FDA to Order Juul E-Cigarettes Off U.S. Market
The Food and Drug Administration is preparing to order Juul Labs Inc. to take its e-cigarettes off the U.S. market, according to people familiar with the matter.
The FDA could announce its decision as early as Wednesday, the people said. The marketing denial order would follow a nearly two-year review of data presented by the vaping company, which sought authorization for its tobacco- and menthol-flavored products to stay on the U.S. market.
An FDA spokesperson told CNN the agency could not provide any information at this time. Juul Labs did not immediately respond to CNN's request for comment.
Altria shares tumbled 8% Wednesday and the stock has fallen 13% this year. The company invested $12.8 billion for a 35% stake in Juul in 2018. The deal quickly went south as concerns mounted about the health risks of vaping, and US regulators pushed for a crackdown on e-cigarettes. Juul was also criticized for selling vape pods with flavors such as mango, creme and cucumber that became popular with teens.
The Journal notes that Juul "could pursue an appeal through the FDA, challenge the decision in court or file a revised application for its products."
This move comes after the Biden administration signaled Tuesday that it will develop a proposed rule to establish a maximum nicotine level in cigarettes and other tobacco products that will essentially lower the amount of nicotine in products available in the US. It is a step that no other administration has taken before and is one public health experts say would be transformative if enacted.
Though e-cigarette products have been allowed to remain on the market for years, in 2020, the FDA asked the companies to submit applications to keep products on the market.