Generally Recognized as Safe (GRAS) Notifications

Generally Recognized as Safe (GRAS) status is a regulatory designation that applies to any substance intentionally added to a food (i.e., a food additive). Securing GRAS status has become more valuable in recent years as new ingredients are being investigated.

Companies typically choose the GRAS determination pathway for a substance they feel has substantial consensus among scientific experts, outside the FDA, that the ingredient is safe for use as intended.

View our blog post, 5 Things You Need to Know About GRAS Filings for Food Ingredients.

To attain GRAS status for an ingredient, the sponsor must be able to demonstrate that the substance in question is not likely to cause harm when used as intended.  This requires a complete review of the safety evidence for the ingredient and the submission of a GRAS filing with the FDA.

Our experienced team at GRAS Associates will walk you through compiling the necessary information for inclusion in a GRAS notification to the FDA.

Looking for more information on GRAS filings? Contact a member of our team today or email us directly at You may also request a customized quote and we will contact you with details within two business days