Allergen cross-contact and undeclared allergens: FDA releases new draft guidance

In a move towards improving food safety for individuals with allergies, the US Food and Drug Administration (FDA) has introduced updated draft guidance. The guidance is specifically designed to assist food facilities in complying with current good manufacturing practices (CGMPs) and preventive controls for food intended for human consumption. The latest addition to the guidance focused on food allergens offers strategies to safeguard food from cross-contact with major allergens and to ensure accurate labeling.    

Food allergies affect millions of Americans, and consumption of products containing allergens can lead to adverse reactions. Though many reactions are mild, some individuals may experience severe or life-threatening symptoms.

Earlier this year, sesame was added to the list of major food allergens under the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, effective as of January 1st. Consequently, food labels must now disclose the presence of sesame, and manufacturers are required to implement measures to minimize cross-contact with sesame allergens.

The introduction of the FASTER Act was intended to facilitate easier identification of sesame in food products, providing greater confidence for individuals with sesame allergies. However, some manufacturers are deliberately adding sesame to their products, which previously did not contain it, solely for the purpose of complying with disclosure laws. While this practice ensures legal compliance, it restricts consumer options and undermines the FDA's intent. Consequently, the FDA urges manufacturers to follow the draft guidance, which offers methods to significantly reduce cross-contact and undeclared allergens, rather than intentionally adding sesame to their products.  

FDA Commissioner Robert M. Califf, M.D., stated, "The FDA is seeking ways to assist consumers with sesame and other major food allergies in finding safe food options. We encourage manufacturers to adhere to the guidelines provided in the draft guidance updates announced today to prevent allergen cross-contact and ensure accurate labeling."    

Recognizing the challenges associated with eliminating allergens from products, the FDA is actively engaging with stakeholders to address this issue. The updated draft guidance, particularly the new chapter on allergens (Chapter 11—Food Allergen Program), serves as a tool to help manufacturers achieve this goal.    

The new chapter on allergens outlines the establishment and implementation of a food allergen program, emphasizing the protection of food from cross-contact with major allergens and the accurate labeling of finished products. It provides numerous examples of ways to minimize cross-contact and prevent undeclared allergens through the implementation of CGMPs and preventive controls. The chapter also addresses labeling errors, the leading cause of FDA food allergen recalls, and provides guidance on monitoring and verifying the proper declaration of allergens on labels.    

Furthermore, Chapter 11 discusses scenarios in which cross-contact with allergens cannot be entirely avoided, despite adherence to appropriate practices. It suggests options that firms can consider, including the voluntary use of allergen advisory statements when deemed appropriate. This chapter complements the FDA's recently released Draft Compliance Policy Guide on Major Food Allergen Labeling and Cross-Contact, which reflects the agency's risk-based and science-based approach to evaluating potential allergen violations.    

The FDA's updated draft guidance offers valuable insights and recommendations to food facilities, enabling them to enhance their practices and protect individuals with allergies. By following the guidance, manufacturers can minimize cross-contact with allergens, accurately label their products, and contribute to a safer food environment for consumers with food allergies.