Regulatory Process

Benefits of the FEMA GRAS Process

There are three key benefits of the FEMA GRAS review process:

Rapid Time for Commercialization. Once a flavor compound is selected for development by our collaborator, based on our experience we expect the time to conduct the safety studies and complete the review by the FEMA expert panel will be 12 to 18 months for the flavor compound, provided no additional studies are requested by the panel or are necessary to explain unexpected safety study findings. This is much faster than the typical eight years or longer to obtain FDA approval under the food additive petition process applicable to other food ingredients. Once the compound is determined to be FEMA GRAS, it can be immediately commercialized in the United States and other countries that recognize the FEMA GRAS process. As described above, the initial phase of commercialization may include compound manufacturing, incorporation of the flavor enhancer into products, and the commercialization of products in consumer test markets.

Low Development Costs. Based on our experience, the total development costs including synthesis of material for safety studies, contract safety studies and preparation and submission of the GRAS application is generally under $1 million per compound.

Facilitated Approval in Other Countries. Approval of flavors for use outside of the United States varies widely by country. According to FEMA, a number of countries, including Brazil, New Zealand and Australia, recognize compounds on the FEMA GRAS list. An additional set of countries recognize compounds on the FEMA GRAS list "in principle". These include China, Philippines, Taiwan, and Turkey. Approval in these countries typically requires specific applications to the food safety authority of the individual countries but no additional safety testing.