Juul Requests Stay of FDA Order

Photo: steheap

Juul Labs today asked a federal appeals court to temporarily block the U.S. Food and Drug Administration’s marketing denial order until it can petition the court for an emergency review.

In its filing, Juul said the FDA’s order was extraordinary and unlawful and it would suffer significant irreparable harm without a stay.

On June 23, the regulatory agency ordered Juul Labs to remove its products from the market, saying the e-cigarette company had provided insufficient evidence in its premarket tobacco product application to demonstrate that its products are “appropriate for the protection of public health.”

In particular, the FDA noted that its concerns about genotoxicity and potentially harmful chemicals leaching from the Juul Labs’ proprietary e-liquid pods had not been adequately addressed.

“We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency,” said Joe Murillo, chief regulatory officer at Juul Labs, in a statement.

We respectfully disagree with the FDA’s findings and decision and continue to believe we have provided sufficient information and data based on high-quality research to address all issues raised by the agency.

Joe Murillo, chief regulatory officer, Juul Labs

“In our applications, which we submitted over two years ago, we believe that we appropriately characterized the toxicological profile of Juul products, including comparisons to combustible cigarettes and other vapor products, and believe this data, along with the totality of the evidence, meets the statutory standard of being “appropriate for the protection of the public health.”

In its court filing, Juul said the FDA’s decision followed “immense political pressure from Congress once it became politically convenient to blame [Juul] for youth vaping, even though several of its competitors now have a larger market share and much higher underage-use rates,” according to The Wall Street Journal.

Juul said that the FDA’s order to immediately remove all Juul products from U.S. stores was a departure from the agency’s practices, which typically have a transitional period. The e-cigarette maker also questioned the agency’s handling of the announcement, pointing to the fact that the order had reported in the press before it was officially announced.

“Regulation through leaks and press releases is no way to handle agency action, much less to order a company to cease essentially all business operations,” Juul said in the court filing.

In a press note, Juul Labs said it is exploring all of its options under the FDA’s regulations and the law. “We remain committed to doing all in our power to continue serving the millions of American adult smokers who have successfully used our products to transition away from combustible cigarettes, which remain available on market shelves nationwide,” the company wrote.







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Meanwhile, the announcement that Juul products must come off the market triggered a run on stores, according to various news outlets, including Bloomberg. “Gonna clear the shelves and hoard ’em like our incandescent bulbs!” one user wrote on Twitter following the news.