FDA WARNING_LETTER - Oxygen Therapy Program - August 31, 2010

On November 10, 2010, the FDA issued a Warning Letter to Mary Lynne Gordon, Founder and Owner of Oxygen Therapy Program, regarding the marketing of "35% Food Grade Hydrogen Peroxide" and "Inositol" on www.oxygentherapyprogram.com.

The FDA's review of the website and an August 31, 2010 investigation revealed that these products are marketed with claims to prevent, treat, or cure numerous diseases, including AIDS, cancer, diabetes, herpes, arthritis, fibromyalgia, asthma, and emphysema. Examples of claims include: "Fight off opportunistic diseases," "[K]ill the AIDS virus," "Viruses, bacteria, AIDS, HIV, Cancer, Diabetes, and all invaders inside your body are killed," and "[l]n larger doses [Inositol] has been shown to kill cancerous cells." These claims were found on the homepage, linked pages, in a "Comprehensive User Manual," and in a video titled "The One Minute Cure Secret For All Diseases." Metatags also included disease terms like "Swine flu, AIDS, HIV, and Cancer."

The FDA determined that these products are unapproved new drugs under Section 201(g)(1) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended for disease treatment and are not generally recognized as safe and effective. Their introduction into interstate