The FDA has backed down from its decision to order all Juul products off the market, issuing an administrative stay last night that puts the previous order on hold.
The agency announced on Twitter it “has determined that there are scientific issues unique to the JUUL application that warrant additional review.”
The FDA had issued a Marketing Denial Order (MDO) for all current Juul products on June 23, claiming Juul had not addressed certain toxicological concerns in its Premarket Tobacco Application (PMTA), which the FDA has been reviewing for nearly two years. Juul Labs reportedly spent over $100 million preparing its PMTA.
The FDA stay suspends Juul’s MDO while the agency re-reviews Juul’s application. In some previous FDA MDO reversals—most notably Turning Point Brands’—the agency rescinded the marketing denial and placed the products back into full scientific review. In the TPB case, the FDA claimed it had “overlooked” relevant scientific data.
Jim McDonald – Vaping360 – 2022-07-06
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