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Chinese Herbal Medicines Coalition Calls For Lifting Of Aristolochia Ban

This article was originally published in The Tan Sheet

Executive Summary

The Chinese Herbal Medicines Coalition intends to demand FDA end its standing import alert against products containing aristolochic acid, the group said.

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Chinese herbals recall

FDA and California Health Services Department recalling 5,000 bottles of Anso Comfort capsules after detecting one lot containing chlordiazepoxide, the active ingredient in Roche's Rx sedative Librium. After hospitalization of one user, recall was initiated Feb. 5 and followed with letter to Internet, mail and phone order buyers as well as several retailers. Marketer NuMeridian (Arcadia, Calif.) is participating in the recall, but parties are unaware of how many bottles are extant and how many contain the drug. California DHS has not learned whether spiking took place in China or U.S. Last year, several Chinese herbals were recalled for containing diabetes drugs (1"The Tan Sheet" Feb. 21, 2000, p. 9)

MCA Permanent Order Banning Aristolochia Use Proposed

The U.K.' s Medicines Control Agency has issued a proposal to continue, on a permanent basis, current provisions prohibiting the distribution of products containing the Aristolochia species or herbal ingredients that may be confused with the species.

Aristolochic acids

FDA issues import alert #54-10 July 6 authorizing the detention of products containing aristolochic acid. The alert also notes products labeled as containing Stephania, Clematis, Cocculus, Akebia, Asarum, Bragantia, Diploclisia, Menispernum or Sinomenium may be detained due to possible mistaken substitution of these plants with Aristolochia. FDA noted its intention to issue an import alert in a May 16 letter to industry (1"The Tan Sheet" May 29, p. 10). The substance, found in Chinese herbal remedies, has been linked to reports of kidney failure

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