Two manufacturers of prescription colon irrigation devices and one "colonic hydrotherapy" provider have agreed to pay $111,000 in civil penalties, fees and court costs in a settlement with Texas authorities.
The settlement also requires that future purchases of the medical devices be authorized by a physician who also supervises their use, and that each procedure on a patient must be ordered by a physician.
The settlements involve two manufacturers -- Colon Therapeutics Inc. and Gentle Colonics Inc., which agreed to permanently go out of business -- and a provider, Abundant Health and Wellness Institute, of Dallas.
The defendants were sued for failing to have physician supervision and orders for each procedure before selling, promoting or using these devices for colonic irrigation.
"State law is clear about how these devices may be used, and violating the law places the patient at risk for injury or even death, which has occurred in at least one case," said Attorney General Greg Abbott. "Those in the industry need to know that it is imperative to obtain supervision from physicians if they wish to offer these services, which must be performed by prescription only."
Prescription colonic cleansing systems and nozzles can only be used for medical purposes, such as prior to radiologic or endoscopic examinations, as authorized by the U.S. Food and Drug Administration.
The uses offered by these and other defendants, which have been marketed and promoted for "general well being" and "re-energizing life," are not recognized by the FDA. In addition, scientifically unsubstantiated claims that the treatments can cure certain cancers and other diseases are not recognized and are unlawful.
The final judgments prohibit the defendants from manufacturing, promoting, selling or using these prescription devices unless the purchases and uses are overseen by a physician and recognized by the FDA.
The defendants will pay a total of $91,000 in civil penalties, $9,000 to the Texas Department of Health, which referred the case for legal action, for its investigative costs, and $11,000 to the Office of the Attorney General for attorneys" fees and investigative costs.
