ABSTRACT

The use of herbal and alternative medicines has increased in the last decade in the United States and is now the subject of clinical and basic science investigations supported by the NIH Office of Dietary Supplements Research and the National Center for Complementary and Alternative Medicine. The Dietary Supplements Health Education Act of 1994 enables manufacturers to market these approaches without proving efficacy or safety. The FDA has limited resources for this purpose and relies on adverse effects reporting to monitor safety, but this method has significant drawbacks in terms ofscientifically examining the causative relationship of a particular herbal or alternative approach to a reported side effect.