FDA Creates New Database For Grandfathered Tobacco Products

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 from standalone grandfathered submissions reviewed by CTP, and does not include grandfathered determinations from SE applications. The database will be updated periodically.

The database can be accessed at https://www.accessdata.fda.gov/scripts/ctpGnd/

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