FDA Issues Alert Regarding TCM Products ContainingFenfluramine

September 23, 2002

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FDA Issues Alert Regarding TCM Products ContainingFenfluramine

WASHINGTON--The Food and Drug Administration (FDA) alerted thepublic Aug. 13 about Chinese weight-loss products that are being promoted asTraditional Chinese Medicine (TCM) but contain the pharmaceutical fenfluramine,which has been banned in the United States. Until 1997, fenfluramine wasprescribed with another drug called phentermine in a combination known as phen-fen,a popular but dangerous weight-loss drug.

FDA released this alert after the Japanese government reported some of itscountry's citizen's had become ill or died after taking these two diet aids,known as Chasu (Jianfei) and Chasu Gempi, most likely due to the fenfluramine inthe products. The exact number of people who have been affected by theseproducts is currently unknown, according to an FDA spokesperson. "FDA istaking this action as a precautionary measure to help assure that people are notexposed to these potentially dangerous products," said Lester Crawford,FDA's deputy commissioner.

The agency reported that the manufacturer of the products is unknown.Reportedly, the products most likely entered the country via individuals and notimporters, and the "supplements" are probably being sold in smallareas with large Asian populations.

The agency spokesperson stated FDA does not know if the products have madetheir way into the U.S.; to date, no adverse events have been reported in thiscountry from taking these products. FDA (www.fda.gov)is also uncertain if these products are related to Slim 10, another Chineseweight-loss "supplement" that contained phenfluramine and madeinternational headlines after it was banned by various Asian countries forcausing health problems.

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