HI / FI China

Evidence of efficacy: China’s regulator urges firms to contribute ingredient data to health food registry

By Tingmin Koe contact

- Last updated on GMT

China’s SAMR is urging firms to contribute concrete ingredient data to speed up the expansion of the country's health food registry. ©Getty Images
China’s SAMR is urging firms to contribute concrete ingredient data to speed up the expansion of the country's health food registry. ©Getty Images

Related tags: regulations, China, plant extracts, Ingredients

China’s State Administration for Market Regulation (SAMR) is encouraging health food firms to contribute to the expansion of the Health Food Raw Materials Directory by presenting evidence to support the functional efficacy of ingredients to the unit.

Supervision Commissioner of SAMR Zhang Jin Jing encouraged firms to do so when speaking at the 6th​ Nutraceutical Industry Development Conference held in Shanghai last month.

At present, the directory consists of only basic vitamins and minerals, and firms are only required to go through the filing process, which typically takes about six months, to obtain approval for manufacturing supplements containing these raw materials. 

However, any other raw materials which are not under the directory would require a longer approval process.

Zhang said that the SAMR had been working to expand the directory, and that has been one of the most daunting task for the government unit, and firms have often reflected to him that the process “had been pretty slow”.

“In fact, we are very willing for enterprises themselves to do this,”​ Zhang said, urging firms to present relevant evidence to the unit to help speed up the process.

He said that currently, coming out with a standard on the management and use of plant extracts was one of the toughest job for the unit, as it required in-depth studies to identify the specific amount of actives for achieving a certain benefit.

“Take ginseng as an example. What are its active ingredients, is it polysaccharide, flavonoids, or saponin?  There are many different compositions. For a certain function, is it due to a certain ingredient or the blend of ingredients? It is very difficult to establish clear findings to it,”​ Zhang said. 

“Every time when I speak to the enterprises, they will talk about a certain ingredient and say that it is very effective, and so we hope that firms themselves would present the supporting evidence that shows the effectiveness of the ingredients.”

Some of the evidence Zhang had urged firms to present include the exact amount of ingredients required to achieve a certain result, functions produced by the ingredients, methods to test for effectiveness, human clinical trial data.

“If enterprises can do so, then this would aid the government unit’s process in standardising the use of plant extracts.”

Zhang acknowledged that there was a handful of firms which had done so, however, the evidence produced were debatable when presented to experts for discussion and evaluation.

To speed up the process, Zhang added that SAMR had applied for government funds to support its research process.

Earlier in March this year, it had called for a public consultation​ to consider the addition of five new ingredients into the directory. They are co-enzyme Q10, melatonin, fish oil, ground ganoderma lucidum powder, and spirulina.

Zhang said that the unit would at the right time, provide an update to the process.

Misleading representations

There have been cases of firms providing misleading representations of its products, which Zhang said was an issue that the unit needed to confront with.

“Previously, there has been a solid beverage brand which modelled its labelling very closely to foods for special medical purposes. A notice has been sent out from the national regulator, and strict inspections were conducted. In fact, this situation, where firms attempt to hint that its products exert certain special functions, is a rather common problem,”​ Zhang said.

“That is why I want to specially emphasise that if your product falls into a certain category, then it should fulfill that certain set of criteria.”

He pointed out that food fraud was a widespread problem elsewhere in the US, Australia, and New Zealand too, as seen from the robust discussions held at the China International Import Expo trade fair last year.

Functional health claims

Another challenge surrounds the use of functional claims.

Currently in China, only health foods can bear functional claims, and others, including infant formula powder and foods for special medical purposes are not allowed to do so.

To prevent contravening the laws, Zhang stressed the need for firms to clearly identify in which category its products belongs to.

In addition, firms are not allowed to make certain functional claims simply because there is the presence of a certain functional ingredient.

“Some have asked, if my product contains pumpkin seeds or grape seeds, can I claim that my product will bring about certain health functions linked to these ingredients? The answer is strictly no. This is a universal law.

“This is because when we talk about the functions, we must first determine the amount required, specify the daily dosage, and the target audience,” ​Zhang said.  

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