A sign advertising Juul brand vaping products is seen outside a store in New York City on February 6, 2019.
Mike Segar. Facebook Sign up with the Facebook logo to connect with Reuters
Juul Labs is seeking a temporary moratorium on banning its e-cigarettes by the Food and Drug Administration, according to a court filing Tuesday.
Criticizing the FDA’s review process, Juul said in the filing that the agency overlooked more than 6,000 pages of data it provides about aerosols generated by heating the liquid in its pods and users eventually inhaling. The FDA said in the company’s application last week Given insufficient or conflicting data about the potential risks of using its products for market approval, including whether potentially harmful chemicals could leach out of Juul pods.
An FDA representative declined to comment on the filing, saying the agency does not comment on the ongoing lawsuit.
“If the FDA had conducted a more thorough review (as it did for other applicants), it would have had data showing that those chemicals cannot be seen in aerosols,” the company said in a filing filed with the US District Court. JUUL users inhale.” Appeal to the District of Columbia Circuit.
Juul also cited a “background of extreme political pressure,” which it said influenced the FDA’s decision. It said in its filing that by temporarily removing its products from store shelves, its brand would be permanently damaged and its customers would either use competitors’ products or return to traditional cigarettes.
In the past year, rival e-cigarette makers British American Tobacco And NJOY has received approval from the FDA for its e-cigarettes, although the agency has rejected some flavored products offered by the companies. The agency said it approved those companies’ tobacco-flavored products because they proved they could benefit adult smokers and reduce risk for younger users.
According to Euromonitor International, Juul was the market leader in e-cigarettes since 2018. As of 2020, the company had a 54.7% share of the $9.38 billion US e-vapor market.
Juul said no other company had denied its application for similar reasons, and the FDA did not provide an explanation as to why it held Juul to a different standard. Juul was seeking approval for its vaping device and tobacco- and menthol-flavored pods.
On Thursday, the FDA denied authorizing the products and said the company must stop selling its products effective immediately. The next day, the US Court of Appeals for the District of Columbia Circuit granted Juul’s emergency request for a stay of the ban pending an appeal of the decision.