Regulatory Process
home » technology » regulatory process » regulation of flavors and flavor enhancers in the united states
Regulation of Flavor Enhancers and Taste Modulators in the United States
In the United States, the majority of flavor compounds are regulated by the FDA as approved food additives, or as GRAS ingredients under the Food, Drug, and Cosmetic Act. The Food Additive Amendments of 1958 prompted the flavor industry to establish in 1960 an Expert Panel of the Flavor and Extract Manufacturers Association, or FEMA, an organization that has administered the GRAS program for flavors on behalf of the industry for over 40 years. Another possible route to approval of a flavoring compound would be a food additive petition to the FDA; however, few flavors are currently approved via this route. We believe that the flavor compounds, including flavors, flavor enhancers and taste modulators, we may discover will be subject to the FEMA GRAS review process as described below.
GRAS Review Process. Flavor compounds that qualify for the GRAS review process are generally intended to be consumed in small quantities and have data supporting their safety under conditions of intended use. An expert panel, convened to undertake a GRAS review, determines whether a compound is generally recognized as safe under the conditions of its intended use. These experts are qualified by scientific training and experience to evaluate the safety of chemicals used in food and may declare certain compounds as having been adequately shown through scientific procedures to be generally recognized as safe under the conditions of their intended use. Under the GRAS process, manufacturers are required to obtain safety data from the scientific literature or through the conduct of safety studies, determine the estimated daily intake of the flavor compound per person and submit a report to the GRAS review panel describing the physical, chemical, safety, and metabolic properties of the flavor compound. The entire GRAS determination process, including the safety and metabolic studies, application preparation and GRAS panel review, can take up to two years or longer. However, if there are prior safety data on the compound or a compound with a related structure, then fewer safety studies may be required for the GRAS review and the GRAS review process may be considerably faster than two years.
The most common types of GRAS review are:
In the United States, the majority of flavor compounds are regulated by the FDA as approved food additives, or as GRAS ingredients under the Food, Drug, and Cosmetic Act. The Food Additive Amendments of 1958 prompted the flavor industry to establish in 1960 an Expert Panel of the Flavor and Extract Manufacturers Association, or FEMA, an organization that has administered the GRAS program for flavors on behalf of the industry for over 40 years. Another possible route to approval of a flavoring compound would be a food additive petition to the FDA; however, few flavors are currently approved via this route. We believe that the flavor compounds, including flavors, flavor enhancers and taste modulators, we may discover will be subject to the FEMA GRAS review process as described below.
GRAS Review Process. Flavor compounds that qualify for the GRAS review process are generally intended to be consumed in small quantities and have data supporting their safety under conditions of intended use. An expert panel, convened to undertake a GRAS review, determines whether a compound is generally recognized as safe under the conditions of its intended use. These experts are qualified by scientific training and experience to evaluate the safety of chemicals used in food and may declare certain compounds as having been adequately shown through scientific procedures to be generally recognized as safe under the conditions of their intended use. Under the GRAS process, manufacturers are required to obtain safety data from the scientific literature or through the conduct of safety studies, determine the estimated daily intake of the flavor compound per person and submit a report to the GRAS review panel describing the physical, chemical, safety, and metabolic properties of the flavor compound. The entire GRAS determination process, including the safety and metabolic studies, application preparation and GRAS panel review, can take up to two years or longer. However, if there are prior safety data on the compound or a compound with a related structure, then fewer safety studies may be required for the GRAS review and the GRAS review process may be considerably faster than two years.
The most common types of GRAS review are:
-
FEMA Expert Panel. An independent panel of experts established by FEMA is available for use by members of FEMA. The conclusions of the expert panel regarding a flavor or flavor enhancer are provided directly to the FDA and published in the journal Food Technology. In 2003, the FEMA expert panel published their findings on 45 new compounds determined to be GRAS for specific flavor applications. We have been an associate member of FEMA since 2003 and we expect to obtain a GRAS determination of our flavor compounds via the FEMA expert panel review.
Specifically Convened Independent Panel. An independent, qualified panel of experts in pertinent scientific disciplines may be formed by the manufacturer to evaluate the safety of a specific compound for GRAS status. This process is known as a "self determination of GRAS status."