Health Law Daily Wrap Up, TOBACCO—FDA GUIDANCE NOTICES: FDA issues final guidance on enforcement priorities for unauthorized tobacco products, (May 15, 2026)
By WK Editorial Staff
The final guidance outlines enforcement priorities for certain unauthorized electronic nicotine delivery systems and oral nicotine pouch products.
The Food and Drug Administration announced the availability of a final guidance outlining its enforcement priorities for certain new tobacco products marketed without required premarket authorization. The guidance focuses on electronic nicotine delivery systems and oral nicotine pouch products that are currently being sold without FDA authorization, which are considered illegally marketed. It is intended to promote transparency and help the agency allocate enforcement resources toward products that are more likely to meet public health standards. The approach is designed to encourage the development and submission of applications for potentially less harmful products while supporting a transition to a more regulated, compliant marketplace (Notice, 91 Fed. Reg. 25892 (May 12, 2026)).
Dates. The announcement of the guidance is published in the Federal Register on May 12, 2026.
FederalRegisterIssuances: FDAGuidanceNotices FDCActNews TobaccoNews