Silver Spring, MD—In the final version of its latest allergen guidance, the U.S. Food and Drug Administration (FDA) left coconuts off of its list of tree nuts with major scientifically established allergenicity to be considered serious food allergens. The news serves as a major victory for the coconut industry.
Through a series of specific points, "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" explains the application of labeling requirements under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). In its latest report, FDA says it understands "that there is no universally accepted botanical definition of the term 'tree nut' and that 'the scientific data relevant to assessing the allergenicity of any such individual entity varies greatly, in quantity and quality, across the broad range of foods potentially encompassed by the general term 'tree nut.'”
The American Herbal Products Association (AHPA) and the Coconut Coalition of the Americas (CCA) have remained vigilant of FDA's reporting. AHPA's Michael McGuffin shared his thoughts: "AHPA has been seeking this change for over a decade...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."
CCA shared: "This development is obviously good news for the coconut category, and also removes trade challenges. For brands and co-mans, this represents the lifting of a major burden, at the same time providing consumers with clear and not misleading information – coconuts are not tree nuts and just because you are allergic to one does not mean you are allergic to or should avoid coconuts."
CCA also has published its own findings regarding the prevalence and burden of coconut allergy in the United States, suggesting that prevalence and severity were in some cases several orders of magnitude less for coconut when compared to other listed major allergens.
The FDA report defines tree nuts for the purpose of complying with the food allergen labeling requirements of the FD&C Act and explains if manufacturers should declare tree nuts that are used as ingredients but not specifically listed in their major food allergens table as allergens.
Tree Nuts FDA Considers to be Major Food Allergens
Common or usual name/Scientific name (Family name is identified in parentheses.)
- Almond / Prunus dulcis (Mill.) D.A. Webb (Rosaceae)
- Black walnut / Juglans nigra L. (Juglandaceae)
- Brazil nut / Bertholletia excelsa Humb. & Bonpl. (Lecythidaceae)
- California walnut /Juglans californica S. Watson (Juglandaceae)
- Cashew / Anacardium occidentale L. (Anacardiaceae)
- Filbert/Hazelnut / Corylus spp. (Betulaceae)
- Heartnut/Japanese walnut / Juglans ailantifolia Carriere var. cordiformis (Makino) Rehder (Juglandaceae)
- Macadamia nut/Bush nut / Macadamia spp. (Proteaceae)
- Pecan / Carya illinoinensis (Wangenh.) K. Koch (Juglandaceae)
- Pine nut/Pinon nut / Pinus spp. (Pineaceae)
- Pistachio / Pistacia vera L. (Anacardiaceae)
- Walnut (English, Persian) / Juglans regia L. (Juglandaceae)
A full copy of the final guidance is available for review here.
