Juul Appeal Case on Hold Pending FDA Review

The court will wait while the agency completes its reevaluation of JUUL products.

July 08, 2022

JUUL Products Sold Here Sign

ALEXANDRIA, Va.—The U.S. Court of Appeals for the D.C. Circuit has agreed to delay Juul’s case until the Food and Drug Administration (FDA) completes its reevaluation of JUUL products. The FDA will need to provide status updates to the court every 60 days. Additionally, the FDA will have an administrative stay in place for at least 30 days after it makes any decision to reinstate a marketing denial order (MDO) on JUUL products.

“As we move through this review process, we will continue to sell our products. We now look forward to re-engaging with the FDA on a science- and evidence-based review to pursue a marketing authorization for JUUL products,” wrote Juul in a letter to retailers.

“Under this review, we will respond to the FDA with clarifying information and our explanation of the issues it raised in the MDO. 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,” Juul said.

Earlier this week, the FDA suspended its ban on JUUL vaping products while the company appeals the agency’s decision.

“On July 5, 2022, FDA administratively stayed the marketing denial order. The agency has determined that there are scientific issues unique to the Juul application that warrant additional review. This administrative stay temporarily suspends the marketing denial order during the additional review but does not rescind it. All electronic nicotine delivery systems, or ENDS products, including those made by Juul, are required by law to have FDA authorization to be legally marketed. The stay and the agency’s review does not constitute authorization to market, sell, or ship JUUL products,” the FDA said via Twitter.

In late June, the FDA issued MDOs for all JUUL products currently sold in the U.S., and the notice called for the removal of JUUL products from the U.S. market.

Shortly after, a federal appeals court granted Juul Labs Inc. an emergency administrative stay of the FDA’s MDOs, pending further order from the court. JUUL products can continue to be marketed for retail sale while Juul Labs pursues legal remedies.

Juul asked the FDA for a longer stay to continue selling its e-cigarettes for the duration of the appeal process. Separately, Juul asked the FDA to stay its own order pending the appeal, reports the Journal.

Initially, the FDA denied Juul’s request for a stay, which led Juul to seek a stay of the ban in court.

In court filings, Juul alleged the FDA mishandled its applications. Juul said the agency overlooked more than 6,000 pages of data that the company submitted to the FDA on the aerosols that users inhale.

Last week, NACS filed an amicus brief in the U.S. Court of Appeals for the D.C. Circuit in support of Juul’s petition for a stay.

NACS argued that the immediate removal of JUUL products would “wreak havoc” on the entire industry, upend an important segment of the economy, endanger countless jobs and impede small businesses’ ability to operate.