In a first, FDA authorizes flavored vape products from Altria's NJOY for sale
Adds background in paragraphs 2 to 6, comments in paragraphs 9, 11
By Emma Rumney and Juveria Tabassum
June 21 (Reuters) -The U.S. Food and Drug Administration authorized four of Altria's MO.N menthol e-cigarette products for sale in the country on Friday, making them the first ever flavored vapes the agency has permitted on the market.
The decision shows vape makers can provide evidence satisfying the FDA that the benefits their products offer in terms of helping smokers quit outweigh the risks posed to youth.
"In this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth," said Matthew Farrelly, director of the Office of Science at the FDA's Center for Tobacco Products.
The FDA first began regulating e-cigarettes in August 2016 and it has authorized 27 e-cigarette products for sale in the U.S. to date, including Altria-owned NJOY's menthol vape products.
The regulator has rejected the vast majority of the 26 million applications it has reviewed so far, including from British American Tobacco BATS.L, and all of those relating to flavored products.
This has sparked pushback from the industry, with manufacturers launching court cases to challenge its decisions, some of which were successful.
The agency's nod to Altria's NJOY menthol vape products was a positive for the broader industry sentiment, and bodes well for flavors ultimately getting back on the market with Bluetooth age-verified technology, Jefferies analyst Owen Bennett said in a note.
The U.S. is the world's largest market for e-cigarettes, and the FDA has had to crack down on the sale and distribution of illicit vapes.
"This decision is especially troubling given the FDA's failure to do its job and clear the market of unauthorized, illegal e-cigarette products," said Yolonda Richardson, CEO of Campaign for Tobacco-Free Kids, adding that the decision was "hard to understand".
The FDA's authorization comes at a time when the U.S. government is reviewing a potential ban on menthol cigarettes.
Earlier this month, the FDA rescinded market denial orders issued in 2022 for four varieties of Juul Lab's tobacco and menthol-flavored pods and its e-cigarette device.
Reporting by Juveria Tabassum and Emma Rumney; Editing by Pooja Desai and Vijay Kishore
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