MHRA alerts consumers to Chinese medicine risks
herbal sector about the poor quality of some traditional chinese
medicines on the UK market, advising them to avoid all products not
labeled in English.
It also underlined the merits of the European Directive on Traditional Herbal Medicinal Products, due to be implemented in 2005, which will set standards for the safety and quality of over the counter traditional herbal medicines.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it has recently identified a number of Chinese medicines, which contain ingredients that could pose a risk to consumers' health. Under current regulations unlicensed herbal medicines do not have to meet set standards of quality and safety. However, if products are found containing illegal or potent ingredients, such as prescription-only medicines, the MHRA can remove them from sale.
The UK's Chinese herbal medicine industry was worth an estimated £54 million ((€79m)in 1999 although it is difficult to quantify. Chinese manufacturers still account for only 3-7 per cent of the market outside China, according to a recent report.
Some of the products currently being investigated by MHRA include the dietary supplement, Shubao, samples of which have been found to contain Fenfluramine (banned worldwide after being linked with cardiac problems) and Fufang luhui jiaonang, found to contain high levels of mercury - 11.7 per cent by weight. This product was recalled from 35 traditional chinese medicine outlets.
The banned ingredient Aristolochia, associated with kidney failure and cancer, as well as prescription-only ingredients glibenclamide (used in the treatment of diabetes) and corticosteroids (found in 'herbal' skin creams), have also been found in a number of forms of Chinese medicine, including pills and capsules.
Sir Alasdair Breckenridge, chair of the MHRA, said: "We recognise that many consumers value traditional chinese medicines but they should be aware that we continue to find some products which are manufactured to low quality standards and which contain potentially harmful substances."
"Our advice to consumers is not to take TCMs if they are not labelled in English. Even then you should be aware that good labelling is not a guarantee of a good quality product. When consulting your doctor or pharmacist about your health, always remember to tell them if you are taking TCMs or other herbal remedies."
He added that MHRA is taking a wide range of action to tackle the situation by enforcing the existing law, providing more information to consumers and improving the regulation of herbal remedies.
"We welcome the fact that many in the herbal sector have supported moves to improve regulation in this area and are working constructively with the agency," continued Sir Alastair.
MHRA recently consulted on proposals to improve the regulation of herbal remedies made up by herbalists for individual patients and are currently considering the responses to this.