[Federal Register Volume 59, Number 2 (Tuesday, January 4, 1994)]
[Rules and Regulations]
[Pages 354-395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 93-31814]


[[Page Unknown]]

[Federal Register: January 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 91N-384D]
RIN 0905-AD96

 

Food Labeling; Requirements for Nutrient Content Claims for 
Dietary Supplements of Vitamins, Minerals, Herbs, and Other Similar 
Nutritionnal Substances

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations to: (1) Include dietary supplements of vitamins, minerals, 
herbs, and other similar nutritional substances (hereinafter referred 
to as ``dietary supplements'') under the coverage of the general 
principles for nutrient content claims; (2) provide for the use of 
expressed and implied nutrient content claims on labels or in labeling 
of dietary supplements; and (3) provide for petitions for nutrient 
content claims for dietary supplements. This final rule is in response 
to the Nutrition Labeling and Education Act of 1990 and to the Dietary 
Supplement Act of 1992.

EFFECTIVE DATE: July 1, 1995.

FOR FURTHER INFORMATION CONTACT: Camille E. Brewer, Center for Food 
Safety and Applied Nutrition (HFS-165), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5483.

SUPPLEMENTARY INFORMATION:

I. Regulatory History

    On November 8, 1990, President Bush signed into law the Nutrition 
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). The 1990 amendments revised the Federal Food, Drug, and Cosmetic 
Act (the act) in a number of important ways. One of the most notable 
aspects of the 1990 amendments is that they establish FDA's authority 
to regulate nutrient content claims on food labels and in food 
labeling. Section 403(r)(1)(A) of the act, which was added by the 1990 
amendments, provides that a product is misbranded if it bears a claim 
in its label or labeling that either expressly or implicitly 
characterizes the level of any nutrient of the type required to be 
declared as part of nutrition labeling, unless such claim has been 
specifically defined (or otherwise exempted) by regulation. The 1990 
amendments also direct the Secretary and, by delegation, FDA to 
promulgate regulations to define specific nutrient content claims 
including ``free,'' ``low,'' ``light'' or ``lite,'' ``reduced,'' 
``less,'' and ``high'' (section 3(b)(1)(A)(iii) of the 1990 
amendments).
    In the Federal Register of November 27, 1991 (56 FR 60421 and 56 FR 
60478), FDA published two documents in which it proposed, among other 
things, to define nutrient content claims, to provide for their use on 
foods labels, and to establish procedures for the submission and review 
of petitions regarding the use of specific nutrient content claims. 
These proposals applied to dietary supplements as well as foods in 
conventional food form.
    On October 6, 1992, the President signed the Dietary Supplement Act 
of 1992, Title II of Pub. L. 102-571 (the DS act). Section 202(a)(1) of 
the DS act established a moratorium on the implementation of the 1990 
amendments with respect to dietary supplements until December 15, 1993. 
Section 202(a)(2)(A) required the Secretary, and by delegation FDA, to 
issue proposed regulations on nutrient content claims for dietary 
supplements no later than June 15, 1993.
    FDA issued final regulations that implemented the 1990 amendments 
with respect to nutrient content claims on foods in conventional food 
form on January 6, 1993 (hereinafter referred to as the ``final rule on 
nutrient content claims'') (58 FR 2302). FDA modified these final 
regulations slightly in a document that made technical corrections to 
them (58 FR 44020, August 18, 1993) (hereinafter referred to as ``the 
technical corrections document''). In response to the requirements of 
the DS act, FDA published in the Federal Register of June 18, 1993 (58 
FR 33731) a proposal to: (1) Include dietary supplements under the 
coverage of the general principles for nutrient content claims; (2) 
provide for the use of expressed and implied nutrient content claims on 
labels or in labeling of dietary supplements; and (3) provide for 
petitions for nutrient content claims for dietary supplements 
(hereinafter referred to as the ``proposal on nutrient content claims 
for dietary supplements'').
    FDA received approximately 500 letters in response to its June 18, 
1993, proposal on nutrient content claims for dietary supplements. Each 
letter contained one or more comments. The letters were from a wide 
range of sources, including consumers; consumer organizations; 
professional associations; Federal, State, and local government 
agencies; industry; and industry trade associations. Many comments 
generally supported the proposal or various provisions of the proposal. 
Other comments addressed issues outside the scope of the proposal 
(e.g., freedom of choice, access to health care, access to dietary 
supplements) and will not be discussed here. Many comments suggested 
modifications, revisions, or revocations of various aspects of the 
proposal. A summary of the comments, the agency's responses to the 
comments, and a complete discussion of the agency's conclusions with 
respect to nutrient content claims for dietary supplements follows.

II. Nutrient Content Claims for Dietary Supplements--FDA Authority

    1. A couple of comments contended that FDA lacks the statutory 
authority to prohibit claims for substances for which no reference 
value (i.e., Reference Daily Intake (RDI) or Daily Reference Value 
(DRV)) has been established. The comments also stated that the agency 
lacks legal authority to promulgate regulations governing products 
bearing a nutrient content claim for a nutrient or other substance not 
explicitly named in section 403(q)(1) or (q)(2) of the 1990 amendments. 
The comments said that the references to section 403(q)(1) or (q)(2) of 
the act are references to those nutrients that the 1990 amendments 
require to be listed (``mandatory nutrients'') on the nutrition label. 
The comments argued that under these provisions, a food may be subject 
to a misbranding charge under section 403(r)(1) of the act only if it 
characterizes, either explicitly or implicitly, the level of a 
mandatory nutrient in the food.
    The comments also stated that the 1990 amendments did not provide 
FDA with misbranding authority over products that bear a claim 
characterizing the level of a nutrient or other substance that is not 
listed in section 403(q)(1) or (q)(2) of the act. The comments 
maintained that, regardless of whether a RDI or DRV has been 
established, no special requirements should apply if a manufacturer of 
a substance not covered by section 403(q)(1) or (q)(2), such as garlic, 
wished to claim that his product was ``high in garlic'' or a ``good 
source of garlic.'' The comments argued that while FDA maintains its 
general misbranding authority over products bearing claims that 
characterize the level of a nonmandatory substance, FDA still must meet 
its burden of proving that any such claims are actually ``false or 
misleading in any particular'' under the general misbranding provision, 
section 403(a)(1) of the act.
    Section 403(r)(1)(A) of the act states that a food intended for 
human consumption is misbranded if it bears a claim that expressly or 
by implication ``characterizes the level of any nutrient which is of 
the type required by paragraph (q)(1) or (q)(2) to be in the label or 
labeling of the food * * *.'' The statute uses the same language in 
section 403(r)(1)(B) to describe the substances that could be the 
subject of a health claim. A health claim is a claim that 
``characterizes the relationship of any nutrient which is of the type 
required by paragraph (q)(1) or (q)(2) to be in the label or labeling 
of the food to a disease or a health-related condition        * * *.'' 
Under section 403(r)(1)(B), a health claim may be made in accordance 
with section 403(r)(5)(D) as well as section 403(r)(3). Thus, because a 
statute must be read as a whole, the language in section 403(r)(1)(A) 
and (r)(1)(B) of the act that describes the substances that may be the 
subject of a nutrient content or of a health claim must be read in 
conjunction with section 403(r)(5)(D), which addresses health claims 
for vitamins, minerals, herbs, or other similar nutritional substances 
that are components of dietary supplements. Thus, the ``nutrients of 
the type required by paragraph (q)(1) or (q)(2)'' that are the subject 
of sections 403(r)(1)(A) and (r)(1)(B) of the act include vitamins, 
minerals, herbs, and other similar nutritional substances.
    The legislative history of ``other nutritional substances'' reveals 
that its coverage is broad and could, in appropriate circumstances, 
include garlic. See 136 Cong. Record S16609 (daily ed. October 24, 
1990) (discussion between Senators Metzenbaum and Symms). Therefore, 
while a label claim that a food contains garlic that is intended to 
describe the taste of the food would not be subject to section 
403(r)(1)(A) of the act, a claim that describes the garlic content in a 
way that reveals that garlic is being referred to as a nutritional 
substance would be subject to that section. Under section 403(r)(1)(A) 
of the act, the latter claim would misbrand the food unless its use has 
been authorized by FDA under section 403(r)(2). Thus, FDA rejects the 
comments that disagreed with the proposed coverage of the nutrient 
content claim provisions.
    FDA has relied on the RDI's and DRV's in defining nutrient content 
claims under section 403(r)(2) of the act because it has concluded that 
if the characterization of the level of a nutrient is to have any 
meaning, there must be a level that can be used as a reference in 
determining whether the characterization is valid and appropriate. The 
RDI's and DRV's provide such levels. Thus, in Sec. 101.54(a) (21 CFR 
101.54(a)), FDA has limited the use of ``good source,'' ``high,'' and 
``more'' claims to use with nutrients for which an RDI or DRV has been 
established. FDA is not aware of any other alternative standards.
    If interested persons are aware of other standards that can be used 
as reference values to establish the validity of content claims for 
substances for which RDI's and DRV's have not been established, those 
persons should make FDA aware of those standards through Sec. 101.69 
(21 CFR 101.69) or other appropriate means. FDA will carefully consider 
using such standards as the basis for content claims for the substances 
involved.

III. Basis for Nutrient Content Claims For Dietary Supplements

A. Relationship to January 6, 1993 Final Rules, Consistency with 
Established Nutrient Content Claims, Scope

    2. Many comments supported consistency in definitions for nutrient 
content claims between foods in conventional food form and dietary 
supplements. However, one comment stated that consistency in 
definitions for nutrient content claims for dietary supplements and 
foods in conventional food form is inappropriate. The comment argued 
that FDA has chosen to define nutrient content claims that are not 
meaningful to the supplement industry and to consumers.
    Many comments pointed out that dietary supplements are intended to 
contribute, with foods in conventional food form, to consumers' daily 
nutrient intake. Thus, the comments argued that it is important that 
the terms used to describe the levels of nutrients in both dietary 
supplements and foods in conventional food form be consistent. These 
comments maintained that consumers would be confused if claims were to 
be allowed on dietary supplements that were not defined in the same 
manner as those for foods in conventional food form.
    FDA disagrees with the comments that said that consistency with 
established nutrient content claims is inappropriate as a basic 
principle for defining nutrient content claims for dietary supplements. 
There is much about dietary supplements that suggests that the 
principles that guide FDA in defining nutrient content claims for 
dietary supplements should be the same as the principles that guide the 
agency in defining nutrient content claims on foods in conventional 
food form. Dietary supplements that are not intended for use as drugs 
have traditionally been regulated as foods and, as such, must be 
evaluated within the context of the total daily diet. In addition, 
nutrients from dietary supplements serve the same physiological 
function as nutrients from foods in conventional food form. While some 
consumers seek to ensure that the nutrient content of their diet is 
adequate through foods in conventional food form, other consumers seek 
to ensure nutritional adequacy by making dietary supplements part of 
their diets (Ref. 1). Consistent use of terms on dietary supplements 
and on foods in conventional food form will thus help consumers to 
construct a nutritionally adequate total daily diet by allowing 
consumers to make meaningful comparisons among these products. It will 
also facilitate use of these terms by consumers.
    Over the years, FDA has stressed the importance of consistent 
definitions and descriptive terms as a necessary requirement for 
effective education and for preventing misleading labeling (Ref. 2). If 
terms were given different definitions depending on whether they were 
to be used to describe foods in conventional food form or dietary 
supplements, it would make it much more difficult for the public to 
understand what these terms are intended to convey about a particular 
food. Moreover, a single definition for a particular term eliminates 
any possibility that ambiguities could be created by the use of that 
term. Therefore, the agency concludes that for nutrient content claims, 
the definition of a particular term should be the same regardless of 
the type of food that it is being used to describe.
    Additionally, FDA has been criticized for treating dietary 
supplements differently than other foods. FDA has no desire to 
discriminate in any way against supplements. Thus, by having a single 
definition for a particular nutrient content claim, FDA is providing 
the basis for dietary supplements to make the same claims as other 
foods and to be factored into the diet like other foods.
    Nonetheless, as discussed in the proposal on nutrient content 
claims for dietary supplements (58 FR 33731), FDA recognizes that 
dietary supplements differ in at least two respects from foods in 
conventional food form. First, dietary supplements are likely to 
contain much higher levels of nutrients than foods in conventional food 
form. Thus, additional nutrient content claims that are specific for 
dietary supplements may be appropriate. As discussed later in this 
document, the agency intends in the near future to initiate a separate 
rulemaking to establish such claims for dietary supplements. Second, 
dietary supplements generally do not contain several nutrients (e.g., 
fat, cholesterol) found in foods in conventional food form. Therefore, 
in this document, FDA is limiting the use of certain claims that are 
useful for describing foods in conventional food form but that do not 
meaningfully describe dietary supplements.

B. General Principles

1. Substitute Foods
    3. One comment objected to the requirement to use the word 
``imitation'' on dietary supplements that are nutritionally inferior to 
other products of the same type. The comment argued that FDA was never 
given the authority to decide on formulations of dietary supplements, 
and that setting such formulations is the exclusive role of the 
manufacturer. Further, the comment stated that there is nothing 
``imitation'' about ``less'' in the supplement industry, and that a 
requirement that a supplement be labeled ``imitation'' if it is 
nutritionally inferior to another product forces manufacturers to 
increase potencies in order that their products will not have to be 
labeled ``imitation.''
    Under section 403(r)(2)(A)(ii) of the act, for a food to be labeled 
as ``[nutrient] free,'' the nutrient must usually be present in the 
food or in a food for which it substitutes, as that term is defined by 
the Secretary (and by delegation, FDA) for the food. Accordingly, the 
agency defined ``substitute foods'' in Sec. 101.13(d) (21 CFR 101.3(d)) 
in the final rule on nutrient content claims (58 FR 2302 at 2411) for 
the purpose of identifying the characteristics that substitute foods 
must have if they are to bear nutrient content claims that highlight 
differences between them and the foods for which they substitute. The 
definition states that a substitute food is one that may be used 
interchangeably with another food that it resembles, i.e., to which it 
is organoleptically, physically, and functionally (including shelf 
life) similar and to which it is not nutritionally inferior, unless it 
is labeled as an ``imitation.'' Additionally, Sec. 101.3(e)(1) (21 CFR 
101.3(e)(l)) states that a food shall be deemed to be an imitation, and 
thus subject to the requirements of section 403(c) of the act, if it is 
a substitute for or resembles another food but is nutritionally 
inferior to that food. Thus, the issue that the agency must consider is 
whether dietary supplements that are foods should be subject to these 
provisions on substitute foods as any other foods are.
    The agency has no evidence that manufacturers will increase the 
potencies for their products to avoid the use of this term and 
disagrees that this provision will interfere with a manufacturer's 
right to decide on product formulations. It is extremely unlikely that 
the term ``imitation'' will ever be used on dietary supplements, 
particularly dietary supplements of vitamins and minerals. The issue of 
whether a supplement would be an ``imitation'' would arise only when a 
manufacturer chooses to make a ``free'' or ``low'' claim for sugar or 
sodium on a dietary supplement (see comment 4). In such circumstances, 
under section 403(r)(2)(A)(ii) of the act, the manufacturer must 
identify a product on the market with which its product can be used 
interchangeably, to which the manufacturers product is not 
nutritionally inferior, and that contains sodium or sugar. Such a 
product may include the version of the manufacturer's product that 
contains sodium or sugar. As long as such a product exists, the 
manufacturer's product need not be labeled as an imitation. Moreover, 
if because of the way the manufacturer has formulated its product, 
there is no product with which it is used interchangeably, the product 
can be called ``------------, a sodium-free food.'' Only in the rare 
situations in which neither of the conditions apply would the product 
have to be called ``imitation'' for it to bear a ``free'' or ``low'' 
sodium or sugar claim.
    Sections 101.13(d)(1) and (d)(2) are designed to ensure that 
material differences between the substitute food and the reference food 
are conspicuously stated on the label or labeling of the food, so that 
consumers can make fully informed judgments about the value of the 
substitute food and its usefulness in maintaining healthy dietary 
practices. If a product has substantially less of a nutrient than the 
reference food, and to that extent is materially different and inferior 
in nutrient content, then ``imitation'' is an entirely appropriate 
term. For this reason, the agency concludes that there is no reason to 
apply the substitute food provisions any differently to dietary 
supplements than to other foods.
2. Requirements for ``Low'' and ``Free'' Claims
    4. Several comments from dietary supplement manufacturers and trade 
associations questioned the need to allow ``low'' and ``free'' claims 
for nutrients such as fat and cholesterol that are not typically found 
in dietary supplements. One comment suggested that ``free,'' ``low,'' 
and ``reduced'' claims for calories, fat, and cholesterol on dietary 
supplements should be permitted only on dietary supplements that are a 
significant source of calories, such as protein supplements. The 
comment argued that consumers do not expect most dietary supplements to 
contain significant amounts of calories, and that it is nonsensical and 
confusing to permit dietary supplements that are not a significant 
source of calories to make a claim about reduced amounts of calories, 
fat, and cholesterol contained therein. Another comment stated that 
Americans who consume dietary supplements do not do so because the 
products are ``low in fat,'' ``cholesterol free,'' or ``low calorie,'' 
and that consumers are not interested in the fat content of dietary 
supplements. The comment argued that consumers care about the 
substances in the products and the benefits that those products can 
have for their health.
    In the proposal on nutrient content claims for dietary supplements, 
the agency requested comment on the need for extending ``free,'' 
``low,'' and ``reduced'' claims to dietary supplements (58 FR 33731 at 
33745). The agency has reviewed the comments that it received and is 
persuaded by them that it not meaningful to allow claims about the 
calorie, fat (including saturated fat), or cholesterol content of most 
dietary supplements. Most of these products do not contain those 
nutrients, and most consumers do not expect that they do. Thus, 
consumers would not generally look to these products in making dietary 
choices that are designed to control the amount of calories, fat, 
saturated fat, and cholesterol in the foods they eat. In fact, claims 
about these nutrients in most dietary supplements would only serve to 
confuse consumers. While it is true that FDA is requiring information 
about these nutrients in the nutrition label of supplements of herbs 
and of other similar nutritional substances, this requirement derives 
mainly from the limitation on the exemption in section 403(q)(5)(F) of 
the act (formerly section 403(q)(5)(E)). See the final rule on general 
requirements for nutrition labeling for dietary supplements published 
elsewhere in this issue of the Federal Register.
    However, the agency recognizes that there are some dietary 
supplements, such as protein supplements, in which the amount of 
calories in the product is significant to consumers. On these products, 
the source of the calories, particularly whether they are from fat, is 
relevant and useful information.
    Therefore, FDA has decided, based on the comments that it received 
to only allow calorie, fat, saturated fat, and cholesterol claims on 
those dietary supplements in which the amount of calories is important 
to consumers. In attempting to define what this level of calories 
should be, the agency looked first to Sec. 101.9(f)(1) and (j)(4), 
which said that a food has ``insignificant'' calories for the purposes 
of nutrition labeling if it has an amount of calories that can be 
rounded to zero. Section 101.9(c)(1) states that ``less than 5 
calories'' per serving may be expressed as zero, the same amount that 
is defined as ``calorie free.''
    While FDA does not have information on the caloric content of 
dietary supplements, it would not be unreasonable to expect that many 
dietary supplements contain more than 5 calories (cal) per serving, 
particularly children's chewable vitamin and mineral supplements, 
supplements that contain herbal extracts, and supplements that contain 
caloric binders and fillers. Thus, to tie the use of ``free,'' ``low,'' 
and ``reduced'' calorie, fat, and cholesterol claims on labels of 
dietary supplements to the presence of more than an ``insignificant 
amount'' of calories in the food would be over-inclusive and would 
allow many products in which the amount of calories is not significant 
to consumers to bear such claims.
    FDA next looked at the definition of ``low calorie'' in 
Sec. 101.60(b)(2) (21 CFR 101.60(b)(2)) for use in determining which 
dietary supplements should be allowed to bear ``free,'' ``low,'' and 
``reduced'' claims. Section 101.60(b)(2) defines a ``low calorie'' food 
as a food that contains 40 cal or less per reference amount customarily 
consumed (hereinafter referred to as reference amount) and per 50 grams 
(g) if the reference amount is small. FDA believes that 40 cal per 
reference amount represents a reasonable level for demarcating a 
dietetically relevant source of calories for dietary supplements. In a 
product that contains this amount of calories, the source of the 
calories (e.g., fat) is of significance to consumers.
    Accordingly, the agency is revising Sec. 101.62(a) (21 CFR 
101.62(a)) by adding paragraph (a)(4) to state that ``free,'' ``low,'' 
and ``reduced'' claims for fat, saturated fat, and cholesterol may not 
be made for dietary supplements that meet the criteria in 
Sec. 101.60(b)(1) and (b)(2) for ``calorie free'' and ``low calorie'' 
claims. FDA is also revising Sec. 101.13(b) by adding new paragraph 
(b)(5) to reflect these provisions. As a consequence, claims that 
identify all products of that class of being ``low'' or ``free'' of a 
nutrient (e.g., ``vitamin C supplement, a fat-free supplement'') will 
also be prohibited.
    However, to use the same criteria (i.e., that a product may not be 
``calorie free'' or ``low calorie'') as a basis for when a calorie 
claim may be made, has the effect of prohibiting the very claims that 
the criterion seeks to permit, namely ``calorie free'' and ``low 
calorie'' claims. Such a criterion would permit only relative calorie 
claims (e.g. ``reduced'') on dietary supplements. Therefore, a slightly 
different scheme for permitting calorie claims on certain dietary 
supplements, such as protein supplements, must be derived.
    While, as stated above, the agency believes that calorie claims 
should not be permitted on most dietary supplements, it does believe 
that ``calorie free'' and ``low calorie'' claims may be appropriate if 
an equivalent amount of a similar food (i.e., another protein 
supplement) that the labeled food resembles and for which it 
substitutes would normally contain an appreciable amount of calories. 
Such a claim would highlight that the labeled food had a different 
calorie profile than would be expected in the similar product. It would 
also serve to direct a consumer to a product that had a lower amount of 
calories. Because the food would meet the criteria for ``low calorie'' 
and would be so labeled, it would not be necessary to highlight any 
comparative differences between the labeled and the similar food as 
would be required for a relative claim.
    Therefore, the agency is revising Sec. 101.62(a) by adding new 
paragraph (a)(4) to state that claims for calories may not be made on 
labels of dietary supplements that meet the criteria in 
Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' and ``low calorie'' 
except when an equivalent amount of a similar dietary supplement (e.g., 
another protein supplement) that the labeled food resembles and for 
which it substitutes normally exceeds the definition for ``low 
calorie'' in Sec. 101.60(b)(2). It is including similar language in 
Sec. 101.13(b)(5).
    The comments specifically objected to claims for calories, fat, and 
cholesterol. Claims for sodium and sugar content were not mentioned. 
Since the sugar and sodium levels in dietary supplements can vary 
substantially, the agency finds that claims about the sugar and sodium 
content of dietary supplements may be useful in helping consumers to 
make purchasing decisions that will assist them in maintaining healthy 
dietary practices. Thus, extending the definitions of ``low,'' 
``free,'' and ``reduced'' for sugar and sodium to dietary supplements 
is appropriate irrespective of the calorie level of the dietary 
supplement. Therefore, FDA concludes that there is no need to place 
limitations on claims for sugar and sodium content other than those in 
Secs.  101.60(c) and 101.61, respectively. As explained below, FDA is 
amending these provisions to reflect their application to dietary 
supplements.
3. Labeling Mechanics
a. Type size
    5. In discussing type size for nutrient content claims, one comment 
stated that every new statement that is required on dietary supplement 
labels will create a problem for manufacturers, particularly if they 
are constrained by minimum-type size requirements.
    The agency acknowledges that dietary supplements are frequently 
packaged in small containers, and for this reason, FDA specifically 
asked for information on the impact of the type size proposal on 
dietary supplements that are packaged in small containers (58 FR 33731 
at 33734). No suggestions or examples were presented to assist the 
agency in deciding how to address this problem. Therefore, the agency 
has made no special provision for dietary supplements in the type size 
requirements for nutrient content claims. FDA discusses the type size 
requirements for the nutrition labeling of dietary supplements in the 
final rule on nutrition labeling of dietary supplements published 
elsewhere in this issue of the Federal Register.
    FDA stated in the technical corrections document (58 FR 44020 at 
44020 and 44021) that there was a need to specify the minimum type size 
for labeling information (e.g., accompanying information) required 
under the nutrient content claims regulation. As a result, the agency 
modified Sec. 101.2(b) to include Secs. 101.13, 101.54, 101.56, 101.60, 
101.61, 101.62, and 101.65 in the list of sections set out in 
Sec. 101.2(b) for which a minimum type size for required label 
information is specified. For consistency, the agency also modified 
Sec. 101.2(f) to include Secs. 101.13, 101.54, 101.56, 101.60, 101.61, 
101.62, and 101.65.The effect of these revisions for dietary 
supplements is that label information required by the nutrient content 
claims regulations, but whose type size is not otherwise specified, 
will be required to be in letters or numbers no less than one-sixteenth 
of an inch in height unless otherwise specified by Sec. 101.2(c). FDA 
believes that making nutrient content claims on dietary supplements 
subject to this requirement is appropriate because this requirement is 
the logical outgrowth of the proposal. In the proposal on nutrient 
content claims for dietary supplements, FDA raised the issue of how to 
make nutrient content claims on dietary supplements. The question of 
how to ensure the legibility of the referral statement, which is 
required by section 403(r)(2)(B) of the act, is one that is at least 
implicitly raised by this issue. Thus, the agency's decision to 
explicitly address the question of the type size of the referral 
statement in this final rule represents the logical outgrowth of issues 
that were raised in the proposal.
    The agency pointed out in the technical corrections document that 
if there are circumstances in which the product is not able to comply 
with type size requirements, manufacturers may request an alternative 
means of compliance (e.g., permission to use a reduced type size) in 
accordance with Sec.  101.9(g)(9). Section 101.9(g)(9) states that when 
it is not technologically feasible, or some other circumstance makes it 
impracticable, for firms to comply with nutrition labeling 
requirements, they may write to the Office of Food Labeling, Food and 
Drug Administration, and request an alternative means of compliance. 
For the reasons explained above, dietary supplements of herbs and other 
similar nutritional substances are appropriately subject to this 
provision even though it was not specifically set out in the proposal 
on nutrient content claims for dietary supplements. A similar provision 
is included in Sec. 101.36(d)(2) of the final regulation for nutrition 
labeling for dietary supplements of vitamins and minerals, in a 
companion document in this issue of the Federal Register. These 
provisions allow flexibility to ensure that there will be either 
sufficient space to make nutrient content claims on the labels of 
dietary supplements, or that manufacturers will have recourse to 
request relief.
b. Disclosure levels
    6. One comment stated that there are a certain number of products, 
such as chewable tablets containing sodium ascorbate, for which 
information on sodium might be useful to consumers in maintaining 
healthy diets. The comment suggested that the agency urge supplement 
manufacturers to include information on sodium content, even though the 
sodium level might not reach the threshold levels established in 
Sec. 101.13(h)(1) that would trigger a required statement.
    The agency disagrees that there is a sufficient basis for requiring 
either the declaration of total sodium content on the principal display 
panel of a dietary supplement or for requiring a referral statement 
directing the consumer to the nutrition label for information about 
sodium content on all dietary supplements. Section 101.13(h)(1) 
specifies that the referral statement (i.e., ``See [appropriate panel] 
for information about [nutrient requiring disclosure] and other 
nutrients'') is required only when the sodium (or fat, saturated fat, 
or cholesterol) content of a product exceeds the disclosure level. FDA 
finds that there is no reason to provide a different rule for dietary 
supplements.
    To the extent, as the comment suggests, that information on sodium 
content would be useful, it will be provided on the nutrition label as 
long as it is present at more than an insignificant level. Section 
101.36(b)(3), which lists the nutrients that must be included in the 
nutrition label of a dietary supplement of a vitamin or mineral, 
provides that all nutrients listed in Sec. 101.9(c), including sodium, 
must be declared on the nutrition label of a dietary supplement of 
vitamins and minerals, except that nutrients present at levels that 
would be declared as zero shall not be declared. (For sodium, the 
amount that is declared as zero is less than 5 milligrams (mg) per 
serving.) Section 101.9(c) itself requires that sodium be listed on the 
nutrition label of other dietary supplements. Consumers thus will be 
able to readily find the amount of sodium in a product by examining the 
nutrition label. Because the comment provided no basis for its 
suggestion other than usefulness, FDA is not making any special 
provision for the declaration of sodium on dietary supplements.
4. Relative Claims, Reference Foods, ``Modified''
    7. One comment requested that the agency clarify in Sec. 101.13(j) 
that for dietary supplements, the reference food may be a source of the 
nutrient in either a dissimilar food within a product category or a 
similar food. The comment stated that the most helpful information to a 
consumer purchasing a dietary supplement often may be a comparison of 
the vitamin or mineral content to a recognized source of the nutrient, 
e.g., ``contains more vitamin C than two 8 oz glasses of orange 
juice.'' In addition, the comment maintained that the examples used in 
the proposed rule on nutrient content claims for dietary supplements 
(58 FR 33731 at 33737) for comparing dissimilar foods within the same 
product category (e.g., potato chips as a reference for pretzels) 
generally does not apply to dietary supplements.
    The agency agrees that a clarification is warranted to reinforce 
that Sec. 101.13(j) applies to dietary supplements as well as to foods 
in conventional food form. Section 101.13(j)(1)(i)(A) states that for 
``less'' (or ``fewer'') and ``more'' claims, the reference food may be 
a dissimilar food within a product category that can generally be 
substituted for one another in the diet (e.g., potato chips as 
reference for pretzels) or a similar food (e.g., potato chips as 
reference for potato chips).
    The agency agrees that adding examples that are specific for 
dietary supplements will clarify that for ``less'' (or ``fewer'') and 
``more'' claims, the reference food may be a dissimilar food within a 
product category for which the labeled food can generally be 
substituted (e.g., orange juice as a reference for vitamin C tablet) or 
a similar food (e.g., one brand of multivitamin as a reference for 
another brand of multivitamin). Accordingly, the agency is revising 
Sec. 101.13(j)(1)(i)(A) to include these examples.
    Additionally, to clarify Sec. 101.13(j)(1)(i)(B) for ``light,'' 
``reduced,'' ``added,'' ``fortified,'' and ``enriched'' claims, the 
agency is revising this regulation to include an example of a reference 
food that is a similar food (e.g., one brand of multivitamin for 
another brand of multivitamin).
    8. One comment agreed that the term ``modified'' would rarely be a 
useful term for vitamin/mineral supplements but stated that this term 
might be useful for certain dietary supplements that contain ``other 
similar nutritional substances.'' The comment stated that there are 
techniques for concentrating certain fish oils that are high in omega-3 
fatty acids. The comment suggested that the use of the term 
``modified'' might serve to distinguish products containing the 
concentrated fish oils from other fish oil products that would have to 
be taken several times a day to provide the same amount of fish oil and 
thus result in the consumption of significantly more calories. The 
comment argued that use of the term ``modified'' on dietary supplements 
should be authorized to maintain the principle of consistency between 
foods in conventional food form and dietary supplements.
    The agency agrees. FDA has defined ``modified'' for use as part of 
the statement of identity on foods to reflect the fact that a change 
has been made in a food (56 FR 60421 at 60454). The term is not to be 
used alone, nor is the term to be used to describe products that have 
not been altered (58 FR 2302 at 2367 and 2412). Based on the comment, 
the agency concludes that this term may have some limited usefulness 
for dietary supplements, and thus this term may be used on such 
products when they meet the conditions of Sec. 101.13(k). FDA finds, 
however, that no change in Sec. 101.13(k) is necessary to authorize 
this use of the term.
5. Reference Amounts
    9. One comment stated that if comparative claims (e.g., ``reduced 
sodium'') were to be made for dietary supplements, there need to be 
reference amounts (i.e., reference amounts customarily consumed) 
established so that one product recommending consumption of, for 
example, one tablespoon (tbsp) per day is not compared to a product 
recommending five tbsp per day. The comment argued that the proposal 
allows very flexible reference amounts for supplements (i.e., whatever 
the manufacturer is recommending for consumption) and suggests that 
reference amounts of reference foods (as established in Sec. 101.13(j)) 
be specified in more concrete terms.
    The agency is not persuaded by the comment that more concrete terms 
are needed for reference amounts at this time. The agency has 
established in the final rule on general requirements for nutrition 
labeling for dietary supplements published elsewhere in this issue of 
the Federal Register a definition for the reference amount customarily 
consumed for dietary supplements in Sec. 101.12(b) as ``the maximum 
amount recommended on the label for consumption per eating occasion or, 
in the absence of recommendations, 1 tablet, capsule, packet, or 
teaspoonful, as appropriate.'' This definition is based on comments 
received on the proposal for mandatory nutrition labeling for dietary 
supplements.
    Section 101.13(p)(1), which FDA proposed to apply to dietary 
supplements, states that unless otherwise specified, the reference 
amount customarily consumed set forth in Sec. 101.12(b) through (f) 
shall be used in determining whether a product meets the criteria for a 
nutrient content claim. The comment did not suggest an alternative to 
the reference amount that could be used as the basis for comparative 
claims for dietary supplements. Therefore, given the fact, as the 
agency said in the proposal on nutrient content claims for dietary 
supplements (58 FR 33731 at 33732), that a consistent approach to 
nutrient content claims on dietary supplements and on foods in 
conventional food form will increase consumers' ability to use and 
understand such claims, FDA is not adopting a different approach to 
comparative claims for dietary supplements than the one that it adopted 
for foods in conventional food form.
    The agency acknowledges that there is a potential for unfair 
marketing and misleading claims if the serving size is manipulated 
upwards or downwards to enable a product to make a nutrient content 
claim. The agency retains the authority to regulate any such misleading 
claims under section 403(a) of the act. Issues concerning serving size 
are further discussed in the companion document on nutrition labeling 
for dietary supplements, published elsewhere in this issue of the 
Federal Register.

IV. Definitions for Specific Nutrient Content Claim Terms

A. Use of RDI's and DRV's in Formulating Definitions

    10. Many comments stated that limiting nutrient content claims to 
those nutrients with RDI's or DRV's was unnecessarily restrictive. 
Several comments suggested that content claims should be authorized 
with respect to a nutrient as long as it has either an RDI or DRV as 
established by FDA in Sec. 101.9(c) or a Recommended Dietary Allowance 
(RDA) as established by the National Academy of Sciences (NAS) (Ref. 
4). Other comments also stated that nutrient content claims should be 
authorized for nutrients for which NAS has established Estimated Safe 
and Adequate Daily Dietary Intakes (ESADDI's). Other comments suggested 
that FDA should expand the number of vitamins and minerals with RDI's 
when it publishes the final RDI/DRV rule following the expiration of 
the DS act moratorium.
    FDA agrees that the current list of RDI's does not represent the 
entire list of nutrients for which dietary recommendations have been 
established. The agency had proposed to establish RDI's for all 
nutrients for which RDA's or ESADDI's were provided in the 1989 edition 
of the NAS RDA's (56 FR 60366). However, under the DS act, the agency 
was constrained to retain the label reference values established in 
Sec. 101.9(c)(8)(iv) until at least November 8, 1993. These values were 
based on the 1968 RDA's. The 1968 RDA's did not contain recommended 
dietary values for a number of nutrients for which NAS has subsequently 
provided RDA's or ESADDI's. RDA's for vitamin K and selenium were 
established subsequent to 1968 and are listed in the 1989 edition of 
the NAS RDA's (Ref. 4). Furthermore, the 1980 and 1989 editions of the 
NAS RDA's provided ESADDI's for chloride, manganese, fluoride, 
chromium, and molybdenum. Now that the moratorium established by the DS 
act has expired, the agency is proposing elsewhere in this issue of the 
Federal Register to establish RDI's for all nutrients for which RDA's 
or ESADDI's are provided in the 1980 and 1989 editions of the NAS's 
Recommended Dietary Allowances but for which RDI's or DRV's have not 
been established by FDA. Once RDI's are established for these 
additional seven nutrients, nutrient content claims may be made for 
them.
    FDA intends to consider revising all of the RDI's to conform to the 
most recent levels established by NAS. However, FDA is aware that NAS 
is in the process of reevaluating the basis on which RDA's are 
determined. It is considering the issue of whether values should be 
selected to prevent deficiencies or to promote optimal wellness. The 
agency believes that its action should await completion of the NAS 
process. FDA is committed to working with NAS to help resolve this 
issue.
    Accordingly, as stated in response to comment number 1 above, FDA 
has concluded that it is not possible to define nutrient content claims 
for nutrients for which no reliable reference standards such as the 
RDI's and DRV's have been established. The agency believes that 
authorization for nutrient content claims for nutrients for which no 
RDI or DRV exists (e.g., vitamin K) needs to be deferred until RDI's or 
DRV's are adopted. In the interim, quantitative nutrient information 
may be listed in the nutrition label as discussed in the final rule on 
general requirements for nutrition labeling for dietary supplements 
published elsewhere in this issue of the Federal Register.
    Also, manufacturers may provide amount or percentage statements as 
described in Sec. 101.13(i)(3) for those nutrients that do not have 
RDI's or DRV's. For example, while there is no RDI for fluoride, under 
this provision, manufacturers may declare the amount of the nutrient 
present (e.g., 2 mg fluoride) on any panel outside of the Nutrition 
Facts box.
    11. One comment stated that claims should be permitted for beta-
carotene.The agency believes that claims regarding beta-carotene (e.g., 
``contains beta-carotene'') are claims about an ingredient that make 
implied representations about the level of vitamin A that is present in 
the food as beta-carotene. This conclusion is consistent with section 
403(r)(1)(A) of the act, which states that a food can be misbranded by 
a statement that expressly or by implication characterizes the level of 
a nutrient in a food. The agency considers that the claim ``contains 
beta-carotene'' implies that there is enough beta-carotene in the food 
to constitute a ``good source'' of vitamin A (i.e., it contains 10 
percent or more of the DV for vitamin A from beta-carotene). Such a 
claim is provided for in Sec. 101.65(c).
    12. One comment advocated defining nutrient content claims for 
ultratrace nutrients including boron, silicon, vanadium, arsenic, and 
tin. The comment stated that claims about these ultratrace elements 
should be permitted on the basis of the RDA, ESADDI, or the amounts 
found in the average well-balanced diet. Additionally, this comment 
argued that reference values should be available for ultratrace 
nutrients once reputable scientific evidence is established that such 
nutrients serve important metabolic or physiological functions in the 
body. The comment also suggested that label information be permitted 
for choline and inositol.
    The agency disagrees. The trace elements arsenic, nickel, silicon, 
boron, cadmium, lead, lithium, tin, vanadium, and cobalt, as well as 
choline and inositol, have not been shown to be essential in humans. No 
RDA's or ESADDI's for these substances have been established by NAS. 
NAS states that several of these substances ``naturally present in 
foods are known to be required in the diets of various animal or 
microbial species, but there is little or no evidence of their dietary 
essentiality for humans'' (Ref. 4). While NAS acknowledges that some of 
these classes of substances may ``one day be candidates for RDA's,'' it 
states that there is currently no evidence that these substances are 
essential in humans (Ref. 4).
    As stated in the ``Summary'' section of the 10th edition of the NAS 
RDA publication (Ref. 4), the NAS RDA's are based not only on data from 
nutrient intake measurements but also on information from nutrient 
balance studies, experimental intake studies, biochemical measurements, 
epidemiological observations of nutrient status, and extrapolation of 
data from animal experiments. FDA does not agree with the comments that 
it is desirable to base label reference values for nutrient content 
claims solely on individual scientific research publications, no matter 
how current, or solely on data on amounts of the trace element found in 
well-balanced diets. The existence of such data does not mean that 
there is scientific agreement on the essentiality of the nutrient or on 
the recommended level in the diet. Should agreement on the essentiality 
of additional nutrients be reached, timely and appropriate changes to 
the label reference values can be made through FDA's rulemaking 
procedures.
    However, as stated above, manufacturers are free to declare the 
amount of the trace elements, or choline or inositol, on the product 
label outside of the ``Nutrition Facts'' panel in accordance with 
Sec. 101.13(i)(3). Such a statement of amount is not considered to 
characterize the level of the nutrient in the food, as would claims 
such as ``high'' or ``more.''
    13. One comment stated that although no RDI's have been established 
for certain vitamins and minerals, nutrient content claims could be 
based on reference foods that are recognized sources of those 
nutrients. For example, the label could state that ``Brand X provides 
more vitamin K than two servings of cabbage,'' based on the vitamin K 
content of the reference amount for vegetables without sauce listed in 
Sec. 101.12, Table 2.
    The agency disagrees. Until a reference standard is established 
there is no basis for confidence that cabbage is a good source of 
vitamin K. There is also no basis for confidence that the amount of 
vitamin K in the food that is to be the subject of the claim is 
nutritionally significant. Elsewhere in this issue of the Federal 
Register, the agency has proposed to expand the list of nutrients with 
RDI's, including vitamin K. At this time, however, FDA concludes that 
it would be premature to authorize such claims.

B. Specific Requirements for Nutrient Content Claims (21 CFR 101, 
Subpart D)--Applicability to Dietary Supplements

1. Sec. 101.54 Nutrient Content Claims for ``Good Source,'' ``high,'' 
and ``More''
a. ``Good source'' and ``high''
    14. One comment encouraged the agency to maintain the proposed 
definitions for ``good source'' and ``high'' for dietary supplements. 
The comment argued that a higher level (e.g., 40 percent of the RDI) 
would suggest to consumers that daily nutrient intakes could be 
achieved by consuming only a few foods, which is inconsistent with 
dietary guidelines. The comment maintained that if a new higher claim 
level was adopted for supplements, it would likely also apply to foods 
in conventional food form based on the logic of the proposal for 
nutrient content claims for dietary supplements (i.e., consistency in 
definitions). The comment stated that users of dietary supplements are 
well aware of the elevated nutrient levels in these products, and that 
a new paradigm is not needed to inform consumers of these levels.
    On the other hand, several comments did not support the proposal to 
use the same definitions for ``good source'' and ``high'' claims as 
those used for foods in conventional food form. The comments argued 
that the terms ``good source'' and ``high'' should not carry the same 
meaning for supplements as for foods in conventional food form, that 
most supplements contain at least 100 percent of the Daily Value for 
most of the nutrients they provide, and that consumers expect most of 
these products to contain at least 100 percent of the Daily Value. The 
comments maintained that allowing any product with as little as 10 or 
20 percent of the RDI to carry ``good source'' and ``high'' claims 
would confuse and mislead consumers.
    One comment questioned whether it is appropriate to permit the use 
of these nutrient content claims on vitamins and mineral supplements 
since it implies that supplements are comparable to, and acceptable 
substitutes for, foods in conventional food form. The comment also 
noted that nutrition educators feel strongly that supplements can 
enhance the nutrient intake from foods in conventional food form but 
can never replace them since foods in conventional food form provides 
other important components. On the other hand, many comments supported 
the proposal to extend the same definitions for ``good source'' and 
``high'' for foods in conventional food form to dietary supplements. 
These comments emphasized the importance of consistency in definitions 
to assist consumer education.
    One comment requested clarification on whether the terms ``good 
source'' and ``contains'' will be permitted for dietary supplements. 
The comment maintained that such claims provide consumers with 
important information regarding the precise content of various 
nutrients and should not be subject to discriminatory treatment solely 
on the basis of whether such claims are made for a nutrient in a 
dietary supplement as opposed to one in a conventional food.
    The agency has reviewed these comments and is not persuaded that 
the definition of the terms ``good source'' and ``high'' should be 
different for dietary supplements than for foods in conventional food 
form. The agency finds that the definitions for foods in conventional 
food form and dietary supplements should be consistent. As directed by 
the 1990 amendments (section 3(b)(1)(A)(iii)(VI)), FDA defined the term 
``high,'' and the synonyms ``rich in'' and ``excellent source of,'' for 
use on labels and in labeling in Sec. 101.54 (58 FR 2302 at 2344). In 
Sec. 101.54(c)(1) of final rule on nutrient content claims, the agency 
stated that the term ``good source'' may be used to describe a food 
when a serving of the food contains 10 to 19 percent of the RDI or the 
DRV for a nutrient. Likewise, the agency stated that the term ``high'' 
may be used to describe a food when a serving contains 20 percent or 
more of the RDI or the DRV. FDA concluded that the use of these terms 
would permit a sufficient number of food items to bear ``good source'' 
and ``high'' claims to allow consumers to use the claims in selecting 
foods that are better sources of nutrients (58 FR 2344).
    While FDA recognizes that under the present definitions, most, if 
not all, dietary supplements of vitamins, minerals, potassium, and 
fiber would qualify for ``good source'' or ``high'' claims, the agency 
does not agree with those comments that argued that the definitions, as 
proposed, would be confusing or misleading to consumers. As suggested 
by the IOM report on nutrition labeling (Ref. 6), the use of consistent 
and targeted content claims increases consumers' confidence in the 
validity of the claim. FDA is aware of no evidence to support an 
alternate conclusion. The basic principle of consistency in definitions 
of nutrient content claims is discussed in detail in comment 2 of this 
document.
    Furthermore, the agency recognizes that consumers expect dietary 
supplements to be concentrated sources of nutrients. Consumer studies 
support this conclusion (Refs. 1 and 5). FDA acknowledges that the 
terms ``good source'' and ``high'' might be of limited utility in 
comparing nutrient content among dietary supplements of vitamins and 
minerals because virtually the entire class of products would qualify 
for such claims. However, these terms may be useful for some single 
source dietary supplements of calcium, biotin, or fiber or for 
multinutrient preparations containing these nutrients. These nutrients 
are generally found in dietary supplements at levels below the Daily 
Value.
    Additionally, FDA believes that these terms would be useful in 
highlighting the nutrient content of some herbs and other similar 
nutritional substances that have nutrients at levels high enough to 
qualify for the definition of one of the above terms. For these 
reasons, the agency is not persuaded to preclude the use of these terms 
for dietary supplements.
    The agency agrees with the comment that stated that dietary 
supplements cannot replace foods in conventional food form in all 
respects because the latter foods supply other important components. 
However, FDA recognizes that dietary supplements can be a useful part 
of the diet for those who wish to make sure that they consume at least 
the RDI amount for all vitamins and minerals or for those who wish to 
increase their daily intake of a particular substance above those 
levels that are ordinarily available from conventional foods. Thus, FDA 
finds that use of these terms on dietary supplements is appropriate.
    FDA is convinced that consistency in definitions of nutrient 
content claims across the food supply is necessary. Consistency 
facilitates consumer education by limiting the number of terms that the 
public must learn and interpret. Moreover, different definitions for 
the same terms for dietary supplements and foods in conventional food 
form would be confusing to consumers because of the difficulties 
inherent in learning alternate definitions for the same term. There is 
a greater chance of error and misinterpretation when several 
definitions must be learned for the same term. Thus, different 
definitions would likely do more harm than good. Accordingly, the 
agency concludes that the proposed definitions for ``good source'' and 
``high'' are appropriate, and that there is no reason to define the 
terms differently for dietary supplements.
    The agency would like to clarify that ``good source'' and 
``contains'' as defined Sec. 101.54(c)(1) are nutrient content claims 
that can be used for foods in conventional food form as well as for 
dietary supplements. There is nothing in this final rule that states 
that the use of these terms would not be allowed for dietary 
supplements.
    15. One comment stated that under FDA's proposal, consumers who 
want truly high levels--that is, levels that exceed the RDI--would have 
no means of identifying those products, other than reading the fine 
print on the back of each supplement label.
    The comment acknowledged that consumers might also be confused if 
``high'' had one meaning when the claim appears on labels of dietary 
supplements and a different meaning when the claim appears on labels of 
foods in conventional food form. To avoid that inconsistency, the 
comment urged FDA to prohibit the claims ``good source'' and ``high'' 
on supplements. Further, the comment suggested that the agency should 
define the term ``high potency'' and allow it to be used only on 
supplements.
    FDA disagrees that the terms ``good source'' and ``high'' should be 
prohibited on the labels of dietary supplements. The agency recognizes 
that a claim of ``high'' will not specifically identify those products 
that have levels of nutrients that exceed the RDI. However, the 
quantitative amount of a nutrient in a dietary supplement is often a 
part of the statement of identity for the product, and additional 
quantitative information regarding the level of a nutrient may also be 
found in amount or percentage statements on the principal display 
panel. In addition, as a result of the agency's new format 
requirements, the nutrition label for dietary supplements of vitamins 
and minerals provides quantitative information on the levels of 
specific nutrients as well as the percent DV for each nutrient in a 
more legible format. Consequently, consumers will have easy access to 
information regarding the levels of specific nutrients and may adjust 
their levels of intake accordingly.
    Further, as discussed in the previous comment, while the terms 
``good source'' and ``high'' may be of limited utility for dietary 
supplements of vitamins and minerals, these terms may be useful in 
highlighting the nutritional content of single nutrients, such as 
biotin and calcium, that are generally found in products at levels well 
below the RDI, as well as of dietary supplements of herbs and other 
similar nutritional products. Therefore, FDA concludes that precluding 
the use of these terms on dietary supplements is unjustified.
    However, FDA believes that there is a sufficient basis to consider 
defining the term ``high potency'' or some similar term as a nutrient 
content claim. FDA's tentative view is that this term, or a similar 
term when defined, could provide a way for manufacturers to describe 
the higher levels of nutrients in dietary supplements. (See comment 25 
for further discussion of this matter.)
b. ``More''
    16. One comment stated that consumers could be misled if 
comparative claims are made among high potency vitamin/mineral 
supplements. The comment stated that if, for example, one brand of 300-
mg vitamin B6 tablets claimed that it contained ``more'' than a 
competitive 250-mg product, then the consumer may get the misleading 
impression that the former product is better. The comment maintained 
that as customers shop for supplements, they will be able to readily 
observe whether one product is more potent than another without label 
claims suggesting superiority of one over another. If such a claim 
resulted in better sales, then a ``horsepower race'' would ensue. The 
comment recommended that ``more'' claims for vitamins and minerals not 
be allowed if the nutrient potency of the reference product already 
meets or exceeds 100 percent of the Daily Value.
    The agency acknowledges that there is the possibility that some 
manufacturers may choose to increase potencies in order to make a 
``more'' claim in comparison to another brand, but the agency disagrees 
that the limitation suggested by the comment is warranted at this time. 
The agency points out that ``more'' claims for nutrients with an RDI or 
DRV, including those products with nutrients in megadoses, such as 
those in the example cited by the comment, must include the following 
information: The percentage (or fraction) that the nutrient was 
increased relative to the RDI or DRV, the identity of the reference 
food, and the quantitative amount of the nutrient present (e.g., 
contains ``20 percent more of the DV for vitamin B6 per tablet than 
product `x'. The vitamin B6 content of product `x' is 250 mg. This 
product contains 300 mg vitamin B6.'') The nutrition label of a product 
containing 300 mg of vitamin B6 must state that the product contains 
1,500 percent of the Daily Value. The agency acknowledges that the 
amount of information required to make a ``more'' claim is 
considerable, but such information is necessary to allow consumers to 
readily see how the amount of a nutrient for which a ``more'' claim is 
made fits into the total daily diet.
    Furthermore, FDA believes that the concern regarding ``horsepower 
races'' in dietary supplements stems from concerns of possible unfair 
marketing among manufacturers as well as from safety concerns inherent 
in the addition of very high levels of nutrients to supplements. 
Similar concerns with foods in conventional food form led to the 
establishment of FDA's fortification policy in 1980. This policy, while 
published in Sec. 104.20, does not have the force of a regulation. 
However, the agency has not found evidence of widespread ``horsepower 
races'' with such foods. The agency urges industry, particularly 
industry associations, to develop standards regarding nutrient levels 
and to monitor compliance with those standards to minimize any safety 
problems.
c. Restrictions on label or labeling claims based on section 
411(b)(2)(B) of the act
    17. One comment from a trade association stated that the literal 
reading of section 411(b)(2)(B) of the act prohibits giving prominence 
on the label of dietary supplements of vitamins or minerals to 
ingredients that are not vitamins or minerals. The comment argued that 
these prohibitions result in the withholding of information that is of 
interest to consumers, and that it is increasingly common for 
manufacturers to market products that offer a combination of vitamins, 
minerals, herbs, and other dietary substances. The comment stated that 
the principal reason for the purchase of these products is not their 
vitamin and mineral content but the other ingredients. The comment 
invited FDA to join the supplement industry in seeking an amendment to 
section 411 of the act that will remedy this problem.
    Another comment disagreed with FDA's interpretation of section 
411(b)(2)(B) of the act and suggested that this section merely 
prohibits giving prominence or emphasis to such ingredients. The 
comment argued that nutrients other than vitamins and minerals or 
sources of vitamins and minerals should be permitted to appear outside 
or immediately following the nutrition label, providing that such 
information is not emphasized by, for example, being presented in type 
size greater than that used in the nutrition label. The comment stated 
that such limited declarations would not conflict with current 
provisions of the act and would be fair and reasonable means of 
communicating about the presence of ingredients that provide added 
value to many dietary supplement products.
    The agency is persuaded by these comments that a clarification of 
those sections of the proposal relating to section 411(b)(2)(B) of the 
act is needed. Section 411(b)(2)(B) of the act states that the labeling 
and advertising for dietary supplements of vitamins and minerals may 
not give prominence to or emphasize ingredients that are not vitamins, 
minerals, or represented as a source of vitamins or minerals. Because 
of this provision, nutrient content claims about ingredients that are 
not vitamins or minerals (e.g., ``more fiber,'' ``high protein'') may 
not be made on dietary supplements of vitamins or minerals.
    It must be emphasized that this provision pertains only to dietary 
supplements of vitamins and minerals. If, for example, an herbal 
extract includes vitamins and minerals but is labeled as an herbal 
extract, in compliance with Sec. 101.9 and other applicable provisions, 
and is advertised as such, section 411(b)(2)(B) of the act would not 
apply. The same is true for a product that is primarily a protein 
supplement. A protein supplement with added vitamins and minerals that 
is labeled and advertised as a protein supplement could declare that it 
is high in fiber. Such claims are permissible as long as they are made 
in accordance with section 403(r) of the act, and they are not false or 
misleading in any particular.
    However, section 411(b)(2)(B) of the act makes clear that in the 
labeling and advertising of dietary supplements of vitamins and 
minerals, ingredients other than vitamins or minerals cannot be 
emphasized or given prominence. FDA interprets prominence not solely as 
a function of type size. Declaring an ingredient outside or immediately 
following the nutrition label is another means of giving prominence. 
For example, a statement such as ``5 g psyllium,'' except in extremely 
limited circumstances, cannot be made on the principal display panel, 
outside the nutrition label, or immediately following the nutrition 
label of a dietary supplement of vitamins and minerals because such 
placements give prominence to that ingredient. However, the declaration 
of psyllium in the ingredient list would not be construed as giving 
prominence to that ingredient. On the other hand, ``5 g psyllium'' 
could be declared in an amount statement on the principal display 
panel, outside, or immediately following the nutrition label on protein 
supplements, on dietary supplements of herbal extracts, and on dietary 
supplements of other similar nutritional substances so long as these 
dietary supplements are not subject to section 411 of the act.
    FDA advises that if a sugar is an ingredient in a dietary 
supplement of vitamins or minerals, claims about the amount of sugar 
actually in the product would have to be restricted. However, ``sugar-
free'' and ``no added sugar'' are absence claims that assert that sugar 
is not an ingredient. The agency concludes that the use of these terms 
is acceptable on dietary supplements of vitamins or minerals, as well 
as on other types of dietary supplements.
    In view of this clarification, the agency believes that section 
411(b)(2)(B) of the act, as written, is sufficiently flexible to 
accommodate claims on products that are not dietary supplements of 
vitamins or minerals. FDA believes that it is therefore unnecessary to 
amend section 411 of the act.
2. Nutrient Content Claims for Sugar Content
    18. One comment questioned the appropriateness of allowing ``sugar-
free'' claims for a dietary supplement containing less than 0.5 g of 
sugars. The comment stated that many supplements come in capsules or 
tablets that weigh slightly less or not much more than 0.5 g, and 
therefore, supplements that are mostly sugars could use the term 
``sugar-free.'' The comment suggested that the term ``sugar free'' on a 
dietary supplement should mean a much lower amount of sugars, or that 
the product should be totally devoid of sugars.
    The comment also argued that terms such as ``negligible source of 
sugar,'' ``dietarily insignificant source of sugar,'' and ``trivial 
source of sugar'' are not synonymous with ``sugar-free'' because such 
terms connote the presence of some sugar content.
    FDA is not persuaded by the comment that 0.5 g or less of sugars 
per serving is an inappropriate definition of insignificance for sugars 
for dietary supplements. Section 101.60(c)(1) provides that for a food 
in conventional food form to make a ``sugar free'' claim, the food must 
contain less than 0.5 g of sugars per reference amount. Less than 0.5 g 
of sugars per reference amount is an amount that is consistent with the 
agency's policy of defining ``free'' claims at or near the reliable 
limit of detection and in an amount that is dietetically 
inconsequential (56 FR 60421 at 60432). As a result, even frequent 
consumption of a food bearing a ``sugar free'' claim would not result 
in an intake of sugars that would affect the overall diet in any 
meaningful way.
    FDA acknowledges that there may be situations in which a dietary 
supplement may contain a significant proportion of sugars on a weight 
basis and be able to make the claim ``sugar free.'' The agency 
believes, however, that even in such instances, if the total amount of 
sugars in a serving of the product is less than 0.5 g, its net 
contribution to the total daily diet would be inconsequential.
    Additionally, FDA considers it important that nutrient content 
claims correspond with the nutrition label, which serves as a source of 
specific information for consumers concerning the nutritional value of 
the food. The nutrition labeling regulations allow foods containing 
less than 0.5 g sugars per labeled serving to declare 0 g of sugars 
(Secs. 101.9(c)(6)(ii) and 101.36(b)(3)).
    FDA rejects the suggestion that it permit use of the term ``sugar 
free'' only where there is an absolute absence of sugars. FDA believes 
that it is appropriate to apply the term ``free'' to a nutrient when a 
food contains that nutrient in a dietetically trivial or 
physiologically inconsequential amount, even though the nutrient is 
present at a level at or near its reliable limit of quantitation, 
because with modern analytical methods, the level at which the presence 
of a nutrient may be quantified is becoming increasingly smaller (58 FR 
2302 at 2320). The agency believes that it is appropriate to focus on 
dietary insignificance, and very trivial amounts have no impact on the 
diet for the purpose of defining ``sugar free.''
    The agency also disagrees that the terms ``negligible source of 
sugar,'' ``dietarily insignificant source of sugar'', and ``trivial 
source of sugar'' are inappropriate synonyms for ``sugar free.'' 
Section 403(r)(2)(A)(i) of the act states that a nutrient content claim 
must be defined by regulation. In addition, section (3)(b)(1)(A)(ix) of 
the 1990 amendments provides that those regulations may include similar 
terms commonly understood to have the same meaning. The agency is not 
aware of any reason why the above terms are inappropriate synonyms for 
``sugar free.'' Although these synonyms do not convey the absolute 
absence of sugar, they reflect that the amounts are dietetically 
trivial and of no dietary significance. Therefore, the agency rejects 
this comment.
    19. One comment stated that the term ``no added sugar'' can be used 
only when a product is expected to contain sugar, but that consumers do 
not know when supplements are expected to contain sugars. The comments 
suggested that FDA should not preclude the use of the term ``no added 
sugars'' as this term would be useful to consumers in identifying those 
products without sugar.
    The agency is persuaded that a review of the conditions for the use 
of the term ``no added sugar'' is warranted. FDA did not propose to 
preclude the use of the term ``no added sugar'' on all dietary 
supplements. The agency finds that this term is appropriate for some 
dietary supplements, such as children's chewable vitamins, that are 
frequently sweetened. Section 101.60(c)(2) states that the terms ``no 
added sugar,'' ``without added sugar,'' or ``no sugar added'' may be 
used only if: (1) No amount of sugars, as defined in 
Sec. 101.9(c)(6)(ii), or any ingredient that contains sugars, or that 
functionally substitutes for added sugars is added during processing or 
packaging, (2) the product does not contain an ingredient containing 
added sugars, (3) the sugars content has not been increased above the 
amount present in the ingredients by some means such as the use of 
enzymes, (4) the food that it resembles and for which it substitutes 
normally is formulated with sugars, and (5) the product bears a 
statement that the food is not ``low calorie'' or ``calorie reduced'' 
(unless the food meets the requirements for a ``low'' or ``reduced 
calorie'' food) and that directs consumers' attention to the nutrition 
label for further information on sugar and calorie content.
    As is the case for foods in conventional food form, the agency 
believes that to avoid misleading consumers, the term ``no added 
sugar'' should be limited to dietary supplements that would be expected 
to contain added sugars. The agency advises that the purpose of a ``no 
added sugar'' claim is to identify a food that differs from a similar 
food because it does not contain the added sugars that would normally 
be present in the similar food. For this provision to be of practical 
benefit to consumers, it must preclude the use of the claim on a food 
where the sugars that are normally added are replaced with an 
ingredient that contains sugars that functionally substitute for the 
added sugars. Thus, the agency concludes that the use of any ingredient 
that contains sugars that would normally be added to a food precludes 
the use of the ``no added sugar'' nutrient content claim. The agency 
believes that claims concerning the absence of added sugars on products 
that would not normally contain added sugar (e.g., dietary supplements 
of vitamins and minerals for adults) are likely to mislead consumers 
into thinking that a particular brand may be more desirable when 
compared to other brands of the same product.
    FDA acknowledges that consumers may not know every type of product 
that could be expected to contain sugar. However, the final rule on 
nutrition labeling for dietary supplements published elsewhere in this 
issue of the Federal Register specifies that sugars will be listed in 
the ingredient label and must be declared in the nutrition label if 
present in more than insignificant amounts. Through these provisions 
the consumer can readily ascertain which products contain sugars.

C. Implied Nutrient Content Claims

1. Claims That are not Nutrient Content Claims
    Section 101.65(b)(1) of the final rule on nutrient content claims 
provides that statements that declare the absence of food components or 
ingredients that are not nutrients of the type required to be declared 
on the nutrition label, and that are intended to facilitate avoidance 
for such reasons as food intolerance (e.g., lactose free), religious 
beliefs, dietary practices such as vegetarianism or other nonnutrition 
related reason, (e.g., ``100 percent milk free''), are not nutrient 
content claims. In the proposal on nutrient content claims for dietary 
supplements, the agency tentatively concluded that this paragraph is 
applicable to dietary supplements and requested comment on other 
examples that are appropriate for dietary supplements.
    20. Comments suggested that other examples of terms in this 
category include the following: gluten free, wheat free, corn free, 
yeast free, starch free, milk free, egg free, soy free, no artificial 
ingredients, nonirradiated, and no synthetic ingredients. The comments 
requested that FDA confirm that these statements are allowed on the 
label.
    None of the terms that were submitted in the comments other than 
``egg free'' would constitute nutrient content claims. The term ``egg 
free'' can be interpreted as an implied claim about cholesterol.
    The agency points out that it does not currently have a definition 
for ``artificial'' except as that term applies to flavors and colors. 
Similarly, it has no definition for ``synthetic'' except as that term 
applies to flavors and colors. Although these terms have not been 
defined by FDA, the agency believes that they are not nutrient content 
claims unless they are used in a context in which they explicitly or 
implicitly describe the level of a nutrient. However, even if these 
terms are not nutrient content claims, manufacturers who use them must 
make sure that their use is not false or misleading.
    21. FDA proposed to include dietary supplements in the coverage of 
Sec. 101.65(b)(4). This section states that when an ingredient 
constitutes essentially 100 percent of a food, so that the name of the 
ingredient is the statement of identity, the name of the ingredient 
generally does not constitute an implied nutrient content claim unless 
it is used in a context to suggest that a nutrient is absent or present 
in a certain amount. FDA used a statement of identity for a dietary 
supplement in which an ingredient constitutes essentially 100 percent 
of a supplement (e.g. ``60 mg--vitamin C'') as an example. One comment 
pointed out that 60 mg vitamin C tablets contain excipients (fillers, 
binders, lubricants, disintegrants) other than vitamin C. The comment 
requested clarification as to whether, in the example of vitamin C 
tablets, Sec. 101.65(b)(4) requires that the amount claimed in the 
statement of identity constitute 100 percent of the claimed amount of a 
food in Sec. 101.65(b)(4).
    In the example added to Sec. 101.65(b)(4), the amount refers to the 
claimed nutrient. A tablet stating ``60 mg--vitamin C tablets'' should 
contain 60 mg of that nutrient. The agency recognizes that a nutrient 
will not constitute precisely 100 percent of some dietary supplements, 
such as vitamin tablets or capsules, and advises that small amounts of 
excipients, binders, lubricants, or disintegrants added for 
technological purposes are allowable in addition to the stated nutrient 
content.
    Additionally, FDA points out that under Sec. 101.3(c), if a food is 
marketed in various optional forms, the particular form is a necessary 
part of the statement of identity. Because vitamin C is marketed in 
tablet, capsule, and liquid form, the form is part of the name. 
Therefore, this food should be called ``60 mg-vitamin C tablets.'' The 
agency acknowledges an error in this regard in the proposal and is 
revising Sec. 101.65(b)(4) to make the correction.
    22. One comment stated that it is not unusual for a dietary 
supplement to contain several nutrients of one type and a single 
nutrient of another type, such as ``multiple-vitamins with iron.'' The 
comment requested confirmation that ``with iron'' would not represent 
an implied nutrient content claim.
    The agency advises that a term such as ``with iron,'' when used on 
the statement of identity of a supplement, is intended to describe the 
nature of the food. When a statement of identity simply states ``with 
iron'' or specifies the amount of iron in a product (e.g., 
``multivitamin with 15 mg iron''), the statement is not a nutrient 
content claim. Such statements fall under Sec. 101.65(b)(5).
    However, as the agency stated in Sec. 101.65(b)(5), there may be 
cases in which other statements on the label or labeling would have the 
effect of making the statement into a nutrient content claim. For 
example, if the labeling of a multivitamin with iron includes a 
discussion of the importance of iron in the diet, FDA believes the 
statement ``with iron'' would be an implied claim that the multivitamin 
is a good source of iron. If the labeling is devoid of such 
information, FDA would be unlikely to consider the name to be an 
implied nutrient content claim. The agency will evaluate such claims on 
a case-by-case basis in the context of the entire label and labeling to 
determine whether they are nutrient content claims.
    23. One comment maintained that FDA failed to address whether the 
currently used claim of ``high in antioxidants'' was within the scope 
of the proposed regulation.
    While the term ``high in antioxidants'' was not explicitly 
discussed in the proposed regulations for nutrient content claims for 
dietary supplements, the agency considers it to be an implied nutrient 
content claim that would come under Sec. 101.65. FDA's view is that 
this claim implies that the food on which it appears contains a 
``high'' amount (i.e., at least 20 percent of the RDI, see 
Sec. 101.54(b)(1)) of each antioxidant. One problem with this claim, 
however, is that there is no established definition of 
``antioxidants.''
    FDA believes that a logical place to start in defining this term is 
section 3(b)(1)(A)(x) of the 1990 amendments. That provision directed 
FDA to determine whether a health claim on antioxidant vitamins and 
cancer, could be authorized under the standard that it established for 
dietary supplements under section 403(r)(5)(D) of the act. In its 
proposed regulations to implement the 1990 amendments, in response to 
this provision, FDA considered the effects of vitamin C, vitamin E, and 
beta-carotene on cancer because these nutrients are the vitamins or 
provitamins that function as antioxidants (56 FR 60624, November 27, 
1991). In the final rule on antioxidant vitamins and cancer, FDA 
concluded that its selection of these nutrients was appropriate (58 FR 
2622, January 6, 1993). Thus, the agency has determined that the 
direct-acting antioxidant vitamins or provitamins include vitamin C, 
vitamin E, and beta-carotene. Based on its review of the information 
presented at a recent conference entitled ``Antioxidant Vitamins and 
Cancer and Cardiovascular Disease,'' which was initiated by FDA, the 
agency is not aware of any basis to expand this list because the 
biological role of other vitamins as direct antioxidants has not been 
confirmed (Ref. 3).
    While it is arguable that FDA could authorize ``high in 
antioxidants'' as an implied claim pertaining to antioxidant vitamins 
as a logical outgrowth of the proposal, because the claim applies to 
foods in conventional food form as well as to dietary supplements, the 
agency believes that the better course is to propose to authorize such 
a claim. In addition, the definition of ``antioxidants'' is not free 
from controversy. The agency is aware, based on its review of dietary 
supplements whose labeling currently includes a ``high in antioxidant'' 
claim, that some manufacturers view this term as including certain 
minerals. Antioxidant minerals have not been addressed by the agency, 
and, therefore, final rules implementing the 1990 amendments do not 
provide for claims about them. Thus, FDA finds that a rulemaking on the 
definition of ``antioxidants'' will provide an opportunity to establish 
the precise meaning of this term.
    Consequently, FDA intends to address this issue as quickly as 
possible in a forthcoming proposal. Given that, elsewhere in this issue 
of the Federal Register, the agency is establishing a date of 
applicability of July 5, 1995, for this regulation, FDA anticipates 
that there is sufficient time to take final action on such a proposal 
before that date.
2. ``Healthier''
    24. One comment from a manufacturer observed that FDA proposed a 
regulation concerning use of the term ``healthy'' (proposed 
Sec. 101.65(d)(2) (58 FR 2949)) in the January 6, 1993 Federal Register 
(58 FR 2944 at 2949). The comment notes that ``healthy'' and similar 
terms are used in a variety of contexts. For example, one of the 
manufacturer's dietary supplements is labeled as ``the way to
a healthier life.'' The comment suggested that this claim should not be 
deemed to be subject to the ``healthy'' definition.
    FDA advises that it is in the process of finalizing regulations on 
the January 6, 1993, proposal for the claim ``healthy.'' The use of 
terms such as ``healthy,'' ``healthier,'' ``healthiest'' will be 
addressed in that final rule.
    In its final rule on nutrient content claims, FDA concluded that a 
claim that a food, because of its nutrient content, may be useful in 
maintaining healthy dietary practices is a claim that characterizes the 
level of a nutrient in that food (58 FR 2302 at 2375). Accordingly, the 
agency provided in Sec. 101.65(d)(1) that such statements are implied 
nutrient content claims and are subject to the requirements of section 
403(r) of the act.
    However, the agency also stated that when a term such as 
``healthy,'' ``wholesome,'' or ``nutritious'' appears on a food label 
in a context that does not render it an implied nutrient content claim, 
it is not subject to the requirements of section 403(r) of the act (58 
FR 2302 at 2375). Under such conditions, the use of the term is subject 
to section 403(a) of the act, and FDA will consider whether it is 
misleading on a case-by-case basis. The agency intends to give more 
specific guidance in the final rule on ``healthy.''
1. General Nutrition Claims Such as ``High Potency,'' ``High 
Absorption,'' and ``Balanced''
a. General issues
    In the proposal on nutrient content claims for dietary supplements, 
FDA requested comment on terms, ``high potency,'' ``high absorption,'' 
and ``balanced,'' which are often encountered on labels or in labeling 
of dietary supplements and which seem to imply that the dietary 
supplement will contribute to good health (58 FR 33731 at 33748). The 
agency requested comment on whether there are established meanings for 
these terms, and, if so, whether they characterize the level of the 
nutrients in the food. FDA stated that if comments demonstrate that 
there are accepted definitions used in the dietary supplement industry 
for these terms that characterize the level of nutrients, and that if 
it determines that these definitions will assist consumers in 
maintaining healthy dietary practices, FDA will proceed with further 
rulemaking to adopt the definitions or to propose new ones.
    FDA also stated that if the agency agrees that such terms are 
nutrient content claims, under the provisions of the statute, such 
claims would be prohibited after the effective date for final rules, 
until such time as they are defined by FDA by regulation. Further, FDA 
stated that if comments demonstrate that there are accepted definitions 
for these terms, and they do not characterize the level of nutrients, 
in accordance with Sec. 101.65(d)(1) such terms would not be subject to 
section 403(r) of the act unless used in a nutritional context in 
association with an explicit or implicit claim or statement 
characterizing the nutrient content of the food.
    25. Several comments maintained that the terms ``high potency,'' 
``high absorption,'' and ``balanced'' are implied nutrient content 
claims and urged the agency to define or prohibit these terms. The 
comments stated that it is inappropriate and fraught with possibilities 
for deception to allow each manufacturer to define such claims. One 
comment stated that although these terms imply features of nutrient 
content to consumers, they do not have any established or useful 
meaning with regard to dietary supplements. The comment argued that 
these terms seem to be more specific to dietary supplements than to 
other food, so that their applicability in helping consumers make 
appropriate nutritional choices from the variety of foods available 
seems limited.
    On the other hand, several comments stated that these terms do not 
inherently refer to the level of nutrients, are not nutrient content 
claims, and therefore should not be defined. These comments maintained 
that such terms are formulation descriptions, which properly and 
truthfully describe the nature and type of the product. These comments 
contended that these terms have been used for many years, and that 
consumers have come to understand that products so described provide an 
amount of the primary nutrients in the formulation that is at least 
equal to the RDA's for those nutrients.
    One comment argued that FDA precedent exists for excluding such 
terms from regulation as nutrient content claims. The comment stated 
that as formulation descriptions, these terms are useful to consumers 
in helping them to make product choices, and manufacturers should be 
allowed to continue to use these terms in a manner that is consistent 
with FDA's policy on claims such as ``maximum strength'' for internal 
analgesics in the over-the-counter drug review (i.e., kept outside the 
scope of this rulemaking).
    The agency agrees that these terms seem to have more direct 
application to dietary supplements than to foods in conventional food 
form. Furthermore, these terms may have some utility in helping 
consumers select among dietary supplements. However, while these terms 
have apparently been used for years to imply superiority, the agency is 
uncertain what they mean to consumers.
    The agency disagrees that these terms should be regulated in the 
same manner as terms such as ``maximum strength,'' which are used on 
the labels of over-the-counter drug products. The over-the-counter drug 
regulations include maximum amount limitations. Section 411(a)(1)(A) of 
the act prohibits limits on the potency of dietary supplements of 
vitamins or minerals except on the basis of safety. Therefore, the 
situations are not analogous.
    The agency believes that each of these terms should be evaluated 
individually because they do not seem to be synonymous. ``High 
potency'' seems to focus on nutrient level or content, but 
``balanced,'' as one comment suggested, seems to be a formulation 
claim. ``High absorption'' seems to focus on how the body responds to 
the nutrient. The agency will address each of these terms in more 
detail in the comments that follow.
b. Definition for ``high potency''
    26. The majority of comments stated that the term ``high potency'' 
or ``full potency'' is an implied nutrient content claim and should be 
defined. Several definitions were offered for this term. A few comments 
stated that multivitamins and minerals are termed ``high potency'' when 
the majority of nutrients with established RDA's are present at the 
levels equal to or in excess of the RDA.
    Similarly, another comment stated that the term should be 
restricted to formulations that contain micronutrients at levels of at 
least twice the applicable RDI or DRV because a multivitamin at 100 
percent of the DV might be ``high potency'' compared to a food in 
conventional food form but not ``high potency'' when compared to other 
dietary supplements.
    Another comment suggested that FDA should require a ``high 
potency'' single-ingredient supplement to contain at least twice the 
RDI, and that the front of the label should disclose what multiple of 
the RDI the supplement contains. The comment acknowledged that under 
this scheme, some nutrients, such as calcium and selenium, would not 
qualify to carry a ``high potency'' claim, because they are rarely sold 
at double the RDI. The comment suggested that if the supplement 
industry begins to market those supplements at higher doses in order to 
make ``high potency'' claims, then FDA could establish a lower minimum 
level, such as 50 percent more than the RDI for selenium or 50 percent 
of the RDI for calcium. Those minimum levels would apply to those 
nutrients only. The comment also suggested that FDA should allow ``high 
potency'' claims on multinutrient supplements when more than one-third 
of the nutrients that they contain meet the minimum level required for 
a high potency claim, and the label discloses which nutrients are 
present at high levels. For example, the label of a ``high potency'' 
multivitamin could carry an asterisk next to the claim, with the 
following disclosure: ``contains high levels of [number] vitamins.''
    Further, the comment stated that it is not reasonable to require 
that all of the nutrients in a multinutrient supplement be present at 
levels that are necessary for high potency claims because many 
nutrients are not--and should not--be sold in such high doses. For 
example, the comment suggested that ``high potency'' claims should be 
allowed on a multivitamin-and-mineral supplement that contains at least 
double the RDI of vitamins A, C, E, B6, B12, thiamin, riboflavin, and 
niacin but smaller amounts of vitamin D, iron, calcium, magnesium, 
zinc, and copper. The comment stated that the latter nutrients are 
typically sold at doses lower than double the RDI and may pose a risk 
at high levels.
    FDA has reviewed the comments and is persuaded that ``high 
potency'' is a claim that characterizes the level of a nutrient and 
therefore meets the definition in Sec. 101.13(b) of a nutrient content 
claim. FDA also is persuaded by the comments that this is a term that 
FDA should define in order to ensure that it will be useful to 
consumers in maintaining healthy dietary practices. However, given the 
range and diversity of the suggested definitions, the agency is not 
prepared to offer a definition of ``high potency'' at this time. FDA 
intends to review the suggestions it received on this issue and based 
on information received in comments, issue a proposed rule on an 
appropriate definition of ``high potency.''
    FDA recognizes that there is a need to provide this definition as 
quickly as possible. Therefore, FDA intends to act on this matter as 
expeditiously as its resources allow.
c. Definitions for ``high absorption''
    27. A couple of comments stated that the term ``high absorption'' 
does not refer to the level of nutrients but rather to bioavailability 
or how efficiently the nutrients are released from the product and 
absorbed into the bloodstream. One comment stated that ``high 
absorption'' means that the product meets the definition for ``high,'' 
and that a ``high amount'' is digested and assimilated.
    Another comment stated that from a biological viewpoint, the extent 
to which nutrients are absorbed from food or supplements depends not 
only on the chemical form of the nutrient itself but on the chemical 
environment presented by the carrier food in which it is contained and 
on the physiological state of nutrient need of the individual consumer. 
Given these factors, the comment stated that it is difficult to provide 
a meaningful definition of absorbability.
    One comment requested that the label should disclose information 
about the bioavailability of the product. Another comment suggested 
that FDA should allow labels to make ``high absorption'' or similar 
claims only when the manufacturer supplies bioavailability data showing 
that the product is better absorbed than a standard supplement. The 
comment stated that the agency should not allow this claim on 
supplements that simply meet or exceed the United States Pharmacopeial 
Convention's (USP's) (or other) standards for disintegration or 
dissolution, because meeting those standards does not ensure that the 
product is well absorbed.
    The agency agrees that the term ``high absorption'' generally 
refers to how well a nutrient is absorbed into the system. A product 
can be well absorbed irrespective of the quantitative amount found in 
the product. Accordingly, FDA finds that ``high absorption'' is not a 
nutrient content claim and thus will not define this term. The use of 
this term is subject to section 201(n) and 403(a) of the act, however. 
The agency expects that any product bearing a ``high absorption'' claim 
will contain the nutrients that are the subject of the claim in a form 
than can be readily assimilated by the body. In addition, manufacturers 
who make a ``high absorption'' claim should have data available to 
support the claim and should be prepared to make such data available to 
regulatory officials on request. Failure to do so could lead the agency 
to conclude that there is no basis for the claim, and thus that it is 
false or misleading.
d. Definitions for ``balanced''
    28. A few comments stated that ``balanced'' is not a nutrient 
content claim. One comment suggested that ``balanced'' refers to the 
ratio of nutrients, not the level, and that the term can apply equally 
to products containing low or high quantities of nutrients. Another 
comment stated that there is little need for FDA to define ``balanced'' 
because most multinutrient supplements that are currently on the market 
do not contain nutrients in proportions that would impair the 
absorption or utilization of other nutrients. The comment suggested 
that until researchers gain further information on the most favorable 
proportions of nutrients in supplements, the agency should leave this 
term undefined and therefore prohibited. Another comment suggested that 
``balanced'' be defined as any supplement containing from 50 to 150 
percent of the RDI for each vitamin and mineral component of the 
product for which an RDI has been established.
    The agency is persuaded by the comments that the term ``balanced'' 
does not typically characterize the level of nutrients, but rather that 
it is a formulation claim that addresses the ratio of nutrients. The 
term ``balanced'' may be used in different ways, each of which relates 
to the formulation of a product. For example, the term ``balanced'' may 
refer to the assortment of nutrients that are present in a product, or 
it may reflect interactions between the nutrients present, such as 
sparing effects or impairment or enhancement of absorption. 
Accordingly, this term does not meet the definition for a nutrient 
content claim in Sec. 101.13(b). Therefore, the use of the term 
``balanced'' is subject to sections 403(a) and 201(n) of the act and 
not section 403(r) of the act. The agency will determine whether the 
use of this term is misleading on a case-by-case basis.
e. Temporary suspension of the use of terms
    29. One comment stated that use of the terms ``high potency,'' 
``high absorption,'' and ``balanced'' should not be suspended 
temporarily during the rulemaking process because such a suspension 
would result in unnecessary labeling costs. Another comment requested 
additional time to comment on the definition of ``high potency'' and 
suggested that until FDA defines this term, the agency should permit 
dietary supplement manufacturers to continue to use this term as it is 
currently being used. The comment suggested that as an executive 
agency, FDA has inherent authority to refrain from enforcing a 
statutory provision in circumstances in which the enforcement would do 
more harm than good. The comment argued that to the extent that ``high 
potency'' is being used as part of a brand name (and was being used 
before October 25, 1989), the 1990 amendments permit its continued use 
in the brand name until FDA has defined the term (section 403(r)(2)(C) 
of the act).
    The comment argued that there is no reason for FDA to prohibit the 
use of a nutrient content claim while a definition is being developed. 
Further, the comment noted that an enforcement moratorium would avoid 
the relabeling problem that would arise if FDA disapproves and then 
reapproves use of the term within a short period of time. The comment 
stated that FDA will continue to have authority to prohibit use of the 
term when such use is false or misleading.
    FDA advises that it intends to define ``high potency'' as a 
nutrient content claim in a separate rulemaking as quickly as possible. 
The agency is postponing the date that it will apply this final rule on 
nutrient content claims on dietary supplements until July 1, 1995. This 
postponement is discussed in detail in the document on the date of 
application for the nutrition labeling and nutrient content claim 
requirements for dietary supplements found elsewhere in this issue of 
the Federal Register. FDA intends to complete its rulemaking on ``high 
potency'' in sufficient time to assure implementation by the time that 
dietary supplement manufacturers will be required to comply with the 
nutrient content claim provisions.
    The agency also advises that the term ``high potency,'' when used 
as part of a brand name, would fall under section 403(r)(2)(C) of the 
act, if as the comment stated, it was used as part of the brand name 
before October 25, 1989. However, once this term is defined by the 
Secretary, it will have to be used in a manner that complies with that 
definition. In addition, use of the term in the brand name is subject 
to section 403(a) of the act, which prohibits the use of false and 
misleading labeling irrespective of whether the use of the term in the 
brand name is exempt under section 403(r)(2)(C) of the act.
    As discussed previously, the comments did not demonstrate that 
there are accepted definitions for any of these terms. However, the 
comments have convinced the agency that the terms ``high absorption'' 
and ``balanced'' do not generally characterize the level of nutrients. 
Accordingly, the agency concludes that these terms are not subject to 
section 403(r) of the act.
4. Age Specific Claims
    30. One comment stated that there are products with brand names 
that imply that the product is especially useful for a particular 
segment of the population. The comment argued that it would therefore 
be appropriate for FDA to require that these special formulas comply 
with clearly defined requirements (e.g., that they contain high amounts 
of particular vitamins and minerals that are needed by the relevant 
group). Another comment maintained that such names mislead consumers 
because they provide no explanation for those special population 
claims, and that in many cases, the supplements do not contain levels 
of nutrients that are appropriate for the special population named in 
the claim. The comment suggested that FDA should, at the very least, 
require labels to provide an explanation for these claims. For example, 
an explanation for a product with a brand name implying that it is 
useful for women might state that ``this product is especially suited 
for young women because it contains 100 percent of the RDI for folic 
acid and iron and 30 percent of the RDI for calcium.''
    FDA agrees that products marketed for special population groups may 
include claims or brand names that can be misleading. These claims and 
brand names seem to imply a particular benefit for certain subgroups of 
the population and often do not disclose how or why they meet the needs 
of that particular subgroup. Disclosure of such facts would help to 
protect a product from being misbranded under section 403(a) of the act 
because its labeling would reveal material facts about the product's 
claimed special usefulness.
    However, such claims about the usefulness of a product for 
particular population groups generally fall under section 403(j) of the 
act to the extent that they represent the product to be for special 
dietary use. As special dietary use claims, they are outside the scope 
of this rulemaking. Among other things, Sec. 105.3 defines ``special 
dietary uses'' as ``uses for supplying particular dietary needs which 
exist by reason of a physical, physiological, pathological or other 
condition, including but not limited to the conditions of disease, 
convalescence, pregnancy, lactation, allergic hypersensitivity to food, 
underweight, and overweight; [and] [u]ses for supplying particular 
dietary needs which exist by reason of age, including but not limited 
to the ages of infancy and childhood'' (Sec. 105.3(a)(1)(i) and 
(a)(l)(ii)). The agency intends to consider proposing regulations for 
such products. However, because of resource constraints and other 
agency priorities, any such proposal will not be available in the 
immediate future. In the interim, such claims will continue to be 
subject to the general misbranding provisions of sections 201(n) and 
403(a) of the act.
5. ``Natural''
    31. Several comments suggested that FDA define the term ``natural'' 
for dietary supplements because that term is widely used in the 
labeling of dietary supplements even though there is no established 
definition of that term, and it is misleading as it is now used. For 
example, one comment stated that studies indicate that natural vitamin 
E (d-alpha tocopherol) is better utilized than synthetic vitamin E (dl-
alpha and other tocopherols), but that ``natural'' claims now appear on 
products containing synthetic vitamin E, misleading consumers who think 
they are getting a better utilized product. The comment stated that in 
other instances, companies use the term ``natural'' to mean that the 
product contains no artificial ingredients.
    One comment acknowledged that FDA has struggled with how to define 
this term for foods in conventional food form. This comment suggested 
that the agency need not resolve the dilemma at this time, but that it 
should simply establish a supplement-specific definition, just as FDA 
has established a special definition for ``natural flavor'' in 
Sec. 101.22. Another comment suggested that FDA should allow 
``natural'' claims on products containing only the naturally occurring 
form of a vitamin. The comment suggested that FDA could request 
comments about whether to limit ``natural'' claims to nutrients, such 
as vitamin E, that appear to offer some advantage when consumed in a 
natural form. The comment also stated that many consumers will want the 
option of purchasing other nutrients in the natural form as well.
    FDA is not persuaded by the comments that the term ``natural'' 
should be defined at this time. As one comment acknowledged, the agency 
has recently expended its resources exploring the use of this term, and 
it was unable to arrive at an acceptable definition (58 FR 2302 at 
2407). FDA currently lacks sufficient resources to thoroughly explore 
and develop proposed regulations for the use of this term on dietary 
supplements.
    In the final rule on nutrient content claims, the agency determined 
that it would maintain its current policy (as discussed in the general 
principles proposal (56 FR 60421 at 60466) of interpreting this term to 
mean that nothing artificial or synthetic (including all color 
additives regardless of source) has been included in, or has been added 
to, a food (Ref. 7). FDA also decided that it would continue to 
distinguish between natural and artificial flavors as outlined in 
Sec. 101.22. The agency concludes that, for the reasons cited above, it 
is appropriate to apply this policy to dietary supplements.
    In this regard, FDA also points out that Sec. 101.9(k)(6) states 
that a food labeled under the provisions of this section shall be 
deemed to be misbranded under sections 201(n) and 403(a) of the act if 
its label or labeling represents, suggests, or implies, ``that a 
natural vitamin in a food is superior to an added or synthetic vitamin 
or to differentiate in any way between vitamins naturally present from 
those added.''

V. Other Provisions

    FDA did not receive any comments that dealt specifically with the 
other provisions of the proposal. In the absence of any basis for doing 
otherwise, FDA is adopting those provisions as proposed.

VI. Economic Impact

    In its dietary supplement labeling proposals of June 18, 1993, FDA 
stated that the proposed rules on the labeling of dietary supplements, 
taken as a whole, would have associated costs of approximately $20 
million. Thus, the agency concluded that the proposed rules would not 
constitute a major rule as defined by Executive Order 12291. In 
accordance with the Regulatory Flexibility Act (Pub. L. 96-354), FDA 
explored whether the proposed rules may have a significant impact on 
small businesses and tentatively concluded that they do not.
    FDA has evaluated the many comments that it received in response to 
its economic impact analysis. Because the issues raised in the comments 
relate to all three proposals, FDA has combined its discussion of these 
comments and presented them in the final rule regarding the date of 
application published elsewhere in this issue of the Federal Register.
    FDA has examined the economic implications of the final rules 
amending 21 CFR as required by Executive Order 12866 and the Regulatory 
Flexibility Act. Executive Order 12866 directs agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects; distributive impacts; and equity). The 
Regulatory Flexibility Act requires the agency to analyze options for 
regulatory relief for small businesses. FDA has concluded, based on its 
review of the available data and comments, that these final rules are 
not significant as defined by Executive Order 12866. Further, in 
accordance with the Regulatory Flexibility Act, the agency certifies 
that these final rules will not have a significant impact on a 
substantial number of small businesses.

VII. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(11) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

VIII. Paperwork Reduction Act

    In the June 18, 1993, proposal on nutrient content claims for 
dietary supplements (58 FR 33731 at 33749), FDA announced that the 
agency had submitted to the Office of Management and Budget (OMB) for 
its review the collection of information requirements contained in 
proposed Sec. 101.69, for petitions regarding the use of nutrient 
content claims in conjunction with food labeling on dietary 
supplements. Also in that document, FDA published its estimated annual 
collection of information burden for this provision.
    None of the more than 500 comments received in response to the 
dietary supplement proposal addressed the content of petitions under 
the proposed nutrient content claim petition requirements. Thus, the 
agency's estimated annual reporting and recordkeeping burden from the 
health claim petition requirements contained in this final rule remains 
unchanged from that announced in June.
    FDA has submitted copies of the final rule to OMB for its review of 
these reporting requirements.

IX. References

    The following references have been placed on file in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Moss, A. J., A. S. Levy, I. Kim, Y. Park, ``Use of Vitamin 
and Mineral Supplements in the United States, Current Users, Types 
of Products and Nutrients,'' Advance Data from Vital and Health 
Statistics of the National Center for Health Statistics, No. 174, 
July 18, 1989.
    2. Pennington, J. A. T., V. L. Wilkening, J. E. Vanderveen, 
``Descriptive Terms for Food Labeling,'' Journal of Nutrition 
Education, p. 51, June 1990.
    3. Transcript to Docket N-289 for FDA-Initiated Public 
Conference: Antioxidant Vitamins and Cancer and Cardiovascular 
Disease, November 1993.
    4. Subcommittee on the 10th Edition of the Recommended Dietary 
Allowances, Food and Nutrition Board, Commission on Life Sciences, 
National Research Council, ``Recommended Dietary Allowances, 10th 
Ed.,'' Washington, DC, National Academy Press, 1989.
    5. Committee on Diet and Health, Food and Nutrition Board, 
Commission on Life Sciences, National Research Council, National 
Academy of Sciences, ``Diet and Health, Implications for Reducing 
Chronic Disease Risk,'' National Academy Press, Washington, DC, 
1989.
    6. Committee on the Nutrition Components of Food Labeling, Food 
and Nutrition Board, Institute of Medicine, National Academy of 
Sciences, ``Nutrition Labeling, Issues and Directions for the 
1990's,'' Washington, DC, National Academy Press, 1990.
    7. Newberry, R., letter to Clinton K. Davies, September 29, 
1988.

List of Subjects in 21 CFR Part 101

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

PART 101--FOOD LABELING

    1. The authority citation for 21 CFR part 101 continues to read as 
follows:
    Authority: Secs. 4, 5, 6, of the Fair Packaging and Labeling Act 
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 
343, 348, 371).
    2. Section 101.13, effective May 8, 1994, is amended by revising 
paragraph (a), by adding paragraph (b)(5), by revising the first 
sentence in paragraph (c), introductory text of paragraph (i), 
(j)(1)(i)(A) and (j)(l)(i)(B), and (n) to read as follows:


Sec. 101.13  Nutrient content claims--general principles.

    (a) This section and the regulations in subpart D of this part 
apply to foods that are intended for human consumption and that are 
offered for sale, including foods in conventional food form and dietary 
supplements of vitamins, minerals, herbs, and other similar nutritional 
substances (dietary supplements).
    (b) *  *  *
    (5) For dietary supplements, claims for calories, fat, saturated 
fat, and cholesterol may not be made on products that meet the criteria 
in Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie'' 
claims, except, in the case of calorie claims, when an equivalent 
amount of a similar dietary supplement (e.g., another protein 
supplement) that the labeled food resembles and for which it 
substitutes, normally exceeds the definition for ``low calorie'' in 
Sec. 101.60(b)(2).
    (c) Information that is required or permitted by Sec. 101.9 or 
Sec. 101.36, as applicable, to be declared in nutrition labeling, and 
that appears as part of the nutrition label, is not a nutrient content 
claim and is not subject to the requirements of this section. *  *  *
* * * * *
    (i) Except as provided in Sec. 101.9 or Sec. 101.36, as applicable, 
or in paragraph (q)(3) of this section, the label or labeling of a 
product may contain a statement about the amount or percentage of a 
nutrient if:
* * * * *
    (j) *  *  *
    (1) *  *  *
    (i)(A) For ``less'' (or ``fewer'') and ``more'' claims, the 
reference food may be a dissimilar food within a product category that 
can generally be substituted for one another in the diet (e.g., potato 
chips as reference for pretzels, orange juice as a reference for 
vitamin C tablets) or a similar food (e.g., potato chips as reference 
for potato chips, one brand of multivitamin as reference for another 
brand of multivitamin).
    (B) For ``light,'' ``reduced,'' ``added,'' ``fortified,'' and 
``enriched'' claims, the reference food shall be a similar food (e.g., 
potato chips as a reference for potato chips, one brand of multivitamin 
for another brand of multivitamin).
* * * * *
    (n) Nutrition labeling in accordance with Sec. 101.9, Sec. 101.10, 
or Sec. 101.36, as applicable, shall be provided for any food for which 
a nutrient content claim is made.
* * * * *
    3. Section 101.54, effective May 8, 1994, is amended by revising 
paragraph (a)(3), (b)(1), (c)(1) and the introductory text of paragraph 
(e)(1) to read as follows:


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

    (a) * * *
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
    (b) ``High'' claims. (1) The terms ``high,'' ``rich in,'' or 
``excellent source of'' may be used on the label and in the labeling of 
foods except meal products as defined in Sec. 101.13(l), main dish 
products as defined in Sec. 101.13(m), and dietary supplements of 
vitamins or minerals to characterize the level of any substance that is 
not a vitamin or mineral, provided that the food contains 20 percent or 
more of the RDI or the DRV per reference amount customarily consumed.
* * * * *
    (c) ``Good Source'' claims. (1) The terms ``good source,'' 
``contains,'' or ``provides'' may be used on the label or in labeling 
of foods except meal products as described in Sec. 101.13(l) main dish 
products as described in Sec. 101.13(m), and dietary supplements of 
vitamins or minerals to characterize the level of any substance that is 
not a vitamin or mineral, provided that the food contains 10 to 19 
percent of the RDI or the DRV per reference amount customarily 
consumed.
* * * * *
    (e) ``More'' claims. (1) A relative claim using the terms ``more,'' 
``fortified,'' ``enriched,'' and ``added'' may be used on the label or 
in labeling of foods to describe the level of protein, vitamins, 
minerals, dietary fiber, or potassium except as limited by 
Sec. 101.13(j)(1)(i) and except meal products as defined in 
Sec. 101.13(l), main dish products as defined in Sec. 101.13(m), and 
dietary supplements of vitamins or minerals to characterize the level 
of any substance that is not a vitamin or mineral, provided that:
* * * * *
    4. Section 101.60 is amended by revising paragraphs (a)(2) and 
(a)(3), by adding new paragraph (a)(4), by redesignating paragraphs 
(c)(4) and (c)(5) as paragraphs (c)(5) and (c)(6), and adding a new 
paragraph (c)(4), and by revising the introductory text of newly 
redesignated paragraph (c)(5) to read as follows:


Sec. 101.60  Nutrient content claims for the calorie content of foods.

    (a) *  *  *
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 101.13;
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
    (4) For dietary supplements, claims regarding calories may not be 
made on products that meet the criteria in Sec. 101.60(b)(1) or (b)(2) 
for ``calorie free'' or ``low calorie'' claims except when an 
equivalent amount of a similar dietary supplement (e.g., another 
protein supplement) that the labeled food resembles and for which it 
substitutes, normally exceeds the definition for ``low calorie'' in 
Sec. 101.60(b)(2).
* * * * *
    (c) *  *  *
    (4) The claims provided for in paragraph (c)(1) and (c)(2) of this 
section may be used on labels or in labeling of dietary supplements of 
vitamins or minerals that are intended specifically for use by infants 
and children less than 2 years of age.
    (5) The terms ``reduced sugar,'' ``reduced in sugar,'' ``sugar 
reduced,'' ``less sugar,'' ``lower sugar'' or ``lower in sugar'' may be 
used on the label or in labeling of foods, except meal products as 
defined in Sec. 101.13(l), main dish products as defined in 
Sec. 101.13(m), and dietary supplements of vitamins or minerals, 
provided that:
* * * * *
    6. Section 101.61 is amended by revising paragraph (a)(3) to read 
as follows:


Sec. 101.61  Nutrient content claims for the sodium content of foods.

    (a) *  *  *
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
* * * * *
    7. Section 101.62 is amended by revising paragraphs (a)(2) and 
(a)(3) and by adding paragraph (a)(4) to read as follows:


Sec. 101.62  Nutrient content claims for fat, fatty acid, and 
cholesterol content of foods.

    (a) *  *  *
    (2) The claim is made in accordance with the general requirements 
for nutrient content claims in Sec. 101.13;
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable; and
    (4) For dietary supplements, claims for fat, saturated fat, and 
cholesterol may not be made on products that meet the criteria in 
Sec. 101.60(b)(1) or (b)(2) for ``calorie free'' or ``low calorie'' 
claims.
* * * * *
    8. Section 101.65 is amended by revising paragraphs (a)(3), (b)(3) 
and (b)(4) to read as follows:


Sec. 101.65  Implied nutrient content claims and related label 
statements.

    (a) *  *  *
    (3) The food for which the claim is made is labeled in accordance 
with Sec. 101.9, Sec. 101.10, or Sec. 101.36, as applicable.
    (b) *  *  *
    (3) A claim about the presence of an ingredient that is perceived 
to add value to the product, e.g., ``made with real butter,'' ``made 
with whole fruit,'' or ``contains honey,'' except that claims about the 
presence of ingredients other than vitamins or minerals or that are 
represented as a source of vitamins and minerals are not allowed on 
labels or in labeling of dietary supplements of vitamins and minerals 
that are not in conventional food form.
    (4) A statement of identity for a food in which an ingredient 
constitutes essentially 100 percent of a food (e.g., ``corn oil,'' 
``oat bran,'' ``vitamin C 60 mg tablet'').
* * * * *

    Dated: December 23, 1993
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 93-31814 Filed 12-29-93; 8:45 am]
BILLING CODE 4160-01-F