Revisiting Herbal Medicine Hyatotoxicity
In the April 2011 issue of Journal of Hepatology, an editorial discussed hepatotoxicity associated with the use of herbal preparations (1). The focus of the article is primarily on the need to develop specific biomarkers for compounds or ingredients suspected to be associated with hepatotoxicity in order to establish clinical specificity when determining if a relationship exists between an adverse event and the consumption of these agents. We agree that identification methods are crucial to product safety and the industry continues to develop and validate identification methods for many commercialized ingredients. This issue is also currently being addressed by the US Food and Drug Administration (FDA) and various other regulatory agencies worldwide. In the US, beginning in 2008, the FDA has enforced the formal requirement for dietary supplement manufacturers to comply with dietary supplement-specific Current Good Manufacturing Practices (cGMP) (2). The regulations outline the requirements that support product quality and safety including ingredient testing, manufacturing equipment and facilities, manufacturing process controls, product testing, product complaint handling and documentation. It is important to appreciate how this higher level of scrutiny for dietary supplements allows for better assurance against potential safety issues, including issues related to contamination, adulteration, distribution, and safety monitoring. It would be equally prudent to acknowledge that since 2008, these manufacturing controls could mitigate ingredient contamination concerns that were suggested as the proposed mechanisms involved with cases of liver injury associated with these products.
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