FDA Backs Away From Its Own Juul Decision With “Additional Review”

    On July 5, just two weeks after the Food and Drug Administration (FDA) ordered Juul to pull its products off the US market, the agency walked back on its decision, issuing an administrative stay on its own marketing denial order (MDO). In a puzzling series of events, the FDA acknowledged to Filter that it is “temporarily suspending the marketing denial order pending additional review,” though not rescinding it. And this seems to be on the basis of legal documents that Juul immediately filed in response to the decision.

    “FDA is 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,” an FDA spokesperson told Filter. The spokesperson added that because Juul’s “products do not have marketing authorization, [the company] cannot legally market, ship or sell their products,” and “the stay does not change this.”

    “With this administrative stay from the FDA now in place, we continue to offer our products to adult smokers while we pursue the agency’s internal review process,” Joe Murillo, the chief regulatory officer at Juul Labs, said in a statement. “We remain confident in the quality and substance of our applications and believe that ultimately we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health. We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for Juul products.”

    The stay can be interpreted, essentially, in one of two ways: Either the FDA is looking to bolster its initial MDO; or it believes it may have erred and could release a full rescission, placing Juul once again in scientific review.

    “It could be that FDA is looking at this with an eye toward issuing an amended MDO that more clearly reflects that they have considered and rejected what Juul is arguing is dispositive evidence—and perhaps also to separate the grounds of rejection so that they stand individually rather than as a collective,” an industry insider, who requested anonymity so as not to affect the PMTA process, told Filter. “In all events, I would think FDA will want to be in the least vulnerable position possible in terms of getting reversed by a court—either by heading off the legal challenge entirely through rescission or by strengthening their position by doing this additional review.”

    Why did the agency take close to two years to make a decision—and then, almost immediately, question the very decision it assertively made?

    While the stay does not technically allow Juul to keep selling its products, it’s ultimately up to the FDA whether to enforce this or not. A court-ordered temporary stay, meanwhile, does allow Juul to continue sales until July 12. (After publication, Juul effectively paused legal proceedings, and the FDA explicitly stated, for the first time, that it does “not intend to take enforcement action against the products subject to JLI’s marketing denial order while the administrative stay is in place.”)

    The press release and a series of tweets that accompanied the semi-reversal, riddled with the vagaries and dubiety that have come to be expected from the FDA, leave retailers, consumers, tobacco harm reduction (THR) advocates and the wider public in a renewed state of confusion: What, exactly, does “additional review” mean? Why did the FDA not rescind the MDO after admitting possible errors, as it has for other companies? Why did the agency take close to two years to make a decision—and then, almost immediately, question the very decision it assertively made?

    And perhaps most perplexing of all, why is there an implication that Juul products are more “illegal” than they have been? The company, like thousands of others, has been selling unauthorized vaping products for years, ever since the FDA “deemed” e-cigarettes under its regulatory authority in 2016. The status quo until recently has been that the FDA did not exercise its enforcement discretion, allowing millions of vaping products to stay on the market as companies pursued expensive and onerous marketing applications that would take years to complete.

    Like all other vape manufacturers, Juul had to file premarket tobacco product applications (PMTAs) by September 2020 and had to prove, essentially, that its products would be “appropriate for the protection of public health” (APPH)—a threshold understood as a given product’s supposed likelihood of helping an adult smoker transition to a safer alternative versus introducing a new generation to nicotine. Juul reportedly spent $100 million on its PMTAs.

    “It looks like the FDA realized it was going to lose and receive a stinging rebuke by the court, so it opted for retreat rather than defeat.”

    The FDA, which has since denied a majority of the millions of PMTAs filed by vapor companies, took nearly two years to evaluate Juul’s submission. And then, on June 22, 2022, an answer apparently arrived: The agency issued Juul an MDO, claiming that it had identified four deficiencies in the PMTA—one of which included insufficient data on potentially harmful chemicals that could “leach” from the pods into the e-liquid.

    Two days later, on June 24, the company sought relief in an appeals court, arguing that the agency’s decision was “arbitrary and capricious,” and came from “immense political pressure from Congress once it became politically convenient to blame Juul for youth vaping, even though several of its competitors now have a larger market share and much higher underage-use rates.”

    The US Court of Appeals in DC swiftly gave Juul a temporary stay, meaning the company could keep selling its products until mid-July, when the court would determine whether to grant a “permanent” stay as legal proceedings went on. As initially reported by the Wall Street Journal, Juul argued in court filings that the FDA overlooked more than 6,000 pages of data, insisting that the information the agency required on aerosols was “right there” all along.

    “It looks like the FDA realized it was going to lose and receive a stinging rebuke by the court, so it opted for retreat rather than defeat,” Clive Bates, the former director of the United Kingdom’s Action on Smoking and Health, told Filter. “The problem is that its PMTA process is wide open to abuse because the agency can set arbitrary standards for what it considers acceptable, and these are invisible to the applicant and have no objective basis. So a vindictive or politically motivated agency can find the slightest pretext buried in evidence and make that the big issue. It’s bullying through the use of unaccountable administrative power.”

     


     

    Update, July 6: This article has been updated to include comment from Juul Labs, as well as a note about Juul pausing its legal proceedings following publication.

    Photograph by Filter

    The Influence Foundation, which operates Filter, has received grants from Juul Labs, Inc. Filters 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.

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