The U.S. Department of Health and Human Services (HHS) proposes to strengthen oversight of food ingredients
The U.S. Department of Health and Human Services (HHS) has proposed requiring manufacturers to notify the U.S. Food and Drug Administration (FDA) when they independently deem a food ingredient to be “generally recognized as safe” — GRAS. The initiative is intended to provide federal authorities with more information about ingredients entering the country’s food supply, according to CNBC.
Current U.S. law generally requires prior FDA approval for substances intentionally added to food products. However, such approval is not required for ingredients that fall under the GRAS exemption. A substance can obtain this status if qualified experts deem it safe for its intended use.
The FDA has had a voluntary reporting program for GRAS substances for years, but companies were not required to inform the agency of their decision to invoke this exemption. The proposed rule does not establish a pre-market approval system for such ingredients, but it is intended to increase the FDA’s awareness of ingredients entering the food supply.
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In addition, the HHS and the U.S. Department of Agriculture have submitted the first federal definition of ultra-processed foods for final review. The text of the definition has not yet been made public. In July 2025, the agencies jointly called on scientists, industry representatives, and other stakeholders to submit proposals regarding this definition.
The initiatives were announced amid several foodborne illness outbreaks in the U.S., including a multistate outbreak of cyclosporiasis linked to shredded iceberg lettuce. The FDA is also conducting several active investigations into outbreaks linked to Salmonella and Listeria.
Food industry representatives have expressed concern about the new definition of ultra-processed foods. The Consumer Brands Association, which represents PepsiCo, Nestlé, and Kraft Heinz, has criticized the definition, calling it too broad. The Consumer Healthcare Products Association has also cautioned about the potential implications of revising the GRAS rules for dietary supplements and over-the-counter drugs. The GRAS proposal will undergo public comment and federal rulemaking procedures before the new requirements can take effect.
