The Food and Drug Administration on Friday authorized the primary menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking.
The FDA said it authorized 4 menthol e-cigarettes from Njoy, the vaping brand recently acquired by tobacco giant Altria, which also sells Marlboro cigarettes.
The choice lends latest credibility to vaping firms’ longstanding claim that their products may also help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually because of cancer, lung disease and heart disease.
Parent groups and anti-tobacco advocates immediately criticized the choice, which comes after years of pushing regulators to maintain menthol and other flavors that may appeal to teens off the market.
“This decision could mean we’ll never give you the option to shut the Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “FDA has once more failed American families by allowing a predatory industry to source its next generation of lifetime customers — America’s children.”
Youth vaping has declined from all-time highs in recent times, with about 10% of high schoolers reporting e-cigarette use last yr. Of those that vaped, 90% used flavors, including menthol.
All of the e-cigarettes previously authorized by the FDA have been tobacco, which is not widely utilized by young individuals who vape.
Njoy is one among only three firms that previously received FDA’s OK for vaping products. Like those products, the menthol varieties come as cartridges that plug right into a reusable device that heats liquid nicotine, turning it into an inhalable aerosol.
Njoy’s products accounted for lower than 3% of U.S. e-cigarette sales up to now yr, based on retail data from Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while a whole bunch of disposable brands account for the remaining.
Most teens who vape use disposable e-cigarettes, including brands like Elf Bar, which are available in flavors reminiscent of watermelon and blueberry ice.
Altria’s data showed Njoy e-cigarettes helped smokers reduce their exposure to the harmful chemicals in traditional cigarettes, the FDA said. The agency stressed the products are neither protected nor “FDA approved,” and that individuals who don’t smoke shouldn’t use them.
Friday’s motion is an element of a sweeping FDA review intended to bring scientific scrutiny to the multi-billion dollar vaping market after years of regulatory delays. Currently the U.S. market includes hundreds of fruit- and candy-flavored vapes which are technically illegal but are widely available in convenience stores, gas stations and vape shops.
The FDA faced a self-imposed court deadline at the top of this month to wrap up its yearslong review of major vaping brands, including Juul and Vuse.
Those brands have been sold within the U.S. for years, awaiting FDA motion on their scientific applications. To remain available on the market, firms must show that their e-cigarettes provide an overall health profit for smokers, without significantly appealing to kids.
“Based upon our rigorous scientific review, on this instance, the strength of evidence of advantages to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” said Matthew Farrelly of FDA’s Center for Tobacco Products.
