The U.S. FDA has warned a major commercial baker to stop using labels that list sesame and nuts as ingredients in breads, when they are not in fact present. In a warning letter, the federal agency told Bimbo Bakeries USA that such product labels are false and misleading.
The FDA says several of Bimbo’s Sara Lee brand breads and one Brownberry brand loaf product are “misbranded.” This is because they do not contain the sesame or nut allergens, despite claims on the packages.
The warning follows FDA inspections of two manufacturing facilities in late 2023 and a review of product labels. Inspectors found “serious violations” of federal food allergen labeling requirements, according to the June 17, 2024 warning letter.
“Our community relies on accurate product labeling for their health and safety,” Robert Earl, vice president of regulatory affairs for the food allergy nonprofit FARE, tells Allergic Living. “These findings about Bimbo Bakeries’ products undermine their trust and further limit choices.”
The FDA warning says sesame is incorrectly listed in the ingredients and “contains” statements of Sara Lee Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat, and Artesano Smooth Multigrain ready-to-eat breads.
As well, the ingredients and “contains” statements of Brownberry brand Whole Grains 12 Grains Seeds say that loaf has nuts. The FDA letter to Bimbo says that walnuts, almonds and hazelnuts are specified. The agency says they are not, in fact, in the ingredients.
“Labeling is not a substitute for adherence to good manufacturing practices or implementation of preventive controls,” the FDA warning states. “Instead, firms must comply with applicable requirements to address allergen cross-contact.”
‘Added’ Sesame Controversy
“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,” said a spokesperson for the baker.
The warning gives the company 15 working days to reply in writing to the FDA. The giant baker must outline steps it will take to remedy the labeling and to prevent the issue from recurring.
“We are corresponding with the FDA to resolve this matter,” the Bimbo Bakeries spokesperson said.
Asked about the warning letter, an FDA spokesperson told Allergic Living: “The agency will take necessary and appropriate steps to protect consumers with food allergies.” This includes “when we become aware of products with ingredients lists and/or “contains” statements that are not consistent with actual product formulations.”
The FDA’s action comes as the food allergy community has grown frustrated with food makers’ response to sesame becoming the ninth major U.S. allergen in January 2023. Consumers with allergies are upset about the emerging practice among commercial bakers of “adding” sesame to baked goods, as a way to avoid cross-contact risk.
The American Bakers’ Association defended that practice in May 2023 as being “for consumer safety.” The association spoke of challenges eliminating sesame seeds on baking equipment. At that time, the FDA simply said it didn’t support the practice, a response some consumer advocates criticized as “tepid”.
By October 2023, the FDA had issued new draft guidance to help manufacturers prevent cross-contact and accurately label packaged food for top allergens.
In the case of Bimbo’s products, sesame was not added. But the FDA says it was labeled as an ingredient when it wasn’t present. The FDA’s stern warning to the company puts a spotlight on sesame and the regulatory radar.
Bimbo FDA Warning: Troubling
The federal Food Drug & Cosmetic Act spells out that ingredients that are major food allergens must be listed in the ingredients and, optionally, in an adjacent ‘contains’ statement.
However, voluntary “may contain” statements can also be used to claim a product has allergen cross-contact risk. The 2023 guidance says manufacturers are only supposed to use such an advisory after every effort is made to prevent allergen cross-contact.
Food safety consultant Dr. Steven Gendel is concerned that the allergen labeling issues at Bimbo Bakeries might be “a sign of a larger problem.”
“I was surprised to see Bimbo Bakeries was claiming the presence of ingredients without putting those ingredients in their products,” Gendel says. The former FDA food allergen coordinator finds it disappointing that none of the baker’s employees prevented the misleading labels.
In response to Allergic Living’s questions, the FDA did not say whether it is cracking down specifically on misleading sesame claims. But the spokesperson did say that since the seed became a major food allergen, “FDA has been taking necessary and appropriate steps to protect consumers with sesame allergies.” The steps include warning letters, import refusals, and assistance with recalls.
The spokesperson said if a food product is misbranded, the agency’s response will depend on the violation. The FDA warning letter to Bimbo says that “failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.”
Gendel also wonders if Bimbo Bakeries’ leaders are checking the rest of the company’s 59 bakeries for similar issues. “FDA has always regarded false claims like this as a very serious issue,” he says.
The expert agrees that if nut and sesame cross-contact are a genuine concern at Bimbo facilities, the company could have shown a “may contain” advisory on the products. However, Gendel says that “does not change the fact that someone at the company should have known better. It is clearly a failure to ensure that their labels are accurate and compliant.”
Fallout for Bimbo Bakeries
Bimbo Bakeries, which has its headquarters in Horsham, Pennsylvania, is the largest commercial baking company in the United States, according to the company. Its brands include Sara Lee, Entenmann’s, Thomas’ and Ball Park Buns & Rolls.
FARE CEO Sung Poblete, PhD, said her organization expected better, “given the size and reach of Bimbo Bakeries.”
She notes the estimated 33 million members of the food allergy community in the United States have considerable buying power. “The community’s frustration and loss of trust and respect for Bimbo Bakeries may extend to the restaurants and institutions that use and sell their products,” Poblete says.
The food allergy community certainly responded vociferously when news emerged that buns and bread at several national eateries, such as Chik-fil-A, would suddenly contain sesame.
The commercial bakeries started adding sesame to products in late 2022. This was just before FASTER Act took effect, which made sesame a top allergen. FARE’s Earl says, “the practice of intentionally adding sesame flour to avoid thorough cleaning or segregating lines is an act of malicious compliance.”
At least one major restaurant chain switched bakery suppliers, so customers with a sesame allergy could safely enjoy their food. In October 2023, Olive Garden, which heard an outpouring of concern over the added sesame, announced that its famous breadsticks would be sesame-free.
Article updated July 1, 2024 with FDA replies to Allergic Living questions.
Related Reading:
Bread Suppliers Adding Sesame as Seed Becomes Top Allergen
With a Peanut Allergy, Are You More at Risk of Sesame Allergy?
