Federal Register #FDA-2025-N-3262

FDA Proposed Rule: Mandatory GRAS Notice Submission for Food Substances

This opportunity involves a proposed rulemaking by the Food and Drug Administration (FDA) under the Department of Health and Human Services: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or commercial vendors are mentioned, as this is not a procurement action - No products or services are being requested for purchase - Key requirements and details: - The FDA proposes to require mandatory submission of Generally Recognized as Safe (GRAS) notices for substances used in human or animal food - Any person introducing a food substance under the GRAS provision must submit a notification to FDA - Submissions must include scientific documentation supporting the safety of the substance for its intended use - Notices must be submitted electronically - The rule aims to improve transparency, address gaps in the current voluntary GRAS notification program, and strengthen public confidence in FDA oversight - The proposal responds to recommendations for increased regulatory oversight and transparency in food safety - No contract value, product line items, or service line items are associated with this notice, as it is a regulatory action, not a procurement

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 FDA's oversight of food additive safety by ensuring that GRAS conclusions have a scientific basis and appropriate documentation. The proposal addresses issues with the current voluntary GRAS notification program and seeks to improve transparency and public confidence in food safety regulation. Comments on the proposed rule are due by December 9, 2026.

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