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News From the Food and Drug Administration
March 2, 2021

Rules Finalized for New Tobacco Product Approvals

JAMA. 2021;325(9):816. doi:10.1001/jama.2021.1478

Two recently finalized rules provide tobacco product manufacturers with additional information on federal requirements they must meet to get their products on the market. Then-FDA Commissioner Stephen Hahn, MD, said finalization of the rules “is an important milestone in the FDA’s regulation of tobacco products.”

The rules apply to 2 of the pathways manufacturers can use to pursue marketing authorization for their products. The premarket tobacco product applications (PMTA) pathway is the expected approval route for electronic nicotine delivery systems, although it has been used for cigarettes and smokeless tobacco. Under it, manufacturers have to provide scientific data that demonstrate the product’s risks and benefits to the entire population, not just the people who use it. The final rule helps to ensure that manufacturers submit enough information on product components, ingredients, additives, toxicology, and health impact for FDA reviewers to complete a substantive product review.