Source:

Press Release

Disclosures: Brown is CEO of the AHA. Califf is FDA Commissioner. Mital is acting director of the FDA’s Center for Tobacco Products. Kathuria is chair of the ATS Tobacco Action Committee. Murillo is chief regulatory officer at Juul Labs.
June 23, 2022
2 min read
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FDA denies authorization to market Juul vaping products

Source:

Press Release

Disclosures: Brown is CEO of the AHA. Califf is FDA Commissioner. Mital is acting director of the FDA’s Center for Tobacco Products. Kathuria is chair of the ATS Tobacco Action Committee. Murillo is chief regulatory officer at Juul Labs.
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The FDA issued marketing denial orders to Juul Labs for all of their vaping devices and related products. As a result, the company must stop selling and distributing these products, and those currently on the U.S. market must be removed.

These products include the Juul device and four types of Juul pods: Virginia tobacco-flavored pods at nicotine concentrations of 5% and 3% and menthol flavored pods at nicotine concentrations of 5% and 3%, according to the FDA press release.

Smoking e-cigarette
Source: Adobe Stock.

“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,” FDA Commissioner Robert M. Califf, MD, said in the release. “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.”

The FDA’s marketing denial orders pertain to importation, distribution and retail sales of the Juul devices, but do not restrict individual possession or use, according to the release.

This action is a result of the FDA’s review of Juul’s premarket tobacco product applications; the agency determined that the applications lacked sufficient evidence on the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health, according to the release. Moreover, the FDA noted that some of the company’s study findings raised concerns due to insufficient and conflicting data on the genotoxicity and potentially harmful chemicals leaching from the e-liquid pods.

According to the statement, the FDA to date has not received clinical information to suggest an immediate hazard associated with the use of Juul products. However, the agency said the marketing denial orders reflect its determination that there is insufficient evidence to assess the potential toxicological risks of using Juul products, according to the release. The agency further said the potential harms of using other authorized or unauthorized products together with Juul products is unknown.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” Michele Mital, acting director of the FDA’s Center for Tobacco Products, said in the release. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

Any products subject to a marketing denial order may not be offered for sale or distributed in the U.S., or the FDA may take enforcement action, according to the release. In addition to ensuring that Juul complies with this order, the FDA said it intends to ensure compliance by distributors and retailers.

In a statement from the American Heart Association made shortly after the FDA’s announcement, AHA CEO Nancy Brown said, “The FDA’s decision sends the strongest possible message that Juul put the health of millions of our nation’s young people at risk with flavored e-cigarettes, high nicotine concentrations and years-long marketing campaigns aimed at kids.”

In addition, the AHA called on the FDA to finalize decisions on all remaining premarket tobacco applications.

The American Thoracic Society also issued a statement applauding the FDA’s decision to remove Juul products from the U.S. market, calling the decision “long overdue.”

“Juul is one of the most popular e-cigarette products among middle and high school kids. Their flavored products are particularly enticing to this group, who are at risk of becoming lifelong nicotine users,” Hasmeena Kathuria, MD, chair of the ATS Tobacco Action Committee, said in the ATS press release. “Removing Juul products, even temporarily, will make a small but important dent in sales to this vulnerable group.”

On June 23, Juul Labs released a statement from Joe Murillo, chief regulatory officer at Juul Labs, regarding the FDA decision.

“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. … 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. 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.”

Editor’s Note: This article was updated on June 24, 2022, to include information from the ATS press release and a statement from Juul Labs.

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