China Food Law
June 29, 2016
CFDA Measures on Foods for Special Medical Purposes Take Effect
The China Food and Drug Administration's (CFDA) Administrative Measures for Registration of Formulated Foods for Special Medical Purposes ("FSMP Measures") will enter into force on July 1, 2016.[1] The Measures define "foods for special medical purposes" (FSMP) to include food specially processed and prepared for people with eating restrictions, digestion and absorption disorders, metabolic disorders, or a particular disease to meet their special dietary or nutritional needs.[2] The Measures now require that domestic and overseas manufacturers intending to market FSMP in China register with CFDA. Domestic producers must file for registration before applying for their FSMP production permits.
 
By way of background, the 2015 amendment to China's Food Safety Law[3] designated FSMP as "special foods" subject to strict supervision and registration.[4] Whether a given product is regulated as an FSMP depends on a variety of factors, including product labeling and claims. Despite the existence of a number of National Standards relating to FSMP production and labeling, no registration and management framework for such products had been established.[5] Consistent with the amended Food Safety Law, the FSMP Measures now provide detailed registration guidance for FSMP producers and clarify CFDA's management and supervision rules.

The FSMP Measures distinguish two primary classifications: (1) FSMP for infants between the ages of 0 and 12 months and (2) FSMP for people over one year of age. With regard to the latter, the Measures further define the following sub-categories:
  • Formulated foods with full nutrition (capable of serving as the sole nutrition source);
  • Formulated foods with special full nutrition (capable of serving as the sole nutrition source for a particular disease or medical condition); and
  • Formulated foods with partial nutrition (which only meet partial nutritional needs).
On April 15, CFDA published five supplementary documents detailing registration and management requirements for public comments.[6] These documents address the following aspects of the registration system:
  • Registration procedures and required application materials
  • Requirements for product stability studies
  • Requirements on clinical trials
  • Specifications for labeling and instructions for use
  • Checklist and decision criteria for field inspections of manufacturing sites
David Ettinger
Wilfred Feng
Jenny Li
Mark Thompson
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With regard to the clinical trial reports, these are only required for the registration of "FSMP with special full nutrition."[7] Clinical trials must be carried out in accordance with Quality Management Code for Clinical Test of Formulated Foods for Special Medical Purposes and conducted at medical institutes certified by CFDA.[8] In this regard, CFDA is expected to release both a quality management code and a list of qualified medical institutes. 

Notably, companies exporting FSMP products into China are subject to field inspections as well as sampling at overseas manufacturing facilities where deemed necessary.
 
Further guidelines may be released regarding the registration and management of FSMP products already on the market. We will keep you apprised of any new developments in this regard. In the meantime, if you have any questions regarding FSMP registration, please do not hesitate to contact Keller and Heckman's Shanghai Representative Office or your contact at Keller and Heckman LLP.


[1]           See Administrative Measures for Registration of Formulated Foods for Special Medical Purposes, available at http://www.sda.gov.cn/WS01/CL0053/146741.html   
[2]           See Article 48 of the FSMP Measures.
[3]           See P.R.C. Food Safety Law, available in Chinese at http://www.sda.gov.cn/WS01/CL0784/118041.html
[4]           See Food Safety Law Articles 74 and 80. Article 80 requires that FSMP be registered with CFDA and registration materials, including the product formulation and details relating to production process, product safety and clinical effects, be provided upon application.
[5]           See, for example, GB25596-2010, GB 29922-2013, and GB 29923-2013.
[6]           Available at http://www.sda.gov.cn/WS01/CL0782/150540.html ; the comment period has been closed on May 15, 2016.
[7]           This term is defined in Article 50 of the FSMP Measures to include FSMP that are capable of serving as the sole nutrition source to meet the nutritional demands of a target population with a particular disease or under special medical conditions (e.g., FSMP for diabetes, respiratory diseases, protein allergies, etc.).
[8]               See Articles 29 and 30 of the FSMP Measures.

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