Taking Charge

The use of flavors in e-cigarettes is the hottest topic in this disruptive industry. Manufacturers’ use of flavorings in e-cigarettes has come under intense scrutiny and is a piece of ammunition often used by those looking to impose stringent regulation on the industry. As we enter 2020, it is perhaps an opportune time to look back at the tumultuous happenings of the past couple of years to examine where the flavor debate has taken us and what we might expect to see in the future.

The inclusion of flavors in e-cigarettes poses many challenges for the industry. Broadly speaking, these challenges fall into three categories: the toxicological impact, the effects on vaper behavior and nicotine delivery, and perhaps most importantly, the impact on population level use among different user cohorts. It is the latter that poses an existential threat to the e-cigarette industry and to its ability to provide a reduced harm alternative to deadly combustible cigarettes.

The potential toxicological impact of flavored e-cigarettes is a relatively simple issue to address. By utilizing robust product stewardship procedures assessing the inclusion of flavor ingredients, utilizing literature and computational approaches to ingredient assessment and utilizing rigorous testing of e-cigarette emissions, manufacturers can easily provide reassurance to consumers that their products are safe. The impact on vaper behavior is another relatively simple issue to consider, and we are now beginning to see scientific evidence showing that flavorings in e-cigarettes can cause differences in nicotine delivery, likely secondary to effects on human puffing behavior (topography).

The greatest challenge comes with assessing the population level impact of e‑cigarette flavors. It is often stated that flavored e-cigarettes are beneficial in assisting adult smokers who want to quit smoking. There is good evidence for this—for example, research carried out by the Centre for Substance Use Research in U.S. adult vapers concluded that those who have completely switched from smoking cigarettes to using e-cigarettes are increasingly likely to have initiated e-cigarette use with nontobacco flavors and to have transitioned from tobacco to nontobacco flavors over time.¹

More recent longitudinal data from the same group similarly demonstrated that the use of Juul “characterizing” flavors (e.g., mint and mango) was associated with greater odds of quitting combustible cigarette smoking. The U.S. Food and Drug Administration (FDA) acknowledges the support that flavored e-cigarettes provide to smokers; in warning letters sent by the FDA in September 2018 to a number of U.S. manufacturers, the agency describes the “emerging evidence that some adults may potentially use certain flavored tobacco products to transition away from combusted tobacco use.”² Analyses of the FDA’s own Population Assessment of Tobacco and Health data have shown an association of nontobacco-flavored e-cigarette use with smoking cessation.³

The concern, though, is not this “off-ramp” for adults, a term used by the former FDA commissioner, Scott Gottlieb, to describe transitioning away from cigarette smoking, but the “on-ramp” for youth use of e-cigarettes and the potential for teens initiating nicotine use through flavored e-cigarettes.⁴ Action from the FDA on flavored e-cigarette use has arisen due to data from the U.S. National Youth Tobacco Survey (NYTS) showing an escalation of youth use of e-cigarettes, something the FDA terms an “epidemic.” While the use of such a term is perhaps an overstatement of the scale of the issue as recent analyses of NYTS data show very little frequent use of e-cigarettes by teens and particularly by those who have never used other nicotine-containing products,⁵ it is difficult to argue against the need for action against what is an escalating concern, regardless of its current scale.

The recent publication of further NYTS data fueled the crisis and has led to stronger calls for regulation of the industry and for the curbing of flavored e-cigarette availability. However, there are no easy solutions, perhaps evidenced by the ever-changing nature of the regulatory measures being discussed and recent data that suggests that even when some flavors are removed from store shelves and online marketplaces, switching to other flavors takes place. Even with the recent U.S. presidential intervention, we still do not have clear sight of what the future marketplace for flavored e-cigarettes will look like or as to what regulatory interventions will take place. And even in the absence of reactionary regulatory measures, the FDA will soon have greater discretion over which flavors are allowed to be sold in the U.S. through its premarket tobacco product application approval procedure.

Clearly, the industry needs to self-regulate since regulatory action, and especially knee-jerk regulatory action, often comes with unintended consequences that may do more harm than good. Many manufacturers have taken such proactive approaches, but there still remains on sale a vast number of e-cigarettes with flavor names and marketing materials that can be seen as targeted toward youth. If such marketing practices are not curbed by manufacturers themselves, regulators will perform this function for them—and with a potentially poor outcome.

It is worth noting that the impact of the U.S. flavor debate is being felt elsewhere. Some Canadian provinces, for example, have outlined their proposals to regulate flavored products. Importantly, we must remember that in the European Union, the Tobacco Products Directive (TPD2), a union-wide directive that regulates e-cigarettes, is due for revision soon. As in the U.S., it is expected that regulatory measures in TPD3 could involve restrictions on flavored e-cigarettes.

Undoubtedly, e-cigarettes have the potential to help reduce the global burden of death and disease caused by combustible tobacco smoking. Further, without doubt, they are a greater tool in helping smokers quit than licensed pharmaceutical products. However, improper regulatory measures may stifle the good that e-cigarettes are doing by limiting smokers’ access to the very products that are helping them quit. But perhaps with some sensible industry self-regulation, as a proactive measure to curb youth use and appease regulators, the widespread reductions in smoking prevalence caused by e-cigarettes will continue for the benefit of smokers and for global public health.