By Allergen Bureau

When does a food become a food allergen?

The FDA has issued draft guidance detailing how it will evaluate the public health importance of food allergens that are not among those currently identified by law in the United States.

Current food allergens that require labelling include milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. Sesame has been added to this list, with legislation coming into effect on Jan. 1, 2023.

According to the FDA, more than 160 foods are known to cause allergic reactions. The draft guidance provides a consistent and transparent process for evaluating evidence about foods that cause allergic reactions, to determine whether further measures are required.

The guidance addresses substances that are currently consumed in food or have previously been consumed in food. It does not address substances that would be new to the food supply.

The FDA is now looking for input on the guidance, including scientific factors, information pertaining to food labelling and its draft recommendations for identifying and evaluating evidence applicable in assessing the public health importance of emerging food allergens.

The draft guidance document “Evaluating the public health importance of food allergens other than the major food allergens listed in the federal food, drug, and cosmetic act: guidance for FDA staff and stakeholders” is available on the FDA website. Comments on the draft guidance can be provided here. Further information about the draft guidelines can be found in a FDA media release.

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