WASHINGTON – The Food and Drug Administration on Tuesday issued an administrative stay on the order it issued for the vaping company last month July to withdraw its electronic cigarettes from the market.
The agency said on Twitter that the stay is temporarily suspending the marketing denial order while it conducts further reviews, but is not lifting it.
The FDA issued its first order banning the sale of Juul on June 23. A day later, a Federal Court of Appeals temporarily blocked the government ban.
The initial FDA action was part of a broader effort by the agency to scientifically scrutinize the multibillion-dollar vaping industry after years of regulatory delays.
To stay in the market, companies must demonstrate that their e-cigarettes benefit public health. In practice, this means proving that adult smokers who use them are likely to quit or reduce smoking, while teens are unlikely to become dependent.
The FDA originally said Juul’s filing left regulators with significant questions and did not provide enough information to evaluate potential health risks. Juul said it submitted enough information and data to resolve any issues raised.
A three-judge panel of the United States Court of Appeals for the District of Columbia Circuit granted Juul’s request for a stay while the court reviews the case.
On Tuesday, the FDA said it had determined that “there are scientific issues unique to the Juul application that require additional review.”
Still, it said, the residency and verification “does not constitute authorization to market, sell, or ship Juul products.”
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https://www.local10.com/news/politics/2022/07/06/fda-temporarily-suspends-order-banning-juul-cigarettes/ The FDA temporarily suspends the ban on Juul cigarettes