When a substance is intentionally added to a food, it is classified as a food additive and subject to market approval by the FDA, unless it has Generally Regarded As Safe (GRAS) status showing the substance is safe under the recommended conditions of use. NHP Consulting can file for GRAS status on your behalf.
At the beginning of 1958, the FDA brought the Food Additives Amendment of 1958 into act, which established a list of 700 food substances that were exempted from the requirement to test food additive before introducing them to the market. Since then, the provision has been referred to as “GRAS”, an acronym for the phrase “Generally Recognized As Safe”.
When a substance is intentionally added to a food, it is classified as a food additive and subject to market pre-approval by the FDA, unless it has been given GRAS status via an approval, based on the regulatory submission demonstrating the substances is safe. As of September 2015, the FDA has received 594 GRAS notices since the program was established in 1998.
For an 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.
Recognizing GRAS status requires a high-level of evidence that demonstrates the substance is safe under the intended use. This procedure can be tedious and involve a long list of documents. NHP Consulting can help identify the status of the ingredient and submit regulatory fillings for GRAS status/clarification.