The company has been widely blamed for the increased rate of vaping for minors, but a recent survey shows a decrease in the rate of teen vaping in the United States.
Juul, the maker of e-cigarettes, has asked a US federal court to block a government order to stop selling its products in the country.
The company on Friday asked the court to stop what it calls an “unusual and illegal action” by the Food and Drug Administration (FDA) that would require it to stop its business immediately.
The company has filed an emergency application with the US Court of Appeals in Washington as it prepares to appeal the Food and Drug Administration’s decision.
The U.S. Food and Drug Administration said Thursday that Juul should stop selling its vaping device, tobacco cartridges and flavored menthol.
The development comes amid a sweeping effort by the agency to impose scientific scrutiny on the multibillion-dollar e-cigarette industry after years of regulatory delays.
To survive in the market, companies must show that e-cigarettes benefit public health. In practice, this means demonstrating that adult smokers who use them are more likely to quit or reduce smoking, while adolescents are less likely to get involved.
The FDA said the Juul app left regulators with important questions and did not include enough information to assess any potential health risks.
Juul said it had provided sufficient information and data to address all of the issues raised. The company said the Food and Drug Administration refused its request to put its order on hold to avoid a major disruption to its business.
While Juul remains a top seller, its share of the US e-cigarette market has almost halved. The company was widely blamed for the rise in underage vaping a few years ago, but a recent federal survey showed a drop in teen vaping and a shift away from Juul products.
The devices heat a nicotine solution into a vapor that is inhaled, bypassing many of the toxic chemicals from burning tobacco.
The company said in a court filing Friday that it submitted a 125,000-page application to the Food and Drug Administration nearly two years ago. She said the app included several studies to assess health risks among Juul users.
Goole said the FDA could not argue that there was a “critical and urgent public interest” in promptly 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 “exceptional and illegal,” citing, among other things, the agency that allowed similar e-cigarette products made by competing manufacturers.
Gul added that the ban was a departure from the agency’s normal practices, which typically include allowing a transition period, and questioned the agency’s “enormous political pressure from Congress.”
In 2019, Juul came under pressure to discontinue all advertising and phase out fruit and sweet flavors after they became popular with middle and high school students. The following year, the U.S. Food and Drug Administration (FDA) limited the flavors in small vaping devices to tobacco and menthol only.
The once-hyper-excited vaping company is also working with its legal advisors on options that include filing for potential bankruptcy if it can’t get relief from the government ban, The Wall Street Journal reported Friday, citing people familiar with the matter.
The US Food and Drug Administration declined to comment on Juul’s file when contacted by Reuters news agency.
Juul also declined to comment on the Wall Street Journal report.