The FDA has proposed a new rule that would overhaul how food ingredients are deemed Generally Recognized as Safe (GRAS), eliminating the current system where companies can self-affirm safety status without federal review.
The agency has added this proposed rule to its spring 2026 agenda, requiring mandatory federal oversight of all GRAS determinations for both human and animal food substances, including ingredients and substances added indirectly (such as from food packaging).
Under the new rule, companies would have to notify the FDA whenever they want to use a substance they believe is safe. Food substances already listed or affirmed as GRAS by regulation, or those that have received a "no questions" letter on the FDA's GRAS notice inventory, would be exempt from this requirement.
The proposed rule would formalize the FDA's public-facing GRAS notice inventory and establish a clear process for determining when a substance does not qualify as GRAS.
AFIA advocates for GRAS pathways
The American Feed Industry Association (AFIA) released a statement noting the Make America Healthy Again (MAHA) Commission's latest report reaffirms the rigorous U.S. regulatory review processes and systems in place that, for decades, have proven the safety of America’s food and animal food supply to domestic and international customers.
“The American Feed Industry Association welcomes the MAHA Commission’s acknowledgement of the important role that American agricultural producers play in promoting nutritious diets," said AFIA president and CEO Constance Cullman. "Safe, quality feed contributes to healthy animals, which in turn provide the nutritious protein and dairy foods that are part of a balanced diet.
"As the Food and Drug Administration considers the recommendations outlined in the latest MAHA report, we caution against eliminating the safe and proven Generally Recognized as Safe ingredient review pathway because GRAS allows for the use of safe feed ingredients that promote proper animal nutrition and productivity," Cullman added.
The AFIA said it shares the MAHA Commission’s goals of improving human health and urges the continued inclusion of farmers, ranchers and food producers in a collaborative stakeholder process throughout all of the commission’s future work.
