Now Available: Meeting Materials from February 2026 Roundtable Discussion on Premarket Applications for ENDS
In February 2026, FDA held a roundtable discussion with small tobacco product manufacturers to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products.
FDA hosted this roundtable to provide small tobacco product manufacturers an opportunity to share their experiences and perspectives on the PMTA process and to offer feedback on how FDA can improve efficiency and streamline PMTA reviews. The topics that were discussed included certain components of ENDS PMTAs such as product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/randomized controlled trial (RCT) studies), and toxicological profile (e.g., estimated lifetime cancer risk).
All materials from the roundtable discussion are available online, including the meeting recording, meeting presentation, the meeting transcript, agenda, list of acronyms, and participants list.
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