China Consults on Adjustment and Cancellation of Health Food Functional Claims

On March 28, 2019, State Administration for Market Regulation (SAMR) began consulting on adjustment to health food functions^[1], specifically an adjustment to the permitted terminology used in 18 of the current 27 acceptable functional claims, cancellation of 3 out of the 27 functional claims, and further investigation on the appropriateness of 6 other claims which skirt the boundaries of medicinal claims. Deadline for comments is April 28. Details are:

Invalidate functions relating to children and pregnant women

Experts think health functions relating to children, pregnant and lactating women should be subject to much more stringent supervision. 3 functions are proposed to be removed^[2].

Cancellation of products approved prior to 2011

There were no technical requirements for health foods prior to 2011, a time when the former Ministry of Health (MOH) was in charge of health food registration. Over 5000 health foods were granted approval before that date without any expiration date on the approval. Even after the National Health and Family Planning Commission (NHFPC) took the place of former MOH and reformed health food management, these previously permitted health food products remained in circulation. With SAMR undertaking responsibilities tasked to the now disbanded NHFPC, China’s health food administrators are finally getting around to addressing this glaring issue. The consultation draft calls to cease production of all previously registered health foods whose function claims are illegal according to current regulations. Functions include but are not limited to:

If the draft regulation is passed successfully products bearing any of the 21 canceled functions will be banned from further production. Products made before implementation of the new requirements can be sold until expiration. The current consultation period can thus be considered a form of de facto grace period.

Refine the expression of 18 health functions by adding “help/aid” or similar terminology

In the draft, 18 functional claims are revised by adding “aid/help” or similar terminology in order to clarify that health foods could only contribute to improved function^[3]. These changes will affect the following claims:

If passed unchanged the new regulation will require relevant stakeholders to change the corresponding expressions in product packaging, labeling and instruction manuals.

Claims and assessment methods of 6 functions to be investigated

For some borderline claims that blur the boundaries between medicine and health foods, the government is currently undertaking research on the appropriateness of continued approval. These functions are^[4]:

These new regulations if passed unchanged will drastically alter China’s health food industry and will lay down a big marker for future regulation in the sector. Interestingly the new changes are a big reversal in government stance outlined in remarks made by the head of SAMR during the two sessions earlier this March^[5] in which it was stated “our goal is to ensure enterprises’ responsibility and expand the scope of permitted claim”.