2Firsts, Dec. 24, 2025, Morning ET — The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) announced Tuesday morning that it will hold a roundtable discussion on Premarket Tobacco Product Applications (PMTAs) for small electronic nicotine delivery systems (ENDS) manufacturers on February 10, 2026, at FDA headquarters in Silver Spring, Maryland.
According to the FDA, the roundtable will be open to small tobacco product manufacturers with fewer than 350 employees, providing an opportunity to share experiences and perspectives on the PMTA submission process and to offer feedback on how the agency can improve efficiency and streamline PMTA reviews.
Topics to be discussed will include key PMTA components such as product characterization, manufacturing controls, pharmacological profiles (including pharmacokinetic studies), studies of adult benefit (including longitudinal and randomized controlled trials), and toxicological assessments, such as estimated lifetime cancer risk.
The FDA said participation in the roundtable will be limited to 30 panelists, representing manufacturers that have previously submitted ENDS PMTAs, including those with applications currently under review. Only one representative per company may participate, and panelists must hold sufficient scientific or regulatory responsibility to speak knowledgeably about their company’s PMTA. Panelist registration will be reviewed on a rolling basis, with a deadline of Jan. 27, 2026 (ET).
Alan Zhao , CEO of 2Firsts, said the announcement indicates that the FDA has begun engaging more directly with PMTA-related challenges faced by small and mid-sized companies in the ENDS sector.
In his view, the move sends a signal that the PMTA framework for e-cigarettes is not exclusively oriented toward large manufacturers, and that smaller companies may also have a viable, compliance-based pathway to participate in the market.
Zhao added that, as regulatory dialogue continues, the PMTA review process may gradually evolve toward greater procedural clarity and improved review efficiency, while remaining within the existing regulatory framework.
The roundtable will be available for public viewing online, with live captioning and a recording to be released after the meeting.
Cover image source: The official website of the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP).
