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PostPosted: Wed Jun 09, 2010 5:35 pm 
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FDA declares war on ozone generators; seizes inventory
by: David Gutierrez
ozone generators, FDA, health news

Declaring ozone generators an unapproved and untested medical device, the FDA seized the inventory of a California manufacturer on January 29.

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

According to an FDA press release, Auburn, Calif. manufacturer Applied Ozone Systems has promoted its devices for the treatment of a variety of health conditions including cancer, AIDS, herpes and hepatitis. The use of ozone machines as medical devices has not received FDA approval, however, making it illegal for the company to market them for those uses.

"The FDA advises health care professionals and consumers to discontinue use of these devices," the FDA said.

The battle over the ozone generators began in October 2009, when the FDA applied for and received a warrant to inspect the Applied Ozone Systems factory, after the company's owner allegedly refused inspectors entry without one. Upon inspecting the facility, the FDA concluded that good manufacturing practices were not being used, and confirmed that they were being marketed without FDA approval. The agency sent a letter to the company on Dec. 21, asking it to voluntarily recall the products from the market. According to the FDA, Applied Ozone Systems never responded to this request.

The raid was carried out by U.S. Marshals on behalf of the FDA, in conjunction with the California Department of Public Health, Food and Drug Branch. Marshals seized 77 ozone generators http://dreddyclinic.com/forum/viewtopic.php?f=7&t=35430 valued at a total of $75,900.

Ozone is classified as a respiratory pollutant, and due to its biocidal properties is also used as a disinfectant. The FDA claims that there is no evidence that ozone http://www.dreddyclinic.com/integrated_med/ozone-therapy.php can be effective as a medical treatment, and expressed concern that patients undergoing ozone therapy might stop using more proven treatments.

The agency also expressed concern over "infection from potential contamination of the applicator or catheter."


Sources for this story include:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199322.htm

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PostPosted: Wed May 11, 2016 9:58 am 
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