On July 5, just two weeks after the Food and Drug Administration (FDA) ordered Juul to pull its products off the US market, the agency walked back on its decision, issuing an administrative stay on its own marketing denial order (MDO).
In a puzzling series of events, the FDA acknowledged to Filter that it is “temporarily suspending the marketing denial order pending additional review,” though not rescinding it. And this seems to be on the basis of legal documents that Juul immediately filed in response to the decision.
“FDA is reviewing the marketing denial orders it issued to JUUL because in the course of reviewing litigation briefing materials the agency determined that there are scientific issues unique to this application that warrant additional review,” an FDA spokesperson told Filter. The spokesperson added that because Juul’s “products do not have marketing authorization, [the company] cannot legally market, ship or sell their products,” and “the stay does not change this.”
“With this administrative stay from the FDA now in place, we continue to offer our products to adult smokers while we pursue the agency’s internal review process,” Joe Murillo, the chief regulatory officer at Juul Labs, said in a statement.
Alex Norcia – Filter – 2022-07-06
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