updated the list of guidance topics that it is considering and expects to publish by the end of 2024. The list of guidance topics was last updated in July 2023.
The following five topics have been added to the list of guidance documents the FDA expects to publish by the end of December 2024:
• Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry
• Action Levels for Lead in Food Intended for Babies and Young Children: Guidance for Industry
• The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry
• Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry
• Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry
New and updated food regulations include:
• Amendments to Registration of Food Facilities
• Amendments to Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
• Revised requirements for Nutrient Content Claims, Definition of Term: Healthy
• Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals – removal of the requirement for manufacturers to obtain written assurance from their commercial customers that they will control a hazard identified but not controlled by the manufacturer/processor of human food.
• Streamlining Provisions Requiring Disclosure to and Receipt of Written Assurances From Commercial Customers in the Foreign Supplier Verification Programs Rule
For a complete list of FDA guidance documents, visit Foods Program Guidance Under Development. Regulatory experts at Deibel Labs can help you assess new/revised FDA guidance as it is released.