FDA WARNING_LETTER - Philemon Pty Ltd - January 22, 2013

The FDA conducted inspections of Waterwheel Premium Foods Pty Limited facilities in Dandenong, Australia, on January 17-18 and January 21-22, 2013. The inspections and subsequent label review revealed significant violations of the Federal Food, Drug and Cosmetic Act and food labeling regulations (21 CFR 101) for their Water Wheel Fine Wafer Crackers Original, Waterthins Cheese Twists Classic Cheddar, and Waterthins Grain Wafer Thins Original products.

Key violations include: 1. **Misbranding (False/Misleading Labels):** * "Water Wheel Fine Wafer Crackers Original" claimed "All Natural" but contained artificial rye flavor. * "Waterthins Cheese Twists Classic Cheddar" ingredient statement listed "cheddar cheese" but the product recipe did not include it. 2. **Misbranding (Nutrient Content Claims):** * "Waterthins Grain Wafer Thins Original" made unauthorized nutrient content claims like "important source of Omega3," "Amino Acids," "Dietary Fibre," "Protein," and "antioxidants" without meeting regulatory definitions or requirements (e.g., no established RDI/DRV, insufficient fiber percentage, missing protein corrected amount, missing antioxidant nutrient names). * The "healthy" claim was used without meeting "low fat" and nutrient percentage requirements. 3