James Myers of OAN
Thursday, June 6, 2024 1:16 PM
The U.S. Food and Drug Administration (FDA) on Thursday lifted a sales ban on Juul Labs, opening the door to the possibility of reapproving the company’s product.
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The announcement comes two years after federal health officials ordered the company to remove its e-cigarette and vaping products from the market.
The FDA initially blocked Juul’s application to market e-cigarettes, tobacco and menthol-flavored pods in June 2022 after spending nearly two years reviewing the manufacturer’s application, finding that the company’s application “lacked sufficient evidence regarding the toxicity profile of the products to demonstrate that the marketing of the products meets the public health standards required by law.”
For several years, Juul has touted its ability to help people quit smoking.
The FDA then suspended the blockage just a few weeks later, in July 2022, for further review.
“At the same time, since the MDO was administratively suspended in 2022, the FDA has gained more experience with a range of scientific issues related to e-cigarette products and new outcomes have emerged in litigation regarding the MDO for other manufacturers’ e-cigarette products,” the FDA said in a statement.
The agency also said that lifting the denial of sale order is not the same as a new decision on whether to formally approve the sale of e-cigarettes. Juul’s application has been put back on “pending” status, the agency said.
Meanwhile, the FDA has issued more than 300 orders refusing to sell new tobacco products since 2021, some of which have since been overturned by the FDA or blocked by federal court rulings.
“We appreciate the FDA’s decision and look forward to working with them again to advance the science-based process to gain marketing approval for JUUL products,” Juul said in a statement.
Juul says its products will remain on the market while the FDA reviews its application.
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