A child experienced a severe allergic reaction after consuming a cupcake mislabeled as “vegan” by a Whole Foods store. The family sued Whole Foods under theories of negligence and strict liability, arising under Texas Law. The District Court dismissed the suit as preempted by the Federal Food, Drug, and Cosmetic Act. But the Fifth Circuit reversed:

β€œAn independent state-law duty may form the basis of a tort claim for which violations of the FDCA may be presented as evidence of breach, assuming that the state-law claims do not (a) add to federal requirements or (b) impinge on the FDA’s sole authority over food-labeling requirements. Those latter requirements appear to be met: no party asserts that the Spanos seek to enforce labeling requirements above and beyond those imposed by the FDA. Nor is there any claim here β€” like a fraud-on-the-FDA claim β€” that would impinge on the FDA’s authority over food labeling. Appellants do not assert that Whole Foods submitted false evidence to the FDA, for example, and their claims do not depend on speculation that the FDA would have taken any particular regulatory action in response to violation of the regulations at issue.”


Spano v. Whole Foods, 65 F.4th 260 (5th Cir. 2023).