Juul seeks to extend stay on FDA ban, citing inadequate evaluation

Juul Labs is seeking to extend a temporary stay on the Food and Drug Administration’s ban of its e-cigarettes, according to a court filing Tuesday.

Juul said in the filing that the agency overlooked more than 6,000 pages of data that it provided about the aerosols generated by heating the liquid in its pods and that users ultimately inhale. The FDA had said last week the company’s application for market approval gave insufficient or conflicting data about the potential risks of using its products, including whether potentially harmful chemicals could leak from Juul pods.

A representative for the FDA declined to comment on the filing, saying the agency does not comment on ongoing litigation.

“Had FDA done a more thorough review (like it did for other applicants), it would have seen data showing that those chemicals are not observable in the aerosol that JUUL users inhale,” the company said in the filing with the U.S. District Court of Appeals for the District of Columbia Circuit.

Juul also cited a “backdrop of immense political pressure” that it said influenced the FDA’s decision. It said in its filing that taking its products off store shelves, even temporarily, would permanently damage its brand and that its customers would either use competitors’ products or return to traditional cigarettes.

Over the last year, rival e-cigarette makers British American Tobacco and NJOY have won approvals from the FDA for their e-cigarettes, although the agency rejected some of the flavored products submitted by those companies. The agency said it approved those companies’ tobacco-flavored products because they proved they could benefit adult smokers and outweighed the risk to underage users.

Juul had been the market leader in e-cigarettes since 2018, according to Euromonitor International. As of 2020, the company held 54.7% share of the $9.38 billion U.S. e-vapor market.

The company said that no other rival had their application denied for similar reasons and that the FDA offered no explanation for why it held Juul to a different standard. Juul had been seeking approval for its vaping device and tobacco- and menthol-flavored pods.

Last Thursday, the FDA denied to authorize the products and said the company had to stop selling its products effective immediately. The next day, the Columbia Circuit Court of Appeals granted the emergency request for a stay, pending its appeal of the decision.