Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007
This guidance provides information on how manufacturers may demonstrate that a tobacco product was commercially marketed in the United States as of February 15, 2007. Tobacco products commercially marketed as of February 15, 2007 are known as “grandfathered tobacco products,” and are not considered new tobacco products. As a result, grandfathered tobacco products are not subject to the premarket requirements of the Food, Drug and Cosmetic Act (FD&C).
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.