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As mandated by the Infant Formula Act of 1980 (IFA), the FDA regulatory authority over the nutrient content of infant formulas has not included specifications for the nutrient content of formulas intended for low birth weight infants born prematurely. In light of our expanded knowledge about the needs of these infants and in response to actions by other international agencies, the FDA asked the LSRO to evaluate the scientific evidence regarding the need for separate specifications for minimum and maximum levels of substances to be included in formulas for preterm infants. The LSRO convened an Expert Panel to evaluate the science with regard to specific nutrients, and the evidence to support the need for separate recommendations based on the premature infant's transition across several stages of clinical care, from birth to discharge from the hospital.
This report is intended to be a companion to the recently released LSRO report, "Assessment of Nutrient Requirements for Infant Formulas". As with the term infant formula report, the scope of this report will include all of the macro (i.e., energy, protein, carbohydrate, fat) and micro-nutrients (i.e., vitamins and minerals) currently listed in the federal regulation. In additon, the report will address a number of substances identified since the last revision of the IFA including long-chain polyunsaturated fatty acids, specific amino acids and other non protein nitrogenous substances. This document addresses particularly complex questions on the cutting edge of modern medicine and will have a profound impact on neonatal health care.
Both the full report (J. Nutr. 2002 132:1395S-1577S) and a data summary are available online.