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Meeting | Mixed

Event Title
February 10, 2026: Roundtable on Premarket Tobacco Product Application (PMTA) Submissions for Electronic Nicotine Delivery Systems (ENDS) Products
February 10, 2026

Date:
February 10, 2026
Time:
9:00 a.m. - 5:00 p.m. ET
Location:
Event Location
White Oak Campus: The Great Room
FDA Headquarters

10903 New Hampshire Avenue
Bldg. 31, Great Room Conference Center
Silver Spring, MD 20993-0002
United States


Organized By:
Organizer

Live Presentation

Meeting Overview

The purpose of the roundtable is to provide small tobacco product manufacturers (fewer than 350 employees) an opportunity to share their experiences and perspectives on the PMTA process and to offer feedback on how FDA can improve efficiency and streamline PMTA reviews. The topics to be discussed will include certain components of 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).

  • Live closed captioning and ASL interpreters will be provided during the roundtable session. If you have issues registering or have any questions, please email CTP-OS-ACS@fda.hhs.gov or call 1-877-CTP-1373 between 9 a.m. and 4 p.m. ET. A transcript and recording will be made available after the roundtable discussion.

Registration for Panelists

If you are interested in participating in the roundtable as a panelist, please email CTP-OS-ACS@fda.hhs.gov by January 27, 2026, 11:59 p.m. Eastern Time to register. Registrants should include the following information for the attendee in their request to participate in the roundtable:  

  • Name of proposed attendee, job title, address, email, and telephone number
  • Name of company and brief company description
  • How many people the company employs (including subsidiaries)
  • Indicate which of the 5 topics you wish to discuss as a panel member (you may select multiple topics):
    • Product Characterization
    • Manufacturing Controls
    • Pharmacological Profile  
    • Studies of Adult Benefit
    • Toxicological Profile

Registration for panelists is on a rolling basis determined by space availability, with priority given to early registrants. FDA will evaluate registrations based on the submitted information until a maximum of 30 participants have been selected for the roundtable and will then inform applicants of selection decisions. Due to time and space constraints, there is a limit of one person to represent and speak on behalf of each company. Participants should be at a sufficiently senior level with significant scientific and/or regulatory responsibility to be knowledgeable about their company’s PMTA. Panel registrants will receive confirmation as to whether they have been selected. If panelist registration closes prior to the submission deadline, we will update the website to reflect that change.  

Register to Be a Panelist

Public Participation Information

Interested persons may present data, information, or views, in writing, on the topics discussed above.  

  • Electronic comments must be submitted to docket number FDA-2025-N-7022 on or before February 3, 2026, to be considered for the roundtable discussion.  
  • All other electronic comments must be submitted on or before March 12, 2026. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 12, 2026. 
  • Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before these dates.
  • The roundtable discussion will be available for viewing online.

View the Roundtable Discussion

For more information about providing comments, orally or in writing, please see the Federal Register notice.

Contact Information

  • Rachel Jang, PharmD, Designated Federal Officer: 1-877-287-1373
  • Jennifer Schmitz, M.P.H., Supervisory Regulatory Health Project Manager, 1-240-402-5892  
  • CTP-OS-ACS@fda.hhs.gov

FDA welcomes the virtual attendance of the public at this meeting and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact FDA at CTP-OS-ACS@fda.hhs.gov at least 7 days in advance of the meeting.

Review the Federal Register notice about this meeting for additional details.  

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