L&C Bio has chosen a frontal approach to the controversy surrounding its human-tissue-based ECM (extracellular matrix) skin booster 'Lituo'. At a press conference on April 29, the company strongly refuted ethical and legal concerns, stating that it only imports and uses tissues from U.S. donors who have explicitly consented to cosmetic use. It also denied any violation of advertising regulations, claiming it does not conduct cosmetic-purpose advertising targeting the general public.
However, promotional brochures found in actual medical settings prominently feature cosmetic and anti-aging effects. The brochures, produced by Humedix (which handles Lituo's domestic sales and marketing), are used for internal sales training and distribution to medical institutions. They list effects such as 'pore reduction', 'improvement of spots and blemishes', 'fine line improvement', 'skin radiance', 'redness reduction', and 'deep hydration'—all typical terms in dermatology cosmetic procedure marketing. Notably, the phrase 'need for seamless anti-aging and slow aging' suggests a focus on the anti-aging cosmetic market rather than disease treatment.
A larger issue is regulatory fairness. General skin boosters and fillers classified as pharmaceuticals or medical devices must undergo pre-approval by advertising review bodies designated by the Ministry of Food and Drug Safety (MFDS), even for in-clinic promotional materials. Such reviews strictly limit claims beyond approved indications. For example, terms like 'regeneration' or 'radiance' require corresponding product approvals.
In contrast, Lituo, as a processed human tissue product, falls under the Human Tissue Safety and Management Act, placing it outside this pre-approval advertising review system. This allows L&C Bio and Humedix to relatively freely use terms like 'elastic regeneration' or 'skin radiance' in marketing, while other device companies face restrictions. Critics argue this constitutes 'loophole marketing' that undermines regulatory equity, despite the company's denial of advertising regulation violations.
The marketing target is also evident from comparisons in the brochures: Lituo is directly compared with hyaluronic acid (HA), salmon-derived PDRN, PDLLA, and porcine collagen—all premium anti-aging materials targeting dermatology clinics. The control group for efficacy claims includes non-crosslinked HA (a popular cosmetic injection).
Controversy also surrounds the effectiveness of donor consent. L&C Bio imports human tissues from overseas tissue banks. The consent forms used by U.S. tissue banks include clauses for 'cosmetic purposes' and 'for-profit organizations', ostensibly securing legal consent for cosmetic use. However, industry insiders question whether grieving families fully comprehend such clauses when signing. This is an ongoing global issue.
On April 26, The Guardian published an opinion piece criticizing the commercial cosmetic use of human tissue, spotlighting 'AlloClae', a cadaver-derived fat filler. AlloClae, dubbed 'zombie filler', is popular among wealthy executives who avoid surgery. The Guardian condemned the commodification of human bodies, where abdominal fat from organ donation is sold to for-profit companies for wrinkle correction or body contouring.
Historically, U.S. tissue banks faced criticism for not adequately informing donors about cosmetic use. A 2012 survey found only 29% of potential donors were clearly informed. Regulations have since tightened, mandating such clauses in consent forms. AlloClae manufacturer Tiger Aesthetics, like L&C Bio, claims all donated tissues are consented for cosmetic use.
The problem is that consent is often broad rather than itemized, failing to capture donors' true intentions. The Guardian lamented: 'In our pursuit of immortality, we’ve come back to the thing we were running away from to begin with: death.' An industry insider noted: 'Even if consent forms include relevant clauses, social consensus on the substance and scope of consent remains insufficient. Proactive verification and management systems for product safety and quality are also needed.'
Source: Read the original report | Published: April 30, 2026