- New regulations on nutritional supplements in China have been released, which impose strict control over all aspects of nutritional supplements.
On Nov. 5, 2014, CFDA released the draft of Administrative Provisions on Nutritional Supplements and Requirements on Dossiers for Nutritional Supplements, which gives detailed instructions on regulatory requirements for nutritional supplements in China. The period for public consultation is until Nov. 30, 2014.
The manufacturing workshop and production process of nutritional supplements should comply with Good Manufacturing Practice of Health Foods. Imported nutritional supplements can only be registered with CFDA after being sold in overseas market for more than one year.
Three batches of samples and relevant materials should be sent to the testing agency for health food registration, and stability testing for all testing items. Product technical requirements will be carried out according to applicable testing method provided by the enterprise.
Main dosage forms should be tablet, capsule, granule, powder or oral liquid. The daily intake of products in solid dosage form should not be more than 20g, and that of liquid dosage form should not be more than 30ml.
The names, types and dosage (or proportion) of nutritional supplement compounds as well as the names and dosage (or proportion) of the auxiliary materials should be identified in the product formula.
Product naming should comply with Naming Rules for Health Food. The name of the supplemented nutrient substance rather than the auxiliary material should be taken as the product name in principle. Only nutritional supplements containing more than three kinds of vitamins or mineral substances can be named as multivitamin or multi-mineral substances nutritional supplement.
Labeling and product descriptions
The nutrient content of the minimum consumption unit should be marked in the nutritional information. There should be specific recommended intake and suggested use for different groups of people.
There should be notes of “not to be used in place of pharmaceutical drugs, inadvisable to consume over the recommended intake or consuming together with other nutritional supplements of the same kind”.
Standardized packaging should be adopted for nutritional supplements to maintain the product stability and for ease of consumption.