July 17 (Reuters) - The U.S. Food and Drug
Administration has authorized the sale of Juul Labs' e-cigarette
device and refill cartridges in tobacco and menthol flavors,
after years of struggle with heightened regulatory scrutiny, the
agency and company said on Thursday.
Juul, which was once a major player in the e-cigarette
market before suffering a backlash after its flavored pods
became popular among teens, has seen its fortunes dwindle amid
lawsuits and plummeting sales.
The FDA's decision will offer a new lease of life to the
vape maker, which came close to filing for bankruptcy following
a federal ban in 2022.
The FDA's 2022 ban on Juul's four varieties of tobacco and
menthol-flavored pods and the e-cigarette device was stayed a
month later after an appeal by the company and rescinded in
2024.
Since the agency began regulating e-cigarette devices and
vapes in August 2016, it has authorized 39 e-cigarette products
for sale in the United States, including Altria's ( MO ) NJOY
menthol vape products, which received the nod last year.
An FDA spokesperson said it had authorized five JUUL
e-cigarette products after additional evidence provided by the
company demonstrated that the benefits to public health
outweighed the risks, namely that the products could appeal to
young people.
The products include the JUUL device, tobacco and menthol
flavor JUULpods of 3% and 5% nicotine concentration each.
"It's a significant milestone for us," said Juul CEO K.C.
Crosswaite, adding while the authorized products are already on
sale in the U.S., such developments signal an opportunity for
regulated products to replace Chinese disposable vapes that have
flooded the market.
The company now plans to launch additional FDA applications,
he said.
The industry has been expecting the Trump Administration to
ease regulatory hurdles for launching new vapes and other
smoking alternatives.
Some companies have seen FDA applications for new nicotine
products languish for years or, like Juul, faced rejections that
were challenged in court.
The FDA has been criticized by companies and some lawmakers
for slow product authorizations and for failing to address the
widespread trade in unauthorized products. The agency has said
it needs more resources to tackle these challenges.