According to the law dietary supplement is considered to be food which does not need pre-market approval by the FDA, and not as a food additive which needs a pre-market approval by the authority. A statement on the label of a dietary supplement is allowed if a benefit is claimed related to a classical nutrient…

The market The use of herbal medicines in the United States is less widespread than in the majority of developed nations as wider distribution through pharmacies is difficult because no medical claims may be made and consumers are dependent on advice from pharmacists who, in majority of cases, have little knowledge about medicinal herbs. Also…

Criteria for registration and requirements for marketing authorizations for herbal remedies are as set out by European Directives and guidelines, such as the Note for Guidance on Quality of Herbal Remedies, the European Pharmacopoeia, and national guidelines and directives such as the guidelines for testing of drugs following section 26 of the Medicines Act. While…

In Germany, issues surrounding quality control and standardization of herbal products are less of a concern than elsewhere because ethical botanical manufacturers use the same high-quality production standards found in the synthetic drug industry. However in terms of legal status, herbal medicines are fully considered as medicines according to the Second Medicines Act of 1978 which…

The market Herbal medicine sales is growing in Germany and herbal remedies represent an important share of the German pharmaceutical market. According to an Institut fur Medizinische Statistik (IMS) report, presented during an ESCOP Symposium in Brussels in October 1990, the German herbal medicines market was worth US $1.7 billion in 1989, which was equal…

Furthermore in order to provide a specific framework for the registration of herbs and botanical preparations, a concept of review involving ‘Standardized Drug Monographs’ (SDM) has been proposed to facilitate registration of those drugs containing herbs that meet requirements of the monographs. Products making reference to such an SDM would require less individual premarket scrutiny…

The market Over the last decade there is a reported increase in the sale and use of herbs in Canada. In North America herbal remedies constitute a $2-billion-a-year industry that is growing at a pace of 15% annually. Legal status Herbal products were generally regulated as foods or drugs under the Food and Drugs Act…

Australian herbal remedies being considered by the TGA to be ‘reasonably safe with less adverse reactions than conventional pharmaceutical treatments’ are allowed to enter the register at a lower level than other pharmaceuticals. Herbal products made from starting materials of pharmacopoeial standards, approved by the TGA, with claims within Advertising Code guidelines containing active ingredients…

Registered medicines are classified as high risk and low risk. The high-risk ones are assessed individually for quality, safety and efficacy and should be manufactured under GMP. The low-risk ones are listed medicines and contain ingredients permitted by the TGA for use in low-risk medicines restricted to indication and claims relating to health maintenance, health…

Therapeutic goods for human use including traditional medicines which are imported or manufactured in Australia must be included in the Australian Register of Therapeutic Goods (ARTG) in accordance with the Therapeutic Goods Act 1989. Instituted by the Common wealth Department of Health and Aged Care, the overall objective of the act is to ensure the…