Allergens - FDA Guidance Beyond the Big 9The U.S. Food and Drug Administration (FDA) issued a draft guidance (4/18/2022) describing the approach it intends to take in evaluating food allergens that are not one of the nine major food allergens (milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, sesame and soybeans--FDA will be adding sesame to this list effective January 1, 2023). FDA’s guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are known to cause the most severe and life-threatening reactions. The draft, “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act”, reviews the evidence that establishes a food as a cause of IgE-mediated food allergy and scientific factors, such as prevalence, severity, and allergenic potency, that the FDA would consider in evaluations. It also reviews the agency’s recommendations for identifying and evidence to determine the public health importance of a non-listed food allergen. |
