavin, niacin, vitamin B6, calcium, iron, thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and potassium for children 1 through 3 years of age.
  
  We invite comment on the adequacy of the proposed RDIs for vitamins and minerals for children 1 through 3 years of age.
  
  7. DRVs and RDIs for Pregnant and Lactating Women
31. Calories--The reference calorie intake of 2,000 used for the general population applies to pregnant and lactating women (Sec. 101.9(c)(9)). The calorie needs for pregnant and lactating women are similar to the general population and few products are purported for pregnant and lactating women. Therefore, we tentatively conclude that it is appropriate to establish a reference calorie intake level for setting DRVs for pregnant and lactating women that is the same as for the general population. Accordingly, we are proposing to use the 2,000 reference calorie intake level for setting DRVs for pregnant and lactating women (Sec. 101.9(c)(9)).
32. Total Fat, Saturated Fat, Cholesterol, Total Carbohydrate, Sodium, and Dietary Fiber--FDA regulations do not provide DRVs for total fat, saturated fat, cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant and lactating women. Quantitative intake recommendations for total fat, saturated fat, cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant and lactating women are generally similar to the general population (Refs. 6 and 23). Therefore, we tentatively conclude that the DRVs for total fat, saturated fat, cholesterol, total carbohydrate, sodium, and dietary fiber for pregnant and lactating women should remain the same as for the general population. Accordingly, we are proposing to amend Sec. 101.9(c)(9) to establish DRVs for pregnant and lactating women using the proposed DRVs for the general population for total fat, saturated fat, cholesterol, total carbohydrate, sodium, and dietary fiber.
33. Trans Fat, Polyunsaturated Fat, Monounsaturated Fat, Soluble Fiber, Insoluble Fiber, Sugars, Added Sugars, and Sugar Alcohols--There are no DRVs for trans fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, sugars, added sugars, or sugar alcohol for pregnant and lactating women. As discussed in sections II.B. and II.D., we are not proposing DRVs for these nutrients for the general population because of a lack of quantitative intake recommendations. Similarly, quantitative intake recommendations are lacking for these nutrients for pregnant and lactating women. Therefore, we are not proposing to establish DRVs for trans fat, polyunsaturated and monounsaturated fat, soluble fiber, insoluble fiber, sugars, added sugars, or sugar alcohols for pregnant and lactating women.
34. Protein--FDA established RDIs of 60 g protein for pregnant women and 65 g protein for lactating women (Sec. 101.9(c)(7)(iii)) based on the highest 1989 RDAs for pregnant and lactating women (58 FR 2206 at 2216). The IOM established 71 g/d protein as the RDA for pregnant and lactating women based on the needs for maternal and fetal development and human milk production. Because the RDA for protein during both pregnancy and lactation is the same (Ref. 84) and given that most foods represented or purported to be specifically for pregnant women are also represented or purported to be specifically for lactating women, we tentatively conclude that it is appropriate to establish a single RDI of 71 g applicable to both pregnant and lactating women. We tentatively conclude that the DV for protein for pregnant and lactating women should remain an RDI (using the RDA) instead of a DRV because the DRV approach used to calculate protein for the general population based on 10 percent of 2,000 calories, which equals 50 g of protein/d, falls short of the recommended protein needs of pregnant and lactating women of 71 g/d. Therefore, we are proposing to amend Sec. 101.9(c)(7)(iii) to establish an RDI of 71 g for protein for pregnant and lactating women.
35. Fluoride--There is no DRV for fluoride for the general population or for pregnant and lactating women. While an AI has been established for fluoride, we are not proposing to establish a DRV for fluoride for the general population for the reasons discussed in section II.G. Similarly, because the AI for fluoride for pregnant and lactating women is not different from the general population (Ref. 90), we are not proposing a DRV for fluoride for pregnant and lactating women.
36. Vitamins and Minerals--While not included in FDA regulations, the preamble to the 1993 DRV/RDI final rule provides a table listing RDIs for pregnant and lactating women (58 FR 2206 at 2213), which is also provided in FDA's food labeling guide (Ref. 144). We reviewed current quantitative intake recommendations for vitamins and minerals for pregnant and lactating women and considered comments received in response to the 2007 ANPRM (Ref. 47) to determine appropriate RDIs for vitamins and minerals for pregnant and lactating women.
  
  For the same reasons stated for the general population (see section II.I.), we consider it appropriate to establish RDIs for pregnant and lactating women for vitamins and minerals that have DRIs, using population-coverage RDAs and AIs, instead of population-weighted EARs. In addition, we are proposing to establish a single set of RDIs intended for both pregnant women and lactating women because nutrient needs during pregnancy and lactation are similar (Refs. 16, 17, 21, 22, 140). Moreover, most foods represented or purported to be specifically for pregnant women are, at the same time, represented or purported to be specifically for lactating women and, as such, using one set of RDIs would address practical concerns related to limited space on food labels.
  
  Therefore, we are proposing to amend Sec. 101.9(c)(8)(iv) to establish RDIs as set forth previously for vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B12, folate, choline, riboflavin, niacin, vitamin B6, calcium, iron, thiamin, biotin, pantothenic acid, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, and potassium for pregnant and lactating women.
  
  Page 11944
  
  Table 3--Prevalence of Nutrient Inadequacy and Adequacy (From Conventional Foods and Water) and From Total
  
  Intake (Conventional Foods, Water, and Supplements) of U.S. Infants 7 Through 12 Months of Age \1\
  
  ----------------------------------------------------------------------------------------------------------------
  
  Usual nutrient intake \2\
  
  ---------------------------
  
  Nutrients EAR \3\ % Below the EAR \4\
  
  ---------------------------
  
  Food Total intake
  
  ----------------------------------------------------------------------------------------------------------------
  
  Iron............................................ 6.9 mg............................ 17.8 3.7
  
  Zinc............................................ 2.5 mg............................ 0.1 0.1
  
  ---------------------------
  
  AI \3\............................ % Above AI \5\
  
  ---------------------------
  
  Choline......................................... 150 mg............................ 23.5 23.5
  
  Folate.......................................... 80 mcg............................ 100 100
  
  Niacin.......................................... 4 mg.............................. 99.9 99.9
  
  Riboflavin...................................... 0.4 mg............................ 100 100
  
  Thiamin......................................... 0.3 mg............................ 99.9 99.9
  
  Vitamin A....................................... 500 mcg........................... 86.9 87.5
  
  Vitamin B6...................................... 0.3 mg............................ 99.9 99.9
  
  Vitamin B12..................................... 0.5 mg............................ 99.8 99.8
  
  Vitamin C....................................... 50 mg............................. 90.1 94
  
  Vitamin D....................................... 10 mcg............................ 28.7 33.6
  
  Vitamin E....................................... 5 mcg............................. 67 70.6
  
  Vitamin K....................................... 2.5 mcg........................... 100 100
  
  Calcium......................................... 260 mg............................ 99.6 99.6
  
  Copper.......................................... 220 mcg........................... 100 100
  
  Magnesium....................................... 75 mg............................. 97.6 97.6
  
  Phosphorus...................................... 275 mg............................ 98.9 98.9
  
  Potassium....................................... 700 mg............................ 98.8 98.8
  
  Selenium \6\.................................... 20 mcg............................ 9.9 9.9
  
  ----------------------------------------------------------------------------------------------------------------
  
  \1\ All prevalence of nutrient inadequacy or adequacy and status biomarker data is based on NHANES 2003-2006
  
  except for vitamin D and choline (NHANES 05-08).
  
  \2\ Usual nutrient intake distributions from conventional foods are determined using the National Cancer
  
  Institute statistical method for all nutrients except iron (see footnote 9 to table 1 and Ref. 48).
  
  \3\ The DRIs (Estimated Average Requirements (EARs) and Adequate Intakes (AIs)) for infants ages 7-12 months are
  
  established by the Institute of Medicine http://www.iom.edu/Activities/Nutrition/SummaryDRIs/~/media/Files/
  
  Activity%20Files/Nutrition/DRIs/New%20Material/2--%20RDA%20and%20AI%20Values--Vitamin%20and%20Elements.pdf.
  
  \4\ The EAR cut-point method was used to compare usual nutrient intakes to the EAR to determine the prevalence
  
  of nutrient inadequacy for iron and zinc. For iron, refer to Table I-5 Probability of inadequate iron intakes
  
  (Refs. 100 and 158).
  
  \5\ For nutrients with an AI, prevalence of nutrient adequacy was determined when usual nutrient intakes are at
  
  or above the AI.
  
  \6\ We did not receive any comments for this nutrient (for which voluntary declaration is permitted) in response
  
  to the ANPRM. In addition, dietary intake and/or biomarker data were not provided in NHANES database for
  
  chromium, biotin, iodine, pantothenic acid, molybdenum, manganese and chloride and, therefore, these nutrients
  
  are not listed in this table.
  
  Table 4--Prevalence of Nutrient Inadequacy and Adequacy (From Conventional Foods and Water and Total Intake
  
  (Conventional Foods, Water, and Supplement) and Status Biomarkers of the U.S. Population of Children 1 Through 3
  
  Years of Age \1\
  
  ----------------------------------------------------------------------------------------------------------------
  
  Usual nutrient intake \2\
  
  --------------------------------------------------------------------------------
  
  % below EAR \4\ Status biomarker
  
  Nutrient ------------------------------------------------------------
  
  EAR \3\ Total % Below
  
  Food intake Biomarker cutoff cutoff
  
  ----------------------------------------------------------------------------------------------------------------
  
  Folate......................... 120 mcg........... 0.1 0.1 Serum folate 12 to 2.4 mug.
  
  (8) In section II.I.6, whether quantitative amounts for nutrients with RDI values that contain three or four digits should be rounded, what the rounding increments should be, and data to support suggested rounding increments for such vitamins and minerals.
  
  (9) We invite comment on issues related to units of measure, nomenclature, and analytical methods, which are discussed in section II.J.;
  
  (10) We invite comment on issues related to nutrition labeling for foods represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women, which are addressed in section II.K., including (a) any available relevant empirical research as to whether the proposed declaration of saturated fat and cholesterol for infants and children 1 through 3 years of age is likely to be confusing to consumers or otherwise result in restriction of fat intakes among these subpopulations; (b) how consumers would understand and use the information on amounts of saturated fat and cholesterol in the nutrition labeling of foods for infants and young children and whether there is a need for an explanatory footnote to accompany such proposed mandatory declaration; (c) our tentative conclusion that declaration of added sugars should be mandatory on foods represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, and pregnant and lactating women; and (d) adequacy of the proposed RDIs for vitamins and minerals for older infants and children 1 through 3 years of age.
  
  (11) We invite comment, including available data and other information on the reformulation of dietary supplement products that may result from proposed changes to the DVs, as well as information on the potential consequences of such reformulations;
  
  (12) We invite comment on whether we should consider changes to the footnote statement ``Percent Daily Values are based on a 2,000 calorie diet'' used on dietary supplement labels to be consistent with any changes to the footnote statement in the Nutrition Facts label.
  
  (13) We invite comment on (a) including the use of an alternative format design or requiring the use of a specific font; (b) our tentative conclusion that emphasizing both the number of calories per serving and the number of servings per container will serve as an anchor to highlight this information and grab the reader's attention, and therefore will assist consumers to effectively use this information in the Nutrition Facts label; (c) whether any of the changes that are being proposed to the Nutrition Facts label should also be required for certain products with Supplement Facts labels that list calories and/or other macronutrients, and if so, under what conditions and for which dietary supplement products should such labeling be required; (d) our tentative view that there is no need to propose changing the order of how serving size and servings per container are listed on the Supplement Facts label, or to make amendments in the type size or capitalization corresponding to our proposed changes for this information on the Nutrition Facts labels; (e) our tentative conclusion that, based on design considerations, the label statement for ``Serving size'' in both household units and gram amounts should be right-
  
  justified on the same line that ``Serving size'' is listed; (f) our tentative conclusion that changing the ``Amount Per Serving'' statement to ``Amount per------'' with the blank filled in with the actual serving size would assist consumers in using the information and may lessen the time and effort needed to locate the target information and improve the accuracy of judgments about the calorie amounts and nutrient contents of packaged food products; (g) the double indented placement of added sugars below total sugars and invite available research data formation; (h) our tentative view that increasing the type size, bolding key elements of the footnote (space permitting), and adding a bar clearly separating it from the micronutrient information directly above will assist consumers in using the information; (i) our tentative view on the need for a footnote statement for enhancing consumers' use and understanding of the percent DV; (j) using data provided consumer research we plan to conduct during this rulemaking that will test consumer reactions to a definition of percent DV, a succinct statement on calories, and several statements related to the ``5/20 rule''; (k) whether or not this calorie conversion information should continue to be optional on the Nutrition Facts label, and whether there are any data suggesting that consumers do or do not use this information; (l) alternative terms that may be more readily understandable than Daily Value, such as Daily Guide or Daily Need; (m) whether the word ``percent'' (or the % symbol) needs to precede whatever term is used in the column heading where the percent DVs are listed; (n) whether there is a need to include vertical lines that are similarly placed on Supplement Facts labels for multiple vitamins in packets (Sec. 101.36(e)(11)(iii)) and for dietary supplements that list ``per serving'' and ``per day'' information (Sec. 101.36(e)(11)(viii)); (o) the appropriate placement of percent DVs in the labeling of foods for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women; (p) our tentative conclusion to insert a 0.25 point hairline rule directly beneath the Nutrition Fact heading on all label formats, with the exception of the linear display for small packages; (q) listing the total carbohydrate content in a serving as ``Total Carbs'' instead of ``Total Carbohydrate'' or ``Total Carb'' and its listing used on all label formats; (r) an alternative concept for the Nutrition Facts label format that indicates ``quick facts'' about a product's nutrient content and explicitly points out nutrients to ``avoid too much'' of as well as nutrients to ``get enough'' of, and; (s) whether a specific font should be required for the Nutrition
  
  Page 11962
  
  Facts label. We request comment on how this display may or may not convey the information in a manner which enables the public to readily observe and comprehend such information and whether separating and placing nutrients such as ``Total Fat'' and ``Saturated Fat'' under different headings would help or hinder consumer's understanding of the Nutrition Facts label. We also are interested in comments on what headings could be used and how to categorize all of the nutrients.
  
  IX. References
  
  The following references have been placed on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and are available electronically at http://www.regulations.gov. (FDA has verified all the Web site addresses in this reference section, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)
  
  1. U.S. Food and Drug Administration. ``Memorandum to the File: Regulatory History Related to Nutrition Labeling for Proposed Rule ``Food Labeling: Revision of the Nutrition and Supplement Facts Label'', 2014.
  
  2. Centers for Disease Control and Prevention. (August 13, 2012) ``Chronic Diseases and Health Promotion''. Retrieved from http://www.cdc.gov/chronicdisease/overview/index.htm.
  
  3. Lloyd-Jones, D., Adams, R.J., Brown, T.M., et al. ``Heart Disease and Stroke Statistics--2010 Update: A Report From the American Heart Association''. Circulation. 2010;121:e46-e215.
  
  4. Centers for Disease Control and Prevention. (2011) ``National Diabetes Fact Sheet, 2011''. Retrieved from http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf.
  
  5. National Cancer Institute. (2011) ``Surveillance Epidemiology and End Results (SEER) Stat Fact Sheets: All Sites''. Retrieved from http://seer.cancer.gov/statfacts/html/all.html.
  
  6. U.S. Department of Agriculture and U.S. Department of Health and Human Services. (2010) ``Dietary Guidelines for Americans, 2010'', 7th Ed., Washington DC: U.S. Government Printing Office. Retrieved from http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm.
  
  7. Flegal, K.M., Carroll, M.D., Ogden, C.L., et al. ``Prevalence and Trends in Obesity Among U.S. Adults, 1999-2008''. JAMA: the Journal of the American Medical Association. 2010;303:235-241.
  
  8. Ogden, C.L., Carroll, M.D., Curtin, L.R., et al. ``Prevalence of High Body Mass Index in U.S. Children and Adolescents, 2007-2008''. JAMA: the Journal of the American Medical Association. 2010;303:242-
  
  249.
  
  9. National Institutes of Health, National Heart Lung and Blood Institute in cooperation with The National Institute of Diabetes and Digestive and Kidney Diseases. (1998) ``Clinical Guidelines on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults: The Evidence Report; NIH Publication No. 98-4083''. Retrieved from http://www.nhlbi.nih.gov/guidelines/obesity/ob_gdlns.pdf.
  
  10. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate, Chapter 6: Sodium and Chloride'', Washington, DC: National Academies Press; 2005. pp. 269-423.
  
  11. U.S. Food and Drug Administration. ``Memorandum to the File: Total Usual Intakes of Sodium for 4 Years and Older'', 2014.
  
  12. Usual Sodium Intakes Compared With Current Dietary Guidelines--
  
  United States, 2005-2008. MMWR Morbidity and Mortality Weekly Report. 2011;60:1413-1417.
  
  13. Institute of Medicine (IOM) of the National Academies. ``The Development of the DRIs, 1994-2004: Lessons Learned and New Challenges, Workshop Summary'', Washington, DC: National Academies Press; 2008.
  
  14. Institute of Medicine (IOM) of the National Academies. ``How Should the Recommended Dietary Allowances Be Revised'', Washington, DC: National Academies Press; 1994.
  
  15. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes: The Essential Guide to Nutrient Requirements'', Washington DC: National Academies Press; 2006.
  
  16. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride'', Washington, DC: National Academies Press; 1997.
  
  17. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline'', Washington, DC: National Academy Press; 1998.
  
  18. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium, and Carotenoids'', Washington, DC: National Academies Press; 2000.
  
  19. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc'', Washington, DC: National Academies Press; 2001.
  
  20. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients), Summary'', Washington, DC: National Academies Press; 2002. pp. 1-19.
  
  21. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate'', Washington, DC: National Academies Press; 2005.
  
  22. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Calcium and Vitamin D'', Washington, DC: National Academies Press; 2011.
  
  23. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients)'', Washington, DC: National Academies Press; 2002.
  
  24. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes: Proposed Definition of Dietary Fiber'', Washington DC: National Academies Press; 2001.
  
  25. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes: Guiding Principles for Nutrition Labeling and Fortification'', Washington, DC: National Academies Press; 2003.
  
  26. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes: Applications in Dietary Planning'', Washington, DC: National Academies Press; 2003.
  
  27. Institute of Medicine (IOM) of the National Academies. ``Strategies to Reduce Sodium Intake in the United States'', Washington, DC: National Academies Press; 2010.
  
  28. Institute of Medicine (IOM) of the National Academies. ``Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase I Report'', Washington, DC: National Academies Press; 2010.
  
  29. Institute of Medicine (IOM) of the National Academies. ``Front-
  
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  146. U.S. Department of Health and Human Services, National Institutes of Health, and National, Heart Lung and Blood Institute. (October, 2012) ``Integrated Guidelines for Cardiovascular Health and Risk Reduction In Children and Adolescents: The Report of the Expert Panel''; NIH Publication No. 12-7486A. Retrieved from http://www.nhlbi.nih.gov/guidelines/cvd_ped/index.htm.
  
  147. Akers, S., Groh-Wargo, S. ``Chapter 5: Normal Nutrition During Infancy''. In: Pediatric Nutrition 4th Ed. Patrica Queen Samour and Kathy King, ed. Sadbury, MA: Jones and Bartlett Learning; 2012; p.71.
  
  148. Devaney, B., Ziegler, P., Pac, S., et al. ``Nutrient Intakes of Infants and Toddlers''. Journal of the American Dietetic Association. 2004;104:s14-s21.
  
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  150. Butte, N.F., Fox, M.K., Briefel, R.R., et al. ``Nutrient Intakes of US Infants, Toddlers, and Preschoolers Meet or Exceed Dietary Reference Intakes''. Journal of the American Dietetic Association. 2010;110:S27-S37.
  
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  152. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride, Chapter 4: Calcium'', Washington, DC: National Academies Press; 1997. pp. 71-145.
  
  153. Greer, F.R., Krebs, N.F. ``Optimizing Bone Health and Calcium Intakes of Infants, Children, and Adolescents''. Pediatrics. 2006;117:578-585.
  
  154. Polhamus, B., Delenius, K., Makentosh, H., Smith, B., and Grummer-Strawn, L. (2011) ``Pediatric Nutrition Surveillance 2009 Report''. Retrieved from http://www.cdc.gov/pednss/pdfs/PedNSS_2009.pdf.
  
  155. Looker, A.C., Dallman, P.R., Carroll, M.D., et al. ``Prevalence of Iron Deficiency in the United States''. JAMA: the Journal of the American Medical Association. 1997;277:973-976.
  
  156. Centers for Disease Control and Prevention. (September 9, 2010) ``Growth Charts''. Retrieved from http://www.cdc.gov/growthcharts/who_charts.htm.
  
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  158. Institute of Medicine (IOM) of the National Academies. ``Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Chapter 12: Zinc'', Washington, DC: National Academies Press; 2001. pp. 442-501.
  
  159. Cusick, S.E., Mei, Z., Freedman, D.S., et al. ``Unexplained Decline in the Prevalence of Anemia Among US Children and Women Between 1988-1994 and 1999-2002''. American Journal of Clinical Nutrition. 2008;88:1611-1617.
  
  160. Gomez-Palacio B., Vit A. Graphic Design Referenced: A Visual Guide to the Language, Applications, and History of Graphic Design. 1st Ed. Beverly, MA: Rockport Publishers, 2012;pp. 50-54.
  
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  Column Nutrition Labeling May Help Consumers Make More Healthful Food Choices''. Journal of the Academy of Nutrition and Dietetics. 2013;113:241-250.
  
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  169. Wogalter, M.S., Leonard, S.D. ``Chapter 7: Attention Capture and Maintenance''. In: Warnings in Risk Communication Philadelphia: Taylor and Francis Inc.; 1999; pp.123-148.
  
  170. Wogalter, M.S., Vigilante, W.J., Jr. ``Effects of Label Format on Knowledge Acquisition and Perceived Readability by Younger and Older Adults''. Ergonomics. 2003;46:327-344.
  
  171. Lupton E. Thinking With Type: A Critical Guide for Designers, Writers, Editors, & Students. 2nd Ed. New York, NY: Princeton Archetectural Press, 2010; pp. 132-133.
  
  172. Marino, C.J., Mahan, R.R. ``Configural Displays Can Improve Nutrition-Related Decisions: An Application of the Proximity Compatibility Principle''. Human Factors. 2005;47:121-130.
  
  173. Vessey, I., Galletta, D. ``Cognitive Fit: An Empirical Study of Information Acquisition''. Information Systems Research. 1991;2:63-
  
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  178. Riis J., Ratner R. ``Simplified Nutrition Guidelines to Fight Obesity''. In: Leveraging Consumer Psychology for Effective Health Communications--The Obesity Challenge Ed. Batra, R., Keller, P.A., Strecher, V.J., eds. Armonk, NY: Society for Consumer Psychology, M.E. Sharp; 2011.
  
  179. U.S. Food and Drug Administration. (2014) ``Spot the Block Campaign''. Retrieved from http://www.fda.gov/food/ingredientspackaginglabeling/labelingnutrition/ucm281746.htm.
  
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  181. U.S. Food and Drug Administration, Office of Nutrition Labeling and Dietary Supplements. ``Memorandum to the File: Documentation of Web sites that Use the 5/20 Rule'', 2014.
  
  182. White A. The Elements of Graphic Design. 2nd Ed. New York, NY: Allworth Press, 2011;pp. 167-169, 187.
  
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  Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments Notice of Proposed Rulemaking (Docket No. FDA-2004-N-0258)'', 2014.
  
  188. U.S. Food and Drug Administration. ``Environmental Assessment for the Revision of the Nutrition and Supplement Facts Labels'', February 14,2014.
  
  189. U.S. Food and Drug Administration. ``Finding of No Significant Impact for the Proposed Revisions to the Nutrition and Supplement Facts Labels'', February 13, 2014.
  
  List of Subjects in 21 CFR Part 101
  
  Food labeling, Nutrition, Reporting and recordkeeping requirements.
  
  Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR part 101 be amended as follows:
  
  PART 101--FOOD LABELING
  
  0
  
  1. The authority for 21 CFR part 101 continues to read as follows:
  
  Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, 264, 271.
  
  0
  
  2. In Sec. 101.9:
  
  0
37. Revise paragraphs (c) introductory text, (c)(1)(i)(A), (c)(1)(i)(C) through (E) (c)(2) introductory text, (c)(5), (c)(6)(i), (c)(6)(iii) and (iv), (c)(7), (c)(8) introductory text, (c)(8)(i), (c)(8)(ii) introductory text, (c)(8)(iii) through (v), (c)(9), (d)(1) introductory text, (d)(1)(ii)(C), (d)(1)(iii) through (v), (d)(2), (d)(3)(i) and (ii), (d)(4) through (8), (d)(10) through (12), (d)(13)(ii), (e), (f) introductory text, (f)(2)(ii), (f)(4) and (5), (g) introductory text, (g)(2), (g)(3)(ii), (g)(4) through (8), (h)(3)(iv), (h)(4) introductory text, (j)(5)(i), (j)(5)(ii) introductory text, (j)(5)(ii)(A), (j)(13)(ii)(A)(1) and (2), (j)(13)(ii)(B) and (C), and (j)(18)(iv) introductory text.
  
  0
38. Remove paragraph (c)(1)(ii), redesignate paragraph (c)(1)(iii) as (c)(1)(ii), and revise newly designated paragraph (c)(1)(ii);
  
  0
39. Remove paragraph (c)(6)(iv), redesignate paragraph (c)(6)(iii) as (c)(6)(iv), and add new paragraph (c)(6)(iii);
  
  0
40. Add paragraphs (c)(1)(i)(F), (c)(8)(vii), (g)(10), and (g)(11);
  
  0
41. Remove and reserve paragraph (d)(9);
  
  0
42. Remove paragraphs (e)(3)(i) and (e)(3)(ii); and
  
  0
43. Remove paragraphs (j)(5)(ii)(B) through (j)(5)(ii)(D), and redesignate paragraph (j)(5)(ii)(E) as (j)(5)(ii)(B).
  
  The revisions read as follows:
  
  Sec. 101.9 Nutrition labeling of food.
  
  * * * * *
  
  (c) The declaration of nutrition information on the label and in labeling of food for adults and children over the age of 4 years, and on foods (other than infant formula) purported to be specifically for infants 7 through 12 months, children 1 through 3 years of age, and pregnant and lactating women, shall contain information about the level of the following nutrients, except for those nutrients whose inclusion, and the declaration of the amounts, is voluntary as set forth in this paragraph. No nutrients or food components other than those listed in this paragraph as either mandatory or voluntary may be included within the nutrition label. Except as provided for in paragraphs (f) or (j) of this section, nutrient information shall be presented using the nutrient names specified and in the following order in the formats specified in paragraphs (d) or (e) of this section.
  
  (1) * * *
  
  (i) * * *
  
  (A) Using specific Atwater factors (i.e., the Atwater method) given in table 13, ``Energy Value of Foods--Basis and Derivation,'' by A. L. Merrill and B. K. Watt, United States Department of Agriculture (USDA) Handbook No. 74 (slightly revised, 1973), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is available from the Office of Nutrition, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.;
  
  * * * * *
  
  (C) Using the general factors of 4, 4, and 9 calories per gram for protein, total carbohydrate (less the amount of non-digestible carbohydrates and sugar alcohols), and total fat, respectively, as described in USDA Handbook No. 74 (slightly revised 1973) pp. 9-11, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section). A general factor of 2 calories per gram for soluble non-digestible carbohydrates shall be used. The general factors for caloric value of sugar alcohols provided in paragraph (c)(1)(i)(F) of this section shall be used;
  
  (D) Using data for specific food factors for particular foods or ingredients approved by the Food and Drug Administration (FDA) and provided in parts 172 or 184 of this chapter, or by other means, as appropriate;
  
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  (E) Using bomb calorimetry data subtracting 1.25 calories per gram protein to correct for incomplete digestibility, as described in USDA Handbook No. 74 (slightly revised 1973) p. 10, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 (the availability of this incorporation by reference is given in paragraph (c)(1)(i)(A) of this section);
  
  or
  
  (F) Using the following general factors for caloric value of sugar alcohols: Isomalt--2.0 calories per gram, lactitol--2.0 calories per gram, xylitol--2.4 calories per gram, maltitol--2.1 calories per gram, sorbitol--2.6 calories per gram, hydrogenated starch hydrolysates--3.0 calories per gram, and mannitol--1.6 calories per gram.
  
  (ii) ``Calories from saturated fat'' or ``Calories from saturated'' (VOLUNTARY): A statement of the caloric content derived from saturated fat as defined in paragraph (c)(2)(i) of this section in a serving may be declared voluntarily, expressed to the nearest 5-calorie increment, up to and including 50 calories, and the nearest 10-calorie increment above 50 calories, except that amounts less than 5 calories may be expressed as zero. This statement shall be indented under the statement of calories as provided in paragraph (d)(5) of this section.
  
  (2) ``Fat, total'' or ``Total fat'': A statement of the number of grams of total fat in a serving defined as total lipid fatty acids and expressed as triglycerides where fatty acids are aliphatic carboxylic acids consisting of a chain of alkyl groups and characterized by a terminal carboxyl group. Amounts shall be expressed to the nearest 0.5 (1/2) gram increment below 5 grams and to the nearest gram increment above 5 grams. If the serving contains less than 0.5 gram, the content shall be expressed as zero.
  
  * * * * *
  
  (5) ``Fluoride'' (VOLUNTARY): A statement of the number of milligrams of fluoride in a specified serving of food may be declared voluntarily, except that when a claim is made about fluoride content, label declaration shall be required. Fluoride content shall be expressed as zero when the serving contains less than 0.1 milligrams of fluoride, to the nearest 0.1-milligram increment when the serving contains less than or equal to 0.8 milligrams of fluoride, and the nearest 0.2 milligram-increment when a serving contains more than 0.8 milligrams of fluoride.
  
  (6) * * *
  
  (i) ``Dietary fiber'': A statement of the number of grams of total dietary fiber in a serving, indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, declaration of dietary fiber is not required or, alternatively, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used, and if the serving contains less than 0.5 gram, the content may be expressed as zero. Dietary fiber is defined as non-digestible soluble and insoluble carbohydrates (with 3 or more monomeric units) and lignin that are intrinsic and intact in plants; isolated and synthetic non-
  
  digestible carbohydrates (with 3 or more monomeric units) that FDA has granted be included in the definition of dietary fiber, in response to a petition submitted to FDA under Sec. 10.30 (21 CFR 10.30) demonstrating that such carbohydrates have a physiological effect(s) that is beneficial to human health; or isolated and synthetic non-
  
  digestible carbohydrates (with 3 or more monomeric units) that are the subject of an authorized health claim. Except as provided for in paragraph (f) of this section, if dietary fiber content is not required, and as a result not declared, the statement ``Not a significant source of dietary fiber'' shall be placed at the bottom of the table of nutrient values in the same type size. Dietary fiber content may be determined by subtracting the amount of non-digestible carbohydrates added during processing that do not meet the definition of dietary fiber from the value obtained using AOAC 2009.01, AOAC 2011.25, or an equivalent method of analysis as given in the ``Official Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 in paragraph (g)(2). The following isolated and synthetic non-digestible carbohydrate(s) have been determined by FDA to have physiological effects that are beneficial to human health and, therefore, shall be included in the calculation of the amount of dietary fiber: beta-glucan soluble fiber (as described in Sec. 101.81(c)(2)(ii)(A)) and barley beta-fiber (as described in Sec. 101.81(c)(2)(ii)(A)(6)). Manufacturers may submit a citizen petition in accordance with the requirements of Sec. 10.30 to request that FDA allow for the declaration of the gram amount of an isolated and synthetic non-digestible carbohydrate or a health claim petition in accordance with the requirements of Sec. 101.70 for an isolated and synthetic non-digestible carbohydrate. The manufacturer must make and keep records in accordance with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of dietary fiber in the label and labeling of food when a mixture of dietary fiber, and added non-
  
  digestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in the food.
  
  (A) ``Soluble fiber'' (VOLUNTARY): A statement of the number of grams of soluble dietary fiber in a serving may be declared voluntarily except that when a claim is made on the label or in labeling about soluble fiber, label declaration shall be required. Soluble fiber must meet the definition of dietary fiber in this paragraph (c)(6)(i). Soluble fiber may be determined using AOAC 2011.25 or an equivalent method of analysis as given in the ``Official Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 in paragraph (g)(2). The manufacturer must make and keep records in accordance with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of soluble fiber in the label and labeling of food when a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food. Soluble fiber content shall be indented under dietary fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.''
  
  (B) ``Insoluble fiber'' (VOLUNTARY): A statement of the number of grams of insoluble dietary fiber in a serving may be declared voluntarily except that when a claim is made on the label or in labeling about insoluble fiber, label declaration shall be required. Insoluble fiber must meet the definition of dietary fiber in this paragraph (c)(6)(i). Insoluble fiber may be determined using AOAC 2011.25 or an equivalent method of analysis as given in the ``Official Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 in paragraph (g)(2) of this section. The manufacturer must make and keep records in accordance with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of insoluble fiber in the label and labeling of food when a mixture of insoluble and added non-
  
  digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food. Insoluble fiber content shall be indented under dietary
  
  Page 11969
  
  fiber and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.''
  
  * * * * *
  
  (iii) ``Added Sugars'': A statement of the number of grams of added sugars in a serving, except that label declaration of added sugars content is not required for products that contain less than 1 gram of added sugars in a serving if no claims are made about sweeteners, sugars, added sugars, or sugar alcohol content. If a statement of the added sugars content is not required and, as a result, not declared, the statement ``Not a significant source of added sugars'' shall be placed at the bottom of the table of nutrient values in the same type size. Added sugars shall be defined as sugars that are either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), syrups, naturally occurring sugars that are isolated from a whole food and concentrated so that sugar is the primary component (e.g., fruit juice concentrates), and other caloric sweeteners. Added sugars content shall be indented under sugars and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When a mixture of naturally occurring and added sugars is present in the food, and for specific foods containing added sugars, alone or in combination with naturally occurring sugars, where the added sugars are subject to fermentation, the manufacturer must make and keep records in accordance with paragraphs (g)(10) and (g)(11) of this section to verify the declared amount of added sugars in the label and labeling of food.
  
  (iv) ``Sugar alcohol'' (VOLUNTARY): A statement of the number of grams of sugar alcohols in a serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or sugars when sugar alcohols are present in the food, sugar alcohol content shall be declared. For nutrition labeling purposes, sugar alcohols are defined as the sum of saccharide derivatives in which a hydroxyl group replaces a ketone or aldehyde group and whose use in the food is listed by FDA (e.g., mannitol or xylitol) or is generally recognized as safe (e.g., sorbitol). In lieu of the term ``sugar alcohol,'' the name of the specific sugar alcohol (e.g., ``xylitol'') present in the food may be used in the nutrition label provided that only one sugar alcohol is present in the food. Sugar alcohol content shall be indented and expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero.
  
  (7) ``Protein'': A statement of the number of grams of protein in a serving, expressed to the nearest gram, except that if a serving contains less than 1 gram, the statement ``Contains less than 1 gram'' or ``less than 1 gram'' may be used as an alternative, and if the serving contains less than 0.5 gram, the content may be expressed as zero. When the protein in foods represented or purported to be for adults and children 4 or more years of age has a protein quality value that is a protein digestibility-corrected amino acid score of less than 20 expressed as a percent, or when the protein in a food represented or purported to be for children greater than 1 but less than 4 years of age has a protein quality value that is a protein digestibility-
  
  corrected amino acid score of less than 40 expressed as a percent, either of the following shall be placed adjacent to the declaration of protein content by weight: The statement ``not a significant source of protein,'' or a listing aligned under the column headed ``Percent Daily Value'' of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the Daily Reference Value (DRV) or Reference Daily Intake (RDI), as appropriate, for protein and expressed as a Percent of Daily Value. When the protein quality in a food as measured by the Protein Efficiency Ratio (PER) is less than 40 percent of the reference standard (casein) for a food represented or purported to be specifically for infants 7 through 12 months, the statement ``not a significant source of protein'' shall be placed adjacent to the declaration of protein content. Protein content may be calculated on the basis of the factor 6.25 times the nitrogen content of the food as determined by the appropriate method of analysis as given in the ``Official Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, except when the official procedure for a specific food requires another factor. Copies may be obtained from AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be inspected at the National Archives and Records Administration (NARA). For more information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
  
  (i) A statement of the corrected amount of protein per serving, as determined in paragraph (c)(7)(ii) of this section, calculated as a percentage of the RDI or DRV for protein, as appropriate, and expressed as Percent of Daily Value, may be placed on the label, except that such a statement shall be given if a protein claim is made for the product, or if the product is represented or purported to be specifically for infants 7 through 12 months or children 1 through 3 years of age. When such a declaration is provided, it should be placed on the label adjacent to the statement of grams of protein and aligned under the column headed ``Percent Daily Value,'' and expressed to the nearest whole percent. However, the percentage of the RDI for protein shall not be declared if the food is represented or purported to be specifically for infants 7 through 12 months and the protein quality value is less than 40 percent of the reference standard.
  
  (ii) The ``corrected amount of protein (gram) per serving'' for foods represented or purported for adults and children 1 or more years of age is equal to the actual amount of protein (gram) per serving multiplied by the amino acid score corrected for protein digestibility. If the corrected score is above 1.00, then it shall be set at 1.00. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8.00 in ``Protein Quality Evaluation, Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation,'' Rome, 1991, except that when official AOAC procedures described in this paragraph (c)(7) require a specific food factor other than 6.25, that specific factor shall be used. The ``Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation'' as published by the Food and Agriculture Organization of the United Nations/World Health Organization is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 and is available from the Office of Nutrition, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug
  
  Page 11970
  
  Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be inspected at the National Archives and Records Administration (NARA). For more information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. For foods represented or purported to be specifically for infants 7 through 12 months, the corrected amount of protein (grams) per serving is equal to the actual amount of protein (grams) per serving multiplied by the relative protein quality value. The relative protein quality value shall be determined by dividing the subject food protein PER value by the PER value for casein. If the relative protein value is above 1.00, it shall be set at 1.00.
  
  (iii) For the purpose of labeling with a percent of the DRV or RDI, a value of 50 grams of protein shall be the DRV for adults and children 4 or more years of age, a value of 11 grams of protein shall be the RDI for infants 7 through 12 months, a value of 13 grams shall be the DRV for children 1 through 3 years of age, and a value of 71 grams of protein shall be the RDI for pregnant and lactating women.
  
  (8) Vitamins and minerals: A statement of the amount per serving of the vitamins and minerals as described in this paragraph, expressed as a quantitative amount by weight using the appropriate unit of measure provided in paragraph (c)(8)(iv) of this section and as a percent of Daily Value calculated as a percent of the RDI provided in paragraph (c)(8)(iv) of this section.
  
  (i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d), (e), and (f) of this section, foods represented or purported to be specifically for infants 7 through 12 months, children 1 through 3 years, and pregnant and lactating women shall use the RDIs that are specified for the intended group. For foods represented or purported to be specifically for both infants 7 through 12 months and children 1 through 3 years of age, the percent of Daily Value shall be presented by separate declarations according to paragraph (e) of this section based on the RDI values for infants 7 through 12 months and children 1 through 3 years of age. When such dual declaration is used on any label, it shall be included in all labeling, and equal prominence shall be given to both values in all such labeling. The percent Daily Value based on the RDI values for pregnant and lactating women shall be declared on food represented or purported to be specifically for pregnant and lactating women. All other foods shall use the RDI for adults and children 4 or more years of age.
  
  (ii) The declaration of vitamins and minerals as a quantitative amount by weight and percent of the RDI shall include vitamin D, calcium, iron, and potassium in that order, for infants 7 through 12 months, children 1 through 3 years of age, pregnant and lactating women, and adults and children 4 or more years of age. The declaration of vitamins and minerals as a quantitative amount by weight and percent of the RDI shall include any of the other vitamins and minerals listed in paragraph (c)(8)(iv) of this section when they are added as a nutrient supplement, or when a claim is made about them. Other vitamins and minerals need not be declared if neither the nutrient nor the component is otherwise referred to on the label or the labeling or advertising and the vitamins and minerals are:
  
  * * * * *
  
  (iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment above 10 percent and up to and including the 50-percent level. Quantitative amounts and percentages of vitamins and minerals present at less than 2 percent of the RDI are not required to be declared in nutrition labeling but may be declared by a zero or by the use of an asterisk (or other symbol) that refers to another asterisk (or symbol) that is placed at the bottom of the table and that is followed by the statement ``Contains less than 2 percent of the Daily Value of this (these) nutrient (nutrients)'' or ``Contains = 4 through 12 Children 1 Pregnant and
  
  years months through 3 years lactating women
  
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  
  Vitamin A....................................... Micrograms RAE \1\ (mcg).......... 900 500 300 1,300
  
  Vitamin C....................................... Milligrams (mg)................... 90 50 15 120
  
  Calcium......................................... Milligrams (mg)................... 1,300 260 700 1,300
  
  Iron............................................ Milligrams (mg)................... 18 11 7 27
  
  Vitamin D....................................... Micrograms (mcg).................. 20 10 15 15
  
  Vitamin E....................................... Milligrams (mg)................... 15 5 6 19
  
  Vitamin K....................................... Micrograms (mcg).................. 120 2.5 30 90
  
  Thiamin......................................... Milligrams (mg)................... 1.2 0.3 0.5 1.4
  
  Riboflavin...................................... Milligrams (mg)................... 1.3 0.4 0.5 1.6
  
  Niacin.......................................... Milligrams NE \2\ (mg)............ 16 4 6 18
  
  Vitamin B6...................................... Milligrams (mg)................... 1.7 0.3 0.5 2.0
  
  Folate \3\...................................... Micrograms DFE \4\ (mcg).......... 400 80 150 600
  
  Vitamin B12..................................... Micrograms (mcg).................. 2.4 0.5 0.9 2.8
  
  Biotin.......................................... Micrograms (mcg).................. 30 6 8 35
  
  Pantothenic acid................................ Milligrams (mg)................... 5 1.8 2 7
  
  Page 11971
  
  Phosphorous..................................... Milligrams (mg)................... 1,250 275 460 1,250
  
  Iodine.......................................... Micrograms (mcg).................. 150 130 90 290
  
  Magnesium....................................... Milligrams (mg)................... 420 75 80 400
  
  Zinc............................................ Milligrams (mg)................... 11 3 3 13
  
  Selenium........................................ Micrograms (mcg).................. 55 20 20 70
  
  Copper.......................................... Milligrams (mg)................... 0.9 0.2 0.3 1.3
  
  Manganese....................................... Milligrams (mg)................... 2.3 0.6 1.2 2.6
  
  Chromium........................................ Micrograms (mcg).................. 35 5.5 11 45
  
  Molybdenum...................................... Micrograms (mcg).................. 45 3 17 50
  
  Chloride........................................ Milligrams (mg)................... 2,300 570 1500 2300
  
  Potassium....................................... Milligrams (mg)................... 4,700 700 3000 5100
  
  Choline......................................... Milligrams (mg)................... 550 150 200 550
  
  Protein......................................... Grams (g)......................... N/A 11 N/A \5\ 71
  
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  
  A percent daily value must be declared on the label for bolded nutrients.
  
  \1\ RAE = Retinol activity equivalents; 1 RAE = 1 microgram retinol, 12 micrograms beta-carotene, or 24 micrograms alpha-carotene, or 24 micrograms
  
  beta-cryptoxanthin.
  
  \2\ NE = Niacin equivalents, 1 milligram niacin = 60 milligrams of tryptophan.
  
  \3\ ``Folic Acid'' must be used for purposes of declaration in the labeling of dietary supplements. It must also be declared in mcg DFE.
  
  \4\ DFE = Dietary folate equivalents; 1 DFE = 1 microgram food folate = 0.6 micrograms folic acid from fortified food or as a supplement consumed with
  
  food = 0.5 micrograms of a supplement.
  
  \5\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant and lactating women.
  
  (v) The following synonyms may be added in parentheses immediately following the name of the nutrient or dietary component:
  
  Calories--Energy
  
  Vitamin C--Ascorbic acid
  
  Thiamin--Vitamin B1
  
  Riboflavin--Vitamin B2
  
  * * * * *
  
  (vii) When the amount of folate is declared in the labeling of a conventional food, the nutrient name ``folate'' shall be listed for products containing either folate alone or a mixture of folate and folic acid. The name of the synthetic form of the nutrient, ``folic acid'' shall be used when the nutrient is declared in the labeling of dietary supplements.
  
  (9) The following DRVs, nomenclature, and units of measure are established for the following food components:
  
  ----------------------------------------------------------------------------------------------------------------
  
  DRV
  
  ---------------------------------------------------------------
  
  Food component Unit of Adults and Infants 7 Children 1 Pregnant and
  
  measurement children >= 4 through 12 through 3 lactating
  
  years months years women
  
  ----------------------------------------------------------------------------------------------------------------
  
  Fat........................... Grams (g)....... \1\ 65 30 \2\ 39 \1\ 65
  
  Saturated fatty acids......... Grams (g)....... \1\ 20 N/A \2\ 10 \1\ 20
  
  Cholesterol................... Milligrams (mg). 300 N/A 300 300
  
  Total carbohydrate............ Grams (g)....... \1\ 300 95 \2\ 150 \1\ 300
  
  Sodium........................ Milligrams (mg). 2,300 N/A 1,500 2,300
  
  Dietary fiber................. Grams (g)....... \1\ 28 N/A \2\ 14 \1\ 28
  
  Protein....................... Grams (g)....... \1\ 50 N/A \2\ 13 N/A
  
  ----------------------------------------------------------------------------------------------------------------
  
  \1\ Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and
  
  for pregnant and lactating women
  
  \2\ Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.
  
  (d)(1) Nutrient information specified in paragraph (c) of this section shall be presented on foods in the following format, as shown in paragraph (d)(12) of this section, except on foods where the tabular display is permitted as provided for in paragraph (d)(11) of this section, on which dual columns of nutrition information are declared as provided for in paragraph (e) of this section, on those food products on which the simplified format is required to be used as provided for in paragraph (f) of this section, on foods for infants 7 months to 12 months of age and children 1 through 3 years of age as provided for in paragraph (j)(5) of this section, and on foods in small or intermediate-sized packages as provided for in paragraph (j)(13) of this section. In the interest of uniformity of presentation, FDA strongly recommends that the nutrition information be presented using the graphic specifications set forth in appendix B to part 101.
  
  * * * * *
  
  (ii) * * *
  
  (C) At least nine points leading (i.e., space between two lines of text) except that at least 12 points leading shall be utilized for the information required by paragraphs (d)(7) and (d)(8) of this section as shown in paragraph (d)(12), and
  
  * * * * *
  
  (iii) Information required in paragraphs (d)(7) and (d)(8) of this section shall be in type size no smaller than 8 point, except the type size for this information required in the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section shall be no smaller than 7 point. Information required in the footnote statement shall be no smaller than 7 point, except the type size for this information required in the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, for the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, and for the simplified format as shown in paragraph (f)(5) of
  
  Page 11972
  
  this section shall be no smaller than 6 point. Information required in paragraph (d)(5) of this section for the ``Calories'' declaration shall be highlighted in bold or extra bold and shall be in a type size no smaller than 16 point except the type size for this information required in the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, and the required information shown in paragraphs (d)(11)(iii) and (e)(6)(ii) of this section shall be in a type size no smaller than 12 point. The numeric amount for the information required in paragraph (d)(5) of this section shall also be highlighted in bold or extra bold type and shall be in a type size no smaller than 24 point, except the type size for this information required in the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section, the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section, and for the required information shown in paragraph (e)(6)(ii) of this section shall be in a type size no smaller than 20 point. The information required in paragraph (d)(6) of this section shall be in a type size no smaller than 7 point. When provided, the information described in paragraph (d)(10) of this section shall be in a type size no smaller than 6 point.
  
  (iv) The headings required by paragraphs (d)(2), (d)(3)(i), and (d)(6) of this section (i.e., ``Nutrition Facts,'' ``----servings per container,'' and ``% DV*''), the calorie information, and the names of all nutrients that are not indented according to requirements of paragraph (c) of this section (i.e., ``Calories,'' ``Total Fat,'' ``Cholesterol,'' ``Sodium,'' ``Total Carbs'' and ``Protein''), and the percentage amounts required by paragraph (d)(7)(ii) of this section shall be highlighted in bold or extra bold type or other highlighting (reverse printing is not permitted as a form of highlighting) that prominently distinguishes it from other information. The names of all nutrients that are indented according to the requirements of paragraph (c) of this section (i.e., ``Saturated Fat,'' ``Trans Fat,'' ``Dietary Fiber,'' ``Sugars,'' and ``Added Sugars'') and the mandatory and any voluntary vitamins and minerals (except sodium), shall be highlighted in a type that is intermediate between bold or extra bold type and the type for all other information.
  
  (v) A hairline rule that is centered between the lines of text shall separate ``Nutrition Facts'' from the servings per container statement required in paragraph (d)(3)(i) of this section and shall separate each nutrient and its corresponding percent Daily Value required in paragraphs (d)(7)(i) and (d)(7)(ii) of this section from the nutrient and percent Daily Value above and below it, as shown in paragraph (d)(12) of this section.
  
  (2) The information shall be presented under the identifying heading of ``Nutrition Facts'' in the nutrition label and, except for labels presented according to the format provided for in paragraphs (d)(11)(iii), (d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and (j)(13)(ii)(A)(2) of this section, unless impractical, shall be set the full width of the information provided under paragraph (d)(7) of this section, as shown in paragraph (d)(12) of this section.
  
  (3) * * *
  
  (i) ``----servings per container'': The number of servings per container, except that this statement is not required on single serving containers as defined in paragraph (b)(6) of this section or on other food containers when this information is stated in the net quantity of contents declaration. The information required in this paragraph shall be highlighted in bold or extra bold and be in a type size no smaller than 11 point except the type size shall be no smaller than 10 point for this information as shown in paragraph (j)(13)(ii)(A)(1) and no smaller than 7 point as shown in paragraph (j)(13)(ii)(A)(2) of this section. This information shall be set the full width of the label as shown in paragraph (d)(12) of this section.
  
  (ii) ``Serving size'': A statement of the serving size as specified in paragraph (b)(7) of this section. The serving size as specified in paragraph (b)(7) of this section must be right justified as shown in paragraph (d)(12) of this section. The information required in this paragraph shall be in a type size no smaller than 8 point except the type size shall be no smaller than 7 point for this information as shown in paragraph (j)(13)(ii)(A)(2) of this section.
  
  (4) A subheading ``Amount per'' followed by the serving size shall be separated from the serving size information by a bar as shown in paragraph (d)(12) of this section and shall be highlighted in a type that is intermediate between bold or extra bold type and the type for all other information, and be in a type size no smaller than 8 point, except the type size for this information required in the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) and the tabular display for small packages as shown in paragraph (j)(13)(ii)(A)(1) of this section shall be no smaller than 6 point, and there shall be no bar separating this information from the serving size information in both of these displays for small packages.
  
  (5) Information on calories shall immediately follow the heading ``Amount per'' followed by the serving size and shall be declared in one line. If ``Calories from saturated fat'' is declared, it shall be indented under ``Calories'' and shall be in a type size no smaller than 8 point.
  
  (6) The column heading ``% DV,'' followed by an asterisk (e.g., ``% DV*''), shall be separated from information on calories by a bar as shown in paragraph (d)(12) of this section. The position of this column heading shall allow for a list of nutrient names and amounts as described in paragraph (d)(7) of this section to be to the right of, and below, this column heading, except for labels with a dual or multiple column format as shown in paragraphs (d)(13)(ii), (e)(5), (e)(6)(i), and (e)(6)(ii) the ``% DV'' column will appear to the right of the list of nutrient names. The column heading described in this paragraph shall not appear on the linear display for small packages as shown in paragraph (j)(13)(ii)(A)(2) of this section.
  
  (7) Except as provided for in paragraphs (d)(13)(ii), (e)(5), (e)(6)(i), (e)(6)(ii), and (j)(13) of this section, nutrient information for both mandatory and any voluntary nutrients listed in paragraph (c) of this section that are to be declared in the nutrition label shall be declared as follows:
  
  (i) The name of each nutrient, as specified in paragraph (c) of this section, shall be given in a column and followed immediately by the quantitative amount by weight for that nutrient appended with a ``g'' for grams, ``mg'' for milligrams, or ``mcg'' for micrograms as shown in paragraph (d)(12) of this section. The symbol ``>'' may be used in place of ``less than.''
  
  (ii) A listing of the percent of the DRV as established in paragraphs (c)(7)(iii) and (c)(9) of this section shall be given in a column aligned under the heading ``% DV'' established in paragraph (d)(6) of this section with the percent expressed to the nearest whole percent for each nutrient declared in the column described in paragraph (d)(7)(i) of this section for which a DRV has been established, except that the percent for protein may be omitted as provided in paragraph (c)(7) of this section. The percent shall be calculated by dividing either the amount declared on the label for each nutrient or the actual amount of each nutrient (i.e., before rounding) by the DRV for the nutrient, except that the percent for protein shall be
  
  Page 11973
  
  calculated as specified in paragraph (c)(7)(ii) of this section. The numerical value shall be followed by the symbol for percent (i.e., %).
  
  (8) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and may be arrayed vertically as shown in paragraph (d)(12) of this section (e.g., Vitamin D 2mcg (10%), Calcium 260mg (20%), Iron 8mg (45%), Potassium 235mg (5%)) or may be listed in two columns. When listed horizontally in two columns, vitamin D and calcium should be listed on the first line and iron and potassium should be listed on the second line.
  
  (9) Reserved
  
  (10) Caloric conversion information on a per gram basis for fat, carbohydrate, and protein may be presented beneath the information required in the footnote statement, separated from that information by a hairline. This information may be presented horizontally as shown in paragraph (d)(12) of this section (i.e. ``Calories per gram: fat 9, carbohydrate 4, protein 4'') or vertically in columns.
  
  (11)(i) If the space beneath the information on vitamins and minerals is not adequate to accommodate the information required in the footnote statement, the information required in the footnote statement may be moved to the right of the column required in paragraph (d)(7)(ii) of this section and set off by a line that distinguishes it and sets it apart from the percent Daily Value information. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.
  
  (ii) If the space beneath the mandatory declaration of potassium is not adequate to accommodate any remaining vitamins and minerals to be declared or the information required in the footnote statement, the remaining information may be moved to the right and set off by a line that distinguishes it and sets it apart from the nutrients and the percent DV information given to the left. The caloric conversion information provided for in paragraph (d)(10) of this section may be presented beneath either side or along the full length of the nutrition label.
  
  (iii) If there is not sufficient continuous vertical space (i.e., approximately 3 in) to accommodate the required components of the nutrition label up to and including the mandatory declaration of potassium, the nutrition label may be presented in a tabular display as shown in the following sample label.
  
  GRAPHIC TIFF OMITTED TP03MR14.003
  
  (12) The following sample labels illustrate the mandatory provisions and mandatory plus voluntary provisions of paragraph (d) of this section.
  
  Page 11974
  
  GRAPHIC TIFF OMITTED TP03MR14.004
  
  (13) * * *
  
  (ii) Aggregate displays shall comply with the format requirements of paragraph (d) of this section to the maximum extent possible, except that the identity of each food shall be specified immediately to the right of the ``Nutrition Facts'' heading, and both the quantitative amount by weight (i.e., g/mg/mcg amounts) and the percent Daily Value for each nutrient shall be listed in separate columns under the name of each food. The following sample label illustrates an aggregate display.
  
  Page 11975
  
  GRAPHIC TIFF OMITTED TP03MR14.005
  
  * * * * *
  
  (e) Nutrition information may be presented for two or more forms of the same food (e.g., both ``as purchased'' and ``as prepared'') or for common combinations of food as provided for in paragraph (h)(4) of this section, for different units (e.g., slices of bread or per 100 grams) as provided for in paragraph (b) of this section, or for two or more groups for which RDIs are established (e.g., both infants 7 through 12 months and children 1 through 3 years of age) as shown in paragraph (e)(5) of this section. When such dual labeling is provided, equal prominence shall be given to both sets of values. Information shall be presented in a format consistent with paragraph (d) of this section, except that:
  
  (1) Following the serving size information there shall be two or more column headings accurately describing the amount per serving size of the form of the same food (e.g., ``Per \1/4\ cup mix'' and ``Per prepared portion''), the combinations of food, the units, or the RDI groups that are being declared as shown in paragraph (e)(5) of this section.
  
  (2) The information required in paragraph (d)(7)(ii) and the quantitative information by weight as required in paragraph (d)(7)(i) of this section shall be presented for the form of the product as packaged and for any other form of the product (e.g., ``as prepared'' or combined with another ingredient as shown in paragraph (e)(5) of this section).
  
  (3) When the dual labeling is presented for two or more forms of the same food, for combinations of food, for different units, or for two or more groups for which RDIs are established, the percent DV and quantitative information shall be separated by vertical lines as shown in paragraph (e)(5) of this section.
  
  (4) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and shall be arrayed vertically in the following order: Vitamin D, calcium, iron, potassium as shown in paragraph (e)(5) of this section.
  
  (5) The following sample label illustrates the provisions of paragraph (e) of this section:
  
  GRAPHIC TIFF OMITTED TP03MR14.006
  
  (6) When dual labeling is presented for a food on a per serving basis and per container basis as required in paragraph (b)(12)(i) of this section or on a per serving basis and per unit basis as required in paragraph (b)(2)(i)(D) of this section, the percent Daily Value as required in paragraph (d)(7)(ii) and the quantitative information by weight shall be presented in two columns, and the percent DV and quantitative information shall be separated by vertical lines as
  
  Page 11976
  
  shown in the displays in paragraph (e)(6)(i) of this section.
  
  (i) Nutrient information for vitamins and minerals shall be separated from information on other nutrients by a bar and shall be arrayed vertically in the following order: Vitamin D, calcium, iron, and potassium as shown in the following sample labels.
  
  GRAPHIC TIFF OMITTED TP03MR14.007
  
  (ii) The following sample label illustrates the provisions of paragraphs (b)(2)(i)(D) and (b)(12)(i) of this section for labels that use the tabular display.
  
  GRAPHIC TIFF OMITTED TP03MR14.008
  
  (f) The declaration of nutrition information may be presented in the simplified format set forth herein when a food product contains insignificant amounts of eight or more of the following: Calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, added sugars, protein, vitamin D, calcium, iron, and potassium; except that for foods intended for infants 7 months to 12 months of age and children 1 through 3 years of age to which paragraph (j)(5)(i) of this section applies, nutrition information may be presented in the simplified format when a food product contains insignificant amounts of six or more of the following: Calories, total fat, sodium, total carbohydrate, dietary fiber, sugars, added sugars, protein, vitamin D, calcium, iron, and potassium.
  
  * * * * *
  
  (2) * * *
  
  (ii) Any other nutrients identified in paragraph (f) of this section that are present in the food in more than insignificant amounts; and
  
  * * * * *
  
  (4) If any nutrients are declared as provided in paragraphs (f)(2)(iii), (f)(2)(iv), or (f)(3) of this section as part of the simplified format or if any nutrition claims are made on the label or in labeling, the statement ``Not a significant source of ------'' (with the blank filled in with the name(s) of any nutrient(s) identified in paragraph (f) of this section that are present in insignificant amounts) shall be included at the bottom of the nutrition label.
  
  Page 11977
  
  GRAPHIC TIFF OMITTED TP03MR14.009
  
  (5) Except as provided for in paragraphs (j)(5) and (j)(13) of this section, nutrient information declared in the simplified format shall be presented in the same manner as specified in paragraphs (d) or (e) of this section.
  
  (g) Compliance with this section shall be determined as follows:
  
  * * * * *
  
  (2) The sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken 1 from each of 12 different randomly chosen shipping cases, to be representative of a lot. Unless a particular method of analysis is specified in paragraph (c) of this section, composites shall be analyzed by appropriate methods as given in the ``Official Methods of Analysis of the AOAC International,'' 19th Ed. (2012), which is incorporated by reference in accordance with 5 U.S.C. 552(a) or 1 CFR part 51 or, if no AOAC method is available or appropriate, by other reliable and appropriate analytical procedures. The availability of this incorporation by reference is given in paragraph (c)(7) of this section.
  
  (3) * * *
  
  (ii) Class II. Naturally occurring (indigenous) nutrients. When a nutrient or nutrients are naturally occurring (indigenous) in an ingredient that is added to a food, the total amount of such nutrient(s) in the final food product is subject to class II requirements, except that when a nutrient or nutrients are not naturally occurring (exogenous) in an ingredient that is added to a food, the total amount of such nutrient(s) in the final food product is subject to class I requirements.
  
  (4) A food with a label declaration of a vitamin, mineral, protein, total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, polyunsaturated or monounsaturated fat shall be deemed to be misbranded under section 403(a) of the Federal Food, Drug, and Cosmetic Act (the act) unless it meets the following requirements:
  
  (i) When a vitamin, mineral, protein, or non-digestible carbohydrate(s) (when the food contains only non-digestible carbohydrates (soluble or insoluble) that meet the definition of dietary fiber) meets the definition of a Class I nutrient, the nutrient content of the composite must be formulated to be at least equal to the value for that nutrient declared on the label.
  
  (ii) When a vitamin, mineral, protein, total carbohydrate, polyunsaturated or monounsaturated fat, or non-digestible carbohydrate(s) (when the food contains only non-digestible carbohydrates (soluble or insoluble) that meet the definition of dietary fiber) meets the definition of a Class II nutrient, the nutrient content of the composite must be at least equal to 80 percent of the value for that nutrient declared on the label. No regulatory action will be based on a determination of a nutrient value that falls below this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.
  
  (5) A food with a label declaration of calories, sugars, added sugars (when the only source of sugars in the food is added sugars), total fat, saturated fat, trans fat, cholesterol, or sodium shall be deemed to be misbranded under section 403(a) of the act if the nutrient content of the composite is greater than 20 percent in excess of the value for that nutrient declared on the label. No regulatory action will be based on a determination of a nutrient value that falls above this level by a factor less than the variability generally recognized for the analytical method used in that food at the level involved.
  
  (6) Reasonable excesses of vitamins, minerals, protein, total carbohydrate, dietary fiber, soluble fiber, insoluble fiber, sugar alcohols, polyunsaturated or monounsaturated fat over labeled amounts are acceptable within current good manufacturing practice. Reasonable deficiencies of calories, sugars, added sugars, total fat, saturated fat, trans fat, cholesterol, or sodium under labeled amounts are acceptable within current good manufacturing practice.
  
  (7) Compliance will be based on the metric measure specified in the label statement of the serving size.
  
  (8) Alternatively, compliance with the provisions set forth in paragraphs (g)(1) through (g)(6) of this section may be provided by use of an FDA approved database that has been computed following FDA guideline procedures and where food samples have been handled in accordance with current good manufacturing practice to prevent nutrition loss. FDA approval of a database shall not be considered granted until the Center for Food Safety and Applied Nutrition has agreed to all aspects of the database in writing. The approval will be granted where a clear need is presented (e.g., raw produce and seafood). Approvals will be in effect for a limited time, e.g., 10 years, and will be eligible for renewal in the absence of significant changes in agricultural or industry practices. Approval requests shall be submitted in accordance with the provisions of Sec. 10.30 of this chapter. Guidance in the use of databases may be found in the ``FDA Nutrition Labeling Manual--A Guide for Developing and Using Data Bases,'' available from the Office of Nutrition, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 or by going to http://www.fda.gov.
  
  * * * * *
  
  (10) The manufacturer must make and keep written records (e.g., analyses of databases, recipes, formulations, or batch records) to verify the declared amount of that nutrient on the Nutrition Facts label as follows:
  
  (i) When a mixture of dietary fiber, and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber, is present in the food, a manufacturer must make and keep written records of the amount of non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber.
  
  (ii) When a mixture of soluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food, a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber.
  
  (iii) When a mixture of insoluble fiber and added non-digestible carbohydrate(s) that does not meet the definition of dietary fiber is present in the food, a manufacturer must make and keep written records necessary to verify the amount of the non-digestible carbohydrate(s) added to the food that does not meet the definition of dietary fiber.
  
  (iv) When a mixture of naturally occurring and added sugars is present in
  
  Page 11978
  
  the food, a manufacturer must make and keep written records of the amount of added sugars added to the food during the processing of the food, and if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient).
  
  (v) When the amount of added sugars added to yeast-leavened bakery products, wines with less than 7 percent alcohol by volume, or beer that does not meet the definition of a ``malt beverage,'' as defined by the Federal Alcohol Administration Act (27 U.S.C. 211(a)(7)), is reduced through the process of fermentation, manufacturers must:
  
  (A) Make and keep records of all relevant scientific data and information relied upon by the manufacturer that demonstrates the amount of added sugars in the food after fermentation and a narrative explaining why the data and information are sufficient to demonstrate the amount of added sugars declared in the finished food, provided the data and information used is specific to the type of fermented food manufactured; or
  
  (B) Make and keep records of the amount of added sugars added to the food before and during the processing of the food, and if packaged as a separate ingredient, as packaged (whether as part of a package containing one or more ingredients or packaged as a single ingredient) and in no event shall the amount of added sugars declared exceed the amount of total sugars on the label.
  
  (vi) When a mixture of all rac-alpha-tocopherol acetate and RRR-
  
  alpha-tocopherol is present in a food, manufacturers must make and keep written records of the amount of all rac-alpha-tocopherol acetate added to the food and RRR-alpha-tocopherol in the finished food.
  
  (vii) When a mixture of folate and folic acid is present in a food, manufacturers must make and keep written records of the amount of folic acid added to the food and folate in the finished food.
  
  (11) Records necessary to verify certain nutrient declarations that are specified in paragraph (g)(10) of this section must be kept for a period of at least 2 years after introduction or delivery for introduction of the food into interstate commerce. Such records must be provided to FDA upon request, during an inspection, for official review and photocopying or other means of reproduction. Records required to verify information on the label may be kept either as original records, true copies (such as photocopies, pictures, scanned copies, microfilm, microfiche, or other accurate reproductions of the original records), or electronic records which must be kept in accordance with part 11 of this chapter. These records must be accurate, indelible, and legible. Failure to make and keep the records or provide the records to appropriate regulatory authorities, as required by this subparagraph, would result in the food being misbranded under section 403(a)(1) of the act.
  
  (h) * * *
  
  (3) * * *
  
  (iv) Nutrition information may be provided per serving for individual foods in the package, or, alternatively, as a composite per serving for reasonable categories of foods in the package having similar dietary uses and similar significant nutritional characteristics. Reasonable categories of foods may be used only if accepted by FDA. In determining whether a proposed category is reasonable, FDA will consider whether the values of the characterizing nutrients in the foods proposed to be in the category meet the compliance criteria set forth in paragraphs (g)(3) through (g)(6) of this section. Proposals for such categories may be submitted in writing to the Office of Nutrition, Labeling and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
  
  * * * * *
  
  (4) If a food is commonly combined with other ingredients or is cooked or otherwise prepared before eating, and directions for such combination or preparations are provided, another column of figures may be used to declare nutrition information on the basis of the food as consumed in the format required in paragraph (e) of this section; e.g., a dry ready-to-eat cereal may be described with the percent Daily Value and the quantitative amounts for the cereal as sold (e.g., per ounce), and the percent Daily Value and the quantitative amounts for the cereal and milk as suggested in the label (e.g., per ounce of cereal and \1/2\ cup of vitamin D fortified skim milk); and a cake mix may be labeled with the percent Daily Value and the quantitative amounts for the dry mix (per serving) and the percent Daily Value and the quantitative amounts for the serving of the final cake when prepared, as shown in paragraph (e)(5): Provided, that, the type and quantity of the other ingredients to be added to the product by the user and the specific method of cooking and other preparation shall be specified prominently on the label.
  
  * * * * *
  
  (j) * * *
  
  (5)(i) Foods, other than infant formula, represented or purported to be specifically for infants 7 through 12 months and children 1 through 3 years of age shall bear nutrition labeling. The nutrients declared for infants 7 through 12 months and children 1 through 3 years of age shall include calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, dietary fiber, sugars, added sugars, protein, and the following vitamins and minerals: Vitamin D, calcium, iron, and potassium.
  
  GRAPHIC TIFF OMITTED TP03MR14.010
  
  (ii) Foods other than infant formula, represented or purported to be specifically for infants 7 through 12 months of age shall bear nutrition labeling, except that:
  
  (A) Such labeling shall not declare a percent Daily Value for saturated fat, trans fat, cholesterol, sodium, dietary fiber, sugars, or added sugars.
  
  * * * * *
  
  (13) * * *
  
  (ii) * * *
  
  (A) * * *.
  
  (1) The following sample label illustrates the tabular display for small packages.
  
  Page 11979
  
  GRAPHIC TIFF OMITTED TP03MR14.011
  
  (2) The following sample label illustrates the linear display.
  
  GRAPHIC TIFF OMITTED TP03MR14.012
  
  (B) Using any of the following abbreviations:
  
  Serving size--Serv size
  
  Servings per container--Servings
  
  Calories from saturated fat--Sat fat cal
  
  Saturated fat--Sat fat
  
  Monounsaturated fat--Monounsat fat
  
  Polyunsaturated fat--Polyunsat fat
  
  Cholesterol--Cholest
  
  Total carbohydrate--Total carbs
  
  Dietary fiber--Fiber
  
  Soluble fiber--Sol fiber
  
  Insoluble fiber--Insol fiber
  
  Sugar alcohol--Sugar alc
  
  (C) Omitting the footnote statement and placing another asterisk at the bottom of the label followed by the statement ``Percent Daily Values are based on a 2,000 calorie diet.''
  
  * * * * *
  
  (18) * * *
  
  (iv) A notice shall be filed with the Office of Nutrition, Labeling, and Dietary Supplements (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 and contain the following information, except that if the person is not an importer and has fewer than 10 full-time equivalent employees, that person does not have to file a notice for any food product with annual sales of fewer than 10,000 total units:
  
  * * * * *
  
  0
  
  3. In Sec. 101.36:
  
  0
44. Revise paragraphs (b)(1)(i), (b)(2)(i) introductory text, (b)(2)(i)(B), (b)(2)(ii)(A), (b)(2)(iii) introductory text, (b)(2)(iii)(D) through (G), (b)(3)(ii)(A), (c)(4), (e) introductory text, (e)(8), (e)(11)(i) through (viii), (e)(12), (f)(2), and (i)(1); and
  
  0
45. Remove paragraph (i) introductory text.
  
  The revisions read as follows:
  
  Sec. 101.36 Nutrition labeling of dietary supplements.
  
  * * * * *
  
  (b) * * *
  
  (1) Serving size. (i) The subheading ``Serving Size'' shall be placed under the heading ``Supplement Facts'' and aligned on the left side of the nutrition label. The subheading ``Servings Per Container'' and the actual number of servings shall be highlighted in bold or extra bold type. The serving size shall be determined in accordance with Sec. Sec. 101.9(b) and 101.12(b), table 2. Serving size for dietary supplements shall be expressed using a term that is appropriate for the form of the supplement, such as ``tablets,'' ``capsules,'' ``packets,'' or ``teaspoonfuls.''
  
  * * * * *
  
  (2) * * * (i) The (b)(2)-dietary ingredients to be declared, that is, total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with Sec. 101.9(c). Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol may be declared, but they shall be declared when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in Sec. 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.
  
  * * * * *
  
  (B) The names of dietary ingredients that are declared under paragraph (b)(2)(i) of this section shall be presented in a column aligned on the left side of the nutritional label in the order and manner of indentation specified in Sec. 101.9(c), except that calcium and iron shall follow pantothenic acid, and sodium and potassium shall follow chloride. This results in the following order for vitamins and minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folic acid, vitamin B12, biotin, pantothenic acid, calcium, iron, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, potassium, and choline. The (b)(2)-
  
  dietary ingredients shall be listed according to the nomenclature specified in Sec. 101.9 or in paragraph (b)(2)(i)(B)(2) of this section.
  
  (1) When ``Calories'' are declared, they shall be listed first in the column of names, beneath a light bar separating the heading ``Amount Per Serving'' from the list of names. When ``Calories from saturated fat'' are declared, they shall be indented under ``Calories.''
  
  (2) The following synonyms may be added in parentheses immediately following the name of these (b)(2)-dietary ingredients: Vitamin C (ascorbic acid), thiamin (vitamin B1), riboflavin (vitamin B2), and calories (energy). Energy content per serving may be expressed in kilojoule units, added in parentheses immediately following the statement of caloric content.
  
  (3) Beta-carotene may be declared as the percent of vitamin A that is present as beta-carotene, except that the
  
  Page 11980
  
  declaration is required when a claim is made about beta-carotene. When declared, the percent shall be declared to the nearest whole percent, immediately adjacent to or beneath the name vitamin A (e.g., ``Vitamin A (90% as beta-carotene)''). The amount of beta-carotene in terms of micrograms (mcg) may be included in the parentheses following the percent statement (e.g., ``Vitamin A (90% (810 mcg) as beta-
  
  carotene)'').
  
  (ii) * * *
  
  (A) The amounts shall be expressed in the increments specified in Sec. 101.9(c)(1) through (c)(7), which includes increments for sodium.
  
  * * * * *
  
  (iii) The percent of the Daily Value of all dietary ingredients declared under paragraph (b)(2)(i) of this section shall be listed, except that the percent of the Daily Value for protein may be omitted as provided in Sec. 101.9(c)(7); no percent of the Daily Value shall be given for subcomponents for which DRVs or RDIs have not been established (e.g., sugars).
  
  * * * * *
  
  (D) If the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein, a symbol shall follow the value listed for those nutrients that refers to the same symbol that is placed at the bottom of the nutrition label, below the bar required under paragraph (e)(6) of this section and inside the box, that is followed by the statement ``Percent Daily Values are based on a 2,000 calorie diet.'' If the product is represented or purported to be for use by children 1 through 3 years of age, and if the percent of Daily Value is declared for total fat, total carbohydrate, dietary fiber, or protein, a symbol shall follow the value listed for those nutrients that refers to the same symbol that is placed at the bottom of the nutrition label, below the bar required under paragraph (e)(6) of this section and inside the box, that is followed by the statement ``Percent Daily Values are based on a 1,000 calorie diet.''
  
  (E) The percent of Daily Value shall be based on RDI or DRV values for adults and children 4 or more years of age, unless the product is represented or purported to be specifically for infants 7 through 12 months of age, children 1 through 3 years of age, or pregnant and lactating women, in which case the column heading shall clearly state the intended group. If the product is for persons within more than one group, the percent of Daily Value for each group shall be presented in separate columns as shown in paragraph (e)(11)(ii) of this section.
  
  (F) For declared subcomponents that have no DRVs or RDIs, a symbol (e.g., an asterisk) shall be placed in the ``Percent Daily Value'' column that shall refer to the same symbol that is placed at the bottom of the nutrition label, below the last heavy bar and inside the box, and followed by a statement ``Daily Value not established.''
  
  (G) When calories or calories from saturated fat are declared, the space under the ``% DV'' column shall be left blank for these items. When there are no other (b)(2)-dietary ingredients listed for which a value must be declared in the ``% DV'' column, the column may be omitted as shown in paragraph (e)(11)(vii) of this section. When the ``% DV'' column is not required, but the dietary ingredients listed are subject to paragraph (b)(2)(iii)(F) of this section, the symbol required in that paragraph shall immediately follow the quantitative amount by weight for each dietary ingredient listed under ``Amount Per Serving.''
  
  (3) * * *
  
  (ii) * * *
  
  (A) These amounts shall be expressed using metric measures in appropriate units.
  
  * * * * *
  
  (c) * * *
  
  (4) The sample label shown in paragraph (e)(11)(v) of this section illustrates one method of nutrition labeling a proprietary blend of dietary ingredients.
  
  * * * * *
  
  (e) Except as provided for small and intermediate sized packages under paragraph (i)(2) of this section, information other than the title, headings, and footnotes shall be in uniform type size no smaller than 8 point. A font size at least two points greater shall be used for ``Calories'' and the heading ``Calories'' and the actual number of calories per serving shall be highlighted in bold or extra bold type. Type size no smaller than 6 point may be used for column headings (e.g., ``Amount Per Serving'' and ``% Daily Value'') and for footnotes (e.g., ``Percent Daily Values are based on a 2,000 calorie diet).
  
  * * * * *
  
  (8) If the product contains two or more separately packaged dietary supplements that differ from each other (e.g., the product has a packet of supplements to be taken in the morning and a different packet to be taken in the afternoon), the quantitative amounts and percent of Daily Value may be presented as specified in this paragraph in individual nutrition labels or in one aggregate nutrition label as illustrated in paragraph (e)(11)(iii) of this section.
  
  * * * * *
  
  (11) * * *
  
  BILLING CODE 4160-01-P
  
  (l) Multiple vitamins
  
  Page 11981
  
  GRAPHIC TIFF OMITTED TP03MR14.013
  
  Page 11982
  
  GRAPHIC TIFF OMITTED TP03MR14.014
  
  Page 11983
  
  GRAPHIC TIFF OMITTED TP03MR14.015
  
  Page 11984
  
  GRAPHIC TIFF OMITTED TP03MR14.016
  
  Page 11985
  
  GRAPHIC TIFF OMITTED TP03MR14.017
  
  (12) If space is not adequate to list the required information as shown in the sample labels in paragraph (e)(11) of this section, the list may be split and continued to the right as long as the headings are repeated. The list to the right must be set off by a line that distinguishes it and sets it apart from the dietary ingredients and percent of Daily Value information given to the left. The following sample label illustrates this display:
  
  Page 11986
  
  GRAPHIC TIFF OMITTED TP03MR14.018
  
  BILLING CODE 4160-01-C
  
  (f) * * *
  
  (2) When it is not technologically feasible, or some other circumstance makes it impracticable, for firms to comply with the requirements of this section, FDA may permit alternative means of compliance or additional exemptions to deal with the situation in accordance with Sec. 101.9(g)(9). Firms in need of such special allowances shall make their request in writing to the Office of Nutrition, Labeling and Dietary Supplements (HFS-800), Food and Drug
  
  Page 11987
  
  Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
  
  * * * * *
  
  (i)(1) Dietary supplements are subject to the special labeling provisions specified in Sec. 101.9(j)(5)(i) for foods other than infant formula, represented or purported to be specifically for infants and children less than 2 years of age.
  
  * * * * *
  
  Dated: February 24, 2014.
  
  Leslie Kux,
  
  Assistant Commissioner for Policy.
  
  FR Doc. 2014-04387 Filed 2-27-14; 8:45 am
  
  BILLING CODE 4160-01-C

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Food Labeling: Revision of the Nutrition and Supplement Facts Labels

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