September 24, 2022
Juul Labs has sued the US Food and Drug Administration (FDA) over the agency’s refusal to disclose documents supporting its order banning the company from selling e-cigarettes on the US market.
In a complaint filed on Sept. 20 with a federal court in Washington, DC, Juul accused the FDA of invoking the “widely abused” deliberative process privilege to improperly withhold scientific materials that are “central” to understanding the basis for the marketing denial order issued on June 23.
Juul said in the filing that the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, and whether the agency’s reasoning was scientifically sound.
“The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinised decisions in recent years,” A Juul spokesperson told Reuters.
Juul has immediately secured a court stay on FDA’s sales ban and the regulator itself put its decision on hold in early July, saying there are scientific issues unique to the Juul application that warrant additional review.