A growing body of scientific studies show that e-cigarettes may serve as an acceptable substitute for smoking tobacco cigarettes, thereby reducing or eliminating exposure to harmful elements in smoke. The success of e-cigarettes is such that sales of these products are rapidly gaining on traditional cigarettes. The rapidly evolving phenomenon is raising concerns for the health community, pharmaceutical industry, health regulators and state governments. Obviously, these products need to be adequately regulated, primarily to protect users. Depending on the form and intended scope, certain regulatory decisions may have diverse unintended consequences on public health and may face many different challenges. Ideally, before any regulations are enacted, the regulatory body will require sufficient scientific research to verify that a problem does exist, quantify the problem, explore all potential solutions including making no change at all, determine the possible consequences of each, and then select the solution that is best for public health. Here we present an overview on the existing and deeming regulatory decisions for electronic cigarettes. We challenge them, based on the mounting scientific evidence with the ultimate goal of proposing appropriate recommendations while minimizing potential unintended consequences of ill-informed regulation.

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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.

The prevalence of vaping, also known as using e-cigarettes, vapes and vape pens, has prompted a demand for reliable, evidence-based research. However, published literature on the topic of vaping often raises concerns, characterized by serious flaws and a failure to adhere to accepted scientific methodologies. In this narrative review, we analyze popular vaping studies published in medical journals that purport to evaluate the association of vaping and smoking cessation, smoking initiation or health outcomes. We analyzed 24 included studies to identify the questions they claimed to address, stated methods, manner of implementation, discussions, and stated conclusions. After critical appraisal, we noted a multiplicity of flaws in these studies, and identified patterns as to the nature of such flaws. Many studies lacked a clear hypothesis statement: to the extent that a hypothesis could be inferred, the methods were not tailored to address the question of interest. Moreover, main outcome measures were poorly identified, and data analysis was further complicated by failure to control for confounding factors. The body of literature on “gateway” theory for the initiation of smoking was particularly unreliable. Overall, the results and discussion contained numerous unreliable assertions due to poor methods, including data collection that lacked relevance, and assertions that were unfounded. Many researchers claimed to find a causal association while not supporting such findings with meaningful data: the discussions and conclusions of such studies were, therefore, misleading. Herein, we identify the common flaws in the study design, methodology, and implementation found in published vaping studies. We present our summary recommendations for future vaping research. Our aim is to prompt future researchers to adhere to scientific methods to produce more reliable findings and conclusions in the field of vaping research.

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