Key Takeaways
- FDA CTP said it reduced the PMTA application backlog by approximately 70% in 2025.
- CTP said there is no longer a queue for PMTAs pending acceptance review.
- CTP is implementing faster filing review, including for nicotine pouch products and ENDS.
- FDA launched a nicotine pouch application review pilot in September 2025 and authorized six new nicotine pouch products in December.
- CTP said no additional products will be added to the nicotine pouch pilot, but lessons learned will be incorporated into all nicotine pouch PMTA reviews.
2Firsts, May 9, 2026
According to a statement from Bret Koplow, acting director of the FDA’s Center for Tobacco Products, CTP is moving forward with steps to accelerate tobacco product premarket application review and improve review efficiency.
PMTA backlog fell about 70% in 2025
Koplow said premarket application review is foundational to establishing a well-regulated marketplace.
CTP is identifying and deploying lessons learned from actions taken over the past five years on premarket tobacco product applications for nearly 27 million tobacco products.
He said CTP staff are working to efficiently evaluate applications, and that in 2025 CTP reduced the application backlog by approximately 70%.
The statement said that by evaluating product applications more efficiently, CTP can better ensure that products meeting the public health standard under the law are available to adult tobacco users who might use them to reduce risks of premature death and chronic disease.
PMTA acceptance review queue has ended
CTP said there is no longer a queue for applications pending acceptance review. The statement said that for the first time in years, a PMTA will, upon receipt, almost immediately enter the first phase of application review.
Koplow said the days when applicants might wait months or even years to learn whether their application was complete enough to be accepted for further evaluation are behind the agency.
CTP is accelerating filing and scientific review
CTP is also adopting efficiencies for the second phase of review, in which FDA determines whether an application contains sufficient information to enable substantive scientific review.
The statement said such efficiencies were used in the past year in filing review of nicotine pouch products and electronic nicotine delivery systems.
For scientific review and decisions, CTP is exploring opportunities to streamline the process. The statement said that when some products included in a submission can receive marketing granted orders while others require additional information, those products are being reviewed separately where appropriate.
This may allow products receiving marketing granted orders to become available to consumers sooner, rather than following the past practice of moving entire submissions together.
CTP plans faster review for certain supplemental PMTAs
CTP is working on a process to prioritize and efficiently review supplemental PMTAs. The work will involve expedited review of certain modifications to products for which FDA has already issued a marketing granted order.
The statement said that when limited information can demonstrate that permitting the marketing of a newly modified product would be appropriate for the protection of public health, the product may be eligible for expedited review. The pilot will allow expedited review for certain changes, such as those related to improvements in electronics technology.
Nicotine pouch pilot produced first decisions in three months
FDA announced in September 2025 an innovative pilot program to explore ways to streamline review of nicotine pouch product applications while preserving the scientific rigor needed to determine whether a product meets the statutory standard of being appropriate for the protection of public health.
The statement said the first decisions under the pilot were authorizations for six new nicotine pouch products issued in December, three months after scientific review began. CTP described this as a record time for FDA’s evaluation of a PMTA.
Some applications still require additional information
Koplow said thorough submissions and rigorous review still take time. In some cases, applicants are working with FDA to respond to questions and agency requests for information, while FDA is awaiting information from applicants.
The statement said this back-and-forth remains necessary for FDA to reach final decisions, but is occurring at an expedited pace. Additional decisions on applications that were part of the pilot program are forthcoming.
If any final decisions result in newly authorized nicotine pouches, those products will be listed on FDA’s authorized nicotine pouch product page.
Real-time communication is improving review efficiency
The statement said that in several cases, FDA requested additional information through real-time communication with applicants while applications were undergoing scientific review.
This gave applicants an earlier start in compiling additional information for FDA that had been omitted from the PMTA but was needed to complete scientific review.
CTP said this is a replicable review model that it intends to implement further, including outside the pilot.
No more products will be added to the nicotine pouch pilot
CTP said no additional products will be added to the nicotine pouch pilot.
Koplow said that because the pilot has achieved significant success in accelerating review of nicotine pouch PMTAs, CTP intends to incorporate lessons learned from the pilot into review for all nicotine pouch PMTAs.
Image Source: FDA
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