[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Rules and Regulations]
[Pages 354-395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31814]
[[Page Unknown]]
[Federal Register: January 4, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 91N-384D]
RIN 0905-AD96
Food Labeling; Requirements for Nutrient Content Claims for
Dietary Supplements of Vitamins, Minerals, Herbs, and Other Similar
Nutritionnal Substances
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to: (1) Include dietary supplements of vitamins, minerals,
herbs, and other similar nutritional substances (hereinafter referred
to as ``dietary supplements'') 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. This final rule is in response
to the Nutrition Labeling and Education Act of 1990 and to the Dietary
Supplement Act of 1992.
EFFECTIVE DATE: July 1, 1995.
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
On November 8, 1990, President Bush 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, 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 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. The 1990
amendments also direct the Secretary and, by delegation, FDA to
promulgate regulations to define specific nutrient content claims
including ``free,'' ``low,'' ``light'' or ``lite,'' ``reduced,''
``less,'' and ``high'' (section 3(b)(1)(A)(iii) of the 1990
amendments).
In the Federal Register of November 27, 1991 (56 FR 60421 and 56 FR
60478), FDA published two documents in which it proposed, among other
things, to define nutrient content claims, to provide for their use on
foods labels, and to establish procedures for the submission and review
of petitions regarding the use of specific nutrient content claims.
These proposals applied to dietary supplements as well as foods in
conventional food form.
On October 6, 1992, the President signed 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) required the Secretary, and by delegation FDA, to
issue proposed regulations on nutrient content claims for dietary
supplements no later than June 15, 1993.
FDA issued final regulations that implemented the 1990 amendments
with respect to nutrient content claims on foods in conventional food
form on January 6, 1993 (hereinafter referred to as the ``final rule on
nutrient content claims'') (58 FR 2302). FDA modified these final
regulations slightly in a document that made technical corrections to
them (58 FR 44020, August 18, 1993) (hereinafter referred to as ``the
technical corrections document''). In response to the requirements of
the DS act, FDA published in the Federal Register of June 18, 1993 (58
FR 33731) a proposal to: (1) Include dietary supplements 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
(hereinafter referred to as the ``proposal on nutrient content claims
for dietary supplements'').
FDA received approximately 500 letters in response to its June 18,
1993, proposal on nutrient content claims for dietary supplements. Each
letter contained one or more comments. The letters were from a wide
range of sources, including consumers; consumer organizations;
professional associations; Federal, State, and local government
agencies; industry; and industry trade associations. Many comments
generally supported the proposal or various provisions of the proposal.
Other comments addressed issues outside the scope of the proposal
(e.g., freedom of choice, access to health care, access to dietary
supplements) and will not be discussed here. Many comments suggested
modifications, revisions, or revocations of various aspects of the
proposal. A summary of the comments, the agency's responses to the
comments, and a complete discussion of the agency's conclusions with
respect to nutrient content claims for dietary supplements follows.
II. Nutrient Content Claims for Dietary Supplements--FDA Authority
1. A couple of comments contended that FDA lacks the statutory
authority to prohibit claims for substances for which no reference
value (i.e., Reference Daily Intake (RDI) or Daily Reference Value
(DRV)) has been established. The comments also stated that the agency
lacks legal authority to promulgate regulations governing products
bearing a nutrient content claim for a nutrient or other substance not
explicitly named in section 403(q)(1) or (q)(2) of the 1990 amendments.
The comments said that the references to section 403(q)(1) or (q)(2) of
the act are references to those nutrients that the 1990 amendments
require to be listed (``mandatory nutrients'') on the nutrition label.
The comments argued that under these provisions, a food may be subject
to a misbranding charge under section 403(r)(1) of the act only if it
characterizes, either explicitly or implicitly, the level of a
mandatory nutrient in the food.
The comments also stated that the 1990 amendments did not provide
FDA with misbranding authority over products that bear a claim
characterizing the level of a nutrient or other substance that is not
listed in section 403(q)(1) or (q)(2) of the act. The comments
maintained that, regardless of whether a RDI or DRV has been
established, no special requirements should apply if a manufacturer of
a substance not covered by section 403(q)(1) or (q)(2), such as garlic,
wished to claim that his product was ``high in garlic'' or a ``good
source of garlic.'' The comments argued that while FDA maintains its
general misbranding authority over products bearing claims that
characterize the level of a nonmandatory substance, FDA still must meet
its burden of proving that any such claims are actually ``false or
misleading in any particular'' under the general misbranding provision,
section 403(a)(1) of the act.
Section 403(r)(1)(A) of the act states that a food intended for
human consumption is misbranded if it bears a claim that expressly or
by implication ``characterizes the level of any nutrient which is of
the type required by paragraph (q)(1) or (q)(2) to be in the label or
labeling of the food * * *.'' The statute uses the same language in
section 403(r)(1)(B) to describe the substances that could be the
subject of a health claim. A health claim is a claim that
``characterizes the relationship of any nutrient which is of the type
required by paragraph (q)(1) or (q)(2) to be in the label or labeling
of the food to a disease or a health-related condition * * *.''
Under section 403(r)(1)(B), a health claim may be made in accordance
with section 403(r)(5)(D) as well as section 403(r)(3). Thus, because a
statute must be read as a whole, the language in section 403(r)(1)(A)
and (r)(1)(B) of the act that describes the substances that may be the
subject of a nutrient content or of a health claim must be read in
conjunction with section 403(r)(5)(D), which addresses health claims
for vitamins, minerals, herbs, or other similar nutritional substances
that are components of dietary supplements. Thus, the ``nutrients of
the type required by paragraph (q)(1) or (q)(2)'' that are the subject
of sections 403(r)(1)(A) and (r)(1)(B) of the act include vitamins,
minerals, herbs, and other similar nutritional substances.
The legislative history of ``other nutritional substances'' reveals
that its coverage is broad and could, in appropriate circumstances,
include garlic. See 136 Cong. Record S16609 (daily ed. October 24,
1990) (discussion between Senators Metzenbaum and Symms). Therefore,
while a label claim that a food contains garlic that is intended to
describe the taste of the food would not be subject to section
403(r)(1)(A) of the act, a claim that describes the garlic content in a
way that reveals that garlic is being referred to as a nutritional
substance would be subject to that section. Under section 403(r)(1)(A)
of the act, the latter claim would misbrand the food unless its use has
been authorized by FDA under section 403(r)(2). Thus, FDA rejects the
comments that disagreed with the proposed coverage of the nutrient
content claim provisions.
FDA has relied on the RDI's and DRV's in defining nutrient content
claims under section 403(r)(2) of the act because it has concluded that
if the characterization of the level of a nutrient is to have any
meaning, there must be a level that can be used as a reference in
determining whether the characterization is valid and appropriate. The
RDI's and DRV's provide such levels. Thus, in Sec. 101.54(a) (21 CFR
101.54(a)), FDA has limited the use of ``good source,'' ``high,'' and
``more'' claims to use with nutrients for which an RDI or DRV has been
established. FDA is not aware of any other alternative standards.
If interested persons are aware of other standards that can be used
as reference values to establish the validity of content claims for
substances for which RDI's and DRV's have not been established, those
persons should make FDA aware of those standards through Sec. 101.69
(21 CFR 101.69) or other appropriate means. FDA will carefully consider
using such standards as the basis for content claims for the substances
involved.
III. Basis for Nutrient Content Claims For Dietary Supplements
A. Relationship to January 6, 1993 Final Rules, Consistency with
Established Nutrient Content Claims, Scope
2. Many comments supported consistency in definitions for nutrient
content claims between foods in conventional food form and dietary
supplements. However, one comment stated that consistency in
definitions for nutrient content claims for dietary supplements and
foods in conventional food form is inappropriate. The comment argued
that FDA has chosen to define nutrient content claims that are not
meaningful to the supplement industry and to consumers.
Many comments pointed out that dietary supplements are intended to
contribute, with foods in conventional food form, to consumers' daily
nutrient intake. Thus, the comments argued that it is important that
the terms used to describe the levels of nutrients in both dietary
supplements and foods in conventional food form be consistent. These
comments maintained that consumers would be confused if claims were to
be allowed on dietary supplements that were not defined in the same
manner as those for foods in conventional food form.
FDA disagrees with the comments that said that consistency with
established nutrient content claims is inappropriate as a basic
principle for defining nutrient content claims for dietary supplements.
There is much about dietary supplements that suggests that the
principles that guide FDA in defining nutrient content claims for
dietary supplements should be the same as the principles that guide the
agency in defining nutrient content claims on foods in conventional
food form. Dietary supplements that are not intended for use as drugs
have traditionally been regulated as foods and, as such, must be
evaluated within the context of the total daily diet. In addition,
nutrients from dietary supplements serve the same physiological
function as nutrients from foods in conventional food form. While some
consumers seek to ensure that the nutrient content of their diet is
adequate through foods in conventional food form, other consumers seek
to ensure nutritional adequacy by making dietary supplements part of
their diets (Ref. 1). Consistent use of terms on dietary supplements
and on foods in conventional food form will thus help consumers to
construct a nutritionally adequate total daily diet by allowing
consumers to make meaningful comparisons among these products. It will
also facilitate use of these terms by consumers.
Over the years, FDA has stressed the importance of consistent
definitions and descriptive terms as a necessary requirement for
effective education and for preventing misleading labeling (Ref. 2). If
terms were given different definitions depending on whether they were
to be used to describe foods in conventional food form or dietary
supplements, it would make it much more difficult for the public to
understand what these terms are intended to convey about a particular
food. Moreover, a single definition for a particular term eliminates
any possibility that ambiguities could be created by the use of that
term. Therefore, the agency concludes that for nutrient content claims,
the definition of a particular term should be the same regardless of
the type of food that it is being used to describe.
Additionally, FDA has been criticized for treating dietary
supplements differently than other foods. FDA has no desire to
discriminate in any way against supplements. Thus, by having a single
definition for a particular nutrient content claim, FDA is providing
the basis for dietary supplements to make the same claims as other
foods and to be factored into the diet like other foods.
Nonetheless, as discussed in the proposal on nutrient content
claims for dietary supplements (58 FR 33731), FDA recognizes that
dietary supplements differ in at least two respects from foods in
conventional food form. First, dietary supplements are likely to
contain much higher levels of nutrients than foods in conventional food
form. Thus, additional nutrient content claims that are specific for
dietary supplements may be appropriate. As discussed later in this
document, the agency intends in the near future to initiate a separate
rulemaking to establish such claims for dietary supplements. Second,
dietary supplements generally do not contain several nutrients (e.g.,
fat, cholesterol) found in foods in conventional food form. Therefore,
in this document, FDA is limiting the use of certain claims that are
useful for describing foods in conventional food form but that do not
meaningfully describe dietary supplements.
B. General Principles
1. Substitute Foods
3. One comment objected to the requirement to use the word
``imitation'' on dietary supplements that are nutritionally inferior to
other products of the same type. The comment argued that FDA was never
given the authority to decide on formulations of dietary supplements,
and that setting such formulations is the exclusive role of the
manufacturer. Further, the comment stated that there is nothing
``imitation'' about ``less'' in the supplement industry, and that a
requirement that a supplement be labeled ``imitation'' if it is
nutritionally inferior to another product forces manufacturers to
increase potencies in order that their products will not have to be
labeled ``imitation.''
Under section 403(r)(2)(A)(ii) of the act, for a food to be labeled
as ``[nutrient] free,'' the nutrient must usually be present in the
food or in a food for which it substitutes, as that term is defined by
the Secretary (and by delegation, FDA) for the food. Accordingly, the
agency defined ``substitute foods'' in Sec. 101.13(d) (21 CFR 101.3(d))
in the final rule on nutrient content claims (58 FR 2302 at 2411) for
the purpose of identifying the characteristics that substitute foods
must have if they are to bear nutrient content claims that highlight
differences between them and the foods for which they substitute. The
definition states that a substitute food is one that may be used
interchangeably with another food that it resembles, i.e., to which it
is organoleptically, physically, and functionally (including shelf
life) similar and to which it is not nutritionally inferior, unless it
is labeled as an ``imitation.'' Additionally, Sec. 101.3(e)(1) (21 CFR
101.3(e)(l)) states that a food shall be deemed to be an imitation, and
thus subject to the requirements of section 403(c) of the act, if it is
a substitute for or resembles another food but is nutritionally
inferior to that food. Thus, the issue that the agency must consider is
whether dietary supplements that are foods should be subject to these
provisions on substitute foods as any other foods are.
The agency has no evidence that manufacturers will increase the
potencies for their products to avoid the use of this term and
disagrees that this provision will interfere with a manufacturer's
right to decide on product formulations. It is extremely unlikely that
the term ``imitation'' will ever be used on dietary supplements,
particularly dietary supplements of vitamins and minerals. The issue of
whether a supplement would be an ``imitation'' would arise only when a
manufacturer chooses to make a ``free'' or ``low'' claim for sugar or
sodium on a dietary supplement (see comment 4). In such circumstances,
under section 403(r)(2)(A)(ii) of the act, the manufacturer must
identify a product on the market with which its product can be used
interchangeably, to which the manufacturers product is not
nutritionally inferior, and that contains sodium or sugar. Such a
product may include the version of the manufacturer's product that
contains sodium or sugar. As long as such a product exists, the
manufacturer's product need not be labeled as an imitation. Moreover,
if because of the way the manufacturer has formulated its product,
there is no product with which it is used interchangeably, the product
can be called ``------------, a sodium-free food.'' Only in the rare
situations in which neither of the conditions apply would the product
have to be called ``imitation'' for it to bear a ``free'' or ``low''
sodium or sugar claim.
Sections 101.13(d)(1) and (d)(2) are designed to ensure that
material differences between the substitute food and the reference food
are conspicuously stated on the label or labeling of the food, so that
consumers can make fully informed judgments about the value of the
substitute food and its usefulness in maintaining healthy dietary
practices. If a product has substantially less of a nutrient than the
reference food, and to that extent is materially different and inferior
in nutrient content, then ``imitation'' is an entirely appropriate
term. For this reason, the agency concludes that there is no reason to
apply the substitute food provisions any differently to dietary
supplements than to other foods.
2. Requirements for ``Low'' and ``Free'' Claims
4. Several comments from dietary supplement manufacturers and trade
associations questioned the need to allow ``low'' and ``free'' claims
for nutrients such as fat and cholesterol that are not typically found
in dietary supplements. One comment suggested that ``free,'' ``low,''
and ``reduced'' claims for calories, fat, and cholesterol on dietary
supplements should be permitted only on dietary supplements that are a
significant source of calories, such as protein supplements. The
comment argued that consumers do not expect most dietary supplements to
contain significant amounts of calories, and that it is nonsensical and
confusing to permit dietary supplements that are not a significant
source of calories to make a claim about reduced amounts of calories,
fat, and cholesterol contained therein. Another comment stated that
Americans who consume dietary supplements do not do so because the
products are ``low in fat,'' ``cholesterol free,'' or ``low calorie,''
and that consumers are not interested in the fat content of dietary
supplements. The comment argued that consumers care about the
substances in the products and the benefits that those products can
have for their health.
In the proposal on nutrient content claims for dietary supplements,
the agency requested comment on the need for extending ``free,''
``low,'' and ``reduced'' claims to dietary supplements (58 FR 33731 at
33745). The agency has reviewed the comments that it received and is
persuaded by them that it not meaningful to allow claims about the
calorie, fat (including saturated fat), or cholesterol content of most
dietary supplements. Most of these products do not contain those
nutrients, and most consumers do not expect that they do. Thus,
consumers would not generally look to these products in making dietary
choices that are designed to control the amount of calories, fat,
saturated fat, and cholesterol in the foods they eat. In fact, claims
about these nutrients in most dietary supplements would only serve to
confuse consumers. While it is true that FDA is requiring information
about these nutrients in the nutrition label of supplements of herbs
and of other similar nutritional substances, this requirement derives
mainly from the limitation on the exemption in section 403(q)(5)(F) of
the act (formerly section 403(q)(5)(E)). See the final rule on general
requirements for nutrition labeling for dietary supplements published
elsewhere in this issue of the Federal Register.
However, the agency recognizes that there are some dietary
supplements, such as protein supplements, in which the amount of
calories in the product is significant to consumers. On these products,
the source of the calories, particularly whether they are from fat, is
relevant and useful information.
Therefore, FDA has decided, based on the comments that it received
to only allow calorie, fat, saturated fat, and cholesterol claims on
those dietary supplements in which the amount of calories is important
to consumers. In attempting to define what this level of calories
should be, the agency looked first to Sec. 101.9(f)(1) and (j)(4),
which said that a food has ``insignificant'' calories for the purposes
of nutrition labeling if it has an amount of calories that can be
rounded to zero. Section 101.9(c)(1) states that ``less than 5
calories'' per serving may be expressed as zero, the same amount that
is defined as ``calorie free.''
While FDA does not have information on the caloric content of
dietary supplements, it would not be unreasonable to expect that many
dietary supplements contain more than 5 calories (cal) per serving,
particularly children's chewable vitamin and mineral supplements,
supplements that contain herbal extracts, and supplements that contain
caloric binders and fillers. Thus, to tie the use of ``free,'' ``low,''
and ``reduced'' calorie, fat, and cholesterol claims on labels of
dietary supplements to the presence of more than an ``insignificant
amount'' of calories in the food would be over-inclusive and would
allow many products in which the amount of calories is not significant
to consumers to bear such claims.
FDA next looked at the definition of ``low calorie'' in
Sec. 101.60(b)(2) (21 CFR 101.60(b)(2)) for use in determining which
dietary supplements should be allowed to bear ``free,'' ``low,'' and
``reduced'' claims. Section 101.60(b)(2) defines a ``low calorie'' food
as a food that contains 40 cal or less per reference amount customarily
consumed (hereinafter referred to as reference amount) and per 50 grams
(g) if the reference amount is small. FDA believes that 40 cal per
reference amount represents a reasonable level for demarcating a
dietetically relevant source of calories for dietary supplements. In a
product that contains this amount of calories, the source of the
calories (e.g., fat) is of significance to consumers.
Accordingly, the agency is revising Sec. 101.62(a) (21 CFR
101.62(a)) by adding paragraph (a)(4) to state that ``free,'' ``low,''
and ``reduced'' claims for fat, saturated fat, and cholesterol may not
be made for dietary supplements that meet the criteria in
Sec. 101.60(b)(1) and (b)(2) for ``calorie free'' and ``low calorie''
claims. FDA is also revising Sec. 101.13(b) by adding new paragraph
(b)(5) to reflect these provisions. As a consequence, claims that
identify all products of that class of being ``low'' or ``free'' of a
nutrient (e.g., ``vitamin C supplement, a fat-free supplement'') will
also be prohibited.
However, to use the same criteria (i.e., that a product may not be
``calorie free'' or ``low calorie'') as a basis for when a calorie
claim may be made, has the effect of prohibiting the very claims that
the criterion seeks to permit, namely ``calorie free'' and ``low
calorie'' claims. Such a criterion would permit only relative calorie
claims (e.g. ``reduced'') on dietary supplements. Therefore, a slightly
different scheme for permitting calorie claims on certain dietary
supplements, such as protein supplements, must be derived.
While, as stated above, the agency believes that calorie claims
should not be permitted on most dietary supplements, it does believe
that ``calorie free'' and ``low calorie'' claims may be appropriate if
an equivalent amount of a similar food (i.e., another protein
supplement) that the labeled food resembles and for which it
substitutes would normally contain an appreciable amount of calories.
Such a claim would highlight that the labeled food had a different
calorie profile than would be expected in the similar product. It would
also serve to direct a consumer to a product that had a lower amount of
calories. Because the food would meet the criteria for ``low calorie''
and would be so labeled, it would not be necessary to highlight any
comparative differences between the labeled and the similar food as
would be required for a relative claim.
Therefore, the agency is revising Sec. 101.62(a) by adding new
paragraph (a)(4) to state that claims for calories may not be made on
labels of dietary supplements that meet the criteria in
Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' and ``low calorie''
except when an equivalent amount of a similar dietary supplement (e.g.,
another protein supplement) that the labeled food resembles and for
which it substitutes normally exceeds the definition for ``low
calorie'' in Sec. 101.60(b)(2). It is including similar language in
Sec. 101.13(b)(5).
The comments specifically objected to claims for calories, fat, and
cholesterol. Claims for sodium and sugar content were not mentioned.
Since the sugar and sodium levels in dietary supplements can vary
substantially, the agency finds that claims about the sugar and sodium
content of dietary supplements may be useful in helping consumers to
make purchasing decisions that will assist them in maintaining healthy
dietary practices. Thus, extending the definitions of ``low,''
``free,'' and ``reduced'' for sugar and sodium to dietary supplements
is appropriate irrespective of the calorie level of the dietary
supplement. Therefore, FDA concludes that there is no need to place
limitations on claims for sugar and sodium content other than those in
Secs. 101.60(c) and 101.61, respectively. As explained below, FDA is
amending these provisions to reflect their application to dietary
supplements.
3. Labeling Mechanics
a. Type size
5. In discussing type size for nutrient content claims, one comment
stated that every new statement that is required on dietary supplement
labels will create a problem for manufacturers, particularly if they
are constrained by minimum-type size requirements.
The agency acknowledges that dietary supplements are frequently
packaged in small containers, and for this reason, FDA specifically
asked for information on the impact of the type size proposal on
dietary supplements that are packaged in small containers (58 FR 33731
at 33734). No suggestions or examples were presented to assist the
agency in deciding how to address this problem. Therefore, the agency
has made no special provision for dietary supplements in the type size
requirements for nutrient content claims. FDA discusses the type size
requirements for the nutrition labeling of dietary supplements in the
final rule on nutrition labeling of dietary supplements published
elsewhere in this issue of the Federal Register.
FDA stated in the technical corrections document (58 FR 44020 at
44020 and 44021) that there was a need to specify the minimum type size
for labeling information (e.g., accompanying information) required
under the nutrient content claims regulation. As a result, the agency
modified Sec. 101.2(b) to include Secs. 101.13, 101.54, 101.56, 101.60,
101.61, 101.62, and 101.65 in the list of sections set out in
Sec. 101.2(b) for which a minimum type size for required label
information is specified. For consistency, the agency also modified
Sec. 101.2(f) to include Secs. 101.13, 101.54, 101.56, 101.60, 101.61,
101.62, and 101.65.The effect of these revisions for dietary
supplements is that label information required by the nutrient content
claims regulations, but whose type size is not otherwise specified,
will be required to be in letters or numbers no less than one-sixteenth
of an inch in height unless otherwise specified by Sec. 101.2(c). FDA
believes that making nutrient content claims on dietary supplements
subject to this requirement is appropriate because this requirement is
the logical outgrowth of the proposal. In the proposal on nutrient
content claims for dietary supplements, FDA raised the issue of how to
make nutrient content claims on dietary supplements. The question of
how to ensure the legibility of the referral statement, which is
required by section 403(r)(2)(B) of the act, is one that is at least
implicitly raised by this issue. Thus, the agency's decision to
explicitly address the question of the type size of the referral
statement in this final rule represents the logical outgrowth of issues
that were raised in the proposal.
The agency pointed out in the technical corrections document that
if there are circumstances in which the product is not able to comply
with type size requirements, manufacturers may request an alternative
means of compliance (e.g., permission to use a reduced type size) in
accordance with Sec. 101.9(g)(9). Section 101.9(g)(9) states that when
it is not technologically feasible, or some other circumstance makes it
impracticable, for firms to comply with nutrition labeling
requirements, they may write to the Office of Food Labeling, Food and
Drug Administration, and request an alternative means of compliance.
For the reasons explained above, dietary supplements of herbs and other
similar nutritional substances are appropriately subject to this
provision even though it was not specifically set out in the proposal
on nutrient content claims for dietary supplements. A similar provision
is included in Sec. 101.36(d)(2) of the final regulation for nutrition
labeling for dietary supplements of vitamins and minerals, in a
companion document in this issue of the Federal Register. These
provisions allow flexibility to ensure that there will be either
sufficient space to make nutrient content claims on the labels of
dietary supplements, or that manufacturers will have recourse to
request relief.
b. Disclosure levels
6. One comment stated that there are a certain number of products,
such as chewable tablets containing sodium ascorbate, for which
information on sodium might be useful to consumers in maintaining
healthy diets. The comment suggested that the agency urge supplement
manufacturers to include information on sodium content, even though the
sodium level might not reach the threshold levels established in
Sec. 101.13(h)(1) that would trigger a required statement.
The agency disagrees that there is a sufficient basis for requiring
either the declaration of total sodium content on the principal display
panel of a dietary supplement or for requiring a referral statement
directing the consumer to the nutrition label for information about
sodium content on all dietary supplements. Section 101.13(h)(1)
specifies that the referral statement (i.e., ``See [appropriate panel]
for information about [nutrient requiring disclosure] and other
nutrients'') is required only when the sodium (or fat, saturated fat,
or cholesterol) content of a product exceeds the disclosure level. FDA
finds that there is no reason to provide a different rule for dietary
supplements.
To the extent, as the comment suggests, that information on sodium
content would be useful, it will be provided on the nutrition label as
long as it is present at more than an insignificant level. Section
101.36(b)(3), which lists the nutrients that must be included in the
nutrition label of a dietary supplement of a vitamin or mineral,
provides that all nutrients listed in Sec. 101.9(c), including sodium,
must be declared on the nutrition label of a dietary supplement of
vitamins and minerals, except that nutrients present at levels that
would be declared as zero shall not be declared. (For sodium, the
amount that is declared as zero is less than 5 milligrams (mg) per
serving.) Section 101.9(c) itself requires that sodium be listed on the
nutrition label of other dietary supplements. Consumers thus will be
able to readily find the amount of sodium in a product by examining the
nutrition label. Because the comment provided no basis for its
suggestion other than usefulness, FDA is not making any special
provision for the declaration of sodium on dietary supplements.
4. Relative Claims, Reference Foods, ``Modified''
7. One comment requested that the agency clarify in Sec. 101.13(j)
that for dietary supplements, the reference food may be a source of the
nutrient in either a dissimilar food within a product category or a
similar food. The comment stated that the most helpful information to a
consumer purchasing a dietary supplement often may be a comparison of
the vitamin or mineral content to a recognized source of the nutrient,
e.g., ``contains more vitamin C than two 8 oz glasses of orange
juice.'' In addition, the comment maintained that the examples used in
the proposed rule on nutrient content claims for dietary supplements
(58 FR 33731 at 33737) for comparing dissimilar foods within the same
product category (e.g., potato chips as a reference for pretzels)
generally does not apply to dietary supplements.
The agency agrees that a clarification is warranted to reinforce
that Sec. 101.13(j) applies to dietary supplements as well as to foods
in conventional food form. Section 101.13(j)(1)(i)(A) states that for
``less'' (or ``fewer'') and ``more'' claims, the reference food may be
a dissimilar food within a product category that can generally be
substituted for one another in the diet (e.g., potato chips as
reference for pretzels) or a similar food (e.g., potato chips as
reference for potato chips).
The agency agrees that adding examples that are specific for
dietary supplements will clarify that for ``less'' (or ``fewer'') and
``more'' claims, the reference food may be a dissimilar food within a
product category for which the labeled food can generally be
substituted (e.g., orange juice as a reference for vitamin C tablet) or
a similar food (e.g., one brand of multivitamin as a reference for
another brand of multivitamin). Accordingly, the agency is revising
Sec. 101.13(j)(1)(i)(A) to include these examples.
Additionally, to clarify Sec. 101.13(j)(1)(i)(B) for ``light,''
``reduced,'' ``added,'' ``fortified,'' and ``enriched'' claims, the
agency is revising this regulation to include an example of a reference
food that is a similar food (e.g., one brand of multivitamin for
another brand of multivitamin).
8. One comment agreed that the term ``modified'' would rarely be a
useful term for vitamin/mineral supplements but stated that this term
might be useful for certain dietary supplements that contain ``other
similar nutritional substances.'' The comment stated that there are
techniques for concentrating certain fish oils that are high in omega-3
fatty acids. The comment suggested that the use of the term
``modified'' might serve to distinguish products containing the
concentrated fish oils from other fish oil products that would have to
be taken several times a day to provide the same amount of fish oil and
thus result in the consumption of significantly more calories. The
comment argued that use of the term ``modified'' on dietary supplements
should be authorized to maintain the principle of consistency between
foods in conventional food form and dietary supplements.
The agency agrees. FDA has defined ``modified'' for use as part of
the statement of identity on foods to reflect the fact that a change
has been made in a food (56 FR 60421 at 60454). The term is not to be
used alone, nor is the term to be used to describe products that have
not been altered (58 FR 2302 at 2367 and 2412). Based on the comment,
the agency concludes that this term may have some limited usefulness
for dietary supplements, and thus this term may be used on such
products when they meet the conditions of Sec. 101.13(k). FDA finds,
however, that no change in Sec. 101.13(k) is necessary to authorize
this use of the term.
5. Reference Amounts
9. One comment stated that if comparative claims (e.g., ``reduced
sodium'') were to be made for dietary supplements, there need to be
reference amounts (i.e., reference amounts customarily consumed)
established so that one product recommending consumption of, for
example, one tablespoon (tbsp) per day is not compared to a product
recommending five tbsp per day. The comment argued that the proposal
allows very flexible reference amounts for supplements (i.e., whatever
the manufacturer is recommending for consumption) and suggests that
reference amounts of reference foods (as established in Sec. 101.13(j))
be specified in more concrete terms.
The agency is not persuaded by the comment that more concrete terms
are needed for reference amounts at this time. The agency has
established in the final rule on general requirements for nutrition
labeling for dietary supplements published elsewhere in this issue of
the Federal Register a definition for the reference amount customarily
consumed for dietary supplements in Sec. 101.12(b) as ``the maximum
amount recommended on the label for consumption per eating occasion or,
in the absence of recommendations, 1 tablet, capsule, packet, or
teaspoonful, as appropriate.'' This definition is based on comments
received on the proposal for mandatory nutrition labeling for dietary
supplements.
Section 101.13(p)(1), which FDA proposed to apply to dietary
supplements, states that unless otherwise specified, the reference
amount customarily consumed set forth in Sec. 101.12(b) through (f)
shall be used in determining whether a product meets the criteria for a
nutrient content claim. The comment did not suggest an alternative to
the reference amount that could be used as the basis for comparative
claims for dietary supplements. Therefore, given the fact, as the
agency said in the proposal on nutrient content claims for dietary
supplements (58 FR 33731 at 33732), that a consistent approach to
nutrient content claims on dietary supplements and on foods in
conventional food form will increase consumers' ability to use and
understand such claims, FDA is not adopting a different approach to
comparative claims for dietary supplements than the one that it adopted
for foods in conventional food form.
The agency acknowledges that there is a potential for unfair
marketing and misleading claims if the serving size is manipulated
upwards or downwards to enable a product to make a nutrient content
claim. The agency retains the authority to regulate any such misleading
claims under section 403(a) of the act. Issues concerning serving size
are further discussed in the companion document on nutrition labeling
for dietary supplements, published elsewhere in this issue of the
Federal Register.
IV. Definitions for Specific Nutrient Content Claim Terms
A. Use of RDI's and DRV's in Formulating Definitions
10. Many comments stated that limiting nutrient content claims to
those nutrients with RDI's or DRV's was unnecessarily restrictive.
Several comments suggested that content claims should be authorized
with respect to a nutrient as long as it has either an RDI or DRV as
established by FDA in Sec. 101.9(c) or a Recommended Dietary Allowance
(RDA) as established by the National Academy of Sciences (NAS) (Ref.
4). Other comments also stated that nutrient content claims should be
authorized for nutrients for which NAS has established Estimated Safe
and Adequate Daily Dietary Intakes (ESADDI's). Other comments suggested
that FDA should expand the number of vitamins and minerals with RDI's
when it publishes the final RDI/DRV rule following the expiration of
the DS act moratorium.
FDA agrees that the current list of RDI's does not represent the
entire list of nutrients for which dietary recommendations have been
established. The agency had proposed to establish RDI's for all
nutrients for which RDA's or ESADDI's were provided in the 1989 edition
of the NAS RDA's (56 FR 60366). However, under the DS act, the agency
was constrained to retain the label reference values established in
Sec. 101.9(c)(8)(iv) until at least November 8, 1993. These values were
based on the 1968 RDA's. The 1968 RDA's did not contain recommended
dietary values for a number of nutrients for which NAS has subsequently
provided RDA's or ESADDI's. RDA's for vitamin K and selenium were
established subsequent to 1968 and are listed in the 1989 edition of
the NAS RDA's (Ref. 4). Furthermore, the 1980 and 1989 editions of the
NAS RDA's provided ESADDI's for chloride, manganese, fluoride,
chromium, and molybdenum. Now that the moratorium established by the DS
act has expired, the agency is proposing elsewhere in this issue of the
Federal Register to establish RDI's for all nutrients for which RDA's
or ESADDI's are provided in the 1980 and 1989 editions of the NAS's
Recommended Dietary Allowances but for which RDI's or DRV's have not
been established by FDA. Once RDI's are established for these
additional seven nutrients, nutrient content claims may be made for
them.
FDA intends to consider revising all of the RDI's to conform to the
most recent levels established by NAS. However, FDA is aware that NAS
is in the process of reevaluating the basis on which RDA's are
determined. It is considering the issue of whether values should be
selected to prevent deficiencies or to promote optimal wellness. The
agency believes that its action should await completion of the NAS
process. FDA is committed to working with NAS to help resolve this
issue.
Accordingly, as stated in response to comment number 1 above, FDA
has concluded that it is not possible to define nutrient content claims
for nutrients for which no reliable reference standards such as the
RDI's and DRV's have been established. The agency believes that
authorization for nutrient content claims for nutrients for which no
RDI or DRV exists (e.g., vitamin K) needs to be deferred until RDI's or
DRV's are adopted. In the interim, quantitative nutrient information
may be listed in the nutrition label as discussed in the final rule on
general requirements for nutrition labeling for dietary supplements
published elsewhere in this issue of the Federal Register.
Also, manufacturers may provide amount or percentage statements as
described in Sec. 101.13(i)(3) for those nutrients that do not have
RDI's or DRV's. For example, while there is no RDI for fluoride, under
this provision, manufacturers may declare the amount of the nutrient
present (e.g., 2 mg fluoride) on any panel outside of the Nutrition
Facts box.
11. One comment stated that claims should be permitted for beta-
carotene.The agency believes that claims regarding beta-carotene (e.g.,
``contains beta-carotene'') are claims about an ingredient that make
implied representations about the level of vitamin A that is present in
the food as beta-carotene. This conclusion is consistent with section
403(r)(1)(A) of the act, which states that a food can be misbranded by
a statement that expressly or by implication characterizes the level of
a nutrient in a food. The agency considers that the claim ``contains
beta-carotene'' implies that there is enough beta-carotene in the food
to constitute a ``good source'' of vitamin A (i.e., it contains 10
percent or more of the DV for vitamin A from beta-carotene). Such a
claim is provided for in Sec. 101.65(c).
12. One comment advocated defining nutrient content claims for
ultratrace nutrients including boron, silicon, vanadium, arsenic, and
tin. The comment stated that claims about these ultratrace elements
should be permitted on the basis of the RDA, ESADDI, or the amounts
found in the average well-balanced diet. Additionally, this comment
argued that reference values should be available for ultratrace
nutrients once reputable scientific evidence is established that such
nutrients serve important metabolic or physiological functions in the
body. The comment also suggested that label information be permitted
for choline and inositol.
The agency disagrees. The trace elements arsenic, nickel, silicon,
boron, cadmium, lead, lithium, tin, vanadium, and cobalt, as well as
choline and inositol, have not been shown to be essential in humans. No
RDA's or ESADDI's for these substances have been established by NAS.
NAS states that several of these substances ``naturally present in
foods are known to be required in the diets of various animal or
microbial species, but there is little or no evidence of their dietary
essentiality for humans'' (Ref. 4). While NAS acknowledges that some of
these classes of substances may ``one day be candidates for RDA's,'' it
states that there is currently no evidence that these substances are
essential in humans (Ref. 4).
As stated in the ``Summary'' section of the 10th edition of the NAS
RDA publication (Ref. 4), the NAS RDA's are based not only on data from
nutrient intake measurements but also on information from nutrient
balance studies, experimental intake studies, biochemical measurements,
epidemiological observations of nutrient status, and extrapolation of
data from animal experiments. FDA does not agree with the comments that
it is desirable to base label reference values for nutrient content
claims solely on individual scientific research publications, no matter
how current, or solely on data on amounts of the trace element found in
well-balanced diets. The existence of such data does not mean that
there is scientific agreement on the essentiality of the nutrient or on
the recommended level in the diet. Should agreement on the essentiality
of additional nutrients be reached, timely and appropriate changes to
the label reference values can be made through FDA's rulemaking
procedures.
However, as stated above, manufacturers are free to declare the
amount of the trace elements, or choline or inositol, on the product
label outside of the ``Nutrition Facts'' panel in accordance with
Sec. 101.13(i)(3). Such a statement of amount is not considered to
characterize the level of the nutrient in the food, as would claims
such as ``high'' or ``more.''
13. One comment stated that although no RDI's have been established
for certain vitamins and minerals, nutrient content claims could be
based on reference foods that are recognized sources of those
nutrients. For example, the label could state that ``Brand X provides
more vitamin K than two servings of cabbage,'' based on the vitamin K
content of the reference amount for vegetables without sauce listed in
Sec. 101.12, Table 2.
The agency disagrees. Until a reference standard is established
there is no basis for confidence that cabbage is a good source of
vitamin K. There is also no basis for confidence that the amount of
vitamin K in the food that is to be the subject of the claim is
nutritionally significant. Elsewhere in this issue of the Federal
Register, the agency has proposed to expand the list of nutrients with
RDI's, including vitamin K. At this time, however, FDA concludes that
it would be premature to authorize such claims.
B. Specific Requirements for Nutrient Content Claims (21 CFR 101,
Subpart D)--Applicability to Dietary Supplements
1. Sec. 101.54 Nutrient Content Claims for ``Good Source,'' ``high,''
and ``More''
a. ``Good source'' and ``high''
14. One comment encouraged the agency to maintain the proposed
definitions for ``good source'' and ``high'' for dietary supplements.
The comment argued that a higher level (e.g., 40 percent of the RDI)
would suggest to consumers that daily nutrient intakes could be
achieved by consuming only a few foods, which is inconsistent with
dietary guidelines. The comment maintained that if a new higher claim
level was adopted for supplements, it would likely also apply to foods
in conventional food form based on the logic of the proposal for
nutrient content claims for dietary supplements (i.e., consistency in
definitions). The comment stated that users of dietary supplements are
well aware of the elevated nutrient levels in these products, and that
a new paradigm is not needed to inform consumers of these levels.
On the other hand, several comments did not support the proposal to
use the same definitions for ``good source'' and ``high'' claims as
those used for foods in conventional food form. The comments argued
that the terms ``good source'' and ``high'' should not carry the same
meaning for supplements as for foods in conventional food form, that
most supplements contain at least 100 percent of the Daily Value for
most of the nutrients they provide, and that consumers expect most of
these products to contain at least 100 percent of the Daily Value. The
comments maintained that allowing any product with as little as 10 or
20 percent of the RDI to carry ``good source'' and ``high'' claims
would confuse and mislead consumers.
One comment questioned whether it is appropriate to permit the use
of these nutrient content claims on vitamins and mineral supplements
since it implies that supplements are comparable to, and acceptable
substitutes for, foods in conventional food form. The comment also
noted that nutrition educators feel strongly that supplements can
enhance the nutrient intake from foods in conventional food form but
can never replace them since foods in conventional food form provides
other important components. On the other hand, many comments supported
the proposal to extend the same definitions for ``good source'' and
``high'' for foods in conventional food form to dietary supplements.
These comments emphasized the importance of consistency in definitions
to assist consumer education.
One comment requested clarification on whether the terms ``good
source'' and ``contains'' will be permitted for dietary supplements.
The comment maintained that such claims provide consumers with
important information regarding the precise content of various
nutrients and should not be subject to discriminatory treatment solely
on the basis of whether such claims are made for a nutrient in a
dietary supplement as opposed to one in a conventional food.
The agency has reviewed these comments and is not persuaded that
the definition of the terms ``good source'' and ``high'' should be
different for dietary supplements than for foods in conventional food
form. The agency finds that the definitions for foods in conventional
food form and dietary supplements should be consistent. As directed by
the 1990 amendments (section 3(b)(1)(A)(iii)(VI)), FDA defined the term
``high,'' and the synonyms ``rich in'' and ``excellent source of,'' for
use on labels and in labeling in Sec. 101.54 (58 FR 2302 at 2344). In
Sec. 101.54(c)(1) of final rule on nutrient content claims, the agency
stated that the term ``good source'' may be used to describe a food
when a serving of the food contains 10 to 19 percent of the RDI or the
DRV for a nutrient. Likewise, the agency stated that the term ``high''
may be used to describe a food when a serving contains 20 percent or
more of the RDI or the DRV. FDA concluded that the use of these terms
would permit a sufficient number of food items to bear ``good source''
and ``high'' claims to allow consumers to use the claims in selecting
foods that are better sources of nutrients (58 FR 2344).
While FDA recognizes that under the present definitions, most, if
not all, dietary supplements of vitamins, minerals, potassium, and
fiber would qualify for ``good source'' or ``high'' claims, the agency
does not agree with those comments that argued that the definitions, as
proposed, would be confusing or misleading to consumers. As suggested
by the IOM report on nutrition labeling (Ref. 6), the use of consistent
and targeted content claims increases consumers' confidence in the
validity of the claim. FDA is aware of no evidence to support an
alternate conclusion. The basic principle of consistency in definitions
of nutrient content claims is discussed in detail in comment 2 of this
document.
Furthermore, the agency recognizes that consumers expect dietary
supplements to be concentrated sources of nutrients. Consumer studies
support this conclusion (Refs. 1 and 5). FDA acknowledges that the
terms ``good source'' and ``high'' might be of limited utility in
comparing nutrient content among dietary supplements of vitamins and
minerals because virtually the entire class of products would qualify
for such claims. However, these terms may be useful for some single
source dietary supplements of calcium, biotin, or fiber or for
multinutrient preparations containing these nutrients. These nutrients
are generally found in dietary supplements at levels below the Daily
Value.
Additionally, FDA believes that these terms would be useful in
highlighting the nutrient content of some herbs and other similar
nutritional substances that have nutrients at levels high enough to
qualify for the definition of one of the above terms. For these
reasons, the agency is not persuaded to preclude the use of these terms
for dietary supplements.
The agency agrees with the comment that stated that dietary
supplements cannot replace foods in conventional food form in all
respects because the latter foods supply other important components.
However, FDA recognizes that dietary supplements can be a useful part
of the diet for those who wish to make sure that they consume at least
the RDI amount for all vitamins and minerals or for those who wish to
increase their daily intake of a particular substance above those
levels that are ordinarily available from conventional foods. Thus, FDA
finds that use of these terms on dietary supplements is appropriate.
FDA is convinced that consistency in definitions of nutrient
content claims across the food supply is necessary. Consistency
facilitates consumer education by limiting the number of terms that the
public must learn and interpret. Moreover, different definitions for
the same terms for dietary supplements and foods in conventional food
form would be confusing to consumers because of the difficulties
inherent in learning alternate definitions for the same term. There is
a greater chance of error and misinterpretation when several
definitions must be learned for the same term. Thus, different
definitions would likely do more harm than good. Accordingly, the
agency concludes that the proposed definitions for ``good source'' and
``high'' are appropriate, and that there is no reason to define the
terms differently for dietary supplements.
The agency would like to clarify that ``good source'' and
``contains'' as defined Sec. 101.54(c)(1) are nutrient content claims
that can be used for foods in conventional food form as well as for
dietary supplements. There is nothing in this final rule that states
that the use of these terms would not be allowed for dietary
supplements.
15. One comment stated that under FDA's proposal, consumers who
want truly high levels--that is, levels that exceed the RDI--would have
no means of identifying those products, other than reading the fine
print on the back of each supplement label.
The comment acknowledged that consumers might also be confused if
``high'' had one meaning when the claim appears on labels of dietary
supplements and a different meaning when the claim appears on labels of
foods in conventional food form. To avoid that inconsistency, the
comment urged FDA to prohibit the claims ``good source'' and ``high''
on supplements. Further, the comment suggested that the agency should
define the term ``high potency'' and allow it to be used only on
supplements.
FDA disagrees that the terms ``good source'' and ``high'' should be
prohibited on the labels of dietary supplements. The agency recognizes
that a claim of ``high'' will not specifically identify those products
that have levels of nutrients that exceed the RDI. However, the
quantitative amount of a nutrient in a dietary supplement is often a
part of the statement of identity for the product, and additional
quantitative information regarding the level of a nutrient may also be
found in amount or percentage statements on the principal display
panel. In addition, as a result of the agency's new format
requirements, the nutrition label for dietary supplements of vitamins
and minerals provides quantitative information on the levels of
specific nutrients as well as the percent DV for each nutrient in a
more legible format. Consequently, consumers will have easy access to
information regarding the levels of specific nutrients and may adjust
their levels of intake accordingly.
Further, as discussed in the previous comment, while the terms
``good source'' and ``high'' may be of limited utility for dietary
supplements of vitamins and minerals, these terms may be useful in
highlighting the nutritional content of single nutrients, such as
biotin and calcium, that are generally found in products at levels well
below the RDI, as well as of dietary supplements of herbs and other
similar nutritional products. Therefore, FDA concludes that precluding
the use of these terms on dietary supplements is unjustified.
However, FDA believes that there is a sufficient basis to consider
defining the term ``high potency'' or some similar term as a nutrient
content claim. FDA's tentative view is that this term, or a similar
term when defined, could provide a way for manufacturers to describe
the higher levels of nutrients in dietary supplements. (See comment 25
for further discussion of this matter.)
b. ``More''
16. One comment stated that consumers could be misled if
comparative claims are made among high potency vitamin/mineral
supplements. The comment stated that if, for example, one brand of 300-
mg vitamin B6 tablets claimed that it contained ``more'' than a
competitive 250-mg product, then the consumer may get the misleading
impression that the former product is better. The comment maintained
that as customers shop for supplements, they will be able to readily
observe whether one product is more potent than another without label
claims suggesting superiority of one over another. If such a claim
resulted in better sales, then a ``horsepower race'' would ensue. The
comment recommended that ``more'' claims for vitamins and minerals not
be allowed if the nutrient potency of the reference product already
meets or exceeds 100 percent of the Daily Value.
The agency acknowledges that there is the possibility that some
manufacturers may choose to increase potencies in order to make a
``more'' claim in comparison to another brand, but the agency disagrees
that the limitation suggested by the comment is warranted at this time.
The agency points out that ``more'' claims for nutrients with an RDI or
DRV, including those products with nutrients in megadoses, such as
those in the example cited by the comment, must include the following
information: The percentage (or fraction) that the nutrient was
increased relative to the RDI or DRV, the identity of the reference
food, and the quantitative amount of the nutrient present (e.g.,
contains ``20 percent more of the DV for vitamin B6 per tablet than
product `x'. The vitamin B6 content of product `x' is 250 mg. This
product contains 300 mg vitamin B6.'') The nutrition label of a product
containing 300 mg of vitamin B6 must state that the product contains
1,500 percent of the Daily Value. The agency acknowledges that the
amount of information required to make a ``more'' claim is
considerable, but such information is necessary to allow consumers to
readily see how the amount of a nutrient for which a ``more'' claim is
made fits into the total daily diet.
Furthermore, FDA believes that the concern regarding ``horsepower
races'' in dietary supplements stems from concerns of possible unfair
marketing among manufacturers as well as from safety concerns inherent
in the addition of very high levels of nutrients to supplements.
Similar concerns with foods in conventional food form led to the
establishment of FDA's fortification policy in 1980. This policy, while
published in Sec. 104.20, does not have the force of a regulation.
However, the agency has not found evidence of widespread ``horsepower
races'' with such foods. The agency urges industry, particularly
industry associations, to develop standards regarding nutrient levels
and to monitor compliance with those standards to minimize any safety
problems.
c. Restrictions on label or labeling claims based on section
411(b)(2)(B) of the act
17. One comment from a trade association stated that the literal
reading of section 411(b)(2)(B) of the act prohibits giving prominence
on the label of dietary supplements of vitamins or minerals to
ingredients that are not vitamins or minerals. The comment argued that
these prohibitions result in the withholding of information that is of
interest to consumers, and that it is increasingly common for
manufacturers to market products that offer a combination of vitamins,
minerals, herbs, and other dietary substances. The comment stated that
the principal reason for the purchase of these products is not their
vitamin and mineral content but the other ingredients. The comment
invited FDA to join the supplement industry in seeking an amendment to
section 411 of the act that will remedy this problem.
Another comment disagreed with FDA's interpretation of section
411(b)(2)(B) of the act and suggested that this section merely
prohibits giving prominence or emphasis to such ingredients. The
comment argued that nutrients other than vitamins and minerals or
sources of vitamins and minerals should be permitted to appear outside
or immediately following the nutrition label, providing that such
information is not emphasized by, for example, being presented in type
size greater than that used in the nutrition label. The comment stated
that such limited declarations would not conflict with current
provisions of the act and would be fair and reasonable means of
communicating about the presence of ingredients that provide added
value to many dietary supplement products.
The agency is persuaded by these comments that a clarification of
those sections of the proposal relating to section 411(b)(2)(B) of the
act is needed. Section 411(b)(2)(B) of the act states that the labeling
and advertising for dietary supplements of vitamins and minerals may
not give prominence to or emphasize ingredients that are not vitamins,
minerals, or represented as a source of vitamins or minerals. Because
of this provision, nutrient content claims about ingredients that are
not vitamins or minerals (e.g., ``more fiber,'' ``high protein'') may
not be made on dietary supplements of vitamins or minerals.
It must be emphasized that this provision pertains only to dietary
supplements of vitamins and minerals. If, for example, an herbal
extract includes vitamins and minerals but is labeled as an herbal
extract, in compliance with Sec. 101.9 and other applicable provisions,
and is advertised as such, section 411(b)(2)(B) of the act would not
apply. The same is true for a product that is primarily a protein
supplement. A protein supplement with added vitamins and minerals that
is labeled and advertised as a protein supplement could declare that it
is high in fiber. Such claims are permissible as long as they are made
in accordance with section 403(r) of the act, and they are not false or
misleading in any particular.
However, section 411(b)(2)(B) of the act makes clear that in the
labeling and advertising of dietary supplements of vitamins and
minerals, ingredients other than vitamins or minerals cannot be
emphasized or given prominence. FDA interprets prominence not solely as
a function of type size. Declaring an ingredient outside or immediately
following the nutrition label is another means of giving prominence.
For example, a statement such as ``5 g psyllium,'' except in extremely
limited circumstances, cannot be made on the principal display panel,
outside the nutrition label, or immediately following the nutrition
label of a dietary supplement of vitamins and minerals because such
placements give prominence to that ingredient. However, the declaration
of psyllium in the ingredient list would not be construed as giving
prominence to that ingredient. On the other hand, ``5 g psyllium''
could be declared in an amount statement on the principal display
panel, outside, or immediately following the nutrition label on protein
supplements, on dietary supplements of herbal extracts, and on dietary
supplements of other similar nutritional substances so long as these
dietary supplements are not subject to section 411 of the act.
FDA advises that if a sugar is an ingredient in a dietary
supplement of vitamins or minerals, claims about the amount of sugar
actually in the product would have to be restricted. However, ``sugar-
free'' and ``no added sugar'' are absence claims that assert that sugar
is not an ingredient. The agency concludes that the use of these terms
is acceptable on dietary supplements of vitamins or minerals, as well
as on other types of dietary supplements.
In view of this clarification, the agency believes that section
411(b)(2)(B) of the act, as written, is sufficiently flexible to
accommodate claims on products that are not dietary supplements of
vitamins or minerals. FDA believes that it is therefore unnecessary to
amend section 411 of the act.
2. Nutrient Content Claims for Sugar Content
18. One comment questioned the appropriateness of allowing ``sugar-
free'' claims for a dietary supplement containing less than 0.5 g of
sugars. The comment stated that many supplements come in capsules or
tablets that weigh slightly less or not much more than 0.5 g, and
therefore, supplements that are mostly sugars could use the term
``sugar-free.'' The comment suggested that the term ``sugar free'' on a
dietary supplement should mean a much lower amount of sugars, or that
the product should be totally devoid of sugars.
The comment also argued that terms such as ``negligible source of
sugar,'' ``dietarily insignificant source of sugar,'' and ``trivial
source of sugar'' are not synonymous with ``sugar-free'' because such
terms connote the presence of some sugar content.
FDA is not persuaded by the comment that 0.5 g or less of sugars
per serving is an inappropriate definition of insignificance for sugars
for dietary supplements. Section 101.60(c)(1) provides that for a food
in conventional food form to make a ``sugar free'' claim, the food must
contain less than 0.5 g of sugars per reference amount. Less than 0.5 g
of sugars per reference amount is an amount that is consistent with the
agency's policy of defining ``free'' claims at or near the reliable
limit of detection and in an amount that is dietetically
inconsequential (56 FR 60421 at 60432). As a result, even frequent
consumption of a food bearing a ``sugar free'' claim would not result
in an intake of sugars that would affect the overall diet in any
meaningful way.
FDA acknowledges that there may be situations in which a dietary
supplement may contain a significant proportion of sugars on a weight
basis and be able to make the claim ``sugar free.'' The agency
believes, however, that even in such instances, if the total amount of
sugars in a serving of the product is less than 0.5 g, its net
contribution to the total daily diet would be inconsequential.
Additionally, FDA considers it important that nutrient content
claims correspond with the nutrition label, which serves as a source of
specific information for consumers concerning the nutritional value of
the food. The nutrition labeling regulations allow foods containing
less than 0.5 g sugars per labeled serving to declare 0 g of sugars
(Secs. 101.9(c)(6)(ii) and 101.36(b)(3)).
FDA rejects the suggestion that it permit use of the term ``sugar
free'' only where there is an absolute absence of sugars. FDA believes
that it is appropriate to apply the term ``free'' to a nutrient when a
food contains that nutrient in a dietetically trivial or
physiologically inconsequential amount, even though the nutrient is
present at a level at or near its reliable limit of quantitation,
because with modern analytical methods, the level at which the presence
of a nutrient may be quantified is becoming increasingly smaller (58 FR
2302 at 2320). The agency believes that it is appropriate to focus on
dietary insignificance, and very trivial amounts have no impact on the
diet for the purpose of defining ``sugar free.''
The agency also disagrees that the terms ``negligible source of
sugar,'' ``dietarily insignificant source of sugar'', and ``trivial
source of sugar'' are inappropriate synonyms for ``sugar free.''
Section 403(r)(2)(A)(i) of the act states that a nutrient content claim
must be defined by regulation. In addition, section (3)(b)(1)(A)(ix) of
the 1990 amendments provides that those regulations may include similar
terms commonly understood to have the same meaning. The agency is not
aware of any reason why the above terms are inappropriate synonyms for
``sugar free.'' Although these synonyms do not convey the absolute
absence of sugar, they reflect that the amounts are dietetically
trivial and of no dietary significance. Therefore, the agency rejects
this comment.
19. One comment stated that the term ``no added sugar'' can be used
only when a product is expected to contain sugar, but that consumers do
not know when supplements are expected to contain sugars. The comments
suggested that FDA should not preclude the use of the term ``no added
sugars'' as this term would be useful to consumers in identifying those
products without sugar.
The agency is persuaded that a review of the conditions for the use
of the term ``no added sugar'' is warranted. FDA did not propose to
preclude the use of the term ``no added sugar'' on all dietary
supplements. The agency finds that this term is appropriate for some
dietary supplements, such as children's chewable vitamins, that are
frequently sweetened. Section 101.60(c)(2) states that the terms ``no
added sugar,'' ``without added sugar,'' or ``no sugar added'' may be
used only if: (1) No amount of sugars, as defined in
Sec. 101.9(c)(6)(ii), or any ingredient that contains sugars, or that
functionally substitutes for added sugars is added during processing or
packaging, (2) the product does not contain an ingredient containing
added sugars, (3) the sugars content has not been increased above the
amount present in the ingredients by some means such as the use of
enzymes, (4) the food that it resembles and for which it substitutes
normally is formulated with sugars, and (5) the product bears a
statement that the food is not ``low calorie'' or ``calorie reduced''
(unless the food meets the requirements for a ``low'' or ``reduced
calorie'' food) and that directs consumers' attention to the nutrition
label for further information on sugar and calorie content.
As is the case for foods in conventional food form, the agency
believes that to avoid misleading consumers, the term ``no added
sugar'' should be limited to dietary supplements that would be expected
to contain added sugars. The agency advises that the purpose of a ``no
added sugar'' claim is to identify a food that differs from a similar
food because it does not contain the added sugars that would normally
be present in the similar food. For this provision to be of practical
benefit to consumers, it must preclude the use of the claim on a food
where the sugars that are normally added are replaced with an
ingredient that contains sugars that functionally substitute for the
added sugars. Thus, the agency concludes that the use of any ingredient
that contains sugars that would normally be added to a food precludes
the use of the ``no added sugar'' nutrient content claim. The agency
believes that claims concerning the absence of added sugars on products
that would not normally contain added sugar (e.g., dietary supplements
of vitamins and minerals for adults) are likely to mislead consumers
into thinking that a particular brand may be more desirable when
compared to other brands of the same product.
FDA acknowledges that consumers may not know every type of product
that could be expected to contain sugar. However, the final rule on
nutrition labeling for dietary supplements published elsewhere in this
issue of the Federal Register specifies that sugars will be listed in
the ingredient label and must be declared in the nutrition label if
present in more than insignificant amounts. Through these provisions
the consumer can readily ascertain which products contain sugars.
C. Implied Nutrient Content Claims
1. Claims That are not Nutrient Content Claims
Section 101.65(b)(1) of the final rule on nutrient content claims
provides that statements that declare the absence of food components or
ingredients that are not nutrients of the type required to be declared
on the nutrition label, and that are intended to facilitate avoidance
for such reasons as food intolerance (e.g., lactose free), religious
beliefs, dietary practices such as vegetarianism or other nonnutrition
related reason, (e.g., ``100 percent milk free''), are not nutrient
content claims. In the proposal on nutrient content claims for dietary
supplements, the agency tentatively concluded that this paragraph is
applicable to dietary supplements and requested comment on other
examples that are appropriate for dietary supplements.
20. Comments suggested that other examples of terms in this
category include the following: gluten free, wheat free, corn free,
yeast free, starch free, milk free, egg free, soy free, no artificial
ingredients, nonirradiated, and no synthetic ingredients. The comments
requested that FDA confirm that these statements are allowed on the
label.
None of the terms that were submitted in the comments other than
``egg free'' would constitute nutrient content claims. The term ``egg
free'' can be interpreted as an implied claim about cholesterol.
The agency points out that it does not currently have a definition
for ``artificial'' except as that term applies to flavors and colors.
Similarly, it has no definition for ``synthetic'' except as that term
applies to flavors and colors. Although these terms have not been
defined by FDA, the agency believes that they are not nutrient content
claims unless they are used in a context in which they explicitly or
implicitly describe the level of a nutrient. However, even if these
terms are not nutrient content claims, manufacturers who use them must
make sure that their use is not false or misleading.
21. FDA proposed to include dietary supplements in the coverage of
Sec. 101.65(b)(4). This section states that when an ingredient
constitutes essentially 100 percent of a food, so that the name of the
ingredient is the statement of identity, the name of the ingredient
generally does not constitute an implied nutrient content claim unless
it is used in a context to suggest that a nutrient is absent or present
in a certain amount. FDA used a statement of identity for a dietary
supplement in which an ingredient constitutes essentially 100 percent
of a supplement (e.g. ``60 mg--vitamin C'') as an example. One comment
pointed out that 60 mg vitamin C tablets contain excipients (fillers,
binders, lubricants, disintegrants) other than vitamin C. The comment
requested clarification as to whether, in the example of vitamin C
tablets, Sec. 101.65(b)(4) requires that the amount claimed in the
statement of identity constitute 100 percent of the claimed amount of a
food in Sec. 101.65(b)(4).
In the example added to Sec. 101.65(b)(4), the amount refers to the
claimed nutrient. A tablet stating ``60 mg--vitamin C tablets'' should
contain 60 mg of that nutrient. The agency recognizes that a nutrient
will not constitute precisely 100 percent of some dietary supplements,
such as vitamin tablets or capsules, and advises that small amounts of
excipients, binders, lubricants, or disintegrants added for
technological purposes are allowable in addition to the stated nutrient
content.
Additionally, FDA points out that under Sec. 101.3(c), if a food is
marketed in various optional forms, the particular form is a necessary
part of the statement of identity. Because vitamin C is marketed in
tablet, capsule, and liquid form, the form is part of the name.
Therefore, this food should be called ``60 mg-vitamin C tablets.'' The
agency acknowledges an error in this regard in the proposal and is
revising Sec. 101.65(b)(4) to make the correction.
22. One comment stated that it is not unusual for a dietary
supplement to contain several nutrients of one type and a single
nutrient of another type, such as ``multiple-vitamins with iron.'' The
comment requested confirmation that ``with iron'' would not represent
an implied nutrient content claim.
The agency advises that a term such as ``with iron,'' when used on
the statement of identity of a supplement, is intended to describe the
nature of the food. When a statement of identity simply states ``with
iron'' or specifies the amount of iron in a product (e.g.,
``multivitamin with 15 mg iron''), the statement is not a nutrient
content claim. Such statements fall under Sec. 101.65(b)(5).
However, as the agency stated in Sec. 101.65(b)(5), there may be
cases in which other statements on the label or labeling would have the
effect of making the statement into a nutrient content claim. For
example, if the labeling of a multivitamin with iron includes a
discussion of the importance of iron in the diet, FDA believes the
statement ``with iron'' would be an implied claim that the multivitamin
is a good source of iron. If the labeling is devoid of such
information, FDA would be unlikely to consider the name to be an
implied nutrient content claim. The agency will evaluate such claims on
a case-by-case basis in the context of the entire label and labeling to
determine whether they are nutrient content claims.
23. One comment maintained that FDA failed to address whether the
currently used claim of ``high in antioxidants'' was within the scope
of the proposed regulation.
While the term ``high in antioxidants'' was not explicitly
discussed in the proposed regulations for nutrient content claims for
dietary supplements, the agency considers it to be an implied nutrient
content claim that would come under Sec. 101.65. FDA's view is that
this claim implies that the food on which it appears contains a
``high'' amount (i.e., at least 20 percent of the RDI, see
Sec. 101.54(b)(1)) of each antioxidant. One problem with this claim,
however, is that there is no established definition of
``antioxidants.''
FDA believes that a logical place to start in defining this term is
section 3(b)(1)(A)(x) of the 1990 amendments. That provision directed
FDA to determine whether a health claim on antioxidant vitamins and
cancer, could be authorized under the standard that it established for
dietary supplements under section 403(r)(5)(D) of the act. In its
proposed regulations to implement the 1990 amendments, in response to
this provision, FDA considered the effects of vitamin C, vitamin E, and
beta-carotene on cancer because these nutrients are the vitamins or
provitamins that function as antioxidants (56 FR 60624, November 27,
1991). In the final rule on antioxidant vitamins and cancer, FDA
concluded that its selection of these nutrients was appropriate (58 FR
2622, January 6, 1993). Thus, the agency has determined that the
direct-acting antioxidant vitamins or provitamins include vitamin C,
vitamin E, and beta-carotene. Based on its review of the information
presented at a recent conference entitled ``Antioxidant Vitamins and
Cancer and Cardiovascular Disease,'' which was initiated by FDA, the
agency is not aware of any basis to expand this list because the
biological role of other vitamins as direct antioxidants has not been
confirmed (Ref. 3).
While it is arguable that FDA could authorize ``high in
antioxidants'' as an implied claim pertaining to antioxidant vitamins
as a logical outgrowth of the proposal, because the claim applies to
foods in conventional food form as well as to dietary supplements, the
agency believes that the better course is to propose to authorize such
a claim. In addition, the definition of ``antioxidants'' is not free
from controversy. The agency is aware, based on its review of dietary
supplements whose labeling currently includes a ``high in antioxidant''
claim, that some manufacturers view this term as including certain
minerals. Antioxidant minerals have not been addressed by the agency,
and, therefore, final rules implementing the 1990 amendments do not
provide for claims about them. Thus, FDA finds that a rulemaking on the
definition of ``antioxidants'' will provide an opportunity to establish
the precise meaning of this term.
Consequently, FDA intends to address this issue as quickly as
possible in a forthcoming proposal. Given that, elsewhere in this issue
of the Federal Register, the agency is establishing a date of
applicability of July 5, 1995, for this regulation, FDA anticipates
that there is sufficient time to take final action on such a proposal
before that date.
2. ``Healthier''
24. One comment from a manufacturer observed that FDA proposed a
regulation concerning use of the term ``healthy'' (proposed
Sec. 101.65(d)(2) (58 FR 2949)) in the January 6, 1993 Federal Register
(58 FR 2944 at 2949). The comment notes that ``healthy'' and similar
terms are used in a variety of contexts. For example, one of the
manufacturer's dietary supplements is labeled as ``the way to
a healthier life.'' The comment suggested that this claim should not be
deemed to be subject to the ``healthy'' definition.
FDA advises that it is in the process of finalizing regulations on
the January 6, 1993, proposal for the claim ``healthy.'' The use of
terms such as ``healthy,'' ``healthier,'' ``healthiest'' will be
addressed in that final rule.
In its final rule on nutrient content claims, FDA concluded that a
claim that a food, because of its nutrient content, may be useful in
maintaining healthy dietary practices is a claim that characterizes the
level of a nutrient in that food (58 FR 2302 at 2375). Accordingly, the
agency provided in Sec. 101.65(d)(1) that such statements are implied
nutrient content claims and are subject to the requirements of section
403(r) of the act.
However, the agency also stated that when a term such as
``healthy,'' ``wholesome,'' or ``nutritious'' appears on a food label
in a context that does not render it an implied nutrient content claim,
it is not subject to the requirements of section 403(r) of the act (58
FR 2302 at 2375). Under such conditions, the use of the term is subject
to section 403(a) of the act, and FDA will consider whether it is
misleading on a case-by-case basis. The agency intends to give more
specific guidance in the final rule on ``healthy.''
1. General Nutrition Claims Such as ``High Potency,'' ``High
Absorption,'' and ``Balanced''
a. General issues
In the proposal on nutrient content claims for dietary supplements,
FDA requested comment on terms, ``high potency,'' ``high absorption,''
and ``balanced,'' which are often encountered on labels or in labeling
of dietary supplements and which 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. FDA stated that if comments demonstrate that
there are accepted definitions used in the dietary supplement industry
for these terms that characterize the level of nutrients, and that if
it determines that these definitions will assist consumers in
maintaining healthy dietary practices, FDA will proceed with further
rulemaking to adopt the definitions or to propose new ones.
FDA also stated that if the agency agrees that such terms are
nutrient content claims, under the provisions of the statute, such
claims would be prohibited after the effective date for final rules,
until such time as they are defined by FDA by regulation. Further, FDA
stated that if comments demonstrate that there are accepted definitions
for these terms, and they do not characterize the level of nutrients,
in accordance with Sec. 101.65(d)(1) such terms would not be subject to
section 403(r) of the act unless used in a nutritional context in
association with an explicit or implicit claim or statement
characterizing the nutrient content of the food.
25. Several comments maintained that the terms ``high potency,''
``high absorption,'' and ``balanced'' are implied nutrient content
claims and urged the agency to define or prohibit these terms. The
comments stated that it is inappropriate and fraught with possibilities
for deception to allow each manufacturer to define such claims. One
comment stated that although these terms imply features of nutrient
content to consumers, they do not have any established or useful
meaning with regard to dietary supplements. The comment argued that
these terms seem to be more specific to dietary supplements than to
other food, so that their applicability in helping consumers make
appropriate nutritional choices from the variety of foods available
seems limited.
On the other hand, several comments stated that these terms do not
inherently refer to the level of nutrients, are not nutrient content
claims, and therefore should not be defined. These comments maintained
that such terms are formulation descriptions, which properly and
truthfully describe the nature and type of the product. These comments
contended that these terms have been used for many years, and that
consumers have come to understand that products so described provide an
amount of the primary nutrients in the formulation that is at least
equal to the RDA's for those nutrients.
One comment argued that FDA precedent exists for excluding such
terms from regulation as nutrient content claims. The comment stated
that as formulation descriptions, these terms are useful to consumers
in helping them to make product choices, and manufacturers should be
allowed to continue to use these terms in a manner that is consistent
with FDA's policy on claims such as ``maximum strength'' for internal
analgesics in the over-the-counter drug review (i.e., kept outside the
scope of this rulemaking).
The agency agrees that these terms seem to have more direct
application to dietary supplements than to foods in conventional food
form. Furthermore, these terms may have some utility in helping
consumers select among dietary supplements. However, while these terms
have apparently been used for years to imply superiority, the agency is
uncertain what they mean to consumers.
The agency disagrees that these terms should be regulated in the
same manner as terms such as ``maximum strength,'' which are used on
the labels of over-the-counter drug products. The over-the-counter drug
regulations include maximum amount limitations. Section 411(a)(1)(A) of
the act prohibits limits on the potency of dietary supplements of
vitamins or minerals except on the basis of safety. Therefore, the
situations are not analogous.
The agency believes that each of these terms should be evaluated
individually because they do not seem to be synonymous. ``High
potency'' seems to focus on nutrient level or content, but
``balanced,'' as one comment suggested, seems to be a formulation
claim. ``High absorption'' seems to focus on how the body responds to
the nutrient. The agency will address each of these terms in more
detail in the comments that follow.
b. Definition for ``high potency''
26. The majority of comments stated that the term ``high potency''
or ``full potency'' is an implied nutrient content claim and should be
defined. Several definitions were offered for this term. A few comments
stated that multivitamins and minerals are termed ``high potency'' when
the majority of nutrients with established RDA's are present at the
levels equal to or in excess of the RDA.
Similarly, another comment stated that the term should be
restricted to formulations that contain micronutrients at levels of at
least twice the applicable RDI or DRV because a multivitamin at 100
percent of the DV might be ``high potency'' compared to a food in
conventional food form but not ``high potency'' when compared to other
dietary supplements.
Another comment suggested that FDA should require a ``high
potency'' single-ingredient supplement to contain at least twice the
RDI, and that the front of the label should disclose what multiple of
the RDI the supplement contains. The comment acknowledged 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 double the RDI. The comment suggested that if the supplement
industry begins to market those supplements at higher doses in order to
make ``high potency'' claims, then FDA could establish a lower minimum
level, such as 50 percent more than the RDI for selenium or 50 percent
of the RDI for calcium. Those minimum levels would apply to those
nutrients only. The comment also suggested 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, and the label discloses which nutrients are
present at high levels. For example, the label of a ``high potency''
multivitamin could carry an asterisk next to the claim, with the
following disclosure: ``contains high levels of [number] vitamins.''
Further, the comment stated that it is not reasonable to require
that all of the nutrients in a multinutrient supplement be present at
levels that are necessary for high potency claims because many
nutrients are not--and should not--be sold in such high doses. For
example, the comment suggested that ``high potency'' claims should be
allowed on a multivitamin-and-mineral supplement that contains at least
double the RDI 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 doses lower than double the RDI and may pose a risk
at high levels.
FDA has reviewed the comments and is persuaded that ``high
potency'' is a claim that characterizes the level of a nutrient and
therefore meets the definition in Sec. 101.13(b) of a nutrient content
claim. FDA also is persuaded by the comments that this is a term that
FDA should define in order to ensure that it will be useful to
consumers in maintaining healthy dietary practices. However, given the
range and diversity of the suggested definitions, the agency is not
prepared to offer a definition of ``high potency'' at this time. FDA
intends to review the suggestions it received on this issue and based
on information received in comments, issue a proposed rule on an
appropriate definition of ``high potency.''
FDA recognizes that there is a need to provide this definition as
quickly as possible. Therefore, FDA intends to act on this matter as
expeditiously as its resources allow.
c. Definitions for ``high absorption''
27. A couple of comments stated that the term ``high absorption''
does not refer to the level of nutrients but rather to bioavailability
or how efficiently the nutrients are released from the product and
absorbed into the bloodstream. One comment stated that ``high
absorption'' means that the product meets the definition for ``high,''
and that a ``high amount'' is digested and assimilated.
Another comment stated that from a biological viewpoint, the extent
to which nutrients are absorbed from food or supplements depends not
only on the chemical form of the nutrient itself but on the chemical
environment presented by the carrier food in which it is contained and
on the physiological state of nutrient need of the individual consumer.
Given these factors, the comment stated that it is difficult to provide
a meaningful definition of absorbability.
One comment requested that the label should disclose information
about the bioavailability of the product. Another comment suggested
that FDA should allow labels to make ``high absorption'' or similar
claims only when the manufacturer supplies bioavailability data showing
that the product is better absorbed than a standard supplement. The
comment stated that the agency should not allow this claim on
supplements that simply meet or exceed the United States Pharmacopeial
Convention's (USP's) (or other) standards for disintegration or
dissolution, because meeting those standards does not ensure that the
product is well absorbed.
The agency agrees that the term ``high absorption'' generally
refers to how well a nutrient is absorbed into the system. A product
can be well absorbed irrespective of the quantitative amount found in
the product. Accordingly, FDA finds that ``high absorption'' is not a
nutrient content claim and thus will not define this term. The use of
this term is subject to section 201(n) and 403(a) of the act, however.
The agency expects that any product bearing a ``high absorption'' claim
will contain the nutrients that are the subject of the claim in a form
than can be readily assimilated by the body. In addition, manufacturers
who make a ``high absorption'' claim should have data available to
support the claim and should be prepared to make such data available to
regulatory officials on request. Failure to do so could lead the agency
to conclude that there is no basis for the claim, and thus that it is
false or misleading.
d. Definitions for ``balanced''
28. A few comments stated that ``balanced'' is not a nutrient
content claim. One comment suggested that ``balanced'' refers to the
ratio of nutrients, not the level, and that the term can apply equally
to products containing low or high quantities of nutrients. Another
comment stated that there is little need for FDA to define ``balanced''
because most multinutrient supplements that are currently on the market
do not contain nutrients in proportions that would impair the
absorption or utilization of other nutrients. The comment suggested
that until researchers gain further information on the most favorable
proportions of nutrients in supplements, the agency should leave this
term undefined and therefore prohibited. Another comment suggested that
``balanced'' be defined as any supplement containing from 50 to 150
percent of the RDI for each vitamin and mineral component of the
product for which an RDI has been established.
The agency is persuaded by the comments that the term ``balanced''
does not typically characterize the level of nutrients, but rather that
it is a formulation claim that addresses the ratio of nutrients. The
term ``balanced'' may be used in different ways, each of which relates
to the formulation of a product. For example, the term ``balanced'' may
refer to the assortment of nutrients that are present in a product, or
it may reflect interactions between the nutrients present, such as
sparing effects or impairment or enhancement of absorption.
Accordingly, this term does not meet the definition for a nutrient
content claim in Sec. 101.13(b). Therefore, the use of the term
``balanced'' is subject to sections 403(a) and 201(n) of the act and
not section 403(r) of the act. The agency will determine whether the
use of this term is misleading on a case-by-case basis.
e. Temporary suspension of the use of terms
29. One comment stated that use of the terms ``high potency,''
``high absorption,'' and ``balanced'' should not be suspended
temporarily during the rulemaking process because such a suspension
would result in unnecessary labeling costs. Another comment requested
additional time to comment on the definition of ``high potency'' and
suggested that until FDA defines this term, the agency should permit
dietary supplement manufacturers to continue to use this term as it is
currently being used. The comment suggested that as an executive
agency, FDA has inherent authority to refrain from enforcing a
statutory provision in circumstances in which the enforcement would do
more harm than good. The comment argued that to the extent that ``high
potency'' is being used as part of a brand name (and was being used
before October 25, 1989), the 1990 amendments permit its continued use
in the brand name until FDA has defined the term (section 403(r)(2)(C)
of the act).
The comment argued that there is no reason for FDA to prohibit the
use of a nutrient content claim while a definition is being developed.
Further, the comment noted that an enforcement moratorium would avoid
the relabeling problem that would arise if FDA disapproves and then
reapproves use of the term within a short period of time. The comment
stated that FDA will continue to have authority to prohibit use of the
term when such use is false or misleading.
FDA advises that it intends to define ``high potency'' as a
nutrient content claim in a separate rulemaking as quickly as possible.
The agency is postponing the date that it will apply this final rule on
nutrient content claims on dietary supplements until July 1, 1995. This
postponement is discussed in detail in the document on the date of
application for the nutrition labeling and nutrient content claim
requirements for dietary supplements found elsewhere in this issue of
the Federal Register. FDA intends to complete its rulemaking on ``high
potency'' in sufficient time to assure implementation by the time that
dietary supplement manufacturers will be required to comply with the
nutrient content claim provisions.
The agency also advises that the term ``high potency,'' when used
as part of a brand name, would fall under section 403(r)(2)(C) of the
act, if as the comment stated, it was used as part of the brand name
before October 25, 1989. However, once this term is defined by the
Secretary, it will have to be used in a manner that complies with that
definition. In addition, use of the term in the brand name is subject
to section 403(a) of the act, which prohibits the use of false and
misleading labeling irrespective of whether the use of the term in the
brand name is exempt under section 403(r)(2)(C) of the act.
As discussed previously, the comments did not demonstrate that
there are accepted definitions for any of these terms. However, the
comments have convinced the agency that the terms ``high absorption''
and ``balanced'' do not generally characterize the level of nutrients.
Accordingly, the agency concludes that these terms are not subject to
section 403(r) of the act.
4. Age Specific Claims
30. One comment stated that there are products with brand names
that imply that the product is especially useful for a particular
segment of the population. The comment argued that it would therefore
be appropriate for FDA to require that these special formulas comply
with clearly defined requirements (e.g., that they contain high amounts
of particular vitamins and minerals that are needed by the relevant
group). Another comment maintained that such names mislead consumers
because they provide no explanation for those special population
claims, and that in many cases, the supplements do not contain levels
of nutrients that are appropriate for the special population named in
the claim. The comment suggested that FDA should, at the very least,
require labels to provide an explanation for these claims. For example,
an explanation for a product with a brand name implying that it is
useful for women might state that ``this product is especially suited
for young women because it contains 100 percent of the RDI for folic
acid and iron and 30 percent of the RDI for calcium.''
FDA agrees that products marketed for special population groups may
include claims or brand names that can be misleading. These claims and
brand names seem to imply a particular benefit for certain subgroups of
the population and often do not disclose how or why they meet the needs
of that particular subgroup. Disclosure of such facts would help to
protect a product from being misbranded under section 403(a) of the act
because its labeling would reveal material facts about the product's
claimed special usefulness.
However, such claims about the usefulness of a product for
particular population groups generally fall under section 403(j) of the
act to the extent that they represent the product to be for special
dietary use. As special dietary use claims, they are outside the scope
of this rulemaking. Among other things, Sec. 105.3 defines ``special
dietary uses'' as ``uses for supplying particular dietary needs which
exist by reason of a physical, physiological, pathological or other
condition, including but not limited to the conditions of disease,
convalescence, pregnancy, lactation, allergic hypersensitivity to food,
underweight, and overweight; [and] [u]ses for supplying particular
dietary needs which exist by reason of age, including but not limited
to the ages of infancy and childhood'' (Sec. 105.3(a)(1)(i) and
(a)(l)(ii)). The agency intends to consider proposing regulations for
such products. However, because of resource constraints and other
agency priorities, any such proposal will not be available in the
immediate future. In the interim, such claims will continue to be
subject to the general misbranding provisions of sections 201(n) and
403(a) of the act.
5. ``Natural''
31. Several comments suggested that FDA define the term ``natural''
for dietary supplements because that term is widely used in the
labeling of dietary supplements even though there is no established
definition of that term, and it is misleading as it is now used. For
example, one comment stated that studies indicate that natural vitamin
E (d-alpha tocopherol) is better utilized than synthetic vitamin E (dl-
alpha and other tocopherols), but that ``natural'' claims now appear on
products containing synthetic vitamin E, misleading consumers who think
they are getting a better utilized product. The comment stated that in
other instances, companies use the term ``natural'' to mean that the
product contains no artificial ingredients.
One comment acknowledged that FDA has struggled with how to define
this term for foods in conventional food form. This comment suggested
that the agency need not resolve the dilemma at this time, but that it
should simply establish a supplement-specific definition, just as FDA
has established a special definition for ``natural flavor'' in
Sec. 101.22. Another comment suggested that FDA should allow
``natural'' claims on products containing only the naturally occurring
form of a vitamin. The comment suggested that FDA could request
comments about whether to limit ``natural'' claims to nutrients, such
as vitamin E, that appear to offer some advantage when consumed in a
natural form. The comment also stated that many consumers will want the
option of purchasing other nutrients in the natural form as well.
FDA is not persuaded by the comments that the term ``natural''
should be defined at this time. As one comment acknowledged, the agency
has recently expended its resources exploring the use of this term, and
it was unable to arrive at an acceptable definition (58 FR 2302 at
2407). FDA currently lacks sufficient resources to thoroughly explore
and develop proposed regulations for the use of this term on dietary
supplements.
In the final rule on nutrient content claims, the agency determined
that it would maintain its current policy (as discussed in the general
principles proposal (56 FR 60421 at 60466) of interpreting this term to
mean that nothing artificial or synthetic (including all color
additives regardless of source) has been included in, or has been added
to, a food (Ref. 7). FDA also decided that it would continue to
distinguish between natural and artificial flavors as outlined in
Sec. 101.22. The agency concludes that, for the reasons cited above, it
is appropriate to apply this policy to dietary supplements.
In this regard, FDA also points out that Sec. 101.9(k)(6) states
that a food labeled under the provisions of this section shall be
deemed to be misbranded under sections 201(n) and 403(a) of the act if
its label or labeling represents, suggests, or implies, ``that a
natural vitamin in a food is superior to an added or synthetic vitamin
or to differentiate in any way between vitamins naturally present from
those added.''
V. Other Provisions
FDA did not receive any comments that dealt specifically with the
other provisions of the proposal. In the absence of any basis for doing
otherwise, FDA is adopting those provisions as proposed.
VI. Economic Impact
In its dietary supplement labeling proposals of June 18, 1993, FDA
stated that the proposed rules on the labeling of dietary supplements,
taken as a whole, would have associated costs of approximately $20
million. Thus, the agency concluded that the proposed rules would not
constitute a major rule as defined by Executive Order 12291. In
accordance with the Regulatory Flexibility Act (Pub. L. 96-354), FDA
explored whether the proposed rules may have a significant impact on
small businesses and tentatively concluded that they do not.
FDA has evaluated the many comments that it received in response to
its economic impact analysis. Because the issues raised in the comments
relate to all three proposals, FDA has combined its discussion of these
comments and presented them in the final rule regarding the date of
application published elsewhere in this issue of the Federal Register.
FDA has examined the economic implications of the final rules
amending 21 CFR as required by Executive Order 12866 and the Regulatory
Flexibility Act. Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects; distributive impacts; and equity). The
Regulatory Flexibility Act requires the agency to analyze options for
regulatory relief for small businesses. FDA has concluded, based on its
review of the available data and comments, that these final rules are
not significant as defined by Executive Order 12866. Further, in
accordance with the Regulatory Flexibility Act, the agency certifies
that these final rules will not have a significant impact on a
substantial number of small businesses.
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. Paperwork Reduction Act
In the June 18, 1993, proposal on nutrient content claims for
dietary supplements (58 FR 33731 at 33749), FDA announced that the
agency had submitted to the Office of Management and Budget (OMB) for
its review the collection of information requirements contained in
proposed Sec. 101.69, for petitions regarding the use of nutrient
content claims in conjunction with food labeling on dietary
supplements. Also in that document, FDA published its estimated annual
collection of information burden for this provision.
None of the more than 500 comments received in response to the
dietary supplement proposal addressed the content of petitions under
the proposed nutrient content claim petition requirements. Thus, the
agency's estimated annual reporting and recordkeeping burden from the
health claim petition requirements contained in this final rule remains
unchanged from that announced in June.
FDA has submitted copies of the final rule to OMB for its review of
these reporting requirements.
IX. References
The following references have been placed on file in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Moss, A. J., A. S. Levy, I. Kim, 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.
2. Pennington, J. A. T., V. L. Wilkening, J. E. Vanderveen,
``Descriptive Terms for Food Labeling,'' Journal of Nutrition
Education, p. 51, June 1990.
3. Transcript to Docket N-289 for FDA-Initiated Public
Conference: Antioxidant Vitamins and Cancer and Cardiovascular
Disease, November 1993.
4. 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.
5. 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.
6. 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.
7. Newberry, R., letter to Clinton K. Davies, September 29,
1988.
List of Subjects in 21 CFR Part 101
Food labeling, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is 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, effective May 8, 1994, is amended by revising
paragraph (a), by adding paragraph (b)(5), by revising the first
sentence in paragraph (c), introductory text of paragraph (i),
(j)(1)(i)(A) and (j)(l)(i)(B), and (n) to read as follows:
Sec. 101.13 Nutrient content claims--general principles.
(a) This section and the regulations in subpart D of this part
apply to foods that are intended for human consumption and that are
offered for sale, including foods in conventional food form and dietary
supplements of vitamins, minerals, herbs, and other similar nutritional
substances (dietary supplements).
(b) * * *
(5) For dietary supplements, claims for calories, fat, saturated
fat, and cholesterol may not be made on products that meet the criteria
in Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie''
claims, except, in the case of calorie claims, when an equivalent
amount of a similar dietary supplement (e.g., another protein
supplement) that the labeled food resembles and for which it
substitutes, normally exceeds the definition for ``low calorie'' in
Sec. 101.60(b)(2).
(c) Information that is required or permitted by Sec. 101.9 or
Sec. 101.36, as applicable, to be declared in nutrition labeling, and
that appears as part of the nutrition label, is not a nutrient content
claim and is not subject to the requirements of this section. * * *
* * * * *
(i) Except as provided in Sec. 101.9 or Sec. 101.36, as applicable,
or in paragraph (q)(3) of this section, the label or labeling of a
product may contain a statement about the amount or percentage of a
nutrient if:
* * * * *
(j) * * *
(1) * * *
(i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the
reference food may be a dissimilar food within a product category that
can generally be substituted for one another in the diet (e.g., potato
chips as reference for pretzels, orange juice as a reference for
vitamin C tablets) or a similar food (e.g., potato chips as reference
for potato chips, one brand of multivitamin as reference for another
brand of multivitamin).
(B) For ``light,'' ``reduced,'' ``added,'' ``fortified,'' and
``enriched'' claims, the reference food shall be a similar food (e.g.,
potato chips as a reference for potato chips, one brand of multivitamin
for another brand of multivitamin).
* * * * *
(n) Nutrition labeling in accordance with Sec. 101.9, Sec. 101.10,
or Sec. 101.36, as applicable, shall be provided for any food for which
a nutrient content claim is made.
* * * * *
3. Section 101.54, effective May 8, 1994, is amended by revising
paragraph (a)(3), (b)(1), (c)(1) and the introductory text of paragraph
(e)(1) to read as follows:
Sec. 101.54 Nutrient content claims for ``good source,'' ``high,'' and
``more.''
(a) * * *
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
(b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or
``excellent source of'' may be used on the label and in the labeling of
foods except meal products as defined in Sec. 101.13(l), main dish
products as defined in Sec. 101.13(m), and dietary supplements of
vitamins or minerals to characterize the level of any substance that is
not a vitamin or mineral, provided that the food contains 20 percent or
more of the RDI or the DRV per reference amount customarily consumed.
* * * * *
(c) ``Good Source'' claims. (1) The terms ``good source,''
``contains,'' or ``provides'' may be used on the label or in labeling
of foods except meal products as described in Sec. 101.13(l) main dish
products as described in Sec. 101.13(m), and dietary supplements of
vitamins or minerals to characterize the level of any substance that is
not a vitamin or mineral, provided that the food contains 10 to 19
percent of the RDI or the DRV per reference amount customarily
consumed.
* * * * *
(e) ``More'' claims. (1) A relative claim using the terms ``more,''
``fortified,'' ``enriched,'' and ``added'' may be used on the label or
in labeling of foods to describe the level of protein, vitamins,
minerals, dietary fiber, or potassium except as limited by
Sec. 101.13(j)(1)(i) and except meal products as defined in
Sec. 101.13(l), main dish products as defined in Sec. 101.13(m), and
dietary supplements of vitamins or minerals to characterize the level
of any substance that is not a vitamin or mineral, provided that:
* * * * *
4. Section 101.60 is amended by revising paragraphs (a)(2) and
(a)(3), by adding new paragraph (a)(4), by redesignating paragraphs
(c)(4) and (c)(5) as paragraphs (c)(5) and (c)(6), and adding a new
paragraph (c)(4), and by revising the introductory text of newly
redesignated paragraph (c)(5) to read as follows:
Sec. 101.60 Nutrient content claims for the calorie content of foods.
(a) * * *
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13;
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
(4) For dietary supplements, claims regarding calories may not be
made on products that meet the criteria in Sec. 101.60(b)(1) or (b)(2)
for ``calorie free'' or ``low calorie'' claims except when an
equivalent amount of a similar dietary supplement (e.g., another
protein supplement) that the labeled food resembles and for which it
substitutes, normally exceeds the definition for ``low calorie'' in
Sec. 101.60(b)(2).
* * * * *
(c) * * *
(4) The claims provided for in paragraph (c)(1) and (c)(2) of this
section may be used on labels or in labeling of dietary supplements of
vitamins or minerals that are intended specifically for use by infants
and children less than 2 years of age.
(5) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar
reduced,'' ``less sugar,'' ``lower sugar'' or ``lower in sugar'' may be
used on the label or in labeling of foods, except meal products as
defined in Sec. 101.13(l), main dish products as defined in
Sec. 101.13(m), and dietary supplements of vitamins or minerals,
provided that:
* * * * *
6. Section 101.61 is amended by revising paragraph (a)(3) to read
as follows:
Sec. 101.61 Nutrient content claims for the sodium content of foods.
(a) * * *
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
* * * * *
7. Section 101.62 is amended by revising paragraphs (a)(2) and
(a)(3) and by adding paragraph (a)(4) to read as follows:
Sec. 101.62 Nutrient content claims for fat, fatty acid, and
cholesterol content of foods.
(a) * * *
(2) The claim is made in accordance with the general requirements
for nutrient content claims in Sec. 101.13;
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
(4) For dietary supplements, claims for fat, saturated fat, and
cholesterol may not be made on products that meet the criteria in
Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie''
claims.
* * * * *
8. Section 101.65 is amended by revising paragraphs (a)(3), (b)(3)
and (b)(4) to read as follows:
Sec. 101.65 Implied nutrient content claims and related label
statements.
(a) * * *
(3) The food for which the claim is made is labeled in accordance
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
(b) * * *
(3) A claim about the presence of an ingredient that is perceived
to add value to the product, e.g., ``made with real butter,'' ``made
with whole fruit,'' or ``contains honey,'' except that claims about the
presence of ingredients other than vitamins or minerals or that are
represented as a source of vitamins and minerals are not allowed on
labels or in labeling of dietary supplements of vitamins and minerals
that are not in conventional food form.
(4) A statement of identity for a food in which an ingredient
constitutes essentially 100 percent of a food (e.g., ``corn oil,''
``oat bran,'' ``vitamin C 60 mg tablet'').
* * * * *
Dated: December 23, 1993
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 93-31814 Filed 12-29-93; 8:45 am]
BILLING CODE 4160-01-F