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Prop. 65

This article was originally published in The Gray Sheet

Executive Summary

The state of California plans to appeal a recent U.S. district court ruling that FDA requirements for dental mercury preempt California's Proposition 65 warning requirements for the product. According to a appeal notice filed by California, the state's appeal brief -- which has not yet been filed -- will raise questions such as "whether the general [FDA] labeling requirements applicable to all medical devices and all prescription devices preempt the specific reproductive toxicity warning requirement imposed by Proposition 65." The district court concluded that preemption is legally necessary because California's rules are "different from, or in addition to" FDA's "specific requirements" for dental mercury. The state maintained that FDA's rules are not "specific requirements" but general controls that apply to all medical devices



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