FDA Preemption

FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it, arguing that the FDA should set both the floor and the ceiling for drug regulation. Michigan is the only state that voluntarily applies FDA Preemption to its own state tort law through a regulatory compliance defense, although Michigan's law has been controversial and efforts to repeal it are underway.