The US Food and Drug Administration (FDA) announced a proposed rule on Monday, August 10th, 2026, that would require food manufacturers to submit notifications for all ingredients introduced to the market under the Generally Recognized As Safe (GRAS) pathway. This move aims to close a regulatory loophole that has allowed companies to use ingredients deemed safe either through scientific research or common use without mandatory FDA notification.

The GRAS framework, established in 1958 as an exemption, has become the primary method for new substances entering the US food supply, surpassing the food additive petition pathway, according to Kyle Diamantas, acting commissioner of the FDA. He stated that if finalized, the rule would transition the GRAS framework from a voluntary program to a mandatory notification system.

However, it remains unclear whether the FDA has the regulatory authority to enforce this mandatory notification. Sanchez noted, “It really is the question on everyone’s mind,” referencing a 2021 federal judge’s ruling that authorized only a voluntary system, with a mandatory system representing a different legal challenge.

The proposal notably omits a definition of “ultra-processed foods,” a key promise made earlier this year by Robert F. Kennedy Jr., secretary of the US Department of Health and Human Services (HHS), who had pledged a definition by April. Diamantas acknowledged in April that defining ultra-processed foods is complex. He also revealed that the HHS and the US Department of Agriculture have submitted a proposed definition intended to strengthen federal nutrition research but said additional information would be shared later.

Marion Nestle, professor emerita at New York University, questioned the delay and scope of the reforms, asking why closing the loophole took so long and where the promised definition of ultra-processed foods was.

The proposed rule was submitted to the Federal Register on August 10th, 2026, amid ongoing concerns about food safety and regulatory reform.

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