Why has FDA asked infant formula manufacturers to do postmarket surveillance of infants consuming formulas containing ARA or DHA?

These are new ingredients that were not used in infant formulas in this country before early 2002, and infant formulas containing ARASCO (ARA Single Cell Oil) and DHASCO (DHA Single Cell Oil) have been marketed in other countries for only a few years. FDA views any evaluation of the safety of use of new food ingredients such as DHASCO and ARASCO as a time-dependent judgment that is based on general scientific knowledge as well as specific data and information about the ingredient. Therefore, scientific data that become available after specific products containing a new ingredient enter the market must be considered as a part of the totality of information about the ingredient. Pre-market clinical studies evaluating the effects of infant formulas containing DHASCO and ARASCO on physical growth and some aspects of development are short-term studies, while some studies suggest that feeding of infant formulas with oils containing DHA and ARA to infants may have long-term effects on growth and development. For all these reasons, manufacturers have been asked to closely monitor these new infant formulas in the marketplace.