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Press release
| Date: | 03 Sep 2004 |
|---|---|
| Time: | 00:00 |
| Subject: | MHRA issues advice about quality of traditional Chinese medicines |
| Contact: | Press Office 020 3080 7651
or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189 |
The Medicines and Healthcare products Regulatory Agency (MHRA) today issued advice to consumers and the herbal sector about the poor quality of some traditional Chinese medicines (TCMs) on the UK market.
.MHRA have recently identified a number of TCMs which contain ingredients that could pose a risk to consumers' health. This has prompted the Agency to remind consumers that they can not give assurances about the quality of these unlicensed herbal remedies and to give an update on action to address the problem.
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.
Examples of incidents currently being investigated by MHRA include:
- the dietary supplement, Shubao; samples have been found to contain Fenfluramine (banned worldwide after being linked with cardiac problems) and/or Nitrosfenfluramine (toxic to the liver);
- a product, Fufang luhui jiaonang, supplied by a TCM outlet was investigated by the Agency and found to contain high levels of mercury - 11.7% by weight. The product was recalled from 35 TCM outlets.
Other ingredients found to be illegally included in TCMs in recent months have included: the banned ingredient Aristolochia, associated with kidney failure and cancer; prescription only ingredients glibenclamide (used in the treatment of diabetes; improper use can be fatal) and corticosteroids (found in 'herbal' skin creams). The TCMs involved have been in a number of forms, 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. If you are taking one of the specific TCM products identified as posing a risk, stop taking it and consult your GP if you feel unwell. When consulting your doctor or pharmacist about your health, always remember to tell them if you are taking TCMs or other herbal remedies.
"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".
The European Directive on Traditional Herbal Medicinal Products will set out clear standards for the safety and quality of over the counter traditional herbal medicines and is due to be implemented in 2005.
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.
Notes to Editor
1. Herbal Safety News is accessible via the home page of the MHRA, website listed and regularly updated as new information emerges. Examples of successful prosecutions can also be found at the same site.
2. The current regulatory regime for unlicensed herbal medicines (Section 12 of the Medicines Act 1968) does not set specific standards for the quality and safety of remedies.
3. The Department of Health recently consulted on proposals for the statutory regulation of the herbal medicine profession. (Regulation of herbal medicine and acupuncture; proposals for statutory regulation; March 2004). The Department is currently considering the responses to this consultation.
4. In September 2001 the then Medicines Control Agency warned about the poor quality of some traditional Chinese medicines found on the UK market.
5. The MHRA has written today to the herbal sector expressing its concern about the situation and seeking their continuing co-operation over measures to address the situation. A copy of this letter can be accessed via Herbal Safety News.
