The Food and Drug Administration on Friday authorized peppermint-flavored e-cigarettes for adult smokers, the first time the agency has opened the door to vaping companies to sell tobacco-free products.
The FDA cleared Njoy, a vaping brand recently acquired by tobacco giant Altria, to market four menthol e-cigarettes. But regulators also said it will review flavored e-cigarette authorization applications on a case-by-case basis and that its actions apply to Njoy’s four products.
In announcing its decision, the FDA said it found that menthol-flavored e-cigarettes can reduce the harms of traditional tobacco smoking. But the agency stressed that it is not approving menthol vapor products, meaning the FDA has determined that a drug is safe and effective for its intended use. Instead, authorization from the agency only means that Njoy has received regulatory approval to market its products to the public.
“We are a data-driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” Matthew Farrelly, director for the FDA’s Center for Tobacco Products, said in a statement. “Based on our rigorous scientific review, in this case, the strength of evidence for the benefits to older smokers of switching completely to a less harmful product was sufficient to outweigh the risks to young people.”
The ruling lends new credence to vaping companies’ long-held claim that their products can help offset the toll of smoking, which is blamed for 480,000 deaths in the U.S. each year from cancer, lung disease and heart disease. the heart.
Parent groups and anti-tobacco advocates immediately criticized the decision, which comes after years of a push by regulators to keep menthol and other flavors that might appeal to teenagers off the market.
“This decision may mean we will 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 secure its next generation of lifelong customers – America’s children.”
Youth vaping has fallen from all-time highs in recent years, with about 10% of high school students reporting e-cigarette use in the past year. Of those who vape, 90% used flavorings, including menthol.
All e-cigarettes previously authorized by the FDA have been tobacco, which is not widely used by young smokers.
Njoy is one of only three companies to have previously received FDA OK for vaping products. Like those products, the menthol varieties come as cartridges that are inserted into a reusable device that heats the liquid nicotine, turning it into an inhalable aerosol.
Njoy’s products accounted for less than 3% of e-cigarette sales in the U.S. last year, according to retail sales data from Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while hundreds of off-the-shelf brands make up the rest.
Most teen smokers use disposable e-cigarettes, including brands like Elf Bar, which come in flavors such as watermelon ice and blueberry.
Njoy’s approval is part of a sweeping FDA review aimed at bringing 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 at convenience stores, gas stations and vape shops.
— The Associated Press contributed to this report.