By Timothy S. Donahue
Top Takeaways:
- Long waits: Nearly 132,000 tobacco product applications remained unresolved at the end of 2025, with an average wait of 1,266 days.
- Deadlines missed: FDA averaged 507 days per completed review and failed to meet its screening goals.
- Oversight gaps: Federal auditors found FDA lacks the data necessary to determine whether it meets scientific review deadlines.
The FDA has cleared millions of tobacco product applications from its backlog. Unfortunately, it still hasn’t mastered the clock.
A new report from the U.S. Government Accountability Office (GAO) found that nearly 132,000 tobacco product applications remained unreviewed at the end of 2025, with manufacturers waiting an average of nearly three and a half years for decisions. The agency has made substantial progress in reducing its massive backlog, but federal auditors found that it continues to miss processing goals and cannot reliably measure how long its scientific reviews take.
According to the report, the FDA received 26,658,777 tobacco product applications between 2018 and 2025 and completed reviews of 26,526,862. As of Dec. 31, 2025, 131,915 applications remained pending final decisions. Most of those pending applications were submitted before 2023.
The backlog largely stems from the FDA’s 2016 Deeming Rule, which extended the agency’s regulatory authority to additional tobacco products, including e-cigarettes. Manufacturers of products already on the market were required to submit applications by Sept. 9, 2020. More than 25 million applications were submitted in 2020 and 2021 alone, compared with just 1,060 in the previous two years.
FDA officials told GAO that most applications submitted since the rule’s implementation involved e-cigarettes.
Across the three tobacco product application pathways examined, the FDA took an average of 507 days to complete reviews from 2018 to 2025. The agency has internal goals ranging from seven to 180 days for different stages of review, but auditors found that it generally failed to meet its screening deadlines.
The delays were particularly pronounced for premarket tobacco product applications (PMTAs). The FDA took an average of 236 days to accept applications, compared with a seven-day goal. Applications refused at the acceptance stage took an average of 542 days, compared with a 21-day target. Applications accepted for further review took an additional average of 141 days to reach filing, compared with a seven-day filing goal.
Federal law requires the FDA to issue marketing decisions on PMTAs within 180 days of receipt, although the agency’s regulations apply that period only to applications that have met filing requirements. GAO found that the FDA’s data systems were not designed to track the individual steps of scientific review, preventing the agency from systematically determining whether it meets its 180-day goal.
The distinction matters for manufacturers whose applications have been pending for years. Without reliable tracking of scientific review timelines, neither the agency nor applicants have a clear picture of how much time the FDA spends evaluating the evidence needed to determine whether a product may legally enter the market.
GAO acknowledged that FDA has made progress. Overall review times have declined since 2023, and screening times have improved as the agency works through the application surge. FDA officials attributed some of those gains to streamlined procedures, additional reviewer training, and improved application quality.
The agency has also introduced changes to make the review process more efficient. In September 2025, the FDA launched a pilot program to accelerate nicotine pouch application reviews, emphasizing increased communication between reviewers and manufacturers to address deficiencies earlier in the process.
According to GAO, the FDA subsequently began incorporating lessons from the pilot into other product categories, including e-cigarettes. Internal guidance issued in April directed reviewers to apply elements of the program to vape applications and to contact applicants before scientific review begins to request updated information.
However, auditors cautioned that the changes were too recent to determine whether they would yield sustained improvements in review timeliness.
The status of pending applications has also become increasingly important under FDA’s May 2026 enforcement guidance on unauthorized e-cigarettes and nicotine pouch products. The policy generally assigns lower enforcement priority to certain qualifying products with accepted and filed applications awaiting decisions, provided they meet additional requirements.
The guidance does not constitute marketing authorization, but it can affect the enforcement risk manufacturers face while the FDA continues reviewing their applications. The policy is also the subject of ongoing federal litigation brought by the Campaign for Tobacco-Free Kids and other plaintiffs, with several manufacturers seeking to intervene to defend it.
The GAO report follows earlier federal criticism of the FDA’s tobacco application review process. In 2013, auditors identified substantial delays and recommended that the agency establish performance measures. The FDA implemented those measures in 2014, but the latest audit found that its ability to monitor the timeliness of scientific reviews remains incomplete.
GAO recommended that the FDA collect the information needed to measure and monitor scientific review timelines across all three tobacco product application pathways. The Department of Health and Human Services concurred with the recommendation.
The watchdog said that more predictable reviews would help manufacturers understand when decisions can be expected and clarify which products are legally marketed, allowing the FDA to better target enforcement against unauthorized products.
The report, Tobacco Products: FDA Should Monitor Timeliness of Application Reviews, was published Sept. 30 and publicly released Oct. 1.
