Ozone Generators Generate Prison Terms for Couple

FDA Consumer, Nov, 1999 by Paula Kurtzweil

"Show us the data," FDA advised a Florida man and his wife who continued to market an unapproved medical device despite FDA warnings to stop. So, when they failed to heed FDA's advice, a federal judge in Florida decided to show them the door--to prison.

Kenneth R. Thiefault and his wife, Mardel Barber, formerly of Jupiter, Fla., were sentenced in the U.S. District Court for the Southern District of Florida in March to prison terms that together total more than eight years and fines that add up to more than $100,000. They illegally distributed ozone generators, devices that turn oxygen into ozone, by claiming that the devices could cure a variety of diseases, including cancer and AIDS. FDA has never approved ozone generators or ozone gas for treating any medical conditions.

They continued to sell the unapproved medical devices, even after FDA informed them several times that FDA approval was necessary to market medical devices or medical gas in this country. This would require the submission of scientific data to support the devices' safety and effectiveness.

Proponents of medical ozone generators believe ozone can kill viruses and bacteria in the body. While ozone is used as a germicide in the cleaning of manufacturing equipment, FDA is not aware of any scientific data that supports the safety or effectiveness of ozone generators for treating medical conditions. In fact, the agency believes that at the levels needed to work effectively as a germicide, ozone could be detrimental to human health.

"These devices keep popping up," says Bob Gatling, a biomedical engineer and director of the program operations staff in FDA's Center for Devices and Radiological Health. "We always tell their makers": `Show us some data,' but no one ever pursues it."

FDA's knowledge of Thiefault's involvement in ozone generators dates to at least 1990, when Thiefault was interviewed during an FDA criminal investigation of one of Thiefault's associates. This associate was later prosecuted and imprisoned for, among other things, manufacturing and selling ozone generators for treating medical conditions. After release from prison, he returned to making and distributing ozone generators for treating medical conditions but fled the country before he could be prosecuted again.

In April 1990 and January 1991, Thiefault acknowledged in an FDA-obtained written affidavit that medical ozone generators needed to be approved by FDA before they could be marketed. He also wrote that his interest in ozone generators was limited to ozone's "antiviral and antibacterial capabilities in relationship to water for dairy cows, swimming pools and spas."

Thiefault's activities came to FDA's attention again, in January 1993, when officials with Florida's Comptroller's Office shared evidence they obtained during a state securities fraud investigation of Thiefault with FDA's Office of Criminal Investigations. State investigators found that one room in Thiefault's former Lake Park, Fla., home served as a medical treatment center, housing a variety of devices, including a frequency generator on which various frequencies were labeled with the names of diseases. At the high end of the frequencies was "AIDS," followed in descending order by "cancer," "syphilis" and "constipation." This evidence suggested that the business Thiefault operated out of his home, Kanzyme Laboratories, was an unlicensed medical practice.

In early 1993, OCI special agents began to collect evidence, and in July, OCI executed a search warrant at Thiefault's Lake Park home, seizing various records and documents and the generators themselves.

With these pieces of evidence, OCI agents learned that:

* Since 1988, Thiefault had been buying components and making ozone generators, selling them for about $4,800 each to customers across the country.

* Each ozone generator, contained in a silver metal case, included a medical-grade humidifier and a medical-grade oxygen cylinder with a label that said the cylinder had been converted from medical to industrial grade. The cylinder was fixed into place with Velcro straps and had on the outside of it tubing that could be used to attach urinary catheters.

* Thiefault presented himself as a scientist and clinical researcher in a promotional videotape. He is not a doctor and lacks a scientific background.

* Thiefault did not have any bank, credit or charge accounts. Instead he funneled proceeds from the ozone generators--estimated to be $1 million--through his wife and other individuals' financial accounts.

* Thiefault and his wife touted ozone as a treatment for many diseases, ranging from AIDS and cancer to herpes, hepatitis and gangrene. In the videotape, Thiefault says, "Ozone will cure almost any disease."

* Product literature recommended several ways to administer the ozone: by catheter into the rectum, vagina or ear; by breathing in through the nose or mouth; or by absorption through the skin, accomplished by standing naked in a body bag into which ozone is blown.