FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars

The U.S. Food and Drug Administration (FDA) on Thursday announced its proposed rule on product standards to ban menthol flavoring in cigarettes and non-tobacco flavors in cigars.

These actions 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, The FDA said in a statement.

“The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” Health and Human Services Secretary Xavier Becerra said in a statement. “Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities,” it added.

“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. It is clear that these efforts will help save lives,” FDA Commissioner Robert M. Califf, M.D said. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”

According to the FDA, In 2019, there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the U.S., with particularly high rates of use by youth, young adults, and African American and other racial and ethnic groups. Published modeling studies have estimated a 15 percent reduction in smoking within 40 years if menthol cigarettes were no longer available in the United States. These studies also estimate that 324,000 to 654,000 smoking attributable deaths overall (92,000 to 238,000 among African Americans) would be avoided over the course of 40 years.

According to the FDA, when finalized, the proposed menthol product standard will:

reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.

The FDA’s enforcement of the rule would not target individual consumers; its rule is intended to confront the industry — manufacturers, distributors and retailers, for instance.

Beginning May 4, 2022, the public can provide comments on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities. The listening sessions are another opportunity for individuals, communities, and organizations to share their perspectives with the FDA and will be recorded and submitted to the dockets.

The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.

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