Journal List > Korean J Nutr > v.43(6) > 1043861

Korean J Nutr. 2010 Dec;43(6):653-660. Korean.
Published online December 31, 2010.  https://doi.org/10.4163/kjn.2010.43.6.653
© 2010 The Korean Nutrition Society
Human Studies on Functional Foods: How They Are Regulated
Joohee Kim, Ji Yeon Kim, Hye Suk Won, Hye Jin Kwon, Hye Young Kwon, Hye In Jeong and Oran Kwon
Department of Food & Nutritional Sciences, Ewha Womans University, Seoul 120-750, Korea.

To whom correspondence should be addressed. (Email: orank@ewha.ac.kr )
Received December 01, 2010.

Abstract

Along with the steady growth of health functional food (HFF) markets, research evaluating the human effects of HFF has been expanding. In this study, we investigated the regulatory and management system of human study on HFF in the USA, Japan and UK, and the Korean domestic regulations on HHF, medicines, medical devices, cosmetics and biotechnology in order to improve the domestic management system. In these four countries, institutional review board (IRB) or research ethics committee (REC) approvals are required for on human study of HHF, but regulatory and management systems differ from country to country. In the USA, human studies on HFF for structure/function claims do not require the FDA's prior approval but clinical trials of the disease treatment effects of HHF require prior approval from the FDA. In the USA, IRBs are managed by the Department of Health and Human Services (DHHS) rather than the FDA, and IRBs in those institutions which would execute the clinical trials requiring prior approval from the FDA or human studies funded by the USA federal government are required to be registered on the DHHS. In the UK, although the government does not require prior approval of human study, authorized RECs managed by the National Research Ethics Service (NRES) and other independent RECs review the human study. In Japan, human study for HFF must conform with "Ethical guidelines for epidemiological research" and IRB registration has not been required. In Korean domestic regulations, the responsibilities, compositions, functions and operations of IRBs on medicines, medical devices and biotechnology are legally specified, but not those of IRB on HHF. These foreign statuses for the management of human study on HFF and comparisons with Korean regulations are expected to be used as basic data to improve the domestic legal system.

Keywords: health functional food; human study; institutional review board (IRB); research ethics committee (REC); subject

Figures


Fig. 1
Regulatory and management system on human study of dietary supplement in the USA.
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Fig. 2
Regulatory and management system on human study of functional food in U.K.
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Fig. 3
Regulatory and management system on human study of functional food in Japan.
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Tables


Table 1
Target agency or institution for research
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Table 2
Analysis on the regulations of health functional food, drug, medical device, cosmetic and biotechnology
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Notes

This research was supported by a grant (10182KFDA562) from Korean Food and Drug Administration in 2010.

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