Nutrient levels in infant formulas: technical considerations

Technical considerations in the design, production, manufacture, process, and quality control of infant formulas are presented. Many of the criteria and systems used by manufacturers to assure the safety and adequacy of infant formulas have been codified by the U.S. Food and Drug Administration. Product label claims represent the minimum levels of nutrient that must be present throughout product shelf life. The precise nutrient level in an infant formula at any given time may differ from the label claim because of the variability of nutrient amounts contributed by major ingredients, a decrease of certain nutrients due to heat or oxygen exposure during processing, changes during storage, nutrient levels added to account for bio-availability, and the variation in analytical results. Infant formula manufacturers use various processes and quality control systems to assure the presence of appropriate amounts of each required nutrient in each batch. Infant formula manufacturers support the review of existing upper limits and the establishment of new limits where there is a justifiable and adequate basis to do so. Where needed, new upper limits should be set with appropriate consideration of existing technical factors affecting product formulation and nutrient content. Control of upper limits can best be achieved within the framework of existing regulations and manufacturing systems to assure that only batches of formula with appropriate levels of nutrients are introduced into commercial distribution.