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University of Miami Law Review

Wendy E. Parmet

Abstract

This article develops a normative framework for assessing public health laws, using the regulation of e-cigarettes as a case study. Although e-cigarettes are likely far less dangerous to individual users than traditional cigarettes, it remains uncertain whether their proliferation will lead to a reduction of smoking-related disease and deaths or to increased morbidity and mortality. This scientific uncertainty, whether and how to regulate e-cigarettes. This article presents a normative framework for analyzing such questions by offering three justifications for public health laws: impaired agency, harm to others, and self-governance. Each justification responds to the common charge that public health laws are impermissibly paternalistic. The selfgovernance rationale, which is the most robust, and most reflective of public health’s own population perspective, has been the least theorized. This article develops that theory, examining the basis for the justification as well as its limitations. The article then applies its normative framework to the regulation of e-cigarettes, focusing on the FDA’s so-called deeming regulations, which at the time the article was written were pending but have since been promulgated in a substantially similar form. The article supports the FDA’s ultimate decision to ban the sales of e-cigarettes to minors and to require the disclosure of warning labels based upon the impaired agency rationale. However, the scientific uncertainty renders the harm rationale inadequate. As a result, the regulations’ pre-market review requirement must rely on the self-governance rationale for its normative justification. Given the lack of clear legislative guidance and political engagement, the article concludes that the pre-market review provisions are normatively problematic: if public health advocates want to claim the mantle of self-governance, they must take it seriously.

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