Facilitate full characterization of substance

Perform feasibility assessment

Determining available information to demonstrate the safety of the substance under the intended conditions of use

Identifying missing key studies/information

1. Developing a strategy to obtain the needed data such as performing chemical analyses, in vitro testing, and more

2. Planning publications for key studies

Prepare information package

• Conduct a comprehensive review of the relevant published literature

• Summarizing natural occurrences and the history of the traditional use of the substance as food material

• Discussion on key toxicological studies, ADME profile, history of safe use, and reported adverse reactions in humans

• Derivation of an acceptable daily safe intake or exposure

• Estimating daily intake or exposure resulting from the intended use of the substance

• Safety substantiation for the intended use

Scientific Expertise: Utilize in-depth knowledge of toxicology and regulatory guidelines to assess the safety of substances

Expert Guidance: Provide expert guidance and recommendations throughout the GRAS determination and notification process to the US FDA