FDA Issues Warning Letter to Whole Foods Market for Misbranded Products

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Silver Spring, MD—FDA has issued a warning letter to Whole Foods Market for engaging in a pattern of receiving and offering for sale misbranded food products under their own brand name. In a press release, FDA explains that in some cases, Whole Foods would receive finished products for repackaging and label them using finished product labels that failed to declare all major food allergens present in the products.

Unlabeled allergens are the leading cause of recalls, the press release states, and a leading cause of reportable foods registry reports. Undeclared allergen-related reportable food reports have steadily increased since the Reportable Food Registry began. In 2020, FDa has issued eight warning letters to registered food facilities that have manufactured and distributed foods with undeclared allergens.

Retail establishments, the press release explains, are responsible for ensuring that the labeling for food manufactured under their brand name and labeling performed in-store is accurate with respect for allergens. The warning sent to Whole Foods Market marks the first time FDA has warned a retail establishment for selling such misbranded products.

Whole Foods Market recalled more than 30 food products due to undeclared allergens between October 2019 and November 2020. The products were sold primarily in the bakery and deli sections of the store and are no longer available for sale. The press release states that FDA noticed similar patterns of numerous recalls for undeclared allergens in previous years as well.

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William A. Correll, Jr., Director, Office of Compliance, Center for Food Safety and Applied Nutrition, said in the press release: “Last week, the FDA warned Whole Foods Market for engaging in a pattern of offering misbranded food for sale—either by receiving finished Whole Foods store brand products from third-party suppliers with misbranded labels or by using misbranded labels when repackaging food—in the bakery and deli sections of their stores. The warning letter follows a series of recalls in the past year of more than 30 food products sold under the Whole Foods brand because the food label did not declare at least one ingredient that is a major food allergen.

“The entire food supply chain can and must do better to prevent exposing consumers to incorrectly labeled packaged food,” Correll added. “To address the problem, the FDA is working to improve industry’s compliance with allergen labeling requirements and reduce food recalls due to undeclared allergens.”

Whole Foods Market must respond within 15 business days of receiving the warning letter to inform FDA of the specific actions the company is taking to address the violation.

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