Challenges and Opportunities for Improving the Safety Assessment of Botanical Dietary Supplements: A United States Pharmacopeia Perspective

Clin Pharmacol Ther. 2018 Sep;104(3):426-429. doi: 10.1002/cpt.1113. Epub 2018 Jul 31.

Abstract

The United States Pharmacopeia (USP) is an independent, nonprofit, science-based organization whose mission is to improve global health through public quality standards for dietary supplements, medicines, and food ingredients.1 Before developing standards for dietary supplement ingredients, the USP performs an "Admission Evaluation" (Figure 1), which includes an assessment to ascertain that an ingredient does not present a serious health risk.2 This article discusses the challenges encountered during the evaluation of botanicals and proposes possible solutions.

MeSH terms

  • Animals
  • Consumer Product Safety / standards*
  • Dietary Supplements / adverse effects
  • Dietary Supplements / standards*
  • Humans
  • Patient Safety / standards*
  • Pharmacopoeias as Topic / standards*
  • Phytotherapy / adverse effects
  • Phytotherapy / standards*
  • Plant Preparations / adverse effects
  • Plant Preparations / standards*
  • Quality Control*
  • Quality Improvement / standards*
  • Risk Assessment
  • United States

Substances

  • Plant Preparations