Are regenerative injections FDA-approved?
This needs to be answered therapy by therapy. PRP is prepared using devices that are FDA-cleared for producing platelet concentrate, but its use for specific orthopedic conditions is generally not an FDA-approved indication. Prolozone is not FDA-approved to treat, cure, or prevent any disease. Stem cell therapy for orthopedic conditions is not FDA-approved and is considered investigational. Any clinic describing these therapies flatly as FDA-approved is not giving you an accurate picture.
Cleared, approved, and unapproved are different things
FDA clearance of a device — such as a centrifuge system used to prepare PRP — means the device may be marketed for a stated purpose. That is not the same as FDA approval of a therapy for treating a particular condition, which is a higher bar requiring specific clinical evidence.
This distinction gets blurred routinely in regenerative medicine marketing. It is worth knowing so you can read a clinic’s claims accurately.
What off-label and investigational mean for you
Off-label use is legal, common across medicine, and does not by itself indicate a treatment is unsafe or ineffective. Investigational means the therapy is still being studied for that use and its benefit has not been established.
What both mean practically is that you carry more of the uncertainty than you would with an approved indication, and that you should expect a provider to be direct about it rather than glossing over it.
What we tell patients
We say plainly where each therapy stands, what the evidence supports for your specific condition, and where it does not. If you are being asked to pay out of pocket for something investigational, you deserve to know that is what it is before you decide, not after.
More about Regenerative Injections
Get a straight answer about your options
Book a consultation with our Folsom naturopathic team for an honest read on what the evidence supports for your specific condition.
Bring recent lab work if you have it — we’ll review it with you.
Medical disclaimer: The information on this page is for general education and is not medical advice, diagnosis, or treatment. Regulatory status is summarized in general terms and may change; it is not legal or regulatory advice. Prolozone is not FDA-approved to cure, treat, or prevent any disease. Stem cell therapy for orthopedic conditions is not FDA-approved and is considered investigational. Discuss regulatory status and evidence with a licensed provider before consenting to any treatment.