June 23, 2024

The FDA is still reviewing Juul’s premarket product application.

The FDA is still reviewing Juul’s premarket product application.
Image: Scott Olson / Staff (Getty Images)

The U.S. Food and Drug Administration (FDA) announced on Thursday that it has reversed its 2022 ban on Juul e-cigarettes, paving the way for the company to receive full federal clearance.

Under federal law, all e-cigarettes products are required to have FDA approval to be sold and marketed in the United States.

In 2022, the FDA required tobacco companies to submit premarket applications for all their new products that entered the market after 2016.

The agency determined that Juul’s application lacked sufficient evidence to show its products met legal health standards. The FDA issued marketing denial orders (MDO) to Juul in June 2022, banning the company from selling its products.

Just a few weeks later, the FDA stayed the orders while Juul appealed the decision. That put Juul in a legal limbo but allowed the company to keep its products on American shelves.

On Thursday, the FDA said it rescinded its ban from 2022, as it has “gained more experience with various scientific issues regarding e-cigarette products.” New litigation outcomes involving cases about MDOs and e-cigarette products have also played a role in the agency’s decision.

“This action is being taken, in part, as a result of the new case law, as well as the FDA’s review of information provided by the applicant,” the FDA said in a statement.

The FDA noted that its decision is not an approval of Juul’s application and that its review is still ongoing.

“We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for Juul products,” the company said in a statement.

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