FDA WARNING_LETTER - Sebastian Joe's Ice Cream Commissary - October 19, 2011

An FDA inspection of Sebastian Joe's Ice Cream Commissary in Minneapolis on October 5, 6, and 19, 2011, revealed significant deviations from food labeling regulations (21 CFR Part 101) for their "Caramel Cashew" ice cream. The product was deemed misbranded under section 403 of the Federal Food, Drug, and Cosmetic Act due to several violations. Firstly, the product label failed to identify major food allergens (milk, soybean, egg) as required by section 403(w)(1) of the Act. Secondly, the labeling lacked a complete list of all ingredients and sub-ingredients by common or usual name in descending order of predominance by weight, specifically for "Sebastian Joe's Ice Cream Mix" and "Mini Caramel Cups," violating 21 CFR 101.4. Additional deficiencies included the net quantity of content not being declared on the principal display panel in conspicuous and legible type, contrary to 21 CFR 101.105(a), (e), and (h). The letter also noted a potential failure to declare coconut oil, if not highly refined, as a major food allergen per section 201(qq) of the Act. Furthermore, the finished product label failed to declare the presence of artificial flavors from the "Mini Caramel Cups" sub-ingredient, violating 21 CFR 135.110(f). The firm must promptly correct these violations and respond in writing within 15 working days with documentation of corrective actions. Failure to comply may lead to regulatory actions like seizure or injunction, and re-inspection fees. The effectiveness of the firm's previously submitted corrective actions will be evaluated during the next inspection.