FDA allows Juul to appeal ban and remain on market pending review

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

The agency’s decision to conduct an internal review effectively takes the dispute out of the public eye in the appeals court, where Juul had initially received a temporary reprieve, and returns it to the agency’s private administrative process. But the FDA warned that her latest move, first announced in a tweet on Tuesday night, should not be misconstrued as a decision rescinding the original order.

The FDA’s decision is a twist in Juul’s path toward seeking official approval under rules that required it and other companies to prove their products do more good than harm public health. She was blamed for the teen vaping crisis more than four years ago, drawing widespread ire from parents, schools and local lawmakers, as well as Congress.

On June 23, the FDA caught many by surprise when it issued an order telling Juul to stop selling its e-cigarette products in the United States. In a statement, the agency said Juul’s applications to remain on the market “lacked evidence” to show they would benefit public health and included “insufficient and conflicting data” about “leaching of potentially harmful chemicals” from its e-liquid pods

The ban was celebrated by those who said the company should be held accountable for enticing teenagers to use its product with appealing mango and crème brûlée flavors and ads depicting youth. The FDA’s decision was criticized by those who pointed to e-cigarettes as an alternative to quitting for millions of adult smokers who switched to the devices, which are widely blamed for being less toxic than traditional cigarettes.

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

For its part, Juul had already filed a brief in support of a longer-term appeal in the US appeals court in Washington, DC, calling the agency’s ban “discriminatory” and accusing it of “threatening” conduct. ”.

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

Juul also said it had been given only one opportunity to address the FDA’s concerns before issuing the denial. In contrast, other companies were allowed to file up to 14 amendments to their applications, Juul said in his 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 did not provide enough data on four chemicals.

The company filing said the four chemicals were identified in a study that looked at toxins that leach from their plastic capsules into the e-liquid inside, which vaporizes when heated and is then inhaled by users. The agency objected to the fact that none of those chemicals had appeared in Juul’s studies listing the aerosol plume composition of its devices, the company said in its court filing.

Juul said it provided thousands of pages of data showing those chemicals would have been revealed if they were detectable in the spray.

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

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

“It is not surprising that a chemical that was originally a liquid is not an aerosol,” said Dr. Crotty Alexander. The names of the chemicals in question were redacted, he noted, making a more detailed assessment difficult.

Joe Murillo, Juul’s director of regulation, said chemicals in the liquid “may not 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 emphasized that the FDA had all the information it needed to make sure any leached chemicals were undetectable in its spray.

Juul “provided that data, 6,000 pages,” the company said in its filing. “Had the FDA conducted a more extensive review (as it has done with other applicants), it would have seen data showing that these chemicals cannot be observed in the spray that Juul users inhale.”

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

“Juul aerosol has significantly lower levels and fewer toxic substances than cigarettes, for sure,” Dr. Wagener said, noting that Juul devices also had lower levels of chemicals than other e-cigarettes. “That’s what made this surprise me.”

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