FDA Says It Won’t Enforce Juul MDO While Review Underway

Agency and e-cigarette company file joint motion to remove emergency stay in court
FDA and Juul logos
Logos: FDA and Juul

SILVER SPRING, Md. — The U.S. Food and Drug Administration does not intend to take enforcement action against the products subject to Juul Labs Inc.’s marketing denial order (MDO) while an administrative stay from the agency is in place.

The FDA made that clear in a July 6 motion, filed jointly by the FDA and Juul Labs Inc in the U.S. Court of Appeals for the D.C. Circuit, where Juul withdrew its emergency motion for a stay.  

“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,” Juul’s Chief Regulatory Officer Joe Murillo said in a statement provided to CSP. “We remain confident in the quality and substance of our applications and believe that ultimately, we will be able to demonstrate that our products do in fact meet the statutory standard of being appropriate for the protection of the public health. We now look forward to re-engaging with the FDA on a science- and evidence-based process to pursue a marketing authorization for Juul products.”

The latest action in court follows several days of back and forth between the FDA and Juul after the FDA on June 23 issued the e-cigarette manufacturer an MDO, effectively banning the sale of Juul’s Virginia tobacco-flavored pods at nicotine concentrations of 5% and 3% and menthol-flavored pods at nicotine concentrations of 5% and 3%. A day after the MDO was issued, though, the court blocked the ban on Juul products and on July 5 the FDA issued an administrative stay on the order pending “additional review.”

“I have determined that a stay is in the public interest to help reduce potential confusion about the status of the marketing denial order during this review. Neither this stay of the marketing denial order nor CTP’s [the Center for Tobacco Product’s] review of the marketing denial order constitute authorization to market, sell or ship the products,” newly appointed CTP Director Brian King said in a July 5 letter to Juul, which was included in the FDA and Juul’s joint motion filed July 6.

Under the FDA’s administrative review, Juul will respond to the agency with clarifying information and its explanation of the issues the FDA raised in the MDO, Gregg Augustine, senior vice president for U.S. commercial at Juul, said in a July 7 letter to Juul partners.

“Our teams have been hard at work developing this package of information, and we will be submitting it in the near future. The FDA will then review the submission and determine whether to rescind the MDO and place our applications back into substantive review, as they have done with a number of other applicants in the category,” Augustine said.

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