Safety Evaluation of Botanical Dietary Supplement: A Systematic Review of the Literature

Abstract

Concerns on the safety of botanical dietary supplements have been raised by healthcare professionals and regulatory agencies as consumer interest in these products has increased. These concerns include the relative safety of individual herbs, the potential for drug interactions, and the safety of use in pregnant and nursing women. A scientific evidence-base is required for sound clinical and regulatory decision making. A recently completed systematic review of the literature on the safety of approximately 550 botanical dietary supplements provides an understanding of safety through organization of data available from clinical trials, pharmacological and toxicological studies, case reports, and historical texts. Many of the findings support empirical data from the traditional use of herbs, and also alleviate many of the newer concerns regarding herb-drug interactions. This review provides assurance for the safety of many botanicals while also highlighting the need for research in a number of areas from basic pre-clinical data through clinical trials. Acknowledgements: Support for this research has been generously provided by the Office of Dietary Supplements and members of the American Herbal Products Association.