On February 10, 2026, the U.S. Food and Drug Administration (FDA) will convene a one-day roundtable discussion focused on Premarket Tobacco Product Application (PMTA) submissions for electronic nicotine delivery systems (ENDS) — the regulatory pathway required for e-cigarettes, vapes, and similar products to be legally marketed in the United States.  

Here’s what business owners and small manufacturers should understand — and how you can participate. 

📌 Official FDA Notice & Event Page (includes agenda, registration details, and webcast info): 

🔗 FDA: February 10, 2026 Roundtable on PMTA Submissions for ENDS Products   

 

📅 What the Roundtable Is About 

 

The purpose of this FDA roundtable is to give small tobacco product manufacturers — defined as companies with fewer than 350 employees — an opportunity to: 

✅ Share real-world experiences with the PMTA process 
✅ Provide feedback on challenges and barriers in preparing submissions 
✅ Offer input on how FDA might improve efficiency, clarity, and predictability in PMTA reviews 

This is the first event of its kind focused specifically on the PMTA process for ENDS products.  

Topics officially scheduled for discussion include: 

• Product characterization 
• Manufacturing controls 
• Pharmacological profile (e.g., pharmacokinetic studies) 
• Studies of adult benefit (longitudinal or randomized controlled trials) 
• Toxicological profile (e.g., estimated lifetime cancer risk)  

 

Why This Matters 

 

Under FDA’s tobacco regulatory framework, PMTAs are required before most new ENDS products can be marketed in the U.S. — and these submissions are often detailed, complex, and costly.  

A typical PMTA must demonstrate, among other things, that allowing a product to be marketed is appropriate for the protection of public health — a standard that involves scientific evidence, risk/benefit analysis, and thorough documentation.  

While many manufacturers have struggled with long review times and evolving expectations from the agency, this roundtable is FDA’s first public step toward gathering direct feedback from small companies about where the process could be improved. 

 

👥 Who Can Participate

 

Panelists 

Manufacturers interested in serving as panelists — i.e., speaking and sharing direct feedback — must register by January 27, 2026, 11:59 p.m. ET. Panelist participation is limited and competitive, with up to 30 individuals selected.  

To register, interested applicants must email CTP-OS-ACS@fda.hhs.gov with: 

• Name & title 
• Company info and workforce size 
• Which PMTA topic(s) they wish to address 
• Contact details  

Public Attendance 

Even if you’re not selected as a panelist, the roundtable will be available to view online. FDA plans to provide a livestream and later make the transcript and recording available.  

 

📝 How to Get Involved (Even If You Can't Attend) 

 

Submit Comments: 

 
FDA is establishing a public docket where written data, information, or viewpoints can be submitted electronically or by mail. Early submission ensures your voice is part of the official record.  

 
➡️ Submit comments via Regulations.gov (search docket FDA-2025-N-7022) 

Watch Live or Catch the Recording:

FDA will offer a live webcast of the roundtable — make plans to watch if you want direct insight into the discussion.  

 

🚀 What This Could Mean for ENDS PMTAs 

 

This roundtable has the potential to shape how the FDA reviews future ENDS PMTAs by highlighting: 

• Real business challenges faced by smaller companies 
• Where regulatory expectations may be unclear 
• Ideas for streamlining data requirements 
• Potential improvements to guidance documents and submission tools 

For manufacturers and stakeholders who have been navigating long review times and regulatory uncertainty, this represents a very tangible opportunity to be heard.  

 

Bottom Line: 
The February 10 PMTA roundtable isn’t just another meeting — it’s a strategic window for small ENDS manufacturers to engage directly with regulators and influence the future of premarket reviews. Whether you choose to speak, submit comments, or simply watch and learn, there’s a stake for every business involved in the vape and ENDS space.