May 16, 2023
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.
The FDA 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 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. The FDA is engaged with various stakeholders on this issue. The 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.
To ensure that comments are received before work begins on the final version of the guidance, submit electronic or written comments within 60 days of publication in the Federal Register. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number FDA-2023-D-1103. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For More Information:
- Federal Register notice
- Compliance Policy Guide Sec. 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact
- Food Allergies