FDA WARNING_LETTER - Bimbo Bakeries USA, Inc. - October 27, 2023

The FDA issued a Warning Letter to Mr. Gavin following inspections of facilities in Phoenix, AZ (October 3-27, 2023) and Topeka, KS (November 13-27, 2023). The inspections, including one by the Kansas Department of Agriculture, revealed serious violations of the Federal Food, Drug, and Cosmetic Act.

The primary violations concern misbranding of ready-to-eat bread products. Sara Lee brand Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain products are misbranded because their labels falsely declare sesame seeds in ingredient and "Contains" statements, despite not being in the formulation. Similarly, Brownberry brand Whole Grains 12 Grains and Seeds products are misbranded as their labels list walnuts, almonds, and hazelnuts, which are not ingredients. The FDA emphasizes that labeling is not a substitute for good manufacturing practices or preventive controls for allergen cross-contact.

Additionally, the Brownberry brand Whole Grains 12 Grains and Seeds product is misbranded for undeclared ingredients, specifically (b)(4) for (b)(4), (b)(4) as (b)(4), and (b)(4) for (b)(4), which the company considers insignificant but FDA previously determined have technical functions and must be declared. The label also incorrectly uses "Kamut®" (a brand name) instead of "K