The U.S. Food and Drug Administration issued a temporary stay allowing the electronic cigarette company Juul to keep selling its products despite a U.S. Food and Drug Administration ban — for now.
On Thursday, the FDA said that it was denying Juul authorization to market its products, effectively banning the company from selling e-cigarettes in the U.S.
“To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods. However, the MDOs issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products,” the FDA said in its statement.
Juul then asked the U.S. Court of Appeals for the District of Columbia Circuit to temporarily delay the ban from going into effect while it appeals the FDA order, The Washington Post reported.
“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,’” the company said, according to Fox Business.
“We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator,” read the statement from Juul Chief Regulatory Officer Joe Murillo.
“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.”
On Friday, the federal court of appeals issued a stay.
“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 said, “and should not be construed in any way as a ruling on the merits of that motion.”
The hold will remain in effect at least until July 12.
But if Juul is ultimately banned from selling Juul products in the U.S., it might have to declare bankruptcy, according to one report.
“In addition to fighting the FDA’s order, Juul has been working with its legal advisers on options that include a possible bankruptcy filing if the company is unable to get relief from the government’s ban, according to people familiar with the matter,” The Wall Street Journal said.