There are many clinics and doctors currently offering patients supposed medical treatment with ozone based therapy. A google search of "prolozone near me" revealed over 15 clinics within about 15 miles of me that currently advertise ozone therapy as a medical treatment...with clinics ranging from chiropractors to physicians to med spas to surgeons.
The Problem? There are no approved medical ozone devices or ozone therapies for ANY medical condition in the USA....so says the only regulatory authority....the FDA.
So, any clinic or doctor advertising ozone therapy or using an ozone device is likely using an adulterated and misbranded device and delivering an adulterated and misbranded drug. And as noted in this recent Federal lawsuit against a Richmond doctor.....patients are being harmed.
So, at this point, regardless of anyone's opinion on the medical benefits of ozone therapy.....we can't do it legally in the USA at the present time.
Without even basic safety data to satisfy the FDA regulators, a clinic or doctor cannot justify using an unapproved drug or unapproved medical device....and is subject to significant medical and legal liability in my opinion.
Stay safe!
Common questions
- Is ozone therapy FDA approved?
- No. FDA regulation 21 CFR 801.415 describes ozone as a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. There are no approved medical ozone devices and no approved ozone therapies for any medical condition in the United States. A clinic advertising ozone therapy is therefore likely using an adulterated and misbranded device and delivering an adulterated and misbranded drug.
- Prolozone clinics are everywhere near me. Does that mean it is allowed?
- No. A search for prolozone near me turned up over 15 clinics within about 15 miles, ranging from chiropractors to physicians to med spas to surgeons. Volume is not authorization. None of them is working from an approved device or an approved therapy, and a recent federal lawsuit against a Richmond physician indicates that patients are being harmed.
- What is the risk to a doctor who offers ozone therapy?
- Significant medical and legal liability. Without even basic safety data to satisfy FDA regulators, a clinic cannot justify using an unapproved drug or an unapproved medical device. That exposure falls on the physician, the practice and its malpractice coverage. It is the reason Texas Orthobiologics does not offer prolozone or any other ozone-based treatment.
