Quality Assurance and Safety of Herbal Dietary Supplements

Abstract

Since the U.S. Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, use of herbal products has been growing rapidly worldwide. To ensure consumer health protection, the quality and safety of herbal plants, particularly those used for dietary supplement preparations, must be determined. To date, toxicological data on the identification of genotoxic and tumorigenic ingredients in many raw herbs and their mechanisms of action are lacking. Thus, identification of carcinogenic components in herbal plants is timely and important. In this review, the issues of quality control and safety evaluation of raw herbs and herbal dietary supplements are discussed. Two examples of tumorigenicity and mechanism of tumor induction are discussed: aristolochic acid and riddelliine, both of which have been detected in Chinese herbal plants. It is proposed that an organized effort with international participation on cancer risk assessment should be actively pursued so that the safety of commercial herbal plants and herbal dietary supplements can be ensured.

Key Words:

• Herbal dietary supplements
• Chinese traditional herbs
• quality assurance
• toxicological effects

ACKNOWLEDGEMENTS

We thank Dr. Frederick A. Beland for critical review of this manuscript.

This article is not an official guidance or policy statement of U.S. Food and Drug Administration (FDA). No official support or endorsement by the U.S. FDA is intended or should be inferred.