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LSRO report: Assessment of nutrient requirements for infant formulas



LSRO report: Assessment of nutrient requirements for infant formulas



Journal of Nutrition 128(11 Suppl.): 2059S-2231S



As mandated by the Infant Formula Act of 1980 (IFA), the Food and Drug Administration (FDA) has responsibility for ensuring the safety and nutritional quality of infant formulas. Regulations for infant formulas contained in the Code of Federal Regulations (CFR) include specifications for minimum levels of 29 nutrients and maximum levels of 9 nutrients (21 CFR 101.00). These nutrient specifications were last revised in 1985. In addition to the need to review the knowledge about those nutrients currently listed, new research has provided information on nutritional needs of infants not available in 1985. It was concluded as a result of this new information that there was a need: To evaluate evidence relative to the inclusion of several minerals not currently listed in CFR 107.100. In 1989, the Food and Nutrition Board (FNB) of the National Academy of Sciences (NAS) published the 10th edition of the Recommended Dietary Allowances (RDA) that included revision of some of the previous RDAs for infants, added an RDA for selenium and proposed for the first time estimated safe and adequate daily intakes (ESADDI) for fluoride, chromium, and molybdenum. None of these minerals is currently listed in 21 CFR 107.100. To consider the advisability of adding long-chain polyunsaturated fatty acids (LCPUFA), nucleotides, lactoferrin, and several other nitrogenous compounds to infant formulas. To reconsider the use of the Protein Efficiency Ratio (PER) as a measure of protein quality of infant formulas; this has been reinforced by recent advances in technology and the understanding of the nutritional needs of infants. To revise the CFR and address these and other issues, the FDA recognized the need for a review of scientific information on the nutrient needs of healthy term infants; and, therefore, asked the Life Sciences Research Office (LSRO) to prepare a state-of-the-art analysis of the scientific literature, with an emphasis on, but not limited to, research published since 1985, and to do this in consultation with expert scientists and professional organizations involved in the field of infant nutrition. LSRO was also asked to consider the positions of other authoritative bodies, both domestic and international, in performing this review and to make recommendations. To assist in accomplishing this task, the LSRO convened an Expert Panel consisting of scientists with particular expertise in the area of infant nutrition (see Chapter XII). This report contains a review of the literature and the specific recommendations of the Expert Panel.

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Accession: 010904245

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