FEMA GRAS--a GRAS assessment program for flavor ingredients. Flavor and Extract Manufacturers Association

The generally recognized as safe (GRAS) assessment program of the Flavor and Extract Manufacturers Association (FEMA) of the United States was initiated in 1959 to provide for the assessment of flavor ingredients as GRAS under the Food Additives Amendment to the U.S. Federal Food, Drug, and Cosmetic Act. FEMA sponsored the formation of an independent panel of experts to perform GRAS assessments and to provide their conclusions to the U.S. Food and Drug Administration, the food and flavor industries, and the public. The program was designed to account for the legal, regulatory, and scientific issues associated with GRAS assessments and has continued to incorporate changes in the law and in science. This review describes the legal and scientific foundation of the FEMA program.