The FDA has issued a draft guidance that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens that are not one of the major nine food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 nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities,” says Susan Mayne, Ph.D., director, Center for Food Safety and Applied Nutrition. “This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed food allergens that can cause serious reactions in a consistent and transparent manner, which can inform potential future actions to better help protect the health of consumers.” 

Food allergies and other types of food hypersensitivities affect millions of people in the U.S. and occur when the body’s immune system reacts to certain proteins in food. Reactions vary in severity from mild symptoms, involving localized hives and lip swelling, to severe, life-threatening symptoms, called anaphylaxis, which may involve fatal respiratory problems and shock. Reactions to some non-listed food allergens have relatively low prevalence rates, with some as low as single cases.

The draft guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which can trigger anaphylaxis and are considered the most severe and immediately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 The draft guidance describes the approach the FDA generally intends to take when evaluating the public health importance of a non-listed food allergen, including a discussion of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, which the FDA intends to consider in its evaluations. Additionally, the guidance 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.

In August 2004, the Food Allergen Labeling and Consumer Protection Act (FALCPA) was signed into law. At that time, eight major food allergens were responsible for 90% of IgE-mediated food allergies and were the most common causes of severe food reactions in the U.S. On April 23, 2021, the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act was signed into law, declaring sesame as the ninth major food allergen recognized by the U.S., effective Jan. 1, 2023.