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(CNN) --
The US Food and Drug Administration (FDA) proposed a rule Thursday to ban menthol cigarettes and flavored cigars.
"Through careful consideration of the scientific evidence and our authorities under the Tobacco Control Act, we have determined that these actions are appropriate for the protection of public health," said FDA Commissioner Dr. Robert Califf. , to a Senate subcommittee.
"The proposed product standards would, among other things, improve the health and reduce the mortality risk of current smokers of menthol or flavored cigarettes by substantially reducing their consumption and increasing the likelihood of quitting. This is another important advance the agency's efforts to combat youth tobacco use and promote health equity."
According to experts, this landmark proposal could have a major impact on public health.
"I want to underscore the momentous aspect of this. It will be a game changer," Erika Sward, associate vice president of national advocacy for the American Lung Association, said Thursday.
"The regulation will have a tremendous impact in preventing children from starting to use tobacco and will critically save the lives of people, especially from diverse backgrounds."
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A long wait
The use of menthol is a fairness issue that the FDA has been considering for more than a decade.
It is the last specialty flavor allowed in US cigarettes. It was drawn from the Tobacco Control Act of 2009, which banned all other flavored cigarettes and gave the FDA the authority to regulate the tobacco industry to protect public health.
The law also required the FDA to conduct and fund research on menthol.
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After several years of investigation by the FDA and public input from hundreds of thousands of stakeholders, the Public Health Law Center and other groups filed a citizen petition calling for the agency to ban menthol in cigarettes.
In 2020, a lawsuit was filed alleging that the FDA had unreasonably delayed issuing a definitive response.
In 2021, the FDA announced that it would continue to develop standards.
About 18.6 million people smoke menthols in the United States.
That's about 36% of all smokers, according to the FDA, and a disproportionate number are people of color.
An equity issue
The tobacco industry has heavily marketed menthol products to communities of color and other minority groups.
About 30% of white smokers choose menthols, but they are the cigarette of choice for almost 85% of black smokers.
About 40% of women smoke menthols, compared to 31% of men, according to the FDA.
People in the LGBTQ community are also significantly more likely to smoke menthols.
A 2013 study that analyzed data from the 2009-10 U.S. Centers for Disease Control and Prevention (CDC) National Adult Tobacco Survey found that 36 % of LGBTQ smokers chose menthols, compared to 29.3% of heterosexual smokers.
"Today marks the beginning of the end for menthol cigarettes, a truly historic moment for public health. For decades, tobacco companies have intentionally pushed menthol cigarettes to hook young people on their deadly products and have used racist advertising practices to intentionally targeting black Americans; the resulting health consequences have been devastating," Dr. Julie Morita, executive vice president of the advocacy organization the Robert Wood Johnson Foundation, said in a statement.
More than half of underage smokers use menthol cigarettes, according to the CDC.
A survey of adult smokers revealed that most started with menthols.
Other studies indicate that minors who smoke menthol cigarettes are more likely to become regular smokers than occasional smokers.
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"The proposed rules will help prevent minors from becoming the next generation of smokers and help adult smokers quit," Health and Human Services Secretary Xavier Becerra said in a statement Thursday.
"In addition, the proposed rules represent an important step in advancing health equity by significantly reducing tobacco-related health disparities."
Smoking rates in the United States hit an all-time low in 2018, according to the CDC, but smoking remains the leading cause of preventable death, disease and disability in the country.
Overall, cigarette smoking is responsible for more than 480,000 deaths a year in the United States, including more than 41,000 deaths from secondhand smoke.
According to the FDA, removing menthol from cigarettes and cigars could have a significant effect on the number of smokers.
By one estimate, it could even prevent 650,000 premature deaths over the next 40 years.
According to another study, the elimination of menthol as a flavoring in cigarettes would lead 923,000 people to quit smoking, including 230,000 black women, in the first year and a half.
Changes to flavored cigars
After the 2009 Tobacco Control Act banned flavored cigarettes, many smokers who preferred flavors, especially minors, may have switched to flavored cigarettes, including menthol and "minor-friendly" flavors such as fruit punch, strawberry and grape.
The FDA stated that the use of flavored cigarettes "increased dramatically" and that public health goals may have been "undermined" by the availability of these products.
According to the FDA, more than half a million young people in the United States smoke flavored cigarettes.
Flavored cigarettes and cigars are especially popular with minors, particularly blacks and Hispanics, who are twice as likely to smoke them as their white peers.
The FDA noted that a survey found that nearly 74% of teens ages 12 to 17 said they smoke cigarettes because they come in flavors they like.
In 2020, more young people said they tried a cigar each day than a cigarette.
"A ban on menthol cigarettes and flavored cigars would mark a historic turning point in the decades-long battle against tobacco use and the epidemic of tobacco-related disease," said Nancy Brown, CEO of the American Tobacco Association. Heart, in a statement on Thursday.
"The science is clear: menthol cigarettes have an adverse impact on public health and no public health benefit compared to non-menthol cigarettes. They increase the likelihood and degree of addiction among young smokers, raising the number of premature deaths from tobacco use. Removing it from the market would have enormous public health benefits in this country."
Individual consumers would not be prosecuted
If enacted, the FDA was careful to note that the rule would be directed only at tobacco companies and industry.
The agency, like state and local law enforcement, does not independently enforce FDA regulations.
The proposed rule would not prosecute individual consumers for possessing menthol products.
Some activists, such as the Rev. Al Sharpton and the Mothers of the Movement, have warned that a ban on menthol products could lead to more violent encounters with law enforcement police.
Anti-smoking advocates discovered that Sharpton and some other civil rights organizations have taken money from cigarette manufacturers for decades.
Sharpton acknowledged to The New York Times in 2019 that Reynolds American has long been a donor to his National Action Network, but said "this is not about money."
Other groups, such as the NAACP and many members of the black caucus in Congress, favor a ban.
"The tobacco industry's targeting and marketing of menthol flavor has had a devastating impact on our community. Menthol cigarettes have induced many minors and adults, leading to lifelong addictions, health problems and ultimately ultimately, the death of our loved ones," the NAACP said in a statement.
"Today is a great victory for fairness, justice and public health."
The FDA said Thursday that it "recognizes concerns related to how state and local law enforcement may enforce their own laws in a way that may affect community fairness and safety, particularly for underserved communities." FDA is seeking comments on, among other things, how it can make clear the role of the agency and of state and local law enforcement, as well as policy considerations related to the potential racial and social justice implications of proposed product standards.
Califf said this is something the agency will address more of in the future.
"We take these concerns very seriously," he said.
"Let's make one thing very clear. These measures and their enforcement will fall on the tobacco industry, not on the individuals who own or use these products."
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Next Step: Public Comment Period
The FDA's ban on menthol and flavored cigarettes will not go into effect immediately.
The next step will be a comment period that will run from May 4 to July 5.
The FDA will also hold public listening sessions on June 13 and 15.
Next, the agency is expected to take some time to review the comments before finalizing the rule.
The standard would enter into force one year after the publication of the final version.
Public health experts are confident that tobacco companies will also try to stop the ban by suing the agency, as companies have done with previous tobacco control laws.
"This is not trivial," Califf said.
Tobacco-related deaths are high, he noted, and so are tobacco-related illnesses.
"My request is that we not lose the sense of urgency in this matter," he said.
"You can literally save lives."
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