The EU wants to ensure food supplements are safe. Legal challengers say it is taking the wrong approach. Sylvia Thompson reports.
What's the difference between food and medicine? If you can get vitamin E from eating food such as eggs and vegetables, for example, does that mean this natural antioxidant, reputed to help ward off cancer and other degenerative diseases, is also food? Should it therefore be available to buy from any health-food shop? Or should we think of it more as a medicine, to be controlled, as if it were made by a drugs company - as, in fact, most of the vitamin E we take as supplements is?
On January 30th, in the High Court in London, the Alliance for Natural Health will challenge the EU Food Supplements Directive, which was adopted in 2002 with a view to limiting the active ingredients in mineral and vitamin-based supplements to a "positive list" of approved substances. The alliance, whose challenge is supported by many Irish health food retailers and manufacturers, says the list omits more than 300 widely used forms of vitamins and minerals.
In a related development Avril Doyle, the Fine Gael MEP for Leinster, challenged the inclusion of a "supremacy clause" in the EU's Pharmaceuticals Directive in Brussels last month. She believes the clause could result in food and food supplements being classified as drugs, as the Pharmaceuticals Directive would subsume the Food Supplements Directive, and thereby come under strict pharmaceutical regulation.
The issue at stake is whether people should be able to buy a wide range of supplements or only those that have passed stringent scientific evaluations. If the directive, or FSD, is implemented, the ban will come into effect throughout the EU in August next year.
"We are challenging the first phase of the FSD because we believe the positive list of vitamins and minerals leaves out many valuable nutrients from food sources and includes many of the more toxic, synthetic forms," says Robert Verkerk, director of the alliance. "We also believe that the positive list should be replaced with a negative list of the vitamins and minerals which are not allowed to be used. We hope that our legal case will be referred to the European Court of Justice in Luxembourg."
Erica Murray, owner of the Hopsack health store in Dublin and member of the Irish Association of Health Stores, says: "We believe it is the consumer's right to promote their health using supplements that have been on the market for a long number of years and that have not caused safety concerns. Prescribed medicine is now the fourth leading cause of death in the Western world. We are supporting the alliance's legal challenge because we do not believe there is any scientific justification for eliminating over 300 nutrients from the marketplace, including some of the most absorbable nutrient forms."
David Byrne, the EU Commissioner for Health and Consumer Protection, will not comment on this month's legal challenge. He has said, however, that the claim that 300 nutrient forms have been left off the positive list misses an important point. "No independent scientific evaluation about the safety and bioavailability of these nutrient forms has yet been carried out at European level," he wrote in this newspaper in 2002. "For a substance currently on the market, a seven-year national derogation may be obtained, during which time the substance in question can be properly evaluated."
The most important issue for consumers must be to balance the safety of a product with its benefit - and to test independently the effect of food supplements and their interactions with pharmaceutical drugs in an unbiased way.