[Federal Register Volume 73, Number 18 (Monday, January 28, 2008)]
[Notices]
[Pages 4875-4877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1362]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0030] (formerly Docket No. 2004D-0466)


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Draft Guidance for Industry: Substantiation for 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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection provisions of 
the draft guidance entitled ``Guidance for Industry: Substantiation for 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.''

DATES: Submit written or electronic comments on the collection of 
information by March 28, 2008.

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: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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. 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, in the Federal Register of November 9, 2004 (69 FR 64962), 
FDA published a notice of availability of the draft guidance document 
providing a 60-day public comment period on the collection of 
information provisions. Thereafter, in the Federal Register of June 7, 
2007 (72 FR 31583), FDA published a 30-day notice responding to 
comments on the collection of information provisions received in 
response to the November 9, 2004, notice and announcing that the 
proposed collection of information had been submitted to OMB. In 
response to a request by OMB, FDA is republishing 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

[[Page 4876]]

of automated collection techniques, when appropriate, and other forms 
of information technology.

Substantiation for Dietary Supplement Claims Made Under Section 
403(r)(6) of the Federal Food, Drug, and Cosmetic Act (OMB Control 
Number 0910--NEW)

    Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (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 statement is 
truthful and not misleading. The draft guidance document entitled 
``Guidance for Industry: Substantiation for Dietary Supplement Claims 
Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic 
Act'' is intended to describe the amount, type, and quality of evidence 
FDA recommends a dietary supplement manufacturer have to substantiate a 
claim under section 403(r)(6) of the act. This draft 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. Persons with access to the Internet may 
obtain the draft guidance at the following Web site: http://
www.cfsan.fda.gov/~dms/guidance.html. A copy of the draft guidance also 
is available for public examination in the Division of Dockets 
Management (see ADDRESSES).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of       Annual Frequency per     Total Annual        Hours per
                      Claim Type                           Respondents            Response           Responses           Response         Total Hours
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Widely known, established                                             667                     1                667                 44             29,348
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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
                                                        .................  ....................  .................  .................  .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                            189,428
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 draft 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 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. We increased this estimated 
burden from 1 hour per claim to 44 hours per claim based on information 
received from industry, as noted in our June 7, 2007, notice in 
response to comment 1 (72 FR 31583 and 31584). 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 Federal Register of January 6, 2000, 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 (65 FR 1000). 
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 percent) made each 
year. If we assume that the 2,001 claims are

[[Page 4877]]

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).
    There are no capital costs or operating and maintenance costs 
associated with this information collection.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: January 18, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1362 Filed 1-25-08; 8:45 am]
BILLING CODE 4160-01-S