P. M. Gaynor, R. Bonnette, E. Garcia, L. S. Kahl, L. G. Valerio, Jr., CFSAN, FDA, College Park, MD
Under the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, any substance intentionally added to food is a food additive and is subject to pre-market approval by FDA unless the use of the substance is generally recognized as safe (GRAS; the GRAS provision) (or otherwise excepted from the definition of food additive - e.g., color additive). By 1961, FDA had amended its regulations to include a list of food substances that are GRAS under certain conditions of use ("the GRAS list"). During the 1960's, many manufacturers requested FDA's opinion on whether their conclusions of GRAS status were justified and received "opinion letters. "In 1969, FDA removed cyclamate salts from its GRAS list as a result of safety questions, and then-President Nixon directed FDA to reexamine the safety of GRAS substances. In the 1970's, FDA announced that it was conducting a "comprehensive review" of presumed GRAS substances and established rulemaking procedures to affirm the GRAS status of substances that were either on the GRAS list or the subject of a petition ("GRAS affirmation"). To eliminate the resource-intensive rulemaking procedures, in 1997, FDA proposed to replace the GRAS affirmation petition process with a notification procedure ("GRAS notification").