/>i- On Monday, June 30, 2025, FDA’s Human Food Program published its proposed 2025 guidance agenda (FDA’s news release shown here). The agenda contains possible new topics for guidance documents or revisions to existing guidance documents.
- The entire list of new guidance topics under the 2025 agenda can be found here. The potential new topics include:
- 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- Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
- Action Levels for Cadmium in Food Intended for Babies and Young Children; Draft Guidance for Industry
- Importantly, guidance documents do not establish legally enforceable rights or responsibilities (see here). Rather, guidance documents represent FDA’s “current thinking” on a particular topic and serve merely as a resource for businesses and organizations. FDA’s good guidance practices outlined in 21 CFR 10.115 provide, among other things, that the agency will seek public comment on any guidance documents that address more than minor changes in interpretation or policy (Level 1 guidance).
FDA Publishes Proposed 2025 Human Foods Program Guidance Agenda
Thursday, July 3, 2025
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