Society has been widely blamed for the increase in underage vaping, but a recent survey shows a drop in vaping rates among teens in the United States.
Juul, the e-cigarette maker, has asked a US federal court to block a government order to stop selling its products in the country.
On Friday, the company asked the court to stay what it calls an “extraordinary and unlawful action” by the Food and Drug Administration (FDA) that would force it to cease operations immediately.
The company has filed an emergency petition with the United States Court of Appeals in Washington as it prepares to appeal the FDA decision.
The FDA said Thursday that Juul must stop selling its tobacco- and menthol-flavored vaping device and cartridges.
The development comes amid a massive push by the agency to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays.
To stay on the market, companies must demonstrate that their e-cigarettes benefit public health. In practice, this means proving that adult smokers who use them are likely to quit or reduce their smoking, while teenagers are unlikely to become addicted.
The FDA said Juul’s application left regulators with important questions and did not include enough information to assess potential health risks.
Juul said it submitted enough information and data to resolve all issues raised. The company said the FDA denied its request to suspend its order to avoid a massive disruption to its business.
While Juul remains a top seller, its share of the US e-cigarette market has dropped to around half. The company was widely blamed for an increase in underage vaping a few years ago, but a recent federal investigation showed a drop in teen vaping rates and a shift away from Juul’s products.
The devices heat a nicotine solution into a vapor that is inhaled, bypassing many toxic chemicals produced by burning tobacco.
The company said in its Friday court filing that it submitted a 125,000-page request to the FDA nearly two years ago. He said the app included several studies to assess the health risks for Juul users.
Juul said the FDA cannot say there was a “critical and urgent public interest” in immediately removing its products from the market when the agency cleared them for sale during its review.
He also said the FDA’s decision to block sales of his products was “extraordinary and illegal,” citing, among other things, the agency approving similar e-cigarette products made by competing manufacturers.
Juul added that the ban was a departure from normal agency practices, which typically involve allowing a transition period, and questioned “the immense political pressure exerted by Congress.”
In 2019, Juul was forced to halt all advertising and phase out its fruit and dessert flavors after they became popular among middle and high school students. The following year, the FDA limited the flavors of small vaping devices to tobacco and menthol.
The once-hot vape company has also been working with its legal advisers on options that include a possible bankruptcy filing if it is unable to obtain relief from the government ban, the Wall Street reported on Friday. Newspaper, citing people familiar with the matter.
The FDA declined to comment on Juul’s filing when contacted by Reuters news agency.
Juul also declined to comment on the WSJ report.