# FDA WARNING_LETTER - McKinnon, Blair - Unknown Date

Source: https://www.globalkeysolutions.net/records/warning_letter/mckinnon-blair/acfe6032-ea79-4ada-a8b7-c428706e030b

> FDA WARNING_LETTER for McKinnon, Blair on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: McKinnon, Blair
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Blair McKinnon regarding the product OXi-MED, promoted and sold on www.chlamydia-cream.com. The FDA determined OXi-MED is marketed to mitigate, prevent, treat, or cure disease in humans, specifically Chlamydia, and to affect the body's structure or function.

The website claims OXi-MED acts against Chlamydia bacteria, with an active ingredient "FDA certified to destroys 99.9992 percent of all pathogenic organisms. ie Chlamydia," and is a localized treatment more effective than oral medicines. It also states bio-oxidatives (like ozone and H2O2 in the cream) stimulate white blood cells, are anti-microbial, increase oxygen delivery, enhance red blood cell flexibility, and increase skin tissue oxygenation.

OXi-MED is classified as a "drug" under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) due to its intended uses. It is also a "new drug" under section 201(p) because it is not generally recognized as safe and effective. Its sale without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

Furthermore, OXi-MED is misbranded under section 502(f)(1) because it is intended for conditions not amenable to self-diagnosis

## Related Officers

- [Michael M. Levy](https://www.globalkeysolutions.net/people/michael-m-levy/3e0fdd21-e691-406d-81cf-4fe2460a6309)
- [Family Physician](https://www.globalkeysolutions.net/people/stephen-mckernan/fc7320b3-3714-4483-abd7-fd0671b8003e)
- [Bronwyn Clark](https://www.globalkeysolutions.net/people/bronwyn-clark/2b9dd712-c0eb-421a-b60e-8135f1cdd50a)

Company: https://www.globalkeysolutions.net/companies/mckinnon-blair/99a6651e-2709-4281-94e2-fcaaadc3f091

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c