WASHINGTON — Based on inspections conducted at two Bimbo Bakeries USA baking plants last fall and a review of the company’s product labels, the Food and Drug Administration has identified “serious violations” of the Federal Food, Drug and Cosmetic Act.
The FDA findings were included in a June 17 warning letter sent to Tony Gavin, president of Horsham, Pa.-based BBU. The letter came from E. Mark Harris, program division director of the FDA’s Office of Human and Animal Food Operations — West Division 4.
In his letter, Harris said inspections were conducted in October over a three-week period at a BBU plant in Phoenix and in November over a two-week period at a company facility in Topeka, Kan.
The inspections found under BBU’s Sara Lee brand, its Artesano Brioche, Sara Lee Delightful Multigrain, Artesano Golden Wheat and Artesano Smooth Multigrain are misbranded “in that the products’ labels are false or misleading because they include sesame seeds in the ingredient and ‘Contains’ statements.” Sesame seeds are not an ingredient in the bread, the FDA said.
The letter said BBU’s Brownberry brand Whole Grains 12 Grains and Seeds bread is similarly mislabeled.
“The product label includes walnuts, almonds and hazelnuts in the ingredient and ‘Contains’ statement,” but the products do not contain the ingredients, the letter said.
“FDA expects food manufacturers to follow good manufacturing practices and implement preventive controls to prevent the unintentional incorporation of allergens into foods which are not formulated to contain them,” Harris said. “Labeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls. Instead, firms must comply with applicable requirements to address allergen cross-contact.”
The FDA also said the Brownberry brand Whole Grains 12 Grains and Seeds variety lists “Kamut” as an ingredient, contending it is “not part of the common or usual name of Khorasan wheat because it is a brand name.” The FDA said Khorasan is misspelled as Khorsan.
Additional unspecified ingredients in the bread are not included on the ingredient list because BBU believes the levels are neither significant nor adequate to provide functional or technical effects, the letter said. Harris said the company previously was informed two of the ingredients do provide technical functions and “must be declared on the labels.”
The letter said investigating and determining the causes of the violations is a responsibility of BBU as is “preventing their recurrence or the occurrence of other violations.” It instructed the company to respond within 15 working days, notifying the FDA of receipt of the letter and specific steps taken to prevent a recurrence of violations.
Asked to comment on the FDA letter, BBU replied with a statement: “Bimbo Bakeries USA takes our role in protecting consumers with allergen sensitivities very seriously, through good manufacturing practices in our facilities and informative labeling on our packages. We are corresponding with the FDA to resolve this matter.”