By Fleur EJ Churchill BA(Hons)

Seventh Wave Supplements is a positive business, a people business; we help our customers feel better, naturally. We love what we do, and our company is built on strong core values of quality, integrity and an exceptional customer experience.

But our customers are unhappy, very unhappy. And they are angry and confused.

On Friday 15th June 2011, the final stock of our GMP assured, organic, additive free, whole herb Milk Thistle was depleted. This was the second of our herbs (the first being Cat’s Claw), to be decimated indirectly by the EU’s Traditional Herbal Medicinal Products Directive (THMPD). Ten more are to follow in the coming weeks and months. Yet more are at risk in the longer term, but we will fight to protect them.

This directive is unjustifiably compromising our business. It’s a European juggernaut steaming through our beloved brand, and there is nothing we can do.

We had sold our herbal medicines exempted from licensing under an exemption for manufactured products that had existed since 1968. But this exemption got consigned to the scrap heap the day the THMPD was fully implemented, on 1st May 2011. To avoid a revolution in the streets, the UK medicines regulator, the Medicines Healthcare products Regulatory Agency (MHRA), allows a “sell through” of stock bought before 30th April. This “sell through” means we can carry on selling granted this previous exemption under UK law, either up until stock runs out or until the use by date is up.

Industry predicted around a 2-year use by period for most products which sounds all well and rosy, but it’s not. Our products have a shorter shelf life than some, being additive free. Also our stock investment was very limited by budget, and we had no way of predicting demand.

We certainly weren’t rabbits in the headlights. This directive has been firmly on the agenda for a long time now. But the reality of it actually hitting home was much harder than we anticipated.

Seventh Wave's Milk Thistle: the company's second product to be lost by the THMPD

Financial and Emotional Repercussions

Turning away custom has obvious and very real financial implications. We have many thousands of customers around the World, some only use certain herbals. In the blink of an eye, we have nothing to offer such single product customers, it is devastating. And growth is stifled; it is a long time since we looked to bring any new herbal supplements onto our range.

There are also more subtle economic effects - our entrepreneurial spirit is subsumed as we work our way through this legislative tangle, staff need to be trained on the legalities, and phone lines are kept very busy handling explanations of the issues. We are of course happy to discuss the matter at length, our accountants however probably take a different view. We are fortunate that the affected herbals only make up a section of our business, so there will be no job losses for the time being. We know other companies will not be so fortunate, especially on the manufacturing side.

But more than that, it is extremely distressing to say the least, that our customer experience has been dramatically altered. We like nothing more than conversing and engaging with our customers. But these days, we have had to come to accept that negative interaction, is part of what we do because of the THMPD.

Customers are having to suspend disbelief as we explain the situation. They are incredulous. They feel their human rights are being totally compromised. And they are very upset. We have even had one elderly lady say she has felt suicidal at the loss of the herbs that keep her healthy – that’s the sad reality of this legislation. We are dismayed to our very core that our treasured customers should be subjected to this.

It is a European Directive gone stark raving mad if you ask us

Company morale is inevitably dented – it’s hard to pack the normal energy and enthusiasm into conversation on such a disheartening issue. We should be sending out our usual health tips and articles, but much of the information we currently disseminate is dominated by this legislation.

We’ve always wanted to be a force for change for good in our industry. This directive means that when it comes to botanical herbs at least, we cannot fulfil our mission, a very sorry situation indeed.

There really is no way of knowing how this impacts on the Seventh Wave brand as a whole. We know marketing experts would tell us not to engage in the politics and negativity, and not to make such a song and dance about it. And we are certainly not political creatures. But how can we not have our voice heard? Morally, we feel we have an obligation to ourselves, our customers and whilst some might consider it hyperbole, the country at large.

Is This About Safety and Quality?

This Directive purports to protect consumer safety. It does nothing of the sort. In the short term, it is causing consumers extreme stress and upset. In the long term, in our opinion, nothing less than the health of the nation is at stake. It is a truly backward step for health and wellbeing.

Customers will be forced to buy from outside the EU in many cases (a ludicrous situation in the current economic climate). They may no longer have the assurance of, for example, good manufacturing practice (GMP) standards. Some may resort to growing their own where possible; but garden centres aren’t noted for providing contraindications or correct dosage on seedlings. The burden on the NHS will be worsened as more minor self-limiting ailments present at GP surgeries. More and more safe, gentle and effective herbs will simply disappear from the market. And those herbs that do remain are starting to look more like processed junk foods in terms of their ingredients.

We’re not talking about unknown, dangerous “black market” quantities here. But instead, thousands of years of collective wisdom; plants that have been enjoyed throughout history, and, overall, with an impeccable safety record, one that surpasses food itself by a long way. ALL people should have access to this vital knowledge if they so choose, not some watered down or manipulated version. And all consumers should be able to choose the brand and quality they prefer. A tiny selection from an oligopoly marketplace is simply not right.

Isn’t freedom of choice an absolute fundamental in this country, or did we miss something?

We are all for improving standards. We already meet and exceed the requirements of a vast amount of legislation. Firm but fair regulation absolutely has its place. And it is true to say there are supplement companies that do need to be brought up to a decent standard – there is already considerable national legislation in place to do so if it was enforced and policed properly. But this EU directive is just not fit for the purpose it was intended.

Some argue that the registration process means that certain herbs will have the official stamp of approval, and must therefore be better. Not so. These are unprecedented times. We are rapidly moving to a situation where mediocre products will totally dominate the marketplace. Even a cursory glance at the successful registrations reveals an unbelievable plethora of additives, fillers and binders. These are in many cases toxic substances that we feel have absolutely no place in the human body.

So its hello to the wonderful pharma-controlled world of herbal medicine. And their marketing machine is already full steam ahead with celebrity GP endorsed websites and the like. But if these are the so-called “consistent safety and quality standards” the governing bodies set their hat on, we’ll pass thank you.

We’re proud to say we would NEVER put our herbs in synthetic polymers, detergents and preservatives. We would never add fancy colours. And we would certainly never extract with acetone, better known as nail polish remover. Why would we? And why do they?

“Additive free, naturally” (always pure and never ever synthetic) is what we do. How can it possibly be justified that herbs (typically extracts, not wonderful, full spectrum, whole herbs) packed with additives in a synthetic base get the seal of approval, yet ours, the best of the best, have been ushered out, purely because our pockets aren’t deep enough? And that would be £1.4 million deep enough or thereabouts for the initially affected herbs on our range, and that’s just for UK registration and does not apply Europe wide. You can add much, much more for the marketing budget required to justify that. We don’t consider ourselves minnows in the industry, but we are small fish in a very big, very aggressive pond. Those sorts of figures are completely out of reach for us, and the majority.

Cat's Claw, the first botanical supplement to be lost from Seventh Wave's product listing

Stringent manufacturing guidelines, clear dosage instructions and advice on contraindications, as required by the THMPD, can be put in place and verified to an exceptionally high standard (and base line cost) without paying an additional £120,000 token fee per product, for the privilege and a little logo on your label. We already do so!

A final word on this aspect, how can it be right that high quality, traditional herbs used safely throughout history are removed from the market and yet there is a myriad of man made, highly questionable substances flowing unregulated though our food chain; GM produce, aspartame, synthetic (fattening) fat substitutes, pesticides and the like. Need we go on?

A Quick Word on Efficacy

This directive in fact requires little to no data regarding efficacy. Traditional use is enough (as long as it’s from the EU of course – it is astonishing that many long standing herbals of China, India and the Amazon for example are automatically barred on the ‘15-year rule’). So those that attack herbal medicine and support this directive do themselves no favours on this count. It certainly doesn’t encourage investment in more clinical trials and studies. Whichever camp you reside in, how can that be a good thing?

Unfair Competition

Healthy competition can be one of the best ways of ensuring quality and innovation that ultimately works in the interest of the consumer.

Indeed, there is supposed to be protection from unfair trading here in the UK. Not when it comes to herbals. We are waving goodbye to healthy competition. If your budget doesn’t stretch, you’re out, no matter the quality standard or effectiveness of your product. This EU Directive, contrary to what we’re told by its protagonists over and over again, has absolutely nothing to do with quality. We couldn’t raise our quality any higher – again we emphasise that we are GMP certified, with full traceability from seed to factory, organic (although we have had to forgo the cost of our own organic marketing license due to this directive), whole herb and additive free. This Directive is about creating a regime that works for a few, and locks out most in the cold. It’s ultimately about money and control — and little else.

Do we sound angry? Well, yes, frankly we are

It would be just as ludicrous to force lets say, oh, pick an industry, we’ll go with ice cream for the sake of argument, and making manufacturers pay £120,000 to the Government simply to register their ice cream. And that would be for each and every flavour. That’s on top of the VAT, taxes, and ongoing costs and substantive requirements associated with GMP and food hygiene standards. The small farms and innovative artisan producers would be forced out in favour of the massive food cartels who pack their ice cream with additives and colours.

Supporters of the THMPD legislation would might say this is a ridiculous example, we say it’s not. The fact is it only becomes ridiculous when you look at it objectively and you’re not a beneficiary of it. Traditional herbs have formed part of our diet around the world for thousands of years. Applying a pharmaceutical methodology of regulation to them simply doesn’t work in practice. Certainly herbs do have very healthy properties, even dare we say, medicinal in some cases, but then so does all (real) food. Would the supporters of this legislation tolerate all foods being regulated in this same fashion and being controlled by a very powerful few? We think not.

Big business and corporate control wins the day here, certainly not the consumer or British business. We and many other wonderful, innovative companies we know of are suffering, and for the wrong reasons. Common sense has gone out of the window. And make no mistake, the British economy is being damaged.

The Consumer Loses Out Financially Too

For want of a better phrase, there are a handful of big companies “cornering the market”. So you’d think these THMPD registered herbs would be cost effective and consumer friendly, think again.

The vast majority of the registered herbs are not yet being actively marketed. But there are some shocking RRPs to be found in those that are. We ourselves are not the cheapest company, that’s because our quality is as good as it gets, and we manufacture without additives in slow, short production runs. But we have already seen a 60 capsule pack of a commonplace herb at £24.95 – we find that staggering for a mass production run. Many others are at nearly twice our typical retail price on herbals.

Seventh Wave's vitality is becoming less accessible to consumers

Ladies and gentlemen, place your bets now… will these pricing structures be changed when the registration costs have been recouped? We sincerely doubt it. And there is no extra value in these premium prices – it is top dollar pricing for what we think are typically very mediocre products.

That’s a big slice of the herbal pie for a very select few. And the consumer pays a heavy price. Did we mention that a good proportion of the registrations are from pharmaceutical owned supplement or phytopharmaceutical companies?

Almost Final Thoughts

Allopathic medicine does not have all the answers. Nor does herbal/natural medicine. But there are wonderful things in both fields. Doesn’t everyone want good health for as many people as possible? Should we not be bringing the best of both worlds together for the benefit of all, not bringing an industry with a lot to offer to its knees, and handing it over to a select few in the name of profit? Onesize fits all legislation is not the way forward, what we need is intelligent progress not bureaucratic nonsense.

But It’s Not Over Yet

The only bright light we can see at the moment is that this is not over yet. We are proud to support the Alliance for Natural Health International, the only organisation bringing real credibility to this battle for human health. We will be outside the High Court when this matter gets its first legal challenge. We hope you will too.

Seventh Wave Supplements - Additive Free, Naturally

Read our on-site article and list of herbals currently affected


ANH homepage

ANH-Intl THMPD legal challenge page

ANH-Intl THMPD briefing paper