FDA Proposes Ban on Menthol-Flavored Cigarettes, All Flavored Cigars

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Strategic Alliance Partnership | <b>American Lung Association</b>

The US Food and Drug Administration (FDA) has shared intent to ban the sale of menthol-flavored cigarettes in the US—the agency’s latest effort to strategically regulate tobacco products in hopes of reducing consumption among key demographics and therefore reducing respiratory disease and mortality risks.

The proposal, announced by FDA commissioner Robert Califf, MD, to a US Senate committee on Thursday morning, would “prohibit menthol as a characterizing flavor in cigarettes and prohibit all other characterizing flavors other than tobacco in cigars,” per a statement. Califf and the FDA expressed belief the ban would impact rates of youth tobacco experimentation and addition—as well as rates of smoking cessation—therefore improving prevalence of combusted tobacco product use-associated disease and death.

Per the Centers for Disease Control and Prevention (CDC), cancer and chronic lower respiratory diseases were the second and sixth leading causes of death in the US in 2020, respectively. There were than 18.5 million current menthol cigarette smokers aged ≥12 years old in the US as of 2019, according to the FDA; among them are significant rates of adolescents, young adults, African American and other racial/ethnic minority groups.

The agency cited modeling studies suggesting an estimated 15% reduction in smoking within 40 years if menthol cigarettes were no longer available in the US. Among the studies’ estimated 324,000 – 654,000 smoking-attributable deaths avoided over the next 40 years, 28-36% would occur among African Americans due to the subgroups’ high rate of menthol cigarette use.

The FDA emphasized in its proposal that this regulation would apply to manufacturers, distributors, wholesalers, importers and retailers—not to individual consumers with possession or using menthol cigarettes or flavored cigars.

The public will be able to provide comment for the FDA to review on these proposed regulations on May 4, and public listening sessions to engage with more directly impacted communities are scheduled for June 13 and 15. The agency’s final decision on the proposal will occur after review of all submitted public comments, which can be delivered electronically or via mail through July 5.

In a statement accompanying the decision, Califf emphasized the “important opportunity” for public input as the FDA undergoes deliberation on this would-be regulation.

“The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit,” Califf said. “It is clear that these efforts will help save lives.”

The FDA’s efforts to continue limiting introduction to and use of combustible cigarettes among adolescents and younger adults has been recently pronounced. Amid a half-decade of deliberation, research and regulation of the burgeoning e-cigarette industry, the agency granted a historic authorization to RJ Reynolds Vapor Company, providing the company approval to market 3 of their electronic nicotine delivery system products for the reduced use of combustible cigarettes in adults in October 2021.

In the June 2021 episode of respiratory podcast series Lungcast, Kevin Walton, PhD, Chief of the Clinical Research Grants Branch at the NIH’s National Institute on Drug Abuse (NIDA), discussed the role of menthol in tobacco addiction with American Lung Association (ALA) chief medical officer Al Rizzo, MD.

“(The proposed rule) is a really important step,” Walton explained. “Menthol is very popular with kids, and it makes (tobacco) less aversive, and also people who smoke menthol find it a harder time to quit, and in measures of addiction, tend to have higher levels of addition than non-menthol smokers. So, it’s really important to take that out of the marketplace.”