FDA To Evaluate Potential Non-listed Food Allergens

19-Apr-2022 - USA

The U.S. Food and Drug Administration announced its plans to evaluate potential non-listed food allergens
that are not one of the major nine food allergens identified by law in the United States.

The agency has issued a draft guidance to outline its approach about the public health importance of non-listed food allergens in the country. At present, more than 160 foods are known to cause food allergic reactions.

The major listed food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. sesame becomes the ninth major food allergen effective January 1, 2023, after the Food Allergy Safety, Treatment, Education, and Research or FASTER Act was signed into law on April 23, 2021.

Federal regulation requires the packaged foods containing these listed ingredients to be labeled.

The FDA noted that the draft guidance focuses on immunoglobulin E antibody or IgE-mediated food allergies. These 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.

It was in 2004 that the eight major food allergens that were responsible for 90 percent of IgE-mediated food allergies then was acknowledged, when the Food Allergen Labeling and consumer protection Act or FALCPA was signed into law.

As per the latest draft guidance, the FDA's approach includes a discussion of the evidence that establishes the food as a cause of IgE-mediated food allergy. It also includes key scientific factors, such as prevalence, severity and allergenic potency, that the FDA intends to consider in its evaluations.(dpa)