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Last update August 2024

Why is ozone therapy considered illegal?

I've heard about ozone therapy being used for various health treatments, but I've also read that it's illegal in some places. Could you explain what ozone therapy involves and why there are legal concerns surrounding its use?

Answered by

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Lisa Miller, Patient Advocate

Ozone therapy involves the administration of ozone gas (O3) into the body to treat various medical conditions. Ozone is a molecule composed of three oxygen atoms, known for its strong oxidizing properties. The therapy can be administered in several ways, including:

  • Intravenous Ozone Therapy: Ozone gas is mixed with a patient's blood and then reintroduced into the bloodstream.
  • Ozone Insufflation: Ozone gas is introduced into body cavities, such as the rectum or vagina.
  • Topical Ozone Therapy: Ozone gas is applied directly to the skin to treat wounds or infections.
  • Ozonated Water or Oils: Patients may drink water or apply oils that have been infused with ozone.

Proponents of ozone therapy claim it can:

  • Improve oxygen delivery to tissues.
  • Enhance immune system function.
  • Reduce inflammation.
  • Kill bacteria, viruses, and fungi.
  • Detoxify the body.

Despite these claims, ozone therapy is controversial and has legal restrictions in many places due to safety concerns and a lack of robust scientific evidence supporting its efficacy. Here are some key points:

  1. Safety Concerns:
    • Toxicity: Ozone is a powerful oxidant and can be toxic if inhaled, causing respiratory issues and lung damage.
    • Lack of Standardization: There is no standardized protocol for ozone therapy, leading to inconsistent dosages and administration methods.
    • Potential Side Effects: Side effects can include chest pain, coughing, nausea, and headaches.
  2. Regulatory Status:
    • United States: The FDA has not approved ozone therapy for any medical condition, stating that ozone is a toxic gas with no known useful medical application.
    • Europe: Some countries in Europe allow ozone therapy under specific regulations, but it remains controversial.
    • Other Regions: The legal status varies widely, with some countries permitting its use under medical supervision and others banning it outright.
  3. Lack of Scientific Evidence:
    • Insufficient Clinical Trials: There is a lack of large-scale, well-designed clinical trials to support the therapeutic claims of ozone therapy.
    • Mixed Results: Existing studies often show mixed results, with some suggesting potential benefits and others indicating no significant effect or potential harm.

In conclusion, ozone therapy remains a contentious treatment with significant legal and safety concerns. While some practitioners and patients report benefits, the lack of standardized protocols and robust clinical evidence, combined with potential risks, has led to regulatory restrictions in many regions. Patients considering ozone therapy should consult with their healthcare providers to weigh the potential benefits and risks and explore approved and evidence-based treatment options.

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