| Traditional Chinese Medicine (TCM) constitutes an important source for China's health foods. Its theories of preservation as well as its long history of practice contributes abundant resources and provides important guidance for the development of China's health foods. At present, however, the applicability of the TCM sources to health foods is unclear. Such uncertainty greatly impedes the healthy and orderly development of China's health foods. Therefore, a systematic classification and study of the TCM's application in health foods has significant practical and pragmatic values.ObjectiveTo systematically classify, analyze and summarize the status quo and characteristics of the TCM's application in health foods; to study the principles and characteristics of the TCM's compositional application and safety dosage issues; to provide data support for decision makers; to provide references and guidance for regulating the technological evaluation of health foods and exploring new evaluation models.MethodThis research is based on the back-end database of the Health Food Evaluation System and raw data of compositions of health foods which have been approved to register in recent years. MySQL database software is used to generate the health food raw database information system. Conditions, components, principles, and safety dosages of TCM components used in 2659 products registered with SFDA between 2003 and 2005 have been studied and analyzed. Results1. Overview of Application of Traditional Chinese MedicineTraditional Chinese medicine products constitutes a major portion of the health foods registered between 2003 and 2005, accounting for 75.6% of the utility category of products and 64% of the total registered health foods. There is a disparity in the usage of different traditional Chinese medicine components. A few components such as Fructus Lyeii and root of Mongolian milkvetch are frequently used while over 60% of the traditional Chinese medicine components are rarely used. Processed traditional Chinese medicine is commonly used, accounting for 8% of the total health food products. There are 50 functional/nominal ingredients, however, mostly focusing on total ginsenosides, total flavonoid and amylose. Compared to products registered between 1996 and 1999 with the Ministry of Public Health, the allocation and the usage frequency and trend of common components are consistent. However, the health food products registered between 2003 and 2005 are more diversified, and their use of traditional Chinese medicine components tends to be safer.2. Classification of Traditional Chinese MedicineWe divide the 201 kinds of traditional Chinese medicine components into 18 categories based on their medical functions and effects. Among them, the species of supplemental medicine constitute the largest group (accounting for 1/4 of the total number of traditional Chinese medicine) and are also more commonly used. We referenced to "Chinese Medicine Dictionary" (2005) and added categorical names of each component, their Latin names as well as the applicable body part. There are some issues with the two attachments to the Public Health Order [2002]51. For instance, names of certain component are mislabeled. There is overlapping between a few categories. Manufacturing processes, production sources and fresh components are not specified for some components.3. Composition AnalysisWe used the anemia improvement products as an example to analyze its compositional characteristics. The typical composition comprises traditional Chinese medicine and supplemental such as iron (about 75% of this category of products). There are only 8% of products which are comprised of pure traditional Chinese medicine. The traditional Chinese medicine selected are mainly blood enrichment, vital energy invigorating, blood circulation stimulating, and/or mind tranquilizing. Summary of the characteristics of the remaining functional ingredients is also provided.4. Dosage and SafetyWe analyzed the dosages of the 40 most commonly used traditional Chinese medicine and compared them against the dosages mandated by the "Chinese Medicine Dictionary" (2005). The abovementioned traditional Chinese medicine dosages are mostly below the lower limit of the corresponding dosages required in the "Chinese Medicine Dictionary." The raw material dosages (median) provided in the Exhibits 1 and 2 of the Public Health Order [2002] 51 Order are mostly congregated within the 20%~30% range of the minimum dosage specified in the "Chinese Medicine Dictionary." The raw material dosages usually are between the (0-3] and the (3-6] scope, predominantly around the former.We selected six commonly used components including Fructus Lyeii, panaxquinquefoliuml and root of Mongolian milkvetch, and compared their daily dosages (median) for their primary health-nourishing functions. The dosages of the same individual component are quite close for its various health-nourishing functions. However, such variations have significant statistical implications.The median dosages of traditional Chinese medicines which have potential safety issues, such as, Ginkgo, Bitter Apricot Seed, Gardenia, Cassiae Torae Semen, Schisandra and Aloe are relatively low. However, the maximum dosages of Schisandra and Radix Polygoni Multiflori Preparata exceed the dosages required by "Chinese Medicine Dictionary." The maximum dosages of Cassiae Torae Semen and Aloe are within the range given by "Chinese Medicine Dictionary." However, they are higher than the reported dosages used in toxic experiment on animals, which should invite serious attention. Conclusions1. There is an urgent need to strengthen the fundamental research on health foods made of traditional Chinese medicine, to establish uniform and normative TCM ingredients purification standard, to perfect the classification system of China's health food ingredients, and to improve the theoretical research and experimental examination of the functional/nominal ingredients.2. We suggest that traditional Chinese medicine component list be revised as soon as possible, that medicine names be formalized, Latin terms and applicable body parts be added, overlapping categories be adjusted, and manufacturing process, product source region and fresh ingredients be specified.3. We suggest strengthening the application of traditional Chinese medicine theories in the prescription of herb health foods, and modern high tech be used to study the functionalities of traditional Chinese medicine.4. We suggest strengthening the utility and safety of traditional Chinese medicine components. The dosages of components which have potential safety issues should not be high. We recommend that a limitation be imposed to Ginkgo and Bitter Apricot Seed which has some toxic effects.This research provides abundant data information for administrative divisions enacting relevant policies and has significant implications in improving the technical review of health food and for exploring new health food evaluation models.
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