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Challenges in developing a safe product for infants: US perspective - Mead Johnson

R. A. BURNS, Nutritional Science, Mead Johnson Nutritionals, 2400 W. Lloyd Expy., Evansville, IN 47721

Human milk, the ideal feeding for infants, provides not only the traditionally accepted nutrients but also other components. It is generally accepted that the presence of many of these components is not accidental and may confer benefits to infants. Thus, the presence of docosahexaenoic acid (DHA) in human milk stimulated research to determine its role in infant development. Initial efforts, using a fish oil source of DHA, suggested that DHA improved visual acuity in preterm infants. However, research also suggested that the growth of preterm infants may be compromised when fish oil is added to formulas and that arachidonic acid (ARA) status of infants is lowered by addition of DHA to formulas. Furthermore, the addition of fish oil to provide human milk levels of DHA, provides other fatty acids at concentrations higher than those in human milk. As a result, further development work used an algal oil source of DHA and a fungal oil source of ARA, which is also found in human milk. Despite the presence of relatively high amounts of the desired fatty acids in these oils and the absence of any undesirable components, the oils were not historically used as dietary ingredients. Therefore, on the advice of an expert panel, a wide range of safety studies were conducted in animals and growth studies conducted in both term and preterm infants. All studies supported the absence of adverse effects and as a result the oils were deemed to be GRAS for infants. In addition, the visual acuity and mental development benefits of providing human milk amounts of DHA and ARA in formulas were confirmed. Formulas with DHA were subsequently marketed in the US in February 2002.

Session 44, Evaluating the safety of bioactive components for infant formula
2:30 PM - 7:00 PM, Monday PM Room 391

2005 IFT Annual Meeting, July 15-20 - New Orleans, Louisiana