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Infant formulas are designed to provide an acceptable substitute for human milk. Their use is indicated for (1) infants whose mothers choose not to breast-feed, (2) infants for whom human milk is contraindicated, (3) infants who require a supplement to human milk because of slow growth, and (4) infants whose mothers choose to discontinue breast-feeding before the infant is 1 year old. Despite successful efforts to increase breast-feeding to levels that exceed 90% in developing countries and 50% to 90% in industrialized countries following birth, fewer than half of infants in many countries are exclusively breast-fed by 3 to 4 months postpartum.1 Thus, infant formula provides a significant portion of the nutrient intake for many infants.

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Guidelines for specific nutrient intakes by the infant intakes are detailed in Chapter 23. Infant formulas are regulated by the Food and Drug Administration in the United States2 and the European Food Safety Authority to ensure that they provide adequate nutrients at optimum bioavailability for complete nutrition for the first 4 to 6 months of infant life. Regulatory requirements include (1) nutrient content and quantity requirements, with minimum levels for 29 nutrients and maximum levels for 9 nutrients; (2) quality-control procedures ensuring bioavailability of nutrients, adequate content throughout the shelf life of the product, and avoidance of contamination; (3) record keeping on testing; (4) recall procedures for removal of unsafe formulas; and (5) labeling requirements.

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Infant formulas commonly available in the United States are detailed in Table 25-1. These are generally available in ready-to-feed, powder, and liquid concentrate forms. Nutrient composition is nearly identical among the various formulations of any specific formula brand, although there may be small differences due to technological requirements in production. Calorie density of standard term infant formulas is about 20 calories per ounce with an osmolarity of 280 to 300 mOsm/kg, both being similar to mature human milk. Infant formulas can be categorized as either standard term infant formulas or specialized formulas. Standard term infant formulas are further categorized according to their protein type and composition: (1) cow milk based, (2) soy based, (3) hydrolyzed, and (4) elemental. Specialized formulas have altered macronutrient or electrolyte content specific for management of a medical condition.

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Table 25-1. Common Infant Formulas Available in the United States 

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