
[Federal Register Volume 76, Number 107 (Friday, June 3, 2011)]
[Notices]
[Pages 32215-32217]
From the Federal Register Online via the Government Printing 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

[[Page 32217]]

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


