Last week FDA took the important step of denying permission for Logic Technology to market is menthol e-cigarettes.
In its press release, FDA specifically recognized the attraction of menthol e-cigarettes to youth:
For non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use. Recent data from the 2022 National Youth Tobacco Survey found most (84.9%) youth who used e-cigarettes in the past 30 days used non-tobacco-flavored e-cigarettes, and of them, 26.6% used menthol-flavored e-cigarettes. Additionally, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk of youth uptake. Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol-flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarette products.
FDA goes on to say that it made this decision because, “The evidence provided within the application does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.” This statement reflects two FDA persistent beliefs that are not supported by the actual evidence:
First, e-cigarettes as consumer products do not help smokers “switch completely,” i.e., stop smoking cigarettes. Indeed, the latest, best studies that followed smokers who tried to quit cigarettes with e-cigarettes for 3 years showed that smokers who used e-cigarettes to quit were 80% less likely to still be off cigarettes than smokers who did not use e-cigarettes.
It is, of course, theoretically possible that, unlike e-cigarettes in general, a specific e-cigarette would help smokers “switch completely.” FDA’s analysis of Logic’s application to sell its’ e-cigarettes does not cite any such specific evidence that Logic would behave any differently than e-cigarettes in general.
Second, FDA ignores its own published research showing that simply cutting down the number of cigarettes does not provide any all-cause mortality benefit for smokers.
Nevertheless, this decision sets a good precedent for denying authorization for marketing all menthol e-cigarettes, ending its de facto authorization of menthol e-cigarettes. Let’s hope FDA moves quickly on the other menthol e-cigarettes FDA has allowed to stay on the market through its inaction.