Document ID: FDA-2011-N-0403-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Substantiation for
Dietary Supplement Claims Made Under the Federal Food, Drug, and
Cosmetic Act
Posted Date: 2015-02-11T05:00Z

[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7610-7612]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02787]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0403]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Substantiation for 
Dietary Supplement Claims Made Under the Federal Food, Drug, and 
Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 7611]]

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
13, 2015.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0626. 
Also include the FDA 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, 8455 Colesville Road; COLE-14526, Silver 
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 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.
    In the Federal Register of November 4, 2014 (79 FR 65409), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Five comments were received. One comment 
agreed with the Agency's burden estimate while the remaining comments 
were not responsive to four information collection topics solicited in 
the notice and are therefore not discussed in this document.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
           Claim type                Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         189,428
----------------------------------------------------------------------------------------------------------------
\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

[[Page 7612]]

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: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02787 Filed 2-10-15; 8:45 am]
BILLING CODE 4164-01-P