News - The traditional herbal medicinal products directive – what next?
At the end of this month, THMPD becomes law. However much the industry has fought against it, the might of the EU has defeated us and we have to work within their rules.
From 30th April 2011, herbs that are classed as ‘medicinal’ can no longer be sold unless they carry the appropriate licences. This means that many herbal products that are known and trusted will no longer be available within the EU.
While this is hugely frustrating for reputable supplement manufacturers, like Higher Nature, who always follow Good Manufacturing Practice and have now had to invest in the licences, from a consumer viewpoint, it does have some benefits. It will mean that some of the most popular and widely used herbs, such as milk thistle, echinacea and agnus castus, will still be available as licensed herbal medicines. This will also provide the customer with reliable information on what the product should be used for and it ensures the quality and safety of the product. From a health food store or pharmacist perspective, they can have trust in the reliability of the medical information, which is stated on the SPC and have greater confidence to prescribe.
However, from a practitioner viewpoint, the water has just become muddier! A statement was issued on 18th February 2011 from the Secretary of State for Health announcing that all practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated. Indeed, the Health Professions Council has been asked to establish a statutory register for practitioners supplying unlicensed herbal medicines.
This is, effectively, good news for practitioners preparing unlicensed herbal medicines on their own premises for the use of individual patients after a consultation, in that once registered, these practitioners will still be able to operate. Clearly, at this stage, there is little information about what the requirements would be in order to obtain registration, but there will be a formal consultation taking place later in 2011. Therefore, until this happens, practitioners of herbal medicines can continue their businesses as they are currently.
For committed manufacturers, such as Higher Nature, obtaining the appropriate licences to ensure the continued supply of important herbs to customers has been paramount and they have invested the time and money in order to achieve this goal. Currently, on the MHRA register, there are around 80 licences that have been granted with 32 different herbs used in the applications granted to date. Each licensed product carries a specific ‘traditional use’ claim as to its benefits. These are quite restricted and while it is only possible to say what the licence specifies, this is often more than can be claimed on food supplements. Unfortunately, as practitioners, we all know that with many herbs, there are a number of additional medical conditions where they have been found to benefit the individual, with evidence sometimes dating back many hundreds of years. However, the licensed herbs can only state the information on the SPC contained within the product pack.
What is still uncertain, however, is which specific herbs are still to be brought under the ‘medicinal’ heading, as there is no definitive list.
On a positive note, the licensing of certain herbs will remove some of the following problems:
The wrong herb being used in a product
The wrong dose or strength being used, compared to what is stated on the pack
The possibility of heavy metal contamination, such as lead, mercury or cadmium
•The possibility of microbial contamination, such as salmonella or coliforms
The presence of pesticides
The potential for residual solvent contamination
These are all real issues that will be eradicated by the new legislation.
So, not for the first time, certain parts of the industry are in a state of flux, but at least some of our most popular herbs will still be readily available and we await further news.