Coconut No Longer Considered an Allergen Requiring Labeling and Other Items from Allergen Guidance

In FDA's guidance release, Q&A document - Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5) that was released in early January (Link), FDA stated the nut allergens requiring labeling. Coconut is not listed and with that, does not requiring allergen labeling.

We reached out to FDA and they provided this:

• Coconut is no longer considered a major food allergen: Coconut has been removed from the “tree nut list” (see Appendix 1, which is also at the end of this email) and is no longer considered a tree nut for allergen labeling purposes. This determination was made after a scientific evaluation was conducted using the scientific criteria outlined in FDA’s allergen framework guidance 

• Other changes to the tree nut list: [FDA] conducted a scientific review of tree nuts to determine if they are allergens of public health significance. [FDA] clarified that only the tree nuts listed in Appendix 1 are considered major food allergens. Other tree nuts not listed in the table should not be included in the “Contains” statement, even if they are used as ingredient, because the “Contains” statement is reserved for major food allergens. In addition to the removal of coconut, beech nut; butternut; chestnut; chinquapin; cola/kola nut; ginkgo nut; hickory nut; palm nut; pili nut; and shea nut were removed from the “tree nut list.”

• FDA expanded interpretation of "milk” as a major food allergen to include milk from goats, sheep, and other ruminants for food allergen labeling purposes. 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 ingredient 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.

• FDA expanded the definition of eggs to include eggs from ducks, quail and other fowl for food allergen labeling purposes. Eggs from birds other than chickens, when used as an ingredient, must be declared in the ingredient list by common or usual name, such as “duck egg”. For food allergen labeling purposes, egg and egg ingredients from birds other than chickens, should also include the name of the bird source, such as “duck egg” and “ovalbumin (duck egg)” in the ingredient list or “Contains duck egg” in a separate Contains statement, or both.

• Additional Information:

o  “Allergen-free” claims should not be accompanied by allergen advisory statements because this would be confusing for consumers, for example, “milk-free” and “may contain milk” should not appear on the same product label and labeling.

o Allergen declaration in an ingredients list or in a “Contains” statement should not also be accompanied by an allergen advisory statement for the same allergen, for example, “Contains milk” and “may contain milk”.

o FDA cannot change the list of major food allergens. Federal law defines “major food allergens,” but the law does not restrict our authority to require labeling for other food allergens by regulation.