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FDA proposes ban on menthol cigarettes, flavored cigars

FDA's Califf testifies to Senate appropriators

FDA Commissoner Robert Califf told Senate appropriators Thursday that the menthol cigarette ban proposal would be coming.
FDA Commissoner Robert Califf told Senate appropriators Thursday that the menthol cigarette ban proposal would be coming. (Bill Clark/CQ Roll Call file photo)

Corrected 5:03 p.m. | The Food and Drug Administration on Thursday proposed a long-awaited ban on menthol cigarettes and flavored cigars, targeting products used by more than a third of smokers.

The agency estimates roughly 18.5 million people use menthol cigarettes. The products are particularly popular with Black smokers, with three out of four reporting using menthol products.

More than a third of smokers under 18 use menthol cigarettes, according to the Centers for Disease Control and Prevention. The FDA’s proposed rule says more than half of young people who smoke cigars use flavors. The ban would take effect one year after the final rule is published.

The agency is considering allowing certain exemptions for some menthol products, like cigarettes with low nicotine levels, on a case-by-case basis.

“Ending the sale of menthol cigarettes and flavored cigars will save lives. It will also help reduce the unjust disparities in tobacco use, primarily caused by the tobacco companies targeting vulnerable communities with menthol cigarettes,” American Lung Association’s National CEO Harold Wimmer said in a statement. “When finalized, we believe this will be the single most significant action taken by FDA in its almost 13-year history of regulating tobacco products.”

FDA Commissioner Robert Califf also said the agency was still working on a separate proposal to reduce the level of nicotine in cigarettes, telling reporters Thursday to “stay tuned.”

The FDA first announced its intention to ban menthol cigarettes and flavored cigars in April 2021.

Advocates have framed the menthol ban as an equity issue, but opponents have raised concerns about discrimination against Black smokers and potential excuses for heavier policing. The issue triggered lobbying on opposite sides of the issue by groups like the NAACP — which supports the ban — and the National Action Network, a group led by the Rev. Al Sharpton that opposes the ban.

The FDA is seeking comments by July 5 on addressing concerns of increased policing and other possible discriminatory effects of the proposal. The ban would apply only to manufacturing and sales, not possession, but the agency said it recognizes the potential for harm since states “enforce their own laws in a manner that may impact equity and community safety.”

FDA acting Director of the Center for Tobacco Products Michele Mital declined to offer a timeline on when the agency would decide whether to move ahead with a final rule, citing unknown issues that might surface through the public comment period.

“We’re committed to completing it as expeditiously as possible,” she told reporters.

The proposal is the latest move to tighten restrictions on the tobacco industry. In January 2020, Congress raised the eligibility age to buy tobacco products from 18 to 21. The FDA is also beginning to regulate vaping products with synthetic nicotine after a loophole was closed in the 2022 omnibus (PL 117-103).

Califf on Thursday told lawmakers that the agency should have control of the synthetic nicotine market by mid-May, but he underscored the importance of Congress greenlighting $100 million in user fees from the vaping industry to help fund the new efforts.

“Because we still got a lot of work to do,” he testified to the Senate Agriculture Appropriations Subcommittee. “Two million, at least two million teenagers are currently vaping. Knowing what we know about nicotine addiction, it’s safe to assume the majority of those are already seriously addicted to nicotine.”

The FDA is also now more than seven months behind a court-ordered Sept. 9, 2021, deadline to rule on e-cigarette applications from some of the country’s largest manufacturers, like Juul, although it has been releasing decisions on individual products in small batches. The agency is expected to publish a review schedule with the court next week.

In September 2021, the agency completed a review of 93 percent of applications, mostly from smaller manufacturers, following a crackdown on flavored products deemed too attractive to teens.

The initial version of this report misstated the percentage of young smokers who use menthol cigarettes.

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