U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. has directed the Food and Drug Administration (FDA) to eliminate the “self-affirmed” Generally Recognized as Safe (GRAS) provision, aiming to enhance transparency and oversight in the approval of food ingredients.
Under the current GRAS rule, companies can independently determine the safety of new food ingredients without mandatory FDA notification or public disclosure. This self-affirmation process has been criticized for allowing substances with potentially unknown safety data to enter the U.S. food supply without adequate oversight.
Kennedy’s initiative seeks to close this loophole by requiring companies to publicly notify the FDA and submit safety data for new ingredients. He stated that eliminating this pathway would ensure that ingredients introduced into foods are safe, thereby enhancing consumer confidence and contributing to public health.
Eliminating the “self-affirmed” GRAS rule could pose significant challenges for fermentation-based and future food startups, potentially delaying innovation and increasing financial burdens. Emerging companies, especially those developing novel proteins through precision fermentation and cell cultivation, typically rely on the current GRAS framework to streamline the regulatory process and bring new products quickly to market. Without this pathway, startups may face lengthy FDA review periods and higher costs associated with extensive safety testing and regulatory compliance.
It also might just result in massive delays in food product introduction for brands big and small. Like many of the departments within government currently being gutted by Trump and Elon’s DOGE purges, the FDA has seen drastic cutbacks in the number of employees, which as a result makes the higher level of oversight required by the elimination of the GRAS provision pretty untenable. Some commenters, like former FDA head of food (and recent Food Truths guest) Susan Mayne, see the the push towards greater food oversight and less overall manpower as challenging to reconcile.
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