Health Supreme by Sepp Hasslberger

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January 26, 2005

Supplements: EU Court Hears Case As UK Commons Debate Directive

Luxembourg - The European Court of Justice heard oral arguments yesterday in a case brought by the Alliance for Natural Health, the British Health Food Manufacturers Association and the National Association of Health Food Stores, to overturn the prohibitive provisions of the European food supplements directive.

The directive, passed in 2002 for the purpose of harmonizing European laws on health products, is set to require expensive research to prove the innocence of numerous vitamin and mineral ingredients in supplements, for products to be allowed to stay on the market. Many current supplements will not make the grade and are expected to vanish some time after August 2005, the date by which supplements must conform to the new rules.

On the same day in London's Westminster Hall, the House of Commons debated an opposition motion asking Tony Blair to re-negotiate the directive in the coming semester of British presidency of the EU. While the government strenuously opposed the motion, conservative politicians as well as some in the ranks of the government's Labour party pointed out that the directive will be bad for both consumers and the smaller, more innovative producers of supplements. The government was unable to provide evidence of any harm that must be averted from consumers and said they got "the best possible deal" in the negotiations leading up to the passage of the directive.

Some of the British Members of Parliament point out that a prohibition of supplements is really without sense because consumers will buy what they will over the internet. The issue is a political hot patato. "Why do people think less and less of Europe", said one of the MPs, continuing "it is precisely because of issues such as this one. Government thinks it's a small matter, but people are concerned about their access to natural products". However despite a good debate, the opposition motion was defeated and replaced by a government sponsored motion that lauds the government's handling of the matter.

Earlier in the day, these same concerns had reverberated around a court room in the European Court of Justice, where a challenge against the British laws to put the directive into effect was heard. At one point, Advocate General Geelhoed described the procedure for adding nutrients to the "positive list" of those allowed by the directive to be "as transparent as a black box". The Advocate General is expected to file an opinion on 5 April, while the final decision of the court is expected to come some time in June, just before the July/August deadline of enforcement for the directive.

- - -

The Alliance for Natural Health, one of the parties to the action, describes the hearing as follows:



The Alliance for Natural Health today presented its oral submission to the European Court of Justice in Luxembourg in its landmark case challenging the ban in the EU Food Supplements Directive on 75% of vitamin and mineral forms currently sold in the EU market. Unless listed on an approved so called “positive list” these nutrients will be banned throughout the EU from 1st August 2005.

Opposing oral submissions were made by the European Commission, the Council of Ministers, the European Parliament and only one EU Member State, Greece.

UK Government does not present its objections to the challenge

Interestingly, neither the UK government nor Portugal attended to present oral arguments despite having filed Written Observations in the case. This means that none of the major EU countries felt the need to oppose the ANH’s application for a declaration that the ban in the Directive was unlawful.

David Hinde Solicitor and ANH Legal Director said:

“Given the vigour with which the UK government resisted this application at the Judicial Review stage, it was extraordinary it did not now think the issue sufficiently important to warrant being represented at the ECJ to make oral submissions. The question inevitably arises whether this signifies a change of attitude on their part and a retreat from their previously bullish position about the legality of the Directive.”

Paul Lasok QC, a world leading expert on EU law, representing the ANH opened the proceedings and systematically undermined the legal and scientific basis of the Directive’s positive list, highlighting contradictions between various arguments put forward by the key bodies involved in developing the Directive, namely the European Commission, the Council of Ministers and the European Parliament.

When asked by Judge Lenaerts as to the origin of the positive list, which appeared to have been derived from a list produced by the European Commission for another Directive with a quite different purpose and so omitted a vast array of nutrients that can normally be found in food, Mr Lasok responded:

“The list was indeed the same, without adding, without subtracting and without thinking.”

Advocate General Geelhoed, (the senior legal Advisor to the Court) appeared to be baffled by the procedure for adding nutrients to the positive list, which he described:

“As transparent as a black box.”

Dr Robert Verkerk, executive director of the ANH said after the hearing:

“It was remarkable that the vast majority of points that we had gone to great length to show the Court were not countered in any effective way by the opposing parties. The Commission, the Council and the Parliament were not able to give any adequate scientific explanations for why so many forms of vitamins and minerals that naturally occur in foods could be banned across the EU.”

Final judgement expected in June 2005

The Advocate General announced that he would deliver his opinion on 5 April 2005, while the Court is expected to give its judgment in June, shortly before the ban would otherwise be set to come into effect on 1 August 2005.

For further information contact:

Alliance for Natural Health

David C. Hinde, Solicitor, Legal Director
Tel: 0207 738 1640
Mobile: 07958 548 186

Dr Robert Verkerk, Executive Director
Tel: 01252 371 275
Mobile: 0771 484 7225

See also related articles:

Financial Times: Vitamin sellers fight EU rules on supplements

Yorkshire Post: Ministers blasted over EU pills ban

The Times: Are health foods good for us?

The Times: Caplin joins protest at EU ban on natural remedies

Mary Ann Sieghart in The Times: Pro-drink, anti-vitamins. How's that for a shot in the foot?

And here some more details about the discussion in Parliament, provided by Paul Taylor:

The Hansard transcript of yesterday's debate in the British House of Commons is enclosed.

Unfortunately, and not at all surprisingly, the opposition motion.....

"That this House regrets the passing of the Food Supplements Regulations (England) 2003; mandates the Government to use the UK Presidency to renegotiate the Food Supplements Directive with the European Union; and indicates a willingness to repeal the regulations if the renegotiation does not reach a satisfactory compromise to protect the interests of consumers and manufacturers in the United Kingdom."

.....was roundly defeated, by 283 votes to 189.

In its place, the Government put an amended motion.....

"That this House congratulates the Government on successfully negotiating a final text of the Directive that works in the interests of UK consumers and industry by ensuring that products are safe, properly labelled, and can be freely traded across EU member states; notes that UK legislation gives maximum flexibility that ensures that as many products as possible can continue to be marketed after the Directive comes into effect on 1st August, and that all of the vitamins and most of the minerals currently on sale in the UK will still be available; agrees with the Government's assessment that re-opening discussion on the Directive at this point runs the risk of making its effects more restrictive and is thus against UK interests; and welcomes the Government's continued commitment to working with the industry on assessing the safety of individual food supplements, and to facilitating negotiations with the European Food Standards Agency."

.....that was passed by 279 votes to 172.

Interested in the details of the debate? Here is the transcript in MS Word (.doc) format for download.

See also:

ISIS Report 13/01/2003 - Hands Off Vitamins and Herbs
Visits to Complementary Alternative Medicine practitioners throughout Europe outnumber those to doctors by two to one. Government figures show UK citizens spend £70 million per year on nutritional supplements and about 20% of the population use vitamins and minerals in their diets. But European Parliament Directives passed in March 2002 will ban food supplements, in a bid to re-classify them as medical drugs. Sam Burcher reports.


posted by Sepp Hasslberger on Wednesday January 26 2005
updated on Wednesday December 8 2010

URL of this article:


Related Articles

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Readers' Comments

If the Euro-communits have their way the supplement business will be run from Bogota within a few years. They may put us out of business but I'll pay whtever the market will bear for my daily supplements.

Posted by: John Livingston on January 27, 2005 04:14 PM


I would like to post some up-to-date research on Kava.
(link no longer active)

In this report all available data concerning the safety of kava kava were critically
reviewed, analysed and evaluated. This comprises data on the traditional use of
kava, all controlled and non-controlled clinical trials, including about 10 000 patients,
all documented case reports of adverse effects and reported side effects that could
be related to kava intake.

In general, kava extracts are very well tolerated. Side effects or adverse reactions are
rare and mild in controlled clinical trials and non-controlled studies. No severe
adverse effects have been observed. Less than 1 % of the patients reported
unwanted effects; the majority of adverse reactions were gastrointestinal complaints.
Pharmacodynamical studies on healthy volunteers have demonstrated that kava
extracts do not have negative effects on vigilance. Furthermore, kava extracts do not
appear to impair the ability to drive or to operate machinery.

A total of 76 cases of severe adverse effects after treatment with kava preparations
have been reported during between 1990 and 2002. After an extensive review of
each single case, mainly based on all original data available and data provided by Dr.
Schmidt and Prof. Nahrstedt, and others, there only remain four cases in which
the causality to the intake of kava is probable. Only in one of these four cases
kava was taken according to the dosage recommended by the German Commission
E in its monograph on kava kava.

According to the sales figures of the German Institute of Medical Statistics,
approximately 250 million daily doses of kava were sold during the last 10 years in
German speaking countries. Correlated to this estimation, the 4 cases that can
probably be related to kava intake, lead to an incidence for hepatic adverse effects of
0.0125 in one million daily doses.
"The purpose of the expert report presented was, to evaluate the benefits and risks
resulting from the intake of kava preparations. This has been done on the basis of a
critical review of all available data concerning kava kava and an evaluation of their
significance and reliability.
All other scientists who critically reviewed the reported cases of hepatotoxic adverse
effects came to similar results and also confirm the expert's evaluations.

The American toxicologist Prof. Waller, after having examined 26 cases reported in
the US and 30 cases reported in Europe, confirmed our results, writing in his Expert
Report "... that "based on the data available to me at this time, there is no clear
evidence that the liver damage reported in the U.S. and Europe was caused by
the consumption of kava�?. He even says that, "kava taken in appropriate doses for
reasonable periods of time has no scientifically established potential for causing liver
damage�? [77].

Denham et al. prepared on behalf of the Traditional Medicines Evaluation Committee,
a subcommittee of the European Herbal Practitioners Association a detailed review of
BfArM's case reports. It was submitted to the U.K. medicines Control Agency and
Committee of Safety of Medicines in January 2002. According to the other
pharmacological experts the report states that most of the adverse events cited by
BfArM should not be attributed to kava [10].


In 1990 the German commission E recommended kava preparations within the
dosage range of 60 – 120 mg kavapyrones for short-term use of not more than 12
weeks [5]. After case reports of liver diseases, which at this time, were related to the
intake of kava preparations, the Commission E revised its recommendations. In a
public statement the Commission E now recommended that kava preparations should
be taken at a daily doses of 120 mg for 4 weeks. Treatment with a daily doses
ranging from 120 mg to 240 mg up to a maximum period of 8 weeks, should always
go together with regular pharmacological, toxicological and clinical controls of liver

The clinical studies cited in this expert report used daily doses of 60 – 280 mg
kavapyrones. Although the results of clinical trials suggest that kava kava seems to
be more effective in doses ranging from 120 to 280 mg of kavapyrones, a proven
efficacy in the treatment of conditions of nervous anxiety, stress, and restlessness
has also been documented at a daily dosage up to 120 mg kavapyrones. Taking into
account that in most of the controlled trials and non-controlled studies, kava was
applicated for four weeks, it seems to be appropriate to the expert that kava usually
should be used for 4 weeks and at the dosage recommended by the Commission E.
However, there are some controlled clinical trials and non-controlled studies,
exceeding a four weeks treatment (Volz & Kieser 1997 [76]: 24 weeks;
De Leo, 2002 [9]: 24 weeks; Lehrl & Woelk, 2002 [49]: 14 weeks; Warnecke,
1991 [78]: 8 weeks) without observing severe adverse effects. Therefore, the expert
agrees with the Commission E and considers an extension of treatment up to 8
weeks as favourable when the patients liver function is regularly controlled during


Regarding the results of paragraphs 2.2. (Pharmacodynamic), 3.1. (Efficacy) and the
conclusions stated in paragraph 4.2.(Efficacy) of this report, the high benefit, for
patients who suffer from conditions of nervous anxiety, stress, and restlessness,
resulting from a treatment with kava kava is proven.

Regarding the results of paragraphs 3.2. (Safety) and the conclusion stated in
paragraph 4.3. (Safety), the risks of possible severe adverse reactions related to the
intake of kava preparations is to estimate as relatively low. However there seems to
be a very low risk, of potential severe liver diseases.

A benefit-risk-ratio should not evaluate weather there is a potential risk related to the
intake of a certain drug or not. The ratio should take into account the severity of the
disease the medication is indicated for, the alternatives being available and the
consequences for the patients resulting from a positive or negative evaluation. On
this bases and regardless the modalities or regulations under which kava
preparations should be presented to the patient, the benefit-risk-ratio of kava kava
is clearly in favour of benefit.

Our result of the benefit-risk-assessment are confirmed by several experts and health
authorities, amongst them the Food and Drug Administration (FDA) [17], the German
Commission E [5, 6], the Bundesverband der Arzneimittelhersteller (BAH) und der
Bundesverband der Pharmazeutischen Industrie (BPI), Prof. Dr. Loew [52] and Prof.
Nahrsted & Dr. Schmidt [68].

Expert Opinion

Evaluating all the available data, the expert considers the drug under review in this
report, kava kava, an effective and safe drug in the treatment of diseases of the
claimed indication. It fulfils all the criteria for evidence based medicine, and thus
should be available for therapy. The Expert considers kava kava as a powerful
alternative to synthetic drugs that are approved for the same indications" (link no longer active)

Joerg Gruenwald, PhD, Cordula Mueller, PhD, Juergen Skrabal, MS
Phytopharm Consulting - a unit of analyze & realyze ag
Waldseeweg 6, 13467 Berlin, Germany
Tel. +49-30-40008100, Fax +49-30-40008500

Posted by: Jim Allen on January 9, 2006 03:25 AM


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The Individual Is Supreme And Finds Its Way Through Intuition


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These articles are brought to you strictly for educational and informational purposes. Be sure to consult your health practitioner of choice before utilizing any of the information to cure or mitigate disease. Any copyrighted material cited is used strictly in a non commercial way and in accordance with the "fair use" doctrine.



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