[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Notices]
[Pages 51425-51427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24123]



[[Page 51425]]

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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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 January 5, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 5, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0403 for ``Substantiation for Dietary Supplement Claims Made 
Under the Federal Food, Drug, and Cosmetic Act.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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, 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.

[[Page 51426]]

    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

    This information collection supports Agency regulations and 
associated guidance. Specifically, 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 claim is truthful 
and not misleading. A nutritional deficiency claim states a benefit 
related to a classical nutrient deficiency disease and states how often 
the disease occurs in the United States. A structure/function claim 
describes the role of a nutrient or dietary ingredient intended to 
affect the structure or function in humans or characterizes how a 
nutrient or dietary ingredient acts to maintain such structure or 
function. A general well-being claim describes general well-being from 
consumption of 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 https://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 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 Recordkeeping Burden \1\
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                                                     Number of                        Average
           Claim type                Number of      records per    Total annual     burden per     Total  hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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Widely known, established.......             667               1             667              44          29,348
Preexisting, 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 have retained the currently approved burden estimate for the 
information collection. Based on our experience with the collection, we 
estimate 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 preexisting 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.

[[Page 51427]]

    In the Federal Register of January 6, 2000 (65 FR 1000), we 
published a final rule (the `structure/function 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 
preexisting widely established claims, novel claims, or preexisting 
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 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24123 Filed 11-3-17; 8:45 am]
 BILLING CODE 4164-01-P