Need for Pharmacopeial Quality Standards for Botanical Dietary Supplements and Herbal Medicines

Abstract

Medicines from natural products have been used throughout human history. Because of growing interest, traditional medicine-based herbal medicines and botanical dietary supplements are popular among consumers. However, due to insufficient quality of many products, safety and efficacy are challenges from the modern medicine's point of view. This is particularly important at the global level because increased international commerce without the evidence of quality at global level makes consumers more prone to being exposed to low quality products. Efforts to ensure the quality of botanical products need the support of global public standards, and their proper use for quality assessments is also highly important. Differences in regulatory status among countries prompted the need for quality standards to include appropriate test methods and specifications. Pharmacopeial monographs define the specifications which herbal products need to show proper quality. Because of the complexity of the botanical materials, building quality standards in pharmacopeias needs careful consideration to include proper methods for identity, purity and strength, as well as appropriate acceptance criteria.