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.
Stanton Glantz blog 
FDA’s denial of Logic’s PMTA for its menthol e-cigarettes leaves a lot of unanswered questions:
— The FDA announcement highlights the fact that 84.9% of youth use non-tobacco flavors, of which 26.6% use menthol. That means about 22.6% of youth users use menthol — and 15.1% use tobacco flavored. Yet FDA seems fine with allowing tobacco flavored e-cigarettes on the market despite that level of youth use when all sorts of other flavors are also available. No discussion of the extent to which kids might just switch from menthol or other non-tobacco flavors to tobacco flavored if and when most or all non-tobacco added flavors are eliminated.
— Continuing past patterns, FDA also said nothing about non-flavored e-cigarettes and whether they might be the e-cigarettes that are the most appropriate for the protection of the public health to allow on the market because they have no added toxicity from added flavorings being converted into inhaled aerosol toxins. Nor has FDA said anything about whether unflavored might be more popular among youth (either generally or as a smoking substitute) or among adult smokers (as a smoking substitute) than tobacco-flavored if no other added flavors are allowed, or if tobacco-flavored were not allowed, as well.
— The FDA announcement indicates that all menthol e-cigarettes are not appropriate for the protection of the public health, but, at the same time, FDA also says that Logic “may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.” That suggests that FDA might think there are still some ways to market menthol e-cigarettes that would be appropriate for the protection of the public health and/or that Logic’s menthol e-cigarettes were denied because its application simply did not include adequate information or analysis to support the menthol e-cigarettes being AFPPH (and perhaps other pending applications have).
— In that regard, the FDA announcement says nothing about what marketing restrictions or other measures were proposed in the Logic PMTA to protect against the menthol e-cigarettes being used by youth — or about whether requiring certain marketing restrictions or other protective measures in a final PMTA order might make certain menthol e-cigarettes AFPPH. In the past FDA has said that there are no marketing restrictions that could make marketing non-tobacco, non-menthol e-cigarettes AFPPH. [But FDA has been ordered to reconsider and clarify that finding by the 11th Circuit, which rejected FDA’s marketing denial order for Bidii e-cigarettes, despite the company proposing marketing restrictions that go far beyond what FDA has required in its orders allowing the marketing of tobacco-flavored e-cigarettes or what any major companies have done to protect against youth e-cigarette use.]
— In the past, FDA has said that certain technological measures might be sufficient to make allowing the marketing of certain flavored e-cigarettes AFPPH (e.g., technologies that do not allow the e-cigarettes to be used except when near the age-verified purchaser’s cell phone). That leaves open the question as to whether FDA might allow the marketing of certain menthol e-cigarettes that have PMTAs that propose such technological protective measures. And it also raises the question as to why FDA has not required those protective technologies for the tobacco-flavored e-cigarettes it has allowed to be marketed, despite more than 15% of youth using tobacco-flavored e-cigs even when they can still obtain e-cigarettes with all sorts of other added flavors.
— It is also unclear why FDA issued a denial only for Logic’s menthol e-cigarettes. Why not better protect youth and the public health by simultaneously rejecting the PMTAs for all other menthol e-cigarettes (or at least those that do not propose stronger marketing restrictions and/or protective technologies than Logic’s PMTA did)? FDA has yet to provide any explanation or justification for following its laborious, industry-favoring and public-health-damaging case-by-case approach that lets e-cigarettes with pending PMTAs be marketed with flavors it has prohibited for e-cigarettes receiving PMTA orders and without having to comply with marketing restrictions FDA has placed on those e-cigarettes with permissive PMTA orders.
— As to why FDA might or might not want to allow some menthol e-cigarettes on the market, the Logic PMTA denial announcement says nothing as to whether FDA has determined that the harm reductions from having menthol e-cigarettes on the market if and when its proposed rules to prohibit menthol e-cigarettes and added-flavor cigars would benefit the public health (from causing some menthol/flavor adult and youth smokers to move to menthol e-cigs instead of to tobacco-flavored cigarettes or cigars in response to the new final rules) are larger or smaller than the harm increases from having menthol e-cigs on the market (from causing some menthol smokers to move to menthol e-cigs instead of quitting all use and from menthol e-cigs attracting more youth to initiate).
So, once again, we will have to wait for further FDA action and statements (and perhaps court rulings) before we have a better sense of what is going on. But at least FDA rejecting the Logic menthol e-cigarette PMTAs is more promising and encouraging than if FDA had allowed their marketing similarly to how it has allowed certain tobacco-flavored e-cigarettes.
– Eric Lindblom
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