Mayo Clinic does not offer ozone therapy at any of its three major campuses (Rochester, Phoenix, and Jacksonville), and it has no plans to add it. Under federal regulation 21 CFR 801.415, the FDA classifies ozone as a toxic gas with no known useful medical application, which keeps it out of federally funded US academic medical centers, even though ozone therapy is a regulated treatment in several other countries.
Key Takeaways
- Mayo Clinic does not offer ozone therapy at any of its campuses or in its Integrative Medicine and Health program.
- The barrier is regulatory: 21 CFR 801.415 classifies ozone as having no known useful medical application, and no ozone treatment is FDA-approved.1
- Ozone therapy is regulated and used clinically in a number of countries, including Germany, Italy, Spain, Cuba, and Russia.3
- Ozone treatment is studied in registered clinical trials, but the evidence has not reached the threshold US academic centers require for adoption.
- If you want ozone therapy, you will need a credentialed private practitioner, not a major academic hospital.
This meter grades acceptance by institutions, not clinical efficacy. Ozone therapy sits in a gap: minimal US academic uptake, established regulated use abroad, and a modest but real trial pipeline.
Does Mayo Clinic offer ozone therapy?
No. As of 2026, Mayo Clinic does not offer ozone therapy at any of its campuses, including Mayo Clinic Rochester (Minnesota), Mayo Clinic in Arizona (Phoenix/Scottsdale), Mayo Clinic in Florida (Jacksonville), and the Mayo Clinic Health System regional sites.
Mayo Clinic does run an Integrative Medicine and Health program, but its published offerings are acupuncture, massage, meditation, yoga, and tai chi. Ozone therapy is not among them.2 Mayo has not published clinical guidance recommending ozone therapy for any condition. The absence is consistent, not an oversight.
Why don’t US academic hospitals offer ozone therapy?
The gap between ozone research abroad and its absence from major US medical centers comes down to regulation and economics, not a single scientific verdict. Our ozone therapy overview explains what the treatment is and how it is delivered; here we focus on why the big hospitals stay out. Three institutional factors drive it.
The FDA classification
Federal regulation 21 CFR 801.415 states that ozone is “a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy,” and notes that a germicidal concentration would exceed what humans can safely tolerate.1 Academic medical centers receive federal funding, participate in Medicare and Medicaid, and face intense regulatory scrutiny. Offering a treatment the FDA classifies this way creates institutional risk regardless of what individual studies show.
That classification is decades old and has not been revised to reflect later clinical work. A substantial clinical literature on ozone therapy has since accumulated, including controlled trials, much of it summarized in mechanism reviews by Bocci and by Viebahn-Haensler.35 The regulation, not the current research, is what sets US hospital policy.
Insurance and reimbursement
Academic hospitals operate inside the insurance reimbursement system, and no major US insurer covers ozone therapy. A treatment that generates no reimbursement while requiring clinic space, equipment, trained staff, and liability coverage makes little financial sense for institutions already at capacity with covered procedures.
Institutional conservatism
Large academic centers adopt new treatments slowly by design. A therapy typically needs FDA clearance, insurance coverage, and specialty-department consensus before it enters the service line. Ozone therapy has none of the three in the US, even though it is a regulated medical treatment in Germany, Italy, Spain, Cuba, and Russia.
One distinction that causes confusion:
- FDA registered means a facility or manufacturer has listed itself with the FDA. It is a paperwork step and says nothing about whether a treatment works. Some ozone clinics describe themselves as “FDA registered.”
- FDA cleared or approved means the FDA has reviewed a specific device or treatment and authorized it for a stated medical use. No ozone therapy has this status.
Where can you get ozone therapy from a credentialed provider?
Mayo Clinic and most top US academic hospitals do not offer ozone, but several types of providers do. The key is credentialing and honest evidence discussion, not the size of the institution.
University-affiliated integrative programs and naturopathic schools
Some integrative medicine departments and teaching clinics attached to naturopathic medical schools (for example Bastyr University or the National University of Natural Medicine) include ozone therapy in clinical training. These sit apart from mainstream hospital service lines but carry academic oversight.
Physician-led private clinics
A number of private integrative clinics are led by MDs or DOs with additional ozone training, often through the American Academy of Ozonotherapy (AAO). A responsible practitioner can cite specific studies for your condition and explain what the evidence does and does not support. For a plain look at the safety record, see our ozone therapy safety guide.
Regulated systems abroad
For patients willing to travel, ozone therapy is a recognized or regulated medical treatment in several countries.
| Country | Regulatory status |
|---|---|
| Germany | Long-standing regulated medical use in private and clinical practice |
| Italy | Recognized in clinical practice; regional health-service use in some areas |
| Spain | Regulated and widely available |
| Cuba | Part of the national healthcare and research system |
| Russia | Approved medical treatment in hospitals |
What clinical trials on ozone therapy are underway?
ClinicalTrials.gov, the US government registry of clinical studies, lists registered ozone therapy trials across several conditions, including herniated disc and back pain, diabetic foot ulcers, knee osteoarthritis, and cancer-related nerve pain. One example is NCT04299893, a randomized controlled trial evaluating ozone as an adjuvant treatment for chemotherapy-induced peripheral neuropathy, run at a Spanish university hospital.4
These studies are conducted under IRB or ethics-committee approval. Their existence shows ozone therapy is an active research area, but registration is not the same as proof, and many trials are small or run outside the US. That combination of real study activity and limited large-scale evidence is exactly why institutions like Mayo Clinic have not adopted it. For how the treatment compares to other oxygen-based options, see our HBOT vs ozone therapy vs IV NAD breakdown.
What this means for patients
If you were hoping Mayo Clinic would validate ozone therapy, it does not, and its silence reflects the FDA classification and the economics of academic medicine more than a case-closed scientific ruling. Ozone inhalation specifically is dangerous and can cause pulmonary irritation and edema, which is why 21 CFR 801.415 flags it and why no credentialed practitioner has patients breathe ozone directly.1
Practical steps if you are still considering it:
- Look for qualified practitioners. Seek MDs, DOs, or NDs with specific ozone training and certification, such as through the American Academy of Ozonotherapy.
- Ask about evidence for your specific condition. A good provider should cite named studies and be candid about their limits.
- Coordinate with your conventional doctors. Tell your specialists what you are considering so care stays connected.
- Understand the cost. Ozone therapy is out of pocket. Our ozone therapy cost guide breaks down pricing by modality, and our overview of whether ozone therapy is FDA approved covers the regulatory picture in full.
The bottom line
Mayo Clinic does not offer ozone therapy and is unlikely to in the near term. The reason is 21 CFR 801.415 and the reimbursement realities of academic medicine, not a fresh scientific rejection. Ozone therapy is regulated and used in other countries and studied in registered trials, but it has not cleared the evidence and regulatory bar that US academic centers require. Patients who want it should look to credentialed private practitioners and go in understanding exactly where the evidence stands.
Sources
- US Food and Drug Administration. 21 CFR 801.415: Maximum acceptable level of ozone. Code of Federal Regulations, Title 21. ecfr.gov
- Mayo Clinic. Integrative Medicine and Health: Overview. mayoclinic.org
- Viebahn-Haensler R, Leon Fernandez OS. Ozone in medicine: the low-dose ozone concept and its basic biochemical mechanisms of action in chronic inflammatory diseases. Int J Mol Sci. 2021;22(15):7890. PMID: 34360655
- ClinicalTrials.gov. Ozone Therapy in Chemotherapy-induced Peripheral Neuropathy: a Randomized Controlled Trial (NCT04299893). US National Library of Medicine. clinicaltrials.gov
- Bocci V. Scientific and medical aspects of ozone therapy. State of the art. Arch Med Res. 2006;37(4):425-435. PMID: 16624639
Medical Disclaimer
The content on BaricBoost.com is for informational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
Author
Seph Fontane Pennock is the founder of BaricBoost.com and Regenerated.com, a clinic directory for regenerative medicine serving 10,000+ providers across the United States. He previously built and sold PositivePsychology.com, which grew to 19 million users and became the largest evidence-based positive psychology resource on the web. Seph brings direct experience as an HBOT patient, having completed protocols at clinics across three continents while navigating mold illness, systemic inflammation, and autoimmune conditions. His treatment journey includes hyperbaric oxygen therapy, peptide protocols, NAD+ therapy, and consultations with specialists from Dubai to Cape Town to Mexico. This combination of entrepreneurial track record and lived patient experience shapes everything published on BaricBoost.com. Every article is grounded in peer-reviewed research, informed by real clinical encounters, and written for patients making high-stakes treatment decisions. Seph's focus is on bringing transparency, scientific rigor, and practical guidance to the hyperbaric oxygen therapy space.
