Is Exosome Therapy Illegal? FDA Approval, Biologics & the Law Explained | Dr. Park @drpark65
Is Exosome Therapy Illegal? FDA Approval, Biologics & the Law Explained | Dr. Park  @drpark65
Uploaded July 2026 | Updated September 2026, 2 weeks ago
Epidural steroids β€” standard of care for back pain β€” are not FDA approved, have never been scientifically proven helpful, and carry a 16-year-old FDA black box warning for risk of toxicity, paralysis, and death. Yet they're routinely reimbursed with no questions asked. Dr. Edward Park, MD uses this example to put exosome therapy in regulatory context: most biologics are not FDA approved, but that does not make them illegal. As he puts it, "You sleep every night, you give hugs, you do deep breathing β€” none of these are FDA approved, and you are not breaking the law." With over a dozen FDA-sponsored MSC exosome trials now underway, the regulatory landscape is shifting.

Full episode: youtu.be/scoxgf9q3So
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Edward Park |

Is Exosome Therapy Illegal? FDA Approval, Biologics & the Law Explained | Dr. Park

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