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- J. Andres Martinez, MD*
- Martha P. Ballew, MEd, RD, CNSC, LDN†
- *Assistant Professor, Director Pediatric Nutrition Support Program, Department of Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Vanderbilt University School of Medicine, Nashville, TN.
- †Pediatric Nutrition Support Dietitian, Department of Nutrition Services, Monroe Carell Jr Children's Hospital at Vanderbilt, Nashville, TN.
Author Disclosure
Dr Martinez and Ms Ballew have disclosed no financial relationships relevant to this article. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.
Objectives
After completing this article, readers should be able to:
Describe the macronutrient content of formulas used as substitutes for human milk for term and preterm infants.
Identify appropriate clinical applications of infant formulas that have altered nutrient contents based on the physiologic significance of specific changes in formula composition.
Discuss the physiologic role and potential health benefits associated with four components added to infant formulas in the past decade.
Delineate current regulatory guidelines that define standards for composition and performance and safety criteria for commercial infant formulas.
Historical Background
Development of infant formulas can be traced to the late 19th century. In 1867, Liebig developed and marketed a product for infant feeding that contained cow milk, wheat flour, malt flour, and potassium bicarbonate. In 1915, Gerstenberger reported a 3-year experience using “synthetic milk, adapted” that contained nonfat cow milk, lactose, oleo oils, and vegetable oils. This product represented early understanding that cow milk required alteration to improve its acceptability for human consumption and is considered the precursor to modern infant formulas. (1)
Government regulation of infant formula composition in the United States began in 1941 and underwent significant expansion with passage of the Infant Formula Act of 1980, a direct and prompt response to an epidemic of a Bartterlike syndrome (hypochloremic, hypokalemic metabolic alkalosis). Most cases were later attributed to consumption of a chloride-deficient soy infant formula. The Infant Formula Act of 1980 and its amendments in 1986 defined minimum concentrations of 29 nutrients and established quality control standards for commercial production of infant formulas. Current standards are summarized in the Electronic Code of Federal Regulations: Title 21:107—Infant Formula. (2 …
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