Federal Appeals Court Stays FDA Ban on Juul E-Cigarettes

WASHINGTON — A federal appeals court on Friday stayed the Food and Drug Administration’s ban on sales of Juul Labs Inc’s e-cigarettes, after the company appealed the agency’s order on the grounds the ban would cause it “irreparable harm.”
The U.S. Circuit Court of Appeals for the District Of Columbia said in its order that the purpose of the stay was to allow the court sufficient time to consider Juul’s briefing for an emergency review and not a ruling on the merits of the case.
As previously reported by The Well News, the Food and Drug Administration on Thursday ordered Juul Labs to pull its electronic cigarettes from the U.S. market, a move intended to curb a multibillion-dollar industry blamed for sparking a national surge in teen vaping.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert Califf in a written statement at the time.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products, and many have played a disproportionate role in the rise in youth vaping,” he said.
The FDA said Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges immediately, and those already on the market must be removed.
In a statement posted on the company’s website, Joe Murillo, chief regulatory officer at Juul Labs, said the company “respectfully” disagreed with the FDA’s findings and would be filing an appeal.
“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,” Murillo said.
“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,” he added.
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