Zoom in / Packs of Juul electronic cigarettes are displayed for sale at Brazil Outlet on June 22, 2022 in Los Angeles, California.

On Tuesday, the US Food and Drug Administration suspended a decision that would have effectively forced Juul out of the US market. On Wednesday, the two sides agreed to postpone their legal battle as the regulator conducted an additional review of Juul’s products.

For people who use Juul’s 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 Juul’s products could remain on the market while the company fights back with the FDA denying his marketing authorization request in court. But in the longer term, it represents an embarrassing setback for the FDA and signals that Juul may have a good chance of getting the denial permanently overturned.

On June 23, the FDA announced that it had denied marketing authorization in the US for all of Juul’s 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 rattled industry watchers, consumers and Juul, which said in court filings that it first learned of the decision through the press leak.

In announcing its denial, the FDA argued 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 leaching from the company’s proprietary e-liquid capsules.”

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

In its emergency petition for a longer stay, Juul argued that its more than 125,000-page permit application included all the toxicological data the FDA claimed was missing. The company also accused the FDA of running a “haphazard regulatory process” and said the regulator was under pressure to ban Juul after it was widely blamed for a youth cigarette epidemic.

Data dispute

A particular point of contention, according to court documents filed by Juul, is that the FDA says it lacks toxicological data on four specific chemicals that leach from the company’s plastic capsules into its e-liquid, which is designed to be heated, vaporized and then this inhaled. Toxicology reports on the aerosol components of this vaporized e-liquid did not include data on these four chemicals. But Juul claims to provide 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 sound. It is possible that the four chemicals in question were converted to something different during the evaporation process. “It’s not surprising that a chemical that was originally a liquid is not an aerosol,” Crotty Alexander told the Times.

It’s important to note that the identities of the four chemicals aren’t public — they’ve been redacted from court documents — so it’s not possible to say whether they should have been 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 petition with the federal appeals court — the agency said it would conduct an additional review of Juul’s data and app.

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

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



https://arstechnica.com/?p=1865015

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