January 25, 2024
To increase transparency and assist stakeholders by highlighting its regulatory agenda, the U.S. Food and Drug Administration’s Foods Program has posted a new website listing regulations it plans to publish by October 2024 and longer-term regulations it is prioritizing for publication at a later date. The FDA also 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.
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.
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FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula; Draft Guidance for Industry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- The Food Traceability Rule: Questions and Answers; Draft Guidance for Industry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Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards: Draft Guidance for Industry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Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods (Edition 2): Draft Guidance for Industry
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. Guidance documents do not impose legally enforceable requirements. While the FDA intends to publish guidance on each of these topics, several factors may impact our ability to do so this year, such as emerging public health issues.
Public comments on the list of guidance topics can be submitted to www.regulations.gov using Docket ID FDA-2022-D-2088.
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