Draft Guidance for Manufacturers, Retailers, Importers and FDA Staff: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or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
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 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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.