Doctor’s Orders: E-cigarettes in U.S. clinical practice

E-cigarettes and related nicotine vapor devices have become extremely popular among smokers in the United States, while attracting remarkably few nonsmokers to continuing nicotine use. According to a May 2016 Reuters/Ipsos poll of 10,000 U.S. adults, about 10 percent vape regularly, which would be equivalent to 24.5 million adults nationwide. Of these adult vapers, about 30 percent have ceased smoking; 62 percent continue to smoke; and about 8 percent of U.S. vapers never smoked cigarettes.

Despite this popularity and despite substantial evidence that e-cigs are far safer than cigarettes; that they have helped many smokers quit smoking; and that they have not, to date, attracted nonsmoking teens to continuing use, American medical and public-health authorities are near-unanimous in their condemnation of these products as unsafe, ineffective and a threat to the health of future generations of teenagers. In addition, the U.S. Food and Drug Administration (FDA) recently promulgated regulations that, if implemented, would eliminate all or almost all e-cig products from the American market by making it far too expensive for any but the largest big-tobacco cigarette companies to comply.

Authorities in the United Kingdom, looking at the same body of evidence, actively endorse e-cigs for harm reduction and smoking cessation. The factors influencing these divergent policy choices (to condemn e-cigs or endorse them) hinge on how the e-cig issue is framed. All agree that it is best never to start recreational use of nicotine delivery products. Once started, it is best to quit. However, if one is unable or unwilling to quit, the question becomes whether public-health endorsements of “switching” behavior – a smoker transitioning to a much lower-risk nicotine-delivery product – would do more harm than good. The British say yes. The Americans say no.

British authorities’ review of the issue takes into account what we know about how and why some tobacco products cause addiction, illness and death, while other tobacco and nicotine products (though still addictive) appear to present little to no risk of potentially fatal tobacco-related illness. Supported by a critical review of those surveys and research studies, the United Kingdom has put forth policy guidelines to best protect and enhance public health.

By contrast, U.S. policy asserts that e-cig products must be presumed to be as harmful as cigarettes unless or until they are proven otherwise. No endorsement will be considered, including FDA approval, unless manufacturers can prove to the satisfaction of American authorities that each individual combination of vaping device, flavor and nicotine strength both presents far less risk of potentially fatal tobacco-related illness than cigarettes and will not attract nonsmokers to cigarette use.

In its proposed rules, the FDA requires that existing e-cig manufacturers submit to a multimillion dollar application process. These would necessitate large prospective and case-control studies on each individual product. British authorities have instead relied on the evidence provided by studies and surveys completed to-date on e-cigs as a class of product. In short, the divergent choices of British and American policymakers stem from the gap between relying on the best available evidence and demanding absolute proof.

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