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The term “health/functional food” (HFF) refers to food supplements containing nutrients or other substances (in a concentrated form) that have a nutritional or physiological effect whose purpose is to supplement the normal diet. The Korean Health/Functional Food Act that came into effect in 2004 requires these products to be marketed in measured doses, such as in pills, tablets, capsules, and liquids. HFFs are of two types: generic and product-specific. There are 37 ingredients listed in the act for generic HFFs, and if an HFF contains a new active ingredient that is not included in the generic 37 products, it is considered a product-specific HFF. The standardization, safety, and efficacy of a new active ingredient are reviewed by the Korean Food and Drug Administration in order to receive approval as a product-specific HFF. Conforming with international standards and protecting public health requires constant upgrading of the Health/Functional Food Act.
The rapid increase in the elderly population is expected to increase the prevalence of chronic diseases such as diabetics, cardiovascular disease, and cancer. These trends have compelled scientists to identify physiologically active components in food, and more and more media output is dedicated to the relationship between diet and health. The increasing amount of public information available regarding the health benefits of foods has resulted in a consumer's interest in health issues becoming a leading factor in purchasing decisions. Therefore, labeling and advertising should be clear and correct, and avoid any misunderstanding or exaggeration. The requirement to protect consumers and ensure their right to accurate information on food functionality has lead to the introduction of regulations about functional food and dietary supplements in many nations since the 1990s, including the US, Japan, and the EU. The Health/Functional Food (HFF) Act introduced in Korea in 2002 (HFFA, 2004) defined only supplement forms of HFF. This paper reports on the scope of functional foods, the strength of the evidence required for their efficacy, safety considerations, and future perspectives in Korea.
Useful Links: Regulations
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Regulations 
