FDA and the role of e-cigarettes in harm reduction

Purpose - This article aims to provide an informed overview of the current policy and upcoming e-cigarette legislation, and their impact on the potential for harm reduction in the tobacco products arena in the USA. The article argues in favor of reasonable regulatory options supportive of harm reduction, and which take into consideration the realities of the emerging US e-cigarette market.Design methodology approach - The authors consider the recent refocus on harm reduction potential in the e-cigarettes, which are growing in popularity but will be soon subject to potentially very restrictive regulation. This article provides an overview of selected, relevant provisions of the US tobacco product regulatory framework as it may soon apply to e-cigarettes, not only for the benefit of the tobacco harm reduction debate, but also to global stakeholders, as well.Findings - FDA needs strong leadership to avoid current political pressures to label all tobacco products as equally dangerous, vilify nicotine and deny a reasonable approach to harm reduction that promotes the benefits of reduced risk as a legitimate approach to better health. Admittedly, more research is needed before a final assessment can be made on the population-level health benefits of e-cigarettes.Originality value - This article provides an informed view of US e-cigarette industry regulatory challenges by two industry regulatory experts, and an overview of possible e-cigarette regulatory outcomes in the USA, in light of the US Food and Drug Administration announcement that such regulation is to be expected shortly.