Draft Guidance for Industry and FDA Staff: Scope of the Prohibition Against Marketing a Tobacco Product in Combination With Another Article or Product, etc.

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

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Draft Guidance for Industry and FDA Staff; the Scope of the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.

SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``The Scope of the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CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by January 4, 2010.

ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ``The Scope of the Prohibition Against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:

1. 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.

2. 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.

3. 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.

4. 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