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FDA reverses its ban on Juul vaping products

The move puts the e-cigarette company's applications for authorization back into review, meaning they are neither approved nor denied at this time.
juul
Posted at 5:21 PM, Jun 06, 2024

The U.S. Food and Drug Administration has reversed its ban on JUUL products, potentially opening the door for the brand to get its e-cigarettes and vapes back on the market.

The FDA had initially issued marketing denial orders to JUUL Labs in June 2022, blocking the company from selling devices and tobacco and menthol-flavored pods. The agency said then that its decision was made over concerns the products' toxicological profile didn't meet public health standards, but after JUUL swiftly appealed the decision, the products were able to stay on shelves.

Since then, the FDA said Thursday, new case law and the agency's review of information provided by JUUL — including in "toxicology, engineering, social science and clinical pharmacology" — led to cancellation of the MDOs while JUUL's premarket tobacco product applications return to pending status. That means JUUL's products are back under "substantive review" by the FDA, neither authorized nor denied market approval, and it's unclear which outcome is more likely.

"The agency’s continued review does not alter the fact that all e-cigarette products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed," the FDA said.

JUUL said in a statement that its device and the pods involved in the aforementioned applications will remain on the market during the review. It stated it appreciated the FDA's decision and looks forward to "re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products."

"We remain confident in the quality and substance of our applications and believe that a full review of the science and evidence will demonstrate that our products meet the statutory standard of being appropriate for the protection of public health," the statement read.

A JUUL package is shown.

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JUUL has kept its standing as one of the top-selling e-cigarette brands on the market, though that rise has been controversial due to its popularity among young users. The CDC said the brand was the primary driver of youth e-cigarette use in 2017 and 2018, when the U.S. Surgeon General declared youth vaping an epidemic and said JUUL was part of the problem.

In 2019, 59.1% of high school students and 54.1% of middle school students who were e-cigarette users reported JUUL was their usual brand, according to a study that attributed the brand's popularity to its flavors, product design and marketing strategies.

And though JUUL nearly went bankrupt — in part due to the FDA's decisions on its authorization as well as a $462 million settlement over accusations it directly marketed to underage people — it's still one of the drivers of increasing e-cigarette sales. A CDC report published last year said overall sales grew by 46.6% in 2022, and the number of brands increased by 46.2% to 269. JUUL ranked No. 2 in sales among all of those brands.

That doesn't mean all 269 are authorized to be sold by the FDA, though. As of May, the agency said it's only authorized 23 e-cigarette products made by three companies to be sold in the U.S., but manufactures are able to sell while their applications are under review. To pass, products must meet certain product standards, which JUUL argues it meets.