SAMR updates the regulations for health food in China

There comes several updates regarding the regulations for health food in China announced by SAMR, the authority for health foods in China.

1. 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. 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 with their safety scientific evidences. Zhang said that the SAMR had been working to expand the directory, and that has been one of the most daunting tasks 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.

   (Note : This means SAMR believe the responsibility of proving the safety is on the firms who want to put the ingredient on the market. We can help those whose functional ingredient is not under the current directory.)

   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.

   (Note : You can hire a professional consulting team to help you on these)

2. Misleading responsibility will be on the product firms. 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. 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. Another challenge surrounds the use of functional claims. Currently in China, only health foods can bear functional claims. Others like infant formula powder and foods for special medical purposes are not allowed to do so. Zhang stressed the need for firms to clearly identify in which category its products belongs to in order to comply with the regulations. In addition, firms are not allowed to make certain functional claims simply because there is the presence of a certain functional ingredient. 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.

   (Note : We can help if you want to have any health claim on your product package or marketing materials with the product. We have plenty experience to help you to get the approval and the Registration/Certification from SAMR if you have enough scientific evidences.)

3. SAMR Issued a new labelling guideline for health foods and the use of health food ingredients for filing and functional health claims. A major change is that health foods manufacturers will have to change the current warning sign “This product cannot replace medicines” to “Health foods are not medicines, they cannot replace medicines in treating diseases.” The move is to better highlight the differences between health foods and medicines. The new labelling guide has made clear a number of specifications. Besides revising the warning phrase, the guide requires firms to place the warning phrase at the “main display area” of the product package.

4. In addition, SAMR said the new guidelines also set standards on how to label the product expiry date. In this case, firms need to present the information in the following way: Product expires on YY/MM/DD – which is the same as how the production date is being labelled. The product expiry date needs to be easily noticeable on the packaging, such as using colours that contrast with the packaging to highlight the expiry date.

5. SAMR also published the rules for Health Function List Management. The Measures stipulate that the health function included in the health function list should meet the following requirements:

   (1) for the purpose of supplementing dietary nutrients, maintaining the health of the body or reducing the risk factors for disease;
   (2) having a clear demand for healthy consumption that can be correctly understood and recognized;
   (3) having sufficient scientific basis, as well as scientific evaluation methods and criteria;
   (4) the health care function guided by the traditional health care theory conforms to the traditional Chinese medicine health care theory;
   (5) have a clear suitable groups and unsuitable groups.