FDA moves to close 'GRAS loophole' with mandatory ingredient notifications

U.S. health regulators have proposed a significant change to how new food ingredients enter the market. The Food and Drug Administration (FDA) announced a plan on Monday that would require manufacturers to formally notify the agency before introducing new additives or ingredients into processed foods.

The proposal targets a long-standing policy that allows companies to self-certify that a new substance is "generally recognized as safe" (GRAS). Under the current system, firms are not obligated to share their safety evidence with the FDA, a practice critics say has allowed thousands of ingredients into the food supply without independent review.

Acting FDA Commissioner Kyle Diamantas said the change would close a "decades-old information gap," giving the agency the visibility it needs to assess postmarket safety. The rule would mandate that companies submit their safety findings, allowing the FDA to investigate potential risks. The agency would have 180 days to review submissions and could request more data or a delay in the ingredient's introduction if concerns arise.

The FDA will accept public comments on the proposal for 120 days. Diamantas noted that the rule would not require all new ingredients to undergo formal FDA review, a step that would require congressional action.

In a separate development, the FDA said it has completed a first-ever federal definition of "ultraprocessed food" and submitted it to the White House for review. Health advocates view an official definition as a key step toward studying and potentially regulating packaged foods linked to chronic diseases like obesity and diabetes.

Ultraprocessed foods typically contain industrial additives, colors, and preservatives not found in home kitchens, including items like sugary cereals, sodas, and frozen pizzas. Experts caution that broad definitions can sometimes include nutritious foods like whole-grain bread or yogurt, and some recent efforts have included carve-outs for items meeting nutrition standards.

Consumer groups have long argued that the GRAS exemption has created a "secret loophole" that undermines food safety. Industry officials maintain that their internal safety reviews are as rigorous as the FDA's own processes.