An Auburn ozone generator business is facing closure as a result of state and federal health concerns about its products.

The Food and Drug Administration is attempting to get Applied Ozone Systems to recall ozone generators that federal health authorities believe are unapproved medical devices that could lead to health problems or death.

And the California Air Resources Board has issued a consumer alert on the company’s generators, warning that they are capable of emitting enough ozone indoors to far exceed outdoor health standards and create unhealthy “smog” conditions inside the home.

Chuck Ankeney, owner of the 16-year-old business, said Monday that he remains convinced that the Applied Ozone Systems generators he sells through a Web site to people around the world are reliable and that – despite government claims – he’s not saying they’re medical devices.

Ankeney said the state put an embargo Dec. 15 on selling his ozone generators and another product – Oxy-Mega Super Oxygenated Colon Cleanser. They’re saying the Oxy-Mega labeling indicates it’s a laxative. Ankeney said the labeling doesn’t.

“Anything is a health claim in their eyes,” Ankeney said. “I’m waiting to see what happens next. They’ll probably come to cart me off.”

The FDA has demanded 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 the 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 warned Ankeney last week that the company’s products need to be tested to see whether they are safe and effective, based on medical claims. Under federal law, any device that claims to treat or mitigate diseases requires FDA approval or clearance.

Ankeney said the information on his Web site is educational and he has already spent several hours taking out several statements that the FDA says are health claims. That effort started back in April and included a three-day visit in October, he said.

“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.”

Ankeney said he’s now making plans to go out of business in the next year.

Karen Riley, an FDA spokeswoman, told The Associated Press that Applied Ozone Systems discusses colonics and medical applications.

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.

The Air Resources Board has put two Applied Ozone Systems generators on a list of 63 that it is recommending consumers avoid purchasing.

“These devices pump a well-known air pollutant into people’s homes putting everyone at risk, especially the most vulnerable among us, including the young, elderly and infirm,” the board stated.

The Associated Press contributed to this report.