European Court of Justice Strikes Down Arbitrary Dosage Limits for Supplements
CategoriesIn a decision published on 29 April 2004, the European Court of Justice said that Germany contravenes its treaty obligation to allow free trade within the Community when it requires pharmaceutical registration for food supplements that contain vitamins exceeding three times the amounts recommended for daily consumption by the German Nutrition Society.
The decision can be accessed from this page in a number of languages, but translations into Danish, English and Swedish have not as yet been put on line.
The European Commission sued the Federal Republic of Germany in October 1999. It charged that the administrative practice of declaring all vitamin products containing more than three times the recommended daily amounts (RDA) to be medicines was arbitrary and disproportionate. The legal action followed a formal Commission challenge of the German policy in 1998, based on complaints from producers in other EU nations. Exporting supplements into Germany had proven an impossible task in the face of the German rules. In April and May 2000, Denmark and Finland, countries with a similarly restrictive attitude, joined the legal proceedings to assist Germany in its defense.
According to the EU court, in principle, a member state may limit dosages of supplements but only if such limits are evaluated case by case and are necessary to protect the health of its citizens. Arbitrary, across-the-board limits on vitamin dosage based on multiples of the RDA were judged to exceed that discretional freedom of action and violate one of the pillars of EU law: the establishment of a free internal market.
The question is: What does this decision mean for the future of foood supplements in Europe?
In immediate terms, for the countries manufacturing and exporting supplements such as the UK and the Netherlands, the decision has little direct influence on nutrient availability to consumers, although it opens the doors to exporting industries.
In the more restrictive EU member countries however, the decision striking down the German restrictions brings about an interesting situation: Countries such as Finland, Denmark, France, Spain Italy and Greece will find they have to re-think their attitude on supplements. Across-the-board restrictions are no longer sustainable.
The EU Court's decision comes as food supplements are to be regulated in a consistent way across the whole of Europe by a directive, which was passed in July 2002 and is to be transposed into national law. The British law of conversion of the directive was recently challenged in a UK court. After hearing the arguments, the London judge is referring the case to the European Court of Justice. The challenge says the directive is too restrictive. It provides for constraints on formulation by listing allowed nutrient sources and calls for dosage restrictions after nutrient safety reviews. It is expected that many products available today will become illegal once the directive is in full force.
The supplement directive's restrictive mindset is somewhat bewildering.
Pharmaceutical medicine is corrupt and has dismally failed in assuring our health. In fact pharma-based medicine has come to be one of the leading causes of death in the western world.
Good nutrition is of paramount importance in maintaining good health. Supplements are not only necessary to ensure we get enough of what our bodies need - they could extract us from the quandary of bankrupt public health systems that are increasingly difficult to sustain financially. So why are we regulating supplements in a restrictive way while giving pharmaceutical drugs a comparatively free reign? The actual record of performance would suggest an exactly opposing course of action: tighten the rules on pharmaceutical medicine and liberalize nutrition!
It remains to be seen in the coming year or two whether the restrictive mindset that has dominated nutritional supplementation over much of Europe since the 1950's is going to win out and perpetuate its nefarious influence in overcautious assessments of nutrient limits, or whether Europe will grab the unique chance of breaking with the pharma paradigm and embrace nutrition as the important health determinant it represents. A change of course would not only benefit public health - it would bring current insane levels of public health expenditure down sharply to come into line with real world possibilities.
posted by Sepp Hasslberger on Thursday May 20 2004
updated on Saturday September 24 2005URL of this article:
http://www.newmediaexplorer.org/sepp/2004/05/20/european_court_of_justice_strikes_down_arbitrary_dosage_limits_for_supplements.htm