Takehome:
- The rules for health food function claims have been redefined. In addition, the evaluation principles and labeling requirements of health food function claims have also been changed.
On Dec. 14, 2016, China CFDA drafted the “Opinions on Health Food Function Claim Management”, which is open for public consultation until Dec. 30, 2016.
In China, health food function claims can be divided into general function claims and claims pertaining to supplementation of vitamin and/or minerals intake. The former category refers to claims associated with alteration of normal physiology, maintenance or improvement of normal physiological parameters which are generally regarded as risk factors in development of human disease.
Expressions of health food functional claims
The requirements for expression of health food function claims have been reformed radically in the new regulation. Three types of descriptive terms are now mandatory:
- Consensus-based claims: it should be indicated as “this product has the function of … validated by substantial scientific evidence.”
- Credibility-based claims: it should be indicated as “this product has the function of … validated by scientific literatures and a small sample of human feeding trials.”
- Possibility-based claims: it should be indicated as “this product has the function of … validated by scientific literatures and animal test data, but has not undergone randomized human clinical trials.”
Evaluation principles of health food functional claims
During the evaluation of health food registration dossiers the supporting evidence for usage of a functional claim must emphasize data generated from high quality randomized human clinical trials. For general function claims, human feeding trials and/or animal tests should be carried out to ensure the safety and efficacy of products. Clinical trials for functions associated with modification of specific risk factors in the development of diseases such as high blood sugar and NIDDM, hypertension and cardiovascular disease or cholesterol/triglycerides and atherosclerosis cannot use trial subjects already suffering from these diseases.
Function claim indication
From Jan. 1, 2018, supporting scientific evidence and defining terms should be indicated in users’ directions of health food according to specific evaluation results (animal test and human feeding trial) in the original application dossiers for health food registration.
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