Topline
Juul will receive authorization from the Food and Drug Administration for its e-cigarettes, the company told Forbes on Thursday, marking a reversal of fortune for the embattled company after it faced a marketing ban from the agency that only lifted last year, and had to pay out over $300 million to consumers after settling a class action lawsuit.
The e-cigarette company paid out over $300 million to customers after settling a class action … More
Key Facts
In a statement sent to Forbes, Juul confirmed that they received marketing granted orders from the FDA.
“FDA decided that an MGO for the JUUL System was ‘appropriate for the protection of public health’ – the standard required by statute for authorization,” Juul said, which came after a “rigorous review of the data.”
The authorization extends to Juul’s original vape product, as well as its refill cartridges for tobacco and menthol flavors, sources told the Wall Street Journal.
The Department of Health and Human Services declined to comment on the record, but Juul Labs was added to the FDA’s list of authorized e-cigarettes.
Key Background
The FDA previously tried to ban Juul products in 2022, but an appeals court allowed the company to continue selling products pending an appeal. The FDA later temporarily suspended that order, but maintained a marketing ban that wasn’t rescinded until June 2024. The company also faced multiple investigations and lawsuits, which ended in hefty settlements that put it on the brink of bankruptcy. In 2022, Juul settled a lawsuit filed by 33 states and Puerto Rico for $438.5 million over claims that the company marketed their products to teenagers. As part of the settlement, Juul agreed to stop using people under 35 in their ads. They also settled a class action lawsuit, paying out $300 million in small increments to previous users.
Tangent
The authorization comes as HHS Secretary Robert F. Kennedy Jr. continues shaking up the department to reflect his “Make America Healthy Again” agenda. In April, the department fired dozens of staff at the FDA’s Center for Tobacco Products, which handles reviewing premarket applications for tobacco products. The cuts included the center’s director and the head of its office of science, and entirely eliminated its office of regulation, according to a letter signed by anti-tobacco advocacy groups in May.
