[Federal Register: October 5, 2009 (Volume 74, Number 191)]
[Notices]
[Page 51160-51161]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05oc09-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0470]
Draft Guidance for Industry and FDA Staff; the Scope of the
Prohibition Against Marketing a Tobacco Product in Combination With
Another Article or Product Regulated Under the Federal Food, Drug, and
Cosmetic 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availability of the draft guidance entitled ``The Scope of the
Prohibition Against Marketing a Tobacco Product in Combination with
Another Article or Product Regulated under the Federal Food, Drug, and
Cosmetic Act.'' This guidance is intended for manufacturers, retailers,
importers, and FDA staff. The Federal Food, Drug, and Cosmetic Act
(FDCA), as amended by the Family Smoking Prevention and Tobacco Control
Act (FSPTCA), states ``A tobacco product shall not be marketed in
combination with any other article or product regulated under this Act
(including a drug, biologic, food, cosmetic, medical device, or a
dietary supplement).'' The guidance discusses certain activities that
FDA believes do or do not fall within the scope of the prohibition. The
guidance is not intended to be an exhaustive analysis of all activities
that may or may not fall within the scope of the prohibition.
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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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 January 4, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``The Scope of the Prohibition Against
Marketing a Tobacco Product in Combination with Another Article or
Product Regulated under the Federal Food, Drug, and Cosmetic Act'' to
the Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to 301-595-7946. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Michele Mital, Center for Tobacco
Products, Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 0850-3229, 301-796-4800, Michele.Mital@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President signed the FSPTCA (Public Law 111-
31) into law. The FSPTCA amended the FDCA (21 U.S.C. 301 et seq.) by
adding a new chapter granting FDA important new authority to regulate
the manufacture, marketing, and distribution of tobacco products to
protect the public health generally and to reduce tobacco use by
minors. Section 201(rr)(4) of the FDCA, as amended by the FSPTCA,
states ``A tobacco product shall not be marketed in combination with
any other article or product regulated under this Act (including a
drug, biologic, food, cosmetic, medical device, or a dietary
supplement).''
This guidance discusses certain activities that FDA believes do or
do not fall within the scope of the prohibition. The guidance is not
intended to be an exhaustive analysis of all activities that may or may
not fall within the scope of the prohibition.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized will represent the agency's current thinking on ``The Scope
of the Prohibition Against Marketing a Tobacco Product in Combination
with Another Article or Product Regulated under the Federal Food, Drug,
and Cosmetic Act.'' 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
requirements of the applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. The guidance document may be accessed at the
Center for Tobacco Products' Web site at http://www.fda.gov/
tobaccoproducts. This guidance document is also available at http://
www.regulations.gov. To receive ``The Scope of the Prohibition Against
Marketing a Tobacco Product in Combination with Another Article or
Product Regulated under the Federal Food, Drug, and Cosmetic Act,'' you
may either send an e-mail request to michele.mital@fda.hhs.gov to
receive an electronic copy of the document or send a fax request to
301-595-7946 to receive a hard copy.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. 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 found
in brackets in the
[[Page 51161]]
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: September 30, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23866 Filed 9-30-09; 11:15 am]
BILLING CODE 4160-01-S