Abstract

The inability of many smokers to quit is a significant public health problem. The demand for a product that can help smokers kick the habit is an entrepreneurial opportunity. In surveys, a majority of smokers express concern for their health and a desire to kick the habit.

Electronic cigarettes (“e-cigarettes” or “e-cigs”) appear to be the most promising smoking alternative to enter the market to date. E-cigarettes have the potential to satisfy smokers’ craving for nicotine in a less dangerous way. The available evidence suggests e-cigarettes expose smokers (and others) to a fraction of the health risks posed by combustible tobacco. For this reason, the use and promotion of e-cigarettes is a potential harm reduction strategy for smoking. Yet the harm reduction potential of e-cigarettes is hampered by federal regulation and the not-so-subtle suggestion from government officials that e-cigarettes are as dangerous as tobacco cigarettes. However well-intentioned, regulatory measures adopted by the Food & Drug Administration (FDA) may come at the expense of public health.

This Article discusses how FDA regulation of e-cigarettes and other alternatives to traditional tobacco products inhibits their lifesaving potential. Part I provides a brief overview of federal tobacco regulation. Part II discusses electronic cigarettes, their use, and potential health effects. Part III details the FDA’s so-called “deeming rule,” through which the FDA has asserted regulatory authority over electronic cigarettes and other “vaping” products. Part IV details how FDA restrictions on truthful health information and comparative risk claims further inhibits potentially life-saving innovation by threatening to keep smokers and other consumers in the dark about the harm-reducing potential of e-cigarettes. The article then concludes with broader comments on the risk tradeoffs inherent in technological innovation.

This abstract has been adapted from the author's introduction.

Document Type

Article

Publication Date

2017

Publication Information

11 New York University Journal of Law & Liberty 712-753 (2017)

Comments

Written for the symposium Medical Innovation and the Law (2017) at NYU School of Law.

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