FDA Details PMTA Backlog Cut to 135,000 and 180-Day Review Goal

The U.S. Food and Drug Administration's Center for Tobacco Products, CTP, has put its pending premarket tobacco product application, or PMTA, backlog at roughly 135,000, down from about 450,000 at the start of 2025, and the agency has described that reduction as one of the clearest signs yet of how far it has moved on the queue.

The figures were given at a recent industry conference, and CTP said that the number of applications waiting to be accepted has fallen from a range of 26,000 to 30,000 to around 600, which means the intake side of the process is running nearly clear of its historical backlog. The agency framed this as a prerequisite to working down the substantive review queue.

CTP also set out its target for review speed, saying it sees a path to a more predictable 180-day timeline beginning from a complete application. Under the current process, the Phase 3 clock is measured from the start of substantive scientific review, and the agency has said it is working to make the overall sequence more predictable for applicants.

The discussion covered the supplemental PMTA, or sPMTA, pilot, which CTP said is now running on a single review cycle with deficiency letters generally not issued. The agency has said it wants applicants to submit sufficient evidence upfront and to justify any data bridging they rely on, and that changes in nicotine concentration, nicotine salt, source or pH can affect sPMTA eligibility and the bridging decisions that follow.

On a related front, CTP said more than 50,300 supplemental evaluation, or SE, reports are still pending as of early September, and that it is using bundled reviews and applying lessons from the nicotine pouch pilot to ENDS review. The agency is working the two queues in parallel, and it has said the pouch-pilot experience is being folded back into how it handles the e-cigarette queue.