FDA Announces Roundtable Discussion with Small ENDS Manufacturerson Premarket Application Submissions

FROM CDA NEWSLETTER:

The U.S. Food and Drug Administration (FDA) has issued a Federal Register notice (FRN) announcing a roundtable discussion with small tobacco product manufacturers (fewer than 350 employees) on February 10, 2026, 9 am–5 pm ET. The discussion aims to solicit input on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products.

Viewing the meeting is open to the public, however 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.

The FDA is hosting this roundtable to provide small ENDS manufacturers an opportunity to share their experience with, and other opinions about, the premarket application process. The topics to be discussed will include 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).

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