FDA temporarily suspends order banning Juul cigarettes
The Food and Drug Administration issued an administrative stay Tuesday on the order it issued last month for vaping company Juul to pull its electronic cigarettes from the market.
The agency said on Twitter that the stay temporarily suspends the marketing denial order while it conducts further review, but does not rescind it.
The FDA issued the initial order banning Juul sales on June 23. A day later, a federal appeals court temporarily blocked the government ban.
The initial FDA action was part of a sweeping effort by the agency to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays.
To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.
The FDA originally said Juul’s application left regulators with significant questions and didn’t include enough information to evaluate any potential health risks. Juul said it submitted enough information and data to address all issues raised.
A three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit granted Juul’s request for a hold while the court reviews the case.
On Tuesday, the FDA said it has determined “there are scientific issues unique to the Juul application that warrant additional review.”
Still, it said, the stay and the review do not “constitute authorization to market, sell or ship Juul products.”