FDA regulates color additives used in the United States, including those used in food, dietary supplements, drugs, cosmetics, and medical devices. The agency evaluates scientific data and information to ensure that a color additive is safe for its intended purposes. Any food, cosmetic, drug, or medical device that contains an unapproved color additive would be considered adulterated under U.S. law and would be subject to enforcement action to remove it from commerce.
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