The U.S. Food and Drug Administration (FDA) has warned an American bakery company to stop falsely labeling some of its products as containing potentially dangerous allergens.
During FDA inspections last year, the agency said it found that some items made by Bimbo Bakeries USA, part of the Mexican-owned Grupo Bimbo, were misbranded and therefore false or misleading.
Bimbo Bakeries USA, the largest commercial baking company in the United States, makes an array of baked goods brands including Oroweat, Thomas’, Entenmann’s, and Ball Park buns and rolls.
Some of the items allegedly misbranded by Bimbo Bakeries USA at its factories in Phoenix and Topeka include its Sara Lee brand Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain ready-to-eat bread loaf products, according to the FDA.
Those item’s labels were false or misleading because they listed sesame seeds as an ingredient in the “contains” section of the product label when sesame seed is not an ingredient in the product formulations, the FDA said.
A sesame allergy is the ninth major food allergen in the United States, with an estimated one million Americans having such an allergy, according to the Academy of Nutrition and Dietetics.
Other items allegedly misbranded include the Brownberry brand Whole Grains 12 Grains and Seeds RTE bread loaf product, which lists walnuts, almonds, and hazelnuts in the ingredient section of the item, despite those ingredients not being in the formulation of the product, according to the FDA.
Walnuts, almonds, and hazelnuts are tree nuts and are also one of the nine most common food allergies, affecting roughly 0.5 to 1 percent of the U.S. population, according to the American Academy of Allergy, Asthma & Immunology.
Precautionary Measure
Some companies, including Bimbo, list allergens such as sesame on labels as a precautionary measure in case of cross-contamination during production, according to a January 2023 petition from the Center for Science in the Public Interest.The petition urged manufacturers to stop intentionally adding sesame and other major allergens to products when they identify allergen cross-contact risks.
“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,” the FDA wrote in its letter to Mr. Gavin.
“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.”
‘Serious Violations’
The FDA inspected plants belonging to Bimbo Bakeries USA in Phoenix, Arizona, from Oct. 3, 2023, to Oct. 27, 2023, according to a June 17 letter the agency sent to Tony Gavin, the president of the company.It also commissioned Kansas Department of Agriculture employees to inspect the company’s plant in Topeka, Kansas, from Nov. 13, 2023, through Nov. 27, 2023, the letter states.
Elsewhere in the letter, the FDA said Bimbo Bakeries USA’s Brownberry brand Whole Grains 12 Grains and Seeds listed ingredients including “Kamut®” which it said “is not part of the common or usual name of Khorasan wheat because it is a brand name.”
Based on the findings of its inspections, the FDA said it had identified “serious violations” of the Federal Food, Drug, and Cosmetic Act among other regulations.
“It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulation,” the agency wrote. “You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.”
The agency concluded its letter by giving Bimbo Bakeries USA 15 days to notify the FDA of the steps it had taken to address any violations or to explain how the bakery’s products do not violate the Federal Food, Drug, and Cosmetic Act.
The Epoch Times Times has contacted a spokesperson for Bimbo Bakeries USA for comment.
