[Federal Register: November 9, 2004 (Volume 69, Number 216)]
[Notices]
[Page 64962-64964]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09no04-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0466]
Draft Guidance for Industry: Substantiation for Dietary
Supplement Claims Made Under Section 403(r)(6) of the Federal Food,
Drug, and Cosmetic Act; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for Industry:
Substantiation for Dietary Supplement Claims Made Under Section
403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' This draft
guidance describes the amount, type, and quality of evidence that FDA
recommends a manufacturer have to substantiate a claim under section
403(r)(6) of the Federal Food, Drug, and Cosmetic Act (act). FDA is
also announcing its decision not to publish additional guidance on
applying the structure/function rule at this time.
DATES: Submit written or electronic comments on the draft guidance and
the collection of information provisions by January 10, 2005, to ensure
adequate consideration in preparation of any final guidance document.
General comments on agency guidance documents are welcome at any time.
ADDRESSES: Submit written comments on the draft guidance document and
the collection of information provisions to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments on the draft
guidance and the collection of information to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Vickey Lutwak, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 301-436-2375, fax: 301-436-2636, e-mail:
Vickey.Lutwak@cfsan.fda.gov
SUPPLEMENTARY INFORMATION:
I. Background--Substantiation Draft Guidance
Section 403(r)(6) of the act (21 U.S.C. 343(r)(6)) requires that a
manufacturer of a dietary supplement making a nutritional deficiency,
structure/function, or general well-being claim have substantiation
that the claim is truthful and not misleading.\1\
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\1\ Under section 403(r)(6)(A) of the act (21 U.S.C.
343(r)(6)(A)), such a statement is one that ``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 for a nutrient or dietary ingredient.''
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This draft guidance document is intended to describe the amount,
type, and quality of evidence FDA recommends a manufacturer have to
substantiate a claim under section 403(r)(6) of the act. This draft
guidance document is limited to issues pertaining to substantiation
under section 403(r)(6) of the act; it does not extend to
substantiation issues that may exist in other sections of the act.
FDA intends to apply a standard for substantiating claims for
dietary supplements that is consistent with the Federal Trade
Commission's (FTC's) standard for dietary supplements and other health
related products of ``competent and reliable scientific evidence.'' FDA
seeks comments on this draft guidance only as they relate to FDA's use
and application of the standard and approach that are described in the
guidance. We (FDA) are not seeking comment on FTC's application, use,
or interpretation of their standard.
The agency has adopted good guidance practices (GGPs) that set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (21 CFR 10.115). The draft
guidance document is being issued as a Level 1 guidance consistent with
FDA's GGPs. The draft guidance document represents the agency's current
thinking on the amount, type, and quality of evidence FDA recommends a
manufacturer have to substantiate a claim under section 403(r)(6) of
the act. It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative method
may be used as long as it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995--Substantiation Draft Guidance
This draft guidance document contains information collection
provisions that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520). Under the PRA, Federal agencies must obtain approval
from the OMB for each collection of information they conduct or
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3)
and 5 CFR 1320.3 and includes agency requests or requirements that
members of the public submit reports, keep records, or provide
information to a third party. Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day
notice in the Federal Register concerning each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is hereby publishing notice of the
proposed collection of information set forth in this document.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Draft Guidance for Industry: Substantiation for Dietary Supplement
Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and
Cosmetic Act; Availability
Section 403(r)(6) of the act requires that a manufacturer of a
dietary supplement making a nutritional deficiency, structure/function,
or general well-being claim have substantiation that the statement is
truthful and not misleading. This draft guidance document is intended
to describe the amount, type, and quality of evidence FDA recommends a
dietary supplement manufacturer have to
[[Page 64963]]
substantiate a claim under section 403(r)(6) of the act. This guidance
does not discuss the types of claims that can be made concerning the
effect of a dietary supplement on the structure or function of the
body, nor does it discuss criteria to determine when a statement about
a dietary supplement is a disease claim.
FDA estimates the burden for this information collection as
follows:
Table 1.--Estimated Reporting Burden\1\
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Total
Claim type No. of Annual Frequency Annual Hours per Total Hours
Respondents per Response Responses Response
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Widely known, established 667 1 667 1 667
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Pre-existing, not widely established 667 1 667 120 80,040
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Novel 667 1 667 120 80,040
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Annual one time burden hours 160,747
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
Dietary supplement manufacturers will only need to collect
information to substantiate their product's nutritional deficiency,
structure/function, or general well-being claim if they chose to place
a claim on their product's label. Gathering evidence on their product's
claim is a one time burden; they collect the necessary substantiating
information for their product as required by section 403(r)(6) of the
act.
The standard discussed in the guidance for substantiation of a
claim on the labeling of a dietary supplement is consistent with
standards set by the FTC for dietary supplements and other health
related products that the claim be based on competent and reliable
scientific evidence. This evidence standard is broad enough that some
dietary supplement manufacturers may only need to collect peer-reviewed
scientific journal articles to substantiate their claims; other dietary
supplement manufacturers whose products have properties that are less
well documented may have to conduct studies to build a body of evidence
to support their claims. It is unlikely that a dietary supplement
manufacturer will attempt to make a claim when the cost of obtaining
the evidence to support the claim outweighs the benefits of having the
claim on the product's label. It is likely that manufacturers will seek
substantiation for their claims in the scientific literature.
The time it takes to assemble the necessary scientific information
to support their claims depends on the product and the claimed
benefits. If the product is one of several on the market making a
particular claim for which there is adequate publicly available and
widely established evidence supporting the claim, then the time to
gather supporting data will be minimal; if the product is the first of
its kind to make a particular claim or the evidence supporting the
claim is less publicly available or not widely established, then
gathering the appropriate scientific evidence to substantiate the claim
will be more time consuming.
FDA assumes that it will take only about an hour to assemble
information needed to substantiate a claim on a particular dietary
supplement when the claim is widely known and established. These are
likely products whose claimed effects have been long studied and the
results of the studies are widely available in credible textbook and
reference books, therefore making the substantiation burden minimal.
FDA believes it will take closer to 120 hours to assemble supporting
scientific information when the claim is novel or when the claim is
pre-existing but the scientific underpinnings of the claim are not
widely established. These are claims that may be based on emerging
science, where conducting literature searches and understanding the
literature takes time. It is also possible that references for claims
made for some dietary ingredients or dietary supplements may primarily
be found in foreign journals and in foreign languages or in the older,
classical literature where it is not available on computerized
literature databases or in the major scientific reference databases,
such as the National Library of Medicine's literature database, all of
which increases the time of obtaining substantiation.
In the final rule on statements made for dietary supplements
concerning the effect of the product on the structure or function of
the body (structure/function final rule (65 FR 1000, January 6, 2000)),
FDA estimated that there were 29,000 dietary supplement products
marketed in the United States (65 FR 1000 at 1045). Assuming that the
flow of new products is 10 percent per year, then 2,900 new dietary
supplement products will come on the market each year. The structure/
function final rule estimated that about 69 percent of dietary
supplements have a claim on their labels, most probably a structure/
function claim (65 FR 1000 at 1046). Therefore, we assume that
supplement manufacturers will need time to assemble the evidence to
substantiate each of the 2,001 claims (2,900 x 69%) made each year. If
we assume that the 2,001 claims are equally likely to be pre-existing
widely established claims, novel claims, or pre-existing claims that
are not widely established, then we can expect 667 of each of these
types of claims to be substantiated per year. Row 1 of Table 1 of this
document shows that the annual burden hours associated with assembling
evidence for claims is 160,747 (667 x 1hr, 667 x 120 hrs, and 667 x 120
hrs).
There are no capital costs or operating and maintenance costs
associated with this information collection.
III. Guidance on Applying the Structure/Function Rule
On January 6, 2000, FDA published a final rule, often referred to
as the ``structure/function rule,'' implementing section 403(r)(6) of
the act concerning the types of statements that can be made regarding
the effect of a dietary supplement on the structure or function of the
body (65 FR 1000). This rule, codified in Sec. 101.93(f) (21 CFR
101.93(f) and (g)), distinguishes between disease claims and structure/
function claims. As discussed in Sec. 101.93, if the label or labeling
of a product marketed as a dietary supplement bears a disease claim as
defined in that rule, the product will be subject to regulation as a
drug unless the claim is an authorized health claim for which the
product qualifies.
[[Page 64964]]
In the preamble to the final rule, FDA stated that it intended to
publish a guidance on applying this rule. In a notice published in the
Federal Register on February 22, 2001 (66 FR 11172), FDA invited public
comments on the topics that should be included in such a guidance. FDA
agrees with the comments that were submitted stating that the preamble
to the structure/function rule and the numerous courtesy letters that
the agency has issued since the enactment of section 403(r)(6) provide
considerable guidance to dietary supplement manufacturers about the
types of claims that the agency considers to be disease claims.
Therefore, FDA has decided not to issue such a guidance at this time.
FDA will continue to monitor dietary supplement manufacturers'
compliance with section 403(r)(6) of the act and Sec. 101.93, take
enforcement action where appropriate, and reconsider the possibility of
issuing guidance if future developments warrant.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the
substantiation draft guidance document. (FDA is not specifically
seeking comment on its decision not to publish additional guidance on
the structure/function rule.) Two copies of mailed comments are to be
submitted, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in brackets in the
heading of this document. The draft guidance and received comments are
available for public examination in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Once
on this site, select 2004D-0466 ``Guidance for Industry: Substantiation
for Dietary Supplement Claims Made Under Section 403(r)(6) of the
Federal Food, Drug, and Cosmetic Act'' and follow the directions.
Copies of this draft guidance may be obtained on the Internet from the
CFSAN homepage at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.cfsan.fda.gov.
Dated: October 25, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24871 Filed 11-4-04; 8:45 am]
BILLING CODE 4160-01-S