FDA Updates Enforcement Priorities for E-Cigarettes and Nicotine Pouches Pending Application Review

The Food and Drug Administration announced a new policy on Friday regarding enforcement of illegal sales of e-cigarettes and nicotine pouches. Under the new FDA guidance, the agency will not prioritize cracking down on illegal sales if manufacturers’ applications have been filed and accepted by the FDA.

For flavored vapes the agency will not prioritize enforcement if manufacturers have provided sufficient data to evaluate whether the product is appropriate for the protection of public health.

The new FDA guidance was first reported by the New York Times. The FDA has a significant backlog of applications from makers of vapes and nicotine pouches seeking authorization to sell their products. Some manufacturers have put their vape and nicotine pouch products on sale while awaiting word from the FDA on their applications.

The FDA guidance skipped the process of issuing a draft and allowing public comments before publishing the final guidance. Mitch Zeller, a former head of the Center for Tobacco Products at the FDA, said the FDA typically only goes straight to final guidance if there is a public health emergency.

Zeller told STAT the only thing he could figure out was that this was a desperate attempt by the commissioner to try to save his job, though he noted the comment was purely speculative. President Trump reportedly plans to fire FDA commissioner Marty Makary, though no official announcement has been made. The agency last week authorized two fruit-flavored vapes from Los Angeles-based company Glas.

The FDA authorization of two fruit-flavored vapes from Glas reversed a previous decision by FDA commissioner Marty Makary. Marty Makary told STAT he had been skeptical that the devices’ technology would be enough to stop underage people from using them.

>"When companies put their products up for sale without the FDA’s permission — whether for tobacco, drugs, or medical devices — that’s illegal," Zeller said.

Illegal flavored vapes imported from China make up about 70% of the black market. The new policy does not address those products, which the Trump administration has frequently spoken against. Implicit in the new guidance is the idea that the FDA will concentrate its enforcement efforts in that area.

Stat reported that the tobacco industry chalked up another win on Friday with the new policy that gives what one expert called a “get-out-of-jail-free-card” to some manufacturers illegally selling e-cigarettes and nicotine pouches.