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After more than a decade of discussing a ban on menthol in tobacco products, on Thursday the FDA finally to eliminate menthol additives in cigarettes and all flavors other than tobacco in cigars.

The rules would apply to heated tobacco products, although FDA Commissioner Robert M. Califf, MD, said in a press briefing that decisions about menthol electronic nicotine delivery system (ENDS) products are pending. Those decisions will be based on data presented by each manufacturer that wants to keep their ENDS products on the market, he added.

The actions against menthol in conventional cigarettes were based on data showing that it not only makes starting smoking easier and more appealing to youth, but that it also makes withdrawal harder by interacting with nicotine in the brain to enhance nicotine's addictive effects.

"The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit," said HHS Secretary Xavier Becerra in the FDA announcement. "Additionally, the proposed rules represent an important step to advance health equity by significantly reducing tobacco-related health disparities."

The American Heart Association (AHA) also cheered the "long-awaited action" as a step toward health equity.

"For decades, the tobacco industry has relentlessly targeted communities of color, underserved populations, and youth with menthol products and other appealing flavors, putting them on the path to a lifetime of nicotine addiction, serious illness, and premature death," noted a statement attributed to Nancy Brown, CEO of the AHA. "Black smokers are disproportionally impacted, suffering the greatest burden of tobacco-related death in the United States."

More than 18.5 million people ages 12 and older smoke menthol cigarettes in the U.S., according to data cited by the FDA. Rates of use are particularly high among minorities, with the proportion of smokers who use menthol cigarettes at 83% among Black people, 48% among Hispanic people, and 42% among Asian people, compared with 32% of white people.

Eliminating menthol cigarettes alone has been projected to lead to a 15% reduction in smoking and would save 324,000 to 654,000 people from smoking-attributable deaths over the course of 40 years.

Menthol is also the preferred flavor among youth, with about half of teen smokers reporting menthol cigarette use, according to the American Cancer Society Cancer Action Network (ACSCAN). "Additionally, cigars are the second most popular tobacco product used by youth and currently the most popular tobacco product among Black youth," the organization said in a statement.

Along with other professional associations, ACSCAN urged swift finalization of the proposed rule and for the FDA to go a step further to end the sale of all flavored tobacco products.

"Our only regret is that it has taken the FDA so long to initiate this essential ruling to protect America's youth and minority populations from flavored tobacco products," said Hasmeena Kathuria, MD, vice-chair of the American Thoracic Society Tobacco Action Committee, on behalf of the organization.

However, the industry has challenged such FDA rules on tobacco products in the past, leading to court battles that dragged out enforcement for years. Some anti-smoking advocates have predicted that the new ban on menthol cigarettes and flavored cigars .

The agency used the Congressional mandate to regulate tobacco products it had gained in 2009 to ban flavors other than tobacco and menthol in cigarettes. But while the FDA advisory committee analyzing the impact of menthol on tobacco products finally released a report deeming it harmful to public health in 2011, the rulemaking process took even longer. In 2020, the agency announced a policy to restrict most e-cigarette flavors other than menthol and tobacco.

FDA had said in April 2021 that it would move on menthol cigarettes and flavored cigars within the year.

Other tobacco regulation plans previously communicated in the agency's included a potential restriction on nicotine content in tobacco products. However, Califf noted that the agency is still working on the science and other aspects. "Stay tuned, it's still a work in progress," he said.

"I'm 100% sure we can do a lot better in terms of the clinical environment being produced to help someone get through the withdrawal from nicotine," he continued, adding that there's commitment across HHS to make sure that means not just vaping, but also behavioral and digital interventions and social support. "It's not just we want to take away menthol; we want to help people stop smoking."

FDA noted that its actions only impact manufacturers, distributors, wholesalers, importers, and retailers within the U.S., without any enforcement against individual consumers who may possess or use flavored tobacco products.

The proposed rules are open for from May 4 through July 5.

"I'm a cardiologist; I'm used to doing things," Califf told MedPage Today during the briefing. "This is going to take some time even beyond where we are today. To get this through to the final goal line, we're going to have to persevere. ... I tried to get this through in 2016. So, it's already been a long road, but we're on the way now and I think this is really a major step."

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