Lakeland Bakery, Inc. – FDA Warning Letter, Jul 7, 2011

The FDA conducted an inspection of Lakeland Bakery, Inc. on July 6 and 7, 2011, and subsequently issued a Warning Letter regarding misbranded products. A review of product labels for Wheat Hamburger Buns (1/2 dozen) revealed several violations of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 101. The product was found to be misbranded because its label was false or misleading, specifically declaring butter as an ingredient when it was not present, violating section 403(a)(1) of the Act. Additionally, the label failed to declare egg, a major food allergen, as required by section 403(w) of the Act. The product was also misbranded under section 403(i)(2) and 21 CFR 101.4 for failing to bear a complete list of all ingredients by common or usual name in descending order of predominance by weight, including sub-ingredients for multi-component ingredients, and omitting other ingredients. Furthermore, the net quantity of content was not declared in the bottom one-third of the label, violating 21 CFR 101.105(f). The FDA requires a written response within 15 working days detailing specific corrective actions, including documentation like revised labeling. Failure to promptly correct these violations could lead to further actions, including product seizure or injunction against the firm's operations.