FDA Announces Rollback of Juul Ban

(HorizonPost.com) – The Food and Drug Administration (FDA) announced last week that it formally withdrew the marketing denial orders it issued to e-cigarette manufacturer Juul Labs two years ago, clearing the way for the once-market leader to pursue sales authorization.

The FDA initially banned the sale of Juul vaping products in June 2022 over concerns that its products contributed to the increase in vaping among juveniles. The ban followed nearly two years of negotiations between the FDA and the San Francisco-based e-cigarette manufacturer over a request that its tobacco- and menthol-flavored vaping products remain on the market.

The FDA said at the time that Juul failed to provide evidence that its product met legal standards.

However, less than a month after imposing the ban, the FDA temporarily suspended it pending further review, during which Juul was permitted to continue selling its products.

The FDA at the time raised concerns over the possible “harmful chemicals” in Juul’s flavor pods and said the e-cigarette company submitted “insufficient and conflicting data.”

In a June 6 update, the FDA said that since it paused the marketing denial orders (MDOs), the agency “gained more experience with various scientific issues” on e-cigarettes, and that there were “new litigation outcomes” from other lawsuits on MDOs from other e-cigarette manufacturers.

The FDA clarified that its withdrawal of the marketing denial orders did not amount to a revised decision on whether to formally authorize the sale of Juul’s e-cigarettes. Instead, Juul’s applications have been moved back to “pending status.”

Since 2021, the FDA has issued over 300 marketing denial orders for new tobacco-related products. Of those, a handful have either been withdrawn by the agency or blocked by a federal judge.

Juul said in a June 6 statement that it appreciated the FDA’s decision to withdraw the MDOs and that it “looked forward” to working with the FDA on a process that is based on science and the evidence “to pursue a marketing authorization for JUUL products.”

While the FDA is reviewing its renewed authorization, Juul will continue selling its Menthol and Virginia Tobacco-flavored Juul pods and its Juul devices, the company said.

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