A few days after a lot of vape businesses had been issued MDOs (Marketing Denial Orders), several of the bigger firms decided to sue the FDA. Although some companies were put back to the review stage in order to avoid a legal battle, the FDA did decide to challenge certain lawsuits in court.
One of the companies that the FDA was able to stand up with was Triton. The reason why the case was notable was because the FDA chose to take the matter to court, and the court agreed with Triton’s appeal. The result was that Triton was granted the right to stay.
A stay is a procedure that suspends any proceedings related to a case before a judge. In Triton’s situation, the holiday would permit them to sell PMTA items until the FDA completed reviewing their PMTA application.
After Triton was granted an extension, Breeze was denied a stay. This is why Breeze had to submit to the Supreme Court, asking them to give the same visit. The FDA has also filed an objection, and Breeze has filed a reply to the FDA’s response. However, Breeze has not yet heard from the Supreme Court has not responded to Breeze’s petition yet.
In addition to the pending cases, Anti-vape groups have also begun to be irritable with the FDA too. They are worried about the fact that the FDA is waiting too long to agree with the largest vape manufacturers, which were supposed to have been given precedence in the PMTA procedure. When the decision was made, the vaping industry was unhappy because the smaller and less financially stable businesses were particularly affected since the grace period that was granted to PMTA products ended. However, many of the smaller firms were given MDOs. Larger corporations, however, are waiting for the results of their PMTAs.
The anti-vaping group sees the FDA as a deliberate attempt to delay the review process to allow these bigger firms more time to ensure they are able to remain in the market. Furthermore, they are major names that hold significant parts of their US market shares. From this viewpoint, it appears that the FDA has not done much to examine a substantial portion of the market for vapes. Therefore, they’ve submitted a request to they request that the FDA make it more clear about their PMTA review procedure.
There are still many large companies and advocacy groups fighting the consequences of the PMTA decision. Although it could affect smaller companies in the vaping industry and the rules that will be in place in the near future, there’s nothing smaller businesses or consumers can do other than wait, stay up, and participate politically in any way we are able to.
