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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Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act Draft Guidance for Manufacturers, Retailers, Importers and FDA Staff September 2009

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2009-D-0470
Issued by:
Guidance Issuing Office
Center for Tobacco Products

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.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0470.

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