“Among other things, the proposed product standards would improve the health and reduce the risk of mortality for current smokers of menthol cigarettes or flavored cigars, significantly reducing their consumption and increasing the likelihood of smoking cessation. This is another important step in the agency’s efforts to tackle youth tobacco use and promote health equity.”
This landmark proposal could have major public health implications, experts said.
“I want to emphasize the important aspect of this. It’s going to be a game changer,” said Erika Sward, associate vice president of the American Lung Association’s national advocacy group, Thursday. “The rules will have a huge impact in discouraging children from taking up tobacco use and will be crucial in saving the lives of people, particularly from diverse backgrounds.”
It will take a long time
Menthol is a stock issue that the FDA has been considering for more than a decade. It is the last special flavor to be approved in cigarettes in the United States. It was excised from the Tobacco Control Act of 2009, which banned all other flavored cigarettes and gave the FDA the power to regulate the tobacco industry to protect public health. The law also required the FDA to conduct and fund research into menthol. After several years of FDA investigation and public contributions from hundreds of thousands of interested parties, the Public Health Law Center and other groups filed a citizens’ petition asking the agency to ban menthol in cigarettes. A 2020 lawsuit alleged that the FDA unreasonably delayed issuing a final response. In 2021, the FDA announced it would move forward with the legislation. About 18.6 million people smoke menthol 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 problem
The tobacco industry has heavily marketed menthol products to communities of color and other minority groups.
About 30% of white smokers opt for menthol, but for almost 85% of black smokers it is the cigarette of choice. According to the FDA, about 40% of women smoke menthol compared to 31% of men. LGBTQ people are also significantly more likely to smoke menthol. A 2013 study looking at data from the US Centers for Disease Control and Prevention’s 2009-10 National Adult Tobacco Survey found that 36% of LGBTQ smokers chose menthol, compared to 29.3% of straight smokers .
“Today marks the beginning of the end of menthol cigarettes – a truly historic moment for public health. For decades, tobacco companies have deliberately promoted menthol cigarettes to tie young people to their deadly products and adopted racist marketing practices to target Black Americans; the resulting health consequences have been devastating,” said Dr. Julie Morita, executive vice president of advocacy for the Robert Wood Johnson Foundation, in a statement.
More than half of children who smoke use menthol cigarettes, according to the CDC. A survey of adults who smoke found that the majority started with menthol. Other studies said that children who smoked menthol cigarettes were more likely to become regular smokers than occasional smokers.
“The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit smoking,” Xavier Becerra, Minister for Health and Human Services, said in a statement on Thursday. “Furthermore, the proposed rules represent an important step in advancing health equity by significantly reducing tobacco-related health disparities.”
Smoking rates in the US hit an all-time low in 2018, according to the CDC, but smoking is still the leading cause of preventable death, disease and disability in the country. In general, cigarette smoking is responsible for more than 480,000 deaths per year in the United States, including more than 41,000 deaths from secondhand smoke. Eliminating menthol in cigarettes and cigars could have a significant impact on the number of smokers, the FDA said. According to one estimate, it could even prevent 650,000 premature deaths over the next 40 years. Another study estimated that eliminating menthol as a cigarette flavoring would help 923,000 people quit smoking in the first year and a half, including 230,000 African Americans.
A switch to flavored cigars
After the Tobacco Control Act of 2009 banned flavored cigarettes, many smokers who preferred flavors — especially children — may have switched to flavored cigars, including menthol and “kid-friendly” flavors like fruit punch, strawberry, and grape.
The FDA said that the use of flavored cigars has “increased dramatically” and that public health goals may have been “undermined” by the availability of these products. More than half a million teenagers in the United States smoke flavored cigars, according to the FDA.
Flavored cigars and cigarillos are particularly popular with children, particularly Black and Hispanic children, who smoke them twice as often as their white classmates.
The FDA noted that a survey found that nearly 74% of teens between the ages of 12 and 17 said they smoke cigars because they contained flavors they liked.
In 2020, more young people said they tried a cigar every day than a cigarette.
“A ban on menthol cigarettes and flavored cigars would mark a historic turning point in the decades-long fight against tobacco use and the tobacco-related disease epidemic,” Nancy Brown, CEO of the American Heart Association, said in a statement Thursday. “The science is clear: menthol cigarettes have negative public health effects and no public health benefits compared to non-menthol cigarettes. They increase the likelihood and degree of addiction among adolescent smokers and increase the number of premature tobacco-related deaths. Their removal from the market would have enormous public health benefits in this country.”
Individual consumers would not be prosecuted
The FDA was careful to ensure that if the rule were passed, it would only target tobacco companies and industry. The agency, state and local law enforcement agencies do not independently enforce FDA rules.
The proposed rule would not prosecute individual consumers for possession of menthol products.
Some activists, like Rev. Al Sharpton and the mothers of the movement, have warned that a ban on menthol products could cause more violent encounters with police if they enforce the rule. Anti-smoking advocates have found that Sharpton and several other civil rights organizations have been receiving money from cigarette makers for decades. Sharpton acknowledged to The New York Times in 2019 that Reynolds American was a longtime donor to his National Action Network, but said, “This isn’t about money.”
Other groups, such as the NAACP and many members of the Congressional Black Caucus, advocate a ban.
“The targeting and marketing of menthol flavoring by the tobacco industry has had a devastating impact on our community. Menthol-flavored cigarettes have tempted many children and adults, leading to lifelong addictions, health problems and ultimately the death of our loved ones,” the NAACP said in a statement. “Today is a great win for justice, equity and public health concerns.”
The FDA said Thursday that it “acknowledges concerns about how state and local law enforcement agencies may enforce their own laws in ways that may impact community justice and safety, particularly for underserved and underrepresented communities.” Among other things, FDA is seeking comments on how best to clarify the respective roles of the agency and state and local law enforcement agencies and policy considerations regarding the potential racial and social justice implications of the proposed product standards.
Califf said this is something the agency will address more in the future.
“We take these concerns seriously,” he said. “Let’s make one thing very clear. These actions and associated enforcement would relate to the tobacco industry, not to individuals who own or use those products.”
Next: Public comment period
An FDA ban on menthol and flavored cigars won’t go into effect immediately.
The next step will be a comment period, which will run from May 4th to July 5th. The FDA will also hold public hearing sessions on June 13th and 15th.
The agency is then expected to take time to review the comments before finalizing a rule.
The rule would come into effect one year after publication of the final version. Public health experts are hopeful that tobacco companies will also seek to stop the ban by suing the agency, as companies did with previous tobacco control legislation.
“It’s not trivial,” Califf said. Tobacco-related deaths are high, he noted, as is tobacco-related disease.
“My plea is that we don’t lose our sense of urgency,” he said. “Literally lives can be saved.”