FDA Reverses Course on Flavored Vapes, Allowing Products Without Authorization to Remain on Market

May 13, 2026

The FDA announced on May 11, 2026 that it will not prioritize enforcement against e-cigarettes and nicotine pouches if manufacturers filed and provided sufficient public health data, even without actual FDA evaluation. The agency skipped the draft guidance and public comment process. The policy does not address illegal flavored vapes from China, which comprise 70% of the black market. The FDA separately authorized two fruit-flavored vapes from Los Angeles-based Glas.

FDA flavored vape policy

▪Mitch Zeller is a former head of the Center for Tobacco Products at the FDA.
▪STAT's coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies.
▪The FDA does not have to actually evaluate the public health data for companies to receive carte blanche under the May 11, 2026 guidance.
▪Under the FDA's May 11, 2026 guidance, manufacturers' applications must have been filed and accepted by the FDA to avoid enforcement prioritization.
▪Under the FDA's May 11, 2026 guidance, manufacturers of flavored vapes must have provided sufficient data to evaluate whether the product is appropriate for the protection of public health to avoid enforcement prioritization.
▪The FDA announced on May 11, 2026 that it will not prioritize cracking down on illegal sales of e-cigarettes and nicotine pouches under two conditions.

Regulatory process violations

▪Mitch Zeller stated that the FDA typically only goes straight to final guidance if there's a public health emergency.
▪The FDA skipped the process of first issuing a draft and allowing public comments before publishing its final guidance on May 11, 2026.
▪President Trump reportedly plans to fire FDA commissioner Marty Makary.
▪Mitch Zeller speculated that the May 11, 2026 FDA guidance was a desperate attempt by the commissioner to try to save his job.

Legal precedent concerns

▪Mitch Zeller stated that the FDA's May 11, 2026 guidance is a horrible precedent that makes no sense legally.
▪Mitch Zeller stated that when companies put their products up for sale without the FDA's permission for tobacco, drugs, or medical devices, that's illegal.

Impact on compliant manufacturers

▪Mitch Zeller stated that the FDA is effectively granting a get-out-of-jail-free card to companies that charged ahead with their products without authorization.
▪Mitch Zeller stated that the FDA's May 11, 2026 guidance is fundamentally unfair to companies that were following the rules and kept their products off of the market.

Chinese black market imports

▪The FDA's May 11, 2026 guidance does not address the problem of illegal flavored vapes imported from China.
▪Illegal flavored vapes imported from China make up about 70% of the black market.
▪The Trump administration has frequently spoken out against illegal flavored vapes imported from China.

Glas authorization reversal

▪Marty Makary told STAT he'd been skeptical that Glas devices' technology would be enough to stop underage people from using them.
▪The FDA's authorization of two fruit-flavored vapes from Glas reversed a previous decision by Marty Makary.
▪The FDA authorized two fruit-flavored vapes from Los Angeles-based company Glas last week.

Perspective of Public health experts and former FDA officials

▪Mitch Zeller stated that the FDA's May 11, 2026 guidance is a horrible precedent that makes no sense legally.
▪Mitch Zeller stated that the FDA's May 11, 2026 guidance is fundamentally unfair to companies that were following the rules and kept their products off of the market.