FDA Warns Bimbo, Manufacturer of Sara Lee and Entenmann’s, About Fake Allergen Claims


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 calls 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 in 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.

You might wonder why a manufacturer would list an allergen in its ingredient list when there is none. To answer that, we need to look back.

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Some 18 years ago, the Food Allergen Labeling Consumer Protection Act (FALCPA) identified 8 major allergens — peanuts, tree nuts, milk, eggs, soy, wheat, fish, and crustacean shellfish — that must be identified by their common name on the package if they are ingredients of the product.

More allergen regulations were introduced in 2011 as a result of the passage of the Food Safety and Modernization Act (FSMA), which raised prevention of allergen cross-contact to the same level of concern as prevention of microbial contamination. One of its regulations known as cGMP which took effect in 2016 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 regulationKellogg’s. They began adding trace amounts of peanuts to their Keebler and Austin lines of crackers, thus allowing them to list the allergen as an ingredient of the product and by doing so avoid the requirements of the FSMA. We called them out on it and circulated a petition that garnered over 29,000 signatures to no avail.

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Since then, we’ve reported on other companies deliberately adding allergens to products including Hostess adding peanuts to Suzy Q’s and Pearson’s Candy adding tree nuts to their mint patties.

With the implementation of the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) in January 2023 — elevating sesame to the 9th ‘Top’ allergen requiring special handling — numerous bakeries began resorting to the same abhorrent practice, adding sesame as an ingredient so they could include it to their ingredient lists in order to circumvent 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.

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 is not really an ingredient, leading to exposure and the possibility of life-threatening reactions.

Bimbo officials have until July 8 to identify steps taken to remedy the issue or to explain why the labeling doesn’t violate FDA standards.

We need the FDA to abolish this practice entirely.

What do you think? Sound off in the comments section below.

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Dave Bloom
Dave Bloom
Dave Bloom is CEO and "Blogger in Chief" of SnackSafely.com.

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  1. While I’m happy that the FDA has called them out on this, I fear that the response will be to actually add sesame as an ingredient to those products. What all of those major bread manufacturers have done (adding trace amounts of sesame) seems to be against the spirit of the FASTER Act. The act was intended to make consumers with sesame allergy safer, not to further limit their options. All of that aside, consumers need truth in labeling. Everyone, and most especially food allergic consumers need to know exactly what is in the food that they are purchasing. Voluntary “contains” and “may contain” statements are useless since they’re inconsistent and not regulated. Food allergic consumers can only rely on the actual ingredient label. Shame on the manufacturers listed in this article who chose a lazy, CYA route. What they should be doing is developing better cleaning protocols of their lines and better yet, they should figure out a way to have a line dedicated to being free of the top 9 allergens. The 1st major bakery to do so will have loyal customers for life.

  2. Do I want a great variety of safe food options for everyone? Of course I do… But to me the most important thing is that an allergen is listed on the label if there is any possibility of it being in there. I don’t think requiring manufacturers to make sesame free bread is reasonable. If certain companies put sesame in all their bread, well I’m sure another company will see a need for sesame free bread and start making it. That’s what happened with other allergens and why so many companies sprang up making dairy free, gluten free products, etc. The same will happen for sesame.

  3. I want companies to list all allergens in the ingredient list AND may contain statement should always be there if they use the same line as a product that has allergens. Companies not listing allergens because their cleaning process should be trusted does not work. How many recalls do you see every week? If these companies are so good with their procedures why the recalls? Errors are being made every day but I should trust that you cleaned the machine correctly and not tell me that there is a possibility of an allergen.

  4. Anything that weakens the integrity of our food allergy warnings can pose an overall health risk to those of us who deal with this serious, potentially life threatening challenge on a daily basis.

  5. I’m gluten sensitive. I can buy brand-name Cheerios that state plainly on tge packaging ‘gluten feee’ but generuc brands lisylt wheat in their ingredients! What the heck??? Is this just some ploy to avoid some regulation? It burns me to have to buy name brand just to be sure I don’t feel ill later.

  6. Sometimes I truly think I’ll lose my mind with the horrendous behavior of American companies purposely skirting their responsibility to food-allergic individuals. The lack of interest/care for others is appalling! I hate that we live in a country that does not care about others … especially our vulnerable life-threatening food-allergic souls. Corporate greed reigns supreme, above all else. Just makes me sick … that is all!!!


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