The State Administration for Market Regulation ("SAMR") has recently drawn up and issued the Provisions on the Filing and Examination of Applications for Being Recognized as Probiotic Dietary Supplements (Draft for Comment) (the "Draft for Comment") for public consultation by April 20, 2019.
The Draft for Comment stipulates that, the bacterial culture (strain) that the national administrative department of health publicly says could be used for food may be added into probiotic dietary supplements, adding that the bacterial culture (strain) shall not only satisfy relevant safety requirements but also be supported with adequate research data and scientific consensus to justify its functions in health improvement. In addition, the Draft for Comment explicitly states that an application for being acknowledged as a type of probiotic dietary supplements requires the submission of extra nine documents, including "the basis of bacterial use and a testing report of raw materials", in addition to application documents listed in the Administrative Measures for the Registration and Record-filing of Dietary Supplements (the "Measures") and in other provisions. Neither genetically-modified bacterial culture nor its metabolite could be added into dietary supplements. According to the Supplementary Provisions of the Draft for Comment, where a type of dietary supplements is produced with the dead bacteria and metabolite of the bacterial culture created by microorganisms, this type of products shall be named in a way compliant with provisions of Article 56 of the Measures and without the term "probiotics", and its generic name shall indicate the actual functions and effects.