At the American Tobacco and Nicotine Forum (ATNF), a panel titled “Building Lasting Regulatory Reforms: Solutions for a Better PMTA Pathway,” brought together legal, regulatory, and scientific experts to examine persistent challenges within the FDA’s premarket tobacco application (PMTA) process and explore potential reforms. Moderated by Issa Abuaita, the head of legal in the U.S. for Haypp Group, the discussion focused on the disconnect between the statutory framework and real-world market dynamics, with panelists broadly agreeing that the current system is slow, costly, and misaligned with both innovation and enforcement realities.
Industry representatives emphasized the need for clearer guidance and more practical tools to navigate the process. Paige Magness, a senior vice president at Altria Client Services, highlighted the “irony” of a system where youth usage has increased in products that remain unauthorized, raising questions about whether the framework is effectively managing real-world outcomes. Kellsi Booth, the Chief Legal Officer for Black Buffalo, pointed to the gap between regulatory language and day-to-day application, suggesting that decision trees or clearer pathways could help companies determine requirements more efficiently. Piotr Kozarewicz, the global head of regulatory affairs for smoke-free products at PMI, argued for a more product-focused and market-informed approach, stressing that regulators should evaluate how products are actually used rather than relying heavily on predictive behavioral studies that may not reflect reality.
Clive Bates, the director of Counterfactual, delivered the sharpest critique, arguing that the PMTA system has become “untethered from reality,” with high evidentiary burdens effectively stifling innovation and contributing to the growth of a large illicit market. He noted that while only a small number of vaping products have been authorized, thousands of combustible products remain on the market, creating a regulatory imbalance. Bates called for a shift toward a more pragmatic framework focused on product safety and marketing controls, alongside faster review timelines closer to the statutory 180-day standard. He also suggested that a compliance-based system, where products meeting defined standards receive expedited review, could improve outcomes and reduce barriers to entry.
Representing the FDA on the panel was Dr. Matthew Farrelly, the director of the Office of Science for the Center for Tobacco Products, who offered several counterpoints, defending the agency’s process while acknowledging its limitations. He noted that the vast majority of PMTA denials stem from incomplete applications, particularly the lack of evidence demonstrating benefits to adult smokers. Farrelly emphasized that FDA is bound by the existing statutory framework and must base decisions on robust scientific evidence, even as it works to clear backlogs and improve engagement with industry. He encouraged earlier dialogue between applicants and regulators and suggested that incremental product changes could be reviewed more efficiently than entirely new designs.
The panel ultimately underscored a shared recognition that while progress is being made, meaningful reform will require clearer standards, better communication, and a more balanced approach to risk, innovation, and enforcement.
