Eric Lindblom, a Senior Scholar at Georgetown Law School’s O’Neill Institute for National & Global Health Law, has published an important new article entitled Effectively Regulating E-Cigarettes and Their Advertising – and the First Amendment in the Food & Drug Law Journal. (Full disclosure: Lindblom was my supervisor when I worked at the FDA Center for Tobacco Products in 2011-2012, and I provided some assistance with this article.) This article seeks to chart a middle ground between those who see e-cigarettes as a panacea and those who see them as a public health menace. It suggests that e-cigarettes could potentially serve a positive public health function—but only if they are regulated and their advertising and marketing is sharply limited. Delving into the complicated structure of the 2009 Tobacco Control Act, the paper explains how the FDA could use its regulatory authority to implement such restrictions without running afoul of the Supreme Court’s increasingly strict application of the commercial speech doctrine.
While there is much more to learn about e-cigarettes (Lindblom uses the “e-cigarettes” to refer generally to electronic nicotine products), we already know that they are addictive and harmful, and yet at least somewhat less harmful than cigarettes. Thus, Lindblom, who previously directed the Office of Policy at the FDA’s Center for Tobacco Products, suggests that an ideal regulatory scheme for e-cigarettes would (1) make them less harmful to users and non-users, (2) increase their use among smokers who would not otherwise quit, and (3) discourage their use among everyone else. E-cigarettes benefit public health only when they encourage smokers who would not otherwise quit to switch entirely to a less harmful product (ideally, though not necessarily, as a pathway to quitting altogether). All other uses of e-cigarettes—by nonsmoking youth and adults, by former smokers, by smokers who use both e-cigarettes and cigarettes—are likely to increase public health harms. Unfortunately, much of current e-cigarette advertising appears to target youth and promote dual use, rather than encourage current smokers to switch completely to e-cigarettes.
Lindblom’s argument relies on the deeming process already underway, which will give the FDA the authority (which it currently lacks) to regulate e-cigarettes. Once the deeming rule goes into effect, the Tobacco Control Act will require all e-cigarette products to undergo premarket review. So as not to disrupt the marketplace too dramatically, the FDA has proposed using its enforcement discretion to allow e-cigarette products to stay on the market during the premarket review period (and, quite generously, it has proposed giving companies two years in which to file the appropriate paperwork that will trigger the review process). Lindblom suggests that the FDA could use its enforcement discretion to allow products to stay on the market during this time period only if they agree to significantly limit their marketing. In particular, in order to ensure that e-cigarettes benefit—rather than harm—public health, he suggests that e-cigarette advertising should, for the most part, be limited to direct communications with current adult smokers. Because the e-cigarette products would technically be on the market illegally during the enforcement discretion period, these restrictions could be implemented without raising any First Amendment concerns and without requiring the FDA to engage in a new rulemaking process.
The final section of Lindblom’s paper argues that parallel, more permanent marketing restrictions could be implemented through the premarket review process, without violating the First Amendment. This section is hard to summarize in brief, but it introduces some important new insights about both the FDA’s flexibility under the Tobacco Control Act and the courts’ application of the Central Hudson test.
The paper is well worth reading, and I hope the FDA, in particular, will pay close attention.