The South Korean government is reviewing measures to strengthen oversight of human tissue-based skin booster products used in dermatology clinics, including restrictions on advertising. The move reflects growing calls for more systematic safety management given that these products are injected into the skin.
According to documents submitted by the Ministry of Food and Drug Safety (MFDS) to Rep. Seo Mi-hwa of the Democratic Party of Korea on the National Assembly's Health and Welfare Committee on the 29th, the MFDS is reviewing amendments to regulations that would restrict advertising of human tissue products for cosmetic purposes, in consultation with related ministries including the Ministry of Health and Welfare and industry stakeholders.
The agency also plans to establish a procedure allowing consumers to directly report adverse reactions from human tissue products to the MFDS. It will review safety management practices in major countries such as the United States to examine the overall management framework for products like Retuo.
In addition, the government plans to shorten the reporting cycle for tissue banks and tissue transplant medical institutions to report adverse reactions beyond serious side effects. It will also require medical institutions to inform consumers that products being used are derived from human tissue when performing tissue transplants.
The MFDS also plans to mandate that the purpose of transplantation be recorded in tissue transplant result documents. The measures come amid concerns that products such as Ellavie Retuo fall into a regulatory blind spot because they are classified as human tissue rather than medical devices, unlike other skin boosters such as Rejuran and Juvelook.
Retuo is composed of extracellular matrix (ECM) derived from donated human skin. It is used in skin regeneration procedures for its effectiveness in restoring the structure and function of damaged tissue.
Rejuran's main ingredient is polynucleotide (PN), a DNA fragment derived from salmon. Juvelook is primarily composed of polylactic acid (PLA), made by polymerizing lactic acid extracted from plants such as corn, and hyaluronic acid.
In South Korea, Retuo is classified as human tissue and is subject to different regulatory procedures than medical devices such as Rejuran and Juvelook. Medical devices must receive approval from the MFDS for each product's intended use and indications before they can be distributed to clinics and hospitals. Some medical devices, including implantable ones, must also undergo clinical trials. In contrast, human tissue products can be supplied to clinics and hospitals without individual MFDS approval. The MFDS is known to have determined that the current human tissue management framework is adequate.
The agency explained that safety is ensured by excluding unsuitable donors, conducting tissue transplant suitability tests, and complying with tissue management standards. For imported human tissue, the MFDS requires a tissue bank license, with approval required for each tissue type and manufacturer before the manufacturer can be registered, the agency said.
However, critics point out that given Retuo is used in clinics and hospitals in a manner similar to medical devices, the level of regulatory oversight should be comparable. According to documents Rep. Seo obtained from the MFDS, a total of 10 complaints related to Retuo were filed with the agency from May last year through February this year. The complaints included demands for stronger safeguards against infection risks such as human immunodeficiency virus (HIV) during procedures, as well as calls to crack down on illegal distribution and treatments.
