By Timothy S. Donahue
Top Takeaways:
- The FDA will host a small-manufacturer ENDS PMTA roundtable on Feb. 10, 2026.
- Participation is limited to 30 representatives from companies with prior or pending ENDS PMTAs.
- Discussions will focus on key scientific and regulatory PMTA requirements, including PK studies and adult-benefit evidence.
The U.S. Food and Drug Administration has issued a Federal Register notice announcing a roundtable discussion with small tobacco product manufacturers focused on the premarket tobacco product application (PMTA) process for electronic nicotine delivery systems (ENDS).
The roundtable is scheduled for Feb. 10, 2026, from 9 a.m. to 5 p.m. Eastern Time and will be hosted by the FDA’s Center for Tobacco Products (CTP). Panelist participation will be limited to 30 individuals representing small manufacturers, defined as having fewer than 350 employees.
According to the notice, eligible participants must represent companies that have previously submitted an ENDS PMTA, including those with applications pending before the agency. Due to space and time constraints, only one representative per company will be permitted to attend the roundtable discussion.
The FDA said the purpose of the meeting is to provide small ENDS manufacturers with an opportunity to share their experiences and perspectives on the PMTA process. Topics slated for discussion include specific scientific and regulatory components of ENDS PMTAs, such as product characterization, manufacturing controls, pharmacological profiles (including pharmacokinetic [PK] studies), evidence of adult benefit (such as longitudinal cohort studies and randomized controlled trials [RCTs]), and toxicological assessments, including estimated lifetime cancer risk.
Panelist registration must be completed through the event webpage by Jan. 27, 2026, at 11:59 p.m. ET. Panelist registrations will be evaluated on a rolling basis, with priority given to early submissions, until the maximum number of participants is reached. FDA said it will assess registrations based on the information provided and notify applicants of their selection status.
The agency specified that panelists should hold sufficiently senior roles within their organizations and have substantial scientific and/or regulatory responsibility to speak knowledgeably about their company’s PMTA submission.
Although participation in the roundtable is limited, the FDA said the meeting will be open to the public for virtual viewing. Details on how to observe the roundtable will be posted on CTP’s website. The session will be captioned and recorded, according to the notice.
FDA has faced sustained criticism from small and mid-sized manufacturers regarding the complexity, cost, and duration of the PMTA process for ENDS products. The roundtable follows a series of agency efforts to solicit stakeholder feedback and refine review practices, as FDA continues to process a large backlog of ENDS applications.
