Botanicals - Modern Herbal Medicine - Government Regulations

Government Regulations

The World Health Organization (WHO), the specialized agency of the United Nations (UN) that is concerned with international public health, published Quality control methods for medicinal plant materials in 1998 in order to support WHO Member States in establishing quality standards and specifications for herbal materials, within the overall context of quality assurance and control of herbal medicines.

In the European Union (EU), herbal medicines are now regulated under the European Directive on Traditional Herbal Medicinal Products.

In the United States, most herbal remedies are regulated as dietary supplements by the Food and Drug Administration. Manufacturers of products falling into this category are not required to prove the safety or efficacy of their product, though the FDA may withdraw a product from sale should it prove harmful.

The National Nutritional Foods Association, the industry's largest trade association, has run a program since 2002, examining the products and factory conditions of member companies, giving them the right to display the GMP (Good Manufacturing Practices) seal of approval on their products.

Some herbs, such as cannabis and coca, are outright banned in most countries. Since 2004, the sales of ephedra as a dietary supplement is prohibited in the United States by the Food and Drug Administration., and subject to Schedule III restrictions in the United Kingdom.

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