- © 2004 Canadian Medical Association or its licensors
Opponents to state regulation of natural health products won a major victory when the London High Court gave a coalition of industry and consumer groups the go-ahead to appeal a European Union (EU) directive restricting food and vitamin supplements.
The challenge was granted in February and is expected to be heard later this year at the European Court of Justice, which has the sole power to overturn an EU directive.
The London judge ruled there is an “arguable case,” for the appeal. The coalition says the regulations are unlawful, threaten health and trade and undermine consumer choice.
The directive, which is now slated to come into effect in August 2005, will produce a list of approved products and restrict the upper limits of supplement doses. Its architects say it will harmonize the natural health products market, promote free movement of goods and ensure consumer protection. Critics worry that such a list will result in the retraction of thousands of vitamins and supplements including calcium, zinc and selenium.
Beate Gminder, spokesperson for the Health and Consumer Protection branch of the European Commission, said “It is not our intention to ban products nor to increase costs. But we feel very clearly that the industry producing food supplements needs to have some data to support [product] safety.”
The Alliance for Natural Health, an organization of supplement manufacturers, retailers, practitioners and consumers that filed one of the challenges in the High Court, declared the ruling “a victory for millions of consumers of advanced food supplements, many of whom have found good health using nutrition as a central approach.”
The ruling comes as international organizations and governments on 3 continents are re-evaluating or implementing legislation of complementary medicines. Canada's new federal regulations came into effect Jan. 1 (CMAJ 2004;170(6):940), and new US legislation is expected to quash the 1994 Dietary Supplements Health and Education Act. Last year Australia created a new drugs agency that will classify and regulate dietary supplements and alternative remedies as pharmaceuticals.
The World Health Organization has entered the fray, issuing guidelines to ensure the quality and sustainability of the production of herbal medicines, an area that their report says is “difficult to regulate properly and get safety assurance for patients.” — Jocalyn Clark, London