Ozone therapy fda The FDA is responsible for ensuring the safety and effectiveness of drugs and medical devices before they can be marketed and used by the public. (a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. What Ozone Therapy Is Good For? Circulatory Disorders: Does ozone therapy help with circulation? Oct 20, 2021 · Ozone has been given GRAS (Generally Recognized as Safe) approval by the USDA and the FDA for direct contact with food products, including all meat and poultry products. But due to a poor financial model, Vasogen folded without producing a fully FDA approved ozone therapy machine. Dec 24, 2024 · U. Aug 28, 2024 · On your firm’s website, your devices are described as using activated oxygen (ozone) to disinfect or sanitize Continuous Positive Airway Pressure (CPAP) therapy devices and CPAP accessories, and This perception of the CFM is corroborated by the US Food and Drug Administration (FDA), which considers ozone a toxic gas with no known medical application. Later, the FDA also approved the use of ozone as a sanitizing agent for bottled water treatment lines, under a similar GRAS petition. As of 1998, the following states have such protection: Alaska, Colorado, Georgia, Nevada, New Mexico, New York, North Carolina, Oklahoma, Texas, Washington and Minnesota. What ozone therapy is and why clear rules are essential How the FDA and state laws guide ozone use in the U. Under a company called Vasogen, ozone therapy made it through rounds one and two of the FDA clinical trials for efficacy and safety. International regulations and the significance of CE marking Professional best practices for safe and ethical ozone administration Current market trends, research updates, and what the future holds Answers to common questions about ozone therapy regulations for both patients and Dec 14, 2023 · The Gist: Ozone therapy is not actually illegal in the U. Why Is Ozone Not Approved by the FDA? EBOO Ozone therapy is not approved by the FDA because it is considered an alternative treatment, and there has not been enough large-scale clinical research to satisfy the agency’s requirements for approval. Medical Ozone History Used medically since the early 1900s Suppressed in the US as pharmaceuticals were issued Germany continued development - ozone generators and medical applications 1976 to date FDA says, “Ozone is a toxic gas with no known medical use”. Ozone (O3) gas discovered in the mid-nineteenth century is a molecule consisting of three atoms of oxygen in a dynamically unstable structure due to the presence of mesomeric states. Extracorporeal Blood Oxygenation & Ozonation Introducing an elegant yet powerful ozone IV treatment to help patients recover faster from chronic illness or infection, and even filter out the ongoing daily toxicants that we are all exposed to. 1-888-INFO-FDA (1-888-463-6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Jan 16, 2023 · The evidence gap map presents an overview of contributions of Ozone treatment in controlling pain, infections, inflammation and wound healing, as well as increasing the quality of life, and it is directed to researchers and health professionals specialized in Ozone treatment. May 1, 2024 · The Food and Drug Administration (FDA) in the United States, for example, prohibits the application of ozone therapy due to its potential harmful effects. Despite claims of therapeutic benefits, Regulatory agencies, such as the U. Learn side effects benefits of OZ therapy . 1-888-INFO-FDA (1-888-463-6332) Contact FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Jul 9, 2025 · This blog post details why clinics and doctors in the USA are currently not able to offer or advertise ozone based therapies because there is no FDA regulatory approval of devices or treatments yet. The final rule from the FDA providing GRAS approval was given in 2001, the USDA followed with the The FDA approved IBWA’s petition for ozone in bottled water, and in 1982 published in the Code of Federal Regulations a formal FDA regulation affirming GRAS Status for use of ozone (FDA, 1982). It can be administered via multiple ways. Feb 7, 2025 · Ozone therapy is a controversial alternative medicine practice. FDA informs patients and health care providers that devices claiming to clean, disinfect or sanitize CPAP devices or accessories using ozone gas or UV light are not legally marketed for this use As of this writing, ozone therapy in the U. No serious adverse effe … May 2, 2024 · Ozone therapy, also known as “oxygen therapy” or “ozone therapy”, can play an effective role in the treatment of many conditions and diseases, from skin diseases to infections, in line with the recommendations of doctors. Food and Drug Administration (FDA). Inhaling ozone can lead to serious lung issues, including irritation and damage, particularly in individuals with respiratory diseases. A federal court entered a permanent injunction halting a purported “ozone therapy” center in Dallas from offering unproven treatments for COVID-19 Safety and Considerations Ozone therapy, including EBOO, has been studied for over a century and is considered safe when administered by trained professionals. Doctors in New York and many other states now practice some form of ozone therapy under the health freedom laws. Ozone Autohemotherapy (Minor and Major) has powerful healing capabilities, and this type of ozone treatment supports circulation and long-term recovery as well as anti-inflammatory effects within Nov 18, 2022 · There are currently no FDA-approved medical indications for ozone therapy. Is EBOO Ozone Therapy Safe? When administered by qualified providers using FDA-compliant equipment, EBOO therapy has an excellent safety profile. “EBOO” stands for Extracorporeal Blood Oxygenation and Ozonation. clevelandclinic. Ozone is naturally occurring and non-patentable medication. Despite the lack of Apr 24, 2025 · 3. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals. Unfortunately, big Pharma is not going to financially back studies on Ozone treatments as it is not a money maker for drug companies. Although the FDA says that ozone is a toxic gas Although this controversial approach is touted by some alternative medicine practitioners as a treatment for various conditions, I don’t recommend ozone therapy and have a number of concerns about its safety. The efficacy of this treatment is questionable, the Jun 25, 2023 · Ozone therapy is not FDA approved as a medical treatment. While ozone therapy has shown promising results in various studies, it has not yet been accepted as a mainstream treatment due to the need for Ion generating devices promoted for medical use are subject to the requirements of the Federal Food, Drug, and Cosmetic Act. Ozone has been used in countries in Europe for 50-70 years and is an everyday practice to treat and prevent a large variety of illness. The United States Food and Drug Administration (FDA) prohibits all medical uses of ozone "in any medical condition for which there is no proof of safety and effectiveness", stating "ozone is a toxic gas with no known useful medical application in For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 801. Aug 29, 2024 · An FDA approved ozone therapy machine is not currently available. While good manufacturing procedures must be in place, no regulations exist on levels of ozone in food processing applications. S. Aug 12, 2024 · The FDA warns against ozone therapy due to insufficient evidence supporting its safety and efficacy. Ozone is not an approved therapy from the FDA. 10+ major books and over 11,000 papers and studies. Jun 6, 2025 · No, ozone therapy is not FDA approved as a primary treatment for any specific disease. However, some ozone generators are FDA-cleared for specific uses, such as water purification. Currently, ozone therapy is a subject of debate in the medical community as many mainstream organizations, such as the FDA and the American Medical Association, don’t recommend it or recognize it as a legitimate medical treatment. Naturopaths in Canada and America have always used ozone. 415 Maximum acceptable level of ozone. Food and Drug May 27, 2025 · Discover how ozone therapy works, what conditions it supports, and why more integrative doctors are offering it. In fact, safety concerns about ozone therapy have led to warnings from the U. The FDA maintains that more research is needed before ozone therapy can be considered a safe and acceptable treatment option for specific ailments. 368 See full list on health. Apr 17, 2022 · Ozone therapy is the process of using ozone gas in medical procedures to treat certain illnesses. Aug 17, 2011 · However, the Board also instructed me to make you aware that, due to the experimental and investigational nature ofthe non-FDA approved therapy, the Board would be extremely concerned should any patient complaints be received related to the use of Ozone therapy. Such devices labeled with unsupported medical claims are in violation Ozone therapy, often marketed as an immune-boosting alternative treatment, lacks robust evidence of efficacy and poses significant safety risks. More research is needed to better understand the uses and benefits, as well as potential risks to this therapy. Food and Drug Administration (FDA) has not approved ozone therapy to treat any medical condition. , but it’s not supported by the U. Aug 20, 2020 · When it comes to ozone therapy there is the perception that it is not only dangerous, but also illegal. It is a gentle ozone IV therapy that is well . Ozone therapy is an alternative medical treatment that introduces ozone or ozonides to the body. While ozone is approved for certain specific uses, such as disinfecting medical devices and treating drinking water, its therapeutic use is considered off-label in many jurisdictions. The FDA regards ozone therapy as quackery and has stated that there is no useful role for it in medicine. Ozone therapy is a treatment that involves exposing the body to ozone gas. is not FDA approved for medical conditions. So then why would it be illegal to practice ozone therapy? Fact is, it’s not. The gas comes from medical-grade canisters. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. org Aug 28, 2025 · The Regulatory Landscape of Ozone Therapy The regulation of medical treatments in the United States falls primarily under the purview of the U. Its use on medical conditions Ozone therapy is the administration of a small dose of medical grade ozone gas into the body. And that although ozone therapy dates back at least 150 years, is safer than most over-the-counter drugs, and has had less documented fatalities than chiropractic. Gain momentum in your health. Ozone (O3) is a super-charged oxygen molecule, which is extremely reactive. The treatment uses ozone gas to heal diseases or wounds. Oxygen / Ozone Therapy Autohemotherapy is a treatment that involves drawing the patient’s blood and re-administering it back into the patient via muscle or vein depending on it being Minor or Major. However, in the world of medical literature, ozone therapy has been proven to be safe and effective for many conditions. This article covers the research, possible benefits, and risks associated with ozone therapy. In fact, the FDA has advised against the medical use of ozone (3) and reportedly even shut down clinic advertisements touting ozone as a medical treatment (4). However, it is important to note that ozone therapy is not FDA-approved, and its efficacy has not been established by the FDA. Patients provide a blood sample, which doctors mix with ozone before injecting it back into their patients. In Texas, with full patient consent, we are legally allowed to offer these therapies. Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter B Part 173 —Secondary Direct Food Additives Permitted in Food for Human Consumption Subpart D § 173. Although O3 has dangerous effects, yet researchers believe it has Jun 18, 2025 · Ozone therapy is not explicitly FDA approved for any specific indication in the United States. The U. d2 xl nes v0rl c37qexah ucg20m rl gywk7 5xqutry gkkqwj