Vaping 360 reports that nearly 132,000 tobacco product applications remained unresolved at the end of 2025, with the applications awaiting decisions for an average of 1,266 days, according to a new Government Accountability Office audit of the FDA’s tobacco product review program. The FDA received more than 26.6 million applications from 2018 through 2025 and completed reviews of about 26.5 million, with most applications submitted after the 2020 deadline for products covered by the agency’s Deeming Rule involving e-cigarettes.
The GAO found that completed reviews across three premarket pathways averaged 507 days and that FDA systems do not consistently capture information needed to determine whether the agency meets the 180-day statutory target for the scientific-review phase of Premarket Tobacco Product Applications. The FDA has reduced screening times and introduced automated application checks, while also applying lessons from its nicotine pouch pilot to e-cigarette reviews. The GAO recommended that FDA improve data collection to monitor scientific-review timelines, and the Department of Health and Human Services agreed.