The FDA is sitting on roughly 130,000 unresolved tobacco product applications as of the end of 2025, according to a new Government Accountability Office report.

Between 2018 and 2025, the agency received more than 26.6 million applications and completed reviews of about 26.5 million, per the GAO findings reported by Tobacco Reporter.

What the backlog means

The 130,000 pending applications represent products that manufacturers submitted for premarket authorization but have not yet received a marketing denial order (MDO) or a marketing granted order (MGO). Until the FDA issues a decision, these products exist in regulatory limbo—many likely already on shelves under enforcement discretion, others pulled voluntarily by manufacturers uncertain of their fate.

For nicotine pouches specifically, the backlog likely includes flavored products submitted during the PMTA wave that began in 2020. The FDA has issued hundreds of thousands of MDOs for flavored products across categories, but the agency's review pace has left a significant tail of applications unresolved.

The scale of the review workload

The 26.6 million figure reflects the FDA's entire tobacco product review burden since the premarket tobacco application (PMTA) process took effect. The vast majority of those applications were for e-cigarette products, which flooded the system ahead of the September 2020 deadline.

Nicotine pouches entered the PMTA pipeline later but in significant volume. Major manufacturers including Swedish Match (ZYN), BAT (VELO), and Altria (on! ) submitted applications for dozens of SKUs each, covering multiple flavors and nicotine strengths.

The FDA's completion rate—99.5 percent of applications received—sounds high, but the 130,000 remainder includes products from manufacturers still waiting years for decisions. Some companies have sued the agency over delays; others have reformulated or exited the market entirely.

Enforcement discretion continues

Products without authorization remain on the market under the FDA's enforcement discretion policy, which the agency has applied inconsistently. The FDA has prioritized enforcement against flavored e-cigarettes and certain unauthorized products but has largely left compliant nicotine pouch brands alone while their PMTAs sit in review.

The GAO report does not break out how many of the 130,000 pending applications are for nicotine pouches versus other tobacco categories.

SOURCES:
Tobacco Reporter — GAO Finds FDA Holding 130K Tobacco Applications to End 2025