A new U.S. Food and Drug Administration (FDA) webpage lists regulations that the Human Foods Program (HFP) plans to publish by October 2024 and longer-term regulations HFP is prioritizing for publication at a later date. FDA also updated the list of guidance topics that it is considering and expects to publish by the end of 2024, which was last updated in July 2023.
HFP regulations under development, as listed on the new webpage, include:
- Frozen Cherry Pie: Proposed Revocation of a Standard of Identity and a Standard of Quality
- Certifications Concerning Imported Foods
- Amendments to Registration of Food Facilities
- Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
- Color Additive Certification: Increase in Fees for Certification Services
- Food Additives: Food Contact Substance Notification That Is No Longer Effective
- Nutrient Content Claims, Definition of Term: Healthy
- Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
- Cheeses and Related Cheese Products: Proposal to Permit the Use of Ultrafiltered Milk Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
- Front-of-Package Nutrition Labeling
- Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods
- The FDA Food Safety Modernization Act: Amendments to Exemption Provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Regulation
- Food Labeling: Health Claims: Soy Protein and Coronary Heart Disease
- Food Standards: General Principles and Food Standards Modernization
- Streamlining Provisions Requiring Disclosure to and Receipt of Written Assurances From Commercial Customers in the Foreign Supplier Verification Programs Rule
- Fish and Shellfish: Canned Tuna Standard of Identity and Standard of Fill of Container
- Permanent Listing of Color Additive Lakes
- Amendment of Procedural Requirements for Food Additive Petitions
- Amendment of Procedural Requirements for Color Additive Petitions.
Additionally, the following five topics have been added to the list of guidance documents that 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FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry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.
Regulations are officially announced by the Office of Information and Regulatory Affairs in the Office of Management and Budget in the Unified Agenda of Regulatory and Deregulatory Actions published each spring and fall. While the FDA intends to publish regulations according to timelines listed in the Unified Agenda, several factors may affect the agency’s ability to do so, including emerging public health issues and new administration priorities.