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Imported Dietary Supplements without “Blue Hat” Registration have been Investigated by Chinese Government

original article from CIRS

Recently, because of the illegally added ingredients or selling without “Blue Hat” registration, four kinds of imported dietary supplements including Puritan's Pride, K - Max, Aurinda and NATURAL ELEMENTS have been charged by a consumer who is working on cracking down counterfeit goods. The following are the brief information for the cases.

Case 1: Puritan's Pride

Puritan's Pride CO Q10 actually is an imported dietary supplement in original country that provides CO Q10 for consumers. Meanwhile, in China CO Q10 belongs to the dietary supplement raw material which is only allowed to be used in the dietary supplements. If a manufacturer adds the active ingredient CO Q10 in food product, the food product should be a dietary supplement. In accordance with the Food Safety Law, it is illegal to sell dietary supplements without “Blue Hat” registration in China, if the food product is claimed as a common food. Therefore, CO Q10 is forbidden to be added into the common food. In addition, according to the Announcement “The registration and review rule of the dietary supplements containing Coenzyme Q10” released by CFDA, the function of dietary supplements containing CO Q10 could be Enhancing immune, Assisting blood lipids reduction, Antioxidative or Alleviating physical fatiguethe. Additionally, the daily intake of CO Q10 in dietary supplements should not exceed 50mg for each Chinese customer. Nevertheless, the daily intake of CO Q10 in Puritan's Pride is 400mg, which may leads to health safety issues for consumers. For the moment, the Puritan's PrideTmall store is removed from Tmall.

Case 2: K - Max, Aurinda and NATURAL ELEMENTS

Previously three dietary supplements named K-Max Soy Isoflavone, Aurinda SOYBEAN EXTRACT ROYAL JELLY COMPLEX CAPSULES and NATURAL ELEMENTS Soy Isoflavone Concentrate Complex added with soy isoflavone were sold as common foods in Tmall. However, soy isoflavone is a dietary supplement raw material which is available only in dietary supplements in China. On the basis of the Announcement “The registration and review rule of the dietary supplements containing soy isoflavone” published by CFDA, food product containing Soy isoflavone should be registered in CFDA before marketing in China. More serious is that the dietary supplements containing soy isoflavone are only allowed to be provided for adult women but not suitable for children, pregnant and lactating women, gynecological tumor patients or the person having gynecological tumor in their family history. Food products containing soy isoflavone without the suitable crowds in the label may cause food safety accidents. Although the above three products had the entry-exit inspection and quarantine sanitary certificates of The People's Republic of China, they had not been registered as dietary supplements in China. In accordance with the Food Safety Law, dietary supplement without “Blue Hat” registration in Chinese market is against the law. Therefore, the three products and their corresponding importers were investigated by Chinese government according the Rule "The entry-exit inspection and quarantine administrative penalty decisions".

With the significant growth of purchasing power in China in recent years, Chinese consumers are particularly fond of imported dietary supplements. However, it is a common phenomenon that dietary supplements without “Blue Hat” are imported into China as common foods illegally. In fact, imported dietary supplements, without “Blue Hat” and noncompliant with Chinese labels, have food safety risks for Chinese customers. New Food Safety Law will be implemented on 1stOctober, 2015, from then on it could be supposed that Chinese government will be no longer tolerate to dietary supplements without “Blue Hat”. Dietary supplements importers and producers are strongly suggested to pay more attention to the related updated laws and regulations to ensure that the imported dietary supplements conform to the registration or record rules of CFDA.

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