Health And Human Services, Department Of- Food And Drug Administration- Fda Office Of Acq Grant Svcs
Review of Infant Formula Nutrient Requirements - The Office of Critical Foods ( OCF) Infant Formula Premarket Review Staff ( IFPRS) within the Food and Drug Administration s ( FDA) Human Foods Program ( HFP) Nutrition Center of Excellence ( NCE) is seeking information to assess the feasibility
Review of infant formula nutrient requirements Comprehensive review of fourteen different nutrients for infant formula, including protein, fat, linoleic acid, carbohydrates, iron, copper, zinc, calcium, phosphorus, magnesium, vitamin k, DHA, ARA, alpha- linolenic acid, and L- carnitine. For each nutrient, a Microsoft Word file including: national and international expert body dietary reference intakes ( DRIs) for healthy term infants; global infant formula nutrient standards and recommendations per 100 kcal; nutrient content of human milk; daily intake estimation, including comparison with DRIs and human milk exposure; background on the nutrient ( function, metabolism, biomarkers, deficiency, toxicity, interactions); additional considerations ( other dietary sources, environmental factors); new or emerging scientific evidence ( clinical studies, health outcomes, safety data, mechanistic studies); proposed action and justification related to current requirements in 21 CFR ****( a).
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