Federal appeals court puts FDA ban on Juul e-cigarette sales on hold
S E E D E D C O N T E N T
The FDA said on Thursday Juul failed to show the sale of its products would be appropriate for public health, following a nearly two-year-long review of data provided by the company.
Juul, partly owned by tobacco giant Altria Group Inc, said it disagreed with the agency's findings.
The temporary freeze on the FDA order lasts at least until July 12, according to the court's scheduling order.
The pause gives Juul time to argue for why the order should be placed on hold for a longer amount of time pending the court's review of it. The D.C. Circuit can extend the pause on the agency's order, or it can let the order take effect while Juul's appeal is pending.
The FDA and Juul declined to comment.
Juul said the FDA's decision to block sales of its products was "extraordinary and unlawful", citing, among other things, the agency authorizing similar e-cigarette products made by competing manufacturers.
BAT's Vuse Solo was the first e-cigarette to get the agency's clearance in October.
Juul also said the FDA's ban was a departure from the agency's normal practices, which typically involve allowing a transitional period, and questioned the agency's "immense political pressure from Congress".
Reuters reporting by Deborah Sophia and Uday Sampath in Bengaluru; Reuters editing by Shinjini Ganguli, Maju Samuel and Shounak Dasgupta.
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Whats this world coming to?
Next thing you know they will be pressuring the EPA to do something about microplastics.
What the FDA says about their ban:
“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” said Michele Mital, acting director of the FDA’s Center for Tobacco Products. “As with all manufacturers, JUUL had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”
[ https://www.fda.gov/news-events/press-announcements/fda-denies-authorization-market-juul-products#:~:text=Currently%20Marketed%20JUUL%20Products%20Must%20Be%20Removed%20from%20the%20US%20Market&text=On%20June%2024%2C%202022%2C%20the,order%20for%20Juul%20Labs%20Inc ] [ . ]
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