The United States Food and Drug Administration has rescinded its marketing denial orders (MDOs) to Juul Labs, Inc, almost two years after the agency ordered the company’s vaping products to be taken off the market.
Juul’s submissions under the FDA’s premarket tobacco products applications (PMTA) process now return to “pending” status, and are back under scientific review.
The significance of the news extends far beyond the company’s own fortunes, when Juul has long been at the epicenter of US arguments about harm reduction and youth vaping. By 2018, Juul dominated the country’s vapes market—its share has since fallen—but its early marketing was heavily criticized for appealing to youth, amid media and political outcry.
Tobacco harm reduction advocates contend that transitioning adults away from cigarettes is by far the biggest public health impact of products like Juul’s. They lined up to condemn the FDA’s 2022 decision to deny Juul—with many seeing it as a political move, driven by a vengeful anti-vaping lobby.
“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.”
On June 6, referencing decisions in court cases brought by manufacturers that have received MDOs, the FDA stated: “This action is being taken, in part, as a result of the new case law [established by the cases], as well as the FDA’s review of information provided by the applicant. 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 FDA issued its MDOs to Juul in June 2022, saying the company’s PMTA applications “lacked sufficient evidence” that the products “met the public standard required by law.”
But just two weeks later, the FDA issued an administrative stay on these MDOs, pausing but not rescinding them. “The agency determined that there are scientific issues unique to this application that warrant additional review,” an FDA spokesperson told Filter at the time. In September that year, Juul filed a federal lawsuit, accusing the agency of withholding documents about the MDO decision.
Juul’s tobacco- and menthol-flavored products have remained on shelves throughout, but with the company in a state of limbo regarding its future.
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers association, played down the immediate practical impact of the latest news.
“A pause and a rescission of an MDO are differences without much distinction,” he told Filter. “Since the pause of the MDO enforcement, Juul has been able to market their products and nothing about this move makes it harder or easier to continue to do so.”
Authorization would guarantee continued access for large numbers of people who quit smoking and now use Juul instead.
Still, if Juul is ultimately to obtain FDA authorization—which again, is not guaranteed—this is a necessary first step.
Authorization would guarantee continued access for large numbers of people who quit smoking and now use Juul instead.
It would also be notable in the sense that all manufacturers of the few FDA-authorized vaping products are owned by tobacco companies. Juul was founded purely as a vape company; while Altria acquired a minority stake in 2018, it sold that stake in 2023. One consistent criticism of the PMTA process from vape advocates has been that it’s so onerous—more so than the pathway for far-more-harmful new cigarettes—that only the biggest companies with the most resources can realistically succeed.
“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 marketing authorization,” Juul said in a statement. “We remain confident … 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.”
Some of the groups that have for years attacked Juul immediately condemned the FDA’s reversal. The anti-vaping American Lung Association said it was “disappointed” and “deeply troubled.” And Yolanda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, called the delay in a final PMTA decision “unacceptable and harmful to America’s kids.”
“The FDA should swiftly finish its review and again deny marketing applications for all Juul products given Juul’s primary role in causing the youth e-cigarette epidemic and the continuing popularity of Juul’s products among youth,” she said in a statement.
Juul was once the most popular vaping brand among youth. But the 2023 National Youth Tobacco Survey found that Juul was only the fourth-most popular choice for youth, far behind the now-dominant Elf Bar. Youth vaping overall has substantially declined in recent years.
“FDA has known for nearly two years that it fumbled its review of Juul’s applications, but sat back and did nothing all this time.”
A rare point on which tobacco harm reduction and anti-vaping groups can agree is that the FDA’s PMTA process has been shambolic.
“What is notable,” Conley said, “is that FDA has known for nearly two years that it fumbled its review of Juul’s applications, almost bankrupting the company in the process, but sat back and did nothing all this time.”
“It remains to be seen,” he continued, “what this means for Juul, which not only has its 2020 applications for its original Juul products pending review once again, but also its next generation product with Bluetooth age-gating technology.”
“Considering the later product would require a nationwide launch and consumer education,” he concluded, “it would be best for consumers if FDA authorized both classes of products.”
Photograph by Filter
The Influence Foundation, which operates Filter, has received unrestricted grants from both Juul Labs, Inc, and Altria Client Services. Filter’s Editorial Independence Policy applies.
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