• May 28, 2024

Juul Sues FDA for Failure to Disclose Documents

 Juul Sues FDA for Failure to Disclose Documents

Credit: Insurance Journal

Credit: Insurance Journal

The battle between Juul Labs and the U.S. Food and Drug Administration continues to gain steam. The vapor manufacturer has now filed a lawsuit against the FDA over the agency’s refusal to disclose documents supporting its marekting denial order (MDO) that bans a company from selling e-cigarettes on the U.S. market.

In a complaint filed on Tuesday with a federal court in Washington, D.C., Juul Labs 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 June 23 issuance of the MDO, according to Reuters.

The company claims the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims Juul e-cigarettes help smokers quit combustible cigarettes, 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 scrutinized decisions in recent years,” Juul Labs stated.

An FDA spokeswoman declined to comment, saying the agency does not discuss pending litigation.

Juul Labs accused the FDA of violating the federal Freedom of Information Act by withholding a majority of the “scientific disciplinary reviews” underlying the sales ban.

The company said it filed an administrative appeal of its MDO through the agency, but the FDA missed a Sept. 13 deadline to resolve it.

A federal appeals court temporarily stayed Juul’s MDO on June 24.

Earlier this month, Juul Labs settled youth marketing lawsuits with 33 states and Puerto Rico.