The Institute of Medicine, through its Food and Nutrition Board, will conduct a 24-month study that will be a thorough and comprehensive review of the evidence base for the safety of ingredients new to oral formulas for term infants.

The methods currently used to assess the safety of ingredients new to infant formula will be evaluated. The extent to which subsequent scientific study designs can enhance the existing methods will be determined. A report will be produced that includes a description of the current methods used to evaluate the safety of ingredients new to infant formulas and possible new study designs that are practical and reasonable and that need to be considered to better evaluate the safety of these ingredients. In addition, the report will evaluate the proposed approach to the specific situation of adding long-chain polyunsaturated fatty acids and possible other ingredients to infant formulas for use in term infants.

This report was released in prepublication form on March 1, 2004.