Global Regulatory Challenges in Injectable Skin Powder Products

In May last year, Taiwan’s Ministry of Health and Welfare (MOHW) dispatched official notices regarding the "Regulations for the Management of Injectable Skin Powder Products" to 18 major medical societies, including the Taiwanese Dermatological Association, and university hospitals. The MOHW pointed out that "injectable skin powder forms"—products that had previously existed in a regulatory blind spot under the guise of being human tissue—lack sufficient scientific evidence.

■Human-Derived Products Must Adhere to "Minimal Manipulation" and "Homologous Use" Principles

Taiwan authorities stated that because injectable skin powder forms are no longer classified as human tissue, they must undergo rigorous clinical trials to prove their efficacy and safety. The government added that such products can only be distributed in the market after obtaining formal marketing authorization based on human clinical data; furthermore, both domestic manufacturing and importation of these products are strictly prohibited.

This is not an isolated decision by Taiwan, but rather part of a global trend. The United States strictly applies the principles of "minimal manipulation" and "homologous use" to human-derived products. In particular, processing dermis into a powder form is considered to exceed the scope of minimal manipulation, leading to its classification as either a medical device or a biological product. Consequently, these products must undergo mandatory clinical trials and formal marketing authorization processes to prove their safety and efficacy.

In particular, Taiwan’s reference to "homologous use" (同源使用) reflects the principles established in U.S. guidelines. This implies the judgment that if injectable skin powder is used for aesthetic or plastic surgery purposes—rather than for restoring the original function of the dermis—it does not qualify as homologous use.

Europe is also tightening its oversight of aesthetic products. Specifically, injectable skin powder forms are subject to regulation due to their invasive nature of being injected into the human body, leading to their classification as medical devices. Consequently, during the CE certification process, it is mandatory to provide not only Clinical Evaluation Reports (CER) but also concrete safety and efficacy data from human clinical trials. Furthermore, post-market surveillance (PMS) for adverse effects is strictly managed.

The stance taken by Taiwan’s Ministry of Health and Welfare—requiring formal registration through clinical trials—aligns with this global trend. This action by Taiwan is highly significant, as it directly addresses long-standing issues concerning "standards for processed human tissue products," "safety verification," and "proof of efficacy."

■How Long Will Patients Be Used as Test Subjects?

The problem lies at home. Currently, in South Korea, skin ECM-based (extracellular matrix) injectables are still classified as "tissue grafts" and are being administered in clinics and hospitals under the marketing name "skin boosters." Neither the Ministry of Food and Drug Safety (MFDS) nor the relevant medical societies have provided clear answers to the fundamental questions: Can the dermis—which supports the skin's structure—truly maintain its original tissue integrity once it has been pulverized for injection? And does such an injection actually comply with the principle of homologous use?

An official from the Ministry of Food and Drug Safety (MFDS) stated, "Acellular Dermal Matrix (ADM) is currently managed as human tissue. We plan to actively review future management strategies following expert consultations and research into international classification cases."

A dermatology professor at a university hospital stated, “The most significant difference between medical devices/pharmaceuticals and human tissue grafts is the requirement for clinical trials to verify safety and efficacy. Human tissue grafts are materials used to restore original functions by transplanting structurally identical tissue into a recipient who lacks it. While clinical trials for efficacy may sometimes be waived because they perform the same role as the original tissue, follow-up management is still essential as safety must be continuously monitored.”
He further noted, “However, if the purpose is to enhance or alter functions rather than restore existing ones, it is imperative to undergo an efficacy validation process. This ensures that the application of such procedures, drugs, or medical devices provides sufficient benefits to outweigh any tangible or intangible losses.”

Equally problematic is the reckless abuse of these products despite the uncertainty regarding the potential extent of consumer harm in the event of adverse reactions. Much like how breast implants—once considered safe—faced recalls and led to corporate bankruptcies due to delayed side effects appearing years later, any substance that remains in the body for a long period must be treated with extreme caution. Notably, while sheet-type tissue grafts can be surgically extracted, powder-type injectables are practically impossible to remove, short of excising the entire area of the affected skin.

Despite these severe risks, companies and clinics continue to mislead consumers with sensationalist marketing, fueling the growth of a massive, unregulated market. The Taiwanese Ministry of Health and Welfare’s sharp rebuke regarding the "lack of scientific evidence" serves as a stern wake-up call to the South Korean Ministry of Food and Drug Safety, which has maintained a relatively permissive stance.

While the government, which should prioritize public health above all else, leaves a regulatory vacuum unaddressed, citizens are being turned into test subjects for unverified injectables. Regulation is not a device meant to hinder industrial development, and no industry should ever take precedence over human health. This is precisely why a clear and safe regulatory framework that aligns with global standards must be established before it is too late.