US: New effort taken to evaluate public health importance of food allergens

The US Food and Drug Administration (FDA) has recently released its draft guidance for staff and stakeholders, which, after being finalized, will represent the agency’s non-binding approach to assessing the public health importance of food allergens that are not currently regulated in the US law (non-listed food allergens).  

Although there are more than 160 foods known to cause food allergic reactions, to date, the Federal Food, Drug, and Cosmetic Act is only effective on eight major food allergens (milk, eggs, fish, crustacean and shellfish, tree nuts, peanuts, wheat, and soybeans). The ninth major food allergen, which is sesame, will become effective on Jan. 1, 2023.  

Food allergies occur when the body’s immune system to a certain food, affecting millions of people in the US. This guidance will narrow the regulation gap, by providing non-binding recommendations to address substances that are not currently regulated.  

According to Susan Mayne, Director of the Center for Food Safety and Applied Nutrition, “the nine major food allergens don’t currently represent all foods nationwide that people are allergic to or that cause food hypersensitivity. This draft guidance is part of the FDA’s efforts to evaluate emerging evidence about other non-listed food allergens that can cause serious reactions in a consistent and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.”  

The draft guidance put an important focus on immunoglobulin E antibody (IgE)-mediated food allergies, which may trigger severe and life-threatening symptoms, such as fatal respiratory problems and shock. It also specifies the scientific factors that the FDA generally intend to consider when evaluating the public health importance of a non-listed food allergen, information relevant to the labeling and production of food containing the food allergen, as well as their recommendations on identifying and assessing the body of evidence that is capable to be considered.  

The draft guidance is open for comments until August 2022, before being finalized.