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  1. CFSAN Constituent Updates

FDA Issues Warning Letter to Bimbo Bakeries Over Food Allergen Labeling Concerns

Constituent Update

June 25, 2024

On June 17, 2024, the U.S. Food and Drug Administration (FDA) issued a warning letter to Bimbo Bakeries USA, Inc. because, during two inspections in late 2023, FDA found that some of the company’s bakery products included ingredients that are or contain major food allergens on their labels, but those ingredients were not included in the product formulations. Food products must bear truthful and non-misleading labeling; otherwise, they are misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, during a late 2023 inspection in Phoenix, Arizona, the FDA found that certain Bimbo Bakeries USA, Inc. ready-to-eat (RTE) 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 RTE bread loaf product listed walnuts, almonds, and hazelnuts in the ingredient and “Contains” statements, without those ingredients being in the formulation.

Food labels must be truthful and not misleading. Firms are required to accurately list ingredients present in their products. In addition, firms are required to follow good manufacturing practices (GMPs) and implement appropriate preventive controls to prevent allergen cross-contact. Allergen cross-contact is the unintentional incorporation of allergens into foods which are not formulated to contain them. Labeling is not a substitute for adherence to GMPs or implementation of preventive controls. Instead, firms must comply with applicable requirements to address allergen cross-contact. The FDA recognizes that 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. 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.

People with food allergies need to be able to utilize accurate labeling to feel confident in their food choices. Following the passage of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which added sesame to the list of major food allergens, the FDA has become aware of practices, like the company’s action described in the warning letter, which may lead to a decrease in choices for consumers with food allergies. The agency is continuing to monitor the situation and will take necessary and appropriate steps to protect consumers with food allergies.

It’s important that food labeling, at all points of the supply chain, appropriately and accurately reflect a food’s contents and formulation, including the presence of all major food allergens. Individuals with food allergies need safe food choices that allow them to take appropriate steps to avoid products that may cause them serious and life-threatening harm. Additionally, it is essential to ensure the integrity of the food label, including the ingredient and “Contains” statements, so that consumers can trust the information on the food label to make informed choices.

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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