Juul ban lawsuit: Company asks court to halt 'extraordinary and unlawful' FDA order
The FDA claims that JUUL did not provide sufficient data on product safety, but the company disputes that assertion
Electronic cigarette company Juul Labs Inc. asked a federal appeals court Friday to block a ban on its products issued by the U.S. Food and Drug Administration.
The company filed an emergency motion for temporary administrative stay following the FDA's directive to pull the company's products from shelves over accusations it has fueled a surge in youth vaping with its marketing.
The FDA ordered Juul Labs Inc. to stop selling its vape devices and cartridges on Thursday, saying that there is "insufficient evidence to assess the potential toxicological risks" of using the products.
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In the court filing, Juul called the FDA's order "extraordinary and unlawful," and maintained that its products are healthier than cigarettes and help adult smokers transition away from smoking.
Read the Juul court filing:
FDA BANS JUUL E-CIGARETTE PRODUCTS
The FDA acknowledged that it "has not received clinical information to suggest an immediate hazard associated" with the use of Juul's devices or pods, but said the agency issued its marketing denial orders (MDOs) against the company because "there is insufficient evidence to assess the potential toxicological risks" of using the products.
Juul disputed any accusations of providing insufficient data, claiming that they had provided the relevant information to the FDA at least two years ago.
"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," Juul said.
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The FDA, in its original press release, directed smokers who want to quit to consider using other e-cigarette products the agency has authorized for use, such as R.J. Reynolds' Vuse projects.
According to a Centers for Disease Control and Prevention (CDC) report from last year, Vuse e-cigarettes were found to be nearly twice as popular among high schoolers who vape as Juul products.
FOX Business' Breck Dumas contributed to this report.