FDA Roundtable: E-Cigs Get Bureaucratic Ear
Published Date: 12/29/2025
Notice
Summary
The FDA is hosting a roundtable on February 10, 2026, to hear from small makers of electronic nicotine delivery systems (like e-cigarettes) about their experiences with the premarket approval process. They want to improve how these products are reviewed, focusing on safety, manufacturing, and health effects. If you’re involved in making or selling these products, now’s the time to share your thoughts and help shape future rules!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
FDA Roundtable for Small ENDS Makers
The FDA is holding a roundtable on February 10, 2026 to hear from small electronic nicotine delivery systems (ENDS) manufacturers about PMTA (premarket tobacco product application) submissions. Topics include product characterization, manufacturing controls, pharmacological profile (e.g., pharmacokinetic studies), studies of adult benefit (e.g., longitudinal cohort/RCT studies), and toxicological profile (e.g., estimated lifetime cancer risk).
Limited Panel Slots and Eligibility Rules
Registration to participate as a panelist is open to "small tobacco product manufacturers" (those with fewer than 350 employees) and is limited to 30 participants representing companies that have previously submitted an ENDS PMTA, including pending PMTAs. Registration is free and panelist registration must be submitted by January 27, 2026, 11:59 p.m. Eastern Time; only one person may represent each company and final eligibility is determined by FDA.
Public Docket, Comment Deadlines, and Remote Access
FDA established a public docket (Docket No. FDA-2025-N-7022) beginning December 29, 2025 for comments on the roundtable topics; electronic comments to be considered for the roundtable must be submitted by February 3, 2026, and all other electronic comments must be submitted by March 12, 2026 (regulations.gov will accept comments through 11:59 p.m. Eastern Time on March 12, 2026). The FDA accepts confidential written submissions under a two-copy process, will provide virtual viewing of the roundtable, and will post a transcript to regulations.gov when available; requests for disability accommodations must be emailed by February 3, 2026.
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