Coconut no longer major food allergen in revised FDA guidance

• By: AHPA
• On: 01/10/2025 16:27:52
• In: AHPA News

January 10, 2025

The U.S. Food and Drug Administration (FDA) has recently published the final version of an allergen guidance entitled “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" (the final guidance). This guidance, intended to explain the application of labeling requirements under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), follows from the publication of a partially finalized version (the draft guidance) in 2022. The American Herbal Products Association (AHPA) submitted comments to this and prior editions of the guidance.
 
The final guidance includes a table of tree nuts the agency considers major food allergens subject to labeling requirements under FALCPA. In a major shift that follows repeated requests from AHPA and aligned industry, this table no longer includes a number of plant parts not properly classified as major food allergens, tree nuts, or in one even the product of a botanical tree. Chief among the plant parts removed is the coconut, which had been incorrectly treated as a major food allergen by FDA despite a lack of scientific evidence to support its inclusion. 
 
"AHPA has been seeking this change for over a decade," said AHPA President Michael McGuffin. "The removal of coconut from the set of major food allergens, coupled with other clarifications, brings FDA allergen policy one step closer to alignment with reality."
 
In accordance with AHPA comments, the table of tree nut allergens now solely reflects plant parts referred to as tree nuts in a Senate report on FALCPA, significantly narrowing the scope of label requirements. Also following AHPA's comments, the guidance treats this table as exhaustive, stating that "[o]nly the tree nuts listed in Table 1 are considered major food allergens..." and are subject to applicable labeling requirements.
 
In its comments, AHPA also recommended that FDA directly state that all other parts of plants bearing covered tree nuts be excluded from labeling requirements. While FDA partially adopted the framing of this recommendation, the final guidance takes the position that other parts of a plant bearing sources of major food allergens are subject to labeling requirements if the resulting food consists of or contains proteins from a major food allergen. As was the case with the Senate report on FALCPA, the definition of "tree nut" remains out of alignment with applicable botanical definitions.
 
The FALCPA allergen labeling requirements originally took effect in 2006. AHPA will continue its work with the herbal products community to ensure food allergen policy facilitates consumer access to safe, beneficial herbal foods and dietary supplements.