The U.S. Food and Drug Administration (FDA) has issued marketing denial orders to Juul Labs (parent company Altria Group, (NYSE: MO)) for all products sold in US markets, making it functionally impossible for Juul to distribute, import, or sell any of its products in the United States.
"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," said FDA Commissioner Robert M. Califf, MD. "The agency has dedicated significant resources to review products from the companies that account for most of the US market. We recognize these make up a significant part of the available products, and many have played a disproportionate role in the rise in youth vaping."
The ban isn't surprising given Juul's past run-ins with regulators, especially as the brand became synonymous with a spike in teenage vape usage. Juul's marketing push put advertisements featuring its nicotine-toting products across social media sites frequented by younger users. The company's marketing would later result in it paying a $40 million settlement to the state of North Carolina for its role in underaged vaping.
Health concerns have also surrounded Juul's products and seem to be the motivation behind the FDA's MDO. The regulator notes having reviewed Juul's premarket tobacco product applications and that the documentation supposedly lacked "sufficient evidence regarding the toxicological profile of the products" to demonstrate appropriate attention to consumer safety.
The FDA claims to have not received convincing enough clinical data from Juul to this end.
In response to the FDA's order, Juul has asked the DC Circuit Court for an emergency administrative stay to give it "meaningful relief." The company has alleged that the FDA was "unfair" in reviewing its products. It is worth noting that Juul's rival, Vuse (parent company British American Tobacco, (NYSE: BTI)), has received PMTA authorization for its products.