The U.S. Department of Health and Human Services announced regulatory proposals on Monday intended to increase federal oversight of food ingredients and the broader food supply. The primary initiative would mandate that manufacturers including major companies like PepsiCo and Nestle inform the FDA when they determine an ingredient qualifies as “Generally Recognized as Safe,” or GRAS. Currently, manufacturers may make such determinations independently without notifying the agency, though a voluntary notification program exists. FDA Acting Commissioner Kyle Diamantas stated the agency is systematically examining ingredients, particularly those viewed as problematic by consumers and foreign governments.
The HHS and the U.S. Department of Agriculture simultaneously submitted for final review the federal government’s first proposed definition of ultra-processed foods, responding to longstanding concerns about the safety implications of heavily processed products. HHS Secretary Robert F. Kennedy Jr., who leads the administration’s “Make America Healthy Again” initiative, emphasized that ultra-processed foods constitute nearly 60 percent of the American diet and are linked to childhood obesity affecting more than one in five American children. However, the administration has not disclosed what specific definition it proposes for these products.
The regulatory moves come as federal and state health officials manage multiple foodborne illness outbreaks, including a multistate cyclospora outbreak associated with shredded iceberg lettuce alongside investigations involving salmonella and listeria. The FDA maintains several active probes into these incidents. Industry representatives expressed reservations about the proposals, with the Consumer Brands Association warning that an overly broad ultra-processed foods definition could capture 80 percent of the nation’s food supply. The Consumer Healthcare Products Association cautioned against revising the GRAS system, arguing that transparency improvements need not require fundamental changes to the existing scientific and risk-based oversight framework. The GRAS notification requirement must proceed through the federal rulemaking process and public comment period before implementation.
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