COURT BLOCKS FDA BAN ON JUUL E-CIGARETTES FOR NOW
Company can keep selling product while appealing its case
Juul can continue to sell its electronic cigarettes, at least for now, after a federal appeals court on Friday temporarily blocked a government ban.
Juul filed an emergency motion earlier Friday, seeking the temporary hold while it appeals the sales ban.
The e-cigarette maker had asked the court to pause what it called an “extraordinary and unlawful action” by the Food and Drug Administration that would have required it to immediately halt its business.
The FDA said Thursday that Juul must 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 multibilliondollar 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 didn’t include enough information to evaluate any potential health risks. Juul said it submitted enough information and data to address all issues raised.
A three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit granted Juul’s request for a hold while the court reviews the case.
While Juul remains a top seller, its share of the U.S. ecigarette 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 vapor that’s 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 that 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.
The company noted that the FDA denied its application while authorizing those submitted by competitors with similar products.
The FDA has approved e-cigarettes from R.J. Reynolds, Logic and other companies, while rejecting many others.
In 2019, Juul was pressured into halting all advertising and eliminating its fruit and dessert flavors after they became popular among middle and high school students. The next year, the FDA limited flavors in small vaping devices to just tobacco and menthol.