Strategies to Support and Effectively Implement the Proposed FDA Nicotine Standard: An Official American Thoracic Society Workshop Report

Tobacco use remains the leading cause of preventable death in the United States (U.S.) and worldwide. The U.S. Food and Drug Administration (FDA) has proposed a product standard to reduce nicotine in cigarettes and other combustible tobacco products to minimally or non-addictive levels, specifically, 0.7 milligrams of nicotine per gram of tobacco. To inform implementation of this standard and future policy directions, the American Thoracic Society's Tobacco Action Committee convened a multidisciplinary workshop that included experts in tobacco treatment, behavioral science, pharmacology, toxicology, pulmonology, cardiology, policy, public health, and advocacy from the U.S., United Kingdom, Lebanon, and Australia. Panelists reviewed the evidence and supported the proposed nicotine standard, citing its potential to reduce addiction, lower daily consumption of smoked tobacco, and increase smoking cessation rates. The panel emphasized that the policy's success depends on a comprehensive rollout strategy that includes complementary measures to protect public health and avoid unintended consequences. These include clear public messaging to prevent misperceptions about product safety, robust surveillance systems to monitor behavioral change and industry responses, and equitable access to FDA-approved cessation support, particularly for disproportionately affected populations. Panelists also addressed the anticipated shift toward non-combustible products, recommending harm minimization strategies, stronger monitoring and enforcement of industry marketing activities, and expanded regulatory authority over emerging products, including nicotine analogues and other addiction-enhancing substances. The panel highlighted the need for improved tools to assess real-world tobacco dependence and toxicant exposure to help ensure that evolving product landscapes are effectively regulated to protect public health.