FDA commissioner Robert M. Califf, in remarks to reporters, said a ban on menthol cigarettes and flavored cigars would save lives and reduce health disparities. Expressing a sense of urgency to finalize the rule, he stressed that 480,000 people a year in the United States die of tobacco-related illnesses, making smoking the leading cause of preventable death.

Still, the effective date for the ban could easily be two years away. The FDA will accept public comments for the next few months and then write a final regulation that will include lead time for manufacturers to shutter production. Court challenges by the industry are expected and could set off a protracted legal battle.

Assuming a federal ban is finalized, it would be the most aggressive action taken by the FDA against the industry since Congress gave the agency the authority to regulate tobacco products in 2009, said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.

“This is a giant step forward” in decreasing health disparities, said Carol McGruder, co-chair of the African American Tobacco Control Leadership Council, an advocacy group that has pushed hard for the change. Because of potential litigation-related delays, she urged states and cities to adopt their own bans.

Manufacturers sold 203.7 billion cigarettes in the United States in 2020, according to the Federal Trade Commission’s annual Cigarette Report. That marked the first increase in two decades but was sharply lower than the peak in the 1980s, when annual sales exceeded 600 billion cigarettes. Menthol cigarettes make up about 36 percent of the market — and 50 percent of sales for Reynolds American Inc., which manufactures Newport, the top-selling menthol brand.

Tobacco companies, which have long expressed opposition to a menthol ban, said a prohibition is unlikely to work and that menthol cigarettes should not be singled out.

“The scientific evidence shows no difference in the health risks associated with menthol cigarettes compared to non-menthol cigarettes, nor does it support that menthol cigarettes adversely affect initiation, dependence or cessation,” Kingsley Wheaton, chief marketing officer of British American Tobacco, which owns Reynolds, said in a statement.

Altria, which makes menthol versions of Marlboro and its other brands, warned that “taking these products out of the legal marketplace will push them into unregulated, criminal markets that don’t follow any regulations and ignore minimum age laws.”

Guy Bentley, director of consumer freedom at the Reason Foundation, said on Twitter: “Serious Volstead Act vibes here,” referring to the 1920 law designed to implement Prohibition, which failed to end sales of alcohol. The Reason Foundation is a think tank that advocates on behalf of libertarian principles.

Thursday’s move was foreshadowed almost exactly a year ago, when the FDA promised to propose a ban of menthol cigarettes and flavored cigars within 12 months.

Menthol has deep roots in Black communities. In the 1950s, about 10 percent of Black smokers used menthol cigarettes. Today, more than 85 percent of Black smokers choose menthol cigarettes — almost three times the proportion for White smokers. Researchers and regulators have found the sharp rise was a result of aggressive marketing in Black communities — especially of menthol cigarettes — by the tobacco industry. The cigarette companies deny targeting Black communities. African Americans die of tobacco-related illnesses, including cancer and heart disease, at higher rates than other groups.

The Biden administration, in proposing the menthol ban, is taking on an issue that has fueled strong emotions. While many Black health leaders and civil rights organizations support prohibiting menthol cigarettes, some prominent individuals and groups warn that a ban would turn Black smokers into law breakers and lead to potentially dangerous confrontations with police.

The Rev. Al Sharpton, who recently met with administration officials, said in a letter to the White House that a prohibition “would exacerbate existing, simmering issues around racial profiling, discrimination, and policing.” He urged the administration instead to create a commission to study the potential effects of a menthol ban on Black communities.

“We’re not opposing anything, we’re raising questions and asking them to get these answers,” Sharpton said in an interview with The Post’s Health 202 this week.

Sharpton is founder and president of the National Action Network, a nonprofit that has received financial support from Reynolds. He said in the interview that contributions don’t influence the organization’s positions.

The American Civil Liberties Union and several other groups also oppose the ban, with some citing the case of Eric Garner, a Black man who was killed in 2014 by New York police after being stopped for selling single cigarettes.

But many Black leaders, and the FDA, reject the view that a menthol ban would result in a crackdown on consumers — and accuse opponents of toeing the industry line.

“These Black leaders are all saying the same thing they have said for a decade, that a ban on menthol will lead to the criminalization of Black youth,” said Delmonte Jefferson, executive director of the Center for Black Health & Equity, a nonprofit. “They are saying, ‘Don’t ban menthol, don’t ban something that is killing us.’ ”

Derrick Johnson, president and chief executive officer of NAACP, said in a statement Thursday that “the targeting and marketing of menthol flavoring by the tobacco industry have had a devastating impact on our community. … Today is a huge win for equity, justice, and public health concerns.”

The FDA said Thursday that consumers would not be in the crosshairs of a ban because the proposal would not bar individuals from possessing or using menthol cigarettes or flavored cigars. Instead, enforcement would be focused on manufacturers, distributors and retailers.

The FDA said it would accept comments from the public between May 4 and July 5. It will also hold two “listening sessions” in June. The ban does not affect menthol-flavored e-cigarettes, which the agency still is reviewing.

Almost all cigarette flavors were banned by the 2009 Family Smoking Prevention and Tobacco Control Act, which conferred on the FDA the authority to regulate tobacco. Menthol cigarettes were exempted partly because of opposition from the Congressional Black Caucus; many members now support a ban. The law directed the FDA to take a close look at how to handle menthol, and the expectation among health groups at the time was that the agency would move quickly to bar those cigarettes. Scientific reviews concluded removing menthol from cigarettes would provide significant public health benefits.

But the Obama administration did not move forward. The Public Health Law Center at Mitchell Hamline School of Law in Minnesota sought to prod federal regulators to ban menthol cigarettes by petitioning the FDA in 2013 on behalf of several health organizations. The Trump administration’s first FDA commissioner, Scott Gottlieb, supported a prohibition, but after he left the agency in 2019, the White House did not follow through. Organizations sued the agency in 2020 to compel it to respond to the petition, prompting a federal judge to set a deadline of last April for the administration to announce its intentions.

Studies have shown that menthol, which has a minty taste and provides a cooling sensation, makes it easier for young people to start smoking by masking throat irritation caused by cigarettes.

The Centers for Disease Control and Prevention and other researchers have found that tobacco companies, over the years, have used discounts and coupons — which are most popular among African Americans, other communities of color and young people — to increase sales. The industry also had a tradition of enlisting prominent Black athletes and sponsoring sporting and cultural events to promote its wares, including menthol cigarettes — though those practices are now barred or sharply restricted.

Some states and cities have moved forward to ban menthol and other flavors. Massachusetts has banned all tobacco flavors, including menthol in cigarettes. California enacted a similar prohibition, but the law is on hold because opponents succeeded in placing it on the November ballot. Dozens of cities also have restricted menthol and other flavors in cigarettes and e-cigarettes.

As of 2019, the FDA said, more than 18.5 million people 12 and older smoked menthol cigarettes. The agency said fruit flavors have made cigars especially appealing to young people. Under its proposed ban, cigars could only be tobacco flavored.

A federal menthol ban has been “a long time coming, and it is really important because we know if we can get menthol cigarettes off the market, we can save a lot of lives,” said Robin Koval, chief executive officer and president of Truth Initiative, an anti-tobacco advocacy group.

A study to be published this week in the peer-reviewed journal Tobacco Control showed that if a menthol cigarette ban in the United States were to have the same effect as a Canadian menthol ban, more than 1.3 million additional smokers would quit, including more than 381,000 African Americans, according to Geoffrey Fong, professor of psychology and public health sciences at the University of Waterloo in Canada and lead author of the study.

The Canadian ban on menthol cigarettes was phased in between 2015 and 2017.

Rachel Roubein contributed to this report.