Court Challenges to MDOs

Shortly after many vape companies were issued MDOs (Marketing Denial Orders), some of the larger companies decided to sue the FDA. While some companies were moved back into the scientific review phase to avoid a legal battle, the FDA did decide to fight back against some of the cases in court.

Notably, one of the companies the FDA decided to fight back against was Triton. The main reason their case was noticeable was that the FDA decided to take the case to court, and the court sided with Triton’s appeal. As a result, Triton was granted a stay.

A stay is an action that would suspend proceedings related to a case in court. In Triton’s case, a stay would allow them to continue selling PMTA products until the FDA finished reviewing their PMTA application again.

Then, after Triton was granted a stay, Breeze was denied a stay. So Breeze managed to submit a request to the Supreme Court, asking them to be granted a stay as well. The FDA has submitted their opposition, and Breeze has filed a response to the FDA’s statement. However, the Supreme Court has not responded to Breeze’s request yet.

On top of pending cases, anti-vape groups have started to become impatient with the FDA as well. These groups are concerned that the FDA is taking too long to reach a verdict on the largest vape companies, which were supposed to have taken priority in the PMTA process. When this decision was announced, many vaping companies were upset as smaller, less financially stable companies would have been particularly hurt when the grace period for PMTA products expired. However, most of the smaller companies simply received MDOs. Larger companies on the other hand, are still waiting for verdicts on their PMTAs.

The anti-vaping groups see the FDA as purposefully dragging out the review process in order to give these larger companies more time in which they can stay on the market. Additionally, these are all big name companies that contain significant portions of the US market share. In the anti-vaping group’s point of view, the FDA has done very little to review a large portion of the vape market. As a result, they have filed a request that the FDA be more transparent with their PMTA review process.

There are still a lot of big companies and advocacy groups fighting out the results of the PMTA decisions. While it may influence smaller vaping companies and what is allowed in the future, there’s not much smaller companies and consumers are able to do besides waiting, keeping up, and being involved politically in the ways we can .

References:

https://twitter.com/VaporAmerican/status/1453033522898345986

Health Groups Demand Regular PMTA Updates

https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/21a176.html