The U.S. Department of Health and Human Services (HHS) announced proposed changes to the Food and Drug Administration's (FDA) oversight of Generally Recognized as Safe (GRAS) substances, as well as a definition for ultra-processed foods. The FDA aims to hold food manufacturers accountable by requiring them to notify the agency when they determine that a substance added to human or animal food is GRAS. This proposed rule is part of the Make America Healthy Again (MAHA) agenda initiated by President Donald J. Trump.
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Under the new proposal, food manufacturers would be required to submit GRAS notifications, thereby improving consumer visibility of food ingredients. Currently, since the GRAS exemption was established in 1958, manufacturers can independently decide what substances constitute GRAS. The FDA's proposed rule would make GRAS reporting mandatory for all substances added to food, while allowing manufacturers to report substances already on the market that they consider GRAS within a specified time frame.
Kyle Diamantas, acting FDA commissioner, emphasized the need for transparent and science-based oversight, stating that the actions taken will provide the FDA with greater visibility into substances entering the food supply.
In collaboration with the USDA, HHS has also put forward a standardized definition of ultra-processed foods, as a response to findings from the Centers for Disease Control and Prevention (CDC). In 2025, the CDC reported that approximately 62% of the daily caloric intake of children and teens and 53% of adults came from ultra-processed foods. HHS notes research that links high consumption of these foods to chronic diseases like type 2 diabetes and heart disease. The lack of a standardized definition has complicated consistent research across federal entities.
The proposed definition was developed through feedback from various stakeholders, including industry representatives, researchers, and consumer organizations. Diamantas highlighted the significance of this definition for enhancing nutrition research.
According to Robert F. Kennedy Jr., HHS secretary, nearly 60% of the American diet consists of ultra-processed foods, with childhood obesity affecting more than one in five American children. These initiatives aim to increase transparency and contribute to the overall transformation of the U.S. food system.