The U.S. Food and Drug Administration on Tuesday put a hold on a decision that would effectively force Juul off the U.S. market. On Wednesday, the two sides agreed to end their legal battle as the regulator conducted an additional review of Juul’s products.
For people who use Juul products, the new development doesn’t change much for now: A panel of Federal Appeals Court judges had already issued an administrative stay on June 24, denying its application for a marketing authorization. bring to court. But in the longer term, it represents an embarrassing backlash from the FDA and indicates that Juul has a good chance of permanently undoing the denial.
On June 23, the FDA announced it had denied US marketing authorization for all Juul products, effectively forcing the company out of the e-cigarette market it had previously dominated. Although the FDA’s decision had been leaked to the press the day before, it still shocked industry watchers, consumers and Juul, who said in court documents it first got wind of the decision through the press leak.
When announcing the denial, the FDA claimed that Juul had not provided sufficient toxicology data to prove its products were safe. In particular, the FDA was partially concerned about data on “potentially harmful chemicals leaching from the company’s proprietary e-liquid pods.”
The next day — June 24 — Juul filed an emergency petition with a federal appeals court to suspend the FDA’s denial, and a panel of judges issued an administrative stay. Under the terms of that stay, Juul had to file an emergency request by June 27 — which it did — and the FDA was to file its response by July 7.
In his emergency extended stay request, Juul argued that his over 125,000 page authorization request contained all of the toxicology data the FDA claimed was missing. Furthermore, the company accused the FDA of conducting an “arbitrary regulatory process,” saying the regulator was under pressure to ban Juul after it was widely accused of a youth vaping epidemic.
Data dispute
One point of contention, according to court documents filed by Juul, is that the FDA claimed it lacked toxicology data on four specific chemicals that leach from the company’s plastic pods into its e-liquid, which is intended to be heated, vaporized, then inhaled. The toxicology reports on the aerosol components of that vaporized e-liquid contain no data on those four chemicals. But Juul argued that it 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 argument is reasonable. It is possible that the four chemicals in question were converted into something else during the evaporation process. “It’s not surprising that a chemical that was originally liquid is not an aerosol,” Crotty Alexander told the Times.
It’s important to note that the identities of the four chemicals are not public – they were redacted from court documents – so it’s 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 file a response to Juul’s emergency request with the federal appeals court — the agency said it would further review Juul’s data and application.
“The agency has identified scientific issues unique to the Juul application that warrant additional review,” the FDA tweeted Tuesday night† “This administrative suspension temporarily suspends the marketing denial during the additional review, but does not revoke it.”
In a statement, Juul Chief Regulatory Officer Joe Murillo said that “with this FDA administrative deferral now in effect, we will continue to offer our products to adult smokers as we continue the agency’s internal review process.”
