Over recent months the Medicines and Healthcare products Regulatory Agency (MHRA) has seen continuing evidence of bad and dangerous practices across parts of the unlicensed herbal sector. All the cases reported have had a common theme: adverse reactions, or the potential for consumer harm.

This has lead to the MHRA investigating and subsequently finding serious examples of very poor practice. They are warning the public about some of these practices by highlighting some of the most recent cases.

The issues found were:

• Reports of suspected adverse drug reactions, which were linked to an illegal unlicensed product being marketed for diabetes, which gave extremely dangerous advice to patients to stop taking prescribed medication. The MHRA took action to remove the product DBCare from the UK market
• A case of liver toxicity where two multi ingredient Traditional Chinese Medicine (TCM) products were being taken. This case highlighted the illegal practice of sticking a different label with a different list of ingredients on top of the original product label, so it’s anyone’s guess as to what the actual ingredient are!
• Poor sourcing practices i.e. buying from companies with bogus addresses and taking samples of unknown provenance from a ‘travelling salesman’ e.g. the case of Tian Li
• Evidence of the adulteration of products with potent pharmaceuticals or toxic ingredients. This is a serious problem that is indicative of low grade manufacturing standards and in some cases a deliberate intention to deceive the public, e.g. Li Da Dai Hua a herbal slimming product which was found to contain Des Methyl Sibutramine (a POM)

Many unlicensed herbal medicines are not made to such low standards. The problem is that consumers have to guess whether these unlicensed products contain the ingredients that are declared, and have reliable information about their use.

Good News for Consumers

• The MHRA is looking to reduce these risks through the new traditional herbal registration scheme (THR), for manufactured over-the-counter traditional herbal medicines.
• Under this scheme products are required to meet assured standards of safety, quality and patient information. Agreed minor claims are permitted on the basis of evidence of traditional use.
• To date the MRHA have received, 35 applications to register herbal products from a total of 12 companies, covering a total of 17 herbs as the active ingredients. Eleven applications have so far been granted, to 2 companies; the remaining 24 applications are under assessment.
• The MRHA are expecting the number of applications received and registrations granted to increase steadily over the coming months as we move towards 2011 when transitional protection for certain existing unlicensed herbal medicines expires. More and more registered products (shown by the THR number on the label) will be coming onto the UK market and consumers wishing to take herbal medicines will be able to choose from a wide range of products made to assured standards. Licensed herbal medicines (shown by the PL number) meeting assured standards also continue to be available.

Full article: http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON014134