Press release: Poor practice in the unlicensed herbal sector - MHRA warns the public to be vigilant

Press release

Date:	04 Mar 2008
Time:	10:00
Subject:	Dangerous practices in the unlicensed herbals sector
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

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. Today we 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 (See notes to editors)
• 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 (See notes to editors)
• 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 we 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.
• We 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.
• The agency is committed to making it easier for consumers to find out how to use herbal medicines safely. Consumers looking for information on the safe use of herbals can view our advice on our website, which is regularly updated. The following link will take you to the relevant information:

 › Information sheets on safe use of herbs

Notes to Editor

Case studies

1. Two suspected adverse drug reactions reports have been received in association with in a multi-constituent Ayurvedic remedy, the product DBCare contained ingredients such as 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.
2. 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 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 TCM products.
   
3. 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 (a POM).
4. A TCM direct marketing flyer for ‘herbguo.com’ was advertising it’s herbal solution to Coronary Heart Disease. Saying they could replace a Coronary Heart Disease operation with a six week herbal treatment. The MHRA is currently investigating this case.
5. The Agency recently received 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.

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 Aristolochia, Sildenafil, Tadalafil, Finasteride, Clotrimazole, Mebhydrolin, Nonivamide, Hydroquinone

Traditional herbal registration scheme

The first product to receive a registration was Atrogel Arnica Gel: an arnica gel traditionally used for the symptomatic relief of muscular aches and pains, stiffness, sprains, bruises and swelling after contusions.

Since then we have registered  (Amended 7 April 2008)

• Flexiherb; a Devil’s claw product traditionally used for the relief of backache, rheumatic or muscular pains and general aches and pains in the muscles and joints
• Migraherb; a Feverfew product traditionally used for the prevention of migraine headaches
• Menoherb; A Black cohosh product traditionally used for relief of symptoms of the menopause, such as hot flushes, night sweats, and temporary changes in mood (such as nervous irritability and restlessness)
• Prostasan; a Saw Palmetto product traditionally used for the relief of lower urinary tract symptoms in men who have a confirmed diagnosis of benign prostatic hypertrophy (BPH)
• Premherb; an Agnus Castus product traditionally used for relief of the symptoms associated with premenstrual syndrome
• Atrosan Tablets; a Devil's Claw product traditionally used for the relief of backache, rheumatic or muscular pains and general aches and pains in the muscles and joints
• Venaforce; a Horse Chestnut product traditionally used for the relief of symptoms associated with chronic venous insufficiency and varicose veins, such as tired heavy legs, pain, cramps and swelling
• Hypericalm; a St Johns Wort product traditionally used for the relief of symptoms of slightly low mood and mild anxiety
• Niteherb; a valerian product which is a traditional herbal medicine used for the temporary relief of sleep disturbances due to symptoms of mild anxiety
• Niteherb Plus; a Valerian Roots Extract & Passiflora extract product which is a traditional herbal medicine used for the temporary relief of sleep disturbances due to symptoms of mild anxiety

Progressively the MHRA will place assessment reports about these registered products on the website. These are available via the hyperlink below:

 › Public Assessment Reports for herbal medicines

As part of our on-going work to ensure that consumers are able to readily distinguish products registered under the scheme from other products on the market, we are developing an identifier symbol. Publicity concerning the identifier will be developed in 2008.

We have also made a number of improvements and updates to the herbal part of the website including adding an e-mail alerting facility to which users can subscribe and receive an e-mail notification when the Herbals Section of the website is updated.