Exhibit 142 ยท Agency guidance
Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization: Guidance for Industry
FDA lacks the resources to pursue enforcement against every product that has not received authorization.
States that all new tobacco products marketed without authorization are illegally marketed, then sets out that FDA generally does not intend to prioritize enforcement against unauthorized e-cigarettes and nicotine pouches whose applications have been accepted and filed, or whose supplemental applications have been pending for more than 180 days. Non-tobacco-flavored e-cigarettes qualify if FDA has determined the application contains the data needed for public-health review. Products with youth-appealing features or greater safety concerns remain enforcement priorities. FDA will publish a list of the products it does not intend to prioritize.
- Source
- U.S. Food and Drug Administration, Center for Tobacco Products
- Date
- May 2026
- Quoted from
- Section II, p. 4
- Grade
- Primary record
- Document
- https://www.fda.gov/media/192403/download
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit