HomeWashington Letter2019 ▶ FDA Issues Draft Enforcement Guidance on Tobacco Products
FDA Issues Draft Enforcement Guidance on Tobacco Products

This week, the FDA issued draft guidance on its enforcement priorities for e-cigarettes and cigars.  The proposed policy would:

  • Require the submission of Premarket Tobacco Applications for e-cigarette products (except mint, menthol and tobacco flavored e-cigarettes) by Aug. 8, 2021 - one year earlier than the current requirement.
  • Limit flavored e-cigarettes (except mint, menthol or tobacco flavored e-cigarettes) sales to online or age restricted areas.
  • Allow the sales of mint, menthol and tobacco flavored e-cigarettes in expanded locations.
  • Target enforcement efforts on e-cigarettes that are marketed to youth.
  • Require flavored cigars, that entered the market after 2/15/2007 to receive FDA approval, through the premarket tobacco application process, before they can be sold on market.

The FDA proposed enforcement guidance is subject to a 30-day public comment period.

While the ATS is pleased the agency is finally taking concrete action on flavored cigars and e-cigarettes, we are disappointed that the FDA is taking such timid and insufficient steps to reduce youth access to these products.  The ATS will continue to strongly advocate for stronger tobacco control policy including:  further limits on tobacco flavorings; accelerated premarket tobacco products application deadlines; immediate action on unregulated products on the market; and a ban on menthol cigarettes.

Last Reviewed: March 2019