In a decisive 10-6 ruling, the Fifth Circuit Appeals Court accused the FDA of leading vape companies on a “wild goose chase” with shifting regulatory goalposts. The stinging rebuke rejected the agency’s justifications and ordered new reviews of marketing applications from Triton Distribution and Vapetasia.
The rare en banc decision saw the conservative-leaning court unanimously side against the FDA after years of perceived bait-and-switch tactics. Judges admonished capricious standards that failed to match official guidance, calling the denials of Triton’s applications “arbitrary and capricious.”
While most circuit courts have backed the FDA on marketing order appeals, the split decisions increase chances of Supreme Court intervention. For now, the ruling delivers a high-profile win to independent vape manufacturers fighting to remain on the market.
The case centers on fair regulatory processes, but has far-reaching implications for millions of adult consumers relying on access to alternative nicotine products. Despite Friday’s reprimand, the FDA shows little sign of relenting in its crackdown on the vast majority of vaping companies and products.