Global Regulations on Exosomes in Cosmetic Products

As a cutting-edge field of biotechnology, exosomes have demonstrated vast potential in medical fields such as tumor research and treatment, anti-inflammatory, and immune regulation. Beyond their therapeutic value, exosomes have sparked considerable interest in the beauty industry, particularly in anti-aging treatment. These position them as a new driving force for innovation in medical beauty and cosmetics.

Exosome's Definition & Application

Exosomes, a subcategory of extracellular vesicles (EVs), are biological nanoparticles typically ranging from 20 to 200 nm in size. They function to transfer substances and information, including proteins, lipids, polysaccharides, and RNA, between cells. Exosomes are widely distributed in various bodily fluids such as blood, urine, saliva, and bile. According to source, exosomes can be divided into human exosomes and non-human exosomes (e.g., plant or animal-derived exosomes).

Exosomes derived from stem cells, as nanoscale vesicles secreted by stem cells, inherit the regenerative properties of stem cells. These exosomes promote skin cell proliferation, collagen synthesis, and skin elasticity, addressing issues such as wrinkles and uneven skin tone. Inevitably, they have become a promising solution in anti-aging, skin repair, and even dermatological treatments.

Currently, they are incorporated into skincare products like creams, serums, and masks and applied in hair management to help improve hair loss issues. Additionally, exosomes are being combined with medical aesthetic treatments, such as mesotherapy (a technique applying microneedles), in addressing various skin concerns, including soothing sensitive skin, treating acne breakouts, and repairing scars and acne marks.

Overview of Exosome Requirements in Key Global Regions

Exosome regulation across various countries typically distinguishes between human and non-human exosomes. Overall, human exosomes are subject to stricter controls, while non-human exosomes are generally evaluated based on their specific properties.

Detailed Regulatory Requirements

1. Chinese Mainland

The research and application of exosomes are still in the early stages. China’s current laws and regulations regarding exosomes remain incomplete. Due to their exceptional multifunctional capabilities and regenerative potentials, exosomes play unique roles across pharmaceuticals, medical devices, and cosmetics. The question of whether exosomes should be classified as drugs, cosmetics, or medical devices remains unresolved. Their multifunctionality and complexity make it challenging to fully encompass them under any single existing category, resulting in legal gaps and ambiguities. Some official documents provide insights into potential regulatory directions as below.

• Restricted in Cosmetics

Regarding cosmetic applications, according to Article 390 of Safety and Technical Standards for Cosmetics 2015, human cells, tissues, or products of human origin are prohibited from being used as cosmetic ingredients. Additionally, there are no specific management requirements for non-human exosomes, and it is recommended to consider them based on the actual situation of the ingredient.

The cosmetic market has seen so-called “high-tech” products with claims of containing exosomes derived from animals or plants. However, many of these products labeled as “exosome cosmetics” may only include ordinary plant extracts or animal-derived ingredients rather than genuine exosomes. In response, regulatory authorities, such as the Guangdong Medical Products Administration and official platforms like CNPHARM, have intervened to clarify that the so-called “exosome cosmetics” are a fabricated pseudo-concept. Related companies are suspected of misleading consumers through false and exaggerated claims, deceptive marketing, and explicit or implicit suggestions of medical efficacies. Consumers are advised to maintain a rational perspective on “exosome-based cosmetics” and stay cautious of commercial gimmicks.

• Potential Regulatory Directions

According to the Summary of the Second Classification Determination Results for Medical Device Products issued by the China National Institute for Food and Drug Control (NIFDC) on October 31, 2024, stem cell exosomes are classified as products that are not recommended to be managed as medical devices.

However, exosomes products may be included in the scope of drug management. The 14th Five-Year Plan for the Bio-economy Development released by the National Development and Reform Commission in 2021 mentioned “exosome therapeutic products” in the special section on bioeconomy innovation capability enhancement projects, indicating that exosomes would be likely to be included in the scope of drug regulation in the future.

2. Taiwan, China

On March 21, 2024, the Taiwan Food and Drug Administration (TFDA) released the Required Documents for Review of the Use of Exosomes Derived from Human Cells in Cosmetics and updated the List of Prohibited Ingredients in Cosmetics. According to the latest list, ingredients derived from human cells, tissues, or products of human origin remain prohibited in cosmetic formulations except for specific exosome ingredients that have been reviewed and approved by the competent authority.

For such case reviews, effective from March 21, 2024, the applicant should submit relevant documents or information, including the qualifications of the exosome donor, preparation processes and inspection reports, stability tests, safety tests, absorption, distribution, metabolism, and excretion tests. If the business successfully passes case reviews, it will be permitted to use exosome ingredients in its products.

This means that exosomes derived from human cells, listed as banned cosmetic ingredients in many countries and regions, can be used in cosmetics in Taiwan if they receive approval from TFDA.

3. USA

The US currently does not impose specific regulations for exosome management. According to the principles of U.S. cosmetic and drug regulations, companies must implement rigorous quality control measures when marketing exosome products to avoid potential non-compliance penalties during post-market surveillance.

Notably, the exosome ingredients market in the U.S. market includes:

• Exosome-related ingredients that obtained the International Nomenclature of Cosmetic Ingredients (INCI) name and included in the wINCI online database of the Personal Care Products Association (PCPC). When registering cosmetics in the U.S., if any ingredient in the formulation lacks a standardized nomenclature, it is advisable to obtain an INCI name

• Exosome-related ingredients that obtained the Drug Master File (DMF) notification published by the Center for Drug Evaluation and Research (CDER) of the U.S. FDA.

4. EU

According to Annex II of the Regulation (EC) No 1223/2009 on Cosmetic Products, cells, tissues, and products of human origin are prohibited from being used as cosmetic ingredients.

5. Japan

According to the Standards for Ingredients of Biological Origin issued by the Japanese Ministry of Health, Labor and Welfare, the use of human exosomes in cosmetics shall meet the requirements in the Standards. For non-human exosomes, there are no specific management requirements. It is recommended to evaluate them based on the actual circumstances of the ingredient.

6. South Korea

According to Annex 1 of Regulation on Safety Standards, etc. for Cosmetics (Notice No. 2023-73) issued by the Korean Ministry of Food and Drug Safety (MFDS) on November 30, 2023, human cells, tissues, and their culture media are prohibited in cosmetics, except for those that meet the safety standards for human cell and tissue culture media outlined in Appendix 3. Additionally, for non-human exosomes, there are no specific management requirements. It is recommended to evaluate them based on the actual circumstances of the ingredient.

REACH24H Consulting Group, the founder of ChemLinked, possesses extensive expertise in guiding companies through the global compliance process. With a dedicated team of 40+ industry specialists, REACH24H offers one-stop global market access solutions, ensuring seamless compliance for your products worldwide. 

If you are interested in learning more about INCI name applications and U.S. DMF regulations, please contact us at [email protected] for expert guidance tailored to your needs.

Conclusion

Exosomes represent one of the cutting edges of beauty and medical innovation. Looking ahead, as the technology continues to mature and regulatory frameworks become more refined, the balance between innovation and safety will eventually be achieved. The exosome sector is expected to enter a new era of growth and development.