Critical Gaps in the Scientific Basis for Electronic Cigarette Regulation: An American College of Chest Physicians Research Statement

Abstract

Background: The 2009 Family Smoking Prevention and Tobacco Control Act granted the FDA regulatory authority over tobacco products, extended to include electronic cigarettes (ECs) in 2016. Regulatory science informs potential market restrictions based on the population health standard. The CHEST Tobacco and Vaping Workgroup (WG) is charged with prioritizing tobacco-related advocacy. To identify critical gaps in the science guiding EC regulation, wean exploration of existing evidence to develop future research recommendations.

Methods: Fifteen WG members with relevant expertise in tobacco science, health policy and methodology prioritized twelve candidate research areas and selected the four highest-ranked questions for review: accessibility limitations, nicotine delivery limits, non-cardiac/non-malignant risks, and flavorant impact on airway biology. A comprehensive literature search was conducted and relevant studies were reviewed to develop recommendations through group consensus.

Key findings and recommendations: While age-appropriate restrictions reduce uptake, alternative access channels limit their impact, necessitating pragmatic trials of various restrictions and enforcement methods. Limiting nicotine delivery may lead to compensatory behaviors and increased toxicant exposure, requiring pharmacokinetic assessments that account for substantive variations in user behavior. Associations between EC use and respiratory symptoms, mood disorders, attentional disturbances and poor academic performance underscore the need for epidemiologic and mechanistic research into non-cardiac/non-malignant health risks. There is strong evidence that flavorant aerosols induce cytotoxicity in mammalian cells; however, their specific effects on humans remain insufficiently studied to inform product regulation.

Conclusion: Gaps in EC regulatory science hinder effective policy development. The panel recommends a focused research agenda addressing pragmatic trials of access restrictions, detailed evaluation of nicotine delivery limits, investigation of non-cardiac/non-malignant risks, and quantification of aerosol toxicity, with attention to diverse real-world use patterns to better inform regulation and protect public health.

Keywords: Addiction; Nicotine; Regulation; Smoking; Smoking Cessation; Tobacco.