The Food and Drug Administration on Tuesday announced an administrative stay on the order it issued last month suspending sales of Juul e-cigarettes.
The agency’s tobacco division wrote in a Twitter thread that the stay temporarily suspends the marketing denial order amid an additional review, but does not rescind it.
“All electronic nicotine delivery systems, or ENDS products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed,” FDA Tobacco wrote. “The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products.”
The FDA had initially issued an order on June 23 banning the sale of Juul e-cigarettes. The agency said at the time that Juul had failed to provide sufficient evidence demonstrating that keeping the products on the market “would be appropriate for the protection of the public health.”
FDA BANS JUUL E-CIGARETTE PRODUCTS
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert Califf said in a statement at the time. “The agency has dedicated resources to review products from the companies that account for most of the US market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
But a day after the order, a federal appeals court temporarily blocked the agency’s ban on Juul. The court noted that granting Juul’s request for a stay would not reflect its ruling on the case.
FDA’S BAN ON JUUL E-CIGARETTES DELAYED BY APPEALS COURT
The FDA said in its Tuesday announcement that it has determined there are “scientific issues unique to the JUUL application that warrant additional review.”
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In order for the e-cigarettes to stay on the market, Juul must prove that adult smokers who use the product are likely to quit or cut down on smoking. The company also must show that teenagers are unlikely to become addicted to the e-cigarettes.