FDA allows Juul to appeal ban and stay on market under review

The Food and Drug Administration has decided to temporarily allow Juul Labs vaping products to remain on the market, citing ‘scientific issues’ that warrant a review of the agency’s decision last month to ban e-cigarettes. of the company.

The agency’s decision to conduct an internal review effectively shifts the dispute out of the public eye to the appeals court, where Juul originally received a temporary stay, and returns it to the agency’s private administrative process. But the FDA warned that its latest decision, first announced in a tweet Tuesday evening, should not be construed as a decision setting aside the initial order.

The FDA decision is a twist in Juul’s journey to seek official clearance under rules that required it and other companies to prove their products deliver more health benefits. public than bad. He was blamed for the teen vaping crisis more than four years ago, drawing widespread anger from parents, schools and local policymakers as well as Congress.

On June 23, the FDA surprised many when it issued an order ordering Juul to stop selling its e-cigarette products in the United States. In a statement, the agency said Juul’s requests to stay in the market “lack evidence” to prove they would benefit public health and included “insufficient and conflicting data” on “product leaching.” potentially harmful chemicals” from its e-liquid pods.

In a statement Wednesday, Joe Murillo, Juul’s chief regulatory officer, said he believes the company will meet the standard of being “appropriate for the protection of public health” as it moves forward with the FDA in a evidence-based process.

The initial ban was celebrated by those who said the company should be held responsible for enticing teenagers to use its product with appealing mango and creme brulee flavors and ads depicting young people. The FDA’s decision was rejected by those who have pointed to e-cigarettes as a smoking cessation alternative for millions of adult smokers who have switched to devices, which are widely recognized as being less toxic than traditional cigarettes.

Vaping companies have been required to seek FDA clearance to sell their products, and many are currently going through this process. The FDA said it has approved a handful of vaping devices and denied more than a million applications.

In the brief filed last week, Juul claimed it had helped two million adult smokers quit smoking traditional cigarettes. Juul also said he was treated unfairly, noting he was singled out by members of Congress who pushed the agency to reject the company.

Juul also said it had only had one opportunity to address the FDA’s concerns before issuing the denial. By contrast, other companies were allowed to submit up to 14 changes to their applications, Juul said in its court filing.

The FDA has not released the document outlining its reasons for denying Juul’s marketing application. Juul’s court filing said the agency argued “in more than two dozen places” that Juul failed to provide sufficient data on four chemicals.

The company’s filing says the four chemicals were identified in a study looking at toxins leaking from its plastic pods into the e-liquid inside, which vaporizes when heated and then inhaled. by users. The agency took offense that none of these chemicals appeared in Juul’s studies listing the composition of the aerosol plume of its devices, the company said in its court brief.

Juul said it provided thousands of pages of data where these chemicals would have been disclosed had they been detectable in the aerosol.

Dr. Laura Crotty Alexander, an e-cigarette researcher and associate professor of medicine at the University of California, San Diego, has published critical studies on the effects of Juul devices on the brains of mice.

But after reviewing the company’s court documents, she said her argument made sense: it’s possible for chemicals that appear in liquid to turn into a different compound after being heated and vaporized. Dr. Crotty Alexander said this happened in his own studies of chemicals in e-cigarettes.

“It’s no surprise that a chemical that was originally liquid isn’t an aerosol,” said Dr. Crotty Alexander. The names of the chemicals in question have been redacted, she noted, making further assessment difficult.

Mr. Murillo, Juul’s chief regulatory officer, said the chemicals in the liquid “cannot be transferred or detected in the aerosol due to a variety of factors, including the volatility of the compound or the chemical structure.”

In its court filing, Juul pointed out that the FDA had all the information it needed to see that any leached chemicals were undetectable in its aerosol.

Juul “provided this data – 6,000 pages,” the company said in its filing. “If the FDA had performed a closer review (as it has done for other candidates), it would have seen data showing that these chemicals are not observable in the aerosol that Juul users inhale.”

Theodore Wagener, director of the Center for Tobacco Research at Ohio State University, said the agency’s initial ban was striking, given that independent research teams, including his own, had found Juul devices to be much less toxic than traditional cigarettes.

“Juul aerosol contains significantly lower levels and fewer toxicants than cigarettes,” Dr. Wagener said, noting that Juul’s devices also had lower levels of chemicals than other e-cigarettes. “That’s what surprised me.”

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