Flavor and Extract Manufacturers Association
The Flavor and Extract Manufacturers Association (FEMA) of the United States was founded in 1909 by several flavor firms in response to the passage of the Pure Food and Drug Act of 1906. Founding members were McCormick & Company, Ulman Driefus & Company, Jones Brothers, Blanke Baer Chemical Company, Frank Tea & Spice Company, Foote & Jenkes, Sherer Gillett Company, and C.F. Sauer Company.
Since its founding, FEMA has played instrumental roles in creating a program to assess the safety and “generally recognized as safe” (GRAS) status of flavor ingredients, advocating for policies that positively impact the food and flavor industry, and in representing its members’ interests during the creation of the 1958 Food Additives Amendment to the Food, Drug and Cosmetic Act.
FEMA GRAS program
The first FEMA Expert Panel met in 1960 to assess the GRAS status of flavor ingredients under the authority provided by the 1958 Food Additives Amendment to the Food, Drug and Cosmetic Act. Since then, the FEMA GRAS™ program has become the longest-running and most widely recognized industry GRAS assessment program.
The FEMA GRAS™ program began with the passage of the Food Additives Amendment, which defined a food additive as:
…any substance…which…may…[become] a component or… [affect] the characteristics of any food…if such substance is not generally recognized, among 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 its intended use.
This definition removed substances that were deemed GRAS from consideration as food additives, thereby explicitly excluding them from mandatory premarket approval by the FDA, allowing the agency to conserve its limited resources.
This exemption from premarket FDA approval provided the impetus for FEMA to evaluate the large number of flavor ingredients that were already in use. FEMA agreed to sponsor the creation of a panel of experts, and to supply them with all available information that in any way related to the safety in use of the substances that they were evaluating. This Expert Panel consists of six to eight members with expertise in chemistry, biochemistry, toxicology, molecular biology, and pathology.
In 1959 and 1960, Food Technology published two articles dealing with the evolving FEMA GRAS™ program, and a partial list of GRAS substances representing the Panel’s early conclusions was published in Food Chemical News in 1961. The first comprehensive list and an accompanying explanation appeared in Food Technology, which has continued to be the journal in which all subsequent FEMA GRAS™ lists have appeared.
These early lists were greeted at first with tacit and then explicit acceptance by FDA, and then later by foreign governmental and intergovernmental agencies. As the backlog of substances already in use began to diminish, FEMA and the Panel began to address the assessment of new substances. The first of these publications (GRAS 4) appeared in 1970. To date, more than 2,700 flavor ingredients have been generally recognized as safe under conditions of intended use.
In addition to evaluating new flavor ingredients, the FEMA Expert Panel has maintained a rigorous program of periodic and comprehensive reviews of the scientific data related to the safety evaluation of flavoring substances. In cooperation with the FDA and the National Academy of Sciences, the Panel concluded its first comprehensive review (GRAS affirmation) of the status of FEMA GRAS flavors in 1985, and began a second comprehensive review in 1994. This second re-evaluation program of chemical groups of flavor ingredients, recognized as the GRAS reaffirmation (GRASr) program, was completed in 2005. As science has progressed so has the Panel’s approach to the safety evaluation of flavor ingredients. The evaluation criteria used by the Panel during the GRASr program reflects the significant impact of advances in biochemistry, molecular biology and toxicology that have allowed for a more complete understanding of the molecular events associated with toxicity.
In 2010, the U.S. Government Accountability Office published a review of the GRAS concept and its application by the Food and Drug Administration. GAO concluded that “the [FEMA] association’s GRAS process achieves a level of public disclosure and agency notification similar to FDA’s voluntary notification program.”