September 29, 2023

FDA Will Evaluate Food Allergens That Are Not Part of the Major Nine

The FDA is going to evaluate food allergens that are not part of the major nine allergens: milk, wheat, soy, finfish, shellfish, eggs, sesame, tree nuts, and peanuts through a new draft guidance. Those allergens make up more than 90% of the allergens that cause illness. But the agency is going to evaluate the public health importance of any allergens that are not required to be listed on food labels. Other food allergens do cause illness.

FDA Will Evaluate Food Allergens That Are Not Part of the Major Nine

There are more than 160 known food allergens, which affect millions of people living in the U.S. Companies are required to list major allergens or ingredients made from the nine major allergens in specific ways on the label. Food manufacturers are also required to prevent allergen cross contact.

The new draft guidance, issued on April 18, 2022, will outline the agency’s approach to evaluating the public health importance of those other allergens. Susan Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition said in a statement, “The nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities. This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed allergens that can cause serious reactions in a consistent and transparent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.

Allergic reactions to food occur when the body’s immune system reacts to proteins in that food. These reactions can vary in severity and intensity from mild symptoms such as localized hives and lip swelling, to anaphylactic shock, which can be fatal. Reactions to some non-listed food allergens have relatively low prevalence rates.

The draft guidance focuses on immunoglobulin E antibody-mediated (IgE-mediated) food allergies, which are capable of triggering anaphylaxis and are considered the most severe food allergies. The nine major food allergens all cause IgE-mediated responses.

The draft guidance includes a discussion of the evidence that establishes the food as a cause of IgE-mediated food allergy and key scientific factors, such as severity, prevalence, and allergic potency. The guidance also provides the FDA recommendations for identifying and evaluating the current body of evidence to determine the public health importance of a non-listed food allergen.

The guidance also provides information on how you can submit comments and requests to the FDA to evaluate the public health importance of a non-listed food allergen.

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