From April 30th 2010, new laws will affect the availability of herbal medicines and how they can be labelled and sold. This is the end of a very long implementation process of a new EU law on herbal medicines. Under this law, unless granted a full market authorisation (i.e. full medicines licence), all herbal medicines sold over the counter will now need a traditional herbal registration (THR) to stay on the market. Herbs that are traditionally sold as teas will remain on sale under food law.

What does this mean for consumers, doctors and patients?

One effect for consumers will be an increase in safety of the herbal medicines available. There have been a few cases where members of the public have been poisoned by herbal medicines that have been mislabelled, misidentified, or adulterated (e.g. with conventional drugs or heavy metals). Although herbal preparations have been overwhelmingly safe for most people, the MHRA (Medicines and Healthcare Products Regulatory Agency) wants to prevent a repeat of these accidents.

The quality of herbs will become more reliable under the new scheme: previously some herbal preparations have been found to be illegally irradiated or lacking quality e.g. ginseng sold that contains little or none of its active principles. It should also prevent one herb being labelled as another – for instance chamomile sold as feverfew.

Chinese and Ayurvedic formulas

However, it is also likely that because of the new regulations there will be fewer herbal medicines available over the counter and that complex combinations of herbs e.g Chinese and Ayurvedic traditional formulae that may contain six or more herbs will only be available by prescription from a qualified herbalists. Many Chinese and Ayurvedic traditional herbal formulae require specialist knowledge for correct use, so these herbal medicines are not particularly well suited direct sale to the public over the counter and are best prescribed by a properly trained herbal practitioner.

Statutory regulation of herbalists

The Government has recently announced that herbalists will become statutorily regulated and, once they are, they will still be able to obtain complex herbal medicines made up for their patients by third party manufacturers. In the meantime, they can still continue to prescribe patients herbal medicines made up on in their own clinics for individual patients. Visiting a herbalist with expert knowledge of the herbs offered may offer greater safety and effectiveness for some patients – but others may find it an unaffordable extra financial burden.

Traditional herbal registrations

Getting a Traditional Herbal Medicine Registration is a significant investment which may cost up to £30,000 per manufacturer, per herb. The THR requires the presentation of data on safety and traditional use as well as detailed quality control measures and some small herbal suppliers and manufacturers have already gone out of business in the face of these demands. Most companies have invested in popular herbs like Echinacea and Valerian which are likely to sell well. Herbs sold under the THR are required to indicate on the packet what they treat. Conditions that are addressed by these THR herbal products are limited to treating mild and self-limiting medical problems. So Echinacea may for instance be sold explicitly as a traditional cold cure.

So far the MHRA, which issues the herbal licenses has approved 100 traditional herbal registrations and more are in the pipeline. Some companies have applied to register herbs very late in the process, so there may be a backlog which sees some herbs disappearing and then reappearing on the market. Even so, all these registrations are a tiny proportion of the hundreds of herbs available in Western herbalism.

Nevertheless, the new rules about herbal medicines sold over the counter do not mean the mass disappearance of herbs. As mentioned, many herbs are also sold as foods – either as culinary spices or in teas. Herbs such as fennel, angelica, chamomile, lemon balm, sage and many others will continue to be available as long as they are sold as foods rather than medicines. This will be a route for the sale of quite a few herbs after April 30th

In a nutshell

• People will have to go to qualified practitioners to get prescriptions of complex and some foreign herbs – more expensive: but leading to greater safety and more effective prescribing
• Some problems with quality will disappear – it’s now unlikely that mislabelled/misidentified and adulterated herbs will get onto the market.
• Some doctors may be more interested in prescribing herbs now it’s easier to get hold of a high quality product.
• For over the counter sales, there may well be less choice of herbs from fewer companies
• With companies seeking to recoup the cost of very expensive herbal licences, the cost of herbal medicines sold over the counter is likely to increase.

 

Case Study: Neal’s Yard Remedies

Neal’s Yard Remedies sells herbs and herb and aromatherapy based cosmetics. They have been talking to the MHRA over several years about the changes. We asked them how they their business would respond to the new laws.

Susan Curtis, Director of Natural Health for Neal’s Yard says, ‘Some aspects of the new legislation remain unclear – whether consumers will notice a big change depends on how the law is implemented in practice. There isn’t for instance, an official list of all the herbs that can be sold as ‘teas’ – although we think that most of the loose herbs we sell fall into that category’.

‘Since the regulation of herbal practitioners went onto a statutory footing, it may be possible for registered practitioners working behind the counter in our stores to fulfill specialist prescriptions.’

Neal’s Yard products

• Dried herbs – will probably continue to be sold as before, as they are not specifically sold as medicines. There may be a few which need licenses if Neal’s Yard continue to sell them e.g. senna.
• Pre-packed tinctures – the cost of registering these means that Neal’s Yard will cease to sell many of these. These include both single tinctures like Echinacea and blends like Black Cohosh and Sage. Others are classified as foods, not medicines, and so will continue to be sold – herbs such as Dandelion and Burdock and Lemon Balm tincture.
• Dispensed tinctures – in-store practitioners will be able to continue to dispense these. Once the statutory regulation of herbalists is in place, Neal’s Yard will employ registered herbalists to continue with the service.
• Herbal medicines – Neal’s Yard will be introducing a small number of herbal medicines licensed under the Traditional Herbal Medicine scheme later in 2011.