[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32215-32217]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-13813]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0403]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Substantiation for Dietary Supplement Claims Made
Under the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
and the guidance entitled ``Guidance for Industry: Substantiation for
Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal
Food, Drug, and Cosmetic Act.''
DATES: Submit either electronic or written comments on the collection
of information by August 2, 2011.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(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(c) 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.
[[Page 32216]]
3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in
the Federal Register concerning each proposed collection of
information, including each proposed extension of an existing
collection of information, before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (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.
Substantiation for Dietary Supplement Claims Made Under the Federal
Food, Drug, and Cosmetic Act--21 U.S.C. 343(r)(6) (OMB Control Number
0910-0626)--Extension
Section 403(r)(6) of the FD&C 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 statement is truthful and not misleading. Under
section 403(r)(6)(A) of the FD&C Act, 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
[(U.S.)], 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.''
The guidance document entitled ``Substantiation for Dietary
Supplement Claims Made Under Section 403(r)(6) of the Federal Food,
Drug, and Cosmetic Act'' provides FDA's recommendations to
manufacturers about the amount, type, and quality of evidence they
should have to substantiate a claim under section 403(r)(6). The
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. The guidance
document is intended to assist manufacturers in their efforts to comply
with section 403(r)(6). Persons with access to the Internet may obtain
the guidance at http://www.cfsan.fda.gov/~dms/guidance.html.
Dietary supplement manufacturers collect the necessary
substantiating information for their product as required by section
403(r)(6). The guidance provides information to manufacturers to assist
them in doing so. The recommendations contained in the guidance are
voluntary. 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 choose to place
a claim on their product's label.
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 Federal Trade Commission 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 estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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No. of Average burden
Claim type No. of responses per Total annual per response Total hours
respondents respondent responses (in hours)
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Widely known, established....... 667 1 667 44 29,348
Pre-existing, not widely 667 1 667 120 80,040
established....................
Novel........................... 667 1 667 120 80,040
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Total....................... .............. .............. .............. .............. 189,428
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
FDA assumes that it will take 44 hours to assemble information
needed to substantiate a claim on a particular dietary supplement when
the claim is widely known and established. 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
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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 Federal Register of January 6, 2000 (65 FR 1000), FDA
published a final rule on statements made for dietary supplements
concerning the effect of the product on the structure or function of
the body. FDA estimated that there were 29,000 dietary supplement
products marketed in the U.S. (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 percent) 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. Table 1 of this
document shows that the annual burden hours associated with assembling
evidence for claims is 189,428 (the sum of 667 x 44 hours, 667 x 120
hours, and 667 x 120 hours).
Dated: May 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-13813 Filed 6-2-11; 8:45 am]
BILLING CODE 4160-01-P