A woman exhales while inhaling vapor from a Juul pen e-cigarette in 2019. A federal court has temporarily placed an FDA ban on the company’s vaping products.
Craig Mitchelldyer / AP
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Craig Mitchelldyer / AP
A woman exhales while inhaling vapor from a Juul pen e-cigarette in 2019. A federal court has temporarily placed an FDA ban on the company’s vaping products.
Craig Mitchelldyer / AP
Juul may continue to sell its e-cigarettes, at least for now, after a federal appeals court on Friday was temporarily blocked government ban.
Juul filed an emergency motion earlier on Friday, seeking custody while appealing the sales ban.
The e-cigarette maker asked the court to halt what the Food and Drug Administration called an “unusual and illegal act,” which would require it to immediately halt operations. its business.
The FDA said on Thursday that Juul must stop selling vaping devices and cartridges flavored with tobacco and menthol.
The move is part of the agency’s sweeping effort to bring scientific scrutiny to the multi-billion dollar vaping industry after years of regulatory delays.
To be on the market, companies must demonstrate that their e-cigarettes are beneficial to public health. In effect, that means demonstrating that adult smokers who use them are likely to quit or reduce smoking, while adolescents are not as likely to be hooked on them.
The FDA says Juul’s app leaves regulators with important questions and doesn’t include enough information to assess any potential health risks. Juul said it submitted enough information and data to resolve all issues raised.
A panel of three judges from the United States Court of Appeals for the District of Columbia Circuit granted Juul’s request for custody while the court considered the case.
While Juul remains the top seller, its share of the US e-cigarette market has dropped to about half. The company was blamed for the rise in teen vaping a few years ago, but a recent federal survey found that teen vaping rates have fallen and shifted away from products. Juul’s product.
These devices heat a nicotine solution into a vapor that people inhale, bypassing many of the harmful chemicals produced when cigarettes are burned.
The company said in a court filing Friday that it filed a 125,000-page application with the FDA nearly two years ago. It says the app includes several studies to assess the health risks of Juul users.
Juul said that the FDA cannot argue that there is an “urgent and urgent public interest” in immediately removing its products from the market when the agency authorizes them to be sold during the review process.
The company noted that the FDA denied its application while licensing applications from competitors for similar products.
The FDA has OK’d e-cigarettes from RJ Reynolds, Logic and others, while rejecting many others.
In 2019, Juul was pressured to stop all advertising and remove fruit and dessert flavors after they became popular with middle and high school students. The next year, the FDA limited the flavors in small vaping devices to only tobacco and menthol.
