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BgVV and BfArM issue warning: Serious health problems caused by the herb Ephedra

09/2002, 08.04.2002

BgVV and BfArM warn against the uncontrolled consumption of products containing the herb 'Ephedra', which have neither been given marketing authorisation as medicinal products nor may be distributed as foods. In the Netherlands Ephedra-containing products are on sale on the Internet as food supplements or tea. Under EU law these products require authorisation as a medicinal product. BgVV and BfArM urgently warn against the uncontrolled consumption of products of this kind. They may lead to adverse reactions like dilatation of the pupil, nervousness, trembling, sweating, cardiac dysrhythmia, high blood pressure and, at higher doses, to seizures and mental disorders. In the USA several hundred people have already become ill as a consequence of the uncontrolled intake of products of this kind; more than 10 have died from its effects (cf. also http://www.fda.gov/ohrms/dockets/dailys/01/Sep01/091001/cp00001.pdf).

Ephedra is a Chinese curative. It is distributed under the Chinese name Ma-huang or as Mormon, Brigham and Mexican tea. The natural ephedrine alkaloids they contain, which are similar in form and character to amphetamines, have pharmacological properties. The herb, Ephedra, is vasoconstrictive, stimulates circulation, raises blood pressure, has a central stimulating effect, a highly dehydrating action, suppresses the appetite and has an anti-convulsant effect on the bronchia.

In Germany Ephedra-containing products are classified as pharmacy-only medicinal products. However, recently, they have been on sale on the Internet as food supplements or foods. Suppliers claim these products suppress appetite, breakdown fat and build muscle. They further claim their products would cure people suffering from hay fever of their allergy. Medical claims of that kind may only be made in Germany for over-the-counter medicinal products, the quality, efficacy and safety of which have been proven in the course of a marketing authorisation procedure. Distribution via the Internet trade gets around these marketing authorisation restrictions. The quality, efficacy and safety of the products are not guaranteed - health-damaging effects cannot be ruled out.

Last year the quality and safety of Ephedra products for the consumer were examined in the Netherlands in a study (http://www.rivm.nl/bibliotheek/rapporten/670220001.pdf). Most of the products tested were found to have higher levels of ephedrine alkaloids than the stated volumes. Caffeine was also identified in some products; it increases the effects of Ephedra and, by extension, the risks of health problems for the consumer. These results confirm that Ephedra products should not be consumed under any circumstances without a medical prescription or only after consulting a physician and under his supervision.

BgVV points out that products which are attributed with a healing effect in advertising claims, are to be considered as medicinal products and, therefore, require marketing authorisation from the Federal Institute for Medicinal Products and Medical Devices. Products without any such marketing authorisation may not be placed on the market. Food supplements, by contrast, are foods for general consumption and no medical claims may be made for them. The manufacturer/distributor is responsible for safety. Comprehensive monitoring by the control authorities of the Länder is not possible because ephedrine-containing products are frequently distributed directly.

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