The Food and Drug Administration officially denied market authorization for e-cigarette products from Juul Labs Inc. on Thursday. The decision means Juul will no longer be able to sell or distribute any of its products in the U.S.
“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 Dr. Robert M. Califf said in a press release.
The denial is a result of an ongoing FDA review of e-cigarette products on the market currently. There is some evidence that e-cigarettes may help some smokers switch from traditional cigarettes to vapes, which are thought to be less harmful, according to the Centers for Disease Control and Prevention. But the availability of such products has also "played a disproportionate role in the rise in youth vaping," Califf noted in the release.
In 2021, over 2 million, or about 7.6%, of middle and high school students in the U.S. reported using e-cigarettes, the most common type of tobacco product reported, according to the FDA and CDC's 2021 Annual National Youth Tobacco Survey. Juul is the top-selling e-cigarette brand in the U.S., according to the CDC. Up to 99% of e-cigarettes contain nicotine, which can harm adolescent brain development, but about two-thirds of Juul users between 15 and 24 did not know that Juul always contains nicotine, per the CDC.
The FDA said it found that Juul's premarket tobacco product applications "lacked sufficient evidence" about the vapes' toxicological profile that would support their use in protecting public health. For instance, the FDA noted that the company provided conflicting evidence or not enough evidence about "potentially harmful chemicals leaching from the company’s proprietary e-liquid pods."
Michele Mital, acting director of the FDA’s Center for Tobacco Products, added in the press 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.”
Juul previously faced scrutiny for marketing strategies that, allegedly, targeted youth. The company stopped selling its mint and fruit-flavored pods in 2019 due to concerns that those may be more appealing to young people than tobacco- and menthol-flavored pods.
At the time of the FDA announcement, Juul had five products on the market (the Juul device itself and four types of pods), all of which can now no longer be sold or distributed. However, the FDA notes that this decision only affects the company itself: "The FDA cannot and will not enforce against individual consumer possession or use of Juul products or any other tobacco products."
Joe Murillo, chief regulatory officer at Juul Labs, told TODAY in a statement: “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.
“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of JUUL products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being 'appropriate for the protection of the public health.'"
"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."