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 that they have warned a top U.S. bakery to stop using labels that say its products contain potentially dangerous allergens when they don't.

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 buns and rolls — listed ingredients such as sesame or tree nuts on labels even when they weren't in the foods.

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

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

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

Advocates with the nonprofit group FARE, Food Allergy Research & Education, said such labeling “does a disservice” to the estimated 33 million people in the U.S. with food allergies. Those consumers have to be constantly aware of foods that can cause potentially life-threatening allergic reactions, said Sung Poblete, FARE's chief executive.

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

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

Concerns over labels at Bimbo and other companies followed a law that took effect in 2022, which added sesame to the list of major allergens that must be listed on packaging.

Because it can be difficult and expensive to keep sesame in one part of a baking plant out of another, some companies began adding small amounts of sesame to products that didn't previously contain the ingredient to avoid liability and cost. FDA officials said that 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 “could be considered truthful and not misleading.” Bimbo officials have until July 8 to identify steps taken to remedy the issue — or to explain why the labeling doesn't violate FDA standards.


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