The FDA’s Center for Food Safety and Applied Nutrition and Office of Food Policy and Response has released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.
The agency anticipates it will publish many of these documents by January 2023. The list is an update on the guidance agenda released in June 2021 and focuses on the Level 1 draft and final guidances.
Level 1 guidances set forth the agency’s initial interpretations of new significant regulatory requirements; describe substantial changes in FDA’s earlier interpretation or policy, and deal with complex scientific or highly controversial issues.
The FDA is taking this action to provide continued transparency for stakeholders regarding foods program priorities. Guidance documents represent the 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 the FDA’s intent is to publish all draft and final guidance topics on the list, modifications in plans may be needed to support emerging issues and Administration priorities.
Public comments on the list of human food and cosmetic 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.
The 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.
Here’s what’s on the list:
| 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Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders | Allergens |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 |
| Testing Methods for Asbestos in Cosmetic Products Containing Talc; Draft Guidance for Industry | Cosmetics |
| Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry | Dietary Supplements |
| New Dietary Ingredient (NDI) Notifications and Related Issues: NDI Notification Procedures and Timeframes; Guidance for Industry | Dietary Supplements |
| Best Practices for Convening a GRAS Panel; Guidance for Industry | Food Additives |
| Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry | Food Additives |
| Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry | Food Safety |
| Action Levels for Lead in Juice; Draft Guidance for Industry | Food Safety |
| Inorganic Arsenic in Apple Juice: Action Level; Guidance for Industry | Food Safety |
| Action Levels for Lead in Food Intended for 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 |
| Compliance Policy Guide Sec. 555.320 Listeria monocytogenes in Human Food; Draft Guidance for FDA Staff | Food Safety |
| Reconditioning of Fish and Fishery Products by Segregation; Guidance for Industry | 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 |
| 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 | FSMA |
| Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry | Labeling |
| Labeling of Plant-Based Alternatives to Animal-Derived Foods; 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 |
Showing 1 to 30 of 30 entries
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