DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 91NÄ384D]

RIN 0905ÄAD96

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.

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 (HFSÄ165), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, 202Ä205Ä5483.

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. 101Ä535). 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. 102Ä571 (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  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  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  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,  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  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  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  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  101.60(b)(1) and (b)(2) for "calorie free'' and "low
calorie'' claims. FDA is also revising  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  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  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  101.60(b)(2). It is including similar language in 
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
 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  101.2(b) to
include  101.13, 101.54, 101.56, 101.60, 101.61, 101.62, and 101.65 in the
list of sections set out in  101.2(b) for which a minimum type size for
required label information is specified. For consistency, the agency also
modified  101.2(f) to include  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  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 
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  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  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 
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  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 
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  101.13(j)(1)(i)(A) to include these examples.

Additionally, to clarify  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  101.13(k). FDA
finds, however, that no change in  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  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  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  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  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  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  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  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  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  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.  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  101.54
(58 FR 2302 at 2344). In  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  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  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  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 ( 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  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 
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,  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 
101.65(b)(4).

In the example added to  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  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  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 
101.65(b)(5).

However, as the agency stated in  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  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  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  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 
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  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  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  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,  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'' ( 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  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  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  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. 96Ä354), 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  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 NÄ289 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:

 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 
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  101.60(b)(2).

(c) Information that is required or permitted by  101.9 or  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  101.9 or  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  101.9,  101.10, or  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:

 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 
101.9,  101.10, or  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  101.13(l), main dish products as defined in 
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  101.13(l) main dish products as described in 
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  101.13(j)(1)(i) and except
meal products as defined in  101.13(l), main dish products as defined in 
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:

 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  101.13;

(3) The food for which the claim is made is labeled in accordance with 
101.9,  101.10, or  101.36, as applicable; and

(4) For dietary supplements, claims regarding calories may not be made on
products that meet the criteria in  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  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  101.13(l), main dish
products as defined in  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:

 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 
101.9,  101.10, or  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:

 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  101.13;

(3) The food for which the claim is made is labeled in accordance with 
101.9,  101.10, or  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  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:

 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 
101.9,  101.10, or  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. 93Ä31814 Filed 12Ä29Ä93; 8:45 am]

BILLING CODE 4160Ä01ÄF