Key Points
- The FDA received more than 25 million tobacco product applications after the 2020-2021 deadlines.
- Nearly 132,000 applications were still without a completed review as of Dec 31, 2025.
- The average review took 507 days between 2018 and 2025.
- The FDA regularly missed its own targets during initial application screening.
- The GAO says the FDA must systematically track whether it is meeting its timeliness goals.
WASHINGTON: The U.S. Food and Drug Administration is still buried under tobacco product applications. A new report from the Government Accountability Office (GAO), the federal watchdog, says nearly 132,000 applications were still without a completed review as of Dec 31, 2025, and the average review took 507 days.
What the GAO Found
The GAO report (GAO-26-108195) examined how the FDA handles reviews of e-cigarette and tobacco product applications. Its central finding is a measurement problem: critical data gaps prevent the agency from evaluating whether it is meeting its own timeliness goals.
The FDA has internal target windows of 7 to 180 days for various stages of the review pipeline. But the GAO found major gaps in how performance is measured, and that the FDA regularly missed its review targets during the initial application screening phase, even though it made gradual progress in recent years.
How the Backlog Built Up
The backlog did not happen overnight. In 2016, the FDA asserted authority over all tobacco products, including millions of e-cigarettes already on the market. When deadline mandates took effect in 2020 and 2021, manufacturers flooded the agency with more than 25 million applications seeking authorization to remain legally on the market. For comparison, roughly 1,000 applications were submitted combined across 2018 and 2019.
The FDA has worked through the vast majority of those submissions. But the sheer volume left a long tail: nearly 132,000 applications still without a completed review at the end of 2025.
How Long Reviews Take
Between calendar years 2018 and 2025, the FDA required an average of 507 days, about 17 months, to complete a single tobacco product application review.
That average matters because it sets expectations for everyone in the market. A manufacturer filing today cannot assume a quick answer. A retailer cannot assume a pending product will be resolved soon. And a state writing a directory law must decide what to do with products whose applications are still pending, which is exactly why many state directory laws include pending PMTA as a qualifying category.
Why the Backlog Matters for Vapes
The backlog is the quiet engine behind much of today vape news. Because so many products sit in pending status, the FDA has relied on enforcement discretion, choosing which products to prioritize for enforcement, and states have built their own directory systems to create clear retail rules. Pennsylvania Act 57 enforcement is one example: the state directory decides what can be sold while federal reviews drag on.
It also complicates enforcement against illicit products. When legal and pending products are hard to distinguish at the store level, and when the agency cannot fully track its own review timeliness, bad actors have more room to operate. The GAO point is not just about speed; it is about whether the system can be measured, managed, and trusted.
What GAO Recommended
The GAO advised the FDA to overhaul its tracking systems and systematically monitor whether it is meeting timeliness goals for tobacco product application reviews. In plain terms: the agency needs better data on where each application stands, how long each stage takes, and where the bottlenecks are, so it can fix them instead of guessing.
What This Means for Readers
For vapers, do not expect a flood of new authorizations overnight. Reviews are slow, and the backlog will take years to clear at current pace.
For retailers, pending status is not the same as authorized, but in many states, a timely filed, still-pending application is what qualifies a product for the state directory. Keep records of each product application status, because that paperwork is what directory checks and inspections turn on.
For manufacturers, the report is a reminder that review timelines are uncertain. Planning around a fast authorization is risky; planning around documentation, compliance, and enforcement policy is safer.
Sources: GAO report GAO-26-108195, summarized by Tobacco Insider (Oct 2026).