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Compliance For ‘Gluten Free’ Claims For Fermented, Hydrolyzed Supplements Relies On Recordkeeping

Without Reliable Testing, US FDA Will Ask For ‘Information That Provides Adequate Assurance’

Executive Summary

Final rule amends FDA regulation on gluten-free labeling to provide alternative means for the agency to verify compliance. It will determine whether a firm is compliant from records it must maintain, and make available for inspection and copying, of the fermented or hydrolyzed supplements and food products bearing the claim.

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