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FDA Issues Final Guidance On Grandfathered Tobacco Products

FDA Center for Tobacco Products 700

This Week in CTP - Updates from the Center for Tobacco Products

Today, FDA issued final guidance that 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). At this time, FDA intends to limit its review of grandfathered status to regulated tobacco products – cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. For more information on the guidance, including how to submit a tobacco product for consideration, please visit our Guidance web page.


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