Wende McIlwain v. Arthur Hull Hayes, Jr., Commissioner, Food and Drug Administration

BORK, Circuit Judge:

Prior to 1960, color additives used in foods, drugs, and cosmetics could be marketed lawfully unless the Food and Drug Administration (“FDA”) tested them and found them unsafe. Because of the FDA’s limited resources, Congress believed this testing process likely to be unduly prolonged. In 1960, therefore, the Color Additive Amendments to the Food, Drug, and Cosmetic Act shifted the burden of testing and proof of safety to industry. A color additive is to be deemed unsafe unless industry proves its safety. Recognizing that this would take time with many commercially…