Federal Register / Vol. 72, No. 212 / Friday, November 2, 2007 / Proposed Rules 62149 

1A list of the acronyms cited in this ANPRM are 

defined in Appendix A. 

Authority: 26 U.S.C. 3304(a)(9)(B); 

Secretary’s Order No. 3–2007, April 3, 2007 

(72 FR 15907). 

§ 616.5 [Removed] 

2. Remove § 616.5. 

3. Revise paragraph (e) of § 616.6 to 

read as follows: 

§ 616.6 Definitions. 

* * * * * 

(e) Paying State. A single State against 

which the claimant files a CombinedWage Claim, if the claimant has wages 

and employment in that State’s base 

period(s) and the claimant qualifies for 

unemployment benefits under the 

unemployment compensation law of 

that State using combined wages and 

employment. 

* * * * * 

4. Add paragraph (f) to § 616.7 to read 

as follows: 

§ 617.7 Election to file a Combined-Wage 

Claim. 

* * * * * 

(f) If a State denies a Combined-Wage 

Claim, it must inform the claimant of 

the option to file in another State in 

which the State finds that claimant has 

wages and employment during that 

State’s base period(s). 

§ 616.8 [Amended] 

5. In § 616.8(a) remove the words ‘‘, 

even if the Combined-Wage Claimant 

has no earnings in covered employment 

in that State’’. 

Signed at Washington, DC, this 29th day of 

October 2007. 

Emily Stover DeRocco, 

Assistant Secretary for Employment and 

Training. 

[FR Doc. E7–21513 Filed 11–1–07; 8:45 am] 

BILLING CODE 4510–FW–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

RIN 0910–ZA30 

[Docket No. 2006N–0168] 

Food Labeling: Revision of Reference 

Values and Mandatory Nutrients 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Advance notice of proposed 

rulemaking. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

advance notice of proposed rulemaking 

(ANPRM) to request comment on what 

new reference values the agency should 

use to calculate the percent daily value 

(DV) in the Nutrition Facts and 

Supplement Facts labels and what 

factors the agency should consider in 

establishing such new reference values. 

In addition, FDA requests comments on 

whether it should require that certain 

nutrients be added or removed from the 

Nutrition Facts and Supplement Facts 

labels. Comments on what factors 

should be considered to update the 

agency’s reference values will inform 

any FDA rulemaking that may result 

from this ANPRM. 

DATES: Submit written or electronic 

comments by January 31, 2008. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2006N–0168, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No. and Regulatory Information 

Number (RIN) for this rulemaking. All 

comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, 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.fda.gov/ohrms/dockets/ 

default.htm 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: 

Paula R. Trumbo, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–2579, or e-mail: 

Paula.Trumbo@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

A. Development of Current DVs 

B. Nutrient Content Final Rule 

C. Labeling of Dietary Supplements 

D. IOM DRIs and Acceptable 

Macronutrient Distribution Ranges 

E. IOM Report on Guiding Principles 

for Nutrition Labeling 

F. IOM Report on the Definition of 

Fiber 

G. Current Regulations on Trans Fat 

H. ANPRM on Prominence of Calories 

I. Carbohydrate Content of Food 

J. ‘‘2005 Dietary Guidelines for 

Americans’’

II. Agency Request for Information 

A. Approach for Setting DVs 

B. Populations for Which the DVs are 

Intended 

C. Labeling of Individual Nutrients 

D. Other Questions 

E. Process Questions 

F. Questions on Consumer and 

Producer Use and Understanding of 

DVs 

III. Comments 

IV. References 

Appendix A Acronyms Used in This 

Document 

Appendix B Examples of Nutrition Facts 

and Supplement Facts Labels 

I. Background1

On November 8, 1990, the Nutrition 

Labeling and Education Act (NLEA) of 

1990 (Public Law No. 101–535) was 

signed into law (the 1990 amendments) 

amending the Federal Food, Drug, and 

Cosmetic Act (the act). The 1990 

amendments made the most significant 

changes in the act and had a direct 

bearing on FDA’s revision of nutrition 

labeling in 1993. The 1990 amendments 

added section 403(q) (21 U.S.C. 403(q)) 

to the act which specified, in part, that: 

(1) With certain exceptions, a food is to 

be considered misbranded unless its 

label or labeling bears nutrition labeling; 

(2) certain nutrients and food 

components are to be included in 


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2The ESADDIs are nutrient values set by NAS for 

essential nutrients for which data are available to 

estimate a range of requirements, but insufficient 

for developing a specific RDA (Ref. 3). 

3In 1993, FDA redesignated the term U.S. RDA to 

RDI because the term U.S. RDA was easily confused 

with the term RDA (58 FR 2206 at 2207). 

nutrition labeling, although the 

Secretary of Health and Human Services 

can add or delete nutrients by regulation 

if it is found necessary to assist 

consumers in maintaining healthy 

dietary practices; (3) nutrition labeling 

is to be provided for the most frequently 

consumed varieties of raw produce 

(fruits and vegetables) and raw fish 

according to voluntary guidelines or, if 

necessary, regulations; (4) a simplified 

nutrition label is to be used when the 

food contains insignificant amounts of 

most nutrients; and (5) FDA is to 

develop regulations governing labeling 

of foods to which section 411 of the act 

(21 U.S.C. 350) applies (i.e., vitamin and 

minerals). 

In response to the NLEA, FDA, in 

1993, issued several rules to modify 

how nutrition information is presented 

on food labels. When the agency issued 

those rules to modify the nutrition label 

information, it considered the diet and 

health information that was current at 

that time, including the National 

Academy of Sciences (NAS) 

Recommended Dietary Allowances 

(RDAs) (Refs. 1 to 3), the NAS Diet and 

Health Report (Ref. 4), the Surgeon 

General’s Report on Nutrition and 

Health (Ref. 5), and the 1990 Dietary 

Guidelines for Americans (Ref. 6). New 

information has since become available 

on nutrient values that the agency 

believes may impact what nutrients it 

should consider requiring to be listed on 

the food label and what nutrient values 

it should use as a basis for the DVs on 

the food label. The new information 

includes revisions to the Dietary 

Guidelines for Americans (Ref. 7), the 

Institute of Medicine’s (IOM’s) 

published reports on the Dietary 

Reference Intakes (DRIs) that update 

recommendations for the intake of 

vitamins, minerals, and macronutrients 

(Refs. 8 to 14), the IOM report on the 

application of the DRIs (Ref. 15), and the 

IOM report on ‘‘Guiding Principles for 

Nutrition Labeling and Fortification’’

that provides recommendations on the 

use of the new DRIs in nutrition labeling 

(Ref. 16). The latter reports stimulated 

extensive discussion in the scientific 

community (e.g. at nutrition and food 

science conferences and in publications 

(Refs. 17 to 19); FDA and the IOM 

recognize that the approach to setting a 

DV in the labeling report (Ref. 16) 

represents a new approach that requires 

evaluation. At the IOM’s 2007 workshop 

on ‘‘The Development of DRI’s 1994–

2004: Lessons Learned and New 

Challenges,’’ there was discussion about 

the limitations of the framework that 

was used to set the DRIs, as well as 

recommendations for future 

consideration. For all of these reasons, 

FDA finds it important to seek comment 

on the recommendations made in these 

reports (Refs. 7 to 16). In addition, the 

agency is considering changes to the 

food label in more recently published 

ANPRMs concerning prominence of 

calories and the labeling of trans fats. 

The agency discusses, below, the 1993 

rules on food labeling, these ANPRMs, 

and publications and reports available 

since 1993, to provide background for 

the questions the agency is asking in 

this ANPRM related to a future 

proposed rule to update the 

presentation of nutrients and content of 

nutrient values on food labels. 

A. Development of Current DVs 

In the final rule on Food Labeling; 

Reference Daily Intakes and Daily 

Reference Values (the 1993 RDI/DRV 

final rule) (58 FR 2206, January 6, 1993), 

FDA amended its regulations to 

establish two sets of label reference 

values: Reference Daily Intakes (RDIs) 

and Daily Reference Values (DRVs) for 

use in declaring the nutrient content of 

a food on its label or labeling. These two 

reference values were used to establish 

a single set of label reference values 

known as the DVs, which were intended 

to assist consumers in both 

understanding the relative significance 

of nutritional information in the context 

of a total daily diet and in comparing 

the nutritional values of food products. 

1. RDIs 

In the Federal Register of July 19, 

1990 (55 FR 29476), FDA proposed to 

replace the U.S. Recommended Daily 

Allowances (U.S. RDAs) as the reference 

values for certain vitamins and minerals 

used in nutrition labeling of foods with 

updated and expanded reference values 

(the 1990 proposal). The U.S. RDAs set 

in 1973 were based primarily on the 

NAS 1968 RDA values for vitamins and 

minerals (Ref. 1). However, the U.S. 

RDAs for certain vitamins and minerals 

for which no RDA had been identified 

(biotin, pantothenic acid, copper, and 

zinc) were based on information cited in 

the NAS’s ‘‘Recommended Dietary 

Allowances,’’ 7th edition (Ref. 1). The 

NAS RDAs were updated in 1974 and 

1980, and again in 1989 along with 

revised values for the listing known as 

‘‘Estimated Safe and Adequate Daily 

Dietary Intakes’’ (ESADDIs).2 In 1990, 

FDA decided that it needed to update 

the U.S. RDA values, in part, due to the 

revisions of the 1989 NAS RDA and 

ESADDI values. FDA proposed to 

redesignate ‘‘U.S. RDAs’’ as ‘‘RDIs,’’3

and to establish five sets of RDIs for 

different developmental groups, i.e., 

adults and children 4 or more years of 

age (excluding pregnant or lactating 

women), children less than 4 years of 

age, infants, pregnant women, and 

lactating women. FDA also proposed 

using a population-weighted average of 

the relevant NAS RDAs and ESADDIs to 

establish the RDIs because it would 

‘‘serve the purpose of providing an 

overall reference value for food labeling 

more appropriately than a highest 

value’’ and ‘‘because of decreasing 

public health concern with nutritional 

deficiencies, it makes less sense to use 

maximum values as the basis for these 

reference values’’ (55 FR 29476 at 

29478). 

In the 1993 RDI/DRV final rule, FDA 

redesignated the U.S. RDA values in 

part 101 (21 CFR part 101) for vitamins 

and minerals as RDIs. In addition, FDA 

established, under 21 CFR part 104, a 

single set of label reference values for 

adults and children 4 or more years of 

age, in part, because of space constraints 

on the food label and the fact that 

children over the age of 4 years 

consume the same foods that the rest of 

the population consumes (58 FR 2206 at 

2213). These RDIs were based on the 

NAS RDAs set in 1968. Although FDA 

proposed in 1990 to base the RDIs on a 

population-weighted average of the 

RDAs and ESADDIs, in the 1993 RDI/ 

DRV final rule FDA used the highest 

RDA for adults and children 4 or more 

years of age (excluding values for 

pregnant and lactating women) to serve 

as label reference values (58 FR 2206 at 

2210 to 2213). FDA found that there was 

considerable and uniform support in the 

comments for continuing to select the 

highest nutrient value from this group 

and that vulnerable or at-risk groups 

would be sufficiently covered by 

electing the highest value. FDA referred 

to this approach as the ‘‘populationcoverage approach.’’

On October 6, 1992, Congress passed 

the Dietary Supplement Act of 1992 

that, in section 203, instructed FDA to 

not issue regulations before November 

8, 1993, that would revise the U.S. 

RDAs (redesignated as RDIs) for 

vitamins or minerals (other than 

existing regulations that established the 

U.S. RDAs specified in § 101.9(c)(7)(iv) 

that were in effect prior to October 6, 

1992). Thus, FDA did not codify new 

nutrient values in the 1993 RDI/DRV 

final rule. In the Federal Register of 

December 28, 1995 (60 FR 67164) (the 

1995 final rule), FDA amended certain 


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4Fluoride is the ionized form of the element 

fluorine. 

5FDA has not acted to prohibit or modify the 

claims, and therefore, manufacturers may use the 

specified claims on the label and in the labeling of 

any food or dietary supplement product that 

qualifies for the claims described in the 

notification. 

RDIs based on the 1989 NAS RDAs and 

ESADDIs. 

In the 1995 final rule, FDA amended 

its regulations to establish RDIs for 

vitamin K and selenium based on the 

1989 NAS RDAs, and for manganese, 

chromium, molybdenum, and chloride 

based on the 1989 ESADDIs (Ref. 3). 

FDA did not establish a DV for fluoride 

in the 1995 final rule because the 1989 

NAS RDA report stated that published 

studies ‘‘do not justify a classification of 

fluorine4 as an essential element, 

according to accepted standards’’ (Ref. 3 

at p. 235) and because the primary 

sources of dietary fluoride (e.g., 

community water supplies, toothpastes, 

mouth rinses) are not required to bear 

nutrition labeling (60 FR 67164 at 

67168). FDA concluded that the 

declaration of percent DV of fluoride 

within nutrition labeling on a limited 

number of foods that are relatively 

minor sources of the nutrient would be 

of little use in assisting consumers in 

maintaining healthy dietary practices 

(60 FR 67164 at 67168). 

In addition, a notification was 

submitted under section 403(r)(2)(G) of 

the act (21 U.S.C. 343(r)(2)(G)) in 2001 

for the use of certain nutrient content 

claims for choline. These statements 

identify the daily value for choline as 

550 milligrams (mg).5 This value is 

based on the Adequate Intake (AI) set by 

the Institute of Medicine (IOM) of the 

NAS in 1998 (Refs. 9 and 20). 

2. DRVs 

The 1993 RDI/DRV final rule also 

identified DRVs for those nutrients that 

are important to diet and health (e.g., 

total fat, saturated fat, cholesterol, total 

carbohydrate (CHO), protein, dietary 

fiber, sodium, and potassium). The 

DRVs are based on the NAS Diet and 

Health Report (sodium, potassium, fat, 

saturated fat, cholesterol, carbohydrate, 

and dietary fiber) (Ref. 4), the Surgeon 

General’s Report on Nutrition and 

Health (dietary fiber) (Ref. 5), and the 

1990 Dietary Guidelines for Americans 

(Ref. 6). The DRV for protein (50 grams 

per day (g/d)) was set at 10 percent of 

2,000 calories based on an adjusted 

average of the 1989 RDA (Ref. 3). The 

use of ‘‘calories’’ to mean ‘‘kilocalories’’

(kcals) is commonly accepted and more 

readily understood by consumers. 

The DRVs in the 1993 RDI/DRV final 

rule (58 FR 2206) were based on a 2,000 

calorie reference diet. In the 1990 

proposal (55 FR 29476 at 29482), FDA 

proposed using a 2,350 calories 

reference diet based on a population 

adjusted mean of recommended calorie 

allowances for persons 4 or more years 

of age (excluding pregnant and lactating 

women) (from table 3–5 of the 10th 

edition of ‘‘Recommended Dietary 

Allowances’’ (Ref. 3)). However, FDA 

received several comments opposing the 

2,350 reference values because of 

concerns that this value was too high, 

especially among women (58 FR 2206 at 

2217). In addition, several comments 

suggested that using 2,000 calories as a 

reference diet would be easier for 

consumers to use in calculations and 

closer to caloric requirements of older 

women who are ‘‘at risk for excessive 

calories and fat’’ (id.). The 2,000 calorie 

reference diet FDA adopted was 

consistent with the ‘‘populationcoverage approach’’ as it selected a 

lower calorie basis for the DRVs for the 

group at risk (i.e., older women). 

B. Nutrient Content Final Rule 

In the Federal Register of January 6, 

1993 (58 FR 2079), FDA published a 

final rule entitled ‘‘Food Labeling: 

Mandatory Status of Nutrition Labeling 

and Nutrient Content Revision, Format 

for Nutrition Label’’ (the 1993 nutrient 

content final rule). The 1993 nutrient 

content final rule: (1) Requires nutrition 

labeling on most foods that are regulated 

by FDA, (2) revises the list of required 

nutrients and food components and the 

conditions for declaring them in 

nutrition labeling, (3) specifies a new 

format for declaring nutrition 

information, (4) allows specified 

products to be exempt from nutrition 

labeling, and (5) prescribes a simplified 

form of nutrition labeling and the 

circumstances in which such simplified 

nutrition labeling can be used. An 

example of a Nutrition Facts label can 

be found in appendix B. 

1. Required and Voluntary Labeling of 

Nutrients on Food Products (§ 101.9(c)) 

With respect to nutrition labeling of 

foods, the 1993 nutrient content final 

rule declared that nutrition information 

on the label and in labeling of foods 

shall contain information about the 

level of the following nutrients: (1) 

Calories or total calories; (2) calories 

from fat; (3) calories from saturated fat 

(voluntary); (4) total fat; (5) saturated fat; 

(6) polyunsaturated fat (voluntary); (7) 

monounsaturated fat (voluntary); (8) 

cholesterol; (9) sodium; (10) potassium 

(voluntary); (11) total carbohydrate 

(including sugars (mono- and 

disaccharides), oligosaccharides, starch, 

fiber, and organic acids); (12) dietary 

fiber; (13) soluble fiber (voluntary); (14) 

insoluble fiber (voluntary); (15) sugars; 

(16) sugar alcohol (voluntary); (17) other 

carbohydrate (voluntary); (18) protein; 

and (19) vitamins and minerals (see 

§ 101.9(c)(1) through (c)(8)). However, 

those nutrients that can be declared 

voluntarily, as described previously in 

this document, must be declared when 

a nutrient content or health claim is 

made (§ 101.9(c)). In the Federal 

Register of July 11, 2003 (68 FR 41434), 

FDA amended its regulations on 

nutrition labeling to require trans fatty 

acids be declared in grams per serving 

in the nutrition label of conventional 

foods and dietary supplements (see 

section G). 

Nutrient information for both 

mandatory and any voluntary nutrients 

that are to be declared in the nutrition 

label, except vitamins and minerals, 

shall be declared with the name of each 

nutrient, and the quantitative amount by 

weight for that nutrient (i.e. g or mg) 

(see § 101.9(d)(7)(i)). A listing of the 

percent DRV as established in 

§ 101.9(c)(7)(iii) and (c)(9) (see table 1 of 

this document for reference values) is 

required under the heading percent DV 

for each nutrient for which a DRV was 

established, except that the percent for 

protein may be omitted (see 

§ 101.9(d)(7)(ii)). 

The regulations require that 

information about these nutrients be 

declared on the nutrition label and that 

no nutrients or food components, other 

than those listed, may be included on 

the nutrition label (§ 101.9(c)). 

A statement about the percent of the 

RDI, expressed as the percent of the DV 

for vitamin A, vitamin C, calcium, and 

iron, in that order, is required (see table 

1 of this document for reference values) 

(§ 101.9(c)(8)(ii)). These four vitamin 

and mineral nutrients are required to be 

declared because of public health 

concerns relative to inadequate intake of 

these nutrients by specific portions of 

the population, as well as the possible 

association between the lack of several 

of these nutrients in the diet and the 

risk of chronic disease (58 FR 2079 at 

2106). The declaration of other vitamins 

and minerals that have an RDI is 

required when they are added as a 

nutrient supplement or when a claim is 

made about them (§ 101.9(c)(8)(ii)). If 

the amount of the vitamin or mineral is 

present at less than 2 percent of the RDI, 

declaration of an amount is not required 

or the content may be expressed as zero 

(§ 101.9(c)(8)(iii)). 


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TABLE 1.—REFERENCE VALUES FOR

NUTRITION LABELING (BASED ON A

2,000 CALORIE INTAKE; FOR ADULTS

AND CHILDREN 4 OR MORE YEARS

OF AGE) 

Nutrient1 Unit of 

Measure 

Daily 

Values 

Total Fat g 65 

Saturated fatty 

acids 

g 20 

Cholesterol mg 300 

Sodium mg 2,400 

Potassium mg 3,500 

Total carbohydrate g 300 

Fiber g 25 

Protein g 50 

Vitamin A International 

Units (IU) 

5,000 

Vitamin C mg 60 

Calcium mg 1,000 

Iron mg 18 

Vitamin D IU 400 

Vitamin E IU 30 

Vitamin K micrograms 

(μg) 

80 

Thiamin mg 1.5 

Riboflavin mg 1.7 

Niacin mg 20 

Vitamin B6 mg 2.0 

Folate μg 400 

Vitamin B12 μg 6.0 

Biotin μg 300 

Pantothenic 

acid 

mg 10 

Phosphorus mg 1,000 

Iodine μg 150 

Magnesium mg 400 

Zinc mg 15 

Selenium μg 70 

Copper mg 2.0 

Manganese mg 2.0 

Chromium μg 120 

TABLE 1.—REFERENCE VALUES FOR

NUTRITION LABELING (BASED ON A

2,000 CALORIE INTAKE; FOR ADULTS

AND CHILDREN 4 OR MORE YEARS

OF AGE)—Continued 

Nutrient1 Unit of 

Measure 

Daily 

Values 

Molybdenum μg 75 

Chloride mg 3,400 

1Nutrients in this table are listed in the order 

in which they are required to appear on a 

label in accordance with § 101.9(c). This list 

includes only those nutrients for which a DRV 

has been established in § 101.9(c)(9) or a RDI 

in § 101.9(c)(8)(iv). 

The declaration of other vitamins and 

minerals with an RDI need not be 

declared if: (1) Neither the nutrient nor 

the component is otherwise referred to 

on the label or in labeling or advertising 

and (2) the vitamins and minerals are 

required or permitted in a standardized 

food (e.g., thiamin, riboflavin, and 

niacin in enriched flour) and included 

in a food solely for technological 

purposes and declared only in the 

ingredient statement (§ 101.9(c)(8)(ii)). 

Foods that are represented or purported 

to be for use by infants (up to 12 months 

of age), children 1 to 4 years of age, 

pregnant women, or lactating women 

must use the RDIs that are specified for 

the intended group (§ 101.9(c)(8)(i)). 

However, FDA has not codified RDI 

values to use for these various groups. 

FDA stated, in the 1995 final rule, that 

it intended to address the issue of RDIs 

for all nutrients for the various age 

groups in a future rulemaking but was 

not doing so in that rule due to the 

continuing questions about how to 

arrive at such values. FDA noted that, 

for conventional foods, there could be 

no declaration on labels of foods 

represented or purported to be for use 

by infants, children less than 4 years of 

age, or pregnant or lactating women for 

vitamin K, selenium, chloride, 

manganese, chromium, and 

molybdenum until such time as RDIs 

are established for such groups (60 FR 

67164 at 67171). FDA stated that these 

six nutrients could be specified in mg or 

μg amounts in dietary supplements 

under § 101.36 with an asterisk in the 

percent DV column that refers to a 

footnote stating ‘‘Daily Value not 

established.’’

Prior to the 1995 final rule, FDA 

noted in the 1993 RDI/DRV final rule 

that manufacturers have continued to 

use the nutrient values that were 

contained in 21 CFR 105.3(b) (FDA 

deleted this paragraph on March 16, 

1979 (44 FR 16005)), as label reference 

values for use on foods purported or 

represented to be for use by infants, 

children under 4 years of age, or 

pregnant or lactating women, without 

objection from FDA (58 FR 2206 at 

2213). The RDIs for the vitamins and 

minerals for these groups are listed in a 

table in the 1993 RDI/DRV final rule as 

guidance (58 FR 2206 at 2213). Such 

table does not include the seven 

nutrients that FDA stated could not be 

on conventional food labeling for these 

specific groups in the 1995 final rule. 

Section 101.9(c)(8)(i) states that all other 

foods must use the RDI for adults and 

children 4 or more years of age. 

2. Application of DVs 

Section 403(q) of the act provides 

discretion to the agency to require 

information about nutrients on the food 

label when the agency determines such 

information will ‘‘assist consumers in 

maintaining healthy dietary practices.’’

Section 2(b)(1)(A) of the 1990 

amendments states 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 

context of a total daily diet.’’ In the 1993 

nutrient content final rule, FDA stated 

that ‘‘the nutrition label can and should 

help consumers make informed food 

choices, and that it can also contribute 

to consumers maintaining healthy 

dietary practices’’ (58 FR 2079 at 2114). 

While the DVs do not represent dietary 

goals for individuals, their intended use 

is to provide an overall population 

reference value on the food label for the 

consumer (55 FR 29476 at 29481). 

In order to determine a nutrition 

labeling format that could be used most 

effectively by consumers, FDA 

conducted consumer research and 

evaluated research conducted by others 

in considering requirements for the 

nutrition label format in the 1993 

nutrient content final rule (58 FR 2079 

at 2115–2121). Based on the results of 

several consumer studies that evaluated 

the ability of nutrition label formats to 

enable consumers to understand the 

relative significance of product nutrition 

information in the context of a total 

daily diet, FDA concluded the 

following: (1) The declaration of 

nutrient amount information as 

percentages of DV or the placement of 

adjectives (e.g., high, medium, or low) 

next to the nutrient amount information 

are effective ways to help consumers 

understand the significance of product 

nutrition information in the context of 

the total daily diet; (2) the percent DV 

declarations moderate dietary 

judgments about a food; and (3) other 

format elements, such as a list of DRVs 


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for important macronutrients, 

highlighting, or grouping nutrients 

according to Dietary Guidelines for 

Americans, did not help consumers to 

make better dietary judgments (58 FR 

2079 at 2118). Upon reviewing the 

results of several studies that evaluated 

the consumer’s use of the nutrition 

label, the two most reported uses 

identified by FDA were to evaluate 

nutrition characteristics of single 

products and to assist in making choices 

between products (58 FR 2079 at 2121 

and references cited therein). 

Informed choices include making 

judgments about a food product’s 

contribution to the total diet and making 

comparisons between the nutritional 

quality of different food products. 

Findings from the FDA Food Label Use 

and Nutrition Education Surveys 

(FLUNES) conducted in 1994 and 1995 

showed that more than half of 

consumers used the Nutrition Facts 

label to make a judgment about the 

overall nutritional quality of a food 

product, especially the fat content (Ref. 

21). 

3. Uses of the DVs in Nutrient Content 

and Health Claims 

The DVs are used to determine, in 

part, whether a food or dietary 

supplement is eligible to bear nutrient 

content claims or health claims. For 

nutrient content claims, a food or 

dietary supplement must contain 10 to 

19 percent of the DV per Reference 

Amount Customarily Consumed (RACC) 

in order to be labeled as a good source 

of a particular nutrient and must 

contain 20 percent or more of the DV 

per RACC in order to be labeled as an 

excellent source of a particular nutrient 

(§ 101.54(b) and (c)). When a health 

claim is about the effects at decreased 

dietary intake levels (i.e., low claim), 

the levels must meet the definition for 

use of the term low that has been 

established for that substance, unless a 

specific alternative level has been 

established (§ 101.14(d)(2)(vi)). If no 

definition for low has been established, 

the level of the substance must meet the 

level established in the regulation 

authorizing the claim. For health claims, 

when a claim is about the effects of 

consuming the substance at other than 

decreased dietary levels (i.e. not a low 

claim), a food must meet the definition 

of high (20 percent of the DV) for the 

substance that is the subject of the 

claim, if the agency has established a 

definition for the use of the term ‘‘high’’

for that substance and the agency has 

not established an alternative level for 

that nutrient in the health claim 

regulation (§ 101.14(d)(2)(vii)). For a few 

health claims authorized in §§ 101.76, 

101.78, and 101.79, an eligibility 

requirement is based upon meeting the 

definition for a good source (10 percent) 

of the DV for a particular nutrient. The 

specific eligibility requirements for each 

authorized health claim are set forth in 

subpart E, §§ 101.70 to 101.83. In 

addition, foods bearing health claims, 

other than dietary supplements or 

where otherwise provided for in 

regulations, must contain 10 percent or 

more of the DV, prior to any nutrient 

addition, for one of the following 

nutrients: Vitamins A, vitamin C, iron, 

calcium, protein, or fiber 

(§ 101.14(e)(6)). 

C. Labeling of Dietary Supplements 

As part of the implementation of the 

Dietary Supplement Health and 

Education Act of 1994, FDA issued final 

regulations in the Federal Register of 

September 23, 1997 (62 FR 49826), 

requiring that a Supplement Facts label 

appear on the label or labeling of all 

dietary supplements. The Supplement 

Facts label is similar to the Nutrition 

Facts label in both content and format. 

Examples of Supplement Facts labels 

can be found in appendix B. The 

Supplement Facts label must include 

the amount and percent DV of the same 

nutrients that are required for 

conventional foods if the nutrients are 

present in the supplement, as well as 

the amount of other dietary ingredients 

present (§ 101.36(b)). Nutrients that 

have established DVs are listed first, 

followed by a horizontal line that 

separates these nutrients from dietary 

ingredients that have no DVs (e.g., 

botanicals). The Supplement Facts label 

must state that percent DVs have not 

been established for these dietary 

ingredients and must indicate these 

ingredients clearly with an asterisk (*) 

(§ 101.36(b)(3)(iv)). 

D. IOM DRIs and Acceptable 

Macronutrient Distribution Ranges 

Beginning in 1997, the IOM began 

publishing a series of reports on 

reference intake values (Refs. 8 to 14), 

collectively known as the DRIs. The 

DRIs are defined intake levels and 

include the AI, estimated average 

requirement (EAR), RDA, and the 

tolerable upper intake level (UL). DRIs 

were set for those vitamins, minerals, 

and macronutrients that are essential in 

humans and/or provide a beneficial role 

in human health. While many of the 

RDAs were revised for nutrients that 

had an existing RDA (e.g., iron and 

vitamin A), some nutrients that had 

RDAs now have an AI (e.g., calcium and 

vitamin K). Those nutrients that had an 

ESADDI, now have either an RDA 

(copper and molybdenum) or an AI 

(manganese, fluoride, and chromium). 

Although not considered to be a DRI 

that provides a defined intake level, the 

IOM also set acceptable macronutrient 

distribution ranges (AMDRs) for 

carbohydrate (i.e., sugars (mono-, diand oligosaccharides) and starch), total 

fat, n-3 and n-6 polyunsaturated fatty 

acids, and protein (Ref. 13 and Ref. 16 

at p. 93). 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. 

1. EAR 

The EAR for a nutrient is defined as 

the daily intake value that is estimated 

to meet the requirement for that 

nutrient, as defined by a specific 

criterion of adequacy or optimal health, 

in half of the apparently healthy 

individuals in a specific life stage and 

gender group. This definition of the 

EAR implies a median, rather than a 

mean or average. The median and mean 

would be the same if the distribution of 

requirements followed a symmetrical 

distribution. 

In the case of energy, the IOM set an 

estimated energy requirement (EER) to 

represent the average dietary energy 

intake that is predicted to maintain 

energy balance in a healthy adult of a 

defined age, gender, weight, height, and 

physical activity level (PAL). PAL is the 

ratio of total energy expenditure (TEE) 

divided by the basal rate of energy 

expenditure. The EER equations use one 

of the four PAL categories: Sedentary, 

low active, active, and very active. In 

children and pregnant and lactating 

women, the EER meets the needs 

associated with the deposition of tissues 

or secretion of milk at rates consistent 

with good health. 

The EAR and the EER are used for 

assessing nutrient intakes of groups. For 

nutrients with an EAR and for the EER, 

the prevalence of inadequacy in the 

population group for the nutrient or 

energy level evaluated is usually the 

approximate percentage of the 

population evaluated whose intakes fall 

below the EAR for the nutrient or the 

EER (Ref. 22). The EAR for the nutrient 

and the EER can also be used to plan for 

an acceptably low prevalence of 

inadequate intakes within a group. The 

EAR for a nutrient and the EER should 

not be used as an intake goal for the 

individual. Examples of planning for 

groups include planning diets in an 

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or planning menus for a school nutrition 

program (Ref. 15). 

2. RDAs 

The RDA is an estimate of the daily 

average intake level that meets the 

nutrient requirements of nearly all (97 

to 98 percent) healthy individuals in a 

particular life stage and gender group 

and assuming a normal distribution of 

requirements (Ref. 8). An RDA cannot 

be set without an EAR. For all nutrients, 

except iron, the RDA was set based on 

the EAR plus 2–times the standard 

deviation (SD) of the EAR : RDA = EAR 

+ 2 x SDrequirement. If data about the 

variability in the EAR for a nutrient 

were insufficient to calculate the SDEAR, 

then a coefficient of variation (CV) of 10 

percent was assumed. 

If individual intakes have been 

observed for a large number of days and 

are at the RDA, or observed intakes for 

fewer days are well above the RDA, 

there can be a high level of confidence 

that the intake is adequate. Under these 

conditions, RDAs can be used for 

assessing intakes of individuals for 

nutritional adequacy. The RDA can also 

be used to plan for intakes of 

individuals. The RDA should not be 

used to plan intakes of groups. The RDA 

is not used to plan intakes of groups 

because the median of a target intake 

distribution for a group will usually 

exceed the RDA because the variance in 

usual intakes exceeds the variance in 

requirements. Thus, the selection of the 

RDA as the median of the target usual 

intake distribution for groups is not 

recommended as it results in a greater 

percentage of inadequacy. The IOM 

report on the application of the DRIs in 

planning diets for individuals provided 

several examples of nutrient-based food 

guidance systems that could be used by 

individuals for planning diets, 

including food and supplement labels 

(e.g., the Nutrition Facts label) (Ref. 15). 

3. AI 

If there is insufficient scientific 

evidence to calculate the EAR and 

therefore insufficient evidence on which 

to establish an RDA for an essential 

nutrient or a nutrient that is beneficial 

for human health, then an AI is 

determined. AIs are based on the 

following: (1) Scientific evidence for 

requirements that is insufficient to set 

an EAR (e.g., calcium, vitamin D, 

choline, biotin, fluoride, sodium); (2) 

experimental data on risk reduction of 

chronic disease that are insufficient to 

set an EAR (e.g., dietary fiber, 

potassium); or (3) median intakes of a 

nutrient usually using national nutrition 

intake survey data, provided there is no 

evidence of a deficiency of the nutrient 

in the United States (e.g., pantothenic 

acid, vitamin K, chromium, manganese, 

linoleic acid, and a-linolenic acid). 

There is much less certainty about an AI 

value than about an RDA value. The AI 

for a nutrient is expected to exceed the 

RDA for that nutrient, and therefore it 

should cover the needs of more than 97 

to 98 percent of individuals. The IOM 

set most AIs for young infants (0 to 6 

months of age) based on the average 

intake of the nutrient consumed 

exclusively from breastfed infants, 

provided that breast milk provides a 

sufficient amount of a nutrient to meet 

the needs of the infant. The AIs for older 

infants (7 to 12 months) were set based 

on: (1) The average intake of the 

nutrient consumed exclusively from 

breastfed infants and, if data were 

available, average intakes of a nutrient 

provided by complimentary weaning 

foods; and/or (2) extrapolated from the 

AI of younger infants; and/or (3) 

extrapolated from adult AIs; and/or (4) 

clinical data. The AIs for iron and zinc 

for older infants could not be set using 

intake from breast milk because the 

level of iron and zinc in human milk is 

not sufficient to meet their needs. For 

iron, zinc, and protein; EARs and RDAs 

for older infants 7 to 12 months were set 

based upon data regarding daily 

requirements. 

Usual individual intakes that are 

equal to or above the AI can be assumed 

adequate. The likelihood of inadequacy 

of usual intakes below the AI cannot be 

determined since there is insufficient 

information of the distribution of 

requirements. The AI can also be used 

to plan for intakes of individuals (Ref. 

15). 

4. UL 

The UL is the highest level of daily 

nutrient intake that is likely to pose no 

risk of adverse health effects for almost 

all individuals in the specific life stage 

group. As intake increases above the UL, 

there is a potential for an increased risk 

of adverse effects. The UL is not 

intended to be a recommended level of 

intake, as there is no established benefit 

for healthy individuals if they consume 

a nutrient in amounts exceeding the 

RDA or AI. 

The UL can be used to estimate the 

percentage of the population at potential 

risk of adverse effects from excess 

nutrient intake. The UL can also be used 

to plan for usual intakes below this level 

for an individual or in planning to 

minimize the proportion of the 

population at risk of excess nutrient 

intake (Ref. 15). 

5. AMDR 

An AMDR is a range of intakes for a 

particular energy source (e.g., fat, fatty 

acids, carbohydrate, and protein) that is 

associated with reduced risk of chronic 

disease while providing adequate 

intakes of essential nutrients. The 

AMDR of a macronutrient (e.g., fat) is 

expressed as a percentage of total energy 

intake because its requirement is 

dependent on other energy sources (e.g., 

carbohydrate and protein). If an 

individual consumes below or above 

this range, there is a potential for 

increasing the risk of chronic diseases 

shown to affect long-term health, as well 

as increasing the risk of insufficient 

intakes of essential nutrients. 

6. DRIs Set for Macronutrients and 

Micronutrients 

Based on the review of all 

macronutrients and micronutrients that 

are known to be essential and/or 

beneficial in humans, the IOM set the 

DRIs that are listed for each nutrient in 

tables 2 to 10 of this document. As can 

be seen from tables 11a and 11b of this 

document, the population-coverage and 

population-weighted AIs for fluoride 

and the population-coverage RDAs for 

synthetic niacin exceed the UL for 

children 4 to 8 years. 

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BILLING CODE 4160–01–C 

E. IOM Report on Guiding Principles for 

Nutrition Labeling 

In 2003 the IOM committee on 

nutrition labeling (the IOM Committee) 

considered how the DRIs can be used to 

develop appropriate reference values for 

nutrition labeling (Ref. 16). The IOM 

Committee’s report recommended the 

following 10 guiding principles for 

nutrition labeling: 

• Nutrition information in the 

Nutrition Facts label should continue to 

be expressed as percent DV. The 

concept of percent DV was developed 

by FDA in response to NLEA to help 

consumers better comprehend the 

nutritional value of food and to 

understand its relative significance in 

the context of a daily diet. The percent 

DV concept was modeled after the 

‘‘percent of U.S. RDAs’’ used in 1973 

labeling. The use of the percent DV 

concept has been supported by 

consumer studies (58 FR 2079). The 

IOM Committee concluded that the 

rationale to use percent DV was 

compelling and suggested no alternative 

approach. 

• The DVs should be based on a 

population-weighted reference value 

using census data and proportions of 

each life stage and gender group. The 

IOM Committee’s rationale for using a 

population-weighted approach was that 

the DRIs for the various age and gender 

groups should be represented by the DV 

of the population in the same 

proportions. A DV defined this way 

would represent a central value of the 

requirement of the base population, 

with individual requirements varying 

around this value. 

As discussed previously in this 

document, the population-weighted 

approach is one of two approaches for 

setting one DV for all individuals 4 

years of age and older. Currently, FDA 

uses the population-coverage approach 

for setting a single DV which represents 

the highest recommended intake level 

among all life stage and gender groups, 

excluding pregnant and lactating 

women. Although the degree of change 

will differ for each nutrient, the DV 

would be lower using the populationweighted approach for most nutrients 

when compared to a DV derived using 

the population-coverage approach (see 

tables 11a and 11b of this document). 

Note that if the DV for a nutrient is 

increased, then a serving of food would 

have a lower percent DV on the 

Nutrition Facts label. 

TABLE 11A. COMPARISON OF THE CURRENT DVS WITH THE EAR, RDA, AND UL USING THE POPULATION-COVERAGE OR

POPULATION-WEIGHTED APPROACH

Nutrient Unit of Measure Current DV Highest RDA Weighted RDA1 Highest EAR Weighted EAR1 UL 4 to 8 years2

Nutrients Assigned an EAR and RDA 

Copper mg 2 .0 0 .9 0 .8 0 .7 0 .7 3 

Folate μg 400 400 378 330 304 400 

Iodine μg 150 150 144 95 91 300 

Iron mg 18 18 11 8 6 40 

Magnesium mg 400 420 341 350 283 110 

Molybdenum μg 75 45 42 34 32 600 

Niacin mg 20 16 14 12 11 15 

Phosphorus mg 1,000 1,250 769 1,055 640 3,000 

Protein g 50 56 47 46 39 - 

Riboflavin mg 1 .7 1 .3 1 .1 1 .1 0 .9 —

Selenium μg 70 55 52 45 43 150 

Thiamin mg 1 .5 1 .2 1 .1 1 .0 0 .9 —

Vitamin A IU 5,000 3,000 2,511 2,100 1,768 —

μg 1,500 RE 900 RAE 754 RAE 630 RAE 531 RAE 900 

Vitamin B6 mg 2 .0 1 .7 1 .3 1 .4 1 .1 40 

Vitamin B12 μg 6 .0 2 .4 2 .3 2 .0 1 .9 —

Vitamin C mg 60 90 74 75 61 650 

Vitamin E IU 30 IU — — — — —

mg atocopherol 15 14 12 11 300 


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6Currently there are DVs that were based on RDAs 

for vitamin A, vitamin C, iron, vitamin E, thiamin, 

riboflavin, niacin, vitamin B6, folate, vitamin B12, 

phosphorous, iodine, magnesium, zinc, selenium, 

and protein. 

TABLE 11A. COMPARISON OF THE CURRENT DVS WITH THE EAR, RDA, AND UL USING THE POPULATION-COVERAGE OR

POPULATION-WEIGHTED APPROACH—Continued 

Nutrient Unit of Measure Current DV Highest RDA Weighted RDA1 Highest EAR Weighted EAR1 UL 4 to 8 years2

Zinc mg 15 11 9 .1 9 .4 7 .7 12 

1Population-weighted means of life-stage and gender specific RDAs, EARs, AIs, and ULs were computed for adults and children 4 or more 

years of age, using 2005 Middle Series Data from Annual Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: Lowest, Middle, Highest, and Zero International Migration Series, 1999 to 2100 (NP-D1-A), (http://www.census.gov/population/www/projections/ 

natdet-D1A.htm), U.S. Census Bureau, Population Projection Program , accessed July 19, 2006. Life-stage and gender specific RDAs, EARs, 

AIs, and ULs were multiplied by the population projection for the corresponding life-stage and gender group (e.g., children 4 to 8 years old, 

males 9 to 13 years old). Sum of these values were divided by the total population projection for adults and children 4 or more years of age. 2The ULs for vitamin E, niacin, and folate apply to synthetic forms obtained from supplements, fortified foods, or a combination of the two. The 

ULs for vitamin A apply only to preformed vitamin A. The ULs for magnesium represent intake from a pharmacological agent only and do not include intake from food and water. 

RE=retinol equivalents, RAE=retinol activity equivalents 

TABLE 11B. COMPARISON OF THE CURRENT DVS WITH THE AIS AND ULS USING THE POPULATION-COVERAGE OR

POPULATION-WEIGHTED APPROACH

Nutrient Unit Of Measure Current DV Highest AI Weighted AI1 Highest UL Weighted UL1 UL 4 to 8 years 

Nutrients Assigned an AI 

Biotin μg 300 30 28 — — —

Calcium mg 1,000 1,300 1,091 — — 2,500 

Chloride mg 3,400 2,300 2,150 3,600 3,536 2,900 

Choline mg 5502 550 460 — — 1,000 

Chromium μg 120 35 27 — — —

Fiber g 25 383 293 — — —

Linoleic acid g — 17 13 — — —

a-Linolenic acid g — 1 .6 1 .3 — — —

Manganese mg 2.0 2 .3 1 .9 — — 3 

Pantothenic acid mg 10 5 5 — — —

Potassium mg 3,500 4,700 4,622 — — —

Sodium mg 2,4004 1,500 1,410 2,300 2,265 1,900 

Vitamin D IU 400 600 280 — — —

μg 10 15 7 50 

Vitamin K μg 80 120 95 — — —

Fluoride mg — 4 3 — — 2 .2 

1Population-weighted means of life-stage and gender specific RDAs, EARs, AIs, and ULs were computed for adults and children 4 or more 

years of age, using 2005 Middle Series Data from Annual Projections of the Resident Population by Age, Sex, Race, and Hispanic Origin: Lowest, Middle, Highest, and Zero International Migration Series, 1999 to 2100 (NP-D1-A), (http://www.census.gov/population/www/projections/ 

natdet-D1A.htm), U.S. Census Bureau, Population Projection Program , accessed July 19, 2006. Life-stage and gender specific RDAs, EARs, 

AIs, and ULs were multiplied by the population projection for the corresponding life-stage and gender group (e.g., children 4 to 8 years old, 

males 9 to 13 years old). Sum of these values were divided by the total population projection for adults and children 4 or more years of age. 2A notification was submitted under section 403(r)(2)(G) of the act (21 U.S.C. 343(r)(2)(G)) in 2001 for the use of certain nutrient content 

claims for choline. These statements identify the daily value for choline as 550 mg (see footnote 5 of this document). This value is based on the 

AI set by the IOM of the NAS in 1998 (Refs. 9 and 20). 3Based on AI of 14g/1,000 calories. 

4Daily reference value to not be exceeded. 

• A population-weighted EAR should 

be the basis for DVs for those nutrients 

for which EARs have been identified. 

The Committee’s rationale for using an 

EAR, rather than the RDA, to set the DV 

was the Committee’s belief that the EAR 

represents the most accurate 

representation of the true contribution 

of food to total nutrient needs in the 

general population. 

Currently, the RDIs are based on 

RDAs, when available. There are 16 

nutrients for which the DV is currently 

based on an RDA and now have a new 

EAR and RDA.6 Because the RDA is 2 

standard deviations greater than the 


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EAR, a DV based on an EAR would be 

lower than when based on the RDA (see 

table 11a of this document). The 

population-weighted EAR yields the 

lowest values compared to populationcoverage RDA, population-weighted 

RDA, or population-coverage EAR (see 

table 11a of this document). The 

population-weighted EAR can vary from 

as little as 21 percent lower than the 

population-coverage RDA for vitamin 

B12, to 41 percent lower for vitamin A, 

to as much as 67 percent lower for iron. 

• If no EAR has been set for a 

nutrient, then a population-weighted AI 

should be used as the basis for a DV. 

An AI is a proxy for an RDA, 

however, the AI is not the equivalent of 

an EAR. Thus, when an AI is set for a 

nutrient, there is no other recommended 

intake level that is set for that nutrient. 

AIs were determined for 15 nutrients 

(tables 2 and 3 of this document). As 

can be seen in table 11b of this 

document, a reference value for labeling 

based on a population-weighted AI is 

lower for most nutrients than a 

reference value that is derived based on 

the population-coverage approach that 

uses the highest AI. As discussed 

previously in this document, AIs for 

children and adults were based on 

experimental data that were not 

sufficient for setting an EAR or were 

based on median intake levels. The IOM 

labeling report did not address the issue 

of whether AIs based on either approach 

should or should not be considered in 

setting a DV. The IOM labeling report 

did not address the AIs set for sodium 

and potassium because the IOM DRI 

report on electrolytes and water was not 

completed (Ref. 14). 

• The AMDR should be the basis for 

the DVs for protein, total carbohydrate, 

and total fat. The IOM labeling 

committee recommended that using the 

AMDRs to set reference values for 

protein, total carbohydrate, and total fat 

is appropriate to promote healthful 

dietary practices and nutritionally 

adequate diets and would provide 

consistency. Because the IOM set 

AMDRs (percent of energy) for all three 

macronutrients, the IOM Committee 

recommended setting the DV based on 

the following: (1) The midpoint of the 

AMDR for carbohydrate (starch and 

sugars), (2) a population-weighted 

midpoint of the AMDR for total fat since 

AMDRs varied for age, and (3) the 

difference (100 percent of energy - (DVfat

+ DVcarbohydrate)) for protein. The IOM 

Committee stated that using the 

midpoint of the AMDR values avoids 

extreme values from the upper or lower 

boundaries and is an approach that 

focuses on moderation. The IOM Panel 

on Macronutrients did not set a UL for 

total or added sugars, but identified a 

suggested maximum intake level of no 

more than 25 percent of energy from 

added sugars. However, the IOM 

Committee recommended against using 

this value for nutrition labeling because 

it could be misrepresented as a desirable 

intake level. Although the IOM panel on 

macronutrients set an AMDR for 

protein, they also set EARs and RDAs 

for protein (see tables 11a and 12 of this 

document). 

Currently, the DV for protein is based 

on 10 percent of 2,000 calories using an 

adjusted average of the 1989 RDA (Ref. 

3). Although protein has a DV, the 

declaration of a percent DV for protein 

on the label is optional unless a claim 

is being made. The declaration of a 

percent DV for protein is optional due, 

in part, to the cost consideration of 

determining the protein digestibilitycorrected amino acid score which is 

necessary to calculate the percent DV of 

protein (58 FR 2079 at 2102). 

TABLE 12.—COMPARISON OF THE CURRENT DVS IN GRAMS TO THE LOWER, MIDPOINT, AND UPPER ACCEPTABLE

MACRONUTRIENT DISTRIBUTION RANGES FOR A 2,000 CALORIE DIET

Current DV AMDR AMDR 

Nutrient Percent of Energy Grams (for 2,000 

calories per day) 

Percent of energy Grams (for 2,000 calories per day)1

Low Midpoint High Low Midpoint High 

Adults 

Protein 10 50 10 22 .5 35 50 112 .5 175 

Fat 302 65 20 27 .5 35 44 .4 61 .1 77 .7 

Linoleic acid — — 5 7 .5 10 11 17 22 

a-Linolenic — — 0 .6 0 .9 1 .2 1 .3 2 2 .7 

Carbohydrate 60 3003 45 55 .0 65 2254 2754 3254

Protein by difference 17 .5 87 .5 

Total energy 100 100 

Children Age 4 to 18 Years 

Protein 10 50 10 20 30 50 100 150 

Fat 302 65 25 30 35 55 .6 66 77 .7 

Linoleic acid — — 5 7 .5 10 11 17 22 

a-Linolenic — — 0 .6 0 .9 1 .2 1 .3 2 2 .7 

Carbohydrate 60 3003 45 55 65 2254 2754 3254

Protein by difference 15 75 

Total energy 100 100 


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TABLE 12.—COMPARISON OF THE CURRENT DVS IN GRAMS TO THE LOWER, MIDPOINT, AND UPPER ACCEPTABLE

MACRONUTRIENT DISTRIBUTION RANGES FOR A 2,000 CALORIE DIET—Continued 

Current DV AMDR AMDR 

Nutrient Percent of Energy Grams (for 2,000 

calories per day) 

Percent of energy Grams (for 2,000 calories per day)1

Low Midpoint High Low Midpoint High 

Age 4 Years and Older (Weighted per IOM Labeling Report, Table B–4) 

Fat5 302 65 21 28 35 46 .7 62 77 .7 

Linoleic acid — — 5 7 .5 10 11 17 22 

a-Linolenic — — 0 .6 0 .9 1 .2 1 .3 2 2 .7 

Carbohydrate6 60 3003 45 55 65 2254 2754 3254

Protein by difference7 34 17 0 170 85 0 

Total energy 100 

1Derived by converting percent energy to g/d using Atwater factors 4 calories/g for carbohydrates and protein and 9 calories/d for fat for a 

2,000 calories diet. 2Based on a Dietary Guideline recommendation of no more than 30 percent of energy from fat. 

3Carbohydrate represents sugars, starch, fiber, and organic acids. 

4Carbohydrate represents starch and sugars. 

5The AMDR for total fat is comprised of population-weighted values computed based on U.S. Census Bureau estimates of the U.S. population 

in 2005. 6No weighting was done for this group. 

7Calculated using the difference (100 percent of energy - (DVfat + DVcarbohydrate)) for protein. 

For the purpose for food labeling, 

total carbohydrate in food is currently 

calculated by subtraction of the sum of 

crude protein, total fat, moisture, and 

ash from the total weight of the food and 

includes starch, sugars, sugar alcohols, 

and fiber (§ 101.9(c)(6)). The current DV 

for total carbohydrate is based on the 

100 percent of energy minus the sum of 

the DV for fat (30 percent) plus the DV 

for protein (10 percent). Thus, the DV is 

60 percent of a 2,000 calorie diet (300 

g) for total carbohydrate. In contrast to 

the calculation of total carbohydrates 

(§ 101.9(c)(6)), the IOM panel on 

macronutrients set an AMDR for 

carbohydrates and also set an EAR and 

RDA for carbohydrate that specifically 

represents starch and sugars, but does 

not include sugar alcohols or fiber (see 

tables 8, 10, and 12 of this document). 

Therefore, the recommendation by the 

IOM Committee to use the AMDR for 

setting a DV for total carbohydrate 

would limit the definition and 

corresponding DV to sugars and starch. 

The current DV for fat (65 g) is based 

on the NAS Diet and Health Report (Ref. 

4) which recommended no more than 30 

percent of energy from fat and 

represents triglyceride content 

(§ 101.9(c)(2)). The IOM panel on 

macronutrients set AMDRs for total fat 

and fatty acids linoleic and a-linolenic 

acid (see table 12 of this document). The 

IOM panel on macronutrients also set 

AIs for linoleic and a-linolenic acid (see 

table 11b of this document). 

Table 12 of this document shows the 

current DV, the lowest, the midpoint, 

and the highest value for each AMDR 

set by the IOM DRI panel on 

macronutrients, and the AMDRs 

adjusted using the population-weighted 

approach. As can be seen in table 12 of 

this document for fat, linoleic acid, alinolenic acid, and carbohydrate, the 

lowest, the midpoint, and the highest 

AMDR values are similar to the values 

obtained using the population-weighted 

AMDRs. The approach that was 

recommended by the IOM Committee, 

i.e., using the midpoint of the AMDR for 

fat and carbohydrate as the basis for 

label reference values, would yield 

values of 62 g/d of fat, 85 g/d protein, 

and 275 g/d carbohydrate. 

• Two thousand calories should be 

used, when needed, as the basis for 

expressing energy intake when 

developing DVs. Although EERs were 

set for all life-stage groups (Ref. 13), the 

IOM Committee recognized that the 

EERs are dependent upon height, 

weight, and physical activity level. In 

addition, the EER equations are based 

on normal weight individuals, and the 

United States has a high prevalence of 

obese and overweight individuals (64 

percent of adults and 15 percent of 

children) (Ref. 16). The IOM Committee 

found that the data necessary to use the 

EER to derive a calorie reference value 

is incomplete. Therefore, the IOM 

Committee recommended retaining the 

current 2,000 calorie reference level 

(Ref. 16). 

• The DVs for saturated fatty acids, 

trans fatty acids, and cholesterol should 

be set at a level that is as low as possible 

in keeping with an achievable healthpromoting diet. The rationale for this 

recommendation is based on the DRI 

macronutrient report (Ref. 13) which 

did not set ULs but recommended that 

saturated fatty acid, trans fatty acid and 

cholesterol intakes should be as low as 

possible while consuming a 

nutritionally adequate diet. The current 

DV for saturated fat (not more than 10 

percent of energy (20 g/d) and 

cholesterol (300 mg/d)) is based on the 

NAS Diet and Health Report (Ref. 4). 

For FDA to establish a DV for trans 

fatty acids, saturated fat, and 

cholesterol, the IOM Committee 

suggested that FDA use food 

composition data, menu modeling, and 

data from dietary surveys to estimate 

minimum intakes consistent with 

nutritionally adequate and healthpromoting diets for diverse populations. 

In April of 2004, FDA held a meeting of 

the Nutrition Subcommittee of the Food 

Advisory Committee on total fat and 

trans fat (the subcommittee) (Ref. 23). 

The subcommittee concluded that 

currently there is not enough scientific 

evidence to recommend a specific 

acceptable daily intake for trans fatty 

acids. 

• While the general population is best 

identified as all individuals 4 years of 

age and older, four distinctive life stages 

were identified for developing separate 

DVs: Infants (< 1 year), toddlers (1 to 3 

years), pregnancy, and lactation. 

Because infants, toddlers, and pregnant 

women and lactating women have 

specific nutritional needs, the IOM 

Committee stated that a single DV for 

the entire population could over- or 

underestimate the nutrient contribution 


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of foods for these four groups. 

Therefore, the IOM Committee 

recommended that separate DVs for 

foods manufactured specifically for 

these four groups be used for that 

specific life-stage group. 

See discussion in section I.B.1 of this 

document on requirements for foods 

that are represented or purported to be 

for the use of infants (up to 12 months 

of age) or children 1 to 4 years of age, 

and pregnant women or lactating 

women. 

• The Supplement Facts label should 

use the same DVs as the Nutrition Facts 

label. The IOM Committee 

recommended that all other guiding 

principles should apply to dietary 

supplement labeling. The IOM 

Committee came up with this 

recommendation because the 

Supplement Facts label requires the 

inclusion of the percent DVs for the 

nutrients that are mandated for 

conventional food (21 U.S.C. 321(ff)). 

Therefore, the comparisons that are 

shown for the Nutrition Facts label in 

tables 11a and 11b of this document are 

the same for the Supplement Facts label. 

• Absolute amounts should be 

included in the Nutrition Facts and 

Supplement Facts labels for all 

nutrients. The IOM Committee 

concluded that including absolute 

amounts (e.g., mg/serving) would assist 

consumers who want nutrient 

information but are yet unable to 

understand the percent DVs. 

Furthermore, absolute amounts for 

macronutrients are already required on 

the Nutrition and Supplement Facts 

labels. Therefore, the IOM Committee 

stated that adding absolute amounts for 

micronutrients would make the labeling 

consistent. The IOM Committee also 

recommended that the units used for 

vitamin A (IU), vitamin D (IU), vitamin 

E (IU), folate (μg), copper (mg), sodium 

(mg), potassium (mg) and chloride (mg) 

be changed to be consistent with the 

units in the new DRI reports (vitamin A 

(μg Retinol Activity Equivalents), 

vitamin D (μg), vitamin E (mg atocopherol), folate (μg dietary folate 

equivalents), copper (μg), sodium (g), 

potassium (g), and chloride (g)). 

F. IOM Report on the Definition of Fiber 

1. Definitions 

Because there is not a formal 

definition for dietary fiber, dietary fiber 

is the material isolated using AOAC 

INTERNATIONAL EnzymaticGravimetric Method 985.29 (Ref. 12). 

This method includes lignin and 

nonstarch polysaccharides and some 

resistant starch, inulin, chitin, chitosan, 

chondroitin sulfate, and 

noncarbohydrate material. This method 

does not include oligosaccharides, 

polydextrose, or resistant maltodextrins. 

Currently, dietary fiber is indented 

under ‘‘Total Carbohydrates’’ in the 

Nutrition Facts label (§ 101.9(c)(6)(i)). 

In 2001 the IOM Panel on the 

Definition of Dietary Fiber (the IOM 

Panel) responded to FDA’s request to 

provide definitions for dietary fiber 

based on its role in human physiology 

and health. The IOM Panel developed 

two categories of definitions of fiber: 

‘‘Dietary Fiber’’ and ‘‘Functional Fiber’’

(Ref. 12). See table 13 of this document 

from the IOM Report on the Definition 

of Dietary Fiber, which lists the 

characteristics of dietary fiber currently 

determined by FDA and by the IOM 

definitions for dietary and functional 

fibers. 

TABLE 13.—CHARACTERISTICS OF VARIOUS DIETARY FIBER DEFINITIONS1

Reference 

Nondigestible 

Animal 

CHOs2

CHOs Not 

Recovered by 

Alcohol 

Precipitation3

Nondigestible 

Mono- and 

Disaccharides 

Lignin Resistant 

Starch 

Intact, Naturally 

Occurring Food 

Sources Only 

Resistant 

to Human 

Enzymes 

Specifies 

Physiological 

Effect 

U.S. Food and Drug 

Administration 

(USFDA), 19874

Yes Some inulin No Yes Some No No No 

Institute of Medicine (IOM) (Proposed), 2001 

Dietary Fiber No Yes No Yes Some Yes Yes No 

Added Fiber Yes Yes Yes Yes Yes No Yes Yes 

1All definitions are assumed to include nonstarch polysaccharides. 

2CHO = carbohydrate. 

3Includes inulin, oligosaccharides (3–10 degrees of polymerization), fructans, polydextrose, methylcellulose, resistant maltodextrins, and other 

related compounds. 4Method-based definition. 

Source: Adapted from the IOM, ‘‘Dietary Reference Intakes: Proposed Definition of Dietary Fiber,’’ Washington, DC: National Academy Press, 

2001. 

a. The IOM Panel defined ‘‘Dietary 

Fiber’’ as nondigestible carbohydrates 

and lignin that are intrinsic and intact 

in plants. Nondigestible means that the 

material is not digested and absorbed in 

the human small intestine. Fractions of 

plant foods are still considered ‘‘Dietary 

Fiber’’ if the plants’ cells and their three 

dimensional interrelationships remain 

largely intact. Examples of ‘‘Dietary 

Fiber’’ include cereal brans; resistant 

starch that is naturally occurring; 

naturally occurring oligosaccharides 

such as raffinose, stachyose, verbacose; 

and low molecular weight fructans. The 

known physiological benefits of foods 

containing ‘‘Dietary Fiber,’’ such as 

attenuation of postprandial blood 

glucose and cholesterol levels and 

improved laxation, are recognized. 

b. The IOM Panel defined ‘‘Functional 

Fiber’’ as isolated, nondigestible 

carbohydrates that have beneficial 

physiological effects in humans. 

‘‘Functional Fibers’’ can be isolated or 

extracted nondigestible carbohydrates, 

using chemical, enzymatic, or aqueous 

procedures or synthetically 

manufactured. Provided that one or 

more beneficial physiological effects are 

demonstrated in humans, examples of 

‘‘Functional Fiber’’ would include 

isolated nondigestible animal 

carbohydrates, pectins or gums, 

resistant starch formed during 

processing, and synthetic fibers such as 

resistant maltodextrin and 

fructooligosaccharides. At this time, 

current FDA regulations have not 

established formal criteria for 

establishing the beneficial physiological 

effects of potential ‘‘Functional Fibers.’’

c. The IOM Panel defined ‘‘Total 

Fiber’’ as the sum of ‘‘Dietary Fiber’’ 


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and ‘‘Functional Fiber.’’ Thus, while 

there is currently one category of dietary 

fiber in the Nutrition Fact label, the 

Panel has provided three definitions of 

fiber for potential use. The AI set by the 

IOM is for ‘‘Total Fiber.’’

2. Soluble and Insoluble Fiber 

The IOM Panel recommended that the 

terms soluble and insoluble fiber be 

phased out and replaced with an 

appropriate physicochemical property 

(e.g., viscous or fermentable fiber) of the 

specific fiber as these become 

standardized. This recommendation is 

based on scientific findings that suggest 

that the physiological benefit of a fiber 

(e.g., attenuation of blood glucose and 

cholesterol concentration and improved 

laxation) is not related to the solubility 

of a fiber. There is evidence indicating 

that viscous fibers and fibers that are 

slowly, incompletely, or not fermented 

can provide beneficial physiological 

effects. The IOM Panel recommended 

that viscosity or fermentability of a fiber 

be considered as characteristics to 

distinguish ‘‘Dietary Fibers’’ and 

‘‘Functional Fibers’’ that modulate 

gastric and small bowel function from 

those that provide substantial stool bulk 

which is affected by fiber solubility and 

may or may not affect gastric and small 

bowel function. 

Currently, a statement of the number 

of grams of soluble (§ 101.9(c)(6)(i)(A)) 

and insoluble (§ 101.9(c)(6)(i)(B)) dietary 

fiber can be voluntarily declared and 

indented under dietary fiber and both 

are identified and quantified using 

AOAC INTERNATIONAL methods. 

3. Analytical Issues 

The IOM Panel recognized that 

adoption of the two definitions for fiber 

would challenge the currently available 

analytical methods, requiring changes to 

the current analytical methods. 

Particularly, separating out ‘‘Dietary’’

and ‘‘Functional Fibers,’’ of which there 

could be a potential overlap (e.g., 

resistant starch and dietary fibers that 

are extracted, concentrated, and added 

to foods (gums, cellulose, pectin)). The 

IOM Panel proposed modifications to 

the current methods. While further 

refinement of these methods is made, 

the IOM Panel indicated that it would 

be more practical to determine ‘‘Total 

Fiber’’ using the current methods. 

G. Current Regulations on Trans Fat 

In the Federal Register of July 11, 

2003 (68 FR 41434), FDA amended its 

regulations on nutrition labeling to 

require trans fatty acids be declared in 

grams per serving in the nutrition label 

of conventional foods and dietary 

supplements (the 2003 trans fat final 

rule). No DV was established for trans 

fatty acids. Required labeling became 

effective on January 1, 2006. 

In the Federal Register of July 11, 

2003 (68 FR 41507), FDA published an 

ANPRM (the 2003 trans fat 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 current 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. FDA also requested comments 

on whether it 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), FDA 

reopened the comment period for the 

2003 trans fat ANPRM to receive 

comments that considered the 

information in the 2003 IOM report on 

nutrition labeling (Ref. 16) that 

addressed the labeling of trans fat (see 

section II.E of this ANPRM). In addition 

to the questions raised in the 2003 trans 

fat ANPRM, FDA sought comments on 

the 2003 IOM labeling report’s approach 

to establish a DV using food 

composition data, menu modeling, and 

dietary survey data to estimate a 

minimum trans fat intake within a 

nutritionally adequate diet. FDA also 

sought comment on whether the IOM 

approach of using food composition 

data, menu modeling, and dietary 

survey data should be used to revise the 

DV for saturated fat. Public comments 

were also sought on the IOM 

recommendation to list saturated fat and 

trans fat on separate lines of the 

Nutrition Facts label, but have one 

numerical value for the percent DV for 

these two nutrients together. In 

addition, if FDA were to use one 

numerical value for the percent DV for 

both trans fat and saturated fat together, 

the agency asked for comment about 

whether such value should be 

determined by adding a new DV 

established for saturated fat to the DV 

for trans fat, or, alternatively, whether 

the agency should establish a joint DV 

for saturated and trans fats that would 

then be used to calculate one numerical 

value as the percent DV for both fats. 

On April 19, 2004 (69 FR 20838), FDA 

extended the comment period for the 

2003 trans fat ANPRM to receive 

comments that considered the 

information in the 2004 subcommittee 

meeting (Ref. 23) that addressed 

whether the available scientific 

evidence supports 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. 

Because of their relevance to the 

Nutrition Facts label, FDA intends to 

consider, as comments to this ANRPM, 

the comments to the 2003 trans fat 

ANPRM on the IOM approach for 

calculating a DV for saturated fat and 

trans fat and listing of saturated and 

trans fats on separate lines of the 

Nutrition Facts label with one 

numerical value for the percent DV for 

both, and how to calculate the percent 

DV as one numerical value. Comments 

to the 2003 trans fat ANPRM on the 

outcome of the subcommittee meeting 

will also be considered. Public 

comments on these issues are being 

asked again in this ANPRM so that these 

issues can be considered in the context 

of the entire Nutrition Facts and 

Supplement Facts labels along with 

other questions being asked in this 

ANPRM. 

H. ANPRM on Prominence of Calories 

In the Federal Register of April 4, 

2005 (70 FR 17008), FDA 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 (OWG) 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. 

FDA also sought comment of 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, FDA also requested comments 

on questions posed concerning the 

declaration of ‘‘calories from fat’’ (70 FR 

17008 at 17010). Because of their 

relevance to the Nutrition Facts label, 

FDA intends to consider, as comments 

to this ANRPM, comments to the 2005 

prominence of calories ANPRM related 

to questions posed on a percent DV for 

total calories and calories from fat. 

Public comments on the specific 

question about establishing a percent 


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7The nine citizen petitions can be found in 

Docket Nos. 2004P–0105/CP1, 2004P–0107/CP1, 

2004P–0110/CP1, 2004P–0297/CP1, 2004P–0298/ 

CP1, 2004P–0299/CP1, 2004P–0293/CP1, 2004P–

0473/CP1, 2004P–0542/CP1. 

DV for total calories and the questions 

posed concerning ‘‘calories from fat’’ are 

being requested in this ANPRM so that 

these questions can be considered in the 

context of the entire Nutrition Facts and 

Supplement Facts labels along with 

other questions being asked in this 

ANPRM. 

I. Carbohydrate Content of Food 

FDA received nine citizen petitions 

that requested, among other things, that 

the agency amend our nutrition labeling 

requirements related to the declaration 

of total carbohydrate content of foods.7

With respect to carbohydrate labeling, 

the agency is requesting comment in 

this ANPRM on questions related to the 

label declaration of carbohydrate in the 

Nutrition Facts and Supplement Facts 

labels (see section II.C.10 of this 

document). 

J. ‘‘2005 Dietary Guidelines for 

Americans’’

The ‘‘2005 Dietary Guidelines for 

Americans’’ (the 2005 Dietary 

Guidelines) developed jointly by the 

U.S. Department of Health and Human 

Services and the U.S. Department of 

Agriculture provide several key 

numerical recommendations with 

respect to micronutrients and 

macronutrients, of which most are based 

on the DRI reports (Ref. 7). These 

recommendations are as follows: 

• Consume less than 10 percent of 

calories from saturated fat and less than 

300 mg/d of cholesterol. These 

recommendations are the same as the 

current DRVs for saturated fat and 

cholesterol. 

• Keep total fat intake between 20 

and 35 percent of calories, the AMDR 

for total fat. 

• Consume less than 2,300 mg/d of 

sodium, the UL for sodium. 

The 2005 Dietary Guidelines also 

identified nutrients of concern based on 

dietary intake data or evidence of public 

health problems. The nutrients of 

concern are identified for: 

• Adults: Calcium, potassium, fiber, 

magnesium, and vitamins A (as 

carotenoids), C, and E; 

• Children and adolescents: Calcium, 

potassium, fiber, magnesium, and 

vitamin E. 

The 2005 Dietary Guidelines also 

identified nutrients of concern for 

specific populations groups. Vitamin 

B12 was identified as a nutrient of 

concern for people over the age of 50. 

Iron was identified as a nutrient of 

concern for women of childbearing age 

who may become pregnant. Folic acid 

was also identified as a nutrient of 

concern for women of childbearing age 

who may become pregnant and those in 

the first trimester of pregnancy. Vitamin 

D was identified as a nutrient of concern 

for older adults, people with dark skin, 

and people exposed to insufficient 

ultraviolet band radiation (i.e., 

sunlight). 

II. Agency Request for Information 

FDA has not updated or set new DVs 

since 1995. In 2003, the IOM completed 

its first review of nutrients using the 

DRI process. This review has generated 

discussion in the scientific community. 

FDA plans to revise the reference values 

used for the Nutrition Facts and 

Supplement Facts labels. FDA requests 

comments on the following questions. 

As part of the comments, FDA requests 

that scientific justification be submitted 

in support of the response. FDA 

recognizes that an individual 

commenter may choose to respond to all 

of the questions or only a subset, based 

on his/her area of expertise. 

A. Approach to Setting DVs 

As discussed in section I.D of this 

document, beginning in 1997, the IOM 

began publishing a series of reports on 

reference intake levels, collectively 

known as the DRIs. The DRIs provided 

revised RDAs and three new reference 

intakes for nutrients (AI, EAR, and UL). 

The IOM also reported on AMDRs for 

macronutrients. FDA requests 

comments on the following questions on 

which DRIs and AMDRs should be used 

for setting DVs. 

• Should the DV be based on an EAR 

for those nutrients for which an EAR 

has been set? Explain why or why not. 

• If EARs are used to set DVs, should 

they be set based on populationcoverage or population-weighted EAR? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

Explain why or why not. 

• Should the DV be set based on an 

RDA for those nutrients for which an 

RDA has been set? Explain why you 

have chosen a particular approach and 

why it is preferable to the other 

approach. 

• If RDAs are used to set DVs, should 

they be set based on populationcoverage or population-weighted RDA? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

• Should any or all AIs, regardless of 

how they are derived, be used to set 

DVs? Explain why or why not. Or, 

should only those AIs based on 

experimental data be used to set DVs 

(i.e., from intervention studies that are 

designed to evaluate nutrient 

requirements rather than dietary intake 

data from national surveys)? Explain 

why or why not. 

• If AIs are used to set DVs, should 

they be set based on populationcoverage or population-weighted AI? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

B. Populations for Which the DVs are 

Intended 

Currently the DVs are for persons 4 

years of age and older. FDA requests 

comments on the following questions on 

the populations for which the DVs 

should be intended. 

• Should the DVs continue to be used 

for persons 4 years of age and older? 

Explain why or why not. 

• Should DVs for different life stage 

groups be developed for labeling of food 

products specific to these groups, as 

recommended in the IOM labeling 

report (i.e., separate DVs: Infants (< 1 

year), toddlers (1 to 3 years), pregnancy, 

and lactation)? Explain why or why not. 

If so, 

• Should DVs for infants (< 1 year) be 

set based on the EARs, RDAs, or AIs for 

older infants (7 to 12 months)? Explain 

why you have chosen a particular 

approach and why it is preferable to the 

other approaches. 

• Should DVs for toddlers (1 to 3 

years) be set based on the EARs, RDAs, 

or AIs for toddlers (1 to 3 years)? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approaches. 

• Should DVs for pregnant women be 

set based on the population-weighted or 

population-coverage EARs, RDAs, or AIs 

for all DRI pregnancy groups (i.e. 14 to 

18 years, 19 to 30 years, 31 to 50 years)? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approaches. 

• Should DVs for lactating women be 

set based on the population-weighted or 

population-coverage EARs, RDAs, or AIs 

for all DRI lactation groups (i.e. 14 to 18 

years, 19 to 30 years, 31 to 50 years)? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approaches. 

C. Labeling of Individual Nutrients 

FDA requests comments on the 

following questions on individual 

nutrients: 

1. Calories 

• Should 2,000 calories continue to 

be used to express reference energy 

intake, as recommended in the IOM 


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labeling report? Explain why or why 

not. 

• Should 2,500 calories also be kept 

on the label footnote? Explain why or 

why not. 

• Should the EER (Estimated Energy 

Requirements) be used to express 

reference energy intake? Explain why or 

why not. 

• If a population-weighted EER or a 

population-coverage EER should be 

used, which PAL (sedentary, low active, 

active, very active) should be used to 

calculate the EER? Explain why you 

have chosen a particular approach and 

why it is preferable to the other 

approaches. 

• Would providing for a percent DV 

disclosure for total calories assist 

consumers in understanding the caloric 

content of the packaged food in the 

context of a 2,000 calorie diet? Explain 

why or why not. 

2. Calories From Fat 

• What data are there on how 

consumers use the listing of ‘‘Calories 

from fat?’’

• How does the listing ‘‘Calories from 

fat’’ adjacent to ‘‘Calories’’ affect 

consumers’ focus on the total calories of 

a food? 

• What are the advantages or 

disadvantages of eliminating the listing 

for ‘‘Calories from fat’’ from the 

nutrition label? 

• What data would be needed to 

determine whether the listing of 

‘‘Calories from fat’’ is or is not necessary 

to assist consumers in maintaining 

healthy dietary practices? 

3. Calories From Saturated Fat 

• Should calories from saturated fat 

continue to be voluntary or should it be 

made mandatory on the food label? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

4. Total Fat 

• Should a population-weighted 

midpoint of the AMDR (e.g. 28 percent 

for adults) be used, as suggested in the 

IOM labeling report? Explain why or 

why not. 

Note: 28 percent of 2,000 calories/d is 

560 calories/d. 560 calories/d divided 

by 9 calories/g is 62 g/d. 

• Should the upper range of AMDR of 

35 percent be used? Explain why or why 

not. 

Note: This would increase the DRV from 

65g/d to 78 g/d for 2,000 calorie diet. 35 

percent of 2,000 calories is 700 calories. 

700 calories divided by 9 calories/g is ~ 

78g. 

5. Saturated Fat 

• Should the current DRV of 20g/d 

from saturated fat remain, as 

recommended by the 2005 Dietary 

Guidelines? Explain why or why not. 

• Should food composition data, 

menu modeling, and data from dietary 

surveys be used to establish a DRV for 

saturated fat that is as low as possible 

while consuming a nutritionally 

adequate diet, as recommended in the 

IOM labeling report? Explain why or 

why not. 

6. Trans Fat 

• Should food composition data, 

menu modeling, and data from dietary 

surveys be used to establish a DRV for 

trans fat that is as low as possible while 

consuming a nutritionally adequate diet, 

as recommended in the IOM labeling 

report? Explain why or why not. 

• Should saturated fat and trans fat 

be listed on separate lines of the 

Nutrition Facts label, but have one 

numerical value for the percent daily 

value for these two nutrients together, as 

recommended in the IOM labeling 

report? Explain why or why not. 

• If one numerical value is used for 

the percent DV for both trans fat and 

saturated fat together, should such value 

be determined by adding the DV for 

saturated fat to the DV for trans fat, or, 

alternatively, should the agency directly 

establish a joint DV for saturated and 

trans fats that would then be used to 

calculate one numerical value as the 

percent DV for both fats? 

7. Polyunsaturated Fat 

• Should polyunsaturated fat 

continue to be voluntary or should it be 

made mandatory on the food label? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

• Should a DRV for polyunsaturated 

fat (n-3 plus n-6) be established using 

the AMDRs for n-6 (5–10 percent) and 

n-3 (0.6–1.2 percent) of total calories? If 

so, should the midpoint be used? 

Explain why or why not. 

Note: 7.5 percent (midpoint) for n-6 and 

0.9 percent (midpoint) for n-3 of 2,000 

calories =19g/d polyunsaturated fat. 

• Should a DRV for polyunsaturated 

fat be derived based upon AIs for 

linoleic acid (n-6 polyunsaturated fat) 

plus a-linolenic acid (n-3 

polyunsaturated fat)? Explain why or 

why not. 

• Should separate DRVs for linoleic 

acid (n-6 polyunsaturated fat) and alinolenic acid (n-3 polyunsaturated fat) 

be established? Explain why or why not. 

• If separate DRVs for linoleic acid (n6 polyunsaturated fat) and a-linolenic 

acid (n-3 polyunsaturated fat) are 

established should they be voluntary or 

should they be made mandatory on the 

food label? Explain why you have 

chosen a particular approach and why 

it is preferable to the other approach. 

8. Monounsaturated Fat 

• Should monounsaturated fat 

continue to be voluntary or should it be 

made mandatory on the food label? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

9. Cholesterol 

• Should the current cholesterol DRV 

of 300 mg/d remain, as recommended 

by the ‘‘2005 Dietary Guidelines for 

Americans’’? Explain why or why not. 

• Should food composition data, 

menu modeling, and data from dietary 

surveys be used to establish a DRV for 

cholesterol that is as low as possible 

while consuming a nutritionally 

adequate diet, as recommended in the 

IOM labeling report? Explain why or 

why not. 

10. Carbohydrate 

• Should the current approach for 

calculating grams of total carbohydrate 

by difference (see section I.E of this 

document) continue to be used? Explain 

why or why not. If not, what other 

approach or method do you 

recommend? If so, what should be 

included or excluded in the current 

calculation of ‘‘total carbohydrate’’? 

• The 2005 Dietary Guidelines 

recommends consuming fiber-rich 

foods. Would the separation of dietary 

fiber from the ‘‘total carbohydrate’’

declaration in nutrition labeling affect 

consumer understanding of label 

information and its application to 

dietary guidelines and what would be 

the impact, if any, on fiber 

consumption? 

• Should ‘‘sugars’’ continue to be 

included in the Nutrition Facts label? 

• Should additional types of 

carbohydrate (e.g., starch) be listed 

separately in the Nutrition Facts label? 

Explain why or why not. 

• Should carbohydrates be classified 

and declared in nutrition labeling based 

on their chemical definition or on their 

physiological effect? Explain why you 

have chosen a particular approach and 

why it is preferable to the other 

approach. If based on a physiologic 

effect, should the DV for carbohydrate 

(i.e., sugars and starch) be based on the 

midpoint of the AMDR (i.e., 55 

percent)? Explain why or why not. 

Note: 55 percent of 2,000 calories/d is 

1,100 calories. 1,100 calories divided by 

4 calories/g would be 275 g/d. 


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11. Dietary Fiber 

• Should FDA continue to use the 

AOAC INTERNATIONAL methods to 

determine dietary fiber? If not, what 

other or additional methods should be 

used? 

• Should the IOM dietary fiber and/ 

or functional fiber definitions replace 

the current FDA definition for dietary 

fiber? Explain why or why not. 

• Do you recommend another name 

for functional fiber? If so, what do you 

recommend and why? 

• Until FDA identifies functional 

fibers and analytical methods are 

established for distinguishing functional 

fiber from dietary fiber, should total 

fiber be used on the label to represent 

dietary fiber? Explain why or why not. 

12. Soluble and Insoluble Fiber 

• Should soluble and insoluble fiber 

continue to be voluntary or should they 

be made mandatory on the food label? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

• Should the terms soluble fiber and 

insoluble fiber be changed to viscous 

and nonviscous fiber, as suggested by 

the IOM? Explain why or why not. 

13. Sugar Alcohols 

• Should sugar alcohols continue to 

be voluntary or should they be made 

mandatory on the food label? Explain 

why you have chosen a particular 

approach and why it is preferable to the 

other approach. 

• How should the energy contribution 

of sugar alcohols be represented on the 

label since energy values vary (e.g., from 

0.2 calories/g for erythritol to 3.0 

calories/g for hydrogenated starch 

hydrolysates)? 

• FDA has not defined how it would 

determine available energy from sugar 

alcohols. What analytical methods 

could be used to determine the energy 

contribution of sugar alcohols? 

14. Protein 

• Should the DRV be based on the 

approach recommended in the IOM 

labeling report (100 percent—(DVfat + 

DVcarbohydrate))? Explain why or why not. 

• Should the DRV be based on the 

midpoint of the AMDR for protein (i.e., 

17 percent)? Explain why or why not. 

Note: Based on 2,000 calories/d, the 

DRV would be 85 g/d. 

• Should the DRV for protein be 

based on the EAR or RDA for protein? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

15. Sodium 

• Should the DRV for sodium be 

based on the UL for sodium (2,300 mg/ 

d) as suggested by the 2005 Dietary 

Guidelines for Americans or should it 

be based on the AI (1,500 mg/d using 

the population-coverage approach)? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

• If the UL should be used, should it 

be adjusted using the same approach 

(population-weighted or populationcoverage) as the other DRIs? Explain 

why or why not. 

16. Chloride 

The IOM set an AI and UL for 

chloride on an equi-molar basis to that 

of sodium since most sodium is 

consumed in the form of sodium 

chloride. 

• Should the DV for chloride 

continue to be an RDI, or should it be 

a DRV like sodium? Explain why you 

have chosen a particular approach and 

why it is preferable to the other 

approach. 

• Should the DV for chloride be based 

on the same DRI (AI versus UL) as used 

to set a DV for sodium? Explain why or 

why not. 

17. Vitamins and Minerals 

Currently vitamin A, vitamin C, 

calcium, and iron are mandatory on the 

food label because they were considered 

to be of public health concern. 

• Are vitamin A, vitamin C, calcium, 

and iron still considered to be of public 

health concern? Explain why or why 

not. 

• Are there other micronutrients that 

should be of public health concern? 

Please be specific in describing what, if 

any, other micronutrients are of public 

health concern and why. 

• For those nutrients given an AI 

under the DRI process, but currently 

have a DV based on an earlier RDA (e.g., 

calcium, vitamin K, vitamin D, 

pantothenic acid, biotin), should the 

current DV be retained or should the 

newer AI be used to develop a new DV? 

Explain why you have chosen a 

particular approach and why it is 

preferable to the other approach. 

• Currently there is no DV for 

fluoride. Since the IOM established an 

AI for fluoride, should there be a DV for 

fluoride? Explain why or why not. 

D. Other Questions 

• Should the IUs that are currently 

used for the DVs for vitamins A, D, and 

E be changed to μg RAE (retinol activity 

equivalents), μg, and mg a-tocopherol, 

respectively? Explain why or why not. 

• Should the current DV units for 

folate (μg), copper (mg), chloride (mg), 

potassium (mg), and sodium (mg) be 

changed to be consistent with the units 

in the IOM DRI reports (folate (μg 

dietary folate equivalents), copper (μg), 

chloride (g), potassium (g), and sodium 

(g))? Explain why or why not. 

• Should the Supplement Facts label 

use the same DVs as the Nutrition Facts 

label, as suggested in the IOM labeling 

report? Explain why or why not. 

• Should absolute amounts (e.g., 

grams or milligrams) be included in the 

Nutrition Facts and Supplement Facts 

labels for mandatory and voluntary 

nutrients? Explain why or why not. 

E. Process Questions 

The following question seeks 

information on the process issues 

related to the Nutrition and Supplement 

Facts labels. 

• If FDA includes functional fiber in 

the Nutrition Facts labels, should FDA 

develop criteria for identifying fibers 

that meet the definition of functional 

fiber (i.e., demonstrates a physiological 

benefit)? If so, what should those 

criteria be? 

F. Questions on Consumer and Producer 

Use and Understanding of DVs 

To help determine which regulatory 

options might address problems 

associated with food package labels 

reflecting current DVs, we request 

comments including available data on 

the following questions: 

• In the 2002 Health and Diet Survey 

(Ref. 24), respondents were asked how 

they use the Nutrition Facts label. The 

most common answers were as follows: 

(1) To see if the product was high or low 

in a specific nutrient, (2) to get a general 

idea of the nutritional content of food, 

and (3) to decide which brand to 

purchase and to compare different food 

items. Do you have information 

indicating how the percent DV found in 

the Nutrition Facts label facilitates any 

of these uses by consumers? For which 

food products and nutrients? 

• Currently, a percent DV is required 

for most nutrients listed in the Nutrition 

Facts label. Do you have any 

information indicating that there are 

nutrients for which consumers would 

value percent DV information, but such 

nutrients are not currently found in the 

Nutrition Facts label? 

• Do you have information suggesting 

the degree to which the percent DV is 

helpful for making purchases? For 

which food products? For which 

nutrients? 

• Do you have information suggesting 

differences between the degree to which 

the percent DV is helpful for making 


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purchases intended for consumers 4 

years of age and older, children younger 

than 4 years of age, infants, and 

pregnant women and lactating women? 

For which food products? For which 

nutrients? 

The following questions address 

information needed by FDA to analyze 

the implications of changes in the 

percent DVs on consumer and producer 

behavior. 

• Do you have any information 

suggesting that changes in percent DV 

(higher or lower), for a nutrient per 

serving, would cause consumers to 

reduce their consumption of some 

products or product categories and 

increase their consumption of other 

products or product categories? If so, 

changes in the percent DVs of which 

nutrients would cause changes in the 

consumption of which products or 

product categories? Why? 

• If changes in the percent DVs of 

some nutrients would alter the 

eligibility of some products or product 

categories to make nutrient content 

claims or health claims, do you have 

any information suggesting that 

manufacturers would reformulate or relabel some of their products in order to 

make a nutrient content claim or a 

health claim? If so, changes in the 

percent DVs of which nutrients would 

cause which products or product 

categories to be reformulated in order to 

make a nutrient content claim or health 

claim? 

• If changes in the percent DVs of 

some nutrients would cause some 

products or product categories to be 

reformulated or re-labeled in order to 

make a nutrient content claim or a 

specific health claim, do you have any 

information suggesting that there are 

public health effects from changes in 

nutrient intakes and consumption 

behavior of newly reformulated or relabeled products or product categories 

that make these claims? If so, what are 

the public health effects from changes in 

nutrient intakes and from changes in the 

consumption behavior of which newly 

reformulated products or product 

categories? 

• The length of time to comply with 

any regulation requiring revision to 

product labels may introduce confusion 

on the part of consumers during a 

transition period in which two different 

percent DVs would be reflected on 

labels of otherwise identically 

formulated products. Do you have 

information suggesting the extent to 

which such confusion might exist for 

compliance periods of 6 months, 12 

months, and 24 months? For which food 

products? 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. 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. FDA has verified the 

Web site addresses but is not 

responsible for subsequent changes to 

the Web sites after this document 

publishes in the Federal Register. 

1. National Research Council (NRC), 

‘‘Recommended Dietary Allowances, Seventh 

Edition,’’ Washington, DC: National 

Academy Press, 1968. 

2. NRC, ‘‘Recommended Dietary 

Allowances, Ninth Edition,’’ Washington, 

DC: National Academy Press, 1980. 

3. NRC, ‘‘Recommended Dietary 

Allowances, Tenth Edition,’’ Washington, 

DC: National Academy Press, 1989. 

4. NRC, Executive Summary, ‘‘Diet and 

Health: Implications for Reducing Chronic 

Disease Risk,’’ Washington, DC: National 

Academy Press, pp. 1 to 20, 1989. 

5. U.S. Department of Health and Human 

Services, ‘‘The Surgeon General’s Report on 

Nutrition and Health,’’ Washington, DC, 

1988. 

6. U.S. Department of Agriculture and U.S. 

Department of Health and Human Services, 

‘‘Nutrition and Your Health, Dietary 

Guidelines for Americans,’’ Washington, DC: 

Home and Gardening Bulletin No. 232, 3d 

ed., U.S. Government Printing Office, 1990. 

Available at http://www.health.gov/ 

DietaryGuidelines/1990thin.pdf. 

7. U.S. Department of Health and Human 

Services and U.S. Department of Agriculture, 

‘‘2005 Dietary Guidelines for Americans,’’

6th ed., Washington, DC: U.S. Government 

Printing Office, 2005. Available at http:// 

www.health.gov/dietaryguidelines/dga2005/ 

document/. 

8. IOM, Executive Summary, ‘‘Dietary 

Reference Intakes for Calcium, Phosphorous, 

Magnesium, Vitamin D, and Fluoride,’’

Washington, DC: National Academy Press, 

pp. 1–20, 1997. 

9. IOM, Executive Summary, ‘‘Dietary 

Reference Intakes for Thiamin, Riboflavin, 

Niacin, Vitamin B6, Folate, Vitamin B12, 

Pantothenic Acid, Biotin, and Choline,’’

Washington, DC: National Academy Press, 

pp. 1 to 16, 1998. 

10. IOM, Executive Summary, ‘‘Dietary 

Reference Intakes for Vitamin C, Vitamin E, 

Selenium, and Carotenoids,’’ Washington, 

DC: National Academy Press, pp. 1 to 20, 

2000. 

11. IOM, Executive Summary, ‘‘Dietary 

Reference Intakes for Vitamin A, Vitamin K, 

Arsenic, Boron, Chromium, Copper, Iodine, 

Iron, Manganese, Molybdenum, Nickel, 

Silicon, Vanadium, and Zinc,’’ Washington, 

DC: National Academy Press, pp. 1 to 28, 

2001. 

12. IOM, ‘‘Dietary Reference Intakes: 

Proposed Definition of Dietary Fiber,’’

Washington, DC: National Academy Press, 

2001. 

13. IOM, Executive Summary, ‘‘Dietary 

Reference Intakes for Energy, Carbohydrate, 

Fiber, Fat, Fatty Acids, Cholesterol, Protein, 

and Amino Acids,’’ Washington, DC: 

National Academies Press, pp. 1 to 19, 2002. 

14. IOM, Executive Summary, ‘‘Dietary 

Reference Intakes for Water, Potassium, 

Sodium, Chloride, and Sulfate,’’ Washington, 

DC: National Academies Press, pp. 1 to 20, 

2004. 

15. IOM, Executive Summary, ‘‘Dietary 

Reference Intakes: Applications in Dietary 

Planning,’’ Washington, DC: National 

Academies Press, pp. 1 to 17, 2003. 

16. IOM, ‘‘Dietary Reference Intakes: 

Guiding Principles for Nutrition Labeling and 

Fortification,’’ Washington, DC: National 

Academies Press, 2003. 

17. Beaton, G.H., ‘‘When Is an Individual 

an Individual Versus a Member of a Group? 

An Issue in the Application of the Dietary 

Reference Intakes.’’ Nutrition Reviews, 

64:221–225, 2006. 

18. Beaton, G.H., ‘‘Choice of DRI Value for 

Use in Nutrition Labeling.’’ Journal of 

Nutrition, 137:694–695, 2007. 

19. Yates, A.A., ‘‘Which Dietary Reference 

Intake Is Best Suited to Serve as the Basis for 

Nutrition Labeling for Daily Values?’’ Journal 

of Nutrition, 136:2457–2462, 2006. 

20. FDA, Center for Food Safety and 

Applied Nutrition, ‘‘Nutrient Content Claims 

Notifications for Choline Containing Foods,’’

(Internet address: http://www.cfsan.fda.gov/ 

~dms/flcholin.html), August 30, 2001. 

21. Derby B., A. Levy, ‘‘Do Food Labels 

Work?’’ In: Handbook of Marketing and 

Society, Thousand Oaks, CA: Sage, 2000. 

22. IOM, Executive Summary, ‘‘Dietary 

Reference Intakes: Applications in Dietary 

Assessment,’’ Washington, DC: National 

Academy Press, 2000. 

23. FDA, ‘‘Meeting Minutes from the 

Nutrition Subcommittee of the Food 

Advisory Committee Meeting on Total Fat 

and Trans Fat,’’ Washington, DC, April 27 to 

28, 2004. Available at http://www.fda.gov/ 

ohrms/dockets/ac/04/minutes/ 

4035m1_FinalSummaryMinutes.htm. 

24. FDA, ‘‘2002 Health and Diet Survey—

Preliminary Topline Frequencies 

(Weighted),’’ 2004. 

This ANPRM is issued under section 

201 et al. of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 321 et al.) and 

under authority of the Commissioner of 

Food and Drugs. 


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APPENDIX A 

ACRONYMS USED IN THIS DOCUMENT

AI Adequate Intake 

AMDRs Acceptable Macronutrient Distribution Ranges 

ANPRM Advance Notice of Proposed Rulemaking 

CV Coefficient of Variation 

DRIs Dietary Reference Intakes 

DRV Daily Reference Value 

DV(s) Daily Value(s) 

EAR Estimated Average Requirement 

EER Estimated Energy Requirement 

ESADDIs Estimated Safe and Adequate Daily Dietary Intakes 

FDA Food and Drug Administration 

FLUNES Food Label Use and Nutrition Education Surveys 

IOM Institute of Medicine 

IU International Units 

NAS National Academy of Sciences 

NLEA Nutrition Labeling and Education Act of 1990 

OWG Obesity Working Group 

PAL Physical Activity Level 

RACC Reference Amount Customarily Consumed 

RDA Recommended Dietary Allowance 

RDI Reference Daily Intakes 

SD Standard Deviation 

TEE Total Energy Expenditure 

U.S. RDA U.S. Recommended Daily Allowance 

UL Tolerable Upper Intake Level 


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62174 Federal Register / Vol. 72, No. 212 / Friday, November 2, 2007 / Proposed Rules 

BILLING CODE 4160–01–C 


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Dated: October 25, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–5440 Filed 11–1–07; 8:45 am] 

BILLING CODE 4160–01–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–HQ–0AR–2007–0510; FRL–8485–8] 

Federal Implementation Plans for the 

Clean Air Interstate Rule: Automatic 

Withdrawal Provisions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to amend 

the Federal Implementation Plans (FIPs) 

for the Clean Air Interstate Rule (CAIR) 

to provide for automatic withdrawal of 

the CAIR FIPs in a State upon the 

effective date of EPA’s approval of a full 

State implementation plan (SIP) 

revision meeting the CAIR 

requirements. EPA believes it is 

appropriate for the FIP withdrawal to be 

automatic because to the extent EPA 

approves the State’s full CAIR SIP, this 

corrects the deficiency that provided the 

basis for EPA’s promulgation of the FIPs 

in that State. 

In the ‘‘Rules’’ section of this Federal 

Register, we are issuing this action as a 

direct final rule without a prior 

proposed rule. If we receive no adverse 

comment, we will not take further 

action on this proposed rule. 

DATES: Written comments must be 

received by December 17, 2007. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ–

OAR–2007–0510, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• E-mail: a-and-r-Docket@epa.gov. 

Attention Docket ID No. EPA–HQ–

OAR–2007–0510. 

• Fax: (202) 566–9744. Attention 

Docket ID No. EPA–HQ–OAR–2007–

0510. 

• Mail: EPA Docket Center, EPA West 

(Air Docket), Attention Docket ID No. 

EPA–HQ–OAR–2007–0510, 

Environmental Protection Agency, 

Mailcode: 2822T, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

• Hand Delivery: EPA Docket Center 

(Air Docket), Attention Docket ID No. 

EPA–HQ–OAR–2007–0510, 

Environmental Protection Agency, 1301 

Constitution Avenue, NW., Room 3334; 

Washington, DC. Such deliveries are 

only accepted during the Docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–OAR–2007–

0510. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through www.regulations.gov 

or e-mail. The www.regulations.gov Web 

site is an ‘‘anonymous access’’ system, 

which means EPA will not know your 

identity or contact information unless 

you provide it in the body of your 

comment. If you send an e-mail 

comment directly to EPA without going 

through www.regulations.gov your email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

docket and made available on the 

Internet. If you submit an electronic 

comment, EPA recommends that you 

include your name and other contact 

information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters and any 

form of encryption, and be free of any 

defects or viruses. For additional 

information about EPA’s public docket 

visit the EPA Docket Center homepage 

at http://www.epa.gov/epahome/ 

dockets.htm. 

Docket: All documents in the docket 

are listed in the www.regulations.gov 

index. Although listed in the index, 

some information is not publicly 

available, e.g., CBI or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically in 

www.regulations.gov or in hard copy at 

the EPA Docket Center EPA/DC, EPA 

West, Room 3334, 1301 Constitution 

Ave., NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the EPA Docket Center is 

(202) 566–1742. 

Rulemaking actions related to the 

CAIR and the CAIR FIPs are also 

available at the EPA’s CAIR Web site at 

www.epa.gov/cair. 

FOR FURTHER INFORMATION CONTACT: 

Carla Oldham, Air Quality Planning 

Division, Office of Air Quality Planning 

and Standards, mail code C539–04, 

Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number: 919–541–

3347; fax number: 919–541–0824; e-mail 

address: oldham.carla@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Why Is EPA Issuing This Proposed 

Rule? 

This document proposes to amend the 

CAIR FIPs to provide for automatic 

withdrawal of the CAIR FIPs in a State 

upon the effective date of EPA’s 

approval of a full SIP revision meeting 

the CAIR requirements. We have 

published a direct final rule making 

such amendments in the ‘‘Rules’’

section of this Federal Register because 

we view this as a noncontroversial 

action and anticipate no adverse 

comment. We have explained our 

reasons for this action in the preamble 

to the direct final rule. 

If we receive no adverse comment, we 

will not take further action on this 

proposed rule. If we receive adverse 

comment, we will withdraw the direct 

final rule and it will not take effect. We 

would address all public comments in 

any subsequent final rule based on this 

proposed rule. We do not intend to 

institute a second comment period on 

this action. Any parties interested in 

commenting must do so at this time. 

The regulatory text for this proposal is 

identical to that for the direct final rule 

published in the ‘‘Rules’’ section of this 

Federal Register. For further 

information and the detailed rationale 

for this proposal, see the information 

provided in the direct final rule. 

II. Does This Action Apply to Me? 

This action does not propose any 

control requirements. It proposes to 

amend the CAIR FIPs to provide for 

automatic withdrawal of the CAIR FIPs 

in a State upon the effective date of 

EPA’s approval of the CAIR SIP for the 

State. EPA promulgated the CAIR FIPs 

on April 28, 2006 (71 FR 25328). 

Categories and entities potentially 

regulated by the CAIR FIPs include the 

following: 


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