FDA backtracks on Juul ban, says it's re-examining the company's 'unique' issues

Expand Getty | Mario Tama

The U.S. Food and Drug Administration on Tuesday suspended a decision that would effectively force Juul out of the U.S. market. On Wednesday, the two sides agreed to put their legal battle on hold as the regulator conducts further review of Juul's products.

For people who use Juul products, the new development doesn't change much at this time: a panel of federal appeals court judges had already issued an administrative stay on June 24, which meant that Juul products could remain on the market while the company fought the FDA's denial of its marketing authorization application in court. But, in the longer term, it represents an embarrassing backlash from the FDA and signals that Juul may have a good chance of reversing the denial permanently.

On June 23, the FDA announced that it had denied U.S. marketing authorization for all Juul products, forcing the company out of the e-cigarette market it had previously dominated. Although the FDA's decision was leaked to the press the day before, it still rattled industry watchers, consumers and Juul, which said in court documents that it got wind of the decision. for the first time thanks to the leak in the press.

In announcing its denial, the FDA claimed that Juul had not provided enough toxicological data to prove its products were safe. Specifically, the FDA was concerned, in part, about data on "potentially harmful chemicals leaking from the company's proprietary e-liquid pods."

The next day, June 24, Juul filed an emergency motion with a federal appeals court to stay the FDA's denial, and a panel of judges issued an administrative stay. Under that stay, Juul had to file an emergency petition by June 27, which it did, and the FDA had to file its response by July 7.

In its urgent request for a longer stay, Juul argued that its more than 125,000-page clearance request included all the toxicology data the FDA claimed was missing. Additionally, the company accused the FDA of conducting a "haphazard regulatory process" and said the regulator was under pressure to ban Juul after it was widely blamed for a youth vaping epidemic.

One particular point of contention, according to court documents filed by Juul, is that the FDA claimed it lacked toxicology data on four specific chemicals that seep from the company's plastic pods into its e -liquid, which is meant to be heated, vaporized, and then inhaled. Toxicology reports on the aerosol components of this vaporized e-liquid did not include data on these four chemicals. But Juul argued that it provided toxicological data on all detectable components of the aerosols.

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 argument was reasonable. It's possible that the four chemicals in question were converted into something different during the vaping process. "It's no surprise that a chemical that was originally liquid isn't an aerosol," Crotty Alexander told The Times.

It is important to note that the identities of the four chemicals are not public - they have been suppressed from court documents - so it is not possible to say whether they should have been present in the aerosol plume or not.

On Tuesday, July 5, two days before the FDA's deadline to submit a response to Juul's emergency motion in federal appeals court, the agency announced it would conduct a review more in depth Juul data and demand.

"The agency has determined that there are scientific issues specific to the Juul app that warrant further review," the FDA tweeted late Tuesday. "This administrative stay temporarily suspends the marketing refusal order during the additional review but does not cancel it."

In a statement, Juul Chief Regulatory Officer Joe Murillo said, "With this administrative stay from the FDA now in place, we continue to offer our products to adult sm...