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.

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Publication Details

Journal
Annals of the American Thoracic Society
Published
2026-07-24
DOI
https://doi.org/10.1093/annalsats/aaoag205
Primary Topic
Smoking Behavior and Cessation
Type
article
Field-Weighted Citation Impact
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article

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

Devika Rao, Yaron Gesthalter, Eric C. Donny, Soha Talih et al.
Annals of the American Thoracic Society
Smoking Behavior and Cessation
article

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

Devika Rao, Yaron Gesthalter, Eric C. Donny, Soha Talih, Gary Ewart, Hasmeena Kathuria, Frank T. Leone, S. Christy Sadreameli, Zachary C. Rich, Ilona Jaspers, CORAL E. GARTNER, Filippos T Filippidis, Anne C. Melzer, Devika Rao, Megan E. Piper, N L Benowitz, Adam Edward Lang, Sven‐Eric Jordt, Neal L. Benowitz, Sven E. Jordt, I Jaspers, Gary Ewart, David C. Motorniak, Eric C Donny, Coral Gartner, David Motorniak, Megan E Piper
article en

Abstract

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.

Annals of the American Thoracic Society
Boston University (US), University of North Carolina at Chapel Hill (US), University of Wisconsin–Madison (US), Harvard University (US), Johns Hopkins University (US), The University of Queensland (AU), Duke University (US), University of California, San Francisco (US), Virginia Commonwealth University (US), Johns Hopkins Medicine (US), American Thoracic Society (US), European Respiratory Society (CH), Yale Cancer Center (US), University of California System (US), Yale University (US), University of Minnesota Medical Center (US), Wisconsin Division of Public Health (US), Johns Hopkins Hospital (US), Wake Forest University (US), Imperial College London (GB), University of Pennsylvania (US), The University of Texas Southwestern Medical Center (US), American University of Beirut (LB)
Good health and well-being
Openalex Percentile: Top 9%
Smoking Behavior and Cessation
DOISourceOpenAlex
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