FDA WARNING_LETTER - McKinnon, Blair

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