South Korea expands probe into asbestos-tainted talc pills
This article was originally published in The Gold Sheet
South Korea's FDA has announced that it will expand its investigation into how asbestos-tainted talc slipped into the manufacturing process for solid oral dosage forms. The talc was used to prevent the pills from sticking to each other in the production process. KFDA's expanded examinations came after an earlier announcement that it had found cancer-causing asbestos in baby powder made by eight companies, who later recalled the products after tendering their apologies to the buyers. However the agency has been criticized for not acting quickly enough and has taken heat from the public for not taking proper safety action even though the agency was warned of these risks in a report five years ago
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The International Pharmaceutical Excipients Council contends that implementing new drug master file regulations for talc is not the best solution for resolving the issue of poor quality talc found in certain drug and cosmetic products in South Korea. A recent incident involving asbestos-tainted talc in these products prompted the Korean Food and Drug Administration (KFDA) to draft proposed DMF requirements for talc (see 1"The Gold Sheet," May 2009). In response to this action, IPEC-Americas and IPEC Europe jointly developed formal comments to Nam-su Kim in the pharmaceutical safety bureau of KFDA objecting to these new DMF requirements. The letter, signed by Janeen Skutnik, chair of IPEC-Americas, states that implementation of a DMF system as proposed will not resolve compliance-based issues. "IPEC believes that the use of modern compendial testing and good supplier qualification practices on the part of the user of the talc provides appropriate control of talc quality as it relates to asbestos contamination and that the proposed talc DMF requirements may lead to an unnecessary increased burden on excipient manufacturers and users without actually improving quality or safety to patients.
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