SFATA's recent newsletter reports that the FDA has issued final guidance that provides information on how manufacturers may demonstrate that a tobacco product was commercially marketed in the United States as of Feb. 15, 2007.
"Tobacco products commercially marketed as of Feb. 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)," the newsletter reads.
SFATA reports that the 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 info on the guidance, including how to submit a tobacco product for consideration, please visit the Guidance Web Page.
No comments:
Post a Comment