U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has instructed the Food and Drug Administration (FDA) to explore ending the “Generally Recognized as Safe” (GRAS) rule, which allows food companies to introduce new ingredients without formal FDA oversight.
The GRAS rule, established in 1972, permits manufacturers to self-certify ingredient safety without notifying the FDA. While the agency evaluates an average of 75 GRAS notices per year, participation is voluntary, and companies can introduce substances into the food supply without formal review. Critics argue this creates a regulatory loophole that undermines food safety.
Kennedy stated that eliminating GRAS would improve transparency and ensure ingredient safety. The move follows growing scrutiny of the rule, including a 2024 Harvard study labelling it a public health risk and a 2022 case where tara flour, approved under GRAS, was linked to liver injuries.
State and federal lawmakers have introduced legislation targeting GRAS and certain additives. California’s Food Safety Act (2023) banned four chemical additives, and a New York bill introduced in 2025 would require companies to disclose GRAS ingredients publicly. In 2024, the Toxic Free Food Act proposed an FDA overhaul of the GRAS process.
Before Kennedy’s tenure, FDA efforts to enhance food ingredient oversight were hindered by funding constraints. Former FDA Deputy Commissioner Jim Jones aimed to establish post-market chemical reviews but resigned in February 2025 after administration-led layoffs. Public health groups have warned that underfunding FDA food safety initiatives could weaken oversight and enforcement efforts.