USA GRAS Determination
For a substance to be recognized as GRAS, there needs to be scientific data and information widely available about the use and recommended purpose. Additionally, there needs to be a consensus among qualified experts on the safety of the substance.
Through the GRAS notification process, high-level evidence and scientific rigor demonstrating the substance is safe under the intended use is submitted to FDA. This submission usually follows a pre-submission meeting with the FDA.
NHP Consulting can help identify the status of the ingredient, and arrange pre-submission meetings and/or file the GRAS notification substantiation on your behalf.