FDA uses specific terminology for biologics versus other drug categories. Where a conventional drug lacking approval is an unapproved new drug, a biologic lacking the required license under section 351 is described as unlicensed. The practical consequence is the same either way: no FDA authorization exists for the stated use.
FDA states that there are no FDA-approved exosome products. These products are generally regulated as biologic drugs under section 351, so any exosome preparation marketed with a clinical intended use is, by the agency's own framing, unlicensed; a manufacturer's "research use only" label does not change that analysis if the product is actually promoted or sold for clinical application. Purchase and clinical-use decisions belong to the physician, working with the physician's own regulatory counsel.
A useful step is asking a vendor what regulatory category it believes a given product falls into, and keeping a written record of that answer alongside other lot documentation.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Recognizing "unlicensed" as a specific regulatory status helps a buyer separate a vendor's documentation claims from actual FDA authorization.