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Swisse Passes Major China Milestone Successfully Obtaining First Blue Hat Certification

According to an announcement issued by China Health Food Evaluation Center on Aug 16, 2018, Swisse sucessfully filed a calcium and vitamin D supplement (filing number is J201800000024).

Product Name

Manufacturer

Filing Number

SWISSE ULTIBOOST CALCIUM VITAMIN D

AUSTRALIAN PHARMACEUTICAL MANUFACTURERS PTY LTD

食健备J201800000024

* see all health food filing approval in our Flist

Swisse in China

In 2015, Biostime acquired Swisse for AU$1.67 billion. In the fourth quarter of the same year, Swisse accounted for 17.6% of its new parent company's total turnover and has performed extremely well in the interim. 

Although Swisse's global market expansion through official channels has gone smoothly, its expansion into China has been lucrative but also challenging. Swisse is a popular product among China's "daigou" purchasers (Chinese diaspora pruchasing products overseas and selling in China through unofficial channels, usually social media). Although Daigou purchasers have been a major contributor to the upturn in Swisse's fortunes, this popularity has also been a double edged sword, making it the target of counterfeiters and precipitating the widespread circulation of fake or adulterated Swisse products in China. Dealing with these issues and protecting its brand is a major concern for Swisse in China. One strategy to ensure traceability and foster consumer trust is to strengten its presence in official offline retail channels like pharmacies, supermarkets etc.

However offline channels are not without their own challenges and traditionally regulatory compliance issues have presented prohibitively time consuming and costly market entry barriers. So far the process required to achieve "Blue Hat" certification (a prerequisite for sale of Vitamin or Mineral products or health products bearing functional claims) has been beyond the reach of Swisse, until now...

Background Policy

According to the current policy, Measures for the Registration and Filing of Health Food, China Food and Drug Administration (CFDA) (now special food registration department of SAMR) shall be responsible for the registration or filing of health food. For products imported for the first time (not belong to vitamin supplements, minerals) or made by the raw material not listed in Health Food Raw Materials List, companies shall apply registration first; for those imported for the first time (belong to vitamin supplements, minerals) and whose raw material are listed in Health Food Raw Materials List, companies are eligible and shall apply for filing approval.

Take Swisse as an example, all its vitamin products shall obtain a filing certificate before being sold and labeled with the health food "Blue Hat" certification. 

At the beginning of this year, Swisse submitted the filing application of Calcium + Vitamin D and it took less than half a year to get approval. This is only the beginning. Swisse will continue to make an effort to file other products. Besides Calcium + Vitamin D, 2 more products may obtain filing approval this year. Meanwhile, Swisse is also engaged in registration work for products bearing functional claims. 

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