FDA has posted a warning letter issued to Whole Foods Market for engaging in a pattern of receiving and offering for sale misbranded food products under their own brand name. In some cases, FDA says that Whole Foods Market would receive finished products for repackaging and label them using misbranded scale labels. These products were misbranded because the finished product labels failed to declare all major food allergens present in the products, as required by the Federal Food, Drug, and Cosmetic Act.
Between October 2019 and November 2020, Whole Foods Market recalled more than 30 food products due to undeclared allergens. The implicated products were sold primarily in the bakery and deli sections of the store and are no longer available for sale. FDA noticed similar patterns of numerous recalls by Whole Foods Market for undeclared allergens in previous years as well.
Although retail establishments, such as Whole Foods Market, are excluded from certain requirements, they are responsible for ensuring the that the labeling for food manufactured under their brand name and the labeling that they perform in-store is accurate with respect to allergens. This is the first time the agency has warned a retail establishment for engaging in a pattern of offering for sale misbranded store brand labeled food products containing undeclared allergens. As part of FDA’s ongoing efforts to address undeclared allergens as the leading cause of food recalls, we have analyzed patterns of recalls, and this letter is part of that work along with other work to improve industry’s compliance with allergen labeling requirements and reduce undeclared allergen-related food recalls.