Direction of TCM Health Food Products under Strict Laws

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Written by: Mengyue Zhang, Jing Ma

Edited by: Wilbur Zhu (WeChat ID: aotokuer), Anna HU

With rapid development of social economy and substantial improvement of living standards, people have higher requirements for both the quality and quantity of food, and thus health foods emerge in response to the needs of times. While traditional Chinese medicine, as the traditional medicine and health as well as health-preservation culture, is the critical theoretical basis and effective source of material for developing China’s health food products.

However, are the TCM health food products in conformity to national provisions? Which category do they belong to? Is there a complete mechanism for the research and development of TCM health food products? Do they really boast the health care function? If true, is the health care function based upon reliable data?

In the Food and Beverage Innovation Forum (FBIF 2017), Ye Zuguang, director of China Academy of Chinese Medical Sciences delivered a speech – the trend of research and development of TCM health food products.

On the topic of research and development of TCM health food products, Director Ye mainly mentioned two aspects: relevant policies and regulations on TCM health food products issued by the state, as well as technical requirements for the research and development of TCM health food products set by the state.

Streamline Administration and Institute Decentralization, Implement the Double-track System

Different from the United States and Europe, China has been implementing the so-called examination and approval system since 1995 in the area of health care products, while the western countries adopt the filing system for health care products. For example, the United States completely carries out the filing system, but the label of the products will clearly state that this product is not subject to the examination and approval of FDA.

Director Ye pointed out that it has remained a problem of concern in the health care industry and academia in recent two years in terms of the great changes in China’s policies and regulations on the examination and approval of health food products. It requires to streamline administration and institute decentralization as stipulated by the state, in the hope that health food products can access the market on the condition of adopting the filing system. In the previous years, by referring to opinions from experts of all aspects, the filing system and the examination and approval system (namely the double-track mode) finally take shape and now the situation has basically come to a foregone conclusion.

The so-called examination and approval system is implemented for all imported health food products. In addition, traditional Chinese medicine is divided into two parts. The examination and approval system will apply to 90% of traditional Chinese medicine while for the rest 10% of compound compatibility, the filing systemwill be carried out. For instance, China Food and Drug Administration plans to issue the filing system for traditional Chinese medicine, then without going through strict formalities for examination and approval, traditional Chinese medicine can appear in the market only after being put on file. But it has not been introduced yet.

In addition, it is apparent that in the new registration management measures, the technical requirements for the examination and approval of health food products have been raised substantially. The administrative department draws the conclusion that there are tens of thousands of health food products in the market, and all exist in a very active form. So the administrative department is determined to raise the threshold of market access for these health food products, specifically as follows:

First of all, it releases a supplementary notice. After releasing the supplementary notice, it is required that the feedback should be provided within three months, and if not, it means retreat from examination. The next is the requirements for compatibility. In the past, only some bases are required for the listed formula, but now it demands to provide compatibility of prescription, the basis for the choices of materials in the prescription as well as the basis of compatibility. There are also two requirements in the next step: first, theoretical explanations must be given. For example, how to associate the blood-enriching effect of donkey-hide gelatin and the qi-invigorating effect of astragalus membranaceus with the declared ones; in terms of the requirements of modern pharmacology, can the figures of modern pharmacology support the declared functions? Taking donkey-hide gelatin as an example, although the traditional Chinese medicine holds that donkey-hide gelatin enriches the blood, but can modern pharmacology prove its blood-enriching effect? Does donkey-hide gelatin exert an impact on bone marrow hematopoiesis? Is there an increase of white blood cells or red blood cells? If the immune function is improved, what on earth is the improved function? Is it humoral immunity function or cell-mediated immunity function? Does it affect cells? Does it affect antibody or phagocytosis to some extent? All these questions should be explained one by one. Moreover, it is stricter than before because there has raised the requirements for compatibility, but how to prove the compatibility? If we only illustrate the rationality based on literature, then the next requirement is to prove the rationality through experiments, which virtually increases the cost of declaration.

The second is to strengthen supervision and regulation, and an important performance is on-site examination. For example, the previous on-site examination and sampling inspection is quite simple, namely, prepare the sample well and deliver it to the third party inspection unit for experimental tests after the supervisors arrive. While now a new concept has been put forward and it requires conducting dynamic sampling online. At the same time, there is another regulation about health care products, namely carrying on re-registration every five years and sampling test will be implemented for every registration. If there exist problems in the previous data declared, then the problems will arise at the time of registration.

It is also prescribed in legal documents that there should be two files, one is that raw materials can be filed, while the other is there must be a function. Once this function is produced, there may be a substantial increase in technical requirements, that is to say, some other functions may either be reduced or increased, and the possibility of reduction is extremely high. Both the academia and administrative department recommend increasing the proportion of clinic, even including immune area.

Another key point is streamline administration and institute decentralization. This can be illustrated from the following points: in the first place, the basis of the formula can be determined by ourselves. Furthermore, the stability and hygiene can be determined by ourselves as well and we do not have to queue up in the inspection department, and scientific research units can also submit an application.

LayStress onTechnology, Enhance the Requirements

Traditional Chinese medicine has three attributes: firstly, it can be used as drugs; secondly, it can be made into food; and thirdly, it is divided into two sub-categories of food, that is to say, it can be treated as the raw materials of both health food products and ordinary food. For instance, donkey-hide gelatin can be taken as drugs or the raw materials of foods. In other words, donkey-hide gelatin can be eaten as drugs or ordinary food, or even treated as the raw materials of health food products.

Director Ye mentioned that we should pay attention to the source of raw materials of health care products. There are extracts in health food products, and quite a number of small enterprises and even large enterprises prefer to buy extracts because in this way, they will prevent their factories from pollution and achieve high efficiency in processing molding. However, the quality of extracts from the raw materials of health food products in China is so uneven that some products even exit from examination from time to time due to the extracts. Therefore, it is recommended that we establish national standards for extracts of health food products. It is pretty intolerable that the data of extracts are all false and implausible.

It is also worth noting that the effective period for supplementing materials is three months. Once the enterprise logo is not well-chosen, increasing an enterprise logo means performing a stability experiment, and with the supplementary materials, it means retreat from examination. The enterprise logo must conform to enterprise standards, and must be consistent with product functions. Director Ye took the lucid ganoderma as an example. Lucid ganoderma has two main components, one is polysaccharide and the other is triterpene. While in the research of modern pharmacology, polysaccharide boasts immune function and triterpene is beneficial for liver, so the enterprise logo can not be determined both on polysaccharide.