The initial PMTA guidance stated that no long-term studies were required to support applications. However, the FDA has now rejected thousands of PMTAs on grounds that such studies are required.
The Texas-based company’s products were among the 55,000 vape applications, or PMTAs, rejected by the FDA for insufficient documentation. The court of appeals rightly stated that the FDA pulled a “surprise switcheroo” from earlier guidance, when it failed to mention that applicants should provide long-term studies to support their applications. The court also pointed out that when the FDA denied Triton’s applications, it failed to consider the brand’s marketing plan which detailed ways to reduce their products’ appeal to youth.
In line with the court’s arguments, the initial PMTA guidance had said that companies would not need long-term studies to support their applications. However, the FDA has now rejected thousands of applications on grounds that such studies are required.
This of course has not been an isolated case exclusive to this brand. The first batch of PMTA rejections came in early August 2021, when the FDA announced that it would not even review the 4.5 million applications from the same company, JD Nova, on grounds that they did not include an adequate Environmental Assessment.
At the end of the same month, the agency issued marketing denial orders (MDOs) for applications related to flavoured vaping products (55,000 from one company and 800 from another), saying that these failed to provide “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”
The FDA will face multiple legal cases
Another brand, My Vape Order (MVO) has recently petitioned a federal court of appeals for “an emergency motion for a stay pending a review and for expedited consideration” on its products. The brand has called the rejections “arbitrary and capricious.”
MVO initially filed a petition for review in the Ninth Circuit Court of Appeals at the end of September, and several other vaping companies have followed suit. Besides highlighting the FDA’s seemingly random demands, they have rightly added that while they have had to scramble to meet the court-imposed PMTA submission deadline, the agency has apologetically missed its own, whilst at the same time failing to take into account vital information submitted by the businesses.
Read Further: Reuters