The trade of botanical ingredients for the production of herbal drugs and phytomedicines,
dietary supplements, and natural cosmetics is global, with supply and quality issues
in one geographical region affecting other areas. Chemical complexity of botanicals
requires added quality control diligence for raw material suppliers and manufacturers.
In recent years there have been numerous cases of accidental misidentification of
botanical materials due to nomenclatural confusion, lack of adequate quality control
measures, etc. Also, there have been persistent cases of inadvertent contamination
with heavy metals, agricultural chemicals, excessive microbial load, excessive solvent
levels in extracts, etc. But there is also the disturbing trend of intentional adulteration
– economically motivated adulteration (EMA) – as well as the „spiking“ of extracts
with undisclosed lower-quality and lower-cost ingredients. This includes the spurious
and illegal addition of active pharmaceutical ingredients (conventional pharmaceutical
drugs), e.g., sildenafil in dietary supplement products for erectile dysfunction and
sibutramine in weight-loss products. This presentation reviews many of these quality
control challenges and notable cases of safety concerns and economic fraud created
by them as is being compiled American Botanical Council and the American Herbal Pharmacopoeia
from information supplied by botanical ingredient suppliers, manufacturers, and laboratories
in the United States and in other countries.
