The U.S. Food and Drug Administration (FDA) has published the final version of an allergen guidance this past week 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 is intended to explain the application of labeling requirements under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) through a series of questions and answers. The Coconut Coalition of the Americas (CCA) has been active and in dialogue with the agency over the past few years.
The U.S. Food and Drug Administration (FDA) has published the final version of an allergen guidance this past week 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 is intended to explain the application of labeling requirements under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) through a series of questions and answers. The Coconut Coalition of the Americas (CCA) has been active and in dialogue with the agency over the past few years.
For some time, FALCPA had been under scrutiny with challenges to its scientific merit based on very broad interpretations of the term ‘tree nut.’ CCA had investigated challenging FALCPA but until 2022, no major changes had tested the law itself. On January 1, 2023, sesame was added as a 9th major allergen class and provided an actual test and process for further changes to FALCPA.
In this new final guidance, specifically questions C7 and C8 and Table 1, FDA makes clear that there is a finite number of what it considers tree nuts with major scientifically established allergenicity to be considered serious food allergens. Coconuts are not on this list.
CCA activities in the past 24 months included supporting and underwriting a paper in which coconut allergenicity prevalence, severity and cross-allergenicity were examined. The data suggested that prevalence and severity were in some cases several orders of magnitude less for coconut compared to listed major allergens.
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.
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