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FDA PREEMPTION OF PROP. 65 DENTAL MERCURY RULES: CALIF. CONSIDERING APPEAL

This article was originally published in The Gray Sheet

Executive Summary

FDA PREEMPTION OF PROP. 65 DENTAL MERCURY RULES: CALIF. CONSIDERING APPEAL of a recent court ruling that FDA requirements for dental mercury preempt California's Proposition 65 warning requirements for the product. Judge Rudi Brewster of the U.S. District Court for the Southern District of Califomia found that "Proposition 65's warning requirements, when imposed on dental mercury or products containing dental mercury, are different from, or in addition to, specific [Food, Drug and Cosmetic Act Medical Device Amendments] requirements applicable to dental mercury or products containing dental mercury, and consequently are preempted." Prop. 65 requires warnings for dental mercury because the state has deemed it a reproductive toxicant.
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