Takehome:

• Registration of health foods will no longer be contingent on proving functional efficacy and safety through mandatory human clinical trials; however, a consumption evaluation report will still be required during product re-evaluation.

• The functional efficacy evaluation methods laid down in the newly amended China Health Food Review and Technical Evaluation Guidance are no longer compulsory, and enterprises are free to use any appropriate methods to substantiate health food functional efficacy and safety provided the methods are scientific and approved.

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