Tobacco cigarettes are the leading cause of disease in the United States, which is why the ‘primary goal of tobacco control is to reduce mortality and morbidity associated with tobacco use’ (p. 326).23 Electronic cigarettes are designed to mitigate tobacco-related disease by reducing cigarette consumption and smoking rates. The evidence reviewed in this article suggests that electronic cigarettes are a much safer alternative to tobacco cigarettes. They are likely to improve upon the efficacy of traditional pharmacotherapy for smoking cessation.

In light of this evidence, it is unfortunate that in the United States, the American Cancer Society, American Lung Association, American Heart Association, Campaign for Tobacco-Free Kids, Action on Smoking and Health, American Legacy Foundation, American Academy of Pediatrics, and the Association for the Treatment of Tobacco Use and Dependence have all issued statements supporting FDA efforts to take them off the US market.34 In the United States, the courts will ultimately determine whether the FDA has the legal authority to do this, but we question the ethical and health policy merits of this approach.

Do products with established user bases warrant a different regulatory approach than entirely new products? This would seem to follow from consistent application of the principal of nonmaleficence – ‘do no harm.’ Products yet to enter the market have only potential beneficiaries, people who can only speculate about what the precise therapeutic effects of the product will be for them. In contrast, products already on the market have users who may already be deriving benefits. By definition, enacting a ban will harm current users, unless the evidence suggests that the harms outweigh the benefits for those already using the product. The burden of proof is on the regulatory agency to demonstrate that the product is unreasonably dangerous for its intended use.

How does this principle apply to electronic cigarettes? For the many vapers who report using them in place of cigarettes,33 the benefits of the product are readily observable, already established. Simply demonstrating that electronic cigarettes are ‘not safe’ may not be sufficient grounds to ban them. Unless the evidence suggests that vaping does not yield the anticipated reduction in harm to the user, enacting an electronic cigarette prohibition will do harm to hundreds of thousands of vapers already using electronic cigarettes in place of tobacco ones – a clear violation of nonmaleficence.

The essential rationale for the FDA's pre-market approval process – to keep dangerous products out of the marketplace – may not easily extend to new nicotine products because a range of extraordinarily deadly nicotine products is already grandfathered into the market. This has led to an awkward nicotine regulatory structure where dirty tobacco products face few barriers to market entry whereas cleaner products are subject to oft onerous hurdles. The FDA contends that they can and should regulate electronic cigarettes as ‘drug-device combinations’ that are required to meet stringent Federal Food Drug and Cosmetic Act (FDCA) safety standards. The FDA reasons that electronic cigarettes do not qualify for the usual exemption from FDCA standards afforded to most other recreational nicotine products because ‘much less is known about the safety of E-Cigarettes’ and ‘it may be possible for E-Cigarettes … to satisfy the FDCA's safety, effectiveness, and labeling requirements and obtain FDA approval’ (p. 26).35 Ironically, the only nicotine products exempted from FDCA safety requirements are those that are too obviously harmful to have any chance of meeting these requirements. Litigation presently before the US Court of Appeals for the District of Columbia may ultimately determine whether the FDA can legally regulate electronic cigarettes as drug-device combinations.36 Regardless of the court's decision, we believe a better regulatory approach would not actively discourage producers of harm reduction products.

Fairchild and Colgrove28 conclude that ‘the later history of tobacco industry deception and manipulation was an important factor contributing to the erosion of public health support for harm reduction’ (p. 201). With entrenched skepticism toward harm reduction now manifested as deep cynicism about electronic cigarettes – a distinct product that actually does reduce risk and threatens cigarette makers – the tobacco industry is ironically benefiting from its own past duplicity. The push to ban electronic cigarettes may repeat the mistakes of the past in the name of avoiding them. Regulatory policy for electronic cigarettes and other novel nicotine products must be guided by an accurate understanding of how they compare to tobacco cigarettes and NRT in terms of reducing toxic exposures and helping individual smokers quit.