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The Food and Drug Administration (FDA) is revisiting the Premarket Tobacco Product Application rule, a 2021 rule that outlined requirements for new tobacco products to be authorized.
The details:
- Based on experience implementing the 2021 rule, the widespread development of an illicit and unregulated market, the pace of new product introductions, and a federal lawsuit challenging the current regulatory framework, FDA intends to evaluate changes. This includes new rulemaking to replace the current framework.
- In the meantime, FDA will continue to process submissions, conduct premarket reviews, and issue regulatory decisions on new tobacco products in accordance with current rules.
The bigger picture: This comes following several other administration efforts to make it easier for more tobacco products to enter the market.
- FDA could simplify requirements for scientific studies and speed review times. These changes would particularly help newer tobacco products, such as vapes and nicotine pouches, which are not eligible for a simplified path to market that exists for older products like cigarettes.
- Tobacco companies have long complained that the FDA review process takes longer than the 6 months mandated by Congress. GAO issued a new report finding that FDA has reviewed most of the 25 million applications it received in 2020 and 2021 following the agency receiving expanded authority to oversee all tobacco products, including millions of e-cigarettes that were already on the market. But almost 132,000 applications remained without a completed review as of the end of 2025. FDA took an average of 507 days to complete its review of applications 2018-2025.
Read more: U.S. Regulators Plan Major Move to Speed Authorizations of Vapes, Tobacco Pouches
Published
October 2026