S. A. Anderson, L. T. Beker, E. S. Cho, G. L. Robert-Baldo, B. M. Silverman, S. K. Suggs-Anderson, L. H. Tonucci, ONPLDS, CFSAN, FDA
In the United States prior to the 1906 Pure Food and Drug Act, there was no regulation of human milk substitutes, predecessors of today's infant formula that included evaporated milk and cow's milk. The regulatory history after the 1906 Act is highlighted in a timeline that includes events, discoveries, and expert opinions that precipitated legislation and regulations. Initially regulated with other foods under the 1906 Act, with the authority of the 1938 Federal Food, Drug, and Cosmetic Act, regulation of these products moved forward in 1941 and 1966 with regulations that required label statements to inform about nutrient quality and content, and also to specify when levels were not met for several nutrients. In 1971, minimum requirements were expanded from 4 to 17 nutrients and label statements were required if these minimum levels were not met. The recognition and regulation of infant formula as a separate food supplying minimum levels of 29 nutrients and maximum levels of nine nutrients came with the Infant Formula Act of 1980, along with the authority to establish requirements for quality factors and quality control procedures. The 1986 amendments included requirements for finished product testing, and additions to requirements for good manufacturing procedures, quality control procedures, and product recall. Greater understanding of infant nutritional needs for healthy growth and development has been and continues to be a key element for development of science-based regulations. Moving into the next century, challenges for infant formula regulation continue to evolve with increasingly complex new ingredients and advances in technology.