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 the tobacco giant. Altriawhich also sells Marlboro cigarettes.
The decision lends new credence to vaping companies' long-standing claim that their products can help mitigate the cost of smoking, which is blamed for 480,000 deaths annually in the United States due to cancer, lung and heart diseases.
Parent groups and anti-tobacco advocates immediately criticized the decision, which comes after years of pressuring regulators to keep menthol and other flavors that can appeal to teens 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 gain its next generation of lifelong customers: America's children.”
Youth vaping has declined from record highs in recent years, and about 10% of high school students reported using e-cigarettes in the past year. Of those who vaped, 90% used flavors, including menthol.
All e-cigarettes previously authorized by the FDA have been tobacco, which is not widely used by youth who vape.
Njoy is one of only three companies to previously receive FDA approval for vaping products. Like those products, menthol varieties come in cartridges that connect to a reusable device that heats liquid nicotine, turning it into an inhalable aerosol.
Njoy's products accounted for less than 3% of U.S. e-cigarette sales last year, according to Nielsen retail data. Vuse, property of american reynoldsand 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 like watermelon and blueberry ice cream.
Altria's data showed that Njoy e-cigarettes helped smokers reduce their exposure to harmful chemicals in traditional cigarettes, the FDA said. 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 scientific scrutiny to the multibillion-dollar vaping market after years of regulatory delays. Currently, the U.S. 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 later this month to conclude its year-long review of major vaping brands, including Juul and Vuse.
Those brands have been sold in the United States for years, 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.
“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 to young people,” said Matthew Farrelly of the Product Center. FDA Tobacco Policy.
