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  1. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

Foods Program Guidance Under Development

(Expected to publish as drafts or finals by the end of December 2025.)

Introduction

The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA’s Human Foods Program is considering.1 We currently intend to develop guidance on each topic; however, the FDA’s Human Foods Program is neither bound by this list of topics, nor required to issue every guidance document on this list. Several factors may impact FDA’s ability to issue the listed guidances, including, for example, new Administration priorities, emerging public health issues, or other extenuating circumstances. We are not precluded from issuing guidance documents on topics not on this list.

You may submit comments on the guidance topics at www.regulations.gov at Docket FDA-2022-D-2088.

Title of Guidance

Category

New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI: Guidance for IndustryDietary Supplements
Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for IndustryFood Additive
Action Levels for Cadmium in Food Intended for Babies and Young Children; Draft Guidance for IndustryFood Safety
Action Levels for Inorganic Arsenic in Food Intended for Babies and Young Children; Draft Guidance for IndustryFood Safety
Action Level for Opiate Alkaloids on Poppy Seeds: Draft Guidance for IndustryFood Safety
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical HazardsFSMA 
The Food Traceability Rule: Questions and Answers; Draft Guidance for IndustryFSMA

[1] Veterinary Medicine also has published a list of Guidances Under Development for 2025.

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