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of Management and Budget Review; Comment Request; Draft Guidance for 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

Federal Register: April 25, 2008 (Volume 73, Number 81)           
                  Page 22423-22424

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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 May 27, 
2008.

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: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-NEW and title, 
``Draft Guidance for Industry: Substantiation for Dietary Supplement 
Claims Made Under the Federal Food, Drug, and Cosmetic Act.'' Also 
include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Draft Guidance for Industry: Substantiation for Dietary Supplement 
Claims Made Under 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 The draft guidance document entitled 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'' (November 9,

[[Page 22424]]

2004; 69 FR 64962) 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. The 
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
    In the Federal Register of January 28, 2008 (73 FR 4875), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours Per
                      Claim Type                           Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Widely known, established                                             667                     1                667                 44             29,348
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pre-existing, not widely established                                  667                     1                667                120             80,040
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.

    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, document 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 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.

    Dated: April 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8973 Filed 4-24-08; 8:45 am]

BILLING CODE 4160-01-S