FDA tells Bimbo Bakeries to stop using labels to claim foods may contain allergens when they don't

HORSHAM, Pa. (KYW Newsradio) — The U.S. Food and Drug Administration says Bimbo Bakeries USA,  based in Horsham, Montgomery County, has mislabeled its products, claiming they contain potentially dangerous allergens even when they don't.

FDA inspectors found that the company — which includes brands such as Sara Lee, Oroweat, Thomas', Entenmann's and Ball Park buns and rolls — would list ingredients such as sesame seeds and tree nuts in certain products, even if those ingredients weren't actually used to make those items.

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

In addition, FDA officials indicated that allergen labeling is a “not a substitute” for doing the work to prevent cross-contamination in factories. “Food labels must be truthful and not misleading,” officials said.

The FDA made this discovery last year after inspecting plants in Phoenix, Arizona, and Topeka, Kansas, that make Sara Lee and Brownberry breads. The nonprofit group Food Allergy Research and Education says 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 international food giant, bills its U.S. operation 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're working with the FDA to resolve this 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.