Exclusive
Ministry of Food and Drug Safety to Push for Research Project on 'Human Tissue Skin Booster Regulations'

[비즈한국] The Ministry of Food and Drug Safety (MFDS) plans to push forward a research project concerning the regulation and improvement of human tissue skin boosters. This follows concerns raised during last year's parliamentary audit regarding the management of human tissues, as human tissue grafts are being used as skin boosters for cosmetic purposes. The MFDS plans to conduct the research project within this year.

As human tissue skin boosters gained popularity in the cosmetic dermatology market last year, ethical concerns regarding the use of human tissues were raised. The human tissues currently in use come from donated cadavers, and existing laws lack clear regulations prohibiting the use of human tissues for cosmetic purposes.

Safety concerns have also emerged. Typically, substances injected into the skin in the form of a skin booster must be approved as drugs or medical devices. This process requires overcoming the significant hurdle of clinical trials. On the other hand, while the management and distribution of human tissues are strictly regulated, there are no clear standards for their method of transplantation. Currently, there is no requirement for verification processes like clinical trials when these human tissues are used as skin boosters.

A greater problem is the lack of a clear regulatory authority. The Ministry of Health and Welfare (MOHW), which manages human tissues, and the MFDS, which manages medical devices, have previously deferred responsibility for human tissue skin boosters to the other department.

An industry insider explained, "Initially, human tissue transplantation was used for essential and indispensable purposes, which is why there were few regulations. It was never used for cosmetic purposes, and because such use was not imagined when the relevant laws were enacted, it does not fit the current legal framework at all."

During the National Assembly Health and Welfare Committee audit last October, lawmakers continuously pointed fingers at the MFDS. At the time, Representative Lee Su-jin (Democratic Party of Korea) noted, "Looking at the Human Tissue Act, I believe that using ECM boosters—made by extracting skin from a cadaver, processing it into powder, and mixing it with saline for injection—for cosmetic purposes is a clear violation of the Human Tissue Act." She added, "Until now, the MFDS has only handled quality and safety management for grafts produced by private tissue banks, but since tissues are now being used in entirely new forms, countermeasures are needed."

Whether human tissue skin boosters can even be considered 'transplantation' also became a point of contention during the audit. Currently, human tissue skin boosters sold on the market are primarily produced by processing human tissue into powder and mixing it with saline to inject into the skin. Representative Lee Su-jin pointed out, "(The U.S. FDA) mandates that it must be minimally manipulated, used for homologous purposes, and must not be combined with other products."

It is understood that following the parliamentary audit, the National Assembly directed the MFDS to regulate these products. The government is also understood to be looking into the matter. Consequently, the MFDS is expected to take the lead in the future.

The MFDS plans to push for the relevant research project within this year. An MFDS official stated, "We plan to carry out a research project this year to investigate overseas cases and improve the system."

An official from the Ministry of Health and Welfare stated, "We are reviewing legislation and other measures to establish a safety management system."