A recent investigation has exposed the deceptive practices within the exosome market. It was found that despite lacking any national drug or medical device approvals, exosome products are being manufactured under borrowed certificates, misrepresented, and subcontracted for production—practices that have become an industry norm. Some companies have even publicly claimed that graded exosomes can be used to treat cancer.

According to industry insiders, prior to the exposure, many businesses were exploiting regulatory gray areas—such as using Class II medical device certificates to sell exosomes. However, following the revelations, regulatory trends are expected to tighten. Exosomes with therapeutic functions that rely on active ingredients will be classified as drugs and must undergo rigorous clinical trials before market approval. This move will effectively shut down the channel for unregulated exosome products in aesthetic medicine.

Exosomes are naturally occurring substances released by cells into the extracellular environment. Research suggests they act as "parcels" exchanged between cells, facilitating the transfer of materials and complex information. As a result, scientists are exploring ways to harness exosomes from specific cells to perform targeted functions or deliver drugs precisely. However, these studies remain confined to laboratories and clinical trials. The broad scope, complex composition, and lack of standardization of exosomes are major hurdles preventing their practical application.

Despite this, there have been numerous incidents of exosome misuse, prompting regulatory agencies to issue warnings. For example, in 2019, the U.S. Food and Drug Administration (FDA) issued a public warning about exosome products after several patients in Nebraska experienced severe adverse events from unapproved treatments. In 2022, Guangdong’s drug regulatory authority also issued a warning regarding "exosome cosmetics."

Regulatory scrutiny intensified in June 2025 when China’s National Medical Products Administration proposed draft guidelines to classify therapeutic exosomes as drugs to prevent misuse. To date, no exosome-based drugs or medical devices containing exosomes have been approved for market sale in China.

An investigation revealed that an exosome product named "Qing Cheng" is highly popular in aesthetic clinics, even labeled as a "Class II medical device." However, a representative from the manufacturer, Haolin (Tianjin) Biotechnology Co., Ltd., admitted that the product is actually using a certificate intended for collagen—a tactic to evade market supervision.

It has been noted that exosome products and services have been available in the aesthetic industry for some time. Suppliers include specialized aesthetic product manufacturers as well as pharmaceutical companies expanding into the aesthetic sector.

Several companies exposed in the investigation claimed to possess formal research backgrounds and advanced technical capabilities. Haolin (Tianjin) Biotechnology Co., Ltd., for instance, described itself as an international high-end biotech firm focused on developing groundbreaking gene therapies, biomedical devices, and organoids. The company also stated it collaborates with several Chinese research institutes for technology transfer.

Another company, Yuanchuang Gene Technology Co., Ltd., based in Zhengzhou, emphasized its strong research foundation. Reports indicate that the company, founded by a postdoctoral researcher from Columbia University, aims to bridge cell therapy industrialization and provide comprehensive technical services. In 2024, the company began operating a cell and gene therapy CDMO platform within a provincial biomedical pilot base.

The company reportedly has established a tripartite R&D and production matrix with over 500 advanced equipment units, offering stem cell, immune cell, and exosome product lines. It has also partnered with more than 20 tertiary hospitals and participated in 12 provincial key research projects.

An executive from an aesthetic platform attributed the exosome chaos to dual issues: inherent scientific limitations and market-driven distortions. The inherent limitation refers to the early stage of exosome research in China, lacking sufficient evidence-based medical support for commercial use. The distortion arises when products are rushed to market driven by profit, leading to compromised production standards, safety neglect, exaggerated claims, and off-label use.

The exposure of this sector sends a clear signal: any new technology applied in aesthetics must adhere to two bottom lines—safety as a legal requirement and evidence-based practice as a scientific principle. The industry is urged to return to rationality, focusing on rigorous clinical research to genuinely explore exosome potential rather than engaging in speculative hype.

Additionally, exosomes face an "identity crisis" from a regulatory perspective. When used for treating diseases—such as neurodegenerative conditions, cancer, or tissue repair—via intravenous injection or targeted drug delivery, they function pharmacologically, immunologically, or metabolically, aligning with drug definitions. However, no exosome-based new drug has been approved globally yet.

When combined with medical devices, such as exosome-loaded dressings or formulations used with aesthetic devices, exosomes may be classified as drug-device combination products if their effects exceed auxiliary functions.

The lowest threshold, and currently the most problematic area, involves exosomes as cosmetic ingredients. While countries like the U.S., Japan, and South Korea allow human-derived exosomes in cosmetics under strict pre-approval processes, many products in the market exploit regulatory loopholes. Some products labeled as "cosmetic-grade" actually contain non-exosome ingredients, such as animal umbilical cord extracts or plant extracts, misleading consumers with high-end terminology.

Products marketed under cosmetic licenses that promote medical claims like "cellular repair" or "regeneration activation" constitute false advertising—a clear violation targeted by regulators.

Prior to the exposure, many companies operated in regulatory gray areas. Post-exposure, the direction is clear: exosomes with therapeutic functions must be regulated as drugs and undergo strict clinical validation. This will effectively close the door on unregulated exosome products in aesthetic medicine.