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Electronic nicotine delivery systems: the need for continued regulatory innovation
  1. Brian J Miller1,2,
  2. Andrew B Meshnick3,
  3. Boris D Lushniak4
  1. 1 Division of Hospital Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
  2. 2 Johns Hopkins University Carey Business School—Baltimore Campus, Baltimore, Maryland, USA
  3. 3 Department of Pediatrics, University of Vermont Children's Hospital, Burlington, Vermont, USA
  4. 4 Office of the Dean, University of Maryland School of Public Health, College Park, Maryland, USA
  1. Correspondence to Dr Brian J Miller, Division of Hospital Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA; brian{at}


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.

  • harm reduction
  • public policy
  • electronic nicotine delivery devices
  • addiction

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  • Contributors BJM conceived of and principally directed the research, drafting and revising of the paper. ABM assisted with research, drafting and revision. 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. BJM reports previously serving as a medical officer at the US Food and Administration. BJM is currently a member of the CMS Medicare Evidence Development and Coverage Advisory Committee and has received fees unrelated to the submitted work from the Federal Trade Commission, the Health Resources and Services Administration, the Heritage Foundation and Oxidien Pharmaceuticals.

    BJM's views are his own and does not represent those of CMS.ABM has received unrelated consulting fees from Resolve to Save Lives.

  • Provenance and peer review Not commissioned; externally peer reviewed.