A California company is refusing to recall its ozone generators that federal health authorities believe are unapproved medical devices that could lead to health problems or death.
The Food and Drug Administration said Applied Ozone Systems, in Auburn, Calif., claims its ozone generator devices treat cancer, AIDS, hepatitis, herpes and other infections and diseases.
Chuck Ankeney, owner of the company, said he is selling the ozone generators as water purifiers and he's not claiming they are medical devices.
"You do a recall on something that's broke. You don't do it on their claims," he said. "It's all based on misinformation and lies."
His company has not responded to an FDA letter dated Dec. 21. In the letter, the FDA requests that the company recall its AOS-1M ozone generator and AOS-1MD ozone generator devices.
The company's Web site says these devices, which sell for $750 and $1,200, can be used for colon cleansing, killing bacteria and viruses as well as wound healing. The company states only at the end of a Web page that the generators are not sold as medical devices.
"High colonic irrigation kills harmful bacteria, parasites, mold yeast infections and virus. Draws toxins through blood, liver, lymph back into large intestine for better elimination. It treats the cause, not the symptoms!" according to one Web page.