FDA Will Hold Small ENDS Enterprise PMTA Roundtable Meeting

The FDA Tobacco Products Center (CTP) will hold a pre-market tobacco product application (PMTA) roundtable meeting for small electronic nicotine delivery system (ENDS) manufacturers on February 10, 2026. This to solicit submission experience and process optimization suggestions.

The US Food and Drug Administration (FDA) Center of Tobacco Products(CTP) announced on the morning of December 23 that a Premarket Tobacco Product Application (PMTA) roundtable meeting for small electronic nicotine delivery system (ENDS) manufacturers will be held on February 10, 2026 at the FDA White Oak Park headquarters in Silver Spring, Maryland. The conference will be open to the public for online viewing, with real-time subtitles and post conference minutes provided.

This meeting will provide a communication platform for small tobacco product manufacturers with less than 350 employees to share their PMTA submission experience and practical challenges, while soliciting opinions on how the FDA can improve review efficiency and optimize the PMTA review process.
The key topics to be discussed at the meeting include product characterization, manufacturing control, pharmacological features (such as pharmacokinetic studies), adult consumer benefit studies (such as longitudinal studies and randomized controlled trials), and toxicological risk assessment (such as lifelong cancer risk estimation).

The FDA stated that the maximum number of guests for roundtable discussions is 30, limited to representatives of manufacturers who have submitted ENDS PMTA (including applications still under FDA review). Each company can only have one person with corresponding scientific or regulatory responsibilities speak. Guest registration will adopt a rolling review mechanism, with a deadline of January 27, 2026 (Eastern Time).
Referemce: FDA Announces Roundtable Discussion with Small ENDS Manufacturers on Premarket Application Submissions | FDA

This announcement indicates that the FDA has begun to address the practical issues faced by small and medium-sized enterprises in the ENDS field during the PMTA application process. Through roundtable discussions, more direct communication will be conducted to enable both parties to have a better understanding and learning, and to implement and complete the work of obtaining approval for future applications
This also reflects another detail: the PMTA mechanism for vape products is not only aimed at large enterprises, small and medium-sized enterprises also participate in market competition through compliance pathways. Based on the current number of products approved by PMTA, small and medium-sized enterprises are very likely to receive huge sales as a return after completing PMTA certification. It is possible for enterprises to take off rapidly.

So far, no Chinese vape manufacturer has applied for PMTA certification, although several Chinese vape brands have tried to apply but have not been approved.
We have no plans to apply for PMTA certification for our vapes. Due to high barriers to entry, high costs, and high requirements, this has hindered the pace of the vast majority of Chinese vape companies.
I hope that future policies will change.