On December 22, the FDA issued a Warning Letter to Whole Foods Market “for a pattern of receiving and offering for sale misbranded food products necessitating a series of food recalls for allergens.” This is the first time the FDA has warned a retailer for engaging in such a pattern of selling misbranded food products containing undeclared allergens.

From October 2019 to November 2020, Whole Foods recalled 32 food products because the presence of major food allergens was not listed on the finished product labels. The FDA noticed similar patterns of recalls for undeclared allergens in previous years as well. The recalled products included a variety of foods sold under the Whole Foods in-house brand, although the foods were primarily from the deli and bakery sections of the store. For example, products were misbranded for failure to declare the presence of milk, eggs, and almonds, among other examples.

As our readers know, food or ingredients that contain one of the eight major allergens must be specifically labeled with the names of the allergen source. The eight major food allergens are milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. According to the FDA, undeclared food allergens have been the number one leading cause of Class I food recalls for at least the last three years. Thus, FDA has ongoing efforts to address undeclared allergens by analyzing patterns of recalls and have begun several initiatives to improve industry’s compliance with allergen labeling. For instance, in 2020, the FDA sent 8 warning letters to companies for issues related to undeclared allergens.

While the Warning Letter is unprecedented it reconfirms FDA’s attention and efforts to reduce the prevalence of allergen recalls. In an FDA press release, William A. Correll, Jr., Director of the Office of Compliance at CFSAN, stated that “[t]he entire food supply chain can and must do better to prevent exposing consumers to incorrectly labeled packaged food […] Manufacturers should also ensure they have controls in place to prevent unintentionally adding allergens during their manufacturing processes. When they fail to follow the law, we will take the necessary action.”