MDO and Stay Issued to Juul Labs

After nearly two years of waiting, Juul Lab’s infamous pod device has been issued an MDO (Marketing Denial Order) and were told to pull their products off the market immediately. Less than a day after the FDA announced the MDO, Juul petitioned the Columbia Circuit Court of Appeals for a stay. A stay would allow Juul to sell their products while they contest the FDA’s decision in court. The stay was granted, and now Juul’s court battle with the FDA begins.

Over 30 smaller vape companies are already contesting their MDOs in court. Most companies are claiming that their applications were not properly reviewed, as the FDA rejected most applications in a mass spree of rejections. Some are claiming that the FDA rejected their application for requirements that were only clarified after the PMTA deadline had passed.

Juul’s case is both similar and different at the same time. The primary reason stated for their denials was “insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications.” Juul claims there were 6,000 pages of data regarding the end aerosols inhaled by users that were ignored.

Additionally, Juul claims that no other rival had their application denied for similar reasons. While many vape companies were rejected due to lack of evidence, the main reason Juul is making that claim is likely due to the NJOY Ace. The NJOY Ace is another pod-based, tobacco flavored vape which was only recently approved. The only flavors Juul submitted for PMTA approval were its Virginia Tobacco and Menthol flavors, which makes the resemblance even stronger.

Lastly, Juul claims a “backdrop of immense political pressure” influenced the FDA’s decision. Juul is the most well-known and controversial vaping company by far. It was commonly seen as the vape of choice used by high-schoolers, making it the target of anti-vaping advocates.

The FDA has until July 7th to respond to Juul’s case. Juul has until July 12 to respond to the FDA’s response. Until the case is settled, the stay means Juul’s pods will be available.

References:

Juul seeks to extend stay on FDA ban, saying agency did not evaluate all its evidence

FDA Denies Authorization to Market JUUL Products

Juul Gets a Temporary Stay, Can Sell Products For Now - Vaping360