On April 28, 2022, FDA released its proposed tobacco product standard prohibiting menthol cigarettes. The justification for prohibiting menthol as a characterizing flavor includes a comprehensive review of the effects of menthol on smoking, including why menthol promotes cigarette initiation and how it makes it harder to quit smoking. In addition to summarizing the behavioral and epidemiological evidence, FDA describes the underlying biological mechanisms that lead to these effects, including the interaction of menthol and nicotine in impacting nerve cells to strengthen the addiction process.
The FDA uses the experience in places that have ended the sale of menthol cigarettes (US cities and states and Canada) to show that, without menthol, many people will stop smoking and fewer kids will start. They also make the point that those menthol smokers who switch to unflavored cigarettes will be no worse off, so there is a certain health benefit even with some people continuing to smoke.
FDA shows how banning menthol will reduce health disparities by benefiting those people who are more likely to smoke menthol cigarettes (because the tobacco industry has so successfully targeted them its marketing and promotions), including African Americans, women, youth, and LQBTQ people.
The FDA also cites industry research based on previously secret tobacco industry documents that shows that the tobacco companies understand all this and have used that understanding to design more addictive cigarettes and promote them.
Because of the effects on quitting, FDA shows a huge positive benefit/cost ratio for the rule, even when not quantifying morbidity benefits and the effects of reduced youth initiation.
The discussion of the scientific justification is remarkably balanced, including discussion of research inconsistent with the FDA’s conclusions, together with strong reasons that these few studies do not nullify the larger literature.
The tobacco companies, their front groups and allies will no doubt make a lot of noise about the rule and certainly sue to try and stop it, but the FDA has built a strong foundation to justify prohibiting menthol as a characterizing flavor in cigarettes.
The justification for FDA granting exceptions to the rule, however, is very weak
The FDA also proposes giving itself the power to grant exceptions to the menthol ban for heated tobacco products and low nicotine cigarettes. (It has already granted PMTA marketing authorization for these menthol cigarettes.) While never explicitly stated, the FDA seems to be assuming that menthol is necessary for these products to remain “off ramps” for menthol cigarette smokers.
This simply does not make sense because the FDA’s strong justification for prohibiting menthol in cigarettes grows out of the biological effects of menthol and how it amplifies the addictive effects of nicotine. Beyond the fact that the aerosol used to deliver the mentho/nicotine mixture is generated by combustion, the fact that the product is a cigarette doesn’t matter. There is no evidence that combustion changes menthol or nicotine in a way that affects the underlying biological mechanisms that lead to the adverse effects of menthol.
There is no reason to think that these effects would be any different if the menthol/nicotine aerosol was generated or delivered by heating a tobacco stick (or in an e-cigarette).
In contrast to the rest of the proposed rule, the review of the science is cursory, often out of date, and highly selective in the evidence FDA presents. Most important, the evidence that the FDA presents earlier in the rule does not show that menthol smokers switch to these products.
If anything, maintaining this exemption will reduce the positive health effects of the rule by promoting youth initiation of these alternative products, a point that the FDA doesn’t even mention.
The exemption should be dropped.
In addition to dropping the exemption on substantive grounds, keeping such a weakly justified element in the rule could open the FDA to challenges to the rule on the grounds that it is arbitrary and capricious.
While the rule is about cigarettes — not e-cigarettes — the underlying weak justification for exempting heated tobacco products (which are essentially solid e-cigarettes) it highlights why FDA has been allowing menthol e-cigarettes on the market by simply not acting of their PMTA applications.
More to come
I am still digesting the proposed rule and will provide more details later. I haven’t yet read the cigar rule and will comment on that later.