FDA Seizes Ozone Generators, Unapproved for Treating Illnesses
The Food and Drug Administration has seized dozens of ozone generators made by a California company and promoted as a way to treat cancer, AIDS, hepatitis, herpes, and other diseases and conditions.
A total of 77 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Ca. were taken by federal regulators. The seized medical devices are valued at $75,900, officials said.
The seizure took place because the FDA has not determined that the devices are safe and effective in treating patients. Also, Applied Ozone Systems never responded to a Dec. 2009 FDA request for a voluntary recall of the ozone generators, officials said.
The FDA was concerned that patients who use these AOS ozone devices as directed by the manufacturer may believe that ozone therapy is an appropriate treatment and either delay or stop using conventional or prescribed effective medical treatments. There is also a risk of infection from potential contamination of the applicator or catheter, the FDA said.
Ozone Generators Raise FDA Concern
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 a form of air pollutant that has harmful effects on the respiratory system, the FDA said.
The seized ozone generators are not manufactured according to FDA requirements and as such are adulterated and misbranded medical devices banned by the agency.
According to the manufacturer, the AOS-1M Medical Ozone Generator and the AOS-1MD Ozone Generator are designed for blowing ozonized air into the rectal and vaginal areas, the FDA said.
“The seized devices are potentially harmful to public health,” Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, said in an FDA news release. “The agency will take action to protect the public from FDA-regulated products that are in violation of the law.”
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