GRAS Determination

GRAS-Generally-Recognized-As-Safe-FDA

  • 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

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.