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.
The FDA says the company's products have not been evaluated for their safety and effectiveness, and under federal law, any device that claims to treat or mitigate diseases requires FDA approval or clearance.
"They are marketing this product for medical purposes. They talk about colonics, they talk about these other medical applications. If there's a medical application, then it has to be FDA-cleared," said Karen Riley, FDA spokeswoman.
The company's owner said he can't control how consumers use the products. But the FDA said in a letter it is concerned consumers could be hurt when they use the product and they might delay or stop their prescribed medical treatments.
Riley said inserting the ozone gas into someone's rectum could cause perforation, bleeding and infection. If it's inhaled, it could worsen asthma or pulmonary conditions, FDA officials said.
Since the company is not responding to the FDA, the agency is considering its options, Riley said. She said anytime a company is in violation of a law, those options include issuing an injunction to halt sales of a product, working with state authorities, fining the company or seizing its products.
Ankeney said he has not received any complaints about his products, except from a woman who used a product too long and began coughing from the ozone.