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The Trump administration has moved to strengthen oversight of food additives by requiring manufacturers to notify the Food and Drug Administration whenever they determine that a substance qualifies as Generally Recognized as Safe, or GRAS. The proposed rule from the Department of Health and Human Services aims to close a gap in the regulatory system that has existed since Congress passed the Food Additives Amendment in 1958.
Under current rules, food manufacturers can unilaterally decide whether new additives meet GRAS standards and introduce them into the U.S. food supply without informing the FDA or the public. While companies remain responsible for maintaining evidence supporting their determinations, federal regulators often have no advance warning when substances enter the market, preventing them from conducting independent safety assessments.
The lack of transparency has allowed major food producers to introduce new substances without FDA review or notification. The tara flour case illustrates the risks of this approach: the additive entered the food supply without a GRAS notice submission, and only after hundreds of illnesses and hospitalizations did the FDA investigate and determine the substance did not meet safety standards.
The proposed rule would require the FDA to maintain a public registry of GRAS notices, enabling researchers, regulators, and consumers to track ingredients entering the marketplace. For substances already in distribution, the administration is proposing a streamlined compliance process to ensure public access to ingredient information.
Proponents argue the measure protects both consumer welfare and responsible manufacturers. Companies investing in transparency and safety standards should not compete at a disadvantage against competitors operating in regulatory gray areas, supporters contend. The change represents modernization of food system oversight without dictating consumer choices, according to the America First Policy Institute.
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