The U.S. Food and Drug Administration (FDA) has implemented significant updates to the Code of Federal Regulations (CFR) affecting advanced manufacturing and food industry operations. These changes aim to enhance food safety, streamline regulations, and promote innovation within the industry.
1. Extension of Food Traceability Rule Compliance Date
The FDA has proposed extending the compliance date for the Food Traceability Rule by 30 months to July 20, 2028. This extension provides additional time for entities to implement the required traceability recordkeeping for foods on the Food Traceability List. The rule aims to improve food safety by enhancing traceability throughout the supply chain. U.S. Food and Drug Administration+1Food & Wine+1
2. Overhaul of FDA’s Human Foods Program
In 2024, the FDA restructured its Human Foods Program to better align with modern food safety needs. This overhaul includes updates to regulations and guidance documents, reflecting the agency’s commitment to enhancing food safety and regulatory efficiency. Morgan Lewis
3. Revocation of 52 Food Standards of Identity
The FDA has revoked or proposed revocation of 52 outdated food standards of identity (SOIs). These SOIs, established in 1939, included specific requirements for products like canned fruits and vegetables, dairy, baked goods, and macaroni products. The revocation aims to reduce regulatory burdens and foster innovation in food manufacturing. Food & Wine+1
4. Updates to Current Good Manufacturing Practices (CGMPs)
The FDA has amended the Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 117. These updates include revisions to sanitation procedures, allergen controls, and preventive measures to enhance food safety and align with modern manufacturing practices. U.S. Food and Drug AdministrationeCFR
5. Introduction of New Traceability Requirements
The FDA has finalized the Food Traceability Final Rule, which introduces new traceability requirements for certain foods. These requirements include maintaining records of Critical Tracking Events (CTEs) and Key Data Elements (KDEs) to improve food safety and facilitate rapid response to foodborne illness outbreaks. Food & Wine+1U.S. Food and Drug Administration
Conclusion
These recent changes in the CFR codes reflect the FDA’s ongoing efforts to modernize food safety regulations and support innovation in the food industry. Manufacturers are encouraged to review these updates and adjust their operations accordingly to ensure compliance and enhance food safety practices.
Recent Coverage on Food Industry Regulatory Changes
Food & Wine
The FDA Is Launching New Traceability Rules for Added Food Safety – and Everyone Is Confused
This article explains the FDA’s new Food Traceability Rule, which requires recordkeeping for foods on the Food Traceability List to improve supply chain transparency and food safety.
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FDA Updates Its Definition of “Healthy” Foods
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The FDA Just Axed 52 Food Standards – Here’s What It Means for Your Groceries
This article details the FDA’s revocation of 52 outdated food standards of identity, explaining how this change affects labeling, product formulation, and industry innovation.
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