The U.S. Food and Drug Administration issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food allergens identified by law in the U.S (non-listed food allergens).
Currently, the major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans, though more than 160 foods are known to cause food allergic reactions. Sesame becomes the ninth major food allergen, effective Jan. 1, 2023.
The draft guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are capable of triggering anaphylaxis and are considered the most severe and immediately life-threatening food allergies. Food allergic reactions caused by the nine major food allergens are all IgE-mediated. The draft guidance describes the approach the FDA generally intends to take when evaluating the public health importance of a non-listed food allergen. It includes a discussion of the evidence that establishes the food as a cause of IgE-mediated food allergy and key scientific factors, such as prevalence, severity and allergenic potency, that the FDA intends to consider in its evaluations. The draft guidance also provides the FDA’s recommendations for identifying and evaluating the relevant body of evidence to determine the public health importance of a non-listed food allergen.
For further information (in English), click on the Link
Check the full text of the documents (in English), click on the Link