General Information
Depending on their purpose of use, dosage, and ingredients, supplements are categorized as food products, pharmaceuticals, or dietetics. All supplements fall under the guidance of the Ministry of Consumer Protection, Nutrition and Agriculture. Some structure/function and nutrient function claims may be made on nutritional products.
Most botanicals are classified as medicines. Some are classified as food products if their use is primarily nutritional. Traditional herbal remedies are limited to botanicals of German/European origin already marked in Germany prior to 1978 with mild or prophylactic properties. Both the European pharmacopoeia and the Deutsches Arzneibuch are considered legally binding.
Fortified or Functional Foods – Fortification of food is not regulated, though vitaminisation is. The addition of herbs is unregulated.
Traditional Medicine status was introduced in January 1992 that permits the re-registration of traditional medicines without requiring rigorous studies and scientific data on a specific product. The standards for the approval of traditional medicines and the scientific standards for herbal drugs must be approved by Commission E in The Commissions of the German Federal Institute for Drugs and Medical Devices (BfArM). Post-marketing surveillance monitors all adverse events of herbal medicines.
In 1976, Germany not only introduced a national policy on TM/CAM, but also all laws and regulations.
Contact
Ministry of Consumer Protection, Nutrition and Agriculture
Ministry of Health
http://www.bmg.bund.de/cln_041/DE/Home/homepage__node.html__nnn=true
The Commissions of the German Federal Institute for Drugs and Medical Devices (BfArM)
