Infant Formula

Human milk serves as the nutritional model for infant formula. The original infant formula was derived from cow milk; however, the concentration and nutrient distribution of cow milk are not appropriate for infants. The protein content is too high, the casein is not well digested, the electrolyte concentration is too great, the fat is largely saturated and poorly absorbed, and the carbohydrate concentration is too low. Adjustments have been made using cow milk as a base, and other components have been formulated to simulate or "humanize" milk. Later in the evolution of infant formula, alternate protein sources were used; initially meat and later, during the 1960s, soy-based formulas were refined. Currently, approximately one-fourth of infant formula utilized in the United States is soy protein based.

Regulatory Aspects

Infant formula is unique in food regulation because it is regulated by specific legislative mandate in the United States. The Infant Formula Act of 1980 and subsequent amendments in 1986 specify nutrient requirements, manufacturing practices, and quality control. This specificity is considered essential because infant formula may provide the sole source of nutrition for an infant for an extended period during critical rapid growth and development.

Functionality

Infant formula has evolved as a nutritional entity to provide all the requirements for an infant during the first 6 months. After 6 months infant formula, like human milk, continues to provide a significant contribution to the nutrition of infants. The adequacy of infant formula to support growth and development is established by clinically controlled feeding trials.

Technologies

Several technologies have been utilized to ensure the safety and nutritional quality of infant formula. Concentration and controlled processing techniques ensure the sterility, keeping quality, and nutrient retention for undiluted infant formula. Drying techniques have been adapted to provide powdered infant formula with quality equivalent to liquid forms. Alternate protein sources predominately soy protein, have been refined to provide adequate protein quality for the normal growth and development of infants. Cow milk protein has been modified to imitate the casein to whey protein distribution of human milk. The carbohydrate and fat components have been adjusted to effectively imitate those of human milk. Clinical trials are used to confirm the nutritional adequacy of infant formula. Formulas based on extensively hydrolyzed protein are effectively used for infants with food protein allergies.

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