Texas Attorney General Reaches Settlement
with Three Colonic Hydrotherapy Providers

Stephen Barrett, M.D.

In July 2004, Texas Attorney General Greg Abbott announced settlements with two manufacturers of prescription colon irrigation devices and one “colonic hydrotherapy” provider that will require payment of $111,000 in civil penalties, fees, and costs to the state. 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. Three similar suits are pending. The suits (filed last year) and prior investigative reports by the Texas Department of Health alleged that the defendants had improperly advertised, promoted, sold or used these devices without physician involvement. In 2003, after one death and four four cases of colon perforation were reported, the Department of Health referred the cases to the Attorney General for legal action.

Prescription colonic cleansing systems and nozzles are legal to market or administer for medical purposes, such as prior to radiologic or endoscopic examinations, as authorized by the FDA. Usage for “ general well being” or “re-energizing life,” is 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 illegal. In a news release last year, Abbott characterized unsupervised use without physician approval as a "ticking time bomb.”

The settlements involve manufacturer Colon Therapeutics Inc. and owner Jimmy J. Girouard, of Jefferson County; manufacturer Gentle Colonics Inc., and its owner, Denson Ingram of Richardson, who agreed to permanently go out of business; and a provider, Abundant Health and Wellness Institute, and its owner, Cordelia Beall of Dallas. 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 for its investigative costs, and $11,000 to the Office of the Attorney General for attorneys’ fees and investigative costs.

For Additional Information

This page was posted on July 16, 2004.

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