SILVER SPRING, MD — The US Food and Drug Administration (FDA) issued a new draft guidance today that, when finalized, will outline the agency’s approach to evaluating the public health importance of food allergens outside of the nine major food allergens identified by law.
The “top nine” is getting a plus one effective Jan. 1, 2023, when sesame joins the ranks of the major allergens, which currently include milk, eggs, shellfish and crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. More than 160 foods are known to cause allergic reactions.
“The nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivities,” said Susan Mayne, Ph.D., director of the 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 “This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed food allergens that can cause serious reactions in a consistent and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 sensitivities affect millions of people in the US, and vary in severity from mild symptoms such as hives and lip swelling to life-threatening symptoms called anaphylaxis. Reactions to some non-listed food allergens have relatively low prevalence rates, with some as low as single cases.
The new draft guidance focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are capable of triggering anaphylaxis and are considered the most severe and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 allergy 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The draft guidance describes the approach the FDA generally intends to take when evaluating the public health importance of a non-listed food allergen.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. It 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.
Comments on the draft can be submitted within 120 days of publication of the draft, as in accordance with the Federal Register. They can be submitted here, using docket ID: FDA-2021-N-0553.
