The U.S. Food and Drug Administration (FDA) has sent a warning letter to Bimbo Bakeries USA Inc. for listing “contains” statements for major food allergens on the labels of products that do not actually contain the listed allergens. FDA has asked the company to respond within 15 days of receipt of the warning letter, stating the specific steps it has taken to address any violations and prevent the recurrence of violations, or providing evidence as to why the company believes it is not in violation of the law.
The warning letter follows a statement made by FDA in September 2023 denouncing a trend of food manufacturers attempting to circumvent allergen cross-contamination requirements for sesame (which became the ninth major food allergen under the FASTER Act in January 2023) by intentionally adding the ingredient to formulations and listing it on “may contain” labels, rather than taking the required steps to eliminate the risk of cross-contamination. The statement was accompanied by an updated Guidance For Industry on Hazards Analysis and Risk-Based Preventive Controls for Human Food to include a new chapter on food allergens that helps food facilities avoid allergen cross-contact and ensure proper labeling.