The U.S. Food and Drug Administration (FDA) has released a draft Compliance Policy Guide (CPG) for FDA staff on the agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG reflects FDA’s thinking on major food allergen enforcement policy based on the current regulatory framework and latest science. When finalized, the draft will replace the existing CPG 555.250 for FDA staff.
Among updates included in the draft CPG, the guide describes the labeling requirements for major food allergens, the proper use of the ingredient list, and the “Contains” statement for major food allergen declarations. The draft CPG also describes requirements for firms to implement controls that prevent or significantly minimize allergen cross-contact.
Furthermore, 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 FDA’s risk- and science-based approach for the evaluation of potential allergen violations.
FDA also 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, as a way to avoid carrying out practices that mitigate cross-contamination. While the draft CPG does not specifically address the issue of industry adding sesame to products that did not previously contain the allergen, the draft CPG does address FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame.
FDA mentioned that the agency is engaged with various stakeholders on the addition of sesame to products. FDA recognizes that sesame’s inclusion in foods may make it more difficult for sesame-allergic consumers to find foods that are safe for consumption, which is an outcome that FDA states it does not support.
In response to FDA’s statement about the inclusion of sesame in foods that did not previously contain the allergen, the Center for Science in the Public Interest (CSPI), a group that petitioned FDA to prohibit this practice in January 2023, expressed its dissatisfaction. CSPI pointed to the inadequacy of FDA’s stance, calling for the agency to actively oppose the inclusion of sesame and release warnings about the possible harm to consumers.
To ensure that comments are received before work begins on the final version of the guidance, electronic or written comments should be submitted within 60 days of publication in the Federal Register. Electronic comments should be submitted to regulations.gov. Written comments can be mailed to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2023-D-1103.