The FDA had not anticipated such a large number of applications, and has therefore found ways to dismiss them without reviewing them.
Bidi Vapor, Diamond Vapor, Johnny Cooper and Vapor Unlimited, are some of the vape companies faced with MDOs as part of the infamous Food and Drug Administration (FDA) premarket tobacco product application (PMTA) process. And the court ruling in favour of these manufacturers is not an isolated event, last January the Fifth Circuit Court of Appeals also granted a stay for Triton Distribution.
After listening to arguments against the FDA’s arbitrary and capricious PMTA rejections from dozens of lawsuits, the court also heard from Eric Heyer’s, the lawyer for mid-sized e-liquid manufacturer Triton Distribution. He questions what were the justifications for the FDA’s decisions, whilst referring to comparable applications by many other denied companies.
In response to these arguments, the Fifth Circuit has like the Eleventh Circuit Court of Appeals, allowed the rejected products to stay on the market at least of the duration of the lawsuit.
What is going on?
A recent blog on Competitive Enterprise Institute’s website highlighted that the amount of applications received by the agency was way over the 25 applications a year the FDA initially expected. “Perhaps that explains why the FDA now seems intent on coming up with excuses to issue sweeping denials and whittle that number down to a size it can handle,” it said.
Subsequently, Filter had revealed the discovery of other documents showing that in fact PMTA reviewers have created a method to get through a backlog of millions of PMTAs, enabling them to quickly dismiss many of them without reviewing their submitted documents.
Read Further: Filter