Regulations on Health/Functional Foods in Korea

This chapter reports on the scope of functional foods, the strength of the evidence required for their efficacy, safety considerations and future perspectives in Korea. 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 to international standards and protecting public health requires constant upgrading of the Health/Functional Food Act.