[2025 Audit] Concerns Raised Over Regulatory Blind Spots in Herbal Medicine, Including Illegal Distribution and Unqualified Preparation

Concerns have been raised regarding inadequate oversight of herbal medicine, including illegal distribution and unqualified individuals preparing herbal remedies by utilizing external herbal preparation facilities.

Jung Eun-kyung, Minister of Health and Welfare, is responding to lawmakers' questions during the National Assembly inspection of the Ministry of Health and Welfare and the Korea Disease Control and Prevention Agency held at the National Assembly in Yeouido, Seoul, on the 15th. Photo by Yonhap News

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At the National Assembly Health and Welfare Committee audit on October 15, Lee Jooyoung, a member of the Reform Party, outlined several principles: ▲ Pharmaceutical products must include information such as active ingredients, efficacy and effects, dosage and administration, and precautions for use; ▲ New pharmaceuticals must be approved by the Ministry of Food and Drug Safety, and manufacturing facilities must be certified for Good Manufacturing Practice (GMP); ▲ Prescription drugs cannot be advertised to the general public regarding their efficacy and effects; ▲ Anti-obesity drugs cannot be prescribed remotely. He stated, "All pharmaceuticals should be subject to the same principles, but herbal medicines prepared by traditional medicine clinics are exempt from all of them. Reckless approval of herbal medicine preparation has led to bizarre cases."

He then cited a case involving a health functional food company, explaining, "This company advertises its diet jelly product as 'prepared herbal medicine.' Consumers enter their health information and make payments on the website, after which a remote consultation with a traditional medicine clinic is conducted by phone, and the medicine is shipped via courier."

He continued, "The problem is that, according to the Ministry of Food and Drug Safety, this company is registered as a health functional food business, and both the prepared herbal medicine and health functional foods are shipped from the same logistics warehouse. This constitutes an illegal structure where a health functional food company is distributing and storing pharmaceutical products."

In response, Jung Eun-kyung, Minister of Health and Welfare, said, "Since prepared herbal medicine is classified as a medical act, pharmaceutical regulations are not being applied. After a comprehensive review, we will report the findings before the final audit, and any unresolved issues will be addressed as long-term tasks with appropriate measures."

There were also concerns raised about unqualified individuals illegally preparing herbal medicine in advance by utilizing external herbal preparation facilities. Han Jia, a member of the People Power Party, stated, "Corporate traditional medicine clinics are mass-producing herbal medicines in external and shared preparation facilities. Mass production of pre-prepared herbal medicine is illegal. Even in the external preparation facilities of well-known traditional medicine hospitals, there are often no dedicated traditional medicine doctors on duty."

She added, "Under current law, even if illegal pre-prepared herbal medicine is detected, there are no effective means of sanction. Even when the Health Insurance Review and Assessment Service reports suspected violations through on-site inspections, there is no legal basis for administrative action."

According to Assemblywoman Han, only 21 out of 127 external herbal preparation facilities nationwide are certified. The rate of herbal medicine prepared by unqualified individuals reached 47.9% at traditional medicine clinics and 33.7% at traditional medicine hospitals.

Nam Insoon, a member of the Democratic Party of Korea, also pointed out, "Herbal medicines are being pre-prepared in external preparation facilities without any herbal pharmacists or traditional medicine doctors present. There is no safety or quality control of the raw pharmaceutical ingredients, and according to reports received, there is also no oversight or supervision."

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