The U.S. Food and Drug Administration on Friday approved the first menthol-flavored electronic cigarettes for adult smokers, recognizing that flavors in vaping can reduce the dangers of traditional tobacco smoking.
The FDA announced that it has approved four menthol e-cigarettes from Njoy, the vaping brand recently acquired by the tobacco giant Altriawhich also sells Marlboro cigarettes.
The decision lends new credibility to e-cigarette manufacturers' long-standing claims that their products can help reduce the effects of smoking. In the United States, smoking is blamed for 480,000 deaths each year from cancer, lung disease and heart disease.
Parents' groups and tobacco opponents immediately criticized the decision. They had previously put pressure on regulators for years to keep menthol and other flavors that could be attractive to young people off the market.
“This decision may mean we will never be able to close the Pandora's box of the youth e-cigarette 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 acquire its next generation of customers for life – America's children.”
Vaping among teens has declined from all-time highs in recent years. About 10% of high school students reported using e-cigarettes in the past year. Of those who vaped, 90% used flavors, including menthol.
All previously FDA-approved e-cigarettes contained tobacco, which is not very common among young vapers.
Njoy is one of only three companies to have previously received FDA approval for vaping products. Like those products, the menthol variants come as cartridges that are inserted into a reusable device that heats liquid nicotine, turning it into an inhalable aerosol.
According to retail data from Nielsen, Njoy's products accounted for less than 3% of U.S. e-cigarette sales last year. Vuse, owned by Reynolds Americanand Juul control about 60% of the market, while hundreds of disposable brands make up 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 the harmful chemicals in traditional cigarettes, the FDA said. The agency stressed that the products are neither safe nor “FDA-approved” and that nonsmokers should not use them.
Friday's action is part of a broader FDA review designed to bring the multibillion-dollar e-cigarette market under scientific scrutiny after years of regulatory delays. There are currently thousands of fruit- and candy-flavored e-cigarettes on the U.S. market that, while technically illegal, are widely available in convenience stores, gas stations and vape shops.
The FDA faced a self-imposed court deadline later this month to complete its years-long review of major e-cigarette brands, including Juul and Vuse.
These brands have been sold in the U.S. for years pending FDA review of their scientific applications. To stay on the market, companies must demonstrate that their e-cigarettes provide overall health benefits to smokers without being particularly attractive to children.
“Based on our rigorous scientific review, the evidence that adult smokers benefit from completely switching to a less harmful product was sufficient, in this case, to outweigh the risks to youth,” said Matthew Farrelly of the FDA's Center for Tobacco Products.
