June 21 (Reuters) - The U.S. Food and Drug
Administration authorized four of Altria's ( MO ) 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 ( MO )-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 ( BTI ), 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 ( MO ) 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Earlier this month, the FDA rescinded market denial orders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.