[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31583-31585]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0466]


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.

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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 July 9, 
2007.

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. All comments should be

[[Page 31584]]

identified with the OMB control number ``0910-NEW'' and title, 
``Substantiation for Dietary Supplement Claims Made Under Section 
403(r)(6) of 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.

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 The draft guidance document entitled 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 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.
    In the Federal Register of November 9, 2004 (69 FR 64962), FDA 
published a Notice of Availability of the draft guidance document with 
a 60-day notice requesting public comment on the collection of 
information provisions. We received a number of letters containing one 
or more comments, several of which responded to our request for 
comments on the proposed information collection.
    (Comment 1) Several comments challenged the accuracy of the 
estimated number of hours it would take to prepare the information 
needed to substantiate a claim when that claim is widely known and 
accepted. We estimated it would take 1 hour because supporting material 
for such claims should be readily available in textbooks and reference 
books. Two comments asserted that the burden estimate was too low but 
did not propose an alternative estimate or provide information to 
support a higher estimate. One comment did provide such information. 
Based on a review of how long it took to assemble the supporting 
information for approximately 50 claims involving products containing 
from 1 to 3 herbs, the comment stated that, for these claims, it took 
18 to 24 hours to assemble the supporting information and an additional 
2 to 4 hours to have a qualified expert review the information. In 
addition, the comment stated that, for products with more complicated 
formulations, it took approximately 40 hours plus the expert review 
time to assemble the supporting information.
    (Response) FDA has considered the information provided in the 
comment. Based on this information, we have increased our estimate of 
the burden of preparing the information needed to substantiate a claim 
on a dietary supplement when the claim is widely known and accepted 
from 1 hour to 44 hours.
    (Comment 2) One comment disagreed with our statement that there are 
no capital, operating, or maintenance costs associated with this 
collection of information. The comment stated that they use staff 
support, copying and scanning equipment, and electronic and hard copy 
file storage when preparing substantiation files. The comment also 
stated that there is a capital cost to maintain a botanical library 
collection of historical references and current scientific journals. 
Finally, it stated there is an on-going cost associated with reviewing 
scientific literature for new scientific developments.
    (Response) FDA believes that it is accurate to state that there are 
no capital, operating, or maintenance costs associated with this 
collection of information. Collecting the required information may 
generate some capital costs associated with using electronic equipment 
such as scanners and computers and using hard-copy file cabinets. 
However, we estimate that this cost is negligible because most firms 
probably already have this equipment, and the incremental cost of using 
this equipment for the purposes described would be very small. The few 
firms that do not own the necessary equipment could pay for access to 
scanners and computers for a minimal charge. Operating costs for this 
equipment would consist of the incremental cost of electricity for this 
equipment during the time it was used for the purposes described. 
Maintenance costs for this equipment would consist of the overall 
maintenance costs pro rated for the time the equipment was used for the 
purposes described. Both operating and maintenance costs would be 
minimal. Personnel costs associated with using this equipment have 
already been included as part of the burden hours that we presented in 
table 1 of this document. Further, we do not agree with the comment's 
assertion that a respondent would need to maintain a botanical library 
collection of historical references and current scientific journals. It 
is not necessary for a respondent to maintain a Botanical Library in 
order to access the requested information. In addition, the guidance 
does not recommend the firms continually update supporting material. We 
do not agree that the on-going cost of reviewing scientific literature 
for new scientific developments is a cost of this information 
collection. Therefore, FDA has not changed its assessment that there 
are no capital, operating, or maintenance costs associated with this 
collection of information.
    FDA estimates the burden for this information collection as 
follows:

                             Table 1.--Estimated Annual One-Time Reporting Burden\1\
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                         No. of        Annual Frequency     Total Annual        Hours per
    Claim type        Respondents        per Response        Responses           Response         Total Hours
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Widely known,                    667                  1                667                 44             29,348
 established
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\1\ There are no capital 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 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 response to comment 1. 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 final rule on statements made for dietary supplements 
concerning the effect of the product on the structure or function of 
the body (structure/function final rule (65 FR 1000, January 6, 2000)), 
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: May 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10911 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S