FDA allows Juul to appeal ban and remain on the market during review

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

agency decision conduct an internal review effectively removes the dispute from public view in the appellate court, where Juul originally received a temporary reprieveand returns it to the agency’s private administrative process. But the FDA has warned that its final step, first announced on twitter on Tuesday evening should not be interpreted as a decision to cancel the original order.

The FDA’s decision marks a turning point in Juul’s path to obtaining regulatory approval under regulations that required him and other companies to prove that their products do more good for public health than harm. He was blamed for the teenage vaping crisis more than four years ago, drawing widespread ire from parents, schools and local politicians, as well as Congress.

On June 23, the FDA took many by surprise when he issued an order directing Juul to stop selling its e-cigarettes in the United States. AT statementThe agency said Juul’s claims to remain on the market “lacked evidence” to prove it would benefit public health and contained “insufficient and conflicting data” about “leaching potentially harmful chemicals” from its capsules. liquid for electronic cigarettes.

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

The initial ban was welcomed by those who said the company should be held accountable for luring teenagers into using its appealing mango and creme brulee-flavored product and ads featuring young adults. The FDA’s decision was criticized by those who pointed to e-cigarettes as a smoking cessation alternative for the millions of adult smokers who have switched to devices that many believe are less toxic than traditional cigarettes.

Vaping companies have had to obtain FDA clearance to market their products, and many of them are now going through the process. The FDA said it approved handful of vaping devices and rejected over a million apps.

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

Juul also said he only had one opportunity to respond to the FDA’s concerns before he issued a waiver. In contrast, other companies were allowed to submit up to 14 amendments to their statements, Juul said in a court filing.

The FDA has not released a document outlining the reasons for rejecting Juul’s marketing application. Juul’s lawsuit says the agency alleged in “more than two dozen places” that Juul did not provide enough data on four chemicals.

The company said in a statement that four chemicals were identified in a study examining the leaching of toxins from plastic containers into the liquid inside, which evaporates when heated and then inhaled by users. The agency disagreed with the fact that none of these chemicals appeared in Juul’s studies listing the composition of its devices’ aerosol plume, the company said at a court briefing.

Juul said it provided thousands of pages of data that would reveal these chemicals if they were found in the aerosol.

Dr. Laura Crotty Alexander, electronic cigarette Researcher and associate professor of medicine at UC San Diego has published critical studies of the Juul devices. impact on mouse brains.

But after examining the company’s court documents, she said her argument makes sense: It’s possible that the chemicals that appear in the liquid turn into a different compound after they’re heated and evaporated. Dr. Crotty Alexander said this happened in her own research on the chemicals in e-cigarettes.

“Not surprisingly, a chemical that was originally liquid is not an aerosol,” says the doctor. Crotty Alexander said. She noted that the names of the chemicals in question had been redacted, making further assessment difficult.

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

In his lawsuit, Juul emphasized that the FDA had all the information it needed to make sure that any leached chemicals did not show up in its aerosol.

July “really provided that data – 6,000 pages,” the company said in a statement. “Had the FDA done a more thorough review (as it has done for other applicants), it would see data showing that these chemicals are not observed in the aerosol inhaled by Juul users.”

Theodore Wagener, director of the Center for Tobacco Research at Ohio State University, said the agency’s initial ban was startling, given that independent research groups, including his own, have found that Juul devices are far less toxic than traditional cigarettes.

“Of course, Juul aerosol has significantly lower levels and fewer toxicants than cigarettes,” says Dr. Wagener said, noting that Juul devices also contain fewer chemicals than other e-cigarettes. “That’s what made it amazing for me.”