‘China must redefine and simplify its health-product registration’
Replying with a detailed report to the State Council’s request last month for public opinion on the draft of the revised food-safety regulations, the US-China Health Products Association said that regulatory reform would greatly improve China’s dietary supplement industry as well as bring greater safety and confidence to its consumers.
Ambigious terminology
However, its first observation concerned the concept of what a health-food product really is.
“Health-food products are marketed in a variety of ways in China that further confuse the situation,” the report said, citing examples of calcium tablets being sold as OTC drugs, as health-food products with a blue-hat registration from CFDA and as general food.
It also mentioned witnessing traditional Chinese medicine companies selling herbal-based products as health-food products with blue-hat registrations. (The "blue hat" is the nickname for the small blue logo a product receives after being successfully registered.)
“The ambiguous nature of the current regulatory system and market environment has created a confusing overall experience for consumers and sends mixed messages about the role of health-food products,” the US-CHPA continued.
“In fact, most consumers in China believe that health-food products are a type of medicine due to their history of being sold in pharmacies as OTC, as well as some unscrupulous companies overstating their functions.”
Moreover, China’s current regulations for dietary supplements are based on product registration and are among the most restrictive in the world, the US-CHPA believes, with the registration process requiring animal testing and in some cases human trials.
One product SKU registration can take as long as two to three years to complete and cost in excess of US$50,000, the representative body warns.
Notification, not registration
To address such confusion, the association has urged the State Council to consolidate the industry under the one term “dietary supplement”.
“This is the term that is globally accepted and it also gives a much clearer definition of what the products are and what their purpose is.”
It also invited the Chinese FDA and the State Council to consider using the US FDA regulatory framework for dietary supplements, which are based on notification, rather than registration.
“If the regulatory system moves toward a system of notification and one based on ingredient not product approvals, the benefits to government, industry and consumers will be substantial,” the US-CHPA urged.
It is expected that China’s FDA will release new regulations for dietary supplements sometime in 2014.
