In a split decision, the U.S. Court of Appeals for the Fifth Circuit ruled the Food and Drug Administration did not act capriciously when it denied premarketing approvals to two flavored nicotine e-cigarette companies.

Despite a heated dissent, the Fifth Circuit panel found its way toward agreement with a 2021 decision in the Sixth Circuit, which denied a stay application of a similar premarketing denial order. In that case, Breeze Smoke v. FDA, the Sixth Circuit disagreed with the company’s complaint that the FDA orchestrated a “surprise switcheroo” when it changed its standards for review in midstream.

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