GRAS Notification Filings & Food Ingredient Analysis

As food research and technology advances, new food ingredients are often introduced into food manufacturing and the U.S. food supply .

Food additives may only be used in conventional food manufacturing if they are Generally Recognized as Safe (GRAS) or if they are the subject of a food additive regulation.

Most food additive GRAS determinations are self-made by the manufacturer of the food or the ingredient. “Prior sanctioned” food additives may be marketed without any prior notification to FDA. Additives that are GRAS for their intended uses – because they were commonly used in food for the intended uses prior to the food additive amendments to the food and drug laws or they are determined to be GRAS based upon scientific evidence – may be used in food without prior notification to FDA.

Although FDA does not require submission of a GRAS assessment determined by the manufacturer, FDA could disagree with the manufacturer and take regulatory action against the food containing an additive that FDA believes is not GRAS. As a consequence of a “not GRAS” determination by FDA, the agency may require the additive be subject to a food additive regulation prior to its use in foods. This can be costly and can have severe consequences for food products that have already gained market acceptance.

FDAImports.com consultants and affiliated attorneys assist clients in determining whether food ingredients are additives subject to FDA's GRAS requirements or if they are GRAS. FDAImports.com advises clients regarding the assessment process and manages food additive data disclosures to FDA or third parties to ensure confidential commercial or trade secret data is kept confidential.