New Rules for Herbal Medicines


According to research, 26 per cent of UK adults in the UK have used an over the counter (OTC) herbal medicine for mild common complaints in the past two years. Like many others, I’ve used herbal products for many years because they are often as or more effective, gentler, and have fewer side effects than pharmaceutical drugs, both prescription and OTC.

However, there is a problem. To date, there’s been no regulation governing herbal medicines. The majority of people believes that ‘natural equals safe’ but that’s not necessarily true. Some plants are poisonous. So the EU has introduced an Herbal Medicines directive, starting this month, to ensure the safety of herbal medicines (it doesn’t cover homoeopathy, aromatherapy or flower remedies). All OTC herbal medicines must have a Traditional Herbal Remedy licence, from the MHRA (Medicines and Healthcare products Regulatory Agency,, which allows the product to carry a THR certification logo. The ‘traditional’ bit means the herb, or combination, has been on the market for at least 30 years, 15 of them in Europe.

As well as safety, the THR licence also covers quality, so denotes that a product contains the correct herb (alarmingly not always the case), contains only permitted levels of heavy metals, pesticides, pharmaceuticals and other contaminants, and will last the specified shelf life. (Be aware, however, that the product might now contain permitted additives such as sodium lauryl sulphate, aspartame or cyclamate, or a range of E numbers, which you might not expect, or want, in a herbal remedy.) It also ensures manufacturing premises for herbals are the same standard as for pharmaceutical drugs, and that the labelling includes comprehensive information about contra indications, side effects, safety for children and in pregnancy etc.

Obviously, this is all desirable but there is still an information gap. Although product labels can state facts about traditional use, gaining a licence doesn’t indicate evidence of proven efficacy. The MHRA explain they’ve taken a pragmatic decision; establishing efficacy could be a long and difficult task so, since people were likely to carry on taking their echinacea or valerian anyway, it was more important to ensure it was safe. In fact, some herbal medicines do have research to back them up, usually ones originating from countries such as Germany and Switzerland where herbal medicine is routinely used, often by doctors. And in many cases, the herbs have been used for centuries for the symptoms listed, both safely and effectively.

So far, about 99 THR applications have been granted but there are around another hundred in the pipeline, so if your usual remedy doesn’t feature a THR logo (it’s okay for retailers to sell existing stock),that may not mean it’s been refused. However, the MHRA told me there is currently no way of checking what stage things are at. Some products may disappear temporarily – while the application is processed – or permanently – because companies, usually small ones with limited budgets, may simply not have applied for a licence as the costs (producing detailed scientific dossiers and/or having to update premises etc) can be high.
If you want to buy a well-known herb you should have plenty of choice. And because medical herbalists in the UK are now licensed by the government means they will be able to prescribe other (unlicensed) herbal medicines. So far no applications have been made for a THR licence for Chinese or Ayurvedic remedies, which the MHRA believes ‘may be more suitable for practitioner prescription’. (However, one manufacturer of Ayurvedic herbal products – Pukka Herbs – has relabelled its products as ‘food supplements’ which it believes will allow them to go on being sold legally.)
As the MHRA spokespeople themselves admitted, the present situation is confused. But ultimately the benefits should outweigh the teething problems.

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Book of the Week: I Will Make You Fit Fast (Quadrille Publishing, pub May 2011)
Fitness and nutrition trainer Matt Roberts, the chap who’s got Sam Cam back in shape after baby Florence, has produced a book giving detailed plans for getting you beach-lean in periods from two (prepare to feel the pain) to 12 weeks (his preference). If you like super-organised, prescriptive schedules, this one’s for you.

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