Menthol: Two wrongs won’t make a right

After refusing to authorize the sale of over a million e-cigarette flavors, the FDA still has not dealt with menthol (or tobacco flavored) e-cigarettes. As detailed in an earlier blog post, I remain concerned that FDA will authorize the sale of menthol e-cigarettes using the incorrect logic that menthol e-cigarettes need to remain available as alternatives to menthol cigarettes as long as menthol cigarettes remain on the market.

Essentially, the argument would be that because FDA hasn’t yet been able to remove menthol cigarettes from the market it should delay authorize menthol e-cigarettes.

FDA has struggled with menthol cigarettes since 2009, when Congress passed the Smoking Prevention and Tobacco Control Act. The big cigarette companies threatened to kill the bill if Congress included menthol together with all the other “characterizing flavors” in cigarettes that the law banned. As a compromise, Congress directed FDA to have its Tobacco Products Scientific Advisory Board (TPSAC) make a recommendation on what the FDA should do about menthol within a year on the assumption that FDA would act promptly.

TPSAC completed this task on time and recommended that removing menthol would improve public health (the standard for action in the law). Industry opposition blocked FDA action. Finally, many reports later and in response to litigation by the African American Tobacco Control Leadership Council and others, on April 29, 2021, FDA announced it would develop a product standard to get rid of menthol.

Among other things, the FDA press release correctly made this important point:

“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products. With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products,” said Acting FDA Commissioner Janet Woodcock, M.D. “Together, these actions represent powerful, science-based approaches that will have an extraordinary public health impact. Armed with strong scientific evidence, and with full support from the Administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.” 

FDA’s 15 page letter to the Public Health Law Center responding to their 2013 citizen’s petition to act on menthol provides an excellent history of the issue and outlines the strong scientific foundation for moving forward.

In particular, the FDA wrote:

Characterizing flavors in tobacco products, including menthol, enhance taste and make them easier to use. Menthol masks the harshness and irritation of tobacco smoke among new smokers and facilitates repeated experimentation and progression to regular use, particularly among youth and young adults. Menthol in cigarettes enhances nicotine addiction through a combination of its flavor and sensory effects, which introduce nicotine to new users in a less aversive manner than non-menthol cigarettes, and interacts with nicotine in the brain. Youth who initiate smoking with menthol cigarettes (compared with youth who initiate with non-menthol cigarettes) are at greater risk of progression from experimentation to established smoking and nicotine
dependence.

Once a user is addicted, menthol’s flavor and sensory effects facilitate continued smoking and menthol makes it harder for them to quit, particularly among daily smokers. This effect is most prevalent among African American menthol smokers, who disproportionately have more difficulty quitting than non-menthol smokers. Consequently, the continued marketing of menthol cigarettes raises profound health equity issues. This is true for active smokers as well as nonsmokers. From 2011-2018, the prevalence of secondhand smoke exposure was approximately twice as high among non-Hispanic Black nonsmokers compared to nonsmokers of other races/ethnicities.

As evidence shows that menthol facilitates experimentation and progression to regular use among youth and young adults and makes quitting more difficult, particularly in African American smokers, FDA believes eliminating menthol as a characterizing flavor in cigarettes would benefit public health. [citations deleted]

While there may be some differences in use patterns, the biology of how menthol interacts with nicotine to promote and sustain addiction that the FDA lists for cigarettes also applies to e-cigarettes.

Perhaps more important, after Juul removed their flavored products — except menthol, mint and tobacco flavors — under pressure from the FDA, youth Juul users just switched to menthol and mint. Juul’s sales rebouunded in weeks. The only flavor Juul (and the other e-cigarette companies) really need is menthol.

Unlike menthol in cigarettes, where regulation will take years, FDA can get rid of menthol e-cigarettes by simply concluding that allowing their continued sale would not be appropriate for the protection of public health and denying authorization to sell menthol (and mint and menthol analogs) e-cigarettes.

Doing so would be a substantial step toward reducing the damage that menthol does, especially to youth. The fact that dealing with menthol cigarettes will take a long time is not a good reason to delay progress in protecting people from menthol e-cigarettes that can be made now.