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KMID : 1142220220170020107
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Regulatory Research on Food, Drug & Cosmetic
2022 Volume.17 No. 2 p.107 ~ p.118
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The Investigational Study on Improvement of the Regulatory Management System for Health Functional Foods
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Hong Young-Bean
Cho Seok-Jin
Kim Kyung-Min
Kim Ju-Hee
Kang Dong-Wook
Zhongchun He
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Abstract
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The health functional foods market continues to grow as the interest in health increases due to improving standards of living and the development of health technology. In addition, consumers are increasingly demanding, and the COVID-19 pandemic has accelerated this phenomenon. In a recent 2021 Consumer Markets Evaluation Indicators report, the reliability of the health functional foods market has steadily increased since 2014. Although this positive recognition as related regulations and management systems have been continuously improved in Korea to develop health functional foods and revitalize the industry, the consumer complaints and damage experiences are still increasing. Since health functional food is a product directly applied to the human body, like drug products and medical devices, it is expected that more efficient management systems regarding safety and product quality can improve consumer perceptions of health functional food. The purpose of this study is to enhance the regulatory management system by comparing and reviewing the system for drug products, medical devices, and health functional foods from the transition process of laws in each field to manufacture/review, clinical trials, audits, and post-marketing safety control (re-examination and re-evaluation system). It is looking forward that industries and regulatory authorities can use this result to resolve consumers' complaints about the safety and reliability of health functional foods in line with market demands.
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KEYWORD
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Health Functional Foods, Drug Products, Medical Devices, Regulatory Management System, Reliability
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