Juul Continues Pushback on FDA Marketing Denial

On June 24, following the Food and Drug Administration’s (FDA) marking denial order (MDO) of Juul products earlier in the month, the D.C. Circuit Court of Appeals granted Juul Labs Inc.’s motion for temporary stay; within the appeal, the court states the intent of granting the order is for the court to have sufficient opportunity to review Juul Labs Inc.’s emergency motion for stay.

A few days later, on June 28, Juul filed a corrected redacted emergency motion for stay regarding the FDA’s MDO of Juul products.

Juul argues that it is likely to prevail on the merits of their toxicology reports and other scientific evidence the FDA misapprehended; Juul also says they face imminent irreparable economic and reputational harm from the MDO without a stay; finally, they say public interest favors Juul products and the removal of the MDO.

Juul Labs Inc. are represented by Kirkland & Ellis LLP.