[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Pages 51988-51991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21236]


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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.

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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 
September 19, 2011.

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 e-mailed to [email protected]. 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 Food, Drug, and Cosmetic Act (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 statement 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 FDA's 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

[[Page 51989]]

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). Persons with access to the Internet may obtain the 
guidance at http://www.cfsan.fda.gov/~dms/guidance.html.
    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 June 3, 2011 (76 FR 32215), FDA 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. FDA received five letters 
in response to the notice, each containing multiple comments. Several 
comments were generally supportive of the necessity of the information 
collection provisions of the guidance. Additional comments were outside 
the scope of the four collection of information topics on which the 
notice solicits comments, and will not be discussed in this document.
    (Comment 1) Several comment letters noted the accuracy of FDA's 
estimate of the burden hours, which ranges from 44 to 120 hours per 
claim depending upon the nature of the claim.
    (Response) FDA agrees. As discussed in this notice, 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.
    (Comment 2) One comment stated that FDA incorrectly estimated that 
there are no capital costs associated with developing information that 
meets the guidance's 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 comment argued that FDA 
did not fully consider that manufacturers invest significant capital 
resources in subscriptions to scientific journals and libraries to gain 
access to full-text scientific literature, consultants to develop 
appropriate wording for claims, and legal review of claims.
    (Response) FDA disagrees. The comment mischaracterizes the 
significant costs associated with hiring consultants, obtaining 
reference materials, and securing legal review of a notification as 
capital costs. For purposes of information collection requests under 
the Paperwork Reduction Act, capital costs are costs for equipment, 
machinery, and construction that, if not for FDA's request or 
requirement, the respondent would not incur. This includes: Buying new 
software and new computer equipment; monitoring, sampling, drilling and 
testing equipment; record storage facilities; the cost of purchasing or 
contracting out information collection services; and postage costs to 
mail in a report. Capital costs do not include costs to achieve 
regulatory compliance with requirements not associated with the 
information collection. Subscriptions to scientific journals and 
libraries to gain access to full-text scientific literature, hiring 
consultants to develop appropriate wording for claims, and legal review 
of claims are costs associated with developing information that the 
manufacturer uses to satisfy itself that it has met the guidance's 
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; thus, these costs are not capital costs 
because they are costs associated with achieving regulatory compliance 
with requirements of the FD&C Act, not costs associated specifically 
with equipment, machinery, and construction needed to retain 
appropriate substantiating evidence. FDA notes that it has added a 
reference to these costs as ``Costs to Respondent'' in section 12(b) of 
the supporting statement component of the Information Collection 
Request that it has submitted to OMB.
    (Comment 3) One comment suggested that, to enhance the quality, 
utility and clarity of the information as well as minimize the burden 
of collection on manufacturers, FDA explore options for electronic 
submission and a digital, interactive database so the information can 
be easily reviewed, collated, analyzed and reported.
    (Response) FDA notes that dietary supplement manufacturers making a 
nutritional deficiency, structure/function, or general well-being claim 
are required by section 403(r)(6) of the FD&C Act to have 
substantiation that the claim is truthful and not misleading. There is 
no requirement in the FD&C Act or recommendation in the guidance 
document that manufacturers submit the substantiation information to 
FDA. The information is retained by the manufacturers in their records. 
The guidance does not specifically prescribe the use of automated, 
electronic, mechanical, or other technological techniques or other 
forms of information technology as necessary for use by dietary 
supplement manufacturers. Companies are free to use whatever forms of 
information technology that may best assist them in developing 
substantiation information.
    (Comment 4) One comment stated that FDA should provide clarity on 
what type of evidence is needed to substantiate a traditional use 
claim. The

[[Page 51990]]

comment argued that Canada, the European Union, and Australia recognize 
traditional use evidence to support appropriate claim statements. The 
comment stated that several authoritative labeling standards monographs 
for herbal products specify traditional use claim statements, such as 
Health Canada Natural Health Products Directorate (NHPD) monographs, 
European Medicines Agency (EMA) European Community Herbal Monographs, 
and World Health Organization (WHO) Monographs on Selected Medicinal 
Plants. The comment recommended that FDA allow such monographs as 
acceptable pieces of evidence to substantiate a traditional use claim. 
The comment concluded that FDA's acceptance of label claim statements 
listed in appropriate monographs and clear guidance on other types of 
evidence that could be used to substantiate traditional use claims 
would significantly reduce the burden of collecting such information.
    (Response) FDA disagrees that traditional use evidence is 
sufficient to meet the substantiation standard of competent and 
reliable scientific evidence applied by FDA in ``Guidance for Industry: 
Substantiation for Dietary Supplement Claims Made Under Section 
403(r)(6) of the Federal Food, Drug, and Cosmetic Act.'' A claim based 
on historical or traditional use is not a claim that is substantiated 
by scientific evidence. Claims permitted by foreign and international 
monographs do not always have to be substantiated by scientific studies 
but may be acceptable if, in some cases, they are accompanied by 
disclosures that the claim is not scientifically established or are 
deemed appropriate merely by their history of use for a particular 
intended use. Therefore, FDA does not believe that these monographs are 
adequate to meet the substantiation standard applied by FDA.
    (Comment 5) One comment suggested that FDA should identify 
monographs that are already recognized in other countries as 
substantiation for claims made for products that are manufactured in 
strict conformity to these monographs. The comment identified two 
specific compendia of monographs and recommended that FDA recognize 
these monographs as ``constituting in and of themselves substantiation 
for a pre-existing widely established claim that may be made for a 
dietary supplement under section 403(r)(6) of the FD&C Act, so long as 
the claim is not a drug claim and is significantly similar to the use 
or purpose described in a monograph, and the conditions and level of 
use of the ingredient(s) that is the basis of the claim is within the 
dosage range described in the monograph.''
    (Response) FDA disagrees that foreign or other third-party 
monographs assure that a claim is substantiated by competent and 
reliable scientific evidence, which is the standard applied by FDA. 
Claims that may be permitted by foreign and international monographs do 
not always have to be substantiated by scientific studies but may be 
acceptable if substantiated, in whole or in part, by evidence not 
deemed adequate for a claim made for a dietary supplement in the United 
States, such as animal data or traditional medicinal use. Therefore, 
FDA does not believe that these monographs are adequate to meet the 
substantiation standard applied by FDA
    (Comment 6) One comment argued that FDA overestimated the burden of 
the information collection by overestimating the number of respondents. 
The comment noted that FDA's website contains a list of notifications 
submitted in compliance with the requirements of 21 CFR 101.93 (a)(1) 
and stated that their review of the notices submitted between December 
2007 and August 2010 indicates that the Agency has received an average 
of approximately 1,600 to 1,650 annually during this time, not the 
2,001 per year estimated by FDA.
    (Response) FDA disagrees that it has overestimated the number of 
respondents and stands by the estimate of 2,001 annual respondents for 
the next 3 years. The number of such notifications received by FDA in 
any given year can vary quite widely (by up to 300). In addition, the 
number of firms keeping records in anticipation of submitting a 
notification may be greater than the number of notification submitted. 
Thus, FDA believes retaining the estimate of 2,001 from the prior 
submission is appropriate.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
           Claim type                Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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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.

    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. 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

[[Page 51991]]

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: August 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21236 Filed 8-18-11; 8:45 am]
BILLING CODE 4160-01-P