The Ministry of Food and Drug Safety (MFDS) has issued a proposed amendment to the “Standards and Specifications for Health Functional Foods” in response to reported adverse health effects, particularly acute hepatitis, associated with the consumption of Garcinia Cambogia extract—a popular functional ingredient in dietary supplements.
Key Technical Points:
Reason for Amendment:
A review by health authorities found a high likelihood of a causal relationship between acute hepatitis cases and the intake of Garcinia Cambogia extract.
Expert opinions also raised concerns about potential liver toxicity when the extract is consumed in combination with alcohol.
Main Changes Proposed:
New Warning Label Requirement:
A new cautionary statement must be added to products containing Garcinia Cambogia extract:
“May rarely cause liver damage. Avoid alcohol consumption during the intake period.”
This is added under Section 3.2.2-25 3) (3) (ma) of the standards.
Implementation Timeline:
Effective Date: January 1, 2027
Applicability:
Applies to all health functional foods manufactured, processed, or imported after the effective date.
Products already manufactured or imported before the effective date may continue to be sold until their expiration date.
Ongoing inspections at the time of implementation will follow the previous regulations.
Public Consultation:
The MFDS is inviting public comments on the proposed amendment until December 16, 2025.
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