The proposed move wouldn’t take effect until at least 2024
The Biden administration proposed a national ban on menthol cigarettes, advancing a regulatory plan that could sweep from the market more than a third of all cigarettes sold in the U.S. The products represent more than $20 billion in annual sales.
The Food and Drug Administration on Thursday published proposed rules laying out the details of the plan. The ban would prohibit the sale of menthol cigarettes and all flavored cigars. The FDA said it is considering allowing exemptions on a case-by-case basis for certain products, such as heated-tobacco devices or cigarettes with very low nicotine levels. The ban wouldn’t affect menthol e-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.
The policy could save hundreds of thousands of lives, FDA Commissioner Robert Califf said Thursday. He said in his career as an intensive-care cardiologist, he had seen many people die of smoking-related diseases.
“We know the majority of smokers want to quit,” Dr. Califf said on a call with reporters. Prohibiting menthol in cigarettes, he said, will give them “a better shot.”
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, BTI 0.26%▲ 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.
“We strongly believe that there are more effective routes to deliver tobacco harm reduction than banning menthol in cigarettes,” BAT Chief Marketing Officer Kingsley Wheaton said Thursday.
Marlboro maker Altria Group Inc. MO -6.99%▼ holds the No. 2 spot in the U.S. menthol-cigarette market.
“Prohibition, at least through history, hasn’t worked,” Altria Chief Executive Billy Gifford said Thursday on a conference call with analysts and reporters. Federal regulators should focus instead on helping smokers switch to lower-risk products such as e-cigarettes, he said.
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 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.
Reynolds has funded opposition efforts led by prominent Black community leaders. They 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.
“We must acknowledge and address the impact smoking has on public health,” said Rep. Yvette Clarke (D., N.Y.), who opposes the menthol ban. “And we must also be conscious of how this FDA ruling will impact Black and brown communities, including… unintended social-justice and policing issues the ban may give rise to.”
Ms. Clarke has received campaign contributions from Reynolds’ political action committee and from leaders at Altria.
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.
“This is not about going after individuals smoking menthol cigarettes; this is about manufacturers and people who are selling them,” White House Press Secretary Jen Psaki said Thursday. “And it would save lives.”
NAACP President Derrick Johnson said the “targeting and marketing of menthol flavoring by the tobacco industry have had a devastating impact on our community.”
“Today is a victory for Black America,” he said.
Tom McGinty and Alex Leary contributed to this article.
Jennifer Maloney – Wall Street Journal – 2022-04-28.
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