E-cigarette regulation and mortality

This presentation evaluates the public health consequences following the judicial exemption of e-cigarettes from U.S. drug regulation in 2010. For approximately six years, e-cigarettes occupied a regulatory vacuum until being classified as tobacco products subject to FDA regulation under the Tobacco Control Act in 2016. During this period of limited oversight, there was substantial innovation in e-cigarette technologies, as evidenced by increased patent applications. The session explores how this innovation impacted public health, revealing that—contrary to historical trends in tobacco industry innovation—e-cigarettes significantly reduced cigarette smoking rates and associated mortality. Using a comparative analysis across demographic groups, the research demonstrates greater smoking declines and mortality reductions among groups initially characterized by high smoking prevalence, a pattern not observed following the introduction of nicotine replacement therapy as a regulated drug in 1984. Overall, e-cigarettes are estimated to have saved approximately 677,000 life-years between 2011 and 2019, roughly one-third of the benefit attributed to early HIV/AIDS treatments up to the year 2000. The presentation concludes by discussing how insights from this unique regulatory case can inform current and future approaches to e-cigarette regulation under the Tobacco Control Act.