'Health food' too broad for effective supplements regulation
The non-profit, which represents companies involved in dietary supplements and other natural health products, had earlier called the draft a “great move in the right direction”, though Jeff Crowther, the USCHPA’s executive director, cautioned that as it stands, the reforms will have a “limited effect on many of the companies and products that are attempting to be sold in China”.
The USCHPA’s report focused on Articles 65 and 66 of the new food safety law draft that was circulated for public comment in the beginning of July. These two articles pertain to dietary supplements, or as they are termed in the report: “Health food.”
Based on this definition, most formula-based products or ingredients that have yet to enter the market will still need to go through China Food and Drug Administration’s registration process, which takes between two and three years to navigate, and costs hundreds of thousands of dollars, Crowther cautioned.
Cause for confusion
However, he did acknowledge that the USCHPA was very happy to see that the National People’s Congress has begun its reform of China’s health food industry.
“This is an important growth industry for China, and plays a significant role in helping China’s citizens lead a more healthy life,” Crowther said after filing the USCHPA submission.
In it, the association had written: “[We and our] members feel the term ‘health food’ has too broad a meaning and can encompass many products such as dietary supplements, yogurt, beverages, certain traditional Chinese medicines and many packaged foods.
“This has lead to confusion among consumers, industry and government to what exactly is a health food. The association suggests using the term ‘dietary supplement’ as that is the internationally accepted term.
“Products that do not fit the designation should be considered ‘functional foods’, or simply ‘food’.”
Expensive and costly
The USCHPA also queried draft Article 65’s statement that “Health food claims should be based on scientific study” by referring to the 27 approved functional claims that marketers of health food products are allowed to make in China.
“The list of 27 functions is too restrictive with regard to what health food products are known to support,” it said in the submission.
“[We] recommend going with a structure/function claim system similar to what the US FDA uses for dietary supplements. This allows marketeers to convey to consumers that dietary supplement ingredients can be helpful in supporting structures or functions of the body.”
The association also called out the draft’s requirement for ingredients that are already known to be safe to still be tested every time a company submits an application to CFDA.
“This is redundant and adds time and fees to the registration process as well as adds unnecessary work to the staff at China’s FDA.”
The USCHPA’s 13-page submission can be found here. Companies and the public have one more day (at the time of writing) to comment on the draft before submissions close on July 31.
The list of approved 27 functions claims
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