Federal Register #FDA2025N3262

FDA Proposed Rule for Mandatory GRAS Notification Program

This opportunity involves a proposed rulemaking by the Food and Drug Administration (FDA) regarding food safety regulations. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are specified, as this is not a procurement action. - Products/Services Requested: - No products or services are being procured. - The notice seeks public comment on a proposed regulatory requirement for mandatory submission of GRAS (Generally Recognized as Safe) notices for substances used in human or animal food. - Unique/Notable Requirements: - Mandatory electronic submission of GRAS notices and supporting documentation - Applies to both human and animal food substances - Aims to enhance transparency and scientific rigor in food safety determinations - No purchase quantities, part numbers, or product/service requests are included, as this is a regulatory proposal, not a solicitation.

Description

The Food and Drug Administration (FDA) is proposing a rule to require the submission of GRAS (Generally Recognized as Safe) notices for substances used in human or animal food under the Federal Food, Drug, and Cosmetic Act. This mandatory notification program aims to enhance transparency and safety by ensuring that GRAS conclusions have a scientific basis and appropriate documentation. The rule would help FDA oversee the safety of the U.S. food supply more effectively and respond to evolving food innovation and consumer demands. Comments on the proposed rule must be submitted by December 9, 2026.

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