FDA authorizes first menthol electronic cigarette for adults

The Food and Drug Administration on Friday authorized the first menthol-flavored e-cigarettes for adult smokers, recognizing that vaping flavors can reduce the harms of traditional smoking.

The FDA said it authorized four menthol e-cigarettes from Njoy, the vaping brand recently acquired by tobacco giant Altria, which also sells Marlboro cigarettes.

The decision gives new credence to vaping companies’ claim that their products can help mitigate the effects of smoking, which is blamed for 480,000 deaths annually in the U.S. from cancer, lung disease and heart disease. E-cigarettes have been sold in the country since 2007, but in recent years their potential benefits for smokers have been overshadowed by their use among teenagers.

Parents and anti-smoking groups immediately criticized the decision, which comes after years of advocacy efforts to keep menthol and other flavors that can appeal to teenagers off the market.

“This decision could mean we will never be able to close Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “The FDA has once again failed American families by allowing a predatory industry to prey on its next generation of lifelong customers: America’s children.”

E-cigarette use among youth has declined from record highs in recent years, with about 10% of high school students reporting e-cigarette use in the past year. Of them, 90% used flavors such as menthol.

All e-cigarettes previously authorized by the FDA were tobacco, which is not widely used by youth who vape.

Njoy is one of three companies that have previously received FDA approval for their vaping products. Like those products, two of Njoy’s menthol varieties come in the form of cartridges that connect to a reusable device that heats liquid nicotine, turning it into an inhalable aerosol. Njoy’s other two menthol products are disposable e-cigarettes.

Njoy’s products accounted for less than 3% of U.S. e-cigarette sales last year, according to Nielsen data. Vuse, owned by Reynolds American, and Juul control about 60% of the market, with the rest accounted for by hundreds of disposable brands.

Most teens who vape use disposable e-cigarettes, including brands like Elf Bar, which come in flavors like watermelon and frozen blueberry.

According to the FDA, Altria data shows that Njoy e-cigarettes help smokers reduce their exposure to harmful chemicals in traditional cigarettes. The agency stressed that the products are not safe or “FDA approved,” and that people who do not smoke should not use them.

Friday’s action is part of a broad FDA review aimed at bringing the multibillion-dollar vaping market under scientific scrutiny after years of delays in regulating it. Today, the U.S. market includes thousands of fruit- and candy-flavored vapes that are technically illegal but widely available in convenience stores, gas stations, and vape shops.

The FDA has given itself a deadline of the end of this month to conclude its year-long review of major vape brands, such as Juul and Vuse.

These brands have been sold for years in the US waiting for the FDA to take action on their scientific applications. To stay on the market, companies must demonstrate that their e-cigarettes provide an overall health benefit to smokers, without significantly appealing to children.

According to Matthew Farrelly of the FDA’s Center for Tobacco Products, “based on our rigorous scientific review, in this case, the strength of the evidence for the benefits to adult smokers of completely switching to a less harmful product was sufficient to outweigh the risks for young people.

Richmond-based Altria previously took a $13 billion stake in Juul in 2018, when the brand controlled most of the U.S. vaping market. But Juul’s value plummeted after it was the subject of lawsuits and investigations over its role in triggering a national spike in underage vaping.