The continuing focus of the current administration on the Generally Recognized as Safe (GRAS) “loophole” of self-affirmation has led to organizations and media digging further into the existing GRAS system and its uses, resulting in some interesting statistics and perspectives.
One of the most compelling is the List of 111 chemicals claimed as GRAS which have not been reviewed by FDA for safety, as compiled by the Environmental Working Group (EWG). Whether or not you are in agreement with the positioning of the EWG article, the lack of pre-market review for self-affirmation and extent some companies have taken to use questionable ingredients make a legitimate argument for the elimination of self-affirmation. At the same time, it is the embodiment of the adage of one bad apple spoiling the whole barrel; that is, one (or several) unethical companies causing the elimination of what could be an efficient system.
GRAS self-affirmation (originally termed self-determination) was initially proposed in 1997 due to the backlog of petitions FDA was receiving from industry requesting substance reviews. The proposed rule allowed an entity to self-determine a GRAS substance, rather than requesting the determination by FDA. But the entity was to notify FDA of its evaluation, to which the agency could respond with further question or approval. However, when the final rule was published in 2016, it proposed, but did not require, that the entity notify FDA of the self-affirmation of a GRAS substance.
What Are the Requirements for Self-Affirming a GRAS Substance?
When the self-affirmation option is followed as mandated, the substance is to meet the same conditions as those which FDA reviews for approval. That is:
- The identity, chemical composition, and basis for safety determination of the substance must be publicly disclosed and scientifically recognized.
- The determination requires the same quantity and quality of scientific evidence as is required to obtain approval of a food additive, and be based on generally available and accepted scientific data, information, or methods, and the application of scientific principles.
- The substance is to be commonly considered by the scientific community as having reasonable certainty that it is not harmful under the conditions of its intended use.
- A GRAS determination applies only to specific uses of the substance; it does not provide for universal usage.
Controversy and Risk of Self-Affirmed GRAS
This lack of required notification and review has led to the “bad apples,” such as the company that submitted two GRAS notices on a substance, then simply withdrew the notices when FDA raised concerns. The company never responded to the concerns or submitted another notice, yet it continues to sell the ingredient into the US commercial market. Additionally, the analysis by which entities make their GRAS self-affirmations are sometimes not publicly disclosed, nor is the scientific evidence upon which the determination is based.
It is also important to note that there is some risk that goes along with self-affirmation. FDA could pursue enforcement actions if it disagrees with an entity’s GRAS affirmation, which would be of particular concern if products with the ingredient already went to market. There is, however, some question as to who bears the burden of proof – FDA or the entity. Additionally, an entity could be held liable by consumers should a self-affirmed GRAS substance cause harm.
Possible FDA GRAS Rule Changes Coming in 2026
GRAS reform has been set as one of the Human Foods Program (HFP) 2026 priority deliverables, with a proposed rule, requiring the submission to FDA of GRAS notices for all new substances claimed to be GRAS, currently under OIRA review with an HFP-slated 2026 publication date.
While neither a final rule nor compliance date is likely for 2026, there is no doubt that the GRAS rule is changing, at the very least to require that entities notify, and submit analysis to, FDA of the self-affirmation of a GRAS substance. With FDA initiating the original self-determination rule to take a load off its desks, it is unlikely that a new rule would resort to the pre-market petitioning of the agency to affirm the GRAS status of a substance, particularly with FDA still dealing with the significant cuts of 2025.
However, we have no doubt that a GRAS rule is in the works and will, in all likelihood, publish as a proposed rule this year. As such, we again advise the food industry to keep a close eye on the evolution of this regulatory issue, and to review your ingredients to determine any substances that were GRAS self-affirmed – by you or a supplier. Then, to be ready to make changes should one get the axe.
Summary: Self-affirmed GRAS determinations have long allowed entities to evaluate ingredient safety without mandated FDA notification. However, regulators’ growing scrutiny of transparency and oversight is pushing the industry toward reform likely to require entities to formally notify the FDA of GRAS self-determinations. As rulemaking discussions progress over the coming months, food manufacturers should review their ingredient portfolios now to prepare for possible regulatory changes.
