U.S. Marshals Seize Unapproved Ozone Generators

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My Cole Petrochko, Staff Writer, MedPage Today

Published: January 31, 2010

 

WASHINGTON -- U.S. Marshals have seized 77 unapproved ozone generators, valued

at almost $76,000 from a California device manufacturer, the FDA announced.

The devices were advertised as treatments for various conditions, including

cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or

efficacy data to support the claims made on their behalf, an FDA release said.

The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif.,

failed to respond to a voluntary recall request last December, the agency said.

The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will

consider it an appropriate treatment for an affliction and delay or stop

FDA-approved and proven medical treatments. Patients using the devices may risk

infection from contamination of the applicator or catheter, the release said.

The FDA recommended that healthcare professionals and consumers cease use of the

devices.

The agency said it obtained an inspection warrant for the company's

manufacturing facilities after the owner refused to admit FDA inspectors. It

said the inspection revealed several breaches of the FDA's good manufacturing

practice requirements for medical devices, which had never been approved in the

first place.

Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal

two. Ozone generators produce ozone from oxygen and have consumer and industrial

applications, but ozone itself is harmful to the respiratory system, even at

relatively low concentrations.

Instructions with the Applied Ozone Systems devices suggest blowing ozoned air

into the rectal and vaginal areas.

Friday's seizure was part of a joint effort of the FDA and the California

Department of Public Health to remove or prevent unapproved or unsafe medical

devices from entering the market.

A statement on the company's Web site said the two ozone generator models, which

sold for $750 and $1,200 respectively, were no longer available by order of the

FDA and California authorities.

 

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