Keller and Heckman Partner Azim Chowdhury was interviewed for the Nicotine Insider article, “As FDA Rethinks PMTAs, What Comes Next?” The article examines how the U.S. Food and Drug Administration’s (FDA) reported reconsideration of the Premarket Tobacco Product Application (PMTA) process could reshape the regulation of vaping products, nicotine pouches, and other noncombustible nicotine products. Azim argues that FDA should adapt its regulatory approach to reflect today’s public health landscape, including historically low smoking rates, declining youth vaping rates, and the need for a more practical pathway for companies seeking authorization.
Key points from Azim include:
- FDA should reassess its assumptions about the nicotine marketplace, noting that cigarette smoking and youth vaping have declined even during years when unauthorized flavored vaping products remained widely available. He said the agency needs to ask “what the experience of the last several years tell[s] us about the relationship between these products, cigarette smoking, and youth use.”
- He emphasized the need for “better regulation and smarter enforcement,” arguing that regulators should recognize the harm-reduction potential of noncombustible products while creating “a realistic way to bring the existing marketplace into compliance.”
- Azim warned that maintaining the current framework could be a missed opportunity for smoking cessation because “adults who might otherwise stop smoking won’t.” He argued that regulators should focus on outcomes such as reduced cigarette use, smoker switching, youth-use trends, and meaningful FDA oversight rather than simply removing products from the market.
- Regarding flavored e-cigarettes, he said FDA should “seriously rethink” its approach, arguing that tobacco flavor is not the natural baseline for e-cigarettes and that many adults seeking to quit smoking may prefer non-tobacco flavors. He stated that flavor should not become “a substitute for conducting the actual population-health analysis.”
- On PMTA reform, Azim said the current process has become “extraordinarily expensive,” often costing millions of dollars and favoring large tobacco companies. He stressed that the solution is not to lower scientific standards but to “make the science smarter” by allowing greater use of bridging data, representative-product testing, master files, and other approaches that reduce duplication while maintaining scientific rigor.
To read the full interview, please click here.