Food & Beverages | GRAS Notification Assessments

Food Ingredients & Food Additive (GRAS) Notifications

As food research and technology advances, new food ingredients are often introduced into food manufacturing and the U.S. food supply. However, food additives may only be used in conventional foods if they are Generally Recognized as Safe (GRAS), if they are the subject of a food additive regulation, or if they are “prior sanctioned” additives (food ingredients that have been used safely in the food supply prior to January 1, 1958).

Food additives achieve GRAS status in two primary ways. First, the manufacturer “self-affirms” the GRAS status of the ingredient. In this scenario, the manufacturer maintains documentary evidence of the safety of the ingredient, including its natural or artificial derivation, the related processing, and the effects of its consumption under specified intended uses. Second, the manufacturer can submit a GRAS Notification filing to FDA, containing similar documentation. Through this process FDA is not determining GRAS status of the food additive. Rather, FDA is merely stating it does not object to the manufacturer’s assessment of the ingredient as GRAS for the intended uses and at the levels described in the GRAS Notification. Many U.S. finished food manufacturers will only purchase food ingredients or food additives if they have, at a minimum, an FDA “No Objection” letter to a GRAS Notification.

If a manufacturer is using a food additive substance which is not already designated as GRAS by FDA regulation or for which FDA has not issued a “No Objection” letter, then it is particularly important for the manufacturer to be able to show and must maintain documentary evidence that the particular ingredient or food additive is GRAS.

Although FDA does not require manufacturers to submit GRAS self-assessments, the agency could disagree with a manufacturer and take regulatory action against a food containing a food additive that FDA believes it can prove is not GRAS. This is far easier for FDA to do at the imported food level of distribution because FDA already has very broad authority to issue FDA import detentions, FDA Import Alerts and FDA import refusals for foods that “appear” to be in violation of federal law or FDA regulations. Therefore, it is very important for foreign food additive and food ingredient manufacturers to have evidence regarding the GRAS status of their food additives and food ingredients.

Foods containing additives, which are not GRAS, are adulterated as a matter of federal law. Foods, which are deemed adulterated, are subject to FDA import detention, FDA Import Alerts, and FDA import refusal of admission. In addition, importing adulterated food may subject the manufacturer or importer to administrative and criminal penalties.

FDAImports.com, LLC assists its clients in determining whether their food ingredients or food additives are subject to FDA's GRAS requirements and, if so, whether they are GRAS. FDAImports.com, LLC advises clients regarding the assessment process and manages food additive GRAS notifications to FDA or third parties to ensure confidential commercial or trade secret data is kept confidential.