On April 28, the FDA announced regulations to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors (other than tobacco) in cigars. The agency said the proposals “have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the number of smokers that quit.”
Between May 4 and July 5, the public can provide comments to the FDA, after which it will issue final rules. Once the final rules are issued, the industry is expected to sue to block them.
Much media attention has been devoted to FDA’s announcement, but another close look is warranted, particularly focusing on concerns about unintended consequences and the demand by some that the menthol ban be extended to all “tobacco products” including e-cigarettes.
Why Ban Menthol in Cigarettes?
First, the basics: Menthol is a regulated drug when used in products like cough medicine and topical pain relievers, but in cigarettes and cigars it is used as a non-medicinal “flavor” additive with a minty aroma and taste that makes it less irritating to inhale smoke. Menthol also interacts with nicotine in the brain to increase addiction.
FDA has explained that the new regulations are based on evidence of the greater addictiveness and harms of these products, expanding the restrictions legislated in 2009 by the Family Smoking Prevention and Tobacco Control Act, which prohibited all characterizing flavors (other than tobacco and menthol) in cigarettes.
The elimination of menthol cigarettes is a social justice and child protection issue. In 2019, there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the U.S., with especially high rates of use by youth, young adults, and African American and other racial and ethnic groups. Over 80% of African Americans who smoke use menthols, compared to 30% of white smokers. Menthols are the favored starter product for youth.
The fact that African Americans suffer disproportionately is no accident. The cigarette industry has aggressively targeted African American communities for decades. The companies misappropriated Black culture and bought allegiance and silence through heavy marketing investments in Black publications and sponsorship of events like the Kool Jazz Festival, while cynically saturating Black community, health, and educational organizations with philanthropic contributions.
Modeling studies, including ours from the FDA-funded Center for the Assessment of Tobacco Regulations, estimate as many as 654,000 smoking-attributable deaths, including 238,000 among African Americans, would be avoided over a 40-year period if menthol cigarettes were no longer available and adult smokers were offered effective nicotine alternatives.
Will There Be Unintended Consequences?
In opposition, cigarette manufacturers and their allies argue the menthol ban will be used as a pretext for police to target Black communities and result in a black market for menthol cigarettes and additives.
The FDA has made clear, however, that the regulations are directed at manufacturers, distributors, wholesalers, importers, and retailers, and do not prohibit individual possession or use. The FDA has acknowledged, however, “concerns related to how state and local law enforcement may enforce their own laws in a manner that may impact equity and community safety, particularly for underserved and underrepresented communities,” and requested public comments.
When it comes to black market concerns, data from Canada suggest little likelihood of a significant illicit market for menthol cigarettes. Surveys have also shown that a ban would encourage African Americans to quit using menthol cigarettes rather than pursue illicit products. Since no country with as large a menthol market as ours has banned menthol cigarettes, we can’t be certain what the illicit market impact will be.
But there are things we can do to manage that risk, and that includes not banning menthol in all products.
Should the Menthol Ban Extend to Noncombustible Products?
This is why I am concerned that some menthol ban supporters are using this moment to urge, without scientific basis, that FDA expand the menthol ban to other “tobacco” products, including e-cigarettes (which don’t contain or burn tobacco). An April 22 letter to FDA Commissioner Robert Califf, MD, from a coalition of health groups led by the Campaign for Tobacco-Free Kids provides impressive scientific documentation supporting the proposed rules, while saying nothing about e-cigarettes or other noncombustible products … that is, until the last line of the letter, which states, without elaboration: “Finally, FDA’s issuance of these rules should be the first step toward a broader set of product standards prohibiting all non-tobacco flavors in all tobacco products.”
The premature demand that menthol be banned in all tobacco products, if implemented, risks handing almost the entire tobacco marketplace over to cigarettes, which kill half of long-term users. Science has demonstrated that a variety of noncombustible products offer reduced-risk alternatives for adult smokers who are either unable or unwilling to quit using nicotine completely. These range from e-cigarettes and oral nicotine lozenges and pouches to such products as a very low-nitrosamine smokeless tobacco called snus. Research to date suggests that retaining menthol in some or perhaps all of them could help adults quit smoking.
To their credit, Commissioner Califf and Michele Mital, the acting director of FDA’s Center for Tobacco Products, made clear the agency is considering exempting certain products from the menthol ban. The agency has already authorized mentholated versions of a nonaddictive, very-low-nicotine cigarette and a heated tobacco product called IQOS, which produces fewer harmful chemicals, determining these products are “appropriate for the protection of public health.”
As I’ve written previously, FDA has a profound responsibility to make evidence-based decisions. It is inappropriate for cigarette companies or health organizations to pressure the agency to make predetermined decisions, disregarding the agency’s expertise and the impact such decisions will have on the lives of tens of millions of addicted adult smokers.
The best thing we can do now as healthcare practitioners, policy experts, and concerned citizens is to support FDA’s life-saving efforts, trust the agency’s scientific expertise, refrain from prejudging the science, and continue to work to drive down smoking as quickly as possible.
The opinions expressed are the author’s and do not necessarily reflect the views of any organization with which he is affiliated.
Clifford E. Douglas, JD, is the director of the University of Michigan Tobacco Research Network and an adjunct professor at the University of Michigan’s School of Public Health.
Douglas is a co-principal investigator for research conducted through the Center for the Assessment of Tobacco Regulations, which is funded by NIH/FDA. He is also an advisor to the Smoking Cessation Leadership Center at the University of California San Francisco relating to behavioral health and tobacco use.