2Firsts, February 11, 2026
Commissioner Appearance Signals Regulatory Attention
FDA Commissioner Marty Makary briefly appeared ahead of the fifth panel of the agency’s February 10 roundtable on Premarket Tobacco Applications (PMTAs) for electronic nicotine delivery systems (ENDS), emphasizing the importance of regulatory predictability for market participants.
In his remarks, Makary stated that the agency remains committed to serving the public through scientifically sound review standards that safeguard public health, particularly youth. He said FDA aims to see products that meet manufacturing safety expectations while fostering innovation and competition. Predictability in regulatory processes, he noted, is important for markets, inventors, manufacturers, and investors.
Makary departed shortly after his remarks to attend another engagement, indicating he would watch the remainder of the session via livestream or recording.
Industry Presses for Quantitative Benchmarks
At the conclusion of the meeting, Matthew C. Farrelly, Ph.D., Director of the FDA’s Office of Science within the Center for Tobacco Products, addressed repeated industry concerns regarding uncertainty in the review process. Farrelly referenced the Commissioner’s appearance and described it as an “unexpected” but positive moment during the session.
Throughout multiple panels, small and mid-sized manufacturers had raised concerns that the absence of clearly defined quantitative benchmarks—such as an explicit risk ceiling or reference threshold—makes it difficult to design studies, allocate research budgets, and assess whether submissions are likely to meet regulatory expectations. Several representatives suggested that uncertainty surrounding how much evidence is “enough” increases the risk of costly repeat studies and delays.
Farrelly said those concerns had been heard. He stated that the agency plans to more thoroughly summarize the discussion in a follow-up document that will publicly record feedback from the roundtable and allow stakeholders to continue contributing input.
No Fixed Numeric Threshold Under APPH
At the same time, he reiterated that FDA’s determinations must remain grounded in the statutory “Appropriate for the Protection of Public Health” (APPH) standard. Risk assessment, he said, is conducted as part of an integrated, multidisciplinary evaluation, and no single metric or fixed numerical value determines whether a product will be authorized.
In response to questions about quantitative risk thresholds, the agency did not provide a specific benchmark.
Farrelly added that while the Office of Science will continue working to improve communication and process clarity, the agency cannot make business decisions for applicants. Case-by-case evaluation remains the governing principle.
Industry representatives also pointed to structural challenges associated with open-system products and to the effect that regulatory uncertainty may have on capital investment decisions. Those concerns, Farrelly said, were noted during the discussion.
While the roundtable provided expanded visibility into FDA’s scientific review framework, the agency maintained its position that authorization decisions will continue to rely on individualized assessment rather than predetermined quantitative cutoffs.
2Firsts will continue to follow developments related to the roundtable and any forthcoming summary document.
（Cover image: FDA Commissioner Marty Makary delivers remarks at the PMTA roundtable. | Source: FDA livestream screenshot）
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