Trump Administration Proposes New Regulations for Food Additives

U.S. health officials on Monday announced a proposed rule change aimed at requiring food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods. This proposal seeks to address a long-standing regulatory loophole that critics argue has permitted a multitude of unvetted ingredients to enter the U.S. food supply.

Under the new rule from the Food and Drug Administration (FDA), companies would be mandated to document and submit their safety rationale for any new ingredients, granting regulators the chance to investigate potential risks. Currently, companies can independently determine if an ingredient or additive is “generally recognized as safe,” or GRAS, without needing to notify or submit evidence to the FDA, although some do.

“Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety,” acting FDA Commissioner Kyle Diamantas stated during a press briefing on Monday.

The FDA is set to accept comments on this proposal for 120 days. Susan Mayne, the former director of the FDA’s food program, remarked that the new requirement would provide the FDA with a clearer understanding of the vast array of ingredients present in the U.S. market, although it is expected that only a small fraction would undergo thorough review.

“This is a reasonable first step towards a more complete inventory, but most self-affirmed GRAS ingredients will still not be reviewed for safety by the FDA, with food ingredient safety continuing to be risk-based,” Mayne, who now serves as a public health expert at Yale University, noted.

In addition to the GRAS proposal, the FDA announced it has completed the first federal definition of ultraprocessed food, although specific details were not disclosed. Health advocates view an official definition as essential for increasing scrutiny on foods linked to chronic health issues in the U.S. A government-backed definition may facilitate further research and potentially lead to warning labels or other restrictions.

“These two actions will change how the federal government oversees what’s in our food and how we understand the foods that Americans eat,” Health Secretary Robert F. Kennedy Jr. emphasized at an event on Monday.

Ultraprocessed foods, which include items like sugary cereals, sodas, chips, and frozen pizzas, are made using industrial processing and additives not typically found in home kitchens. The FDA proposal regarding food additives is not expected to have an immediate impact on American diets, which are often high in fats, sugars, and sodium, contributing to chronic diseases such as obesity and diabetes. However, both initiatives are considered top priorities for Secretary Kennedy, who has committed to addressing issues surrounding artificial colors and additives.

In the U.S., about 10,000 additives are permitted in food, including thickeners and preservatives. Consumer advocates have long argued that many of these ingredients lack proper vetting due to the FDA’s existing policies that allow manufacturers to self-certify that additives are GRAS.

Diamantas clarified that the new policy would not necessitate that all new ingredients undergo FDA review, stating, “What we’re doing is requiring companies that utilize the pathway to notify us of their conclusions so that we have greater visibility.” The FDA anticipates reviewing new ingredient submissions within 180 days and may request further information if safety concerns arise.

Consumer advocates, however, argue that the FDA’s proposal should encompass more than just advance notice. “It must also include strong, science-based safety standards and thorough, independent FDA review before chemicals are allowed in our food,” urged Melanie Benesh of the Environmental Working Group.

Kennedy indicated that the administration would seek congressional support for additional FDA powers over food ingredients. “Congress needs to give FDA the additional tools it needs to keep pace with the changing food supply and protect the American people,” he stated.

The existing GRAS framework has faced criticism for creating a “secret GRAS loophole,” allowing many synthetic and natural additives to enter the food supply without independent review. Food industry representatives assert that their internal reviews are as rigorous as the FDA’s process.

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