The FDA issued a warning letter to Bimbo Bakeries USA, Inc. over including ingredients that are or contain major food allergens on labels, without those ingredients being included in the product formulations.

An inspection carried out late last year in Phoenix, Arizona, found that certain Bimbo Bakeries USA, Inc. ready-to-eat bread loaf products, including Sara Lee brand Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain, listed sesame as an ingredient and in their ‘Contains’ statements even though there was no sesame in the product formulations. Additionally, at another late 2023 inspection in Topeka, Kansas, the FDA found that the company’s Brownberry brand Whole Grains 12 Grains and Seeds ready-to-eat bread loaf product listed walnuts, almonds, and hazelnuts in the ingredient and ‘Contains’ statements, without those ingredients being in the formulation.

Instead, an advisory statement such as “may contain” could be considered truthful and not misleading in addressing situations where there are low levels of potential unintended allergens present due to cross-contact, despite the use of strong GMPs, the FDA said in a statement. However, listing a major food allergen in the ingredient statement or “Contains” statement when it is not present in the product formulation does not comply with FDA labeling requirements.

The FDA has asked the company to respond within 15 days of receipt of the warning letter, stating the specific steps it has taken to address any violations and prevent the recurrence of violations or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.

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