CTP Acting Director Statement: New Steps Forward in Accelerating Innovation and Efficiency in Product Review

By Bret Koplow, Ph.D., J.D., Acting Director of the Center for Tobacco Products
May 7, 2026

In a rapidly evolving environment like tobacco regulation, the FDA recognizes the need for communication and updates on the agency’s critical work protecting the public health. As the acting director for the FDA’s Center for Tobacco Products, I am pleased to provide some updates on CTP’s work.

Premarket application review is foundational to establishing a well-regulated marketplace. CTP is identifying and deploying lessons learned in the course of having taken action over the past five years on premarket tobacco product applications (PMTAs) for nearly 27 million tobacco products. CTP's staff are working diligently to efficiently evaluate applications, as evidenced by the fact that, in 2025, CTP reduced the backlog of applications by approximately 70 percent. 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.

We continue to make tremendous progress, including:

There is no longer a queue for applications pending Acceptance Review: 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.
CTP is implementing ways to accelerate Filing Review: CTP is also adopting new efficiencies for the second phase of review, in which FDA determines if an application contains sufficient information to enable substantive scientific review. In the past year, such efficiencies have been realized in conducting filing review of nicotine pouch products and electronic nicotine delivery systems (ENDS).
CTP is exploring opportunities to streamline scientific review and decisions: Upon review, if there are products included in a submission which can receive marketing granted orders (MGOs) while others require additional information, these are being reviewed separately where appropriate. By doing so, products being issued a marketing granted order may be made available to consumers sooner rather than past practice where entire submissions moved together.
CTP is working on a process to prioritize and efficiently review supplemental PMTAs (sPMTA): This work will involve expedited review of certain modifications to products for which FDA has already issued a MGO, and where the submission of limited information could demonstrate that permitting the marketing of the newly modified product would be appropriate for the protection of the public health. The pilot will allow for expedited review for certain changes such as those to account for improvements in electronics technology.

In September 2025, FDA announced the launch of an innovative pilot program to explore opportunities 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 the public health.

Review in record time: 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.
Thorough submissions and rigorous review still take time: In some cases, the applicant is working with FDA to respond to questions and agency requests for information and the agency is awaiting information from the applicant. 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. Additional decisions on applications that were part of the pilot program are forthcoming. Should any final decisions result in newly authorized nicotine pouches, they will be listed at www.fda.gov/authorizednicotinepouches.
Communication is creating efficiencies: In several cases, FDA requested additional information via real-time communication with the applicant while the application was undergoing scientific review. 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. This is a replicable model for review that CTP intends to implement further, including outside this pilot.
Applying the pilot’s lessons learned: No additional products will be added to the nicotine pouch pilot. 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.

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