Summary: There is every indication that recent events unfolding in Europe by Member States of the European Union, relative to legislation affecting nutraceutical products, including herbal medicines, will have a long-term effect on countries world-wide that export products into Europe. The author reviews the recently passed Food Supplements Directive (FSD), recent amendments to the Pharmaceutical Directive, and the Traditional Herbal Medicinal Products Directive (THMPD), with comments on their impact, including proposed legal challenges to the FSD that may set the stage for similar challenges to the restrictions imposed by the THMPD.
There has been much activity—and much confusion—about recent regulatory developments in Western Europe that affect the manufacture and sale of herbs and herbal products. Manufacturers, suppliers, retailers, practitioners, and consumers in Europe have received a wide range of sometimes conflicting messages about the likely impact of the European Union (EU) legislation on the availability of dietary supplements to Europeans. EU legislation may have a profound impact on the availability of a wide range of dietary supplements in the future, particularly traditional botanical medicines found outside of Europe and not yet in the European marketplace. (See sidebar for summary of EU legislation.)