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GUIDANCE DOCUMENT

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 Guidance for Manufacturers, Retailers, Importers and FDA Staff September 2009

Final

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

Issued by:
Guidance Issuing Office
Center for Tobacco Products

September 2009

This guidance is intended for manufacturers, retailers, importers, and FDA staff.  The guidance describes FDA’s current thinking regarding the scope of the provision prohibiting the marketing of a tobacco product in combination with another product regulated under the Federal Food, Drug, and Cosmetic Act (FDCA).  It is not intended to be an exhaustive analysis of all activities that may or may not fall within the scope of the prohibition.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Contact CTP
Document Control Center
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Ave WO71-G335
Silver Spring, MD 20993-002
AskCTP@fda.hhs.gov
(877) 287-1373 (9am EST-4pm EST)