So-called "ECM skin boosters," which process skin tissue imported from cadavers and inject it into human skin, are raising concerns as they are administered at costs ranging from 400,000 won to 800,000 won per procedure without undergoing the safety and efficacy verifications equivalent to pharmaceuticals or medical devices.
The Minister of Health and Welfare also acknowledged that there are regulatory gaps in the current system.
Representative Park Ji-won of the Democratic Party of Korea pointed out issues regarding the safety verification and regulatory oversight of ECM skin boosters during the National Assembly Health and Welfare Committee audit today (Oct. 7).
According to Representative Park, this product is used by processing imported dermal tissue from cadavers into a powder form, turning it back into a liquid, and injecting it into the skin.
It is being marketed for cosmetic effects such as wrinkle reduction and anti-aging.
The issue lies in safety verification.
Although it is a product injected directly into human skin, it is not classified as a pharmaceutical or medical device, meaning it does not undergo separate verification for safety and effectiveness as a beauty injection.
When Representative Park asked whether the product undergoes safety and efficacy tests comparable to those for medical devices, Minister of Health and Welfare Jung Eun-kyeong replied, "It is not currently managed as a medical device."
Criticism was also raised over whether current laws can properly regulate such cosmetic procedures.
The current Act on Human Tissues is premised on cases where donated skin and other tissues are transplanted to restore damaged bodies.
However, because this product processes donated skin tissue for cosmetic purposes such as wrinkle improvement and injects it, critics argue that a separate management system is needed.
Minister Jung also agreed that therapeutic transplantation and cosmetic use are different, noting that a separate management system and safety and efficacy verification are necessary.
She stated that there are limitations in regulating this under the current Act on Human Tissues, adding that "there is a regulatory gap."
Concerns were also raised over whether it aligns with the non-profit principle under the Act on Human Tissues for companies to generate profits using products derived from donated human tissue.
When Representative Park asked if there has been any investigation or corrective order issued regarding this, Minister Jung replied, "I do not recall any."
Minister Jung stated, "We will consult with the Ministry of Food and Drug Safety to promptly devise management measures."
Reported by Kim Min-jeong | Video by Ahn Jun-hyeok | Graphics by Lee Su-min | Produced by SBS Digital News
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