Triton MDOs Overturned

In a much-anticipated ruling, a federal appeals court has finally overturned the Marketing Denial Orders (MDOs) handed down to Triton Distribution and Vapetasia. The court has directed the FDA to conduct fresh evaluations of the companies’ marketing applications. The en banc panel of judges decisively voted 10-6 in favor of granting Triton and Vapetasia the opportunity for a comprehensive review.

The decision unloads on the FDA. In a 52-page decision filled with barbs, the Fifth Circuit Court of Appeals, through the majority opinion authored by Judge Andrew S. Oldham, found the FDA’s rejection of Triton’s premarket tobacco product applications (PMTAs) to be “arbitrary and capricious.”

First, the agency gave manufacturers detailed instructions for what information federal regulators needed to approve e-cigarette products. Just as importantly, FDA gave manufacturers specific instructions on what regulators did not need. The agency said manufacturers’ marketing plans would be “critical” to the success of their applications. And the agency promulgated 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 FDA’s instructions. The regulated manufacturers dutifully spent untold millions conforming their behavior and their applications to FDA’s say-so….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 particular 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.

Triton

The Court raises other concerns with FDA’s approach. In a footnote the opinion raises a question about whether FDA adopted a ban without following the required notice and comment period.

FDA’s categorical ban has other statutory problems. For example, the TCA states that FDA must follow notice-and-comment procedures before adopting a “tobacco product standard.” See 21 U.S.C. § 387g(c)–(d). And Congress specifically called a ban on tobacco flavors a “tobacco product standard.” See id. § 387g(a)(1)(A) (referring to tobacco flavors, “including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke”); see also id. § 387g(a)(2) (cross-referencing noticeand-comment obligation to revise flavor standards). FDA unquestionably failed to follow § 387g’s notice-and-comment obligations before imposing its de facto ban on flavored ecigarettes.

Fn. 5

In October, the Supreme Court refused to hear an appeal from Avail Vapor. There is little question that the FDA will appeal the ruling today to the Supreme Court. It’s likely the Court will finally be compelled to address the split in Circuit Court rulings.