ALEXANDRIA, Va.—Juul Labs Inc. is suing the U.S. Food and Drug Administration (FDA) because the agency has refused to disclose documents that support its order that bans the company from selling its products in the U.S. Juul said the FDA is using the "widely abused" deliberative process privilege to improperly withhold scientific materials that are "central" to understanding the basis for the June 23 sales ban, reports Reuters.
"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," Juul said.
The e-cigarette company says that the undisclosed FDA documents would show whether the FDA balanced the public health benefits and risks of its products, which is legally required, and whether the agency’s reasoning was scientifically sound.
“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 said in an email to NACS Daily. "This action will help us obtain information about the FDA review of our applications relevant to our continued appeal of the agency’s decision.”
Juul has accused the FDA of violating the federal Freedom of Information Act because the agency has withheld most of the "scientific disciplinary reviews" underlying the sales ban.
In late June, the FDA issued marketing denial orders (MDOs) for all JUUL products currently sold in the U.S., and the notice called for the removal of JUUL products from the U.S. market.
Shortly after, a federal appeals court granted Juul Labs an emergency administrative stay of the FDA’s MDOs, pending further order from the court. JUUL products can continue to be marketed for retail sale while Juul Labs pursues legal remedies.
In July, the FDA suspended its ban on JUUL vaping products while the company appeals the agency’s decision. Also in July, the U.S. Court of Appeals for the D.C. Circuit agreed to delay Juul’s case until the FDA completes its reevaluation of JUUL products.
Juul asked the FDA for a longer stay to continue selling its e-cigarettes for the duration of the appeal process. Separately, Juul asked the FDA to stay its own order pending the appeal, reports the Journal.
Initially, the FDA denied Juul’s request for a stay, which led Juul to seek a stay of the ban in court.
In court filings, Juul alleged the FDA mishandled its applications. Juul said the agency overlooked more than 6,000 pages of data that the company submitted to the FDA on the aerosols that users inhale.
NACS filed an amicus brief in the U.S. Court of Appeals for the D.C. Circuit in support of Juul’s petition for a stay.
NACS argued that the immediate removal of JUUL products would “wreak havoc” on the entire industry, upend an important segment of the economy, endanger countless jobs and impede small businesses’ ability to operate.