Executive Summary
Flavored tobacco products have long been the subject of controversy, especially with regards to their potential appeal to youth. In 2009, the federal government banned the manufacture and sale of all combustible cigarettes flavored to taste like clove, candy or fruit, but made an exception for menthol. The reason given for banning these products is that certain flavors could be especially attractive to children, luring them into smoking and serving as a gateway to lifelong cigarette addiction.
The debate over e-cigarette flavors is fundamentally different from the one over flavored cigarettes. Unlike combustible cigarettes, e-cigarettes are a harm reduction product that offers smokers a significantly less dangerous alternative to smoking cigarettes. To do so, they deliver nicotine and/or flavorings that consumers want in a vapor that contains far fewer toxicants than cigarette smoke, the inhalation of which leads to the deaths of more than 480,000 Americans every year.
When FDA Commissioner Scott Gottlieb announced an advanced notice of proposed rulemaking (ANRPM) on the regulation of flavored tobacco products in March 2018, he recognized the role flavors can play in tobacco harm reduction:
I’ve talked to ex-smokers, who’ve told me that they quit cigarettes altogether and that they now vape. And they’ve also told me it was the flavors that helped them make that transition off combustible cigarettes. Now I know anecdotes aren’t the same as data. And the ANPRM specifically seeks data on this issue. But these personal stories are important to me as we shape our overall approach to smoking cessation.
Gottlieb has since emphasized that while e-cigarettes can play a role in reducing tobacco-related harms, it must not come at the expense of addicting a new generation of teens to nicotine. Gottlieb echoes the main objection to the widespread availability of e-cigarettes and their promotion as a tool for smoking cessation. While they may present a benefit for adult smokers, critics argue, they could prove a threat to adolescents. So-called “kid-appealing” flavors are regularly singled out as targeting children and being of little interest to adult smokers trying to switch to vaping.
In September 2018, FDA Commissioner Scott Gottlieb announced that e-cigarette use among teenagers had reached “epidemic” levels. To combat this alleged epidemic, Gottlieb asked the nation’s five largest e-cigarette manufacturers to submit plans to tackle youth use. If these plans do not meet FDA’s approval, all non-tobacco flavors could be withdrawn from the market, and the deadline for e-cigarette product applications could be brought forward from the current 2022 deadline. If implemented, these policies could provide a devastating and possibly irreparable blow to the independent e-cigarette industry.
While flavor plays a role in the decision of some youth to try vaping, the evidence shows that it is one of many factors and is often not the leading reason for youth vaping. Curiosity, peer influence, and rebellion are also major influences as they are with youth use of many adult products. There is no reason to believe that banning e-cigarette flavors would, in fact, reduce youth vaping. Removing these flavors would not necessarily alter their decision to experiment with e-cigarettes to begin with. It is a leap in logic to suggest that without a variety of flavors kids would not experiment with e-cigarettes as they do with other adult products such as alcohol.
In this way, the role e-cigarette flavors play in youth vaping initiation is grossly exaggerated. As well, while all youth use of e-cigarettes is undesirable, rates of use are not significantly higher than other adult products that teens experiment with. In fact, youth e-cigarette use is lower than for other illicit products.
Nonetheless, non-tobacco flavors are consistently labeled “kid-appealing.” While it is true that the majority of kids who vape use non-tobacco flavors, that is not the end of the story. Non-tobacco flavors such as fruit, dessert, and pastry are in fact the most popular choices among adult vapers also. According to the largest surveys ever conducted, most adults switching from cigarettes to vaping opt to switch with a non-tobacco flavor. Increasingly, literature both from testimonials and longitudinal studies shows that flavor varieties assist smoking cessation among adult smokers who switch to vaping. There is nothing in the data to suggest that non-tobacco flavors are inherently and solely “kid-appealing,” that adults do not like flavors, or that e-cigarette companies use these flavors to target minors.
While debates over the possible long-term impact of e-cigarette use remain a subject of intense discussion, there is an overwhelming consensus that these products are significantly less harmful than cigarettes and can play an essential role in helping adult smokers quit. A substantial emerging literature demonstrates that the majority of adult vapers use flavored products when transitioning away from cigarettes and maintaining cigarette abstinence. As such, e-cigarettes are a harm reduction product in that they pose vastly less danger to their users than traditional cigarettes, and smokers who switch to these products will dramatically lower their risk of smoking-related disease.
As it stands, there is no justification by way of scientific evidence or consumer welfare analysis for a tobacco product standard prohibiting or severely limiting the number of e-cigarette flavors. Developing such a standard would be counterproductive, degrading the appeal and user experience of products which, when used exclusively in place of combustible cigarettes, dramatically reduce the risks of tobacco-related disease. The FDA itself has stated that e-cigarettes are a vital part of the policy mix to reduce deaths from smoking, and Scott Gottlieb has said that if every smoker in America switched to e-cigarettes, it would be a net benefit to public health.
The key objective for FDA should be to maximize the public health potential of e-cigarettes by ensuring widespread availability of e-cigarette products in the forms that actually appeal to adult smokers, which is for the most part in non-tobacco flavors. At the same time, FDA must use its authority to limit sales of these products to youth as much as possible.
To tackle youth use, FDA should use its enforcement power to prevent and punish illegal sales of these products to minors. But banning or severely restricting the most popular category of a tobacco harm reduction product in order to tackle underage use is misguided and presents a net harm to public health by removing a popular option for adult smoking cessation.
The FDA does not have to make a choice between helping adults quit smoking and preventing youth from vaping. A sensible regulatory policy can achieve both these objectives at the same time. If FDA gets the correct balance between enforcement and ensuring a thriving market for tobacco harm reduction products, the results could be millions of lives saved.
