Is Exosomes legal in the United States?

A randomised trial in 110 people with diabetic foot ulcers found faster healing. Almost nothing sold in a clinic resembles that preparation, and the field published a standards document because it could not consistently describe what it was studying.

Exosomes are the most interesting thing on this site that cannot be evaluated as a single product, and understanding why is more useful than any individual result. They are small vesicles that cells release to carry proteins, lipids and nucleic acids to other cells.

Mechanism: Small extracellular vesicles, generally 30 to 150 nanometres, formed inside multivesicular bodies and released when those fuse with the cell membrane. They carry proteins, lipids, messenger RNA and microRNA, and they transfer that cargo to recipient cells, altering gene expression and behaviour.

Regulatory history: No exosome product is approved by the FDA for any indication. The agency has stated publicly that there are no approved exosome products and has acted against clinics marketing them, so anything sold in a clinic is unapproved regardless of how it is described.

Approves prescription drugs by indication and polices unapproved products, including peptides sold online. Compounding pharmacies may prepare some compounds under a prescription when the FDA places them on a permitted bulk-substances category.

The classification above is the The Longevity Archive reading of U.S. Food and Drug Administration listings for Exosomes at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.