ABSTRACT
When putting together a developmental package for a new Over-the-Counter (OTC) product for any regulatory agency in the world, the most responsible and successful approach is to treat a potential OTC drug or product just as one would an ethical pharmaceutical. Nutraceuticals are "food, or parts of food, that provide medical or health benefits, including the prevention and treatment of disease". Dietary supplements have been routinely used as part of the diet for centuries in Europe and particularly Japan and are deeply rooted in folklore and tradition. The culture entwining the use of dietary supplements is different in the US, so the US government attempted to address the growing use of and problems associated with nutraceuticals with the passage of legislation. In 1990, the Nutritional Labeling Enforcement Act exempted medical foods from the health claim and labeling requirements applied to foods sold to healthy people.
