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FDA backpedals on Juul ban, says it’s re-reviewing company’s “unique” issues

in great shape , Juul used a fashionable, “cool” marketing tactic before the backlash.

The US Food and Drug Administration on Tuesday withheld a decision that would effectively discontinue Juul from the US market. On Wednesday, the two sides agreed to halt their court battle as the regulator conducted an additional review of Juul’s products.

For people using 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, which meant that Juul products could be marketed. May remain in the U.S. while the company battles the FDA. Denying your marketing authorization request in court. But, in the long term, this represents an embarrassing backpedal by the FDA and signals that Juul may have a good chance of permanently reversing the denial.

On June 23, the FDA announced that it had denied US marketing authorization for all Juul products, effectively forcing the company to exit the e-cigarette market it had previously dominated. Although the FDA’s decision was leaked to the press the day before, it shocked industry watchers, consumers, and Joule, who said in court documents that it first got wind of the decision through a press leak. .

In announcing its denial, the FDA claimed that Juul failed to provide sufficient toxicology data to prove its products safe. In particular, the FDA was concerned, in part, about data on “potentially harmful chemicals released from company-owned e-liquid pods.”

The next day—June 24—July filed an emergency motion in a federal appeals court to overturn the FDA’s refusal, and a panel of judges issued an administrative stay. Under the terms of that stay, Juul was required to file an emergency petition by June 27 — which it did — and the FDA would need to file its response by July 7.

In its emergency petition to stay longer, Juul argued that its more than 125,000-page authorization request contained all the toxicology data that the FDA claimed was lacking. In addition, the company accused the FDA of carrying out an “unstable regulatory process” and said regulators were under pressure to ban Juul after it was widely blamed for the youth vaping epidemic.

data dispute

One particular point of contention, according to court documents filed by Joule, is that the FDA claimed it lacked toxicology data on four specific chemicals that seeped from the company’s plastic pods into its e-liquid, intended for heating and cooling. , to be vaporized, then inhaled. The toxicology report on aerosol components from that vaporized e-liquid did not include data for 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 Joule’s court documents at the request of The New York Times and said Joule’s argument was reasonable. It is possible that the four chemicals in question were changed to something different during the evaporation process. “It should come as no surprise that a chemical that was originally liquid is not an aerosol,” Krotty Alexander told the Times.

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

Tuesday, July 5 — two days before the FDA’s deadline to submit a response to Juul’s emergency petition in federal appeals court — the agency said it would conduct another review of Juul’s data and application.

“The agency has determined that there are unique scientific issues to the Juul application that warrant additional review,” FDA tweeted Tuesday evening, “This administrative stay temporarily suspends the marketing refusal order during additional review but does not revoke it.”

In a statement, Juul Chief Regulatory Officer Joe Murillo said that “now with this administrative pause from the FDA, we continue to offer our products to adult smokers while we advance the agency’s internal review process.” “

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