The FDA released a draft compliance policy guide, Tuesday, titled “CPG Sec 555.250 Draft: Major Food Allergen Labeling and Cross-contact,” to provide guidance for FDA staff on FDA’s enforcement policy regarding major food allergen labeling and cross-contact.
The updated guide more accurately reflects FDA’s thinking on major food allergen enforcement policy based on the current regulatory framework and the latest science, according to FDA. When finalized, it will replace the existing CPG 555.250 for FDA staff, titled “Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens” which was released in November 2005.
Among the updates, the draft describes the labeling requirements for major food allergens, the ingredient list’s proper use, 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. Additional allergen labeling violations are also outlined. FDA staff are directed to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations.
FDA indicated 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. FDA says it does not support this practice, as it makes it more difficult for consumers with a sesame allergy to find safe-to-eat foods. While the draft does not specifically address this issue, it does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame.
FDA is accepting comments on the draft guidance before it begins working on the final version.
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