Last month the U.S. FDA published a 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” Coconut was removed from the major set of food allergens, where it had previously been classified incorrectly as a tree nut allergen. The final guidance takes the approach 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. Prior to the updated guidance, the FDA had considered coconut an allergen even though there was no scientific evidence to support this. FDA’s new guidance also delisted other plant parts from its list of tree nuts including kola nut, butternut and chestnut.
Many experts feel that the removal of these items from the allergen list, particularly coconut, is more realistic and will narrow the scope of label requirements for foods that contain tree nuts. The delisting of coconut as an allergen also removes trade challenges in the coconut category and eases manufacturing burdens for some facilities. The clarification to the major allergen list was made after repeated requests from industry groups and consumers.
About the Author
Julie Holt is a subject matter expert in the areas of food and beverage, additives and regulatory strategy. Ms. Holt’s expertise includes the beverage industry, with current consulting support across multiple beverage categories.
Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, she supported several food and beverage clients including a Fortune 50 company. Holt has provided global regulatory knowledge covering more than 200 countries. Her consulting efforts have supported global regulatory needs, R&D projects, sustainability goals and innovation initiatives.
