FDA WARNING_LETTER - Shatila Food Products, Inc. - December 28, 2012

The FDA inspected Shatila Food Products, Inc. from December 3-28, 2012, identifying multiple misbranding violations on product labels, primarily for "Premium Mediterranean Pastries" and "Holiday Tin" products, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 343) and 21 CFR Part 101. Key deficiencies include the failure to declare all major food allergens (e.g., almonds, cashews, pine nuts, pistachios, walnuts) as required by section 403(w). Labels also failed to bear the common or usual name of each ingredient (section 403(i)(2)), specifically for tree nuts and "vegetable gums," and inadequately declared wheat flour sub-ingredients. Furthermore, products lacked required nutrition facts information (section 403(q), 21 CFR 101.9), including Trans-fat content for "Gourmet Mixed Pastries," and failed to state the net quantity of contents (section 403(e)(2), 21 CFR 101.105(a)). Required label information was also improperly placed on the bottom of tins. The firm's response to the Form FDA 483 did not address these labeling concerns. Shatila Food Products must promptly correct these violations and implement preventative procedures. Failure to comply could lead to regulatory actions like seizure or injunction. The FDA also suggested exploring Small Business Nutrition Labeling Exemptions.