FDA Proposes Mandatory GRAS Notification Requirements for Food Substances
The U.S. Food and Drug Administration (FDA) has initiated a 120-day consultation period on a proposed rule that would mandate the submission of Generally Recognized As Safe (GRAS) notices for substances used in human and animal food. This proposal aims to replace the current voluntary GRAS notification program with a mandatory system, requiring any entity introducing a substance into interstate commerce under the GRAS provision of the FD&C Act to notify the FDA. The goal is to enhance transparency and ensure that GRAS conclusions are supported by adequate scientific evidence and documentation. Key proposed changes include specifying circumstances where a GRAS notice is not required, identifying ineligible uses for GRAS notice submission, and updating regulations to reflect the transition to a mandatory program. The FDA also plans to revise the threshold of regulation (TOR) exemption framework to incorporate current scientific approaches and expand its scope. 
