Reading Room Document

FDA Authority to Preempt California Proposition 65

The document discusses the authority of the Food and Drug Administration (FDA) to preempt California Proposition 65 (Prop 65). It concludes that the FDA has the authority to preempt Prop 65, but only if California's implementation presents a direct conflict with federal authority. The document presents three bases for preemption: express preemption, implied preemption, and conflict preemption. It also suggests that the FDA should consider initiating a rulemaking proceeding to further develop the factual record concerning California's implementation of Prop 65. The questions presented for review include whether California enforces conflicting warning requirements and whether such requirements stand as an obstacle to the accomplishment of the full purposes of FDA regulations.

September 19, 1988