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Save our Supplements

Vitamins & Minerals &Herbal Remedies Why the Fuss

A Briefing pack

for Members of parliament

on

The Food Supplements Directive

and

The Traditional Herbal Medicinal

products Directive
January 2003

Consumers for Health Choice

9 Old Queen Street

London SW1H 9JA

Tel: 020 7222 4182 Fax: 020 7222 4192

Email: enquiries@healthchoice.org.uk

Web: www.healthchoice.org.uk

1. About CHC

Consumers for Health Choice: CHC is an independent consumer organisation, which has 6,000 members in the UK, and over 260,000 supporters on its database. It is run by a Board of Directors who are elected annually. CHC has offices in London and Brussels and works with similar organisations around Europe. CHC is funded by donations from individual consumers and small independent retailers. It receives campaign support from major companies such as Holland and Barrett, Health & Diet/GNC, Tree of Life Optima Health, Solgar and Biocare.

2. About the Threats

The continued right of UK consumers to have access to a wide range of safe, popular and effective vitamin/mineral supplements and herbal remedies is under threat as a result of two European initiatives:

The Food Supplements Directive:

Unless changed from its present form, this directive will result in the loss of up to 300 currently available safe nutrients, and nutrient sources from the UK market, and the imposition of unnecessary and unacceptable limits on the dose level at which vitamins and minerals can be present in such supplements undermining their effectiveness substantially. This would affect literally thousands of individual products that have been safely on the market for decades. The Directive has now been finalised by the EU and was published in the Official Journal on 12 th July 2002.

The Traditional Herbal Medicinal products Directive:

Unless changed from its present form, this directive will result in the loss from the UK market of a wide range of safe and popular herbal remedies, plus a large number of products that are a mixture of nutrients (vitamins and minerals) with herbs. This Directive is now making rapid progress through the EU legislative process.

Although Ministers have been making sympathetic and placatory comments about both these threats, we believe they may have been misled by the Medicines Control Agency (MCA) about the potential impact of some of the proposed changes to EU law; and that even though the Food Standards Agency appears to be sympathetic to our concerns, the political reality in Europe is that those concerns have been substantially overlooked.

3. The Food Supplements Directive

In May 2000, the European Commission published a Directive on Food Supplements. After considerable debate in the Council of Ministers and the European parliament that Directive has now been finalised and was published in the Official Journal on 12 th July 2002, with its main provisions being implemented over a period of several years.

Although presented as essential to ensure consumer safety, the Food Supplements Directive is actually designed to standardise the different regulatory regimes for vitamin and mineral supplements across the 15 Member countries of the European Union (EU). This may mean some slight liberalisation of the market in France, Germany and some other countries, but for the existing liberal markets of the United Kingdom and the Netherlands in particular, where millions of consumers have been using higher dose vitamins and minerals for several decades, it will mean the loss of a substantial number of products.

a. Reduced potency

The first threat is that the Directive introduces a system of maximum permitted levels for nutrient content. These levels are expected to be set substantially lower than the scientifically assessed upper safe level. The process will start with a cautious assessment of safe level (e.g. vitamin B6 at 25mg/day, niacin at 10mg/day) by the EU Scientific Committee on Food. That level will then be further reduced by the European Commission to take into account risk management factors such as nutrient intake from other dietary sources and population reference intakes (an outdated concept of nutritional need which is the minimum required to avoid diseases like scurvy and beriberi nothing to do with the levels necessary to achieve and maintain optimum health). political considerations at the relevant EU Standing Committee will then come into play with the Governments of France, Germany, and others, seeking to block everything except the lowest possible dose levels in line with their existing markets.

Millions of British consumers regularly use higher range vitamins and minerals. Removing them from general sale will not stop consumers wanting them. Indeed, such action would raise a very real moral hazard by forcing consumers to seek them from unregulated outlets such as overseas mail-order companies and the Internet, putting consumer safety at risk. In addition, if high dose nutrients are lost, it would genericise the entire market; putting a question mark over the future of all natural healthcare and alternative therapies, plus putting at risk the livelihood of specialist retailers and manufacturers.

b. Loss of Nutrients

The second threat is that the Directive contains a list of permitted nutrients and nutrient sources which may be used in supplements. If a nutrient is not on the list then it cannot be used. At present there are more than 300 safe and popular nutrients and nutrient sources on the UK market that are not on the list. To get a substance added to the list now would require the submission of a safety dossier for consideration by the EU Scientific Committee on Food (SCF). There is a short window of opportunity for the submission of such dossiers (by July 2005). production of acceptable dossiers is extremely expensive, particularly if full supportive clinical evidence is not readily available and needs to be commissioned, and we know EU industry cannot afford to submit more than a handful. If a nutrient has been on the market for decades without even a whisper of a safety issue, a major scientific dossier should not be required.

The Directive has now been finalised by Europe and will be transposed into the laws of the member countries in just a few months. The full text of the Directive can be found at:

http://europa.eu.int/eur-lex/pri/en/oj/dat/2002/l_183/l_18320020712en00510057.pdf

The Food Supplements Directive will have a substantial impact on the UK market for vitamins and minerals. It will deny consumers access to safe and beneficial food supplements of their choice, and have major implications for the Governments own public health strategies (forexample, promoting folic acid supplementation by pregnant women or women planning to become pregnant).

The UK Government must immediately be pressed to use every opportunity to persuade the Commission and the Governments of other EU Member States to allow the most liberal possible interpretation of the legislation. If the UK Government delays such action safe higher potency supplements will be lost. The Government must also force an early review of the procedures of the EU Scientific Committee on Food so that the requirement to submit dossiers for nutrients currently not on the permitted lists is not overly burdensome and expensive.

The EU is imposing expensive scientific requirements, mandatory for novel chemicals such as food additives (colourings, preservatives, sweeteners, etc) that are not reasonable requirements for naturally occurring nutrients that are processed by the body as foods, rather than toxic chemicals.

Above all, the UK Government must work now for an amendment to the Directive that would allow those safe supplements which would otherwise lie outside the Directive's technical restrictions, to remain on the UK market.

4. Traditional Herbal Medicinal products Directive

Europe is also considering a Traditional Herbal Medicinal products Directive, proposed by the UK Medicines Control Agency (MCA). This Directive will have a devastating affect on herbal products currently on the UK market and in some other European countries.

The draft Directive proposes a regulatory regime that allows some herbal remedies to be licensed as medicines without proving their efficacy (in the way that pharmaceutical drugs have to do). They would need to demonstrate that they were safe, were manufactured to high quality standards, and that the finished product, not just the ingredients, had been on the market for 30 years (15 years of which would need to be in Europe amendment to 10 years passed by European parliament ).

But, the practical effect of the detailed proposals now contained within the Directive is that it would remove many safe and popular products from the market because:

some products have not been on the market for the necessary period of time; so the imposition of the arbitrary 30 year period would jeopardise the position of products introduced over a period of nearly 3 decades and prevent all future product innovation. no new products could be brought to market even if they had been available for many years in another non-EU country with a good safety record. the manufacturing and testing standards proposed are inappropriate for herbal remedies which should not be treated in the same way as pharmaceutical drugs. the Directive would not allow for products which are combinations of otherwise legal ingredients (for example, existing mixtures of herbs with nutrients such as vitamins and minerals); this would leave some of these products (which represent an important section of the market) in a regulatory vacuum. the earlier drafts of the Directive related to ingredients but the text now deals with products, making it difficult in practice to provide evidence of market presence over the period of time required and requiring manufacturers of basically identical products to duplicate registrations at great expense. in most cases manufacturers will simply not be able to afford the cost of complying with the registration procedures and technical pharmaceutical standards which will lead to the loss of many products that are otherwise within the scope of the new legislation.

partial Regulatory Impact Assessment

We have studied closely the partial Regulatory Impact Assessment produced by the Medicines Control Agency. It is woefully inadequate. paragraphs 26 and 27 substantially underestimate the impact of the proposed Directive on retailers and their customers,- the consumers of these products. This gravely concerns us.

The MCA is already aware from discussions with consumer organisations that there is substantial concern about the position of products that lie outside the scope of the proposed Directive, but they have so far failed to address the issue. We are particularly anxious to secure the continued availability of those products that are mixtures of herbal ingredients with nutrients such as vitamins and minerals.

These combination products are safe, popular and the fastest growing sector of the industrys product range, much favoured by consumers, since they enable them to buy one single supplement containing a wide range of ingredients at relatively low cost. The alternative of buying several different products to obtain a balanced intake of ingredients would otherwise be prohibitively expensive.

We can see no public policy objective that would be served by requiring a full medicines product licence for a safe product which is simply a mixture of one or more safe ingredients, which would require no such licence if sold separately.

Furthermore, the Assessment makes ill informed and generalised statements about the limited shelf space allocated to herbal remedies that are sold alongside other natural health products. This is fundamentally to misunderstand the specialist nature of health food retailing. Many health food products are now widely available through other retail outlets, including supermarkets. It is the Unique Selling point of the specialist retailer that he/she is able to offer products that are not otherwise generally available. It is these specialist supplements, combined with detailed knowledge about these supplements, which attract customers who then purchase other more widely available products. The loss of such specialist products would have a serious and substantial impact upon the retail sector to an extent which is completely ignored by the MCA Assessment.

As consumers, we greatly value our specialist health food retailers and do not wish to lose them.

The proposed Directive would have a damaging economic impact, far greater than that acknowledged in the consultation document.

Despite the intentions of the Minister, and for the reasons set out above, CHC believes that the Traditional Herbal Medicinal products Directive is deeply flawed. It would in practice fail to meet the Ministers stated objective of finding a secure home in European law for herbal remedies currently exempt from licensing under Section 12 of the Medicines Act 1968.

We are aware that officials of the Medicines Control Agency have been at pains to stress that they would seek to apply the provisions of the proposed Directive with a light touch appropriate to herbal remedies. We feel unable to rely on these assurances, especially in light of the recent prohibition of kava-kava, and firmly believe that despite such good intentions, the proposed Directive is flawed. It would fail to achieve the Governments objectives for Section 12 products, would jeopardise the status of other safe and popular products already on the market, would restrict consumer choice, would hamper practitioners and would have a serious and substantial impact upon both the retail and manufacturing sector.

The Government should immediately bring forward proposals to review the law in the United Kingdom so that safe and popular herbal remedies and combinations of herbs with nutrients continue to be available under appropriate national regulations, rather than the inappropriate EU medicines law.
5. The Safety Question
Neither of these two Directives are in any way necessary to ensure consumer safety.

Food supplements , such as vitamins and minerals, are sold under food law, and are required to conform to the provisions of the Food Safety Act, which requires that they are safe and appropriately labeled. The Minister, at the initiative of the Food Standards Agency, already has powers under this Act to ban particular nutrients if they are found to be unsafe, and prosecutions can already be brought against individual manufacturers and retailers if they market unsafe products. The whole range of general consumer protection legislation also applies to them.

Legislation in this area is already adequate to guarantee consumer protection, a fact accepted by the Food Standards Agency (FSA). A senior official of the FSA, responsible for policy on the Food Supplements Directive (Mr Grant Meekin) told a delegation of concerned retailers and consumers in September 2001 that the Directive was an outrage. When the delegation explained their concern that the salami slicing of their product range by excessive regulation had reached the end of the sausage and was about to slice off their fingertips, he vigorously agreed stating that the debate, however, was no longer about whether to stop at their fingertips, but whether their wrists, elbows, or shoulders would go as well!.

Some Herbal remedies are sold under food law in which case they are regulated as food supplements under the Food Safety Act (as above). Other herbal remedies are sold as medicines under the provisions of the Medicines Act 1968 which requires them either to be fully licensed as drugs, or to be marketed within strict provisions under Section 12 as medicines exempt from licensing. The Medicines Control Agency already has powers to act swiftly against any ingredient or product, which it considers to be unsafe. It has done so recently against Kava Kava (now banned unjustifiably!) and St Johns Wort (which is the subject of special labeling requirements).

These two Directives will reduce consumer safety . Consumers can at present buy specialist products at reputable high street retailers or responsible mail order companies. If the products of their choice are banned, there is a serious risk of them being purchased from overseas sources (internet sites and mail order) from companies which do not maintain the high standards which apply in the UK. There would be no quality control, no hygiene control, and no guarantee that the product contained what it said on the label. Some consumers would also decide to visit herbal practitioners some of whom are unqualified and not therefore regulated at all at present, and whose manufacturing processes are not covered by the above legislation, exposing them to substantial potential risks.
6. Conclusion: The Effect of the 2 Directives
The combined effect of the two directives is:

- loss of thousands of safe and popular products - completely unnecessary restrictions on consumer choice - substantial job losses in the specialist retail sector - the bankruptcy of several specialist manufacturers and retailers - a reduction in consumer safety - an adverse impact on public health, and - substantial increases in visits to general practitioners.

Consumers for Health Choice

9 Old Queen Street

London SW1H 9JA

Tel: 020 7222 4182 Fax: 020 7222 4192

Email: enquiries@healthchoice.org.uk

Web: www.healthchoice.org.uk

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