London/Bengaluru — The US Food and Drug Administration has authorised the sale of Juul Labs’ e-cigarette device and refill cartridges in tobacco and menthol flavours, 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 flavoured 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 after a federal ban in 2022.
The FDA’s 2022 ban on Juul’s four varieties of tobacco and menthol-flavoured pods and the e-cigarette device was stayed a month later after an appeal by the company and rescinded in 2024.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 authorised 39 e-cigarette products for sale in the US, including Altria’s NJOY menthol vape products, which received the nod last year.
An FDA spokesperson said it had authorised 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 flavour Juul pods of 3% and 5% nicotine concentration each.
“It’s a significant milestone for us,” said Juul CEO KC Crosswaite, adding while the authorised products are already on sale in the US, 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 criticised by companies and some legislators for slow product authorisations and for failing to address the widespread trade in unauthorised products. The agency has said it needs more resources to tackle these challenges.
Reuters
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.