The U.S. Department of Health and Human Services announced a regulatory proposal on Monday designed to expand federal oversight of the food supply. The primary component of the initiative requires food manufacturers to notify the Food and Drug Administration when they determine that an ingredient meets the criteria for “Generally Recognized as Safe,” or GRAS status. Currently, companies are not obligated to inform the agency of such determinations, though a voluntary notification program exists.
Simultaneously, HHS and the U.S. Department of Agriculture submitted for final review the government’s first proposed definition of ultra-processed foods. This effort aligns with HHS Secretary Robert F. Kennedy Jr.’s broader public health agenda focused on improving the nation’s dietary patterns. Officials indicated that nearly 60 percent of the American diet consists of ultra-processed foods, and they cited childhood obesity statistics as a public health concern warranting systemic changes.
The proposals emerge amid ongoing foodborne illness investigations across multiple states this summer, including cyclospora and salmonella outbreaks. FDA officials stated that the initiatives aim to enhance the agency’s ability to monitor ingredients entering the food supply through greater transparency. However, the announcements do not directly target the specific factors that experts identified as contributing to recent food safety incidents.
Industry representatives have raised objections to the regulatory approach. The Consumer Brands Association, representing major food manufacturers, characterized a broad ultra-processed foods definition as fundamentally problematic, claiming it could encompass approximately 80 percent of the nation’s food supply. Trade groups representing dietary supplement and over-the-counter medicine manufacturers similarly expressed concerns about potential consequences of revising GRAS procedures.
The GRAS notification requirement will proceed through the federal rulemaking process, including a public comment period, before any mandate takes effect. Officials emphasized that the proposal would not establish a premarket approval system for GRAS substances, meaning manufacturers could still introduce products while the FDA gains enhanced visibility into ingredient decisions.
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