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’s Critical Objectives revolve around supporting its members through Science, Advocacy, Communication, and Intellectual Property Protection.

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 and admired 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, therefore explicitly excluding them from mandatory premarket approval by FDA, which allowed the agency to conserve its limited resources.

This exemption from premarket FDA approval provided the impetus for FEMA to employ GRAS as a practical and innovative approach to the safety evaluation of the large number of flavor ingredients that were already in use. FEMA agreed to sponsor the creation of a panel of eminently qualified experts, and to supply them with all available information that in any way related to the safety-in-use of each substance. Then and now, the Expert Panel consists of six to eight members and has comprised some of the world’s top experts in the fields of chemistry, biochemistry, toxicology, molecular biology, and pathology.

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