Since the late nineteenth century, coal tar dyes have been used to maintain or enhance the appearance of processed foods and to offset color loss due to exposure to light, air, temperature extremes, and the effects of moisture and storage conditions. Since 1906 the U.S. Food and Drug Administration (FDA) has been responsible for regulating all colorings.
The Color Additive Amendments of 1960 required that only color additives listed as “suitable and safe” for a given use could be used in foods, drugs, cosmetics, and medical devices. The Delaney Clause to the amendment specifically prohibited the listing of a color additive known to be a carcinogen. At the time that the amendment was passed there were about two hundred color additives in commercial use. They were all provisionally approved and could be used until scientific data established their safety.