Source:  FDA, 8/24/22


On Aug. 19, FDA’s Center for Tobacco Products (CTP) updated the term “grandfathered tobacco product” to “pre-existing tobacco product” on all the Center’s systems. As described in the Premarket Tobacco Application (PMTA) and Substantial Equivalence (SE) final rules published in 2021, the updated terminology more clearly and appropriately describes these products. Additionally, the term “grandfathered” – when used to describe someone or something exempt from a new law or regulation – has its roots in 19th century racist voting laws. Therefore, this terminology has been updated in accordance with CTP’s commitment to diversity, equity, inclusion, and accessibility.

A pre-existing tobacco product has the same definition as a grandfathered product. Specifically, a pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of Feb. 15, 2007. FDA interprets “as of” to mean “on” that date. As was the case with submitting a grandfathered determination request, submitting a request to determine the pre-existing status of your tobacco product is voluntary and not required under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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