On May 16, 2023, FDA released a draft compliance policy guide (“draft CPG”) for major food allergen labeling and cross-contact, which updates the 2005 CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens. CPGs are intended to advise FDA staff, including investigators, of the agency’s strategy for assessing and enforcing industry compliance. The draft CPG contains FDA’s current policies on major food allergen labeling requirements, allergen cross-contact, voluntary allergen information (e.g., advisory label statements), thresholds, and regulatory actions. The draft CPG is more comprehensive than the 2005 CPG and is intended to create a uniform standard and minimize the possibility that individual FDA staff will follow differing regulatory approaches.
The draft CPG details the allergen labeling requirements of the Federal Food, Drug, and Cosmetic Act. We do not discuss those requirements here, but instead focus on the policies the draft CPG discusses that are not addressed, in detail, in other FDA allergen documents, such as the recent draft guidance, Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act.
I. Allergen Cross-Contact
Allergen cross-contact is the unintentional incorporation of a food allergen into a food that does not contain that allergen as an ingredient. The draft CPG notes that the likelihood an allergen will be present due to cross-contact can be impacted by factors such as the characteristics of the food, the distribution of the allergen within a food (homogeneous versus particulate), the type of manufacturing process, the equipment used, and the cleaning procedures applied (e.g., dry cleaning versus wet cleaning). While FDA acknowledges these factors, the agency states that cross-contact may occur due to practices such as the failure to clean shared equipment adequately or segregate allergens properly, improper rework addition, or improper production scheduling. The draft CPG does not explicitly acknowledge that even with adequate CGMPs, sanitation, and preventive controls, cross-contact can still occur.
The draft CPG also confirms FDA’s position that “[m]ajor food allergens unintentionally incorporated into a food are not to be declared in the ingredient list or the ‘Contains’ statement.”