
[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65409-65410]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26142]


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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 or we) is announcing an 
opportunity for public comment on our proposed collection of certain 
information. 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 
invites 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 January 5, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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 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, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our 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 Federal Food, Drug, and Cosmetic Act (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 claim 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, 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 our recommendations to manufacturers 
about the amount, type, and quality of evidence they should have to 
substantiate a claim under section 403(r)(6) of the FD&C Act. 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) of the FD&C Act. Persons with access to the 
Internet may obtain the guidance at http://www.fda.gov/FoodGuidances.
    Dietary supplement manufacturers collect the necessary 
substantiating information for their product as required by section 
403(r)(6) of the FD&C Act. 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

[[Page 65410]]

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.
    We estimate the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                    Average burden
           Claim type                Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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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.

    We assume 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 believe 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 (65 FR 1000), we 
published a final rule on statements made for dietary supplements 
concerning the effect of the product on the structure or function of 
the body. In that final rule, we 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 
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: October 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26142 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P


