FDA WARNING_LETTER - Big Island Candies, Inc. - May 29, 2024

On May 29, 2024, the FDA issued a Warning Letter to Ms. Holi of Big Island Candies, citing misbranding of their Makana Brownie Assortment Box. The recalled product (10 oz. boxes with 8 assorted brownies) was found to be misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) because its label failed to declare peanuts, a major food allergen.

The recall, initiated on January 10, 2024, occurred after the firm discovered Milk Chocolate Covered Peanut Butter Brownies were unintentionally packed instead of Milk Chocolate Covered Macadamia Nut Brownies. This error, attributed to human error by workers, led to a consumer experiencing an allergic reaction. The product in question was manufactured on (b)(4) (Batch Code RFFIC 326760).

The FDA noted that the firm's facilities are subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Failure to comply with preventive controls for undeclared allergens is prohibited by section 301(uu) of the Act.

Big Island Candies provided corrective actions on January 15, 2024, including ceasing peanut product production and removing all peanut ingredients from the facility. If peanut products are reintroduced, additional measures will include color