Juul Takes FDA to Court to Force Document Release

Electronic cigarette maker Juul Labs Inc. has filed a lawsuit to force the U.S. Food and Drug Administration to provide access to documents it used in issuing a marketing denial order of all company products.

Juul’s lawsuit was filed Sept. 20 in the U.S. District Court for the District of Columbia.

The marketing denial order, known as an MDO, was issued June 23 and essentially would have banned Juul products. A day later, though, Juul asked for, and received, a temporary stay order from the U.S. Court of Appeals D.C. Circuit Court.

On July 5, the FDA suspended its original order, saying it needed more time for additional review, but did not rescind its MDO. Products are currently being sold as before, including four types of Juulpods and the original vaping device that would have been banned.

Juul believes the FDA intentionally left out key toxicological evidence before announcing its intent to ban the products and also failed to balance the public health benefits of Juul vaping products against the risks. 

Juul also has questioned “whether the FDA’s reasoning is 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,” Juul said in a statement. “This action will help us obtain information about the FDA review of our applications, relevant to our continued appeal of the agency’s decision.”

FDA Stops Freedom of Information Act Request

The FDA has been under increasing pressure from governmental agencies, legislators, education lobbyists and multiple regulators to restrict Juul Labs, which has been blamed for fueling the issue of teenage vaping.

Juul’s recent lawsuit was filed after the FDA twice denied Freedom of Information Act requests from Juul. The act gives the public the right to request access to records from any federal agency.

The FDA has invoked the “deliberative process privilege,” which allows federal agencies to deny releasing materials under the belief that it could hurt internal agency deliberations.

“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 in its filing. “The agency invoked one of the most widely abused exemptions – the deliberative process privilege – to withhold the majority of those materials.”

According to the lawsuit, the FDA agreed to release only 115 of the 292 pages of documents that were requested and used in the MDO. The agency is being accused of hiding the “scientific disciplinary reviews.”

A spokesperson for the FDA declined comment on the recent lawsuit and said the federal agency does not discuss pending legislation. 

Juul Faces Ongoing Legal Battles

The recent filing is just the latest exchange between Juul and governmental agencies. Juul earlier this month agreed to pay $438.5 million to 33 states and Puerto Rico after allegations from attorneys general that its highly addictive e-cigarettes had been marketed directly to young adults. 

It also agreed to refrain from several marketing practices that were thought attractive to younger people. 

Similar claims in nine more states and thousands of personal injury e-cigarette lawsuits also are pending against Juul. Many school districts across the country have been contemplating taking legal action.

Juul became the market leader in 2018, just three years after launching its original promotions, which were aimed at younger adults.

Despite the growing pressure, Juul reported sales of $1.9 billion in 2021. Its sales, though, have declined recently and it now trails R.J. Reynolds Vapor Company, a subsidiary of the Reynolds American tobacco company.

Industry analysts have cited the regulatory and legal uncertainty surrounding Juul products for the significant and most recent market-share decline.