On January 7, 2025, the Food and Drug Administration (FDA) issued revised food allergen labeling labeling guidance. This fifth edition came with no fanfare, but it includes some remarkable changes.
Special requirements apply to allergens that are declared to be major food allergens. Over 160 foods have been reported to cause allergic reactions but far fewer are deemed as “major” allergens. The FDA now reduced the number of major allergens under the Food Allergen Labeling and Consumer Protection Act (FALCPA) by eliminating 10 tree nuts from the list for a total of 12 major tree nut allergens.
Without providing details, the guidance states the list “includes those tree nuts for which a robust body of scientific evidence supports their inclusion in the list of tree nuts that FDA considers to be major food allergens.”
- The Tree Nuts FDA that Considers as Major Food Allergens with their common names and scientific names:
- Almond (Prunus dulcis Mill)
- Black walnut (Juglans nigra L.)
- Brazil nut (Bertholletia excelsa Humb. & Bonpl.)
- California walnut (Juglans californica S. Watson)
- Cashew (Anacardium occidentale L.)
- Filbert/Hazelnut (Corylus spp.)
- Heartnut/Japanese walnut (Juglans ailantifolia Carriere var. cordiformis)
- Macadamia nut/Bush nut (Macadamia spp.)
- Pecan (Carya illinoinensis)
- Pine nut/Pinon nut (Pinus spp.)
- Pistachio (Pistacia vera L.)
- Walnut, English, Persian (Juglans regia L.)
Only the tree nuts listed above are considered major food allergens. Note that Pinus, Macdamia, and Corylus (pine, macadamia and hazelnut) genera are listed in their entirety, but Juglans and Carya (walnut and hickory) are not.
The FDA no longer considers the following tree nuts to be major food allergens. These tree nuts would still be required to be listed by common or usual name in the ingredient statement on the label (21 CFR 101.4). However, because they are no longer considered major food allergens, they may not be included in an allergen “Contains” statement.
- Beech nut (Fagus spp.)
- Butternut (Juglans cinerea)
- Chestnut (Castanea spp.)
- Chinquapin (Castanea pumila)
- Coconut (Cocos nucifera)
- Ginko nut (Ginkgo biloba)
- Hickory nut (Carya spp.)
- Lichee nut (Litchi chinensis)
- Pili nut (Canarium ovatum)
- Shea nut (Vitellaria paradoxa)
In addition, note that FDA considers “eggs” as eggs from domesticated chickens, ducks, geese, quail, and other fowl. For food allergen labeling purposes, egg and egg ingredients from birds other than chickens must include the name of the bird source, such as “duck egg” or “ovalbumin (duck egg)” in the ingredient list or “Contains duck egg” in a separate “Contains” statement, or both.
Milk from ruminant animals other than cows, when used as an ingredient, must be declared in the ingredient list by common or usual name, such as “goat milk.” For food allergen labeling purposes, milk and milk ingredients from animals other than cows should also include the name of the animal source, such as “goat milk” and “whey (goat milk)” in the ingredient list or “Contains goat milk” in a separate “Contains” statement, or both.
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