EU supplements directive based on bad science
The European Union has issued a directive on food supplements which must be incorporated into national law by the member countries by the end of July 2003.
There have been numerous protests and challenges to the EU legislators from consumers, health shops, manufacturers and practitioners, but the apparency is that of a decision made that cannot be undone. As consumers and sometimes patients we will lose access to a large number of the natural health products that are now available to us, although the process is designed to be very gradual.
Some call this way of action "boiling the frog slowly". As long as you put the frog in a pan of cold water and increase the temperature slowly, it will not know to jump out before it is too late.
Mike Abrahams, chairman of the British National Association of Health Stores shows two instances of how the discussion around supplements is slanted in a very unscientific way. Chromium and vitamin B 6 are picked by way of example. The arguments, although written for the situation in the United Kingdom, are relevant for all the EU member countries.
Comments on the Chromium Risk assessment
by the Expert Group on Vitamins and Minerals (EVM)Mike Abrahams BSc PhD
Chairman, National Association of Health Stores
June 8th 2003Chromium is an essential trace element involved in the control of blood sugar levels and other metabolic functions. Over the last century the availability of chromium has decreased due to modern agricultural practices, and the absorption and retention of this mineral in the human body has been affected by a multitude of environmental factors.
As with most of the minerals on the positive list, organic forms of chromium have been excluded in favour of the inorganic salts, despite the fact that inorganic mineral salts are extremely difficult to absorb, and can often be toxic. So while there is no chromium picolinate (CP) on the positive list, it is puzzling that this compound is chosen to be highlighted for attention. This compound has now been referred to the Committee on Mutagenicity for assessment. However, the EVM has determined a safe upper level for chromium using a study that involves chromium picolinate.
How can this be sensible? Surely if it remotely likely to be carcinogenic, the EVM should not be using a study on chromium picolinate for safety assessment.
As with vitamin B6, we find that buried amongst the large number of reports are many that demonstrate the safety of CP (One appears to have been censored in the final EVM report. On p78 of Part 3 Trace Elements, the reference in the study by Anderson et al (1997), the words “..which was well reported and which investigated CP (one of the more bioavailable forms)..” have been excised).
The report has an odd heading “Brief overview of non-nutritional beneficial effects.” and nothing on nutritional beneficial effects. The paragraph on deficiency acknowledges that deficiency symptoms have been noted, but only in the context of long-term parenteral nutrition. However there is much research which has been ignored and which demonstrates that many people are deficient in chromium and exhibit many of the listed symptoms. For example, according to the USDA (US Dept. of Agriculture), only one in every ten Americans gets the recommended amount of chromium in their diet. Studies conducted on several occasions, (Anderson and Kozlovsky, O.A. Levander and Dr. Walter Mertz to name a few) have shown that exercise and high sugar consumption increase the body's need for chromium. A shortage of chromium in the diet can cause some serious problems with energy, stamina, muscle building, and weight maintenance, not to mention diabetes and hypoglycaemia. See also Colgan, Ph.D., Michael, The New Nutrition: Medicine for the New Millennium (Vancouver: 1995, Apple Publishing), pages 10-11. ISBN 0-9695272-4-1
While it is acknowledged throughout the text that mineral salts of chromium are poorly absorbed, it then assumes that because CP is easily absorbed, it is therefore dangerous. On the other hand it cannot find supplementation studies that support the supposition. Further, while dismissing the concept that absence of evidence of toxicity can be considered as evidence of absence, the EVM then makes the following statement: “In general, in vitro mutagenicity tests have yielded positive results for hexavalent chromium (my comment: known to be highly toxic, not the form we are talking about, and not on sale as a supplement anywhere in the world) and negative results for trivalent. However two studies in mammalian cells (no other details or reference given) have shown that chromium picolinate (a form of trivalent chromium) may cause DNA damage” (My italics).
This is the single shred of evidence against the use of chromium picolinate. Two reports, and apparently even one of these disagrees with the other on the nature of the cause.
Meanwhile I have been using CP successfully for the last 16 years or so to control chronic hypoglycaemia. I was subjected to an unplanned “blinded test” when, in the interest of economy, I changed to a cheaper brand. Within a week, my hypoglycaemia had returned. It was only after I had challenged the manufacturers, who refused to engage, that I reverted to the more expensive product and my problem disappeared overnight, just the way it had done the first time I tried CP.
Comments on the vitamin B6 Risk assessment
by the Expert Group on Vitamins and Minerals (EVM)
The original draft version of the EVM used the widely discredited Dalton & Dalton study to justify its choice of an upper safe level (USL) of 10mg, together with deriving this USL from a 25 year old study involving five beagles.Following a torrent of well-researched critiques of many of their choices, but especially of the B6 USL, the final version has reluctantly let go of the Dalton study and, despite a very large number of human studies all showing safety of B6 exceeding a 200mg level, has switched to one report based on a total of just 5 beagles. The dogs received the equivalent of 18 grams (18,000 mg) for a 60Kg person. This is a huge dose by any standards, and 90 times the 200mg suggested by most of the industry as being very safe.
There is a plethora of human studies showing that vitamin B6 is safe up to 500mg. Despite this, the EVM decided to take the results of the dog study and then load it with “uncertainty factors” because, after all, it was a dog study, and only performed on a handful of dogs. The SUL was determined by reducing the safe level demonstrated in dogs by a factor of 300, resulting in a mere 10mg for humans.
This is absurd when there is so much high quality human evidence available, and is an incredibly high uncertainty factor that is normally only applied to dangerous chemicals such as those used in drug manufacture, not to life sustaining essential nutrients.
Many people depend on large doses of vitamin B6 for their health and wellbeing. For example, there are those who find that Carpal Tunnel Syndrome and Repetitive Strain Injury can be adequately managed by taking up to 300 mg of B6 per day. Others find 100mg per day together with magnesium and evening primrose oil helps them manage their Pre-Menstrual-Syndrome. Yet others find that nervous and anxiety symptoms can be relieved by taking 50-100mg B6. All of these will become at risk from the moment that their access to this safe and natural nutrient is removed from the market. The only alternative will be to submit to the medical/pharmaceutical alternative. For Carpal Tunnel Syndrome it is surgery (with all its attendant risks and poor long-term results), while most of the rest can look forward to the misery of being drugged on tranquillisers, with all their attendant risks.
At the time of writing, medical intervention is one the largest killers in the civilized world; it is documented as the fourth biggest killer in the USA. Injury from medical intervention adds countless thousands more to the tally.
There are 17,818 serious adverse reaction reports and 260 deaths recorded world-wide regarding the active ingredient present in Zyban.
The 21-year-old son of a friend of mine has just been told that he will lose the use of his legs because of the necrosis of the bone caused by the steroids used as part of his treatment for leukaemia. This, apparently is “normal side effect of the drug” – why are we prevented from talking about natural and safe alternatives?
The consideration of natural and essential nutrients as xenobiotic chemicals is simply wrong.
Chronic illness in the UK is mounting beyond the capacity of our resources. Most chronic disease can be demonstrated to have its roots in basic nutritional deficiencies. It is sheer folly to compound the problem by denying an enlightened public access to basic nutrients in meaningful doses.
Reasons to reject the Statutory Instrument for the adoption of the European Food Supplements Directive into Law.
The positive list known as Annex 1 misses three important nutrients: boron, silicon and sulphur, plus dozens of trace elements and rare earths which although not clearly recognised as being essential today, may, as our diet becomes increasingly depleted of nutrients, prove to be important in the future, when they will be unable to be adopted because of this law.The positive list known as Annex 2 excludes nearly 300 nutrient forms currently in common use, most of which are organically bound, these being the most bioavailable presentations. Most of the products on Annex 2 are rarely found in the field of nutrition because they are in the mineral salt forms, which have poor bioavailability and in some cases are known to be toxic (for instance, caustic soda). In practice, when they become the only option, the majority of consumers will find that they just won’t work.
Thus when this Directive becomes law, the population of the UK will no longer have access to those forms of nutrients that are currently keeping them healthy. Instead they will be forced onto the medical/pharmaceutical establishment and be advised to use drugs instead. It does not make sense to assume that nutritional deficiencies can be cured by drugs or surgery. A car with an empty tank will not start up if we fill it with paraffin or chop a wheel off…
It does not make sense, either, to adopt a law for which the Safe Upper Levels have not yet been defined, and will not be defined until shortly before the Directive is implemented in August 2005. When they are eventually defined, we will have no appeal against whatever levels are set. From the obvious lack of expertise shown in setting up the two positive lists, and some of the inexplicable findings of the Expert Group on Vitamins and Minerals, there is not too much confidence in expecting the Safe Upper Levels to be anything like realistic, or remotely useful.
posted by Sepp Hasslberger on Thursday June 12 2003
updated on Wednesday December 8 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2003/06/12/eu_supplements_directive_based_on_bad_science.htm
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