Heilpraktikerverband to the medicinal herbal petition

Medicinal Products Commission of German Holistic Practitioners: Duty of Admission to Dietary Supplements: As a reaction to the mail campaigns to the Food Code (LMBG) and the EU guidelines for traditional plant preparations, the Drug Commission of the Association of German Holistic Practitioners e.V..

Authorization for dietary supplements
Under German law, food additives were subject to authorization and, in combination with the ban on harmful ingredients in food, this represented consumer protection in the dosage of potentially problematic additives. This also applied to dietary supplements. In addition, e.g. Vitamins and minerals are approved as drugs or as medical devices and are therefore also prescribed by the naturopath properly.

In a ruling of 25 July 2007 (BVerwG 3 C 21.06), the Federal Administrative Court found that a certain grape seed plant extract was to be classified as a characteristic ingredient of a dietary supplement essentially consisting of it and was therefore not subject to prior authorization as a food and feed additive Feed Code required. This unclear legal situation is currently being clarified by a new version of this law. In the interests of preventive health protection, this law seeks to clarify that such substances are subject to the authorization requirement.

If the food industry or the manufacturer of the dietary supplements spread the concern that the traditional and proven applications are at risk here, it must be noted that this is a judicial interpretation of the law since 2007, that is certainly not a long-standing tradition.

However, according to the new version of the law, all dietary supplements that have no health risk can be approved as additives. Vitamins, minerals or similar in medicines and medical devices are not affected by this legislation. The Drug Commission of German Naturopaths is involved in the examination of the law and will also take a stand in the case of relevance to the naturopathic profession.

European guideline for traditional plant preparations
The EU Directive on Traditional Plant Preparations (THMPD 2004/24 / EC), which has been implemented in European countries for many years and will finally take effect by 2011, has been implemented and effective in Germany for many years.

It should be noted that the European Directive has no current relevance, but is old. There are now the German and the European registration for traditional plant preparations and this has proven itself. All plant preparations with a proof of efficacy and the right to indications must be approved. In the licensing procedure, the representatives of the Drug Commission are also included in the Admissions Commission E..

The limitation in the mixture of plant preparations, vitamins and minerals in a drug has indeed quite sense, because a therapeutic dose differs from the substitution of vitamins and minerals. The regulation of single plant drugs (with positive or null monograph) remains unchanged and is not restricted in Germany.

Incidentally, the whole discussion is an old discussion, since the directive is from 2004 and even then the Pharmaceutical Commission and the non-medical practitioner volumes were involved and have just influenced the traditional registration of the plant preparations. Anything that is a "century-old or millennia-old" tradition, but has the registration option, because there must be only 30 years of application. (Association of German Non-medical Practitioners, 14.11.2010)

Also read:
Naturopathy: Dubious petition for medicinal plants
Home remedies for common cold
Naturopathy petition to the Bundestag
Association of Naturopaths