Bio: 

l CEO of Good Being Center, Total Detox Service, Subsidiary Company of Sookmyung Women’s Univ., Seoul, Korea (2019-present)

l Professor, Dept. of Toxicology, College of Pharmacy, Sookmyung Women’s Univ., Seoul, Korea (2004-present)

l Assistant Professor, Dept. of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea (2000-2004)

l Postdoctoral Fellow, Div. of Molecular Epidemiology, National Center for Toxicological Research (NCTR), FDA, Jefferson, AR, USA (1998-2000)

l Ph.D., Dept. of Environmental Health, Medical School, Univ. of Occupational and Environ-mental Health, Kitakyushu, Japan (1994-1998)

Abstract: In Korea, raw material screening, functional recognition, and functional labeling were conducted through evidence-based evaluation, centered on the Act on Health Functional Foods, since 2003. Health Functional Foods are largely divided into two categories, notification and recognition types. In the case of notified raw materials, health functional food standards and specifications are evaluated. However, in the case of raw materials that are not notified, they are individually recognized by government, i.e., Minister of Food and Drug Safety (MFDS). Standards for recognition must be in compliance with the law. In addition, safety and efficacy must be ensured. For safety, the recognition process includes data of intake (traditional use records, domestic and international recognition/use status), safety (DB of domestic and international academic journals and government reports on side effects, interactions, etc.), toxicity tests (single administration, 90 days for repeated dose toxicity, genotoxicity, etc.), and human application experiments for blood and blood biochemical safety indicators. MFDA also evaluates quality of the data, relevance of indicators (functional mechanisms), and consistency of results for efficacy. After COVID 19, various novel dietary supplements for the respiratory have been developed. I will cover them in more detail with the balance between safety and efficacy.