The day after FDA denied Juul’s application to continue selling its e-cigarettes on June 23, 2022, Juul sued and obtained an emergency Stay from the US Court of Appeals. On July 5, the FDA announced that it was issuing its own Administrative Stay and allowed Juul to remain on the market while the FDA considers “scientific issues unique to the JUUL application that warrant additional review.”
While the details of Juul’s application, FDA’s deliberations, and FDA’s next steps all remain secret, the real issue is that FDA has consistently not addressed the core realities: (1) e-cigarettes as consumer products do not help smokers quit (or, “switch completely” in the tobacco industry and FDA’s lexicon); and (2) e-cigarettes, including menthol flavored e-cigarettes, led by Juul, have recruited millions of kids to nicotine addiction.
By ignoring these important realities, and because FDA has broadly embraced e-cigarettes, including bending over backwards to authorize RJR’s Vuse Solo, NJOY and JTI/Logic’s e-cigs, FDA has missed the real justifications for denying Juul marketing authorization. Given the permissive stance that FDA has adopted for the other e-cigarettes, it’s no wonder Juul was taken by surprise when FDA denied its application on toxicological grounds.
Basing its decision on a narrow (but undisclosed to the public) toxicological basis raises the question whether FDA is just delaying addressing the hard realities of e-cigarette use and leaves open the possibility that even if FDA prevails in court, Juul may be able to amend its application to remedy the (unknown to the public) issue FDA identified (a point Juul made publicly).
FDA may have also carelessly given Juul an argument that is not supported by the evidence. In FDA’s press release announcing it had said “no” to Juul, FDA added, “Some current JUUL users who will not have access to JUUL products following this action or current smokers who want to transition away from cigarettes and cigars may decide to switch to other ENDS products that have been reviewed and authorized by the FDA based on their potential to benefit adult smokers.”
So, if FDA authorizes Juul or the status quo drags on for months or years on the Juul decision, what’s left for the health community to do?
Force FDA to block all menthol e-cigarettes now.
FDA has de facto authorized the sale of menthol e-cigarettes by allowing menthol e-cigarettes to remain on the market while it sits on applications for menthol e-cigarettes despite blocking all other flavored e-cigs. FDA has never publicly justified this policy, but my guess is that they believe getting rid of menthol e-cigs will mean fewer adults will “switch completely” from menthol cigarettes to menthol e-cigarettes. (As noted above, this view ignores the fact that e-cigs as consumer products don’t help smokers quit. Indeed, the latest long-term studies show e-cigarettes depress quitting cigarettes.)
Menthol is also more important for kids than FDA assumes. The CDC/FDA 2021 National Youth Tobacco Survey showed that menthol is the second most popular flavor for pod e-cigs among middle and high school students: “The most commonly used flavor types among current flavored pod or cartridge users were fruit (57.9%; 270,000); menthol (46.3%; 210,000); mint (30.7%; 140,000); and candy, desserts, or other sweets (28.2%; 130,000).” (Menthol use was a bit less popular in disposable e-cigs, but that’s likely because all the other kid-friendly flavors are available in disposables.)
Getting rid of menthol e-cigs is particularly important because, as FDA explains in detail in its proposed product standard eliminating menthol cigarettes, menthol is more than just a “characterizing flavor.” Menthol interacts with nicotine at a cellular level and makes nicotine more addictive and it harder to quit. This interaction between menthol and nicotine has nothing to do with combustion.
The good news is that new FDA Center for Tobacco Products Director Brian King has a deep understanding of the importance of flavors and how partial flavor restrictions just drive kids to the remaining flavors, particularly menthol. The July 2022 issue of American Journal of Public Health includes King’s paper “Flavors remain a major driver of youth e-cigarette use.” Although he wrote the paper several months ago while still at the CDC Office on Smoking and Health, it is more relevant than ever right now. King wrote:
Flavors remain a major driver of youth e-cigarette use. A majority of youths who currently use e-cigarettes report flavors are a reason they used the products, and, in 2021, 84.7% of youths who used e-cigarettes reported using a flavored product; the most commonly used flavor types among youths were fruit (71.6%), followed by candy, desserts, or other sweets (34.1%); mint (30.2%); and menthol (28.8%).
Noncomprehensive policies, such as those that exempt certain flavors, can lead to shifts in behaviors by consumers that might diminish the policy’s intended effects. For example, following the January 2020 national restriction on the sale of certain flavored cartridge-based e-cigarettes (excluding menthol and tobacco), increases occurred in US sales of menthol-flavored e-cigarettes and disposable e-cigarettes, the latter of which were still available for sale with fruit, candy, mint, and other flavors.
Efforts at the national, state, and local levels remain critical to make flavored e-cigarettes less acceptable, accessible, and appealing to youths. These efforts include restrictions on the sale of flavored e-cigarettes that appeal to youths, without exemptions that diminish policy impact. [citations dropped, emphasis added]
In addition, in contrast to getting rid of menthol in cigarettes which requires a years-long rulemaking process, getting rid of menthol in all e-cigarettes just requires saying “no” to the applications to sell menthol e-cigarettes.
Limiting Juul (and other e-cigs) to tobacco flavor will do a lot less damage than leaving menthol on the market, especially for kids.
Forcing the FDA to prohibit menthol e-cigarettes now is the best we can do given the mess FDA has made on e-cigs so far.