The FDA denied two Freedom of Information Act requests from Juul for the “scientific disciplinary reviews” used to reject marketing authorization for Juul’s products, the company alleged Tuesday in a complaint filed in the US District Court for the District of Columbia.
The filing marks the latest move in the standoff between Juul and the FDA, which in July administratively suspended its ban on Juul products after determining there were additional scientific issues it needed to review.
According to the complaint, the FDA withheld the requested documents by citing “the deliberative process privilege,” which allows the federal government to deny materials that could hurt internal agency deliberations if released. Juul argued that because the FDA issued its marketing denial order, the “materials incorporated or relied on in final agency action are, by definition, no longer pre-decisional materials protected” by that privilege.
The agency initially banned Juul’s products on June 23, citing a lack of evidence defending their safety and noting their “
The FDA subsequently stayed its ban pending additional review, effectively allowing Juul to continue selling its products for the time being.
Cause of Action: Violation of the Freedom of Information Act.
Relief: Enjoin FDA from continuing to withhold documents; declare failure to disclose records violates FOIA; costs and fees.
Attorneys: Juul is represented by Jason M. Wilcox and other attorneys from Kirkland & Ellis LLP.
Comment: The FDA said it declines to comment on possible, pending, or ongoing litigation.
The case is Juul Labs Inc. v. FDA, D.D.C., No. 1:22-cv-02853, Complaint Filed 9/20/22.
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