Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced a proposed rule on Monday aimed at expanding federal oversight of food ingredients. The new regulation would mandate that food manufacturers notify the Food and Drug Administration (FDA) when they determine a substance qualifies as "generally recognized as safe" (GRAS) for use in food products. This move targets a decades-old system that has allowed companies to make such safety determinations independently without prior formal FDA approval or even mandatory notification.
"These two actions will change how the federal government oversees what’s in our food and how we understand the foods that Americans eat." — Robert F. Kennedy Jr., Health and Human Services Secretary
Under the existing framework, established in part by an FDA policy from 1997, manufacturers are not compelled to inform the agency about their self-determined GRAS substances, although some voluntarily do so. This practice has drawn criticism from consumer advocates who argue it creates a regulatory loophole, allowing ingredients into the food supply without direct federal review. The Center for Science in the Public Interest, for example, has characterized the practice as a significant gap in oversight.
Acting FDA Commissioner Kyle Diamantas addressed this concern, stating on Monday, "Shifting to a mandatory notification system closes a decades-old information gap." He emphasized that the proposed rule would provide regulators with enhanced visibility into the vast array of ingredients entering the nation's food supply.
The GRAS exemption itself dates back to 1958, when Congress established an exception for substances with a long history of safe use, such as common ingredients like vinegar and various spices, from the rigorous pre-market approval process required for new food additives. However, the interpretation and implementation of this exemption have evolved, leading to the current system of company self-determination based on scientific evidence and expert consensus.
The proposal outlines a structured process for manufacturers. Companies would be required to submit detailed information supporting their GRAS safety determinations to the FDA. Upon submission, the FDA would have a 45-day window to assess whether the submission contains all the necessary information. Following this, the agency would have up to 180 days to conduct a more substantive review of the submitted data. It is important to note, however, that under this proposed rule, manufacturers would not be required to await explicit FDA approval before introducing products containing these GRAS substances to the market. Federal officials clarified that mandating formal FDA approval for every GRAS determination before market entry would necessitate additional legislative authority from Congress. Secretary Kennedy has publicly called upon Congress to provide the FDA with such expanded tools to enhance its oversight capabilities for food ingredients.
This proposed rule is a component of Secretary Kennedy’s broader "Make America Healthy Again" (MAHA) agenda, which has prioritized issues related to artificial colors, additives, and highly processed foods in the American diet. In a related development announced on the same day, the FDA confirmed it has completed its work on a federal definition for "ultraprocessed food." While the specific language of this definition has not yet been released to the public, officials confirmed it has been submitted to the White House for further review. Secretary Kennedy underscored the significance of both initiatives at an HHS event, stating, "These two actions will change how the federal government oversees what’s in our food and how we understand the foods that Americans eat."
Consumer advocacy groups have largely welcomed the introduction of a mandatory notification requirement, viewing it as a step towards greater transparency. However, some argue that the proposal does not go far enough to ensure comprehensive food safety. Melanie Benesh of the Environmental Working Group called for the implementation of stronger safety standards and a requirement for independent FDA review *before* chemicals are permitted in food products. Similarly, Thomas Gremillion of the Consumer Federation of America raised concerns about the FDA's existing resources and staffing levels, questioning whether the agency possesses adequate capacity to thoroughly review the increased volume of information it would receive under the new notification system, according to NOTUS.
The proposed rule will now enter a 120-day period for public comment, allowing stakeholders and the public to provide feedback to the agency. The ultimate scope of the FDA's authority regarding GRAS substances, particularly any move towards pre-market approval, remains contingent on potential future action by Congress.
