A ban targeting only open-system e-cigarettes is unlikely to prevent a future EVALI-like outbreak among e-cigarette users

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Strong evidence suggests that the national outbreak of electronic-cigarette, or vaping, product use–associated lung injury (EVALI) was caused by use of vitamin E acetate in cannabis vaporizers, and not by nicotine e-cigarettes [1].

Nevertheless, this outbreak raises legitimate concerns about future outbreaks among nicotine e-cigarette users, precipitated by, for example, use of e-liquid constituents with considerable toxicity, or contamination of e-liquids with toxic substances.

This possibility is not an abstract thought. After all, substances with known harmful effects have been used in e-cigarettes before, like diacetyl, a compound that causes “popcorn lung” (bronchiolitis obliterans) in occupational settings [23]. To avert such an outbreak, the US Food and Drug Administration (FDA) has sought ways to prevent consumers from modifying or adding substances to their e-cigarettes that are not intended by manufacturers [4]. One approach would be to ban open-system e-cigarettes, an action I have publicly urged the FDA to take [5]. However, Hall and colleagues argued against such proposals, stating that “Governments should protect consumers by regulating rather than banning vaping products. Bans preclude regulation and encourage an illicit market in these products” [6]. This commentary considers Hall and colleagues’ argument and arrives at the conclusion that a ban on open-system e-cigarettes might not serve its intended public health purpose.

A ban targeting only open-system e-cigarettes might not serve its intended public health purpose of preventing future EVALI-like outbreaks among e-cigarette users because such outbreaks can be facilitated by closed-system e-cigarettes, as seen with EVALI among cannabis vaporizer users. Further, a ban on open-system e-cigarettes would create an illicit market for these products that would heighten the risk of future outbreaks due to no regulatory oversight of associated constituents, components, and parts.

Unlike closed-system e-cigarettes, which are designed to allow minimal user modification of component parts and contents, open systems allow users to readily manipulate various settings (e.g., power and temperature) and parts (atomizer heads/coils), and allow infinite iterations of e-liquids to be vaped through refillable tanks. Given the ease at which enforcement of flavor and other e-liquid regulations can be circumvented with open systems [7], it appears that banning open-system e-cigarettes on the US market to prevent future outbreaks would be a prudent regulatory policy.

However, the EVALI outbreak from use of illicit cannabis vapes is instructive. The EVALI outbreak was not facilitated through use of open-system vapes but by closed systems. Cannabis oils are also typically sold in prefilled cartridges (i.e. closed system). Further, vitamin E acetate was not introduced into cannabis oils by individual users, but by “manufacturers” of illicit products. These products had no regulatory oversight and no product standards. This suggests that a ban targeting only open-system e-cigarettes would not be protective. Instead, FDA should enforce safety testing of all e-liquids, whether they are used in open- or closed-system e-cigarettes, and mandate labelling that informs consumers of e-liquid constituents and health risks, proposals that Hall and colleagues support [6].

Further, there may be unintended public health consequences of a ban on open-system e-cigarettes. Open systems are already widely used on the US market, and studies indicate that variable-power mods (which are open systems) deliver nicotine more effectively than other e-cigarettes [811]. Effectiveness of nicotine delivery is a key determinant of the efficacy of e-cigarettes for smoking cessation [12]. A ban on open systems would eliminate a potential smoking cessation or harm reduction tool for adult smokers. In addition, it is unlikely that users of open-systems will discard their devices en masse if a ban is implemented. Instead, reducing the availability of refill liquids on the US market would likely lead to increased do-it-yourself e-liquid-mixing, increasing the possibility of nicotine poisoning, and introduction of toxic chemicals as flavorants by individual users. Also, the international market continues to produce open-system devices, often with appealing, advanced technological features, and would be available on the illicit market in the US. With no regulatory oversight on safety, this would likely increase risk of harm.

Finally, while youth use of e-cigarettes is a public health concern [13], the drivers of youth uptake of e-cigarettes are different from those that caused the EVALI outbreak. The drivers of e-cigarette use among youth include attractive flavors, targeted advertising, and increasing availability of easily concealable cartridge/pod closed-systems, such as JUUL [13]. Public health actions to reduce youth use must focus on these drivers, and should include efforts to make flavored e-cigarettes less appealing and accessible to youth [14]. But given the choice of e-cigarettes among youth (i.e. small closed-system devices), a ban on open systems would not protect youth from future e-cigarette-related outbreaks.

In conclusion, I agree with Hall and colleagues that strict regulation of e-cigarettes, instead of a ban of subclasses of e-cigarettes, would be more likely to prevent future EVALI-like outbreaks among e-cigarette users.

Read full article here.

Gideon St.Helen – Society for the Study of Addiction – 2020-08-19.

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