FDA authorizes Juul’s e-cigarettes for sale in US after 3-year ban

Juul Labs said Thursday the Food and Drug Administration has authorized the sale of its e-cigarette device and refill cartridges in tobacco and menthol flavors, after years of struggle with heightened regulatory scrutiny.

The 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.

Thursday’s decision followed rigorous evaluation of the data provided by Juul, based on which FDA decided that a marketing approval for the system was “appropriate for the protection of public health,” the company said in a statement.

The decision follows wider expectations in the industry that the Trump Administration would 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.

The Wall Street Journal first reported the approval.