The U.S. Food and Drug Administration (FDA) has released a draft Compliance Policy Guide to provide guidance for FDA staff on the FDA’s enforcement policy regarding major food allergen labeling and cross-contact. The draft CPG more accurately reflects FDA’s thinking on major food allergen enforcement policy based on the current regulatory framework and latest science. When finalized, it will replace the existing CPG 555.250 for FDA staff.
Among the updates, the draft CPG describes the labeling requirements for major food allergens and the proper use of the ingredient list and the “Contains” statement for major food allergen declarations. It also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact. Further, the draft CPG describes additional allergen labeling violations. It also directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations. The updated CPG reflects the FDA’s risk-based and science-based approach for the evaluation of potential allergen violations.