Skin booster products using human tissue have recently gained popularity, but concerns about insufficient proof of safety and ethical controversy persist. With criticism mounting that they are effectively in a regulatory blind spot due to a lack of rules, the government has begun working on measures to supplement the system.
Kwon Dong-joo, head of the Biohealth Center at Yoon & Yang LLC, said at the K-biohealth forum held on the 16th at the National Assembly Members' Office Building in Yeouido, Seoul, "While other medical devices secure approval after years of clinical trials and massive investment, some human tissue-derived products are subject to relatively lax standards."
At the discussion that day, participants focused on the regulatory vacuum and the need for rules surrounding the cosmetic use of human tissue. Key issues included loopholes in the current system that allow human tissue-based skin boosters to be distributed without clinical trials or item approval, and ethical concerns about uses that run counter to the intent of donation.
In particular, the issue of products being distributed without clinical validation came under scrutiny. At the center of the controversy is the recently used "extracellular matrix (ECM) skin booster" for cosmetic dermatology procedures.
The ECM skin booster is produced by extracting the extracellular matrix from skin tissue donated by deceased individuals, turning it into powder, diluting it in saline, and injecting it directly into the skin with a syringe. The expense per session is known to be about 600,000 won.
The problem is that although such products are essentially injected into the human body, they have not undergone clinical trials or item approval, and no adverse event reporting system has been established.
This is because products made from human tissue are classified as "human tissue," not as medical devices or pharmaceuticals, and are therefore subject to a separate regulatory framework. As a result, they can be distributed on the market without clinical trials or product-level approval, fueling controversy over fairness.
Among skin boosters currently distributed on the market, some are medical devices approved by the Ministery of Food and Drug Safety. For example, PharmaResearch's Rejuran and VAIM's Juvelook have received approval as Class IV medical devices after years of clinical trials and large-scale investment.
By contrast, Re2O from L&C BIO, which sits at the center of the current popularity of human tissue-based ECM skin boosters, has drawn fairness concerns because it has not gone through a separate medical device approval process on the grounds that it is a human tissue-derived product.
Consumer groups are also raising concerns. They argue that, because the procedure involves direct injection into the human body, the same standards for verifying safety and efficacy should apply.
The gap in the management system is also cited as a problem. The Ministery of Food and Drug Safety and the Ministry of Health and Welfare have not clearly divided regulatory responsibility, citing their respective jurisdictions, and although related issues were raised during last year's National Assembly audit, system improvements have been delayed.
Even compared with overseas cases, Korea's management level is considered insufficient. In the United States, to classify human-derived materials as mere human tissue, strict requirements such as minimal manipulation and homologous use must be met, and if those conditions are not satisfied, premarket approval akin to biological products is required. Europe likewise mandates standardized quality control systems, documentation, and third-party management systems for human tissue-based products.
However, domestic ECM skin boosters are effectively without a management system at this level. Some also note that donors, their families, and consumers receiving procedures do not fully know how the tissue is being used.
Ethical controversy is also significant. Human tissue donation is originally intended to restore life and function for patients, such as for burn or wound treatment. Using it for cosmetic procedures, however, could undermine the intent of the system.
The Health Consumer Union criticized, "Donors and their families decide to donate on the premise of therapeutic use, but in reality it is being used for premium cosmetic procedures."
Kwon also called on the government to: ▲ explicitly ban cosmetic use ▲ incorporate the products into the pharmaceutical and medical device approval systems ▲ conduct a full-scale inspection ▲ strengthen donor notification obligations.
Public perception is also shifting toward stronger regulation. In a survey of 1,034 adults nationwide conducted by professor Lee Dong-han of Sookmyung Women's University, 60.9% responded that "the cosmetic use of human tissue should be legally banned or strictly restricted."
In the industry, given the pace of advances in regenerative medicine, there is a growing call for urgent system overhauls that clarify safety and ethical standards along with social consensus on the scope of human tissue use.
The government is also reviewing an overhaul of the system as controversy over the cosmetic use of human tissue spreads. Supplementary measures under discussion focus on strengthening labeling and advertising regulations, improving adverse event reporting systems, and managing intended use.
Kim Hee-seon, head of the Blood and Organ Policy Division at the Ministry of Health and Welfare, said, "We are currently conducting legislative discussions with multiple lawmakers' offices on the appropriate level of regulation for the use of human tissue," adding, "However, we will carefully set the scope and level of regulation so that rules intended to address certain issues do not end up discouraging therapeutic uses such as existing tissue transplants."
The Ministery of Food and Drug Safety is reviewing measures to supplement the system from the position that using human tissue for cosmetic purposes is inappropriate.
Lim Sang-woo, Head of the Advanced Biopharmaceutical TF at the Ministery of Food and Drug Safety, said, "Human tissue is not an item that is approved on the premise of efficacy and effect like drugs or medical devices; it is managed with a focus on safety and transplant suitability," adding, "Given these characteristics, the current legal system lacks direct regulation of advertising or intended use."
Lim, the Head of Team, added, "We are reviewing system improvements such as strengthening labeling and advertising management, managing intended use by tissue banks, and improving adverse event reporting systems."