[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