FDA Creates Database for Grandfathered Tobacco Products
SILVER SPRING, Md. — The Food and Drug Administration (FDA) is making it easy to search tobacco products that fall under the grandfather clause.
The FDA refers to a tobacco product that was commercially marketed — other than exclusively in test markets — in the United State as of Feb. 15, 2007, as a grandfathered tobacco product. The date was set in the 2009 Family Smoking Prevention and Tobacco Control Act.
These grandfathered products are not subject to the premarket requirements of the Federal Food, Drug, and Cosmetic Act and may serve as the predicate tobacco product in an application demonstrating substantial equivalence (SE) for a new tobacco product, according to the agency.
The FDA's new database contains determination information from standalone grandfathered submissions reviewed by the agency's Center for Tobacco Products, and does not include grandfathered determinations from SE applications.
The agency will update the database periodically. To access the database, click here.