US FDA OKs first menthol vape, citing potential to help adult smokers

This file photo shows a vape or e-cigarette user emits smoke in a public place in Manila. INQUIRER/EDWIN BACASMAS

WASHINGTON — The US Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes or vapes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco 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 lends new credibility to vaping companies’ longstanding claim that their products can help blunt the toll of smoking, which is blamed for 480,000 US deaths annually due to cancer, lung disease, and heart disease. Vapes have been sold in the United States since 2007 but in recent years, their potential benefits for smokers have been overshadowed by their use by adolescents and teens.

Parents and anti-tobacco groups immediately criticized the decision, which follows years of advocacy efforts to keep menthol and other flavors that can appeal to teens off the market.

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

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Youth vaping has declined from all-time highs in recent years, with about 10 percent of high schoolers reporting e-cigarette use last year. Of those who vaped, 90 percent used flavors, including menthol.

All the e-cigarettes previously authorized by the FDA have been tobacco, which isn’t widely used by young people who vape.

Njoy is one of only three companies that previously received US FDA’s authorization for vaping products. Like those products, two of the Njoy menthol varieties come as cartridges that plug into a reusable device that heats liquid nicotine, turning it into an inhalable aerosol. The other two Njoy menthol products are disposable e-cigarettes.

Njoy’s products accounted for less than 3 percent of US e-cigarette sales in the past year, according to retail data from Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while hundreds of disposable brands account for the rest.

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

Altria’s data showed Njoy e-cigarettes helped smokers reduce their exposure to the harmful chemicals in traditional cigarettes, the FDA said. The agency stressed the products are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

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This image provided by NJOY in 2024 shows packaging for the company’s menthol-flavored electronic cigarette product. On Friday, June 21, 2024, the US Food and Drug Administration authorized the first menthol-flavored electronic cigarettes for adult smokers, the government’s strongest indication yet that vaping flavors can reduce the harms of traditional tobacco smoking. The FDA said it authorized four menthol e-cigarettes from NJOY, the vaping brand recently acquired by tobacco giant Altria, which also makes Marlboro cigarettes. (NJOY via Associated Press)

Friday’s action is part of a sweeping FDA review intended to bring scientific scrutiny to the multibillion-dollar vaping market after years of regulatory delays. Currently, the US market includes thousands of fruit- and candy-flavored vapes that are technically illegal but are widely available in convenience stores, gas stations, and vape shops.

The FDA faced a self-imposed court deadline at the end of this month to wrap up its years-long review of major vaping brands, including Juul and Vuse.

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

“Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” said Matthew Farrelly of FDA’s Center for Tobacco Products.

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