Vaping giant Juul Labs Inc. filed an emergency appeal with the court on Monday to ask a federal appeals court to block a government ban on its e-cigarettes and flavored pods.
The San Francisco-based vaping company asked the US Court of Appeals for the District of Columbia to pause what it called an “extraordinary and unlawful” action by the US Food and Drug Administration last week when it ordered the company to stop selling its products†
In Monday’s filing, Juul said the FDA acted under political pressure from Congress by blaming it for the youth vaping epidemic. By rejecting the application to stay on the market, the FDA held the company to a different standard than it does for other e-cigarette makers, the filing said.
A panel of three appeals court judges granted Juul a reprieve Friday to temporarily suspend the FDA’s ban. The court must now decide whether Juul can continue to sell its products while the company appeals the FDA’s decision. The FDA must respond to Juul’s motion by July 7 to ask the court to hear the appeal. Juul then has until 12 July to respond.
On Thursday, the FDA cited “inadequate and conflicting” data in Juul’s filing to continue selling its vaping device and four types of liquid pods: Virginia tobacco-flavored and menthol-flavored pods with 5% and 3% nicotine levels.
The FDA has reviewed marketing applications from Juul and hundreds of other companies after calls from anti-tobacco groups to crack down on products that have led to an increase in youth vaping over the past decade.
But the company claimed in its motion that: removing its products from the market immediately pending appeal would “harm the public” as “more than two million adult smokers have completely switched from smoking cigarettes because of Juul products.”
In 2020, the FDA required all e-cigarette and vape companies to submit applications to continue marketing products. The agency also banned fruit and mint-flavored fruit juice pods used in e-cigarettes and vaping products, a ban that didn’t apply to menthol and tobacco-flavored products.
The FDA evaluated whether e-cigarettes would benefit public health. That could mean that adult smokers are likely to quit smoking in favor of electronic devices that deliver nicotine and that teens are unlikely to become addicted to them.
The agency said Juul’s application to continue selling its products contained no evidence that the chemicals used “would be suitable for protecting public health”. While the FDA said it has not received any clinical information indicating a danger of using Juul’s vaping device or liquid pods, the agency has determined that there is not enough evidence to “assess the potential toxicological risks of using the Juul.” assess products”.
Ken Alltucker is on Twitter at @kalltucker, or can be emailed at [email protected]