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FDA Announces Roundtable for Small ENDS Manufacturers

Date: December 24, 2025
Location: Silver Spring, Maryland

On Tuesday morning, the U.S. Food and Drug Administration (FDA) announced a significant event regarding Premarket Tobacco Product Applications (PMTAs) for small electronic nicotine delivery systems (ENDS). A roundtable discussion is scheduled to take place on February 10, 2026, at the FDA headquarters, providing a platform for small manufacturers to engage in critical discussions surrounding the PMTA process.

Purpose of the Roundtable

The FDA’s Center for Tobacco Products (CTP) has emphasized that this roundtable is specifically targeted at small tobacco product manufacturers, defined as those with fewer than 350 employees. This initiative aims to create a collaborative environment where manufacturers can share their experiences and insights regarding the PMTA submission process. Furthermore, it allows them to provide feedback on how the FDA might enhance the efficiency and streamline the review processes associated with PMTAs.

Discussion Topics

The roundtable will cover several important topics related to the PMTA process, including:

1. Product Characterization: Understanding the unique characteristics of ENDS products.
2. Manufacturing Controls: Exploring the regulatory requirements for manufacturing practices.
3. Pharmacological Profiles: An analysis of pharmacokinetic studies and their implications.
4. Studies of Adult Benefit: Discussions on adult benefit studies, including longitudinal and randomized controlled trials.
5. Toxicological Assessments: Reviewing assessments like the estimated lifetime cancer risk associated with ENDS products.

Participation Criteria

The FDA has noted that participation in this roundtable will be limited to 30 panelists. These panelists will represent manufacturers that have previously submitted ENDS PMTAs and include those with applications still under review. Importantly, only one representative per company can attend, and they must possess sufficient scientific or regulatory expertise to effectively discuss their company’s PMTA.

Those interested in participating should note that registrations will be reviewed on a rolling basis, with a final deadline of January 27, 2026 (ET), ensuring a punctual and organized selection process.

Industry Insights

Alan Zhao, the CEO of 2Firsts, expressed optimism regarding this development. He noted that the announcement signifies the FDA’s commitment to engaging more directly with the range of challenges faced by small and mid-sized companies in the ENDS sector. Zhao believes this initiative indicates a shift in the PMTA framework, suggesting that it is not solely focused on larger manufacturers. Smaller companies now see a viable path towards compliance and market participation.

He further commented that as the dialogue around regulations continues, we may witness the evolution of the PMTA review process towards greater clarity and efficiency, while still maintaining adherence to existing regulatory guidelines.

Access to the Roundtable

The roundtable will not only foster direct interaction among stakeholders but will also be accessible for public viewing online. Live captioning will be provided, and a recording of the discussions will be released following the meeting, promoting transparency and broader participation.

How AI legalese decoder Can Help

Navigating the complexities of the PMTA process can be daunting for small manufacturers. This is where the AI legalese decoder becomes an invaluable tool. It can simplify the legal jargon that often accompanies regulatory documents, making them easier to understand for stakeholders who may not have a legal background. By decoding complex language, the AI can help manufacturers grasp the intricacies of compliance requirements, thereby empowering them to make informed decisions throughout the PMTA process.

Additionally, the AI legalese decoder can assist companies in preparing their submissions by ensuring that they meet the necessary legal standards and regulatory expectations, thus enhancing their chances for successful application approvals.

In conclusion, the FDA’s roundtable marks a pivotal step toward supporting small ENDS manufacturers, and tools like the AI legalese decoder can further empower these businesses as they navigate the regulatory landscape.

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