Safety Assessment of Panax Ginseng

Abstract

Since the 1994 Dietary Supplement Health and Education Act, the consumption of botanical supplements has increased to the point where ginseng is the third best selling herbal supplement in the United States and it is now also being used as a flavoring agent in foods. The predominant pharmacologically active constituents of Panax are ginsenosides, at least 25 of which have been identified and are present in variable amounts and ratios to one another, depending on the particular species, variety, and conditions of growth. The toxicological profile of ginseng indicates it to be of rather low acute oral toxicity (LD50 > 5000 mg/kg for rats and mice, approximating 200 mg ginsenoside/kg.) No toxicological effects were identified in mini pigs at a dose of 2000 mg/kg (80 mg ginsenoside/kg). As concluded from a 90-day dog study and in reproduction studies in rats and mice, 15 mg/kg (∼ 0.6 mg ginsenoside/kg) was without effect. No effect was seen in rats administered 4000 mg/kg (160 mg ginsenoside/kg) for 20 days. There was no mutagenic activity observed in Salmonella typhimurium TM677 system with the use of ginseng in the presence or absence of metabolic activation. The no-observed-adverse-effectlevel (NOAEL) in rodents is likely within the range of 50 to 100 mg ginsenoside/kg. There are no confirmed reports of adverse reactions in humans attributed to ginseng alone. Importantly, no consistent symptomology or findings have been attributed to, or identified as being associated with, ginseng consumption. Ginseng extracts standardized at a concentration of 4 mg ginsenosides/100 mg capsule and given at a dose of up to 114 θ g ginsenoside/kg have not resulted in untoward effects when administered to humans for periods of up to 12 weeks.