[Federal Register Volume 73, Number 1 (Wednesday, January 2, 2008)]
[Notices]
[Pages 197-200]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-6266]


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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Draft Guidance for Industry: Questions and Answers Regarding the 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availability of a draft guidance entitled ``Questions and Answers 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This draft guidance is intended to assist the dietary supplement 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Office of Nutritional Products, Labeling, and Dietary 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number to which the draft guidance may be sent.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

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INFORMATION section for electronic access to the draft guidance.
    Submit written comments on the draft guidance, including comments 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

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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