On September 20, Juul Labs filed a federal lawsuit in the US District Court of the District of Columbia, stating that the Food and Drug Administration (FDA) is withholding documents crucial to the agency’s new review of the company’s vaping products.
Like other vapor manufacturers, Juul had to file premarket tobacco product applications (PMTAs) by September 2020, showing that its products were “appropriate for protection of public health”—a threshold that has come to be understood as helping adults switch from cigarettes to a safer alternative while not introducing a new generation to nicotine.
The company submitted PMTAs for its menthol pods, Virginia tobacco pods, device and locked device (likely similar to the Juul2 that’s available in the United Kingdom and features age-verification software).
On June 23, 2022, after a lengthy delay, the FDA denied authorization for Juul and ordered it off the US market. The dramatic move surprised observers, who had seen a handful of other tobacco-flavored vaping products made by large companies authorized, even as reams of applications from smaller companies were denied. Many saw it as politicized punishment for Juul’s alleged earlier role in stoking a youth vaping “epidemic.” Millions of adults have used the company’s products to replace cigarettes. Juul obtained a temporary court stay on the decision the very next day.
Alex Norcia – Filter – 2022-09-21.
Want More Investigative Content?
