Talk about “endless wars.”
Juul Labs Inc. fired the latest salvo in its long-running skirmish with the U.S. Food and Drug Administration on Tuesday over the agency’s refusal to release documents related to its review of the company’s vape products.
The FDA has denied two Freedom Of Information requests from Juul, which wants to know the agency’s rationale for banning its products on June 23—only to reverse itself shortly thereafter following a court order in Juul’s favor.
In banning Juul products, the FDA rejected the company’s premarket tobacco product applications, which were filed in July of 2020 and are required to provide evidence that Juul products are “appropriate for protection of public health.”
The purpose of requiring PMTAs is to ensure that devices like vapes are a safer alternative than cigarettes but do not introduce a new generation to possible nicotine dependence.
Juul’s website displays these statements: “To be clear, nicotine is addictive and can cause certain harms to health. It would be best if no one used any nicotine product.”
On June 24, Juul obtained an emergency court order blocking the FDA’s denial. Two weeks later, the FDA admitted that it had not thoroughly reviewed more than 125,000 pages of data and other evidence submitted by Juul.
Juul products have been allowed to remain on the market pending “additional review.”
In the lawsuit, the company is essentially accusing the FDA of unlawfully hiding the “scientific disciplinary reviews” that led to its June 23 PMTA denials.
The FDA has invoked the “deliberative review process,” which enables federal agencies to withhold materials that could hurt internal agency deliberations.
Among other things, Juul wants to know if the FDA balanced the public health benefits and risks of its products and “whether the FDA’s reasoning is scientifically sound.”
The FDA said it does not comment on possible, pending, or ongoing litigation.
As a result of its actions with regard to Juul and other vape marketers—along with its regulation of infant formulas during a retail shortage this year—the FDA is in the midst of a review by the nonprofit Reagan-Udall Foundation. According to its website, the Foundation "serves as a crucial conduit between FDA and the public, providing a means for FDA to interact directly with stakeholders," but "does not participate in regulatory decision-making or offer advice to FDA on policy matters."