Key Takeaways:
- The FDA Human Foods Program (HFP) released its agenda for releasing draft guidance for the remainder of 2025.
- The agenda includes new guidance on topics such as new dietary ingredient notifications, food colors derived from natural sources, and action levels for cadmium and inorganic arsenic in food for babies and young children.
On June 30, 2025, the U.S. Food and Drug Administration (FDA) published its proposed Human Foods Program (HFP) guidance agenda for 2025. The agenda identifies new topics under consideration for future guidance and potential revisions to existing guidance documents. Of particular note, the agenda includes forthcoming draft guidance documents addressing action levels for cadmium and inorganic arsenic in food intended for babies and young children.
The complete list of potential new guidance topics includes:
- New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI: Guidance for Industry
- Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
- Action Levels for Cadmium in Food Intended for Babies and Young Children; Draft Guidance for Industry
- Action Levels for Inorganic Arsenic in Food Intended for Babies and Young Children; Draft Guidance for Industry
- Action Level for Opiate Alkaloids on Poppy Seeds: Draft Guidance for Industry
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards
- The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry
The HFP was established in 2023 as part of the FDA's reorganization to streamline oversight and strengthen public health protections. The program consolidated the Office of Food Policy and Response with field operations from the Office of Regulatory Affairs.
As detailed in the notice, the HFP plans to develop a draft or final guidance on each of the listed topics by the end of December 2025. However, the HFP is not bound by this list of topics or required to issue all proposed guidance documents.
FDA guidance documents reflect the agency's current thinking on specific topics and are intended to provide information to help stakeholders anticipate and prepare for potential regulatory changes.
Summer Associate Annalise Hinkle contributed to this article.
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