Abstract
In 1959 the Flavor and Extract Manufacturers Association (FEMA) initiated the review of flavor ingredients that could be considered, through expert assessment, to generally recognized as safe (GRAS). This program is in accord with the concept of GRAS under the Food Additives Amendment to the U.S. Federal Food, Drug, and Cosmetic Act. The FEMA GRAS assessments are carried out by an independent panel of experts through a program that is sponsored by FEMA. The outcomes of the GRAS assessments are provided to the U.S. Food and Drug Administration (US FDA), the food and flavor industries, and to the public. In more than 50 years of operation, the FEMA GRAS program has remained consistent with the legal, regulatory, and scientific issues associated with the GRAS concept in the United States, and incorporated changes where appropriate based on legal considerations and sound science. This review describes the legal and scientific foundation of the FEMA program and its relationship to the US FDA.
