- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Medical Products and Tobacco, Center for Tobacco Products
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).
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:
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-2011-D-0125-0009.