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BULLETIN DATE: August 9, 2005 FROM: CFSAN Retail Food Protection Program TO: Food Service and Retail Food Store Industry SUBJECT: Cake Batter Ice CreamTM and Similar Products The U.S. Food and Drug Administration (FDA) is informing the retail and food service industries that incorporating an ingredient that is intended to be cooked into a ready-to-eat food that will not be cooked or otherwise treated to eliminate microorganisms of public health concern can pose a serious food safety risk. A recent multi-state outbreak of Salmonella Typhimurium has been associated with consumption of "cake batter" ice cream. FDA wants to alert the industry that Salmonella is known to occasionally be present in flour and other non-animal foods such as barley, cereal powder, and yeast. For these reasons, FDA is asking food service operations to review their menus for these types of products and to either work with their suppliers to ensure all ingredients are intended to be ready- to-eat or to process their final products to eliminate microorganisms of public health concern. Also, routine precautionary measures should also be taken to prevent cross-contamination from raw products and surfaces that have not been adequately cleaned and sanitized. • During the past two months, health and agriculture officials investigated a multi-state outbreak of salmonellosis related to an ice cream product. Ill individuals have been identified in Washington, Oregon, Minnesota, Ohio, Michigan and Arizona. • Cake Batter Ice CreamTM, sold only at Cold Stone Creamery stores, has been recalled by the company. No other flavors of ice cream have been associated with illness to date. • U.S. Food and Drug officials, during their investigation, have confirmed that the sweet cream ice cream base was pasteurized and the dry cake mix that was added to the ice cream base was labeled “bake before use” by the manufacturer. • This Cake Batter Ice Cream was prepared in food service establishments. The preparation involved adding a dry cake mix to a pasteurized sweet cream base and the combination did not undergo additional processing prior to freezing. Dry cake mix is a product that has been designed to be rehydrated and then cooked. Dry cake mix should not be considered a ready-to-eat food because it has not been processed to ensure that pathogens have been destroyed or reduced in numbers to an acceptable level. Ready- to-eat foods are typically processed to ensure that they are safe to consume without further cooking. Similar products, such as "cookie dough" ice creams and "cake mix" milk shakes, could also pose a serious food safety risk if they are prepared with ingredients that are intended to be cooked. CONTACTS: If you have any further questions, please contact the Retail Food Protection Program, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, at [PHONE REDACTED] or [PHONE REDACTED].