QUICK ANSWER
A Government Accountability Office report released October 1, 2026 found that 131,915 tobacco product applications were still waiting for a completed FDA review at the end of 2025, after an average wait of 1,266 days. Completed reviews took an average of 507 days, even though the law calls for decisions within 180 days. That backlog is why only 48 e-cigarette products are FDA-authorized while thousands of others sit in legal limbo.
What the GAO found
A huge backlog: 131,915 applications had no completed review as of December 31, 2025, and they had been waiting an average of 1,266 days.
A flood in 2020 and 2021: the FDA received 25,396,571 applications in those two years, compared with just over 1,000 in 2018 and 2019 combined, driven by the 2020 deadline for vapes already on the market.
Slow reviews: completed reviews averaged 507 days from 2018 through 2025. The FDA applies the 180-day legal clock only to the scientific review phase.
Missed screening goals, but improving: PMTA acceptance has a 7-day goal and averaged 236 days. Filing times fell from 845 days in 2022 to 156 days in 2025.
Fewer staff, unspent money: the Center for Tobacco Products went from 1,195 staff in fiscal 2024 to 1,090 in fiscal 2025, and carried $374 million in unspent user fees into fiscal 2026.
Average days (lower is better)
More than 130,000 applications were still waiting at the end of 2025.
What the GAO recommends
The GAO recommended that the FDA collect the data needed to track whether it meets its own scientific review timeliness goals, and HHS agreed. The GAO also said the FDA’s September 2025 nicotine pouch pilot program was too new to evaluate.
Why it matters to vapers
The backlog is the reason the legal market looks so strange: a handful of authorized products, and a huge number of products whose applications are pending, denied or never filed. That limbo matters more every year, because states such as Pennsylvania and Virginia now tie what stores can sell to a product’s FDA application status. The FDA has also said it intends to rethink the PMTA process.
Each application can include years of lab, clinical and market data.
Frequently asked questions
How many vape applications are waiting at the FDA?
The GAO counted 131,915 tobacco product applications with no completed review as of December 31, 2025. The report does not break that number down by product type.
How long does FDA review of a vape take?
Completed reviews averaged 507 days from 2018 through 2025, and pending applications had waited an average of 1,266 days.
Why did the FDA get so many applications?
Vapes already on the market had to file by September 2020, which led to more than 25 million applications in 2020 and 2021, many of them for individual e-liquid flavors and strengths.