title: A Risk Assessment Matrix for Public Health Principles: The Case for E-Cigarettes.
abstract: Besides nicotine replacement therapies, a realistic alternative for smoking cessation or for smoking substitution may come from electronic cigarettes (ECs), whose popularity has been steadily growing. As for any emerging behaviour associated with exposure to inhalational agents, there is legitimate cause for concern and many health organizations and policy makers have pushed for restrictive policy measures ranging from complete bans to tight regulations of these products. Nonetheless, it is important to reframe these concerns in context of the well-known harm caused by cigarette smoking. In this article, we discuss key public health principles that should be considered when regulating ECs. These include the concept of tobacco harm reduction, importance of relative risk and risk continuum, renormalization of smoking, availability of low-risk product, proportionate taxation, and reassessment of the role of non-tobacco flavours. These public health principles may be systematically scrutinized using a risk assessment matrix that allows: (1) to determine the measure of certainty that a risk will occur; and (2) to estimate the impact of such a risk on public health. Consequently, the ultimate goal of responsible ECs regulation should be that of maximizing the favourable impact of these reduced-risk products whilst minimizing further any potential risks. Consumer perspectives, sound EC research, continuous post-marketing surveillance and reasonable safety and quality product standards should be at the very heart of future regulatory schemes that will address concerns while minimizing unintended consequences of ill-informed regulation.
authors.affiliation: Department of Clinical and Experimental Medicine, University of Catania, Via Palermo 636, 95121 Catania, Italy. danisaitta@unict.it.
authors.forename: Daniela
authors.initials: D
authors.lastname: Saitta
authors.affiliation: Keller and Heckman LLP, 1001 G Street N.W., Suite 500W, Washington, DC 20001, USA. chowdhury@khlaw.com.
authors.forename: Azim
authors.initials: A
authors.lastname: Chowdhury
authors.affiliation: Department of Law, University of Catania, Via Gallo 24, 95124 Catania, Italy. giancarloantonioferro@gmail.com.
authors.forename: Giancarlo Antonio
authors.initials: GA
authors.lastname: Ferro
authors.affiliation: School of Specialization in Occupational Medicine, University of Messina, Via Consolare Valeria 1, 98122 Messina, Italy. nalis@hotmail.it.
authors.forename: Federico Giuseppe
authors.initials: FG
authors.lastname: Nalis
authors.affiliation: Department of Clinical and Experimental Medicine, University of Catania, Via Palermo 636, 95121 Catania, Italy. polosa@unict.it.|Centre for Tobacco Cessation and Prevention, Teaching Hospital "Policlinico-V. Emanuele", Via S. Sofia 78, 95123 Catania, Italy. polosa@unict.it.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Polosa
mesh_terms: D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D066300:Electronic Nicotine Delivery Systems / Q000009:adverse effects / Q000331:legislation & jurisprudence*; D005060:Europe; D040261:Harm Reduction; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006801:Humans; D018570:Risk Assessment; D012907:Smoking / Q000009:adverse effects; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D014481:United States
keywords: cigarette smoking; electronic cigarettes; public health; regulation; risk assessment; risk continuum; tobacco harm reduction