Professional Overview of Ozone Therapy Regulatory Guidelines

Medical information and sources

Medical information: This article is for general education and does not replace individualized medical advice, diagnosis, or treatment. Treatment suitability, risks, benefits, alternatives, and monitoring should be discussed with a licensed clinician. Seek urgent care for severe or rapidly worsening symptoms.

Evidence note: Ozone is not FDA-approved to treat disease. Federal regulation describes ozone as a toxic gas and restricts ozone-generating devices; discussion of ozone-based procedures should clearly distinguish investigational or off-label use from FDA approval.

Authoritative sources: eCFR: 21 CFR 801.415

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