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FDA says it will finalize ban on menthol tobacco products ‘in coming months’

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The US Food and Drug Administration says it still plans to finalize rules that would prohibit the sale of menthol cigarettes and flavored cigars this year, but the agency is running behind schedule.

In April 2022, when the FDA initially announced that it was going to ban the popular flavor, it set a deadline of August 2023 to work out the details. That deadline is still listed online, but a spokesperson said it will instead complete work on the rule “in the coming months.”

Flavors in cigarettes were banned in 2009, but after serious lobbying from the industry, menthol was left out of the ban. Many public health leaders say that regulations on the last flavor allowed in cigarettes can’t come soon enough.

“The law passed in 2009 and we’re here in 2023, 14 years later, so while we worked very closely with FDA on this issue, we’re pretty unhappy that they’ve taken such a long time to get this done,” said President and CEO of the Campaign for Tobacco-Free Kids, Yolonda Richardson. “Fourteen years is just way too long.”

It’s hardly the first missed deadline when it comes to tobacco regulations. In this case, though, no one is suing the FDA to spur quicker action, like health groups did in 2018 when it appeared that the agency was dragging its feet on regulating e-cigarettes.

In 2019, a judge ordered the agency to speed up its e-cigarette regulating process. It took until this year for the FDA to issue marketing denial orders to thousands of products. But it still isn’t done making decisions about these products, four years after the judge’s order.

The FDA has been considering menthol regulations for more than a decade. Scientists have long understood that the flavor can make cigarettes more addictive than tobacco-flavored ones. A 2015 study found that it makes people want to smoke more.

And because the flavor masks the taste of tobacco, it makes cigarettes more attractive to new smokers, especially children who are more likely to get hooked for life.

Studies have found that children who smoked menthol cigarettes were more likely to become regular smokers than occasional smokers. More than half of kids who smoke use menthol cigarettes, according to the US Centers for Disease Control and Prevention.

Tobacco companies have aggressively targeted minority communities with menthol marketing, the CDC says, and menthol cigarettes have played a role in widened health disparities.

While the number of people who smoke cigarettes in the US has fallen to one of the lowest levels in history, the proportion of people who smoke menthols has been increasing, according to the CDC.

Smoking is still the No. 1 cause of preventable death, disease and disability in the country. Cigarette smoking is responsible for more than 480,000 deaths per year in the US – and it doesn’t just kill smokers. More than 41,000 people die in the US each year from exposure to secondhand smoke, according to the CDC. A ban would lead to a 15% decline in smoking by 2026 the study predicts and by 2060, the number of deaths would decline 5% which may not sound like much, but that would be 650,000 lives saved and life-years lost would be reduced by 8.8% or 11.3 million years. A third of the lives that would be saved would be among the Black community.

If and when the FDA bans menthol, it could save up to 654,000 lives within just four decades, according to the Campaign for Tobacco-Free Kids. A third of those lives saved would be among the Black community.

A ban could make such a marked difference with the Black community because for years, the tobacco industry has aggressively targeted menthol products to racial and ethnic minority groups, the LGBTQ+ community and women, the CDC says. The focused outreach has been highly effective, particularly among the Black community.

“We feel really strongly that this issue is not only bad for public health, it’s bad for equity issues and bad for the country’s commitment to addressing systemic racism and so we really feel strong that the FDA needs to get this rule out,” Richardson said.

A 2020 study showed that while 43% of all adult smokers smoked menthols, more than 83% of Black smokers did. Only about 30% of White smokers chose menthols.

Members of the Congressional Black Caucus sent a letter urging the FDA to meet its August deadline on menthol cigarettes and flavored cigars, as have other congressional leaders.

The missed deadline is “disappointing” and harmful, the African American Tobacco Control Leadership Council said in a joint statement with Action on Smoking & Health, the American Medical Association and the National Medical Association.

“FDA is dragging their feet again. They should become part of the solution and not continue to be part of the problem; Black Lives Matter, Black Lives are at Stake!” Dr. Phillip Gardiner, co-founder of the African American Tobacco Control Leadership Council, said in the statement.

American Medical Association President Dr. Jesse Ehrenfeld said the delay harms Black people, and Black youth, in particular.

“We implore the FDA to move swiftly to remove these harmful products from the market once and for all and keep them out of the hands of our nation’s youth — their health and well-being must be the first priority,” he said.

Tobacco companies used similar tactics with the LGBTQ+ community as they did with the Black community. They placed ads in gay publications, advertised in largely gay neighborhoods and became sponsors of Pride parades and other community events as early in the 1990s, when other large companies were not as likely to support the community.

Hispanic and LGBTQ people are significantly more likely to smoke menthols. In 2020, 51% of Hispanic adults currently smoked menthols, compared with 34% of White adults, the CDC said. A 2013 study that involved 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.

Ads targeted women too, according to the American Heart Association, designing “feminine package designs” and labeling some cigarettes with “feminine names.” The companies specially sought out female customers with ads in women’s magazines promoting brands like Virigina Slim and now more than 40% of women smoke menthols, compared with 31% of men, according to the FDA.

A ban on menthol cigarettes could eliminate some significant health disparities, according to a study from the Council on Foreign Relations.

Black people die at significantly higher rates than White people of smoking-related illnesses including stroke, heart disease and lung cancer. Within five years, the elimination of menthol cigarettes could close the gap in lung cancer deaths, the study found.

When Congress banned all flavors in cigarettes — with the exception of menthol — in 2009, many smokers switched to flavored cigars, undermining the healthy intention of the flavor ban, the FDA says. Cigars come in kid-friendly flavors like chocolate, honey, grape, cherry, vanilla and more. Regulating flavored cigars is also important, according to Dr. David Levy, professor of oncology in the School of Medicine at Georgetown University who worked on the study that predicted how many lives would be saved with such a ban.

“In recent years we’ve seen cigarette use really drop dramatically, even more than anybody could have predicted five years ago for those in high school, or 18 to 24; however, cigar use has increased, by not as much, but enough to be a problem. So there seems to be a nexus there,” Levy said. “The evidence is quite clear that cigars and cigarettes are both very harmful.”

Flavored cigars and cigarillos also seem to be attractive to children, particularly Black and Hispanic kids who are twice as likely to smoke them as their White classmates. In 2020, more young people said they tried a flavored cigar every day than tried a cigarette, according to the FDA. If flavors in cigars are eliminated, and cigar smokers are left with just the harsh taste of some nonflavored products, researchers think it could increase the likelihood current users may stop smoking them.

Two states didn’t wait to for the FDA to ban menthol cigarettes. In 2020, Massachusetts became the to ban all flavored tobacco products. California’s ban went into effect went into effect at the end of last year. R.J. Reynolds and other tobacco companies sued to stop California’s ban, but federal courts have allowed it to stay in place.

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The bans seem to be having an impact.

The Massachusetts ban, studies show, reduced the sale of menthol products and did not seem to increase sales in neighboring states that allowed the menthol products.

Even when the FDA enacts a nationwide ban, it could be many years before it goes into place.

Tobacco companies are expected to sue, as they have with nearly every other tobacco restriction.

R.J. Reynolds, one of the companies that makes menthol cigarettes, sued when California introduced its flavor ban. It also introduced a new product that does not contain menthol but provides a “cooling” sensation like menthol does. The cigarettes come in boxes that look similar to the menthol versions, and the company is marketing them to menthol smokers.

Still, the company said menthol should not be banned.

“We strongly believe there are more effective ways to deliver tobacco harm reduction than banning menthol in cigarettes. Evidence from other markets including Canada and the EU where similar bans have been imposed, demonstrates little impact on overall cigarette consumption,” said Luis Pinto, vice president of communications, said in an email Thursday.

Campaign for Tobacco-Free Kids, which has been urging the government to take action for a while said that even before the FDA issues anything, it will have to send the new policy over to Office of Information and Regulatory Affairs for review and that process could take months.

While the FDA is expected to face lawsuits, Richardson said she and other public health leaders hope it will act soon.

“There’s no reason for them not to go ahead and act,” she said.

Correction: A quote in this story was updated to accurately reflect the number of years since flavors were banned in cigarettes.

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