The U.S. Department of Health and Human Services unveiled a regulatory proposal on Monday designed to expand federal oversight of food ingredients and the broader food supply. The centerpiece of the initiative involves requiring manufacturers to inform the Food and Drug Administration when they determine that an ingredient qualifies as “Generally Recognized as Safe,” or GRAS. Acting FDA Commissioner Kyle Diamantas stated that the agency is conducting a systematic review of ingredients, particularly those viewed with concern by consumers and other nations.
Concurrently, HHS and the U.S. Department of Agriculture submitted a proposed federal definition of ultra-processed foods for final review. This move aligns with the “Make America Healthy Again” initiative led by HHS Secretary Robert F. Kennedy Jr., which has emphasized concerns about the long-term health effects of heavily processed food consumption. The announcements coincide with ongoing federal and state efforts to address multiple foodborne illness outbreaks occurring throughout the summer, though officials noted the proposals target broader ingredient safety rather than the specific issues linked to recent outbreaks.
Under current law, food ingredients typically require FDA approval before entering commerce unless they meet specific exemptions, including GRAS status. While the FDA has operated a voluntary notification program for GRAS ingredients for years, manufacturers have not been obligated to inform the agency of their own safety determinations. The proposed rule would mandate such notification, providing regulators with greater transparency into the ingredients entering the food supply without establishing a mandatory premarket approval process.
Industry representatives have expressed concerns about the initiatives. The Consumer Brands Association, representing major manufacturers, criticized the potential ultra-processed foods definition as overly broad, warning that such criteria could capture approximately 80 percent of the nation’s food supply. The Consumer Healthcare Products Association raised concerns about the potential impact on dietary supplements and over-the-counter medications.
The GRAS notification proposal will proceed through public comment and the standard federal rulemaking process before taking effect. HHS previously sought stakeholder input in July 2025 regarding how ultra-processed foods should be defined, though the specific language of the submitted definition remains undisclosed.
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