The U.S. Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released an updated list of priority draft and final guidance documents related to foods and dietary supplements that the agency intends to publish in the next year.
The FDA had previously released in June 2021 a list of draft and final guidance documents it intended to publish over the next year and noted that it would release an update to the list every six months.1 The updated list2 released this week includes six new proposed guidance documents.
Newly-Announced Guidance Documents
The following proposed guidance documents have been added to the FDA’s list. The new items include draft and final guidance documents related to pre-market activities for cell-cultured products, foods derived via gene editing, labelling of plant-based foods (in addition to the previously-announced forthcoming guidance on plant-based milks), and notifications for new dietary ingredients.
- Food Additives
- Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
- Food Safety
- Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
- Reconditioning of Fish and Fishery Products by Segregation; Guidance for Industry
- Labeling
- Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
- Dietary Supplements
- New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry
Complete List of Planned Guidance Documents to Be Published by January 2023
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Title of Guidance
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Category
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Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders
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Allergens
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Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Draft Guidance for Industry
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Allergens
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Testing Methods for Asbestos in Cosmetic Products Containing Talc; Draft Guidance for Industry
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Cosmetics
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Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry
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Dietary Supplements
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New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry
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Dietary Supplements
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Best Practices for Convening a GRAS Panel; Guidance for Industry
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Food Additives
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Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry
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Food Additives
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Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry
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Food Safety
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Action Levels for Lead in Juice; Draft Guidance for Industry
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Food Safety
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Inorganic Arsenic in Apple Juice: Action Level; Guidance for Industry
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Food Safety
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Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry
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Food Safety
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Detention Without Physical Examination (DWPE) of Fish and Fishery Products Due to the Appearance of Adulteration by Bacterial Pathogens, Unlawful Animal Drugs, Scombrotoxin (Histamine), or Decomposition – Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer's Goods from DWPE; Draft Guidance for Industry
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Food Safety
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Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule; Guidance for Industry
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Food Safety
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Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting; Guidance for Industry
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Food Safety
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Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff
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Food Safety
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Reconditioning of Fish and Fishery Products by Segregation; Guidance for Industry
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Food Safety
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Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and/or Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry
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FSMA
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Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry
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FSMA
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Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry
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FSMA
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Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry
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FSMA
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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
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FSMA
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Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry
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FSMA
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Questions and Answers Regarding the Accredited Third-Party Certification Program: Draft Guidance for Industry
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FSMA
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Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry
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FSMA
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Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Guidance for Industry
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FSMA
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Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations: Guidance for Industry
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FSMA
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Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry
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Labeling
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Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry
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Labeling
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Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry
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Labeling
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Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein; Draft Guidance for Industry
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Nutrition
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Next steps
The planned guidance initiatives could have a significant impact on the food industry, and the ambitious agenda signals a busy year ahead at the FDA. We will continue to monitor the FDA’s issuance of guidance documents affecting the food and dietary supplement industries.
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