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 devices
- harm reduction
- public policy
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Contributors ABM conceived of and led the research, drafting and revision of the paper. LEF assisted with conception, revision and supervision of the paper. BDL assisted with conception, revision and supervision of the paper. All three authors take responsibility for the paper.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests BDL reports previous service as US Deputy and Acting Surgeon General and has received unrelated speaking fees and honoraria. LEF has received tobacco control funds from the Vermont Department of Health. ABM has received unrelated consulting fees from Resolve To Save Lives.
Provenance and peer review Not commissioned; externally peer reviewed.