FDA Delays Enforcement on Some Flavored Vapes and Nicotine Pouches with Pending Applications

The Food and Drug Administration announced a new policy on or before May 11, 2026, that will not prioritize enforcement against some flavored vapes and nicotine pouches sold without authorization. The policy applies if manufacturers have filed applications that were accepted by the FDA.

For flavored vapes, manufacturers must also have provided what the agency deems sufficient data to evaluate whether the product is appropriate for the protection of public health.

Under the new FDA policy, the agency does not have to complete its evaluation of the public health data for manufacturers to avoid enforcement. The FDA published the new guidance without first issuing a draft for public comment. Mitch Zeller, a former head of the Center for Tobacco Products at the FDA, said the FDA skipped the process of issuing a draft guidance and allowing public comments.

"It is alarming," Zeller said, because typically the FDA only goes straight to final guidance if there is a public health emergency. Zeller added that the new policy gives a get-out-of-jail-free card to companies that were selling without authorization. He said the policy is unfair to companies that followed the rules and kept their products off the market.

Zeller stated that selling products without FDA permission is illegal. The FDA last week authorized two fruit-flavored vapes produced by Glas, a company based in Los Angeles. That authorization reversed a previous decision by Commissioner Marty Makary.

Marty Makary told STAT he had been skeptical that the Glas devices’ technology would be enough to stop underage people from using them. Illicit e-cigarettes imported from China make up about 70% of the black market. The new FDA policy does not address illegal flavored vapes imported from China.

President Trump reportedly plans to fire FDA commissioner Marty Makary. Sarah Todd is a Reporter covering Commercial Determinants of Health for STAT and returned to reporting in January 2025.