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Congress's audit wing just put a number on FDA's pouch backlog: 132,000 products, 3.5 years and counting

A new GAO audit found 131,915 tobacco product applications still waiting for a final FDA decision at the end of 2025 — pending applications had waited an average of 1,266 days against a 180-day statutory goal. It also confirms FDA's nicotine pouch pilot is now the template for how other categories get reviewed.

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The US Government Accountability Office has published its audit of how long FDA actually takes to review tobacco product applications — and the numbers are stark. As of 31 December 2025, 131,915 applications submitted since 2018 were still sitting without a final decision, and pending applications had been waiting an average of 1,266 days. The statutory deadline for a scientific review is 180 days.

For nicotine pouches, the report is both a diagnosis and a backhanded compliment: the category's PMTA pilot programme is the one part of the system working well enough that FDA is copying it elsewhere.

What the audit found

The report (GAO-26-108195, released 1 October 2026) covers applications received from 2018 through 2025. The raw numbers look apocalyptic — 26.66 million applications received — but the real story is the 2020–21 surge, when more than 25 million submissions landed after the 2016 deeming rule forced e-cigarettes already on the market to apply for authorisation. FDA bundled similar submissions for joint review, collapsing those 26.66 million individual applications into 18,197 grouped ones.

What remains is the residue: 131,915 applications without a completed review at the end of 2025, most filed before 2023. Across all pathways, FDA took an average of 507 days to finish a review — against legal and internal goals of 180 days or less.

The more awkward finding is about measurement, not speed. For the final, scientific phase of review, FDA's data systems were simply not built to track when reviews start or when the clock pauses. The agency therefore cannot say systematically whether it is meeting its own timeliness goals for the phase that matters most. HHS agreed with GAO's recommendation and committed to upgrading the tracking systems across all three premarket pathways.

The nicotine pouch pilot takes centre stage

The most pouch-relevant section is short but significant. In September 2025, FDA created a pilot programme to streamline PMTA reviews for nicotine pouches — four manufacturers, 158 applications. GAO notes FDA now plans to apply the lessons from that pilot to other product types, and separately reports that in April 2026 the agency folded the pilot's lessons into internal guidance for e-cigarette PMTA reviewers.

In other words: pouches were the test bed for fixing a process everyone agrees is broken. The ZYN authorisations that came out of the pilot track — including the 11 ZYN Ultra products authorised in August 2026 — went through a faster, more structured review than the 132,000 stranded applications ever got.

Why it matters

The report lands in the middle of an unusually active fortnight for US pouch regulation. On 28 September, FDA announced it intends to evaluate changes to the entire PMTA framework, "including through initiation of new rulemaking to replace the current framework," citing the illicit market, a federal lawsuit in Texas, and the pace of new product introductions. Two days later it published a transparency roadmap. Congress requested this GAO audit — House Energy & Commerce chairman Brett Guthrie and health subcommittee chair Morgan Griffith — and Griffith's response frames the political direction: the delays "stall the progress of the tobacco harm reduction movement," while illicit sellers "jump the line."

The practical consequence for pouch makers and consumers is the same one running through all three documents: whichever products are still waiting in the backlog face years more limbo, while unauthorised competitors sell freely in the meantime. GAO's own framing makes the point — faster, more predictable reviews would "clarify which products are legally marketed," which is what lets FDA act against the unauthorised ones.

Nothing in the audit changes the rules today. Reviews continue under the existing framework, and any rewrite goes through rulemaking with public comment. But the paper trail Congress is building — backlog audit, framework review, transparency roadmap — is now pointing the same way.

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