Results of the revision of herhal drugs in the Federal Republic of Germany with a special focus on risk aspects*

Abstract: Herbal remedies are defined as medicinal products in the German Medicines Act of 24 August 1976 and within the EEC in the CD 65165 ff. As a consequence of these regulations a revision of the efficacy and safety of these products is necessary. In Germany this is done by a multidisciplinary expert committee, the so-called Commission E. A more general result of the work of the committee is that for herbal remedies benefits and risks must be balanced in the same way as for all other drugs. The argument that herbal drugs are safe because they are -natural- is wrong as is the argument that, as a rule, traditional remedies are not safe and affective. About 213 of the monographs published mention risks. These may be allergic reactions or in few cases even carcinogenic effets. Consumers can expect to be informed on the risks and the possible benefits of herbal remedies as they arc informed on other drugs. Only if they arc clearly informed on the potential benefit, they can decide if a potential risk is acceptable. It is being discussed if herbal drugs can be regulated by a traditional use labelling without further assessment.

Keyword(s): herbal remedies

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