FDA Extends Comment Period for Food Chemical Assessment Proposal

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FDA Extends Comment Deadline for Proposed Post-Market Assessment Approach

Saturday, November 23, 2024

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The U.S. Food and Drug Administration (FDA) is extending the comment period for its proposed systematic process for post-market assessment of chemicals in foods. FDA will give stakeholders until January 21, 2025 to submit comments, which is an additional 31 business days from the previous December 6, 2024 deadline.
As we previously reported, FDA’s proposed approach includes three stages: food chemical signal monitoring, a quality and impact assessment, and a focused and/or comprehensive assessment. FDA’s proposal seeks to proactively initiate post-market assessments of GRAS ingredients, food additives, color additives, food contact substances, and contaminants under its new Human Foods Program. FDA’s updated approach comes as multiple states propose legislation targeting additives and ingredients of public concern, such as “generally recognized as safe” (GRAS) substances, synthetic food dyes, and other chemicals.
FDA specifically requests input on public engagement, review frequency and mechanisms, the potential integration of an advisory committee review, the appropriateness of the Fit-for-Purpose Decision Tree, the appropriateness of the Prioritization of Risks scheme, and the appropriateness of the two-pronged Focused and Comprehensive approaches.