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Bimbo Bakeries in hot water over misleading US allergen labels

17 Jul 2024

The FDA issued a warning to Bimbo Bakeries for falsely listing allergens, including sesame, on its product labels in the US. The warning comes amid reports of manufacturers adding allergens to both product labels and formulations to avoid cross-contamination events and rigorous cleaning procedures required by new labelling laws.

Bimbo Bakeries USA, the American division of Grupo Bimbo, a Mexican multinational bakery company, received a warning letter from the US Food and Drug Administration (FDA) on 17 June 2024 due to significant labelling violations discovered during inspections at the company’s Phoenix and Topeka facilities in late 2023. Bimbo Bakeries brands include Sara Lee, the Cheesecake Factory at Home, and Nature’s Harvest, among others.

The FDA identified that several ready-to-eat bread products were misbranded under the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they listed major food allergens on their labels that were not present in the product formulations. According to the FDA, via a constituent update, food products must "bear truthful and non-misleading labelling" and that failing to do so, means they are considered misbranded.

In addition, the FDA acknowledged that such practices could decrease choices for consumers with food allergies. It also reiterated the importance of accurate and truthful labelling across the supply chain to protect consumers.

Bimbo Bakeries incorrectly lists various nuts on labels

The FDA inspection of the Phoenix facility from 3 -27 October 2023, found that products including the Sara Lee brand, Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain, listed sesame in their ingredient and "Contains" statements, despite there being no sesame in the formulations.

Similarly, the Brownberry brand Whole Grains 12 Grains and Seeds product, inspected at the Topeka facility between November 13 - 27, 2023, incorrectly listed walnuts, almonds, and hazelnuts in the ingredient and "Contains" statements without these nuts being part of the product formulation. The FDA said: “Firms are required to accurately list ingredients present in their product.” The FDA added that firms must not rely on misleading labels as a substitute for following good manufacturing practices (GMPs) and must implement appropriate preventive controls to prevent allergen cross-contact.

Manufacturers intentionally add allergens to previously allergen-free products

In January 2023 sesame was added to the list of major food allergens, as part of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, in the US. What this means is that food manufacturers using sesame in their formulations need to declare its presence on both the ingredients list and in the “Contains” statement, as well as ensure procedures are in place to avoid cross-contamination and that manufacturing equipment is thoroughly cleaned between production lines.

However, following the 2023 enactment, there have been multiple reports of manufacturers responding to the allergen labelling laws by intentionally adding allergens like sesame to previously allergen-free products to avoid the need for rigorous cleaning procedures to prevent cross-contamination.

This practice has been criticised by organisations like the Center for Science in the Public Interest (CSPI), which filed a regulatory petition to the FDA in 2023, urging the FDA to rein in manufacturers intentionally adding sesame to their formulations. In a press release Sarah Sorscher, director of regulatory affairs at CSPI said:“The allergen labeling and food safety rules give companies a responsibility to identify and reduce risks, […] their approach is completely backwards.”

Sorscher also highlighted the danger of this practice by manufacturers, adding “If companies can do this with sesame, there is nothing to stop them from adding other peanuts, milk, or other major allergens instead of cleaning the lines for allergens in between products.”

Bimbo Bakeries facing industry backlash over the incident

In response to the FDA warning letter, the non-profit organisation Food Allergy Research & Education (FARE) issued a statement, in which Robert Earl, vice president of regulatory affairs said: “Our community relies on accurate product labelling for their health and safety and these findings about Bimbo Bakeries’ products undermine their trust and further limit choices."

This stance was further emphasised by Sung Poblete, FARE’s CEO, who added "Given the size and reach of Bimbo Bakeries to American consumers, FARE expects better. Losing the food allergy community's respect also extends to the restaurants and institutions that buy their products, beyond retail packaged products. The food allergy community shouldn’t have to deserve less.”

Lauren Handel, principal attorney at Handel Food Law LLC, based in New York, also posted to her LinkedIn about the incident. She said: “If these allegations are true, why would a big, sophisticated food manufacturer say that its product contains allergens when it does not?”

She added: “With undeclared food allergens being the top reason for food recalls (and recalls being an expensive hassle), it is understandable that manufacturers would seek to reduce the risk of a recall by declaring an allergen that could unintentionally be present in the product due to cross contact.”

She, however, criticised the practice of using misleading labels, stating, “The important lesson here is that food labels must be truthful and not misleading. You should not use a label to make up for deficiencies in manufacturing processes.”

Response from Bimbo Bakeries expected within 15 working days

In the warning letter, the FDA has requested a response from Bimbo Bakeries within 15 working days, detailing the specific steps the company has taken to address the violations or providing a justification if Bimbo Bakeries believes it is not in violation.