Juul, the electronic cigarette maker, has asked a federal court in the United States to block a government order to stop selling its products in the country.
The company on Friday asked the court to pause what it calls an “extraordinary and unlawful action” by the Food and Drug Administration (FDA) that would require it to immediately halt its business.
The company filed an emergency motion with the US Court of Appeals in Washington, DC as it prepares to appeal the FDA’s decision.
The FDA said on Thursday that Juul must stop selling its vaping device and its tobacco and menthol flavoured cartridges.
The development comes amid a sweeping effort 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 show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.
The FDA said Juul’s application left regulators with significant questions and did not include enough information to evaluate any potential health risks.
Juul said it submitted enough information and data to address all issues raised. The company said the FDA refused its request to put its order on hold to avoid a massive disruption to its business.
While Juul remains a top seller, its share of the US e-cigarette market has dipped to about half. The company was widely blamed for a surge in underage vaping a few years ago, but a recent federal survey showed a drop in the teen vaping rate and a shift away from Juul’s products.
The devices heat a nicotine solution into a vapour that is inhaled, bypassing many of the toxic chemicals produced by burning tobacco.
The company said in its Friday court filing that it submitted a 125,000-page application to the FDA nearly two years ago. It said the application included several studies to evaluate the health risks among Juul users.
Juul said the FDA cannot argue that there was a “critical and urgent public interest” in immediately removing its products from the market when the agency allowed them to be sold during its review.
It also said the FDA’s decision to block sales of its products was “extraordinary and unlawful”, citing, among other things, the agency authorising similar e-cigarette products made by competing manufacturers.
Juul added that the ban was a departure from the agency’s normal practices, which typically involve allowing a transitional period, and questioned the agency’s “immense political pressure from Congress”.
In 2019, Juul was pressured into halting all advertising and eliminating its fruit and dessert flavours after they became popular among middle and high school students. The next year, the FDA limited flavours in small vaping devices to just tobacco and menthol.
The once red-hot vape company has also been working with its legal advisers on options that include a possible bankruptcy filing if it is unable to get relief from the government’s ban, the Wall Street Journal reported on Friday, citing people familiar with the matter.
The FDA declined to comment on Juul’s filing when contacted by the Reuters news agency.
Juul also declined to comment on the WSJ report.