FDA Ordered to Reconsider Vape Product Denials

Two makers of flavored liquid for e-cigarettes will get another chance for FDA approval.

January 08, 2024

A federal appeals court ordered the U.S. Food and Drug Administration (FDA) to reconsider its decision barring two makers of flavored liquid for e-cigarettes from marketing their products, reported Reuters. The court said the agency had been arbitrary and capricious in refusing to consider the companies' marketing plans.

The 9-5 decision by the New Orleans-based 5th U.S. Circuit Court of Appeals reversed a July 2022 decision by a three-judge panel of that court.

The two makers, Wages and White Lion Investments LLC, doing business as Triton Distribution, and Vapetasia LLC, will get another chance to obtain FDA approval, said Bloomberg Law.

The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham.

Oldham, who was appointed to the court by Republican former president Donald Trump, wrote for the majority that the FDA had first asked e-cigarette companies for their detailed marketing plans, saying those plans were crucial, but then denied their applications without looking at them, reported Reuters.

FDA “circulated hundreds of pages of guidance documents, hosted public meetings, and posted formal presentations to its website—all with the (false) promise that a flavored-product manufacturer could, at least in theory, satisfy the instructions,” wrote Oldham in the ruling. “The regulated manufacturers dutifully spent untold millions conforming their behavior and their applications to FDA’s say-so.”

“Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the one million plans,” the ruling added.

“FDA justifies its behavior with two principal arguments. First, FDA argues that its years’ worth of regulatory guidance was not worth the paper it was printed on because it was hedged with cautious qualifiers and never guaranteed that any submission would be granted. Second, and most disturbingly, FDA argues that its capriciousness should be forgiven as harmless because the agency promises to deny petitioners’ applications even if we remand to make the agency follow the law,” Judge Oldham wrote in the ruling. “Today we reject both propositions.”

Eric Heyer, a lawyer for liquid makers Triton Distribution and Vapetasia LLC, said he was pleased with the ruling and hoped it would lead the FDA to make "a significant course correction by communicating with specificity" what companies must do to get approval.

While the opportunity for reconsideration is only open to the two manufacturers in this case, the issue is now again in front of FDA. It is not clear what FDA will do, and the case highlights exactly why NACS has emphasized its position for more clarity from FDA regarding which products can and cannot be sold.