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GUIDANCE DOCUMENT

Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 Guidance for Industry September 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0125
Issued by:
Guidance Issuing Office
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).

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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-2011-D-0125.

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