After more than two years in the waiting room, Juul Lab’s famous pod device was issued the MDO (Marketing Denial Order). It was instructed to remove its products from the market immediately. Just a few hours after the FDA gave the MDO, Juul petitioned the Columbia Circuit Court of Appeals to stay the decision. A stay would permit Juul to market its products while arguing against the FDA’s ruling in the court. This stay has been granted, and Juul’s dispute with the FDA has started.
More than 30 smaller vape businesses have already filed a lawsuit against their MDOs in the courtroom. Many companies claim their applications were not adequately evaluated, given that the FDA has rejected most applications in a massive swath of rejections. Some claim that the FDA denied their application due to specific requirements that were clarified following the PMTA deadline.
Juul’s situation is like and distinct in the same way. The main reason for Juul’s denials is “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 states that it has over 6,000 pages of information about the final aerosols inhaled by the users, but they were not considered.
Furthermore, Juul claims that no competitor was rejected for the same reasons. While several manufacturers were denied due to insufficient evidence, the primary reason Juul claims to have been rejected is most likely to be NJOY Ace. It is the NJOY Ace is another pod-based tobacco-flavored vape that was approved just recently. One flavor Juul offered while getting PMTA approbation was Virginia Tobacco and Menthol, which give the impression of being more similar.
In the end, Juul claims a “backdrop of immense political pressure” has influenced the FDA’s decision. Juul has the highest profile and most controversial company of all. Juul was widely regarded as the favored vape for high school students, which makes it the object of vaping opponents.
The FDA has until July 7 to reply to Juul’s request. Juul is given until July 12 to respond to the FDA’s decision. As long as the case remains unresolved by Juul, Juul’s pods will remain available.