FDA in difficult position as court rules its vaping review was arbitrary and hasty

A ruling by the Fifth Circuit Court of Appeals allows two e-cigarette companies to resubmit their marketing applications to the U.S. Food and Drug Administration (FDA). The ruling found that the FDA acted "arbitrarily and capriciously" in rejecting the premarket tobacco product applications (PMTAs) of Wages and White Lion Investments (operating under Triton Distribution) and Vapetasia to sell their products.

The court stated that the FDA "left manufacturers of flavored e-cigarette products in the dark," telling them the conditions needed for product approval and then rejecting all applications. Judge Andrew S. Oldham stated in the ruling that the FDA "never informed applicants that they needed to conduct long-term studies on their specific flavored products."

Judge Oldham noted that manufacturers faithfully spent millions of dollars to "align their actions and applications with the FDA's statements." He stated, "Then, just months after receiving hundreds of thousands of applications based on its guidance, the FDA turned around, pretended it had never given anyone any guidance on anything, imposed new testing requirements without notice, and rejected a million flavored e-cigarette applications for failing to anticipate the agency's flip-flop. Worse, after telling manufacturers that their marketing plans were crucial to their applications, the FDA admitted it had not read a single word of a million plans."