Juul Lawsuit Accuses FDA of Hiding Documents Key to Denial Decision

    On September 20, Juul Labs filed a federal lawsuit in the US District Court of the District of Columbia, stating that the Food and Drug Administration (FDA) is withholding documents crucial to the agency’s new review of the company’s vaping products.

    Like other vapor manufacturers, Juul had to file premarket tobacco product applications (PMTAs) by September 2020, showing that its products were “appropriate for protection of public health”—a threshold that has come to be understood as helping adults switch from cigarettes to a safer alternative while not introducing a new generation to nicotine. The company submitted PMTAs for its menthol pods, Virginia tobacco pods, device and locked device (likely similar to the Juul2 that’s available in the United Kingdom and features age-verification software).

    On June 23, 2022, after a lengthy delay, the FDA denied authorization for Juul and ordered it off the US market. The dramatic move surprised observers, who had seen a handful of other tobacco-flavored vaping products made by large companies authorized, even as reams of applications from smaller companies were denied. Many saw it as politicized punishment for Juul’s alleged earlier role in stoking a youth vaping epidemic.Millions of adults have used the company’s products to replace cigarettes. Juul obtained a temporary court stay on the decision the very next day.

    Just a couple of weeks later, on July 5, the FDA seemingly backed away, issuing its own administrative stay, while not rescinding its decision, to allow Juul to remain on shelves pending additional review.

    Juul, which critics have contended deferred to the FDA for far too long, has now gone much more on the offensive.

    “Given FDA’s actions to publicize its decision, it should not be permitted to hide its supporting work in the shadows,” the company’s complaint reads. “FDA’s decision to deny [Juul Labs, Inc.’s] PMTAs generated immense public interest. Government officials with knowledge of the FDA’s order leaked the decision to The Wall Street Journal before it was even issued to JLI. The following day, when the order issued, FDA published a provocative press release, blaming JLI for a purported youth vaping epidemic (even though this purported epidemic was not the stated reason for denying the applications). This press release, along with the order itself, JLI’s successful attempts to temporarily stay the order, and FDA’s decision to ultimately re-review its own decision all received extensive press coverage.”

    The basis for the lawsuit is simple enough: Following the FDA’s marketing denial order (MDO) at the end of June, Juul filed a request through the Freedom of Information Act (FOIA), requesting documents pertinent to the denial. The FDA, in turn, agreed to release more than half of the pages but maintained that the rest of them were exempt through something known as “deliberative process privilege”—a rule meant to preserve “the integrity of the deliberative or decision-making processes within the agency by exempting from mandatory disclosure opinions, conclusions, and recommendations included within inter-agency or intra-agency memoranda or letters.”

    Juul appealed that decision, and when the FDA did not respond within 30 days, as required, the company escalated the situation to court—maintaining that these documents do not apply to policy but rather would demonstrate “whether FDA’s reasoning is scientifically sound.” (An FDA spokesperson told Filter that the agency declines to comment on possible, pending or ongoing litigation.”)

    Juul, which critics have contended deferred to the FDA for far too long, has now gone much more on the offensive—fighting for its own survival, sure, but also trying to paint the FDA as an agency under the constant sway of prohibition-minded politicians.

    “We remain concerned about the inequitable treatment of our application given the political pressure on the agency.”

    “We took this necessary action as we remain concerned about the inequitable treatment of our application given the political pressure on the agency to reach a specific result,” a Juul spokesperson told Filter. “This action will help us obtain information about the FDA review of our applications relevant to our continued appeal of the agency’s decision.”

    Juul’s initial denial was a mess from the start. When the FDA temporarily walked back its decision on July 5—just a couple of days after Brian King assumed the role as the new head of the agency’s Center for Tobacco Products (CTP)—an FDA spokesperson told Filter that it was “reviewing the marketing denial orders it issued to Juul because in the course of reviewing litigation briefing materials the agency determined that there are scientific issues unique to this application that warrant additional review.” The Wall Street Journal reported, too, that Juul said the FDA had overlooked 6,000 pages of its 125,000-plus-page PMTAs. Given that the FDA’s Juul decision was almost a year overdue, this would represent an extraordinary lapse by the agency.

    Politico, which broke the news of the lawsuit, also reported that Juul has asked for meetings with FDA commissioner Robert Califf, and that the agency responded that he would not be available due to scheduling issues.

     


     

    Photograph by Filter

    The Influence Foundation, which operates Filter, has received grants from Juul Labs, Inc. Filter’s Editorial Independence Policy applies.

    • Alex is Filter’s news editor. He previously worked as a reporter and copy editor at VICE, and has been published in The New York Times MagazineThe Columbia Journalism Review, The Los Angeles Times and The New Republic, among other outlets. He was also previously a freelance editorial consultant for the Foundation for a Smoke-Free World; The Influence Foundation, which operates Filter, has received grants from the Foundation for a Smoke-Free World. He is currently based in Los Angeles.

    • Show Comments