On May 16, the FDA released a draft Compliance Policy Guide (CPG) to provide guidance for FDA staff on the enforcement policy regarding major food allergen labeling and cross-contact. The guide 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 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. In addition, the draft CPG describes additional allergen labeling violations and directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations.
The agency stated that it is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address this issue, the FDA said that it recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume—an outcome that the FDA does not support, and that the agency is engaging with stakeholders on this issue. The draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame.
Stakeholders can submit electronic or written comments within 60 days of publication in the Federal Register.