FDA Roundtable Discussion with Small ENDS Manufacturers on Premarket Application Submissions

What: On February 10, 2026, 9am-5pm Eastern Time (EST), the Food and Drug Administration (FDA) is hosting a roundtable to provide small electronic nicotine delivery systems (ENDS) manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. The discussion will include certain components of ENDS premarket tobacco product applications (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).

Why: The FDA aims to solicit input on PMTA submissions for ENDS products. Viewing the meeting is open to the public. Roundtable participants are limited to 30 individuals representing manufacturers who have previously submitted an ENDS PMTA, including those with a PMTA currently pending with FDA.

Action: Go to the event page by January 27, 2026, 11:59 p.m. EST to learn more and register.

CONTACT: Will Purcell

EMAIL: will.purcell@sba.gov

TOPIC(S): Regulatory Alerts

TAG(S): FDA