Warnings about poor practice in the unlicensed herbal sector

The Medicines and Healthcare products Regulatory Agency issued a press release on 4 March 2008, warning of the continued evidence of bad and dangerous practices across parts of the unlicensed herbal sector.
›   Press release: Poor practice in the unlicensed herbal sector - MHRA warns the public to be vigilant

All the cases reported have had a common theme: adverse reactions or the potential for consumer harm through inadequate or poor patient information and labelling; poor sourcing practices; evidence of adulteration of products with potent pharmaceutical or toxic ingredients; and suggestions that herbal remedies can replace conventional medication. This has lead to the MHRA investigating and consequently finding serious examples of very poor practice.

The main issues which have come to light over recent months were:

• Two suspected adverse drug reactions reports have been received in association with in a multi-constituent Ayurvedic remedy, DBCare, containing the ingredients Trigonella foenum-graecum, Tinospora cordifolia, Syzygium aromaticum, Phyllanthus emblica. This product claimed to allow patients to stop taking their prescribed diabetic medicines. One patient experienced loss of diabetic control and the other patient experienced liver problems, increased blood glucose and increased blood pressure. Due to the very serious nature of the claims made on this illegal product, the Agency took action, removing the product from the market and closing down the website selling the products.
• A man collapsed after consuming a product called Tian Li, which claimed to give sexual enhancement. He was also taking Viagra on prescription. Whilst no permanent ill health was suffered by the consumer, the result of our analysis showed the presence of a prescription only medicine hydroxyhomosildenafil, at a level of 39.6mg per capsule and tadalafil at 14.4mg per capsule. MHRA enforcement officers subsequently seized a quantity of the product from the supplier. As a result of our investigation it transpired that the company’s warehouse was approached by a sales person selling packets of Tian Li, which were then supplied to about six of the company’s retail outlets. MHRA were also alerted to wholesalers who are being regularly approached by salesmen trying to sell Traditional Chinese Medicine (TCM) products.
• A woman who purchased a slimming product called Li Da Dai. She used this product for three days and felt a bit weak and vomited. She wasn't sure if these were side effects or not but had been on the internet and found the item on our website about Li Da Dai Hua reported by the Dutch authorities to contain Sibutramine. MHRA subsequently tested the product and confirmed the presence of Des methyl sibutramine. Sibutramine should only be prescribed under specific circumstances and requires the supervision of a registered doctor as it can cause a rise in blood pressure.
• A TCM direct marketing flyer for ‘herbguo.com’ was advertising its herbal solution to Coronary Heart Disease, saying they could replace a Coronary Heart Disease operation with a six week herbal treatment.
• A complaint from a clinician who has expressed concern that an Ayurvedic practitioner had advised a patient not to take his medicine for schizophrenia and instead go to India for other treatments. An associated website also makes potentially dangerous and unsubstantiated claims about the various products they sell.

The MHRA continues to seize, or receive from other agencies, for analysis a significant quantity of suspect herbal products. In recent months products being sold as herbal, natural and safe have tested positive for dangerous and illegal substances including Aristolochia, Sildenafil, Tadalafil, Finasteride, Clotrimazole, Mebhydrolin, Nonivamide, Hydroquinone.

Whilst many unlicensed herbal medicines are not made to such low standards it is difficult for consumers to know which unlicensed products contain the ingredients declared, are of acceptable safety, and have reliable information about the safe use of the product. The MHRA is looking to reduce these risks to consumers through the new traditional herbal registration scheme for manufactured over-the-counter traditional herbal medicines. Under this scheme products meet assured standards of safety, quality and patient information. Agreed minor claims are permitted on the basis of evidence of traditional use. Increasingly, 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.

Consumers looking for information on the safe use of herbals can view the new herbal information sheets that will progressively be placed on our Website. The information sheets are non product-specific and may be of particular help to consumers who are concerned about the weak product information available with some unlicensed products.
› Information sheets on safe use of herbs