Claims about the ability of health foods to reduce the risk of diseases and harms, to lose the weight, or to enhance the health continue to captivate the general public in spending their money for the products. However, this increasing trend has caused the health authorities around the world to sit up and notice the way health foods are being produced and marketed. Social media tends to go overboard in stressing the benefits of health foods. And this often leads the public to misuse health foods. The news of health foods that caused harm is abundant and has made the validity and safety of health foods an issue of grave conce. How should health foods be taken? Is there any side effect or possible threat of health foods? What is the long-term effect of health foods? To resolve these perplexing issues, animal experimentation serves as one of the effective means to gain an in-depth understanding of the safety and health care effects of health foods.
In relation to the above, Taiwan's Department of Health has promulgated the health food control act to enhance the management and supervision of matters relating to health foods, protect the health of the people of the republic and safeguard the rights and interests of consumers. Under this act, a health food permit for commercialization could be issued only if the safety and health care effects of a particular health food meet the certain evaluation and verification standards. Such requirements prescribe a specific regime of different scientific assessments to generate data conceing the adverse effects, and definite and stable health care effects of a specific health food. The obtained information serves as a base for the Department of Health to determine whether the efficacy of a specific health food outweigh its risk of harms to human health. In this regard, precision toxicity tests are conducted on the premise that all materials are potentially toxic and side effects could occur at high enough dosages.
Presently, the NARL's National Laboratory Animal Center (NLAC) strives for impROVed pathological techniques so to accurately determine probable toxicological changes and accumulated effects of a particular health food on the test animal. Animals are usually administered with different doses of a test health food to determine whether one or more organs or system is adversely affected (before clinical symptoms appear) following different durations of exposure. Subsequently, the diagnosis based on the microscopic examination of cells and tissues embedded in slice specimen or wax blocks, and anatomical inspection of organs and whole bodies (autopsy) is carried out by veterinary pathologists. Test results are then analyzed to determine what, if any, adverse effects occur at different exposure levels and, where possible, to identify the lowest exposure level at which no adverse effects are observed, which is known as the no observed adverse effect level (NOAEL). Then, the lowest NOAEL is taken and scaled up by a safety factor to account for the differences between test animals and humans in coming up with the acceptable daily intake (ADI) per body weight per day. Thereafter, the description on the true nature of an appROVed health food, its health care effect, effective ADI, ingredients, possible discomfort, duration of use, etc. is conspicuously displayed on the containers, packaging or written instruction. Regulations also exist to prevent misleading statements.
To safeguard against the unforeseen risk of harms occur after marketing of appROVed health foods, slice specimens and wax blocks from tested animals are filed in a long-term storage facility. Should any suspect risk associated with a particular health food is reported, the slice specimen and wax blocks related to that health food are drawn from the file and examined once again by veterinary pathologists. Slice specimen and wax blocks serve as important evidences in the post-mortem for the cases of this nature. And these post-mortem findings need to corroborate with the stored records of any behavioral disorder or symptom such as neurotic disorder, drowsiness, blood in the urine (hematuria), diarrhea, loss of appetite, weight loss, etc., and results of numerous biochemical tests of blood and other body fluids of the very animals that have been sacrificed. By pooling these data, the experienced veterinary pathologists are to confirm whether the suspected health food is indeed harmful.
In recent years, growing aging population, changing lifestyles, increased education, and more disposable income have created an increasing demand for health foods in Taiwan. This increasing trend is driving up the production, importation, number and market share of health foods. Heath foods as luxury goods in the past have been transformed into indispensable goods. In this situation, health foods are incorporated into the daily diet as means to impROVe health and to prevent diseases. And in some disagreeable cases, health foods even are used by some as natural remedies and curatives without scientific evidences. Hence, it is only a thin line between a rightful and a wrongful use of health food, a health food and a drug, or a drug and a poison. This fine line impels both public and private sectors to comply with the regulations of health foods, to develop guidelines for the correct use, and to rese
