Changes in the Regulation of Herbal Remedies and what they mean to you

By Terry & Patricia Gallagher, HRI Herbal Medicine

Since the new European legislation on the sale of herbal medicines came into effect in April 2011, manufacturers of traditional herbal medicines have had to meet more stringent criteria concerning the safety, stability and quality of new products, although shops and online suppliers have been allowed to sell old stocks which pre-date the introduction of the regulation.

Most of these older stocks have now sold out, so it is increasingly important that the estimated 8 million users who use or have used traditional herbal remedies in the UK understand that, to protect their health, they should only choose products that carry the THR (Traditional Herbal Registration scheme) mark. This shows that traditional herbal medicines have been approved by the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

Why choose regulated products?
Unregulated products may be ineffective and, at worst, actually harmful as there is no control over what they contain. One key part of the regulation requires approved suppliers to include detailed patient information which explains the recommended dosage, any potential side effects and contra- indications, such as compatibility with other drugs. The changes apply to products sold in the UK through chemists, supermarkets, health food stores and online.

What is a ‘traditional’ herbal medicine?
The THR mark indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC. To qualify as a ‘Traditional’ herbal medicine, products must have been in use for the past 30 years, including 15 years within the EU.

Only products carrying the THR mark are can be classified as herbal medicines:  other products containing traditional herbs can be sold, but the amounts of herbal content are below therapeutic levels, so they cannot be sold as medicines.

Herbal products have to go through rigorous procedures to obtain a THR.

What will the changes mean for regular users?
Consumers may find that the price of some of their favourite traditional herbal remedies go up with regulation – hopefully by just a little. This is due to various factors:

*  Manufacturers have had to incur significant costs to gain THR approval and, in order to ensure consistency of quality, have to undertake more in-depth analysis of the individual herb and strive for more consistency (there will always be some variance as herbs are naturally grown and factors such as the weather can make a difference year to year)
*  Compliance with Good Manufacturing Practice and Good Distribution Practice regulations incurs additional costs for manufacturers – especially where herbs which are grown abroad. These elements of the new THR regulations are designed to prevent falsification of medicines.
*  Admin is increased as manufacturers have to provide more information about where the herbs come from, such as which farmers’ fields they are grown in and what cultivation process was used to demonstrate Good Agricultural Practice, including sustainability.
*  Supermarkets in particular have previously sold many traditional herbal remedies at a loss but now need to sell them at market value.

As part of the changes, HRI Herbal Medicines has changed its packaging for HRI Clear Complexion and HRI Water Balance traditional herbal remedies to blister packs rather than bottles. This gives us more room to carry all the information demanded by the THR scheme on the boxes and is consistent with the other HRI products. We have also had feedback from customers that they find them more convenient as they can slip a sheet of tablets in a pocket or handbag, rather than carrying around a rattling bottle of pills.

We hope this explains the changes clearly for you, but if you have any questions please do get in touch!

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