Exosomes (topical)
Status
No approved product. No FDA-approved labeling exists and no exosome product is approved for any use in the United States. The FDA has published a safety notification on unapproved exosome products following serious adverse events, and has taken enforcement action against marketers.
What it is
Cell-derived vesicles used in aesthetic practice with early evidence.
What published research measured
Extracellular vesicles isolated from cultured cells, most often mesenchymal stem cells, carrying proteins and nucleic acids that mediate signalling between cells. The underlying science is a legitimate and active research field. The commercial products are a different matter, and the regulatory record here is unusually pointed: the FDA issued a public safety notification about unapproved exosome products after patients in Nebraska were hospitalized with serious bacterial infections traced to one, and has since maintained that no exosome product is approved for any indication and that such products are biologics requiring approval. Independent characterization studies of commercial preparations have found wide variation in vesicle content and, in some samples, little of what the label describes. Applied to intact skin the vesicles are unlikely to penetrate meaningfully; the products used after microneedling bypass that barrier and, with it, the skin's infection barrier.
Source
FDA public safety notification on unapproved exosome products following serious adverse events
Sources
No linked primary source is on file for this entry yet.
Educational use only, never medical advice. No doses.