WASHINGTON, Feb. 1 (UPI) — Federal marshals, at the request of the U.S. Food and Drug Administration, have seized 77 ozone generators because they had not been proved safe or effective.
The FDA said the generators, models AOS-1M and AOS-1MD valued at $75,000, were seized from Applied Ozone Systems of Auburn, Calif.
FDA inspectors said the medical devices were said to treat cancer, AIDS, hepatitis, herpes and other diseases and conditions, but were produced under poor manufacturing conditions and posed public health risk
“The FDA advises healthcare professionals and consumers to discontinue use of these devices … (because) 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 Dec. 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 believe that ozone therapy serves as an appropriate treatment and as a result delay or stop conventional or prescribed effective treatment.” officials said. “There is also a risk of infection from potential contamination of the applicator or catheter.”
Ozone generators are devices that produce ozone from oxygen. FDA officials said administration methods suggested by the manufacturer of the seized generators include using a catheter to blow ozonized air into rectal and vaginal areas.
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