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What regulators have said about ozone therapy and EBO2
Find the primary source behind a regulatory claim, and read the document's own words.
Last checked
September 28, 2026
Records
34 records, dated 1976 to 2026.
Source
The issuing body's own page or document, for every record.
Each record is a primary source we opened ourselves: the agency's, court's, or legislature's own page or document.
The quoted language is copied from that source. A script checks each quote against the saved text of the regulatory sources we read, pooled across all of them rather than against one named page; the saved copies are not published. The summary is ours.
Warning letter after a 2023 inspection. FDA says the firm's Champion Full Spectrum and EBOO Full Spectrum UV autohemotherapy devices, which expose blood to ozone and UV light for UBI or EBOO, are adulterated and misbranded for lack of premarket approval or clearance. It also cites registration, UDI, and quality-system failures, and notes the EBOO kits included purchased hemodialyzer filters.
Your products are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not for these devices have approved applications for premarket approval (PMA) in effect
From the source: FDA, Center for Biologics Evaluation and Research, Warning letter to O3UV, LLC (CBER 25-668840), July 7, 2025.
Ozone devices
Ozone generators and other devices that make or use ozone. 5 records, newest first.
Agência Nacional de Vigilância Sanitária (Anvisa), Brazil
Type
Guidance
Jurisdiction
Other countries
Status
Current
Technical note from Brazil's health regulator listing the uses it recognizes for ozone-emitting medical devices: skin cleansing with ozonated vapour, local dental uses, and, only as an adjunct, bagged ozone-oxygen gas for diabetic foot ulcers and acute infected wounds in adults. It says devices may be sold only for approved indications, warns of severe harm from other routes or doses, and replaces Note 43/2022.
qualquer dispositivo emissor de ozônio somente poderá ser comercializado para as indicações previamente aprovadas e constantes nas respectivas instruções de uso.
From the source: Agência Nacional de Vigilância Sanitária (Anvisa), Brazil, Nota Técnica nº 41/2026/SEI/GQUIP/GGTPS/DIRE3/ANVISA, June 16, 2026.
U.S. Department of Justice, U.S. Attorney's Office for the Eastern District of Virginia
Type
Enforcement action
Jurisdiction
United States (federal)
Status
Current
Party named
Jawad Bhatti
Press release on charges in the 2025 National Health Care Fraud Takedown. A Richmond pain physician was indicted on health care fraud, false statement, adulterated and misbranded device, and misbranded drug counts. The indictment alleges he used three FDA-unapproved medical ozone generators, injected patients with ozone, and billed ozone treatments as nerve blocks. The release notes charges are only allegations.
As alleged in the Indictment, in his first scheme, Bhatti received in interstate commerce three FDA-unapproved devices that produced medical ozone gas
From the source: U.S. Department of Justice, U.S. Attorney's Office for the Eastern District of Virginia, U.S. Attorney Erik S. Siebert announces charges as part of DOJ’s national health care fraud enforcement action, June 30, 2025.
FDA consumer update on home machines sold to clean CPAP equipment with ozone gas or UV light. It says no device is FDA cleared or approved for cleaning, disinfecting, or sanitizing CPAP machines, that ozone can leak into the home and stay above safe limits inside the equipment for hours, and that FDA has received reports of asthma attacks, headaches, and breathlessness after ozone cleaner use.
The FDA has received reports from people who use CPAPs that they experienced unexpected asthma attacks, headaches, and breathlessness after using devices claiming to use ozone gas to clean CPAP accessories such as hoses and masks.
From the source: FDA, Office of the Commissioner, Do You Need a Device That Claims to Clean a CPAP Machine?, August 26, 2024.
Public advisory (RA-72150) saying ozone saunas need a Canadian medical device licence, that none has been licensed, and that it is illegal to sell or advertise unlicensed medical devices. It lists advertised uses including detoxing and treating infections and cancer, sets out risks such as lung injury and fire, and says Health Canada is asking sellers to stop and contacting clinics and spas.
To date, Health Canada has not received any submissions with evidence to support medical treatment claims for ozone saunas.
From the source: Health Canada, Unlicensed ozone saunas may pose serious health risks to users and anyone in close proximity, November 2, 2022.
FDA, Center for Devices and Radiological Health (medical device recall database)
Type
Enforcement action
Jurisdiction
United States (federal)
Status
Historical
Party named
William C. Domb, D.M.D., A Professional Corporation
FDA recall database entry for a Class 2 recall of a corona-discharge ozone generator listed under the product code for operative dental units. It records the firm's reason (the generator is not approved or cleared by FDA for medical use), FDA's determined cause (no marketing application), 16 units distributed in the US and abroad, and termination of the recall in January 2015.
William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
From the source: FDA, Center for Devices and Radiological Health (medical device recall database), Class 2 Device Recall Enaly 1000 BT12 Ozone Generator (Recall Number Z-1576-2014), May 9, 2014.
Ozone therapy
Laws, rules, guidance, court decisions, and enforcement about ozone therapy as a practice. 14 records, newest first.
Resolution of Brazil's Federal Council of Medicine authorizing ozone therapy as an adjuvant medical treatment for four kinds of wound (topical use only), knee osteoarthritis and disc-related low back pain, with facility and specialist rules. It bars use on cancerous wounds outside approved research, requires Anvisa-regularized generators, and revokes Resolution 2.181/2018.
Fica expressamente vedada a utilização de ozonioterapia para o tratamento de feridas neoplásicas em qualquer estágio, exceto em contexto de pesquisa clínica formalmente aprovada.
From the source: Conselho Federal de Medicina (CFM), Brazil, Resolução CFM n° 2.445, de 21 de agosto de 2025, August 21, 2025.
Order barring a Penrith clinic from providing any health services, including ozone therapy, for five years. The Commission found its non-registered practitioner used an ozone generator and UV device not approved by the TGA, obtained heparin unlawfully and lacked infection control and records, and that, according to expert opinion, his treatment most likely caused a patient's infection leading to septic shock.
Dr Phan was using equipment and devices in the provision of ozone therapy at the Clinic, that were not approved by the TGA, including the EXT120 Ozone Generator and the Champion Full Spectrum UV device.
From the source: NSW Health Care Complaints Commission (HCCC), Ozone Healing Clinic, Penrith: Time-bound Prohibition Order, April 8, 2025.
Interim order, made under section 45B of the Health Care Complaints Act 1993 while the Commission investigated, barring a Castle Hill ozone clinic and anyone working under it from providing any health service, including medication and intravenous or skin puncture procedures. Effective 1 August 2024 and renewed 11 March 2025, the page lists it as ending 6 May 2025. The page states no findings.
must not under any circumstances provide, or cause to be provided, any health service, including but not limited to the administration of any medication and/or intravenous and skin puncture procedures
From the source: NSW Health Care Complaints Commission (HCCC), The Ozone Clinic, Castle Hill: Interim Prohibition Order, August 1, 2024.
Board decision adopting a stipulated settlement: the license is revoked, the revocation stayed, and five years' probation imposed, during which the physician may not perform intravenous ozone therapy. He admitted the accusation, which says a patient lost consciousness during IV ozone treatment in 2020 and was diagnosed with air embolism and stroke, and charges failures of informed consent and equipment maintenance.
During probation, Respondent is prohibited from performing intravenous ozone therapy treatment.
From the source: Medical Board of California, In the Matter of the Accusation Against German Zermeno, M.D., Case No. 800-2022-088393: Decision and Stipulated Settlement, June 21, 2024.
New York Supreme Court, Appellate Division, Third Department
Type
Court decision
Jurisdiction
United States (states)
Status
Historical
Party named
Howard Robins (appellant); Betty Rosa et al. (respondents)
Appeal by a New York podiatrist who used ozone therapy for ailments unrelated to podiatry. The court recounts that the city medical examiner attributed a patient's death to intravenous ozone-oxygen gas, that courts upheld that finding, and that state regulators opened a misconduct investigation. It affirms dismissal, for improper service, of his suit to bar use of those findings against him.
which determined that an intravenous injection of ozone-oxygen gas was the cause of the patient's death and ruled it a homicide due to extreme medical negligence
From the source: New York Supreme Court, Appellate Division, Third Department, Matter of Robins v Rosa, 2024 NY Slip Op 01757 [225 AD3d 1110], March 28, 2024.
Brazil: National Congress and President of the Republic
Type
Regulation or law
Jurisdiction
Other countries
Status
Current
Brazilian federal law authorizing ozone therapy nationwide as a complementary procedure on three conditions: only a university-level health professional registered with a professional council may perform it, only with a medical ozone generator regularized by the health regulator Anvisa, and the professional must tell the patient that the procedure is complementary.
Fica autorizada a realização da ozonioterapia como procedimento de caráter complementar, observadas as seguintes condições
From the source: Brazil: National Congress and President of the Republic, Lei nº 14.648, de 4 de agosto de 2023: Autoriza a ozonioterapia no território nacional, August 4, 2023.
New York Supreme Court, Appellate Division, First Department
Type
Court decision
Jurisdiction
United States (states)
Status
Historical
Party named
Howard Robins DPM (appellant); New York City Office of Chief Medical Examiner (respondent)
The court unanimously affirmed dismissal of a podiatrist's challenge to the New York City medical examiner's July 2020 finding that his patient's death was a homicide due to extreme medical negligence. It cites record evidence that he injected the patient intravenously with ozone gas, that cardiac arrest followed within 15 minutes, and that gas emboli were attributed to the ozone injection.
The medical examiner also observed gas emboli and concluded, based on their existence in both small and large blood vessels, that they were attributable to the injection of ozone.
From the source: New York Supreme Court, Appellate Division, First Department, Matter of Robins v New York City Off. of Chief Med. Examiner, 2023 NY Slip Op 00286 [212 AD3d 541], January 24, 2023.
Regione Toscana, Organismo Toscano per il Governo Clinico (Comitato Tecnico Scientifico)
Type
Guidance
Jurisdiction
Italy
Status
Current
Party named
Istituto Internazionale Barco SRL
Supporting annex to a decision of Tuscany's clinical governance body on an intravenous 'liquid polyatomic oxygen' therapy. It says the practice cannot be counted as oxygen-ozone therapy and may be given only in authorized facilities within controlled trials with ethics approval. Summarizing Italian ozone society guidelines, it says the oxygen-ozone gas mixture must not be given by direct intravenous injection.
la miscela gassosa di ossigeno-ozono non deve essere utilizzata in somministrazione endovenosa diretta per il pericolo di embolia gassosa polmonare
From the source: Regione Toscana, Organismo Toscano per il Governo Clinico (Comitato Tecnico Scientifico), Allegato alla Decisione CTS n. 20 del 11/12/2018, December 11, 2018.
Opinion of the Tuscany regional health council classing colon hydrotherapy, chelation therapy and ozone therapy as invasive procedures whose premises need health authorization. It attaches the National Blood Centre's opinion on ozonated autohemotherapy and states that the practice is not a transfusion activity, needs sterile preparation, and is reintroduction of manipulated autologous material, not venipuncture.
Questa pratica, di dubbia efficacia clinica, non rientra a nessun titolo nelle attività trasfusionali.
From the source: Regione Toscana, Consiglio Sanitario Regionale, Parere 67/2015: Prestazioni di idrocolonterapia, terapia chelante e ozonoterapia, November 3, 2015.
Opinion of the Tuscany regional health council on oxygen-ozone therapy in private outpatient facilities. It sets out which premises need regional authorization, refers to the Health Ministry's January 2005 circular on the doctor's personal responsibility, and says that, apart from that, oxygen-ozone therapy is possible only in controlled clinical trials with the local ethics committee.
le attività di ossigeno-ozono terapia sono possibili solo in regime di sperimentazione clinica controllata
From the source: Regione Toscana, Consiglio Sanitario Regionale, Parere 10/2007: Utilizzo ossigeno-ozono terapia in strutture ambulatoriali private, March 6, 2007.
Opinion of the Tuscany regional health council on oxygen-ozone therapy. It finds no top-grade evidence for intradiscal ozone, proposes only randomized trials in suitable centres with ethics committee approval, limits indications to symptomatic disc herniation treated by intraforaminal or intradiscal injection, and says other use is at the doctor's own responsibility with informed consent.
Non esiste alcuna indicazione per altre affezioni.
From the source: Regione Toscana, Consiglio Sanitario Regionale, Parere 31/2006: Ossigeno ozonoterapia, September 5, 2006.
Ministero della Salute, Direzione Generale dei Farmaci e Dispositivi Medici
Type
Guidance
Jurisdiction
Italy
Status
Current
Italian Health Ministry circular to regional health departments and the Carabinieri health command, published by the Tuscany region as an annex. It says its 2002 note restricting oxygen-ozone therapy to hospital trials is not legally binding, warns that departing from the Superior Health Council's view could expose doctors to liability, and relays that Council's opinion of 19 November 2003, quoted here.
a suo giudizio, non sono oggi disponibili studi clinici controllati a supporto dell'efficacia della OOT, e che questa metodica può causare effetti collaterali gravi e potenzialmente letali.
From the source: Ministero della Salute, Direzione Generale dei Farmaci e Dispositivi Medici, Ossigeno-ozono terapia (nota N° DGFDM.III/P/1752/I.4.C.C.), January 20, 2005.
Oregon Board of Medical Examiners (now Oregon Medical Board)
Type
Enforcement action
Jurisdiction
United States (states)
Status
Historical
Party named
John E. Gambee, M.D.
Final order after a contested case hearing. The board found that a physician's ozone therapy for a terminally ill myeloma patient was unproved and unnecessary treatment and not an accepted modality in the United States, and concluded it was unprofessional conduct. It was one of four independent grounds on which the board revoked his license, effective December 31, 1994.
The treatment of patient D.B. with Ozone therapy constitutes the use of unproved and unnecessary treatment.
From the source: Oregon Board of Medical Examiners (now Oregon Medical Board), In the Matter of John E. Gambee, M.D., Final Order, October 13, 1994.
Federal device labeling regulation (source 41 FR 6896, 1976). It states that ozone has no known useful medical application, describes irritation of the lungs and delayed pulmonary edema, and says a device that generates ozone is adulterated and/or misbranded if used above 0.05 ppm in occupied spaces or in any medical condition without proof of safety and effectiveness.
Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy.
From the source: FDA (Code of Federal Regulations, Title 21), 21 CFR 801.415 Maximum acceptable level of ozone, February 13, 1976.
Dialysis filters
How regulators classify hemodialysis filters and systems. 1 record, newest first.
Federal classification regulation for high-permeability hemodialyzers and the systems that use them (65 FR 17145, 2000). It identifies the device as an artificial kidney system for patients with renal failure, fluid overload, or toxemic conditions, used for hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration, and places it in Class II with special controls.
A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions
From the source: FDA (Code of Federal Regulations, Title 21), 21 CFR 876.5860 High permeability hemodialysis system, March 31, 2000.
Health claims
Warnings and rulings about what may be claimed for a treatment or device, including claims about FDA status. 13 records, newest first.
FDA consumer update on what "FDA approved" means. It says FDA does not approve health care providers, that registering an establishment or listing a device does not denote approval or mean a product may be legally marketed, that most high-risk devices need premarket approval, and that moderate-risk devices such as dialysis equipment are marketed through 510(k) clearance.
Generally, manufacturers of moderate-risk medical devices (Class II) (for example dialysis equipment and many types of catheters) may market such devices pursuant to so-called “510(k) clearance,”
From the source: FDA, Office of the Commissioner, Is It Really 'FDA Approved'?, May 4, 2026.
Advertising Standards Authority (ASA) and Committee of Advertising Practice (CAP)
Type
Enforcement action
Jurisdiction
United Kingdom
Status
Current
Party named
The Detox Clinic Ltd
Entry on the ASA's list of non-compliant online advertisers, added on 31 March 2022 after its ruling on the company's IV ozone therapy claims. It says the site still made efficacy claims, such as that the therapy may strengthen the immune system and destroy fungi, bacteria and viruses, and that the listing stays until the claims are removed or amended.
Despite requests from the CAP Compliance team to remove or amend the health-related claims, The Detox Clinic Ltd continues to feature them on thedetoxclinicltd.com.
From the source: Advertising Standards Authority (ASA) and Committee of Advertising Practice (CAP), Non-compliant online advertisers: The Detox Clinic Ltd, March 31, 2022.
Upheld ruling by the UK advertising regulator on a clinic web page for 'IV Ozone Therapy' that said ozone raises dissolved blood oxygen, improves energy and is anti-inflammatory, antibacterial, antiviral and antifungal. The clinic gave no evidence; the ASA found the claims unsubstantiated and misleading and told it not to repeat them without a substantive body of evidence, including trials on people.
We had not previously seen evidence that oxygen therapy had health benefits or could prevent or treat illness or disease.
From the source: Advertising Standards Authority (ASA), ASA Ruling on The Detox Clinic Ltd, March 2, 2022.
FDA consumer page on the terms "FDA Registered", "FDA Certified", and "FDA Registration Certificate", which it says may be used to mislead. It says a registration and listing entry is not approval, clearance, or authorization, that FDA issues no device registration certificates, that firms displaying such certificates to imply FDA review misbrand the device, and how to check Devices@FDA.
When a facility registers its establishment and lists its devices, the resulting entry in the FDA's registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices.
From the source: FDA, Center for Devices and Radiological Health, Are There "FDA Registered" or "FDA Certified" Medical Devices? How Do I Know What Is FDA Approved?, March 3, 2021.
American Regenerative Clinic; Health and Wellness of Carmel; Howard Robins, DPM; The Fuel Stop
FTC press release announcing its ninth set of COVID-19 warning letters, bringing the total to more than 330 recipients. Four recipients are grouped under ozone therapy, stem cell and immunotherapy, and intravenous therapy. The FTC says the claims are unsubstantiated, tells recipients to stop them and report within 48 hours, and notes it may seek court injunctions and refunds.
Some of the letters announced today target products and “treatments” the FTC has warned companies about previously, including intravenous (IV) Vitamin C infusions, ozone therapy, and supplements.
From the source: Federal Trade Commission, FTC Sends Letters Warning 20 More Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Prevent or Treat COVID-19, November 12, 2020.
FDA (Center for Drug Evaluation and Research) and Federal Trade Commission
Type
Warning letter
Jurisdiction
United States (federal)
Status
Historical
Party named
Center for Wellness and Integrative Medicine
Joint FDA and FTC COVID-19 warning letter to a Soquel, California clinic. FDA says a COVID supplement pack, thymosin-alpha, and methylene blue capsules on its site are unapproved new drugs and misbranded. The FTC section lists other claims it says lack competent and reliable scientific evidence, such as "Ozone immune & metabolic stimulation" and weekly injections of the patient's blood mixed with saline and ozone.
Additional examples of claims for products or services that are not supported by competent and reliable scientific evidence include:
From the source: FDA (Center for Drug Evaluation and Research) and Federal Trade Commission, Warning letter to Center for Wellness and Integrative Medicine (MARCS-CMS 608693): Unapproved and Misbranded Products Related to COVID-19, June 30, 2020.
FDA (Center for Food Safety and Applied Nutrition) and Federal Trade Commission
Type
Warning letter
Jurisdiction
United States (federal)
Status
Historical
Party named
Center for New Medicine/Perfectly Healthy by Connealy MD
Joint FDA and FTC COVID-19 warning letter to an Irvine, California clinic. FDA says six supplement products on the firm's websites are unapproved new drugs and misbranded. The FTC section lists further claims it says lack competent and reliable scientific evidence, among them posts stating that ozone destroys viruses and that ozone treatments help treat and prevent viruses, and tells the firm to stop them.
Additional examples of claims for products or services that are not supported by competent and reliable scientific evidence include:
From the source: FDA (Center for Food Safety and Applied Nutrition) and Federal Trade Commission, Warning letter to Center for New Medicine/Perfectly Healthy by Connealy MD (MARCS-CMS 605804): Unapproved and Misbranded Products Related to COVID-19, May 6, 2020.
U.S. Department of Justice, Office of Public Affairs
Type
Enforcement action
Jurisdiction
United States (federal)
Status
Current
Party named
Purity Health and Wellness Centers; Jean Juanita Allen
Justice Department press release. A federal court in the Northern District of Texas entered an agreed permanent injunction against a Dallas ozone therapy center and one of its principals over COVID-19 claims. DOJ says court filings alleged the center called its ozone treatments 95 percent effective and the "only prevention" for COVID-19, and notes that the complaint's claims are allegations.
The defendants agreed to be bound by a permanent injunction barring them from representing that ozone could be used to treat or cure COVID-19.
From the source: U.S. Department of Justice, Office of Public Affairs, Court Prohibits Dallas Health Center from Touting "Ozone Therapy" as a COVID-19 Treatment, April 24, 2020.
American Medical Aesthetics; RowenSu Clinic; TRLYHEAL Pty. Ltd.; Vidaful Medicine
FTC press release announcing its third set of COVID-19 warning letters, covering IV vitamin C, stem cell, acupuncture, and ozone therapy claims. It lists three recipients under an "Ozone Therapy" heading and a fourth whose claims included ozone therapy, and says the letters tell recipients to stop the claims and report back within 48 hours.
However, there is currently no scientific evidence that these products or services can treat or cure coronavirus.
From the source: Federal Trade Commission, FTC Sends 21 Letters Warning Marketers to Stop Making Unsupported Claims That Their Products and Therapies Can Effectively Treat Coronavirus, April 23, 2020.
FTC staff warning letter to a Santa Rosa, California clinic after a review of its website. It cites a "Treating Coronavirus" page promoting intravenous and other ozone services and claims calling ozone therapy a cost-effective and likely effective remedy for viral disease, says no study is known to support such COVID-19 claims, and tells the clinic to stop them and reply within 48 hours.
We have determined that you are unlawfully advertising that certain services treat Coronavirus Disease 2019 (COVID-19).
From the source: Federal Trade Commission, Southwest Region, Warning Letter to RowenSu Clinic: Unsubstantiated Claims for Coronavirus Treatment, April 10, 2020.
Press release from Italy's national public health institute answering press reports that it had approved ozone therapy for COVID-19 patients. It says granting such authorizations is not its role and that it gave none, and that evidence offered for this use should be confirmed by a trial authorized by the Italian Medicines Agency (AIFA).
L’ISS non ha rilasciato un’autorizzazione in tal senso ma, in un carteggio informale, ha invece sottolineato che le evidenze portate a sostegno dell’utilizzo di questa terapia per il trattamento del COVID-19, dovrebbero essere confermate
From the source: Istituto Superiore di Sanità (ISS), CS N° 25/2020 - Ozonoterapia, non rientra nei compiti dell’ISS autorizzare sperimentazioni, March 26, 2020.
Federal device regulation (source 42 FR 42526, 1977). It says that registering a device establishment with FDA, or holding a registration number, is not approval of the establishment or its products, and that any representation giving an impression of official approval because of registration is misleading and is misbranding.
Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products.
From the source: FDA (Code of Federal Regulations, Title 21), 21 CFR 807.39 Misbranding by reference to establishment registration or to registration number, August 23, 1977.
Federal device regulation (source 42 FR 42526, 1977). It says that a 510(k) premarket notification, and FDA's finding that a device is substantially equivalent to a legally marketed one, do not denote official approval of the device, and that representing compliance with these rules as official approval is misleading and is misbranding.
Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding.
From the source: FDA (Code of Federal Regulations, Title 21), 21 CFR 807.97 Misbranding by reference to premarket notification, August 23, 1977.
What this is not
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Not every action is made public, and this list is not complete.
A warning letter states an agency's position on the date it was sent. It is not a court finding, and the recipient
may have responded or resolved the matter since.
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