Trends in ingredients added to infant formula: FDA's experiences in the GRAS notification program.

While human milk is considered the optimal source of nutrition for infants for the first six and twelve months of age, with continued benefit of breastfeeding with complementary foods, a safe alternative, nutritionally adequate to support infant growth and development, is necessary. In the United States, the Food and Drug Administration (FDA) establishes the requirements necessary to demonstrate the safety of infant formula within the framework of the Federal Food, Drug, and Cosmetic Act. FDA's Center for Food Safety and Applied Nutrition/Office of Food Additive Safety evaluates the safety and lawfulness of individual ingredients used in infant formula, whereas the Office of Nutrition and Food Labeling oversees the safety of infant formula. Most infant formula ingredients are either from sources with history of safe consumption by infants or are like components in human milk. Information demonstrating the regulatory status of all ingredients is required in submissions for new infant formulas, and ingredient manufacturers often use the Generally Recognized as Safe (GRAS) Notification program to establish ingredient regulatory status. We provide an overview of ingredients used in infant formula evaluated through the GRAS Notification program to highlight trends and discuss the data and information used to reach these GRAS conclusions.