Coconut Removed from FDA US Major Tree Nut Allergen List

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Coconut Removed from FDA US Major Tree Nut Allergen List – Customer Statement

Dear iTi Tropicals Customer,

As you may be aware, the FDA has recently updated and published a new list of US Major Tree Nut Allergens which are required to be declared either in the ingredient statement (parenthetically), or in a “Contains” statement, as an allergen on product labels. The new list of US Major Tree Nut Allergens can be found on the following document (p. 15, Table 1).

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry, January 2025

Among other changes, Coconut is no longer included as a US Major Tree Nut Allergen on this document. This means that Coconut should no longer be declared as an Allergen on product labels for products containing Coconut. However, if coconut is present in the product, it will still be required to be listed by common or usual name in the ingredient list 21CFR101.4.

We are reaching out to our suppliers of products to update Allergen Statements and product labels by appropriately removing coconut as a Major US Allergen in the near future.

Since this will take time to get the updated Allergen forms and updated product labels in place where appropriate, we recommend you consult your regulatory personnel for appropriate labeling of any of your products containing coconut.

We hope the information provided is helpful.

Thank you,

iTi Tropicals Quality Team

Donald Giampetro: Executive Vice President – Innovation & Quality, iTi Tropicals

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