The FDA tobacco review delays just got a fresh audit, and the number is hard to shrug off. At the end of 2025, 131,915 tobacco product applications still had no completed review. They had been sitting for an average of 1,266 days. That is a little over three and a half years in the inbox.
The Government Accountability Office laid out the problem in a September 2026 report written for congressional requesters. A free-market think tank then took the findings one step further and argued the delays carry a public health price. That second part is opinion, and it matters to keep the two apart.
What the GAO actually found about PMTA review delays
The report covers applications filed from 2018 to 2025. Applicants submitted most of the ones still pending before 2023. Across the three application pathways GAO examined, reviews took an average of 507 days to finish.
FDA sets its own goals for each phase of review, ranging from 7 to 180 days. According to GAO, the agency did not meet its screening-phase goals, though it has made progress toward them.
There is a bigger gap, too. GAO says FDA lacks the data to tell whether it meets its scientific-review deadlines at all. Hence the report’s title: FDA “should monitor timeliness of application reviews.” In plain English, the agency can’t fully prove it is on time because it isn’t fully tracking the clock.
None of this is new. GAO first flagged tobacco review timing in 2013 and said FDA needed to set time frames. FDA’s authority grew in 2016 to cover all tobacco products, which raised the same questions again.
FDA says the tobacco backlog is shrinking
The agency tells a different story. In May, acting Center for Tobacco Products director Bret Koplow said the backlog had shrunk by about 70%. He added that “the days when applicants might wait months or even years to learn if their application was complete enough to be accepted for further evaluation are behind us.”
Can both numbers be true? Yes. FDA measures its cut against its earlier backlog. GAO counts applications from 2018 to 2025 that never got a completed review. Different yardsticks, different answers. That said, a 70% cut from a very large pile can still leave a very large pile. Regulators love a good yardstick, much like the agencies behind the phase-out of artificial food dyes, where timelines also matter more than headlines.
The public health argument is R Street’s, not GAO’s
Here is the thing readers should know. The R Street Institute, which runs a tobacco harm reduction program, says smoking and secondhand smoke cause more than 480,000 U.S. deaths a year. It points to CDC analysis of 2022 survey data: about two-thirds of adults who smoke want to quit, and more than half tried in the past year. Fewer than one in 10 recently succeeded.
From there, the commentary argues that the FDA tobacco review delays keep adults smoking longer by holding back alternatives. But R Street itself says the GAO report “establishes administrative failures only.” The public health impact is R Street’s own inference, and the group concedes nobody can calculate the precise cost. Treat it as an argument, not a finding.
Also worth noting: FDA officials told GAO that most applications filed since the 2021 rule took effect involved e-cigarettes.
Why FDA tobacco product reviews matter beyond the paperwork
For manufacturers, a slow clock means products stuck in limbo. For adults trying to quit, the question is whether that limbo helps or hurts. Honest researchers disagree, and a backlog number alone can’t settle it.
The fight is also moving to court. On Sept. 2, tobacco manufacturers and retailers sued FDA in the Northern District of Texas. They argue FDA controls when the 180-day review clock starts, which makes the deadline impossible to meet. The same blog says FDA has discontinued a nicotine-pouch fast-track pilot, and that even its fastest authorization took 361 days.
Meanwhile, FDA issued enforcement guidance in May that lowers priority for certain qualifying products with accepted applications pending. That is not a marketing authorization, so it softens the wait without ending it. For a similar story about a product category caught between regulators and the market, see how peptide compounding could get temporary sales.
What to watch next as FDA tobacco review delays continue
The lawsuit is pending, and no ruling date has surfaced. FDA’s formal response to GAO’s recommendation was not available. And CTP says it is developing expedited review for modified products that already have marketing orders, with no date given.
So the real test is simple. Do the FDA tobacco review delays shrink from that 1,266-day average, and will FDA finally publish the numbers to prove it?
