United States: FDA called out for inaction on menthol

A group of 24 attorneys general, in support of an initiative initiated by civil society health organizations, have just contacted the American public agency, the US Food and Drug Administration (FDA), in order to ban menthol cigarettes.

In a letter submitted to the FDA on January 22, 2021, 24 attorneys general urge the FDA to respond to a petition filed on April 12, 2013 by several medical and public health organizations relating to the banning of menthol as a flavor characterizing cigarettes[1]. In this interpellation from the FDA[2], attorneys general argue that banning menthol cigarettes would save thousands of lives. While the country is seeing an overall decline in smoking, the prevalence of menthol cigarette smoking has remained steady in recent years. Health organizations say menthol cigarettes are a barrier to quitting smoking and reducing smoking-related health problems.

On June 17, 2020, the African American Tobacco Control Leadership Council (AATCLC) and the American organization Action on Smoking and Health (ASH), quickly joined by other organizations, filed a lawsuit against the FDA.[3]. The purpose of this procedure is to get the public agency to respond to the 2013 citizen petition and fulfill its mandate in regulating tobacco products. Characteristic flavors have been banned since 2009, but the list established did not include menthol and therefore the sale of menthol cigarettes, which are particularly toxic, remains possible.[4].

FDA Research Supports Need to Ban Menthol Cigarettes

The 2009 law gives the FDA responsibility for regulating the tobacco industry's activities and product regulation, including the issue of menthol (Family Smoking Prevention and Tobacco Control Act). Congress recognized that " Menthol cigarettes may pose specific health risks to those who smoke them " and urged the FDA " to resolve these issues as quickly as possible ".

Following passage of the law, the FDA established a Tobacco Products Scientific Advisory Committee. The committee conducted extensive research into the public health effects of menthol in cigarettes. On March 23, 2011, the committee issued its report[5] which concludes that " The availability of menthol cigarettes has a negative impact on public health by increasing the number of smokers, leading to premature deaths and avoidable morbidity " The report also states that menthol cigarettes contribute to the initiation of smoking among young people, who become particularly addicted. Finally, the report notes that menthol cigarette use by young people is even higher among minorities, particularly African-Americans. Despite these findings, the FDA has not taken action to ban menthol in cigarettes.

Banning menthol cigarettes would save thousands of lives

The letter of referral elaborates on the FDA's own data on the addictiveness of menthol cigarettes. According to the public agency itself, more than 19.5 million Americans are currently smokers of menthol cigarettes and the agency discusses the full range of risks of menthol.

In this light, if measures to ban menthol cigarettes had been taken in 2010, about 17,000 premature deaths would have been prevented and 2.3 million more people would not have started smoking over the next decade, according to estimates provided in the FDA advisory committee report. About 4,700 premature deaths among African Americans would have been prevented. If ban measures were taken today, the authors estimate that by 2050, 327,000 premature deaths could be prevented and more than 9.1 million people would have been spared from tobacco addiction.

Objection of illicit trade resulting from an invalid prohibition

In the submission to the FDA, the objection that illicit trade would increase following the adoption of a federal ban on menthol cigarettes is addressed and refuted. In May 2015, the Canadian province of Nova Scotia became the first jurisdiction in the world to specifically ban menthol cigarettes. The tobacco industry had warned that “the primary effect of this legislation would be to increase the illegal tobacco market in Nova Scotia.” But contrary to these claims, no increase in illicit trade in these products has been documented.[6]. Similarly, no significant increase in illegal sales of flavored cigarettes has been reported following the 2009 ban on other flavors in the United States. The FDA is, however, urged to be vigilant with regard to objections from the tobacco industry, which are part of a strategy to influence public decision-making.

Keywords: Menthol, FDA, United States, Public health, Cigarettes©Tobacco Free Generation

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[1] Generation Without Tobacco, Menthol: 10 million additional smokers in the United States, March 1, 2021, accessed March 2, 2021[2] Docket No. FDA-2013-P-0435 – Comments on Tobacco Control Legal Consortium, et. al., Citizen Petition to the Federal Food and Drug Administration Related to Prohibiting Menthol as a Characterizing Flavor in Cigarettes (April 12, 2013), January 22, 2021,[3] The African American Tobacco Control Leadership Council (AATCLC) and Action on Smoking and Health (ASH) file lawsuit against the FDA, June 17, 2020, ASH, accessed March 2, 2021[4] Generation Without Tobacco, United States: Menthol and disposable e-cigarettes continue to drive youth vaping epidemic, September 28, 2020, accessed March 2, 2021[5] Neal L. Benowitz, MD, and Jonathan M. Samet, MD, The Threat of Menthol Cigarettes to US Public Health, June 9, 2011 N Engl J Med 2011; 364:2179-2181 DOI: 10.1056/NEJMp1103610[6] Stoklosa M., No surge in illicit cigarettes after implementation of menthol ban in Nova ScotiaTobacco Control 2019;28:702-704.National Committee Against Smoking |