Infant Formula

For many babies, formula is the sole food source during roughly the first four to six months. Because infants depend on it entirely while their bodies grow and their brains develop, its nutritional adequacy matters greatly, since shortfalls at this age carry the gravest risks. Vitamins and minerals have long been added to formula under established safety guidelines and rules, and those have served well. Manufacturers now want to add many novel ingredients that aim to copy what breast milk is believed to offer, and the existing framework was not built to evaluate that range.

Written at the request of the US Food and Drug Administration and Health Canada, this report examines the regulatory and scientific questions central to judging whether such new ingredients are safe for infants.