The FDA considers misbranded products to be in violation of the Federal Food, Drug, and Cosmetic Act3. Consequences for misbranded products can include seizure of the products, injunctions, fines, and even criminal penalties in some cases. Misbranding can result from false or misleading labeling, lack of required information on the label, or inadequate directions for safe use of the product.
Bimbo Bakeries USA has been given a deadline of 15 days from the receipt of the warning letter to respond to the FDA. The company must state the specific steps it has taken to address any violations and prevent their recurrence, or provide reasoning and supporting information as to why it believes it is not in violation of the law5.
Bimbo Bakeries mislabeled specific allergens such as sesame and tree nuts, including walnuts, almonds, and hazelnuts, on their product labels even when they were not present in the products. This led to the FDA issuing a warning letter to the company for listing "contains" statements for major food allergens on the labels of products that did not actually contain the listed allergens2.