Through an Order that the Secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. (RFK) called an act of “radical transparency,” the U.S. Food and Drug Administration (FDA) has been directed to explore rulemaking and guidance to end the commonly used pathway to establish the safety of a new food ingredient. With broad reliance on the regulatory pathway and reduced staffing at the FDA, the move could have sweeping consequences for the food industry and consumers.
RFK Jr. ordered the FDA to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and Related Guidance to eliminate the self-affirmed GRAS pathway. The Secretary called the self-affirmed GRAS pathway a “loophole,” and said the change “...will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.” The food industry, including makers of conventional and specialty foods, food ingredients, and potentially, adult beverages and dietary supplements rely on the self-affirming process to establish the safety of food ingredients generally recognized as safe, but the GRAS process is not available to new food additives, a new use of an existing food additive, color additives, and GMO (Genetically Modified Organism) foods not substantially equivalent to the non-GMO food.
Currently, the self-affirming GRAS process is one regulatory pathway for food additive approval that includes GRAS Notifications and Food Additive Petitions. To obtain GRAS status, a company must conduct a thorough safety assessment using qualified experts to determine whether the ingredient is generally recognized as safe by qualified experts under the conditions of its intended use, or through experience based on common use in food, requiring companies to demonstrate a substantial history of consumption for food use by a significant number of consumers. The self-affirming GRAS process requires the same standard of evidence and recordkeeping as GRAS Notifications, but submission to the FDA is voluntary.
The FDA does not approve GRAS Notifications, but issues a determination letter, or a “Good Day” letter to the notifying company of the agency’s objection or non-objection to the notification. Where the agency objects, the ingredient may not be lawfully used in food. Currently, the FDA has 180 days to respond to the notification and may extend by 90 days. According to the Order, “The FDA has completed and published more than 1,000 GRAS notices and evaluates an average of 75 notices per year.”
Acting FDA Commissioner Sara Brenner, M.D., M.P.H. said in response to the Order, “The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness.” With the recent staff firings and resignations in the FDA’s Human Foods Program and likely cuts to the FDA’s budget, the elimination of the self-affirming GRAS process could create a crush of notifications and a regulatory bottleneck that could have far-reaching impacts for the food industry.
This potential change comes at a time when the food industry faces increasing uncertainty arising from staffing cuts at the FDA and the U.S. Department of Agriculture (USDA), tariffs, and calls for major changes to U.S. food regulations. While food industry leaders have broadly supported the Secretary’s healthy food objectives, many have expressed concerns that the change could increase costs, stifle innovation, and lead to regulatory hurdles that may be addressed through enforcement of the current framework to ensure compliance.
