U.S – The Food and Drug Administration (FDA) has issued a draft guidance for FDA staff and other stakeholders titled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.”

The draft guidance, when finalized, will outline FDA’s current thinking on the approach it generally intends to take when the agency evaluates the public health importance of food allergens that are not one of the major food allergens identified by law in the U.S.

The major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans. Effective Jan. 1, 2023, sesame will become the ninth major food allergen.

For the purposes of this draft guidance, FDA refers to food allergens that are not major food allergens as non-listed food allergens.

Food allergies and other types of food hypersensitivities affect millions of people living in the U.S., and there are more than 160 known food allergens.

To protect those with food allergies and other food hypersensitivities, FDA requires companies to list major food allergens or ingredients that are made from major food allergens in specific ways on the label of packaged foods.

FDA also enforces regulations that require food manufacturers to prevent allergen cross-contact (or, the unintentional incorporation of a major food allergen into a food).

This draft guidance is part of FDA’s efforts to evaluate emerging evidence about non-listed food allergens in a consistent and transparent manner to inform potential future actions.

FDA’s approach to non-listed food allergens focuses on immunoglobulin E antibody (IgE)-mediated food allergies, which are considered the most severe and immediately life-threatening food allergies.

The draft guidance discusses the scientific evidence that establishes a food as a cause of IgE-mediated food allergy and the scientific factors, such as prevalence, severity and allergenic potency, that the FDA intends to consider in its evaluations.

It further provides 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In addition, the draft guidance also includes information on how stakeholders may submit requests to FDA to evaluate the public health importance of a non-listed food allergen.

“We propose stakeholders submit data demonstrating that the food causes IgE-mediated allergy, together with data on prevalence of the food allergy, severity of the allergic reactions and allergenic potency of the food allergen for the agency to consider in its review.

“We also propose that stakeholders provide other information, such as the information about the labeling and production of food containing the non-listed food allergen,” said the agency.

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