What’s next for Juul after FDA bans sales

Packages of Juul mint flavored e-cigarettes are displayed at San Rafael Smokeshop on November 07, 2019 in San Rafael, California. Juul, a leading e-cigarette company, announced that it is halting sales of their popular mint flavor e-cigarette after the release of two studies that showed a surge in teen use. (Photo by Justin Sullivan/Getty Images)
Packages of Juul mint flavored e-cigarettes are displayed at San Rafael Smokeshop on November 07, 2019 in San Rafael, California. Juul, a leading e-cigarette company, announced that it is halting sales of their popular mint flavor e-cigarette after the release of two studies that showed a surge in teen use. (Photo by Justin Sullivan/Getty Images) Photo credit (Photo by Justin Sullivan/Getty Images)

In a response to the U.S. Food and Drug Administration’s ban on the sale of Juul Labs vaping products, Juul CRO Joe Murillo said Thursday that the company is looking for ways to override the decision.

As of Friday afternoon, Juul had already asked a federal appeals court for a temporary block on the Food and Drug Administration’s ban of its e-cigarettes, CNBC reported. If the request is granted, the company and retailers would be able to keep distributing and selling Juul products while the court reviews the FDA decision.

“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” Murillo said Thursday. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide.”

According to Johns Hopkins Medicine, vaping products such as Juul – which heat liquids containing nicotine to create an inhalable aerosol – are less harmful than traditional combustible cigarettes. However, they could still be harmful and have been associated with injuries and deaths, said the institution.

Marketing denial orders announced Thursday by the FDA require Juul to stop selling and distributing vaping products, which include Juul devices, Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%.

“In addition, those currently on the U.S. market must be removed, or risk enforcement action,” said the administration. The FDA cannot enforce against individual consumer possession or use of Juul products.

The decision to ban Juul product sales came after the FDA reviewed the company’s premarket tobacco product applications. Through the review, “the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”

FDA concerns included data regarding potentially harmful chemicals leaching from the company’s proprietary e-liquid pods and potential DNA damage.

“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Murillo’s statement. He said that Juul submitted applications two years ago.

In its announcement, the FDA said it has not received clinical information to suggest an immediate hazard associated with the use of Juul products. Yet, the FDA found their insufficient evidence to negate the potential risks and therefore issued the orders.

“There is also no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods,” with Juul devices, the administration said, and “users are encouraged to report any unexpected health problems or product problems to the FDA through the Safety Reporting Portal and to seek medical attention as necessary.”

A 2021 National Youth Tobacco survey found that more than 11% of middle and high schoolers reported using e-cigarettes such as Juul, which accounted for 42% of the e-cigarette market as of 2020, according to The New York Times.

Anti-tobacco group Truth Initiative reported in 2018 that most youth e-cigarette users obtained their devices from physical retail locations. Other sources include social providers (such as friends or family) and online sellers.

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

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