The US Food and Drug Administration is expected to announce a proposed rule this week to ban menthol from cigarettes, as well as to ban flavored cigars. It’s a step that public health officials say is essential to protect public health.
“I’m really excited about the possibility. At our foundation, we’ve cared about issues of smoking and preventable deaths for so long,” said Dr. Richard Besser, a former director of the US Centers for Disease Control and Prevention who now serves as the president of the Robert Wood Johnson Foundation, a public health advocacy organization.
“To see an issue that disproportionately affects African American smokers, disproportionately affects women, LGBT people who smoke, lower-income individuals. To say that these lives count just as much as any other life and a preventable death, that gives me real, real hope.”
Menthol by the numbersMenthol is an equity issue that the FDA has been considering for more than a decade.
About 18.6 million people smoke menthols in the US. That’s about 36% of all smokers, according to the FDA, and a disproportionate number are people of color.
About 30% of White smokers choose menthols, but they are by far the cigarette of choice for nearly 85% of smokers who are Black. About 40% of women smoke menthols, compared with 31% of men, according to the FDA.
LGBTQ people are also significantly more likely to smoke menthols. A 2013 study that looked at data from the CDC’s 2009-10 National Adult Tobacco survey found that 36% of LGBTQ smokers chose menthols, compared with 29.3% of straight smokers.
More than half of kids who smoke use menthol cigarettes, according to the CDC. A survey of adults who smoke found that the majority started with menthols. Other studies said kids who smoked menthol cigarettes were more likely to become regular smokers than occasional smokers.
Smoking rates in the US reached an all-time low in 2018, according to the CDC, but smoking is still the No. 1 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 US, including more than 41,000 deaths from secondhand smoke.
Cutting out menthol in cigarettes and cigars could have a significant effect on the number of smokers, the FDA said. By one estimate, it could even prevent 650,000 premature deaths over the next 40 years.
Another study projects that an elimination of menthol as a cigarette flavor would lead 923,000 people to quit smoking, including 230,000 African Americans, in the first year and a half.
The long road to banning mentholMenthol is the last special flavor allowed in cigarettes in the US.
It’s a chemical compound found naturally in peppermint that can also be made in a lab. This minty flavor creates a cooling sensation on the throat and softens the harshness of the tobacco taste. It’s a quality that, studies show, makes smoking more addictive and more palatable to children and new smokers.
“Like a menthol cough drop does when you have a sore throat, it soothes,” said Erika Sward, assistant VP of national advocacy for the American Lung Association.
In part to keep kids from smoking, Congress banned flavored cigarettes with its 2009 Tobacco Control Act, with the exception of menthol. The same act gave the FDA the authority to regulate the tobacco industry to protect public health.
That regulation allows the FDA to enact product standards to limit the toxicity, appeal and addictiveness of tobacco. The law also requires the FDA to conduct and fund research on menthol and gives the agency the authority to ban it if appropriate.
In the more than a decade that the FDA has been looking into the issue, there have been several slow steps toward a ban.
“This is long-awaited. The evidence has been there for years,” said Robin Koval, CEO and president of the Truth Initiative, an organization dedicated to geting young people to reject smoking, vaping and nicotine.
In 2011, the FDA’s Tobacco Products Scientific Advisory Committee issued a report based on its review of evidence on menthol and cigarettes. It concluded that a ban would benefit public health but said that there were gaps in its understanding and further research is needed.
In 2013, the FDA issued an advanced notice of proposed rulemaking, or ANPRM, to gather additional data and research about menthol that it would use to inform further actions. The agency got an “unusually large” number of comments, according to the US Government Accountability Office. More than 174,000 people weighed in, the FDA said.
In 2018, when the FDA issued another ANPRM on menthol, it was flooded with even more comments: About 520,000 people weighed in on the topic.
Yet still, nothing happened.
The Public Health Law Center and other groups filed a citizens petition requesting that the agency prohibit menthol in cigarettes. And in 2020, a lawsuit alleged that the FDA unreasonably delayed issuing a final response.
“Ultimately, the American Medical Association joined the African American Tobacco Control Leadership Council and others to sue the FDA, essentially saying, ‘you’ve ignored the citizens petition for too long,’ ” Sward said. “The judge sided with them and gave FDA the deadline of last April to essentially to say what they were going to do.”
In April 2021, the FDA said it would pursue rulemaking to prohibit menthol in cigarettes, as well as all flavors of cigars.
“Our decision is based on clear science and evidence established the addictiveness and harms of these products,” Kathy Crosby, director of the Office of Health Communication and Education at the FDA Center for Tobacco Products, said in February during an FDA webinar.
Last week, the proposal passed one regulatory hurdle with the US Office of Management and Budget. This executive-branch agency is responsible for making sure the FDA follows the rules in creating a policy. It’s also where a policy can get watered down when industry, retailers, public health associations and government agencies lobby the organization on what the rule should say.
“The strongest the rule ever, with very rare exception, is when the FDA finally sends it on to the White House to OMB for review,” Sward said. She said lobbying groups and other interested parties have held dozens of meetings with the OMB on the topic.
What the final menthol rule will look like is anyone’s guess, but public health officials hope it will be a strong ban like the FDA initially proposed.
A switch to flavored cigarsAfter the 2009 Tobacco Control Act banned flavored cigarettes, many smokers who preferred flavors – especially children – may have shifted to flavored cigars, including menthol.
The FDA said that the use of flavored cigars “increased dramatically” and that public health goals may have been “undermined” by the availability of these products.
Flavored cigars and cigarillos are especially popular among children, particularly Black and Hispanic kids, who are twice as likely to smoke them as their White classmates.
The FDA noted that one survey found that nearly 74% of teens 12 to 17 said they smoked cigars because they came in flavors that they enjoyed.
In 2020, more young people said they tried a cigar every day than tried a cigarette.”We’ve seen in the past, limitations are placed on one product but not on another. The business quickly gravitates, it’s so important for these rules to happen together,” the Truth Initiative’s Koval said.