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U.S. Department of Health and Human Services

Tobacco Products

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


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.





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For General Inquiries:

Center for Tobacco Products Food and Drug Administration

10903 New Hampshire Avenue

Building 71, Room G335

Silver Spring, MD 20993-0002