Juul Labs Inc. filed a petition to the D.C. Circuit Court of Appeals for review of the Food and Drug Administration’s Marketing Denial Order, which denies Juul’s premarket tobacco product application for their electronic nicotine inhalant products.
In the petition, Juul Labs Inc. requests an emergency administrative stay until the court receives a complete briefing of their petition and their emergency motion for a stay. The petition declares the Marketing Denial Order filed by the FDA extraordinary and unlawful; the petition also states that the FDA has singled out and denied Juul Labs Inc. throughout the process of resolving their technical concerns.
The petition alleges that the FDA cannot credibly argue there is crucial public interest in removing Juul products from the market immediately; and, aside from isolated data points on the toxicology report, the data demonstrates Juul products are not toxic.
The petition states that an immediate instatement of the Marketing Denial Order would irreparably harm their company.
Juul Labs Inc. is represented by Kirkland & Ellis LLP.