Regulatory systems and scientific evidence for health functional foods in Korea
- Author:
Seung-Won OH
1
Author Information
- Publication Type:Continuing Education Column
- From:Journal of the Korean Medical Association 2025;68(5):311-318
- CountryRepublic of Korea
- Language:Korean
- Abstract: The health functional food (HFF) market is rapidly growing globally. South Korea is no exception to this trend, with most households actively consuming these products. Despite the widespread use of HFFs, clinicians in Korea generally have limited knowledge and awareness of the regulatory framework and evidence supporting these foods, leading to potential gaps in patient counseling and care. This review addresses the need for increased physician awareness regarding HFFs and the associated regulatory context.Current Concepts: Korea’s HFF regulatory system was formally introduced with the enactment of the Health Functional Food Act in 2002. This law established a structured framework distinguishing HFFs from conventional foods and drugs. However, limited or weak scientific evidence exists for many currently authorized functional ingredients, primarily due to permissive regulatory standards. Internationally, regulatory approaches vary significantly, with the European Union enforcing stringent pre-market approval requirements, the United States relying largely on post-market controls, and Japan adopting an intermediate regulatory approach. Critical limitations exist within the Korean HFF regulatory system, notably the leniency in scientific evidence requirements and associated consumer misconceptions. Using popular ingredients such as red ginseng (limited evidence on efficacy) and green tea extract (recent safety concerns) as illustrative examples, the necessity for improvements becomes clear.Discussion and Conclusion: To address these issues, stricter regulatory criteria, regular re-evaluations of approved ingredients, strengthened post-market safety monitoring, clearer product labeling, and improved clinician education are recommended. Implementing these measures would ensure that HFF usage aligns with scientific evidence, ultimately enhancing clinical care quality and protecting public health.
