The U.S. Food and Drug Administration’s (FDA's) Center for Food Safety and Applied Nutrition and Office of Food Policy and Response has announced a list of draft and final guidance topics that they will make a priority to complete within the next 12 months. 

FDA estimates it will publish many of these documents by January 2023. This updated list adds to the guidance agenda released in June 2021 and focuses on Level 1 draft and final guidances.

FDA is taking this action to provide continued transparency for stakeholders regarding foods program priorities. Guidance documents represent FDA’s current thinking on a specific topic, and the information can help stakeholders plan for potential changes that may impact their businesses and organizations. They do not impose legally enforceable requirements.

Although FDA's intent is to publish all draft and final guidance topics on the list, modifications may be needed to support emerging issues and FDA priorities. 

Public comments on the list of human food guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553.

FDA’s list of guidance topics is just one of several resources that the foods program routinely shares with stakeholders and partners to help inform them of agency priorities. Most proposed and final rules are tracked collectively and are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget. The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies government-wide. A list of those FDA regulations and guidance documents under Administration review is available on the Office of Management and Budget website. 

The food safety topics on the list include:

  • 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Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders 
  • Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Draft Guidance for Industry
  • Best Practices for Convening a GRAS Panel; Guidance for Industry    
  • Premarket Consultation on Cultured Animal Cell Foods; Draft Guidance for Industry  
  • Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry 
  • Action Levels for Lead in Juice; Draft Guidance for Industry   
  • Inorganic Arsenic in Apple Juice: Action Level; Guidance for Industry   
  • Action Levels for Lead in Food Intended for Babies and Young Children; Draft Guidance for Industry    
  • 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   
  • 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   
  • Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting; Guidance for Industry    
  • Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff   
  • Reconditioning of Fish and Fishery Products by Segregation; Guidance for Industry    
  • 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    
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry    
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry    
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: Validation of Process Controls; Draft Guidance for Industry    
  • 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
  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry    
  • Questions and Answers Regarding the Accredited Third-Party Certification Program; Draft Guidance for Industry (FSMA)
  • Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry (FSMA)
  • Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Guidance for Industry    
  • 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
  • Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry
  • Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry    
  • Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry.