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MFDS "Cosmetic Use of Human Tissue is Inappropriate," Considers Restricting Advertisements

[비즈한국] The Ministry of Food and Drug Safety (MFDS) stated in a written response during a parliamentary audit that it "will consider amending laws to restrict advertisements for human tissue used for cosmetic purposes." This announcement follows criticisms regarding the cosmetic use of human tissue during the National Assembly Health and Welfare Committee audit on the 21st. Although the MFDS had previously claimed that matters concerning human tissue were outside its jurisdiction, it outlined a management plan for human tissue skin boosters following persistent questioning from lawmakers during the audit.

According to the "written response" submitted by the MFDS to the National Assembly Health and Welfare Committee on the 28th, the agency disclosed its management plan for the use of human tissue for cosmetic purposes.

In response to a written inquiry from Rep. Nam In-soon (Democratic Party of Korea) asking, "Is the use of human tissue for skin beauty purposes ethically appropriate?", the MFDS replied, "Considering the intent of human tissue donation, we believe that using human tissue for skin beauty purposes is inappropriate."

The agency also shared its position on the regulation of human tissue skin boosters. Regarding whether "it is necessary to implement strict regulations similar to those in the U.S. and Europe, where human tissue processed for cosmetic or non-allogeneic purposes is subject to strict regulations comparable to drugs and biological products," the MFDS stated, "We will research safety management cases from major countries like the U.S. and Europe through research projects to evaluate the necessity of domestic adoption."

There was also criticism that advertisements for human tissue used as skin boosters are misleading, implying they are 'medical devices.' Regarding the inquiry from Rep. Kim Ye-ji (People Power Party) on 'human tissue skin booster advertisements,' the MFDS stated, "The Human Tissue Act does not currently regulate advertisements for human tissue," adding, "We will consult with relevant ministries such as the Ministry of Health and Welfare and the industry to consider amending laws to restrict advertisements for human tissue used for cosmetic purposes."

The agency added, "Before the legal amendments, we will request that tissue banks refrain from advertising human tissue for cosmetic purposes and continue to educate tissue bank personnel on the appropriate purposes for human tissue usage."

The MFDS also announced it would review requiring the purpose of the transplant to be recorded in tissue transplant result reports. In response to Rep. Nam In-soon's question regarding "Minister Oh Yu-kyoung’s stance on clarifying the purpose of use in human tissue transplant records," the agency stated, "We agree with the representative," and added, "We will review a plan to require the 'purpose of transplant' to be documented in tissue transplant result reports."

The agency is also reviewing a plan to ensure patients are informed when receiving human tissue transplants. This is because some patients undergo human tissue skin booster procedures without knowing they are made from human tissue. In response to Rep. Nam In-soon’s inquiry on "the necessity of mandating that patients be informed that the product is derived from human tissue during skin booster procedures," the MFDS stated, "We will review a plan for tissue banks, which supply the human tissue, to cooperate with medical institutions performing the transplant to notify patients that the product is human tissue-derived."

Remedies for side effects from human tissue transplants are also expected to be strengthened. Regarding Rep. Kim Ye-ji's written inquiry on "the direction of human tissue system improvements, including establishing procedures for victim relief in the event of side effects," the MFDS stated, "We will review procedures for consumers to report side effects directly and look into shortening the reporting cycle for non-serious side effects by tissue banks and medical institutions."

An official from a lawmaker’s office on the Health and Welfare Committee stated, "Unlike current issue inquiries, the parliamentary audit requires the government to report the results of its actions to the National Assembly. Based on the responses provided, the MFDS is obligated to carry out follow-up measures."