Juul seeks to extend FDA ban, citing inadequate assessment

A sign promoting Juul vaping products outside a store in New York City on February 6, 2019.

Mike Segar | Reuters

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

Juhl said in a statement that the agency overlooked more than 6,000 pages of data it provided about the aerosols generated when the liquid in its capsules are heated and which users end up inhaling. The FDA said last week that the company’s statement provided insufficient or conflicting data for market approval regarding the potential risks of using its products, including whether potentially harmful chemicals could leak from Juul capsules.

An FDA spokesman declined to comment on the filing, saying the agency does not comment on the ongoing lawsuit.

“Had the FDA conducted a more thorough review (as it has done with other applicants), it would see data showing that these chemicals are not observed in the aerosol that JUUL users inhale,” the company said in a statement to the U.S. District Court. . Appeals for the District of Columbia.

Juul also cited a “background of enormous political pressure” that he said influenced the FDA’s decision. The statement said that taking the product off the shelves, even temporarily, would permanently damage its brand and that its customers would either use competitors’ products or return to traditional cigarettes.

Over the past year, competing manufacturers of electronic cigarettes british american tobacco and NJOY received FDA approval for their e-cigarettes, although the agency rejected some of the flavored products submitted by these companies. The agency said it approved these companies’ tobacco-flavored products because they have proven they can benefit adult smokers and outweigh the risk to underage smokers.

Juul has been the market leader in e-cigarettes since 2018 according to Euromonitor International. As of 2020, the company owned 54.7% of the US $9.38 billion e-cigarette market.

The company said that no other competitor has had their application denied for similar reasons, and that the FDA has not provided any explanation as to why Juul is held to a different standard. Juul sought approval for its vaping device and tobacco and menthol flavored pods.

Last Thursday, the FDA refused to authorize the products and said the company should stop selling its products immediately. The following day, the Colombian Circuit Court of Appeals granted an urgent request for a stay pending an appeal of the decision.