Document ID: FDA-2009-D-0470-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and FDA Staff; the Scope of the Prohibition Against Marketing a Tobacco Product in Combination With Another Article or Product Regulated Under the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
Posted Date: 2009-10-05T04:00Z

[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Draft Guidance for Industry and FDA Staff; the Scope of the 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availability of the draft guidance entitled ``The Scope of the 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``The Scope of the Prohibition Against 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