Friday Feb 05 2010
FDA moves to seize Auburn company’s ozone generators
By: Gus Thomson, Journal Staff Writer
Chuck Ankeney looks at the 77 ozone generators now off limits and behind yellow tape at his Auburn business and says he’s ready to call it a day and close up shop for good. A contingent of U.S. Marshals entered Ankeney’s Applied Ozone Systems on Streeter Road on and put the generators – worth an estimated $76,000 – under a seizure order. The seizure process is being conducted at the request of the U.S. Food and Drug Administration, who contend the generators are being marketed illegally as medical devices. Ankeney’s position is that the FDA needs to back off because he’s never said they are for medical uses. Ankeney, 65, said the FDA has left him no other choice. He’ll reluctantly be closing his 16-year-old business and retiring by the end of March. The FDA has given him until March 15 to contest the Jan. 29 seizure notice or forfeit the generators. A hearing would be in the summer. Ankeney isn’t happy with his run-in with the federal government. “I get the feeling that the government isn’t going to stop with me – it’s only the beginning,” Ankeney said. “We need jobs and businesses and they’re trying to put you out of business. We have 300,000 people dying from pharmaceuticals and I haven’t harmed anyone but they’re going after me.” The FDA had initially demanded that Applied Ozone Systems recall is AOS-1M and AOS-1MD ozone generator devices. The company’s Web site says the devices, which sell for $750 and $1,200, can be used for colon cleansing, killing bacteria and viruses as well as wound healing. At the end of its Web page, it states 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 issued a strongly worded release from its Washington, D.C. office this past week stating that healthcare professionals and consumers should discontinue ozone-generator use “which Applied Ozone Systems claims can treat cancer, AIDS, hepatitis, herpes and a number of other diseases and conditions.” “The FDA has not determined that the seized products are safe and effective in treating the diseases or conditions,” the statement said. Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs, said the seized devices are potentially harmful to public health. Ankeney maintains that information on his Web site is educational only and he had spent several hours taking out statement the FDA says are health claims. Chappell said the agency is concerned that patients who use the AOS ozone devices as directed by Ankeney‘s business might believe ozone therapy serves as a treatment alternative and may delay or stop conventional or prescribed treatment that could be effective.