Regulating traditional Chinese medicine

Moves are afoot to ensure the safety of Chinese herbal remedies, says Alyson Huntley

The case of a Birmingham woman who was recently fined £10,000 for the illegal sale and supply of the traditional Chinese herbal medicine (CHM) slimming product Shubao highlights continuing problems with the CHM industry in the UK.

The products in question were found to contain nitrosofenfluramine, which is toxic to the liver and is a derivative of the banned substance fenfluramine, which can cause heart disease and pulmonary hypertension.

 Also in April 2004 the MHRA reported a UK case of irreversible liver failure with Shubao found in CHM outlets in the West Midlands.

Toxicity and contamination
The factors affecting the safety of traditional CHM and conventional herbal medicine in general include toxicity, allergy, adulteration, substitution, contamination, mis-identification, lack of standardisation, incorrect preparation and inappropriate labelling.

Aristolochia species in CHM preparations for eczema is a good example. Aristolochia is associated with hepatotoxicity, cardiomyopathy and renal failure, and in 1999 aristolochic acid in a Mutong treatment for eczema derived from Aristolochia manshuriensis was cited as the cause of renal failure in two women undertaking long-term CHM for eczema.

Mutong can be derived from species of akebia and clematis, which do not contain artistolochic acid, and soon after this report of renal failure, aristolochia species were banned in the UK.

Heavy metals such as mercury, lead and arsenic have also been found, as well as human placenta and bat excreta.

CHMs contaminated with conventional medications are also found, such as fenfluramine derivatives and corticosteroids — some patients with eczema choose these products because they believe them to be a natural alternative to topical corticosteroids.

Production standards
The Medicines Control Agency, which later became the MHRA, publicised its concerns about the safety of some CHM products in 2001.

Manufacturing standards of CHM products in the UK market were said to be unreliable at best, and CHMs containing potentially dangerous and often illegal ingredients continued to be available.

The traditional CHM industry is not yet under statutory regulation. The industry is fragmented, with as many as four traditional Chinese medicine practitioner organisations in the UK: the Register of Chinese Herbal Medicine, the Chinese Medical Institute and Register, the Association of Traditional Chinese Medicine and the Society of Chinese Medicine.

An umbrella organisation for herbal practice, the European Herbal Practitioners’ Association, is working towards statutory self-regulation for herbal medicine in the UK, and new EU regulations including an herbal medicine directive came into force in the UK in 2005.

The DoH has published a consultation document and is currently setting up a stakeholder working group to move towards regulation.

Traditional Chinese medicine practitioners will be under statutory regulation in the near future, and the 2005 EC Traditional Herbal Medicinal Products Directive, introduced to assure the quality and safety of registered products is likely to be tightened up, with third-party suppliers of CHM products asked to prove good manufacturing practice.

The MHRA also publishes the online publication Herbal Safety News to publicise the issues and promote vigilance against unscrupulous herbal practitioners or product suppliers. The recent case in the Midlands is an example of the success of this approach.

Perhaps the best news for the CHM industry is that the MHRA aims to work with the main traditional Chinese medicine practitioner organisations and the Chinese Medicine

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