FDA has issued a draft compliance policy guide (draft CPG) concerning major food allergen labeling and cross-contact. This draft CPG updates the 2005 CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens and aims to provide guidance to FDA staff on assessing and enforcing industry compliance. It covers various aspects such as major food allergen labeling requirements, allergen cross-contact, voluntary allergen information, thresholds, and regulatory actions. The goal of the draft CPG is to establish a consistent standard and minimize regulatory discrepancies among FDA staff.
The draft CPG focuses on allergen cross-contact, which refers to the unintentional presence of a food allergen in a product that does not contain that allergen as an ingredient. It acknowledges that factors such as food characteristics, distribution of allergens within the food, manufacturing processes, equipment used, and cleaning procedures can affect the likelihood of cross-contact. The draft CPG also recognizes that cross-contact can occur due to inadequate cleaning of shared equipment, improper allergen segregation, improper rework addition, or improper production scheduling. However, it does not explicitly address the possibility of cross-contact even when adequate controls and preventive measures are in place.
The draft CPG confirms FDA’s stance that major food allergens unintentionally incorporated into a food should not be declared in the ingredient list or the “Contains” statement.
When allergens are detected through testing or suspected due to adverse reactions, but their origin in the product is unknown, FDA may request additional information from the company, such as product formulation, ingredient details, and information about related products produced on the same line or in the same process environment.
Regarding FDA’s regulatory approach to allergen violations, the draft CPG emphasizes a case-by-case evaluation based on the specific circumstances of each situation. If evidence, including findings from facility inspections, suggests that allergen cross-contact may pose a health risk, FDA may consider the product adulterated. The presence of an allergen advisory statement on the label does not guarantee compliance if there is evidence of inadequate controls. Analytical test results indicating the unintentional presence of an allergen can prompt consultation with the CFSAN/Office of Compliance to determine the health hazard posed by the product. Factors considered in the evaluation include estimated allergen exposure per eating occasion, likelihood of consumption by allergic individuals, allergen information on the product, evidence of unsanitary practices, characteristics of allergen residues, and consumer adverse reactions.
The FDA also considers a product misbranded if its label lacks complete or consistent information about major food allergens. If there is a reasonable likelihood of serious health consequences or death due to allergen misbranding or adulteration, FDA may take immediate action to remove the food from the market. If the company does not initiate a voluntary recall, FDA can pursue mandatory recall, administrative detention, or suspension of facility registration.
The draft CPG addresses voluntary allergen information and emphasizes that allergen advisory statements should not replace adherence to good manufacturing practices (CGMPs) and preventive controls. However, it acknowledges that the presence of such statements may be considered a mitigating factor if allergen cross-contact is appropriately managed in line with CGMPs, preventive controls, or other control measures. The assessment of allergen advisory statements’ appropriateness remains a case-by-case retrospective evaluation.
Additionally, the draft CPG discusses allergen-free claims, emphasizing that they must be truthful and not misleading. For example, a product labeled “milk-free” should not contain any milk allergen. However, it does not provide specific details on the controls or processes required to substantiate allergen-free claims.
FDA recognizes that consumer adverse reactions can provide evidence that labeling information or other factors have not effectively mitigated health risks associated with allergen hazards in the product.
In terms of thresholds, the FDA clarifies in the draft CPG that it has not established specific thresholds for major food allergens. However, it acknowledges the existence of published dose-response data that suggests low-level exposure to allergens may not pose a health hazard to the majority of food-allergic individuals. When making determinations related to health hazards, the FDA will consider analytical test results and estimate the allergen exposure per eating occasion. It also indicates that the allergenicity threshold of the allergic population will be taken into account on a case-by-case basis when assessing whether a product is adulterated due to cross-contact.
The FDA invites comments on the draft CPG within a 60-day period, ending on July 17, 2023. While the agency welcomes feedback during this specific timeframe, it accepts comments on guidance documents at any time.
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