FDA WARNING_LETTER - Buddy Squirrel LLC - February 25, 2011

An FDA inspection of Buddy Squirrel LLC's food manufacturing facility on February 24-25, 2011, revealed several labeling violations for products including Marshmallow Eggs-Milk (bulk), Chocolate Covered Marshmallow Eggs (retail), Vanilla Caramels-Dark, and Cheezzzy Cheese Corn (retail). The products were found to be misbranded under sections 403(w), 403(q), and 403(i) of the Federal Food, Drug, and Cosmetic Act, and relevant CFR regulations. Specific deficiencies included the failure to declare soybean, a major food allergen, on Marshmallow Eggs-Milk (bulk) and Vanilla Caramels-Dark labels, as required by section 403(w)(1). The Chocolate Covered Marshmallow Eggs (retail) lacked an adequate common or usual name on the principal display panel, violating section 403(i)(1) and 21 CFR 101.3. Vanilla Caramels-Dark labels failed to provide a complete list of all ingredients, including sub-ingredients, in descending order of predominance by weight, contrary to section 403(i)(2) and 21 CFR 101.4. Additionally, Cheezzzy Cheese Corn (retail) labels provided an inaccurate serving size, violating section 403(q) and 21 CFR 101.9(b)(2)(iii). The FDA also noted that retail Marshmallow Eggs-Milk packages could be misbranded for undeclared soybean and that required label information (name/place of business, nutrition facts, ingredient statement) was not properly consolidated on the information panel as per 21 CFR 101.2(d) and (e). The firm must promptly correct these deviations and respond in writing within 15 working days with documentation of corrective actions to avoid potential regulatory actions like seizure or injunction.