Three and a half years. That is how long, on average, a tobacco product application has been waiting for the FDA to make a decision. A new Government Accountability Office audit puts the unresolved pile at nearly 132,000 applications at the end of 2025, and says the average case in that pile had been waiting 1,266 days.
For the vape industry, that number is the whole ballgame. While manufacturers wait years for an answer, their products sit in a legal gray zone: on the market, but without the authorization the FDA’s own rules demand. Enforcement then becomes a lottery, and retailers never quite know what is safe to sell. A backlog this large does not just slow paperwork. It quietly decides which companies survive and which give up.
The scale behind the audit is staggering. The FDA received more than 26.6 million tobacco product applications from 2018 through 2025 and completed reviews of about 26.5 million, with most submissions arriving after the 2020 deadline for products covered by the Deeming Rule, including e-cigarettes. The nearly 132,000 left standing are the ones that survived screening but have yet to get a final decision, and the 507-day average across completed reviews in the three premarket pathways shows the process was slow even for the lucky ones.
The audit also found a measurement problem. GAO says FDA systems do not consistently capture the information needed to determine whether the agency meets the 180-day statutory target for the scientific-review phase of PMTAs. In plain terms, the agency cannot reliably show whether it is meeting its own legal deadlines.
There is some good news. The FDA has reduced screening times, introduced automated application checks, and applied lessons from its nicotine pouch pilot to e-cigarette reviews. GAO recommended the agency improve its data collection, and HHS agreed. What remains is the question every manufacturer is asking: how fast can the backlog actually move now that the problems are on paper.
For vapers watching from the sidelines, the practical takeaway is simple. Until the pile shrinks, expect more uncertainty about which products stay legal, not less. Keep an eye on the FDA authorized vapes list to see which products have actually cleared the process so far.
Source: U.S. Government Accountability Office audit of the FDA tobacco product review program, reported October 8, 2026.