This presentation will describe the history of regulation of color additives and colorants by the U.S. Food and Drug Administration (FDA). Color additives are dyes and pigments permitted for coloring food, drugs, cosmetics, and medical devices in the U.S. Colorants are dyes and pigments permitted for coloring food-contact materials. Federal oversight of food colors began in the late 19th Century and continued with the 1906 Food and Drugs Act and the 1938 Federal Food, Drug, and Cosmetic Act. The term �color additive� was defined in the 1960 Color Additive Amendments to the 1938 Act and the term �colorant� was established in 1983 when FDA issued requirements for colorants in polymers. Both color additives and colorants have premarket approval requirements. The policies resulting from various regulatory issues related to these requirements and current challenges to the agency will be discussed.

History of FDA regulation of color additives and colorants

245th National Meeting (2013)

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