Juul on Friday asked a federal court to block the government’s order to stop selling e-cigarettes.
The e-cigarette maker asked the court to stop what it called an “extraordinary and unlawful act” by the Food and Drug Administration that would require it to stop its business immediately. The company filed an emergency lawsuit with the U.S. Court of Appeals in Washington as it prepared to appeal the FDA’s decision.
The FDA said on Thursday that Juul should stop selling its vaping device and its tobacco and menthol flavored cartridges.
The action was part of 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 demonstrate that their e-cigarettes benefit public health. In practice, this means proving that adult smokers who use them are more likely to quit or reduce smoking, while younger people are less likely to become addicted to them.
The FDA said Juul’s application leaves important questions to regulators and does not contain enough information to assess any potential health risks. Juul said it offers enough information and data to address all the issues raised. The company said it rejected the FDA’s request to put the order on hold to avoid a major disruption to its business.
While Juul remained a bestseller, its share of the US e-cigarette market fell in half. The company was widely blamed for the surge in underage vaping a few years ago, but a recent federal survey showed a decline in teen vaping and turning away from Juul’s products.
The devices heat a nicotine solution to an inhaled vapor, bypassing many of the toxic chemicals produced by burning tobacco.
The company said in a court filing Friday that it filed a 125,000-page filing with the FDA nearly two years ago. He said the app includes several studies to assess health risks among Juul users.
Juul said the FDA could not argue that it was in a “critical and urgent public interest” to immediately remove its products from the market when it allowed products to be sold during its review.
The company noted that the FDA rejected its application while allowing those offered by competitors with similar products.
The FDA approved e-cigarettes from RJ Reynolds, Logic, and other companies, while rejecting others.
In 2019, Juul came under pressure to stop all commercials and eliminate fruit and sweet flavors after it became popular with middle and high school students. The following year, the FDA restricted flavors in small vaping devices to tobacco and menthol only.
