[비즈한국] As the number of companies advertising and selling human tissue harvested from cadavers as "skin boosters for skin rejuvenation" grows, concerns are being raised that related regulations need to be overhauled. Although these products are only approved as "human tissue grafts" and have not received approval as medical devices or pharmaceuticals, they are being used for skin booster procedures in dermatology and plastic surgery clinics. At a recent National Assembly Health and Welfare Committee audit, this was pointed out as a "violation of the Human Tissue Act."
"Ministry of Food and Drug Safety (MFDS) approved," "fundamentally solves whitening, wrinkles, pores, and skin texture," "relieves redness, improves skin radiance, and refines pores." These are the advertising slogans attached to human tissue skin boosters. While they appear to be approved by authorized agencies such as the MFDS and verified for cosmetic skin benefits, the reality is different.
Human tissue skin boosters are made by processing skin tissue harvested from donated cadavers. Under the Human Tissue Act, tissue banks are subject to verification by the MFDS regarding their facilities and quality control. However, the efficacy of this human tissue as a skin booster is not subject to verification. No clinical procedures are required, either.
Bizhankook's investigation revealed that among human tissue skin boosters, there were no products that had received approval as a medical device or pharmaceutical from the MFDS.
Inquiries regarding this were also made during the National Assembly Health and Welfare Committee's national audit. On the 21st, officials were criticized for allowing human tissue grafts to be used as cosmetic skin boosters without regulation or clinical trials (Related article: Human Tissue Skin Boosters for 'Cosmetic Purposes' Also a Subject of Controversy at MFDS National Audit).
On the 22nd, questions regarding this were directed at the Korea Public Tissue Bank. Rep. Nam In-soon of the Democratic Party of Korea asked Baek Hyeong-hak, acting head of the Korea Public Tissue Bank, "I am asking about the use of human tissue for cosmetic purposes rather than for medical treatment." She added, "Human skin tissue should be used for treatment purposes, and I am concerned that it could become a problem if private tissue banks divert supplies for the purpose of skin beauty. Do we not need institutional improvements for this issue?"
Some point out that the use of human tissue-derived grafts for cosmetic purposes violates the Medical Service Act. One dermatologist criticized the situation, stating, "Many cosmetics that gather high expectations for efficacy cannot cross the barrier of medical device or pharmaceutical approval, which proves how difficult it is to get such approval. Since human tissue-derived skin boosters have not undergone clinical trials for cosmetic purposes, it is currently difficult to conclude that they have any effect, and side effects cannot be predicted. They are being distributed and advertised in a legal blind spot by exploiting the fact that they are human tissue, without medical device approval or clinical trials. In some cases, patients receive the procedure without even knowing that the skin booster is a human tissue graft."
An industry insider said, "Because they advertise using terms like 'MFDS-approved' skin boosters, there is a high possibility that consumers mistake them for medical devices that have been verified for safety and efficacy. This is a situation where criticism of the authorities' lack of management and oversight is inevitable."
A medical lawyer pointed out, "It can be seen as existing in a legal gray area due to legislative deficiency. Since human tissue skin boosters are already being used in practice, it appears that laws are needed to regulate the current situation."
Health authorities have stated they will review the points raised during the national audit. An official from the Ministry of Health and Welfare stated, "As pointed out during the (MFDS) national audit, this is a kind of new field, and we plan to discuss many issues, including the entity responsible for management and supervision, with the MFDS. The Human Tissue Act only covers human tissue transplantation, so we will need to discuss whether this (skin booster) should be regulated under the Human Tissue Act alone."
An MFDS official stated, "We plan to discuss specific matters with the Ministry of Health and Welfare after the conclusion of the Health and Welfare Committee's national audit."