[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Proposed Rules]
[Pages 427-432]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31816]


[[Page Unknown]]

[Federal Register: January 4, 1994]


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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