Kang Ning Ltd, Upper Lisburn Road, Belfast pleaded guilty to four charges of possessing, with the intention of placing on the market, adulterated herbal medicines.
The charges related to four products which were seized in February 2006 after Inspectors from the Department of Health, Social Services and Public Safety’s (DHSSPS) Pharmacy Branch carried out a number of searches in TCM retail outlets in Northern Ireland.
Following analysis by the Medicines and Healthcare products Regulatory Agency (MHRA) a number of illegal and toxic substances were discovered in some of the products seized. These products were:
a. Mr Dragon 100% Natural Male Tonic
b. Dragon Power
c. King 100% Natural Male Tonic
d. Zhandaodi
The products were found to include Sildenafil (or Tadalafil) which are the active ingredients of Viagra and Cialis and are prescription only medicines.
Commenting on today’s judgement, Dr Mike Mawhinney, Head of Inspection and Investigation, DHSSPS said: “The Department of Health recognises that many people value herbal remedies, such as traditional Chinese medicines.
“However, we now have evidence that, in some cases, the medicines controls applying in this country to provide for public confidence and safety are being breached. While many individual remedies are unlikely to pose any threat to public health, there is concern that examples of TCMs containing potentially dangerous and often illegal ingredients continue to be found on the market.
“The Department is doing everything in its power to clampdown on the sale of illegal and harmful medicines and has instructed all TCM outlets here to withdraw these particular adulterated products from sale and to ensure the safety and efficiency of all herbal remedies offered for sale from their premises. While there is no totally reliable way for the public to identify those which could be unsafe, patients should avoid buying any remedies where they are uncertain as to the nature and quality of the ingredients.
“It is inadvisable to buy products which are not labelled properly or which do not include a full list of ingredients in English. People should always inform their doctor or pharmacist if they are taking a herbal remedy.”
Departmental officers in conjunction with MHRA have taken steps to ensure that these products have been withdrawn from sale and will carry out appropriate follow up action.
Notes to Editors:
1. A range of products were seized from six Traditional Chinese Medicines (TCMs) outlets during February 2006.
2. Following analysis by the Medicines and Healthcare products Regulatory Agency (MHRA) a number of illegal and toxic substances were discovered in some of the products seized. These products were:
a) Mr Dragon 100% Natural Male Tonic
b) Dragon Power
c) King 100% Natural Male Tonic
d) Zhandaodi
3. The Medicines Inspectorate, Department of Health, Social Services and Public Safety is responsible for inspection and enforcement of statutory medicines controls in Northern Ireland and works closely with the UK Medicines and Healthcare products Regulatory Agency (MHRA).
4. The MHRA is the Government Agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe, taking any action necessary to protect the public.
5. A new framework for authorising the marketing of traditional herbal remedies, the traditional herbal medicines registration scheme – as required by the European Directive on Traditional Herbal Medicinal Products – came into force on 30 October 2005. The new legislation will enhance public confidence with respect to the safety and quality of over the counter (OTC) herbal remedies. Manufacturers will be required to meet consistent quality and safety standards that reflect good practice in the herbal industry.
6. This is a significant improvement in regulation. Previously, unlicensed herbal remedies in the UK have not had to meet set standards for safety, quality and consumer information and, as a result, the consumer had no way of knowing which products are made to acceptable standards. There is well documented evidence of an international trade in low grade, and sometimes unsafe, herbal medicines.
7. Further information about the traditional herbal medicine registration scheme can be found on the MHRA website: www.mhra.gov.uk. Further information about herbal safety issues can be found on the MHRA’s dedicated herbal Safety News pages.
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