The Food and Drug Administration announced Thursday it had formally withdrawn marketing denial orders it had issued to Juul Labs in 2022, making it possible for the once-dominant e-cigarette manufacturer to pursue authorization for its sales.
The marketing denial orders were effectively paused by the agency not long after they were issued, leaving the product in limbo for years amid court litigation and “additional review” the FDA said it was conducting of Juul’s applications.
At the time, the FDA had raised concerns over “potentially harmful chemicals” in Juul’s e-cigarettes and “insufficient and conflicting data” it said the company had submitted.
“In parallel, in the time since the MDOs were administratively stayed in 2022, the FDA has gained more experience with various scientific issues regarding e-cigarette products, and there have been new litigation outcomes in cases about MDOs for e-cigarette products from other manufacturers,” the FDA said in a statement.
The agency said that rescinding the marketing denial orders was not the same as a new decision on whether to formally authorize sales of the e-cigarettes. Juul’s applications have been returned to “pending status,” the FDA said.
The FDA has issued more than 300 marketing denial orders for new tobacco products since 2021. A handful have since been rescinded by the agency or blocked by federal court rulings.
“We appreciate the FDA’s decision and now look forward to re-engaging with the agency on a science- and evidence-based process to pursue a marketing authorization for JUUL products,” Juul said in a statement.
Juul’s products will continue to be on the market during the FDA’s renewed review of the application, the company said.
