Regulation of Herbal and Homeopathic Medicines

Abstract

Currently, national and international regulations for herbal products and homeopathic remedies are subject to extensive review and revision. This is a result of increased consumer demand and a growth in the international marketing of these products. New legislation addresses issues such as concerns regarding product quality, accessibility, depletion of sources of plants leading to extinction, and toxic effects of some medicinal herbs. Evidence-based medicine has increased the need for demonstrable efficacy and safety. Homeopathic products are safe and generally conform to proscribed quality standards but proving therapeutic effectiveness has been controversial. The long-term future for this widely used system of complementary medicine requires more research with positive outcomes. More quality research is required on the efficacy and safety of many herbal health products. Approaches to regulation and licensing of herbal and homeopathic products vary among countries and cultures. There is a need for greater international harmonization and homogeneity. Canada has adopted legislation introducing a Natural Health Products Directorate responsible for a wide range of complementary medicines including herbal and homeopathic products. The objective is to provide ready access to these therapeutic agents while ensuring quality, safety, and efficacy. Products that provide health benefits and resemble food are considered as Functional Foods under food legislation. Regulators in the European Union (EU) are developing legislation to facilitate international trade in herbal and homeopathic products within the Union. Member countries have their own laws, which must be adapted to conform to those of the central parliament. Australia regulates herbal products and homeopathic remedies under the Therapeutic Products Act, 1989, where they are considered as medicines. Homeopathic agents constitute a special section, with modified standards. Countries which accept homeopathic therapy generally acknowledge compendial standards in major national homeopathic pharmacopoeias. This inhibits licensing approval for any new product or delivery system not in the compendia. The US categorizes most herbal products as supplements under the Dietary Supplement Health Education Act of 1994. There is postmarket notification and the US FDA has to demonstrate any problem with safety. The World Health Organization (WHO) is promoting standards for regulating Traditional Medicine, including quality, safety, and efficacy. Important therapeutic systems covered by WHO include those of China, Japan (Kampo) and India (Ayurveda). New regulations for herbal products will enable the consumer to make informed choices based upon improved research data, quality standards, and product labeling.