[Federal Register Volume 60, Number 249 (Thursday, December 28, 1995)]
[Proposed Rules]
[Pages 67176-67184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31193]
Federal Register / Vol. 60, No. 249 / Thursday, December 28, 1995 /
Proposed Rules
[[Page 67176]]
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: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
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
proposing to specify how (i.e., text, placement, and type size) the
disclaimer required by the Federal Food, Drug, and Cosmetic Act (the
act) is to be presented with statements of nutritional support.
Additionally, FDA is proposing to remove the definition of ``dietary
supplements'' and to change the terminology used to describe dietary
supplements in regulations governing health claims for food products.
This action is being taken to implement in part the Dietary Supplement
Health and Education Act of 1994 (the DSHEA).
DATES: Written comments by March 13, 1996. The agency is proposing that
any final rule that may issue based upon this proposal become effective
January 1, 1997.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857, 301-245-1064.
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 November 8, 1990, the President signed into law the Nutrition
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). The 1990 amendments amended the act in a number of important
ways. One of the most notable aspects of the 1990 amendments is that
they established FDA's authority to regulate nutrient content and
health claims on food labels and in food labeling. Section 403(r)(1)(A)
of the act (21 U.S.C. 343(r)(1)(A)), which was added by the 1990
amendments, provides that a product is misbranded if it bears a claim
in its label or labeling that either expressly or implicitly
characterizes the level 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. Section
403(r)(1)(B) of the act, also added by the 1990 amendments, provides
that a product is misbranded if it bears a claim that characterizes the
relationship of a nutrient to a disease or health-related condition,
unless the claim is made in accordance with sections 403(r)(3) of the
act (which pertains to foods in conventional food form) or 403(r)(5)(D)
(which pertains to dietary supplements).
In the Federal Register of November 27, 1991 (56 FR 60421 and 56 FR
60478), FDA published two documents, one general and the other on fat,
fatty acid, and cholesterol claims, in which the agency 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 to
foods in conventional food form. In the same issue of the Federal
Register, FDA proposed general requirements on the use of health claims
and on petitions to the agency to authorize health claims (56 FR
60537).
On October 6, 1992, the President signed into law the Dietary
Supplement Act of 1992 (the DS Act) (Pub. L. 102-571). 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) of the DS Act required that the
Secretary of Health and Human Services (the Secretary), and by
delegation FDA, issue new proposed regulations applicable to dietary
supplements no later than June 15, 1993, and final regulations by
December 31, 1993.
In the Federal Register of January 6, 1993, FDA published final
regulations that implemented the 1990 amendments with respect to
nutrient content claims (hereinafter referred to as the ``1993 nutrient
content claims final rule'') (58 FR 2302) and health claims
(hereinafter referred to as the ``1993 health claims final rule'') (58
FR 2478) on foods in conventional food form. In the Federal Register of
August 18, 1993 (58 FR 44020 and 44036), FDA made technical amendments
to these final regulations.
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 of vitamins, minerals, herbs, and other
similar nutritional substances under the coverage of the general
principles for nutrient content claims; (2) provide for the use of
express 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 ``1993
nutrient content claims for dietary supplements proposal''). In the
same issue of the Federal Register, FDA also proposed to make dietary
supplements of vitamins, minerals, herbs, and other similar nutritional
substances subject to the general requirements that apply to all other
types of food with respect to the use of health claims (hereinafter
referred to as the ``1993 dietary supplement health claims proposal'')
(58 FR 33700).
FDA received approximately 500 letters in response to its 1993
nutrient content claims for dietary supplements 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 were published in the Federal Register
of January 4, 1994 (59 FR 378), in the final rule on nutrient content
claims for dietary supplements (hereinafter referred to as the ``1994
nutrient content claims for dietary supplements final rule''). FDA
received over 1,200 letters in response to the 1993 dietary supplement
health claims proposal. FDA summarized and responded to these comments
in the final rule on health claims for dietary supplements in the same
issue of the Federal Register (59 FR 395).
On October 25, 1994, the President signed into law the DSHEA (Pub.
L. 103-417). The DSHEA, among other things, defined ``dietary
supplement'' (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 (adding section
403(r)(2)(F) to the act), and amended section 411 (b)(2) and (c)(1) of
the act (21 U.S.C. 350 (b)(2) and (c)(1))
[[Page 67177]]
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 nutritional support statement must
prominently contain the following disclaimer:
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)).
This proposal addresses how this disclaimer is to be presented on
the label or in labeling of a dietary supplement. The agency is issuing
this proposal in response to requests from the dietary supplement
industry that FDA define how this statement is to be presented. In
addition, this proposal seeks to bring the agency's nutrient content
claim and health claim regulations into conformance with the DSHEA and
provides for the use of statements that characterize the percentage
level of dietary ingredients that do not have RDI's or DRV's on labels
and in labeling of dietary supplements.
II. Proposed Regulations
A. Coverage
As discussed in the preamble to the 1994 nutrient content claims
for dietary supplements final rule (59 FR 378 at 379), 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, i.e., 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 must be made in accordance with
section 403(r)(3) or section 403(r)(5)(D). The latter section, which
addresses health claims for dietary supplements of vitamins, minerals,
herbs, and other similar nutritional substances, is relevant to this
proceeding. The legislative history of the phrase ``other similar
nutritional substances'' reveals that its coverage is broad (136
Congressional Record S16609 (October 24, 1990)).
Section 3(a) of the DSHEA amends section 201 of the act by adding
section 201(ff), which defines a ``dietary supplement'' as a product,
other than tobacco, intended to supplement the diet that bears or
contains one or more of the following dietary ingredients: A vitamin; a
mineral; an herb or other botanical; an amino acid; a dietary substance
for use by man to supplement the diet by increasing the total dietary
intake; or a concentrate, metabolite, constituent, extract, or
combination of any of the aforementioned dietary ingredients. In
effect, the list of dietary ingredients in section 201(ff)(1) is an
explication of the term ``other similar nutritional substances'' in
section 403(r)(5)(D). Thus, based on the foregoing analysis, all
dietary ingredients may qualify, in appropriate circumstances, as
``nutrients of the type required by paragraph (q)(1) and (q)(2)'' for
purposes of section 403(r) the act.1 To clarify this point in its
regulations, FDA is proposing to amend Sec. 101.13(b) (21 CFR
101.13(b)) by adding a reference to Sec. 101.36 Nutrition labeling of
dietary supplements of vitamins and minerals (21 CFR 101.36), so that
Sec. 101.13(b) will read, in part, if this amendment is adopted: ``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) * *
*.''
1 While all dietary ingredients can be ``nutrients of the
type required by paragraph (q)(1) and (q)(2) to be in the label or
labeling of the food'' in appropriate circumstances, all dietary
ingredients are not nutrients as that term is generally understood,
in that they do not all have nutritive value. The DSHEA recognizes
this fact by using the phrase ``nutrient or dietary ingredient''
(e.g., see section 403(r)(6) of the act), indicating that the two
terms are not mutually inclusive. Furthermore, all dietary
ingredients are not necessarily ``ingredients'' within the
traditional meaning of that term under section 403(i) of the act.
For example, in a ``calcium dietary supplement,'' calcium would be
the ``dietary ingredient,'' whereas calcium carbonate or some other
calcium salt would be the ``ingredient,'' i.e., the ``source'' of
the dietary ingredient, calcium. In a dietary supplement of garlic,
garlic could be the dietary ingredient, while the common or usual
name of the ingredient might be ``dried, powdered garlic.'' However,
if the manufacturer promoted the same supplement for its allicin
content, allicin could be the dietary ingredient and the source of
allicin, i.e., the ingredient, would be ``dried, powdered garlic.''
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The broad range of substances that can be dietary ingredients under
section 201(ff) has the potential to create ambiguities as to the
coverage of the nutrient content claim regime. With respect to some
substances that can be dietary ingredients, the context in which
statements about them are made will determine whether they are nutrient
content claims or not. For example, garlic can be the dietary
ingredient. A claim on the label or in the labeling of a dietary
supplement that it is ``high in garlic,'' or that it ``now contains
more garlic,'' is a nutrient content claim within the meaning of the
act, and the food is misbranded unless such a claim has been authorized
by FDA through regulation. The claim characterizes the level of garlic
in a food in which the garlic is a ``nutrient which is of the type''
required to be listed in the nutrition label because the food is
intended to supplement the dietary intake of garlic. On the other hand,
a label statement on garlic bread, for example, that the product now
contains more garlic would not be a nutrient content claim if the bread
is not labeled as a dietary supplement, and if it is clear from the
context in which the claim is made that the claim refers to the taste
of the product. As FDA has provided in Sec. 101.65(b)(3) (21 CFR
101.65(b)(3)), a claim about the presence of an ingredient that is
perceived to add value to the product, which would clearly be the case
when one adds more garlic to garlic bread, is not an implied nutrient
content claim.
B. Terminology
1. Nutrient Content Claims
Current Sec. 101.13(a), on nutrient content claims, states:
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).
As discussed above, new section 201(ff) of the act creates a new
definition for the term ``dietary supplement.'' To reflect this
definition and to simplify its regulations in the manner that the new
definition permits, FDA is proposing to amend Sec. 101.13(a) to read as
follows: ``This section and the regulations in subpart D of this part
apply to foods that are intended for human consumption
[[Page 67178]]
and that are offered for sale, including conventional foods and dietary
supplements.''
2. Health Claims
Under the general principles governing health claims,
Sec. 101.14(a)(4) (21 CFR 101.14(a)(4)) currently states that ``dietary
supplement'' means a food, not in conventional food form, that supplies
a component to supplement the diet by increasing the total dietary
intake of that component. This definition has been superseded by the
definition of ``dietary supplement'' found in new section 201(ff) of
the act. Further, because section 201(ff)(2)(A) makes it clear that
dietary supplements can be in a variety of forms, including
conventional food form, FDA is proposing to remove Sec. 101.14(a)(4)
and redesignate current Sec. 101.14 (a)(5) and (a)(6) as Sec. 101.14
(a)(4) and (a)(5), respectively.
A similar conforming change is necessary in Sec. 101.14(b)(3)(i) in
the preliminary requirements for a substance to be eligible to be the
subject of a health claim. This regulation refers to the fact that the
food in which a substance is found may be ``in conventional food form
or dietary supplement form.''
To bring this section into conformance with section 201(ff) of the
act, FDA is proposing to revise Sec. 101.14(b)(3)(i) to read as
follows:
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 * * *.
Section Sec. 101.14(d)(3) currently states:
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 of vitamins or minerals, in accordance with
Sec. 101.36. The requirements of the introductory text of paragraph
(d)(3) of this section are effective as of May 8, 1993, except:
(i)-(ii) [Reserved]
(iii) For dietary supplements of vitamins, minerals, herbs, or
other similar nutritional substances for which the requirements of
paragraph (d)(3) of this section will be effective July 5, 1994.
In the Federal Register of March 31, 1994 (59 FR 15050), the
effective date was corrected for the nutrient content claims provision
to July 1, 1994. Because of the passage of the DSHEA, the agency
published a notice in the Federal Register of February 9, 1995 (60 FR
7711), stating that it does not intend to enforce the Nutrient Content
Claim regulations for dietary supplements until after December 31,
1996.
As above, the terminology for dietary supplements (i.e., ``dietary
supplements of vitamins and minerals'') used in Sec. 101.14(d)(3) is
too narrowly drawn in light of new section 201(ff) of the act. In
addition, since the effective date is past, there is no longer a need
to include it in the regulations. Therefore, FDA is proposing to revise
Sec. 101.14(d)(3) to remove ``of vitamins and minerals'' as a qualifier
of the types of dietary supplements and to remove the language setting
out the effective date in the second sentence of Sec. 101.14(d)(3).
These changes also mean that there is no need for paragraphs (d)(3)(i)
through (d)(3)(iii). Accordingly, proposed Sec. 101.14(d)(3) reads as
follows:
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.
C. 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. Thus, section 403(r)(2)(A)(i)
of the act limits the type of nutrient content claims that can be made
to those terms that are defined and authorized by regulation. The
effect of section 403(r)(2)(F) of the act is to permit the use on the
labels or in the labeling of dietary supplements of statements that
have not been defined by FDA that characterize the percentage level of
a dietary ingredient for which an RDI or DRV has not been established.
In the absence of any substantive legislative history on this
provision, the agency interprets section 403(r)(2)(F) of the act as
authorizing claims on the label or in labeling of a dietary supplement
that disclose the percentage level in the dietary supplement of a
dietary ingredient for which an RDI and DRV has not been established in
a product (e.g., ``40 percent omega-3 fatty acids'') as well as
statements that characterize the percentage of such dietary ingredients
in relation to an equivalent or increased/decreased amount found in
another food product (e.g., ``100 percent of the allicin in a bulb of
garlic,'' ``twice the allicin as (product alternative)'' [where
``twice'' is another way of saying 200 percent]).
Section 3(b)(1)(A)(iv) of the 1990 amendments directed the agency
to promulgate regulations that permit statements describing the amount
and percentage of nutrients in food that are not misleading and that
are consistent with the terms defined under section 403(r)(2)(A)(i) of
the act. Consequently, FDA provided in Sec. 101.13(i) for statements
about the amount or percentage of nutrients when specified criteria are
met. While this regulation did not specifically include a provision for
the use of such statements with respect to dietary ingredients for
which no RDI or DRV had been established, Sec. 101.13(i)(3) allowed for
the use of amount or percentage statements that do not implicitly
characterize the level of the nutrient in the food (e.g., claims that
do not imply whether the amount is high or low based on an established
RDI or DRV value), and that are not misleading in any way. In ``Food
Labeling, Questions and Answers'' (Ref. 1, p. 36, C23), FDA stated that
statements about a nutrient for which there is no established daily
value (i.e., no RDI or DRV) could be made under Sec. 101.13(i)(3) as
long as the claim specifies only the amount of the nutrient per serving
and does not imply that there is a lot or a little of that nutrient in
the product. The example ``x grams of omega-3 fatty acids'' was given.
Accordingly, percentage claims such as ``40 percent omega-3 fatty
acids'' that do not in any way characterize the level of a nutrient in
terms of defined claims such as ``high,'' ``low,'' or ``reduced'' were
permitted on dietary supplements as well as conventional foods before
the enactment of the DSHEA. To memorialize this fact and to implement
the DSHEA by reflecting that labels or labeling of dietary supplements
may bear statements that characterize the percentage level of a dietary
ingredient for which an RDI or DRV has not been established even though
those statements have not been defined by FDA, the agency is proposing
to amend Sec. 101.13 by adding new paragraph (q)(3)(ii) to read as
follows:
Under section 403(r)(2)(F) of the act, a statement that
characterizes the percentage level of a dietary ingredient for which
an RDI or daily reference value (DRV) has not been established
(e.g., ``40 percent omega-3 fatty acids,'' ``100 percent of the
allicin in a bulb of garlic,'' or ``twice the allicin as (name of
[[Page 67179]]
product alternative)'' * * *) may be made on the label or in labeling
of dietary supplements without a regulation that specifically
defines such a statement. * * *
Because this provision allows for an exemption to the nutrient content
claims rules and is somewhat similar to the exemption in
Sec. 101.13(q)(3) for percentage statements for vitamins and minerals,
the agency is placing the new paragraph in Sec. 101.13(q)(3) by
redesignating current Sec. 101.13(q)(3) as Sec. 101.13(q)(3)(i) and
adding new Sec. 101.13(q)(3)(ii).
The agency believes that percentage statements on the label or in
labeling of a dietary supplement 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, such as ``100 percent of the allicin in a
bulb of garlic'' and ``twice the allicin as (name of product
alternative),'' 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 both foods being compared and a meaningful difference between the
two foods being contrasted. However, because many dietary ingredients,
which are the subject of clause (F), do not have established reference
amounts for daily consumption, there is not a single, consistent way to
describe the amount or difference that would be considered meaningful
for the broad spectrum of these dietary ingredients. Therefore, firms
will need to determine on a case-by-case basis whether the stated
amount of a dietary ingredient for which an RDI or DRV has not been
established, and the difference between the amount of such a dietary
ingredient in two products, is meaningful. In making such a
determination, published literature on the dietary ingredient,
knowledge of the functional properties of the dietary ingredient, and
any additional information available to the manufacturer, packer, or
distributor should be taken into account.
It should be noted that while FDA is proposing in
Sec. 101.13(q)(3)(ii) to provide for statements that characterize the
percentage level of dietary ingredients for which no RDI or DRV has
been established, the proposed regulations do not provide for use of
the defined terms, such as ``more,'' ``good source,'' ``high,'' and
``as much as.'' For example, the statement ``300 percent of the
bioflavonoids in a large grapefruit'' is permissible, but a claim such
as ``high in bioflavonoids'' is not. As discussed in the nutrient
content claims for dietary supplements proposal and final rule, FDA has
concluded that if the defined term (i.e., the nutrient content claim)
is to have any meaning, there must be a level that can be used as a
reference in determining whether the claim is valid and appropriate.
The RDI's and DRV's provide such levels. Thus, FDA has limited the use
of ``good source,'' ``high,'' and other defined terms to use with
nutrients for which RDI's or DRV's have been established.
By way of exception, ``contains'' and ``provides'' are listed in
Sec. 101.54(c)(1) (21 CFR 101.54(c)(1)) as synonyms for ``good source''
(e.g., ``Contains vitamin C'' is considered synonymous with ``good
source of vitamin C'') and are therefore dependent on the establishment
of an RDI or DRV for the nutrient to qualify for the claim. However,
the agency has stated that these words may be used with nutrients that
do not have RDI's or DRV's when specific amounts are given for the
nutrient (Ref. 1, p. 37, C24). Accordingly, the agency has no objection
to statements such as ``Contains 4 grams of omega-3 fatty acids per
serving'' being made for dietary ingredients for which RDI's and DRV's
have not been established provided the specific amount of the nutrient
is stated.
It should be noted that section 403(r)(2)(F) of the act applies
only to dietary supplements. Congress did not provide this exemption
for conventional foods. Therefore, except for the statements discussed
in the preceding paragraph that come under Sec. 101.13(i)(3),
statements that characterize the level of a dietary ingredient without
an established RDI or DRV will continue to be prohibited on
conventional foods.
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) for referral statements (i.e.,
``See [location] for nutrition information'') or from other
requirements for nutrient content claims. Accordingly, FDA is proposing
to require in Sec. 101.13(q)(3)(ii) that a referral statement (or
disclosure statement when fat, saturated fat, cholesterol, or sodium
exceed specified limits) accompany the claim in accordance with
Sec. 101.13 (g) or (h).
In addition, the agency tentatively concludes that when percentage
statements are made comparing or contrasting the amount of a dietary
ingredient for which an RDI or DRV has not been established in a
dietary supplement to that in a reference food, information on the
identity of the reference food and on the quantitative amount of the
dietary ingredient in both foods are material facts. Consumers need
this information to evaluate and understand the claim being made, and
the claim would be misleading under sections 403(a) and 201(n) of the
act without it (see 56 FR 60421 at 60446, and 58 FR 2302 at 2365). This
situation is analogous to that encountered with relative claims for
nutrients, where there is a requirement in Sec. 101.13(j)(2)(iv) for
quantitative information comparing the amount of the subject nutrient
in the product with that in the reference food. Inclusion of this
information is particularly important because, while the nutrition
label on dietary supplements will include information about the amount
of dietary ingredients for which RDI's and DRV's have not been
established that are present in the food (see proposed
Sec. 101.36(b)(3) 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), the nutrition label on conventional foods will not (except
for nutrients provided for in Sec. 101.9(c) such as sugars and
polyunsaturated fat that do not have RDI's and DRV's established).
Accordingly, when conventional foods are used as the reference food,
information about the amount of a dietary ingredient for which there is
no RDI or DRV that is present in the food is likely to only be
available when it is provided as accompanying information, in
accordance with Sec. 101.13(j)(2)(iv).
For these reasons, FDA is proposing in Sec. 101.13(q)(3)(ii) to
require that whenever statements characterizing the percentage level of
a dietary ingredient for which there is no RDI or DRV are made in
comparison to the amount in a reference food, the reference food be
clearly identified, and information on the actual amount of the dietary
ingredient in both foods be provided in accordance with
Sec. 101.13(j)(2)(iv). Section 101.13(j)(2)(iv)(B) requires that this
quantitative information be placed adjacent to the most prominent claim
or to the nutrition label, except that when the nutrition label is on
the information panel, the quantitative information may be placed
elsewhere on that panel in accordance with Sec. 101.2 (21 CFR 101.2)
(see 60 FR 17202, April 5, 1995).
[[Page 67180]]
D. Disclaimer for Statements of Nutritional Support
1. Exclusion From Drug Definition
As mentioned previously, the DSHEA added section 403(r)(6) to the
act, which provides for certain statements of nutritional support for
dietary supplements, including a statement that ``describes the role of
a nutrient or dietary ingredient intended to affect the structure or
function in humans.'' Section 201(g)(1)(C) of the act states that a
``drug'' is an article (other than food) intended to affect the
structure or any function of the body of man or other animals. Section
10(a) of the DSHEA adds the following statement to section 201(g)(1) of
the act:
A food, dietary ingredient, or dietary supplement for which a
truthful and not misleading statement is made in accordance with
section 403(r)(6) is not a drug under clause (C) solely because the
label or the labeling contains such a statement.
Under section 10(a) of the DSHEA and section 403(r)(6) of the act,
for a firm to take advantage of the exclusion from the ``drug''
definition for a statement of nutritional support on the label or in
labeling of a dietary supplement, it must meet each of the conditions
established under section 403(r)(6), including having substantiation
that the claim is truthful and not misleading and having the disclaimer
required in section 403(r)(6) displayed in conjunction with the
statement. To implement the latter requirement, FDA is proposing in
Sec. 101.94, as stated in proposed Sec. 101.94(a), to set forth the
requirements for the text, placement, and typesize of the disclaimer
that must accompany the statement of nutritional support for it to be
subject to the exemption in section 201(g)(1)(C) of the act.
2. Text
Section 403(r)(6)(C) requires the following disclaimer to be
prominently displayed in boldface type:
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.
Based on inquiries that FDA has received from the dietary
supplement industry, FDA tentatively finds that aspects of the
statutory requirements for the disclaimer (e.g. ``prominent display'')
need to be defined and implemented through regulations. Prominence is a
relative term, and without regulations, the agency would be forced to
evaluate prominence on a case-by-case basis. Such an approach would not
provide firms with sufficient guidance to be assured that product
labels would not trigger regulatory action.
A literal reading of section 403(r)(6)(C) of the act suggests that
each nutritional support statement must contain the disclaimer in its
entirety, without any deviation from the statutory language. FDA
tentatively concludes that, where a label contains only one nutritional
support statement, there is no reason not to adopt such a reading of
the act. Accordingly, the agency is proposing in Sec. 101.94(b)(1) that
where the label contains one statement of nutritional support provided
for in section 403(r)(6) of the act, the label or labeling must
prominently contain the disclaimer as required by the act without
modification to the text.
However, where there are multiple nutritional support statements,
or where the same statement appears several times, the agency
recognizes that repeated use of the statutory text with each
nutritional support statement could be confusing to consumers and
burdensome to manufacturers. For example, if a dietary supplement
includes three nutritional support statements on the same label panel,
or in a piece of labeling such as a brochure, the literal reading of
the act would require that each statement include the complete
disclaimer. Because the statutory text is of some length, only very
large label panels could conform to this requirement if they contained
multiple statements.
FDA wishes to implement the statute in a practical way that still
fully effectuates the purposes of the statute. In light of this fact,
the agency tentatively concludes that it is appropriate to provide that
the disclaimer required in section 403(r)(6)(C) of the act can be
slightly modified to reflect the use of multiple statements of
nutritional support. FDA is proposing in Sec. 101.94(b)(2) to require
that, where there is more than one statement of nutritional support,
each statement contain the disclaimer as required by the act, or that
the first sentence of the disclaimer be modified to the plural form to
read as follows: ``These statements have not been evaluated by the Food
and Drug Administration.'' Under this proposal, the second sentence
will remain as required by the act. For convenience, FDA will refer to
this modified form of the disclaimer as ``the plural disclaimer.''
3. Placement
The juxtaposition of the disclaimer to the statement of nutritional
support as required by the act is one way to ensure prominence. Because
the act states that the statement of nutritional support must
``contain'' the disclaimer, the agency tentatively concludes that the
disclaimer must be part of the statement of nutritional support. When
there is only one such statement, this inclusion can be readily
accomplished by presenting the disclaimer as part of the claim.
Accordingly, FDA is proposing in Sec. 101.94(c)(1) that the disclaimer
be contained in each statement of nutritional support by placing the
disclaimer immediately adjacent to the statement of nutritional support
with no intervening material.
However, consistent with its desire to interpret section 403(r)(6)
of the act in a practical way, FDA is proposing to provide for an
alternative placement for the disclaimer on the label or in labeling in
situations in which repetitive presentation of the disclaimer could be
burdensome. In these situations, FDA wants to provide an approach to
placement of the disclaimer that will give the disclaimer a prominence
that will ensure that it will be read and understood by consumers but
that will result in its presentation only once on the label panel or in
labeling.
FDA tentatively concludes that where the label or labeling contains
multiple statements of nutritional support, and the relationship
between each of those statements and the disclaimer can be made
obvious, the statutory requirement of prominent display of the
disclaimer can be met without requiring that each statement of
nutritional support actually include the disclaimer. FDA experience has
been that one of the most effective ways of tieing two label statements
that are physically separated on the same label panel is through the
use of a symbol such as an asterisk. Symbols have been used within
nutrition labeling since its inception in 1973 and have proven to be an
effective way of relating label information to explanatory footnotes.
For example, asterisks have been used adjacent to names of vitamins and
minerals present at very low levels to refer the consumer to a footnote
stating ``Contains less than 2 percent of the Daily Value (formerly the
U.S. Recommended Daily Allowance).'' FDA is unaware of any data
indicating consumer difficulties with such use of symbols. The use of
symbols would also help consumers differentiate between label
statements to which the disclaimer is referring and other label claims
to which the disclaimer does not apply (e.g., authorized health claims
or nutrient content claims).
Accordingly, FDA is proposing in Sec. 101.94(c)(2) that where there
is more than one statement of nutritional support on a label panel or
in labeling
[[Page 67181]]
other than a label, and the manufacturer, packer, or distributor wishes
to comply with section 403(r)(6) of the act without having to place the
disclaimer immediately after each statement of nutritional support, it
can place a symbol (e.g., an asterisk) at the end of each statement of
nutritional support that refers to the same symbol placed elsewhere on
the same label panel or in the labeling that is followed by the
disclaimer.
In a citizen petition dated March 20, 1995 (petition number 95P-
0079/CP 1), the Nutritional Health Alliance (NHA) requested, among
other things, that FDA issue regulations implementing section 403(r)(6)
of the act. With respect to the placement of the disclaimer, NHA
suggested that an asterisk follow each statement of nutritional support
to refer the consumer to a specific place on the label, such as the
information panel, where the disclaimer would appear only once.
Although FDA is proposing to provide most of what this petition
seeks, the agency tentatively rejects the last aspect of this
suggestion. Splitting the statement of nutritional support from the
required disclaimer and allowing the disclaimer to appear on another
panel does not establish an obvious relationship between the two pieces
of information. The agency is concerned that the placement of the
disclaimer on another panel would not reveal material facts in
conjunction with the statement of nutritional support that are
necessary for consumers to fully understand the significance of the
statement. However, the agency will consider establishing provisions
for the use of asterisks that refer to the disclaimer in a single
specific location (such as the information panel), instead of on each
panel bearing a statement of nutritional support, if the comments
convince it that such an approach is consistent with the statute and
would be useful to consumers. FDA requests any data that bear on the
question of the effect that splitting a statement from a disclaimer in
this manner will have on the likelihood that consumers will read the
disclaimer. Specifically, the agency requests data on whether a
consumer will track a symbol from one label panel or page of labeling
to another to obtain the information about a statement of nutritional
support that follows the symbol.
In addition, the requirement in the act for prominent display means
that when the disclaimer does not appear immediately adjacent to a
statement of nutritional support, it must be presented on the label or
labeling in a manner that renders it as readily observable and as
likely to be read as the statement of nutritional support itself. In
this regard, the agency's experience with the graphic requirements for
the new nutrition label has been that a box around required label
information greatly increases the prominence of the information placed
inside the box (Ref. 2). Moreover, focus group discussions regarding
warning labels show that messages put in a boxed area help consumers to
distinguish the message from other information as well as draw
attention to it (Ref. 3). Therefore, FDA is proposing in
Sec. 101.94(c)(2) to require that a box be drawn around the disclaimer
when the disclaimer is not immediately adjacent to the statement of
nutritional support.
For example, a side panel of a dietary supplement label may contain
paragraphs of text that include more than one statement of nutritional
support. Assuming that the manufacturer did not choose to place the
disclaimer immediately after each statement of nutritional support,
each such statement would be followed by a symbol, and the referenced
symbol and disclaimer would be placed in a box on the same panel with
the first sentence reading ``*These statements have not been evaluated
by the Food and Drug Administration,'' as proposed in section
Sec. 101.94(b)(2).
4. Type Size and Style
With respect to the style of type to be used in the disclaimer, the
DSHEA specifies that ``boldface type'' shall be used (section
403(r)(6)(C) of the act). FDA has reiterated this provision in proposed
Sec. 101.94(d).
With respect to type size requirements, FDA notes that even though
section 403(r)(6) of the act does not include specific type size
requirements for the accompanying information referred to as the
disclaimer, other sections of the act, and the regulations promulgated
thereunder, address a variety of requirements for information that is
to accompany a claim. Sections 403(r)(2)(A)(iii) through (r)(2)(A)(v)
of the act require that statements that disclose the level of fat,
saturated fat, or cholesterol, which must be presented in conjunction
with certain nutrient content claims, ``have appropriate prominence
which shall be no less than one-half the size of the claim.'' The
agency tentatively concludes that, for consistency, this requirement
should be considered a key element of ``prominent display'' for the
disclaimer.
FDA has long held that accompanying information should be in a size
reasonably related to that of the information that it modifies. This
relative prominence, when codified, has (except in the case of
provisions pertaining to nutrient content claim referral and disclosure
statements in Sec. 101.13) been one-half the type size of the
information modified (see, e.g., Secs. 101.22(i)(2) and
102.5(b)(2)(ii)). For nutrient content claims, FDA did establish type
size requirements for referral and disclosure statements related to the
area of the surface bearing the principal display panel rather than to
the type size used for the nutrient content claim. However, nutrient
content claims often have very large type size, whereas nutritional
support statements will likely not appear in such large type because
they are intended to convey more lengthy information. Certainly the
statements that would qualify as nutritional support statements under
section 403(r)(6) of the act that have appeared in dietary supplement
labeling are of much greater length than most nutrient content claims.
Because nutritional support statements are likely to be more
lengthy, firms are likely to use relatively small type for them. The
agency is concerned that one-half the size of the type commonly used
for long statements or paragraphs may be too small for consumers to
read easily. Thus, FDA is proposing one-sixteenth of an inch as the
minimum type size for the disclaimer in Sec. 101.94(d).
One-sixteenth of an inch is specified in Sec. 101.2(c) as the
minimum type size for most other mandatory information on the principal
display panel or information panel, e.g., designation of ingredients,
name and place of business, and warning and disclaimer statements.
Further, one-sixteenth of an inch is the minimum size required in
Sec. 101.105(i) for net quantity of contents statements. Consequently,
the agency tentatively concludes that a minimum type size of one-
sixteenth of an inch for the disclaimer is necessary to ensure that it
is prominently displayed in accordance with section 403(r)(6)(C) of the
act.
E. Prominence of Ingredients That Are Not Vitamins or Minerals
Section 7(d) of the DSHEA strikes section 411(b)(2)(B) of the act.
Before it was removed by the DSHEA, section 411(b)(2)(B) stated that
the labeling and advertising of dietary supplements of vitamins and
minerals could 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, the agency stated that nutrient
content claims about ingredients that are not
[[Page 67182]]
vitamins or minerals (e.g., ``more fiber,'' ``high protein'') could not
be made on dietary supplements of vitamins or minerals (59 FR 378 at
387). This limitation was carried through in the final rule for
nutrient content claims for dietary supplements in Sec. 101.54(b)(1),
(c)(1), and (e)(1) that addressed ``high,'' ``good source,'' and
``more'' claims, respectively, for dietary supplements.
For example, Sec. 101.54(b)(1) as amended by the nutrient content
claims for dietary supplements final rule (59 FR 378 at 394) reads:
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.
(emphasis added).
Similar restrictions were added to Sec. 101.54(c)(1) and (e)(1) by
the 1994 nutrient content claims for dietary supplements final rule.
In response to section 7(d) of the DSHEA, FDA is proposing to amend
Sec. 101.54(b)(1) for ``high'' claims, Sec. 101.54(c)(1) for ``good
source'' claims, and Sec. 101.54(e)(1) for ``more,'' ``fortified,''
``enriched,'' and ``added'' claims to remove these restrictions on
claims on dietary supplements that characterize the levels of
substances that are not vitamins and minerals. These restrictions are
no longer required under the act.
III. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. In accordance with the Regulatory Flexibility Act,
the agency certifies that the proposed rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
The proposed 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 statements of
nutritional support so long as those statements include an appropriate
disclaimer, and the manufacturer has substantiation that the statement
is truthful and not misleading. 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 nutritional support statements will incur the additional cost of
redesigning labels to include the disclaimer. When the label or
labeling contains more than one nutritional support statement, the cost
of the disclaimer will depend on whether the disclaimer must be made on
each label panel, page, or piece of labeling that contains a statement
of nutritional support, or whether the disclaimer need only appear
once.
FDA is unable to quantify the benefits from this proposed rule. It
may be that some consumers will benefit from the additional information
about dietary ingredients that will become available. However, because
statements of nutritional support may now be made for some dietary
ingredients without any publicly available information to demonstrate
that the dietary ingredient is safe, or that it will have its claimed
effect, it is uncertain whether this proposed rule will in fact provide
any significant benefits to consumers. FDA requests comment on this
issue.
IV. 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.
V. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling, or other third party disclosure
requirements; thus there is no ``information collection'' necessitating
clearance by the Office of Management and Budget. However, to ensure
the accuracy of this tentative conclusion, FDA is asking for comment on
whether this proposed rule to amend its regulations establishing
requirements for the use of nutrient content claims and health claims
for dietary supplements and to specify how the disclaimer required by
section 403(r)(6)(C) of the act is to be presented on the labels or
labeling or dietary supplements imposes any paperwork burden.
VI. Effective Date
FDA is proposing to make this regulation effective on January 1,
1997. This is consistent with section 7(e) of the DSHEA, which states
that dietary supplements must be labeled in accordance with the
amendments of that section after December 31, 1996.
VII. Comments
Interested persons may, on or before March 13, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
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. Office of Food Labeling, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, ``Food Labeling, Questions
and Answers,'' August, 1993.
2. Wilkening, Virginia L., Memo to the Record, June 30, 1995.
3. Macro International Inc., ``Iron Supplement Warning Label
Focus Group Report,'' U.S. Department of Health and Human Services,
Food and Drug Administration, April 14, 1995.
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
[[Page 67183]]
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,
343, 348, 371).
2. Section 101.13(a) is amended by revising paragraphs (a) and (b),
redesignating paragraph (q)(3) as (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),
with the exception of such claims on restaurant menus, 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) Under section 403(r)(2)(F) of the act, a statement that
characterizes the percentage level of a dietary ingredient for which an
RDI or daily reference value (DRV) has not been established (e.g., ``40
percent omega-3 fatty acids,'' ``100 percent of the allicin in a bulb
of garlic,'' or ``twice the allicin as (name of product alternative)''
[where ``twice'' is another way of saying 200 percent]) 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. In addition, whenever a
statement that characterizes the percentage level of a dietary
ingredient for which there is no RDI or DRV is made in a way that draws
a comparison to the amount of the dietary ingredient in a reference
food, the reference food shall be clearly 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.
* * * * *
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 (e)(1) introductory text 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. Section 101.94 is added to subpart F to read as follows:
Sec. 101.94 Statements of nutritional support; disclaimer.
(a) The requirements in this section apply to the label or labeling
of dietary supplements where the dietary supplement bears a statement
of nutritional support that is provided for by section 403(r)(6) of the
Federal Food, Drug, and Cosmetic Act (the act), and where the
manufacturer, packer, or distributor wishes to take advantage of the
exemption to section 201(g)(1)(C) of the act by complying with section
403(r)(6) of the act.
(b) Text for disclaimer. (1) Where there is one statement of
nutritional support on the label or in the labeling, the disclaimer
shall be placed in accordance with paragraph (c)(1) 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 statement of nutritional support
on the label or in the labeling, each statement shall bear the
disclaimer in accordance with paragraph (b)(1) of this section, or a
plural disclaimer may be placed in accordance with paragraph (c)(2) 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.
(c) Placement. (1) Except as provided in paragraph (c)(2) of this
section, the disclaimer shall be contained in each statement of
nutritional support. The disclaimer shall be placed immediately
adjacent to the statement of nutritional support with no intervening
material.
(2) Where there is more than one statement of nutritional support
on a label panel or in labeling other than a label, and the
manufacturer, packer, or distributor wishes to comply with section
403(r)(6) of the act without having to place the disclaimer after each
statement of nutritional support, it shall place a symbol (e.g., an
asterisk) at the end of each statement of nutritional support that
refers to the same symbol placed elsewhere on the same label panel or
piece of labeling that is followed by the disclaimer. In this
[[Page 67184]]
situation, the referenced symbol and disclaimer shall be placed in a
box.
(d) Typesize. The disclaimer in paragraph (b) of this section shall
appear in boldface type in letters of a type size height no smaller
than the larger of:
(1) One-half the type size of the largest statement of nutritional
support; or
(2) One-sixteenth inch.
Dated: September 26, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-31193 Filed 12-27-95; 8:45 am]
BILLING CODE 4160-01-P
