FDA NEWS RELEASE
For Immediate Release: Jan. 29, 2010
Media Inquiries: Tom Gasparoli, 301-796-4737, thomas.gasparoli@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
United States Seizes Unapproved Ozone Generators
FDA inspection shows devices produced under poor manufacturing condition; pose public health risk
At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 77 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.
The FDA advises health care professionals and consumers to discontinue use of these devices, which Applied Ozone Systems 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 Dec. 21, 2009 FDA request for a voluntary recall of these ozone generators.
