On June 17, the US Food and Drug Administration (FDA) issued a letter to Bimbo Bakeries USA warning them to stop claiming their products contain allergenic ingredients when they don’t.
The letter called out the manufacturer of such brands as Sara Lee, Entenmann’s, Thomas’, and Ball Park for listing sesame and tree nuts in their ingredient lists when they aren’t actually added to the products. The FDA cited violations of section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act:
The product labels are false or misleading because they include sesame seeds in the ingredient and “Contains” statements; however, sesame seed is not an ingredient in the product formulations.
Responding to the FDA, Bimbo officials are sticking to their guns, refusing to change their labeling practice.
The company stated it manufactures in facilities where some products are made with sesame while some are not and insists that it declares sesame as an ingredient and uses the same packaging for all of the products to prevent people from inadvertently eating foods that can trigger potentially life-threatening reactions.
“We think our approach is the most protective of sesame-allergic consumers,” the company wrote in a July 1 letter obtained by the advocacy group Center for Science in the Public Interest (CSPI) and shared with The Associated Press.
Why would Bimbo choose to label products with sesame as an ingredient when it is not?
The passage of the Food Safety and Modernization Act (FSMA) in 2016 raised the prevention of allergen cross-contact to the same level of concern as the prevention of microbial contamination. One of its regulations, cGMP, forced manufacturers to adopt procedures to minimize the opportunity for a top allergen from one product to contaminate another that does not contain that allergen as an ingredient.
Soon after the FSMA took effect, we reported on the first major company to skirt the regulation: Kellogg’s. They began adding trace amounts of peanuts to their Keebler and Austin crackers, thus allowing them to list the allergen as an ingredient and avoid the FSMA requirements.
A number of other manufacturers have followed suit over the years, adding trace amounts of allergens to skirt cGMP regulations, an abhorrent practice but one that is legal.
That practice accelerated with passage of the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) in January 2023 — which elevated sesame to the ninth ‘Top’ allergen requiring special handling. Numerous bakeries began adding sesame as an ingredient so they could include it to their ingredient lists in order to circumvent the costs and complexities of cGMP. This change meant that individuals with sesame allergies could no longer consume products they had trusted for years, even if sesame wasn’t previously an ingredient. For many, this has made it incredibly challenging — if not impossible — to find bread that is safe for their consumption.
Bimbo has taken this practice a step further by listing sesame as an ingredient but not adding it to the product at all in violation of regulations.
In 2023, CSPI petitioned the FDA to stop the practice of adding sesame to foods in order to prevent the risks of cross-contamination. Sarah Sorscher, CSPI’s director of regulatory affairs, stated that it is unclear what action the agency will take regarding Bimbo’s refusal to heed a warning letter.
“It’s so unusual to see a big company like Bimbo calling the FDA’s bluff,” she added.
We at SnackSafely.com abhor the practice of adding trace amounts of an allergen to save on costs — predicting it would become common practice in 2016 — and excoriated the commissioner of the FDA when he claimed he was blindsided by this practice after the FASTER Act was passed.
Learning that manufacturers aren’t even adding the allergens they claim to be adds insult to injury. It also introduces the inevitability that some consumers with food allergies may assume the allergen isn’t really an ingredient, leading to exposure and the possibility of life-threatening reactions.
We need the FDA to press forward and hold Bimbo accountable. Then we need the agency to rewrite the regulations to eliminate this practice entirely.
