ABSTRACT
Medical foods is a topic few people associate with pharmaceuticals. Many would
consider them a new direction for pharmaceutical products. Medical foods in
reality are products prescribed by a physician for a patient with a medical
problem. The medical food may be used to manage a disease or health condition,
or in the case of an infant, it may be the sole source of nutrition for the child
during its first year of life. Medical food sustains the patient under the care of a
physician over an extended period of time (1). Infant formula provides nutrition
to babies when the breast milk is unavailable or inadequate to meet the infant’s
nutritional needs. Both types of products have a variety of unique characteristics
and regulations required for manufacture and packaging. These requirements go
beyond those normally associated with foods and highlight some of the problems
of multiple agencies and multiple regulations affecting production.
