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 In this section:

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

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

                        Foods Program Guidance Under Development
          Foods Program Regulations Under Development


                        Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information
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          Seafood Guidance Documents & Regulatory Information Home
          Food
          Guidance & Regulation (Food and Dietary Supplements)
          Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
          Foods Program Guidance Under DevelopmentGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements) Foods Program Guidance Under Development
  
  	
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    Print*(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
			CategoryQuestions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5): Guidance for Industry
			AllergensEvaluating 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
			AllergensNotifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry
			Critical FoodsProtein 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 FoodsNew Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes: Guidance for Industry
			Dietary SupplementsNew Dietary Ingredient Notification Master Files for Dietary Supplements; Draft Guidance for Industry
			Dietary SupplementsPreparation of Premarket Submission for Food Contact Substances (Chemistry Recommendations); Draft Guidance for Industry
			Food AdditivesPremarket Consultation on Cultured Animal Cell Foods; Draft Guidance for Industry
			Food AdditivesFoods Derived from Plants Produced Using Genome Editing; Guidance for Industry
			Food AdditivesCompliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff
			Food SafetyEvaluation and Establishment of Safety of Low-Moisture Ready-to-Eat Foods Following Equipment Microbiological Contamination Event; Draft Guidance for Industry
			Food SafetyRecommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE: Guidance for Industry
			Food SafetyAction Levels for Arsenic in Food Intended for Babies and Young Children; Draft Guidance for Industry
			Food SafetyAction Levels for Cadmium in Food Intended for Babies and Young Children; Draft Guidance for Industry
			Food SafetyAction Levels for Lead in Food Intended for Babies and Young Children; Guidance for Industry
			Food SafetyHazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
			FSMAHazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 9: Validation of Process Controls; Draft Guidance for Industry
			FSMAHazard 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
			FSMAThe Food Traceability Rule: Questions and Answers; Draft Guidance for Industry
			FSMAHazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards; Draft Guidance for Industry
			FSMALabeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
			LabelingUse of Nutrient Content Claims for Added Sugars in the Labeling of Human Food Products; Draft Guidance for Industry
			LabelingVoluntary 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

[1] Veterinary Medicine also has published a list of Guidances Under Development for 2023.

                                                                                  Content current as of:
      01/25/2024
              
              
Regulated Product(s)
		 Food & BeveragesGuidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)

          
                        Foods Program Guidance Under Development
          Foods Program Regulations Under Development


                        Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information
          Biotechnology Guidance Documents & Regulatory Information
          Bottled Water/Carbonated Soft Drinks Guidance Documents & Regulatory Information
          Chemical, Metals, Natural Toxins & Pesticides Guidance Documents & Regulations
          Dietary Supplements Guidance Documents & Regulatory Information
          Egg Guidance, Regulation, and Other Information
          Food Allergens/Gluten-Free Guidance Documents & Regulatory Information
          Food Defense Guidance Documents & Regulatory Information
          Imports & Exports Guidance Documents & Regulatory Information
          Infant Formula Guidance Documents & Regulatory Information
          Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information
          Juice Guidance Documents & Regulatory Information
          Labeling & Nutrition Guidance Documents & Regulatory Information
          Meat Guidance Documents & Regulatory Information
          Medical Foods Guidance Documents & Regulatory Information
          Milk Guidance Documents & Regulatory Information
          Produce & Plant Products Guidance Documents & Regulatory Information
          Reportable Food Registry Guidance Documents & Regulatory Information
          Retail Food Protection Guidance Documents & Regulatory Information
          Salmonella Guidance Documents & Regulatory Information
          Sanitation & Transportation Guidance Documents & Regulatory Information
          Seafood Guidance Documents & Regulatory Information
 
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