The 20th publication by the Expert Panel of the Flavor and Extract Manufacturers Association on recent progress in the consideration of flavoring ingredients generally recognized as safe under the Food Additives Amendment

n 1958, Congress enacted the Food Additives Amendment (FAA) to the Federal Food, Drug, and Cosmetics Act amid growing concern over the safety of substances added to foods. The FAA set forth standards and guidelines by which the safety of food additives must be established before they can be added to foods (FAA, 1958). The FAA contained an exclusion provided by Congress for substances “generally recognized, by experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures . . . to be safe under the conditions of intended use.” Based on this, substances “generally recognized as safe” (GRAS) are not considered to be food additives, and are excluded from mandatory premarket approval by the Food and Drug Administration (FDA). However, GRAS substances must meet strict criteria specified by Congress (Degnan, 1991). As a result, in 1960, the Flavor and Extract Manufacturers Association of the United States (FEMA) created the FEMA GRAS program in which the safety of flavor ingredients would be evaluated for potential GRAS status by an independent panel of experts in the fields of chemistry, toxicology, pharmacology, medicine, pathology, and flavor safety assessment. The conclusions of the Expert Panel would be provided to FDA, the food and flavor industries, and the public. FDA has acknowledged the validity of the FEMA GRAS program and has recognized the FEMA GRAS publications as “reliable industry GRAS lists” within the context of the agency’s bulk labeling regulations for flavors codified at 21 CFR Sec. 101.22(b) (2001). FDA expressed significant support for the FEMA GRAS program in the preamble to its proposed voluntary GRAS notification program (FDA, 1997). The 20th publication by the Expert Panel of the Flavor and Extract Manufacturers Association on recent progress in the consideration of flavoring ingredients generally recognized as safe under the Food Additives Amendment