On February 6, 2019, you’ll see a sign outside the New York City shop promoting Juul branded vaping products.
Mike Seger | Reuters
According to a court filed on Tuesday, Juul Labs is trying to temporarily extend the Food and Drug Administration’s ban on e-cigarettes.
Criticizing the FDA’s review process, Juul said in a filing that he overlooked the more than 6,000 pages of data the FDA provided about the aerosol produced by heating the liquid in the pods, and that users would eventually inhale. The FDA released its application last week Data on the potential risks of using the product, such as whether potentially harmful chemicals could leak from the Juul pod, were inadequate or inconsistent in order to obtain market approval.
A representative of the FDA said it had not commented on the proceedings in progress and refused to comment on the application.
“If the FDA had done a more thorough review (as with other applicants), we would have seen data showing that these chemicals are not observable in aerosols inhaled by JUUL users.” Said the company in a filing with the US District Court. Appeal for the District of Columbia Circuit.
Juul also quoted the “background of huge political pressure” that said it influenced the FDA’s decision. In the filing, he states that taking the product out of the store, even temporarily, will cause permanent damage to the brand and customers will either use a competitor’s product or return to traditional cigarettes.
Last year, a rival e-cigarette maker British American Tobacco And NJOY received e-cigarette approval from the FDA, but the FDA rejected some of the flavored products submitted by the company. The agency said it approved tobacco-flavored products from these companies because they proved that they could benefit adult smokers and outweigh the risks of minors.
According to Euromonitor International, Juul has been the market leader in e-cigarettes since 2018. As of 2020, the company had a 54.7% share of the US e-vapor market of $ 9.38 billion.
Juul said no other company had the application rejected for similar reasons, and the FDA did not provide an explanation for why Juul was the different standard. Juul sought approval for its vaping device and tobacco and menthol-flavored pods.
On Thursday, the FDA refused to approve the product, saying the company must stop selling the product immediately. The next day, the United States Court of Appeals for the District of Columbia Circuit granted Juul’s urgent request to suspend the ban while awaiting the appeal of the decision.