The U.S. Food and Drug Administration on Friday approved four menthol e-cigarettes from Altria Inc. for sale in the U.S., making them the first flavored e-cigarettes the agency has allowed to hit the market.
This decision demonstrates that e-cigarette manufacturers can provide persuasive evidence to the FDA that the benefits of their products in helping smokers quit outweigh the risks to young people.
“In this case, the strength of the evidence of the benefits to adult smokers of switching completely to less harmful products was sufficient to outweigh the risks to youth,” said Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products.
The FDA first began regulating e-cigarettes in August 2016 and has so far approved 27 e-cigarette products for sale in the U.S., including Altria-owned NJOY menthol vape products.
Regulators have rejected most of the 26 million applications they have reviewed so far, including one from British American Tobacco, as well as all of the applications relating to flavored products.
This sparked a backlash from the industry, with manufacturers filing lawsuits challenging the decision, some of which were successful.
Jefferies analyst Owen Bennett said in a note that regulators’ approval of Altria’s NJOY menthol vape products is positive for overall industry sentiment and signals an eventual return of flavors to the market with Bluetooth age verification technology.
The United States is the world’s largest e-cigarette market, and the FDA has been forced to crack down on the sale and distribution of illegal e-cigarettes.
“This decision is particularly disturbing given that the FDA has shirked its duties and failed to remove unauthorized and illegal e-cigarette products from the market,” said Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids, adding that the decision is “incomprehensible.”
The FDA approval comes at a time when the U.S. government is considering a possible ban on menthol cigarettes.
Earlier this month, the FDA rescinded a market denial order issued in 2022 against four Juul Labs tobacco- and menthol-flavored pods and e-cigarette devices.
