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FDA rescinds ban on Juul vape products, resumes scientific review

The FDA Thursday rescinded marketing denial orders for Juul e-cigarette products, returning them to scientific review. Juul welcomed the move and said the company is looking an FDA marketing authorization. File Photo by Sarahj1 Pixabay
The FDA Thursday rescinded marketing denial orders for Juul e-cigarette products, returning them to scientific review. Juul welcomed the move and said the company is looking an FDA marketing authorization. File Photo by Sarahj1 Pixabay

June 6 (UPI) -- The U.S. Food and Drug Administration Thursday reversed an earlier ruling banning Juul vaping products almost two years after ordering the products off the market.

The FDA said in a statement Thursday that court decisions establishing new case law, combined with more FDA experience with various scientific issues regarding e-cigarette products, led to it rescinding the marketing denial order.

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"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," FDA's statement said. "Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied."

The agency said that this action returns the Juul products "to pending status, under substantive review by the FDA."

The FDA said on July 5, 2022 the Juul MDOs were stayed because certain scientific issues warranted additional review.

Juul said in a statement, "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.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."

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Juul said the products in question - the JUUL device and Virginia Tobacco and Menthol JUUL pods in 5.0% and 3.0% nicotine concentration - will remain on the market during the FDA review.

The FDA said Thursday that the original marketing denial orders were done because the FDA had determined that Juul's approval applications for the vaping products "lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that the marketing of the products met the public health standard required by law."

The FDA said some of Juul's study findings were concerning because of insufficient and conflicting data regarding genotoxicity, as well as potentially harmful chemicals leaching from Juul's proprietary e-liquid vape pods.

The agency said rescinding of the MDOs doesn't change the requirement that all e-cigarette products must have FDA authorization to be legally marketed.

The FDA has granted approval so far to just 23 e-cigarette products manufactured by just three companies.

Juul has long claimed that the company's e-cigarette products can help people stop smoking cigarettes, But the vape products still deliver nicotine, an addictive ingredient in tobacco products.

In August 2023 Juul announced that it was laying off almost a third of its workforce to increase profits. Juul said at the time it was carrying out a restructuring specifically aimed at maximizing profitability and cash-flow by cutting workers from the payroll.

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