FDA warns maker of Sara Lee and Entenmann’s not to claim foods contain allergens when they don’t

Federal food safety regulators said Tuesday they have warned a leading U.S. bakery to stop using labels that say their products contain potentially dangerous allergens when they do not.

U.S. Food and Drug Administration inspectors found that Bimbo Bakeries USA — which includes brands such as Sara Lee, Oroweat, Thomas’, Entenmann’s and Ball Park sandwiches — listed ingredients such as sesame or nuts on labels, even if they were not included. the food items.

Under FDA regulations, such products are “mislabeled,” FDA officials said in a warning letter sent earlier this month to officials at the company’s headquarters in Horsham, Pennsylvania.

“Food labels must be truthful and not misleading,” officials said. The warning followed inspections late last year at Bimbo factories in Phoenix, Arizona and Topeka, Kansas, where Sara Lee and Brownberry breads are made.

In addition, FDA officials indicated that allergen labeling is “not a substitute” for preventing cross-contamination in factories.

Advocate for the nonprofit FARE, Food Allergy Research & Education says such labeling “does a disservice” to the estimated 33 million people in the U.S. with food allergies. Those consumers need to be constantly aware of foods that could potentially cause life-threatening allergic reactions, says Sung Poblete, CEO of FARE.

“Our community relies on accurate product labeling for their health and safety,” Poblette said in an email. “These findings about Bimbo Bakeries products undermine their confidence and further limit their choices.”

Bimbo, a Mexico City-based food giant, calls its U.S. operations the country’s largest commercial baking company. In an email, company officials said they “take their role in protecting consumers with allergen sensitivities very seriously” and are corresponding with the FDA to resolve the issue.

Concerns about labels at Bimbo and other companies followed a law which came into effect in 2022, adding sesame to the list of major allergens that must be declared on packaging.

Because keeping sesame in one part of a baking plant from another can be difficult and expensive, some companies began adding small amounts of sesame to products that previously did not contain the ingredient to avoid liability and costs. FDA officials said this violated the spirit, but not the letter, of federal regulations.

Some companies, including Bimbo, began listing allergens such as sesame on labels as a precaution” in case of cross-contamination.

FDA officials acknowledged Tuesday that statements that a product “may contain certain allergens” can be considered truthful and not misleading. Bimbo officials have until July 8 to identify steps taken to correct the problem — or explain why the labeling does not violate FDA standards.

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