A Study on the Human Panel Test of Health Functional Food

Abstract

A health functional food is a product that has different functions from pharmaceuticals, and is a kind of food manufactured using raw materials or ingredients with useful functionalities for the human body. Scientific evidence is needed as to whether these health functional foods are functioning properly, such as maintaining or improving the actual health function or reducing the risk of disease, and whether they are safe for the human body. The process carried out to verify the functionality and safety of health functional foods is the human panel(application) test. Compared to the public s high interest in food safety, the safety of health functional food appears to have remained relatively outside the public s interest. So, the public s awareness of the significance and importance of human panel tests to confirm the safety or functionality of health functional foods seems to be lacking. As a result, acts or statutes to regulate human panel test of health functional foods have not been properly enacted, and the ｢Guideline for Human Panel Test Design｣ issued by the Ministry of Food and Drug Safety is only serving as a guideline. Health functional food has a character that is located halfway between foods and medicinal products(pharmaceuticals) in that it helps to maintain or promote functions beneficial to health. Accordingly, the legal discussion on human panel test of health functional food starts with deciding whether to classify health functional food as food or medicinal product. This is because, depending on the classification of food or medicinal product, the basic orientation or regulatory intensity for the legal regulation of human panel test is determined. In Korea, health functional foods are classified as food and do not require approval from the Minister of Food and Drug Safety to conduct human panel tests. But, it is designed to comply with the International Committee for Harmonization of Pharmaceutical Regulations - Good Clinical Practice of medicinal products or medical devices. However, in the case of health functional food, it cannot be treated in the same way as medicinal products in terms of hazard or risk to the human body. Ignoring each characteristic of health care products and uniformly applying clinical trial principles and ICH-GCP with the highest regulatory intensity can ultimately act as a factor hindering the development of the food industry. In short, in the human panel test of health functional food, a legal standard that is relaxed compared to the stringent ICH-GCP should be prepared separately. For example, in the case of human panel tests, it is necessary to improve the legal and institutional dimensions, such as differentiating clinical trial principles and/or GCP by reflecting the characteristics of health functional food, and simplifying the process of clinical trial conducts. On the other hand, the legal rules for the safety and protection of subjects will not be fundamentally different from clinical trials of medicinal products. The purpose of this study is to prepare a forum for a intensive discussion on human panel test of health functional foods, which has not received much attention in the field of law. To this end, we first examine the significance and procedure of human panel tests for health functional foods, analyze the current legal regulations on human panel tests and their limitations, and then conduct a comparative review of each country s human panel test system. Based on the derived various implications, we present a legal improvement plan for human panel test of health functional foods.