GAO Finds 132,000 Tobacco Applications Still Stuck in FDA Backlog

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Nearly 132,000 tobacco product applications remained unresolved at the finish of 2025, and those applications had been waiting an average of 1,266 days for a decision, according to a fresh Government Accountability Office audit of the FDA's tobacco review program.

The numbers expose the scale of a premarket setup responsible for determining which vaping and additional nicotine products can legally enter the U.S. market.

The GAO also found that the FDA doesn't collect adequate data to determine whether it meets its own timelines for scientific review.

The FDA received 26,658,777 tobacco product applications from 2018 through 2025 and completed reviews of 26,526,862.

Across the three premarket pathways examined by the GAO, completed reviews took an average of 507 days.

Federal law requires FDA to act on PMTAs within 180 days of receipt, although the agency applies that timeline to the scientific-review phase after an application has met filing requirements.

It has also begun applying lessons from its nicotine pouch pilot to vape applications.

Reviewers may also contact applicants before scientific review begins to ask for updated details.

That shift could benefit applicants who have spent years waiting for a decision.

Application status also matters under the FDA's May enforcement guidance for unauthorized vaping and nicotine pouch products , which distinguishes between products based partly on application status.

Under that policy, the agency generally doesn't prioritize enforcement against qualifying products with accepted and filed applications, subject to additional conditions.

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