Nearly 132,000 tobacco product applications remained unresolved at the end of 2025, and those applications had been waiting an average of 1,266 days for a decision, according to a new Government Accountability Office audit of the FDA's tobacco review program.
The numbers expose the scale of a premarket system responsible for determining which vaping and other nicotine products can legally enter the U.S. market. The GAO also found that the FDA doesn't collect enough 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. Most of the massive influx followed the 2020 deadline for manufacturers of products covered by the agency's 2016 Deeming Rule. FDA officials told the GAO that most applications received since the rule involved e-cigarettes.
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. However, the GAO found that FDA's systems don't consistently capture the information needed to measure that phase, making it impossible for the agency to systematically determine whether it is meeting the 180-day target.
The agency has made progress. The GAO found that screening times have fallen in recent years, and the FDA has introduced automated application checks and other changes. It has also begun applying lessons from its nicotine pouch pilot to vape applications. In August, the FDA said efficiencies developed during the pouch pilot were being applied to other PMTAs.
The pilot increased direct communication between FDA reviewers and applicants, allowing some problems to be addressed without waiting for formal deficiency letters. According to the GAO, the FDA issued internal guidance in April directing reviewers to incorporate lessons from the program into e-cigarette PMTA reviews. Reviewers may also contact applicants before scientific review begins to ask for updated information.
That change 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. The policy does not grant marketing authorization; eligibility depends on the application type, product characteristics, and other requirements.
The GAO recommended that the FDA collect the information necessary to monitor scientific-review timelines across all three premarket pathways. The Department of Health and Human Services agreed.
After years of PMTA delays, that would at least establish something surprisingly difficult to determine today: how long the FDA actually spends conducting the scientific reviews that decide which products may legally reach American consumers.
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