From Regulation to Evidence: Why Clinical Research Matters More Than Ever - Katarzyna Jarus-Dziedzic

This presentation explores the evolving regulatory landscape of novel nicotine products, including e-cigarettes, heated tobacco products, and nicotine pouches, and highlights the growing importance of clinical and real-world evidence in shaping policy and public health decisions. In recent years, regulators in both the European Union and the United States have significantly strengthened their approaches toward emerging nicotine categories. Measures such as flavour bans, extended product scope under existing directives, and stricter premarket authorisation requirements reflect a shift toward more comprehensive oversight. At the same time, patterns of nicotine use are rapidly changing. While traditional cigarette smoking is declining in many regions, the use of alternative products—particularly among youth—is increasing, raising new public health challenges. The presentation addresses the growing complexity of the scientific and regulatory debate, where potential harm reduction for adult smokers must be balanced against concerns related to youth uptake, addiction, and long-term health risks. Against this background, clinical research is becoming central to regulatory decision-making. Increasingly, authorities require robust evidence not only on product composition, but also on real-world use, behavioural patterns, and population-level impact. The session will provide an overview of key regulatory trends, discuss current evidence gaps, and emphasise the critical role of high-quality clinical data in supporting both innovation and responsible public health policy.