Lately in the beauty and plastic surgery market, so-called "skin booster" procedures, which inject ingredients effective for the skin to promote skin regeneration, are popular.
Among them, L&C BIO's "Elravie Re2O (Re2O, hereafter Re2O)" sits in a regulatory gray area with vague management standards, raising concerns about fairness and safety.
Skin boosters are largely divided into injectable medical devices that use micro-needles to evenly deliver drugs to the skin surface and cosmetics applied to the skin.
In Korea, PharmaResearch's "Rejuran," VAIM's "Juvelook," and L&C BIO's "Re2O" are representative products for cosmetic skin procedures.
The main ingredient of Re2O is derived from the human body. It extracts the extracellular matrix (ECM), a substance that supports cells and helps tissue regeneration, from skin tissue donated by deceased individuals, pulverizes it, dilutes it in saline, and injects it into the skin. It was released in Korea in Nov. 2024, and sales rose quickly as it gained a reputation for skin regeneration effects.
That in turn sparked several controversies. First, although Re2O uses an injection procedure similar to other skin boosters, it was able to avoid medical device regulations.
Unlike other skin boosters developed with synthetic or animal-derived raw materials, Re2O uses donated skin tissue as its raw material, so the legal framework for "human tissue," not medical devices or drugs, applied.
As a result, it entered the market without clearing medical device regulatory hurdles such as mandatory clinical trials to prove safety and efficacy and product-level approvals.
Another skin booster, Rejuran, was developed with PDRN extracted from salmon testes, and Juvelook was developed with the synthetic polymer PDLLA; each went through clinical trials and was approved as a medical device before entering the market.
An industry official who requested anonymity said, "Re2O is subject to an approval and management system centered on tissue banks, so there is no obligation to submit clinical data at the product level," adding, "It is hard to see that there has been sufficient accumulation of not only a priori verification procedures based on clinical data but also long-term safety data."
Given that it is actively used as a skin booster procedure applied to the human body, the market says stronger verification of safety is needed.
There is also an ethics controversy because the raw material is tissue donated by deceased individuals. The civic group Korea Health Consumer Federation issued a statement on the 25th saying, "Human tissue donation has legitimacy on the public-interest premise of treating conditions such as burns and wounds," and, "Using it for invasive cosmetic procedures risks undermining the intent of the system."
The issue also came under scrutiny during last year's parliamentary audit. Over the cosmetic use of human tissue, the Ministry of Food and Drug Safety viewed the Ministry of Health and Welfare as the competent authority for human tissue management, while the Health and Welfare Ministry took the position that product safety issues fall under the Food and Drug Safety agency, drawing criticism that management responsibility is unclear. No clear institutional overhaul has followed since.
L&C BIO says there is no problem because it followed lawful procedures.
A company official said, "Re2O is being lawfully manufactured and distributed in accordance with relevant laws, including the current Human Tissue Safety Management Act."
Regarding the criticism that using donated human tissue for cosmetic purposes is ethically problematic, the company countered by pointing to its "100% U.S. raw material" sourcing.
The company said, "We procure 100% of our primary materials and supplies in the United States, and we manufacture and produce legally using only inputs for which the local donation consent process clearly distinguishes cosmetic use." It also said, "As a company handling human tissue, we undergo annual reviews by the Ministry of Food and Drug Safety and comply with management systems."
Even so, there is a growing call for regulators to overhaul the vague management standards and institutional gaps for cosmetic products derived from human tissue.
The Korea Health Consumer Federation criticized, "The government bears responsibility for leaving a management vacuum and prompting circumvention of the legal net, as does the National Assembly for allowing a legislative vacuum." The group added, "The Ministry of Health and Welfare said in Sept. last year that it would regulate the cosmetic and plastic surgery use of human tissue, and the Ministry of Food and Drug Safety said during last year's audit that it would push a related research project, but no subsequent concretized status has been disclosed."
Some also say the Re2O controversy arose as more corporations entered the skin booster market, intensifying competition among companies.
L&C BIO is growing in scale on the back of rising sales of Re2O. The company's annual sales last year were 85.5 billion won, up about 18.5% from the previous year. The company set this year's Re2O sales target at 50 billion won, a 733% increase from last year. It plans to roughly double Re2O's production capacity from current levels and expand overseas to more aggressively grow the market.
According to market research firm Straight Research, the global skin booster market, from $1.78 billion (about 2.5646 trillion won) last year, is projected to grow at an average annual rate of 8.6% to $2.69 billion (about 3.8757 trillion won) by 2030.