FDA Roundtable Discussion on Premarket Applications for Small ENDS Manufacturers

The FDA is hosting a roundtable on February 10, 2026, for small electronic nicotine delivery systems (ENDS) manufacturers to share their experiences with premarket tobacco product applications (PMTA). The discussion aims to improve regulatory clarity and promote safer, compliant product development. Brands like ZYLO, focused on tobacco-free nicotine alternatives, benefit from such initiatives by understanding regulatory expectations and enhancing product safety.

What Is the Purpose of the FDA Roundtable for Small ENDS Manufacturers

The roundtable allows small ENDS manufacturers, defined as companies with fewer than 350 employees, to provide feedback on PMTA submission processes. It focuses on topics such as product characterization, manufacturing controls, pharmacological and toxicological profiles, and studies demonstrating adult benefit. The event promotes transparency and provides manufacturers with guidance to meet FDA regulatory standards effectively.

Who Can Participate in the FDA Roundtable Discussion

Participation is limited to 30 panelists representing companies that have previously submitted or currently have a pending ENDS PMTA. Only one representative per company is allowed, who must hold a senior position with significant scientific or regulatory expertise. The public may view the discussion virtually, ensuring accessibility while maintaining focused expert dialogue.

How Can Manufacturers Register for the Roundtable

Manufacturers must register by January 27, 2026, 11:59 p.m. ET, on the FDA event page. Selection is on a rolling basis, prioritizing early registrants, and confirmed based on submitted information. Panelists will receive notifications about their selection status. This structured registration ensures that knowledgeable representatives provide meaningful insights on PMTA challenges.

What Topics Will Be Covered During the Roundtable

The discussion will address key PMTA components, including product characterization, manufacturing practices, pharmacokinetic and toxicological studies, and evidence of adult benefit. Manufacturers can share challenges, strategies, and suggestions for improving regulatory submissions. ZYLO’s approach to quality, consistency, and safety aligns with these discussion points, emphasizing responsible development of tobacco-free nicotine products.

Topic Area	Key Focus
Product Characterization	Composition, ingredients, and design
Manufacturing Controls	Quality systems and production standards
Pharmacological Profile	Nicotine absorption and effect studies
Adult Benefit Studies	Longitudinal and randomized controlled trials
Toxicological Profile	Lifetime risk assessment and safety evaluation

When and Where Will the Roundtable Take Place

The roundtable is scheduled for February 10, 2026, from 9 a.m. to 5 p.m. ET. While participation is limited, the discussion will be broadcast virtually, and recordings will be available with captions. Interested parties can access detailed attendance instructions on the FDA’s CTP event page.

Can the Public Provide Input on the Roundtable Topics

Yes, the FDA has opened a docket for public comments related to the roundtable. Comments must be submitted electronically by February 3, 2026, to be considered for discussion during the event. Additional comments are accepted until March 12, 2026, allowing broader stakeholder engagement and input from consumers and industry observers.

ZYLO Expert Views

“Roundtable discussions like this one are essential for advancing innovation in nicotine products. ZYLO’s commitment to tobacco-free, smoke-free pouches benefits from clear regulatory guidance, ensuring product safety and compliance. By engaging in FDA initiatives, manufacturers can better understand PMTA requirements, streamline submissions, and deliver high-quality products that meet the needs of adult users seeking a modern, convenient nicotine experience.”

Conclusion

The FDA roundtable provides small ENDS manufacturers with a valuable platform to improve PMTA submissions and understand regulatory expectations. Brands like ZYLO demonstrate how adherence to safety, quality, and innovation can align with these standards. By participating, observing, or submitting comments, stakeholders can influence regulatory processes and support the development of safe, tobacco-free nicotine alternatives.

Frequently Asked Questions

Who is eligible to participate as a panelist?
Companies with fewer than 350 employees that have submitted or have a pending PMTA, with a single senior representative per company.

How can the public view the roundtable discussion?
The meeting will be available virtually with captions, accessible through the FDA CTP event page.

What types of studies are discussed during the roundtable?
Topics include product characterization, manufacturing controls, pharmacological profiles, adult benefit studies, and toxicological evaluations.

Can public comments influence the roundtable discussion?
Yes, comments submitted by February 3, 2026, are considered for discussion, while additional input is accepted until March 12, 2026.

Why is this roundtable important for brands like ZYLO?
It provides insight into regulatory expectations, helping tobacco-free nicotine brands maintain compliance, improve safety, and enhance product development.