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Think You’re Using Exosomes? Why the EU Banned Them (and What You’re Actually Getting)

Think You’re Using Exosomes? Why the EU Banned Them (and What You’re Actually Getting)

Published on May 22, 2025

TL; DR: Exosomes are nanoscale, membrane-bound vesicles released by cells to transfer biological signals that influence the behavior of other cells. In skincare, they’re being investigated for anti-aging, hydration, pigmentation, and wound healing — but the field is still in its early stages, and strong clinical evidence is lacking.

Only a few ingredients have been characterized as true extracellular vesicles with exosome-like properties. Human-derived exosomes are banned in EU cosmetics due to concerns over traceability, safety, and overlap with medicinal product regulation.

Many ingredients marketed as “exosomes” — including conditioned media, ferments, plant stem cell extracts, and many INCI names ending in “vesicles” — are not purified or validated as exosomes. Without isolation, size confirmation, or marker data, their biological relevance remains unproven.

Table of Contents

What Are Exosomes?

Exosomes are "nano-sized extracellular vesicles (typically about 30–150 nm in diameter)" that are naturally released by cells [1]. They can be thought of as tiny messenger packets enclosed in a lipid membrane, carrying a rich cargo of bioactive molecules such as proteins, lipids, and nucleic acids [1]. Because exosomal membranes contain specialized lipids and proteins, they can fuse with target cells and deliver their cargo effectively [2]. In this way, exosomes serve as important mediators of intercellular communication, shuttling signals and molecular instructions between cells [1].

Sources and Types of Exosomes for Skincare

Virtually all cell types in the body (and even in plants and microorganisms) release exosomes, but their contents and functions vary depending on the source [1]. In the context of skincare, several types of exosomes are being explored as cosmetic ingredients or delivery vehicles:

Human Cell-Derived Exosomes:

Often obtained from cultured human cells such as mesenchymal stem cells (MSCs), fibroblasts, or platelets. These exosomes tend to be rich in human growth factors, cytokines, and other signals that can promote tissue repair. For instance, exosomes from human MSCs have demonstrated the ability to stimulate fibroblast growth, boost collagen production, and accelerate wound healing in experimental models [2]. Human-derived exosomes are considered highly promising for skin rejuvenation due to their potent regenerative cargo, with many studies focusing on adipose-derived stem cell exosomes for anti-aging and healing applications [2]. However, their use in products faces regulatory hurdles (they blur the line between a cosmetic and a biologic drug), and as of now no exosome product has approval as a therapeutic [1]. Strict regulations in regions like the EU explicitly prohibit human-derived exosome ingredients in cosmetics [3], motivating the search for alternatives.

Plant-Derived Exosomes:

Plants also release nanovesicles (sometimes termed plant-derived extracellular nanoparticles, PDENs) that are similar in size to exosomes [1]. These vesicles can carry plant bioactives such as antioxidants, polyphenols, and RNAs. Because they originate from edible or botanical sources, plant exosomes are generally regarded as safe and are not encumbered by the ethical/regulatory issues of human exosomes. Early research suggests they can have skincare benefits; for example, exosome-like vesicles isolated from beetroot were shown to have strong antioxidant activity and to stimulate the skin’s own hyaluronan synthase enzyme (which produces hyaluronic acid), leading to improved moisture retention and collagen synthesis in the skin [2]. Plant exosomes are also being investigated as natural delivery systems – one study demonstrated that packing a cosmetic peptide into engineered plant exosomes dramatically enhanced its skin penetration and efficacy compared to the free peptide [4]. Given their easier regulatory path and stability, plant-derived exosome ingredients are increasingly appearing in experimental skincare formulations.

Synthetic or Engineered Exosomes (Exosome Mimetics):

These are lab-designed nanovesicles made to mimic the structure and function of natural exosomes. For example, scientists can create exosome-like lipid vesicles or force cells through extruders to produce uniform vesicles termed exosome mimetics [5]. The goal is to overcome some limitations of natural exosomes by designing vesicles with defined content and high stability. In cosmetics, “synthetic exosomes” are being explored as a way to deliver beneficial molecules in a controlled fashion, while avoiding the use of human-derived materials. Researchers note that using plant or synthetic exosome mimetics could bypass ethical and regulatory concerns [6] associated with human exosomes, yet potentially retain similar functionality on the skin.

Biological Roles and Skin Benefits of Exosomes

Boosting Collagen and Dermal Regeneration:

Early lab research suggests that certain exosomes — especially those from skin cells like fibroblasts or stem cells — may help maintain and restore the skin’s structural support. In one study using skin cells and UV-exposed mice, exosomes from fibroblasts helped protect collagen by reducing enzymes that break it down (like MMP-1) and boosting signals that promote collagen production (via the TGF-β pathway) [7]. Other research has found similar benefits using plant-derived exosomes from apples, which increased collagen levels and reduced collagen-degrading enzymes in skin cells by calming inflammatory pathways [8].

While these early results are promising, real-world evidence in humans is still limited. One small pilot study did report visible improvements in fine lines and skin tone after six weeks of using a topical exosome product, but larger clinical trials are needed to confirm these effects [9].

Improving Hydration and Barrier Function:

Healthy skin barrier function is crucial for maintaining hydration. Exosomes can support the skin barrier in multiple ways. Some exosomes deliver lipids and enzymes that bolster the barrier’s lipid content – for example, exosomes from adipose-derived stem cells have been shown to increase the production of ceramides and other barrier lipids in skin cells [10]. Ceramides are natural fats in the outer skin layers that seal in moisture; by boosting ceramide levels, exosomes may help repair a compromised barrier and reduce transepidermal water loss. Other exosomes promote the skin’s production of hyaluronic acid (a key natural humectant) as noted with the beetroot vesicles enhancing hyaluronan synthesis [2]. In a clinical context, one sensitive skin study found that applying a formulation containing human MSC exosomes for 28 days led to a measurable decrease in transepidermal water loss and an increase in skin hydration, indicating strengthened barrier function [11]. These findings suggest exosome-based products could improve skin moisturization and resilience, making them attractive for dry or compromised skin conditions.

Reducing Inflammation and Pigmentation:

Exosomes often carry anti-inflammatory molecules (like IL-10, or microRNAs that suppress inflammatory pathways) which can help calm irritated or inflamed skin. They can dial down excessive inflammation and promote a healthier recovery environment [12].

Another aspect under exploration is pigmentation control. Some exosomes (depending on their source) appear capable of influencing melanocytes (the pigment-producing cells). In one human trial, topical application of exosomes derived from a probiotic bacterium (Lactobacillus plantarum, part of the skin microbiome) led to a reduction in hyperpigmented spots and a more even skin tone over one month [13]. While the exact mechanisms are still being unraveled, the early evidence suggests exosome treatments might lighten excess pigmentation or at least modulate pigment production pathways, offering a novel approach to issues like age spots or melasma.

Wound Healing and Skin Repair:

Skin healing is a complex process that can benefit from the kind of growth factors and genetic signals packed in exosomes. Multiple preclinical studies show that adding exosomes to wounded or damaged skin markedly accelerates repair. For example, stem cell exosomes applied to a wound bed increased fibroblast migration and proliferation, leading to faster closure of the wound and greater collagen deposition in the new tissue [14]. Exosomes seem to help orchestrate healing by promoting blood vessel formation (angiogenesis) and by reducing scar formation – they can modulate the behavior of cells that form scar tissue.

In animal models, treating burn wounds or incisions with certain exosome preparations has resulted in less inflammation and more organized collagen fibers, translating to improved scar outcomes [15]. Clinically, dermatologists have begun to use exosome-rich serums as add-ons to procedures like laser resurfacing or microneedling [16], aiming to speed up recovery. Reports from these applications (still anecdotal) note quicker reduction of redness and enhanced tissue repair compared to standard post-care, which aligns with the biological actions observed in the lab.

Clinical Validation and Future Outlook

Despite growing interest, clinical research on exosome skincare remains limited. A recent review identified just over a dozen clinical studies to date, most with small sample sizes, no control group, and short follow-up [6]. While many report improvements in hydration, elasticity, and pigmentation, larger placebo-controlled trials are still needed to confirm efficacy [6].

While detailed tolerability data are scarce, available short-term studies of topical exosome use have not reported significant adverse effects, and overall safety profiles appear favorable based on current reports [1,6, 12], but long-term safety is still under review [6].

Exosome-based skincare remains constrained by regulatory concerns. The EU prohibits human-derived exosomes in over-the-counter cosmetics [3], and the FDA has issued warnings against unapproved therapeutic claims [1]. As a workaround, many products use plant- or yeast-derived vesicles or cell-conditioned media, which may contain exosomes but are not purified [6].

The future of exosome-based skincare depends on better clinical trials, regulatory clarity, and standardized formulations to ensure both safety and efficacy [6].

What Exosome Ingredients Actually Appear in Skincare?

Some of the most common (confirmed) exosome ingredients are:

Milk exosomes Used in some serums/creams (e.g. “milk exosome” complexes) as a skin-conditioning emollient. Milk is a well‐documented source of extracellular vesicles (~30–150 nm) carrying proteins/RNAs. For example, biomolecular studies isolate vesicles from cow’s milk by ultracentrifugation and confirm exosome markers (CD63, CD81, etc.) [17].
Human-derived ingredients The CosIng database also lists similarly named exosome ingredients from human stem cells (e.g. “Human Adipose Derived Mesenchymal Cell Exosomes”, “Human Cord Blood Progenitor Cell Exosomes”, etc). These are true nano-vesicles by definition, but all human‐derived ones are banned in EU cosmetics. This is for multiple reasons: any material taken from human tissue carries a non-trivial risk of transmitting pathogens; their sourcing raises ethical problems: without airtight donor consent and traceability, the EU cannot verify that the cells were obtained responsibly; exosomes behave like biologic drugs rather than passive cosmetic ingredients, which would normally require a full medicinal-product dossier and EMA approval.

Cosmetic products outside the EU may market such human exosomes (some regenerative‐medicine brands do), but in Europe they cannot be used.

Ingredients ending in “Extracellular Vesicles” (potentially) Typically originate from plant cell cultures — often callus tissue — and are among the most scientifically plausible sources of plant-derived exosomes in cosmetics. For example, Centella Asiatica Callus Culture Extracellular Vesicles and Rosa Damascena Callus Culture Extracellular Vesicles are both listed in CosIng and are used in commercial formulations marketed as exosome-based. In published studies [18], [19], vesicles isolated from these cell cultures have shown particle sizes consistent with exosomes (~100 nm) and, in some cases, the presence of exosomal protein markers. These findings support their potential classification as extracellular vesicles with exosome-like properties. However, the presence of such an INCI name alone does not guarantee that a given product contains functional, intact exosomes — unless the manufacturer provides data confirming proper isolation, characterization, and stability in the final formulation.

Frequently claimed “exosome” ingredients that are not confirmed exosomes:

Human bone marrow stem cell conditioned media Like other conditioned media, this is whole cell culture supernatant, not an isolated exosome preparation. Unless a purification step is specified, it contains mixed proteins and possibly cell debris, so it is not a defined extracellular vesicle product.
Human adipose derived stem cell conditioned media Again, this is culture fluid from adipose stem cells, not a separated vesicle fraction. Brands may imply regenerative activity, but without EV purification, it’s not confirmed exosomes.
Lactobacillus ferment Often in INCI as e.g. Lactobacillus ferment or in complex names (e.g. Lactobacillus ferment filtrate). Some brands explicitly market it as exosomes. Unless the vesicles are specifically isolated, a plain ferment is just the whole probiotic culture broth (proteins, enzymes, polysaccharides). By itself it is not a characterized exosome product; it would contain a mixture of metabolites, not a purified EV fraction.
Fermented plant/yeast extracts Ingredients like Saccharomyces ferment filtrate, Galactomyces ferment filtrate, or mixed Lactobacillus/Aloe ferment often appear on labels. These are general fermentation filtrates (rich in vitamins, peptides, organic acids) and are not evidence of containing discrete vesicles. Unless a vendor provides particle‐size data or EV markers, a “ferment filtrate” is not the same as isolated exosomes.
Plant stem cell extracts Phrases like “stem cell extract” (e.g. Malus domestica fruit cell culture extract) are popular in marketing. These are typically plant cell extracts or juices, not purified EVs. No standardized “stem cell culture exosome” process exists for plants. Products with such ingredients have not demonstrated nano‐vesicles with exosomal markers.
Most ingredients ending in “vesicles” INCI names like Centella Asiatica Leaf Vesicles or Cannabis Sativa Root Vesicles (without the "extracellular" word) are often marketed as containing plant-derived exosomes. However, the official INCI Nomenclature Conventions clarify that such ingredients “have not been characterized to the extent as those derived from mammalian cells” and are named simply as "vesicles" based on their plant source [20] — not on any demonstrated purification or exosomal identity. These terms lack standardized scientific validation, and in practice, are more likely to represent plant extracts or emulsified fractions repackaged as advanced-sounding actives. While they may contain extracellular vesicles, they also may not — and without published characterization, the presence of true exosomes remains unverified.

In summary, only ingredients explicitly described and isolated as extracellular vesicle preparations (with supporting characterization) qualify as “real exosomes.” Other terms like “conditioned media,” “ferment filtrate,” or vague “cell extract” are not verified exosome ingredients. For example, CosIng lists bona fide EV ingredients (as above), whereas ingredients labeled merely as “conditioned media” or “ferment” are understood to be bulk culture fluids without purified vesicles.

References:

  1. Haykal, D., Wyles, S., Garibyan, L., et al. (2025). Exosomes in cosmetic dermatology: A review of benefits and challenges. Journal of Drugs in Dermatology, 24(1), 12–18. https://jddonline.com/articles/exosomes-in-cosmetic-dermatology-review-of-benefits-challenges-S1545961625P8872X

  2. Bai, G., Truong, T. M., Pathak, G. N., et al. (2024). Clinical applications of exosomes in cosmetic dermatology. Skin Health and Disease, 4(6), e348. [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11608875/]

  3. European Parliament and Council. (2009/2025). Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (consolidated version, updated 1 May 2025). Official Journal of the European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20250501

  4. Hou, J., Wei, W., Geng, Z., et al. (2024). Developing plant exosomes as an advanced delivery system for cosmetic peptide. ACS Applied Bio Materials, 7(5), 3050–3060. Developing Plant Exosomes as an Advanced Delivery System for Cosmetic Peptide - PubMed

  5. Wang, L., et al. (2023). Mesenchymal stromal cell–derived magnetic nanovesicles for enhanced skin retention and hair follicle growth. Cytotherapy, 25(11), 1176–1185. https://www.sciencedirect.com/science/article/abs/pii/S1465324923009866

  6. Villarreal-Gómez, L. J., et al. (2025). Use of exosomes for cosmetics applications. Cosmetics, 12(1), 9. https://www.mdpi.com/2079-9284/12/1/9

  7. Park, A. Y., et al. (2023). Exosomes derived from human dermal fibroblasts inhibit UVB-induced MMP-1 expression via TGF-β signaling. International Journal of Molecular Medicine. Exosomes derived from human dermal fibroblasts protect against UVB‑induced skin photoaging

  8. Trentini, M., Zanolla, I., Zanotti, F., et al. (2022). Apple derived exosomes improve collagen type I production and decrease MMPs during aging of the skin through downregulation of the NF-κB pathway as mode of action. Cells, 11(24), 3950. https://www.mdpi.com/2073-4409/11/24/3950

  9. Mayo Clinic Department of Otolaryngology. (2025). Tapping into the potential of platelet-derived exosomes in aesthetics. Mayo Clinic Medical Professional News. https://www.mayoclinic.org/medical-professionals/otolaryngology/news/tapping-into-the-potential-of-platelet-derived-exosomes-in-aesthetics/mac-20582898

  10. Thakur, A., Shah, D., Rai, D., et al. (2023). Therapeutic values of exosomes in cosmetics, skin care, tissue regeneration, and dermatological diseases. Cosmetics, 10(2), 65. https://www.mdpi.com/2079-9284/10/2/65

  11. Ye, C., Zhang, Y., Su, Z., et al. (2022). hMSC exosomes as a novel treatment for female sensitive skin: An in vivo study. Frontiers in Bioengineering and Biotechnology, 10, 1053679.https://www.frontiersin.org/articles/10.3389/fbioe.2022.1053679/full

  12. Mahmoud, R. H., Peterson, E., Badiavas, E. V., Kaminer, M., & Eber, A. E. (2025). Exosomes: A comprehensive review for the practicing dermatologist. Journal of Clinical and Aesthetic Dermatology, 18(4), 33–40.
    https://jcadonline.com/exosomes-comprehensive-review-practing-dermatologists/

  13. Song, C. J., Myung, C. H., Yoon, Y. C., et al. (2022). The effect of Lactobacillus plantarum extracellular vesicles from Korean women in their 20s on skin aging. Current Issues in Molecular Biology, 44(2), 526–540. https://www.mdpi.com/1467-3045/44/2/36

  14. Zhang, J., Guan, J., Niu, X., et al. (2015). Exosomes released from human induced pluripotent stem cells-derived MSCs facilitate cutaneous wound healing by promoting collagen synthesis and angiogenesis. Journal of Translational Medicine, 13, 49. https://pmc.ncbi.nlm.nih.gov/articles/PMC4371881/

  15. Liu, L., Yu, Y., Hou, Y., et al. (2014). Human umbilical cord mesenchymal stem cells transplantation promotes cutaneous wound healing of severe burned rats. PLOS ONE, 9(2), e88348. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0088348

  16. Proietti, I., Battilotti, C., Svara, F., et al. (2024). Efficacy and tolerability of a microneedling device plus exosomes for treating melasma. Applied Sciences, 14(16), 7252. https://www.mdpi.com/2076-3417/14/16/7252

  17. Di, S., Huang, Y., Qiao, W., et al. (2024). Advances in the isolation and characterization of milk-derived extracellular vesicles and their functions. Frontiers in Nutrition, 11, Article 1512939.
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  18. Chang, T.-M., Wu, C.-C., Huang, H.-C., et al. (2024). Centella asiatica tissue culture-derived extracellular vesicles: A multifaceted approach to skincare applications. bioRxiv.
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  19. Theodorakopoulou, E., Aguilera, S. B., & Duncan, D. I. (2024). A new therapeutic approach with rose stem-cell-derived exosomes and non-thermal microneedling for the treatment of facial pigmentation. Aesthetic Surgery Journal Open Forum, 6, ojae060.
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  20. Personal Care Products Council (2022). INCI Nomenclature Conventions and Reference Information. Washington, D.C. https://www.personalcarecouncil.org/wp-content/uploads/2022/01/Conventions-2022_v1.pdf

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