FDA Belatedly and Arbitrarily Approves Menthol Vapes

The agency's inscrutable approach to harm-reducing nicotine products sacrifices consumer choice and public health on the altar of youth protection.

The Food and Drug Administration (FDA), which until Friday had approved only tobacco-flavored nicotine vaping products, has now officially allowed the sale of menthol-flavored NJOY Daily disposable e-cigarettes and menthol-flavored pods for the previously authorized NJOY Ace device "after extensive scientific review." The decision reflects the FDA's preference for closed, nonrefillable "electronic nicotine delivery systems" (ENDS) and its aversion to letting former smokers buy the flavors they prefer, both of which sacrifice the interests of adult consumers in the name of preventing underage use.

"Evidence submitted by the applicant showed that these menthol-flavored products provided a benefit for adults who smoke cigarettes relative to that of the applicant's previously authorized tobacco-flavored products—in terms of complete switching—that is sufficient to outweigh the risks of the product, including youth appeal," the FDA said. In this case, explained Matthew Farrelly, director of the Office of Science at the FDA's Center for Tobacco Products, "the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth."

The FDA is applying a standard established by the Family Smoking Prevention and Tobacco Control Act of 2009, which says the agency should approve new nicotine products when they are "appropriate for the protection of the public health." The agency is supposed to take into account "the risks and benefits to the population as a whole, including users and nonusers." That, in turn, entails considering "the increased or decreased likelihood that existing users of tobacco products will stop using such products" as well as "the increased or decreased likelihood that those who do not use tobacco products will start using such products."

In the ENDS context, as Farrelly's comment reflects, that evaluation comes down to weighing the benefit of a given product in helping adult smokers quit against the risk that it will appeal to teenagers. But those judgments, which hinge on predictions of how adults and teenagers will respond to a particular product, are inherently uncertain and debatable. Furthermore, there is no legal formula for weighing the benefit of increased smoking cessation among adults, which entails a dramatic reduction in health hazards, against the risk of underage vaping, which entails a relatively modest increase in health hazards compared to complete nicotine abstinence. And the FDA refuses to consider the benefit of replacing smoking with vaping among teenagers, since it deems any ENDS use by minors unacceptable, even when the long-term effect might be a reduction in tobacco-related morbidity and mortality.

This "public health" standard is a black box in practice, and the FDA's interpretation of it contradicts its statutory mission to minimize risks and maximize benefits for "the population as a whole." It is therefore hard to take Farrelly seriously when he declares that "we are a data driven agency and will continue to follow the science to inform our review of premarket tobacco applications."

The FDA is not simply "follow[ing] the science." It is engaging in fallible predictions and making value judgments about whether adults should be allowed to buy products they want—products that could literally save their lives if they are appealing enough to motivate and maintain the switch from smoking to vaping—based on its perception of the likelihood that teenagers, who are not legally allowed to buy ENDS, might also be inclined to use those products. This approach is a recipe for arbitrary bureaucratic edicts.

The FDA's dubious understanding of its statutory mission is just part of the problem. By charging the agency with conducting a collectivist calculus of how a product might affect "the population as a whole," Congress has invited regulators to restrict consumer choice in service of that hazy mission. Under that standard, it is not enough that adults want to use a particular vaping product, that the product is demonstrably less hazardous than combustible cigarettes, and that replacing the latter with the former will make them healthier and extend their lives. The FDA can still ban the sale of the product based on concerns about underage use.

According to the FDA, that will happen when "the risks to youth" outweigh "the strength of evidence of benefits to adult smokers." That standard is incomprehensible, since these two things are neither precisely measurable nor comparable.

The FDA says NJOY presented compelling evidence that smokers are more likely to successfully switch if they can vape menthol-flavored nicotine e-liquids. Yet that evidence, according to the FDA, applies only to these specific products; it cannot be extended to surmise that the same would be true of other brands. In any case, the "strength" of that evidence, however "strength" is defined, cannot logically be weighed against a "risk" of underage use, however that is defined. It is baffling what units of measurement the FDA purports to be using here.

If the benefits of menthol-flavored ENDS must be established "on a case-by-case basis," as the FDA insists, it is not surprising that the agency refuses to apply similar logic to other flavors. When given the choice, we know from survey data, former smokers prefer flavors other than the two that the FDA has deigned to allow.

Surveys conducted in 2018 and 2020, for example, found that just 30 percent of dual users and switchers most often used tobacco-flavored or unflavored e-liquids, while 17 percent picked "menthol/mint." Most preferred the flavors that are anathema to the FDA because it considers them too kid-friendly. This was especially true for respondents who used the refillable, economical, and versatile tank systems that the FDA abhors, 64 percent of whom favored "fruit/other." In a 2022 study of people who vaped instead of smoking, "sweet flavors were most frequently preferred by participants (44.8%), followed by menthol/mint (34.7%), tobacco (12.6%), and other (7.9%)."

A 2019 study suggested that "multiple flavor use at initiation…may discourage rejecting ENDS," while "current use of traditional cigarette flavors (ie, tobacco, menthol) may promote sustained smoking." A 2022 study similarly found that "e-cigarette users with nontobacco flavors were more likely to succeed in quitting compared to those exclusively using non-flavored or tobacco-flavored e-cigarettes." A 2023 study found that legal restrictions on ENDS flavors were associated with increases in smoking, exactly the opposite of what the FDA is ostensibly trying to achieve.

According to a systematic review published last year, "the evidence about the role of different flavored ENDS use and smoking cessation outcomes is inconclusive, reflecting highly heterogeneous study definitions and methodological limitations." The authors added that "more high-quality evidence, ideally from randomized controlled trials, is required." But it stands to reason that letting smokers buy the ENDS flavors they demonstrably prefer will make them more likely to try vaping and more inclined to stick with it. Conversely, restricting their flavor choices is apt to result in more smoking-related disease and death, which hardly seems "appropriate for the protection of the public health."

The FDA has now conceded that point with regard to menthol ENDS, although it bizarrely insists that the principle applies only to the specific NJOY products it has approved. A more consumer-friendly approach, one that did not make individual choice contingent on inscrutable cost-benefit analyses by bureaucrats, would let adults decide for themselves which products best suit them.