There has been a lot of talk in Europe lately about the Traditional Herbal Medicine Directive which will be in full effect for all 27 member states as of 1 April 2011, after a seven year transition period. It has raised a lot of concerns that many herbs will not be available any longer after this.
Let me start by explaining a little about the Directive, because there are many alarming e-mails going around which are not quite correct, saying that "all herbs will be banned" and so forth.
In the US and in Europe, medicinal claims are not legal for nutritional products, even though they are well documented scientifically. To sell the same product with a medicinal claim (which includes any preventive purposes!), it has to be registered as a new drug, the same way as any pharmaceutical drug. How costly the process to register a new drug is can be seen from the fact that the FDA only gets about two dozen applications per year. For an herb, which cannot be patented, it would be all but impossible for any small company to register it as a medicine.
The authorities' true purpose is, of course, to clearly distinguish between foods which are "useless for medicinal purposes" and medicines which are effective. Of course we all know that this is not true and serves only the industry.
Europe has decided that it should be easier to sell traditional herbal medicines and for that purpose has created a law that reduces the cost and effort it takes to register an herb as a traditional herbal medicine. So one would think that this law should be welcomed by the natural health community. And it is, by some.
But the Directive is a double edged sword.
The positive side is that herbs can be sold with their medicinal claims and the registration of a traditional herbal remedy will cost no more than maybe $100,000 per product. Still a lot, but still affordable even for a small company, for a limited amount of products.
But there are substantial negatives:
- Some herbs may be deemed toxic and disallowed form the process of being registered altogether. Again the authorities display the same attitude here they generally display, namely that for pharmaceutical drugs it is OPK when people drop dead when taking them (see the Starfield report); but for natural remedies, no one must ever have the slightest side effects.
- Only herbs that have been used traditionally fall under this Directive. Paradoxically, this rules out most Traditional Herbal Medicine, which has been in use for a couple of thousand years -- because it is not traditional IN EUROPE.
- Furthermore, the authorities lay down standards for such remedies. Those may require standardized extracts or other requirements, but those procedures sometimes require an adulteration of the natural product. The customer will therefore not have a choice in the matter any longer.
- Finally, the most important question is which herbs will MANDATORILY have to be registered as traditional herbal remedies and which can be sold as nutritional supplements without medicinal claims, like they have been. The only Government I know that has set down half way clear rules about this is the British. In a nutshell, their rule is that if an herb has any history of food use, it can be sold as a nutritional supplement, but if it does not, it has to be a traditional herbal remedy. That means that a number of herbs will disappear as of 1 April, 2011 unless the company has gone through the registration process. The process takes about 2 years, so this can't be remedied quickly. Other Governments have not commented and only time will tell whether this turns into a major issue or whether life will mostly go on the same way.
http://www.anh-europe.org/news/anh-press-release-pressure-against-eu-herb-laws-mount
Source: http://www.drclark.net/
