The U.S. Department of Health and Human Services (HHS) has directed the FDA to explore eliminating a process allowing companies to self-declare food ingredients as safe without federal review. HHS Secretary Robert F. Kennedy Jr. announced plans to revise the FDA’s GRAS (Generally Recognized as Safe) regulations, requiring manufacturers to publicly submit safety data and seek FDA approval before adding new ingredients to foods.
Currently, companies can bypass FDA oversight by self-affirming ingredient safety, a loophole critics say has let untested substances enter the food supply. Under proposed changes, all new ingredients would need prior FDA notification and review. Over 1,000 GRAS notices have been reviewed publicly since the program began, but the shift aims to ensure stricter scrutiny and transparency for consumers.
FDA Acting Commissioner Sara Brenner emphasized the agency’s commitment to safeguarding food safety through rigorous evaluations. HHS also plans to collaborate with Congress on legislation to permanently close the loophole, aligning efforts to “Make America Healthy Again.”
Source: https://www.hhs.gov/about/news/2025/03/10/hhs-secretary-kennedy-directs-fda-explore-rulemaking-eliminate-pathway-companies-self-affirm-food-ingredients-safe.html