On FDA's behest, the US Marshals has seized 77 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, California. The FDA advises to discontinue use of these devices, which the company claims can treat cancer, AIDS, hepatitis, herpes, and a number of other diseases and conditions.
The FDA has not determined that the seized products are safe and effective in treating the diseases or conditions, and officials at Applied Ozone Systems never responded to a December 21, 2009 FDA request for a voluntary recall of these ozone generators.
In addition, the agency is concerned that patients who use these AOS ozone devices, as directed by the manufacturer, may have a risk of infection from potential contamination of the applicator or catheter.
Michael Chappell, acting associate commissioner for regulatory affairs at FDA, said: “The seized devices are potentially harmful to public health. The agency will take action to protect the public from FDA-regulated products that are in violation of the law.”
Ozone generators are devices that produce ozone from oxygen. Ozone is present in low levels throughout the earth’s atmosphere and has many industrial and consumer applications. It also is an air pollutant that has harmful effects on the respiratory system.
The seizure action was jointly conducted by the FDA and the State of California Department of Public Health, Food and Drug Branch, as part of ongoing efforts to ensure that unapproved medical devices do not enter the marketplace.