FDA Revises Food Labeling Compliance Program: Key Updates for 2025
9/5/2025 (US FDA Published: June 26, 2025)
The U.S. Food and Drug Administration (FDA) has revised its compliance program CP 7321.005 and released it under the title: “General Food Labeling Requirements and Labeling-Related Sample Analysis – Domestic and Import.” This updated version replaces the 2010 edition and reflects the most recent regulations and enforcement priorities in food labeling.
Why This Matters
This compliance program serves as an operational manual for FDA inspectors conducting food facility inspections in both domestic and international contexts. The revisions are intended to improve clarity and ensure consistent application of existing food labeling regulations during inspections.
Main Changes in the 2025 Revision
- • Sesame Added as Major Allergen: In accordance with the FASTER Act (2021), sesame is now recognized as the ninth major allergen requiring labeling.
- • Clearer Gluten-Free Labeling: Guidance for “gluten-free” claims has been clarified to reduce ambiguity.
- • Nutrition Facts Label Consistency: Aligns with the 2016 update to the Nutrition Facts Label, including format and nutrient content declarations.
What Businesses Need to Know
While this revision does not introduce new laws, it will be used by FDA inspectors starting June 25, 2025 to assess compliance. This means any labels not in line with existing laws such as the FASTER Act or the revised Nutrition Facts Label are now at increased risk of being cited.
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Source: " U.S. Food & Drug Administration: FDA Updates General Food Labeling Requirements Compliance Program
