By Timothy S. Donahue
Top Takeaways:
Backlog slashed: FDA says PMTA backlog fell roughly 70% in 2025
Pouch momentum: Nicotine pouch pilot now shaping broader PMTA strategy
Process changes: FDA moving toward faster reviews and supplemental PMTA pathways
The FDA’s tobacco center says it is fundamentally reshaping the PMTA process, signaling what could be one of the biggest operational shifts in nicotine regulation since the agency began reviewing premarket tobacco applications.
In a May 7 statement, Bret Koplow, acting director of the Center for Tobacco Products, outlined a series of changes to accelerate application reviews, reduce bottlenecks and expand lessons learned from the FDA’s nicotine pouch pilot program.
“Premarket application review is foundational to establishing a well-regulated marketplace,” Koplow wrote.
According to FDA, the agency has now taken action on PMTAs covering “nearly 27 million tobacco products” over the last five years while reducing its review backlog by “approximately 70 percent” during 2025 alone.
“By more efficiently evaluating product applications, CTP can better ensure that products meeting the public health standard in the law are available to the adult tobacco users who might use them to reduce their risks of premature death and chronic disease,” Koplow said.
One of the most significant operational changes involves the earliest phase of PMTA review. “There is no longer a queue for applications pending Acceptance Review,” Koplow wrote. “For the first time in years, a PMTA will, upon receipt, almost immediately enter the first phase of application review.
“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.”
FDA also said it is implementing faster Filing Review procedures involving nicotine pouch products and electronic nicotine delivery systems (ENDS). The agency additionally confirmed it is separating products within larger submissions when some appear ready for authorization while others still require additional information.
“Products being issued a marketing granted order may be made available to consumers sooner rather than past practice where entire submissions moved together,” Koplow wrote.
The statement strongly reinforces FDA’s growing emphasis on nicotine pouch regulation and review efficiency. In September 2025, FDA launched a pilot program designed to accelerate scientific review of nicotine pouch PMTAs while maintaining what the agency describes as rigorous public-health standards.
“The first decisions – authorizations for six new nicotine pouch products – were issued in December just three months after launching scientific review, a record time for the FDA’s evaluation of a PMTA,” Koplow said.
FDA acknowledged that many applications still require additional information exchanges between regulators and manufacturers.
“The back and forth during this review stage is still necessary for FDA to reach a final decision but is occurring at an expedited pace,” Koplow wrote. “Additional decisions on applications that were part of the pilot program are forthcoming.”
One of the agency’s biggest procedural changes may involve real-time communication during scientific review. According to Koplow, FDA has already begun requesting missing information from applicants earlier during the process instead of waiting for later review stages.
“This process has given the applicants an earlier start for compiling additional information for submission to the FDA that had been omitted from the PMTA but is needed to complete scientific review,” he said.
FDA described the approach as “a replicable model” the agency plans to expand across future reviews.
The agency also revealed it is developing a framework for expedited supplemental PMTA reviews involving products that already hold marketing granted orders. According to FDA, the supplemental process could allow faster review of limited product modifications, including updates tied to electronics technology improvements.
Importantly for nicotine pouch manufacturers, FDA said no additional products will formally enter the existing pouch pilot. Instead, the agency plans to apply the pilot’s lessons more broadly.
“No additional products will be added to the nicotine pouch pilot,” Koplow wrote. “Instead, because the pilot has realized significant success in accelerating review of nicotine pouch PMTAs, CTP intends to incorporate lessons learned from the pilot into the review for all nicotine pouch PMTAs.”
