U.S. Marshals Seize Ozone Generators

U.S. marshals have seized 77 ozone generators from Applied Ozone Systems in Auburn, Calif., according to the U.S. Food and Drug Administration (FDA), after the company failed to comply with a voluntary recall of the devices in December.

The generators, models AOS-1M and AOS-1MD, are valued at $75,900, according to the FDA.

The FDA is asking healthcare professionals and consumers to stop using the devices, which Applied Ozone Systems, based in Auburn, Calif., claims can treat cancer, AIDS, hepatitis and herpes.

The agency 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, the agency said.

The FDA inspected the Applied Ozone Systems facility in October 2009 after obtaining an inspection warrant when the owner of the company refused to allow agency staff to inspect the facility. The agency’s inspection revealed that the company was not following good manufacturing practice requirements for medical devices and confirmed that the company had not obtained FDA marketing approval for these devices.

“The seized devices are potentially harmful to public health,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The agency will take action to protect the public from FDA-regulated products that are in violation of the law.”

A notice on the Applied Ozone Systems Web site reads, “Important Notice: Due to the economy and other circumstances beyond our control we will be going out of business in the next couple of months.” When Medical Product Outsourcing attempted to call the company, there was only a dial tone.

Healthcare professionals and consumers may report serious side effects or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm.