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  5. Foods Program Guidance Under Development
  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 2026.)

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. 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.

Guidance for Industry

Food Chemical Safety, Dietary Supplements, and Innovation

Title of Guidance

Action Levels for Cadmium in Food Intended for Babies and Young Children; Draft 
Guidance for Industry
Action Levels for Inorganic Arsenic in Food Intended for Babies and Young Children; Draft Guidance for Industry
Action Level for Opiate Alkaloids on Poppy Seeds; Draft Guidance for Industry
Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry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Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards; Draft Guidance for Industry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

Microbiological Food Safety

Title of Guidance

Evaluation and Establishment of Safety of Low-Moisture Ready-to-Eat Foods Following Equipment Microbiological Contamination Event; Guidance for Industry
Guide to Minimize Food Safety Hazards of Fresh-cut Produce; Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 10: Sanitation Program; Draft Guidance for Industry
The Accredited Third-Party Certification Program: Questions and Answers; Guidance for Industry
The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry

Nutrition

Title of Guidance

Compliance Policy Guide for Determining the Identity, Quality, and Purity of Olive Oil and Olive-Pomace Oil Products; Draft Guidance for FDA Staff
Food Labeling for Online Grocery Shopping Platforms; Draft Guidance for Industry
Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Guidance for Industry

 

 

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