WASHINGTON — Bimbo Bakeries USA (BBU) is standing by its approach to declaring sesame, a food allergen, in labels on some products even when the items don’t contain it as an ingredient.

Horsham, Pa.-based BBU reiterated its stance after the consumer groups Center for Science in the Public Interest (CSPI) and Food Allergy Research & Education (FARE) on Oct. 9 expressed “ongoing concern” over the baked foods manufacturer’s practice following its response to a Food and Drug Administration warning letter on sesame labeling this summer.

“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,” BBU said in an Oct. 9 statement. “Recently, the FDA identified that a limited number of products declared sesame as an ingredient on their packaging despite no sesame being included in the product. Because these products are formulated with sesame at some of our bakeries and without it at others, we have taken the conservative approach of uniform labeling for these nationally distributed products.

“This labeling approach is used to ensure sesame-allergic consumers have consistent labeling across the country and supplements our rigorous good manufacturing processes (GMPs) and preventive controls to address potential sesame cross-contact,” BBU said.

BBU responds to FDA warning

In mid-June, BBU received a warning letter from the FDA stating that a November 2023 inspection of its facility in Topeka, Kan., found “false or misleading” product labels for Sara Lee Artesano Brioche, Delightful Multigrain, Artesano Golden Wheat and Artesano Smooth Multigrain loaf bread. The agency said the labels for those products include sesame seeds in the ingredient and “contains” statements, even though sesame seed isn’t an ingredient in those products’ formulations.

“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 said in the June 17 letter. “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.”

Also in the letter, the FDA said food companies “may choose to voluntarily place allergen advisory statements on products to alert consumers to the possible presence of major food allergens due to cross-contact. Any allergen advisory statement must be truthful and not misleading.”

In response, BBU on July 1 sent the FDA a letter — obtained by CSPI via a Freedom of Information Act request to the agency — explaining that it set “nationally uniform labels” declaring sesame for the four Sara Lee bread products “because at some of our bakeries they are formulated with sesame and at others they are not,” such as at the company’s FDA-inspected Phoenix facility.

“We think it very important that sesame allergic consumers who may purchase these products at various locations throughout the country see consistent labeling of sesame so they can avoid these products where they truly contain sesame,” BBU said in the response letter. “This labeling approach is not employed to avoid the application of rigorous GMPs and preventive controls to address potential sesame cross-contact, nor do we believe that allergen advisory labeling is a suitable alternative under our circumstances.”

Consumer groups take issue with BBU

Washington-based CSPI, however, said BBU’s practice of declaring sesame as an ingredient for all products with the same name, even those items that don’t contain sesame as an ingredient, “clearly violates the requirement that labels not be false or misleading.”

“It’s a perverse response to food safety rules,” said Sarah Sorscher, director of regulatory affairs for CSPI. “You add an ingredient that could trigger a harmful food allergy reaction, slap a label on it and say you’ve solved the problem. Then you label even those versions that contain no sesame as containing it. We call on Bimbo Bakeries and other manufacturers to find a better approach for addressing cross-contact risks and take sesame out of these products, where it never should have been added to begin with.”

BBU explained in its letter to the FDA that its current sesame labeling approach came in response to the 2021 Food Allergy Safety, Treatment, Education and Research (FASTER) Act, which requires food manufacturers to prevent sesame cross-contamination.

“BBU conducted extensive analyses of its facilities, production lines, GMPs and allergen cross-contact preventive controls and made significant changes to reduce the risk of sesame cross-contact as much as possible,” the company said the letter. “We moved the production of certain products to other locations and created dedicated production lines where feasible. But as BBU and other baking company stakeholders have explained in our dialogue with FDA on this issue since the passage of the FASTER Act, sesame presents unique challenges in the baking sector, both because of the nature of sesame seeds used as a topping, and because of the regional distribution model needed to get fresh bread to consumers, which limits the industry’s ability to use dedicated facilities and production lines.

“We found that despite best practices for rigorous GMPs and stringent preventive controls, we could not eliminate the risk that potentially significant traces of sesame could be found on a regular basis in products not intended to contain sesame that were produced on the same lines.”

For example, BBU said that although its Phoenix facility doesn’t use sesame in the bread line, it does make the four Sara Lee bread varieties at issue, which also are produced in other facilities on lines with sesame-containing products.

“We therefore determined that the most protective approach for sesame-allergic consumers is that for BBU products that are baked on the same line as products that contain sesame, we formulate those products to include sesame and declare it in the ingredient list and ‘contains’ statement,” BBU said. “BBU products that are baked in a facility that uses sesame but are not baked on the same production lines as sesame are labeled with the allergen advisory statement ‘made in a bakery that may also use sesame.’”

CSPI said it had previously petitioned the FDA to stop the practice of adding allergens or “falsely declaring ingredients” after some companies started adding sesame to bakery products following the FASTER Act’s enactment. In a response to the petition, the FDA stated it can’t prohibit companies from adding sesame or other food allergens but can prevent them from falsely declaring them as an ingredient, according to the consumer group.

“The companies’ apparent intent was to evade costly recalls when an undeclared allergen was discovered, which can be required even if the label contained a ‘may contain’ type of unregulated precautionary allergen labeling statement,” CSPI said about its petition.

McLean, Va.-based FARE said it supported the CSPI petition and previously credited the FDA for warning Bimbo against the practice of declaring sesame on labels when not contained in the product.