Regulating the Nutritional Adequacy of Infant Formula in the United States

Infant formula must be not only safe but also effective in doing what it is supposed to do, meaning it must be nutritionally adequate. Regulatory agencies have given a great deal of attention to the safety of infant formula, but they have not given enough attention to the issue of nutritional adequacy. In 1981, the Codex Alimentarius Commission said, "Infant formula means a breast-milk substitute specially manufactured to satisfy, by itself, the nutritional requirements of infants during the first months..." However, in new rules published in June 2014, the only functional test of infant formula required by the U.S. Food and Drug Administration (FDA) was to require research as whether infant formula led to adequate physical growth. The research is to be done by the manufacturers. The FDA issued no clear guidance on how the research findings were to be assessed and used. The FDA could do much more to ensure that parents, healthcare workers, and relevant government agencies know how different methods of infant feeding compare in relation to their nutritional adequacy.