The United States Food and Drug Administration outlined 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 US (non-listed food allergens) Monday.

The major food allergens are currently milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans, although more than 160 foods are known to cause food allergic reactions, according to the FDA. Sesame becomes the ninth major food allergen on 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,” Susan Mayne, the director of the Center for Food Safety and Applied Nutrition, said in a statement.

“This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed food allergens that can cause serious reactions in a consistent and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,” Mayne continued.


Food allergies and other types of food hypersensitivities affect millions of people in the US and occur when the body’s immune system reacts to certain proteins in food, the FDA wrote. Food allergic 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 new 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 guidance states that the FDA generally intends to consider 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 when evaluating public health 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 US On April 23, 2021, the Food Allergy Safety, Treatment, Education and Research (FASTER ) Act was signed into law, declaring sesame as the 9th major food allergen recognized by the US, effective Jan. 1, 2023.

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