Louise Mclean talked to Dr Robert Verkerk, Executive Director of the Alliance for Natural Health, in order to establish the facts on the EU Food Supplements Directive and get his views on how the ban would affect consumers
by Louise Mclean
The EU Food Supplements Directive became law in the European Union in June 2002 and was later transposed into UK law in July 2003. This Directive, if unopposed, could mean up to 5000 products disappearing from independent health food shops across the UK after 1st August 2005.
The Alliance for Natural Health brought its case to the High Court of Justice in London in January 2004 in an attempt to get this highly restrictive Directive referred to the European Court of Justice In Luxembourg. The hearing was successful and Mr. Justice Richards referred the case on to the European Court.
The ANH's landmark challenge to the EU Food Supplements Directive was subsequently heard in Luxembourg on 25thJanuary 2005, with the Advocate-General giving his Opinion on 5th April. A final ruling will be made in June 2005.
Louise Mclean talked to Dr. Robert Verkerk, Executive Director of the Alliance for Natural Health, in order to establish the facts and get his views on how the ban would affect consumers' access to vitamins and nutritional supplements.
1. When did you first realise there would be a threat to natural healthcare through the EU Food Supplements Directive?
While I was still working with Imperial College I had a very strong interest in the natural health area from a personal point of view. I had signed up on the Rath Foundation petition thinking that was all I needed to do.
Then a large vitamin company, asked for my views on the EU Food Supplements Directive because they had been informed by the UK Health Food Manufacturers Association that it would not be a major problem. This was around January 2002, just as the Directive was coming into its second reading at the European Parliament.
This company had looked at the Directive and seen the so-called Positive List of allowed vitamins and minerals on it. The list contained vitamins and minerals that would be allowed to be sold in Europe after 1st August 2005. A huge range of natural food supplements and organic forms of vitamins and minerals had been omitted from the list which contained mainly inorganic forms.
The company decided that the Directive was potentially a significant problem because of ingredients used in their products. So I went to the European website, downloaded the Directive and discovered there was a dossier provision for getting nutrients onto the Positive List if submitted before 12th July 2005.
I then looked at the technical requirements for these dossiers and went to a contract laboratory to find out what it would cost to put a dossier together for a single ingredient. I got a quotation back from the laboratory for £800,000! That was based on the fact that there was no pre-existing information on the ingredient, though the cost would be significantly less if there was some available data.
As it happened, I had spent many years campaigning on environmental issues while living in Australia for 12 years. I had led campaigns against agrochemical companies and also internationally including in South East Asia.
Although there was a campaign in existence through the Rath Foundation and La Leva, the Italian consumer association, I felt we needed to bring together all the groups working in this area under a unified umbrella to work in a positive manner in the European Parliament and try to affect the vote at second reading.
I believed we needed to employ a public affairs specialist company in Brussels, a PR company in the UK and work around the clock for 2 weeks to see if we could start to shift MEP opinion that was generally pro the Directive. Within about 24 hours the campaign was born. I asked for some time out from my job at Imperial College to take a three month sabbatical to fight this battle.
2. If vitamins and minerals aren't on this so-called Positive List, will they be banned?
Yes, unless companies can produce a dossier for each ingredient, but the type of vitamins and minerals that are on the Positive list ignore many food form nutrients. I could immediately see that natural mixed carotenoids were not there, nor the natural forms of vitamin E, folic acid or selenium. Neither were the most digestible, absorbable and safest forms of ascorbic acid (Vitamin C) or magnesium. It was very odd that the safest, most bioavailable nutrients were missing from the list. In fact it turned out that 75% of all vitamins and mineral forms were not there!
3. People have been greatly heartened by the Opinion released on 5th April, of Advocate General Geelhoed of the European Court. He states that the Food Supplements Directive infringes the principle of proportionality because basic principles of Community law, such as the requirements of legal protection, of legal certainty and of sound administration have not properly been taken into account and that it is therefore invalid under EU law.
Advocate General Geelhoed is the most senior Advocate General at the ECJ and his considered reasoning vindicates ANH's legal analysis and position.
It should be stressed that the Advocate General's pronouncement is not a ruling. That will come from the ECJ judges later - probably around June. But typically, in the vast majority of cases, the Court Judgment follows the recommendations of the Advocate General.
If his recommendations are adopted, the ban on vitamin and mineral forms not included on the EU's Positive list, due to come into effect on 1 August 2005, will be declared illegal. In essence, the positive list will be deemed to be too narrow, too restrictive, and based on flawed science.
If the Advocate General's recommendations are endorsed by the ECJ judges, it will represent the culmination of three years dogged determination, dedication and hard work on the part of ANH and its many supporters around the world.
With rapidly declining vitamin and mineral content in fruit vegetables and other foods, and continuing increases in degenerative diseases such as heart disease and cancer in the West, this has always been a very big issue worth fighting for. Fundamentally, an amended Directive would help to slow down the agenda of the Codex Alimentarius Commission to export worldwide an onerous, EU-style regime for food supplements.'
4. Is it true that by 2007 the EU FSD will apply to limit access to essential fatty acids, amino acids, enzymes and probiotics, as well as other nutrient groups?
Unless our case is successful, we believe that proposed restrictions on other nutrient forms could be even more catastrophic than the restrictions on vitamins and minerals. It is one of the absolutely fundamental reasons why it's so important to support the work of ANH because we are now the single biggest route in terms of creating a positive influence because of the case we submitted to the European Court.
5. The EU FSD was passed into law with very little media coverage. The public weren't really aware of its existence.
No, the public weren't really informed. This Directive had been 10 years on the drawing board with the major trade associations having input on it. The general view in the industry was that the second reading amendments were the best compromise that could be reached after some ten years of discussion. We felt the Directive itself had advantages because it was a safe harbour for food supplements outside the medicines regime but the big killer was the Positive List.
We need positive media, supporting the use of natural health ingredients because public opinion plays a role in this. If there are hundreds of negative media articles being ‘manufactured' to put a negative spin on nutritional supplements, that doesn't help us.
We know very well that many of these negative stories are the results of either flawed or misrepresented studies that were conducted some time ago and which reappear in meta-analyses. If you look closely, you will often find that the authors themselves recognise serious limitations but the media machines pick up these negative findings and create headline news that ‘vitamins kill' based on a completely flawed interpretation of science.
6. There is a growing body of scientific evidence that demonstrates that the nutritional quality of the average Western diet is inadequate. Though we in the West have never had so much food available, much of it is deficient in nutrients. Many people are actually malnourished! Add to this the harmful effects of pollution in the air and chemicals in the environment. Those people who are not well are heavily reliant on natural source micronutrients to supplement their diet.
There are very real problems with the modern western diet. We have got to help the authorities differentiate between what an ideal diet might be and what the average diet actually is.
I would agree that if you buy organically grown farm fresh produce and consume large amounts of it, it would certainly be possible to eat food that is micro-nutritionally and macro-nutritionally sufficient. However there are an incredibly small number of people who have the time and the funds to be able to eat diets of that sort of quality. So we must look at what the average person is eating and there are some serious issues in terms of dietary habits and dietary choices. The reality is that our society consumes far too much simple carbohydrate and far too few fresh fruit and vegetables.
For example, the National Cancer Institute in the US says that men should consume more than 9 portions of fruit and vegetables to guard against prostate cancer and there are other authorities that have suggested that you require upwards of 12, 13 or 14 portions a day. It's very difficult for people to consume that amount every day. So there are large numbers of people who are taking concentrated sources of nutrients as nutritional supplements to make up the shortfall.
You could argue that it is a natural evolutionary adaptation to develop forms of concentrated nutrients. As an ecologist and scientist I find it quite remarkable that here we have a piece of legislation that actually could impede what is a completely natural solution to the decreasing quality of our diet.
Interestingly, there are a number of studies showing an association between those who spend more time in food preparation, take more exercise and dietary supplements and use far fewer prescription medicines. The irony is that we see the regulators giving nutritional supplements a hard time, yet it is the people who use significant numbers of high quality supplements who are the least drain on our healthcare system. They are often doing this in association with a number of lifestyle factors that are keeping them healthier than the average person.
7. Saving money for the National Health Service.
8. Why do you think there is this great emphasis on safety? Do you have any statistics of adverse effects through vitamin overdose?!
When you compare the adverse events profile of nutritional supplements with foods, then compare it again with medicines, you will discover that nutritional supplements are the safest group of products that we put in our mouths. They are on average many hundreds of times safer than foods and many tens of thousands of times safer than the average medicine.
There have been very few adverse events associated with vitamins or minerals. The irony is that many of the vitamin and mineral forms that have been associated with adverse effects are actually on the Positive List!
For example ferrous sulphate, which is a form of iron that can lead to stomach cramps, constipation or even diarrhoea, is on the allowed List. Whereas a much safer form, iron bisglycinate, which is widely used by practitioners, is not on the list and will be banned from 1st August 2005 unless our court case succeeds.
The main problem with the existing paradigm is that it is built on a faulty foundation around the precautionary principle. For example, you take a nutrient group such as magnesium which is quite arbitrary. This is because it may contain an organic form such as magnesium gluconate or an inorganic form, such as magnesium sulphate. They are both forms of magnesium but the sulphate form is also a form of sulphur. So we have a relatively arbitrary categorisation of nutrient groups.
9. Is it true that many forms of vitamins and minerals on the Positive List will be subject to lowered potency and dosage? I believe that the ANH is working hard to try and raise these limits.
The major regulatory authorities around Europe are still not convinced of the fact that the conventional diet is substantially deficient in nutrients and one of the problems here is that they are frequently using the wrong yardsticks to measure sufficiency or insufficiency. They're still widely using RDAs, sometimes referred to as Recommended Dietary Allowances, other times referred to as Ridiculous Dietary Arbitraries! RDAs have been systematically discredited scientifically. What has been shown very conclusively from the science is that RDAs do not have any bearing on the safety of nutrients, nor do they have any bearing on the amounts required for optimum health.
As a result, if you are using a system that primarily measures levels of deficiency diseases such as scurvy, rickets, or beri-beri, you will massively underestimate the extent of micronutrient insufficiency in the population. So there is a fundamental flaw in how regulators and so called competent authorities are interpreting the micronutrient status of the diet.
The danger with any population based criteria is that it will tend to be based on averages and one thing that is revealed about the human condition is that there are very substantial variations, not only between different population groups but also between individuals within specific population groups. For example, someone who has a malabsorption problem of a particular nutrient may need to take 50 to 100 times over the RDA of a particular vitamin or mineral to counteract that problem. If they are able to do that, that person may be able to enjoy perfect health.
10. What you are saying is that nutrient intake is a very individual thing.
Nutritional supplements are in a three way squeeze. The ingredients they contain are severely under threat through the European Food Supplements Directive. Dosages are also severely under threat. There is a provision in Article 5 of the Food Supplements Directive that provides for a two stage process for which maximum levels will be decided.
This involves a so-called Nutrient Risk Assessment system, currently being undertaken by a FAO/WHO Project, to determine so-called upper safety levels and maximum permitted levels, taking into account factors such as dietary intake and population group susceptibilities.
The FAO/WHO expert Committee asked for applications to assess all these various approaches in a Workshop. Our submission has been endorsed by a very large number of medical doctors and scientists and was really the only one that comprehensively argued for a new paradigm showing all the pitfalls that were associated with the existing one.
What the risk assessment system does is take the most toxic form of a nutrient. It then looks at the most susceptible groups in our population and gives you a result that is a worst case scenario. We would like to see this radically altered.
It also looks at population groups that are consuming the most of this nutrient because it takes into account dietary intake. So yes, it will present a result that ensures that the nutrient is completely safe for the vast majority of people in a population but it ignores the benefits that quantities well above those dosages would have for certain people who are deficient. The whole process does not involve a risk/benefit analysis. It purely involves a risk analysis using a worst case scenario precautionary principle type of approach.
11. Tell me about the EU Nutrition and Health Claims regulations.
Yes, the third squeeze is on what you can say about something through the EU Nutrition and Health Claims regulations. If it goes through, it will severely impact on what companies can say to consumers and what practitioners can say to patients about the benefits of supplements. It has already been knocked out of the European Parliament once and just going through for the second time.
12. So if a practitioner were to recommend a particular product, it would be illegal?
Yes. Any communication about the benefits or health claims of a product would become illegal and also under Article 11 they will ban any weight loss claims of any sort and any claims that refer to behavioural changes.
So for example, though we have a very substantial problem in our society with consumption of inappropriate foods, to say that taking Omega 3 fatty acids are good for ADHD children, would be illegal. Yet that may be a very important and fundamental piece of advice a practitioner needs to give to their client or patient.
Unless your product is licensed as a medicine, you are not allowed to talk about its benefits, even if it is a food. We believe that there's a reasonable chance that the Nutrition and Health Claims regulations could also be illegal under European Law.
13. It would severely hamper the work of nutritionalists and other therapists.
We believe that it could represent a very severe infringement of freedom of speech because it will prevent people talking about the true benefits of a range of products.
In terms of coming back to doses, there's a very real possibility that the sort of dosages that are regularly used safely by nutritional therapists, will be made illegal unless the scientific process for determination of maximum doses is radically reformed.
Under the EU Nutrition and Health Claims regulations, even if you have scientific evidence of the role of a particular nutrient, you cannot state it, unless that nutrient has gone through a formal process of substantiation. This involves costs, with manufacturers having to put their data to the regulators in Europe and then having it approved. It might not be approved, simply because the manufacturer hadn't got enough money to collate the data for the Health Claims procedure. So then you can no longer state the health benefits of your product.
The burden of proof is being put back heavily on companies. Only the big companies have sufficient funds to get through the door. If you are a smaller company and can't afford to get your ingredient through a dossier or get your health claim through the pass claims procedure, you are not allowed to use the ingredient and you're not allowed to promote it because it hasn't been approved. So it is a classic case of big business wins every time.
If you look at the whole marketplace for nutritional supplements today, there is no doubt that the supermarkets represent the bottom end and nutritional therapists represent the most developed end of that market and therefore they would have their toolboxes destroyed more or less completely.
14. Do you think the pharmaceutical companies want to take over this lucrative market?
There are a number of vitamin companies that have been bought up by pharmaceutical companies. The most well known example is that of Wyeth Laboratories buying up Solgar and Lamberts being bought by Merck.
The pharmaceutical companies are currently responsible for the supply of some 70% of raw vitamin and mineral ingredients used across Europe so they are heavily involved in the market already. There is undoubtedly an interest from their part to see what they would consider a level playing field. They are asked when they supply drugs to fulfil very detailed studies on both efficacy and safety to get a drug to market. So they're saying right, if vitamins and minerals and other nutrients are to be used for healthcare purposes, should they not go through the same regime? They say yes and we say no. Just as we would expect to go to our local market and buy broccoli and carrots without those being tested because they've been part of our food supply for hundreds of years.
15. Is it possible that in time the only way people will be able to obtain vitamins will be through their doctor by prescription?
No, vitamins would always be available. The problem with the European legislation is that the market for food supplements would be a very limited range of products. These would inevitably be ‘me too' products and the supermarkets and pharmacies would control that market. Suddenly there would be no ability for practitioners or independent retailers to supply products that were different and as a result they would not be able to compete.
An analogy would be the same with the wine trade. Increasingly supermarkets have taken over the wine trade because they are able to sell at a lower price than the corner store off licence.
It will be drug companies who will be able to manage a Food Supplements Directive regime in a cost efficient manner. So the likelihood is that over time they may be the sole players left in the marketplace but they would make low dose, narrow spectrum products.
16. Can you explain the purpose of the Codex Alimentarius Commission meetings that have been held over the past few years? Will these guidelines have to be adopted by countries worldwide?
Codex Alimentarius is a food code. The United Nations developed the code. They developed guidelines for its 160 or so member countries. The UN has done extensive work in areas such as ensuring for example, infant formulae are improved in terms of quality. Some 10 years ago it turned its attention to vitamins and minerals as well.
The reality is that Codex is following a very close parallel to the EU Food Supplements Directive. In fact the primary concern of Codex in relation to vitamins and minerals, are dosages. The proposed way forward is identical to that which is included in Article 5 of the Food Supplements Directive. It has all the same problems associated with it. If it goes through in the current state it will be based on deeply irrational and flawed science and we'll end up producing guidelines that are far too low for many vitamins and minerals. In the future that flawed science will be applied to other categories of nutrients as well.
There is considerable debate about the effects of the guidelines and whether they are binding. In order for a country to remain competitive it would be very likely to follow the guidelines. Under the process of global harmonisation and through the World Trade Organisation, many countries would end up following the guidelines irrespective of whether it was compulsory to do so.
The whole Codex process is very much under discussion. The text was finalised in November last year but the biggest area open to negotiation now, is the risk assessment process which we are very heavily involved in. The guidelines will be ratified at a meeting in Rome in July this year.
We need a combination of heavyweight scientists behind a new paradigm as well as getting as many countries as possible behind our message. What we have become aware of is the countries that are able to understand the problems with the risk assessment are those that are not necessarily linked to major commercial producers that have an interest in low dosages. These include many developing countries. We are working with a number of key countries at the moment in order to try and stimulate a snowball effect.
Regulatory and industry pressure through the EU Food Supplements Directive was always likely to translate globally, particularly to the US, through Codex and the World Health Organisation.
17. There are two other EU Directives that are causing concern among natural health practitioners and companies. One is the Human Medicinal Products Directive and the other the Traditional Herbal Medicinal Products Directive. I believe you are working hard to push for amendments.
There are a number of pieces of other EU regulation that could pose very serious problems for natural health practitioners. One of them is the Human Medicinal Products or Pharmaceuticals Directive which passed into European Law in 2004 and is presently being transposed into Swedish member state law. We are following this very closely.
In a nutshell it has got two major problems. It is designed to control pharmaceutical products but has such a wide definition, that it can affect virtually any product it chooses. The definition basically includes any substance or combination of substances used to correct, modify or restore physiological functions that exert an immuniological, metabolic or physiological function of the body. It is so broad that even foods fit this category.
The second aspect of the Human Medicinal Products Directive is that it has a provision that allows it to trump any other piece of European Law. If for example something fits as a food supplement, it would also fit as being a drug under this Directive. So that gives the regulators a big gun to more or less choose at will whatever product they want and call it a drug.
18. Sweeping powers
Yes, and we're beginning to see a number of natural products already being classified as drugs. Glucosamine, which is used very widely by people to manage arthritis, has already been reclassified as a drug in both Sweden and Denmark.
Because this Directive has already passed into European law, it must be challenged through the Courts. We put through a number of significant amendments to the Human Medicinal Products Directive during the first reading but those were all lost in a compromise package that was put together at the last minute. So we have a paper trail of very positive work. We also know the European Parliament was very supportive of the amendments we tried to put through and we now say that the law is a bad one, particularly as it relates to natural products. We are presently investigating mechanisms for bringing a legal challenge against it.
The Traditional Herbal Medicinal Products Directive is due to come into effect in the UK on 30th October, 2005. It is a subset of the Pharmaceutical Directive and it is only regulating what are termed medicinal herbs. There's a real question mark as to what you consider to be an herb that's medicinal because it still needs to comply with that very erroneous definition of a medicine.
So it allows the regulators to say if they believe a plant extract is medicinal, you've got to go through a drugs licence procedure if you want to bring it to market. The THMPD is like a fast track for a medicinal licensing system. It simply says that if you can prove 30 years safe use, of which 15 years is in an EU member state, we will allow you through the door without submitting all the safety data to us.
19. So Bach flower remedies would get through?
Yes, but what it will impact particularly badly on is non-EU traditional medicinal regimes, for example Ayurvedic medicine.
Essentially what the system is saying is that a free randomised placebo controlled study is of much greater value than several thousand years of development of a traditional medicinal culture.
20. Tell me about your background and how you came to be working in this field?
My background is first and foremost as an ecologist. I took a degree in ecology between 1978 and 1981 because I’ve always been concerned about the state of the planet. I’ve had a very long term interest in sustainability and one of my key concerns has been sustainability of the natural environment. I spent some 10 years with Imperial College, London, working in the field of sustainable agriculture and did two degrees there, a Masters degree and a PHD. Then I worked as a post-doctoral research Fellow.
My key interest has been looking at interactions within agricultural systems, between plants or crops and herbivorous insects (people sometimes erroneously refer to as pests). Natural systems are complex. The more we manipulate agricultural systems the more we start to confuse the balance of nature. In a natural environment, there is a balance between different trophic levels. When we look at an agricultural system, many people believe the only way you can stop plants and crops being defoliated or ravaged by pests, is to put pesticides into that environment to try and regulate it.
I started to appreciate that there are real similarities between the external environment and the internal human environment. There is a real analogy between people being interested in sustainable agriculture and people interested in natural health. Those interested in natural health are trying to find a natural balance within their bodies, just as those interested in organic agriculture are not going to put toxins into their agricultural environment.
Pharmaceutical drugs are analogous to pesticides. You put them into your body and they create an imbalance. The body responds in many different ways to try and deal with toxins introduced and the reality is that it’s not sustainable.
Just like conventional agriculture is not sustainable, orthodox medicine is not sustainable. We know that just by looking at the statistics of the side effects of drugs. We have more than enough indicators to suggest that we cannot continue with the so called orthodox healthcare paradigm, where people are living their lives yet are not sufficiently in control of taking responsibility for their health.
The other thing that drew my interest to natural healthcare was the understanding that nutrient quality in agricultural systems is vital. The more you look at conventional agricultural systems, the more you recognise that the quality of foods we eat today is extremely inferior to those we have eaten and evolved with over thousands of years.
This is not just because we are eating a lot of hydroponically produced foods or sowing crops in land that has been depleted of minerals. It is because the actual crop cultivators that are being grown today are genetically and in every other way, very, very different from the foods with which we have evolved.
So it’s no great surprise to me that we have large numbers of people with wheat allergies and food allergies generally. It’s quite simply that our bodies have not adjusted to the foods available today.
Those are the primary factors that drew me into this area.