In May 2023, The U.S. Food and Drug Administration FDA Releases Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact.
The U.S. Food and Drug Administration (FDA) has published draft guidance for labeling of major food allergens and cross-contact.
The published Compliance Policy Guide provides guidance to FDA staff on the enforcement policy for labeling these products.
The draft CPG more accurately reflects FDA’s thinking on enforcement policy for major food allergens based on the current regulatory framework and the latest science.
The updated CPG reflects the FDA’s risk-based and science-based approach for the evaluation of potential allergen violations.
Requirements Described by CPG Project:
- Requirements for major food allergens.
- “Contains” declaration for major food allergen statements.
- Requirements for companies to implement controls to prevent or significantly minimize allergen cross-contact.
- Additional allergen labeling violations
- Directs FDA personnel to examine potential product adulteration.
- Potential labeling violations
- Cross-contact controls for major food allergens, including sesame.
Submission Documentation to FDA:
- Submit comments before work begins on the final version of the guidance.
- Submit electronic or written comments within 60 days of publication in the Federal Register
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
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