It is imperative that infants and children consume foods that are safe and nutritionally adequate for optimal health. This chapter discusses regulatory processes by which new food ingredients and infant formulas to which infants and children will be exposed are reviewed by FDA; how composition and labeling are regulated and gives examples of new ingredients intended for infant formula have challenged existing regulatory processes.
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Two terms that have very similar meanings, substances and ingredients, have overlapping regulatory definitions. The word substance in the definition of the term "food additive" includes a food or food component consisting of 1 or more ingredients. The term substance is thus, more general than the term ingredient, and includes materials that become a part of the food (which may be ingredients, and may be direct food additives) as well as materials that do not become part of the food (secondary direct and indirect food additives), such as enzymes used in processing the foodstuff or food contact materials used in packaging. Ingredients are required to be listed on food labels; ingredients typically have standards of identity and common usual names. Food also is defined in 21 CFR 170.3, which lists 43 categories of foods. "Ingredients" is used here with respect to additions of substances to infant formula because the substances will appear on the ingredients list of the infant formula.