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Vitamin dosage in supplements divides Europe

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The European Commission is holding a consultation intended to allow industry and consumer input before setting dosage limits for vitamins and minerals in supplements and foods sold in the EU. The answers received are showing up deep divisions among member states and also among groups with an interest in nutrition and supplementation.

The European Directive on Food Supplements mandates dosage levels to be considered and limits to be set where needed. At the time of its passage, the directive drew protest and criticism from consumers. Some of the arguments can be seen on La Leva's site here. During a legal challenge to the directive's legitimacy, the Advocate General of the European court of justice called the directive's procedures "as transparent as a black box", but the court, in its subsequent decision, gave the go-ahead for the new rules..

The directive, while mandating controls on supplement formulation, did not address the specifics - it left the details to be decided later. So the same spiny questions that characterized the original discussions but were never resolved at the time are now coming back to haunt the legislator.

The European Commission has provided a discussion paper inviting comments from member states and interested groups, asking a number of specific questions. The answers, now posted on the Commission's website, show widely diverging opinions.

Some EU member nations such as Germany, France and the Nordic countries argue that precaution must be exercised and that the availability of nutrients should be sharply curtailed. The UK and the Netherlands in contrast are more open to allowing their citizens to decide how they wish to increase the nutrient content of their daily chow.

Industry and nutritionists are also divided, although a majority would gladly do without undue restrictions. La Leva has argued that supplements should be left alone, but BEUC, the European consumer federation sponsored by the EU Commission follows the official German line of "can't be careful enough - there might be some dangers lurking in those nutrients somewhere"!

The real question seems to be: should consumers be able to choose vitamin supplements freely or should this choice be restricted in the name of public health. One particular submission addresses this basic question in an admirable manner, pointing out the biased nature of the whole process. The comments filed by the Irish Association of Health Stores put the arguments in the right context.

Their submission is well worth reading for anyone who wants to get a good grasp of the central issue and the way the European Union is (mis)handling it.

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Here are a few quotes from the Irish submisson:

From the introducton:

Good nutrition is fundamental to good health, and the relationship of diet and lifestyle factors to the maintenance of good health is now well established and recognised by all health authorities. Food supplements may be utilised as an additional health promotion measure, not only to ensure adequate nutrition levels, but to enhance normal physiological function by ensuring optimal nutrition levels.

The Commission's discussion paper, say the Irish, is based on three major flaws, resulting in a biased process:

1) The false premise that high levels of vitamins and minerals are a greater risk than low levels

2) Risk Assessment for nutrients does not take benefits into account

3) Existing Major Risk Assessment Studies have been ignored

The paper goes into a more specific discussion of the "too little" side of nutrition and the ignored benefits. problems:

In 1990 and again in 1998 national nutrition surveys carried out in the UK have shown that large minorities are not reaching their dietary targets for Reference Nutrient Intake (RNI). In 2000, the National Diet and Nutrition Survey has revealed that 91% of girls aged 4-6 years failed to reach the RNI for zinc. In the same survey it was reported that 97 % of girls aged 15 to 18 years, do not reach the RNI for magnesium, 73% do not reach the RNI for zinc which is an important nutrient for the immune system, and very significantly 53 % do not reach the RNI (200mcg) for folic acid, even though an intake of 400mcg per day is recommended to reduce the risk of spina bifida. In Ireland the North/South Ireland Food Consumption survey identified a prevalence of inadequate intake of calcium in women and of iron in women of reproductive age. The survey showed that 48% of women aged between 18-50 had inadequate iron intake. Only 2% of women aged 18-35 reached the RDA for folate. Inadequate intakes of vitamin A were identified in 20% of men and 17% of women. Inadequate intakes of vitamins D, E and riboflavin were also identified.

The potential benefits of food supplements are similarly ignored by most national health authorities, despite overwhelming positive evidence in the scientific literature to indicate that the use of food supplements can be a beneficial enhancement to health. At least this has been recognised by the European Commission which stated in an Explanatory Memorandum to the Food Supplements Directive that “potential health benefits may accrue from the intake of recommended or higher than recommended levels of these nutrients”.

Supplements could greatly reduce the costs associated with healthcare and they have - contrary to all appearances seeing the scramble to "manage their risks" - an excellent record of safety.

After answering the specific questions of the Commission, the Irish submission comments on several attempts at describing risk assessment, pointing out their inadequacy for the job at hand.

A discussion of how the Supplements directive will be detrimental for the nutrient-supplying industry, the shops that sell them and the consumers who normally use them concludes the submission:


Implications for Industry

The industry estimates that the omissions of nutrients from the Positive list, will necessitate the re-formulation of approximately 85% of vitamin/mineral supplements including nearly all of the multivitamin preparations on our shelves. Moreover, the SCF opinion on just one nutrient (vitamin B6) will result in the loss of 75% of all B complex and B6 supplements from health store shelves.

Thus it can readily be seen that the Food Supplements Directive will have quite a severe impact on the range of food supplements currently being sold in health stores. As food supplements form over 50% of most of IAHS members’ stock in trade at any one time, the livelihood of many members is at stake. Although designed to remove barriers to trade, as well as to protect public health, the Directive will in fact achieve the opposite. As virtually none of the food supplements being imported from outside the EU, from countries such as the USA, Canada or Australia will comply with the Directive, these products will be barred from entering the EU. Within the EU, many of the smaller manufacturers will not have the resources to be able to comply with these requirements, and will close down, leading to loss of jobs. Remaining food supplement manufacturers will be forced to drastically reduce or re-formulate their product range, thus adding immeasurably to costs once again. In Ireland this will be more acutely felt because nearly all of the 120 companies involved in the industry are Small to Medium-sized Enterprises (SMEs).


Implications for the consumer

The stated purpose of the Directive is to harmonise the market, and also to protect public health. Both are laudable objectives, but the net effect of this directive will almost certainly be the removal of many food supplement products from the marketplace, not because they are unsafe, but because of overly restrictive regulations based on false premises, and utilising multiple “safety factors”. This represents an unacceptable curtailment of consumer choice for no good reason. This, in turn, will lead to loss of jobs in the manufacturing, distribution and retail areas. Consumers will still want these products, so they will turn to mail order, the black market and the Internet as a source for them, where quality and safety controls are non-existent.


Compliance costs

The compliance cost to industry is a major concern.

Re-labeling costs to industry have been calculated to be in the region of GB£300-500 (approx. €450-€750) per product by the UK Food Standards Agency (FSA).

The FSA also estimate reformulation to be in the region of GB £3,000 (c. €4,500) per product.

However, the main costs to industry involve the submission of a full safety dossier to the SCF, which is estimated at between GB £80,000 (c. €120,000) and GB £250,000 (c. €375,000) per ingredient (not per product).

Our members rely, in the main, on products manufactured by the smaller innovative companies, as opposed to the multinational pharmaceutical companies. These smaller companies will undoubtedly suffer under the FSD due to compliance costs and other restrictions.

The UK Food Standards Agency reports that “small specialist retailers (such as health stores) stand to lose significant amounts of business if a wide range of specialist products is no longer available”.

Conclusions

The IAHS considers that the data presented above show conclusively that vitamin/mineral supplements are amongst the safest products ingested. The data also demonstrates that vitamin/mineral supplements have substantial benefits to health. Moreover, the safety and benefits of vitamin/mineral supplements far outweigh any threat to human health that they may pose. The data shows that nutritional deficit is a far greater threat to human health than high supplemental levels of nutrients.

It follows therefore that rigorous risk assessment and management of vitamin/mineral supplements is, for the most part, not indicated, and if applied will contravene the sprit and purpose of the Food Supplements Directive and reduce consumer choice markedly. Certainly most of the risk assessment models reviewed by the discussion paper and the measures they entail are wholly disproportionate to the risks present by food supplements. Finally, over-regulation will encourage black market conditions where no quality or safety standards exist at all.



The full text of the Irish submission can be downloaded here.

Links to all the submissions are available from this page.

Of particular interest:

The submission by the Alliance for Natural Health

A view from the US - The National Health Federation

Comments submitted for La Leva di Archimede


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An appeal by Consumers for Health Choice to join the action:


Spread the word

The Save-Our-Supplements campaign has moved into top gear this week as representatives from eleven Member States join the fight to keep supplements available. Taking the lead is the lobby group Consumers for Health Choice (CHC), who want your help in increasing the pressure on the Commission as it starts to set maximum dose levels that will be allowed for vitamins and minerals across Europe.

This is how you can help.

Log on to the CHC website at www.healthchoice.org.uk then click onto EU Campaign Tool Kit - then click onto your national flag and just follow the directions. Clicking onto Tool Kit takes you straight to the kit that provides you with everything you need to join in the action. Contact names and addresses of regulators across Europe, draft letters to guide you and full information of what Brussels is proposing.

Then write, write, write!

It doesn't matter if you are a manufacturer, retailer or consumer; your letters are very important, especially if they are hand written and sent by post. E-mails are acceptable too; they are better than not writing at all but in reality don't have the same impact. Letters from everyone - letters from your friends, your family, your work colleagues - in fact, you could encourage everyone in your complete e-address book to join in.

If every business and household receiving this e-cast generates just two letters to Mr Kyprianou - he will certainly get the message - "if a product is safe, we should be allowed to use it. It is a simple matter of consumer choice".

www.healthchoice.org.uk



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