1- Kenneth R. Thiefault and his wife, Mardel Barber, formerly of Jupiter, Florida, were sentenced in the U.S. District Court for the Southern District of Florida in March to prison terms that together total more than eight years and fines that add up to more than $100,000. They illegally distributed ozone generators, devices that turn oxygen into ozone, by claiming that the devices could cure a variety of diseases, including cancer and AIDS. FDA has never approved ozone generators or ozone gas for treating any medical conditions. .

They continued to sell the unapproved medical devices, even after FDA informed them several times that FDA approval was necessary to market medical devices or medical gas in this country. This would require the submission of scientific data to support the devices’ safety and effectiveness.

Proponents of medical ozone generators believe ozone can kill viruses and bacteria in the body. While ozone is used as a germicide in the cleaning of manufacturing equipment, FDA is not aware of any scientific data that supports the safety or effectiveness of ozone generators for treating medical conditions. In fact, the agency believes that at the levels needed to work effectively as a germicide, ozone could be detrimental to human health.

(a) Ozone is a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals.

(b) Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs to result in pulmonary edema. The onset of pulmonary edema is usually delayed for some hours after exposure; thus, symptomatic response is not a reliable warning of exposure to toxic concentrations of ozone. Since olfactory fatigue develops readily, the odor of ozone is not a reliable index of atmospheric ozone concentration.

(c) A number of devices currently on the market generate ozone by design or as a byproduct. Since exposure to ozone above a certain concentration can be injurious to health, any such device will be considered adulterated and/or misbranded within the meaning of sections 501 and 502 of the act if it is used or intended for use under the following conditions: