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If tobacco smoking did not exist in the United States, there would be no reason, from a public health perspective, to allow addictive, nicotine-containing e-cigarettes to be marketed and sold. Because e-cigarette use, by itself, is neither beneficial nor benign to users and nonusers, the only public health justification for allowing e-cigarettes in the existing U.S. market would be if doing so would not sustain or increase existing smoking levels but would help smokers quit completely or provide addicted smokers a less harmful way to obtain the nicotine they crave. Yet e-cigarettes are now pervasive in the U.S. market, being sold with unnecessary harmful characteristics and being advertised in ways that encourage youth experimentation and use. Unless effectively regulated, e-cigarette use will be more harmful than necessary and their advertising will work to: (a) increase initiation among both youth and non-tobacco-using adults; (b) prompt former smokers to relapse back into addicted nicotine use; (c) encourage smokers to use e-cigarettes where they cannot smoke; and (d) prompt smokers to switch to e-cigarettes instead of quitting all tobacco and nicotine use. This paper proposes a viable way to regulate e-cigarettes and their advertising both to minimize the health harms they might cause and to allow e-cigarettes to fulfill their potential as cessation aids or harm-reduction products. Normally, any efforts by FDA to establish effective advertising restrictions must accommodate considerable constraints from the First Amendment’s commercial speech protections. However, because of existing text in the Tobacco Control Act, on the effective date of the final FDA deeming rule that puts e-cigarettes under FDA’s active tobacco product jurisdiction all nicotine-containing e-cigarettes will be on the U.S. market illegally until they can obtain permissive orders from FDA. That situation should reduce applicable First Amendment constraints, providing FDA with a tremendous opportunity to place the kinds of substantial restrictions and requirements on e-cigarette advertising necessary to minimize their harmful aspects and maximize their potential to produce substantial net public health benefits.

Publication Citation

70 Food & Drug L.J. 57-94 (2015)