Regulatory Obstacles to Harm Reduction: The Case of Smoking
Cigarette use remains the leading cause of avoidable death in the United States.1 Smoking rates have declined over the past several decades, but millions of Americans continue to smoke.2 Many find it difficult to quit, whether due to nicotine addiction or a dependence upon smoking as a behavioral habit.3
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.4 Product innovations that help smokers quit, whether by satisfying nicotine addiction in a less harmful manner or by helping wean smokers from current habits, could reduce the death toll of tobacco and prove profitable for innovative firms. In the case of tobacco harm reduction, entrepreneurs have the opportunity to do well by doing good. Yet, as in many areas, government regulation threatens to hamper welfare-enhancing innovation and discourage the use of life-saving technologies.
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. 5 The available evidence suggests ecigarettes expose smokers (and others) to a fraction of the health risks posed by combustible tobacco. 6 For this reason, the use and promotion of e-cigarettes is a potential harm reduction strategy for smoking. 7 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.8 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.
