FDA authorizes first menthol-flavored e-cigarettes

The U.S. Food and Drug Administration (FDA) announced on Friday its authorization of the first menthol-flavored electronic cigarettes for adult smokers. 

The FDA’s authorization includes four menthol e-cigarette products from Njoy, a vaping brand recently acquired by Altria, a major tobacco company known for its Marlboro cigarettes.

Smoking-related diseases, including cancer, lung disease, and heart disease, are responsible for approximately 480,000 deaths annually in the U.S.

E-cigarettes have been available in the U.S. since 2007, but their potential benefits for smokers have often been overshadowed by concerns about their popularity among adolescents and teenagers. Parent groups and anti-tobacco advocates have been vocal in their criticism of the FDA’s decision, fearing that the introduction of menthol-flavored e-cigarettes will exacerbate the youth vaping epidemic.

“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.”

Despite a decline in youth vaping rates from their peak, about 10% of high school students reported using e-cigarettes last year. Of these users, 90% preferred flavored options, including menthol. Previously, the FDA had only authorized tobacco-flavored e-cigarettes, which are less popular among young vapers.

Njoy is now one of three companies to receive FDA authorization for vaping products. The newly approved menthol varieties include both disposable e-cigarettes and cartridges that can be plugged into reusable devices. Njoy’s market share in the U.S. has been relatively small, accounting for less than 3% of e-cigarette sales over the past year.

The market is dominated by brands like Vuse, owned by Reynolds American, and Juul, which together control about 60% of sales. A plethora of disposable brands, such as Elf Bar with flavors like watermelon and blueberry ice, make up the rest.

The FDA’s decision was influenced by data provided by Altria, demonstrating that Njoy e-cigarettes can help smokers reduce their exposure to harmful chemicals found in traditional cigarettes. However, the FDA emphasized that these products are not safe and are not “FDA approved.” The agency warned that non-smokers should avoid using them.

This authorization is part of a comprehensive FDA review aimed at bringing scientific oversight to the multibillion-dollar vaping industry after years of regulatory delays. Currently, the U.S. market is flooded with thousands of fruit- and candy-flavored vapes that are technically illegal but readily available in various retail outlets.

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