Originally published in Issue 3 2005 icon
Banned Or Not?
The real story about the EU directive and what the future holds for anyone wanting to take responsibility for their own health.
By Ginny Fraser
Most of us have been aware of something going on with the European Parliament and vitamins. You probably don’t know all the details, but it may have been disheartening to read in the newspapers in mid-July that a bid to have the EU lift their "ban" on many of the regular high street vitamins had failed. Anyone using a lot of supplementation as part of their cancer treatment might have been particularly worried.
But the papers got it wrong. There was no wholesale ban on vitamins.
The Silver Lining
Yes, the European Court of Justice DID rule to uphold the controversial Food Supplements Directive, but the Alliance for Natural Health (ANH) along with their top European lawyers found there was a silver lining hidden within the small print of the Court’s ruling that means it is almost impossible for the feared, wide-scale exclusion to go ahead.
What Is The ANH?
The ANH is a Europe-wide association of consumers, complementary practitioners, distributors, retailers and manufacturers who have an interest in food supplements and natural health, established to protect health freedoms threatened by moves such as the EU Directive, but also other worldwide agencies of which more later. The ANH challenged the ban implied by the Directive and achieved what they describe as "a major victory".
So What Is The Victory?
First a bit of background. Originally, the Food Supplements Directive scraped through the European Parliament by the skin of its teeth back in early 2002. Its purpose was ostensibly to harmonise regulation across Europe and therefore benefit trade as well as protecting public safety. Like lots of the EU legislation most people were unaware of it until it was almost too late. The system proposed by the EU was going to exclude ingredients simply because the supplement companies did not have the financial capacity to meet the requirement for huge amounts of data for the scientific dossiers demanded by the EU authorities. If the directive had been unchallenged, over 5000 products would have disappeared from the shelves of UK health shops as a result of the ban removing over 300 vitamin and mineral ingredients.
If the directive had been unchallenged, over 5000 products would have disappeared from the shelves of UK health
shops
These included a whole range of substances, for instance, the main natural forms of Vitamin E, several forms of Vitamin C, the key natural form of folic acid and other B vitamins plus a whole range of minerals. All of them were substances that many of us have been taking daily for years with only positive effects.
The Three Year Battle
When the Directive was first passed, the Alliance for Natural Health was set up specifically to oppose the restrictive parts of this legislation. It has been battling for three years and has now successfully contested the Directive, allowing many of us to continue taking responsibility for our own health and choices. In short, without the ANH’s legal challenge, the ban on thousands of products would have occurred on August 1st. It will now be very difficult, says the ANH, for the regulators to ban products unless they can produce evidence showing harmfulness of particular ingredients at specific doses.
One of the reasons the ANH disagrees with the media’s interpretation of events revolves around the distinction between those vitamins and minerals which are normally found in our diet and those which are derived from chemical substances (i.e. not naturally). Nothing in the former category will be banned. Those substances in the second category will only be given the green light after strenuous scientific research. Another win for the Alliance is simplification of requirements to get products on to the EU’s allowed, or on the"positive" list and the fact that the burden of proof has been transferred (to a large degree) from manufacturers (often small companies) to the regulator.
Time Limit
The Directive will allow ingredients available before 2003 to be used at least to the end of 2009, provided that technical dossiers had been submitted for subsequent consideration by the European Food Safety Authority.
Some 505 dossiers for vitamin and mineral ingredients were submitted by 12 July, the official deadline
Accordingly, some 505 dossiers for vitamin and mineral ingredients were submitted by 12 July, the official deadline. To facilitate the process further, the UK’s Food Standard Agency also extended the dossier deadline until August 1st. All products containing ingredients subject to dossiers will remain on the market to at least the end of 2009 unless they are given an unfavourable review, on the grounds of risks to public health, by the European Food Safety Authority.
So, is the battle over? Is everything OK now? The ANH would say a resounding NO.
To begin with the Food Supplements Directive will shortly lay down terms which will limit dosages - and these terms are riddled with flawed science, says the ANH. High dosages of some substances are very effective in treating cancer, and this could still be under threat. Naturopathic cancer doctor, Etienne Callebout said, "It’s not just a case of taking a higher numbers of pills (which means greater expense) but it also means consuming greater quantities of fillers just to get the right amount of active ingredient." Should this come into effect, it could lead to the development of a black market where we buy our supplements illegally over the internet.
There is also the Traditional Herbal Medicinal Products Directive (THMPD), which comes into force later this year and may restrict availability of many herbal products because of the "pharmaceutical standards" set by the Directive. Again, the EU promises to provide for a "simplified pharmaceutical registration for herbal medicines" - but only for substances that have been in safe use for 30 years, 15 of them within the EU, singly or in the same combinations. Thus, medicinal herbs in centuries-long use outside the community cannot benefit from the fast-track licence procedure.
Clouds On The Horizon
Taking a larger world-view, there are events occurring in the US that present a threat for the future. These are documented by award-winning film-maker Kevin Miller in his film called We Become Silent: the last days of health freedom. Narration is by Dame Judi Dench, a supporter of the ANH. It is a frightening, but compulsive piece of work.
Taking a larger world-view, there are events occurring in the US that present a threat for the future
The film - viewable on the ANH website - looks at how the health-food industry has always been under attack, threatened, it is claimed, by the powerful pharmaceutical lobbies, particularly in the US. In 1963 a Commission was set up called Codex Alimentarius, a combination of two UN bodies, the Food and Agriculture Organisation and the World Health Organisation. Its early brief was innocuous enough - to provide nutritious food for developing nations and a guide to dangerous industrial chemicals in foods.
This changed, however, to incorporate dietary (food) supplements, and Codex took on a whole new complexion, which, according to the Miller film, is a lot more worrying, although again, harmonising trade and safeguarding the public are claimed to be the motivating force.
The Pharmaceutical Lobby
In recent years the whole natural health foods and supplements industry has grown massively, and so has opposition from, claims the ANH, the interests of the pharmaceutical companies who still control the vast majority of the synthetic vitamins and minerals market. Hence the view of Codex has been that pharmaceutical drugs are safe, because they are tested, whereas supplements are not, because they haven’t been through rigorous testing.
Time For Action
On the video, Dr Robert Verkerk, Director of the ANH, says, "People are waking up to the fact that the healthcare system they place their trust in is not delivering the health care they need." Indeed what the campaign is bringing to our awareness is the fact that at a time when we really need to be taking better care of ourselves (cancer levels increasing; pollution decimating the vitamin content of natural foods; living in sea of chemicals and radio-waves), the very ways we can do that are in danger of being put out of our reach.
The ANH’s battle has been described as a David and Goliath
confrontation
The ANH’s battle has been described as a David and Goliath confrontation (remember what happened to Goliath?), and the work goes on. "We must now move from a legal battle to a scientific battle", says Verkerk. "The risk assessment framework that is being considered by the authorities has been borrowed from those systems assessing intrinsically toxic substances such as drugs and pesticides, and has no place for use with nutrients that are essential to life. A new paradigm for safety benefit analysis is needed specifically for nutrients." The ANH has commissioned a new framework that could be used EU-wide and internationally through Codex.
For any of us relying on supplements to stay healthy or get well, it’s good to know that there is a crusader out there fighting on our behalf. To support the organisation in its work or for more information go to: www.alliance-natural-health.org.
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