Trump administration proposes rule to tighten how new chemical ingredients enter food under FDA’s GRAS pathway

The Trump administration on Monday proposed a Food and Drug Administration rule intended to close what it describes as a loophole in the agency’s “generally recognized as safe” (GRAS) pathway, which the proposal would tighten for certain new chemical ingredients used in the food supply. Under GRAS, companies can conclude an ingredient is safe and market it without submitting a premarket notice to FDA, effectively allowing the addition of some ingredients without prior agency review, according to the reporting.

Reporting on the proposal said the rule is aimed at the specific practice of introducing new chemical ingredients and doing so without informing FDA. The administration’s stated goal is to reduce reliance on self-certification for particular ingredient types by creating a more direct point of oversight for FDA before such chemicals reach consumers.

Health and Human Services Secretary Robert F. Kennedy Jr. is described as seeking to “close” the alleged gap that permits new chemical ingredients to be used without the agency being notified first. The proposal would therefore shift some responsibility from company declarations toward earlier FDA awareness and review, while still operating within the GRAS framework, the reporting indicated.

The GRAS pathway has long been central to how the U.S. food industry brings ingredients to market, especially when companies argue that the ingredient is widely recognized among qualified experts as safe under the conditions of intended use. The administration’s proposal centers on the contention that some new chemical ingredients can be brought in through GRAS in ways that do not provide FDA sufficient visibility.

The proposal also raises questions about regulatory enforcement and the allocation of review resources, because FDA would gain earlier knowledge about which chemical ingredients companies are planning to introduce. That could affect how quickly the agency can respond to safety concerns and how companies document their safety assessments, given that the current GRAS approach can allow ingredients to be used while the agency learns about them through different channels.

The rule’s next steps would follow the standard federal rulemaking process, which typically includes the publication of the proposed text in the Federal Register and a period for public comment before any final action. Until FDA finalizes the proposal, companies would continue to rely on existing GRAS practices, subject to whatever transitional approach the agency ultimately sets out.

Opponents of changes to GRAS procedures have previously argued that tightening the pathway could raise compliance burdens and slow product innovation, while supporters have said FDA should be informed earlier so it can evaluate emerging safety issues. The administration’s proposal, as described in the reporting, would be the centerpiece of that dispute as the rule enters the comment period.