FDA takes major step toward banning menthol cigarettes and flavored cigars

(CNN) — The U.S. Food and Drug Administration took a “momentous” step Monday toward banning menthol in cigarettes and banning flavored cigars, proposing a rule that public health experts say could save hundreds of thousands of lives.

The FDA has been talking about banning menthol and flavored cigars for years and has said the issue is important for the agency.

In April, it announced it would move ahead with proposed product standard restrictions because such a move had “the potential to significantly reduce disease and death” and reduce “youth experimentation and addiction” as well as increase the number of smokers who quit.

The agency has sent the rule to the White House Office of Management and Budget for final review.

“Finalizing these two product standards remains a top priority for the FDA. The posting of both rules on the OMB website means they have reached the final step of review for regulatory documents,” Dr. Brian King, director of FDA’s Center for Tobacco Products said in an email to CNN.

The American Lung Association said it may be the most significant action the agency has taken in the 14 years since it was given the authority to regulate tobacco.

“It’s a big, vital and critical step on the way to banning these products,” said Erika Sward, assistant vice president of national advocacy with the American Lung Association. “Truly, it’s momentous.”

The association and several other groups, including the Campaign for Tobacco-Free Kids, are urging the Office of Management and Budget to act quickly and expedite the review so the final regulations could be issued by the end of the year.

“Once implemented, they will protect kids from tobacco addiction, advance health equity and save hundreds of thousands of lives, especially Black lives,” said Yolonda Richardson, president and CEO of Campaign for Tobacco-Free Kids.

The National Association of Tobacco Outlets, the national retail trade association representing more than 66,000 stores that sell tobacco products, don’t think a ban on menthol cigarettes and flavored cigars will suddenly make everyone quit. Instead, it will prompt criminal activity.

“The supply of these products will shift from responsible, licensed and regulated retailers to drastically expand an already existing illicit marketplace,” the association said in an email to CNN.

Scientists have long understood that menthol flavor can make those cigarettes more addictive than tobacco-flavored ones. Menthol flavoring is attractive, particularly to new smokers, because it masks the harsh taste of tobacco, and a 2015 study found that it makes people want to smoke more.

For years, tobacco companies have aggressively targeted minority communities with menthol marketing, according to the US Centers for Disease Control and Prevention. The focused outreach has been highly effective, particularly among the Black community, and menthol cigarettes have played a role in widened health disparities.

A 2020 study showed that while 43% of all adult smokers smoked menthols, more than 83% of Black smokers did. Only about 30% of White smokers chose menthols.

A ban on menthol cigarettes could eliminate some significant health disparities, according to a study from the Council on Foreign Relations.

Black people die at significantly higher rates than White people of smoking-related illnesses including stroke, heart disease and lung cancer: They make up 12% of the population in the US, but people who are Black account for 41% of smoking-related premature deaths and 50% of the life-years lost associated with menthol tobacco product use between 1980 and 2018, one study found.

Within five years, the elimination of menthol cigarettes could close the gap in lung cancer deaths, the study found.

Prohibiting menthol cigarettes would save up to 654,000 lives in the US within 40 years, including the lives of 255,000 members of the Black community, a 2022 study found.

More than half of kids who smoke use menthol cigarettes, according to the CDC. Studies have found that children who smoked menthols were more likely to become regular smokers than occasional smokers.

Flavored cigars and cigarillos also seem popular with children, particularly Black and Hispanic kids who are twice as likely to smoke them as their White classmates. In 2020, more young people said they tried a flavored cigar every day than tried a cigarette, according to the FDA. But if flavors in cigars are eliminated, researchers think it could increase the likelihood that users may quit.

The FDA has tried to regulate other kid-friendly menthol products. Just last week, it issued marketing denial orders to R.J. Reynolds Vapor Co. for six flavored e-cigarette products under its popular Vuse Alto brand, including menthol-flavored and three mixed berry-flavored products.

The FDA has been considering menthol regulations for more than a decade. Although the number of people who smoke cigarettes in the US has fallen to one of the lowest levels in history, the proportion who smoke menthols has been increasing, according to the CDC. Smoking is still the No. 1 cause of preventable death in the US.

Two states didn’t wait for the FDA to ban menthol cigarettes. In 2020, Massachusetts became the first to ban all flavored tobacco products, including menthol. In 2022, California’s ban went into effect.

In the meantime, in an effort to work around the two state bans and to lay the groundwork for a potential federal ban, tobacco companies have introduced cigarettes with a menthol-like synthetic cooling agent. They come in boxes that look similar to menthol versions, and they’re marketed to menthol smokers. A study published in the medical journal JAMA last week found that one ingredient in some brands provided even more cooling activity than the menthol equivalent.

Flavors in cigarettes, with the exception of menthol, were banned in 2009. But another ingredient recently introduced to these products produces a kind of vanilla and tropical taste, the JAMA study found.

The final rules could address these tobacco company workarounds, Sward said, but it’s not clear whether they will do so.

Once the federal government makes its final rules, tobacco companies are expected to sue, as they have with nearly every other tobacco restriction.

Sward said that between now and when the administration signs off, the tobacco industry will probably go full-tilt in an effort to slow or stop a ban.

“It’s a big deal for them because it is how they attract and sustain people’s addiction,” she said. “So if this stands, they will have lost a major tool that they’ve used to addict and sustain an addiction for millions of people.”