This is a revision of the bulletin originally posted on August 9, 2005. It contains revisions made August 19, 2005.

Bulletin to the Food Service and Retail Food Store Industry Regarding Cake Batter Ice Cream and Similar Products

FROM:  CFSAN Retail Food Protection Program
TO:  Food Service and Retail Food Store Industry
SUBJECT:  Cake Batter Ice Cream 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 ingredients that may be listed on the dry cake mix label. 21 CFR 135.110 requires ice cream be made from pasteurized mix and FDA has confirmed that the sweet cream base mix was pasteurized as well as any egg in the dry cake mix.

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. The following states have had laboratory confirmed Salmonella Typhimurium illness cases: Massachusetts, Virginia, Washington, Oregon, Minnesota, Ohio, Michigan, and California. A case in Illinois was confirmed but is counted in Virginia since that is where the person ate the ice cream.
• Cold Stone Creamery recently recalled its cake batter ice cream. 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 by the manufacturer a baking mix. All recipe variations included instructions for baking.
• 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 301-436-2440 or 301-436-2438.