The 5th U.S. Circuit Court of Appeals has ruled in favour of Texan brand Triton Distribution, allowing it to keep its products on the market, after having them rejected by the U.S. Food and Drug Administration (FDA).
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.
Diane Caruana – Vaping Post – 2021-10-29.