The U.S. Food and Drug Administration (FDA) is looking to ban menthol cigarettes and flavored cigars due to concerns these tobacco products are harming American youth.
The FDA submitted the final rule for regulatory review to the Office of Management and Budget (OMB) on Friday. “This final rule is a tobacco product standard to prohibit the use of menthol as a characterizing flavor in cigarettes,” according to an OMB website. Legal resource center Law Insider defines the term “characterizing flavor” as meaning “a taste or aroma, other than the taste or aroma of tobacco” that is imparted either prior to or during the use of the tobacco product. Flavored cigars would also be banned under the rule.
The FDA has long been pushing to ban menthol cigarettes and flavored cigars. Last year, the agency announced it was proposing rules to this effect to “prevent youth initiation [and] significantly reduce tobacco-related disease and death,” according to an April 28 press release.
Menthol is a flavor additive with a minty taste and aroma that aids in reducing the harshness and irritation of smoking, the agency said. This boosts the appeal for cigarettes and makes the menthol variants popular among youth and young adults. Menthol can also interact with nicotine in the brain, enhancing the nicotine’s addictive effects.
“The combination of menthol’s flavor, sensory effects, and interaction with nicotine in the brain increases the likelihood that youth who start using menthol cigarettes will progress to regular use. Menthol also makes it more difficult for people to quit smoking,” the FDA said.
The agency estimated there were 18.5 million menthol cigarette smokers aged 12 and above in the United States in 2018, with “particularly high rates of use by youth, young adults, and African Americans and other racial and ethnic groups.”
If menthol cigarettes were not available, there would be a 15 percent reduction in smoking within four decades, the agency said citing multiple studies. This would translate into 324,000–654,000 saved lives.
The FDA expressed hope that once the rule comes into effect, it would reduce the appeal of cigarettes among youth and young adults, thus reducing the chances that nonusers who experiment with menthol cigarettes end up progressing to regular smoking.
The OMB review is the last step to be completed to finalize the rule.
Harm to Youngsters
In an Oct. 16 statement, Harold Wimmer, president of the American Lung Association (ALA), called the FDA rules banning menthol cigarettes and flavored cigars “the most significant actions that the FDA’s Center for Tobacco Products has taken in its 14-year history.”
“The American Lung Association is eager for these lifesaving rules to be implemented and urges the White House to finalize these rules before the end of the year. The science and data are clear. Ending the sale of menthol cigarettes and flavored cigars will save lives,” it said.
“One study estimates almost one million smokers would quit smoking within 17 months of the end of the sale of menthol cigarettes, including almost a quarter of a million black individuals living in America. After Canada stopped selling menthol cigarettes in 2017, the country saw an increase in quit attempts and cessation among people who smoked menthol cigarettes.”
The Campaign for Tobacco-Free Kids also welcomed the FDA proposal, asking the OMB and the White House to consider expediting the review and issuing final regulations by the end of the year given the “profound, lifesaving benefit” of the rules, according to an Oct. 16 press release.
Tobacco is the number-one cause of preventable death in the United States, it said. Cheap, flavored cigars are sold in “kid-friendly flavors” like “berry fusion,” “cherry dynamite,” and “iced donut,” the organization stated.
“These flavored products have flooded the market in recent years and fueled the popularity of cigars with kids.” The group cited the 2022 National Youth Tobacco Survey which showed that cigars are the “second most popular tobacco product” after e-cigarettes among American high school students.
Crackdown on E-Cigarettes
Some have argued against the ban. In March last year, the Tax Foundation warned in a report that the federal menthol ban would result in losses for local governments due to the high level of taxation and the large market share of flavored cigarettes.
In the United States, excise taxes alone make up 40 percent of the retail price of tobacco products on average, it said. A third of the market is made up of flavored cigarettes.
“Federal action does not only impact federal revenue, and combined, governments stand to lose more than $6.6 billion in the first full year following prohibition,” the group stated.
Meanwhile, the FDA is also cracking down on flavored e-cigarettes. Last week, the agency issued denial orders for the marketing of six flavored e-cigarette products being sold under the Vuse Alto brand, including three menthol-flavored ones.
“Evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth,” the agency said.
In July, it issued a marketing denial order for a menthol-flavored e-cigarette made by Fontem US. In May, the FDA issued similar orders to 10 companies that collectively marketed around 6,500 flavored e-cigarette and e-liquid products.
