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The Traditional Herbal Medicinal Products Directive (THMPD) and How it Affects You

This EU Directive came into force in May 2011, following a 7 year transition period.  If you or your family have ever enjoyed herbal supplements, this affects you!

It's a very complex piece of legislation. But in short, requires certain "medicinal" herbs to have a THMPD registration to be on the marketplace.  In 2011, this was at a cost of £110,000 per herb, PER EU country. So put these herbals into the hands of only the very large (often pharmaceutical) companies.  It should be noted that large pharmaceutical companies campaigned very heavily for this legislation.

Much of this article was written at the time, but we have tried to apply updates.

 

THMPD News Updates

  • 2016 - it's 5 years now since we travelled to Brussels representing UK retailers campaigning against this Directive with The Alliance for Natural Health (ANH).
  • As predicted, the marketplace is now largely dominated by pharmaceutical extracts. Some companies continue to flout the legislation and there are grey areas causing immense confusion for customers.
  • The EU referendum raises interesting questions, and may potentially mean we could supply herbals outside of this Directive.

 

Old Updates

  • The key products on our range affected are Black Cohosh, Cats Claw, Echinacea, Devils Claw, Ginkgo Biloba, Milk Thistle, Red Clover and Saw Palmetto
  • We do have a range of well known "herbals" not affected by this directive as they have a legal status as food supplements. All are pure and additive free; click here.
  • The Alliance for Natural Health (ANH) contine to try and mount a legal challenge.
  • The ANH asked us to detail how the Directive affected us - Click Here

 

Introduction

Our herbals are GMP assured, additive free, and organic, the purest, highest quality money can buy, but they will not be available once stocks are depleted. A legal challenge may mean we can supply in the future, but this is likely to take several years to go through the Courts.

We were entitled to "sell through" stock when the directive came into force. All herbs affected are now sold.  This legislation only applies to medicinal herbs. Our Broad Spectrum and Specialised ranges of supplements are not affected. Nor are those herbs considered "botanical" food supplements not medicinal, although this itself is a grey area.

The Health of the Nation is at Stake

It is not an overstatement to state that this directive is a tragedy for human rights, human health and consumer choice. From a business perspective, a vibrant, proud and important section of the UK economy will be completely stifled. And finally, this directive is nothing short of xenophobia when it comes to the traditions of for example, Chinese and Ayurvedic herbal medicine. These cultures have a fine, long standing, safe use of herbs, yet many of these herbs will be entirely removed from the EU because they have not had 15 years of use in the EU.

After a so called transition period of 7 years (this time frame is itself controversial as companies were not given adequate or full information until recently), the THMPD came into full force on the 1st May 2011.

The Seventh Wave Company Directors traveled to Brussels on the 23rd March for a meeting convening representatives from all over Europe, all with a passion for protecting our herbal traditions. In addition we and our customers contributed supporting documents to the High Court case detailed on the right. We have donated what we can to support the legal challenge.

The EU bureaucrats argue that this directive is to protect consumer safety. It does nothing of the sort. We will explain why it doesn't below, but first lets look at the directive in action.

£120,000 Registration (PER Herb, PER EU Country)

For many herbals to remain on the market, they require a THMPD registration. The process is unbelievably complex, unsuited to herbals being more akin to a pharmaceutical drug registration, and the cost is staggering - up to £120,000 per single herb. For us, this would represent a £1.4 million pound investment simply to register the initially affected / those with clear status herbals on our range (for the UK only, not the rest of Europe!). That sort of investment is completely unthinkable for us, and the majority of companies in the industry.

Frankly, even if we could make that sort of investment, we would be unlikely to do so considering the flawed, unworkable and disproportionate nature of this directive. In our opinion, those companies that have gone down this route have done a great injustice to consumers and industry alike. Had the industry stood as one, and said it was unworkable, then perhaps legislators would have been forced to address the issues?

Which Products Are Registered?

At the time of writing, 79 products have completed this process in the UK. The UK's licensing body, the MHRA has the dubious accolade of having given the most licenses, with Germany in second place. Across Europe, the total stands at a mere 200. Just 34 botanical species are represented from the many thousands that exist across the World. 80% of registrations are single herbs, with a handful containing two or three. This is an insult to traditional herbalism where complex herbal formulas play a valuable role.

27 of the registrations are for just two products - Echinacea and Valerian. And just 26 companies hold these 79 licenses, many are German and Swiss, not British companies. View the full list of those licensed here.

The THMPD has put the entire marketplace into the hands of a small number of large corporations creating an undesirable oligopoly situation. Many of them are owned by pharmaceutical companies. Many of them clearly care little for the great traditions of herbal medicine. And it won't surprise you when we say that this directive was openly lobbied for by the pharmaceutical industry.

Quality Compromised Not Improved

We pride ourselves on the highest quality 100% pure, additive free, whole herbs. We are dismayed that our superior products will be outlawed by this directive in favour of vastly inferior ones. Those registered to date, are packed with a staggering range of additives (colours, sweeteners, detergents, polymers and more).

Most are also in an pharmaceutical type extract form. We supply whole herbs because they have greater therapeutic properties, hundreds of nutrients create “biological intelligence”, they work together not in isolation. You can read more on the differences in this article - Whole Herbs Compared to Standardised Extracts

We already meet the high standards of Good Manufacturing Process (GMP) along with the requirements of many other pieces of national legislation. All of the herbals on our range have absolutely impeccable safety records over many, many hundreds of years (although not necessarily in the good old EU of course).

Additionally, all of our herbs are Certified Organic with full traceability from seed to factory. But the implications of the herbal directive mean that we have had to put to one side the securing of our organic marketing license which means we cannot promote this important aspect to you, our customer.

It is simply ludicrous to suggest that if one Echinacea (for example) packed with additives in an extract form is safe, that another Echinacea of a definitively higher standard and in a safer, more gentle whole herb form should not remain on the market.

Here's an example of one of the Milk Thistles you will have to use now our pure brand is gone...

"Each capsule contains 193 - 261mg of dry extract Milk Thistle, mannitol, cellulose microcrystalline, croscarmellose, sodium, silica colloidal anhydrous, magnesium stearate, gelatin, purified water, sodium lauryl sulphate, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide hydrate, (E172)"

We think that's absolutely disgraceful.

 

Is There Really a Safety Issue?

Herbal medicine is the oldest form of medicine, and the safest. It has been handed down through generations and has been protected as a healing tradition since Henry VIII's Royal Charter. Herbalists have always self regulated to impeccable standards, and nowhere is the Hippocratic principle of "first do no harm" more prevalent than within these long standing traditions.

In contrast, allopathic medicine whilst it has its rightful place, and saves millions of lives, also does a great deal of harm. Pharmaceutical medicines kill thousands every year, cause numerous health problems, and often fails to get to the root cause of health problems.

There have only been a tiny handful of issues with herbal medicines. One case that is seen to be central to the creation of this directive relates to a Chinese herb Aristolochia. But the people that were affected by this herb were given it by orthodox doctors, not specialist Chinese herbal practitioners. And they gave them a whole cocktail including many (now banned) amphetamine like substances. A study of the case found it to be a major cover up story, and a blatant attack on herbal medicine, even though herbal medicine was absolutely not to blame. You can read more on this story here

Kava Kava is another herbal that some might highlight. It is true that 70 users around the World suffered problems because of this herb. Firstly, that was out of millions of doses, and secondly, this herb is known to be problematic with alcohol. Those affected were old, and some had cirrhosis of the liver, and this herb was absolutely not suitable for them - an issue easily resolved with clear labeling. But the key point in this example, problems were identified, and this herb was made illegal in the UK - so the current system already allows to protect consumers in cases such as these.

"Problems" with herbs are few and far between. You would be hard pressed to find many . They have been consumed in billions of doses over the years, toxicity issues would have been identified if there were any.

We ourselves issue the following contraindications on our range as a precaution;

  • Black Cohosh is not recommended for those with liver problems (although a recent study questions this).
  • Devils Claw is not recommended if you have an ulcer.
  • Ginseng is not recommended if you have hypertension.
  • Milk Thistle is not suitable if you have an allergy to the daisy family.
  • Many herbs are not recommended during pregnancy due to a lack of data.

 

These are examples where contraindications are well known, are generally minor, and limited to small numbers of people. Responsible companies and herbalists will always make such advisories clear. If consumers are forced to turn to the black market, these issues may not be clearly identified.

Yes, we are all for high standards, and consumer protection and safety. Yes, regulate the black market traders out of the industry. But existing national legislation already ensures excellent safety standards.

Consumer safety will in fact be compromised by this directive. People will inevitably turn to illegitimate sources of herbs, where there will absolutely no guarantee of quality and safety - an utterly crazy situation.

What Exactly is the Position Now?

There are many grey areas, as a vast number of products fall between food law and the Herbal Directive. The MHRA have indicated they will not accept dual classification of a product, so where products have been registered by one company, other companies will not be able to sell under food law without a registration in place. There is also a vast interpretation of the law required, and as such, different member states are applying the Directive in wildly different manners. Products can be medicinal by either presentation (ie health claims of which we already make none in the line with the Medicines Act 1968), and / or by function. But this is a complex area, and one which the legal challenge will expose.

In the fairly short term, you will begin to see us presenting herbals as botanical food supplements.

We are entitled to "sell through" any stock that we hold, and you the customer are entitled to make such purchases. We made as large an investment as we could to put stock on the floor of the herbals, we estimate we have 4 - 6 months worth of stock depending upon demand which is difficult to predict.

Aside from the practical aspect, a lot hinges on the High Court hearing (see the right hand column for further info), we will advise customers of the date as soon as it is released. If successful, then the whole directive will be thrown into question until the case is presented in Europe, and the situation may remain fairly fluid.

Will You Still Be Able to See a Herbalist?

Yes, after years of discussion, the UK Government announced recently that a statutory register is to be created for herbalists. This will allow for them to continue "prescribing" those herbs that are "unlicensed". Whilst this does offer some protection for the consumer, and for herbalists, it does not solve the major problems of the Traditional Herbal Medicinal Directive. And it would mean that for many herbs, you would have to pay a consultation fee of up to £40 to access products you have previously been able to buy from your favourite trusted retailers. You can read a press release on the confusion this aspect has caused here.


Other Links

The key campaign group - http://www.anh-europe.org

If you wish to read the full text of the Traditional Herbal Medicinal Products Directive (THMPD), you can find this HERE

If you want to read the MHRA documents on the Traditional Herbal Medicinal Products Directive (THMPD) you can do so HERE

Press Release from Euractive.com
on the Herbal Directive

Basis for the legal challenge - http://www.anh-europe.org/news/together-toward-a-better-thmpd

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