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Juul seeks to block FDA ban on its e-cigarettes in US


Juul requested a federal court to block an order by the government to stop selling its electronic cigarettes.


The e-cigarette maker asked the court to pause what it calls an “extraordinary and unlawful action” by the Food and Drug Administration. As it prepares to appeal the FDA decision, the company filed an urgent motion with the U.S Court of Appeals in Washington.


FDA saidThursday, Juul must stop selling its vaping devices and its tobacco and mint flavored cartridges.


The agency’s broad effort to bring scientific scrutiny to the multibillion dollar vaping industry was part of its comprehensive effort to do away with years of regulatory delays.


Companies must prove that e-cigarettes are good for public health in order to remain on the market. In practice, that means showing that adult smokers who use e-cigarettes are likely to quit smoking or reduce their dependence on them.


FDA saidJuul’s application left regulators asking many questions and didn’t provide enough information for them to evaluate potential health risks. Juul saidIt provided sufficient information and data to address all concerns.


Juul is still a top-selling brand, but its share in the U.S. ecigarette market has dropped to around half. Although Juul was widely blamed for the rise in vaping among teenagers a few years back, a federal survey revealed a decline in teen vaping and a shift away Juul’s products.


The devices heat nicotine solutions into vapor that can be inhaled. This eliminates many of the harmful chemicals found in smoking tobacco.


The company saidFriday’s court filing stated that it submitted a 125,000 page application to FDA almost two years ago. It saidThe application included several studies that evaluated the health risks for 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 FDA denied the company’s application, but approved applications submitted by other companies with similar products.


FDA has approved e-cigarettes by R.J. Reynolds, Logic as well as other companies, but rejected many others.


After Juul’s popularity among middle- and high-school students, the FDA pressured Juul into stopping all advertising and removing its dessert and fruit flavors. The FDA reduced the number of flavors available in small vaping devices to only tobacco and menthol the next year.


The Howard Hughes Medical Institute’s Department of Science Education supports the Associated Press Health and Science Department. All content is solely the responsibility of Associated Press.

Source: CTV