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The vitamin laws

MagazineFebruary 2001 (Vol. 11 Issue 11)The vitamin laws

A concerted worldwide effort by the European Union and a United Nations committee would severely impede your ability to buy supplements and herbal remedies unless you act now to stop them

A concerted worldwide effort by the European Union and a United Nations committee would severely impede your ability to buy supplements and herbal remedies unless you act now to stop them.

Several moves are afoot in Europe which may severely impede your ability to buy the alternative health care products of your choice.

These measures, influenced by pharmaceutical interests, would seek to sharply curtail the ability of the consumer to buy certain high dose vitamin supplements or alternative products.

The measures are insidious, carried out behind closed doors and without media fanfare by unelected officials in Europe who are formulating policy which could have one of the most profound effects on health of any such law in recent history.

The nature of these is so worrying that WDDTY will be helping to organise a worldwide protest next year. You can help us to keep healthcare free by getting involved in our international protest. For details, see p 4.

For some 13 years, Europe has wrestled with creating a standardised market for vitamin and mineral supplements under the guise of setting a universal standard of safety, but individual member states have always got in the way. In 1992, Brussels attempted such a directive, where supplement content would be limited to one to three times the Recommended Daily Allowance (RDA). The directive soon foundered, and finally collapsed under a sustained and concerted protest by the UK government.

Britain and its consumers have always enjoyed one of the most liberal supplement markets in Europe. Many UK consumers, like their American counterparts, believe that high dose vitamins can help to prevent disease, not simply ward off deficiencies.

Although Brussels appeared to have backed off on supplements, behind the scenes, it was plotting something quite different, largely due to continual pressure from European supplement manufacturers.

No sooner had we rounded the corner to the new Millennium than the European Commission made an abrupt volte face. In a White Paper on Food Safety, adopted on 14 January 2000, the Brussels Commission announced that it was putting forth a proposal on the subject in two months' time.

The ministers of the European Union declared in their document 500PCO222, which is basically a food supplements proposal, that there is a wide disparity between the stated laws of individual EU members on the dosages allowed for vitamin supplements. In France and Germany, for instance, no products containing more than one to three times the RDA may be sold without a pharmaceutical licence.

In contrast, countries like the UK and the Netherlands have always enjoyed liberal laws relating to the content of vitamins, with few restrictions. Both countries also have few trade restrictions for export across other European countries. The effect of this is that, in certain countries of Europe, local suppliers have to stand by watching helplessly, their hands tied by their own stringent laws while British exporters declare open season on their local vitamin business. Naturally, the industry which spent the most money lobbying the European ministers is the pharmaceutical industry.

It was amid such a climate of obvious trade disparity that the EU suggested a directive which would standardise laws concerning vitamin supplements all across Europe. The trade advantages were obvious. It would allow the big vitamin giants to sell their products across Europe without having to reformulate them to comply with the requirements of individual countries. This means products can be produced in bulk quantities at a cheaper cost and with greater profits.

Although painted with a consumerist face some of the articles of the directive would demand more detailed labelling, and specify which substances could be given to infants and young children this directive is patently about creating a level commercial playing field. If passed into European law, it must be adopted by all member states. As a trade directive, there is no possibility of opting out, such as there are with other categories of directives, such as taxation.

The directive seeks to create a single market for food supplements through several means, including devising a list of ingredients which may be used in supplements, creating common maximum permitted levels of these nutrients, providing common criteria for purity and labelling, and requiring that all member states prohibit any trade in products not complying with the directive.

For many countries like Germany and France, this represents a liberalising of their currently stringent laws. They may have the ability to increase the nutrient levels of food supplements and, thus, have more popular products on the shelves.

But, for Britain and the Netherlands, this directive is almost certain to be more restrictive.

One of the main problems centres around the use of a 'positive list' of permitted ingredients. At the end of the directive, a list is attached of nutrients which are approved for inclusion in food supplements.

The list is incredibly conservative, listing only the most well known vitamins and minerals for which RDAs have been established. At the moment, a number of important nutrients such as inositol and choline which are known to be vital to human health but where RDAs haven't been established, have been excluded. Missing also are new supplements such as MSM, glucosamine and the like. Any vitamin or mineral not on the list when the directive is put in force will not be allowed to be sold anywhere in Europe.

The most worrying portion of the directive concerns the criteria for determining permitted levels of nutrients. According to Article 5 of the directive, setting these maximum limits should take into account several factors. These include the upper safe level (USL) of the total intake of each nutrient from dietary sources. This is the highest intake shown to be safe before adverse events appear.

To give you some idea of the types of levels we're talking about, in the US, the National Academy of Sciences has determined that the USL of vitamin B6 is 100-200 mg and that the USL of vitamin A is 10,000 IU. These are levels which many members of the population take routinely every day of their lives. Indeed, many vitamins in both Britain and the US contain the USL of each nutrient as a standard dose.

The directive also wishes to take into account the Population Reference Intakes (PRIs) of nutrients (a newfangled version of the RDA) particularly when these are close to the USL.

Finally, it includes intakes of nutrients from other dietary sources, such as fortified foods and from food itself.

The USL of each nutrient is to be established by the Scientific Committee for Food (SCF), which will pass its determinations on to the Commission. The Commission will then make its recommendations for the supplement levels to the Standing Committee for Foodstuffs. In making their determination, the Commission has indicated that it will take into account the intake of nutrients from a 'normal' diet, plus the intake from 'fortified foods'. They've also indicated that they will subtract some amounts just to be on the safe side.

What this means in practice is that the levels will be set well below the USLs, which are likely to be absurdly low in the first place.

The SCF, a body composed of food technologists rather than nutritional doctors, has made a few noises about where it stands on a number of nutrients which are, in themselves, worrying. For instance, it has indicated that the USL on B6 should be 25 mg far lower than the US National Academy of Sciences' USL. Indeed, as their support for their safety level of B6, they relied on the Dalton study, a trial which was soundly criticised when the UK government considered and ultimately abandoned a law that would limit the sale of B6.

>From that 25 mg then would be subtracted a certain amount for the B6 in a normal diet, another amount to compensate for fortified foods and a final amount to provide a wider safety margin to demonstrate the SCF's intention to use "caution in risk management". What may finally emerge is a level of B6 as low as 5 mg. This would mean that British women taking B6 for premenstrual syndrome (PMS) usually 50-100 mg per day would have to swallow 10 to 20 vitamin pills a day just to maintain the levels they are used to.

These limits may also reflect the majority views of the member states. Although the UK, Holland and Sweden are likely to vote to keep high dose vitamins alive, in 1992, 11 of the EU governments sought a very low upper potency limit for their products.

In some cases, this amounted to 2-3 mg for vitamins B1, B3 or B6. This is 1/25th of the amount usually stipulated by nutritional doctors, such as those members of the British Society for Nutritional and Environmental Medicine who may recommend, as standard, 50 mg of some of the B vitamins as a minimum dosage.

The problem with these criteria is that they attempt to encapsulate the eating habits and climate of every individual European member state into one broad ruling. It puts into the same hopper countries that use lots of fortified foods with those who mainly use fresh ingredients. A country like Britain, which has a highly processed diet, is placed in the same category as one of the Mediterranean countries, which consumes a healthier diet. It means that cold northern countries such as the UK and Scandinavia will have the same levels of vitamin D in their supplements as sun rich countries like Spain and Italy.

Any vitamin which exceeds the doses set will be cleared off the shelves unless the company applies for, and receives, a pharmaceutical licence. Such a licence is so prohibitively expensive that it will be beyond the reach of all but the very largest vitamin firms.

The crux of the issue, according to Ralph Pike, director of the National Association of Health Stores in England, is the criteria the Commission will use to determine USLs. Most, if not all, the ministers will be unfamiliar with the breakthrough work in nutritional medicine, which uses high doses of vitamins to prevent and treat disease. It is more than likely that they will rely heavily on standard intake measures or a limited tool like the RDA, which is a standard of the minimum nutrients needed to prevent deficiency diseases such as scurvy (see box, p 2).

Furthermore, if the recent meeting of 6 December is anything to go by, a number of the member states would like to restrict things even further. For instance, Austria and Greece are pushing to have the directive's criteria eliminate USLs and use PRIs, a move that will limit vitamins to the very low levels of the RDA. France, Germany, Italy and Spain are also pushing hard to use population reference levels.

The UK, Ireland, Sweden, Holland and Finland want to adopt the directive as it is now written, warts and all, under the assumption that this is as good as it will get and that it shouldbe passed before it is watered down even further.

But even if adopted as is, the directive will virtually clear the shelves of most UK, Dutch and Irish supplements, which contain potencies close to or at the USLs.

The UK's National Association of Health Stores worries that the Commission will extend the definition of food supplements to include ingredients other than just 'concentrated nutrients'. It may mean that a substance such as pycnogenol, which is not approved by the Novel Foods Commission, will no longer be allowed to be sold.

The directive is now under consideration by the Environment Committee of the European Parliament. Amendments to the report will be considered at a meeting of the Committee sometime during the week of 22 January 2001. A resulting report will then be sent for consideration by the entire European Parliament at its plenary session in February.

If the directive is adopted, the intended timetable is that member states will pass laws so that products complying with the directive may be sold after 1 June 2002. All products which do not comply will be banned after 1 June 2004.

Traditional Medicines Directive

Vitamins are not the only supplements that Europe has its sights on. At the moment, a directive has been drafted, largely driven by the UK's Medicines Control Agency (MCA), to create a Europe wide regulation for traditional medicines such as herbs. At this time, the directive has no formal status, but its future is likely to be determined within the next few months.

At the moment, every member state of the EU controls herbal products in a different way. Indeed, 13 of the 15 countries already contravene the European Medicines Directive (65/65).

The Traditional Medicines Directive currently would allow each member state individuality but, eventually, there would be moves to harmonise.

The crux of this directive is that herbs must be 'registered'. To become registered, the manufacturers of such a product must submit reasons for its authorisation within the member state; "expert evidence" (which is never defined) must show that the product, or a similar one, has been in use for a period of at least 30 years before the date of the application.

In a wonderful demonstration of the absurdity of bureaucracy, the directive allows a product a licence if it has been used for 25 years outside the EU and then for five years in one member state. The important criterion is that its use adds up to an aggregate of 30 years.

Any new herbal remedies presumably would be banned, unless they can be shown to be in use in territories outside the EU or in another member state for at least 30 years. This means that new, promising herbal products cannot get a registration.

There are a few exceptions to this, but the product must be part of a certain classification.

The biggest obstacle is what is required of any manufacturer in order to register a product to Europe's satisfaction. A manufacturer must provide a host of detail about its product, including active ingredients and constituents, pharmacokinetic particulars (which is not absolutely essential), contraindications, interactions with other medications, overdose levels and shelf life. In the view of the National Association of Health Stores, these requirements are well beyond the financial capabilities of all but the largest companies.

At a recent meeting of the MCA, the feeling was strong that this directive wouldn't work as now worded. Nevertheless, there is pressure for the UK to adopt its own laws to more closely match 65/65. At the moment, herbs are exempt from medicinal licencing. However, if Europe has its way, none but the largest companies (read drug companies) will be able to meet the competition or the draconian new regulations.

!ALynne McTaggart


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