FDA Issues Draft Guidance on Evaluating Non-Listed Food Allergens
The U.S. Food and Drug Administration (FDA) is heightening its efforts to protect the public from food allergens. The agency recently published a draft guidance that is intended to clarify how FDA will evaluate the public health risk of food allergens that are not one of the major food allergens identified by law in the Federal Food, Drug, and Cosmetic Act. At present, the major allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans; sesame, the ninth allergen, becomes applicable to the law on January 1, 2023. Under the law, food companies are required to label foods containing any of the nine major allergens and follow regulations that prevent cross-contact.
Regarding non-listed food allergens, 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 guidance specifies: