GRAS Determination
GRAS Determination
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
Developing a strategy to obtain the needed data such as performing chemical analyses, in vitro testing, and more
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
Frequently Asked Questions
GRAS (Generally Recognized As Safe) is a U.S. FDA designation indicating that a substance added to food is considered safe based on expert consensus. Achieving GRAS status is essential for market access, allowing ingredients to bypass premarket approval and enabling faster commercialization.
There are two primary pathways: ·GRAS Notification: Submit a comprehensive GRAS dossier to the FDA with safety data and expert evaluations. ·Self-Affirmed GRAS: Independently establish safety through expert consensus and existing scientific evidence.
Yes. Novel ingredients can achieve GRAS status through a rigorous scientific evaluation of toxicology, exposure, and safety data. Expert consensus ensures the ingredient is safe under its intended use.
A robust GRAS determination provides regulatory confidence, legal defensibility, and consumer safety assurance. It ensures the ingredient is backed by comprehensive toxicology and exposure data, mitigates FDA enforcement risk, and strengthens credibility for product launch in the U.S. and global markets.
We apply a scientifically driven, stepwise approach: comprehensive review to examine toxicology, ADME, and historical safety data, identify critical information to support safety, determine the best method to generate any additional data, and compile a robust GRAS dossier with safety evaluations and exposure assessments to support the determination.