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.
