June 21, 2024 – The U.S. Food and Drug Administration (FDA) has given the green light for four menthol e-cigarette products from Altria’s NJOY to be sold in the United States. This marks the first time the agency has authorized the sale of flavored vape products.
The FDA’s decision indicates that vape manufacturers can present evidence proving that the benefits of their products in aiding smokers to quit outweigh the risks to youth. Matthew Farrelly, director of the Office of Science at the FDA’s Center for Tobacco Products, stated, “In this case, the compelling evidence showing benefits to adult smokers from switching to a less harmful product was enough to outweigh the potential risks to youth.”
Since it began regulating e-cigarettes in August 2016, the FDA has authorized 27 e-cigarette products for sale in the U.S., including the recent approval of NJOY’s menthol vapes. However, the regulator has denied the majority of the 26 million applications reviewed to date, particularly those related to flavored products. Companies like British American Tobacco have faced rejections, sparking industry pushback and legal challenges, some of which have been successful.
Jefferies analyst Owen Bennett noted that the approval of NJOY’s menthol vape products is a positive signal for the broader industry. It suggests that flavors might eventually return to the market, potentially with advanced age-verification technologies like Bluetooth.
The U.S. holds the largest market for e-cigarettes globally, prompting the FDA to crack down on the sale and distribution of illegal vape products. Yolonda Richardson, CEO of Campaign for Tobacco-Free Kids, expressed concern, stating, “This decision is especially troubling given the FDA’s failure to clear the market of unauthorized, illegal e-cigarette products.”
The FDA’s authorization of NJOY’s menthol products comes amidst the U.S. government’s consideration of a potential ban on menthol cigarettes. Earlier this month, the FDA also rescinded market denial orders issued in 2022 for four varieties of Juul Labs’ tobacco and menthol-flavored pods and its e-cigarette device.
In summary, the FDA’s recent approval of NJOY‘s menthol vape products marks a significant milestone for the industry. It highlights the agency’s willingness to consider the benefits of vaping for adult smokers while balancing the risks to youth. As the regulatory landscape continues to evolve, the future of flavored vape products remains a closely watched topic.