WASHINGTON, May 17, 2024 - IDFA recently provided written comments on the draft guidance the U.S. Food and Drug Administration (FDA) has published regarding the establishment of a food allergen program to meet the requirements of the Hazard Analysis and Risk-Based Preventive Controls for Human Food final rule. The draft guidance is intended to explain how to establish and implement a food allergen program that ensures protection of food from major food allergen cross-contact and that the finished food is properly labeled with respect to the major food allergens.
IDFA supported a systems-based approach to supplier verification efforts that is more consistent with the Food Safety Modernization Act’s risk-based, preventive approach to food safety. IDFA applauded FDA for beginning to address allergen dose response thresholds in this guidance, but recommended more clarity on how and when these thresholds can be applied. The comments also highlighted the need for more guidance on the appropriate use of allergen advisory statements and recommended that FDA remove coconut from the list of major food allergens due to a lack of science supporting its inclusion.
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John Allan
Vice President, Regulatory Affairs and International Standards