The American Lung Association is putting more pressure on the White House to finalize rules to end the sale of menthol cigarettes and flavored cigars in the United States.
A scathing edition of the association’s annual State of Tobacco Control report, published Wednesday, calls on the Biden administration to finalize the proposed rules and says that failing to do so will result in more death and disease caused by smoking, especially among historically marginalized Black communities.
“Menthol cigarettes make it both easier to start and harder to quit by reducing the harshness of the smoke and cooling the throat,” the report notes. Researchers estimate that a regulation banning menthol cigarettes would save about 654,000 lives over the next 40 years, especially those of Black smokers, who are disproportionately more likely to smoke menthols.
In October, the US Food and Drug Administration sent rules for banning the manufacturing and sale of menthol cigarettes and flavored cigars to the White House’s Office of Management and Budget (OMB) for review. Within the OMB is the Office of Information and Regulatory Affairs, which is responsible for reviewing all regulatory action – and this review process is a key step before a final rule may be published in the Federal Register.
But no action on this regulation has been made since it was submitted to the OMB. Under a “timetable” for each rule – on menthol in cigarettes and flavors in cigars – a final rule action has been given the date of March.
“In an extremely disappointing end to 2023, the White House bowed to tobacco industry pressure and failed to move forward in 2023 with finalizing rules to eliminate menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors in cigars,” the new report says. “This lack of action prioritizes politics and tobacco industry profits over public health and if the White House fails to finalize the rules.”
Proponents of the regulation were hoping that the rule would be finalized by January 20. That would have given it exactly a year to be implemented ahead of Inauguration Day, when there could be changes coming to the White House.
“That would have given the FDA the year’s time it claimed was necessary to implement the regulation,” said Daniel Karon, an attorney based in Cleveland who has been following the menthol cigarette rule and who teaches consumer law at the University of Michigan Law School and The Ohio State University Moritz College of Law.
“Even if the Biden administration freed up the regulation to go forward, the question is, would that be sufficient time for the FDA to enact it? Or would it just die on the vine because Trump could come in and stop the rulemaking process in its tracks?” he said of the potential Republican nominee. “If the White House does not at least make an internal decision this week and Biden does not win a second term, a new president could kill the regulation before it ever gets started.”
Another hurdle if the rules are implemented: Tobacco companies will probably sue in federal court, Karon said.
“Big Tobacco will petition for two things: declaratory relief, that is, a declaration or order that what the FDA issued is illegal, and equitable relief, that is, an injunction requiring withdrawal of the regulation,” he said. “Declaratory and injunctive relief are likely going to be on Big Tobacco’s mind when it inevitably files its federal lawsuit against the federal government.”
Menthol cigarettes have emerged as a pivotal issue for President Joe Biden, who is facing an election year with worries over diminished enthusiasm from Black voters.
Some civil rights leaders with ties to the tobacco industry have raised concerns with the White House that a ban would criminalize menthol cigarettes and lead to an increase in deadly police interactions. Meanwhile, the NAACP and the Congressional Black Caucus have endorsed the ban, along with dozens of public health experts, saying it would save hundreds of thousands of Black lives.
The FDA proposal would ban the manufacturing and sale of menthols but would not police smokers themselves. The rule explicitly states, “This regulation does not include a prohibition on individual consumer possession or use, and FDA cannot and will not enforce against individual consumers for possession or use of menthol cigarettes. FDA’s enforcement will only address manufacturers, distributors, wholesalers, importers, and retailers.”
The divide among Black leaders has made the proposed ban a ripe political issue for the administration. It has delayed a decision on the issue three times.
Tobacco remains the leading cause of preventable death and disease in the US, according to the new State of Tobacco Control report. About 16 million people in the US live with a tobacco-related disease.
“Tobacco use is responsible for 480,000 deaths each year, including 45,000 Black individuals. Right now, President Biden can take action and save lives if he finalizes the rules to end the sale of menthol cigarettes and flavored cigars,” Harold Wimmer, president and CEO of the American Lung Association, said in a news release Wednesday.
“Once these rules are final, fewer people will start smoking, millions will begin their journey to quit and lives will be saved,” he said. “We know that the tobacco industry will do anything to protect their profits at the expense of public health, so the White House must focus on implementing lifesaving policies and push back against the industry’s delay tactics.”
What tobacco control looks like in the US
The State of Tobacco Control report acts as a “report card” that evaluates state and federal policies. In the new edition, the federal government gets an A grade for its mass media campaigns that encourage people to not smoke or vape. But it received a C grade for its federal regulation of tobacco products, a D grade for how federal health care plans may be required to cover tobacco cessation and an F grade for its tobacco tax policies.
Taxes are considered one of the most effective ways to reduce smoking, particularly among children, studies suggest. But Congress hasn’t raised federal tobacco taxes in 15 years, since 2009. The federal cigarette tax remains $1.01 per pack, and taxes can vary among other tobacco products.
In the new report, the American Lung Association lists five “key actions” for the Biden administration and Congress to take this year to help eliminate death and disease caused by tobacco use. These include for the FDA to finalize its premarket review of tobacco product applications, for Congress to at least maintain current funding for the US Centers for Disease Control and Prevention’s Office on Smoking and Health and to pass the Helping Tobacco Users Quit Act, which would expand comprehensive Medicaid coverage for tobacco cessation. Another key action is for the FDA and Departments of Justice and Homeland Security to remove all illegal tobacco products from the marketplace.
The White House “swiftly” finalizing the two rules that will remove menthol cigarettes and flavored cigars from the market was No. 1 among those key actions.
“This report highlighted how the tobacco industry continues to exert its political and economic power to undermine, delay, or prevent the enactment of effective tobacco control policies in the US,” Daniel Giovenco, assistant professor of sociomedical sciences at Columbia Mailman School of Public Health, who was not involved in the new report, wrote in an email.
“While tremendous progress has been made in reducing tobacco use over the last several decades, social inequalities in tobacco use persist, contributing to grave tobacco-related health disparities,” he said. “US lawmakers and public health agencies must double down on efforts to enact legislation and increase funding for tobacco control initiatives in order to mitigate a leading cause of preventable disease, disability, and death in the US.”
A ‘worrying’ rise in US adult tobacco use
The State of Tobacco Control report also highlights how a decline in adult cigarette smoking rates has stalled, with about 11.6% of adults reporting smoking in 2022, compared with 11.5% in 2021, according to data from the CDC’s 2022 National Health Interview Survey. Overall tobacco use among adults increased in 2022, driven by a rise in e-cigarette use from 4.5% to 6%.
“The increases in e-cigarette use over the past two years have been driven by the 18- to 24-year-old age group and 65.5% of e-cigarette users in this age group did not smoke cigarettes previously in 2022,” the report says. “The increase in adult tobacco use in 2022 is a worrying sign, and an indication that state and federal lawmakers must redouble their efforts to prevent and reduce tobacco use in 2024.”
In the report’s evaluation of state-by-state tobacco control policies, Alabama and Georgia were rated the worst in the nation, scoring grades of F in all five categories: tobacco prevention and control funding, tobacco tax policies, state smoking restrictions for smoke-free air, access to cessation services and restrictions on flavored tobacco products.
The low grades given to many states stood out to attorney Karon.
“I was disappointed yet not surprised to see such meager activity at the state level. Under the 10th Amendment to the US Constitution, any power that is not specifically given to the federal government or withheld from the states is reserved for the states. To me, state involvement should be a bipartisan issue,” he said.
“Liberal states should want to participate in saving lives, while conservative states should want to act independently of the federal government,” he said. “That is something I would have liked to see more activity on.”
The report gave the best grades to California, which earned A grades for smoke-free air and access to cessation services; the District of Columbia, which earned A grades for tobacco tax policies, smoke-free air and restrictions on flavored tobacco products; and Massachusetts, which earned As for smoke-free air and flavored tobacco product restrictions.
California and Massachusetts are the only states with statewide bans on the sale of menthol cigarettes, according to the Association of State and Territorial Health Officials. In 2020, Massachusetts became the first to ban flavored tobacco products. California’s ban went into effect at the end of 2022.
Public health groups push for action
The American Lung Association has been joined by other public health groups – including the Campaign for Tobacco-Free Kids and the Association of State and Territorial Health Officials, or ASTHO – in urging the White House to ban menthol cigarettes.
Last week, Michael Fraser, ASTHO’s chief executive officer, sent a letter to President Biden asking for the administration’s support in adopting and implementing the federal rule to prohibit the sale of menthol-flavored combustible cigarettes as soon as possible.
“The more time that passes, the more likely that more youth are going to be sort of addicted to cigarettes and creating a new generation of smokers. So we want to make sure that the momentum is really sharp right now,” said Jeffrey Ekoma, ASTHO’s senior director of government affairs.
“If [the White House is] talking about this and they’re actively talking to stakeholders, we want to make sure that they’re hearing not just the voice of the tobacco industry but also the voices of tobacco control advocates like ASTHO and others to make sure that they’re not just hearing one side of the issue,” Ekoma said.
RJ Reynolds, the manufacturer of Newport cigarettes, the most popular brand of menthol cigarettes in the US, said in a statement in December that it thinks a ban would ultimately do more harm to Black smokers than good.
“Reynolds has been clear on where it stands on banning menthol – we strongly believe there are more effective ways to deliver tobacco harm reduction than banning products. A ban on menthol cigarettes would harm, not benefit, public health,” the statement says.
ASTHO’s letter argues that although the tobacco industry and others who are against the ban claim that the rule would increase the potential for criminal charges in Black communities and create an underground market, the FDA has no authority to criminally charge consumers of banned products.
“It’s important to note that the regulations would not penalize the use or possession of these products among consumers, only companies that make or sell non-compliant products,” Columbia’s Giovenco said in his email.
“The tobacco industry and some organizations that have received tobacco industry funding have propagated a false narrative that the ban would contribute to over-policing, particularly in Black communities where menthol smoking is common. Unsurprisingly, the industry fails to acknowledge how their own targeted and exploitative marketing practices are directly responsible for the deaths of hundreds of thousands of Black Americans,” he said. “The proposed ban has the support of virtually every major public health and medical association, as well as many prominent civil rights and social justice advocacy groups, who understand the devastating health toll caused by menthol cigarettes and flavored cigars.”
