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Whole Foods said it's working closely with the FDA to ensure its stores "meet if not exceed" food safety requirements.

FDA warns Whole Foods over products with undeclared food allergens

Agency cites more than 30 recalled items by specialty grocer over one-year period

The Food and Drug Administration has issued a warning to Whole Foods Market over what the agency called a “pattern” of recalls related to food allergens not listed on product packaging.

In a warning letter to Whole Foods posted yesterday, the FDA said the Austin, Texas-based specialty grocer “engaged in a pattern” of receiving and offering for sale “misbranded food products” under its own label that failed to declare all major food allergens among their ingredients, as required by the Federal Food, Drug and Cosmetic Act. In turn, between October 2019 and November 2020, Whole Foods recalled 32 products because of undeclared allergens, the agency reported.

The affected products were sold mainly in the bakery and deli departments and are no longer available for sale, the FDA said, noting that it has seen similar patterns of “numerous recalls” by Whole Foods for undeclared allergens in previous years. The agency sent the warning letter to John Mackey, president and CEO of Whole Foods, on Dec. 16. 

“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,” William Correll, director of the Office of Compliance in the FDA’s Center for Food Safety and Applied Nutrition, said in a statement.

“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,” he added.

A subsidiary of Amazon, Whole Foods noted that it’s working with the FDA to resolve the issue.

“Whole Foods Market takes food safety very seriously,” a Whole Foods spokesperson said in a statement. “We are working closely with the FDA to ensure all practices and procedures in our stores meet, if not exceed, food safety requirements. We remain committed to maintaining the highest quality standards in the industry.”

Among the allergen-related recalls, the FDA said, are Whole Foods Market Minestrone Soup (undeclared milk); Whole Foods Market Raspberry Cheesecake Italian Gelato (undeclared egg); Whole Foods Market White Parkerhouse Rolls (undeclared milk and egg); Chantilly Key Lime Tartlets repackaged with Whole Foods scale labels (undeclared almonds); and various varieties of Whole Foods and other branded individually sliced cheeses in plastic wrap with scale labels (undeclared egg). 

In its recall documentation, Whole Foods cited such issues as the labeling system for repackaged foods not being updated to reflect current ingredient listings and a contract manufacturer packaging a product with the incorrect label, the FDA reported. Other reasons included retail employees applying a label that didn’t reflect the ingredient listing on the manufacturer’s label, and a master carton ingredient statement not being fully transferred to the scale label used for individual containers.

The eight foods identified as major food allergens, according to the FDA, 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.

“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,” the FDA said. “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.” 

Whole Foods, which operates 487 U.S. stores, has 15 business days from receipt of the warning letter to respond, the FDA said.

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