Dianne's Fine Desserts – FDA Warning Letter, Mar 17, 2020

The FDA issued a Warning Letter to Mr. Knowles on March 2, 2020, following the recall of peanut butter brownies mislabeled as chocolate turtle brownies. The FDA determined the recalled product was misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) because the labels failed to declare peanuts, a major food allergen.

The firm also failed to comply with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule) (21 CFR Part 117). Specifically, the firm did not identify and implement adequate preventive controls for undeclared allergens at the packaging step, as required by 21 CFR 117.135(a)(1) and (c)(2).

The firm initiated a recall on December 31, 2019, attributing the issue to a temporary breakdown in production and packaging processes, specifically during product changeover. In a January 13, 2020, email, the firm stated it implemented corrective actions, including controlling packaging on and near production lines, checking and documenting correct packaging, utilizing photo standards, and employee training. The FDA will verify these actions during the next inspection.

The letter emphasizes that peanuts are a "major food allergen" under section 201(qq) of the Act, and products containing them must declare them as