China publishes new draft Rules on Inserts and Labels for dietary supplements

The China Food and Drug Administration (“CFDA”) published the new draft Rules on Health Food Inserts and Labels on September 30, 2013, soliciting public comments by October 15, 2013. The new draft is the third version published by CFDA on this topic since 2010. Global dietary supplement and functional food manufacturers should take note that this regulatory scheme is quite different than those imposed by other countries. Over the years, while the concept of “health food” is somewhat equivalent to “dietary supplements,” for these products China has adopted a regulatory regime similar to that applicable to pharmaceutical and medical device products.

In the new draft CFDA makes it clear that manufacturers, as opposed to others in the distribution chain, will be responsible for compliance. For products made outside China, the local agents of foreign manufacturers may also be responsible. Manufacturers are required to actively monitor the post-marketing safety and efficacy of the products and in a timely manner to revise product inserts and labels when necessary with safety information.

Inserts and labels of health food products marketed in China, including functional foods and nutrition supplements as defined by CFDA, must contain information on: major raw materials, targeted populations, manufacturing date, batch number, as well as detailed information listing manufacturers and contract manufacturers (if applicable).

For products made outside China, the country of origin, contact details for the foreign manufacturer as well as China agents must be specified. Entities that do not manufacture or distribute the underlying products should not appear on product labels and inserts. Wording such as “manufactured under the supervision of xxx,” “in cooperation with xxx” or “authorized/recommended by xxx” are also prohibited.

Manufacturers are required to place specified warning language on labels and inserts. One important example is: as “this product is not a substitute for drugs and should not be used for prevention or treatment of diseases.” The new draft also prohibits manufacturers from using confusing or misleading trademarks on product labels and inserts.