Botanical drugs are heterogeneous mixtures that contain:
Multiple chemical components
Potentially more than one chemical component that contributes meaningfully to the mixture’s physiological or pharmacological action
Chemical components in a botanical mixture and their biological activities are generally not well characterized.
Botanical drugs exhibit batch-to-batch variations in properties (e.g., chemical composition).
Natural variability at the plant and raw material levels
Greater than the variability typically observed in non-botanical drugs (e.g., chemically synthesized and purified drug molecules)
Many botanical drug candidates have previous human-use experience.
Dietary supplements in the U.S.
Herbal medicines (e.g., Europe)
Traditional medicines (e.g., China)