What is GRAS Status

Generally Recognized as Safe (GRAS) status is a regulatory designation first introduced by the U.S. Food and Drug Administration (FDA) as part of the 1985 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act).  According to the FDA,

"any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive."

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.  The findings result in establishing compliance with FDA regulations for the food ingredient.

A GRAS determination can be either self-determined or submitted to the FDA in the form of a notification for the Agency’s assessment.  Learn more about the different GRAS Procedural Alternatives.