Issues in regulating E-cigarette clinical research

Abstract E-cigarettes have become popular in many countries, despite a lack of long-term safety data and limited clinical evidence for a role in smoking cessation. Indeed, in England, they have overtaken nicotine replacement therapy as a preferred product for cessation support. However, e-cigarettes have reached the market without evaluation of cessation efficacy and safety, bypassing the route required by regulatory authorities for pharmaceuticals that make therapeutic claims. Adequately powered clinical trials that evaluate the cessation efficacy potential of these products compared with current cessation treatments are needed; although the novel features and challenges of assessing this product group, such as wide diversity, rapid evolution and range of user behaviors, do not fit well within the standard clinical trial framework. This should be taken into account by regulators. Alternative designs that are pragmatic, accommodate user preferences, and include smoking reduction end-points may also be required. A more consistent approach to the regulation of products that deliver nicotine—one that does not favor tobacco—should be considered as part of a comprehensive nicotine regulatory model.