Trump Administration Proposes FDA Food Additive Rule to Tighten GRAS Oversight
The Trump administration is proposing new federal scrutiny of food additives by requiring companies to notify the Food and Drug Administration when they conclude that a substance added to human or animal food is generally recognized as safe.
HHS announced Monday that the FDA proposal would make GRAS notifications mandatory and expand a public-facing inventory of submitted notices. The agency said the change would give regulators more visibility into substances entering the food supply while preserving a streamlined pathway for substances already on the market.
The practical consequence is transparency, not full premarket approval. Under the current system, companies can determine that an ingredient is GRAS without notifying FDA, though some companies voluntarily submit notices. FDA officials said mandatory review of all new ingredients would require Congress to change the agency’s legal authority.
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The proposal targets a long-running dispute over what consumer advocates call the GRAS loophole. AP reported that advocates blame the system for allowing thousands of unvetted ingredients into the U.S. food supply, while food industry officials argue their internal safety reviews are as rigorous as FDA’s own process.
Reaction showed the split. Vani Hari, a prominent social media voice on food additives, called the proposal a major step forward because it would increase transparency. Former FDA Commissioner David Kessler told STAT the proposal does not tackle the root causes of chronic disease, and Marion Nestle said companies would still be responsible for hiring experts to support their own safety conclusions.
HHS also said it submitted the federal government’s first proposed definition of ultra-processed foods for final review. That definition has not been released, leaving the next stage of the administration’s food policy fight unresolved.
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