FDA approves first menthol e-cigarettes
The FDA authorised four menthol e-cigarettes from Njoy, a brand recently acquired by Altria, known for its Marlboro cigarettes.
The Food and Drug Administration (FDA) has granted approval for the first menthol-flavoured electronic cigarettes aimed at adult smokers, citing their potential to mitigate the risks associated with traditional tobacco smoking.
The FDA authorised four menthol e-cigarettes from Njoy, a brand recently acquired by Altria, known for its Marlboro cigarettes.
Njoy, alongside just two other companies, had previously gained FDA approval for their vaping products.
Among Njoy's offerings, two menthol variants are designed as cartridges that are inserted into a reusable device, heating liquid nicotine for inhalation. The other two menthol products by Njoy are disposable e-cigarettes.
Despite its FDA clearance, Njoy's market presence has been modest, comprising less than 3% of total US e-cigarette sales in the past year, based on Nielsen's retail data.
In contrast, Reynolds American's Vuse and Juul dominate approximately 60% of the market share, with numerous disposable brands making up the remainder.
"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 from the FDA's Center for Tobacco Products.
This decision emphasises vaping companies' long-standing assertion that their products could offer a less harmful alternative to smoking, which claims 480,000 U. deaths annually due to cancer, lung disease, and heart disease.
Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes, expressed concern over potential consequences, stating, "This decision could mean we'll never be able to close the Pandora's box of the youth vaping epidemic. FDA has once again failed American families by allowing a predatory industry to source its next generation of lifetime customers — America's children."
Youth vaping rates have fluctuated over recent years, with approximately 10% of high school students reporting e-cigarette use last year, mostly with flavoured products including menthol.
Critics argue that flavoured e-cigarettes, despite their potential benefits for adult smokers, continue to attract younger users.
The FDA's review is part of a broader effort to scrutinise the vaping market, evaluating claims of health benefits against concerns about underage use and addiction. Companies like Njoy, which now has FDA approval for its menthol products, play a significant role in this evolving regulatory landscape.
Altria, the parent company of Njoy, has reported data suggesting that their e-cigarettes help smokers reduce exposure to harmful chemicals found in traditional cigarettes. Nonetheless, the FDA stressed that the products are neither safe nor "FDA approved," and that people who don't smoke shouldn't use them.
The approval of menthol e-cigarettes is seen as a step forward in regulating the multibillion-dollar vaping industry, which has faced scrutiny and legal challenges in recent years.
The FDA's decision comes as a response to a court-imposed deadline to finalise evaluations of major vaping brands, aiming to balance public health benefits with potential risks to youth.
Moving forward, the debate over flavoured e-cigarettes is likely to intensify, as stakeholders weigh the benefits for adult smokers against concerns about their appeal to younger demographics.