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 major U.S. bakery to stop using labels indicating its products contain potentially dangerous allergens when that is not the case.

U.S. Food and Drug Administration inspectors found that Bimbo Bakeries USA – which includes brands such as Sara Lee buns and rolls, Oroweat, Thomas’, Entenmann’s and Ball Park – listed ingredients such as sesame or nuts on labels even when they were not present. Food.

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

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

Additionally, FDA officials have indicated that allergen labeling is “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 33 million people with food allergies in the United States. These consumers need to be constantly aware of foods that can cause life-threatening allergic reactions, said Sung Poblete, general director of FARE.

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

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

Concerns about labels at Bimbo and other companies followed a law entered into force in 2022, which added sesame to the list of major allergens that must appear on packaging.

Because it can be difficult and expensive to keep sesame in one part of a baking plant versus another, some companies have begun adding small amounts of sesame to products that did not previously contain the ingredient. to avoid any liability and cost. FDA officials said this violated the spirit, but not the letter, of federal regulations.

Some companies, including Bimbo, have started listing allergens such as sesame on their 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 problem — or to explain why the labeling does not violate FDA standards.


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Education Media Group. The AP is solely responsible for all content.

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