EU Supplements Directive 'Is Good For Consumers' - British MP

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Geoff Sherman of Pembrokeshire asked his Member of Parliament, NICK AINGER MP/AS, the House of Commons' Labour Member for Carmarthen West and South Pembrokeshire, why food supplements are being banned by the British government on behest of the European Community, when there are really no problems with these products as they are, and when many people like himself find nutrients a good way to keep in perfect health.

The response is perfectly typical and could have come from a member of Parliament in any European country. It explains the European "rationale" for regulating supplements. MP Ainger says that "[t]he Directive is designed to provide reassurance for consumers that the ingredients used in food supplements have been thoroughly assessed for safety."

One might ask why consumers need assurance at all that ingredients used in food supplements have been thoroughly assessed for safety, when by actual statistics, food supplements including herbal remedies are by far the safest product category in existence - far safer than normal, everyday foods, and infinitely safer than registered medicines, which are responsible for hundreds of thousands of deaths every year. If there is no safety related problem with supplements, one might ask, why bother to legislate and restrict consumers' health choices in the process.

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MP Ainger's letter further reads: "It is important to note at the very beginning that none of the vitamins currently used in supplements on sale in the UK are excluded from sale under this Directive."

This statement shows the extent of misinformation that has been spread quite officially about the food supplements directive in Europe. "Don't worry, nothing will be taken off the market". That is simply at variance with the list of "allowed" ingredients and the ingredients for vitamin and mineral supplements that can be found on the market today - not only in England but in many countries of Europe.

Campaigners have pointed out that close to 300 forms of both vitamins and minerals are in fact left off the directive's prescriptive list. Those that are on, are types of ingredients used predominantly in pharmaceutically made supplements of simple formulation and low dose. They are the "less natural" simple chemical salts of minerals and the "active fraction" of vitamins such as alpha-tocoperol in the case of vitamin E.

For a large part, those simple forms have been replaced by closer-to-nature forms of the nutrients in practically all but the mainstream pharmaceutical supplements. Perhaps it is little understood that anyone taking supplements with a serious health related intent would tend to buy the more advanced forms with better bioavailability, rather than those contained in "mainstream" pharmaceutically made supplements.

For that reason, the "don't worry" argument is false. It is really saying "if you want supplements in the future, you will have to be content with what is offered by the pharmaceutical mainstream. Innovative products are out - sorry."

In fact, the confirmation for this state of affairs comes in MP Ainger's next statement: "In addition, the Directive only deals with food supplements - it does not affect vitamins and minerals that are licensed medicinal products and consumers who still need these products will still be able to get them."

When did MP Ainger last check in his local pharmacy for high dose vitamin supplements registered as medicines? I bet he did not, because he's not a "consumer" - if he was, he would know that there are few if any licensed medicinal products sporting vitamins that any health conscious person would voluntarily consider using.

But not to worry, everything should be ok, because we already warned you years ago. In fact, continues MP Ainger, "the suppliers and manufacturers of food supplements have had three years to prepare for the regulations coming into effect. The Government has provided maximum flexibility in national legislation to ensure that as many products as possible can continue to be marketed after the Directive comes into effect later this year on 1st August."

The reference here is to a procedure outlined in the food supplements directive, by which ingredients may be added to the list of "allowed ingredients". The procedure requires - for each form of a nutrient, regardless of how long it may have been on the market without problems - that experiments be performed (yes, that does include experiments on laboratory animals) to show what's known as the "toxicological profile" of the nutrient. The procedure has been characterised "as transparent as a black box" by the Advocate General in a recent hearing of the European Court of Justice in a legal case challenging the directive.

One might argue that this "safety requirement" is going just a bit too far. In effect, foods - supplements are foods, after all - now must "prove their innocence", they must "show safety", before they can be sold. This might be justifiable if there was a widespread problem of unsafe supplements wreaking havoc with consumers' health, but that is clearly not the case. Occasionally we see press reports on supplements and potential safety problems all blown out of proportion, but such reports are usually inspired by "the competition", meaning the large pharma makers, and they are definitely not a substitute for actual scientific data. The real data show that there is no problem that needs intervention.

For all the talk about having been soft on the manufacturers however, the black box does turn out not to be very flexible. Evidence of this is that no ingredient has been newly approved under the directive's procedure in the last three years, and a measly twenty to thirty dossiers have been filed at all.

Dossiers showing safety are one of the trappings of pharmaceutical medicines. Not that they are very effective in showing safety - we see one drug after another taken off the market despite having "shown safety" under these drug related procedures. To require such dossiers for nutrient food substances is not only ineffective by actual record, it also is extremely vexing to producers of natural health products and it is telling consumers: "sorry chap, you must buy pharmaceutical".

Let me be quite clear about it at the risk of being repetitive: there is NO RATIONAL JUSTIFICATION for such a course of action except to protect the larger pharmaceutical manufacturers over the smaller and medium sized ones that are smart enough to be putting closer-to-nature ingredients into their products. It lets down consumers who spend their own hard earned money on what they believe are the best products they can find, forcing them to go for an inferior thing.

MP Nick Ainger proceeds to explain that looking at "folic acid for example, it's important not to take too much because this could be harmful. Folic acid works together with vitamin B12 to form healthy red blood cells, but if you're not getting enough vitamin B12 - known as vitamin B12 deficiency - taking doses of folic acid higher than 1 mg can hide this fact."

This "danger" is highly theoretical. There are no confirmed cases in medical literature that show excessive intake of folic acid causing real health problems. On the contrary, folic acid is indispensable for our health and - big surprise - most painkillers deplete the body of folic acid.

And let's for a moment assume that there really was a danger of folic acid hiding a possible B 12 deficiency. What would be wrong with recommending to take vitamin B 12 together with folic acid? Problem resolved. What would be wrong with a label warning on bottles of folic acid tablets: "watch our for your status of B 12". Problem resolved. But no, we are rushing to prohibit any supplement containing "too much" folic acid. The intention is clear: limit nutritional health intervention, limit the individual-driven prevention of illness with nutrients in favor of government-driven pharmaceutical "treatment".

Some of the minerals that have been found to be useful for health are banned outright. Not to be used - verboten! MP Ainger mentions six: "vanadium, tin, cobalt, silicon, boron and nickel." He goes on to state: "Long-establish empirical research (sic) carried out by the medical profession has established that deficiency of any of these chemicals is not known in humans."

One should add that the six minerals named are but the tip of a huge iceberg. Beneath the waves we barely see a large number of trace minerals and rare earth elements that have been part and parcel of our nutrition for eons, but they are suddenly "illegal", at least in the new and regulated type of supplements we are meant to swallow in the future.

And the six that are "above the water line"? All of these minerals have some recognized role in human health, although we haven't been able to find specific deficiency symptoms caused by their absence. But is that a good enough reason to prohibit their use?

Are we not throwing the baby out with the bath water here?

It certainly seems so from my vantage point.

The full text of the letter:

From: geoff sherman
Sent: Thursday, February 03, 2005 10:00 AM
Subject: Vitamins and Food supplements

At least my MP has bothered to reply - though I do not trust his reply at all!

I would be grateful if those who know more than me (not difficult!) would be kind enough to comment on what he has sent me.

I have reproduced it below for those who do not like attachments (though the attachment is virus scanned) and as an attachment for those who prefer the formatting to be retained!

Geoff Sherman

NICK AINGER MP/AS

Labour Member for Carmarthen West and South Pembrokeshire
Aelod Llafur dros Gorllewin Caerfyrddin a De Benfro
House of Commons, London SW1A 0AA
Tel/Ffon: 020 7219 4004 Fax/Ffacs: 020 7219 2690

Constituency Office/Swy