Health Food Administrative Approval System to Be Cancelled

On February 17, 2014, CFDA announced a total of 29 administrative approval items. Health food registration approval no longer requires administrative approval which will have a huge influence on the health food administration system.

According to Article 5 of Provisions for Health Food Registration (Interim), China Food and Drug Administration are in charge of registration approval of health foods. Prior to market release, health foods require registration with the CFDA, subject to corresponding testing requirements carried out in the testing institutes recognized by CFDA. Once successfully registered, the health food “blue cap” logo is printed on product label.

Advantages and disadvantages of health food administrative approval system

Advantages: the registration approval system for health food is beneficial for the development of health food industry and product safety. Major safety issues are extremely unlikely to occur for products successfully approved. The cancellation of the administrative approval system means that the requirements for market access are now clearly outlined.

Disadvantages: 1.Registration is extremely costly both financially and in terms of time invested. The duration is generally one to two years. Repeat testing is often required and is a waste of resources. 2. Only research data generated in laboratories designated by the CFDA is acceptable. 3. There has been no successful case for approving products with new function claims for many years. Since safety responsibilities are shouldered by the government, the government is extremely cautious in issuing approval which hampers R&D and investment in this industry.

The Counsel of Health food and Cosmetics Supervision Division of CFDA Zhang Jingjing indicated that classification and risk evaluation will be carried out for health food. Classification of health foods will be addressed after the revision of Food Safety Law of the People’s Republic of China.