Biden Administration Advances Ban on Menthol Cigarettes

The proposed menthol ban wouldn’t take effect for at least two years. The FDA will invite public comments on the proposed rules; the agency must then review them all. It could publish final rules as early as 2023, and the ban could be set to take effect in 2024. At least two tobacco companies have indicated that they might then sue, which could further delay the ban.

The plan, which has been in the works for more than two decades, is the biggest move the federal government has made to curb cigarette sales since the FDA gained regulatory control over the tobacco industry in 2009.

For tobacco companies, menthols are a crucial segment of the cigarette business. Because menthol smokers skew younger than average, they represent a longer potential lifetime of smoking. The share of U.S. smokers who use menthols has risen continuously, from 30.5% in 2005 to 43% in 2020, according to a Wall Street Journal analysis of data from the National Survey on Drug Use and Health.

A U.S. menthol ban would be a big blow to

British American Tobacco

PLC, which in 2017 spent about $50 billion to take full control of Reynolds American Inc. Reynolds makes Newport, the leading menthol-cigarette brand in the U.S. Menthols account for more than half of BAT’s U.S. cigarette unit sales and roughly 30% of its global profits, according to Morgan Stanley analyst Pamela Kaufman.

Marlboro maker

Altria Group Inc.

holds the No. 2 spot in the U.S. menthol-cigarette market.

The Family Smoking Prevention and Tobacco Control Act, signed by President

Barack Obama

in 2009, gave the FDA regulatory authority over the tobacco industry for the first time. The law banned candy, fruit and spice flavorings in cigarettes because of their potential appeal to children, but left unsettled the question of menthol. The law stipulated that the FDA could prohibit menthol cigarettes only if it could demonstrate that a ban was a net benefit to public health and took into account unintended consequences such as an illicit market.

The agency concluded in 2013 that menthols were harder to quit and likely posed a greater health risk than regular cigarettes. But the Obama administration didn’t move the policy forward after that. In 2017,

Scott Gottlieb,

then commissioner of the FDA, sought and obtained support from the Trump administration to advance the menthol-cigarette ban as part of a broader regulatory plan for the tobacco industry. When he left the agency in 2019, Trump administration officials shelved the plan, according to people familiar with the matter.

When President Biden took office in 2021, his team had to decide quickly whether or not it would support a menthol-cigarette ban because the FDA faced a court deadline to declare its intentions. The Biden administration embraced the plan, and the FDA since then has been working on the proposed rules.

“The day of reckoning for menthol has finally come,” said

Mitch Zeller,

who retired earlier this month after serving nine years as director of the FDA’s Center for Tobacco Products.

Menthol, a compound that occurs naturally in mint plants, has been added to cigarettes since the 1920s. Menthol cigarettes create a cooling sensation in the mouth and throat, similar to that of a mentholated cough drop. Health officials say that eases the throat irritation caused by cigarette smoke, making menthols more appealing to young people and people who have never smoked. Menthol also interacts with nicotine in the brain to enhance nicotine’s addictive effects, the FDA said.

U.S. health officials say a menthol ban would reduce youth initiation, increase the success rate for smokers trying to quit, and address health disparities across racial groups. The ban is part of the Biden administration’s Cancer Moonshot initiative to reduce the death rate from cancer by at least 50% over the next 25 years, the FDA said.

In the U.S., 81% of Black smokers and 51% of Hispanic smokers used menthols in 2020, compared with 30% of white smokers, according to the National Survey on Drug Use and Health.

Smoking is a major contributor to heart disease, cancer and strokes—the three leading causes of death among African-Americans, according to the Centers for Disease Control and Prevention. And Black people in the U.S. die at a higher rate than other groups from smoking-related cancers, according to CDC research.

The smoking rate has been declining in the U.S. for decades, though it did tick up slightly in 2020 when the pandemic hit. About 12.5% of adults in the U.S., or 30.8 million people, were cigarette smokers in 2020, according to the CDC.

A recent study from the University of Waterloo in Canada projected that a ban on menthol cigarettes in the U.S. would prompt 1.3 million smokers to quit, including more than 380,000 Black smokers, in the first four to 23 months after the ban went into effect.

Altria and Reynolds have disputed the FDA’s conclusions on the health effects of menthols and have said a ban would have unintended consequences.

Black community leaders funded by Reynolds American have said menthol bans would expand the illicit market for cigarettes and lead police to racially profile Black smokers. The American Civil Liberties Union and some members of the Congressional Black Caucus have expressed similar concerns.

The FDA and other proponents of a national menthol ban, including the NAACP, have countered that the prohibition would apply to manufacturers, importers, wholesalers, distributors and retailers—not individual consumers.

—Tom McGinty contributed to this article.

Write to Jennifer Maloney at jennifer.maloney@wsj.com