More than 900 bottles of the product in question – Jingzhi Kesou Tan Chuan Wan – were still on-shelves despite a February recall issued by the distributor in the UK.
Ekong International (UK) Ltd distributed the products to about 20 traditional Chinese medicine (TCM) outlets, according to the UK Medicines and Healthcare products Regulatory Agency (MHRA).
It said the products had been manufactured in China using Chinese labels but had been over-labelled in English to conceal the fact the products contained extracts derived from the Aristolochia plant.
Such extracts have been linked with kidney failure and the development of some cancers including urinary tract cancer. They have been banned in the UK since 1999 due to links to this potential toxic and carcinogenic behaviour which has included some deaths according to a 2000 European Medicines Agency EMA) report.
Those who had taken the supplement were recommended to consult a medical expert immediately.
The MHRA said more than three quarters of the 900 bottles distributed by Ekong remained unaccounted for. An MHRA spokesperson told NutraIngredients the agency was in the process of confirming with Ekong the exact whereabouts of these products, but noted it was likely that many of them had already been sold.
It had written to TCM trade and practitioner groups to ensure that none of their members are supplying the product that has no license under the Traditional Herbal Medicines and Products Directive (THMPD).
Ekong was unavailable for comment at the time of publication.
Natural but not safe
“This is a clear example where natural does not necessarily mean safe,” said MHRA head of herbal policy, Richard Woodfield.
“Aristolochia is a highly toxic plant that can cause serious injury and even death if taken. I would strongly advise anyone who has used this product to stop taking it and to immediately consult their doctor.”
MHRA has acted against Aristocholia-containing products before most recently in 2005 when two products, 'M2' and 'Energy 2000', making a host of sexual performance, immunity, fever and other claims, were recalled.
In its report, the EMA noted Aristolochia extracts were used as anti-inflammatory agents for gout, arthritis, rheumatism and skin diseases.
Aristolochia extracts are available as highly diluted homeopathic preparations in some European Union member states, EMA said.
“The Aristolochic acids have also been shown to exert strong mutagenic effects in bacterial and mammalian cell systems and have been shown to be potent carcinogens in rats and mice at low dose levels and also in humans at ug per kg levels,” EMA wrote in its 2000 report.