On May 16, FDA released a draft Compliance Policy Guide, “Sec. 555.250: Major Food Allergen Labeling and Cross-contact,” to provide guidance for FDA staff on the Agnecy’s enforcement policy regarding major food allergen labeling and cross-contact. When finalized, the police guide is expected to replace the existing CPG 555.250 for FDA staff.

Among other things, the draft CPG describes the labeling requirements for major food allergens, as well as 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 pursuant to good manufacturing practices. 

The draft CPG directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations, reflecting FDA’s risk-based and science-based approach for the evaluation of potential allergen violations. FDA’s policy regarding cross-contact explains that a food is not adulterated as a result of cross-contact unless the product is injurious to health and that is determined based on a case-by-case review. If the product bears an allergen advisory statement (e.g., “may contain sesame”) but there is evidence of inadequate allergen cross-contact controls, then the product could still be adulterated.

In FDA’s Constituents Update, it recognized the fact 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 the issue of industry adding sesame to products that did not previously contain it, the draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame. FDA 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.

FDA requests that interested parties submit either electronic or written comments on this draft guidance by July 17, 2023. The link to upload comments can be found here.