[Federal Register Volume 60, Number 249 (Thursday, December 28, 1995)]
[Proposed Rules]
[Pages 67184-67194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31194]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 95N-0347]
RIN 0910-AA23


Food Labeling; Nutrient Content Claims: Definition for ``High 
Potency'' Claim for Dietary Supplements and Definition of 
``Antioxidant'' for Use in Nutrient Content Claims for Dietary 
Supplements and Conventional Foods

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 define the term ``high potency'' as a nutrient 
content claim for dietary supplements; define the term ``antioxidant'' 
for use in nutrient content claims on labels or in labeling of dietary 
supplements and conventional foods; and correct an omission pertaining 
to the use of ``sugar free'' claims on dietary supplements. FDA is 
taking these actions to provide for the use of additional nutrient 
content claims in response to provisions of the Nutrition Labeling and 
Education Act of 1990. This proposed rule will benefit consumers by 
providing established definitions for use in food labeling for the 
terms ``high potency,'' ``antioxidant,'' and ``sugar free.''

DATES: Written comments by March 13, 1996. The agency proposes that any 
final rule that may issue based upon this proposal become effective 
January 1, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
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. Regulatory History

A. The Nutrition Labeling and Education Act of 1990 and Subsequent 
Proposals

    On November 8, 1990, the President signed into law the Nutrition 
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). The 1990 amendments revised the Federal Food, Drug, and Cosmetic 
Act (the act) in a number of important ways. One of the most notable 
aspects of the 1990 amendments is that they establish FDA's authority 
to regulate nutrient content claims on food labels and in food 
labeling. Section 403(r)(1)(A) of the act (21 U.S.C. 343(r)(1)(A)), 
which was added by the 1990 amendments, provides that a product is 
misbranded if it bears a claim in its label or labeling that either 
expressly or implicitly characterizes the level, in the food, of any 
nutrient of the type required to be declared as part of nutrition 
labeling, unless such claim has been specifically defined (or otherwise 
exempted) by regulation.
    In the Federal Register of November 27, 1991 (56 FR 60421 and 56 FR 
60478), FDA published two documents (``Food Labeling: Nutrient Content 
Claims, General Principles, Petitions, Definition of Terms;'' and 
``Food Labeling: Definitions of Nutrient Content Claims for the Fat, 
Fatty Acid, and Cholesterol Content of Food'') in which it proposed, 
among other things, to define nutrient content claims and to provide 
for their use on food labels. FDA intended that these proposals would 
apply to dietary supplements as well as conventional foods. -

B. The Dietary Supplement Act of 1992, Final Labeling Rules, and the 
Dietary Supplement Health and Education Act of 1994

    On October 6, 1992, the President signed into law the Dietary 
Supplement Act of 1992, Title II of Pub. L. 102-571 (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 until December 15, 1993. Section 202(a)(2)(A) of the DS Act 
directed the Secretary of Health and Human Services to issue new 
proposed regulations that are applicable to dietary supplements of 
vitamins, minerals, herbs, and other similar nutritional substances.
    FDA published final regulations that implemented the 1990 
amendments with respect to nutrient content claims in the Federal 
Register of January 6, 1993, in a document entitled ``Food Labeling; 
Nutrient Content Claims; General Principles, Petitions, and Definition 
of Terms'' (hereinafter referred to as ``the 1993 nutrient content 
claims final rule''). As a result of the DS Act, this final rule 
applied only to the use of such claims on conventional foods (58 FR 
2302 as corrected at 58 FR 17341). FDA made technical corrections to 
these final regulations in documents published in the Federal Register 
on August 18, 1993 (58 FR 44020).
    In response to the requirements of the 1990 amendments and the DS 
Act, FDA published in the Federal Register of June 18, 1993 (58 FR 
33731), a proposal entitled ``Food Labeling; Requirements for Nutrient 
Content Claims for Dietary Supplements of Vitamins, Minerals, Herbs, 
and Other Similar Nutritional Substances'' (hereinafter referred to as 
the 1993 nutrient content claims proposal) to: (1) Include dietary 
supplements of vitamins, minerals, herbs, and other similar nutritional 
substances under the coverage of the general principles for nutrient 
content claims; (2) provide for the use of expressed and implied 
nutrient content claims on labels or in labeling of dietary 
supplements; and (3) provide for petitions for nutrient content claims 
for dietary supplements. FDA received approximately 500 letters in 
response to its 1993 nutrient content claims proposal. FDA issued final 
regulations on nutrient content claims for dietary supplements on 
January 4, 1994 (59 FR 378) (hereinafter referred to as the 1994 
nutrient content claims final rule).
    On October 25, 1994, the President signed into law the Dietary 
Supplement Health and Education Act of 1994 (the DSHEA) (Pub. L. 103-
417). Among other things, the DSHEA provided a statutory definition for 
``dietary supplements,'' provided for some flexibility in the manner in 
which ingredient and nutrition labeling information is to be provided 
for dietary supplements, and made provision for statements that 
characterize the percentage level of dietary ingredients for which 
Reference Daily Intakes (RDI's) and Daily Reference Values (DRV's) have 
not been established. However, these changes do not bear directly on 
this rulemaking.
    In the 1994 nutrient content claims final rule, FDA used the terms 
``dietary supplements of vitamins, minerals, herbs, and other similar 
nutritional 

[[Page 67185]]
substances'' and ``food in conventional food form.'' With the passage 
of the DSHEA, however, Congress has defined the term ``dietary 
supplement'' and has modified the act in sections 201(ff) and 411(c)(1) 
(21 U.S.C. 321(ff) and 350(c)(1)) to make clear that the form of the 
food is not necessarily determinative of whether it is a dietary 
supplement or not. Therefore, in this document, FDA will use the more 
simple terms ``dietary supplement'' and ``conventional food.''

II. FDA Authority

    Section 403(r)(2)(A)(i) of the act states that claims that 
characterize the level of a nutrient may be made only if the claim uses 
terms that are defined in regulations. In response to this section, the 
agency is proposing to amend its regulations on nutrient content claims 
to define the term ``high potency'' as a nutrient content claim for use 
on labels and in labeling of dietary supplements and the term 
``antioxidant'' for use in nutrient content claims for dietary 
supplements and conventional foods.
    FDA has authority to take these actions regarding nutrient content 
claims under sections 201(n) and 403(a), as well as section 403(r), of 
the act (21 U.S.C. 321(n) and 343(a)). These sections prohibit labeling 
that: (1) Is false or misleading in that it fails to reveal facts that 
are material in light of other representations made in the labeling or 
that are material with respect to the consequences that may result from 
use of the food, and (2) uses terms to characterize the level of any 
nutrient in a food that have not been defined by regulation by FDA.

III. Proposed Rules

A. ``High Potency''

1. Background
    In the 1993 nutrient content claims proposal, FDA requested comment 
on several terms, including ``high potency,'' that are often 
encountered on labels or in labeling of dietary supplements and that 
seem to imply that the dietary supplement will contribute to good 
health (58 FR 33731 at 33748). The agency requested comment on whether 
there are established meanings for these terms, and, if so, whether 
they characterize the level of the nutrients in the food. The agency 
received about 10 comments from trade associations, manufacturers of 
dietary supplements and conventional foods, academicians, and consumer 
groups regarding the term ``high potency.''
    FDA was persuaded, based on comments that suggested definitions for 
the term, that ``high potency'' is a claim that characterizes the level 
of a nutrient or nutrients and, therefore, meets the definition in 
Sec. 101.13(b) of a nutrient content claim (59 FR 378 at 391). However, 
given the time constraints under which FDA prepared the final rule, and 
the range and diversity of the suggested definitions, the agency was 
not able to adopt a definition of ``high potency'' in the final rule on 
nutrient content claims for dietary supplements. FDA announced its 
intention to review the suggestions for a definition of ``high 
potency'' and, based on information received in the comments, to 
propose an appropriate definition for this term (59 FR 378 at 391). In 
this document, the agency is proceeding with its commitment to propose 
a definition for ``high potency.''
2. Limitation to Dietary Supplements
    In the 1994 nutrient content claims final rule, the agency 
determined that, in many respects, the regulations issued in the 1993 
nutrient content claims final rule (58 FR 2302) are directly applicable 
to dietary supplements (59 FR 378 at 380). However, FDA acknowledged 
that dietary supplements differ in several respects from conventional 
foods in their history of use and in their perceived function in the 
diet (59 FR 378 at 380). This fact and the fact that certain dietary 
supplements are likely to contain much higher levels of nutrients than 
conventional foods led FDA to conclude that nutrient content claims 
that are specific for dietary supplements may be appropriate (59 FR 378 
at 380). Comments to the nutrient content claims proposal for dietary 
supplements stated that the term ``high potency'' seems more 
appropriate for dietary supplements than for conventional foods (59 FR 
378 at 390).
    In considering the coverage of this term, FDA has relied, in part, 
on the National Academy of Sciences' (NAS) Institute of Medicine's 
(IOM) recommendations found in ``Nutrition Labeling, Issues and 
Directions for the 1990's'' (Ref. 1). In discussing claims, the IOM 
suggested that the terms that should be defined are those that are most 
commonly used (Ref. 1, p. 296). FDA has no evidence that the term 
``high potency'' is used with any frequency on conventional foods, that 
the term was used on conventional foods before the enactment of the 
1990 amendments, or that consumers expect or would understand it in 
association with conventional foods. In contrast, the term ``high 
potency'' was in widespread use on the labels of dietary supplements 
before the enactment of the 1990 amendments, continues to be used on 
dietary supplements, and appears to convey information to the consumer 
about the level of the nutrients in dietary supplements.
    Lacking a clear history of use, or any other indication of the 
usefulness, of the term ``high potency'' on conventional foods, the 
agency tentatively concludes that this term should be limited to use on 
dietary supplements. Accordingly, FDA is proposing to amend part 101 
(21 CFR part 101) by adding new Sec. 101.13(b)(6), which states that 
the term ``high potency'' may be used only on dietary supplements.
    FDA recognizes that defining a nutrient content claim exclusively 
for use on labels and in labeling of dietary supplements is a departure 
from previous practice. However, the agency tentatively concludes that 
limiting this claim to dietary supplements is the appropriate course 
for the reasons stated above. Comment is requested on this tentative 
conclusion.
3. Definition of ``High Potency'' as a Nutrient Content Claim
    a. Describing a nutrient. FDA received several comments that 
presented a wide range of views on how ``high potency'' should be 
defined. One comment to the proposed rule on nutrient content claims 
suggested that the term ``high potency'' have the same definition as 
``high'' (i.e., 20 percent or more of the RDI), but did not provide any 
elaboration on why this suggested definition is appropriate. Other 
comments asserted that this term could be used to establish an 
hierarchy of absolute claims (i.e., ``good source,'' ``high,'' and 
``high potency'') to describe dietary supplements. This hierarchy, the 
comments suggested, will enable consumers to use the claims to quickly 
differentiate between varying nutrient levels in dietary supplements.
    A few comments suggested that the term be defined to mean that the 
product contains 200 percent of the RDI. These comments argued that 
while a multivitamin supplement at 100 percent of the RDI might be 
``high potency'' compared to a conventional food, it is not ``high 
potency'' when compared to other dietary supplements. These comments 
suggested that defining ``high potency'' as twice the RDI or more would 
more accurately reflect the level of nutrients found in dietary 
supplements. One of these comments stated that, in addition to 
requiring that single nutrient supplements be twice the RDI for that 
nutrient, FDA should require that the principal display panel disclose 
what multiple of the RDI the supplement contains. For example, the 
comment suggested that the principal display panel of a 250 milligram 
(mg) 

[[Page 67186]]
vitamin C supplement carry an asterisk next to the words ``high 
potency'' with the following disclosure: ``Contains four times the RDI 
for vitamin C.'' The comment went on to state that under this scheme, 
some nutrients, such as calcium and selenium, would not qualify to 
carry a ``high potency'' claim because they are rarely sold at 200 
percent of the RDI. The comment suggested that if the supplement 
industry begins to market those nutrients at higher doses to make 
``high potency'' claims, FDA could establish a lower minimum level, 
such as 50 percent of the RDI for selenium and 50 percent of the RDI 
for calcium. The comment stated that those minimum levels would apply 
to those nutrients only.
    Several comments, however, argued that the term ``high potency'' 
should mean 100 percent or more of the RDI because that is the current 
industry practice, and it has been helpful in directing consumers in 
their choice of products. One comment from the dietary supplement 
industry stated that, in their experience, the term ``high potency'' 
has generally been used for the last 20 years to refer to formulations 
that are at levels above the U.S. Recommended Daily Allowances (U.S. 
RDA's).
    FDA acknowledges that many dietary supplements, particularly 
dietary supplements of vitamins or minerals, are likely to contain much 
higher levels of nutrients than conventional foods (Ref. 2). Currently 
approved nutrient content claims are of limited value in identifying 
those dietary supplements that contain amounts of vitamins or minerals 
at or above the Daily Value (DV). Claims such as ``good source'' and 
``high'' are adequate to describe nutrient levels found in the majority 
of conventional foods, but they do not allow for differentiation of 
dietary supplement products containing much higher levels of nutrients. 
Therefore, the agency is in agreement with the comments that suggested 
that the term ``high potency'' should be defined in a way that permits 
such differentiation.
    Accordingly, FDA rejects the comment that suggested that ``high 
potency'' be defined as 20 percent or more of the RDI. Such a 
definition would make ``high potency'' synonymous with ``high'' and 
thus would not help consumers differentiate between relatively low 
nutrient levels in many dietary supplements in the marketplace and 
those at higher levels.
    FDA is not persuaded by the comments that suggested that 200 
percent of the RDI is an appropriate definition for ``high potency.'' 
While the agency acknowledges that dietary supplements of vitamins and 
minerals often contain levels that meet or exceed 200 percent of the 
RDI per unit, that fact alone does not justify defining ``high 
potency'' at that level.
    Supplement users report a variety of reasons for taking dietary 
supplements, including ensuring adequacy of intake of specific 
nutrients (Refs. 3, 4, and 5). FDA is interested in ensuring, and the 
nutrient content claim provisions were intended to ensure (see, e.g., 
section 403(r)(2)(A)(ii)(II) of the act) that consumers have useful 
label information that will help them maintain healthy dietary 
practices, in part by constructing nutritionally adequate diets. 
However, the agency is not persuaded that proposing a definition for 
``high potency'' at 200 percent or more of the RDI will contribute to 
this goal. The RDI's are based on the NAS Recommended Dietary 
Allowances (RDA's), which are intended to reflect ``the levels of 
intake of essential nutrients that, on the basis of scientific 
knowledge, are judged by the Food and Nutrition Board, NAS to be 
adequate to meet the known nutrient needs of practically all healthy 
persons'' (Ref. 6). FDA is aware that the NAS is in the process of 
reevaluating the basis on which RDA's are determined and is considering 
expanding the RDA concept to include reducing the risk of chronic 
disease (Ref. 7). Until that debate is resolved, the agency tentatively 
concludes that it is appropriate to define ``high potency'' at a level 
that will assist consumers interested in using dietary supplements in 
obtaining an adequate intake as determined by established RDI values.
    The agency tentatively concludes that 100 percent of the RDI per 
serving is a reasonable definition of ``high potency'' because this 
level is high enough ``to meet the needs of practically all healthy 
persons.'' RDI values represent the highest NAS RDA values from among 
the various age/sex groups specified by the NAS for persons 4 or more 
years of age (58 FR 2206 at 2210). Thus, a person consuming a ``high 
potency'' vitamin or mineral will be assured of meeting his or her need 
for the nutrient described as ``high potency.'' Such action would be a 
healthy dietary practice.
    FDA tentatively concludes that the proposed definition of ``high 
potency'' makes sense for two additional reasons. First, as stated in 
the comments, it is consistent with current industry practice. Second, 
as a matter of common sense, providing of 100 percent of the RDI for a 
vitamin or mineral is to provide an amount of the vitamin or mineral 
that is highly potent.
    FDA's tentative conclusion does not mean, however, that the agency 
is opposed to the presence of more than 100 percent of the RDI of a 
nutrient per serving. Manufacturers can formulate and describe the 
level of a nutrient as multiples of the RDI (e.g., using the 
terminology ``Daily Value'' to represent RDI's on the label, a vitamin 
C tablet containing 500 mg would declare ``833 percent of the Daily 
Value of vitamin C''). Nonetheless, because the purpose of nutrient 
content claims is to assist consumers in maintaining healthy dietary 
practices, and given the recommendations of the NAS on which the RDI's 
are based, FDA tentatively concludes that it is appropriate to tie a 
``high potency'' claim to the RDI itself.
    In addition to the nutrients for which RDI's have been established, 
FDA is proposing that the claim ``high potency'' may be used to 
describe protein and dietary fiber for which DRV's have been 
established in Sec. 101.9(c)(9). Because dietary guidelines recommend 
that consumers moderate or reduce dietary levels of four other 
nutrients for which DRV's have been established (i.e., total fat, 
saturated fat, cholesterol, and sodium) to reduce the risk of 
developing certain chronic diseases (Ref. 8), FDA does not expect, and, 
therefore, is not proposing, that ``high potency'' claims be used to 
apply to them.
    Additionally, the agency is not proposing that ``high potency'' 
claims be used to apply to two other nutrients, total carbohydrate and 
potassium, for which DRV's have been established. Section 101.54(a) 
precludes the use of the claims listed in that section in relation to 
total carbohydrate.\1\ In the case of potassium, tablets containing 
potassium chloride or other potassium salts, which supply 100 mg or 
more of potassium per tablet, are considered to be drugs. (See 21 CFR 
201.306.)

    \1\In the 1993 nutrient content claims proposal, FDA stated that 
consensus reports and dietary recommendations generally encourage 
the increased consumption of complex carbohydrates, while suggesting 
that sugars be consumed in moderation (56 FR 60421 at 60444). The 
agency concluded that a nutrient content claim such as ``high in 
carbohydrate'' may provide misleading dietary advice because the 
claim does not allow for the distinction between high levels of 
complex carbohydrates and high levels of sugars (56 FR 60421 at 
60444).
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    The agency is not aware of any reason why ``high potency'' claims 
should not be allowed to be used with protein and dietary fiber. FDA 
established the DRV's at levels for each nutrient that represent 
scientific consensus on the characteristics of foods Americans should 
choose both to have a healthier diet and to reduce risk factors for 
chronic diseases and conditions (58 FR 

[[Page 67187]]
2206 at 2217). Nutrient content claims that assist consumers in 
constructing diets by identifying foods, including dietary supplements, 
that contain protein and dietary fiber at such levels should be 
allowed.
    FDA tentatively concludes that, consistent with the agency's 
treatment of the claim for nutrients for which RDI's have been 
established, ``high potency'' should be defined for protein and dietary 
fiber at 100 percent of the DRV. The agency notes that throughout its 
rulemakings on nutrient content claims, it has used identical values 
for nutrients for which a DRV has been established as for those that 
are the subject of an RDI (e.g., ``good source'' claims are defined in 
Sec. 101.54(c) as 10 to 19 percent of the RDI or DRV per reference 
amount customarily consumed).
    Accordingly, FDA is proposing in Sec. 101.54(f)(1) that the term 
``high potency'' may be used on the label or in labeling of a dietary 
supplement to describe a nutrient that is present at 100 percent or 
more of the RDI for vitamins and minerals or the DRV for protein or 
dietary fiber per reference amount customarily consumed.
    In response to the comment that suggested that FDA require that the 
principal display panel disclose what multiple of the nutrient's RDI is 
present (e.g., ``Contains 400 percent of the Daily Value of Vitamin 
C''), FDA is not persuaded that this action would be helpful to 
consumers. The referral statement, ``See -------------- for nutrition 
information,'' which directs the consumer to the nutrition panel is 
required for all nutrient content claims as specified in 
Sec. 101.13(g). As proposed in a companion document published elsewhere 
in this issue of the Federal Register and entitled ``Food Labeling; 
Statement of Identity; Nutrition Labeling and Ingredient Labeling of 
Dietary Supplements,'' the nutrition label for dietary supplements of 
vitamins and minerals will have to provide quantitative information on 
the levels of specific nutrients as well as the percent Daily Value 
(DV) for each nutrient. Consequently, the consumer will have easy 
access to information regarding the levels of specific nutrients and 
may adjust their level of intake accordingly.
    In addition, not requiring any additional information or disclosure 
beyond the referral statement is consistent with rules for the use of 
other expressed nutrient content claims, e.g., ``good source'' and 
``high'' claims, which do not have to disclose the fraction of the RDI 
present. While FDA tentatively concludes that there is no need for 
additional disclosure requirements for products bearing a ``high 
potency'' claim, the agency points out that manufacturers may 
voluntarily place a statement on the label that discloses the amount or 
percentage of nutrients in relation to the DV as provided for in 
Sec. 101.13(i) and (q)(3) (e.g., ``50 percent of the RDI for calcium,'' 
``10 mg of iron'').
    In response to the comment that suggested that the agency consider 
establishing a definition for ``high potency'' at lower levels for some 
nutrients if manufacturers start increasing amounts of the nutrients so 
that they can meet the criterion for the claim ``high potency,'' the 
agency believes that such action is unnecessary and potentially 
confusing to consumers. The agency tentatively concludes that the term 
``high potency'' should have the same definition for all nutrients. In 
instances in which the product does not meet the proposed criteria for 
the claim ``high potency,'' the product may qualify to use another 
nutrient content claim, such as ``good source'' (defined in 
Sec. 101.54(c) as 10 to 19 percent of the RDI or DRV) or ``high'' 
(defined in Sec. 101.54(b) as 20 percent or more of the RDI or DRV). 
For example, when calcium is present in a dietary supplement at 20 
percent or more of the RDI, the manufacturer can use the nutrient 
content claim ``high'' to describe the level of calcium. In addition, 
as stated above, under Sec. 101.13(i) and (q)(3) the manufacturer may 
declare the amount or percentage of the nutrient on the label.
    b. Describing a dietary supplement product. The comments stated 
that in addition to being used to describe the level of a nutrient in a 
product, the term ``high potency'' is also often used to describe 
multinutrient dietary supplement products themselves. Several comments 
discussed the use of a ``high potency'' claim on multinutrient 
products, and whether all nutrients in such a product would have to be 
present at levels that would meet the criterion for the claim. One 
comment stated that the claim should be permitted on any supplement 
that contains 100 percent of the RDI for each vitamin and mineral that 
is included in the product and for which an RDI has been established. 
The comment went on to state that the presence or absence of vitamins, 
minerals, or other substances for which no RDI's have been established 
should not affect a product's eligibility to bear the claim, so long as 
those nutrients for which RDI's have been established are present at 
required levels.
    In contrast with this comment, a few comments stated that 
multinutrient products should be termed ``high potency'' when the 
majority of nutrients with RDI's are present at levels equal to or in 
excess of the RDI. Another comment stated that FDA should allow ``high 
potency'' claims on multinutrient supplements when more than one-third 
of the nutrients that they contain meet the minimum level required for 
a ``high potency'' claim. The latter comment stated that it is not 
reasonable to require that all of the nutrients in a multiingredient 
supplement be present at the level that is defined as ``high potency'' 
because many nutrients are not, and should not, be sold in such high 
doses. For example, the comment stated that ``high potency'' claims 
should be allowed on a multinutrient supplement that contains high 
levels of vitamins A, C, E, B6, B12, thiamin, riboflavin, and niacin, 
but smaller amounts of vitamin D, iron, calcium, magnesium, zinc, and 
copper. The comment stated that the latter nutrients are typically sold 
at lower doses, and some may pose a risk at high levels.
    FDA has considered the comments that ``all,'' ``most,'' or ``one-
third'' of the nutrients in a dietary supplement be present at 100 
percent of the RDI or DRV for the supplement to qualify to bear the 
term ``high potency.'' A review of an informal FDA survey of labels of 
dietary supplements that bear the term ``high potency'' revealed that 
most multinutrient products that used the claim contained a majority, 
but not all, nutrients at 100 percent or more of the RDI (Ref. 9). FDA 
agrees with the comment that it may be impracticable to include 100 
percent of the RDI or DRV for several nutrients for technological 
reasons. For instance, the bulkiness of calcium, phosphorus, magnesium, 
and fiber may make it difficult to provide sufficient amounts of those 
nutrients for them to be included in ``high potency'' tablets if they 
must be present at 100 percent of the RDI or DRV.
    FDA tentatively concludes that it is not necessary to prohibit the 
use of a ``high potency'' claim on multinutrient dietary supplements if 
the supplements do not contain 100 percent or more of the RDI for each 
vitamin and mineral that is present, or 100 percent of the DRV for 
protein or dietary fiber, when present. The agency is persuaded by the 
comments that the public will be better served from a public health 
perspective if some nutrients are allowed to be present in such 
products at levels that are below 100 percent of the RDI or DRV. 
Without such an allowance, those nutrients that cannot be included at 
100 percent levels because of technological difficulties could not be 
included at all if the dietary supplement is to bear a 

[[Page 67188]]
``high potency'' claim. The exclusion of these nutrients will not 
necessarily help consumers to engage in healthy dietary practices.
    Having tentatively concluded that some nutrients may be present in 
a ``high potency'' multinutrient dietary supplement at less than 100 
percent of the RDI or DRV, the agency must determine what percentage of 
nutrients must be present in the product at 100 percent of the RDI or 
DRV for the product to qualify to make a ``high potency'' claim. A 
logical starting point is determination of: (1) How many nutrients have 
had RDI's and DRV's established for them, and (2) of those nutrients, 
how many cannot, or should not, be expected to be present at 100 
percent of the RDI or DRV for technological reasons or because of 
public health concerns.
    In the RDI/DRV final rules published on January 6, 1993 (58 FR 
2206), FDA established RDI's in Sec. 101.9(c)(8)(iv) for 19 vitamins 
and minerals (i.e., vitamin A, vitamin C, calcium, iron, vitamin D, 
vitamin E, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin 
B12, biotin, pantothenic acid, phosphorus, iodine, magnesium, zinc, and 
copper) and DRV's in Sec. 101.9(c)(9) for eight nutrients (i.e., total 
fat, saturated fat, cholesterol, total carbohydrate, dietary fiber, 
sodium, potassium, and protein). In addition, in a companion document 
entitled ``Food Labeling: Reference Daily Intakes'' published elsewhere 
in this issue of the Federal Register, FDA is establishing RDI's for 
six additional vitamins and minerals (i.e., vitamin K, selenium, 
chloride, manganese, chromium, molybdenum). Thus, there are a total of 
33 nutrients for which RDI's or DRV's have been established. Of these 
33 nutrients, 4 (i.e., calcium, phosphorus, magnesium, and fiber) have 
already been mentioned as being difficult to include in dietary 
supplements in amounts equal to 100 percent of the DV because of 
technological problems related to their bulk.
    Other nutrients that should not be expected to be present at 100 
percent of the DV include total fat, saturated fat, cholesterol, and 
sodium. It would be nonsensical to associate the term ``high potency'' 
with these nutrients because, as discussed earlier, dietary guidelines 
recommend that intake of these nutrients be limited or moderated in the 
diet (Ref. 8). In addition, it is not useful to include chloride at 
high levels in multinutrient supplements. Salt is the primary source of 
dietary chloride, and the typical American diet already contains 
significant levels of chloride because of high intakes of salt (Refs. 6 
and 10). (See the discussion of the exemption of chloride in 
Sec. 101.3(e)(4)(ii) in the final rule entitled ``Food Labeling: 
Reference Daily Intakes'' published elsewhere in this issue of the 
Federal Register.) Lastly, as discussed earlier, potassium would be 
considered a drug at such high levels, so it should not be included in 
dietary supplements at 100 percent of the DRV.
    Therefore, FDA tentatively concludes that there are 11 nutrients 
(calcium, phosphorus, magnesium, dietary fiber, total carbohydrate, 
total fat, saturated fat, cholesterol, sodium, chloride, and potassium) 
for which it would be impracticable or imprudent to require that, when 
present in a multinutrient product, they be present at levels at or 
above 100 percent of the RDI or DRV for the product to qualify for the 
use of the nutrient content claim ``high potency.'' This amounts to 
one-third of the nutrients for which RDI's and DRV's have been 
established (11 out of 33 nutrients). Accordingly, the agency believes 
that it would be reasonable to expect that the remaining two-thirds of 
the nutrients for which RDI's and DRV's have been established could be 
present at 100 percent of the RDI or DRV in a ``high potency'' 
multinutrient dietary supplement product that contained all 33 
nutrients for which RDI's and DRV's have been established.
    FDA finds merit in the comment that suggested that not all 
nutrients need be present at or above the RDI for the product to 
qualify for the claim. This comment suggests that the agency establish 
a standard for ``high potency'' that applies to supplements that do not 
contain all of the 33 nutrients for which RDI's and DRV's have been 
established as well as those that do. FDA tentatively concludes that 
two-thirds represents a reasonable standard; it provides flexibility 
for supplements that do not contain all 33 nutrients, and it provides a 
consistent standard for all supplement products. Finally, it is a 
familiar fraction that is easy to use. With a two-thirds standard, the 
manufacturer would have latitude to decide, in formulating a product 
that will qualify to bear a ``high potency'' claim, which nutrients to 
include at 100 percent of the RDI or DRV. The alternative would be to 
require that any of the 22 nutrients that can be present at 100 percent 
of the DRV be present at that level if the supplement is to bear a 
``high potency'' claim. FDA is concerned, however, that such a 
requirement would set too high a standard and not provide appropriate 
flexibility. Comment is requested on the agency's tentative conclusion.
    Based on these factors, the agency is proposing in 
Sec. 101.54(f)(2) that the term ``high potency'' may be used on the 
label or in the labeling of a dietary supplement to describe the 
product (e.g., ``High potency multivitamin, multimineral dietary 
supplement tablets'') if the product contains 100 percent or more of 
the RDI or DRV for at least two-thirds of the vitamins, minerals, 
protein, and dietary fiber present in the product. This proposed 
requirement will mean that each nutrient (i.e., vitamin, mineral, 
protein, or dietary fiber) in a dietary supplement containing only one 
or two nutrients will have to be present at 100 percent or more of the 
RDI or DRV because two-thirds of one or two nutrients does not result 
in a whole number that is different from the original number (e.g., 2 
times 2/3 equals 1.34; the product 1.34 indicates that more than one 
nutrient is needed to meet the criterion; therefore both nutrients 
would have to meet or exceed 100 percent of the RDI or DRV).
    The agency recognizes that dietary supplements that consist of an 
assortment of dietary ingredients are widely available in the 
marketplace. FDA agrees with the comment that stated that the presence 
or absence of dietary ingredients for which RDI's or DRV's have not 
been established (e.g., omega-3 fatty acids, choline, boron) 
(hereinafter referred to as ``other dietary ingredients'') should not 
affect the claim so long as those nutrients with RDI's or DRV's are 
present at levels required for the claim. The presence or absence of 
other dietary ingredients for which RDI's and DRV's have not been 
established is immaterial to the claim, and, therefore, the agency 
finds no basis for proposing alternate requirements for such products. 
It is important to note that because the definition that FDA is 
proposing is based on the presence of a nutrient at 100 percent of the 
RDI or DRV, dietary supplements that do not contain nutrients for which 
RDI's or DRV's have been established will not be able to use the term 
``high potency.''
    c. Disclosure requirement. One comment stated that the label of a 
``high potency'' multivitamin product should disclose the names or 
number of nutrients that are present at high levels. For example, the 
comment suggested that the label could carry an asterisk next to the 
claim, with the following disclosure: ``contains high levels of 
[number] vitamins.''
    The agency rejects this comment. The agency tentatively concludes 
that such a requirement for the label or labeling of a ``high potency'' 
multinutrient dietary supplement is not needed to prevent consumers 
from being misled by the claim. Section 403(s) of the act, added by the 
DSHEA, states that a dietary 

[[Page 67189]]
supplement is misbranded if its label or labeling fails to list the 
quantity of each dietary ingredient present. (See implementing 
regulations proposed in a companion document published elsewhere in 
this issue of the Federal Register entitled ``Food Labeling; Statement 
of Identity, Nutrition Labeling and Ingredient Labeling of Dietary 
Supplements.'') In accordance with the proposed and current nutrition 
labeling regulations, information on what, and how many, nutrients are 
present at 100 percent or more of the RDI or DRV can be readily 
determined from the nutrition label.
    In addition, it would be cumbersome for a product containing 100 
percent of the RDI for several nutrients for which RDI's or DRV's have 
been established to list all of those nutrients on the principal 
display panel. Many comments to the agency's proposals on the labeling 
of dietary supplements have addressed the lack of available space to 
meet current labeling requirements on multinutrient dietary supplement 
products. Therefore, the agency tentatively concludes that it is 
unnecessary, and would be impracticable, to require a list on the 
principal display panel of the number or names of all nutrients present 
at 100 percent or more of the RDI or DRV.
4. Synonyms
    Although the agency asked for specific comment on the term ``high 
potency,'' several comments in response to the nutrient content claims 
proposal for dietary supplements used the term ``full potency'' in 
discussions. FDA requests comment on whether the term ``full potency'' 
is generally viewed by consumers as a synonym to ``high potency,'' and 
if there are other terms that appropriately can be defined as 
synonymous with ``high potency.'' If reasonable synonyms are suggested 
in the comments, and the comments establish that use of these terms 
will not be misleading, the agency will consider defining them as 
synonyms with ``high potency'' in the final rule.

B. Nutrient Content Claims Using the Term ``Antioxidants''

1. Background
    One comment to the 1993 nutrient content claims proposal (58 FR 
33731) stated that FDA failed to address whether the currently used 
claim of ``high in antioxidants'' was within the scope of the proposed 
regulation. The agency stated in the 1994 nutrient content claims final 
rule that while this claim was not explicitly discussed in the 1993 
nutrient content claims proposal. FDA considered it to be a nutrient 
content claim (59 FR 378 at 389). One problem noted with the claim, 
however, was that there is no established definition of the term 
``antioxidants.''
    In an informal survey of dietary supplement products sold in the 
Washington, DC area, FDA found that the claim ``high in antioxidants'' 
often refers to a variety of nutrients and other dietary ingredients 
that are present in widely varying amounts (Ref. 9). This inconsistent 
use of the claim can lead to consumer confusion. To ensure that 
consumers are not confused or misled, Congress found in passing the 
1990 amendments that it is appropriate for FDA to establish specific 
definitions to standardize the terms used by manufacturers to describe 
the nutrient content of foods. Accordingly, in this document, FDA is 
proposing to define ``antioxidants'' so that it can be used in a clear 
and consistent manner in conjunction with currently defined nutrient 
content claims such as ``good source,'' ``high,'' and ``more'' and the 
proposed ``high potency'' claim. The agency is following up on the 
commitment that it made in the 1994 nutrient content claims final rule 
to propose to adopt a definition for the term (59 FR 378 at 389).
    The term ``antioxidants'' is unique in comparison to the names of 
other nutrients associated with nutrient content claims. Unlike 
previously approved nutrient content claims that characterize the level 
of a particular nutrient (e.g., ``low sodium''), a term such as ``high 
in antioxidants'' ties a claim (i.e., ``high'') to a class of nutrients 
that share a specific characteristic (i.e., they are antioxidants) 
whose very name indicates a metabolic function. Because of this fact, 
it is important to make a clear distinction between the term when used 
as part of a nutrient content claim and possible uses of the term as 
part of a health claim or a statement of nutritional support.
    Nutrient content claims expressly or implicitly characterize the 
level of a nutrient in a food and are regulated under Sec. 101.13. 
Health claims are claims that expressly or by implication characterize 
the relationship of any substance to a disease or health-related 
condition. They are regulated under Sec. 101.14. Moreover, statements 
of nutritional support, authorized by section 403(r)(6) of the act, 
which was added by the DSHEA, encompass label statements on dietary 
supplements that claim a benefit related to a classical nutrient 
deficiency disease, describe how a nutrient or dietary ingredient 
affects the structure or function in humans, characterize the 
documented mechanism by which a nutrient or dietary ingredient acts to 
maintain the structure or function, or describe general well-being from 
consumption of a nutrient or dietary ingredient.
    In the case of a claim such as ``high in antioxidants,'' a set of 
substances is clearly identified (i.e., ``antioxidants'') and a level 
of nutrients is stated (i.e., ``high''), but there is no disease or 
health-related condition stated or implied, and the descriptive or 
characterizing aspects of nutritional support statements are not 
present. Accordingly, such a term is properly regulated as a nutrient 
content claim.
2. Express Versus Implied Nutrient Content Claims
    In the 1994 nutrient content claims final rule, FDA stated that it 
considered ``high in antioxidants'' to be an implied nutrient content 
claim that would come under Sec. 101.65 (59 FR 378 at 389). However, 
after further consideration, the agency tentatively concludes that when 
the term ``antioxidants'' appears in association with expressed 
nutrient content claims (i.e., ``good source,'' ``high,'' ``more,'' and 
the proposed ``high potency''), the claim is more properly classified 
as an expressed claim. Therefore, the agency is defining the term 
``antioxidants'' in Sec. 101.54 Nutrient Content Claims for ``Good 
Source,'' ``High,'' and ``More.'' This placement is consistent with the 
manner in which fiber claims (e.g., ``high in fiber'') are regulated. 
(See Sec. 101.54(d).) Accordingly, the agency is proposing to add 
paragraph (g) to Sec. 101.54 to address nutrient content claims using 
the term ``antioxidants.''
3. Definition of ``Antioxidants''
    As stated, the agency is proposing to define the term 
``antioxidants'' for use with nutrient content claims such as ``good 
source,'' ``high,'' and ``more'' that are defined in Sec. 101.54, and 
with the proposed ``high potency.'' This task entails determining which 
nutrients are to be included within the coverage of the term 
``antioxidants.''
    In a previous rulemaking, FDA has reviewed the characteristics of 
three vitamins that function as antioxidants. Section 3(b)(1)(A)(x) of 
the 1990 amendments directed the agency to address the relationship 
between antioxidant vitamins and cancer. In its proposed regulations to 
implement the 1990 amendments, FDA considered the effects of vitamin C, 
vitamin E, and beta-carotene on cancer (56 FR 60624, November 27, 
1991). In that document, FDA summarized the antioxidant properties of 
those nutrients. 

[[Page 67190]]

    FDA stated that vitamin C serves as an effective free-radical 
scavenger to protect cells from damage by reactive oxygen molecules (a 
free-radical being an atom containing an unpaired electron which tends 
to give the atom more reactivity, often leading to a pro-oxidative 
chain reaction which can damage cells). The basic biological function 
of vitamin E was found to be as an antioxidant where it acts as a 
defense against potentially harmful reactions with oxygen by 
deactivation of the free-radicals. In the case of beta-carotene, the 
agency stated that it was chosen because it is an antioxidant, and, 
although it is not recognized as a vitamin itself, it is a provitamin 
and makes important contributions to the vitamin A activity of most 
diets. Beta-carotene acts by trapping, deactivating, and destroying 
reactive oxygen molecules and preventing the damage that they can 
cause. FDA did not include vitamin A (retinol) and retinoic acid in its 
consideration because their biological functions are not achieved 
through an antioxidant role, and because vitamin A cannot function in a 
fashion similar to that of beta carotene (carotenoids) and vitamins C 
and E (Refs. 11 and 12).
    In the final rule on antioxidant vitamins and cancer, FDA concluded 
that this selection of nutrients was appropriate (58 FR 2622, January 
6, 1993).
    In addition, a recent conference entitled ``Antioxidant Vitamins 
and Cancer and Cardiovascular Disease,'' initiated by FDA, supported 
this conclusion and affirmed that the biological role of other vitamins 
as direct antioxidants remains unsubstantiated (Ref. 13). Riboflavin 
and niacin, two of the B-vitamins, are precursors of coenzymes that are 
involved in large numbers of oxidation and reduction reactions. By 
themselves, however, these vitamins do not have direct antioxidant 
activities. Moreover, after conversion to their coenzyme forms, they 
have indirect effects that are both antioxidant and pro-oxidative in 
character (Refs. 14 and 15). When pro-oxidative conditions (i.e., the 
opposite of antioxidative) predominate, oxidative damage occurs to 
cells, lipids, proteins, and carbohydrates (Ref. 16). Thus, FDA 
tentatively concludes that these nutrients should not be classed as 
antioxidants.
    As stated earlier, the 1990 amendments specifically required that 
the agency evaluate the relationship of antioxidant vitamins to cancer. 
Antioxidant minerals were not mentioned in the statute and were not 
considered by the agency. However, in this rulemaking to define 
``antioxidants'' for use in nutrient content claims, FDA is not 
restricted in the nutrients that are to be encompassed by this term. 
Based on its informal survey, the agency notes that some dietary 
supplements, including both single nutrient and multinutrient products, 
use the term ``antioxidant'' on their label and in labeling to describe 
minerals such as copper, zinc, manganese, iron, and selenium (Ref. 9). 
Accordingly, FDA has reviewed the literature on the biological 
activities of these minerals.
    As a result of its review, the agency tentatively concludes that 
there is no evidence that these substances have direct antioxidant 
properties, and that, in fact, some of them are pro-oxidative at 
certain levels. For example, copper, manganese, and zinc activate 
specific forms of the enzyme superoxide dismutase (SOD) which acts to 
remove the superoxide radical, and thus these minerals have indirect 
antioxidant effects (Refs. 17, 18, and 19). However, copper and 
manganese, in their free forms, are effective catalysts for oxidation 
reactions (i.e., pro-oxidants). Their role as an indirect antioxidant 
would be expected to predominate only at intakes at or below the 
quantities needed to saturate SOD. Higher intakes would be expected to 
have pro-oxidative effects (Refs. 17 and 18). Zinc does not have direct 
antioxidant or oxidant effects. It activates one form of SOD and thus 
has only indirect antioxidant activity (Ref. 19). Iron, another 
mineral, is an activator of catalase, which destroys peroxides, and 
thus has indirect antioxidant effects, but, again, iron itself 
catalyzes oxidative reactions (Ref. 20). Selenium is required for the 
activity of the enzyme glutathione peroxidase and thus has indirect 
antioxidant effects (Ref. 21).
    The agency's tentative view is that it is appropriate to identify 
only those nutrients having a clear, direct antioxidant function in 
defining the coverage of the term ``antioxidants.'' Because none of the 
minerals discussed above function directly as antioxidants, the agency 
tentatively concludes that they should not be included in the 
definition of the term ``antioxidants'' for purposes of making a 
nutrient content claim. -Accordingly, FDA is proposing in 
Sec. 101.54(g)(1), in part, that ``antioxidants'' be defined as a 
collective term inclusive of vitamin C, vitamin E, and beta-carotene 
when used as a part of nutrient content claims (e.g., ``good source of 
antioxidants,'' ``high in antioxidants'') that describe food products. 
FDA also provides in the proposed regulation that the food must contain 
the requisite amounts of each of the three nutrients to qualify to bear 
the claim (e.g., for ``high in antioxidants,'' the product must contain 
20 percent or more of the RDI for vitamin C and vitamin E per reference 
amount customarily consumed, and 20 percent or more of the RDI for 
vitamin A must be present as beta-carotene per reference amount 
customarily consumed).
    Because there is a recent history of use of nutrient content claims 
for ``antioxidants'' on both dietary supplements and conventional 
foods, the agency is proposing in Sec. 101.54(g)(1) that such claims be 
allowed on both types of foods. It should be noted, however, that 
because the agency is proposing in this document that the term ``high 
potency'' be limited to dietary supplements, the term ``high potency 
antioxidants'' could be used only on dietary supplements.
    FDA notes that some herbs and other dietary ingredients use the 
term ``antioxidants'' in association with a nutrient content claim 
(e.g., ``raspberry leaf--high in antioxidants''). The agency advises 
that the regulations being proposed would not permit such nutrient 
content claims unless the product contains the nutrients identified in 
the proposed definition of ``antioxidants.''
4. Beta-carotene
    Nutrient content claims are authorized for nutrients for which 
there are RDI's or DRV's. This approach has the advantage of linking 
nutrient content claims to established reference values, thereby 
providing a consistent and quantitative basis for defining terms. As a 
pro-vitamin, beta-carotene does not have an RDI or DRV. However, FDA 
stated in the final rule on nutrient content claims for dietary 
supplements that claims regarding beta-carotene (e.g., ``contains beta-
carotene'') are claims that make implied representations about the 
level of vitamin A that is present in the food as beta-carotene (59 FR 
378 at 384). Accordingly, the agency stated that it considers that the 
claim ``contains beta-carotene'' implies that there is enough beta-
carotene in the food for the food to qualify as a ``good source'' of 
vitamin A (i.e., it contains 10 percent or more of the DV for vitamin A 
from beta-carotene) (59 FR 378 at 384). Such a claim is provided for in 
Sec. 101.65(c).
    The agency tentatively concludes that this standard should also 
apply to beta-carotene when it, either by itself or in association with 
other antioxidants, is the subject of an ``antioxidant'' claim. This 
standard allows beta-carotene to be tied to vitamin A, a nutrient with 
an RDI, as an implied claim, thereby 

[[Page 67191]]
permitting nutrient content claims to be made about this substance. 
Therefore, proposed Sec. 101.54(g)(1) includes a requirement that 
vitamin A present as beta-carotene be present at a sufficient level to 
qualify for the claim (e.g., for ``high in antioxidants,'' 20 percent 
or more of the DV for vitamin A must be present as beta-carotene; for 
``high potency antioxidant,'' 100 percent or more of the DV for vitamin 
A must be present as beta-carotene).
    FDA acknowledges that the antioxidant role of beta-carotene was not 
taken into account by the NAS in setting the RDA's for vitamin A (Ref. 
6). Therefore, there is no reason to believe that the amount of beta-
carotene potentially useful as an antioxidant is related to the RDI for 
vitamin A. However, the agency tentatively concludes that the above 
approach is a practical means of quantifying the level of beta-carotene 
that must be present for a food to qualify to bear an antioxidant 
nutrient content claim.
5. Disclosure Requirement
    FDA is aware of the availability of products that do not contain 
all three of the nutrients included in the proposed definition of 
``antioxidants'' (i.e., vitamin C, vitamin E, and beta-carotene) yet 
that highlight the antioxidant properties of a particular nutrient 
(e.g., ``Contains antioxidant vitamin E'') on the label or in labeling. 
FDA tentatively concludes that it is appropriate to allow products to 
bear such claims because the antioxidant properties of each nutrient 
are significant enough to highlight. However, the agency finds that 
when a food makes a claim for ``antioxidants'' yet fails to contain all 
three nutrients, the disclosure of the specific antioxidant nutrients 
that are present in the product is necessary to ensure that consumers 
are not misled into thinking that the product contains all three 
nutrients. Such a disclosure is necessary to reveal a fact that is 
material in light of the antioxidant claim (section 201(n) of the act), 
that is, to disclose which nutrients with antioxidant effects are 
present in the product at the highlighted level.-
    Accordingly, the agency is proposing in Sec. 101.54(g)(2) that when 
a nutrient content claim using the term ``antioxidant'' is included on 
the label or in labeling of a product that does not contain all three 
antioxidants at the required levels, the claim may only be used on the 
label or in labeling when the food contains at least one of the 
nutrients at the requisite level, and the label or labeling discloses 
the antioxidants contained in the product in sufficient amounts to 
qualify for the claim (e.g., ``High in antioxidant vitamins C and E'').
6. Collective Claims
    Collective claims such as ``complete antioxidant complex'' and 
``antioxidant formula'' seem to convey that the product contains each 
antioxidant. Because FDA has identified three vitamins with direct 
antioxidant activity, it is reasonable to expect that a dietary 
supplement or conventional food making such a collective claim about 
antioxidants will contain each of these vitamins. Further, such claims 
imply that each nutrient is present at a level sufficient to make a 
significant contribution to the total daily diet, or at a minimum, is a 
``good source'' of each nutrient.
    Therefore, FDA tentatively concludes that collective claims about 
antioxidants, such as ``complete antioxidant complex'' or ``antioxidant 
formula'' state that the labeled product contains 10 percent or more of 
the RDI of vitamin C and vitamin E, and that 10 percent or more of the 
RDI for vitamin A is present as beta-carotene. -
    Accordingly, FDA is proposing to add Sec. 101.54(g)(3) to provide 
for the use, under section 403(r)(2)(A)(i) of the act, of such 
collective antioxidant terms (e.g., ``complete antioxidant formula,'' 
``antioxidant complex'') as nutrient content claims provided that 
vitamin C and vitamin E are present at 10 percent or more of the RDI 
per reference amount customarily consumed, and that 10 percent or more 
of the RDI for vitamin A is present as beta-carotene per reference 
amount customarily consumed when such a term is used. This definition, 
if adopted, would not preclude the presence of other nutrients (e.g., 
selenium and zinc) in the product, nor would this definition preclude 
manufacturers from making other nutrient content claims that 
characterize the level of other nutrients that have RDI's or DRV's. 
Further, manufacturers may also describe the nutritional properties of 
other ingredients as long as the statements are not false or misleading 
or do not constitute unauthorized health claims or unapproved drug 
claims.

C. Limitation of ``High Potency'' and Nutrient Content Claims Using the 
Term ``Antioxidant'' on Products for Infants and Toddlers

    The agency points out that Sec. 101.13(b)(3) states that except for 
percentage claims regarding vitamins and minerals described in 
Sec. 101.13(q)(3), no nutrient content claims may be made on food 
intended specifically for use by infants and children less than 2 years 
of age unless the claim is specifically provided for in parts 101, 105, 
or 107 (21 CFR parts 105 and 107).
    The agency sees no reason why an exception should be made to extend 
the use of the terms discussed in this rulemaking to products for 
infants and toddlers. FDA is not aware of any evidence that the intake 
of dietary supplements at ``high potency'' levels, or that an increased 
intake of antioxidants, are appropriate for infants and toddlers. 
Relatively little attention has been given to the role of the diet of 
children less than 2 years of age in modifying the risk of chronic 
diseases, such as hypertension and cancer, found in adults (Refs. 10 
and 22). Thus, FDA is not aware of any basis on which to conclude that 
these claims would be useful to the parents of young children. In fact, 
such terms would be misleading on foods for infants and toddlers 
because they imply benefits that have not been demonstrated.
    In addition, the definitions of nutrient content claims for both 
``high potency'' and for the several possible levels of 
``antioxidants'' (e.g., ``good source,'' ``high,'' and ``more'') are 
dependent upon calculation of the percent of the RDI for the 
appropriate nutrient present in the product. However, no RDI's are 
currently established for infants and children less than 2 years of 
age. The agency has stated that it intends to address the issue of 
RDI's for infants, children less than 4 years, and pregnant and 
lactating women in future rulemaking (59 FR 427 at 430, January 4, 
1994), and it reiterates that intention in the final rule on RDI's 
published elsewhere in this issue of the Federal Register. However, 
until it establishes these levels, there is no basis on which to define 
these terms for use on foods intended for infants and children less 
than 2 years of age.

D. Amendment to Sec. 101.60 Concerning Nutrient Content Claims for the 
Calorie Content of Foods for Dietary Supplements

    Section 101.60(c)(1) states that consumers may reasonably be 
expected to regard terms that represent that the food contains no 
sugars or sweeteners as an indication that a product is low in calories 
or is significantly reduced in calories. This section also states that 
a food cannot be labeled ``sugar free'' or ``no sugar'' unless it meets 
the following conditions: (1) The food contains less than 0.5 gram (g) 
of sugars per reference amount and per labeled serving, (2) the food 
contains no ingredient that is a sugar or that is generally understood 
by consumers to contain sugars unless the 

[[Page 67192]]
listing of the ingredient in the ingredient statement is followed by an 
asterisk that refers to a statement below the list of ingredients such 
as ``adds a negligible amount of sugar,'' and (3) it is labeled ``low 
calorie'' or ``reduced calorie'' or bears a relative claim of special 
dietary usefulness, or is labeled ``not a reduced calorie food,'' ``not 
a low calorie food,'' or ``not for weight control.''
    In the 1994 nutrient content claims final rule, FDA added paragraph 
Sec. 101.60(a)(4) to state that ``calorie free'' and ``low calorie'' 
claims may not be made on dietary supplement products, except when an 
equivalent amount of a dietary supplement that the labeled food 
resembles and for which it substitutes (e.g., another protein 
supplement), normally exceeds the definition for ``low calorie'' in 
Sec. 101.60(b)(2). The agency also similarly revised Sec. 101.13(b)(5). 
This change in Secs. 101.13(b)(5) and 101.60(a)(4) had the unintended 
effect of limiting the use of ``sugar free'' or ``no sugar'' claims on 
dietary supplements that would otherwise meet the requirements for 
``low calorie'' in Sec. 101.60(b)(2) but are not permitted to bear the 
claim because they do not substitute for a similar dietary supplement 
that normally exceeds the definition for ``low calorie.''
    In the 1994 nutrient content claims final rule, FDA had found that, 
because the level of sugars in dietary supplements can vary 
substantially, claims about the sugars content of dietary supplements 
may be useful in helping consumers make purchasing decisions that will 
assist them in maintaining healthy dietary practices (59 FR 378 at 
382). Thus, the agency concluded that extending the definitions of 
``sugar free'' and ``reduced sugar'' to dietary supplements was 
appropriate irrespective of the calorie level of the dietary 
supplement. Therefore, FDA did not modify the requirements governing 
claims for sugars in Sec. 101.60(c) for dietary supplements. In not 
making a change to Sec. 101.60(c), however, FDA overlooked the impact 
of new Secs. 101.13(b)(5) and 101.60(a)(4).
    In order to allow for ``sugar free'' or ``no sugar'' claims on 
dietary supplements that meet the other criteria for the claim (i.e., 
contain less than 0.5 g of sugars per reference amount and contain no 
ingredient that is a sugar or that is generally understood by consumers 
to contain sugars unless an appropriate statement is added after the 
ingredient list), the requirement that the product be labeled ``low 
calorie'' should have been modified for dietary supplements that were 
prohibited from making ``low calorie'' claims because no other dietary 
supplement that the labeled food resembles and for which it substitutes 
exceeded the definition for ``low calorie.'' FDA is proposing to make 
that change now. No modification is needed for dietary supplements 
labeled ``reduced calorie'' since that claim was not changed by the 
final rules on nutrient content claims for dietary supplements or for 
those dietary supplements that are not low or reduced in calories.
    The agency is not aware of any reason why its position in 
Sec. 101.60(c)(1) that consumers may be expected to regard ``sugar 
free'' and ``no sugar'' claims as indicative of a product that is low 
or reduced in calories should be different for dietary supplements than 
for conventional foods. Therefore, FDA is proposing to revise 
Sec. 101.60(c)(1)(iii)(A) to excuse only dietary supplements that 
otherwise meet the definition of ``low calorie'' under 
Sec. 101.60(b)(2) but that are prohibited by Secs. 101.13(b)(5) and 
101.60(a)(4) from bearing the claim.

IV. Effective Date

    FDA is proposing an effective date of January 1, 1997. This date is 
consistent with the effective date proposed in two companion proposals 
published elsewhere in this issue of the Federal Register entitled 
``Food Labeling; Statement of Identity, Nutrition Labeling and 
Ingredient Labeling of Dietary Supplements'' and ``Food Labeling; 
Requirements for Nutrient Content Claims, Health Claims, and Statements 
of Nutritional Support for Dietary Supplements.'' This date will allow 
firms to make all label changes associated with the DSHEA and with the 
two companion proposals at the same time.

V. 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 analyzing 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.
    Many currently marketed foods and dietary supplements use the terms 
``high potency'' and ``high in antioxidants'' to describe the level of 
nutrients in the products. Without definitions for these terms, 
manufacturers will not be able to continue to use them. This proposed 
rule will require that any manufacturer currently using the terms 
``high potency'' or ``antioxidant'' bear the costs of removing such 
statements from their labels only if the products do not meet the 
proposed definition. FDA does not believe that the number of products 
that would not meet the proposed definition is high.

VI.- Paperwork Reduction Act

    FDA tentatively concludes that this proposed rule contains no 
reporting, recordkeeping, labeling, or other third party disclosure 
requirements; thus there is no ``information collection'' necessitating 
clearance by the Office of Management and Budget. However, to ensure 
the accuracy of this tentative conclusion, FDA is asking for comment on 
whether this proposed rule to define the term ``high potency'' as a 
nutrient content claim for dietary supplements, to define the term 
``antioxidant'' for use in nutrient content claims for dietary 
supplements, and to correct an omission pertaining to the use of 
``sugar free'' claims on dietary supplements imposes any paperwork 
burden.

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. Comments

    Interested persons may, on or before March 13, 1996, 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.

IX. References

    The following references have been placed on file in the Dockets 
Management Branch (address above) and may be seen by interested persons 


[[Page 67193]]
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Committee on the Nutrition Components of Food Labeling, Food 
and Nutrition Board, Institute of Medicine, National Academy of 
Sciences, ``Nutrition Labeling, Issues and Directions for the 
1990's,'' Washington, DC, National Academy Press, 1990.
    2. Park, Y. K., I. Kim, and E. A. Yetley, ``Characteristics of 
Vitamin and Mineral Supplement Products in the United States,'' 
American Journal of Clinical Nutrition, 54:750-759, 1991.
    3. Moss, A. J., A. S. Levy, I. Kim, and Y. Park, ``Use of 
Vitamin and Mineral Supplements in the United States, Current Users, 
Types of Products and Nutrients, Advance Data from Vital and Health 
Statistics of the National Center for Health Statistics,'' No. 174, 
July 18, 1989.
    4. Bender, M. M., A. S. Levy, R. E. Schucker, and E. A. Yetley, 
``Trends in Prevalence and Magnitude of Vitamin and Mineral 
Supplement Usage and Correlation with Health Status,'' Journal of 
the American Dietetic Association, 92:1096-1101, 1992.
    5. Levy, A. S. and R. E. Schucker, ``Patterns of Nutrient Intake 
Among Dietary Supplement Users: Attitudinal and Behavioral 
Correlates,'' Journal of the American Dietetic Association, 87:754-
760, 1987.
    6. Subcommittee on the 10th Edition of the Recommended Dietary 
Allowances, Food and Nutrition Board, Commission on Life Sciences, 
National Research Council, ``Recommended Dietary Allowances, 10th 
ed.,'' Washington, DC, National Academy Press, 1989.
    7. Food and Nutrition Board, Institute of Medicine, National 
Academy of Sciences, ``How Should the Recommended Dietary Allowances 
Be Revised,'' Washington, DC, National Academy Press, 1994.
    8. 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 Garden Bulletin, 3d ed., 
U.S. Government Printing Office, 1990.
    9. Memorandum from C. E. Brewer, FDA, to file, nutrient content 
of multinutrient products, March 28, 1994.-
    10. Committee on Diet and Health, Food and Nutrition Board, 
Commission on Life Sciences, National Research Council, National 
Academy of Sciences, ``Diet and Health, Implications for Reducing 
Chronic Disease Risk,'' National Academy Press, Washington, DC, 
1989.
    11. Merrill, A. H., Jr., A. Foltz, D. B. McCormick, ``Vitamins 
and Cancer,'' edited by Alfin-Slater, R. B., and D. Kritchevsky, 
Cancer and Nutrition, pp. 261-320, Plenum Press, New York, 1991.
    12. Olson, J. A., ``Vitamin A, Retinoids, and Carotenoids,'' 
edited by Shils, M. E., J. A. Olson, and M. Shike, Modern Nutrition 
in Health and Disease, pp. 287-307, Lea & Febiger, Philadelphia, 
1994.
    13. Transcript to Docket 93N-0389 for FDA-initiated public 
conference on antioxidant vitamins and cancer and cardiovascular 
disease, November, 1993.
    14. McCormick, D. B., ``Riboflavin,'' edited by Shils, M. E., J. 
A. Olson, and M. Shike, Modern Nutrition in Health and Disease, pp. 
367-375, Lea & Febiger, Philadelphia, 1994.
    15. Swendseid, M. E., and R. A. Jacob, ``Niacin,'' edited by 
Shils, M. E., J. A. Olson, and M. Shike, Modern Nutrition in Health 
and Disease, pp. 376-382, Lea & Febiger, Philadelphia, 1994.
    16. Thomas, J. A. ``Oxidative Stress, Oxidant Defense, and 
Dietary Constituents,'' edited by Shils, M. E., J. A. Olson, and M. 
Shike, Modern Nutrition in Health and Disease, pp. 501-512, Lea & 
Febiger, Philadelphia, 1994.
    17. Turnland, J. R., ``Copper,'' edited by Shils, M. E., J. A. 
Olson, and M. Shike, Modern Nutrition in Health and Disease, pp. 
231-241, Lea & Febiger, Philadelphia, 1994.
    18. Nielsen, F. H., ``Ultratrace Elements,'' edited by Shils, M. 
E., J. A. Olson, and M. Shike, Modern Nutrition in Health and 
Disease, pp. 269-286, Lea & Febiger, Philadelphia, 1994.
    19. King, J. C., and C. L. Keen, ``Zinc,'' edited by Shils, M. 
E., J. A. Olson, and M. Shike, Modern Nutrition in Health and 
Disease, pp. 214-230, Lea & Febiger, Philadelphia, 1994.
    20. Fairbanks, V. F., ``Iron in Medicine and Nutrition,'' edited 
by Shils, M. E., J. A. Olson, and M. Shike, Modern Nutrition in 
Health and Disease, pp. 185-213, Lea & Febiger, Philadelphia, 1994.
    21. Levander, O. A., and R. F. Burk, ``Selenium,'' edited by 
Shils, M. E., J. A. Olson, and M. Shike, Modern Nutrition in Health 
and Disease, pp. 242-251, Lea & Febiger, Philadelphia, 1994.
    22. U.S. Department of Health and Human Services, ``The Surgeon 
General's Report on Nutrition and Health,'' DHHS (Public Health 
Service) Publication No. 88-50210 (Government Printing Office Stock 
No. 017-001-00465-1), U.S. Government Printing Office, Washington, 
DC, 1988.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

    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 101.13 is amended by adding new paragraph (b)(6) to read 
as follows:


Sec. 101.13  Nutrient content claims--general principles.

 * * * * *
    (b) * * *
    (6) The term ``high potency'' may only be used on the labels or in 
the labeling of dietary supplements as defined by section 201(ff) of 
the Federal Food, Drug, and Cosmetic Act.
 * * * * *
    3. Section 101.54 is amended by revising the section heading and 
adding new paragraphs (f) and (g) to read as follows:


Sec. 101.54  Nutrient content claims for ``good source,'' ``high,'' 
``more,'' and ``high potency.''

 * * * * *
    (f) ``High potency'' claims. (1) The term ``high potency'' may be 
used on the label or in the labeling of dietary supplements to describe 
a nutrient that is present at 100 percent or more of the RDI for 
vitamins and minerals or of the DRV for protein and dietary fiber per 
reference amount customarily consumed.
    (2) The term ``high potency'' may be used on the label or in the 
labeling of dietary supplements to describe a product that contains 100 
percent or more of the RDI, or of the DRV, for at least two-thirds of 
the vitamins and minerals, and of the protein and dietary fiber, 
present in the product (e.g., ``High potency multivitamin, multimineral 
dietary supplement tablets'').
    (g) ``Antioxidants'' claims. (1) The term ``antioxidants'' is 
defined as a collective term inclusive of vitamin C, vitamin E, and the 
provitamin beta-carotene when used as part of a nutrient content claim 
(e.g., ``good source of antioxidants,'' ``high in antioxidants'') on 
labels or in labeling of conventional foods or dietary supplements. The 
levels of vitamin C and vitamin E and the level of vitamin A present as 
beta-carotene in the food that bears the claim all must be sufficient 
to qualify for the claim (i.e., for ``high in antioxidants,'' the 
product must contain 20 percent or more of the RDI for vitamin C and 
vitamin E per reference amount customarily consumed and 20 percent or 
more of the RDI for vitamin A must be present as beta-carotene per 
reference amount customarily consumed).
    (2) The term ``antioxidants'' may only be used on the label or in 
labeling of a food that does not contain each of the three antioxidants 
(i.e., vitamin C, vitamin E, and beta-carotene) in sufficient amounts 
to qualify for the claim if the food contains at least one of these 
nutrients at the requisite level, and the claim discloses which 
antioxidants in the food meet the required level (e.g., ``High in 
antioxidant vitamins C and E'').
    (3) A collective claim about antioxidant nutrients (e.g., 
``complete antioxidant formula,'' ``antioxidant complex'') may be used 
on the label or in labeling of foods provided that 

[[Page 67194]]
vitamin C and vitamin E are present at 10 percent or more of the RDI 
per reference amount customarily consumed, and that 10 percent or more 
of the RDI for vitamin A is present as beta-carotene per reference 
amount customarily consumed.
    4. Section 101.60 is amended by revising paragraph (c)(1)(iii)(A) 
to read as follows:
Sec. 101.60  Nutrient content claims for the calorie content of foods.

 * * * * *
    (c) * * *
    (1) * * *
    (iii)(A) It is labeled ``low calorie'' or ``reduced calorie'' or 
bears a relative claim of special dietary usefulness labeled in 
compliance with paragraphs (b)(2), (b)(3), (b)(4), or (b)(5) of this 
section, or, if a dietary supplement, it meets the definition in 
paragraph (b)(2) of this section for ``low calorie'' but is prohibited 
by Secs. 101.13(b)(5) and 101.60(a)(4) from bearing the claim; or
 * * * * *

    Dated: December 18, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-31194 Filed 12-27-95; 8:45 am]
BILLING CODE 4160-01-F