A huge backlog became a smaller—but still unresolved—queue
The Food and Drug Administration received more than 25 million tobacco-product applications in 2020 and 2021 after its authority expanded to products including e-cigarettes. That compared with just over 1,000 applications in 2018 and 2019, according to the Government Accountability Office.
FDA reviewed most of the surge, but nearly 132,000 applications still lacked a completed review as of December 31, 2025. The progress is substantial; the remaining number is not evidence that 132,000 distinct products were legally authorized or found safe.
The average review took 507 days
Across calendar years 2018 through 2025, GAO calculated an average of 507 days to complete a tobacco-product application review. FDA sets goals for individual phases ranging from seven to 180 days, but GAO found the agency did not meet its screening goals even as performance improved.
An overall average cannot show how long every application waited. Different product pathways, incomplete submissions and the extraordinary 2020-2021 volume can produce wide variation around that figure.
| Measure | Finding |
|---|---|
| Applications received in 2018-2019 | Just over 1,000 |
| Applications received in 2020-2021 | More than 25 million |
| Incomplete as of Dec. 31, 2025 | Nearly 132,000 |
| Average completion time, 2018-2025 | 507 days |
FDA could not measure a critical review phase
GAO said FDA's data system was not designed to track steps in the scientific-review phase. Without those data, the agency cannot determine whether it is meeting its own timeliness goals for examining the evidence manufacturers submit.
The watchdog recommended that FDA collect the necessary information and monitor performance across all application pathways. The Department of Health and Human Services agreed, but GAO listed the recommendation as open when the report was released October 1.
Authorization is not a safety endorsement
Completing a review clarifies whether a product may be legally marketed; it does not make tobacco harmless or convert an authorization into an FDA approval in the way consumers may understand that term.
The measurable follow-up is whether the open queue shrinks, whether scientific-review timing becomes auditable and whether FDA can act more quickly on products that lack authorization.