Robert F. Kennedy Jr., serving as U.S. Secretary of Health and Human Services, has launched a significant initiative to reform the FDA’s Generally Recognized as Safe (GRAS) process. This regulatory loophole permits food companies to independently certify additives as safe without FDA scrutiny, a practice RFK Jr. seeks to end. Since 2000, nearly 99% of new food chemicals have bypassed FDA review, relying instead on industry self-approval, prompting concerns over consumer safety.
The GRAS designation, introduced in 1958, initially allowed widely accepted food substances to be classified as safe. A pivotal change occurred in 1997 when the FDA made GRAS notifications voluntary, enabling companies to introduce new ingredients without agency oversight. This has resulted in controversial additives, such as brominated vegetable oil (BVO) and red dye No. 3, remaining in use despite evidence of harm. BVO faced a ban in 2024, while red dye No. 3, linked to cancer risks, was prohibited in 2025.
In March 2025, RFK Jr. instructed the FDA to investigate eliminating the self-affirmed GRAS pathway. His directive mandates that companies submit safety data and notify the FDA before adding new ingredients, aiming to bolster transparency. He has engaged with executives from major firms like PepsiCo and General Mills, urging the phase-out of artificial dyes and other questionable additives. Furthermore, RFK Jr. intends to collaborate with Congress to draft legislation that would permanently close the loophole.
This push has ignited a broader debate. The food industry defends the current GRAS system, asserting it accelerates innovation and meets market demands efficiently. Public health advocates, however, endorse stricter controls, arguing that untested additives pose unacceptable risks to consumers.
Should RFK Jr.’s reforms succeed, the impact could be profound, enhancing food safety standards and supporting his “Make America Healthy Again” vision to combat chronic illness. Yet, opposition from the food sector highlights a persistent divide between industry priorities and public health goals. This initiative marks a critical step toward redefining how food safety is regulated in the United States.
