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Do Not Use! Germany Bans the Dietary Supplement Kava-Kava

Worst Pills, Best Pills Newsletter article August, 2002

Germany’s Federal Institute for Drugs and Medical Devices, the counterpart of our Food and Drug Administration (FDA), announced on June 17, 2002 a ban on the sale of the herbal dietary supplement kava-kava, to take effect immediately, because of reports of liver toxicity.

Kava-kava is a pharmacologically active extract from the root of the shrub Piper methysticum. Some of its aliases are awa, intoxicating pepper, kawa, salau, and tonga. It has been used for a bewildering array of disorders...

Germany’s Federal Institute for Drugs and Medical Devices, the counterpart of our Food and Drug Administration (FDA), announced on June 17, 2002 a ban on the sale of the herbal dietary supplement kava-kava, to take effect immediately, because of reports of liver toxicity.

Kava-kava is a pharmacologically active extract from the root of the shrub Piper methysticum. Some of its aliases are awa, intoxicating pepper, kawa, salau, and tonga. It has been used for a bewildering array of disorders including epilepsy, psychosis, depression, migraine, colds, tuberculosis, and rheumatism, to name a few. South Pacific islanders use it as a ceremonial beverage to induce relaxation but are said not to drink it chronically.

Kava-kava is hawked in this country in health food stores and on the Internet primarily to relieve, stress, anxiety, insomnia, and tension.

We reported in the January 2002 Worst Pills, Best Pills News that the German authorities were considering banning the product after 24 case reports were received linking it to liver damage, including one death and three liver transplants. The German authorities are now aware of more than 40 cases of severe liver toxicity with suspected links to the use of Kava-Kava. Of these 40 cases, six led to complete liver failure that required an organ transplant and three cases resulted in death.

Where has America’s self-proclaimed “most important consumer protection agency” been all this time? The FDA finally issued a consumer alert on March 25, 2002 about liver toxicity with kava-kava (see the May 2002 issue of Worst Pills, Best Pills News. This action came four months after German authorities issued a similar warning to their citizens. Between the time Germans were warned and the FDA finally acted, drug regulatory authorities in Switzerland, France, Canada, and the United Kingdom had taken actions ranging from warnings to outright banning.

What You Can Do

If you use herbs and dietary supplements, including kava-kava, you are on your own. Their use is risky. They are not tested and for all practical purposes are unregulated. If you have purchased any of them, take them back and demand a refund.