2FIRSTS | FDA PMTA Roundtable: Ongoing Comprehensive Coverage by 2Firsts
2Firsts provides comprehensive coverage of the FDA's PMTA roundtable, detailing discussions on scientific standards for e-cigarette regulation.Summary
On February 10, 2026, the FDA held a roundtable on Premarket Tobacco Applications (PMTAs) for electronic nicotine delivery systems (ENDS), involving agency officials and industry representatives. Discussions covered product characterization, manufacturing controls, pharmacological assessment, adult benefit studies, and toxicological review, offering insight into the agency’s “Appropriate for the Protection of Public Health” (APPH) framework. 2Firsts published eight reports covering each panel session, highlighting key regulatory signals and industry responses. Key concerns raised by smaller manufacturers included unclear standards for product characterization and manufacturing, the cost of clinical studies, and the lack of defined benchmarks for demonstrating adult benefit and acceptable toxicological risk. The FDA emphasized the importance of predictability in regulation and will issue a summary of the feedback received, while maintaining that authorization decisions are not based on fixed quantitative risk benchmarks.
(Source：2Firsts)
