Electronic cigarettes made by Juul Labs can continue to be sold, for now, after a federal appeals court on Friday issued a temporary stay on a government ban.
Court temporarily halts FDA ban on Juul e-cigarettes
A day later, the once-booming Silicon Valley start-up sought an emergency motion for a temporary hold while it appeals the sales ban, calling it an “extraordinary and unlawful action” by the FDA.
The U.S. Court of Appeals for the District of Columbia Circuit granted Juul’s request for a hold on the FDA order until at least July 12, while the court reviews the case.
“The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review,” the court order said, “and should not be construed in any way as a ruling on the merits of that motion.”
The FDA issued “marketing denial orders” to Juul on Thursday, stating that the company “must stop selling and distributing” all of its products currently marketed in the United States.
It accused Juul of issuing “insufficient and conflicting data” regarding the “toxicological profile” of some of its products and said the company could not demonstrate that “marketing of the products would be appropriate for the protection of the public health.”
However, the FDA underscored that it had not received any clinical information to suggest an “immediate hazard” associated with Juul devices or pods to consumers.
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s center for tobacco products.
“JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” she said in a statement. “However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
Juul hit back, arguing that it has “appropriately characterized the toxicological profile” of its products. The company said it submitted the required data and information, adding that it would explore options, including a legal appeal of the ban.
“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,” Juul chief regulatory officer Joe Murillo said in a statement. “We remain committed to doing all in our power to continue serving the millions of American adult smokers.”
The FDA is due to decide by Sept. 9 whether the embattled company — which has been widely blamed for igniting a surge in youth vaping — will be allowed to keep selling its products in the United States and, if so, under what conditions. The FDA also says it is scrutinizing millions of other products made by hundreds of cigar, pipe and e-cigarette companies.
Laurie McGinley contributed to this report.
Source: WP
