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FDA schedules online roundtable to gather small manufacturers’ input on ENDS PMTA requirements

Feb.10
FDA schedules online roundtable to gather small manufacturers’ input on ENDS PMTA requirements
FDA announced it will convene a Feb. 10, 2026 roundtable with small tobacco product manufacturers to gather feedback on PMTA submissions for ENDS products. The discussion will be viewable online, and a public docket is open for comments through March 12, 2026.

Key points

 

  • FDA will hold a roundtable on Feb. 10, 2026 (9 a.m.–5 p.m. ET) with small tobacco product manufacturers (<350 employees).
  • The session will solicit input on PMTA submissions for ENDS products and will be available to view online.
  • Topics include PMTA components: product characterization, manufacturing controls, pharmacological profile (e.g., PK studies), adult benefit studies (e.g., cohort/RCT), and toxicological profile (e.g., lifetime cancer risk estimates).
  • FDA opened a public comment docket; electronic comments are due by 11:59 p.m. ET on March 12, 2026 via Regulations.gov.

 

 

2Firsts, Feb 10, 2026

 

According to the U.S. Food and Drug Administration (FDA), the agency issued a Federal Register notice on Dec. 23, 2025 announcing a roundtable discussion with small tobacco product manufacturers (fewer than 350 employees) on Feb. 10, 2026, from 9 a.m. to 5 p.m. ET. The session will solicit feedback on premarket tobacco product application (PMTA) submissions for electronic nicotine delivery systems (ENDS) products and will be available to view online.

 

FDA said the roundtable is intended to give small ENDS manufacturers an opportunity to share their experiences with the premarket application process. Topics will include key PMTA components such as product characterization, manufacturing controls, pharmacological profile (including pharmacokinetic studies), studies of adult benefit (including longitudinal cohort and randomized controlled trial studies), and toxicological profile (including estimated lifetime cancer risk).

 

FDA also established a public docket for comments on the roundtable. Electronic comments must be submitted via Regulations.gov by 11:59 p.m. ET on March 12, 2026 to be considered.

 

Image source: FDA

 

References:
[1] FDA Announces Roundtable Discussion with Small ENDS Manufacturers on Premarket Application Submissions
Also Read:
[1] U.S. FDA Posts Final ZYN MRTP Materials, Sets March 4 Deadline for Public Comments

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