The U.S. Food and Drug Administration (FDA) has unveiled a major proposal to tighten federal oversight of food additives, marking one of the most significant changes to food ingredient regulation in decades and signaling a broader effort by the Trump administration to increase transparency in the American food supply.
The proposed rule would require food manufacturers to notify the FDA whenever they determine that a substance added to food is “Generally Recognized as Safe” (GRAS), ending a long-standing practice that allowed companies to make those safety determinations internally without informing regulators. Media outlet reported that the FDA announced the proposal on Monday as part of a wider initiative aimed at strengthening consumer confidence and closing what officials described as a decades-old information gap. The agency said it will accept public comments for 120 days before moving toward a final rule.
Closing the GRAS loophole
The GRAS exemption was created under the 1958 Food Additives Amendment, which allows certain substances to bypass the formal food-additive approval process if they are widely accepted by qualified experts as safe for their intended use. Over time, companies have been able to self-affirm GRAS status and market ingredients without mandatory FDA review or public disclosure.
Acting FDA Commissioner Kyle Diamantas said the new proposal is intended to ensure that regulators are aware of substances entering the food supply and that consumers have greater access to information about those ingredients.
Under the proposed framework, manufacturers would need to submit:
- The identity of the ingredient;
- The intended use in food products;
- The scientific basis for concluding that the substance is safe; and
- Supporting evidence used in the company’s safety assessment.
The FDA would then add those submissions to a public inventory of GRAS notices, giving researchers, consumer groups, and state regulators greater visibility into ingredients used in processed and packaged foods.
Part of a broader “Make America Healthy Again” agenda
The food-additive proposal is closely tied to Health and Human Services Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” (MAHA) initiative, which has prioritized food safety, artificial ingredients, and the health effects of highly processed foods.
In a related announcement, the FDA said it has completed work on the federal government’s first official definition of “ultra-processed food” and submitted it to the White House for review. While the definition has not yet been released publicly, officials say it could eventually support new labeling standards, nutrition guidance, and future regulatory actions targeting heavily processed foods.
Kennedy has argued that ultra-processed foods make up a substantial share of the American diet and contribute to rising rates of obesity, diabetes, and other chronic diseases, particularly among children.
Additional food-safety measures
The FDA also announced that it plans to issue new guidance aimed at reducing biological hazards in fresh-cut produce, following recent outbreaks of foodborne illnesses linked to products such as lettuce and jalapeño peppers.
The guidance is expected to focus on:
- Improved sanitation practices;
- Environmental monitoring in processing facilities;
- Enhanced traceability systems; and
- Preventive controls designed to reduce contamination risks before products reach consumers.
Food safety experts say the produce initiative reflects growing concern about recurring outbreaks associated with minimally processed fresh foods.
Industry reaction
Consumer advocacy organizations broadly welcomed the proposal, arguing that the current GRAS system has allowed thousands of substances to enter the food supply with limited federal scrutiny.
The Center for Science in the Public Interest and other public-health groups have long called for mandatory FDA notification and stronger post-market review of food chemicals, citing concerns about potential conflicts of interest when companies fund their own safety evaluations.
However, food industry representatives contend that manufacturers already conduct rigorous scientific assessments before introducing new ingredients and warn that additional reporting requirements could increase regulatory costs and slow innovation in the food sector.
Some industry groups have also expressed concern that a formal federal definition of ultra-processed food could lead to stricter state regulations, warning labels, or restrictions on certain products.
Oversight questions remain
Although the proposal would make notification mandatory, legal experts note that it does not automatically require FDA approval before an ingredient can be marketed. Companies could still potentially introduce a substance while the agency reviews the submission, meaning Congress would likely need to act if lawmakers wanted to establish a pre-market approval requirement for all GRAS substances.
The FDA has indicated that the proposal is part of a broader modernization of its Human Foods Program, which was reorganized in 2024 to improve coordination across food safety, nutrition, and chemical oversight activities. Earlier FDA planning documents identified GRAS reform as a priority deliverable for 2026, suggesting that Monday’s announcement is the culmination of a longer regulatory effort.
Why the change matters
If finalized, the rule would represent the largest expansion of FDA visibility into food additives since the GRAS notification program was established. It would give federal regulators a more complete picture of substances being added to foods sold in the United States and could provide researchers with valuable data for evaluating long-term health effects.
The proposal also reflects a growing international trend toward greater transparency in food-ingredient regulation, as governments face increasing public pressure to scrutinize artificial additives, preservatives, and processing aids used in modern packaged foods.
For now, the FDA’s announcement begins what is expected to be a lengthy rulemaking process, with food manufacturers, consumer advocates, scientists, and lawmakers likely to debate how far federal oversight of food additives should go and whether the United States should move beyond industry self-certification toward a more comprehensive pre-market review system.
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