Juul Labs Suing FDA to Release Documents Under Review
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Juul Labs Inc. is suing the U.S. Food and Drug Administration over the federal agency’s refusal to disclose documents used in an attempt to ban Juul’s electronic cigarettes.
The lawsuit filed Sept. 20 in a Washington, D.C., federal court came 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.
According to the company filing, the FDA is being accused of unlawfully hiding the “scientific disciplinary reviews” that led to the original e-cigarette ban on June 23, which was reversed temporarily the next day by a court order.
The FDA has invoked the “deliberative process privilege,” which allows federal agencies to deny releasing materials that could hurt internal agency deliberations.
In July, the FDA suspended its original ban, saying it needed more time to review scientific issues unique to Juul. The agency has not said how much longer the review will take. The suspension has allowed Juul to continue selling its e-cigarettes and related products.
“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.”
Balancing E-Cigarette Benefits Against Risks
The FDA’s concerns involve Juul’s original vaping device and four types of its Juulpods. FDA Commissioner Robert M. Califf has said that Juul has played a major role in the rise of vaping among youth in the U.S.
Juul has questioned in the past whether the FDA has balanced the public health benefits of Juul vaping products, which the company says can help curb cigarette smoking, against the risks, and “whether the FDA’s reasoning is scientifically sound.”
An FDA spokesperson said the federal agency does not discuss pending legislation and declined any comment.
This recent filing is just the latest salvo in the ongoing battle between Juul and several governmental agencies, which blame the company for fueling the teenage vaping issue.
Juul Faces Ongoing Legal Battles
Earlier this month, Juul agreed to pay at least $438.5 million to 33 states and Puerto Rico to settle allegations that its highly addictive e-cigarettes had been marketed directly to young adults.
The company is still facing similar claims from attorneys general in nine more states and thousands of personal injury Juul lawsuits. Local school districts across the country have been contemplating also taking legal action against the company.
Juul has not acknowledged any wrongdoing, although it also agreed earlier this year to refrain from several marketing practices that were thought attractive to younger adults.
The sale of Juul e-cigarettes first soared in 2015 when Juul launched its original promotions aimed at young adults. In the last two years, though, it has promoted its vaping products more as a safer alternative to cigarettes for older adults.
Company Still Targeted over Business Practices
Juul was the market leader by 2018, but also the target of multiple regulators and considerable criticism over its business practices. Despite growing pressure to restrict the company, Juul reported sales of $1.9 billion in 2021.
The use of e-cigarettes by youth in the U.S. has slowed in recent years, primarily because the minimum age to purchase all tobacco products was raised to 21 in 2019.
Juuls has said several times that it has taken substantial steps toward improving its reputation, hoping to reset the FDA’s view of its products. The lawsuit was just the latest attempt to convince the FDA that Juul is headed in the right direction.
“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.”