Enlarge / Juul e-cigarette packs are on sale at the Brazil Outlet store on June 22, 2022 in Los Angeles, California.
The U.S. Food and Drug Administration on Tuesday paused a decision that would effectively force Juul out of the U.S. market. On Wednesday, the two sides agreed to suspend their legal battle, as the regulator was conducting an additional review of Juul’s products.
For people using Juul products, the new development doesn’t change much at the moment: a panel of federal appeals court judges had already issued an administrative suspension on June 24, meaning Juul products could remain in the market while the company was fighting the FDA. denial of their application for marketing authorization before the courts. But in the long run, it represents a shameful setback for the FDA and indicates that Juul may have a good chance of permanently reversing the denial.
On June 23, the FDA announced that it denied U.S. marketing authorization for all Juul products, effectively forcing the company to abandon the previously dominant e-cigarette market. Although the FDA decision had leaked to the press the day before, it still shook industry observers, consumers and Juul, who said in court documents that he first knew the decision through the leak. of press.
In announcing its refusal, the FDA stated that Juul did not provide sufficient toxicology data to prove that its products were safe. Specifically, the FDA was concerned, in part, about data on “potentially harmful chemicals leaching from the company’s patented electronic liquid pods.”
The next day, June 24, Juul filed an emergency motion in federal appeals court to suspend the FDA’s denial, and a group of judges issued an administrative suspension. Under the terms of that stay, Juul had to file an emergency petition by June 27, which he did, and the FDA should file its response by July 7.
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In his emergency request for a longer stay, Juul argued that his request for authorization of more than 125,000 pages included all the toxicology data the FDA claimed was missing. In addition, the company accused the FDA of conducting a “random regulatory process” and said the regulator was under pressure to ban Juul after he was widely blamed for a juvenile vaping epidemic.
Data conflict
A particular point of controversy, according to court documents filed by Juul, is that the FDA claimed it had no toxicology data on four specific chemicals that were leached from the company’s plastic pods into its electronic liquid, which is intended to be heated, vaporized, and then inhaled. Toxicology reports on the aerosol components of this vaporized electronic liquid did not include data on these four chemicals. But Juul argued that he provided toxicology data on all detectable aerosol components.
Laura Crotty Alexander, an e-cigarette researcher at the University of California, San Diego, reviewed Juul’s court documents at the request of The New York Times and said Juul’s line of argument is reasonable. It is possible that the four chemicals in question became something different during the vaporization process. “It’s not uncommon for a chemical that was originally liquid not to be an aerosol,” Crotty Alexander told the Times.
It is important to note that the identities of the four chemicals are not public, they were removed from the court documents, so it is not possible to say whether they should have been present on the spray pen or not.
On Tuesday, July 5, two days before the FDA deadline to file a response to Juul’s emergency petition to the federal court of appeal, the agency said it would conduct an additional review of the data and Juul’s application.
“The agency has determined that there are scientific issues exclusive to the Juul application that warrant further review,” the FDA tweeted Tuesday evening. “This administrative suspension temporarily suspends the marketing refusal order during the additional review, but does not terminate it.”
In a statement, Juul regulatory director Joe Murillo said that “with this now-suspended FDA administrative suspension, we continue to offer our products to adult smokers while we follow the agency’s internal review process.”