The Food and Drug Administration on Thursday announced it will order top-seller Juul to take its e-cigarettes off the shelves in the U.S. market.
Why it matters: The move comes amid a push to cap nicotine in cigarettes and signals the Biden administration is escalating its attempt to limit tobacco use in the U.S., Axios' Arielle Dreher reports.
The big picture: The decision follows a nearly two-year review by the FDA of Juul's data as the vaping company sought authorization for its products to stay on the U.S. market, according to the Wall Street Journal.
Details: The order impacts the JUUL device and four types of JUULpods, the FDA said.
- The agency said that the company's application to market the product "lacked sufficient evidence ... to demonstrate that marketing of the products would be appropriate for the protection of the public health."
What they're saying: "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 said in a statement.
- He added that Juul products may have played a "disproportionate role in the rise in youth vaping."
Joe Murillo, the chief regulatory officer at Juul Labs, said in a statement that the company disagrees with the FDA's decision.
- Murillo said the company believes the data sent to the FDA in its application showed that Juul products have met public health standards.
- "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," Murillo said.
- The company will seek a stay and explore other options "under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator."
The decision deals a blow to Altria, which in 2018 paid $12.8 billion for a 35% stake in Juul.
- Since then, Juul's value has plummeted amid regulatory crackdowns and declining sales.
- Altria valued its Juul stake at $1.6 billion as of March 31, per the WSJ.
Flashback: In 2021, FDA removed thousands of electronic cigarettes off U.S. shelves but delayed its decision on Juul.
- The agency rejected applications for about 950,000 flavored e-cigarettes and related products because of their appeal to underage teens and flavor profiles.
- The FDA based its review of the applications on whether e-cigarettes are effective in getting smokers to quit and, if so, whether the benefits to smokers outweigh the health damage to new users, including teenagers.
Juul has also faced scrutiny from regulators, public health officials, and lawmakers over its products. The company halted U.S. sales for several of its flavors back in 2019 due to pressure from critics who said the product was being targeted at minors, Reuters reports.
Worth noting: The decision comes as the FDA announced plans for a proposed product standard that would decide on maximum nicotine to level to reduce the addictiveness of cigarettes and other tobacco products.
Editor's note: This story was updated with a statement from Juul Labs.
