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Color Additive


A color additive is a dye, pigment or other substance, which is capable of imparting color when added or applied to a food, drug, cosmetic, or to the human body. Color additives for use in food, drugs, and cosmetics require premarket approval. Color additives for use in or on a medical device are subject to premarket approval, if the color additive comes in direct contact with the body for a significant period of time.