FDA approves Juul’s tobacco and menthol e-cigarettes

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By Emma Rumney and Anuja Bharat Mistry

(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and menthol-flavored pods and the e-cigarette device was stayed a month later after an appeal by the company and rescinded in 2024.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 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.

(Reporting by Emma Rumney in London, Anuja Bharat Mistry, Juveria Tabassum and Savyata Mishra in Bengaluru; Editing by Leroy Leo, Kirsten Donovan)