Our FDA GRAS Ingredient Services Include:
- Conduct a feasibility review of your ingredient to determine GRAS or NDI status
- Determine gaps in evidence to support safety and layout a strategy to obtain GRAS status either as self-affirmation or with a GRAS notice to the FDA
- If applicable, through our clinical trial partners, organize a toxicological study
- Prepare the GRAS notification dossier, engage expert panel members, where applicable to attest to GRAS status
- If applicable, file with the FDA and answer all questions from the agency
- If applicable, have a meeting with the FDA (on-site or virtual)
