Can the FDA Regulate Vaping as an Ethical Alternative to Tobacco Cigarettes?

Posted in: Health Law

In general, it is recognized that the government has an ethical obligation to pass laws and regulations that protect its citizens from harm and, by extrapolation but more controversially, promote their welfare. As such, entities such as the U.S. Food and Drug Administration (FDA) have been established to execute this goal. Currently there is much debate and controversy surrounding electronic nicotine delivery systems (ENDS), the use of which is called vaping, Juuling, or using e-cigarettes. The Tobacco Control Act of 2009 gave the FDA legal authority to regulate the manufacture, distribution, and marketing of tobacco products. In 2016 the FDA, through its Center for Tobacco Products (CTP) introduced the “Deeming Rule” which extends regulation to ENDS. Attempts at regulation of ENDS, from restrictions on the sale and advertising enacted by the FDA and expanded by proposed federal legislation (reversing the Youth Tobacco Epidemic Act of 2019) to outright bans as in San Francisco (currently facing a legal challenge), have blossomed in the last several months. As recently as September 4, Michigan banned the online and retail sale of flavored ENDS for six months.

The FDA standard for judging medical products is “safe and effective,” but this standard does not apply to tobacco products. Instead, it uses a public health standard that considers risk and benefit to the population as a whole, including users and nonusers. The health hazards of traditional cigarettes, also called combustible tobacco products, are well known and are derived from two sources: the direct absorption of nicotine which has numerous systemic effects, most prominently cardiovascular, and the toxic materials inhaled through combustion. Additionally, nicotine has an extremely addictive property that compels its continued use.

By comparison, the actual health hazards of ENDS are not known precisely. Our current scientific understanding of ENDS places these devices somewhere on the continuum between combustible tobacco products and prescription nicotine replacement therapy (NRT). Conclusions reached by the National Academies of Sciences, Engineering, and Medicine (NASEM) in the report Public Health Consequences of E-Cigarettes (2018) included that there is substantial evidence that exposure to potentially toxic substances, except for nicotine, is less when using e-cigarettes compared to the combustible variety. However, there have been reports of seizures, a potential toxicity resulting from nicotine delivered in high doses by ENDS and the New York Times recently reported a series of severe acute respiratory illnesses possibly associated with ENDS. In all, there is little longitudinal data to make definite claims about the health risk or safety of ENDS.

Although the FDA established oversight of ENDS products in 2016 and initially called for submission of health data from ENDS manufacturers by 2022, there has been much legal haggling back and forth between public health advocates and representatives of ENDS manufacturers over when the information would actually be required for review. In mid-August, the Vapor Technology Association—an ENDS industry group—sued the FDA, challenging the most recent deadline of May 2020 for submission of data.

The kind of public scrutiny and proposed regulation of ENDS that has surfaced in the last several months has also largely ignored their more hazardous cousin, combustible tobacco products, and has largely been prompted not by data regarding the intrinsic health risks but on results from the 2018 National Youth Tobacco Study. Among findings compelling increased government regulation was that among high school students, there was a 78% increase in current ENDS users from 11.7% in 2017 to 20.8% in 2018, and a 48% increase among middle school students during that same period. A 2015 study found that around 59% of adults who had used ENDS within the past 30 days were also current cigarette smokers, so-called dual users. Beyond the unknown long-term effects of ENDS as a delivery system, the concern here is that addicting minors to nicotine through ENDS will result in an increased risk of using combustible products based on high dual-user rates. In addition, youth appear to be particularly vulnerable to the deleterious effects of nicotine itself. Nicotine affects the adolescent brain by disrupting circuits that control attention, learning, and susceptibility to addiction. Thus, the urgency in regulating ENDS is focused on preventing youth from addiction to nicotine, which can be intrinsically harmful but also can lead to the use of combustible tobacco products.

Given the intrinsic risk of nicotine and its inhalation, whether it be by electronically heating a liquid extract or burning a combination of combustible materials, using the FDA standard that considers risk and benefit to the population as a whole, what possible good can ENDS serve? Put another way, do ENDS provide an opportunity for the government to actualize its legal and ethical obligation to protect its citizens from harm and control unnecessary health care costs while also recognizing the liberty of its citizens to partake of pleasurable substances?

The potential benefits of ENDS would be twofold. First, as an innovative nicotine delivery system for adults who enjoy the effects without the hazards associated with combustible products. We have traditionally recognized the liberty of individuals to engage in the use of pleasurable substances such as alcohol and in some states, cannabis, each of which has some potential harms. Would it not also be reasonable to extend this same opportunity for adults to use nicotine if they so choose, if we were to eliminate the serious harms associated with the combustible delivery mechanism?

Additionally, ENDS have the potential to deliver a consistent, quantifiable dose of nicotine, thereby allowing for the possibility that there is an “ideal” dose or concentration that would provide the desired effects while minimizing the deleterious ones, including addiction. Whether or not this ceiling/floor axis is achievable is as of yet scientifically unproven, but it is an intriguing notion. If a level of nicotine were found to be pleasurable but minimally harmful and not addictive, ENDS might be a safer delivery system than combustibles. Used in this way, ENDS could serve as a means to stop or reduce the use of combustibles, minimize the harmful effects of nicotine, while recognizing that some adults may enjoy the pleasurable effects. However, this possibility requires three assumptions: 1) combustibles would not be available or would gradually become less available, 2) a minimally harmful but maximally pleasurable dose of nicotine is feasible and 3) the method of nicotine delivery through the inhalation of a heated liquid is determined to be safe. In this, the ethical obligation of the government to protect its citizens from harm and reduce unnecessary health care costs while also recognizing the individual liberties of its citizens might be achieved.

(In the past few weeks, there has been a spate of vaping-related injuries and deaths widely reported in the media. Based on what is presently known, these injuries likely resulted from the use of refillable vaping devices, which may contain contaminants that even a strictly regulated ENDS market cannot foresee or prevent, in much the same way that homemade spirits like moonshine or self-rolled combustible products may contain contaminants or inconsistent concentrations of chemicals.) What we suggest as an alternative to combustible tobacco products would demand a safe delivery system manufactured in such a way to minimize the risk of contamination.

The FDA has been clear that ENDS are not forms of NRT, since this would require pharmaceutical-type regulation; rather, it is treating ENDS as a potentially safer method of nicotine delivery. Regardless of how it is termed, one can imagine ENDS striking a balance between allowing adults to enjoy the pleasurable effects of nicotine while reducing the health risks associated with combustibles. The foundational regulatory change would of course be banning combustible tobacco products. If the delivery system (ENDS) were to be deemed safe and the concentration of nicotine refined, then the arguments for allowing combustible tobacco products to continue to be sold would be moot. This proposal urges regulation based on data-driven decisions that serve a reasonable public health goal. The goal would not be prohibition of nicotine as a pleasurable substance, but the elimination of the toxic substances associated with a combustible delivery system. In this, the ethical mandate that the government protect its citizens from known harms and control health care costs while allowing individual expressions of liberty might find a balance.

Posted in: Health Law

Tags: FDA, public health, vaping