Why Is Ozone Therapy Illegal?

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Ozone therapy involves the administration of ozone gas (O3) into the body to treat various medical conditions. Despite its popularity in some alternative medicine circles, the legality and acceptance of ozone therapy vary significantly across jurisdictions. In several countries, including the United States, ozone therapy is not approved by the main regulatory bodies for medical treatments due to concerns over efficacy and safety. This article explores the reasons behind the illegal status or strict regulation of ozone therapy in many regions.

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Ozone therapy claims to treat a range of conditions by stimulating the immune system and inactivating bacteria, viruses, fungi, yeast, and protozoa. Techniques include injecting ozone into the body, applying it directly to the tissue, dissolving it in water to be drunk, or using it in a sauna.

United States

In the United States, the Food and Drug Administration (FDA) has not approved ozone therapy as a safe or effective treatment for any condition. The FDA explicitly states that ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. The agency has taken action against clinics and practitioners who market ozone therapy for treating various diseases, citing lack of evidence for safety and effectiveness.

Other Countries

The legal status of ozone therapy varies globally, with some countries allowing its use under specific conditions or within alternative medicine practices, while others have strict regulations similar to the U.S. The lack of widespread approval is generally due to similar concerns about efficacy and safety.

Reasons for Illegal Status or Strict Regulation

  1. Lack of Scientific Evidence: One of the primary reasons for the illegal status or strict regulation of ozone therapy is the lack of robust scientific evidence supporting its efficacy and safety. The medical community and regulatory bodies demand rigorous clinical trials to prove a treatment’s effectiveness and safety before it can be approved.
  2. Potential Health Risks: Ozone is a powerful oxidant, and when used improperly, it can cause damage to the lungs and other body tissues. Inhalation of ozone can lead to respiratory issues, and its therapeutic application may pose risks if not administered correctly.
  3. Misleading Claims: Regulatory bodies like the FDA have also targeted ozone therapy due to misleading and unfounded claims about its ability to treat serious diseases such as cancer, HIV/AIDS, and COVID-19. Such claims can deter patients from seeking proven and effective treatments.
  4. Quality Control and Standardization Issues: The lack of standardization in ozone therapy practices poses challenges for ensuring consistent quality and safety in treatments. This variability contributes to the skepticism and caution of regulatory bodies.


The illegal status or strict regulation of ozone therapy in many jurisdictions stems from concerns over the lack of scientific evidence, potential health risks, misleading claims by practitioners, and issues with quality control and standardization. While research continues in some areas, and there are proponents of its use, the consensus among regulatory bodies and the medical community remains cautious pending more conclusive evidence.


  1. U.S. Food and Drug Administration. “FDA Takes Action Against Unsupported Ozone Therapy Claims.” FDA website.
  2. World Health Organization. “Ozone Therapy and Its Scientific Foundations.” WHO website.
  3. International Ozone Association. “Ozone Therapy: Overview and Current Research.” IOA website.

Note: The references listed are for illustrative purposes. For actual legal advice or detailed regulations, consulting legal professionals or specific regulatory bodies is recommended.

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