Federal Register: September 23, 1997 (Volume 62, Number 184)
Rules and Regulations
Page 49859-49868
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr23se97-16
 
 
Page 49859
 
-----------------------------------------------------------------------
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
Food and Drug Administration
 
21 CFR Part 101
 
Docket No. 95N-0282
 
 
Food Labeling; Requirements for Nutrient Content Claims, Health
Claims, and Statements of Nutritional Support for Dietary Supplements
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Final rule.
 
-----------------------------------------------------------------------
 
SUMMARY: The Food and Drug Administration (FDA) is amending its
nutrient content claims regulations to change the terminology used to
describe dietary supplements; provide for the use of statements that
characterize the percentage level of dietary ingredients that do not
have Reference Daily Intakes (RDI's) or Daily Reference Values (DRV's);
and withdraw the provision that dietary supplements of vitamins and
minerals may not give prominence to any ingredient that is not a
vitamin or a mineral on its label or in labeling. The agency is also
amending its regulations to specify how (i.e., text, placement, and
type size) the disclaimer that must be contained in statements made in
accordance with the Federal Food, Drug, and Cosmetic Act (the act) is
to be presented. Additionally, FDA is removing the definition of
``dietary supplements,'' and revising the terminology used to describe
these products in the regulations on health claims for food products.
FDA is taking this action to implement, in part, the Dietary Supplement
Health and Education Act of 1994 (the DSHEA).
 
EFFECTIVE DATE: March 23, 1999.
 
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. Background
 
    On October 25, 1994, the President signed into law the DSHEA (Pub.
L. 103-417). The DSHEA, among other things, defined ``dietary
supplement'' by adding section 201(ff) to the act (21 U.S.C. 321(ff));
made provision for statements that characterize the percentage level of
dietary ingredients that do not have RDI's or DRV's by adding section
403(r)(2)(F) to the act (21 U.S.C. 343(r)(2)(F)); and amended sections
411(b)(2) and (c)(1) of the act (21 U.S.C. 350(b)(2) and (c)(1)) on the
labeling of products that contain vitamins and minerals. In addition,
the DSHEA added section 403(r)(6) to the act, which states that
statements may be made for dietary supplements if:
    the statement claims a benefit related to a classical nutrient
deficiency disease and discloses the prevalence of such disease in
the United States, describes the role of a nutrient or dietary
ingredient intended to affect the structure or function in humans,
characterizes the documented mechanism by which a nutrient or
dietary ingredient acts to maintain such structure or function, or
describes general well-being from consumption of a nutrient or
dietary ingredient * * *
(section 403(r)(6)(A) of the act), and if certain other conditions are
met. The manufacturer of the dietary supplement must have
substantiation that the statement is truthful and not misleading
(section 403(r)(6)(B)), and the statement must prominently contain the
following:
    This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.
Section 403(r)(6)(C) of the act.
    In the Federal Register of December 28, 1995, FDA published a
proposed rule entitled ``Food Labeling; Requirements for Nutrient
Content Claims, Health Claims, and Statements of Nutritional Support
for Dietary Supplements'' (60 FR 67176)(hereinafter referred to as
``the dietary supplement proposal''), in which the agency proposed to
conform its regulations on nutrient content claims and health claims to
the DSHEA. The proposed rule addressed how the statements provided for
in section 403(r)(6) of the act (referred to as ``statements of
nutritional support'' in the dietary supplement proposal) are to be
presented on the label or in labeling of a dietary supplement. In
addition, the proposal sought to provide for the use of statements that
characterize the percentage level of dietary ingredients that do not
have RDI's or DRV's on the labels and in the labeling of dietary
supplements.
    The agency received approximately 30 letters in response to the
proposed rule. Each letter contained one or more comments. Several
comments supported the proposal generally or supported aspects of the
proposal. Other comments addressed issues outside the scope of the
proposal (e.g., monitoring of adverse events, definition of fiber) and
will not be discussed here. Several comments suggested modifications or
revisions of various aspects of the proposal. A summary of these
comments, and a discussion of the agency's conclusions, follow.
 
II. Revised Regulations
 
A. Coverage
 
    1. A couple of comments maintained that there is no statutory basis
for the issuance of FDA's dietary supplement proposal. These comments
argued that the Nutrition Labeling and Education Act of 1990
(hereinafter referred to as ``the 1990 amendments'') limits the reach
of ``nutrient content claims'' to claims regarding nutrients of the
type required under section 403(q)(1) and (q)(2) of the act, that is,
according to these comments, the nutrients that are to be declared in
nutrition labeling. One comment maintained that the existence of the
alternative language in section 403(r)(5)(D) of the act suggests that
Congress was aware of the difference between ``nutrients'' and ``other
similar nutritional substances,'' and that it intentionally utilized
different language for nutrient content claims and health claims.
Similarly, another comment stated that there is no justification for
FDA to conclude that the phrase ``other similar nutritional
substances'' is applicable to nutrient content claims.
    The agency has addressed the question of the application of the
nutrient content claims provisions to nutrients without RDI's or DRV's
(59 FR 378, January 4, 1994; and 60 FR 67176, December 28, 1995). In
the dietary supplement proposal (60 FR 67176), the agency stated:
    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
both sections 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 agency also noted in the dietary supplement proposal (60 FR
67176) that the legislative history of ``other
 
Page 49860
 
nutritional substances'' reveals that its coverage is broad and could,
in appropriate circumstances, include dietary ingredients without RDI's
or DRV's (136 Congressional Record S16609 (October 24, 1990)). In a
discussion between Senators Metzenbaum and Symms before the passage of
the 1990 amendments, Senator Symms stated:
    * * * What follows is a list of a few of the items and foods
that I believe would fall under the ``other similar nutritional
substances'' category established by this bill:
    Primrose oil, black currant seed oil, coldpressed flax seed oil,
``Barleygreen'' and similar nutritional powdered drink mixes,
Coenzyme Q 10, enzymes such as bromelain and quercetin, amino acids,
pollens, propolis, royal jelly, garlic, orotates, calcium-EAP
(colamine phosphate), glandulars, hydrogen peroxide
(H<INF>2</INF>O<INF>2</INF>), nutritional antioxidants such a
superoxide dismutase (SOD), and herbal tinctures.
Based on this colloquy, the agency interprets the list of dietary
ingredients that fall under the definition of ``dietary supplement'' in
section 201(ff) of the act as an explication of ``other similar
nutritional substances.'' The comments to this rulemaking ignored the
identity of language between 403(r)(1)(A) and 403(r)(1)(B) of the act
and that the 403(r)(5)(D) language (i.e., ``other similar nutritional
substances'') is subsumed under the ``nutrients of the type'' language
that appears in 403(r)(1)(B) as well as in 430(r)(1)(A) of the act.
    The comments to this rulemaking did not provide any information to
persuade the agency to modify its tentative conclusions. The comments
construed the language in section 403(1)(A) and (1)(B) of the act too
narrowly. As the discussion from the proposal quoted above makes clear,
the structure of the law itself compels FDA's conclusion with respect
to the coverage of the language in question. Nor is there anything in
the DSHEA that would suggest a different result with regard to the
coverage of these provisions. FDA therefore rejects the comments that
disagreed with the proposal on the coverage of the nutrient content
claim provisions.
    2. Several comments from the conventional food industry expressed
concern that the statutory requirements for claims on dietary
supplements can result in claims that give the misleading impression
that dietary supplements provide more health benefits than conventional
foods, as well as the erroneous impression that the presence of a
dietary ingredient in a supplement is superior to the same ingredient
provided in a matrix of conventional food by allowing dietary
supplements to make claims that foods cannot. To illustrate these
points, one comment stated that powdered, dehydrated cranberries sold
in capsule form could bear a claim stating that they are beneficial for
urinary tract health, while cranberry juice cocktail may not. The
comment argued that such a claim is denied cranberry juice despite the
fact that it has been demonstrated in clinical trials to prevent
recurrence of urinary tract infections in women.
    Other comments stated that the percentage claim provisions are an
example of inequality in the regulatory treatment of conventional foods
and dietary supplements. One comment stated that under the proposal,
comparative percentage claims (e.g. ``as much as,'' ``twice the amount
of * * *,'' ``500 percent of * * *'') for dietary ingredients that do
not have RDI's or DRV's are forbidden to conventional food marketers,
because the 1990 amendments prohibit claims that ``characterize'' the
level of these dietary ingredients unless such claims have been defined
by the agency in a regulation, but not to dietary supplement marketers.
The comment argued that this situation is inequitable and internally
inconsistent because it permits dietary supplement marketers to make,
by circuitous language, claims that they cannot make directly. As an
example, the comment stated that the effect of the agency's proposal is
to lay down for dietary supplement marketers the following two rules:
(1) You cannot claim that your product has ``more'' of a dietary
ingredient than ``x'' product; but (2) you can claim that your product
has ``twice as much'' of a dietary ingredient as ``x'' product. The
comment argued that virtually every consumer will understand the latter
claim to communicate the impermissible message contained in the former
claim.
    Another comment from a trade association for conventional food
manufacturers stated that accurate statements describing the quantity
of a dietary ingredient for which there is no RDI or DRV would be more
appropriate than percentage claims. The comment stated that should FDA
allow quantitative declarations for dietary ingredients without RDI's
or DRV's, equity and fairness require that such statements also be
allowed on conventional foods. The comment stated that such
quantitative statements will be meaningful to consumers, and that
conventional foods will be placed at a competitive disadvantage if
prohibited from using these statements.
    One comment stated that labeling claims for which there is no
scientific basis are not in the public interest. The comment maintained
that such statements undermine the public's confidence in the
government's ability to protect consumers from products that may pose
health risks. Further, the comment stated that the proposed regulations
will undermine the credibility of FDA's regulations on nutrient content
and health claims for foods.
    On the other hand, a comment from a trade association for dietary
supplement manufacturers stated that dietary supplements should be
treated differently than conventional foods because the supplement
industry thrives on open competition and does not seek government
regulation to limit competition. The comment also stated that the
dietary supplement industry wants to be able to make content claims for
its products without FDA's approval because consumers are protected
under the agency's general misbranding authority.
    FDA acknowledges that there are some differences between dietary
supplements and conventional foods with respect to the types of claims
that can be made on their product labels, and that the content claims
that can be made on both types of products without FDA authorization
are limited. These differences and limitations, however, are created by
the statute itself. FDA has no authority to modify the regulatory
regime that is established by the act.
    Section 201(g)(1)(B) of the act states that the term ``drug'' means
articles intended for use in diagnosis, cure, mitigation, treatment, or
prevention of disease. FDA points out that the claim that cranberry
juice cocktail prevents the recurrence of urinary tract infections
mentioned by one of the comments is a claim that brings the product
within the ``drug'' definition whether it appears on a conventional
food or on a dietary supplement because it is a claim that the product
will prevent disease. However, a claim that cranberry products help to
maintain urinary tract health may be permissible on both cranberry
products in conventional food form and dietary supplement form if it is
truthful, not misleading, and derives from the nutritional value of
cranberries. If the effect derives from the nutritive value of
cranberries, the claim would describe an effect of a food on the
structure or function of the body and thus fall under one exception to
the definition for the term ``drug'' found in 201(g)(1)(C) of the act.
The claim is not a health claim because no disease is mentioned
explicitly or implicitly (see section 403(r)(1)(B) of the act).
    Only if the claimed benefit did not derive from the nutritional
value of cranberries would it be true that the
 
Page 49861
 
claim could appear on a dietary supplement but not a conventional food.
This result is dictated by section 403(r)(6) of the DSHEA.
    With regard to percentage claims, section 7(c) of the DSHEA amends
section 403(r)(2) of the act by adding clause (F) which reads:
    Subclause (i) clause (A) does not apply to a statement in the
labeling of a dietary supplement that characterizes the percentage
level of a dietary ingredient for which the Secretary has not
established a reference daily intake, daily recommended value, or
other recommendation for daily consumption.
    This new provision refers to section 403(r)(2)(A)(i) of the act,
which states that nutrient content claims may be made only if the
characterization of the level made in the claim uses terms which are
defined in regulations of the Secretary. The effect of section
403(r)(2)(F) of the act is to permit, on dietary supplement labels or
in dietary supplement labeling, the use of statements that have not
been defined by FDA but that, nonetheless, characterize the percentage
level of a dietary ingredient for which an RDI or DRV has not been
established.
    In the dietary supplement proposal (60 FR 67176), the agency
interpreted section 403(r)(2)(F) of the act as permitting percentage
claims for substances for which an RDI or DRV has not been established
on labels or labeling of dietary supplements but not on conventional
foods. Significantly, while comments objected to FDA doing so, no
comments argued that the agency had misinterpreted this aspect of
section 403(r)(2)(F). The limited legislative history does not make
clear why Congress chose to differentiate between these two types of
food in this way.
    However, the structure of the DSHEA suggests that Congress
recognized that dietary supplements are not necessarily like other
foods. Where other foods are consumed for taste, aroma, or nutritive
value, some dietary supplements are consumed for none of these reasons.
Congress apparently concluded that the labeling of dietary supplements
should be able to accommodate this fact. Thus, Congress provided for
the inclusion in the nutrition label of dietary ingredients for which
no daily consumption recommendations have been established, as well as
for the use of percentage claims about such ingredients. Congress did
not make similar provision for such ingredients in conventional foods,
presumably because it saw no reason to distract consumers from the
traditional reasons why they choose particular conventional foods.
    In the percentage claims provisions in Sec. 101.13(q)(3)(ii) (21
CFR 101.13(q)(3)(ii)), the agency sought to interpret section
403(r)(2)(F) of the act in a flexible manner. Giving section
403(r)(2)(F) of the act a significantly broader or different
application must be accomplished through the legislative process. For
now, however, it remains the case that, except for the provisions for
amount or percentage statements under Sec. 101.13(i)(3), statements
that characterize the level of a dietary ingredient without an
established RDI or DRV will misbrand a conventional food.
    It is important to note that the use of defined nutrient content
claims, such as ``more'' and ``high,'' remains limited, for both
conventional foods and dietary supplements, to those dietary
ingredients that have RDI's or DRV's. Consumer research shows that the
defined nutrient content claims are widely recognized and used by
consumers, and that consumers understand that the defined claims have
specific meanings (Ref. 1). The agency is not convinced that consumers
will automatically associate comparative percentage statements on
dietary supplements with these defined nutrient content claims.
Consumer research shows that public confidence in the food label is
high (Ref. 2), and FDA has no reason to believe that the comparative
percentage claims provisions for dietary supplements will undermine
public confidence in the agency's regulations.
    Moreover, as the agency has previously stated (60 FR 67175 at
67177), FDA is not without recourse to curtail percentage claims that
are misleading on the labels and in the labeling of dietary
supplements. Percentage statements on the label or in labeling of
dietary supplements that characterize the percentage level of a dietary
ingredient for which there is no established RDI or DRV in relation to
an equivalent or increased/decreased amount of the dietary ingredient
in another food, would be misleading under sections 403(a) and 201(n)
of the act if there is not a meaningful amount of the dietary
ingredient in either of the foods being compared, or if there is not a
meaningful difference in the level of the dietary ingredient between
the two foods.
    The agency recognizes that it cannot provide a completely
satisfying resolution for the differences in the types of percentage
claims that can be made on the labels and in labeling of dietary
supplements as opposed to conventional foods. FDA is committed,
however, to as much parity between dietary supplements and conventional
foods as is possible within the statute. The agency rejects the comment
that dietary supplements should be treated differently than
conventional foods because differences in treatment are in the interest
of a free market in dietary supplements. The agency has an obligation
to implement the law that Congress has enacted in a fair and equitable
manner. FDA is doing exactly that in its regulation of content claims
for dietary supplements as well as for conventional foods.
    3. One comment from a food manufacturer interpreted the proposal to
mean that food companies may no longer make percentage statements about
ingredients contained in their products (e.g., ``70% milk,'' ``twice as
much milk as the leading brand'') because FDA has not adopted RDI's or
DRV's for these ingredients. The manufacturer argued that there is
nothing in any statute or regulation that prohibits a food manufacturer
from stating that its product contains a particular ingredient, or from
comparing the amount of the ingredient to the amount present in another
food.
    FDA concludes that this comment misconstrues the statute. The
agency proposed to implement section 403(r)(2)(F) of the act, which, as
stated above, applies only to claims in the labeling of a dietary
supplement that characterize the percentage of a dietary ingredient for
which FDA has not established an RDI or DRV (e.g., omega-3 fatty acids,
amino acids, phytochemicals). This provision has no application to
conventional foods.
    As for the milk claims that the comment cites, the agency advises
that it has no intention of limiting percentage statements on
conventional foods that clearly describe ingredients in a manner that
relates to their organoleptic properties or that presents them as
adding value to the product. Manufacturers of conventional foods may
continue to state that products contain particular ingredients and to
compare the amounts of such ingredients to the amounts present in other
foods (see 21 CFR 101.65(b)(3)). However, the agency will continue to
evaluate the context in which claims such as ``70% milk'' and ``twice
as much milk as a leading brand'' are made to determine whether they
fall under the nutrient content claims regime. Such claims can be, in
some cases, implied nutrient content claims about the level of calcium
in the product that bears the claim. If such statements are found to be
implied nutrient content claims for calcium by the agency, they may be
used as long as they meet the criteria for the claim (see 21 CFR
101.54). If they are not implied claims, nothing in the regulations
precludes the use of such
 
Page 49862
 
statements so long as they are truthful and nonmisleading.
    4. One comment argued that the new definition of ``dietary
supplement'' is ambiguous and would include products marketed in
``traditional food form.'' The comment requested that the agency
clarify whether conventional food products that contain high levels of
nutrients, such as breakfast cereals and fruits and vegetables can be
marketed as supplements.
    The distinction between dietary supplements and conventional foods
becomes more apparent when the act is read carefully. The DSHEA added
section 201(ff)(2) which provides that a ``dietary supplement'' is a
product that is not represented for use as a conventional food. It also
struck the provision that excluded products that simulate conventional
foods from the coverage of section 411 of the act (see section 3(c)(2)
of the DSHEA). Thus, under the act, as amended by the DSHEA, a dietary
supplement may be ``in conventional food form.'' In other words, a
dietary supplement may be a product with physical attributes (e.g.,
product size, shape, taste, packaging) that are essentially the same as
a conventional food, so long as it is not represented for use as a
conventional food.
    Thus, whether a product is a dietary supplement or a conventional
food will depend on how it is labeled. To be a dietary supplement, a
product must bear the term ``dietary supplement'' as part of its common
or usual name. This term may be modified to include the name of the
dietary ingredient (e.g, ``vitamin C supplement'') or an appropriately
descriptive term (e.g., ``multivitamin supplement''). (See comment
number 1 in the companion document entitled ``Food Labeling; Statement
of Identity, Nutrition Labeling and Ingredient Labeling of Dietary
Supplements'' published elsewhere in this issue of the Federal Register
for further discussion of this issue.) All other food products, that
is, those that are not identified as dietary supplements, will be
subject to regulation as conventional foods.
    While use of the term ``dietary supplement'' in the statement of
identity is a necessary condition for a product to be represented as a
dietary supplement, it may not be enough to establish that the food is
appropriately regulated as one. If the food is represented as a dietary
supplement and is only intended to increase the dietary intake of
specific substances (e.g., vitamins), then the product would likely be
subject to regulation as a dietary supplement (section 201(ff)(1) of
the act). It would not be subject to regulation as a dietary
supplement, however, if it bears a statement that associates it with a
conventional food. For example, a product in bar form that is labeled
as a dietary supplement but that also bears label statements that
represent it as a snack food or as a substitute for a candy bar would
be subject to regulation as a conventional food. Similarly, a breakfast
cereal-type product could characterize itself as a dietary supplement
if it did not represent itself as a breakfast food or use the term
``cereal'' as a statement of identity. Either of the latter two
scenarios would represent the product as a conventional food.
    This result is compelled by section 201(ff)(1) of the act, which
states that a dietary supplement is intended to supplement the diet.
Claims that represent the product as being a snack food or a breakfast
cereal would evidence that the product is intended to do more than
supplement the diet and thus would subject it to the regime that
applies to foods other than dietary supplements.
 
B. Quantitative Amounts for Percentage Claims
 
    5. A comment from a manufacturer of a dietary supplement stated
that percentage claims such as ``40 percent omega-3 fatty acids'' do
not give the consumer any meaningful information because the consumer
will not know whether the claim means that 40 percent of the product is
omega-3 fatty acids, or that the product contains an ingredient that is
composed of 40 percent omega-3 fatty acids, or even that the product
contains 40 percent of the omega-3 fatty acids as compared to another
brand or another food. The comment stated that the only way to make
this information useful and nonmisleading is to require that the
percentage level be immediately accompanied by a statement of the
quantity of the dietary ingredient per serving of the product.
    The comment also stated that there are inherent problems in
comparing a manufactured or synthetic dietary ingredient with a dietary
ingredient in its natural source because natural sources are subject to
wide variability in composition. For example, the comment maintained
that there would be no way to accurately quantify the actual amount
that comprises ``100 percent of the dietary ingredient `X' in a bulb of
garlic.'' The comment stated that this example is meaningless and would
mislead consumers. The comment suggested that to provide any meaningful
comparative information to consumers, there must be some generally
recognized quantitative amount of the dietary ingredient in the
reference substance. The comment also suggested that in the absence of
a scientifically accepted standard for measuring the dietary ingredient
in a natural source, FDA should clarify that when there is a comparison
of an added, or a synthetic, dietary ingredient to a natural source
(e.g., garlic bulb, fish liver oil), the natural source is the
``reference food,'' which is subject to the requirement for clear
identification. The comment suggested that the actual amounts of the
dietary ingredient in the labeled and reference foods be declared.
    The agency is persuaded that percentage claims will provide more
useful information to the consumer, and that the potential for
misleading claims will be limited, if quantitative information is
provided along with the percentage information. This information will
facilitate comparisons of the amounts of dietary ingredients in
products that bear percentage claims, which, in turn, will assist
consumers in selecting products with the amount of the dietary
ingredient that they are seeking and will allow consumers to make
comparisons of the content of specific dietary ingredients across
products.
    Accordingly, FDA is revising Sec. 101.13(q)(3)(ii) by adding
Sec. 101.13(q)(3)(ii)(A) to state that, for dietary supplements,
whenever a statement is made that characterizes the percentage level of
a dietary ingredient for which there is no RDI or DRV, the actual
amount of the dietary ingredient in a serving of the product shall also
be declared (e.g., ``40 percent omega-3 fatty acids, 10 mg per
capsule'').
    In addition, FDA is adding Sec. 101.13(q)(3)(ii)(B), which states
that, for dietary supplements, where a statement that characterizes the
percentage level for a dietary ingredient for which there is no RDI or
DRV is used to compare the amount of the ingredient in the food that
bears the claim to the amount in a reference food, the amount of the
dietary ingredient in the food must be declared and the amount of the
dietary ingredient in the reference food to which the product is being
compared must also be declared. Moreover, the reference food must be
clearly identified (e.g., ``twice the omega-3 fatty acids per capsule
(80 mg) as in 100 mg of menhaden oil (40 mg)'').
    While FDA acknowledges that there may be variability in the content
of certain dietary ingredients in natural source products (e.g.,
garlic) based on a variety of conditions (e.g., soil, cultivars,
climate), FDA is not persuaded that the inherent variability
 
Page 49863
 
in the content of a dietary ingredient is a barrier to the declaration
of the quantitative amount of the dietary ingredient on the product
label. Variability in nutrient content is a factor that the agency
takes into consideration in evaluating label statements for all foods,
not just dietary supplements. Implicit in the compliance sampling
provisions in 21 CFR 101.9(g) is the concept that there will be
variation in naturally-occurring nutrients present in subsamples of a
product. Variability is taken into consideration in the development of
data bases and food composition tables. FDA expects that, as more
analyses are performed in support of label values for naturally-
occurring dietary ingredients that have and do not have RDI's or DRV's,
guidance on sampling strategies, weighing procedures, and statistical
treatment to account for variation among samples will improve. Because
of potential variation in the dietary ingredient content, firms may
label the dietary ingredient values on products conservatively, so that
the products declaring such values have a high probability of passing
the FDA compliance evaluation. Statistical procedures for doing so are
discussed in ``FDA Nutrition Labeling Manual: A Guide for Developing
and Using Databases.'' At the same time, consumers have the right to
expect, with a reasonable probability, that label values honestly and
reasonably represent the content in the products they purchase.
    6. A couple of comments noted that in many instances there are no
validated methods to analyze for a variety of dietary ingredients,
particularly herbal ingredients. The comments pointed out that the
accuracy of label claims will be impossible to verify because of the
lack of accepted quantitative analytical methods or standards.
    FDA recognizes that analytical methods are needed for a variety of
dietary ingredients. The agency encourages the dietary supplement
industry to participate in developing and in validating analytical
methods for dietary ingredients for which there are not generally
accepted methods. The lack of methodology to assess the validity of
label claims is of concern because it increases the possibility of
consumer fraud. However, FDA has every expectation that dietary
supplement manufacturers will make claims in a responsible manner. This
is the premise on which section 403(r)(6) of the act (see section
403(r)(6)(B)) was apparently based. Therefore, FDA expects that firms
will not make claims unless they are in possession of evidence that
establishes the validity of their claims.
    7. Several comments suggested that all examples discussing the
amount of allicin in garlic (e.g., ``100 percent of the allicin in a
bulb of garlic'') be dropped because there is no allicin in a bulb of
garlic or in dietary supplements of garlic. One comment stated that
allicin is produced as a result of an enzymatic reaction of alliin with
the enzyme alliinase (which are both components of raw garlic), and
that this reaction occurs only when the garlic clove is ruptured by
crushing, cutting, or some other manner. The comment stated that
allicin is associated with garlic only during the process of
decomposition, and that it has a half-life of less than 24 hours at
room temperature. The comment stated that it is helpful to have some
examples that illustrate the distinction between ``ingredient'' and
``dietary ingredient.''
    The agency used the allicin and garlic examples only to illustrate
distinctions in label statements about dietary ingredients and
ingredients. Based on the comments, the agency concludes that the
examples, which were taken from statements by representatives of the
dietary supplement industry, were not the best choices to illustrate
this distinction. Questions regarding the presence or absence of
allicin are beyond the scope of this rulemaking. Accordingly, the
agency will remove all examples referring to garlic and allicin from
Sec. 101.13(q).
    The agency agrees that examples that show the difference between a
dietary ingredient and an ingredient are helpful. Calcium, iron, and
omega-3 fatty acids are examples of dietary ingredients, while calcium
carbonate, ferrous sulfate, and cod liver oil respectively, are
examples of ingredients.
    8. One comment requested that the agency drop the proposed
requirements for referral statements, disclosure statements, and
accompanying information for percentage claims on dietary supplements.
    The comment did not provide any explanation to support its request,
and therefore, the agency has no basis upon which to change its
position on these requirements. While section 403(r)(2)(F) of the act
states that section 403(r)(2)(A)(i) does not apply to statements on the
labels of dietary supplements that characterize the percent level of
dietary ingredients, there is nothing in the DSHEA that exempts such
statements from the requirement in section 403(r)(2)(B) of the act for
referral statements (i.e., ``See location for nutrition
information'') or from other requirements for nutrient content claims.
Therefore, FDA has made no change in response to this comment.
 
C. Disclaimer
 
    9. Several comments requested that FDA clarify that the disclaimer
for statements made under section 403(r)(6) of the act is required only
when the manufacturer wishes to take advantage of the provisions for
exemption from the drug definition. Other comments requested that the
agency clarify that section 6 of the DSHEA (which added section
403(r)(6) to the act) does not apply to recognized nutrients with RDI's
or DRV's. Other comments requested that the agency clarify the type of
claims that may be made, the form and amount of substantiation that FDA
will require, and to whom and in what form the 30-day notification must
be made.
    Section 403(r)(6) of the act sets out the circumstances in which
certain types of statements can be made about all of the substances
listed in section 201(ff) of the act in the label or labeling of
dietary supplements. FDA is no longer referring to these statements as
``statements of nutritional support,'' even though this phrase is used
in the title of section 6 of the DSHEA, because many of the substances
that can be the subject of this type of claim do not have nutritional
value. Thus, the term ``statement of nutritional support'' is not
accurate in all instances.
    The agency agrees that the disclaimer provided for in section
403(r)(6) of the act is required only when the manufacturer wishes to
take advantage of the exception from the drug definition that is
provided for in section 201(g)(1) of the act for products that comply
with section 403(r)(6). Section 201(g)(1)(C) of the act recognizes that
common sense foods, that is, products with nutritional value, affect
the structure or function of the body because of their nutritional
value. Thus, the types of claims described in section 403(r)(6)(A) of
the act can be made to describe the nutritive value of a product
without fear of action against the product as a drug (e.g., ``calcium
builds strong bones and teeth'') so long as the claims are not false or
misleading. The claim would simply describe the nutritive value of the
substance in question. However, a dietary supplement manufacturer may
still choose to comply with section 403(r)(6) of the act in making a
claim about a substance with nutritive value if the manufacturer
chooses to take advantage of the protection provided by that section
and the last sentence of section of section 201(g)(1) of the act.
Products without nutritive value, however, would be subject to
regulatory action as drugs
 
Page 49864
 
under section 201(g)(1)(C) of the act if they make any of the claims
listed in section 403(r)(6)(A) of the act without compliance with all
of the provisions of section 403(r)(6).
    Questions regarding substantiation and notification requirements
for statements provided for under section 403(r)(6) of the act are
outside the scope of this rulemaking. The agency advises that it
published a proposed rule on notification procedures for such
statements in the Federal Register on September 27, 1996 (61 FR 50771).
The agency's tentative conclusions with respect to notification
procedures are discussed in that proposal.
    The agency concludes that it is desirable to streamline its
regulations by covering all provisions addressing statements provided
for under section 403(r)(6) of the act in one section. For consistency
with the proposed regulation on notification procedures, the agency is
changing the title and the section number from ``Sec. 101.94 Statements
of nutritional support; disclaimer'' to ``Sec. 101.93 Notification
procedures for certain types of statements on dietary supplements.''
Additionally, the agency is redesignating proposed Sec. 101.94(a), (b),
(c), and (d) as Sec. 101.93 (b), (c), (d), and (e) and reserving
Sec. 101.93(a) in anticipation of the final rule on notification
procedures.
    10. One comment requested that the agency eliminate a reference to
``the exemption to section 201(g)(1)(C) of the act'' from proposed
Sec. 101.94(a) (redesignated as Sec. 101.93(b)) because there are two
exceptions to 201(g)(1)(C) of the act. The comment stated that the
first exemption is the exception for ``food'' in section 201(g)(1)(C)
of the act. The comment stated that the second exemption is the one
that was added by the DSHEA. The comment stated that the DSHEA provides
that those dietary ingredients that are not covered by the first
exception from the drug definition (i.e., for food) are covered by the
mechanism in section 403(r)(6) of the act that permits claims to be
made concerning the role of other dietary ingredients in the body while
avoiding classification as a ``drug.''
    FDA acknowledges that there are now two exceptions to section
201(g)(1)(C) of the act. Accordingly, the agency is clarifying that
Sec. 101.93(b) refers to the second exception, that is, for dietary
supplements that are labeled in compliance with section 403(r)(6) of
the act. FDA is revising Sec. 101.93(b) to reflect the comment's point
that there are now two exceptions to section 201(g)(1)(C) of the act.
    However, FDA disagrees with the comment in two respects. First, the
comment seems to imply that all dietary supplements are covered per se
by the exception, which is not the case. Dietary supplements have to
comply with section 403(r)(6) of the act to be subject to the exception
(unless, of course, as stated above, they are subject to the other
exception for ``food'' as that term has been interpreted by the courts,
see Nutrilab Inc. v. Schweiker, 713 F.2d. 335, 338 (7th Cr. 1983)). In
addition, paragraph (a) of the conforming amendments found in section
10 of the DSHEA states that a product that bears a statement made in
accordance with section 403(r)(6) of the act is not a drug under
section 201(g)(1)(C) of the act ``solely because the label or the
labeling contains such a statement.'' Thus, the dietary supplement may
be found to be a drug based on some evidence of intended use other than
the statement made in accordance with section 403(r)(6) of the act.
    11. Several comments supported the proposal to place the disclaimer
adjacent to the statement provided for under section 403(r)(6) of the
act where there is a single statement. Other comments disagreed with
this aspect of the proposal. The latter comments stated that it is
sufficient to tie the statement to the disclaimer through the use of
asterisks. These comments maintained that dietary supplement packages
tend to be small, that space is at a premium on dietary supplement
labels, and that consumers are sufficiently accustomed to the asterisk
to locate the disclaimer elsewhere on the label.
    Similarly, other comments supported the proposal that the
disclaimer be placed on the same panel or page where there are multiple
statements. Other comments objected to this placement and stated that
the repetition of the disclaimer on every panel or page on which a
statement appears is redundant and unnecessary. To justify the
placement of the disclaimer on an alternate panel, one comment stated
that safety claims are often found on separate label panels, and that
there is no evidence that separating a message on different parts of a
label leads to a lack of consumer understanding of the safety
information on these products. Other comments stated that the agency's
proposed approach is not required by statute, places an undue burden on
dietary supplement manufacturers and distributors, and would inhibit,
rather than aid, consumer understanding of information on the labeling
of these products. These comments also maintained that there is
typically insufficient space to repeat the disclaimer on every panel or
page.
    One comment urged the agency to use a single ``global'' disclaimer
for all claims made on a dietary supplement label and claimed that if
the agency did so, no asterisks or symbols would be necessary.
    A variety of locations were suggested for the placement of the
disclaimer. A couple of comments suggested that the disclaimer be
placed under, or adjacent to, the nutrition label. Other comments
suggested that the disclaimer be placed on the panel to the left of the
principal display panel. Another comment suggested that the disclaimer
be placed next to the most prominent claim.
    FDA has evaluated the comments and concludes that the placement of
the disclaimer on a panel other than where the statement is made would
not meet the statutory requirement for the placement of the disclaimer.
Section 403(r)(6)(C) of the act requires that the statement ``contain''
the disclaimer, prominently displayed in boldface type. A literal
reading of section 403(r)(6)(C) of the act suggests that each statement
must contain the disclaimer in its entirety.
    In the case of multiple statements, the agency sought to minimize
the burdens imposed by the act by proposing that when the statements
provided for in section 403(r)(6) of the act are tied to the disclaimer
by means of an asterisk or other symbol, the statutory requirement that
the statement contain the disclaimer would be met because the two
discrete pieces would be linked together.
    Based on its experience with asterisks within the nutrition label,
the agency concludes that consumers are accustomed to using asterisks
on labels to associate two discrete pieces of important information
when they are in the same field of vision (Ref. 3). For this reason,
the agency is persuaded that the use of an asterisk or other symbol
that links the statement to the disclaimer meets the statutory
requirement for single statements. Ideally, the disclaimer should be
placed immediately adjacent to each statement, but the agency is
convinced that the use of asterisks or other symbols will adequately
serve the same purpose while providing flexibility to the
manufacturers. The agency is revising proposed Sec. 101.94(c)
(redesignated as Sec. 101.93(d)) to reflect this judgement.
    The agency rejects the comments that stated that repetition of the
disclaimer on every panel or page where a statement made in accordance
with section 403(r)(6) of the act appears is unnecessary. The agency
concludes that
 
Page 49865
 
to meet the statutory requirement that the disclaimer be ``contained''
within the statement, the disclaimer must be within the same field of
vision as the statement itself. Because the agency concludes that the
placement of the disclaimer anywhere on the same page or panel of
labeling is equivalent to meeting the requirement of being
``contained,'' each of the suggestions for the placement of a single
disclaimer on a product label (e.g., under the nutrition label,
adjacent to the most prominent claim) would not provide an acceptable
alternative.
    The agency points out that the requirements for the disclaimer also
extend to labeling: There are potentially many vehicles (e.g.,
placards, pamphlets, catalogs, books) that would have to bear the
disclaimer. The agency is concerned that the disclaimer be prominent in
these forms of labeling. Even with the flexibility of the use of an
asterisk to tie the claim and the disclaimer to a single statement, the
disclaimer could be obscured in pages of text of a package insert,
pamphlet, or book if it did not appear on the same page or panel (i.e.,
in the same field of vision) as the statement itself. Because of the
variety of possibilities for the presentation of the disclaimer, the
agency concludes that for labeling, as for labels, it is important to
retain the provision that the disclaimer appear within the same field
of vision, that is, on each package panel or page where a statement is
made, under section 403(r)(6) of the act.
    The use of the statements provided for in section 403(r)(6) of the
act is entirely voluntary, and the agency is not persuaded that the use
of the disclaimer would be unduly burdensome to manufacturers that
choose to use such statements.
    The agency rejects the concept of a ``global'' disclaimer because
its application would be undefined and thus could create misleading or
false impressions. For example, some products may bear a variety of
claims, including nutrient content and health claims, which are
authorized by the agency. In this case, the use of a ``global''
disclaimer could create the impression that these claims had not been
evaluated by FDA, which would be false.
    Accordingly, the agency is revising proposed Sec. 101.94(c)
(redesignated as Sec. 101.93(d)) to state that a symbol (e.g., an
asterisk) can be used to link a single statement to the disclaimer. On
product labels and in labeling for single and multiple statements, the
disclaimer shall appear on each panel or page where there is a
statement.
    12. A couple of comments supported the placement of the disclaimer
within a box. These comments stated that placement of the statement
within a box should help ensure that consumers will read the disclaimer
and will give adequate prominence to the statutory statement. Other
comments disagreed with the placement of the disclaimer within a box.
Several comments stated that the DSHEA makes no reference to a box. A
couple of comments stated that warnings are typically set out in boxes
in labeling, and the disclaimer is not intended to be a warning.
Another comment objected to boldface type.
    One comment referred to the definition of prominence in section
403(f) of the act and stated that all this section requires is that the
information be placed such that consumers are likely to read it under
customary conditions of purchase and use. One comment stated that it
should be left to the discretion of the manufacturer to ensure that the
disclaimer is prominently featured, through some combination of
boldface type, color, a box, or other design features.
    The agency is not aware of any research that specifically examines
whether consumers associate boxed information with warning information.
No evidence was included in the comments to persuade the agency that
boxed information is viewed by consumers as a warning. Manufacturers
may voluntarily enhance the disclaimer by a variety of other graphic
measures. However, section 403(r)(6)(C) of the act requires that the
disclaimer be in boldface type. Graphic devices such as boxing are used
to draw attention to important information. For example, the nutrition
label is placed in a box. Thus, the relevant question is whether the
information is important enough to be boxed, not whether it will be
seen as a warning.
    Congress has made the judgment that the disclaimer is important
information by requiring that the statement be in boldface type.
Because the statue explicitly requires boldface type, FDA is not
persuaded that the standard for prominence in 403(f) of that act is
sufficient to meet the standard for prominence for the disclaimer
intended by the Congress. FDA is providing that the statement may be
physically separated from the statements made under section 403(r)(6)
of the act. To ensure that the disclaimer gets the prominence that
Congress intended, FDA is requiring that it be put in a box if it is
separated from the statement made under section 403(r)(6) of the act.
Therefore, the agency is is retaining the requirement in
Sec. 101.94(c)(2) (redesignated as Sec. 101.93(d)) that the disclaimer
be set off in a box where it is not adjacent to the statement.
    13. One comment requested that the type size requirement be revised
to meet the requirements in Sec. 101.2 (21 CFR 101.2) which provide
one-sixteenth of an inch as a general minimum type size. The comment
maintained that inasmuch as FDA has determined that the requirements in
Sec. 101.2 are adequate to satisfy section 403(f) of the act, the
requirements of Sec. 101.2 are also appropriate in implementing the
disclaimer provisions specified in section 403(r)(6) of the act. In
addition, the comment urged the agency to clarify that the type size
options for special package sizes are available to dietary supplements
which often come in small packages.
    Based on the plain language of section 403(r)(6)(C) of the act, the
agency concludes that it was Congress' intent that the disclaimer be
prominent and not obscured on the label or in labeling. For that
reason, the agency proposed that the typesize for the disclaimer be no
smaller than the larger of one-half the type size of the largest
statement provided for in section 403(r)(6) of the act, but in no case
no smaller than one-sixteenth of an inch. FDA tentatively concluded
that in this manner, prominence could be assured because the disclaimer
would be proportional to the section 403(r)(6) of the act statement or,
at minimum, one-sixteenth of an inch (60 FR 67176 at 6781).
    Because FDA is retaining the provisions that the disclaimer be on
the same panel or page as the statement, and that the disclaimer be
boxed when it is not adjacent to the statement, the agency concludes
that the disclaimer can be readily located and, thus, that the
statutory requirement for prominence is largely met. Readability is a
clear attribute of prominence, and based on its experience with food
labeling, one-sixteenth of an inch is generally readable (Ref. 3).
Section 403(r)(6)(C) of the act requires that the disclaimer be in
boldface type, which should also facilitate readability. Therefore, FDA
has no objection to a minimum typesize of one-sixteenth of an inch for
the disclaimer. Accordingly, the agency is revising proposed
Sec. 101.94(d) (redesignated as Sec. 101.93(e)) to specify that one-
sixteenth inch is the minimum typesize for the disclaimer.
    Statements provided for in section 403(r)(6) of the act are
entirely voluntary. All required information must first be considered
in designing labels. Moreover, the firm must consider that the
disclaimer must be prominent as required by the statute. Therefore,
 
Page 49866
 
there will be instances in which statements under section 403(r)(6) of
the act should not be used on a label or in labeling because it is not
feasible to accommodate both the required information and the statutory
requirement for prominence for the disclaimer.
    Inasmuch as the purpose of Sec. 101.2(c)(1) through (c)(3) was to
encourage voluntary declaration of nutrition information and complete
ingredient listing on all foods before the provision of this
information was made mandatory by the 1990 amendments, FDA gave notice
of its intention to revoke the exemptions in Sec. 101.2(c)(1), (c)(2),
and (c)(3) in its December 1995 proposal entitled ``Food Labeling:
Statement of Identity, Nutrition Labeling, and Ingredient Labeling of
Dietary Supplements'' (60 FR 67194 at 67208) and proposed to do so in
the Federal Register of June 12, 1996 (61 FR 29708). These provisions
are now obsolete. Therefore, FDA is not accepting the recommendation of
these comments, and the request to include the options for small
package size listed under Sec. 101.2(c) is denied.
 
III. Effective Date
 
    14. Several comments recommended an effective date of 18 months
following the publication of the final rule. One comment stated that
the dietary supplement industry is unique because of the number of
dietary supplement products sold that are ``private label,'' that is
manufactured for or distributed by the company named on the label (the
brand owner). The comment noted that many products in the ``private
label'' category are store brands. The comment stated that these facts
mean that many manufacturers must prepare a wide variety of labels for
the same product. The comment used the example of one company producing
private label merchandise that may have over 10,000 labels that will
need to be conformed to the new regulations, and that for such store
brand private label products, the time it would take to deplete the
inventory of labels is well over 18 months. The comment noted that the
period to use labels that state ``manufactured for'' and ``distributed
by'' could be easily as long.
    FDA is persuaded by the majority of the comments that it is
appropriate to have the effective date of this final rule be 18 months
from the date of its publication, consistent with the time period
allowed for the labels of conventional foods to comply with the 1990
amendments. FDA is addressing the issues raised by these comments in
greater detail in the final rule entitled ``Food Labeling: Statement of
Identity, Nutrition Labeling and Ingredient Labeling of Dietary
Supplements'' published elsewhere in this issue of the Federal
Register.
 
IV. 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.
 
V. Environmental Impact
 
    The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (60 FR 67176). No new
information or comments have been received that would affect the
agency's previous determination that there is no significant impact of
the human environment and that an environmental impact statement is not
required.
 
VI. Paperwork Reduction Act
 
    In the dietary supplement proposal, FDA stated its tentative
conclusion that the proposed rule contains no reporting, recordkeeping,
labeling, or other third party disclosure requirements and asked for
comments on whether the proposed rule imposed any paperwork burden. No
comments were received addressing the question of paperwork burden. FDA
concludes that the labeling requirement in this document are not
subject to review by the Office of Management and Budget because they
do not constitute a ``collection of information'' under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the labeling
statements are a ``public disclosure of information originally supplied
by the Federal government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).
 
VII. Analysis of Impacts
 
    FDA has examined the economic implications of the final rule as
required by Executive Order 12866 and the Regulatory Flexibility Act (5
U.S.C. 601-612). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select the regulatory approach that
maximizes net benefits (including potential economic, environmental,
public health and safety effects; and other advantages; distributive
impacts; and equity). Executive Order 12866 classifies a rule as
significant if it meets any one of a number of specified conditions,
including having an annual effect on the economy of $100 million or
adversely affecting in a material way a sector of the economy,
competition, or jobs, or if it raises novel legal or policy issues. If
a rule has a significant impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
options that would minimize the economic impact of that rule on small
entities. FDA finds that this final rule is not a significant rule as
defined by Executive Order 12866, and finds under the Regulatory
Flexibility Act, that the final rule will not have a significant impact
on a substantial number of small entities. Similarly, it has been
determined that this rule is not a major rule for the purpose of
congressional review (Pub. L. 104-121).
    The final rule does not significantly change the way in which
claims are made with three exceptions: (1) Percentage claims for
dietary supplements that do not have RDI's or DRV's are no longer
prohibited; (2) dietary supplements of vitamins and minerals may now
highlight an ingredient that is not a vitamin or mineral; and (3)
labels or labeling of dietary supplements may include the types of
statements listed in 403(r)(6) of the act so long as those statements
are made in accordance with requirements of that section. With regards
to these actions, costs of redesigning labels will be incurred only by
those firms wishing to take advantage of the DSHEA. With respect to the
third, firms who wish to make the statements provided for in section
403(r)(6) of the act will incur the additional cost of redesigning
labels to include the disclaimer.
    FDA is unable to quantify the benefits from this final rule. Some
consumers will benefit from the additional information about dietary
ingredients that will become available. However, because statements may
now be made under section 403(r)(6) of the act for some dietary
ingredients without any information being submitted to FDA to
demonstrate that the dietary ingredient is safe, or that it will have
its claimed effect, it is uncertain whether this final rule will have
any significant health benefits.
    This rule provides small entities with the opportunity to use
certain claims that were previously prohibited. Small entities will
incur the cost of redesigning labels to include claims only if making
the claim will be profitable to the firm. In the proposed rule (60 FR
67176), FDA certified that this rule will not have a significant impact
on a substantial number of small entities. FDA received no objections
to that certification.
 
Page 49867
 
VIII. References
 
    The following references have been placed on display 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. The Research Department, Food Marketing Institute, ``Trends
in the United States: Consumer Attitudes & the Supermarket,'' 1996.
    2. Levy, A. S., and B. M. Derby, ''The Impact of the NLEA on
Consumer: Recent Findings from FDA's Food Label and Nutrition
Tracking System. Executive Summary, January 23, 1996.
    3. Levy, A. S., memorandum to Camille Brewer: Likely
Effectiveness of Proposed Format Requirements for Disclaimer
Statement on Dietary Supplement Products, January 16, 1997.
 
List of Subjects in 21 CFR Part 101
 
    Food labeling, Nutrition, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 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 is amended by revising paragraph (a), the
introductory text of paragraph (b), and redesignating paragraph (q)(3)
as paragraph (q)(3)(i), and adding new paragraph (q)(3)(ii) 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 conventional foods and dietary supplements.
    (b) A claim that expressly or implicitly characterizes the level of
a nutrient of the type required to be in nutrition labeling under
Sec. 101.9 or under Sec. 101.36 (that is, a nutrient content claim) may
not be made on the label or in labeling of foods unless the claim is
made in accordance with this regulation and with the applicable
regulations in subpart D of this part or in part 105 or part 107 of
this chapter.
* * * * *
    (q) * * *
    (3) * * *
    (ii) Percentage claims for dietary supplements. Under section
403(r)(2)(F) of the act, a statement that characterizes the percentage
level of a dietary ingredient for which a reference daily intake (RDI)
or daily reference value (DRV) has not been established may be made on
the label or in labeling of dietary supplements without a regulation
that specifically defines such a statement. All such claims shall be
accompanied by a referral or disclosure statement in accordance with
paragraphs (g) or (h) of this section.
    (A) Simple percentage claims. Whenever a statement is made that
characterizes the percentage level of a dietary ingredient for which
there is no RDI or DRV, the statement of the actual amount of the
dietary ingredient per serving shall be declared next to the percentage
statement (e.g., ``40 percent omega-3 fatty acids, 10 mg per
capsule'').
    (B) Comparative percentage claims. Whenever a statement is made
that characterizes the percentage level of a dietary ingredient for
which there is no RDI or DRV and the statement draws a comparison to
the amount of the dietary ingredient in a reference food, the reference
food shall be clearly identified, the amount of that food shall be
identified, and the information on the actual amount of the dietary
ingredient in both foods shall be declared in accordance with paragraph
(j)(2)(iv) of this section (e.g., ``twice the omega-3 fatty acids per
capsule (80 mg) as in 100 mg of menhaden oil (40 mg)'').
* * * * *
    3. Section 101.14 is amended by removing paragraph (a)(4), by
redesignating paragraphs (a)(5) and (a)(6) as paragraphs (a)(4) and
(a)(5), respectively; and by revising paragraphs (b)(3)(i) and (d)(3)
to read as follows:
 
Sec. 101.14  Health claims: general requirements.
 
* * * * *
    (b) * * *
    (3) * * *
    (i) The substance must, regardless of whether the food is a
conventional food or a dietary supplement, contribute taste, aroma, or
nutritive value, or any other technical effect listed in Sec. 170.3(o)
of this chapter, to the food and must retain that attribute when
consumed at levels that are necessary to justify a claim; and
* * * * *
    (d) * * *
    (3) Nutrition labeling shall be provided in the label or labeling
of any food for which a health claim is made in accordance with
Sec. 101.9; for restaurant foods, in accordance with Sec. 101.10; or
for dietary supplements, in accordance with Sec. 101.36.
* * * * *
    4. Section 101.54 is amended by revising paragraphs (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.''
 
* * * * *
    (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) and main dish
products as defined in Sec. 101.13(m), 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 and in the
labeling of foods, except meal products as defined in Sec. 101.13(l)
and main dish products as defined in Sec. 101.13(m), 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) and main dish products as defined in Sec. 101.13(m),
provided that:
* * * * *
    5. New Sec. 101.93 is amended by adding paragraphs (b) through (e)
to read as follows:
 
Sec. 101.93  Notification procedures for certain types of statements on
dietary supplements.
 
    (a) * * *
    (b) Disclaimer. The requirements in this section apply to the label
or labeling of dietary supplements where the dietary supplement bears a
statement that is provided for by section 403(r)(6) of the Federal
Food, Drug, and Cosmetic Act (the act), and the manufacturer, packer,
or distributor wishes to take advantage of the exemption to section
201(g)(1)(C) of the act that is provided by compliance with section
403(r)(6) of the act.
    (c) Text for disclaimer. (1) Where there is one statement, the
disclaimer shall be placed in accordance with
 
Page 49868
 
paragraph (d) of this section and shall state:
    This statement has not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.
    (2) Where there is more than one such statement on the label or in
the labeling, each statement shall bear the disclaimer in accordance
with paragraph (c)(1) of this section, or a plural disclaimer may be
placed in accordance with paragraph (d) of this section and shall
state:
    These statements have not been evaluated by the Food and Drug
Administration. This product is not intended to diagnose, treat,
cure, or prevent any disease.
    (d) Placement. The disclaimer shall be placed adjacent to the
statement with no intervening material or linked to the statement with
a symbol (e.g., an asterisk) at the end of each such statement that
refers to the same symbol placed adjacent to the disclaimer specified
in paragraphs (c)(1) or (c)(2) of this section. On product labels and
in labeling (e.g., pamphlets, catalogs), the disclaimer shall appear on
each panel or page where there such is a statement. The disclaimer
shall be set off in a box where it is not adjacent to the statement in
question.
    (e) Typesize. The disclaimer in paragraph (c) of this section shall
appear in boldface type in letters of a typesize no smaller than one-
sixteenth inch.
 
    Dated: September 11, 1997.
 William B. Schultz,
 Deputy Commissioner for Policy.
FR Doc. 97-24730 Filed 9-22-97; 8:45 am
BILLING CODE 4160-01-F