Food Labeling: Reference Daily Intakes

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 90N-0134]

RIN 0905-AD08

Food Labeling: Reference Daily Intakes

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

its regulations to establish Reference Daily Intakes (RDI's) for

vitamin K, selenium, chloride, manganese, fluoride, chromium, and

molybdenum for use in declaring the nutrient content of a food on its

label or labeling; change the units of measure for biotin, folate,

calcium, and phosphorus; and make consideration of selenium,

molybdenum, fluoride, and chromium optional when determining

nutritional inferiority. The agency is taking this action to assist

consumers in understanding the nutritional significance of the levels

of these nutrients in the context of the total daily diet and in

recognition of the fact that the National Academy of Sciences (NAS) has

established Recommended Dietary Allowances (RDA's) or Estimated Safe

and Adequate Daily Dietary Intakes (ESADDI's) for these nutrients.

DATES: Submit written comments by March 7, 1994. The agency is

proposing that any final rule that may issue based on this proposal

become effective 30 days after date of publication of that final rule.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Camille E. Brewer, Center for Food

Safety and Applied Nutrition (HFS-165), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-205-5483.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of July 19, 1990 (55 FR 29476), in a

document entitled ``Food Labeling; Reference Daily Intakes and Daily

Reference Values'' (hereinafter referred to as the July 1990 proposal),

FDA proposed to amend its food labeling regulations by revising and

expanding the list of label reference values for nutrients in foods

that it had established. This list was known as the ``U.S. Recommended

Daily Allowances'' (U.S. RDA's) (Sec. 101.9(c)(7)(iv) (21 CFR

101.9(c)(7)(iv)). The agency proposed to replace the U.S. RDA's with

RDI's for protein and 26 vitamins and minerals for which RDA's or

ESADDI's were provided in the 9th and 10th Editions of NAS'

``Recommended Dietary Allowances'' (proposed Sec. 101.9(c)(11)(iv) (56

FR 60366 at 60390)). FDA proposed to establish RDI's for vitamins and

minerals for five groups: Adults and children 4 or more years of age,

children less than 4 years of age, infants, pregnant women, and

lactating women. It also proposed to establish Daily Reference Values

(DRV's) for eight nutrients and food components (i.e., total fat,

saturated fat, unsaturated fat, cholesterol, total carbohydrate,

dietary fiber, sodium, and potassium) for adults and children 4 or more

years of age.

During the comment period on this proposal, Congress passed, and

the President signed into law, the Nutrition Labeling and Education Act

of 1990 (Pub. L. 101-535) (hereinafter known as ``the 1990

amendments''). In response to this new law, in the Federal Register of

November 27, 1991 (56 FR 60366, and corrected at 57 FR 8178, March 6,

1992), FDA issued a document entitled ``Food Labeling: Reference Daily

Intakes and Daily Reference Values; Mandatory Status of Nutrition

Labeling and Nutrient Content Revision'' (hereinafter referred to as

``the supplementary proposal''). In that document, FDA republished and

supplemented the July 1990 proposal and a proposal on nutrition

labeling that FDA had also published in July of 1990 to make clear that

in the agency's view, with some modifications, these proposals

addressed the requirements of the 1990 amendments.

FDA received approximately 800 responses to the July 1990 proposal,

and approximately 700 responses to that part of the supplementary

proposal that addressed the RDI's and DRV's, from trade and retail

associations, government organizations, retailers, consumer groups,

State groups, private organizations, professional societies, and

universities. Each of the responses contained one or more comments. FDA

summarized and reviewed these comments in the final rule entitled

``Food Labeling; Reference Daily Intakes and Daily Reference Values''

that it published in the Federal Register of January 6, 1993 (58 FR

2206, and corrected at 58 FR 17104, April 1, 1993) (hereinafter

referred to as ``the RDI/DRV final rule'').

However, on October 6, 1992, before FDA issued a final rule in

response to the July 1990 and the supplemental proposals, Congress

passed the Dietary Supplement Act of 1992 (Pub. L. 102-571)

(hereinafter referred to as the ``DS act''). Section 202(a)(1) of the

DS act established a moratorium on the implementation of the 1990

amendments with respect to dietary supplements of vitamins, minerals,

herbs, or other similar nutritional substances (hereinafter referred to

as ``dietary supplements'') until December 15, 1993. Section 203 of the

DS act prohibited FDA from promulgating before November 8, 1993,

regulations that require the use of, or that are based upon,

recommended daily allowances of vitamins or minerals, other than

regulations establishing the United States recommended daily allowances

specified in Sec. 101.9(c)(7)(iv) as in effect on October 6, 1992. The

label values in Sec. 101.9(c)(7)(iv) were based, to a large extent, on

the 1968 RDA's and thus were almost 25 years old. Nonetheless, with its

discretion constrained by section 203 of the DS act but faced with a

need to establish a labeling scheme that manufacturers could implement

as quickly as possible, FDA simply adopted the values in

Sec. 101.9(c)(7)(iv) as in effect in 1992 in its new regulations (see

the RDI/DRV final rule).

However, this solution created a new set of problems. Section

101.9(c)(7)(iv) as in effect in 1992, and the 1968 RDA's that it was

based on (Ref. 1), did not contain reference values for a number of

nutrients that were included in the 1989 RDA's (Ref. 2). Thus, there is

no provision in the RDI's for a number of nutrients whose importance

for good nutrition has been generally accepted. To remedy this

situation, FDA is proposing to establish RDI's for these nutrients.

FDA is not proposing to change the RDI levels for those nutrients

for which it has already established RDI's. FDA recognizes that there

is active debate within the scientific community as to the basis on

which such levels should be established, and therefore, the agency

considers it premature to modify its current levels. However, FDA

believes that at least the list of nutrients for which it has RDI's, if

not the RDI levels themselves, should reflect scientific consensus.

Therefore, FDA is proposing to establish RDI's for seven additional

nutrients.

II. Authority for Additional Label Reference Values

Section (2)(b)(1)(A) of the 1990 amendments states that nutrition

label information shall be conveyed in a manner that, among other

things, enables the public to understand its relative significance in

the context of a total daily diet. In the legislative history of this

provision, Congress stated that this provision requires the Secretary

to specify requirements that would permit the consumer to understand

the nutrition information pertaining to a particular food in relation

to recommended dietary information (H. Rept. 101-538, 101st Cong., 2d

sess. 18 (1990)). Thus, FDA has required that a presentation of the

percent of the daily value of the nutrients listed in the nutrition

label be a fundamental part of the nutrition label format (see 58 FR

2079 at 2123 through 2135). Given the approach that FDA has taken, it

is clear that the more nutrients for which RDI's or DRV's are clearly

established, the easier it will be for consumers to understand

information about that nutrient in the context of the total daily diet.

In the RDI/DRV final rule, FDA stated that over the last 20 years,

there have been significant advances in scientific knowledge with

respect to essential nutrient requirements (58 FR 2206). In 1980, NAS

established ESADDI values for vitamin K, biotin, pantothenic acid,

copper, manganese, fluoride, chromium, selenium, molybdenum, sodium,

potassium, and chloride for the first time (Ref. 3). These suggested

intake values were based on less complete scientific data than the RDA

values and were regarded as more tentative and evolutionary (Ref. 3).

In 1989, NAS updated the values for vitamin K and selenium, making them

RDA's rather than EASDDI's (Ref. 2). At that time, NAS continued to

provide ESADDI values for manganese, fluoride, chromium, and molybdenum

but dropped the suggested values for sodium, potassium, and chloride,

giving instead estimated minimum requirements for healthy persons at

various ages.

Thus, given the usefulness of RDI values in conveying the

information that Congress has said should be conveyed by nutrition

labeling, and given the fact that NAS has developed the basis for RDI's

that are not included on the current list, FDA tentatively concludes

that it is appropriate to establish reference values for these seven

nutrients.

III. The Need for Change

Under Sec. 101.9(c)(8) that becomes effective May 8, 1994, only

those vitamins and minerals for which FDA has established label

reference values may be listed in the nutrition labels of food in

conventional food form. FDA proposed to take a similar position with

respect to nutrition labeling of dietary supplements of vitamins and

minerals (58 FR 33715, June 18, 1993). Several comments on the dietary

supplement proposal argued, however, that because RDA's or ESADDI's

have been established by NAS for vitamin K, selenium, manganese,

fluoride, chromium, molybdenum, and chloride, manufacturers of dietary

supplements of vitamins or minerals should be allowed to declare these

nutrients in products' nutrition labels with an asterisk in the

``Percent Daily Value'' column. The comments suggested that the

asterisk refer to a footnote stating ``No Daily Value has been

established.''

Based on its consideration of these comments and because the format

that FDA proposed for dietary supplements of vitamins and minerals

provides for the listing of quantitative amounts for vitamins and

minerals (in contrast to the format for the nutrition labeling of foods

in conventional food form, which provides for only a listing of the

percent of the daily value for each vitamin and mineral provided by the

food), FDA provided for the listing of these nutrients in the manner

that was suggested by these comments in the final rule entitled ``Food

Labeling; Requirement for Nutrient Content Claims for Dietary

Supplements of Vitamins, Minerals, Herbs, and Other Similar Nutritional

Substances,'' published elsewhere in this issue of the Federal

Register. However, as an ultimate matter, FDA considers this solution

to be deficient in two respects. First, even on dietary supplements of

vitamins and minerals, this solution provides no basis for a

declaration of the percent of the daily value for these nutrients,

information that is, as stated above, important for consumers in

putting the information presented in the nutrition label in the context

of the total daily diet. Second, the agency's action with respect to

dietary supplements of vitamins and minerals does nothing to provide

information on the levels of these nutrients in foods whose labeling is

subject to Sec. 101.9.

Moreover, the comments on the proposed rule on nutrient content

claims for dietary supplements (58 FR 33715 at 33731) pointed to a

third type of problem created by the lack of reference values for the

nutrients in question. Several of those comments requested that

nutrient content claims be allowed for all vitamins or minerals for

which NAS has established RDA's or ESADDI's. These comments could not

be readily accommodated, however, because, as explained in the final

rule on nutrient content claims for dietary supplements published

elsewhere in this issue of the Federal Register, FDA's regulations

define terms such as ``high'' and ``good source'' based on the RDI or

DRV for the nutrient that is the subject of the claim. This approach

has the advantage of linking nutrient content claims to established

reference values that provide a consistent, quantitative basis for the

claims. However, because the agency's current list of RDI's and DRV's

does not reflect the entire list of nutrients for which dietary

recommendations have been established, no claims can be made about

nutrients whose essentiality is generally recognized unless the list of

nutrients with RDI's is updated as quickly as possible.

Thus, FDA is proposing to establish RDI's for vitamin K, selenium,

chloride, manganese, fluoride, chromium, and molybdenum for three

reasons. First, it will permit the declaration of these nutrients in

the nutrition labeling of all foods. Second, it will permit consumers

of dietary supplements of vitamins and minerals, as well as other foods

that contain these nutrients in significant amounts, to understand the

amount of these nutrients present in these products in the context of

the total daily diet. Third, it will permit nutrient content claims to

be made for these nutrients on all foods.

IV. The Proposed Rule

A. Basis for RDI's for Vitamin K, Selenium, Chloride, Manganese,

Fluoride, Chromium, and Molybdenum

FDA has determined that NAS RDA's are an appropriate basis for

label reference values. Strong and uniform support was provided for the

use of NAS RDA's during the initial development of label reference

values in 1972 as well as in response to the July 1990 proposal and the

supplementary proposal. The agency continues to believe that these

established nutrient allowances are the most widely accepted and

respected source of information on human nutrient requirements and

recommended intakes.

In proposing RDI's for these seven nutrients, the agency recognizes

that if it adopts this proposal, some label reference values will be

based on the 1968 NAS RDA's, while others will be based on the 1980 and

1989 NAS RDA's. The agency believes, however, that providing label

information regarding the seven additional nutrients covered by the

proposal would be useful to consumers in making healthy dietary

choices. As discussed in the previous section, without RDI's, there can

be no percent Daily Values expressed for these nutrients on the

nutrition label, and nutrient content claims cannot be made for them.

Therefore, FDA tentatively concludes that the advantages of having a

reference value for all nutrients that NAS has found to be essential

outweighs any disadvantages that derive from the fact that some of

these values are more reflective of current scientific thinking than

others.

As stated above, NAS is in the process of reevaluating the basis on

which RDA's are determined. NAS is considering whether values should be

selected to prevent deficiencies or to promote optimal wellness. The

agency believes that any action to establish a set of RDI's with

consistent derivation should await completion of the NAS process. FDA

is committed to working with NAS to help resolve this issue.

B. Determination of Reference Amounts for Vitamin K, Selenium,

Chloride, Manganese, Fluoride, Chromium, and Molybdenum

Based on its consideration of comments on the 1990 proposal and on

the supplementary proposal, FDA determined in the RDI/DRV final rule

that there is considerable support for the general approach of

establishing label reference values for vitamins and minerals by

selecting the highest NAS RDA value from among those for persons 4 or

more years of age (excluding pregnant and lactating females) (58 FR

2206 at 2211). The comments stated that vulnerable or at-risk groups

would be sufficiently covered by selecting the highest value.

Therefore, in the RDI/DRV final rule, FDA tentatively determined that

in establishing label reference values from NAS' RDA values, it would

be appropriate to select the highest value from among those for adults

and children 4 or more years of age, excluding values for pregnant

females and lactating females (58 FR 2206 at 2211). FDA referred to

this approach as the ``population coverage approach.''

FDA is proposing to use this approach in adopting RDI's for vitamin

K, selenium, chloride, manganese, fluoride, chromium, and molybdenum.

In doing so, the agency is setting forth a quantitative amount as well

as a unit of measure for each nutrient.

In regard to vitamin K, a review of the 1989 RDA values shows a

range of recommended levels from 20 micrograms (g) for

children 4 to 6 years of age to 80 g for adult males from 25

to 51+ years of age (Ref. 2). Accordingly, using the population

coverage approach, FDA is proposing to adopt 80 g as the RDI

for vitamin K.

A review of the 1989 RDA values for selenium shows a range of

recommended levels from 20 g for children 4 to 6 years of age

to 70 g for adult males from 19 to 51+ years of age (Ref. 2).

Using the population coverage approach, FDA is proposing to adopt 70

g as the RDI for selenium.

A review of the 1980 ESADDI values for chloride shows a range from

700 to 2,100 milligrams (mg) for children 4 to 6 years of age to 1,700

to 5,100 mg for adults (Ref. 3). To be consistent with the population

coverage approach being used for vitamins and minerals with RDA's, FDA

said in the RDI/DRV final rule that when nutrients had ESADDI values,

it would select the highest ESADDI within the specified age groups to

serve as the label reference value. When the ESADDI value is presented

as a range, FDA said it would use the midpoint of that range as the

RDI. No comments were received that objected to this approach (58 FR

2206 at 2212). Therefore, in accordance with this procedure, FDA is

proposing to adopt 3,400 mg (the midpoint between 1,700 to 5,100 mg) as

the RDI for chloride.

A review of the 1989 ESADDI values for manganese shows a range from

1.5 to 2.0 mg for children 4 to 6 years of age to 2.0 to 5.0 mg for

adults (Ref. 2). Consistent with the procedure discussed above, FDA is

proposing to adopt 3.5 mg (the midpoint between 2.0 to 5.0 mg) as the

RDI for manganese.

For fluoride, a review of the 1989 ESADDI values shows a range from

1.0 to 2.5 mg for children 4 to 6 years of age to 1.5 to 4.0 mg for

adults. Consistent with the procedure discussed above, FDA is proposing

to adopt 3.0 mg (rounding the midpoint between 1.5 to 4.0 mg, 2.75 mg,

to 3.0 mg) as the RDI for fluoride.

For chromium, a review of the 1989 ESADDI values shows a range from

30 to 120 g for children 4 to 6 years of age to 50 to 200

g for adults and children 7 or more years of age. In

accordance with the population coverage approach, FDA is proposing to

adopt 130 g (rounding the midpoint between 50 to 200

g, 125 g, to 130 g) as the RDI for chromium.

Lastly, a review of the 1989 ESADDI values for molybdenum shows a

range from 30 to 75 g for children 4 to 6 years of age to 75

to 250 g for adults and children 11 or more years of age. In

accordance with the population coverage approach, FDA is proposing to

adopt 160 g (rounding the midpoint between 75 to 250

g, 162.5 g, to 160 g) as the RDI for

molybdenum.

In summary, FDA is proposing to amend Sec. 101.9(c)(8)(iv) to

include the following values:

Vitamin K, 80 micrograms

Selenium, 70 micrograms

Chloride, 3,400 milligrams

Manganese, 3.5 milligrams

Fluoride, 3.0 milligrams

Chromium, 130 micrograms

Molybdenum, 160 micrograms

One comment to the proposal on nutrition labeling for dietary

supplements recommended that biotin and folate be declared in terms of

micrograms, not milligrams, and that calcium and phosphorus be declared

in terms of milligrams instead of grams. The comment stated that

consumers are more familiar with these nutrients being expressed in

this manner.

FDA proposed in 1990 (56 FR 29476) to use the units suggested by

this comment. However, section 203 of the DS act limited the values

that FDA could use in establishing RDI's to those contained in

Sec. 101.9(c)(7)(iv) until after November 8, 1993. Accordingly, as

stated above, FDA adopted the current U.S. RDA values as the RDI's,

with biotin and folate expressed in terms of milligrams, and calcium

and phosphorus expressed in terms of grams. Public health guidelines

and nutrition education efforts typically use the same units of measure

as those found in the 10th Edition of NAS' RDA and repeated in the 1990

proposal. Therefore, the agency agrees with the comment that changing

the current units of measure of biotin, folate, calcium, and phosphorus

to those units specified in the 1990 proposal will facilitate consumer

comprehension of quantitative nutrient information.

Therefore, FDA is proposing to amend Sec. 101.9(c)(8)(iv) by

changing the units of measure for biotin, folate, calcium, and

phosphorus to the following:

biotin-micrograms

folate-micrograms

calcium-milligrams

phosphorus-milligrams

FDA points out that in following the provisions of the DS act and

retaining the label reference values in current Sec. 101.9(c)(7)(iv),

it did not adopt label reference values in the RDI/DRV final rule for

use on foods purported to be or represented for use by infants,

children under 4 years of age, or pregnant or lactating women. Given

the continuing questions about how to arrive at such values, FDA is

deferring action on this issue with respect to the issue of updating

the RDI's. FDA intends to propose RDI's for all nutrients, including

vitamin K, selenium, chloride, manganese, fluoride, chromium, and

molybdenum, for infants, children under 4 years of age, and pregnant

and lactating women in a future rulemaking.

As a result of the lack of reference values for infants, children

under 4 years of age, and pregnant and lactating women, labels of

dietary supplements of vitamins or minerals that are intended for these

specific groups and that are regulated under Sec. 101.36 (21 CFR

101.36) may continue to specify the milligram or microgram amounts of

these nutrients with an asterisk in the percent Daily Value column. The

asterisk would refer to a footnote stating ``Daily Value not

established.'' However, since milligram and microgram amounts are not

listed for vitamins and minerals on labels of foods in conventional

food form, until such time as RDA's are established for infants,

children less than 4 years of age, and pregnant and lactating women,

and barring a significant change in agency position in the final rule

in this proceeding, the seven subject nutrients may not be declared on

labels of foods in conventional food form that are represented or

purported to be for use by these groups. FDA requests comment on

whether or not this position is appropriate.

One possible alternative would be to allow foods in conventional

food form that are represented or purported to be for use by infants,

children less than 4 years of age, or pregnant and lactating women to

list vitamin K, selenium, chloride, manganese, fluoride, chromium, and

molybdenum when they are present in the food in more than insignificant

amounts but without milligram or microgram amounts, only an asterisk

that refers to a footnote stating that a Daily Value has not been

established. This alternative would alert consumers to the presence of

these nutrients in the food, although it would not give any indication

of the amount present. FDA solicits comment on this and other

alternative approaches.

C. Issues Concerning Specific Nutrients

1. GRAS Status of Selenium, Fluoride, and Chromium

In the RDI/DRV final rule, FDA reviewed several comments expressing

concern about the GRAS status of selenium, fluoride, and chromium (58

FR 2206 at 2215). These comments centered primarily around issues of

their use in supplements.

As the agency stated in the final rule on mandatory nutrition

labeling (58 FR 2079 at 2170), decisions with regard to whether the use

of sources of these nutrients is GRAS are outside the scope of this

rulemaking. Any direct addition of these trace minerals to a food is

based on the manufacturer's judgment that use of the nutrient sources

is GRAS.

2. Alternative Products

The RDI/DRV final rule also addressed the effect of the label

reference values on alternative products (e.g., reduced fat foods). One

comment suggested that with a larger number of vitamins and minerals

listed in Sec. 101.9(c)(8), selected vitamins and minerals should be

removed from the list of nutrients that, under Sec. 101.3(e)(4)(ii) (21

CFR 101.3(e)(4)(ii)), must be present at the same level in a substitute

food if that food is to be considered not nutritionally inferior to the

food for which it substitutes and resembles (58 FR 2206 at 2225). The

agency acknowledged that an increase in the number of nutrients for

which label reference values (RDI's) are established would mean that

efforts to obtain nutritional equivalency may require the addition of

nutrients to substitute foods (58 FR 2206 at 2225).

In considering this comment, FDA acknowledged that there were no

FDA-approved sources of selenium, fluoride, chromium or molybdenum for

direct addition to foods (58 FR 2206 at 2225). Since there are no

listed sources for these four nutrients, the agency stated in the RDI/

DRV final rule that if RDI's had been established for these nutrients,

FDA would have amended Sec. 101.3(e)(4)(ii) to state that these

nutrients are not required for nutritional equivalency (58 FR 2206 at

2225).

Having received no objections to this statement, FDA is proposing

to amend Sec. 101.3(e)(4)(ii) to state that selenium, molybdenum,

fluoride, and chromium need not be considered in determining

nutritional inferiority. If adopted, this amendment will mean that a

product that substitutes for another food that contains at least 2

percent more of the RDI for selenium, molybdenum, fluoride, or chromium

will not have to be fortified with these nutrients to avoid being an

``imitation.''

The agency feels compelled, however, to point out that there are

circumstances in which adequate amounts of selenium, chromium, and

molybdenum need to be supplied by particular foods because those foods

may well be the sole item of the diet. These foods include infant

formulas, medical foods, or total diet replacement formulas. The agency

notes that selenium, molybdenum, and chromium have been used for

several years in some infant formulas, medical foods, and total diet

replacement product without apparent problems. Although the agency has

not determined whether the use of certain compounds used by

manufacturers of such products as sources of these nutrients is GRAS,

FDA has not objected to these additions at levels that result in daily

intakes that do not exceed the upper limits of the NAS' ESADDI's.

V. Conforming Amendments

The proposed revision of the nutrition labeling regulations in

Sec. 101.9 to provide RDI's for vitamin K, selenium, chloride,

manganese, fluoride, chromium, and molybdenum necessitates that FDA

revise Sec. 101.36(b)(3), (b)(4), and (b)(4)(vi) as finalized in the

document entitled ``Food Labeling; General Requirements for Nutrition

Labeling for Dietary Supplements of Vitamins, Minerals, Herbs, or Other

Similar Nutritional Substances'' published elsewhere in this issue of

the Federal Register. Section 101.36(b)(3) specifically provides for

vitamin K, chloride, chromium, fluoride, manganese, molybdenum, and

selenium to be listed in the nutrition label of dietary supplements of

vitamins and minerals when present and for quantitative amounts of the

nutrients to be declared. Section 101.36(b)(4) states that no percent

of Daily Value shall be given for these seven nutrients in the

nutrition label, and Sec. 101.36(b)(4)(vi) states that when no percent

is given, an asterisk shall be placed in the ``Percent Daily Value''

column in the nutrition label that refers to another asterisk that is

placed at the bottom of the nutrition label that is followed by the

statement ``Daily Value not established.'' FDA is proposing to amend

Sec. 101.36(b)(3) to remove all references to vitamin K, chloride,

chromium, fluoride, manganese, molybdenum, and selenium. Because these

nutrients are proposed to be included in Sec. 101.9(c)(8)(iv), they

will be permitted to be listed in nutrition labeling without specific

provision.

With regard to Sec. 101.36(b)(4) and (b)(4)(vi), once RDI's are

established for vitamin K, chloride, chromium, fluoride, manganese,

molybdenum, and selenium for adults and children 4 or more years of

age, the percent Daily Value of these nutrients will be able to be

calculated for this group. However, because RDI's are not being

proposed for infants, children less than 4 years of age, and for

pregnant or lactating women (as discussed in section IV.C.1. of this

document), labels of products represented or purported to be for use by

those groups will not be able to declare the percent Daily Value for

these nutrients. Therefore, FDA is proposing to amend Sec. 101.36(b)(4)

and (b)(4)(vi) to provide for the use of an asterisk that will refer to

the statement ``Daily Value not established'' for the seven subject

nutrients on products represented or purported to be for use by

infants, children less than 4 years of age, and pregnant or lactating

women.

VI. Comments

Interested persons may, on or before July 7, 1994, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. Two copies of any comments are to be submitted, except

that individuals may submit one 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 office above between 9

a.m. and 4 p.m., Monday through Friday.

VII. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(11) that this

action is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

VIII. Economic Impact

FDA has examined the economic implications of the proposed rule

amending 21 CFR as required by Executive Order 12866 and the Regulatory

Flexibility Act (Pub. L. 96-354). Executive Order 12866 directs

agencies to assess all costs and benefits of available regulatory

alternatives and, when regulation is necessary, to select regulatory

approaches which maximize net benefits (including potential economic,

environmental, public health and safety effects; distributive impacts;

and equity). The Regulatory Flexibility Act requires that agencies

analyze options for regulatory relief for small businesses. FDA finds

that this proposed rule is not a significant rule as defined by

Executive Order 12866. In accordance with the Regulatory Flexibility

Act, the agency certifies that the proposed rule will not have a

significant impact on a substantial number of small businesses.

This proposed regulation allows manufacturers of foods in

conventional food form and dietary supplements to declare certain

nutrients within the nutrition panel and to make content claims about

those nutrients. The proposal provides flexibility for those

manufacturers who wish to disclose information about these seven

nutrients without imposing requirements on those firms producing

products without these nutrients. Manufacturers of food in conventional

food form must change food labels if any of the nutrients are added to

the product or if any claims are made. FDA is unsure of the extent to

which this will occur. FDA believes that the costs of this regulation

are minimal. This regulation will create benefits to the extent that

the additional information allowed in nutrition labeling will help

consumers make healthy dietary choices.

IX. References

The following references have been placed on display in the Dockets

Management Branch (address above) and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday through Friday.

1. Food and Nutrition Board, Division of Biology and

Agriculture, National Research Council, ``Recommended Dietary

Allowances, 7th ed., 1968,'' Publication 1694, Printing and

Publishing Office, NAS, Washington, DC, 1968.

2. Subcommittee on the 10th Edition of the RDA's, Food and

Nutrition Board, Commission on Life Sciences, National Research

Council, ``Recommended Dietary Allowances, 10th Edition,''

Washington, DC, National Academy Press, 1989.

3. Committee on Dietary Allowances, Food and Nutrition Board,

Assembly of Life Sciences, National Research Council, ``Recommended

Dietary Allowances, 9th Revised ed., 1980,'' Washington, DC,

National Academy Press, 1980.

List of Subjects in 21 CFR Part 101

Food labeling, Reporting and recordkeeping requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

1. The authority citation for 21 CFR part 101 continues to read as

follows:

Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act

(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 371).

2. Section 101.3, effective May 8, 1994, is amended by revising

paragraph (e)(4)(ii) to read as follows:

Sec. 101.3 Identity labeling of food in packaged form.

* * * * *

(e) * * *

(4) * * *

(ii) For the purpose of this section, a measurable amount of an

essential nutrient in a food shall be considered to be 2 percent or

more of the Daily Reference Value (DRV) of protein listed under

Sec. 101.9(c)(7)(iii), of potassium listed under Sec. 101.9(c)(9), and

of the Reference Daily Intake (RDI) of any vitamin or mineral listed

under Sec. 101.9(c)(8)(iv), except that selenium, molybdenum, fluoride,

and chromium need not be considered.

* * * * *

3. Section 101.9, effective May 8, 1994, is amended by revising

paragraph (c)(8)(iv) to read as follows:

Sec. 101.9 Nutrition Labeling of foods.

* * * * *

(c) * * *

(8) * * *

(iv) The following RDI's and nomenclature are established for the

following vitamins and minerals which are essential in human nutrition:

Vitamin A, 5,000 International Units.

Vitamin C, 60 milligrams.

Calcium, 1000 milligrams.

Iron, 18 milligrams.

Vitamin D, 400 International Units.

Vitamin E, 30 International Units.

Vitamin K, 80 micrograms.

Thiamin, 1.5 milligrams.

Riboflavin, 1.7 milligrams.

Niacin, 20 milligrams.

Vitamin B6, 2.0 milligrams.

Folate, 400 micrograms.

Vitamin B12, 6 micrograms.

Biotin, 300 micrograms.

Pantothenic Acid, 10 milligrams.

Phosphorus, 1000 milligrams.

Iodine, 150 micrograms.

Magnesium, 400 milligrams.

Zinc, 15 milligrams.

Selenium, 70 micrograms.

Copper, 2.0 milligrams.

Manganese, 3.5 milligrams.

Fluoride, 3.0 milligrams.

Chromium, 130 micrograms.

Molybdenum, 160 micrograms.

Chloride, 3,400 milligrams.

* * * * *

4. Section 101.36 is amended by revising paragraph (b)(3), (b)(4)

introductory text, and (b)(4)(vi) to read as follows:

Sec. 101.36 Nutrition labeling of dietary supplements of vitamins or

minerals.

* * * * *

(b) * * *

(3) A listing of all nutrients required in Sec. 101.9(c) that are

present in the dietary supplement in quantitative amounts by weight

that exceed the amount that can be declared as zero in Sec. 101.9(c).

Those nutrients that are not present, or that are present in amounts

that would be declared as zero, shall not be declared. In addition,

potassium shall be declared except when present in quantitative amounts

by weight that allow a declaration of zero. The name of each nutrient

listed shall be immediately followed by the quantitative amount by

weight of the nutrient. Nutrient names and quantitative amounts shall

be presented in a column under the heading ``Amount Per Serving'' and

aligned on the left side of the nutrition label. The heading ``Amount

Per Serving'' shall be separated from other information on the label by

a bar above and beneath it, except that when calories are listed, the

bar shall be placed beneath the calorie declaration. When the serving

size of the product is one unit (e.g., 1 tablet), a heading consistent

with the declaration of serving size, such as ``Amount per Tablet'' or

``Each Tablet Contains,'' may be used in place of the heading ``Amount

per Serving.'' Other appropriate terms, such as capsule, packet, or

teaspoonful, may be used in place of the term ``Serving.''

(4) A listing of the percent of the Daily Value (i.e., the percent

of the RDI as established in Sec. 101.9(c)(8)(iv) or DRV as established

in Sec. 101.9(c)(9)), where appropriate, of all nutrients listed in the

nutrition label, except that the percent for protein may be omitted as

provided in Sec. 101.9(c)(7), no percent shall be given for sugars,

and, for labels of dietary supplements of vitamins and minerals that

are represented or purported to be for use by infants, children less

than 4 years of age, or pregnant or lactating women, no percent shall

be given for vitamin K, chloride, chromium, fluoride, manganese,

molybdenum, or selenium. This information shall be presented in one

column aligned under the heading of ``% Daily Value'' and to the right

of the column of nutrient names and amounts. The headings ``% Daily

Value (DV),'' ``% DV,'' ``Percent Daily Value,'' or ``Percent DV'' may

be substituted for ``% Daily Value.'' The heading ``% Daily Value''

shall be placed on the same line as the heading ``Amount Per Serving''

or placed beneath this heading and the bar underneath it, except that

``% Daily Value'' shall be placed beneath this bar when calorie

information is required to be declared. Calorie information shall be

placed beneath ``Amount Per Serving'' and above the bar.

* * * * *

(vi) When no percent is given for sugars, or, on labels of dietary

supplements of vitamins and minerals that are represented or purported

to be for use by infants, children less than 4 years of age, or

pregnant or lactating women, when no percent is given for vitamin K,

chloride, chromium, fluoride, manganese, molybdenum, or selenium, an

asterisk shall be placed in the ``% Daily Value'' column that shall

refer to another asterisk that is placed at the bottom of the nutrition

label and followed by the statement ``Daily Value not established.''

* * * * *

Dated: December 23, 1993.

David A. Kessler,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 93-31816 Filed 12-29-93; 8:45 am]

BILLING CODE 4160-01-F