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After years of study and tentative steps toward restricting menthol flavorings in cigarettes and cigars, the FDA finally pulled the trigger on Thursday -- announcing a rough timeline leading to a full ban.

"The FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars," the .

Next will be publication of proposed rules in the Federal Register followed by a public comment period, toward which the FDA said it is "working expeditiously."

On a press call with reporters, Acting FDA Commissioner Janet Woodcock, MD, said the agency had now accumulated sufficient evidence "establishing the addictiveness and harm from menthol" in cigarettes, and flavorings of all kinds in cigars.

With these to-be-proposed bans, "this launches us on a trajectory" toward ending tobacco-related disease and death, she said.

The move comes more than a decade after an FDA advisory committee determined that menthol makes cigarettes even more harmful than the unflavored kind, by making them more appealing to youth and more addictive in general.

That did not trigger immediate action, of course, even though the FDA had gained regulatory oversight over tobacco products in 2009 (notably, Congress did not give the agency authority to ban cigarettes outright). More than 2 years elapsed after that advisory committee meeting before the agency officially began a rulemaking process with the potential to restrict or ban menthol-flavored cigarettes, which the tobacco industry fought tooth and nail.

And movement after that was marked by more fits and starts. Despite pressure from anti-smoking advocates, FDA officials insisted they needed more study before they could take real action against one of the most popular forms of tobacco products.

Only in November 2018 did then-FDA Commissioner Scott Gottlieb, MD, agree to push the rulemaking process forward, saying the agency definitely intended to ban menthol additives in conventional cigarettes (although he left the door open for menthol-flavored e-cigarette liquids to remain on the market).

Thursday's announcement was still light on details, giving no specifics beyond "within the next year" for when the ban could take effect. Indeed, the FDA subtly acknowledged that the plan could still go awry, with the phrase "if implemented" prefacing a description of the proposed action.

Rather, the agency focused on the rationale for banning menthol additives.

"In the U.S., it is estimated that there are nearly 18.6 million current smokers of menthol cigarettes," the press release said. "But use of menthol cigarettes among smokers is not uniform: out of all Black smokers, nearly 85% smoke menthol cigarettes, compared to 30% of White smokers who smoke menthols. In addition, among youth, from 2011 to 2018, declines in menthol cigarette use were observed among non-Hispanic White youth but not among non-Hispanic Black or Hispanic youth."

In a , HHS Secretary Xavier Becerra called it a "science-based decision [intended] to tackle health disparities in our most marginalized communities."

The American Lung Association (ALA), which has long criticized the agency's slow pace on the issue, said it was pleased with Thursday's announcement.

"Removing menthol cigarettes and flavored cigars from the marketplace will prevent many kids from starting to smoke and promote cessation especially among Black Americans. These actions have the potential to save millions of lives," said the ALA's assistant vice president of national advocacy, Erika Sward, in an emailed statement.

"We expect the tobacco industry to throw everything they have at stopping this bold, game-changing proposal but President Biden and his administration should not be deterred. As our nation works to address a myriad of racial inequities, it can and must also address the public health injustices caused by the tobacco industry targeting Black and brown communities with menthol cigarettes," she said.

Other organizations applauding the FDA's announcement included the , the , and the The University of Texas MD Anderson Cancer Center in Houston.

Mitch Zeller, JD, head of the FDA's Center for Tobacco Products, stressed during the press call that any rule when implemented would be directed at manufacturers, distributors, and retailers -- not individual consumers.

Moreover, local law enforcement would not be involved in policing the bans, so individuals shouldn't worry about being caught with illicit menthol cigarettes during routine traffic stops.

Neither Zeller nor Woodcock would speculate on when rules could go into effect beyond the vague timeline given in the press release. The time needed to digest and respond to public comments is unpredictable, they suggested, and that's without the likely prospect of litigation seeking to block any restrictions.

Asked why it took so long for the agency to reach this stage, Zeller recounted some of the steps taken in the previous decade, but offered no real explanation for the lack of further action following the 2013 advance notice of rulemaking.

"As a regulator, it's too pat to say these things take time," he said.

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