Clinical Testing of Infant Formulas with Respect to Nutritional Suitability for Term Infants

摘要

The report discusses the utility of clinical studies, when such studies should be performed, and what kind of studies might be needed. The report suggested that data requirements for formulas for normal, term infants fall into three categories: weight gain, selected serum chemical indices, and specific nutrient balance information. The data collected in any specific study would depend upon the nature of the formula. New formulas, including any formula by a manufacturer not currently marketing formulas in the United States, would require an entire panel of tests. Eight types of changes in formulas, e.g., change in protein mixture or iron source, would require selected tests related to the potentially altered nutrition characteristics. A report on formulas for preterm infants is also available.