Abstract
Because of the production of nutrient-deficient infant formulas (IFs), the United States Congress passed regulations on the composition and production of IF, referred to as the Infant Formula Act (IFA), in 1980, which was amended in 1986. More detailed FDA rules have been created since then, specifying the ranges or minimum intakes of nutrients and providing details for the safe production and evaluation of infant formulas. Although generally effective in ensuring safe IF, recent events have made it clear that a re-evaluation of aspects of all the nutrient composition regulations for IF is needed, including consideration of adding requirements related to bioactive nutrients not mentioned in the IFA. We propose that, as principal examples, the requirement for iron content needs to be re-evaluated and that DHA and AA should be considered for addition to the nutrient requirements after scientific review by a panel such as those established by the National Academies of Sciences, Engineering, and Medicine. Additionally, there is no specific requirement in current FDA regulations for the energy density of IF, and this should be added alongside potential revisions of the protein requirement. It would also be ideal to have specific FDA rules on nutrient intakes for premature infants as these are exempted from the specific nutrient regulations of the amended IFA.