The U.S. Food and Drug Administration (FDA) has released a draft Compliance Policy Guide (CPG) relating to the enforcement policy for labelling major food allergens, including allergens that are unintentionally present. The draft CPG reflects the FDA’s updated thinking based on the current regulatory framework and latest scientific knowledge.
The draft CPG outlines the labelling requirements for major food allergens and emphasises the proper use of ingredient lists and the “Contains” statement for declaring major food allergens. It also highlights the need for companies to implement controls to prevent or minimise allergen cross-contact. Additionally, the draft policy guide directs FDA staff to investigate potential product adulteration and labelling violations related to allergen cross-contact. The updated CPG aligns with the FDA’s risk-based and science-based approach to evaluating potential allergen violations.
The FDA acknowledges that some manufacturers are now intentionally adding sesame to products that previously did not contain sesame and labelling them accordingly. Although the draft CPG does not specifically address this issue, the FDA is said to be actively engaging with relevant stakeholders, as such practices are not endorsed by the FDA as they may make it harder for sesame-allergic consumers to find safe foods.
Instructions on how to submit comments on the draft compliance policy guidance can be found on the USFDA website.
