“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), 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 excepted from the definition of a food additive.
Put simply, substances that are GRAS under conditions of their intended use are not food additives and do not require premarket approval by FDA.
Submission of a GRAS Notice to FDA
A substance that will be added to food is subject to premarket approval by FDA unless it is generally recognized, among qualified experts, to be safe under the conditions of its intended use. On August 17, 2016, FDA issued a final rule (The GRAS final rule; 81 FR 54960) that formalized a notification procedure and established the regulations in Subpart E of part 170. The regulations state that any person may notify FDA of a conclusion that a substance is GRAS under the conditions of its intended use. The regulations explain that any person may notify FDA of a view that a substance is not subject to the premarket approval requirements of section 409 of the FD&C Act based on that person’s conclusion that the substance is GRAS under the conditions of its intended use.
FDA strongly encourages any person to make a submission to our GRAS notification program following the available procedures for FDA oversight of GRAS conclusions.
FDA’s Responses to GRAS Notices
In general, FDA’s response has been in one of three categories:
- The agency does not question the basis for the notifier’s GRAS conclusion;
- The agency concludes that the notice does not provide a sufficient basis for a GRAS conclusion (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the notified substance); or
- The response letter states that the agency has, at the notifier’s request, ceased to evaluate the GRAS notice.
GRAS Determination vs. Food Additive Safety Determination
Irrespective of whether a substance is deemed to be GRAS or if its safety is established through a premarket approval process, the safety determination is always limited to the substance’s intended conditions of use. The difference between a GRAS determination and a premarket approval relates to who has access to the scientific data and information and who has reviewed the scientific data and information.
For a substance to be GRAS, the scientific data and information about the use of a substance must be widely known and there must be a consensus among qualified experts that those data and information establish that the substance is safe under the conditions of its intended use. GRAS determinations made in this manner are said to be made through scientific procedures. For a food additive, privately held data and information about the use of a substance are sent by the sponsor to FDA, which evaluates those data and information to determine whether they establish that the substance is safe under the conditions of its intended use (21 CFR 171.1). Thus, for a food additive, FDA determines the safety of the ingredient; whereas a determination that an ingredient is GRAS can be made by qualified experts outside of government.
There is, however, an additional way that a GRAS determination can be made. For a substance used in food before 1958, a GRAS determination can be made through experience based on common use in food. It should be noted that determinations based on common use in food require a substantial history of consumption in food by a significant number of consumers (21 CFR 170.30(c) and 170.3(f)), and that this basis for GRAS determination is seldom relied on today.