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  • Infant Formula Act, 21 U.S.C. § 350a
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Infant Formula Regulation

Metabolic Formula

A special exemption had to be made for metabolic formula. Infants with inborn errors of metabolism (IEM) require food that is controlled in the substrate they cannot metabolize. For example, an infant with phenylketonuria (PKU) cannot metabolize the essential  amino acid (EAA) phenylalanine. When the by-products of this error of metabolism build up in the child's body, mental growth is delayed.  However an infant with PKU has a requirement for a a certain amount of phenyalanine to support growth and development. This child requires a formula that has a controlled amount of this EAA. 

To achieve the goals of growth and development AND prevention of mental retardation, a formula that is free of any phenylalanine is manufactured. This "metabolic formula" is prepared and mixed with calculated amounts of breast milk or infant formula to provide the child with the proper amount of the EAA phenylalanine. As you can see the phenylalanine free formula is deficient in an essential amino acid. This formula does not meet the minimum set by the law. To do so, an exemption was written into the Infant Formula Act to produce products to meet these special needs.

There are many inborn errors of metabolism that require "metabolic formula", examples are:
  • Methymalonic aciduria
  • Maple syrup urine disease
  • Urea cycle defects 
Different amino acids have to be controlled for each of the four diseases named so far. There are many more IEMs and there are as many special formulae to manage each condition. (List of exempt infant formula)

 
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