The FDA issued its long-awaited decision regarding Juul vape devices and pods earlier this week and included the controversial devices in its sweeping bans of electronic nicotine delivery systems. Citing “insufficient and conflicting” data in the company’s application to continue selling products, the order includes the sale and marketing of its vape devices as well as its remaining tobacco- and menthol-flavored liquids. The company made the voluntary move to stop selling fruit and other flavors in 2019 in an effort to appease regulators and outraged parent groups over accusations that it targeted children and other young people with its marketing.
Shares of Altria – the tobacco company that owns more than a one-third stake in Juul – dropped sharply on the news and sank 8% as company spokespeople and lawyers reacted. “FDA’s decision is arbitrary and capricious and lacks substantial evidence, and an immediate administrative stay is critical to protect [Juul Labs Inc.], its commercial partners and its customers,” the company said. It is also citing unfair treatment and scrutiny in its application to the FDA to keep products on shelves. FDA’s order for Juul required immediate enforcement, which is a measure that is generally only taken if a dire and urgent risk exists for consumers. Instead, the FDA said in its decision that no information had been received indicating a hazard from the use of Juul’s devices or pods and instead noted that evidence did not exist to “assess the potential toxicological risks of using the Juul products.”
Juul filed for a stay of the FDA’s order in the DC Circuit Court of Appeals and called the agency’s order “extraordinary and unlawful.” That stay was granted and the company can continue selling its products as it navigates the legal process which can include a hearing on the merits of the FDA’s actions as well as the data used to arrive at the decision. Industry insiders on both sides will no doubt watch these future actions closely as Juul is among the first company included in the FDA’s recent bans with the resources necessary to mount a substantial legal defense.