Fifth Circuit to consider e-cigarette marketing denial en banc

Tobacco companies have long fought regulatory action to protect consumer health and safety, and while there has been a shift from smokeable products to “e-cigarettes,” the legal battles continue.

In 2016, the FDA issued a rule deeming e-cigarettes “new tobacco products,” and requiring manufacturers to submit premarket tobacco product applications (“PMTAs”) before they could sell those products. After years of delay, and litigation over that delay, the “deeming rule” finally went into effect in September 2020. Manufacturers then submitted applications to market flavored e-cigarettes–with flavors including “peachy strawberry” and “Jimmy the Juiceman Strawberry Astronaut.” FDA denied these applications, and others, citing the well-documented risks to youth associated with such novelty flavored addictive tobacco products.

Since 2016, the e-cigarette industry has filed numerous cases challenging various aspects of the premarket application regime, including to the deeming rule itself and FDA’s denial of applications for specific products. For the most part, these challenges have failed. The DC Circuit’s 2019 Nicopure Labs v. FDA  decision dispensed with arguments that the deeming rule violated the First Amendment and was arbitrary and capricious, and that court has since rejected a variety of other claims, as have the Seventh and Third Circuits. The Eleventh Circuit, on the other hand, granted one set of petitions for review on the narrow grounds that the FDA failed to consider the e-cigarette companies plans to “mitigate” the harms their products posed to youth.

The Fifth Circuit has thus far been a mixed bag. In 2020, the court rejected a non-delegation clause challenge to the underlying statutory regime, and the Supreme Court denied certiorari. In 2021, though, a panel of the court issued a stay of an FDA marketing denial order issued to Triton, a Texas e-cigarette manufacturer, finding Triton was likely to succeed on the merits of its claim that the agency’s denial was arbitrary and capricious in violation of the APA. In 2022, though, a merits panel reached a different conclusion and, over a dissent, denied Triton’s petition for review on the merits. A flip appears likely again, though, as last week, the Fifth Circuit vacated the panel decision and granted en banc rehearing. In some ways, this fact-bound case seems an odd one for en banc review, but the fact that the motions panel and merits panel reached different outcomes, and the fact that one of the judges on the merits panel is no longer on the court, likely played a role. The two panel opinions reflect starkly different views of both the role of regulation of consumer products, and the dangers of tobacco to youth — a division that will likely be on display when the en banc court hears the case later this year.



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