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June 26, 2024

FDA warns Horsham-based Bimbo Bakeries USA to stop 'misbranding' products

Inspectors found the company, which includes Thomas' and Sara Lee, claimed some of its food contained an allergen when it didn't.

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Bimbo bread Bimbo Bakeries/for PhillyVoice

The FDA has warned Bimbo Bakeries USA, headquartered in Horsham, that it has "misbranded" some of its products as containing allergens, such as sesame, when they actually do not. Artesano Golden Wheat was one of the products the FDA cited in its warning as being mislabeled.

Food and safety regulators have warned a top international bakery company, whose U.S. headquarters are in Horsham, not to use allergen labeling on products when they don't actually contain allergens.

Inspectors from the U.S. Food and Drug Administration found that Bimbo Bakeries USA, which includes brands such as Entenmann's, Sara Lee, Thomas' and Oroweat, had put warning labels that certain products contained sesame and tree nuts when, in fact, they did not.

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"Any allergen advisory statement must be truthful and not misleading," the FDA wrote in its warning letter to Bimbo on June 17. The FDA said Bimbo had "misbranded" certain products, among other violations, and gave the company 15 working days from the receipt of the letter to notify the regulators about steps the company was taking to remedy the issues.

The estimated 33 million Americans who have food allergies need to be able to trust that labeling is accurate for health and safety reasons, and labeling food allergens that are not present in products unnecessarily limits food choices. "Misbranding" products as potentially containing allergens may also represent a way for manufacturers to tiptoe around labeling requirements that have become stricter in recent years, health advocates said. 

Legislation passed in 2021, which took effect in 2023, requires food manufacturers to list sesame as an allergen on packaged foods, including dietary supplements. In order to avoid cleaning lines or creating segregated manufacturing lines to avoid cross-contact with sesame, some manufacturers have added small amounts of sesame powder to foods and listed them on labels, according to the Center for Science in the Public Interest. 

"We request that the Food and Drug Administration issue a notice to manufacturers stating they cannot meet their food safety obligation to mitigate allergen cross-contact risks by, paradoxically, adding sesame or other major allergens intentionally to foods," the watchdog group wrote to the FDA last year.

Robert Earl, vice president of the nonprofit group Food Allergy Research & Education, wrote in an email: "Just as FARE finds the practice of intentionally adding sesame flour to avoid thorough cleaning or segregating lines to be an act of malicious compliance, including sesame and other food allergens in an ingredient list and ‘Contains statement’ also does a disservice to those with food allergies."

Bimbo, which has its corporate headquarters in Mexico City, calls itself the "largest commercial baking company in the U.S." The FDA warning came after inspections last year at plants in Phoenix and Topeka, Kansas. The company is one of the Philadelphia Union's main sponsors, with "Bimbo" printed on the front of the soccer club's jerseys.

Bimbo Bakeries takes its "role in protecting consumers with allergen sensitivities very seriously, through good manufacturing practices in our facilities and informative labeling on our packages," the company said in a statement, adding that it was corresponding with the FDA to resolve the matter.

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