Analysis of FDA's Vuse market authorisation: limitations and opportunities.

This special communication provides a physicians' critique of the US Food and Drug Administration (FDA)'s decision to authorise the Vuse Solo (Vuse) Premarket Tobacco Application (PMTA). The PMTA authorisation represents the first time that FDA has authorised an Electronic Nicotine Delivery System (ENDS) for marketing in the USA. Using the FDA Decision Summary, the special communication identifies significant unanswered public health and scientific questions that prevent the authors from reaching FDA's conclusion that Vuse meets the Appropriate for the Protection of the Public Health (APPH) standard. The authors recommend FDA suspend the market authorisation and use these questions to re-evaluate the PMTA, and to prospectively monitor whether Vuse meets APPH standard. The special communication advances the ENDS harm reduction conversation because it calls for national tobacco regulators to develop an epidemiological prediction of ENDS impact on the population and to expand the scope of their analysis to evaluate the impacts of ENDS on congenital birth defects, abuse liability and non-flavour drivers of youth usage. Through learning from the American experience regulating Vuse, national tobacco regulators around the globe will be better equipped to evaluate the impact of ENDS on the public health.

Electronic nicotine delivery systems: the need for continued regulatory innovation.

The recent surge in electronic nicotine delivery systems (ENDS) or electronic cigarette use among both adolescents and adults challenged tobacco regulatory frameworks worldwide. In this article, we review recent US Food and Drug Administration regulatory approaches to tobacco products, including attempts to regulate nicotine concentration and address youth use. We examine recent drives to promote a harm reduction approach in other product markets such as opioids, where the use of methadone and related therapies promote the public health. We describe the potential of a harm reduction framework for ENDS regulation based on tiered nicotine exposure standards coupled with risk-based product distribution controls that would enable ENDS products to meet the 'Appropriate for the Protection of the Public Health' standard required for tobacco product market entry. A harm reduction approach to ENDS regulation could help countries achieve the laudable public health goals of transitioning existing combustion cigarette users to ENDS products while preventing adolescent ENDS use and subsequent nicotine addiction.