FDA In Brief: FDA Issues Warning Letter to Whole Foods Market After Repeated Recalls of Foods Packaged with Incorrect Allergen Labeling
December 22, 2020
Media Contact: Courtney Rhodes, 202-281-5237
Consumer Inquiries: 888-INFO-FDA
The following quote is attributed to William A. Correll, Jr., Director, Office of Compliance, Center for Food Safety and Applied Nutrition:
“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 FDA is committed to protecting the health of the American people. It’s important that food packaging, at all points of the supply chain, appropriately lists the presence of all major food allergens so that individuals with food sensitivities can take appropriate steps to avoid products that may cause them serious and life-threatening harm.
“Undeclared food allergens are the number one leading cause of Class I food recalls for at least the last three years. Consumers deserve to know exactly what they are buying to eat and to trust that the product labels clearly list all major food allergens.
“The entire food supply chain can and must do better to prevent exposing consumers to incorrectly labeled packaged food. 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.
“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.”
- Today, the U.S. Food and Drug Administration 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, 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 section 403(w)(1) of 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 the 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.
- Unlabeled allergens continue to be the leading cause of recalls and a leading cause of reportable foods registry reports. In addition, undeclared allergen-related reportable food reports have steadily increased since the Reportable Food Registry began. The FDA has issued eight warning letters to registered food facilities that have manufactured and distributed foods with undeclared allergens in 2020.
- The eight foods identified as major food allergens are milk, eggs, fish (such as bass, flounder, or cod), crustacean shellfish (such as crab, lobster, or shrimp), tree nuts (such as almonds, walnuts, and pecans), peanuts, wheat, and soybeans.
- Whole Foods Market needs to respond within 15 business days of receiving the warning letter to inform the FDA of the specific things the company is doing to address this violation.
- Recalls, Market Withdrawals, & Safety Alerts
- Recalls Background and Definitions
- Food Allergies
- Guidance for Industry: Questions and Answers Regarding Food Allergens
- Whole Foods Warning Letter Constituent Update
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.