The committee recommends the development of specific guidelines that define normal growth and establish a level of difference in growth that represents a safety concern. Specifically, the committee recommends that any addition of an ingredient new to infant formulas should be judged against 2 controls (i.e. the previous iteration of the formula without the added ingredient and human milk). The proposed rule does not define ‘normal’ growth, nor does it identify what
represents a biologically meaningful level of difference in growth among groups of infants consuming different formulas. Th e Committee recognized that there is very little scientific evidence to establish a level of difference in growth associated with long- or short- term health consequences. However, the Committee concluded that any systematic and statistically significant difference in size and growth rate among infants fed a formula with the new ingredient versus human milk or an already approved formula should be a safety concern.