Juul Labs tobacco- and menthol-flavored vaping e-cigarette products are displayed in a convenience store. Photo: Patrick T. Fallow/AFP via Getty Images
Juul Labs on Tuesday filed a lawsuit against the Food and Drug Administration over the agency's refusal to disclose documents supporting its order to take Juul's e-cigarettes off the shelves in the U.S. market.
The big picture: The FDA in June ordered Juul to take its e-cigarettes off the market saying the company hadn’t submitted enough evidence that they were safe. But the ban was later suspended after a federal appeals court granted Juul a temporary stay on the order.
Details: Juul accused the FDA of violating the Freedom of Information Act by withholding a majority of the "scientific disciplinary reviews" underlying the sales ban, according to the complaint filed in a court in Washington, D.C.
- Juul alleges the FDA denied the FOIA requests, invoking the deliberative process privilege to withhold the majority of those materials.
- "Withholding the disciplinary reviews that would answer these questions impedes JLI’s ability to seek appropriate relief from [the] FDA’s decision and is also completely at odds with the purpose of FOIA and the transparency Congress expects from administrative agencies," the complaint alleges.
- "The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years, especially where even FDA recognizes its order is suspect."
What they're saying: “We took this necessary action as we remain concerned about the inequitable treatment of our applications given the political pressure on the agency to reach a specific result," a Juul spokesperson told Axios in an emailed statement.
- "This action will help us obtain information about the FDA review of our applications relevant to our continued appeal of the agency’s decision,” the spokesperson added.
- The FDA declined to comment on ongoing litigation.
Go deeper: Juul asks court for temporary ban on FDA's e-cigarette order
Editor's note: This story has been updated with additional details.