Vapetasia Scores Major Victory Against FDA in 2024 Ruling!
VAPETASIA VS FDA
After a long wait, the U.S. Court of Appeals for the Fifth Circuit has issued its decision in our case against the Food and Drug Administration. By a vote of 10-6, the court sided with Vapetasia (Wages and White Lion Investments), overturning the FDA's original marketing denial orders (MDOs) for our products.
Though the FDA had previously said that it would provide guidance for the PMTA process, the Agency never made it clear what a successful application required — and, at times, moved the goalposts after we had filed our submissions. Our PMTA applications had to prove, in other words, that our products were 'appropriate for the protection of public health' (APPH), but the FDA was not transparent in how to meet that standard.
We remain optimistic that the FDA will now give us concrete instructions on what, if anything, is missing from our PMTAs — information that should benefit many of the small businesses that created this industry together.
We could not have gotten this far without the help of our good friends at Triton Distribution, Suicide Bunny, and everyone who has supported our company by either selling or consuming our products.