The U.S. Food and Drug Administration (FDA) has issued warning letters to two food companies, Big Island Candies Inc. and Cookies-n-Milk LLC, for violations related to misbranding and undeclared allergens, which pose serious health risks to consumers.
Big Island Candies Inc.
Big Island Candies Inc., based in Hawaii, received a warning following their recall of the Makana Brownie Assortment Box. The recall, initiated on January 10, came after the company discovered that Milk Chocolate Covered Peanut Butter Brownies were mistakenly packed instead of Milk Chocolate Covered Macadamia Nut Brownies. This error led to the absence of an allergen statement or ingredient declaration for peanuts on the packaging. The issue came to light when a consumer reported an allergic reaction after consuming a brownie from the assortment box.
The FDA’s warning letter, dated May 29, emphasized the seriousness of this misbranding. Peanuts are a major food allergen, and failure to properly label them can result in severe allergic reactions. The letter detailed that the firm’s product labeling did not comply with federal regulations requiring clear allergen declarations.
Additionally, the FDA noted that Big Island Candies’ facilities are subject to the Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation requirements. The company is required to implement preventive controls to minimize or prevent hazards such as undeclared allergens. The full warning letter can be viewed on the FDA’s website.
Cookies-n-Milk LLC
Cookies-n-Milk LLC, based in McKinney, Texas, also received a warning letter from the FDA following an inspection from October 3-19, 2023. The inspection revealed that their Ready-to-Eat (RTE) Peanut Butter Cup Edible Cookie Dough was misbranded due to undeclared peanuts, a major food allergen. The product’s label also failed to declare all common or usual names of each ingredient, including milk powder, baking soda, and salt, which were part of the formulation.
The FDA’s warning letter, issued on April 22, highlighted significant violations, including:
Hazard Analysis and Risk-Based Preventive Controls:
The company did not identify and evaluate undeclared allergens as a known hazard requiring preventive control at the packaging/labeling step.
Mycotoxins, particularly aflatoxin associated with peanut butter, were not identified as a hazard requiring preventive control. The company also failed to conduct supplier verification activities for mycotoxins in peanut butter and related ingredients.
Misbranding:
The firm’s product labels did not comply with requirements for declaring major food allergens, such as peanuts.
The ingredient list did not include all components, including milk powder and baking soda, and failed to separately list added salt.
The FDA stressed the importance of accurate labeling to prevent consumer health risks and required the company to take corrective actions to address these violations.
These warnings underscore the FDA’s commitment to ensuring food safety and proper labeling practices to protect consumers, especially those with food allergies. Companies are urged to rigorously adhere to federal regulations and implement robust preventive controls to avoid such violations.