FDA v. Wages and White Lion Investments, LLC, Docket No. 23-1038

The Supreme Court vacated the Fifth Circuit's decision that found the FDA acted arbitrarily and capriciously in denying marketing authorization for flavored e-cigarette products. The Court held that the FDA's denial orders were sufficiently consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type, and thus did not violate the change-in-position doctrine. The Court remanded the case for the Fifth Circuit to reconsider whether the FDA's failure to review marketing plans constituted harmless error under the proper legal standard.music for the podcast provided by ⁠ Dimitry Taras