E-cigarette maker Juul Labs is suing the Food and Drug Administration (FDA) over the agency’s refusal to release documents supporting its order to remove Juul’s products from the US market.
In a lawsuit filed Tuesday in federal court in Washington, D.C., the company alleged the FDA violated the Freedom of Information Act by refusing to hand over the “scientific disciplinary reviews” underlying the ban on the sale of the FDA.
“The agency relied on one of the most widely used exemptions — the deliberative process privilege — to withhold the majority of these documents,” the lawsuit said. “But the documents withheld are essential to understanding the basis of the FDA’s marketing denial order” and whether the agency has balanced the public health benefits and risks of Juul’s products as required by law, as well as whether the agency’s reasoning is “scientifically sound.”
In late June, the FDA announced a nationwide ban on the sale of Juul e-cigarettes, saying the company had failed to demonstrate that keeping its products on the market “would be appropriate for the protection of public health. “.
The next day, a federal appeals court granted a temporary administrative stay of the decision.
The FDA then suspended the order about two weeks later and announced that other scientific issues needed to be investigated.
“Withholding disciplinary reviews…hampers JLIs [Juul’s] ability to seek appropriate relief from the FDA’s decision and is also completely at odds with the purpose of the FOIA and the transparency that Congress expects from administrative agencies,” Juul’s lawsuit said.
“The public deserves a full picture of the scientific facts behind one of the agency’s most controversial and scrutinized decisions in years, especially where even the FDA acknowledges its order is suspect.”
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