Should there be concern about the safety of botanical dietary supplements?

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization whose mission is to improve the health of people around the world through public standards and related programs that help ensure the quality and safety of medicines, dietary supplements (DS), and foods. To this end USP developes written quality standards and reference materials for medicines, dietary supplements (DS), and foods. DS monograph development is preceded by an evaluation of the safety of the article for which a monograph is sought. The purpose of the evaluation is not to determine intrinsic safety of the article but to determine whether or not it can be admitted for monograph development.

The most appropriate method for evaluating the safety of DS is Evidence-based review (EBR) methodology which provides scientifically-valid and defensible means to assess safety of DS. EBR methods are systematic thus enables safety determination on the basis of strength of available evidence (volume, quality, consistency of data and precision). However, limitations in the available evidence may not permit EBR for many DS. Such assessments require an approach that incorporates a broader evidence base including information from human clinical trials, post-marketing surveillance data, adverse events, pharmacological data, reproductive toxicity data and pharmacokinetics data. USP Admission Evaluation Subcommittee of the Dietary Supplements Herbal Medicines Expert Committee incorporates all these elements when conducting evaluations to determine suitability of articles for monograph development according to the USP Admission Evaluation Guideline. In this talk the USP safety evaluation of Schisandra chinensis will be presented to illustrate the USP safety evaluation process and inform on the potential safety concerns about Schisandra chinensis.