Foods Program Guidance Under Development
Expected to publish as drafts or finals by the end of June 2022
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-2021-N-0553.
| Title of Guidance | Category |
|---|---|
| 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Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders | Allergens |
| Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 5); Draft Guidance for Industry | Allergens |
| Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry | Dietary Supplements |
| Best Practices for Convening a GRAS Panel: Guidance for Industry | Food Additives |
| Action Levels for Lead in Juice; Draft Guidance for Industry | Food Safety |
| Inorganic Arsenic in Apple Juice: Action Level; Guidance for Industry | Food Safety |
| Lead action levels for categories of foods consumed by babies and young children: Draft Guidance for Industry | Food Safety |
| 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– Evidence Recommended for Release of Goods Subject to DWPE and Removal of a Foreign Manufacturer's Goods from DWPE; Draft Guidance for Industry | Food Safety |
| 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 | Food Safety |
| Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting; Guidance for Industry | Food Safety |
| Scombrotoxin (Histamine)-Forming Fish and Fishery Products--Decomposition and Histamine; Draft Guidance for FDA Staff | Food Safety |
| Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food: Draft Guidance for FDA Staff | Food Safety |
| 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 | FSMA |
| Hazard Analysis and Risk-Based Preventive Controls for Human Food; Appendix 1: Potential Hazards for Foods and Processes; Draft Guidance for Industry | FSMA |
| Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 11: Food Allergen Controls; Draft Guidance for Industry | FSMA |
| Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 16: 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 |
| Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 18: Acidified Foods; Draft Guidance for Industry | FSMA |
| 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 | FSMA |
| Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry | Labeling |
| Questions and Answers About Dietary Guidance Statements in Food Labeling; Draft Guidance for Industry | Labeling |
| 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 | Nutrition |
| Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Guidance for Industry | Nutrition |
[1] FDA’s Center for Veterinary Medicine also has published a list of Guidances Under Development for 2021.