By Allergen Bureau

FDA Helps Minimise Allergen Cross-contact 

The U.S. Food and Drug Administration has released an updated draft guidance designed to help food facilities comply with the requirements for current good manufacturing practices and preventive controls. It includes a new chapter dedicated to food allergens. 

The chapter entitled “Food Allergen Program” is among other chapters that have been added since the draft guidance, “Hazard Analysis and Risk-Based Preventive Controls for Human Food”, was first issued in 2016. 

The new chapter outlines ways to ensure protection of food from cross-contact with the major food allergens and to ensure that the allergen labelling on the finished food is accurate. 

Labelling errors are the cause of most FDA food allergen recalls. The new chapter aims to help address this and includes guidance on how to monitor or verify that the food allergens are properly declared, and the correct label is used for the product. Many examples are provided to show ways to significantly minimise or prevent allergen cross-contact and undeclared allergens using current good manufacturing practices and preventive controls. Scenarios for including a voluntary allergen advisory statement are also included. 

The chapter complements the FDA’s “Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact”, that was released earlier in 2023. 

See the FDA website for the full media release and links to more information.