[Federal Register: January 2, 2008 (Volume 73, Number 1)]
[Notices]
[Page 197-200]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja08-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0491]
Draft Guidance for Industry: Questions and Answers Regarding the
Labeling of Dietary Supplements as Required by the Dietary Supplement
and Nonprescription Drug Consumer Protection Act; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Questions and Answers
Regarding the Labeling of Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act.''
This draft guidance is intended to assist the dietary supplement
industry in complying with the labeling requirements prescribed for
dietary supplement manufacturers, packers, and distributors by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act
(the DSNDCPA). Separate guidance, issued by the Center for Drug
Evaluation and Research on labeling requirements for nonprescription
(over-the-counter) human drugs marketed without an approved
application, is announced elsewhere in this issue of the Federal
Register.
DATES: Although you can comment on any guidance at any time (see 21
CFR 10.115(g)(5)), to ensure that the agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 3, 2008.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Nutritional Products, Labeling, and Dietary
Supplements (HFS-800), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send one self-addressed adhesive label
to assist the office in processing your request, or include a fax
number to which the draft guidance may be sent. See the SUPPLEMENTARY
[[Page 198]]
INFORMATION section for electronic access to the draft guidance.
Submit written comments on the draft guidance, including comments
regarding proposed collection of information, to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to either http://www.fda.gov/dockets/ecomments or http://www
.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Vasilios Frankos, Center for Food
Safety and Applied Nutrition (HFS-810), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2375.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Guidance for Industry: Questions and Answers Regarding the Labeling
of Dietary Supplements as Required by the Dietary Supplement and
Nonprescription Drug Consumer Protection Act.'' On December 22, 2006,
the President signed into law the DSNDCPA (Public Law 109-462, 120
Stat. 3469). This law amends the Federal Food, Drug, and Cosmetic Act
(the act) with respect to serious adverse event reporting for dietary
supplements and non-prescription drugs marketed without an approved
application. The draft guidance document contains questions and answers
relating to the new labeling requirements for dietary supplements under
the DSNDCPA.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on this topic. It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirement of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 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.
With respect to the following collection of information, FDA
invites comment 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 on respondents, including through the use of automated
collection techniques, when appropriate, and other forms of information
technology.
Title: Dietary Supplement Labeling Requirements and Recommendations
under the Dietary Supplement and Nonprescription Drug Consumer
Protection Act.
Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors of dietary
supplements marketed in the United States.
The draft guidance is intended to assist the dietary supplement
industry in complying with the dietary supplement labeling requirements
of section 403(y) of the act (21 U.S.C. 343(y)), which was added by the
DSNDCPA.
Section 403(y) of the act requires the label of a dietary
supplement being marketed in the United States to include a domestic
address or domestic telephone number through which the responsible
person may receive a report of a serious adverse event with such
dietary supplement. If the label does not include the required domestic
address or telephone number, the dietary supplement is misbranded. When
the responsible person chooses to provide a domestic address (rather
than a telephone number) for adverse event reporting, FDA concludes
that the statute requires the product label to bear a full U.S. mailing
address that includes the street address or P.O. box, city, state, and
zip code of the responsible person (i.e., the manufacturer, packer,
distributor, or retailer identified on the dietary supplement label).
This labeling requirement helps to ensure that any mailed adverse event
report will reach the responsible person. Similarly, when the
responsible person chooses to provide a domestic telephone number for
adverse event reporting, FDA concludes that the statute requires the
telephone number on the product label to include the area code. Without
the area code, the telephone number is incomplete and does not serve
its intended purpose of enabling the consumer to contact the
responsible person to report a serious adverse event.
In addition to discussing the statutory requirement for dietary
supplement labels to include a domestic address or a domestic telephone
number, the draft guidance recommends that the label bear a clear,
prominent statement informing consumers that the domestic address or
telephone number is for reporting serious adverse events associated
with use of the product.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Respondents per Response Responses Response Total Hours
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Domestic address or telephone number labeling 1,460 15.4616 22,574 4 90,296
requirement (21 U.S.C. 343(y))
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FDA recommendation for label statement explaining 1,460 15.4616 22,574 4 90,296
purpose of domestic address or telephone number
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Total Burden Hours 180,592
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Using FDA's Labeling Cost Model, FDA estimates that there are
22,574 stockkeeping units (SKUs) for unique dietary supplement pills
and liquids for which labels would have to bear the complete domestic
address or domestic telephone number of the responsible person for that
supplement. This estimate of the number of SKUs for dietary supplements
is an underestimate of the total number of dietary supplements on the
market because dietary supplements are marketed in a variety of forms
other than pills and liquids. However, this is the most comprehensive
estimate available to FDA. FDA requests comments on the total number of
SKUs for dietary supplements that are marketed in the United States.
In the economic impact analysis of the Dietary Supplement Good
Manufacturing Practices final rule (the GMP final rule) FDA estimated
that there were about 1,460 dietary supplement manufacturers, re-
packagers, re-labelers, and holders of dietary supplements (June 25,
2007; 72 FR 34752 at 34920). Assuming the 22,574 SKUs are split equally
among the firms, then each firm would be responsible for updating about
15 SKUs. The estimate of the number of manufacturers, re-packagers, re-
labelers, and holders of dietary supplements from the GMP final rule is
FDA's best estimate of the number of firms that are ``responsible
persons'' who must comply with the new labeling requirement added by
the DSNDCPA; however, it is not a precise estimate because the number
of dietary supplement establishments covered by the GMP final rule is
likely to be larger than the number of ``responsible persons,'' where a
``responsible person'' is a dietary supplement manufacturer, packer, or
distributor whose name is listed on the label of a dietary supplement
associated with a serious adverse event (see section 761(b)(1) of the
act (21 U.S.C. 379aa-1(b)(1)). Thus, FDA's estimate for number of
respondents in table 1 of this document may be over inclusive. FDA
requests comments on the number of firms that would be subject to the
labeling requirements of the DSNDCPA.
FDA does not know how many of the 22,574 dietary supplement SKUs
would have to undergo a label change to include the complete domestic
address or domestic telephone number of the responsible person as
required by the DSNDCPA. Based on the agency's experience with
regulating dietary supplements, FDA believes that some dietary
supplement labels (SKUs) already have the full domestic address or
telephone number of the responsible person printed on the label and
thus will not need to be redesigned to comply with section 403(y) of
the act. The agency does not have any information on which to base a
quantitative estimate of the number of labels that already meet the
requirements of section 403(y) of the act, however. Therefore, FDA is
assuming conservatively that all labels will need to be redesigned.
Assuming further that redesigning a dietary supplement label to add
a domestic address or telephone number requires one color change, and
no analytical tests are performed on the new label, then FDA believes
that designing the label change should not take longer than 4 hours per
label. This time would be used to assess the current layout of each
label and choose the best location for the domestic address or
telephone number. Automated printing of the labels should only require
a few seconds per label.
In addition to changing their labels to meet the statutory
requirement for a domestic address or a domestic telephone number,
dietary supplement firms may also choose to adopt the draft guidance's
recommendation that the label bear a clear, prominent statement
informing consumers that the domestic address or telephone number is
for reporting serious adverse events associated with use of the
product. In the absence of any information about how many firms are
likely to add such an explanatory statement to their dietary supplement
labels, FDA is assuming conservatively that the explanatory statement
will be added to all dietary supplement labels.
FDA estimates that the burden of including the recommended
explanatory statement on the label will be similar to the burden of
adding the full domestic address or telephone number to the dietary
supplement label. We assume it will take 4 hours per label to assess
the current layout of each label and choose the best location for the
explanatory statement. Again we assume this label modification would
require one color change and that no premarket testing of the label
wording would be performed. FDA requests comments on how many dietary
supplement firms and products would follow FDA's recommendation to
include such an explanatory statement on the product's label. FDA also
requests comments on the burden associated with placing this
explanatory statement on the dietary supplement label.
The likely overestimate of the total burden caused by FDA's
conservative assumption that all dietary supplement labels (SKUs) will
be redesigned to add a domestic address or telephone number and to
include an explanatory statement for consumers is offset to some degree
by the underestimate of the number of SKUs in the marketplace resulting
from FDA's lack of information on the number of SKUs for dietary
supplements that are sold in a non-liquid or non-pill form. FDA
requests comments on the burden estimates presented in table 1 of this
document. The agency is especially interested in comments that include
information about: (1) The number of dietary supplements marketed in
the United States in all forms and (2) the number or percentage of
dietary supplements marketed in the United States that will not require
a label change to comply with the requirement that dietary supplements
bear a complete domestic address or telephone number. The agency would
also welcome information on whether dietary supplement firms plan to
add the recommended explanatory statement to their product labels.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the draft
guidance, including comments regarding proposed collection of
information. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number
[[Page 200]]
found in brackets in the heading of this document. The draft guidance
and received comments are available for public examination in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Please note that in January 2008, the FDA Web site is expected to
transition to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. After the
transition date, electronic submissions will be accepted by FDA through
the FDMS only. When the exact date of the transition to FDMS is known,
FDA will publish a Federal Register notice announcing that date.
IV. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at http://www.cfsan.fda.gov/guidance.html.
Dated: December 26, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-6266 Filed 12-27-07; 3:08 pm]
BILLING CODE 4160-01-S