SOT FDA Colloquium: The Big 8—Advances in Food Allergy Risk Assessment and Management

The Society of Toxicology in conjunction with the US FDA Center for Food Safety and Applied Nutrition (CFSAN) have partnered to provide this colloquia series. The series presents scientific information that is high-quality, cutting-edge, future-oriented toxicological science to provide a well-grounded foundation to inform the work of US FDA employees.

On October 11, 2018, SOT and US FDA hosted a colloquium that explored the latest issues influencing the food allergy risk assessment and management landscape, including 1) identification and characterization of IgE-mediated allergen hazards, 2) clinical prevention and treatment of food allergies, 3) understanding dose thresholds, and 4) implementation of allergen preventive controls and labeling.

Food allergies are increasing in prevalence and pose a significant public health burden. Major food allergens (The Big 8) are defined in the Food Allergen Labeling and Consumer Protection Act (FALCPA) and are also addressed in the risk-based Preventive Controls for Human Food rule of the FDA Food Safety Modernization Act (FSMA). Yet, presence of incidental and poorly declared levels of allergens in food products continues to present challenges for the food industry, regulators, and consumers and are an important cause of food recalls and accidental allergic reactions.