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September 28, 2004  
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Kaiser Pharmaceutical Co., Ltd. Unjustly Listed on FDA Import Alert

By Editorial Staff

On September 24, 2004, Acupuncture Today received the following release from Kaiser Pharmaceutical Co., Ltd., the manufacturer of KPC Herbs. The release was issued in response to Food and Drug Administration's listing of two products from KPC Herbs on an FDA Import Alert earlier this year.

The release is being published in its entirety for review by the acupuncture and Oriental medicine profession.

*     *     *

On May 11, 2004, Kaiser Pharmaceutical Co., Ltd. (KP), manufacturer of the KPC Herbs line, unexpectedly appeared on the Food and Drug Administration's Import Alert #54-10,1 which addresses products that might perhaps be adulterated with aristolochic acid (AA). Attachment D of this alert explicitly names KP as a company that should be monitored for the illicit importation of these potentially unsafe products. The sequence of events that immediately preceded this errant and negligent inclusion would give every reason to believe that events would have proceeded in precisely the opposite fashion -- that Kaiser Pharmaceutical would have been thanked, rather than maligned, for their candor. Thanked they were not.

It began with a large shipment of herbs that were purchased from KP by KPC Products. Included amongst the hundreds of different herbs were ten cartons of xi xin (common name: asarum), one of the handful of products that the FDA views as being at high risk for adulteration with aristolochic acid; nevertheless, this is a product that KPC has imported for a decade, tested at FDA-accepted labs, and distributed without objection. For each of these items, KP conducts AA testing at its on-site laboratory in Taiwan, and this occasion was no exception. As is the custom, the products were dispatched to the U.S. several days before the multitude of test results were returned from the lab. Upon their completion, it was revealed that AA was detectable at a level of 0.4 parts per million (ppm).

The Food and Drug Administration maintains a zero tolerance policy for AA, which would imply that it takes the detection of the substance very seriously. It follows naturally that the FDA would test for AA at a sensitivity that would eliminate any reasonable risk; the FDA's established testing limit is 0.5ppm. The AA in Kaiser Pharmaceutical's xi xin was less than this. Applying the FDA's own standards, the amount of aristolochic acid in this batch of xi xin was negligible, or better said, insignificant.

Despite this, KP immediately notified KPC Products of their findings, and in turn, KPC informed the FDA that they wished to refuse the xi xin in the shipment, in deference to the policy of zero tolerance. As per their request, the cases were refused, and KPC had the choice to destroy or re-export the items. They decided on the former, and the products were left in their warehouse until May, when they were destroyed under the supervision of a U.S. customs agent. Given the forthrightness of both manufacturer and importer, and the destruction of the products, the reasonable assumption was that the issue had been resolved. But a few days later, Attachment D appeared on IA #54-10.

While we will venture no concrete suppositions based on these events, the end result seems suspiciously at odds with the events leading to it. What would motivate the FDA to target a demonstrably conscientious company that is a significant force in the TCM industry?

Reference

  1. www.fda.gov/ora/fiars/ora_import_ia5410.html.

 

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