China Food and Drug Administration Recalls Tons of Substandard Ginkgo biloba Extracts and Products

The China Food and Drug Administration (CFDA) has published results of the outcome of an investigation into the quality of ginkgo (Ginkgo biloba, Ginkgoaceae) leaf extracts in a series of announcements starting in late May. The latest announcement,¹ dated July 7, 2015, established the total number of companies in China which have registered health foods containing ginkgo extracts at 203. Among them, 129 enterprises are currently in operation, while 74 companies have ceased to produce ginkgo-extract-containing health foods. Among the companies in operation, 12 companies used unqualified ginkgo extract raw materials. The inspection found 5.94 metric tons (MTs) of unqualified raw material, of which 2.28 MTs have already been used, 1.37 MTs have been destroyed, and 2.29 MTs are currently in quarantine. The investigation also found 30.864 MTs of substandard finished products. At the moment of the announcement, 10.4 MTs of these products have been recalled, 24 kilograms have been destroyed, and 20.44 MTs have been quarantined.

Twelve companies were found to have bought substandard ginkgo raw material from nine suppliers. These suppliers include Ningbo Lihua Pharmaceutical Co., Ltd., Chongqing Kerui Nanhai Pharmaceutical Co., Ltd., Karma Deason Natural Pharmaceutical Co., Ltd., Tianjin Taiyang Pharmaceutical Co., Ltd., Xuzhou Heng Kai Ginkgo Products Co., Shaanxi Jiahe Plant Chemical Co., Ltd. (renamed Shaanxi Jiahe Biological Technology Co., Ltd.), Zhejiang Huisong Pharmaceutical Co., Ltd., Ningbo Chinese Pharmaceutical Co., Ltd., and Xuancheng Baicao Pharmaceutical Company Limited. Companies that manufacture or sell ginkgo ingredients and products are required to verify the quality of their materials and report the results to the CFDA, and at the same time provincial CFDA branches were asked to continue the inspections and to report the findings to the CFDA by July 25, 2015.

Comment: In order to sell ginkgo products at retail in China, a company needs to have a pharmaceutical license and needs to buy raw material (including ginkgo extract) from suppliers with pharmaceutical licenses. The companies involved in this investigation are companies selling into the Chinese retail market, or manufacturers that sell ginkgo extract to these companies. Problems mentioned in the reports from CFDA pertain to these companies’ buying materials from unlicensed sources, falsifying documentation to cover this up, and in one case, using hydrochloric acid rather than ethanol as an extraction solvent. However, it is important to understand that these ginkgo extracts and finished goods appear to be limited to the domestic market in China and there is no evidence that they are exported. Thus, they do not appear to be linked to the well-documented problems regarding ginkgo extract adulteration in materials supplied to the North American and European markets.

Reference

1.     China Food and Drug Administration. Announcement of the China Food and Drug Administration on the use of Ginkgo biloba extract on the production of health food companies troubleshoot situations. No. 28. July 7, 2015.