,The U.S. Food and Drug Administration (FDA), through its Center for Tobacco Products (CTP), will host a roundtable on February 10, 2026, focused on Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS), including e-cigarettes and vape products. The meeting aims to provide small tobacco product manufacturers (fewer than 350 employees) an opportunity to share their experiences with the PMTA process and offer feedback on how the FDA can improve efficiency and streamline application reviews. Discussion topics include product characterization, manufacturing controls, pharmacological profiles (including pharmacokinetic studies), studies of adult benefit (such as longitudinal cohort or randomized controlled trials), and toxicological profiles (including lifetime cancer risk assessments). The FDA invited panelist registration and public comments in advance of the meeting. A transcript and recording of the session will be made publicly available. The roundtable is part of the agency’s ongoing regulatory oversight of tobacco products under the federal premarket authorization framework.
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