FDA warns major US bakery to stop claiming its foods contain allergens when they don’t

The U.S. Food and Drug Administration (FDA) sent a stern warning to a top U.S. bakery to stop using labels that say its products contain potentially dangerous allergens when they don’t. 

FDA inspectors discovered Bimbo Bakeries USA – responsible for brands like Thomas’, Entenmann’s, Sara Lee, Oroweat and Ball Park Buns and Rolls – labeled their products to include sesame or tree nuts, even when they were not in the products.

In a warning letter to the company’s headquarters in Horsham, Pennsylvania, FDA officials said such products are “misbranded.”

The warning came after the FDA conducted inspections in October and November 2023 at Bimbo plants in Phoenix and Topeka, Kansas, which make Sara Lee and Brownberry breads.

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Officials also told the company that allergen labeling is “not a substitute” for preventing cross-contamination in factories.

For example, the FDA told the company the Sara Lee brand Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain ready-to-eat bread loaf products are misbranded, in that the product labels are mislabeled to say the foods include sesame seeds in the ingredient and “Contains” statements, though sesame seed is not an ingredient in the product formulations.

“Food labels must be truthful and not misleading,” officials said.

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The FDA warned Bimbo that it “must be truthful” with its food labels. (Scott Olson/Getty Images / Getty Images)

“Bimbo Bakeries USA takes our role in protecting consumers with allergen sensitivities very seriously, through good manufacturing practices in our facilities and informative labeling on our packages,” a spokesperson for the company told FOX Business. “We are corresponding with the FDA to resolve this matter.”

Bimbo bills its operations in the U.S. as the largest commercial baking company in the country.

In 2022, a new law went into effect requiring all foods made and sold in the U.S. to be labeled if they contain sesame, which Congress designated as the nation’s ninth major allergen.

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The FDA gave Bimbo 15 days, or until July 8, to address the situation and provide steps the company has taken to correct the issue. Alternatively, Bimbo can defend itself by demonstrating to the FDA that it did not violate standards with its labeling.