The U.S. Department of Health and Human Services (HHS) announced a proposed rule on August 10 that would require food manufacturers to notify the U.S. Food and Drug Administration (FDA) when determining that an ingredient qualifies as Generally Recognized as Safe (GRAS). The change shifts the decades-old GRAS process from a voluntary notification system to a mandatory one, aiming to increase transparency in the nation’s food supply.
The FDA would gain greater visibility into substances introduced into human and animal food, according to FDA Acting Commissioner Kyle Diamantas. The rule is part of a broader effort to modernize food safety oversight, alongside the federal government’s first proposed definition of ultra-processed foods, which was submitted for final review by HHS and the U.S. Department of Agriculture.
The proposals follow a series of foodborne illness outbreaks this summer, including a multistate cyclospora outbreak linked to shredded iceberg lettuce and ongoing investigations into salmonella and listeria cases. The FDA currently lists multiple active food safety probes.
Key details of the proposed rule
Under the current GRAS system, manufacturers self-certify ingredients as safe without notifying the FDA. The new rule would require mandatory notification for any person introducing a GRAS additive into the food supply. The FDA would then have the opportunity to review and object to these determinations.
FDA oversight expansion
Diamantas stated that the rule would enable the FDA to regulate the safety of the nation’s food supply more efficiently and knowledgeably. The proposal aligns with broader concerns about the long-term safety of heavily processed foods, which have been a focus of HHS Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” initiative.
Ultra-processed foods definition
In addition to the GRAS rule, HHS and the USDA submitted a first-ever federal definition of ultra-processed foods for final review. This move addresses growing concerns about the health impacts of highly processed foods, though the proposals do not directly address specific factors cited by experts as contributing to food safety issues.
The announcements mark a shift in federal food oversight, aiming to provide regulators with greater transparency into the substances used in food production. The rule is currently under review and has not yet taken effect.