The FDA refers to a tobacco product that was commercially marketed (other than exclusively in test markets) in the U.S. as of Feb. 15, 2007, as a “grandfathered” tobacco product. 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. The FDA’s new database contains determination information […]
