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U.S. Department of Health and Human Services

For Industry

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Color Certification

Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except coal tar hair dyes, are subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time. In addition, many of these color additives must be batch certified by FDA. The following are resources related to the certification of color additives. 

 

 

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