China NMPA Drug Inspection - Jiangxi Pengshi Guoyaotang Pharmaceutical Co., Ltd. - Dodder (salted dodder)

On February 23, 2017, China's State Food and Drug Administration (SFDA) issued Announcement No. 33, detailing findings from inspections of Traditional Chinese Medicine (TCM) decoction pieces. The announcement reported that 23 batches of unqualified TCM decoction pieces, specifically Cuscuta chinensis (dodder seed) and salted Cuscuta chinensis, were identified. These products were manufactured by 22 different companies, including Hainan Shounanshan Ginseng Industry Co., Ltd., Guoyao Lerentang Hebei Pharmaceutical Co., Ltd., and Anhui Wansheng Traditional Chinese Medicine Pieces Co., Ltd.

The primary issues found involved substandard quality related to appearance, identification, content determination, and levels of acid-insoluble ash and total ash. These deficiencies indicate a failure to meet established quality standards for medicinal products.

In response, provincial food and drug administrations initiated control measures such as seizing and sealing the affected products, mandating sales suspension, product recalls, and requiring rectification from the implicated enterprises. The regulatory framework for these actions is based on Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China. The SFDA has directed local authorities to investigate the illegal production and sale of these substandard products, issue penalty decisions within one month, report the outcomes, and publicly disclose the penalties, holding responsible individuals accountable. Enterprises have the right to dispute findings, which triggers further investigation.