Experimental Forum 1: The 2020 Food and Drug Administration Guidance on E-Cigarettes

This new format of the AJPH Forum has an experimental dimension. The objective is to facilitate a dialogue among public health practitioners on emerging health issues that might otherwise go unnoticed. The first theme in this format focuses on national guidance by the Food and Drug Administration (FDA) on e-cigarettes (“Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products”; hereafter “Guidance”). It is accompanied by a dozen invited editorial comments forecasting potential consequences of the regulation. The comments were submitted two months before the Guidance’s going into effect in May 2020, and we will invite everyone to reassess the situation in a year. In an information culture where predictions are forgotten soon after they are issued, we are interested in developing a format for scientific discourse that encourages greater reflection.

We selected the recent FDA Guidance on e-cigarettes because of the widespread topical interest in vaping and the recent outbreak of vaping-associated lung injuries, as well as the potential role in tobacco cessation. The section is anchored by an invited commentary from the director of the FDA Center for Tobacco Products (CTP), Mitch Zeller, who introduces the Guidance to a broad public health audience (Zeller, p. 772). We are thankful to him and CTP staff of the FDA for their participation.

We then invited tobacco control experts, including academics, advocates, health officials, and lawmakers. The commenters were purposefully selected to deliver a wide range of views on e-cigarettes, ranging from permissive to restrictive. Given concurrent efforts in other countries, we included perspectives from Houston et al. (p. 781) in Canada, McKee (p. 782) in the United Kingdom, and Wodak and Mendelsohn in Australia (p. 783). The comments were internally reviewed and a dozen were deemed relevant.

Readers will notice that commenters paint a stark tableau from their reading of the Guidance, the unanimity of which came as a surprise to AJPH editors. In theory, if the criticisms come to bear, we would expect a cascade of negative public health outcomes, specifically the following: reversal of recent smoking declines among youths, increased popularity of Puff Bar and other disposable e-cigarettes among youths, switching back to combustible cigarettes among adults, Big Tobacco dominating applications for approval, and the emergence of illicitly manufactured flavoring pods. Fortunately, the FDA has an opportunity to prove these critics wrong as they begin implementing the Guidance in May 2020. In addition, we hope the editorial by Zeller clarifies how the Guidance will be enforced, which was generally bemoaned by commenters as lacking.

FOUR THEMES FROM COMMENTERS

We note four specific themes among the solicited comments, including those of emphasis and interpretation. We also highlight the role that Congress plays in addressing perceived shortcomings. In addition, we note a repeated theme: that the evidence base for the use of e-cigarettes as a path to quitting smoking is less rigorous than expected.

First, our commenters homed in on the FDA’s authority for interdiction. Only Rodu (p. 778) and Nadelmann (p. 780) mention the substantial educational campaign and research agenda that the CTP also sponsors. In addition to false claims, the FDA has the authority to examine the adequacy of the industry’s age-verification systems. Thousands of onsite inspections have been conducted, resulting in 11 000 warning letters. With the recent raising of the age of purchase to 21 years, an additional dimension for oversight lies ahead.

Second, a common interpretation of the Guidance appears to be that prioritization of certain products means others will be exempted or excluded. Some commenters saw this as a loophole. However, the CTP editorial (Zeller) highlights that establishing priorities does not preclude enforcement against emerging concerns. As the CTP points out, the intent is to pursue action against any emerging products that are marketed to youths.

Third, the role of Congress to buttress the Guidance was highlighted by some commenters. Gee (p. 776) specifically notes the Protecting American Lungs and Reversing the Youth Tobacco Epidemic Act of 2020 (HR 2339) for removing all flavorings, including menthol. Its passage remains in question as of this writing. Hemmerich et al. (p. 774) propose an alternative approach whereby a list of approved ingredients would be explicitly stated by the CTP, excluding flavorings.

Finally, the promise of e-cigarettes as a step to quitting smoking of combustible products has an evidence base that is unfortunately and surprisingly limited. There may be a research bias operating here, whereby industry-sponsored studies are discredited or there is an overwhelming focus on toxicity. We wonder if there is a role for publicly funded randomized trials, even if they are not required in commercial applications for approval. In addition, Nadelmann laments the absence of studies using in-depth interviews of former smokers who now vape e-cigarettes to understand the potential for harm reduction. Repeated cross-sectional population-based surveys have been the prime source of information in setting e-cigarette policy. There is an urgent need for additional high-quality research with robust longitudinal and ethnographic study designs.

PUBLIC PERCEPTION AND FEEDBACK

It is worth noting that no currently marketed e-cigarette is lawfully on the market because none has been formally approved by the FDA. They have remained on the market through enforcement discretion, presumably because of their potential to be an alternative to deadly combustible products. Like many aspects of government regulation, these legal nuances are often overlooked by commenters and the general public. We suggest that broader engagement is critical to building consensus on the role that tobacco harm reduction could play in attenuating the grave public health threat from continued smoking.

The process for drafting and issuing FDA guidance involves the opportunity for public comment and is intentionally slow and deliberative. Despite regulations.gov being an exemplary Web site for gathering open feedback, more could be done beyond the Federal Register notices to convey the importance of comments on draft regulations by the general public. We posit that, just as voting is a civic responsibility, public participation in government regulation should be considered a hallmark of civic duty in our technology-enabled age.

MISSING PERSPECTIVES

Although we approached a range of experts from different sociodemographic backgrounds to participate, those who accepted our invitation were a rather homogeneous cadre. Not surprisingly, none of the commenters adequately addressed how the Guidance may disproportionately affect communities of color or marginalized populations. Specifically with regard to mentholated products, there is legitimate concern that African American neighborhoods could face enhanced enforcement scrutiny, insofar as the experience of prohibitions on other psychoactive substances are a bellwether. These concerns should be explicitly allayed through unbiased enforcement.

The comments display a range of perspectives. Corporate interests have a voice in the regulatory process, and we therefore specifically solicited comment from Derek Yach (Erkkila et al., p. 777) of the Foundation for a Smoke-Free World, which is funded by Philip Morris. However, most of the comments were framed against the backdrop of preventing large corporations from profiting from new products marketed to youths. Although these concerns are surely legitimate, Iowa attorney general Tom Miller (p. 788) acknowledges that the views of small businesses are also part of the complicated calculus, and their involvement in age verification at the point of sale is a critical, albeit nontraditional, component of public health infrastructure.

We invite readers to contribute to the dialogue on the following pages, especially from perspectives that may have been left out by our process. An inclusive dialogue is critical to shaping the future of government regulation.