Consumer groups concerned by Bimbo Bakeries' response to FDA warning letter

Bakery doubles down on decision to add sesame in lieu of taking steps to prevent cross-contamination

Consumer groups CSPI (Center for Science in the Public Interest) and FARE (Food Allergy Research & Education) today announced ongoing concern over baked goods manufacturer Bimbo Bakeries’ response to a Food and Drug Administration warning letter, stating it planned to continue adding sesame, a major food allergen, to its products while also falsely declaring sesame on its labels in products that don’t contain it.

Bimbo Bakeries is the self-titled largest commercial baking company in the U.S., whose brands include household names like Sara Lee, Entenmann’s, Thomas’ and others.

The bakery received a warning letter from the FDA in June after food safety inspectors discovered that the bakery was falsely declaring sesame as an ingredient on some of its labels of Sara Lee brand bread and other products when sesame was not an ingredient. The agency pointed out that companies can use truthful precautionary allergens statements, such as “may contain sesame,” to identify potential unintentional contamination with sesame, as an alternative to falsely declaring sesame as an ingredient.

In a response letter sent in June, obtained by CSPI through a request to FDA under the Freedom of Information Act, the bakery doubled down on its labeling practices, stating that it had chosen to add sesame to some of its product lines in response to new food safety requirements under the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act that require food manufacturers to prevent sesame cross-contamination.

Bimbo claimed that it had not been able to control trace amounts of sesame in some of its manufacturing facilities, and "determined that the most protective approach for sesame-allergic consumers” was to add sesame as an actual ingredient to all products that are baked on the same line as products that contain sesame. This practice varies by facility, so to create consistency, Bimbo declares sesame as an ingredient for all products with the same name, even when sesame is not an ingredient. This clearly violates the requirement that labels not be false or misleading.

CSPI had previously petitioned FDA to ban the practice of adding allergens or falsely declaring ingredients to evade food safety rules after multiple companies began adding sesame to bakery products following passage of the FASTER Act. The companies’ apparent intent was to evade costly recalls when an undeclared allergen was discovered, which can be required even if the label contained a “may contain” type of unregulated precautionary allergen labeling statement. FDA responded to the petition by stating it cannot bar companies from adding sesame or other food allergens, but can stop them from falsely declaring them as an ingredient, which is the case here in its warning letter to Bimbo Bakeries.

“It’s a perverse response to food safety rules,” says Sarah Sorscher, Director of Regulatory Affairs for Center for Science in the Public Interest. “You add an ingredient that could trigger a harmful food allergy reaction, slap a label on it, and say you’ve solved the problem. Then you label even those versions that contain no sesame as containing it. We call on Bimbo Bakeries and other manufacturers to find a better approach for addressing cross-contact risks and take sesame out of these products, where it never should have been added to begin with.”

FARE and other allergen groups supported the CSPI petition to ban the practice of intentionally adding food allergens, and previously credited FDA for warning Bimbo against the practice of falsely declaring sesame on its labels.

"FARE represents a patient community of more than 33 million people in the U.S. alone who live with the disease of food allergy every day—and there are lives at stake," said Sung Poblete, PhD, RN, CEO of FARE. "We are disappointed to learn that Bimbo Bakeries is defending its poor behavior under the guise of feigning concern for this patient community. In the long run, we are confident that those who respect and work to earn the loyalty of this community will win. We hope that Bimbo Bakeries and the brands that it manufactures learn this lesson and change their behavior. The community is watching."

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