The Food and Drug Administration (FDA) released its plan to ban menthol cigarettes and flavored cigars on Thursday, saying the actions have the potential to significantly reduce disease and death.
"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."
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The rules, the FDA said, build on the Family Smoking Prevention and Tobacco Control Act and are also a critical component of the Biden administration's Cancer Moonshot.
Last April, the Biden administration pledged to try to ban menthol within the year.
Tobacco use is a leading cause of cancer and death from cancer, with approximately 30% of all cancer deaths in the U.S. from smoking, according to the FDA.
The menthol product standard will reduce the appeal of cigarettes — particularly to youth and young adults — and improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.
Menthol has particularly high rates of use by youth, young adults and African Americans and other racial and ethnic groups.
The FDA said eliminating menthol cigarettes could prevent between 300,000 and 650,000 smoking deaths over 40 years.
In addition, the flavored cigar product standard would reduce the appeal of cigars, decrease the likelihood of experimentation and development of nicotine dependence and improve public health by increasing the likelihood that existing cigar smokers may quit.
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The FDA noted that it cannot and will not enforce against individual consumers for the possession or use of menthol cigarettes or flavored cigars.
Should the rules be finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who manufacture, distribute or sell such products within the U.S. that are not in compliance with applicable requirements.
Notably, state and local law enforcement agencies do not independently enforce the Federal Food, Drug and Cosmetic Act and do not – and cannot – take enforcement actions against any violation of FDA’s tobacco authorities, including its regulations, on the FDA’s behalf.
"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 Dr. Robert Califf 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."
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Menthol's elimination would be a blow to tobacco companies and previous efforts have met resistance from Big Tobacco, members of Congress and competing political interests under both Democratic and Republican administrations.
The FDA has been under legal pressure to issue a decision after anti-smoking and civil rights groups sued the administration for "unreasonably" delaying action on earlier requests to ban menthol.
The Associated Press contributed to this report.