FDA Announces Warning Letter on Allergen Labelling

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FDA Issues Warning Letter Related to Allergen Labeling Practices

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Wednesday, June 26, 2024

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Yesterday FDA announced that it had issued a warning letter to Bimbo Bakeries USA, Inc. for, among other things, including allergen labeling elements in certain product labels (e.g. “contains sesame”), even where they did not contain the allergen(s) in question.
Some of the products included sesame in the ingredient lists and “contains sesame” allergen statements, even though sesame was not an added ingredient. Similarly, other products were labeled with walnuts, almonds, and hazelnuts in the same manner, even where these ingredients were not added ingredients.
Sesame cross-contact controls have been a particular challenge for industry as the seeds are difficult to completely remove from processing equipment. Some members of industry think that the risk of cross-contact is so high that the voluntary “may contain [allergen]” statement does not adequately apprise consumers of the allergen risk and have in some cases intentionally added sesame to allow for allergen labeling elements (ingredient list disclosure and/or a “contains” statement).
Last year, in a response to a petition from the Center for Science in the Public Interest (CSPI), FDA indicated that including mandatory allergen labeling where the allergen (e.g., sesame) was not intentionally added was unlawful. However, the agency indicated the practice of intentionally adding an allergen to a food that would not otherwise contain the allergen, while discouraged, was not an unlawful provided that mandatory allergen labeling was in place. FDA prefers that industry implement appropriate GMPs and preventive controls.
If industry continues to feel that GMPs and preventive controls are insufficient to deal with certain (e.g., sesame) cross-contact situations, the effect of this warning letter (and similar enforcement activity) could be the intentional addition of more allergens to foods to allow for mandatory allergen labeling, a legal but discouraged practice which could further limit options for individuals with food allergies.