The FDA's enforcement policy faces challenges on multiple fronts:
- Public health lawsuit (July 2026): A coalition including the Campaign for Tobacco-Free Kids and the American Academy of Pediatrics filed a federal lawsuit claiming the enforcement policy violates the Tobacco Control Act's regulatory requirements.
- Altria lawsuit (September 2, 2026): Tobacco giant Altria sued the FDA over the timeliness of its PMTA review process, arguing the agency's delays are unlawfully long.
- Potential industry follow-on: Experts warn that if Reynolds' move succeeds without consequences, other manufacturers may conclude that compliance offers little advantage over launching first and dealing with regulatory consequences later.




