The US Food and Drug Administration (FDA) held a roundtable discussion on 10th February 2026 focused on Premarket Tobacco Product Application (PMTA) submissions for electronic nicotine delivery systems products. The event was aimed at small manufacturers with fewer than 350 employees and provided a forum for sharing experiences and feedback on improving the efficiency of PMTA reviews.
Discussions covered product characterisation, manufacturing controls, pharmacological profiles including pharmacokinetic studies, studies of adult benefit such as longitudinal cohort or randomised controlled trial designs, and toxicological profiles including estimated lifetime cancer risk.
Chris Allen, CEO of PMTA specialist Broughton, offered reflections from the opening session, stating that no entirely new concepts emerged but rather a reinforced focus on applying existing expectations rigorously.
A central theme was the characterisation of Electronic Nicotine Delivery Systems (ENDS) as fully formulated consumer products whose risk profiles stem directly from design choices. The FDA emphasised that ingredients, materials and emissions must be evaluated at the specific product level, noting that broad comparisons to other products provide limited value.
Applicants are expected to submit detailed ingredient disclosures, measurements of harmful and potentially harmful constituents, and stability evidence linked to chemical endpoints to demonstrate full understanding of the product.
Stability data received particular attention. Monitoring nicotine degradants over time was described as integral to understanding product behaviour. A successful PMTA must demonstrate product performance across its intended shelf life, not only at the point of release.
Manufacturing oversight was highlighted as essential to ensuring that characterised products match those placed on the market.
Variability in nicotine concentration was linked directly to abuse liability risks, while weaknesses in assembly or process discipline could lead to contamination or malfunction hazards. The FDA stressed that characterisation data should reflect commercial-scale production, supported by documentation and batch records showing that controls are embedded in routine operations.
Stability programmes were again emphasised, particularly in relation to long-term chemical integrity and microbiological consistency.
Open-system products were identified as adding further complexity. Hardware selection and operating conditions can affect emissions, requiring clear technical justification. While additional guidance may follow, applicants are expected to explain their technical choices thoroughly.
The toxicology session broadened the discussion beyond the standard list of harmful and potentially harmful constituents to include degradation products and material-derived constituents. References were made to compounds newly classified by the International Agency for Research on Cancer, indicating that assessments should reflect current scientific knowledge.
Estimated lifetime cancer risk modelling was highlighted as an important quantitative tool for linking product design to long-term public health outcomes. Ingredient choices influence emissions, material quality affects leachables potential, and formulation parameters shape degradation patterns. Toxicological modelling is used to evaluate these effects.
Across sessions, a consistent message emerged. Product definition informs risk modelling, manufacturing oversight ensures consistency between characterised and marketed products, and quantitative toxicology evaluates long-term implications.
For companies preparing PMTAs, the roundtable underscored the need for evidentiary discipline, sustained manufacturing control and transparent risk assessment. As approaches such as estimated lifetime cancer risk modelling become further integrated into reviews, submission strategies are expected to combine formulation science, process oversight and exposure modelling from the outset.
The roundtable reinforced that strong product characterisation is essential for ENDS submissions to demonstrate risk understanding and regulatory compliance.