On January 3, 2024, the United States Court of Appeals for the Fifth Circuit invalidated the FDA's premarket application orders (MDOs) for Triton Distribution and Vapetasia's e-cigarette products, ruling that the FDA's (Food and Drug Administration) premarket application (PMTA) applications were issued arbitrarily , and ordered the FDA to re-examine the two companies' PMTA applications .
In this case, the FDA (Food and Drug Administration) argued the following two points:
- FDA operates a cautious regulatory process and cannot guarantee that it will approve an application for any particular product.
- The FDA is mandated to continue rejecting applications regardless of the outcome of the ruling, so it does not matter if the decision is arbitrary.
However, the Fifth Circuit dismissed the FDA's arguments . This ruling overturned the Fifth Circuit's ruling against Triton Distribution in 2022 .
Incidentally, the Fifth Circuit is considered the most conservative of the 13 federal appellate courts in the nation. All 10 justices who voted for Triton Distribution were appointed by Republican presidents, as were the three who voted against it. The other three justices who voted for the FDA were appointed by Democrats.
Other circuits have generally sided with the FDA in appeals of marketing denial orders (MDOs), but the 11th Circuit has ruled in favor of e-cigarette manufacturers, and marketing denial orders are currently being appealed in several other circuits .
Source (https://vaping360.com/vape-news/128052/fifth-circuit-court-rips-fda-grants-triton-appeal/ )
