- Brazilian Federal Law CE14,648 of 2023 (August 4) authorized “ozone therapy throughout the national territory.”
- The Brazilian Federal Council of Medicine (CFM), bound by this federal law, very recently (August 29, 2025) regulated “the use of ozone therapy as an adjuvant medical procedure in the treatment of wounds and musculoskeletal pain.”
- Previously, the CFM spoke out publicly, vehemently, and forcefully against ozone therapy as a medical treatment, threatening physicians with sanctions (including the lifetime revocation of their medical licenses) if they practiced it.
- The 2025 CFM resolution specifies that ozone therapy “as an adjuvant medical procedure in the treatment of wounds and musculoskeletal pain” is “an exclusively medical procedure.”
- Treatment “must be preceded by a nosological diagnosis of the type and cause of the injury” to reduce “the risk of complications” and “improve the management of adverse effects.”
- The CFM states that ozone therapy is a medical procedure and a complementary treatment.
- The physician “must keep systematic records in the medical history”: indication, technique used, ozone concentration, exposure time or volume injected, frequency of applications, and clinical results.
- Brazil has also authorized and regulated the practice of ozone therapy in dentistry (2015); physiotherapy (2018); pharmacy (2020); nursing (2020); veterinary medicine (2020); and biomedicine (2020).
- The Madrid Declaration on Ozone Therapy has affirmed, in its various editions, that ozone therapy is a complementary treatment, a medical procedure, and supports the regulation of the therapy.
- AEPROMO has been providing legal support to its Brazilian colleagues by publishing several in-depth legal analyses on the legal evolution of ozone therapy in this South American country.
The Brazilian Federal Medical Council (CMF) https://www.jusbrasil.com.br/diarios/1385824575/dou-secao-1-29-08-2025-pg-201
obliged by “Federal Law No. 14,648/2023, which authorized ozone therapy as a complementary procedure throughout the country,” had to fulfill its duty “to define the criteria, indications, and limits for the safe practice of the procedure by physicians,” as stated in the “Statement of Reasons for CFM Resolution No. 2,445/2025. This “regulates the use of ozone therapy as a complementary medical procedure in the treatment of wounds and musculoskeletal pain, repeals CFM Resolution 2181/2018, and other provisions.” https://portal.cfm.org.br/wp-content/uploads/2025/08/Resolucao-CFM-n-2.4452025.pdf
For many years, the CFM had been repeatedly, vehemently, and forcefully speaking out against ozone therapy as a medical treatment, even threatening doctors with sanctions (including the lifetime revocation of their medical licenses) if they dared to practice it. Its most recent reminder was on August 6, 2020, where it categorically stated that ozone therapy was not “recognized for the treatment of COVID-19, or for any other disease.” It pointed out that this treatment did not offer “physicians and patients the certainty that” it was “an effective and safe procedure.”
And once again, it threatened that “doctors who did not” comply with “the ethical standards established by the CFM and the Regional Medical Councils would be subject to complaints and investigations into their conduct related to the prescription of ozone therapy.” https://portal.cfm.org.br/noticias/ozonioterapia-nao-e-valida-para-nenhuma-doenca-inclusive-a-covid-19
The ban on ozone therapy was lifted by the CFM (Federal Council of Medicine), as it is obliged to obey and therefore implement the content of Federal Law 14,648 of 2023 (August 4), which authorized “ozone therapy throughout the national territory.” https://aepromo.org/en/brazil-by-law-ozone-therapy-is-authorized-throughout-the-national-territory/
The CFM has extraordinary power over physicians, as do other professional health associations in Brazil, such as dentists, veterinarians, nurses, pharmacists, etc. This immense power lies in authorizing and regulating the practice of different therapies. In the vast majority of countries, government authorities are responsible for authorizing and regulating the practice of therapies. In Brazil, this power has been delegated to federal councils. Furthermore, these, as in many professional associations in other countries, have the power to sanction professionals for violations of their codes of ethics. https://aepromo.org/en/legal-status-of-ozone-therapy-in-brazil-update/
Content of CFM Resolution No. 2,445/2025
“The use of ozone therapy is authorized as a complementary medical therapy for the treatment of the following conditions:
“I – diabetic foot ulcers;
“II – ischemic arterial ulcers;
“III – acute infectious wounds;
“IV – chronic venous ulcers.”
For these diseases, ozone therapy “must be performed exclusively topically, using an airtight plastic bag (ozone bag), ozonized oil, or ointment, with concentrations and frequency defined in care protocols based on available scientific evidence.” And it must be performed “in a hospital setting or in a medical center that has, at least, the infrastructure of a Group 2 facility.” (Article 1)
The resolution “expressly prohibits the use of ozone therapy for the treatment of neoplastic wounds at any stage, except in the context of a formally approved clinical investigation.”
“Authorizes the use of ozone therapy as a complementary medical therapy for the treatment of the following musculoskeletal pain conditions:
“I – knee osteoarthritis;
“II – low back pain due to a herniated disc.” (Art. 3)
“For the treatment of knee osteoarthritis, ozone therapy must be administered by intra-articular injection and may be performed in a specialized clinic or medical center with physical infrastructure compatible with the criteria for Group 3 facilities.” (Art. 4)
“For the treatment of low back pain caused by a herniated disc, ozone therapy, by paravertebral or intradiscal injection, must be performed exclusively by physicians in an outpatient hospital or in a hospital setting with a controlled surgical space, rigorous aseptic technique, and image guidance.” (Article 5)
Procedures for these musculoskeletal pain conditions must be performed by “physicians with a Specialist Qualification Registry (RQE) in the following specialties: anesthesiology, neurosurgery, orthopedics, and traumatology; or in the following practice areas: interventional radiology and angioradiology or pain medicine.” (single paragraph)
“Ozone therapy requires ozone-generating medical equipment duly certified and regulated by the National Health Surveillance Agency (Anvisa). (Article 6)
“The indication for ozone therapy is an exclusively medical procedure, as it must be preceded by a nosological diagnosis of the type and cause of the injury. This diagnosis is essential for the correct application of adjuvant therapy, reducing the risk of complications and improving the management of adverse effects.” (Article 7)
“The treating physician must keep systematic records in the medical history, detailing the indication, the technique used, the ozone concentration, the exposure time or volume injected, the frequency of applications, and the clinical results observed.” (Article 8)
Regulation of ozone therapy in other health care areas
Brazil is the country with the most current regulations on ozone therapy, which are specifically aimed at different health professions. This country, through its respective professional associations, has authorized and regulated the practice of ozone therapy in the following health professions: dentistry (2015); physiotherapy (2018); pharmacy (2020); nursing (2020); veterinary medicine (2020); and biomedicine (2020). https://aepromo.org/en/brazil-bill-that-authorizes-ozone-therapy-in-the-national-territory-sent-for-the-signature-of-the-president-of-the-republic-lula-da-silva/
Madrid Declaration on Ozone Therapy,” ISCO3, 4th ed., 2025, at Regarding CFM Resolution 2.445/2025
Ozone Therapy: Complementary Treatment. It is worth noting that the “Madrid Declaration on Ozone Therapy,” in its four editions, has stated that “Ozone therapy is a complementary treatment and should be performed alongside, not instead of, allopathic medicine. Understanding the difference between complementary and alternative medicine is important for the ozone therapist. The application of ozone therapy complements other allopathic treatments, such as pharmacological interventions and surgical procedures, and does not replace them as an alternative.” (paragraph 1.3)
Ozone therapy: Medical procedure. Ozone therapy is a medical procedure and must be prescribed and performed by a physician. (paragraph 1.4). “Ozone therapy is a medical procedure and must be performed by physicians and applied with scientific rigor.” For this reason, in “medical centers where ozone therapy is practiced (…) must have a qualified physician with recognized training and experience in ozone therapy. This person will be responsible for prescribing and administering the treatment.” (paragraph 19)
Regulation of ozone therapy. Since its first edition in 2010, the Madrid Declaration on Ozone Therapy has spoken out in favor of the regulation of ozone therapy by the relevant authorities. The 4th edition states: ” Welcoming with great satisfaction that the practice of ozone therapy has been legalized to date” in 15 countries.
AEPROMO (Spanish Association of Medical Professionals in Ozone Therapy) and its contributions to the regulation of ozone therapy in Brazil
Since its founding in 2008, under the presidency of Dr. Adriana Schwartz, AEPROMO has advocated for ozone therapy to be practiced within a legal framework and duly protected by the legislation of each country where it is practiced.
In the specific case of Brazil, it has published detailed legal analyses on the legal evolution of ozone therapy in this South American country. Its first specific support came in 2011. https://aepromo.org/3er-congreso-iberoamericano-de-oxigeno-ozonoterapia-2o-congreso-brasilero-de-ozonoterapia-1er-congreso-brasilero-de-hidro-ozonoterapia/
After legal advice from AEPROMO and intensive documentation gathering by ABOZ (Brazilian Association of Ozone Therapy), the association submitted its petition to the Federal Council of Medicine in December 2013, which is empowered to recognize medical procedures and therapies in Brazil,
In 2015, AEPROMO, along with the 21 national ozone therapy associations from different countries, members of the then-existing IMEOF (International Medical Ozone Federation), sent a letter to the CFM, requesting that ozone therapy be regulated as a medical procedure. In this way, he continued to support ABOZ (Brazilian Ozone Therapy Association) in its goal of regularizing ozone therapy. https://aepromo.org/imeof-apoya-a-aboz-en-su-objetivo-de-regularizar-la-ozonoterapia-en-brasil/
Legal support was based on the document published by the legal section of ISCO3 (International Scientific Committee of Ozone Therapy) entitled “Ozone Therapy and Legislation – Analysis for its Regularization” by Roberto Quintero et al. November 18, 2012. 2nd updated and extended edition May 20, 2015. https://isco3.org/wp-content/uploads/2015/09/Update-May-2015-for-ISCO3.pdf
In 2018, legal support continued to be provided to the objective of regulation in Brazil with the publication of the document “Preliminary Legal Evaluation – Legal Situation of Ozone Therapy in Brazil” by Roberto Quintero et al., August 1, 2018. Due to the important decisions to regulate ozone therapy adopted by several Brazilian professional health associations, and the government decision to approve ozone therapy in the public sector (2017), the same authors published the “Legal status of ozone therapy in Brazil – Update”. https://aepromo.org/en/legal-status-of-ozone-therapy-in-brazil-update/
This content is also available in: Spanish
