Drug Dev Ind Pharm. 1998 Dec; 24(12): 1177-95.
Scientific and regulatory aspects of nutraceutical products in the United States.
M. K. Kottke Consulting, Hudson, New Hampshire 03051, USA.
Within the past decade, the so-called health food industry has experienced a tremendous growth such that these products are commonplace in most community pharmacies within the United States. These products have since been defined, by those in the industry, as nutraceuticals. Passage of the Nutrition Labeling and Education Act of 1990 and the Dietary Supplement Health and Education Act of 1994 has had a significant impact on the information available to the consumers to enable them to make educated decisions when "self-medicating" with this class of products. This paper is an attempt to summarize the current state of scientific and regulatory issues that are relevant to nutraceutical products.