Foods Program Guidance Under Development

(Expected to publish as drafts or finals by the end of December 2024.)

Introduction

The following list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA Foods Program is considering [1]. We currently intend to develop guidance on each topic; however, the FDA 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
Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry	Allergens
Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act; Guidance for FDA Staff and Stakeholders	Allergens
Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry	Critical Foods
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	Critical Foods
Preparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations); Draft Guidance for Industry	Food Additives
Premarket Consultation on Cultured Animal Cell Foods; Draft Guidance for Industry	Food Additives
Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff	Food Safety
Evaluation and Establishment of Safety of Low-Moisture Ready-to-Eat Foods Following Equipment Microbiological Contamination Event; Draft Guidance for Industry	Food Safety
Action Levels for Arsenic in Food Intended for Babies and Young Children; Draft Guidance for Industry	Food Safety
Action Levels for Cadmium in Food Intended for Babies and Young Children; Draft Guidance for Industry	Food Safety
Action Levels for Lead in Food Intended for Babies and Young Children; Guidance for Industry	Food Safety
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 9: Validation of Process Controls; Draft Guidance for Industry	FSMA
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 17: Classifying Food as Ready-To-Eat or Not Ready- to-Eat; Draft Guidance for Industry	FSMA
The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry	FSMA
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards	FSMA
Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry	Labeling
Use of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products; Draft Guidance for Industry	Labeling
Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry	Nutrition

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[1] Veterinary Medicine also has published a list of Guidances Under Development for 2024.